linjc16/ctgov huggingface dataset:
Less Neuropathy After Yoga- Managing Diabetic Neuropathy With Yoga

Study Overview
=================
Brief Summary
-----------------
The long-term goal is to identify and establish effective mind-body interventions (as an aspect of complementary and alternative medicine) to improve health and Quality of Life (QoL) for people with disabilities. Preliminary data suggest that engagement in yoga is feasible and beneficial for multiple study populations, and it may relieve symptoms of neuropathy. The central hypothesis is that individuals who complete yoga will have significantly better balance, mobility, and QoL after 8 weeks of yoga.

Detailed Description
-----------------
assessments completed before and after yoga. yoga was delivered twice a week for 8 weeks for one hour each session. Yoga included sitting, standing, and floor postures, breath work, and meditation

Official Title
-----------------
Less Neuropathy After Yoga

Conditions
-----------------
Diabetic Neuropathy

Intervention / Treatment
-----------------
* Other: yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone age 18 and over with DPN from Diabetes Mellitus and a balance impairment. and be able and willing to attend twice weekly sessions for 8 weeks. Exclusion Criteria: not have consistently engaged in yoga for greater than a year.

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 |
| --- | --- |
| Experimental: yoga<br>yoga, 2 times a week for 8 weeks | Other: yoga<br>* 8 weeks of yoga, twice a week. sitting, standing, and floor postures with meditation and breath work<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Neuro-QoL | used to assess health related quality of life in people with neuro disability | baseline and 8 weeks | 
| change in Berg balance Scale | assess static and dynamic balance | baseline and 8 weeks | 
| change in 6 minute walk | amount of feet walked in 6 minutes, used to assess endurance | baseline and 8 weeks | 
| change in 10 meter walk | amount of time to walk 10 meters, measures gait speed | baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
yoga, balance
Fatigue Self-Management in Primary Care

Study Overview
=================
Brief Summary
-----------------
This study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. The hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.

Official Title
-----------------
Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics

Conditions
-----------------
Medically Unexplained Chronic Fatigue, Chronic Fatigue Syndrome

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral self-management
* Behavioral: Symptom monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of unexplained chronic fatigue diagnosis of chronic fatigue syndrome Exclusion Criteria: medically explained fatigue any psychosis or dementia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Self-Management<br>Cognitive-behavioral self-management | Behavioral: Cognitive-behavioral self-management<br>* Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.<br>|
| Active Comparator: Symptom Monitoring<br> | Behavioral: Symptom monitoring<br>* Daily symptom via web diary<br>|
| No Intervention: Standard Medical Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale |  | 3 months, 6 months, 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Anxiety Inventory |  | 3 months, 6 months, 15 months | 
| Beck Depression Inventory |  | 3 months, 6 months, 15 months | 
| SF-36 physical function subscale |  | 3 months, 6 months, 15 months | 
| Global Impression of Change Rating |  | 3 months, 6 months, 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medically unexplained chronic fatigue, Chronic fatigue syndrome, Cognitive-behavior therapy, Self-management, Primary care, Nurses, Economic analysis, Cost effectiveness, One year follow-up
Using a Infrared Thermometer to the Early Detection of Catheter Related Infections

Study Overview
=================
Brief Summary
-----------------
This is a pilot study which aims to show the temperatures measured on body surface with an infrared thermometer on inpatients who need a central venous catheter (CVC) for medical care. Because the local temperature could be altered, at least during local infectious processes, seems to be reasonable to think that this approach could be helpful to its early diagnosis.

Detailed Description
-----------------
By convenience sampling, it was expected that during 4 months, a minimum of 30 inpatients of the metabolic, clinical or intensive care wards, at the Clinical Hospital of Ribeirão Preto Medical School, São Paulo, Brazil, would have their data collected

Official Title
-----------------
Using Non-contact Infrared Thermometry to Detection of Central Venous Catheter Related Infection.

Conditions
-----------------
Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Need of a central venous catheter for medical care. Be an inpatient of the metabolic, clinical or intensive care wards Exclusion Criteria: Be in treatment course of a catheter related infection.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Central venous catheter<br>Inpatients with CVC for medical care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body temperature measured with a non-contact infrared thermometer. | It was used a non-contact forehead infrared thermometer, model IR200® (Extech, USA). Fifteen minutes after bath, mobilization or warm or cold compresses, 3 measurements were obtained at the following sites: 1) close to CVC insertion, 2) at the equivalent contralateral site of CVC and 3) at the forehead. The variables values will be displayed in form of descriptive statistics (mean, standard deviation, standard error, proportions of the observations, confidence intervals) according to: sex, central venous catheter type (guide wire or port-a-cath), location of insertion, reason of the central venous catheter indication (like parenteral nutrition or antibiotics), number of catheter lumens and age. Also, the mean differences between the three locations measured will be presented. | 15 minutes after bath, mobilization or warm or cold compresses | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
body temperature, Thermometry, Infrared Rays, catheter related infection
Selective Dose Escalation for Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
This prospective study was designed to assess the outcomes (survival and failure patterns) of therapy for localized esophageal cancer with conventional dose radiation (RT; 50.4 Gy) with concurrent continuous infusion 5-fluorouracil (5-FU) and weekly carboplatin/paclitaxel. Patients with less than complete response (CR) or partial response (PR) received dose escalation of radiation to 59.4 Gy with the same chemotherapy.

Detailed Description
-----------------
we prospectively enrolled patients with T1-4, N0-1, M0-1a esophageal carcinoma to receive paclitaxel 45 mg/m2 IV over 1 hour and carboplatin AUC 2 IV over 30 minutes on days 1, 8, 15, 22, 29 and 36. 5-FU 225mg/m2 was delivered as a continuous infusion on days 1-38. RT was given 1.8Gy 5 days/wk for 5.5 wks (50.4Gy in 28 fx). After 6-8 weeks, patients underwent repeat staging with computed tomography (CT) scan, endoscopic ultrasound (EUS), and biopsy. Patients with a positive biopsy, or less than PR by CT and EUS, received a boost of 9 Gy with the same concurrent chemotherapy. Patients were followed every 4 months with CT/EUS first year, every 6 months thereafter.

Official Title
-----------------
Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: carboplatin, 5FU, Taxol and radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1-4, N0-1, M0-1a esophageal carcinoma Exclusion Criteria: distant metastases

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

| Intervention/Treatment |
| --- |
|Drug: carboplatin, 5FU, Taxol and radiation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival at 4 years |  |  | 
| local control at 4 years |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal cancer, chemotherapy, radiation
UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies

Study Overview
=================
Brief Summary
-----------------
The researchers want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment.

Official Title
-----------------
UARK 2006-28 Human Cord Blood Transplantation in Advanced Hematological Malignancies

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: Transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced hematological malignancies who have failed at least two lines of therapy. Karnofsky performance score > 60, unless due to disease and then > 50. Age > 18 years. An expected survival of > 3 months. Subjects must have signed an IRB-approved consent and been informed about the investigational nature of the study. Cord blood must have negative serology for HIV. Release of cord blood. The nucleated cell count of the CBU shall equal or exceed 1 x 107 per kg of recipient body weight. Exclusion Criteria: Liver function: total bilirubin > 2x ULN or AST/ALT > 3x ULN. Creatinine > 3.0 mg/dL.

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood | Procedure: Transfusion<br>* Approximately 24 hours after the chemotherapy is completed you will receive the transfusion of the human cord blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The researchers on this study want to find out if subjects treated on this study will achieve long term bone marrow recovery (engraftment) and if their tumors will respond to this treatment. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The researchers also want to find out what types of side effects, if any, subjects will experience with this treatment. |  | 12 months |
Case Studies of Patients Who Had Experienced Near Death Experience

Study Overview
=================
Brief Summary
-----------------
An prospective observational study to interview patients who had near death experiences among those who had received intensive care unit intervention during admission in hematology ward.

Official Title
-----------------
Case Studies of Patients Who Had Experienced Near Death Experience

Conditions
-----------------
Near Death Experience

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (≥19yrs) who are in admission in the Hematology ward of Seoul National University Hospital, and one of the following conditions. recovered after cardiopulomary resuscitation recovered after mechanical ventilator recovered after ICU care recovered after emergent operation recovered after Shock, coma, altered mentality Other medical conditions approaching death Exclusion Criteria: Those who do not agree to participate this study Those who can not be interviewed due to insufficient recovery from critical medical problems

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervension|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of near death experience (NDE) | Incidence of case with NDE scale ≥7 point | 5 years |
Fatty Acid Quality and Overweight (FO-study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the health effects of fatty acid quality in healthy, overweight individuals.

Official Title
-----------------
Fatty Acid Quality and Overweight

Conditions
-----------------
Weight Reduction and Insulin Sensitivity

Intervention / Treatment
-----------------
* Dietary Supplement: fatty acid quality and overweight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no use of medication, healthy, 27<BMI<40 Exclusion Criteria: pregnant and lactating women, chronic diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Low intake of ALA and triacylglycerols<br>Sunflower oil | Dietary Supplement: fatty acid quality and overweight<br>* Duration 12 weeks<br>|
| Experimental: high intake of ALA and triacylglyceroles<br>Canola and linseed oils | Dietary Supplement: fatty acid quality and overweight<br>* Duration 12 weeks<br>|
| Experimental: high intake of ALA and diacylglycerols<br>Canola and linseed oils | Dietary Supplement: fatty acid quality and overweight<br>* Duration 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Will intake of fat as diacylglycerols give weight reduction in overweight individuals? |  | baseline (0 weeks), 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Will a high intake of ALA involve reduced levels of inflammatory markers? |  | baseline (0 weeks), 12 weeks | 
| Will a high intake of ALA involve changes in insulin sensitivity? |  | baseline (0 weeks), 12 weeks |
Registry of COVID-19 Patients Treated With the Seraph 100 Microbind Affinity Blood Filter

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry study is to investigate the effectiveness and safety of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of COVID-19 patients.

Detailed Description
-----------------
During the ongoing COVID-19 pandemic, millions of people have been infected with SARS- Cov-2 worldwide. In the absence of an approved vaccine or medical treatment, there is an emerging need for treatment options, especially in critically ill patients. Multiple pharmacological and non-pharmacological therapies are being investigated. In 2019, the Seraph® 100 Microbind® Affinity Blood Filter (ExThera Medical Corporation, CA, USA) was approved for the removal of pathogens in Europe. On April 17th the FDA granted Authorization for Emergency Use in patients with COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.

Official Title
-----------------
Registry for the Evaluation of Safety and Effectiveness of the Seraph 100 Microbind Affinity Blood Filter in the Therapy of COVID-19 Patients (COSA)

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Device: Seraph 100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COVID-19 infection Treatment with the Seraph® 100 Microbind® Affinity Blood Filter Voluntary consent to participate in Registry Exclusion Criteria: - none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| COVID-19 patients with Seraph 100 therapy<br> | Device: Seraph 100<br>* Seraph 100 therapy during a COVID-19 infection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Overall Survival after Seraph 100 therapy session | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay | Time spend in the ICU after Seraph 100 therapy session | 30 days | 
| Length of Hospital stay | Time spend in the hospital after Seraph 100 therapy session | 30 days | 
| Length of ventilator therapy | Time spend on ventilator after Seraph 100 therapy session | 30 days | 
| Adverse events | Report of any Seraph 100 therapy related adverse events | 30 days |
To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily.

Official Title
-----------------
Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: NYC 0462 Ointment
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of stable, symptomatic plaque psoriasis Good health with the exception of psoriasis % BSA and plaque elevation requirements Exclusion Criteria: Subjects who are pregnant, nursing or planning a pregnancy within the study participation period. Subjects who have any systemic or dermatological disorders with the exception of psoriasis

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>NYC 0462 Ointment | Drug: NYC 0462 Ointment<br>* To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in plaque elevation score |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Investigator´s Global Evaluation, erythema and scaling scores |  | 8 weeks |