linjc16/ctgov huggingface dataset:
Effect of Enzyme Therapy on Protein Metabolism in Chronic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
Pancreatic exocrine insufficiency is known to impair nutrient absorption, especially fat, but few data exist about protein absorption. We aimed to investigate this question and assess the enzyme substitution efficiency using a sensitive method.

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Drug: Creon
* Other: No enzyme therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic pancreatitis Pancreatic insufficiency Enzyme therapy treatment Exclusion Criteria: Hepatic failure Pregnancy Positive serology to HIV, HCV, AGHbS, gastro-intestinal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pancreatic enzymes<br> | Drug: Creon<br> <br> |
| Placebo Comparator: control<br> | Other: No enzyme therapy<br>* Current enzyme therapy of the patient is stopped during 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transfer of dietary nitrogen to metabolic pools |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Protein absorption in pancreatitis, Protein metabolism in pancreatitis
Metabolic and Immunological Phenotyping in Patients With Cancer

Study Overview
=================
Brief Summary
-----------------
An observational study to investigate cachexia in participants with non-haematological cancer.

Detailed Description
-----------------
A single-centre, non-randomised, observational study. This study will investigate the systemic metabolic and immunological changes that occur in cachexia. The aim is to better understand the mechanism(s) underlying weight loss in people with non-haematological cancer. This will help to facilitate future research to generate treatments to reverse weight loss and improve outcomes.

Official Title
-----------------
Metabolic and Immunological Phenotyping in Patients With Cancer

Conditions
-----------------
Cancer, Non-Hematologic Malignancy

Intervention / Treatment
-----------------
* Other: Observational assessments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent to participate Be aged 18 years or over at the time of signing the informed consent form Have a histological or cytological diagnosis of a non-haematological cancer Are willing and able to comply with study procedures and visits Exclusion Criteria: Active infection, as determined by the investigator based on clinical symptoms and / or fever and / or requirement for antibiotics Current treatment with chemotherapy, oral steroids or other immunosuppressive drugs (within 7 days of baseline investigations or during the study phase) Significant acute, chronic or psychiatric condition or laboratory abnormality which in the judgment of the investigator would place the patient at undue risk or interfere with the study. Intolerance to dairy products Women, who are pregnant, plan to become pregnant or are lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Cancer<br>Assessments and observations for up to 40 days with one overnight hospital stay. | Other: Observational assessments<br>* Clinical assessments<br>|
| Healthy Volunteers - Group A<br>Assessments and observations for up to 2 days with one overnight hospital stay. | Other: Observational assessments<br>* Clinical assessments<br>|
| Healthy Volunteers - Group B<br>Assessments and observations for up to 2 days. | Other: Observational assessments<br>* Clinical assessments<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum cortisol level | Blood serum cortisol levels in weight losing and weight stable patients at baseline and Day 2 | Change from baseline serum cortisol level at Day 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Non-haematological
Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how effective ward-based clinical pharmacists and computerized physician order entry systems are in reducing serious medication errors in pediatric inpatients.

Detailed Description
-----------------
This is a prospective cohort study at Children's Hospital and Brigham and Women's Hospital (BWH), before and after the introduction of two distinct interventions. The first intervention at Children's Hospital was the introduction of clinical pharmacists on inpatient pediatric wards to target errors at the stages of physician ordering and nurse transcription. The second intervention is technological: the introduction of physician computer order entry at the BWH neonatal intensive care unit (NICU). This intervention will most effectively target errors at the stage of physician ordering, and secondarily address errors at the stage of pharmacy dispensing and nurse transcription. Data on serious medication errors will be collected pre and post each intervention.

Official Title
-----------------
Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies

Conditions
-----------------
Medication Errors

Intervention / Treatment
-----------------
* Behavioral: computerized physician order entry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the BWH NICU in the study pods during the study period Exclusion Criteria: Patients in other units, non-study pods, or outside of the study period
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Introduction of A Clinical Pharmacist<br> | Behavioral: computerized physician order entry<br> <br> |
| Experimental: Technological<br> | Behavioral: computerized physician order entry<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serious medication errors |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medication errors, medical records systems, computerized, patient safety
Ivermectin Versus Albendazole for Chronic Strongyloidiasis

Study Overview
=================
Brief Summary
-----------------
A prospective controlled trial to compare the efficacy and safety of 7-day albendazole, single dose ivermectin, and 2-single dose ivermectin in 72 patients with chronic strongyloidiasis will be conducted at Siriraj Hospital, Bangkok, Thailand.

Official Title
-----------------
Efficacy and Safety of Ivermectin Versus Albendazole for Chronic Strongyloidiasis

Conditions
-----------------
Chronic Strongyloidiasis

Intervention / Treatment
-----------------
* Drug: Ivermectin
* Drug: ivermectin
* Drug: Albendazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with positive strongyloides larva in the stool Exclusion Criteria: Pregnancy Lactating women Known allergy to any study drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Albendazole<br>Albendazole for 7 days | Drug: Albendazole<br>* Albendazole 7 days<br>|
| Experimental: ivermectin<br>ivermectin 200 mcg/kg single dose | Drug: Ivermectin<br>* single dose of 200 mcg/kg<br>* Other names: stromectal;|
| Experimental: ivermectin 2 doses<br>ivermectin 200 mcg/kg two doses in 2 weeks | Drug: ivermectin<br>* two single dose of 200mcg/kg in 2 weeks<br>* Other names: stromectal;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cure rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
strongyloidiasis, ivermectin, albendazole
A Study of BMS-562086 in Patients With Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome (D-IBS)

Official Title
-----------------
A Dose-Ranging Study of the Pharmacodynamic Effects of BMS-562086 on Gastrointestinal Transit in Women With Diarrhea-Predominant Irritable Bowel Syndrome

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: BMS-562086


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects with D-IBS symptoms based on Rome II criteria and the subject's responses to the Bowel Disease Questionnaire Exclusion Criteria: Clinically significant prolonged diarrhea with dehydration requiring IV fluid within 60 days prior to baseline visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>0 mg | Drug: Placebo<br>* Tablets, Oral, once daily, 2 weeks<br>|
| Other: 2<br>25 mg | Drug: BMS-562086<br>* Tablets, Oral, once daily, 2 weeks<br>|
| Other: 3<br>100 mg | Drug: BMS-562086<br>* Tablets, Oral, once daily, 2 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit |  | taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms. |  | throughout the study | 
| Safety |  | Safety labs at screening, nominal study days -3, 8, 15, 42, and 70 (discharge). ECGs will be taken at screening, nominal days 5 or 6, 14, and discharge. Vital signs will be taken at screening, on nominal days 3, 4, 5, 7, 8, 10, 11, 42 and discharge | 
| Blood pharmacokinetics |  | PK samples will be taken on nominal days 8, 14 (serial: predose 0.5, 1, 2, 4, 6, 9 hours post dose), 15 (pre dose and 9 hours post dose), 16, 42 and discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diarrhea-predominant irritable bowel syndrome
Supplementary Food on Prevention of Moderate Malnutrition in Children

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children. Children will be divided in two groups; one will received the cookie plus 12 educative sessions and the other just the educative program. The study will last 12 months

Official Title
-----------------
The Effect of Supplementary Food Cookies on Prevention of Moderate Malnutrition in Preschool Children in Rural Mexico

Conditions
-----------------
Moderate Acute Malnutrition (MAM)

Intervention / Treatment
-----------------
* Other: Nutritional cookie


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (2-5 years old), who are from low socioeconomic classes (E and D classes) reside in rural areas, and with WHZ- between > -3 and ≤ -2, and informed consent given by the subject's mother or caregiver Exclusion Criteria: Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24) Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter) (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours). Current consumption of other supplementary foods. Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional oats cookie and educational session<br>Nutritional cookie with oats and nuts | Other: Nutritional cookie<br> <br> |
| No Intervention: Educational session only<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (kg) for height (cm) Z-score |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (kg) gains |  | 12 months | 
| height (cm) for age (months) Z-score |  | 12 months | 
| weight (kg) for age (months) Z-score |  | 12 months | 
| Mid-upper arm circumference (cm) (MUAC) |  | 12 months | 
| height (cm) gains |  | 12 months |
A Study to Assess the Safety and Efficacy of an Investigational Drug (MK-686) in Patients With Osteoarthritis (0686-006)

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to assess the safety and tolerability of MK-0686 and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.

Official Title
-----------------
A 4-Week, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MK0686 in Patients With Osteoarthritis of the Knee or Hip

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0686


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee,either prior NSAID or Acetaminophen users within the ARA functional class I,II or III and with no clinically significant diseases Patients required to demonstrate a flare of the signs and symptoms of OA following withdrawal of NSAID treatment Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA females must be either post-menopausal or surgically sterilized Exclusion Criteria: No history of concurrent arthritic disease No history of neoplastic disease within a specified duration No history of disease that causes malabsorption Chronic use of certain medications excluded

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0686|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale. |  | over 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability over a 4-week treatment period |  | over a 4-week treatment period |
Web-based Support for People With Schizophrenia and Their Families

Study Overview
=================
Brief Summary
-----------------
This study will assess the feasibility of using the internet and in-home computers to provide advice from health care professionals, social support, and health information to people with schizophrenia and their families.

Detailed Description
-----------------
The objective of this study is to assess the feasibility of using the World Wide Web (Web) and in-home computers to provide patients suffering from schizophrenia and their families advice from health care professionals, social support, and information. The purposes of this intervention are to improve: 1) the availability, convenience and use of needed mental health services; 2) family support for their ill family members; and 3) patient and family outcomes.

Official Title
-----------------
Support to Patients and Families

Conditions
-----------------
Relapse Rates Related to Website Usage

Intervention / Treatment
-----------------
* Behavioral: (relapse rate)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia Able to speak and read English Regular contact with a family member Exclusion Criteria: Enrolled in another study

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: (relapse rate)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The outcome, patient relapse, will be assessed for the patients in the intervention group and control group by estimating the size of the intervention's effect on relapse rate. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For the primary caregiver, the distribution of the psychological distress measure will be examined and transformation will be made if necessary for further analysis. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Relapse, Psychological distress
Does Hepatitis C Management Protect Egyptian Population Against Severe Corona Virus Disease-2019?

Study Overview
=================
Brief Summary
-----------------
Modulation of the renin angiotensin system by the chronic hepatitis C virus treatment either by (Daclatasvir and Sofosbuvir), (Daclatasvir and Sofosbuvir plus Ribavirin), or (Ribavirin and Interferon) protocols could give an explanation for the low incidence of COVID-19 among Egyptian population. Adding it may play a role in COVID 19 prophylaxis.

Detailed Description
-----------------
The interaction of severe acute respiratory syndrome corona virus-2 (SARS-CoV-2) and the renin angiotensin system (RAS) via angiotensin converting enzyme-2 (ACE-2), the receptor used by the SARS-CoV-2 to gain access to cells could provide an explanation for the several unusual clinical findings observed in COVID-19 Although chronic hepatitis is one of the risk factors listed by WHO for severe COVID-19, low incidence of COVID-19 was observed among HCV patients admitted to Egyptian hospitals. Modulation of the RAS by the chronic hepatitis C virus treatment either by (ACEI or ARBS), (Daclatasvir and Sofosbuvir), (Daclatasvir and Sofosbuvir plus Ribavirin), or (Ribavirin and Interferon) protocols could give an explanation for the low incidence of COVID-19 among Egyptian population. Adding it may play a role in COVID 19 prophylaxis.

Official Title
-----------------
Does Hepatitis C Management Protect Egyptian Population Against Severe Corona Virus Disease-2019 (COVID-19)?

Conditions
-----------------
Corona Virus Infection, Hepatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients who were diagnosed to have COVID-19 and admitted to Zagazig University Hospitals during the period from May 2020 to January 2021 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of chronic hepatitis C among COVID-19 hospitalized patients. | incidence of chronic hepatitis C among COVID-19 hospitalized patients. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the impact of previous exposure to different HCV management protocols on the clinical characteristics and outcome of COVID-19 among COVID-19 hospitalized patients | the impact of previous exposure to different HCV management protocols on the clinical characteristics and outcome of COVID-19 among COVID-19 hospitalized patients | 7 months |