linjc16/ctgov huggingface dataset:
Primary Ovarian Insufficient Patients

Study Overview
=================
Brief Summary
-----------------
The Prospective Cohort Study for Primary Ovarian Insufficient Patients was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.

Detailed Description
-----------------
Premature ovarian insufficiency (POI) is a rare cause of infertility in women affecting 1% of the population. It is characterized by amenorrhea, hypoestrogenism and elevated gonadotrophin levels in women younger than 40 years of age. Other than the reproductive outcome of these patients, the short- and long-term health consequences are still unknown. Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. The current project plans to recruit POI participants in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for POI prognosis.

Official Title
-----------------
Prospective Cohort Study for Primary Ovarian Insufficient Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)

Conditions
-----------------
Healthy Related

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: younger than 40 years of age at least four or more months of amenorrhea, two or more instances in which the serum FSH level is > 40 U/L (i.e., two inspections at intervals of 1 month or more), with an oestradiol level of <20pg/ml Exclusion Criteria: -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSH (Follicle stimulating hormone) | mIU/mL | Change from Baseline FSH at each6 months | 
| LH (luteinizing hormone) | mIU/mL | Change from Baseline LH at each6 months | 
| Estrogen | pg/ml | Change from Baseline Estrogen at each6 months | 
| Progesterone | ng/ml | Change from Baseline Progesterone at each6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of uterus and ovary | Record the Length (mm)*Width (mm)*Height (mm) of uterus, and each ovary | Change from Baseline volume at each6 months |
Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of conservative treatments of obesity with surgery (gastric bypass).

Detailed Description
-----------------
The aim of this study is to evaluate 3 different treatments of obesity with gastric bypass. Two groups will be treated in different clinics and 1 group will be treated at our outpatient clinic. Sixty patients will participate in each group. Behavioural changes and weight loss over 4-5 years will be followed. We will also analyse changes in hormones, mental status, sexual behaviour, effect of training and quality of life.

Official Title
-----------------
Morbid Obesity: Effects of Conservative Treatments and Gastric Bypass Surgery

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Behavioral: lifestyle changes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) > 40 or BMI > 35 with complications Exclusion Criteria: Unstable atherosclerotic disease Psychologically unstable Unable to participate in the training program

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: lifestyle changes|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight reduction |  |  | 
| quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in obesity complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, lifestyle, treatment, Complications, endocrine changes, Lipids, C18.654.726.500.495
Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Sizes

Study Overview
=================
Brief Summary
-----------------
Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose. The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes .

Detailed Description
-----------------
Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose. The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes (voxel size 0.4mm & 0.2mm)

Official Title
-----------------
Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Size in Computer Guided Implantology Randomized Clinical Trial

Conditions
-----------------
Accuracy of Surgical Guide in Implants

Intervention / Treatment
-----------------
* Other: Surgical guide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: partially edentulous patients seeking for dental implant Bucco-lingual width more than 6 mm Medically free patients Exclusion Criteria: patients with thin ridges that may need augmentation patients with systematic diseases that may affect bone quality completely edentulous patients patients with limited mouth opening
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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Surgical guide designed from voxel size 0.2mm<br>Surgical guide will be designed based on CBCT voxel size 0.2mm | |
| Active Comparator: Surgical guide designed from voxel size 0.4m<br>Surgical guide will be designed based on CBCT voxel size 0.4 mm | Other: Surgical guide<br>* Surgical Guide for this group will designed from 0.4mm voxel size<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angular deviation | Evaluation of angular deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm) | Immediate post operative | 
| Linear deviation | Evaluation of linear deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm | Immediate post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical guide, Computer guided implantology, CBCT voxel size
A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Methacholine Chloride (SK-1211)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FEV1/forced vital capacity(FVC) must be 70% or more <10% decrease in FEV1 in response to inhalation of normal saline Exclusion Criteria: Moderate airflow limitation (FEV1 < 60% predicted or < 1.5 L) Heart attack or stroke in last 3 months Uncontrolled hypertension, systolic BP>200, or diastolic BP>100

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 Years

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asthma patients<br> | Drug: Methacholine Chloride (SK-1211)<br>* Subjects received saline and 0.039-25 mg/mL of Methacholine chloride<br>|
| Experimental: Healthy volunteers<br> | Drug: Methacholine Chloride (SK-1211)<br>* Subjects received saline and 0.039-25 mg/mL of Methacholine chloride<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL) | Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2. | Visit 2 (Day 1) |
Confinement and Spondyloarthritis Treatment

Study Overview
=================
Brief Summary
-----------------
Evaluate the impact of confinement on treatment use in spondyloarthritis. Study hypothesis that with the confinement, subjects will stop their treatment. The main objective is to study the impact of confinement on treatment. And secondly to look for for specific psychological profile linked to the interruption of the treatment. the study population consists of patients with spondyloarthritis and belonging to a patient association (ACS). All patients over 18 are included. A mailing questionnaire will be send to all patients. data on diseases activity and treatment will be collected

Official Title
-----------------
Impact of Confinement on the Treatment of Spondyloarthritis.

Conditions
-----------------
Spondyloarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: spondyloarthritis, age over 18 ans treatment by NSAID or biological treatment to be part of the patient association ACS (action contre les spondylarthropathies).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| treatment use | treatment continuation | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activity of disease | number of crisis | 1 week | 
| psychological aspects | Ten Item Personality Inventory rated on a scale from 1, disagree strongly, to 7, agree strongly) | 1 month | 
| psychological aspects | quality of life questionnaire (EQ-5D) evaluating mobility, self care, usual activity, pain and anxiety | 1 month |
Organized Self-Management Support Services for Chronic Depression

Study Overview
=================
Brief Summary
-----------------
The purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. Using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (UC); or an 18-month organized treatment program focused on outreach and engagement, including a weekly group self-management training program, monthly visits with a psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer support specialist. All intervention components are intended as adjuncts to any existing depression treatment (usually antidepressant medication) provided by participants' regular providers.

Official Title
-----------------
Organized Self-Management Support Services for Chronic Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Behavioral: organized care program for chronic or recurrent depression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients will meet criteria for recurrent major depression or dysthymia Exclusion Criteria: bipolar disorder or psychotic disorder

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>18-month organized treatment program focused on outreach and engagement for chronic or recurrent depression | Behavioral: organized care program for chronic or recurrent depression<br> <br> |
| No Intervention: Usual Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors) |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examination of moderators of treatment response |  | 18 months | 
| An estimate of the program's costs and effect on the costs of treatment for depression |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic or recurrent depression
Zenith Alpha™ Abdominal Endovascular Graft

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.

Official Title
-----------------
Post-Market Study for Zenith Alpha™ Abdominal Endovascular Graft

Conditions
-----------------
Abdominal Aortic, Aorto-iliac Aneurysm

Intervention / Treatment
-----------------
* Device: Zenith Alpha™ Abdominal Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient is considered eligible for inclusion in the study if the patient has an infrarenal abdominal aortic or aorto-iliac aneurysm and is intended to be treated with the Zenith Alpha™ Abdominal Endovascular Graft Exclusion Criteria: Life expectancy less than (<) 2 years Inability or refusal to give informed consent by the patient or legally authorized representative Unwilling or unable to comply with the study follow-up

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

| Intervention/Treatment |
| --- |
|Device: Zenith Alpha™ Abdominal Endovascular Graft|Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | Technical success (successful introduction and deployment of the device in the absence of surgical conversion or mortality) plus freedom from the following: abdominal aneurysm rupture, conversion, Type I or III endoleak, graft limb occlusion and abdominal aneurysm size increase > 5 mm. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Iliac Aneurysm, Vascular Diseases, Cardiovascular Diseases, Aortic Diseases
Prevention of Noise-induced Damage by Use of Antioxidants

Study Overview
=================
Brief Summary
-----------------
The current study is a dubble-blinde placebo-controlled cross-over study verifying the preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which should be taken 1h before leisure noise above 100dB for at least 30 minutes.

Conditions
-----------------
Noise-induced Tinnitus, Noise-induced Hearing Loss

Intervention / Treatment
-----------------
* Drug: Antioxidantia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-25 years old Temporary tinnitus after noise exposure: loudness >5 on a VAS Exclusion Criteria: middle ear problems Allergy for magnesium or n-acetylcystein Use of hearing protection when going out

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: sugar pill<br> | |
| Active Comparator: Antioxidantia<br>Dosage: 600mg n-acetylcystein and 200mg magnesium intake: 1 hour before leisure noise exposure above 100dB of at least 30 minutes frequency: 4 separate events (2x placebo, 2x antioxidants) | Drug: Antioxidantia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protection against noise-induced tinnitus due to antioxidants | Antioxidants protect against temporary threshold shift. The most prevalent cause of noise-induced tinnitus is noise-induced hearing loss. Therefore, it is assumed that the preventive intake of antioxidants prior to a loud event, might protect against threshold shift as well as noise-induced tinnitus. A 50% decrease of tinnitus loudness scored on a Visual Analogue Scale (VAS) compared to placebo trials is expected. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tinnitus duration | It is expected that with the intake of antioxidants noise-induced tinnitus is prevented or reduced after loud music exposure. In addition, it is expected that the tinnitus persistence is shortened compared to the placebo arm. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prevention, noise-induced tinnitus, noise-induced hearing loss, young population
A Comparison of the Effects of Tiotropium Inhalation qd and Salmeterol Inhalation Bid on Arterial Blood Gases.

Study Overview
=================
Brief Summary
-----------------
To evaluate changes in PaO2 following inhalation of Tiotropium by HandiHaler compared to Salmeterol MDI in patients with moderate to severe COPD.

Official Title
-----------------
A Comparison of the Effects of Tiotropium (18 Mcg) Inhalation Capsule q.d. and Salmeterol (50 Mcg) Inhalation Aerosol b.i.d. on Arterial Blood Gases in a Double-blind, Double-dummy, 4-week Crossover Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Tiotropium
* Drug: Salmeterol


Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tiotropium|nan|
|Drug: Salmeterol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline (Visit 2) in the PaO2 area under the curve (AUC) for the time period 0 to 105 minutes obtained through arterial blood gases (ABGs) at the end of each treatment period. |  | up to day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum decline in PaO2 from baseline |  | up to day 90 | 
| Maximum increase in alveolar-arterial oxygen gradient from baseline |  | up to day 90 | 
| Change from baseline (Visit 2) in FEV1 prior to insertion of catheter and 15 minutes post removal of catheter |  | up to day 90 | 
| Change from baseline (Visit 2) in FVC prior to insertion of catheter and 15 minutes post removal of catheter |  | up to day 90 | 
| Rescue medication use |  | up to day 90 | 
| COPD symptom score |  | up to day 90 | 
| Occurrence of adverse events |  | up to day 90 | 
| Pulse rate and sitting blood pressure in conjunction with spirometry |  | up to day 90 |