linjc16/ctgov huggingface dataset:
Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical research study is learn about side effects and the success of bronchoscopies when performed in cancer patients with and without symptoms. This is an investigational study. Up to 110 patients will take part in this study. All will be enrolled at MD Anderson.

Detailed Description
-----------------
If participant agrees to take part in this study, researchers will collect information from participant's medical records. Length of Study: Researchers will continue to collect participant's medical information for up to 2 years. Additional Information: Participant's data will be kept in a database on a password-protected computer in a secure office. This information will only be available to the study doctors and staff.

Official Title
-----------------
Comparative Effectiveness of Bronchoscopic Interventions for Malignant Airway Obstruction

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

Intervention / Treatment
-----------------
* Behavioral: Medical Data Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ° All patients undergoing interventional bronchoscopy during the first 12 months will be enrolled, with follow-up occurring out to 2 years from the study startup (the duration of the grant). Exclusion Criteria: Age less than 18 years, Inability to participate in telephone 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bronchoscopy Data Collection<br>Medical information collected after bronchoscopy for up to 2 years. | Behavioral: Medical Data Collection<br>* Medical information collected after bronchoscopy for up to 2 years.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Any Complication Requiring Treatment | Researchers will estimate the hazard function of time to any complications in the framework of competing risks while death is the competing risk.3 Researchers will graphically visualize the hazard function of time to any complications using Kernel smoothing method. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality-Adjusted Survival | Researchers will evaluate the relationship between covariates and quality-adjusted survival. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Data collection post bronchoscopy
Balance Measures During Stance and Gait: Comparison of Gyroscopic Measurements of Trunk Sway

Study Overview
=================
Brief Summary
-----------------
To investigate whether an extended version of Valedo®Motion (termed Sensoro for brand management purposes), has the same trunk sway measures similar normal reference values of SwayStar. Offline data analysis of data obtained from Sensoro will be compared to data obtained by SwayStar, a highly accurate and widely accepted system for measuring balance control.

Detailed Description
-----------------
Determine a long time recording (over 60s) description of any differences in the drift and noise for the 2 systems during simultaneous recordings with the systems aligned with each other at rest. Compare Sensoro trunk sway measures with those of SwayStar for a battery of 17 stance and gait tasks. The tasks to range from tasks with small velocities (standing on 2 legs eyes open, ca 0.1 deg/s or eyes closed on foam ca.10 deg/s) through tandem and gait tasks with velocities of ca 70 deg/s to the most dynamic with high velocities (rising from a chair, ca 150 deg/sec). Estimate the additional value of adding trunk sway values for the yaw axis as an outcome measure of balance control. Estimate the advantage of adding one or two sensors on the legs to help identify gait balance events and body posture.

Official Title
-----------------
Quantified Balance Measures During Stance and Gait: Comparison of a New Micro-mechanical Gyro-system (Sensoro Von Hocoma AG) With SwayStar (Balance Int. Innov.) for Measurements of Balance Control of Healthy Controls.

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self reported lack of balance problems (checked by the ability to stand on 1 leg, eyes closed, for at least 14 secs). Exclusion Criteria: orthopaedic problems presence of diseases which cause balance problems.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Normal 1<br>SwayStar device used 1st, Sensoro used 2nd | |
| Normal 2<br>Sensoro device used 1st, SwayStar used 2nd | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trunk sway angular velocity and displacement stance and gait tasks. | Is trunk sway angular velocity and displacement measured with SwayStar different when measured with Sensoro for a battery of stance and gait tasks | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Balance control, Body-mounted sensors, Balance Measures
A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korean Patients

Study Overview
=================
Brief Summary
-----------------
This is a safety and efficacy study of BOTOX® (Botulinum Toxin Type A) in the Treatment of Adult Korean Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder.

Conditions
-----------------
Urinary Incontinence, Overactive Bladder

Intervention / Treatment
-----------------
* Biological: Botulinum Toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis Symptoms of urge urinary incontinence, urgency, and frequency due to overactive bladder Exclusion Criteria: Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis Use of botulinum toxin therapy of any serotype in the 3 months prior to screening Has acute urinary retention who do not routinely perform clean intermittent self-catheterization (CIC)

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BOTOX® 100U<br>Botulinum Toxin Type A 100U into the detrusor muscle on Day 1 in patients with Overactive Bladder | Biological: Botulinum Toxin Type A<br>* Botulinum Toxin Type A into detrusor muscle on Day 1<br>* Other names: onabotulinumtoxinA;|
| Experimental: BOTOX® 200U<br>Botulinum Toxin Type A 200U into the detrusor muscle on Day 1 in patients with Neurogenic Detrusor Overactivity | Biological: Botulinum Toxin Type A<br>* Botulinum Toxin Type A into detrusor muscle on Day 1<br>* Other names: onabotulinumtoxinA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the baseline in the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) total score |  | Baseline, Day 28 |
Stop Menstruation and Pregnancy Rates in Antagonist Protocol

Study Overview
=================
Brief Summary
-----------------
The proposal of this study is to evaluate the association between the achievement of ongoing pregnancy and hormonal levels on the first day after the period had stopped in rec-FSH/GnRH- antagonist cycles.

Detailed Description
-----------------
Ovarian stimulation will be achieved by rec- FSH, Puregon® starting on day 2 of the cycle at a dose of 200 IU/day. The dose of rec-FSH remains unchanged during stimulation until day 10 of the cycle. If it is necessary to increase the dose of rec-FSH after 10 days of stimulation, or to decrease the dose of rec-FSH due to a risk of OHSS, the patient will be dropped out of the study. To inhibit premature LH surge daily GnRH - antagonist (orgalutran 0,25mg ) is used from the morning of day 6 of stimulation. Final oocyte maturation will be achieved by administration of 10.000 IU of HCG (Pregnyl®) as soon as ≥ 3 follicles ≥ 17 mm are present. E2 levels should not be criteria for HCG administration. Oocyte retrieval will be carried out 36 hours after HCG administration. Conventional IVF or ICSI will be carried out. Embryo transfer will be carried out day3 or day5 after oocyte retrieval. Similar luteal support for all patients with vaginal administration of 600mg natural micronised progesterone in three separate doses (Utrogestan® 200mg 3xday) starting one day after oocyte retrieval will be used. Hormonal assessment (E2,FSH,LH,Progesterone) will be performed at initiation of stimulation, on the first day after the period had stopped and every 2 days until the day of HCG administration.

Official Title
-----------------
Is Hormonal Exposure of Endometrium on the First Day After Menstruation Associated With the Probability of Pregnancy in Patients Treated With Rec-FSH/ GnRH Antagonist? A Prospective Trial

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:- Age ≤ 39 years Body mass index between 18 and 29 kg/m²¬ Regular cycles between 25-34 days Presence of both ovaries Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle Treatment with IVF/ICSI Embryo transfer day 3 or day 5 (1 or 2 embryos) Patients can enter in the study only once Exclusion Criteria: Presence of endometriosis stage ≥3(AFS) Polycystic ovarian syndrome (Rotterdam criteria) Need for preimplantation genetic diagnosis (PGD) Azoospermia testicular sperm extraction (TESE)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 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 |
| --- | --- | --- |
| Ongoing pregnancy rate. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hormonal values, menstruations, pregnancy, antagonist
Comparison of NovoFine® Needles (4 mm vs. 6 mm)

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this investigation is to explore the safety of a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with diabetes.

Official Title
-----------------
A Comparative, Randomised Study With NovoFine® 4 mm Needle Versus NovoFine® 6 mm Needle in Regard to Anatomical Deposition of Sterile Air in Children and Thin Adults With Diabetes and Backflow of Test Medium (Only Adults) After Injection in Thigh and Abdomen

Conditions
-----------------
Delivery Systems, Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Device: NovoFine® needle 6 mm
* Device: NovoFine® needle 4 mm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children Type 1 diabetes Insulin treatment for more than ½ year BMI lesser than or equal to 19 kg/m2 Last HbA1c taken within the last year lesser than 10.5% Girls: only prepubertal Boys: both pre pubertal and pubertal. Adults Type 1 and 2 diabetes Insulin treatment for more than ½ year BMI lesser than or equal to 23 kg/m2 Last HbA1c taken within the last year lesser than 10.5% Exclusion Criteria: Known or suspected allergy to trial product(s) or related products. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any). Skin disease at abdomen and/or thigh

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 75 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NovoFine® needle 6 mm|nan|
|Device: NovoFine® needle 4 mm|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deposition of sterile air depositions. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of 1) dermis and 2) distance from skin surface to muscle fascia |  |  | 
| Amount of backflow |  |  |
Extracellular RNA Biomarkers of Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
Current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. The investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. The purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample.

Official Title
-----------------
Extracellular RNA Biomarkers of Duchenne Muscular Dystrophy

Conditions
-----------------
Duchenne Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with DMD or BMD based on genetic testing. Control subjects are unknown to have any other muscular dystrophy by history and may have had no genetic testing. Able to provide informed consent or assent for participation in the study. Demographic characteristics for biofluid collection: Males age 5 years and older with DMD or BMD; males and females ages 18 years and older without muscular dystrophy. Exclusion Criteria: Medical history of any of the following: State of immunosuppression; coagulopathy; pre-existing liver or kidney disease; documented HIV positive; documented hepatitis B and/or C positive. Use of anti-platelet drugs within 7 days prior to blood draw; use of anticoagulants within 60 days prior to blood draw. Inability or unwillingness of the subject to give written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biofluid collection<br>Eligible volunteers will be asked to provide a single urine sample and undergo a single blood draw. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extracellular RNA in biofluids | The extracellular RNA biomarkers in the muscular dystrophy groups will be evaluated and compared with the extracellular RNA content in control groups. Statistical analysis will be used to evaluate the sensitivity and specificity of these markers as measurements of disease activity and severity. | 4 years |
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease

Study Overview
=================
Brief Summary
-----------------
To assess the proximity of the catheter to the vessel wall and to correlate excised tissue with images collected by the integrated Optical coherence Tomography (OCT) imaging system. The primary endpoints are correlation between OCT images and histological characterization of excised tissue.

Official Title
-----------------
A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease

Conditions
-----------------
Peripheral Vascular Diseases

Intervention / Treatment
-----------------
* Device: NightHawk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requires treatment for peripheral arterial disease (PAD). Patient is willing and able to provide Informed Consent. Patient has at least one focal, de novo infrainguinal lesion in a native vessel. The minimum reference vessel diameter is 2.0 - 4.5 mm, dependent on the NightHawk device used. The lesion is ≥ 50% stenosed by quantitative vascular angiography. The lesion is ≤ 7 cm in length. The patient must be able to take at least one form of anti-platelet or anti-thrombotic therapy. Exclusion Criteria: Patient presents with degree of limb disease or a co-existing medical condition that makes revascularization inappropriate. The patient has diffuse peripheral arterial disease and/or the disease is heavily calcified. Patient presents with concomitant disease contraindicating an endovascular intervention. Patient is pregnant. The patient has a hypersensitivity to contrast materials that cannot be adequately pretreated.
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 |
| --- |
|Device: NightHawk|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
-----------------
CLI, Critical Limb Ischemia, PAD, Paripheral Arterial Disease, Artherosclerosis, Leg pain, Cardiovascular, Atherectomy, NightHawk
Effect of Transfusion of Plasma on Endothelial During Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
To study the effects of plasma transfusionon during liver transplantation on endothelial condition and short-term outcome in patients with end-stage liver disease.

Official Title
-----------------
Effect of Transfusion of Plasma During Orthotopic Liver Transplantation on Endothelial Glycocalyx Layer and Short-term Outcome in Patients With End-Stage Liver Disease

Conditions
-----------------
End Stage Liver DIsease, Liver Transplantation

Intervention / Treatment
-----------------
* Biological: fresh frozen plasma
* Diagnostic Test: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child A/B cirrhosis patients who undergo the first OLT Informed and consented complete follow-up cooperate with treatment Exclusion Criteria: re-transplant combined liver and other organ transplantation BMI≥30Kg/m2 patients with hypertension, diabetes, coronary heart disease, chronic renal insufficiency, preoperative pulmonary infection, pleural effusion acute liver failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: control group<br>perform artificial colloidal solution transfusion during anhapetic phase. | Diagnostic Test: blood sample<br>* get blood samples at several specific points in time during perioperation<br>|
| Experimental: anhapetic group<br>Perform plasma transfusion during anhapetic phase. | Biological: fresh frozen plasma<br>* perform plasma transfusion in different phases during perioperation<br>Diagnostic Test: blood sample<br>* get blood samples at several specific points in time during perioperation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial glycocalyx layer shedding markers | plasma concentration of endothelial glycocalyx layer shedding markers | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory cytokines | levels of inflammatory cytokines | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelial, plasma