linjc16/ctgov huggingface dataset:
Accuracy of Rhythm Detection by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)

Study Overview
=================
Brief Summary
-----------------
It is an attempt to see the reliability of the Wearable Smart Watch in identifying atrial fibrillation and other arrhythmias compared to the data detected from ILRs.

Detailed Description
-----------------
The sensitivity, specificity, positive and negative predictive values for successful identification of normal sinus rhythm, atrial fibrillation and other rhythm disorders from the smart watch will compared to that of an ILR.

Official Title
-----------------
Accuracy of Rhythm Detection and Managing Data Deluge by a Wearable Smart Watch for Cardiac Arrhythmias (The WATCH-RHYTHM Study)

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

Intervention / Treatment
-----------------
* Other: AFib detection with wearable smart watch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years old Patients who have an implantable loop recorder for heart rhythm monitoring purposes Having IOS iphone device that can be integrated into Apple Watch Willing to sign a consent form and participate in the study Exclusion Criteria: Hemodynamically unstable patients Over 90 years of age Presence of wrist tattoos Presence of AV fistula on the wrist on which the wearable is worn. (If the contralateral wrist is unaffected, those patients can be included) Presence of Implantable Cardiac Pacemaker and/or ICD Patients with Parkinsons disease or tremors

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Smart Watch<br>The patients will wear the Smart Watch to generate data to assess their rhythm as confirmed by the ILR done during the same time. | Other: AFib detection with wearable smart watch<br>* Patients will transmit two rhythm strips every day through both the devices and additional transmission whenever they have symptoms (palpitations, skipped beats, shortness of breath and chest pain). The transmitted rhythm strips are de-identified and analyzed after assigning a unique ID for research purposes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AFib detection with heart rate data measured by Smart Watch | Heart rate data generated by Smart Watch is used to assess their rhythm as confirmed by the ILR done during the same time. | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wearable technology, ILR, Smart Watch, AFib detection
Flash Open Trial With Therapists In Training

Study Overview
=================
Brief Summary
-----------------
This study will test the eye movement desensitization and reprocessing (EMDR) based Flash technique and a progressive counting (PC) based variant. EMDR-trained therapists will be trained in the standard Flash, and PC-trained therapists will be trained in PC Flash. In each group they will try it with a minor upsetting memory, and then with two more significant upsetting memories. Participants will use the subjective units of distress scale (SUDS) to rate distress pre- and post-treatment.

Official Title
-----------------
Flash Open Trial With Therapists In Training

Conditions
-----------------
Trauma, Psychological

Intervention / Treatment
-----------------
* Behavioral: PC-based Flash
* Behavioral: EMDR-based Flash


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Therapist trained by Trauma Institute & Child Trauma Institute in EMDR or PC
Sexes Eligible for Study
-----------------
All

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PC-trained therapists<br> | Behavioral: PC-based Flash<br>* Progressive counting with Flash technique<br>|
| Experimental: EMDR-trained therapists<br> | Behavioral: EMDR-based Flash<br>* Eye movement desensitization and reprocessing with Flash technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SUDS following treatment | Subjective units of distress scale | Pre-treatment, immediately post-treatment, one week post-treatment, and one month post-treatment |
Effect of Post Traumatic Stress Disorder on Parenting

Study Overview
=================
Brief Summary
-----------------
PTSD affects a wide variety of symptoms, some of which have been shown to disrupt family relationships. This study will examine some of the effects on parenting, from the perspective of the parent with PTSD.

Official Title
-----------------
Parenting With and Without PTSD: The Effect of Attachment, Symptoms and Posttraumatic Growth

Conditions
-----------------
Post Traumatic Stress Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ptsd (PSS>15) children under age 18 Exclusion Criteria: non ptsd (pss<15) children under age 18

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| PTSD group<br>Patients with PTSD | |
| Control Group<br>non PTSD group | |

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
-----------------
ptsd, parenting
A Nutritional Approach to Minimal Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
This trial will study a possible effect of standard Israeli breakfast (30% of caloric value and 21 gram protein) on cognitive and executive functions (working memory, visual memory, concentration and coordination), on patients with mild-moderate liver cirrhosis.

Official Title
-----------------
A Nutritional Approach to Minimal Hepatic Encephalopathy

Conditions
-----------------
Minimal Hepatic Encephalopathy

Intervention / Treatment
-----------------
* Other: Nutritional Intervention
* Other: Nutritional Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consented adults (age > 18), with the diagnosis of CHILD A cirrhosis with MELD score of < 10. Diagnosis of liver cirrhosis as documented by liver biopsy (stage IV) and / or fibroscan (score > 12 kpa) and / or fibrotest (score > 0.74) and /or imaging. Exclusion Criteria: History of > grade II hepatic encephalopathy (HE). Diagnosis of dementia, Parkinson disease, Schizophrenia (Patients with major depression will be noted but not excluded). Use of sedatives, tranquilizers or anti- psychotic medication during and/or 2 weeks prior to enrolling Use of antibiotics for any length of period during and/or 2 weeks prior to enrolling. Current use of lactulose or neomycin. Use of alcohol or elicit drugs during and/ or 6 months prior to enrolling.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Nutritional intervention, standard Israeli breakfast | Other: Nutritional Intervention<br>* Cognitive and executive functions before and after standard israeli breakfast (30% of caloric value and 21 gram protein)<br>|
| Active Comparator: B<br>Nutritional Intervention, fast | Other: Nutritional Intervention<br>* Cognitive and executive functions during fast<br>|

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
-----------------
Encephalopathy, Cirrhotics
Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum.

Study Overview
=================
Brief Summary
-----------------
Chronic obstructive pulmonary disease (COPD)is a multifactorial, progressive chronic lung disease that causes airflow restriction. Study was conducted To Compare the effects of supervised and self-directed pulmonary rehabilitation on cough and sputum expectoration in patients of chronic obstructive pulmonary disease.

Detailed Description
-----------------
To Compare the effects of supervised and self-directed pulmonary rehabilitation on cough and sputum expectoration in patients of chronic obstructive pulmonary disease. It was a randomised control trial and participants were COPD Patients.

Official Title
-----------------
Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum Expectoration in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COPD, Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Physiotherapy Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 40 to 60 Gender: Both Males & Females. Diagnoses with an exacerbation of COPD. Informed consent obtained. Exclusion Criteria: Inability to provide informed consent or complete a self-administered questionnaire. Patients with trauma. Females who were pregnant and breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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: Group A<br>home based plan of aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing | Other: Physiotherapy Treatment<br>* Pulmonary Rehabilitation Techniques<br>|
| Placebo Comparator: Group B<br>Supervised aerobic exercises, strengthening exercises of upper and lower limbs and huffing and coughing | Other: Physiotherapy Treatment<br>* Pulmonary Rehabilitation Techniques<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk test | to measure distance walked in six minutes | 6 months | 
| Cough & sputum assessment questionnaire. | recall assesses the frequency and severity of cough and sputum and their impact on everyday life | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leicester cough questionnaire | This questionnaire is designed to assess the impact of cough on various aspects of your life. | 6 months |
Saline Challenge in Monitoring Asthma Control

Study Overview
=================
Brief Summary
-----------------
It is generally accepted that symptoms and lung function are not sufficient ways to monitor asthma control. Therefore, several objective tests have been developed to help asthma control monitoring, each having their own shortcomings. We have developed a new test, the hypertonic saline cough challenge. In our previous publication this test has proven useful in diagnosing asthma. The present study is planned to investigate whether hypertonic saline cough challenge could be used to monitor asthma control. A group of steroid-naive asthmatics will be recruited. A treatment with inhaled budesonide is started. Asthma control is monitored at regular intervals utilising a validated questionnaire. At the same time points, hypertonic saline cough challenges will be performed. We will analyse whether changes in the responsiveness to the cough challenge reflects the changes in asthma control

Official Title
-----------------
Saline Challenge in Monitoring Asthma Control

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: budesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic asthma Exclusion Criteria: usage of inhaled or oral corticosteroids recent febrile respiratory infection severe, unstable asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide<br>All patients receive this treatment to induce a change in asthma control | Drug: budesonide<br>* Budesonide is given via inhalation utilising a dry powder inhaler called Easyhaler. The dosage is 400 ug twice daily. The duration of the study is 12 weeks but very probably the patients continue the usage of this drug as a part of their routine clinical management.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in responsiveness to hypertonic saline cough challenge |  | Before budesonide treatment, and after 1, 4, and 12 weeks' treatment |
The Study on the Clinical Utility of Liquid Biopsy in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Through this prospective clinical trial,the investigators will focus on the relationship between circulating tumor biomarkers (i.e. circulating tumor cells, circulating tumor DNA and other biomarkers) and the status of primary tumor to discuss its application for assessing prognosis and individualized therapeutic direction. Moreover, the relationship between the circulating tumor cell subpopulations based on epithelial-mesenchymal transition and molecular pathological classification of breast cancer will be determined, which may enable the determination of the value of its application in therapeutic decision making.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients aged ≥18 years with histologically confirmed breast cancer. The patients diagnosed with breast cancer for the first time, including postoperative patients within one month and the patients diagnosed with Stage IV breast cancer for the first time. Exclusion Criteria: The patients who has begun medication for breast cancer.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| the enumeration of circulating tumor biomarkers |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liquid biopsy, breast cancer,circulating tumor biomarker
Study Evaluating the Safety and Tolerability of SCA-136 in Healthy Japanese and Non-Japanese Female Subjects

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate the safety and tolerability of ascending multiple oral doses of SCA-136 adminstered to healthy Japanese and non-Japanese female subjects.

Official Title
-----------------
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SCA-136 Administered Orally to Healthy Japanese and Non-Japanese Female Subjects

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: SCA-136


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Japanese women or non-Japanese of child bearing potential using nonhormonal contraceptives. Japanese female subjects are defined as being born in Japan but living outside of Japan for less than 5 years. Exclusion Criteria: Any significant disease. Positive urine drug screen, increased liver funtion tests, use of prescription drugs.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SCA-136|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, safety laboratories results, vital signs, and ECGs will be used to monitor subject safety. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Pharmacodynamics
Irinotecan, 5-Fluorouracil and Leucovorin With or Without Iressa in the Treatment of Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine if Iressa added to chemotherapy with Irinotecan, 5Fluorouracil and Leucovorin can prolong the period of time without any disease worsening (Time to Progression) in patients with metastatic colorectal cancer.

Official Title
-----------------
A Randomised, Non-Comparative, Multicentre, Phase II, Parallel-Group Trial Of ZD1839 (Iressa™) In Combination With 5 Fluorouracil, Leucovorin And Cpt-11 (Irinotecan) In Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Metastatic Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Iressa (Gefitinib)
* Drug: Irinotecan
* Drug: 5Fluorouracil
* Drug: Leucovorin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed metastatic colorectal cancer Presence of measurable metastases No previous treatment for metastatic cancer Exclusion Criteria: No presence of Central Nervous System metastases No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Iressa (Gefitinib)|nan|
|Drug: Irinotecan|nan|
|Drug: 5Fluorouracil|nan|
|Drug: Leucovorin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression (6 months after Last patient in) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate, Duration of Response, Disease control rate, Overall Survival, (6 months after Last patient in) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Colorectal Cancer
Pregabalin In Partial Seizures Extension Study

Study Overview
=================
Brief Summary
-----------------
To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive treatment in patients with partial seizures.

Official Title
-----------------
Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial

Conditions
-----------------
Seizures

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: met the inclusion/exclusion criteria for A0081005 have completed the 21-week study and have shown a significant clinical response and wish to continue treatment Exclusion Criteria: Having a treatable cause of seizure. Having a progressive neurological or systemic disorder

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: Single Arm<br> | Drug: Pregabalin<br>* Pregabalin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in seizure frequency. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure-free patients during each 3-month period |  | 18 Months | 
| Responder Rate 50% during each 3-month period (proportion of patients with 50% or greater reduction of seizures). |  | 18 Months | 
| Responder rate 75% during each 3-month period (proportion of patients with 75% or greater reduction of seizures). |  | 18 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phase 4, open label, seizures, epilepsy, add-on therapy, pregabalin, lyrica