linjc16/ctgov huggingface dataset:
Effect of CPAP on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of CPAP treatment on blood pressure in patients with sleep apnea syndrome (SAS) and refractory arterial hypertension (RAH). Also, some of the mechanisms mediating SAS and RAH (systemic inflammation, oxidative stress, sympathetic hyperactivity) will be analyzed.

Official Title
-----------------
Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Blood Pressure in Patients With Sleep Apnea and Refractory Hypertension

Conditions
-----------------
Obstructive Sleep Apnea, Refractory Arterial Hypertension

Intervention / Treatment
-----------------
* Device: CPAP
* Device: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: refractory arterial hypertension and sleep apnea with apnea-hypopnea index over 15 Exclusion Criteria: excessive sleepiness professional drivers secondary arterial hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Positive Airway Pressure<br>nocturnal continuous positive airways pressure | Device: CPAP<br>* continuous positive airways pressure<br>|
| Other: Control<br>Waiting list,3 months without any change in their treatment, come into the CPAP procedure after that time | Device: Control<br>* Patients are 3 months without any change in their treatment, and are in the waiting list to come into the CPAP procedure after that time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours blood pressure monitoring |  | basal and after three months of CPAP treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress and inflammatory mediators |  | basal and after three months of CPAP treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, refractory arterial hypertension, continuous positive airways pressure
Autologous Stem Cell Rescue for Primary Amyloidosis

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis.

Detailed Description
-----------------
To learn about the use of high dose chemotherapy followed by transplantation using peripheral blood stem cells.

Official Title
-----------------
High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis

Conditions
-----------------
Amyloidosis, Blood and Marrow Transplant (BMT)

Intervention / Treatment
-----------------
* Procedure: high dose chemo then auto hematopoietic cell transplant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Primary amyloidosis 2. Age < 75 years. 3. Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. 4. Patients who have undergone bone marrow transplantation previously will not be eligible. 5. Patients must have a Karnofsky performance status greater than 70%. 6. Patients must have a serum creatinine less than 2 mg/dl or creatinine clearance greater than 30 ml/min, bilirubin less than 2 mg/dl, transaminases less than two times normal, left ventricular ejection fraction >45% on echocardiography, cardiac index > 1.8 liters/min/m^2 and pulmonary function tests demonstrating FEV1 and DLCO > 60%. 7. Patients must be HIV negative. 8. Pregnant or lactating women will not be eligible to participate. 9. Patients must provide signed informed consent. 10. Patients with multiple myeloma and amyloid are eligible. Exclusion Criteria:1. prior blood or marrow transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: high dose chemo then auto hematopoietic cell transplant|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis |  |  |
Maintenance Plasma Exchange for Neuromyelitis Optica

Study Overview
=================
Brief Summary
-----------------
Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance PLEX) is sometimes used to prevent relapses. This observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX for NMO.

Detailed Description
-----------------
Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance PLEX) is sometimes used to prevent relapses. This observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX for participants with NMO, NMO spectrum disorders, and recurrent idiopathic longitudinally extensive transverse myelitis.

Official Title
-----------------
A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)

Conditions
-----------------
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis

Intervention / Treatment
-----------------
* Procedure: Plasma exchange (PLEX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neuromyelitis optica Neuromyelitis optica spectrum disorder Recurrent idiopathic longitudinally extensive myelitis Age 18 years or greater Exclusion Criteria: Any condition that in the opinion of the investigator could increase a participant's risk by participating in the observational study or confound the outcome of the study

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 |
| --- | --- |
| Maintenance PLEX<br> | Procedure: Plasma exchange (PLEX)<br>* Regular maintenance PLEX courses, typically 3 procedures monthly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who complete planned maintenance PLEX regimen |  | One year | 
| Number of participants with adverse events |  | One year | 
| Annualized clinical relapse rate |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Expanded Disability Status Score (EDSS) |  | One year |
Effectiveness of Combination of Arimidex and Nolvadex in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and tolerability of 3 years treatment with anastrozole after a prior 2 years' treatment with tamoxifen versus 5 years treatment with tamoxifen in postmenopausal women with early breast cancer

Official Title
-----------------
A Prospective, Multi-Centre, Randomised, Open Parallel Group Study to Compare the Effectiveness and Compatibility of ARIMIDEX (ZD 1033) With NOLVADEX After a Prior 2 Years' Treatment With Tamoxifen in Adjuvant Therapy of Breast Carcinoma in Postmenopausal Women.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Anastrozole
* Drug: Tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, Post-menopausal women ≤75 years, histologically confirmed invasive breast carcinoma (no distant metastases), positive hormone receptor status, continuous 2-year adjuvant tamoxifen therapy 20 mg/30 mg with 4 weeks after primary surgery Exclusion Criteria: menopause status maintained by medication, pre-operative chemotherapy or hormone therapy or radiation therapy, relapse or second carcinoma or previous cancerous disease, breast carcinoma in situ, simultaneous carcinoma of the opposite side or secondary breast, 10 or more tumour-infiltrated lymph nodes. serious accompanying diseases

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

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

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: 1<br>Anastrozole | Drug: Anastrozole<br>* oral<br>* Other names: ZD1033;|
| Active Comparator: 2<br>Tamoxifen | Drug: Tamoxifen<br>* oral<br>* Other names: Nolvadex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess difference in overall survival between the two treatment arms |  |  | 
| To assess difference in disease recurrence between the two treatment arms |  |  | 
| To assess difference in safety and tolerability between the two treatment arms |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Early Breast Cancer
CardioFocus HeartLight Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.

Detailed Description
-----------------
This is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the HeartLight System during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal atrial fibrillation.

Official Title
-----------------
Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: HeartLight
* Procedure: Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation failure of at least one anti-arrhythmic drug others Exclusion Criteria: overall good health as established by multiple criteria

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 |
| --- | --- |
| Other: Treatment<br>Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System | Device: HeartLight<br>* HeartLight Endoscopic Ablation System<br>Procedure: Ablation<br>* Pulmonary vein isolation ablation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter/atrial tachycardia (AFL/AT) lasting longer than 30 seconds post the 90 day blanking period | The outcome will be assessed from 91 days post procedure through 12 months | Day 91 through 12 months |
Effects of Vibrations on the Biceps Brachii Muscle and Grip Strength

Study Overview
=================
Brief Summary
-----------------
It has been suggested that applying acute vibration exercises enhances muscle force, like several weeks of resistance training. The present study investigated the effects of local vibration with two different frequencies on biceps brachii isometric muscle strength and grip strength in healthy young men. Isometric strength of the biceps brachii muscle and grip strength were assessed at baseline and after vibration training (immediate, 10 minutes, and 20 minutes post vibration training).

Official Title
-----------------
Effects of Localized Vibration Training on the Biceps Brachii Muscle and Grip Strength in Healthy Adult Males: An Experimental Study

Conditions
-----------------
Muscle Strength

Intervention / Treatment
-----------------
* Other: Vibration training with 42 Hz
* Other: Vibration training with 63 Hz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult males Exclusion Criteria: history of recent upper extremity injury sensory deficits in the upper extremity history of recent upper extremity surgery participation in any resistance training

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two group parallel design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 42 Hz group<br>Vibration training with 42 Hz was given to participants. | Other: Vibration training with 42 Hz<br>* Vibration exposure was given using a handheld vibration device.<br>|
| Active Comparator: 63 Hz group<br>Vibration training with 63 Hz was given to participants. | Other: Vibration training with 63 Hz<br>* Vibration exposure was given using a handheld vibration device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric strength of Biceps brachii muscle | Isomeric strength of the biceps brachii muscle of the dominant arm was measured at an Angle of 90 degree flexion using a handheld dynamometer | 20 minutes | 
| Hand grip strength | Hand grip strength was measured using a standard adjustable Jamar hand dynamometer. | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vibration Training, Biceps Brachii, Muscle Strength, Handgrip
Bioequivalence Study of Rivaroxaban

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to establish the bioequivalence between rivaroxaban tablet 15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of rivaroxaban 15 mg in healthy adult male subjects.

Official Title
-----------------
Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 15 mg and a Rivaroxaban Granule 15 mg in Japanese Healthy Adult Male Subjects

Conditions
-----------------
Embolism, Atrial Fibrillation and Venous Thrombosis

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (BAY 59-7939)
* Drug: Rivaroxaban (Xarelto, BAY 59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese healthy male subjects 20 to 40 years of age 17.6 to 26.4 kg / m² of body mass index (BMI) Exclusion Criteria: Subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal Subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction Subject with known coagulation disorders (eg von Willebrand's disease, hemophilia) Subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer) Subject with known sensitivity to common causes of bleeding (eg nasal)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY59-7939 Rivaroxaban granule<br> | Drug: Rivaroxaban (BAY 59-7939)<br>* Rivaroxaban granule15mg for one day<br>|
| Active Comparator: BAY59-7939 Rivaroxaban tablet<br> | Drug: Rivaroxaban (Xarelto, BAY 59-7939)<br>* Rivaroxaban tablet15mg for one day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum observed drug concentration in measured matrix after single dose administration) |  | Multiple time point up to 3 day | 
| AUC(0-tlast) (AUC from time 0 to the last data point > LLOQ (lower limit of quantitation)) |  | Multiple time point up to 3 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | Up to 30 day |
Role of Vaginal Misoprostol Prior to IUCD Insertion in Women Who Delivered Only by Elective Caesarean Section.

Study Overview
=================
Brief Summary
-----------------
Role of vaginal misoprostol prior to IUCD insertion in women who delivered only by elective caesarean section.

Detailed Description
-----------------
Misoprostol ( 400mcg ) vaginally administrated 3 hours prior to IUCD insertion increases the ease and success of insertion and decrease associated pain among women who had delivered only by elective caesarean section.

Official Title
-----------------
Role of Vaginal Misoprostol Prior to IUCD Insertion in Women Who Delivered Only by Elective Caesarean Section.

Conditions
-----------------
IUD Insertion Complication

Intervention / Treatment
-----------------
* Drug: misoprostol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women will be 20 to 40 years of age. Desires IUCD placement and able to participate. Negative pregnancy test. Willing to follow- up in 6-8 weeks for a standard IUCD follow-up visit. Delivered only by cesarean section. Exclusion Criteria: Active cervical infection. Current pregnancy. Uterine anomaly. Fibroid uterus. Copper allergy/Wilson's disease. Undiagnosed abnormal uterine bleeding. Cervical or uterine cancer. Allergy to misoprostol. Previous vaginal delivery.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>2 tablets vaginally | Drug: Placebo<br>* starch pills manufactured to mimic misoprostol 200 mg tablets<br>|
| Experimental: misoprostol group<br>400 mcg vaginally | Drug: misoprostol<br>* misoprostol 2 tablets<br>* Other names: cytotec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of failed IUCD insertions regardless of the reason . | pain reported by particiepant during insertion graded from 1 to 10 on visual analogue scale | during insertion | 
| the degree of difficulty of the IUCD insertion . | Judged as the resistance of the internal cervical os experienced by the investigator and measured by a 5-point scale. | during insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heavy bleeding | heavy bleeding and blood clots | 7 days | 
| partial or total expulsion | not insitu by U/S | 4 to 6 weeks |