linjc16/ctgov huggingface dataset:
Long-Term Safety and Efficacy of Itopride Hydrochloride (HCl) in Patients Suffering From Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
Itopride is a compound already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. Patients feel full after eating; they have bloating and have stomach pain. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

Detailed Description
-----------------
All patients who have completed study ITOFD04-03 will be offered to continue to be treated with itopride for a period of up to one year in duration. A target of 300 patients will be followed up for 6 months. Of these, a target of 100 patients will be kept on treatment for an additional 6 months. Patients will need to come to the clinic for evaluations every 8 weeks during the trial. Evaluations done at these visits will include: lab tests, evaluation of the heartburn condition, and a questionnaire needed to be completed by the patient to see if the drug is helpful in relieving their symptoms.

Official Title
-----------------
A Multicentre, Open-Label Extension Phase to Study the Long-Term Safety and Efficacy of Itopride HCl in Patients Suffering From Functional Dyspepsia

Conditions
-----------------
Dyspepsia

Intervention / Treatment
-----------------
* Drug: Itopride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have completed the 8 week double-blind study ITOFD04-03 Female patients must not be pregnant (must have a negative serum pregnancy test) Exclusion Criteria: Patients with any newly occurring medical condition which was an exclusion criterion at ITOFD04-03 study entry

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety |  | every 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term relief of symptoms |  | every 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal Symptom Relief, Fullness, Bloating, Indigestion, Functional dyspepsia
Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Tract Symptoms in Egypt

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to calculate the prevalence of gastroesophageal reflux disease (GERD) by mean of GERD-Q questionnaire in patients with upper gastrointestinal tract symptoms in Egypt.

Detailed Description
-----------------
Prevalence of Gastroesophageal reflux disease (GERD) in patients with upper gastrointestinal tract symptoms in Egypt

Official Title
-----------------
Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Tract Symptoms in Egypt

Conditions
-----------------
Patients With Upper Gastro-intestinal Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and above Attending the medical office and reporting symptoms suggestive of upper gastrointestinal tract symptoms such as heartburn/regurgitation, abdominal pain, bloating, belching and nausea/vomiting. Exclusion Criteria: Participating on a clinical trial during the last 3 months. Patients not able to read and/or understand the GERD-Q questionnaire. Patients already included in the study in other participating site. Patients taking PPIs or H2blockers in the l

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Gastrointestinal Trackt Symptoms<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients scoring ≥ 8 in GERD-Q | Percentage of patients scoring ≥ 8 in GERD-Q will be considered as suffering from GERD. The GERD-Q is a potentially useful tool for family practitioners and other health care professionals in diagnosing and managing GERD without initial specialist referral or endoscopy. The Egyptian-validated version of the GERD-Q will be used for the study purposes. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD) | Descriptive analysis of socio-demographic characteristics of patients diagnosed with gastroesophageal reflux disease (GERD) in Egypt. | baseline | 
| Treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD) | Descriptive analysis of treatment patterns in patients diagnosed with gastroesophageal reflux disease (GERD) in Egypt. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
upper gastro-intestinal symptoms, GERD
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Indonesia

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Indonesia.

Official Title
-----------------
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Indonesia

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months Patients willing to sign informed consent form Exclusion Criteria: Previous participation in this study Unable to comply with protocol requirements Confirmed or suspected pregnancy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with diabetes mellitus (type 2)<br> | Other: No treatment given<br>* Patients will fill out a questionnaire by interview.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7% |  | Evaluated at the first visit (only one study visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Postprandial Plasma Glucose (PPG) of patients |  | Evaluated at the first visit (only one study visit) | 
| Mean HbA1c of patients |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having dyslipidemia |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having hypertension |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having cardiovascular complications |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having peripheral vascular disease |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having diabetic nephropathy |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having diabetic eye complications |  | Evaluated at the first visit (only one study visit) |
A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

Official Title
-----------------
A Phase 3, Multicenter Study to Assess the Long Term Safety and Tolerability of ALKS 3831 in Subjects With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: ALKS 3831


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days. Agrees to use an acceptable method of contraception for the duration of the study. Additional criteria may apply. Exclusion Criteria: Subject is currently taking medications that are contraindicated with olanzapine use. Subject has a positive test for drugs of abuse at study entry. Subject is pregnant, planning to become pregnant, or breastfeeding during the study. Additional criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 3831<br>Olanzapine + samidorphan; administered as a coated bilayer tablet. | Drug: ALKS 3831<br>* Tablets were administered for daily dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) |  | Up to 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Safety
Efficacy, Effect on Gametocytes and Tolerability of the Addition of Artesunate to Amodiaquine in Colombia

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to quantify the benefit of adding artesunate to amodiaquine in treating patients with uncomplicated P. falciparum malaria, in a low transmission area in Colombia. The benefit will be assessed in terms of: Efficacy Tolerability Time of fever clearance Time of parasite clearance Proportion of gametocyte carriers

Official Title
-----------------
Randomised, Double Blind Clinical Trial of the Efficacy, Effect on Gametocytes and Tolerability of Amodiaquine Vs Amodiaquine Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Quibdo, Colombia

Conditions
-----------------
Malaria,Falciparum, Malaria, Antimalarials

Intervention / Treatment
-----------------
* Drug: Artesunate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pure P. falciparum infection parasitaemia >500 and <50,000 asexual parasites/μL (subsequently the lower limit was modified to >250 asexual parasites/μL) age between 1 and 65 years old availability to return for follow-up Exclusion Criteria: Pregnancy history of allergy to the study drugs history of taken complete treatment with an antimalarial drug in the previous 72 hours or sulphas, clindamycin or tetracycline in the previous week have a medical history of untreated hypertension or chronic heart, kidney or liver disease present any danger signs of severe malaria.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment failures |  |  | 
| adverse events |  |  | 
| gametocyte carriage |  |  |
A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This open-label, fixed sequence, two-period study will assess the effect of multiple dose carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of 3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose of RO4917838 on Day 16.

Official Title
-----------------
A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE CARBAMAZEPINE ON SINGLE DOSE PHARMACOKINETICS OF RO4917838 IN HEALTHY MALE VOLUNTEERS

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: RO4917838
* Drug: carbamazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy male volunteers, 18-65 years of age inclusive Body mass index (BMI) 18-30 kg/m2 inclusive Exclusion Criteria: History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic or psychiatric disease, or cancer Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator Native Asians or subjects with Asian racial origin

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: RO4917838<br>* Single oral dose, Day 1 of study period 1 and Day 16 of study period 2<br>Drug: carbamazepine<br>* multiple oral doses, Days 1-24 of study period 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentraion-time curve/maximum concentration (AUC/Cmax) of single dose RO4917838 with multiple dose carbamazepine administration |  | approximately 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | up to 13 weeks |
Cognition and QoL After Thyroid Surgery

Study Overview
=================
Brief Summary
-----------------
The development of cognitive dysfunction can profoundly affect HR-QoL as well as the possibility of societal participation and ability to work, and thereby relevantly impacts prospects for cancer survivorship. The aim of the study is to obtain improved understanding of the scope and magnitude of objective cognitive dysfunction in DTC survivors, and its relation to subjective cognitive dysfunction, thyroid hormone levels, physical activity and HRQoL. This is done in a prospective study where patients operated for a thyroid nodule (Bethesda IV-VI, i.e., benign [goitre with nodule and fibroadenomas], low-risk DTC and intermediate-high risk DTC) are included and asked to serially perform online neuropsychological testing as well as to complete questionnaires related to HR-QoL, physical activity and additional psychological and physical complaints. Blood is analysed for levels of thyroid hormones and systemic inflammation.

Detailed Description
-----------------
The primary aim of this study is to prospectively assess objective cognitive functioning in patients undergoing thyroid surgery for different indications by means of an online neuropsychological test, the Amsterdam Cognition Scale (ACS). Three patient groups are defined; 1) patients with follicular adenomas, 2) patients with extreme low-risk differentiated thyroid cancer (DTC; pT1a and pN0/x tumours), 3) patients in all other DTC risk groups (i.e., low, intermediate and high-risk). The primary comparison confers to groups 1 and 3.

Official Title
-----------------
Longitudinal Evaluation of Objective Cognitive Function and Quality of Life in Patients Undergoing Surgery for Malignant and Benign Thyroid Nodules

Conditions
-----------------
Survivorship, Thyroid Nodule, Thyroid Cancer, Cognitive Decline, Symptoms, Cognitive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years old, indication for surgery because of a thyroid nodule Bethesda IV-VI Able to read and understand the Swedish language Access to desktop computer or laptop with internet connection Able and willing to provide written informed consent Exclusion Criteria: A previous diagnosis of (auto-immune) hypothyroidism A previous cancer diagnosis (excluding basal cell cancer of the skin) Indications for surgery other than (solely) a thyroid nodule (i.e., concomitant Graves) A diagnosis of medullary and anaplastic thyroid cancer

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective cognitive functioning by means of an online neuropsychological test (Amsterdam Cognition Scale, ACS) | change in total score on ACS | pre-surgery to 12 months post-surgery |
Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is to measure how much of varenicline tartrate is in Chinese healthy smokers' blood and urine after taking a single dose and several doses respectively, and also to test the safety (the impact of the study drug on Chinese healthy smokers' body) of varenicline.

Official Title
-----------------
A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Drug: varenicline tartrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female Chinese subjects between the ages of 18 and 45 years, inclusive. Body Mass Index (BMI) of approximately 19 to 24 kg/m2; and a total body weight ≥50 kg. Individuals who have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 months in the past year. Exclusion Criteria: Heart rate>100 bpm, QRS Interval>120 msec, QTc Interval >430 msec, PR Interval>220 msec, or any other abnormalities observed on the Electrocardiogram. Subjects with a sitting blood pressure of 140/90 mmHg or above at screening. Subjects with evidence or history of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurological disease, or any condition possibly affecting drug absorption.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: varenicline tartrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To gather safety data from Day 0 to Day 17 of the study. |  |  |
Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole

Study Overview
=================
Brief Summary
-----------------
Infertility is defined as a couple's inability to become pregnant after one year of unprotected intercourse in women 35 years old and younger, and for six months in women over age 35 years. In any given year, about 15 percent of couples in North America and Europe who are trying to conceive are infertile

Official Title
-----------------
Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Letrozole
* Drug: Clomiphene Citrate plus N acetyl cystine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All primary and secondary. Infertility due to anovulation Exclusion Criteria: Male factor infertility, tubal factor. Endocrineopathy Hypothyrodism Morbid obesity Under weight Patient with previous surgery including drilling of ovary, Clomiphene Citrate resistant to ovulation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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 |
| --- | --- |
| Experimental: Lertozole<br>oral tablets 5 mg start from third day cycle for 5 days | Drug: Letrozole<br>* oral tablets 5 mg<br>|
| Active Comparator: clomiphene plus N- acetyl cystiene<br>clomiphene 100 mg plus N-acetyl cystiene 600 mg start from third day cycle for 5 days | Drug: Clomiphene Citrate plus N acetyl cystine<br>* Clomiphene Citrate 100 mg oral tablets+ N acetyl cystiene 600 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of ovulation | ultrasound evaluation | 3 months |