linjc16/ctgov huggingface dataset:
Cycle and Ovulation Study Expansion

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to collect menstrual cycle, health sensor data and general health information to understand correlations between menstrual cycle and health sensor data, and how those correlations may be affected by general health. Participants entered menstrual cycle information (such as start dates, end dates, symptoms, flow), basal body temperature as measured by a thermometer, and ovulation and progesterone test results via apps installed on their iPhone. Additionally, participants were provided with an Apple Watch and a wrist-worn hardware prototype wrist-worn sleep band to collect physiological sensor data. Both menstrual cycle information and physiological sensor data stored on the participants' iPhone prior to enrolling in the study (up to 18 months) was also collected. This study aimed to collect data from females aged 14 and older who are currently menstruating with irregular and regular menstrual cycles.

Official Title
-----------------
Cycle and Ovulation Study Expansion

Conditions
-----------------
Menstruation

Participation Criteria
=================
Eligibility Criteria
-----------------
At least 14 years of age (19 for residents of Alabama and Nebraska and 21 for residents of Mississippi) Can communicate in written and spoken English Own functioning iPhone iOS 14 or later, with access to reliable data plan and Wifi Access to reliable Wifi in the bedroom Willingness to participate in remote visits and follow study procedures for the duration of the study, including use of Apple Watch and a wrist-work hardware prototype Able to read and understand the written consent form Reside in the US for the duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Menstrual patterns<br>Regular menstrual cycles and irregular menstrual cycles; irregular menstrual cycles are defined as having variation in menstrual cycles of greater than 2 days and less than 2 months | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective ovulation day estimate | Retrospective ovulation day estimation (algorithm uses multiple measurements including menstrual flow, urine ovulation prediction testing, basal body temperature, overnight aggregated wrist temperature) | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
menstruation, ovulation, menstrual cycle
The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
This research is a clinical trial of administering mesenchymal stem cell secretome to rheumatoid arthritis patients.

Detailed Description
-----------------
This research is experimental. The research subjects were 30 rheumatoid arthritis patients. The control group received a placebo, and the treatment group received mesenchymal stem cell secretome on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th. The data collected were erythroblastic acidity, hsCRP, interlukin 6, DAS-28, and assessment of drug side effects before and after therapy. Statistical test with paired difference test with p<0.05

Official Title
-----------------
The Effects of Mesenchymal Stem Cell Secretome in Rheumatoid Arthritis Patients

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Messenchymal stem cell secretome
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid Arthritis Patients Exclusion Criteria: Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: This study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled day
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Messenchymal stem cell secretome<br>The hypoxic mesenchymal stem cell secretome has been developed up to chapter 7, stored at -196 C to -135 C in cryopreservation, and has passed quality tests. | Drug: Messenchymal stem cell secretome<br>* Mesenchymal stem cell secretome obtained from Kalbe Pharma Company<br>* Other names: Messenchymal stem cell Concitioned Media;|
| Placebo Comparator: Placebo<br>Nacl 0,9% infusion | Drug: Placebo<br>* NaCl 0,9% infusion<br>* Other names: NaCl 0,9% infusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rheumatoid Arthritis Disease Activity | Disease Activity Score 28-joint count (DAS28) before and after therapy. | The change of Disease activity score patients at 1 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Messenchymal stem cell secretome
Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis: Phase III Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients with knee Osteoarthritis

Official Title
-----------------
Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Drug: SKCPT
* Drug: Celebrex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males and females aged 20 to 75 years Kellgren-Lawrence (KL) grade 1 to 3 Individuals who voluntarily decide to participate in the study and provide written informed consent form Individuals who can understand and follow instructions and can participate in the study during the entire study period Exclusion Criteria: Individuals who have clear secondary osteoarthritis caused by inflammatory, infectious, metabolic arthritis, or other conditions such as rheumatoid arthritis, rather than primary knee osteoarthritis as determined by the investigator Individuals with other factors that could potentially affect the assessment of this clinical study due to pain caused by osteoarthritis or other conditions in the hip joint Individuals who have undergone knee joint arthroplasty Individuals who have undergone open knee surgery (ligament reconstruction, osteotomy) within 3 years prior to the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SKCPT group<br> | Drug: SKCPT<br>* the randomly assigned subjects took the study drug for 12 weeks<br>|
| Active Comparator: Celebrex group<br> | Drug: Celebrex<br>* the randomly assigned subjects took the study drug for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| K-WOMAC Pain Subscale | The average changes in the K-WOMAC(Western Ontario and McMasters Universitis) Pain Subscale (range: 0-100 mm, higher scores mean a worse outcome) | 84 days |
A Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension

Official Title
-----------------
A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

Conditions
-----------------
Diabetes Mellitus, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those diagnosed with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab. Those who voluntarily signed a written personal information agreement to participate in this clinical study. Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion. Exclusion Criteria: Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.) Those who have a history of taking dapagliflozin within 4 weeks of baseline (Visit 1) Those who are expected to need insulin prescription during the study period Pregnant women, breast-feeding women

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Target blood pressure control rate |  | 12weeks after administration | 
| Target blood glucose achievement rate |  | 12weeks after administration |
Evaluation of Pulp Response to Castor Oil

Study Overview
=================
Brief Summary
-----------------
The present study was conducted to evaluate and compare pulp response to Castor oil versus Formocresol as Pulpotomy Medicaments in Primary Teeth

Official Title
-----------------
Comparative Evaluation of Pulp Response to Castor Oil Versus Formocresol as Pulpotomy Medicaments in Primary Teeth :An in Vivo Study

Conditions
-----------------
Pulp Response to Castor Oil

Intervention / Treatment
-----------------
* Drug: Castor oil
* Drug: Formocresol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy cooperative children with sound primary canines indicated for extraction for orthodontic reasons Exclusion Criteria: caries primary canines Presence of systemic pathology

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 9 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 |
| --- | --- |
| Experimental: Castor oil<br>Castor oil applied to one side of the selected primary canine | Drug: Castor oil<br>* Procedure :pulpotomy procedure and histological evaluation. A sample of sixty two primary teeth from thirty healthy cooperative children of both sexes who were between 7-9 years and referred to Pediatric Dentistry Department. Two sound teeth without pulpotomy procedure were extracted and subjected to histological procedures to examine the normal pulp tissue and tissue organization (Negative control). The pulpotomy procedure was performed in sixty primary teeth (by split mouth design). group I treated with castor oil<br>|
| Experimental: Formocresol<br>Formocresol applied to other side | Drug: Formocresol<br>* Group II treated with formocresol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of pulp inflammation using score. | The degree of pulp inflammation using scores from 0 to 5 , 0 mean no inflammation ,5 mean abscess formation . Measurement the effect of the castor oil as pulp medicament in treated teeth which subjected to decalcification procedure for histological evaluation under light microscope | 2 weeks to 3 months | 
| The presence or absence of dentin chips formation by using scores 0 or 1. | The presence or absence of dentin chips formation by using scores 0 or 1. Measurement the effect of the castor oil as pulp medicament in treated teeth which subjected to decalcification procedure for histological evaluation under light microscope | 2 weeks to 3 months |
Efficacy of Ultrasound-assisted Caudal Epidural Pulsed Radiofrequency for Anal Pain in Cancer Patients,

Study Overview
=================
Brief Summary
-----------------
Our primary goal will be to investigate the analgesic efficacy of ultrasound (US)-assisted caudal epidural PRF (pulsed radiofrequency)( stimulation in patients with perineal or anal pain cancer patients using (visual analog scale (VAS) scores from 0 to 10 at the baseline (pretreatment), two, four, and eight weeks; secondary outcomes will be the effects on opioid use and total opioid use in the 24 h, quality of life, patient satisfaction and opioid and intervention related side effects.

Official Title
-----------------
Efficacy of Ultrasound-assisted Caudal Epidural Pulsed Radiofrequency for Anal and Perineal Pain in Cancer Patients, a Prospective Randomized Clinical Study

Conditions
-----------------
Perineal Pain

Intervention / Treatment
-----------------
* Procedure: US assisted caudal epidural pulsed radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiology physical status of I or III (ASA), of both sex cancer-related anal or perineal pain Exclusion Criteria: coagulopathies allergies to the contrast dye patients with moderate or significant cardiac/respiratory disease or hepatic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ultrasound (US) assisted caudal epidural pulsed radiofrequency<br> | Procedure: US assisted caudal epidural pulsed radiofrequency<br>* patients will receive US assisted caudal epidural pulsed radiofrequency and followed up to 8 weeks<br>|
| No Intervention: conventional medical treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale (VAS) score 4 weeks post-intervention | Our primary goal will be to investigate the analgesic efficacy of ultrasound-assisted caudal epidural PRF stimulation in patients with perineal or anal pain cancer patients using VAS scores from 0 to 10 at the baseline (pretreatment), two, four, and eight weeks | 8 weeks |
Study for the Clinical Roadmap and Prognosis of Pulmonary Artery Sarcoma.

Study Overview
=================
Brief Summary
-----------------
This is an observational study in which patients with pulmonary artery sarcoma were followed up for at least 36 months and survival was investigated.

Detailed Description
-----------------
This is an observational study covering mainland China, and patients with pulmonary artery sarcoma were followed up for at least 36 months and survival was investigated.

Official Title
-----------------
A Multicenter, Observational Study for the Clinical Roadmap and Prognosis of Pulmonary Artery Sarcoma.

Conditions
-----------------
Pulmonary Artery Sarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Computed tomography pulmonary angiography indicated that there were intraluminal defects Malignant histopathology was sarcoma Informed consent form was signed Exclusion Criteria: Life expectancy was less than 3 months due to diseases other than pulmonary artery sarcoma Expected inability to complete follow-up
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 |
| --- | --- | --- |
| Progression-free survival | Time to death or disease progression | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time to death | 36 months | 
| Postoperative survival | Time from surgery to death | 36 months |
PROMIS Evaluation Study

Study Overview
=================
Brief Summary
-----------------
A total of 250 total hip arthroplasties (THA) are performed at the Bezirkskrankenhaus St. Johann. In a majority of those, implants from the company Falcon Medical (Austria) are used. Those implants are undergoing constant development and improvement. To guarantee their clinical performance, this clinical study is evaluating safety and efficacy of all implants produced by Falcon Medical. The purpose of this study is to evaluate the effcacy and safety of implants produced and distributed by Falcon Medical. All patients with primary THA and usage of a Falcon Medical implant are included. The outcome measures include intra-operative complications, early post-operative complications, revision for any cause and patient reported outcome (WOMAC questionnaire). All data is prospectively collected in a standardized fashion.

Official Title
-----------------
Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty

Conditions
-----------------
Hip Arthropathy, Osteoarthritis, Hip, Perthes Disease, Osteonecrosis, Femoral Neck Fractures

Intervention / Treatment
-----------------
* Device: PROMIS Stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary total hip arthroplasty with the PROMIS stem Exclusion Criteria: n/a

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br> | Device: PROMIS Stem<br>* Primary Total Hip Arthroplasty with the PROMIS Stem (Fa. Falcon Medical, Mödling, Austria)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stem Migration | Stem Migration measured with the validated EBRA method. The stem migration is assessed in millimeters. The radiograph before surgery and sequential radiographs after surgery are assessed. | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Score | Patient reported outcome score that is assessed before the surgery and one year after the surgery, 5 years after the surgery, 10 years and 20 years after the surgey. | 20 years |
Discrimination Harassment of Pain Staff Perpetrated by Patient

Study Overview
=================
Brief Summary
-----------------
Chronic pain is associated with mental disorders, and some patients have behavioral issues. Some patients may sexually or racially harass pain clinic staff. Healthcare staff do not usually report sexual or racial harassment perpetrated by patients. Quantitative and qualitative analysis of prospective electronic and clinic diary data. Evaluation of incidents of sexual and racial harassment of clinic staff; perpetrated by patients. Analysis of causative factors, incident outcome, system factors and lessons learned.

Detailed Description
-----------------
Chronic pain disorder may be associated with mental health disease. Many patients exhibit behavioral problems. Some of the patients may sexually or racially harass the pain clinic staff. Typically, healthcare providers do not report racial or sexual harassment perpetrated by patients. This is a quantitative analysis of prospective electronic and clinic diary data. It evaluates many incidents of sexual and racial harassment of pain clinic staff; perpetrated by patients. It analyzes the incident causative factors, incident outcomes, system factors and lessons learned. The qualitative information of each incident is presented in a sensitive and careful format.

Official Title
-----------------
Discrimination and Harassment of Pain Clinic Staff Perpetrated by Patients

Conditions
-----------------
Abuse, Sexual, Abuse, Workplace

Intervention / Treatment
-----------------
* Behavioral: Behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult chronic pain patients Exclusion Criteria: pediatric chronic pain patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 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 |
| --- | --- |
| Adult chronic pain patients<br>Adult chronic pain patients who sexually harass pain clinic staff | Behavioral: Behavioral therapy<br>* Behavioral and supportive therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who sexually or racially harassed clinic staff | Percentage of patients who sexually or racially harassed clinic staff | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Harassment by patients