linjc16/ctgov huggingface dataset:
A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.

Official Title
-----------------
A 4 Month Extension to a 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long-term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study. absence of ongoing severe adverse events at Visit 10.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months |  |  | 
| Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months |  |  | 
| Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months |  |  | 
| Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline |  |  | 
| Blood pressure less than 140/90 mmHg |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, aliskiren, hydrochlorothiazide
Study of Tadalafil for the Treatment of Diabetic Patients With Symptoms of Upset Stomach and Delayed Stomach Emptying

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine whether an experimental drug known as tadalafil can reduce symptoms of dyspepsia (fullness after eating, inability to finish a regular meal, bloating, discomfort or pain in the upper abdomen, belching after meals, nausea, vomiting) in diabetic patients, and/or reduce the amount of time the stomach takes to empty the contents of a standard meal. The safety of tadalafil given once daily for 8 weeks in this population will also be studied.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study of IC351 (LY450190) in Patients With Diabetic Gastroparesis

Conditions
-----------------
Gastroparesis

Intervention / Treatment
-----------------
* Drug: tadalafil
* Drug: tadalafil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of diabetes mellitus Delayed gastric emptying 3 month minimum history of chronic upper abdominal discomfort Symptoms of dyspepsia (upset stomach) Exclusion Criteria: Major gastrointestinal surgery or medical conditions known to affect gastric motility Irritable Bowl Syndrome Medications known to affect gastric motility Angina treated with nitrates Uncontrolled diabetes mellitus and history of certain heart problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: placebo<br>* Placebo tablet taken by mouth once a day for 8 weeks<br>|
| Active Comparator: 2<br>5 mg tadalafil | Drug: tadalafil<br>* 5 mg tadalafil tablet taken by mouth once a day for 8 weeks<br>* Other names: IC351;|
| Active Comparator: 3<br>20 mg tadalafil | Drug: tadalafil<br>* 20 mg tadalafil tablet taken by mouth once a day for 8 weeks<br>* Other names: IC351;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 5 mg tadalafil compared to placebo |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of change from baseline to endpoint using the Total Symptom Severity Score in patients taking 20 mg tadalafil compared to placebo |  | 8 weeks | 
| Measure of change from baseline to endpoint using the Visual Analog Score and Nepean Dyspepsia Index Symptom Checklist in patients taking 5 mg tadalafil, 20 mg tadalafil and placebo |  | 8 weeks |
Respiratory Complications of Operated Esophageal Atresia in Children

Study Overview
=================
Brief Summary
-----------------
The respiratory complications of esophageal atresia have already been identified. They are mainly related to tracheomalacia linked to the esophageal malformation, and are aggravated by frequently associated gastroesophageal reflux. In this context, symptoms of asthma (or bronchial hyperreactivity) occur more frequently than in the general population and persist into adulthood. Their pathogenesis is still poorly understood and is the subject of much discussion. The therapeutic management of these respiratory complications, poorly codified, remains very heterogeneous from one center to another. In France, the summary of knowledge is updated by the Reference Center for chronic and malformative diseases of the esophagus.

Official Title
-----------------
Respiratory Complications of Operated Esophageal Atresia in Children

Conditions
-----------------
Esophageal Atresia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Child aged 1 to 12 years old Child operated on for esophageal atresia between 01/01/2010 and 31/12/2020 and followed up at the University Hospitals of Strasbourg Child who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research Parental authority having not expressed, after being informed, their opposition to the reuse of their child's data for the purposes of this research. Exclusion criteria: Subject and/or parental authority having expressed their opposition to participating in the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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 |
| --- | --- | --- |
| Retrospective study of respiratory complications of esophageal atresia in children |  | Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, esophageal atresia, esophageal malformation, gastroesophageal reflux, bronchial hyperreactivity
A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects

Study Overview
=================
Brief Summary
-----------------
Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).

Official Title
-----------------
A Phase 1, Open-Label Study to Evaluate the Pharmacodynamics, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: GMI-1271
* Drug: Filgrastim
* Drug: Placebo Injection
* Drug: Placebo Infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult male and/or females, 19 to 60 years of age, inclusive. Medically healthy with no clinically significant screening results as deemed by the PI. Exclusion Criteria: History of presence of clinically significant medical condition or disease in the opinion of the PI. Alcoholism or drug abuse. Liver disease. Female subjects who are pregnant or lactating. Known history or evidence of active hepatitis A, B, or C or HIV. Clinically significant cardiovascular disease. Participation in another clinical trial within 28 days prior to the first dose of GMI-1271 or filgrastim, whichever occurs first.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GMI-1271<br>GMI-1271 | Drug: GMI-1271<br> <br> Drug: Placebo Injection<br> <br> |
| Active Comparator: Filgrastim<br>Filgrastim | Drug: Filgrastim<br> <br> Drug: Placebo Infusion<br> <br> |
| Experimental: GMI-1271 with Filgrastim<br>GMI-1271 with Filgrastim | Drug: GMI-1271<br> <br> Drug: Filgrastim<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of subsets of WBC |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events as a measure of safety and tolerability |  | 19 days |
Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The objective of the study aims to collect tumor tissue at the moment of progression under Immune checkpoint inhibitors (ICI) in biological resources center in Ambroise Paré hospital, in order to insure later study on molecular mechanism involving the progression of NSCLC and SCLC under ICI. The further analysis of research will be performed in the EA 4340 unity, Biomarkers and Clinical Trials in cancerology and onco-hematology, UVSQ, University of Paris-Saclay.

Detailed Description
-----------------
The study will consist of creation a tumor tissue bank, all sampling will be stored in the biological resources center of Ambroise Paré hospital.

Official Title
-----------------
Tumor Rebiopsy During Progression Under Immunotherapy for Patients With Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Rebiopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed NSCLC or SCLC; Patient treated priorly by ICI and progressed under ICI; Have provided written informed consent for the study; Be >/= 18 years of age on day of signing informed consent. Exclusion Criteria: Patient under guardianship or curatorship; Unable to provide written informed consent for the study; Technical impossibility to carry out tissular rebiopsy under local anesthesia.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rebiopsy<br> | Procedure: Rebiopsy<br>* Biopsy will be carry out with flexible bronchoscopy as usual practice under local anesthesia: under endobronchial ultrasound, punction under CT scan or ultrasonography, percutaneous pleural puncturing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of specific histomolecular resistance | Banking of tumor samples at progression with immune checkpoint inhibitor (ICI) in lung cancer, to evaluate the incidence of specific histomolecular resistance mechanisms to ICI by immunohistochemistry and molecular testing. | At the end of study, up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, rebiopsy, immunotherapy, progression
Non-Invasive Diagnostic and Functional Evaluation of Cardiac Involvement in Patients With Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in systemic sclerosis patients and to establish whether it reflects the severity of RV overload.

Detailed Description
-----------------
Elevated serum brain natriuretic peptide (BNP) levels released from myocytes of ventricles upon stretch have been found in patients with isolated right ventricular (RV) pressure overload. However, limited data suggest that serum BNP may be elevated in patients with systemic sclerosis (SSc), especially with RV dysfunction. The aim of this study was to assess serum N-terminal proBNP (NT-proBNP) in SSc patients and to establish whether it reflects the severity of RV overload.

Conditions
-----------------
Systemic Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of systemic sclerosis Exclusion Criteria: Cardiovascular disorders other than pulmonary hypertension Significant pulmonary function abnormalities Impaired renal function

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
systemic sclerosis, pulmonary hypertension, echocardiography, N-Terminal proBNP
Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)

Study Overview
=================
Brief Summary
-----------------
This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.

Official Title
-----------------
Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Drug: Azathioprine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who undergo lung transplantation and azathioprine tablets were administered Exclusion Criteria: Subjects with hypersensitivity to the ingredients of azathioprine tablet Subjects who is pregnant or might be pregnant Subjects whose white count is lower than 3000/cubic millimeter
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 prescribed azathioprine tablet<br>Subjects prescribed azathioprine tablet during study period after the lung transplantation | Drug: Azathioprine<br>* At the start of treatment, 2 to 3 mg per kg of body weight each day. For the rest of treatment, 1 to 2 mg per kg of body weight each day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events related to azathioprine tablets |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antirejection
Searching of Apraxia of Speech in Children With Specific Language Impairment

Study Overview
=================
Brief Summary
-----------------
Searching of Apraxia of Speech in Children with Specific Language Impairment

Official Title
-----------------
Searching of Apraxia of Speech in Children With Specific Language Impairment

Conditions
-----------------
Apraxia of Speech

Intervention / Treatment
-----------------
* Diagnostic Test: Mansora Arabic test battery for childhood apraxia of speech


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children from 4 to 8 years old diagnosed as specific language impairment Exclusion Criteria: 1. Children with mental retardation or hearing impaired . 2. Children with any neurological or psychiatric disorders.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Mansora Arabic test battery for childhood apraxia of speech|Searching of apraxia of speech in children with Specific Language Impairment in able to better management of these cases.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mansora Arabic test battery for childhood apraxia of speech |  | one houre |
The 3q25 rs2305619 Polymorphism Associates With Microvascular Obstruction in STEMI

Study Overview
=================
Brief Summary
-----------------
The investigators enrolled 217 patients with acute STEMI undergoing primary PCI. The rs2305619 polymorphism was evaluated by real time PCR and plasma PTX3 concentration was assessed by human PTX3 ELISA kit.

Detailed Description
-----------------
The investigators enrolled 217 patients with acute STEMI undergoing primary PCI in a tertiary care academic cardiovascular center. The rs2305619 polymorphism was evaluated by real time PCR and plasma PTX3 concentration was assessed by human PTX3 ELISA kit. The primary outcome of the study was the incidence of coronary microvascular obstruction defined as thrombolysis in myocardial infarction (TIMI) grade <3 flow after primary PCI or TIMI grade 3 flow with myocardial blush grade 0 or 1. Patients were grouped based on the genotypic variants (AA, AG and GG). The primary outcome was compared among the three variants, as well as the PTX3 concentration and 30-day mortality.

Official Title
-----------------
The 3q25 rs2305619 Polymorphism is Associated With Coronary Microvascular Obstruction Following Primary Angioplasty for Acute ST-segment Elevation Myocardial Infarction

Conditions
-----------------
STEMI, Microvascular Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Long pentraxin 3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute STEMI with symptom onset <12 h and treated by primary PCI Exclusion Criteria: STEMI patients who received fibrinolytic therapy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Genotypic variants<br>AA, AG and GG genotype | Other: Long pentraxin 3<br>* Primary PCI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of microvascular obstruction | Percentage | Immediate after pci | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of mortality | Percentage | 30 days |
FMS European Long-Term Study

Study Overview
=================
Brief Summary
-----------------
Investigation of the long-term (12 months) efficacy and safety of milnacipran used in the treatment of fibromyalgia syndrome.

Official Title
-----------------
A European Phase III, Multicentre, Double-blind, Randomised, Monotherapy, 12-month Study of Milnacipran for the Treatment of the Fibromyalgia Syndrome

Conditions
-----------------
Fibromyalgia Syndrome

Intervention / Treatment
-----------------
* Drug: milnacipran
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who completed the 3-month F02207 GE 302 study patient with a diagnosis of fibromyalgia according to the 1990 ACR criteria at entry of F02207 GE 302 study Exclusion Criteria: known hypersensitivity to milnacipran major depressive episode significant risk of suicide generalised anxiety disorder substance abuse clinically significant cardiac disease pulmonary dysfunction active liver disease renal impairment autoimmune disease current systemic infection epileptic active cancer severe sleep apnoea active peptic ulcer inflammatory bowel disease unstable endocrine disease (for men) prostatic enlargement or other genito-urinary disorders (for women) pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 71 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minalcipran 100 mg<br> | Drug: milnacipran<br>* hard capsule<br>Drug: Placebo<br>* hard capsule<br>|
| Experimental: Minalcipran 150 mg<br> | Drug: milnacipran<br>* hard capsule<br>Drug: Placebo<br>* hard capsule<br>|
| Experimental: Minalcipran 200 mg<br> | Drug: milnacipran<br>* hard capsule<br>Drug: Placebo<br>* hard capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the long-term safety of milnacipran used for the treatment of FMS at doses of 100 mg, 150 mg and 200 mg daily |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the long-term efficacy (including the durability of efficacy) of milnacipran in treating fibromyalgia over 12 months of exposure at doses of 100 mg, 150 mg and 200 mg daily |  | 12 months |