linjc16/ctgov huggingface dataset:
FR01 and FR20 IUS (Intrauterine System) Wearing Study

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate two different placebo intrauterine systems, placebo FR01 and FR20 with different types of inserters, for wearing comfort, insertion/removal ease and pain compared to a placebo T-frame intrauterine system.

Official Title
-----------------
A Multi-center, Single-blinded, Randomized, Controlled, Parallel-group Study to Evaluate the Wearing Comfort of Two Different Placebo Intrauterine Systems FR01 and FR20 Compared to a Placebo T-frame Intrauterine System for 3 Cycles in Healthy Women Aged 18-40 Years

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Placebo: Flexi ring FR01
* Drug: Placebo: Flexi ring FR20
* Drug: Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Female subject Age 18-40 years (inclusive) History of regular cyclic menstrual periods at baseline (cycle length 21 to 35 days) Women using any COC (combined oral contraceptive) for contraception with a monthly regimen before the study entry. Confirmed uterine sound depth of 6 to 10 cm Exclusion Criteria: Pregnancy or lactation Sterilized Nulliparous Congenital or acquired uterine anomaly Vaginal or cesarean delivery within 8 weeks prior to insertion

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Flexi ring FR01<br> | Drug: Placebo: Flexi ring FR01<br>* Intrauterine device, inserted once for 3 months<br>|
| Placebo Comparator: Flexi ring FR20<br> | Drug: Placebo: Flexi ring FR20<br>* Intrauterine device, inserted once for 3 months<br>|
| Placebo Comparator: Ultra low dose LCS<br> | Drug: Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)<br>* Intrauterine device, inserted once for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic pain during the IUS wearing period (wearing comfort) measured by 5-point Likert scale (no pain/mild/moderate/severe/very severe pain) |  | 3 months |
Assessment of Safety & Efficacy of Light Weight Breast Implant

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation.

Detailed Description
-----------------
This is a Single-center. The purpose of the study is to evaluate safety and effectiveness of LWBI in breast augmentation.

Official Title
-----------------
Assessment of Safety & Efficacy of Light Weight Breast Implant

Conditions
-----------------
Breast Implants

Intervention / Treatment
-----------------
* Device: Light Weight Breast Implants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetic women at ages 18 to 65 seeking breast enlargement Signed informed consent Agreement to complete all required follow up visits A medically acceptable candidate Sufficient breast tissue for proper implant coverage (≥20 mm by pinch test) Exclusion Criteria: Patients with active infection anywhere in their body Women who are currently pregnant or nursing Insufficient tissue covering in the prospective area of implantation (e.g. after preceding breast reduction), radiation damage or reduced vascularization Abscesses, malignant tumors(cancer or recurrent metastases), advanced fibrocystic diseases Patients with a history of psychiatric treatment Patients that been implanted with any silicone implant (e.g. silicone artificial joints, facial implants) Expected allergies or extraordinary immune response to implants Wound healing impairments or heavy burn scars Existing costal injuries The Patient Participated in an investigational trial within 30 days of enrollment

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light Weight Breast Implants<br>Assessment of Safety and Efficacy of Light Weight Breast Implant | Device: Light Weight Breast Implants<br>* Light Weight Breast Implants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No reoperation |  | during 6 months follow up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration for all adverse events (AEs) on per patient and per implant basis will be recorded and analyzed. |  | 6 month |
Studying Tumor Tissue Samples From Patients With Soft Tissue Sarcoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor tissue samples from patients with soft tissue sarcoma.

Detailed Description
-----------------
OBJECTIVES: To develop a pilot program for the collection, archiving, and experimental analyses of soft tissue sarcomas (STS). To obtain STS tumors from cancer patients undergoing tumor removal or core needle biopsies. To evaluate cellular and molecular factors involved in STS oncogenesis by studying samples derived from human tumor specimens. To develop an accompanying bioinformatics database of the demographics of STS patients from which tumor specimens are derived for experimental study. OUTLINE: Tumor tissue samples are analyzed for gene and protein expression by cDNA microarray analysis, RT-PCR, immunohistochemistry, in vitro transformation assays, RNA interference, and Western blot or immunoprecipitation.

Official Title
-----------------
LABORATORY STUDIES OF SOFT TISSUE SARCOMAS

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Genetic: DNA analysis
* Genetic: gene expression analysis
* Genetic: protein expression analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Genetic: western blotting
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Meets one of the following criteria: Patients with soft tissue sarcoma (STS) undergoing evaluation, treatment, and/or follow-up at the Arizona Cancer Center or University Medical Center Patients undergoing surgical treatment for STS removal or core needle biopsy for medically indicated diagnostic or therapeutic purposes PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA analysis|nan|
|Genetic: gene expression analysis|nan|
|Genetic: protein expression analysis|nan|
|Genetic: reverse transcriptase-polymerase chain reaction|nan|
|Genetic: western blotting|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of molecular targets that would improve the diagnosis, prognosis, and/or treatment of STS |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult soft tissue sarcoma, childhood soft tissue sarcoma
Cephea Early Feasibility Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral regurgitation ≥ Grade III in whom transcatheter therapy is deemed more appropriate than open heart surgery.

Official Title
-----------------
Cephea Early Feasibility Study

Conditions
-----------------
Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: Cephea Mitral Valve System


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Mitral regurgitation ≥ Grade III per American Society of Echocardiography criteria. LVEF ≥ 30% In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery. Key Exclusion Criteria: Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. Need for emergent or urgent surgery.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment of mitral regurgitation with the Cephea Mitral Valve System | Device: Cephea Mitral Valve System<br>* Transcatheter mitral valve replacement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Freedom from all-cause mortality, which will be assessed at 30 days post implant. | 30 days post implant | 
| Primary Effectiveness Endpoint | Proportion of subjects with mitral regurgitation less than Grade II will be assessed at 30 days post implant. | 30 days post implant |
Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC

Study Overview
=================
Brief Summary
-----------------
Intubated preterm infants between 800-1200 grams and under 32 weeks of gestational age will start with PRVC ventilation mode, basal blood gases and work of breathing will measured. After that mode will shift to Bilevel Volume Guarantee mode for two hours than clinical and other parameters will be checked again. After this intervention, patients will allocated to PRVC or Bilevel VG group for remaining time.

Official Title
-----------------
Two Different Types of Ventilation in Preterm Neonates; Bilevel Volume Guarantee and Pressure Regulated Volume Control

Conditions
-----------------
Newborn Morbidity, Respiratory Failure, Bronchopulmonary Dysplasia, Mechanical Ventilation Complication

Intervention / Treatment
-----------------
* Device: GE ventilator with two different modes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Need for mechanical ventilation 800-1200 grams of birthweight Surfactant received under 32 weeks of gestational age Exclusion Criteria: No need to intubation Congenital anomalies -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 3 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PRVC<br>Preterm infants with need of mechanical ventilation will receive PRVC mode until extubation | Device: GE ventilator with two different modes<br>* GE ventilator with two different modes<br>|
| Bilevel VG<br>Preterm infants with need of mechanical ventilation will receive Bilevel VG mode until extubation | Device: GE ventilator with two different modes<br>* GE ventilator with two different modes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Duration of mechanical ventilation | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen dependency | Need for supplemantal oxygen | 8 weeks |
Ultrasonography Biofeedback for Diaphragm Training in Athletes With Lumbo-pelvic Pain

Study Overview
=================
Brief Summary
-----------------
Objective: To determine the effectiveness of diaphragm biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in athletes with lumbo-pelvic pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 80 athletes with lumbo-pelvic pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with diaphragm biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. Outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.

Official Title
-----------------
Effectiveness of Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumpo-pelvic Pain

Conditions
-----------------
Ultrasonography, Low Back Pain

Intervention / Treatment
-----------------
* Other: Experimental
* Other: Active comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Athletes with non-specific lumbopelvic pain during 6 weeks Exclusion Criteria: Neural disorders Systemic disorders Cognitive disorders

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diaphragm biofeedback reeducation plus inspiratory training<br> | Other: Experimental<br>* Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks<br>|
| Active Comparator: Isolated high-intensity inspiratory muscle training<br> | Other: Active comparator<br>* Isolated high-intensity inspiratory muscle training during 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm muscle thickness | Diaphragm muscle thickness evaluated in centimeters by ultrasonography | Change from Baseline diaphragm muscle thickness at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold | Pressure pain threshold evaluated in kilograms / squared centimeter by algometer | Change from Baseline pressure pain threshold at 8 weeks |
Positive Effects of Haematococcus Astaxanthin on Oxidative Stress and Lipid Profile in Overweight and Obese Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether astaxanthin (ASX) supplementation will reduce obesity-induced oxidative stress and improve lipid profile in overweight and obese adults.

Conditions
-----------------
Healthy, Overweight, Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: astaxanthin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with BMI over 25.0 kg/m2 Non-smoker Exclusion Criteria: Excessive alcohol consumption Pregnant or lactating women Dyslipidemia, hyperglycemia, or other chronic diseases. Subjects who were taking vitamin supplements

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: astaxanthin|astaxanthin 20mg for 12 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the plasma MDA (malonaldehyde) level | MDA is a three chain aldehyde produced during the composition of a lipid hydroperoxide and is a well known indicator of lipid peroxidation. The purpose of this stduy is to determine whether ASX supplementation lowers oxidative stress using MDA,a biomarker. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy adults with BMI over 25.0 kg/m2
Evaluation of Pain Measurement Device

Study Overview
=================
Brief Summary
-----------------
This longitudinal observational study will attempt to objectively measure pain with an experimental, non-invasive device. Patients and volunteers will receive a baseline screening with psychophysical tests and questionnaires. Investigators will apply the device to measure pain during routine clinical care and correlate patients pain ratings and analgesia requirements to that measured by the device. A more standardized approach with experimental pain stimuli will be pursued in human volunteer studies.

Official Title
-----------------
Longitudinal Observational Pilot Study to Assess the Capabilities of an Experimental Device to Objectively Measure Pain.

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-100 years Exclusion Criteria: inability to sign consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| surgical patients<br>no interventions, observational study | |
| laboring women<br>no interventions, observational study | |
| volunteers<br>pain induction by noxious heat stimulation, measurement of pain by device and documentation of pain reported by subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between pain as measured by the device and reported pain and clinical events, respectively |  | average 4 hours |
Effects Neuromuscular Taping Technique on Upper Limbs Edema in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
This study aims to verify the efficacy of the decompression technique of neuromuscular taping on cardiac surgery patients in whom edema of the upper limbs occurs due to post-operative water overload.

Official Title
-----------------
Effects Neuromuscular Taping Technique on Upper Limbs Edema in Cardiac Surgery Patients

Conditions
-----------------
Edema Limbs

Intervention / Treatment
-----------------
* Device: neuromuscolar tape
* Behavioral: antigravity arm position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac surgery patients with postoperative edema of the upper limbs due to water overload Exclusion Criteria: absence of edema, previous mastectomy and lymphadenectomy, surgery or fractures or infection of the upper limb, previous or current deep vein thrombosis.
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treated group<br>neuromuscolar tape application | Device: neuromuscolar tape<br>* neuromuscalar tape application in decompression technique (hand and arm)<br>|
| Active Comparator: control group<br>antigravity position | Behavioral: antigravity arm position<br>* antigravity arm position<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| circumference's change of index finger, metacarpus, wrist, mid forearm, elbow and upper arm | measure tissue edema change by circumference change in specific site of the limb ( index finger, metacarpus, wrist, mid forearm, elbow and upper arm) | measure in millimeter on first postoperative day: before application of tape; and then, every day for the first 3 days, after tape removing, and before the new application. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of the intensity of pain | measurement of the intensity of pain during mobilization of fingers, wrist and arm using a VAS scale( 0 is no pain and 10 is the worst possible pain) | Measure every day for the 3 days of treatment, before application of tape | 
| movement ability of wrist, hand and arm | measure angle variation in pronosupination and flexion extension, ulnar and radial deviation of the wrist with articular goniometer | measure every day for the 3 days of treatment, before application of tape | 
| muscle strength measure | measurement of the handheld gripping force by means of a dynamometer | measure every day for the 3 days of treatment, before application of tape |