linjc16/ctgov huggingface dataset:
Effectiveness of Relaxation Techniques

Study Overview
=================
Brief Summary
-----------------
The study aims to assess the validity of a relaxation app. This will be accomplished by obtaining self-report measures about mood and respiratory symptoms. We hypothesize that self-report in the relaxation app condition will be different from that of the relaxation only condition.

Official Title
-----------------
Efficacy of an Application as a Relaxation Technique

Conditions
-----------------
Stress, Psychological

Intervention / Treatment
-----------------
* Behavioral: Relaxation Application
* Behavioral: Relaxation Only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Student enrolled in SMU Speaks English Exclusion Criteria: Must have an Apple Watch to use during time of participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of the two groups as they enter the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relaxation Application<br>Participants will follow the relaxation application. | Behavioral: Relaxation Application<br>* The use of an application for relaxation.<br>|
| Active Comparator: Relaxation Only<br>Participants will use any relaxation technique they normally use to relax. | Behavioral: Relaxation Only<br>* The individual's personal method to relax.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensations Questionnaire | Perceived bodily sensations. Scores range from 10-100, where higher scores indicate sensitivity to bodily sensations. | at study completion, up to 2 years | 
| Positive and Negative Affect Schedule | Immediate experience of mood. The measure consists of two scales, negative and positive items. Scores range from 10-50 for the positive scale, where higher scores indicate greater positive mood, and scores range from 10-50 for the negative scale, where higher scores indicate greater negative mood. | at study completion, up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breathe, breathing, relax, relaxation, respiration, stress
Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?

Study Overview
=================
Brief Summary
-----------------
Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a significant pain relief and decrease of evoked potentials and has been used to analyze conditioned pain modulation (CPM). However, it is unknown whether the pain relief results from habituation to the repeated painful electric stimulation. We compared the effects of CPM and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether increased attention by a random change of electric intensities amplifies the habituation effects.

Official Title
-----------------
Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?

Conditions
-----------------
Habituation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: any kind of disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief | pain intensity of painful cutaneous electrical stimulation on a numeric rating scale (NRS 0-100) | during the measurement | 
| N1P1-amplitude | Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV | during the measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N1-latency | Latency of the peak N1 of painful cutaneous electrical stimulation evoked potentials in msec | during the measurement | 
| P0N1-amplitude | Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV | during the measurement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Painful cutaneous electrical stimulation, Conditioned Pain Modulation
Surgical Technique To Control Postpartum Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Placenta accreta is an obstetrical complication where the placenta becomes firmly adherent to the uterine wall. Placenta accreta can lead to considerable maternal morbidity and mortality due to hemorrhage, infection, or other surgical complications such as those resulting from hysterectomy. Retained placenta accreta is usually a rare condition, but its prevalence is increasing due to the rise in the rate of deliveries by Cesarean section. Placenta accreta is a potentially life-threatening obstetric condition that requires a multidisciplinary approach to management. The incidence of placenta accreta has increased and seems to parallel the increasing cesarean delivery rate. Women at greatest risk of placenta accreta are those who have myometrial damage caused by a previous cesarean delivery with either an anterior or posterior placenta previa overlying the uterine scar. Diagnosis of placenta accreta before delivery allows multidisciplinary planning in an attempt to minimize potential maternal or neonatal morbidity and mortality.

Official Title
-----------------
New Surgical Technique To Control Postpartum Hemorrhage Due To Placenta Accreta

Conditions
-----------------
Post Partum Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Modified surgical technique for placenta accreta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Estimated gestational age between 34 -40 weeks . Presence of total or focal parts of placenta accreta morbidly adherent placenta . Cases with mild vaginal bleeding or not having any vaginal bleeding Exclusion Criteria: Severe attack of bleeding require an immediate intervention. Associated with placental abruption Patients with known bleeding disorders or on anticoagulant therapy. Preoperative decision to do peripartum hysterectomy.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Modified surgical technique for placenta accreta<br> | Procedure: Modified surgical technique for placenta accreta<br>* suturing of the myometrium splitted by the placenta in cases presented by placenta accreta<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of blood loss (mL) |  | 24 hours |
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine

Study Overview
=================
Brief Summary
-----------------
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.

Official Title
-----------------
An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine

Conditions
-----------------
Chronic Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients is currently clevudine treatment. Patients with HBV DNA < 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine Patient who is able to give written informed consent prior to study start and to comply with the study requirements. Exclusion Criteria: Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. Patient is pregnant or breast-feeding. Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease. Patient, in the opinion of the investigator, unsuitable for the study. Showing Muscle-related Symptom who any other evidence.
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 |
| --- | --- | --- |
| Proportion of patients with sustained antiviral activity effect |  | at week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of sAg |  | at week 48 | 
| Proportion of sAg loss |  | at week 48 | 
| The change of HBV DNA form the baseline | (log copies/mL) | at week 48 | 
| Proportion of patients with ALT normalization |  | at week 48 | 
| Proportion of HBeAg loss/seroconversion |  | at week 48 |
Disease Course in an IBD Cohort in the Era of Biological Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to do a 7-year follow-up of a consecutive inception cohort of 562 adults and children diagnosed and registered with inflammatory bowel disease in 2003-04 in order to evaluate the consequences of biological therapy in the treatment of IBD. The cohort is established after the implementation of biological agents in the treatment of IBD and the investigators hypothesis is that a) Severe disease course in IBD can be predicted by phenotypic presentation by serological, genetic, clinical and endoscopic characteristics to be used as guidance in the selection of treatment strategy and b) Introduction of biological treatment changes the course of disease in IBD and reduces the need of surgical procedures. Methods: Medical records will be reviewed to register the use of medication, flare ups (medical and surgical) and hospital admissions. Diagnosis, disease localization and behavior will be evaluated. At outpatient visits patients will get a clinical examination, blood and faeces will be collected to biobank and patients will be offered an endoscopical examination. The Montreal classification, The Harvey & Bradshaw's activity index (CD) and the SCAAI score (UC) will be used to describe disease localization, extent, behavior and severity. An electronic database will be established in use of processing data.

Official Title
-----------------
Risk of Surgery Among Patients Wih Ulcerative Colitis and Croh'ns Disease After Seven Years of Follow-up in the Era of Biological Treatment.

Conditions
-----------------
Crohn's Disease, Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients wil be followed up and diagnosis will be reassessed. Exclusion Criteria: Non-IBD (after reassessing diagnosis)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Disease course<br>562 patients diagnosed with Crohn's disease (209), ulcerative colitis (326) or indeterminant colitis (27) in the period of 1st of January 2003 to 31st of December 2004 in Copenhagen City and County (an area covering 23% of the Danish population). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical rate | The risk of intestinal surgery from inception (2003-04) until 7 years of follow-up in Crohn's disease and ulcerative colitis | 7 years from inception (2003-04) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory bowel disease, Crohn's disease, Ulcerative colitis, Disease course, Phenotype, Biological treatment
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.

Detailed Description
-----------------
Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.

Official Title
-----------------
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)

Conditions
-----------------
Heroin Dependence, Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Heroin Dependence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Heroin Dependence|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Retention |  |  | 
| Subjective dose estimate |  |  | 
| Observed withdrawal rating |  |  | 
| Opioid agonist rating |  |  | 
| Opioid antagonist rating |  |  | 
| Pupil diameter |  |  | 
| Compliance |  |  | 
| Analog rating scale for drug effects |  |  | 
| Drug effect characteristics |  |  | 
| Dose order estimate-nurse |  |  | 
| Dose order estimate-client |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heroin Dependence
French Lumbar Total Disk Replacement Observational Study

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To evaluate the rate of re-operation during the first 5 years following the fitting of lumbar total disk replacement at the operated level and / or floors above and / or underlying, whatever the reasons

Detailed Description
-----------------
Secondary objectives: The secondary objectives are: Describe the reasons for re-interventions operated floor and / or (x) level (s) adjacent (s) Describe the evolution of the function with the functional Oswestry score Describe the evolution of lumbar radicular pain by visual analog scale (VAS) Describe the evolution of the quality of life assessed by the SF12 score Describe the evolution of work status Describe patient satisfaction Describe the complications (intraoperative, early postoperative (within 3 months of surgery), late, death)

Official Title
-----------------
French Lumbar Total Disk Replacement Observational Study (FLTDR Observational Study)

Conditions
-----------------
Lumbar Total Disk Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who needs, according to his surgeon, a PTDL placement and has given his consent for the PTDL placement Patient who agrees to participate in the observational study after information by the surgeon Patient living in France and having the ability to respond alone to the questionnaire Exclusion Criteria: None
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 |
| --- | --- | --- |
| Evaluate the rate of re-intervention during the first 5 years after fitting of total disk replacement |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumbar Total Disk Replacement
An Observational Study to Evaluate the Treatment of Newvast® Tab(Atorvastatin) in Korean Patients With Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
In this study, dyslipidemia patients visited the institutions during the study period and the effectiveness and safety of the treatment of Newvast® Tab(Atorvastatin) in real-practice. During the routine medical visit, according to the investigator's judgment, with diagnosis that the Newvast® Tab(Atorvastatin) prescription is appropriate, regardless of medical history and concomitant-medication, and after deciding to start treatment, patients with Dyslipidemia who agreed to participate in the study were administered Newvast® Tab(Atorvastatin). As this study is a non-interventional observational study, all subjects received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

Detailed Description
-----------------
This study is a multicenter, prospective, non-interventional, observational study of patients administering Atorvastatin(Newvast® Tab) to treat Dyslipidemia. Data will be collected from patients receiving routine treatment at hospitals in South Korea. Each subject visits the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Atorvastatin(Newvast® Tab). This study will approved by the institutions' IRBs and is in compliance with clinical research ethics regulations.

Official Title
-----------------
An Observational Study to Evaluate the Safety and Effectiveness of Newvast Tab(Atorvastatin) in Korean Dyslipidemia Patients

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: single arm, single group(No interventional)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient was diagnosed with Dyslipidemia Those who voluntarily consented in writing to this study Exclusion Criteria: (1) Patients for whom use of Newvast® Tab is prohibited
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: single arm, single group(No interventional)|(Newvast® Tab, 10 to 80 mg daily administered per the locally approved product information)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of myalgia | The incidence of myalgia associated with Newvast® Tab(Atorvastatin) treatment | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyslipidemia, Atorvastatin, Statin
To Evaluate the Efficacy and Safety of JS002 in HoFH Patients

Study Overview
=================
Brief Summary
-----------------
JS002 is a recombinant human anti-PCSK9 monoclonal antibody. This phase II open-label, single-arm study aims to evaluate the efficacy and safety of JS002 in patients with homozygous familial hypercholesterolemia A dose group (450 mg) was set up in this study.Thirty subjects are planned to be enrolled. Each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.

Official Title
-----------------
An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients With Homozygous Familial Hypercholesterolemia

Conditions
-----------------
Hyperlipemia

Intervention / Treatment
-----------------
* Drug: JS002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent. Age ≥12 and ≤75 years old; Weight ≥40kg at the time of screening Patients diagnosed with HoFH Low-density lipoprotein cholesterol (LDL-C) level ≥3.4mmol/L at the time of screening Fasting triglycerides ≤4.5 mmol/L; Exclusion Criteria: History of NYHA class III-IV heart failure or EF<30% History of uncontrolled arrhythmia within 3 months History of MI,UA, PCI or CABG, stroke within 3 months. History of DVT or pulmonary embolism within 3 months. Planned cardiac surgery or revascularization. Uncontrolled hypertension. Uncontrolled diabetes mellitius (HbA1c>8.0%）. Other conditions that the researchers considered inappropriate to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 12 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: subcutaneous injection of JS002, 450mg, Q4W, 3/13 times.<br> | Drug: JS002<br>* Biological: JS002 Administered by subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of effectiveness | Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 | JS002 is administered subcutaneously every 4 weeks, from 12 or 52 weeks after initial administration |