Neoplasms

All Conditions

Head and Neck Neoplasms

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Amoxicillin-Potassium Clavulanate Combination

Penicillins

Antibiotics, Antitubercular

Percutaneous endoscopic gastrostomy tube placement - A 20 Fr PEG tube (Cook Medical, or Boston Scientific) will be placed endoscopically using Ponsky's pull technique, under conscious sedation, as a day-case procedure. A single dose of a prophylactic intravenous antibiotic (1.2g co-amoxiclav, 30 minutes prior to the procedure, unless evidence of penicillin allergy) will be given to all patients undergoing PEG tube insertion. Patients will be monitored for one hour prior to discharge following PEG tube insertion

Nasogastric tube placement - All nasogastric tubes will be inserted in a standard manner by a Gastroenterology Fellow or an Internal Medicine resident. Ordinarily, a 14 Fr, fine-bore NG feeding tube will be inserted at the bedside or, if unsuccessful, inserted under radiological guidance. A post-procedure abdominal x-ray will be performed to confirm correct placement of all NG tubes.

A 20 Fr PEG tube (Cook Medical, or Boston Scientific) will be placed endoscopically using Ponsky's pull technique, under conscious sedation, as a day-case procedure. A single dose of a prophylactic intravenous antibiotic (1.2g co-amoxiclav, 30 minutes prior to the procedure, unless evidence of penicillin allergy) will be given to all patients undergoing PEG tube insertion. Patients will be monitored for one hour prior to discharge following PEG tube insertion.

percutaneous endoscopic gastrostomy tube placement

All nasogastric tubes will be inserted in a standard manner by a Gastroenterology Fellow or an Internal Medicine resident. Ordinarily, a 14 Fr, fine-bore NG feeding tube will be inserted at the bedside or, if unsuccessful, inserted under radiological guidance. A post-procedure abdominal x-ray will be performed to confirm correct placement of all NG tubes.

nasogastric tube placement

Waleed Zafar, MBBS, ScD

M. Aasim Yusuf, MBBS, FRCP

Arif Jamshed, MBBS, FRCR

M. Qayyum Khan, MBBS, MRCP

Syed R Hussain, MBBS, FDSRCS

Faisal Zeb, MBBS, MRCPS

Hala Mansoor, MBBS, FCPS

M. Adnan Masood, MBBS, FCPS

Purpose:

To compare the effect of prophylactic enteral feeding tube placement (either percutaneous endoscopic gastrostomy (PEG) tube or nasogastric (NG) tube) in patients undergoing treatment for head and neck cancer (HNC) on nutritional status, quality of life, mental and emotional health, rates of clinical complications, and cost of care.

Study Design:

Prospective randomized controlled trial with 2 arms and equal allocation ratio

Study Objectives:

1. The primary objective is to assess, among HNC patients randomized to receive either prophylactic PEG tube or NG tube for enteral support and who are undergoing chemo-radiation at SKMCH\&RC, the change from baseline in nutritional status at the end of 24 weeks after treatment initiation.
2. The secondary objectives are to assess, among HNC patients randomized to receive either prophylactic PEG tube or NG tube for enteral support and who are undergoing chemo-radiation at SKMCH\&RC, the change from baseline in nutritional status at the end of 12 weeks; the rates of complications; quality of life including symptoms of depression and anxiety; and cost of care (all related to enteral feeding tube placement only) at baseline and at the end of 12 weeks and 24 weeks after treatment initiation.

Patients and methods:

Eligible patients will be enrolled consecutively from the gastroenterology outpatient clinics at Shaukat Khanum Memorial Cancer Hospital and Research Center (SKMCH\&RC), Lahore and randomly assigned to receive either PEG tube or NG tube placement prior to commencement of treatment. Patients will receive counseling from a trained nutritionist regarding adequate nutrition during treatment and enteral feeding tube care. Detailed information regarding demographics, cancer location, type and staging, clinical status, nutritional status, quality of life, mental and emotional health, and cost of care will be obtained at baseline (time at which cancer treatment is initiated) and on 21st day (3 weeks), 42nd day (6 weeks), 84th day (12 weeks) and 168th day (24 weeks) after initiating chemoradiation. The primary endpoint will be to compare the nutritional status between the two treatment groups on an intent-to-treat basis on 168th day (24 weeks) after initiating chemoradiation.

A Trial Comparing Two Modalities of Prophylactic Nutritional Support During Treatment for Head and Neck Cancer

Prophylactic Nutritional Support During Treatment for Head and Neck Cancer: A Single-Center, Open-label, Prospective, Randomized, Controlled Trial Comparing Feeding With Percutaneous Endoscopic Gastrostomy Tubes and Nasogastric Tubes

Nutritional status will be assessed using three methods: (1) Patient-Generated Subjective Global Assessment (PG-SGA) tool, (2) anthropometric data, and (3) biochemical data. Biochemical assessment will be done by measuring serum albumin and electrolytes and kidney function tests. Primary outcome will be analyzed at aggregate level and after stratifying by age, sex, location of tumor, disease severity, and grade of dysphagia.

The quality of life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) version 3.0. and Functional Assessment of Cancer Therapy Head and Neck (FACT H\&N) version 4. Patients will also be assessed for their mental and emotional health. For this purpose, Hospital Anxiety and Depression Scale (HADS) will be used. All of these questionnaires are available in Urdu.

Data on cost of care associated with nutritional support will be assessed from the hospital's and patient's perspective.

Rate of minor and major clinical complications related to placement of PEG or NG tube will be assessed

Nutritional status will be assessed using three methods: (1) Patient-Generated Subjective Global Assessment (PG-SGA) tool, (2) anthropometric data, and (3) biochemical data. Biochemical assessment will be done by measuring serum albumin and electrolytes and kidney function tests. All secondary outcomes will be analyzed at aggregate level and after stratifying by age, sex, location of tumor, disease severity, and grade of dysphagia.

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Depression

Depressive Disorder

Breast Diseases

Skin Diseases

Behavioral Symptoms

Moving on ABC Plus is combination of two interventions. The culturally adapted CBT and Moving on ABC. CBT will be integrated with The Moving on After Breast Cancer (ABC), which has been developed by Dr Anneela Saleem who suffered from breast cancer. The integrated intervention will consist of 12 sessions (60-90 minutes). The first 8 sessions will be delivered weekly and the last four sessions will be delivered fortnightly

This will consist of routine assessment and management as usually conducted by oncology clinics and general practice. GP's will be informed about the psychiatric diagnosis.

The intervention has two components. CBT Moving on After Breast Cancer

Moving on ABC Plus

Nasim Chaudhry, MD

Breast cancer (BC) ranks second among all the types of cancer and is equally common in developing as well as developed countries. Breast cancer is most common type of cancer worldwide and its diagnosis as well as early treatment is associated with distress. The aim of this study is to explore the feasibility of integrating a 'Moving on After Breast Cancer (ABC)' manual developed by service user (Dr A Saleem) with Cognitive Behavior Therapyfor Pakistani women who are breast cancer (BC) survivors attending primary care and oncology services in Pakistan B) refine the Moving on ABC plus so as to develop a culturally appropriate therapeutic programme to be tested in a future definitive randomized controlled trial.

According to an estimate of World Health Organization (2000) cancer was responsible for 12% of all the deaths from all causes worldwide and rate of cancer is expected to increase 50% by the year 2020. In Pakistan every ninth women has a chance of developing breast cancer, which is highest rate in Asia. The estimated incidence rate of breast cancer in Pakistan is 50/100,000. Despite the high association of distress with breast cancer, data on prevalence of depression in women with breast cancer especially in low income countries is limited .

The proposed project consists of two phases: 1) Phase 1: Integration of the two existing interventions Moving On ABC and the Cognitive Behavior Therapy and the refinement of the integrated intervention. 2) Phase 2: Randomized Control Trial (RCT). Sample size of Phase II will be comprised of 50 patients. Patients will be divided into two groups. One group will receive Group moving on ABC Plus intervention and other group will receive routine care. The total sample size of the effectiveness trial 354.

Moving on After Breast Cancer Plus- for Breast Cancer Survivors

A Culturally Adapted Positive Health Programme - Moving on After Breast Cancer Plus- for Breast Cancer Survivors: A Feasibility Randomized Controlled Trial

Patient Health Questionnaire-9 (PHQ-9) will be used to diagnose depression.Minimum score of PHQ-9 is 0 and maximum score is 27. This scale categorizes depression in 5 different categories: minimal depression (score range 1-4), Mild depression (5-9), Moderate depression (10-14), Moderately severe depression (15-19), and Sever depression (20-27).

This is a short self-report measure to assess the presence and severity of generalized anxiety.

EuroQol-5D (EQ-5D), a 5-itme scale, will be used to assess the quality of life. Lower raw score indicates better quality of life

Multidimensional Scale for Perceived Social Support (MSPSS) will be used to assess level of social support. Higher scores indicate higher level of support

We will measure Breast Cancer distress with the 7 item subscale of the revised Impact of Event Scale which is reported to be sensitive to change in BC survivors who are receiving a CBT intervention

This is a ten item Likert scale to measure self-esteem. Higher scores indicate better self esteem.

This is one of the most widely used scales to measure health-related quality of life in BC patients. Minimum total score on the scale is "0" and maximum score is 148. Higher score on the scale indicate poor quality of life

This is a well validated self-report measure of client/ patient satisfaction with health services. Minimum total score is "1" and maximum score is "32". Higher score indicate higher level of satisfaction with the services.

Pakistan Institute of Living and Learning

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Anovulation

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

Micronutrients

Bone Density Conservation Agents

Vitamins

Mineral

Metformin

Vitamin D

Cholecalciferol

Calcium

Calcium, Dietary

Progesterone

Trace Elements

Vitamin D3

Calciferol

Calcium Supplement

Experimental Group (Group A; n=71):

The intervention (experimental) group will receive VD injections 600,000 I.U I/M once with 1 gram calcium supplemental daily in the initial 12 weeks. After that standard PCOS care; i) Glucophage XR 750 mg (once for 15 days then twice daily) ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off) and iii) calcium supplements will be given for next 12 weeks.

Control Group (Group B; n=71):

Participants will receive standard PCOS treatment; Glucophage XR 750 mg once at dinner for 15 days then twice daily and Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off for initial-- 12 weeks.

Then VD supplementation (600,000 IUI/M) will be given once during the study period with Calcium 1000 mg/day and continued Standard PCOS treatment from 12- 24 weeks

Intervention Group Initial 12 weeks;

* VD supplementation (600,000 IU I/M) once during the study period
* Elemental calcium 1000 mg/day From 12-24 weeks: Standard PCOS;
* Glucophage XR 750 mg once at dinner for 15 days then twice daily
* Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off
* Calcium 1000 mg/day

Active Comparator (Group B; n=71):

Initial-- 12 weeks;

* Standard PCOS;
* Glucophage XR 750 mg once at dinner for 15 days then twice daily
* Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off From 12- 24 weeks
* VD supplementation (600,000 IUI/M) once during the study period
* Calcium 1000 mg/day
* Standard PCOS Continued

Active Comparator

Rehana Rehman, PhD

Poly cystic Ovarian Syndrome (PCOS) is an endocrine disorder of reproductive age defined by "the presence of any two out of three criteria: oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound". Considering role of vitamin D (VD) (3, 4) and high prevalence (58%) of deficiency in PCOS of Pakistan. Researchers hypothesized that its correction would improve response to standard PCOS treatment. The objective is to compare PCOS parameters in intervention group (Group A) receiving VD supplementation and then PCOS care with control group (Group B) receiving standard PCOS care and then VD supplementation. A randomized open label trial: delayed-start design will be conducted on VD deficient PCOS females VD \< 20ng/ml ; Group A will receive VD injections 600,000 I.U I/M once with 1 gram calcium supplement daily in the initial 12 weeks. After that standard PCOS care; i) Glucophage XR 750 mg (once for 15 days then twice daily) ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off) and iii) calcium supplements will be given for next 12 weeks. PCOS females in Group B will receive standard PCOS care (same) with addition of VD and calcium supplementation after 12 weeks till study end point. Study outcomes will be comparison of i) hyperandrogenism by Free Androgen Index \[Total Testosterone, Steroid Hormone Binding Globulin ii) insulin Resistance by HOMA-IR (serum Insulin, Fasting Blood Glucose) and iii) oxidative stress by Total Antioxidant Capacity after 24-weeks in these Groups'd levels after supplementation will be assessed for confirmation of correction and calcium and albumin levels for detection of hypercalcemia. Results of this study will inform the clinicians to add VD before or after the standard PCOS care for rectification of endocrine and metabolic derangements as a cost-effective treatment and prevention strategy in these females.

This study will comprise of two groups (A and B) with 71 participants in each group carried for a duration of 24 weeks.

Intervention Details for Group A (Duration 1-12 weeks):

Participants will be given Vitamin D (VD) supplementation at a dose of 600,000 IU along with Calcium 1000 mg/day.

Mid-Point (At 12 weeks):

Patients will have a consultation for clinical interpretation. They will undergo biochemical assessment, including the estimation of Insulin Resistance, Free Androgen Index, and Total Antioxidant Capacity.

After 12 weeks They will receive standard treatment for Polycystic Ovary Syndrome (PCOS), which includes Glucophage XR 750 mg once at dinner for 15 days, then twice daily. Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off and Calcium 1000 mg/day

Intervention Details for Group B (Duration 1-12 weeks):

Participants in Group B will receive standard PCOS treatment mentioned earlier:

Glucophage XR 750 mg once at dinner for 15 days, then twice daily. Capsule Progeffik 100 mg once at night every 3 weeks, then 1 week off. Additionally, they receive Calcium 1000 mg/day.

Mid-Point (At 12 weeks):

Patients will have a consultation for clinical interpretation. They will undergo biochemical assessment, including the estimation of Insulin Resistance, Free Androgen Index, and Total Antioxidant Capacity.

Intervention Details for Group A (After 12 weeks)

They will receive VD supplementation (600,000 IU) during this time and continue to receive Calcium 1000 mg/day.

Calculations of HOMA-IR and Free Androgen Index will be done at 12 and 24 weeks and the results will be compared.

{HOMA-IR: HOMA- IR index, a commonly used marker of IR, will be calculated using the formula: HOMA-IR = fasting glucose levels \[mmol/L\] × fasting insulin levels \[μU/mL\]/22.5 Free Androgen Index will be derived from TT and SHBG, normally measured in nanomoles per liter. FAI =100 (TT /SHBG)}

Infertile females with Polycystic Ovarian Syndrome

Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome

Efficacy of Vitamin D Supplementation in Females With Polycystic Ovary Syndrome: a Randomized Open Label Delayed-start Design

hyperandrogenism by Free Androgen Index \[Total Testosterone, Steroid Hormone Binding Globulin

HOMA-IR (serum Insulin, Fasting Blood Glucose)

Pakistan Science Foundation

Aga Khan University

Professor

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Muhammad Shadab Khan

Bushra Shirazi

Muhammad Arsalan Khan

In Pakistan, due to the lack of a National based cancer registry exact number of CRC cases is unknown. However, minimal data that is present in literature shows an increase in CRC cases with a concerning increase in incidence in younger age groups11. This makes it pertinent to understand current pattern of CRC and its risk factors from a local perspective. This will direct future strategies in an attempt to reduce the incidence and mortality associated with CRC in our general population.

Exploring the Risk Factors for Colorectal Cancer in Our General Population Using Asian Pacific Screening Score: a Survey From Pakistan

evaluate internationally validated risk factors for colorectal cancer in our general population using a questionnaire based on the modified Asian Pacific Colorectal Screening score.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Trial Comparing Two Modalities of Prophylactic Nutritional Support During Treatment for Head and Neck Cancer	NCT01985438	Head and Neck N...	percutaneous en... nasogastric tub...	18 Years -	Shaukat Khanum Memorial Cancer Hospital & Research Centre
Moving on After Breast Cancer Plus- for Breast Cancer Survivors	NCT03571984	Breast Cancer F... Depression	Moving on ABC P...	18 Years -	Pakistan Institute of Living and Learning
A Trial Comparing Two Modalities of Prophylactic Nutritional Support During Treatment for Head and Neck Cancer	NCT01985438	Head and Neck N...	percutaneous en... nasogastric tub...	18 Years -	Shaukat Khanum Memorial Cancer Hospital & Research Centre
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome	NCT06045351	Anovulatory Inf...	Vitamin D Active Comparat...	18 Years - 45 Years	Aga Khan University
A Trial Comparing Two Modalities of Prophylactic Nutritional Support During Treatment for Head and Neck Cancer	NCT01985438	Head and Neck N...	percutaneous en... nasogastric tub...	18 Years -	Shaukat Khanum Memorial Cancer Hospital & Research Centre
Exploring the Risk Factors for Colorectal Cancer in Our General Population Using Asian Pacific Screening Score: a Survey From Pakistan	NCT05617378	Colorectal Canc... Colorectal Neop...		18 Years -	Sindh Institute of Urology and Transplantation

Spots Global Cancer Trial Database for pakistan

Every month we try and update this database with for pakistan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pakistan

Every month we try and update this database with for pakistan cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pakistan cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.