linjc16/ctgov huggingface dataset:
A Drug-Drug Interaction Study of Losartan and PA21

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if Losartan potassium is affected by PA21.

Official Title
-----------------
A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Losartan Potassium in Healthy Male and Female Adults

Conditions
-----------------
Drug Interaction Potentiation

Intervention / Treatment
-----------------
* Drug: PA21 and Losartan with Food
* Drug: No PA21; Losartan with food
* Drug: PA21 with food and Losartan 2 hours later


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Written informed consent Exclusion Criteria: No significant medical conditions Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PA21 and Losartan with food<br> | Drug: PA21 and Losartan with Food<br>* The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.<br>|
| Experimental: No PA21; Losartan with food<br> | Drug: No PA21; Losartan with food<br>* The maximum dose of Losartan will be 100 mg/day.<br>|
| Experimental: PA21 with food and Losartan 2 hrs later<br> | Drug: PA21 with food and Losartan 2 hours later<br>* The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of PA21 on Losartan potassium | To assess the effect, if any, of PA21 on Losartan potassium exposure | PK assessment on Day 0, 11, 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of PA21 on the active metabolite of Losartan potassium | To assess the effect, if any, of PA21 on the active metabolite of Losartan potassium | PK assessment on Day 0, 11, 22 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-drug interaction, Pharmacokinetics, PA21
A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients

Study Overview
=================
Brief Summary
-----------------
this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment

Official Title
-----------------
A Phase I PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients

Conditions
-----------------
Advanced or Metastatic NSCLC

Intervention / Treatment
-----------------
* Drug: Sintilimab (M1b)
* Drug: Sintilimab (approved)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC patients who have received or been intolerant to at least one prior line of standard treatment. No EGFR mutation or ALK rearrangement. ECOG PS score 0 or 1. BMI ≥ 21.0kg/m2 and ≤ 26.0kg/m2 Body weight ≥ 60.0kg and ≤ 75.0kg. Adequate organ function per protocol-defined criteria. Exclusion criteria Exposure to any anti-PD-1, PD-L1, PD-L2 antibodies. Allergic to any component of sintilimab. Active autoimmune diseases. Clinically unstable central nervous system metastasis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: sintilimab (M1b) 200mg<br> | Drug: Sintilimab (M1b)<br>* Intravenous infusion<br>|
| Active Comparator: sintilimab (approved) 200mg<br> | Drug: Sintilimab (approved)<br>* Intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK is defined as AUC0-∞. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK is defined as Cmax. |  | 28 days | 
| Safety of sintilimab (approved) versus sintilimab (M1b). AE is defined as treatment-related adverse events assessed by CTCAE v5.0. |  | from randomization through 90 days after last dosing |
Effects of Inspiratory Muscle Training on Breathing Pattern in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The improvement in inspiratory muscle function might result in beneficial changes in breathing pattern during whole body exercise. The hypothesis is the effect of inspiratory muscle training as an adjunct to a pulmonary rehabilitation program improves the breathing pattern during an incremental cycle exercise.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Muscle Weakness Conditions

Intervention / Treatment
-----------------
* Procedure: Inspiratory muscle training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically stable COPD patients maximal inspiratory pressure <100% of the predicted normal value Exclusion Criteria: Major comorbidities preventing successful participation in an 8 week exercise training intervention

Ages Eligible for Study
-----------------
Minimum Age: 40 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory muscle training<br> | Procedure: Inspiratory muscle training<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in breathing pattern during an incremental cycle exercise test | At comparable levels of ventilation breathing frequency, inspiratory time (Ti), expiratory time (Te), total time of the respiratory cycle (Ttot), inspiratory duty cycle (Ti/Ttot), and inspiratory flow rates will be compared. | Baseline and 8 weeks follow-up |
Examining The Efficacy, Safety And Improved Tolerability Of Travoprost BAK Free Ophthalmic Solution (Travatan-Z) Compared To Prior Prostaglandin Therapy

Study Overview
=================
Brief Summary
-----------------
Examine the safety, tolerability and efficacy of travoprost benzalkonium chloride (BAK) free ophthalmic solution compared to either latanoprost or bimatoprost monotherapy.

Official Title
-----------------
Examining The Efficacy, Safety And Improved Tolerability Of Travoprost BAK Free Ophthalmic Solution (Travatan-Z) Compared To Prior Prostaglandin Therapy

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Travatan-Z


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with a clinical diagnosis of ocular hypertension, or primary open-angle, pigment dispersion or exfoliation glaucoma in at least one eye (study eye) Exclusion Criteria: Age

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: Travatan-Z|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma
Bioequivalency Study of 7.5 mg Pilocarpine Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Pilocarpine tablets, 7.5 mg, to SALAGEN® Tablets, 7.5 mg (MGI) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, 2-Sequence Crossover Bioequivalency Study of 7.5 mg Pilocarpine Tablets Under Fed Conditions

Conditions
-----------------
Dry Mouth

Intervention / Treatment
-----------------
* Drug: Pilocarpine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Pilocarpine or any comparable or similar product.

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |
An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the safety and efficacy of three different foscarnet maintenance therapy regimens. To determine the pharmacokinetics of intermittent administration of foscarnet with or without concomitant administration of zidovudine (AZT).

Official Title
-----------------
An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients

Conditions
-----------------
Cytomegalovirus Retinitis, HIV Infections

Intervention / Treatment
-----------------
* Drug: Foscarnet sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose). Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic and/or hypertensive retinopathy. Known allergy to foscarnet. Recurrent episode of cytomegalovirus (CMV) retinitis. Concurrent Medication: Excluded: Nephrotoxic drugs. Patients with the following are excluded: Recurrent episode of cytomegalovirus (CMV) retinitis. Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose). Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy. Known allergy to foscarnet. Prior Medication: Excluded: Ganciclovir for cytomegalovirus (CMV) retinitis. Foscarnet for CMV retinitis. Patients with AIDS as defined by the CDC with manifest first episode cytomegalovirus (CMV) retinitis, as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography. Patients must be able to give informed consent.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Foscarnet sodium|nan|

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
-----------------
Retinitis, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Foscarnet, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine
Eyelid Movement Sensor Device- Blinking Characterizing

Study Overview
=================
Brief Summary
-----------------
The investigators have developed a simple to use device that facilitates the monitoring of the upper eyelids motion, acquires the eyelid vertical movement and enables analysis and graphic presentation of the results. the device system consists 3 components : glasses for the patient including magneto sensitive probes, hardware and dedicated software. Our purpose is to characterize eyelid motion in normal population. The methods include measuring each patient 10 minutes during watching a short movie.

Detailed Description
-----------------
Essentially, for Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid.

Official Title
-----------------
Eyelid Movement Sensor Device- Blinking Characterizing

Conditions
-----------------
Eyelid Movement Disorders

Intervention / Treatment
-----------------
* Device: eyelid motion sensor device (Hall-probe)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy 18-67 year olds with no eye medical history Exclusion Criteria: pregnancy head trauma history using contact lens

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eyelid motion sensor device<br>all volunteers will wear the monitor eyelid sensor device (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance. | Device: eyelid motion sensor device (Hall-probe)<br>* all volunteers will wear the eyelid motion sensor device (Hall-probe) (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate and describe measurable blinking character in normal population.(Hall-probes monitor the magnetic field generated by a tiny magnets attached to the upper eyelid) |  | 10 minutes |
Early Detection of Breast Cancer and Cervical Cancer in Women in India

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Health education programs and screening methods, such as clinical breast examination and examination of the cervix, may help reduce the number of women who develop breast cancer and cervical cancer. PURPOSE: This randomized clinical trial is studying the early detection of breast cancer and cervical cancer in women in India.

Detailed Description
-----------------
OBJECTIVES: To investigate the effectiveness of well planned health education programs (HEP) and low-cost screening methods (e.g., clinical breast examination [CBE] and visual inspection of the cervix painted with 4% acetic acid [VIA]) in down-staging and reducing the incidence of and mortality due to breast and cervical cancer. OUTLINE: Patients are randomized to 1 of 2 arms. Arm I (intervention): Participants undergo intervention comprising health education programs (HEP), clinical breast examination (CBE), and visual inspection of the cervix painted with 4% acetic acid (VIA) every 2 years for up to 8 years. Participants also undergo active surveillance over 8 years. Arm II (control): Participants receive one HEP. Participants also undergo active surveillance over 8 years.

Official Title
-----------------
Early Detection of Common Cancers in Women in India

Conditions
-----------------
Breast Cancer, Cervical Cancer

Intervention / Treatment
-----------------
* Other: active surveillance
* Other: educational intervention
* Procedure: examination
* Procedure: long-term screening


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Resides in 1 of 20 geographically defined clusters within the slums of Mumbai, India PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: active surveillance|nan|
|Other: educational intervention|nan|
|Procedure: examination|nan|
|Procedure: long-term screening|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of well planned health education programs and low-cost screening methods (e.g., clinical breast exam and visual inspection of the cervix) in reducing the incidence of and mortality due to breast and cervical cancer |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, cervical cancer
Genetic Origin of Lipid Disorders

Study Overview
=================
Brief Summary
-----------------
Several lipid disorders are without known genetic origin. The scope of this project is to sequence genes superior involved in lipid and carbohydrate metabolism in patients with severe lipid disorders. The resulting mutations will be tested in suitable in vitro systems to detect their part in development of the specific disease.

Detailed Description
-----------------
See brief summary above.

Official Title
-----------------
Genetic Origin of Lipid Disorders

Conditions
-----------------
Lipid Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: proven written informed consent prior to recruitment male or female 18-55 years old patients with severe lipid disorders fasting plasma cholesterol, triglyceride or glucose, blood pressure or waist circumference/BMI out of normal range Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 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
-----------------
Lipid disorder, Gene mutation
Cognitive-Behavioral Therapy (CBT) in Children With Diabetes

Study Overview
=================
Brief Summary
-----------------
Diabetes mellitus in children and adolescents is a source of stress and poor quality of life for themselves and their family. Development of adaptive coping strategies may be improved by focused parent and children training. This study assesses a cognitive behavioral treatment (CBT) for children/adolescents with diabetes and their parents in comparison with standard health educational interventions. The investigators main aim is to verify that the CBT program improves overall balance of glycaemia better than phone contact without CBT content (control group). Secondary objectives are expected improvements of health-related quality of life and coping styles in parents and children.

Official Title
-----------------
Assessment of a Cognitive-behavioral Group Intervention in Children With Diabetes Mellitus and Their Parents

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Behavioral: CBT (Cognitive-Behavioral Therapy)
* Behavioral: Control (telephonic support without CBT content)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and teenagers from 6 years-old to 18 years-old Having diabetes treated by insulin for at least 1 year Followed in pediatric diabetology department of Arnaud de Villeneuve Hospital in University Hospital of Montpellier Study Inform Consent signed by both children and parents Exclusion Criteria: Children with developmental delay, severe mental disorders or language delay Non French-speaking family Children who does not live with at least one of his/her parents Children whose residence is not compatible with frequent visits at University Hospital of Montpellier Clinical status not compatible with study questionnaires assessment.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT group<br> | Behavioral: CBT (Cognitive-Behavioral Therapy)<br> <br> |
| Sham Comparator: Control group<br> | Behavioral: Control (telephonic support without CBT content)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin (HbA1c) level |  | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus, glycaemia, cognitive-behavioral treatment, coping, parents, children