Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Gland and Hormone Related Diseases

Premature Birth

Primary Ovarian Insufficiency

Menopause, Premature

Menopause

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Reproductive Control Agents

Hormones

Epinephrine

Racepinephrine

Epinephryl borate

Contraceptive Agents

Contraceptives, Oral

Alkylating Agents

* Prior exposure to alkylating agent chemotherapy and/or radiation therapy
* At least 1 year from completion of chemotherapy and/or radiation therapy
* Uterus and at least one ovary are present
* Not pregnant or breastfeeding in the past 3 months
* Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits
* No medical condition (other than cancer) known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome).

* Never exposed to chemotherapy or radiation therapy
* Regular menstrual cycle (every 21-35 days)
* Uterus and at least one ovary are present
* Not pregnant or breastfeeding in the past 3 months
* Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits
* No medical condition known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome).

Clarisa R Gracia, MD, MSCE

Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience endocrine changes more similar to women in their late reproductive years than to same-age peers. These changes will be more dramatic in women who receive high dose therapy compared to women who receive low dose therapy.

At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual diary keeping, pelvic ultrasound and blood hormones tests will be used to measure "ovarian reserve" , that is the number and quality of the eggs that remain in the ovaries. The study will also try to learn if those who received higher doses of certain chemotherapies are more likely to have changes in these tests sooner than those women who received smaller doses of these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look for gene variations that may predict susceptibility to ovarian damage from cancer treatments. Information learned from this study may help researchers to develop guidelines to identify problems with a female cancer survivor's ovaries before irregular menses or other symptoms of ovarian failure occur.

Up to 400 females will participate in this study in one of three cohorts:

* 150 females ages 11-35, with history of exposure to alkylating agent chemotherapy and/or radiation therapy
* 150 Unexposed peers, ages 11-35, never exposed to chemotherapy or radiation therapy
* 100 Unexposed females, ages 40-50 never exposed to chemotherapy or radiation therapy

Assessing Fertility Potential in Female Cancer Survivors

Data will be shared with Dr. Jill Ginsberg, a co-investigator of the study.

Primary Outcomes for this study will include mean and changes in reproductive hormone measures obtained during the early follicular phase of the menstrual cycle (days 1-4).

All ovarian follicles and cysts will be measured by transvaginal or transabdominal ultrasound. Follicles will be measured in millimeters and grouped according to size: 2-5 mm, 6-9 mm, and \>10 mm in diameter.

Children's Hospital of Philadelphia

University of Pennsylvania

Symptoms and General Pathology

Neoplasms

Nausea

Vomiting

Postoperative Nausea and Vomiting

Genital Neoplasms, Female

Signs and Symptoms, Digestive

Postoperative Complications

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antiemetics

Gastrointestinal Agents

Dimenhydrinate

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

The aim of this clinical trial is to learn if Dimenhydrinate works to prevent postoperative nausea-vomiting in adult women who undergoing abdominal hysterectomy. The primary question is: Does Dimenhydrinate lower the proportion of postoperative nauseavomiting during the day 1 after surgery. Researcher will compare Dimenhydrinate to a placebo (a-look-alike substance that contains no drug) which will give intravenously when the patient come back to the ward, to see if Dimenhydrinate work to prevent nauseavomiting during the postoperative day1. All participants will receive standard treatment during pre-operative, intra-operative and the immediate post-operative periods. Participants will receive Dimenhydrinate or placebo only one dose after discharge from the recovery room. During the day 1 postoperative, participants will report their symptoms and keep a diary of the number of tmes they use additional anti-emetic drugs.

The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial

Preeyaporn Jirakittidul

Assist Prof Dr. Preeyaporn Jirakittidul

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Sing Huang Tan, MBBS

The primary objective of this prospective pilot study is to examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal therapy) and compare this to a group of healthy controls to evaluate if there is a difference. All randomized patients and their respective controls would be required to complete the computerized neuropsychological assessment CANTAB at certain time-points.These patients and controls would also be given on the same day as CANTAB testing, a set of questionnaires to evaluate subjective factors such as anxiety, depression, fatigue or menopausal symptoms which may also have an effect on cognition. Subjective assessment of cognitive function will rely on self-reporting by study participants using a validated questionnaire.The potential risks to subjects are minimal, as this is a study without any intervention regarding the medical management of patients. By participating in this study, subjects will be helping in the aim of determining if there is cognitive impairment post-therapy, and if so, how prevalent is this phenomenon, when it arises and how it changes with time. This will consequentially play an important role with regard to patient knowledge. Furthermore, if chemotherapy is shown to be associated with cognitive impairment, further studies can be carried out to determine the exact pathophysiology behind this phenomenon. This will allow for sensitive and timely detection of cognitive dysfunction in patients who have received chemotherapy and/or anti-hormonal therapy, and subsequently open the avenue for research in preventing or alleviating this phenomenon. This is crucial in improving patients' quality of life, social and occupational performance.

The investigators hypothesis is that systemic adjuvant therapy in the form of chemotherapy and/or anti-hormonal therapy given to primary breast cancer patients can cause cognitive impairment.

A Prospective Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive Function of Breast Cancer Patients

To examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal therapy) and compare this to a group of healthy controls to evaluate if there is a difference.

National University Hospital, Singapore

Sang-Yoon Park

Myong Cheol Lim

To validate the FSFI(Female Sexual Function Index)-K, FSFI - 6 item and Quality of Sexual Function(QSF) version in Korean language of the cancer patients.

Due to the observational nature of the study which aims to evaluate the internal consistency and validity of the Korean version of Questionnaire, formal sample size and power calculations were not performed. When the number of observations (items) per subject ranges from 4 to 6, roughly 152-199 patients are required to show 10% increase in intraclass correlation from baseline ICC of 30% with 85% power and 5% type I error rate. The sample size was determined based on this calculation and practical considerations.

The pilot study will be performed based on 30 people (include reference), and the main study will include 1100 people (considering 10% drop-out from 200 people in each group) cancer type (ovary, cervix, endometrium, and breast) and healthy female. Total 1130 patients.

Validation of Sexual Function Scale in Female Cancer

National Cancer Center, Korea

Senior researcher

Nutritional and Metabolic Diseases

Digestive System Diseases

Diabetes Mellitus

Kidney Diseases

Liver Diseases

Gastrointestinal Diseases

Three Healthy Voluntary (HV) women were give the same starting daily dose of 100 g Jarlsberg

Based on the results from the starting dose 5 + 5 HV get a new daily doses of Jarlsberg cheese

Based on the results from the second design level, the daily dose of Jarlsberg cheese for the next 7 HVs was given

Jarlsberg cheese

Helge Lundberg, MD

Aim: To estimate an oral administered recommended minimum efficacy daily dose (MED) of Jarlsberg cheese in order to obtain the needed increased level of Osteocalcin defined as the ratio \[Carboxylated / Under Carboxylated\] Osteocalcin.

Study population: Healthy Voluntary (HV) women between 20 years and pre-menopausal age.

Design: Open and randomised two-dimensional single-centre trial with 3-level between-patient Response Surface Pathway (RSP) design in the first dimension and 3-level within-patient RSP design in the secondary dimension.

The recruited HV women fulfil the inclusion without the exclusion criteria for the study will undergo a clinical investigation and blood sampling. The participants will be asked to avoid use of other cheese, but eat as usually. One week later, the first clinical investigation will take place including blood sampling. The HV women verified to fulfil the criteria for participation and signed the informed consent form will be included in the study. The trial treatment consisting of a given gr/day Jarlsberg cheese will start the day after this investigation, denoted as Day 0, and the participants receiving a study identification numbers. They will be instructed not to change eating habit except replace use of other chees with Jarlsberg.

The cheese can be consumed with other food at breakfast and/or lunch. The dose of Jarlsberg cheese per day is fixed per participant and varies from 20 gram per day to 180 gram per day with a mid-dose of 100gr/day. The three patients included at the first design level will all receive this mid-dose of 100gr/day. Clinical investigation and blood sampling after start of the treatment, will be performed after 3, 4, and 5 weeks and the ratio \[Carboxylated / Under Carboxylated\] Osteocalcin will be calculated. This increased Osteocalcin Ratio (OR) based on the results obtained by the blood sampling at week 3 will be classified in five groups and used for determination of the Jarlsberg cheese dose for the five HV women at design level 2. The classifications of increased OR used are: increased OR \< 0.5 classifies as Low; 0.5 ≤ increased OR ≤ 0.9 classifies as Moderate Low; 0.9 \< increased OR \< 1.1 classifies as Suitable; 1.1≤increased OR≤1.5 classifies as Moderate High; increased OR \> 1.5 classifies as High. In case the increased OR is found Low or Moderate Low, the daily dose of Jarlsberg cheese will be reduced for the participants at the second design level. If increased OR classifies as Suitable the same dose as at design level 1 will be recommended applied at the second level and if increased OR classifies as moderate High or High, the Jarlsberg cheese-dose will be increased.

The same procedure based on the results obtained from the five participants at the second design level will be used to determine the daily Jarlsberg-dose for the seven HV women at design level 3. With randomization of the recommended cheese-doses at one design level to be used in the next, the between-patient Response-Surface-Pathway (RSP) design-arm is applied.

The within-patient RSP design-arm is applied and related to the duration of the cheese intake. All the participants will consume Jarlsberg cheese during minimum three weeks. Participants obtaining an increased OR ≥ 1 can stop the study. If not, they have to continue until this limit is reached or until maximum five weeks.

The study will be performed as an open, randomised two-dimensional single-centre trial with 3-level between-patient Response Surface Pathway (RSP) design in the first dimension and 3-level within-patient RSP design in the secondary dimension.

Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese

Estimation of Minimum Efficacy Daily Dose (MTDD) of Jarlsberg Cheese in Healthy Women in Order to Obtain Needed Level of Osteocalcin: A Phase I Dose-finding Study

Ratio between carboxylated and undercarboxylated osteocalcin

Tine

Prof Stig Larsen

Professor

Herbal and Botanical

Garlic

270 kcal white bread with 15 g margarine and 5 g crushed garlic

Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume 270 kcal white bread with 15 g margarine.

Control

Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume 270 kcal white bread with 15 g margarine and 5 g crushed garlic.

Garlic treatment

This study is being done to study the healthful benefits of eating garlic. Previous studies suggest that garlic may help prevent cancer. The investigators are recruiting healthy volunteers to participate in a study to determine the ways in which eating garlic may reduce cancer risk.

A crossover design will be utilized with each participant completing each treatment phase; participants will be randomly assigned to a sequence of dietary treatments. There will be a 17-day washout period in between diet periods. Participants will consume a garlic-free diet for the first 10 days of each diet period. The dietary treatments will be administered on day 11 of each diet period. Dietary treatments will be incorporated into food as follows: 1) 5 g (0.175 oz.) of garlic mixed with 15 g margarine on top of 270 kcal white bread, served as breakfast, or 2) 15 g margarine on top of 270 kcal white bread, served as breakfast.

Garlic Intake And Biomarkers Of Cancer Risk

Garlic metabolites will be measured in blood and urine.

Lymphocyte microarray analysis, lymphocyte DNA genotyping. Microarray results will be confirmed by RT-PCR.

Serum nitrate/nitrite, malondyaldehyde, glutathione, glutathione reductase, glutathione S-transferase, catalase, protein carbonyls, F2-isoprostanes.

C-reactive protein (CRP), vascular endothelial growth factor, IL-1, IL-6, TNF-α.

USDA Beltsville Human Nutrition Research Center

Research Physiologist

Uterine Cervical Neoplasms

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

The participants will identify their accompanying influential person (e.g., spouse, partners, parents, children, friends) with whom they will be attending the 1.5-2 hour face-to-face education session on cervical cancer and screening. Their accompanying influential person is eligible if they are (a) aged 18 or older and (b) willing to participate in the study.

Only the participants will attend the 1.5-2 hour face-to-face intervention on cervical cancer and screening.

The participants will identify their accompanying influential person(s) (e.g., spouse, partners, parents, children, friends) with whom they will be attending the 1.5-2 hour face-to-face education session on cervical cancer and screening. At the end of the intervention, time will be allowed for questions, as well as distributing fridge magnets and a pamphlet. Fridge magnets contain Pap test guidelines and availability of local clinics. The pamphlet covers the following topics: (a) information about female anatomy and cervical cancer, (b) risk factors for cervical cancer, (c) facts of cervical cancer incidence and mortality, and screening rates among American women, (d) methods to reduce cervical cancer (e.g., HPV vaccination), (e) Pap test procedure, (f) Pap test guidelines, and (g) availability of clinics and cost of Pap test. The participants will be encouraged to spread the message to family members and friends.

family-based intervention

Only participant will attend the 1.5-2 hour face-to-face education session on cervical cancer and screening. At the end of the intervention, time will be allowed for questions, as well as distributing fridge magnets and a pamphlet. Fridge magnets contain Pap test guidelines and availability of local clinics. The pamphlet covers the following topics: (a) information about female anatomy and cervical cancer, (b) risk factors for cervical cancer, (c) facts of cervical cancer incidence and mortality, and screening rates among American women, (d) methods to reduce cervical cancer (e.g., HPV vaccination), (e) Pap test procedure, (f) Pap test guidelines, and (g) availability of clinics and cost of Pap test. The participants will be encouraged to spread the message to family members and friends.

Participant only intervention

The purpose of this study is to find out the impact of the involvement of an influential person(s) (e.g., spouse, partners, parents, children, friends) on Pap test screening intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap test screening among Chinese American immigrant women. These data specific to the impact of the involvement of an influential person on Pap test screening could be used to develop successful cancer prevention programs that target the specific needs of Chinese populations.

The importance of the support from family, spouse, friends, or significant others has been noted among Chinese American immigrant women (CAIW), but little attention has been paid to the effects of family-based (FB) interventions, especially for cervical cancer screening. Understanding the role of CAIW's family in promoting Pap screening and other influences can lead to the creation of more culturally appropriate screening interventions. The objective of this study is to test the effects of a FB intervention on Pap test intention and behaviors, Pap test self-efficacy, and perceived benefits and barriers to Pap tests among under-screened CAIW aged 21-65. This pilot test of the FB intervention will be conducted using a randomized controlled design with two groups only, experimental and control groups. Interventions will be delivered by bilingual and bicultural CAIW trained facilitators. Post-test and follow-up telephone surveys will be conducted at 2 weeks and 6 months after the intervention.

A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women

Evaluation of A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women

Change from baseline in use of a Pap test 2 weeks after intervention

Change from baseline in use of a Pap test 6 months after intervention

Change from baseline in intention to receive a Pap test 2 weeks after intervention

Change from baseline in intention to receive a Pap test 6 months after intervention

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing Fertility Potential in Female Cancer Survivors	NCT01143844	Effects of Chem...		11 Years - 50 Years	University of Pennsylvania
The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial	NCT06395064	Gynecologic Neo... Healthy Women	Dimenhydrinate	18 Years - 65 Years	Mahidol University
A Prospective Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive Function of Breast Cancer Patients	NCT01596439	Breast Cancer		21 Years - 64 Years	National University Hospital, Singapore
Validation of Sexual Function Scale in Female Cancer	NCT01809405	Sexuality Cancer Healthy Women		18 Years -	National Cancer Center, Korea
Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese	NCT04185454	Heathy Women Pre Menopausal ... Exlution Criter... Liver Disease Diabetes Cancer Kidney Disorder	Jarlsberg chees...	20 Years -	Meddoc
Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese	NCT04185454	Heathy Women Pre Menopausal ... Exlution Criter... Liver Disease Diabetes Cancer Kidney Disorder	Jarlsberg chees...	20 Years -	Meddoc
Validation of Sexual Function Scale in Female Cancer	NCT01809405	Sexuality Cancer Healthy Women		18 Years -	National Cancer Center, Korea
A Prospective Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive Function of Breast Cancer Patients	NCT01596439	Breast Cancer		21 Years - 64 Years	National University Hospital, Singapore
Garlic Intake And Biomarkers Of Cancer Risk	NCT01293591	Healthy Men Healthy Women	Control Garlic treatmen...	40 Years - 80 Years	USDA Beltsville Human Nutrition Research Center
Assessing Fertility Potential in Female Cancer Survivors	NCT01143844	Effects of Chem...		11 Years - 50 Years	University of Pennsylvania
A Family-based Intervention to Improve Pap Test Screening Among Under-screened Chinese American Immigrant Women	NCT03961412	Cervical Cancer Healthy Women	family-based in... Participant onl...	21 Years - 65 Years	University of Nevada, Reno

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