linjc16/ctgov huggingface dataset:
Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)

Study Overview
=================
Brief Summary
-----------------
This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.

Official Title
-----------------
Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

Conditions
-----------------
Emphysema

Intervention / Treatment
-----------------
* Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than or equal to 35 years of age bilateral heterogenous emphysema Patient has stopped smoking for a minimum of 8 weeks Read, understood and signed the Informed consent form Exclusion Criteria: Patient has a history of recurrent significant respirator infection Patient has an inability to walk > 140 meters Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Patient is pregnant or lactating Patient has clinical significant bronchiectasis Patient has had previous LVR surgery, lung transplant or lobectomy Patient has been involved in other pulmonary drug studies within 30 days prior to this study

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Lung Volume Reduction Coil (LVRC)<br>Lung Volume Reduction Coil (LVRC) | Device: Lung Volume Reduction Coil (LVRC) (PneumRx's)<br>* Lung Volume Reduction Coil<br>* Other names: Lung Volume Reduction Device (LVRD);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| St. George's Respiratory Questionnaire | Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emphysema, COPD, RePneu
Effect of Shock Waves on Dental Parameters

Study Overview
=================
Brief Summary
-----------------
This randomized clinical trial investigates the effect of the extracorporeal shockwave therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically approved non invasive method to influence bone turnover and tissue regeneration. The hypotheses of this trial are that ESWT increases the periodontal stability of orthodontically aligned teeth as well as increase the blood flow. Increasing the periodontal stability would reduce the retention phase, relapse risk and accelerate the rehabilitation of the surrounding tissues.

Official Title
-----------------
Effect of Low-energy Extracorporeal Shock Waves on Periodontal and Endodontic Parameters

Conditions
-----------------
Tooth Stability, Blood Flow

Intervention / Treatment
-----------------
* Device: Extracorporeal shockwave therapy
* Device: No extracorporeal shockwave


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy patients which don´t fulfill the exclusion criteria Exclusion Criteria: diseases (syndroms, infections,...) which influence the bone turnover and blood flow medication, which influences the bone turnover and blood flow pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESWT<br>Extracorporeal shockwave therapy | Device: Extracorporeal shockwave therapy<br>* 1000 impulses<br>* Other names: Orthogold 100 MTS;|
| Placebo Comparator: ESWT Placebo<br>No extracorporeal shockwave therapy | Device: No extracorporeal shockwave<br>* 0 impulses, acoustic effect<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periodontal stability of orthodontically aligned teeth |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulpal blood flow |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tooth mobility, periodontal status, irregularity index, pulpal blood flow
Seroquel on Glucose Metabolism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether six months treatment with the antipsychotic medicine Seroquel (quetiapine) may affect the schizophrenic patient's glucose metabolism

Official Title
-----------------
Seroquel on Glucose Metabolism

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

Intervention / Treatment
-----------------
* Drug: Seroquel (quetiapine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent. Exclusion Criteria: Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT. Previous use of atypicals (3 months) or other medications that might influence glucose metabolism Contraindications or non-responsiveness for any of the treatments or other safety issues Expected non-compliance to treatment and/or study procedures

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Seroquel (quetiapine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose metabolism, blood lipid levels and weight |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia
Study of Hot Flashes and Night Sweats in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen

Study Overview
=================
Brief Summary
-----------------
This pilot study was designed to explore the effects of combined treatment with raloxifene HCl 60 mg and oral 17 beta-estradiol 1mg/day on the number of vasomotor episodes (hot flashes plus night sweats) in postmenopausal women discontinuing continuous combined hormone replacement therapy (ccHRT) compared to women treated with raloxifene HCl 60 mg alone.

Official Title
-----------------
Study of Vasomotor Symptoms in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen

Conditions
-----------------
Vasomotor Symptoms, Endometrial Safety

Intervention / Treatment
-----------------
* Drug: Raloxifene
* Drug: medroxyprogesterone acetate
* Drug: estrogen
* Drug: 17 beta estradiol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post menopausal women, 50-70 years of age Had taken ccHRT for at least 6 months prior to study entry No unexplained vaginal bleeding in the 3 months prior to study entry Understand and sign an informed consent document Exclusion Criteria: Prior hysterectomy Endometrial thickness (excluding endometrial fluid) greater than 8 mm or endometrial fluid greater than or equal to 4 mm at study entry Abnormal Pap smear at study screening or within the preceding 3 years Abnormal transvaginal ultrasound result at study screening Past or current history of malignant neoplasms

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Raloxifene|nan|
|Drug: medroxyprogesterone acetate|nan|
|Drug: estrogen|nan|
|Drug: 17 beta estradiol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the number of vasomotor symptoms at 12 weeks between those women taking the combination of raloxifene with oral estradiol versus those taking raloxifene alone. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effect of treatment with combined raloxifene and estradiol compared with raloxifene alone on the severity of vasomotor symptoms as well as on the frequency and severity of hot flashes and night sweats |  |  | 
| Determine the effects of treatment with combined raloxifene and estradiol in postmenopausal women on endometrial and general safety |  |  |
Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to study light scattering properties of maternal-fetal tissue.

Detailed Description
-----------------
The ISS customized commercial frequency domain oximeter is used to obtain light scattering information from the maternal abdomen for 10-20 minutes preoperatively and postoperatively in subjects who are having a scheduled C-section.

Official Title
-----------------
Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

Conditions
-----------------
Fetal Distress

Intervention / Treatment
-----------------
* Device: ISS Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with singleton pregnancies, vertex or breech presentation, scheduled for non-emergent cesarean delivery, including cesarean delivery for failure to progress with reassuring electronic fetal heart rate tracing Age greater than or equal to 18 years of age. Healthy women at equal to or greater than 36 weeks gestation undergoing non-emergency cesarean delivery Spinal or epidural anesthesia Exclusion Criteria: Emergency cesarian delivery Non-reassuring fetal heart rate tracing Less than 18 years of age Multiple gestation (twins, triplets) Presentation other than vertex or breech Less than 36 weeks of gestation General anesthesia

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ISS Device|The ISS Device (commercial and prototype) is used to measure tissue light scattering.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical signal from maternal and fetal tissues | The study of light scattering through maternal/fetal tissue and through maternal tissue alone and newborn tissue alone using a commercial frequency domain oximeter and 2nd generation prototype. | Peri-operative |
PACU Stay After Lower Limb Revascularisation

Study Overview
=================
Brief Summary
-----------------
This study aims to describe the postoperative functions of patients with ischaemic lower extremities after undergoing revascularisation surgery . Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent discharge from PACU to the general ward. This include Aldrete scores and other complications that can be registrered descriptively. Furthermore, the study seeks to compare the complications outcomes between acute and elective revascularisation surgery.

Detailed Description
-----------------
As above

Official Title
-----------------
Perioperative Mechanisms for Postoperative Function - Case of Lower Extremities Revascularisation

Conditions
-----------------
Perioperative, Enhanced Recovery

Intervention / Treatment
-----------------
* Procedure: Acute vs elective


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptoms of ischaemic lower extremities for instance intermittent claudication, resting leg pain, non-healing/gangrenouswounds and acute cold leg. Patients who underwent one or more of the following surgical procedure: PTA + TEA, TEA, bypass, thrombectomy, embolectomy, femoral-femoral crossover bypass, axillary-femoral bypass. Exclusion Criteria: Only PTA intervention Only thrombolysis intervention

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 |
| --- |
|Procedure: Acute vs elective|non-intverention study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications assessed by aldrete score |  | up to 7 days |
Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults

Study Overview
=================
Brief Summary
-----------------
In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence. The aim of this study is to evaluate the efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with CD4 cell count over 100/mm3, antiretroviral naive.

Detailed Description
-----------------
In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Side effects of this products and the number of pills may induce a lower adherence, and thus a lower efficacy. 40 patients with a CD4 count over 100/mm3, a HIV RNA over 5,000 copies/ml and antiretroviral naive, take the once daily combination of FTC, ddI, efavirenz during 24 weeks. The primary end-point is the viral success maintained from 12 weeks until 24 weeks. Secondary end-point is the adherence to the association and safety. The trial is prolonged during a total of 72 weeks.

Official Title
-----------------
Pilot Study on Efficacy and Safety of a Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults. ANRS 091 MONTANA

Conditions
-----------------
HIV Infections, Antiretroviral Naive

Intervention / Treatment
-----------------
* Drug: emtricitabine, FTC (drug)
* Drug: didanosine, ddI (drug)
* Drug: efavirenz (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection Antiretroviral naive CD4 cell count over 100/mm3 Plasma HIV RNA load over 5,000 copies/mL Signed written informed consent Exclusion Criteria: Hepatitis B infection Pregnancy Alcool abuse Acute infection, past neurological or pancreatic disease, biological abnormalities Chemotherapy or immunotherapy

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: emtricitabine, FTC (drug)|nan|
|Drug: didanosine, ddI (drug)|nan|
|Drug: efavirenz (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virological success |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment adherence |  |  | 
| CD4 cell count |  |  | 
| Safety |  |  | 
| Progression of HIV infection |  |  | 
| Pharmacokinetics criteria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV infections, Reverse Transcriptase Inhibitors
Can a Vocal Stimulus Provoke Spontaneous Breathing in an Ischemic Stroke Patient Dependent on Mechanical Ventilation?

Study Overview
=================
Brief Summary
-----------------
Vocal stimulation may encourage spontaneous breathing in patients dependent on mechanical ventilation. The study will include 30 patients on mechanical ventilation that will be intervened by the vocal stimulation and 30 patients on mechanical ventilation will serve as the control group.

Detailed Description
-----------------
Vocal stimulation may encourage breathing in ventilated patients dependent on mechanical ventilation. The study will include 30 patients on mechanical ventilation that will be intervened by the vocal stimulation and 30 patients on mechanical ventilation that will be our control group.

Official Title
-----------------
Phase 1 - Vocal Stimuli to Provoke Spontaneous Breathing

Conditions
-----------------
Patients Ventilated by Mechanical Ventilation With Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ischemic stroke men and women older than 18 years old and younger than 80 years old Exclusion Criteria: coma from other reasons other than ischemic stroke hemmorhagic stroke active malignancy renal failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| spontaneous breathing | we anticipate a better response and recurring spontaneous breathing in the treatment group. | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical ventilation, ischemic stroke
Retrospective Evaluation of Lung Pathology in Subjects With COVID-19

Study Overview
=================
Brief Summary
-----------------
Non-interventional, retrospective, multi-center, follow-up study evaluating the effect of C21 on lung pathology in subjects previously hospitalised with COVID-19 and enrolled in the VP-C21-006 trial.

Detailed Description
-----------------
The study will collect available HRCT scans obtained prior to, during treatment with C21 or placebo and up to 24 weeks after trial completion. HRCT scans will be assessed for ground glass opacity, reticulation, band opacity, fibrosis and consolidation by a central, blinded HRCT reader.

Official Title
-----------------
Non-interventional, Retrospective, Multicenter, Follow-up Study Evaluating the Effect of C21 on Lung Pathology in Subjects Previously Hospitalized With COVID-19 and Enrolled in the VP-C21-006 Trial

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Previously included in the VP-C21-006 trial and received at least one dose of investigational medicinal product (IMP) Available record of at least one HRCT performed within 24 weeks after completion of VP-C21-006. Exclusion Criteria: Participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C21<br>Subject treated with C21 in the VP-C21-006 trial | |
| Placebo<br>Subject treated with placebo in the VP-C21-006 trial | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Averaged total lung score for both lungs percent measured by per lung percent scores | Based on ground glass opacity, reticulation, band opacity, fibrosis and consolidation, on HRCT | Up to 24 weeks after completion of VP-C21-006 | 
| Change from baseline in percent lung involvement measured totally (averaged total lung score for both lungs percent) and by each of ground glass opacity, reticulation, band opacity, fibrosis and consolidation on follow-up HRCT |  | Up to 24 weeks after completion of VP-C21-006 |