linjc16/ctgov huggingface dataset:
Work-To-Rest Ratios

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare physiological responses to two hours of work adhering to two variations of a work-to-rest ratio in a hot environment.

Official Title
-----------------
Work-To-Rest Ratios

Conditions
-----------------
Hyperthermia

Intervention / Treatment
-----------------
* Other: Work to rest cycles of 40:20 minutes
* Other: Work to rest cycles of 20:10 minutes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy 18-39 year old individuals Physically active Exclusion Criteria: History of cardiovascular, metabolic, respiratory, neural, or renal disease Hypertensive or tachycardic during the screening visit (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, resting heart rate ≥ 100 bpm) Taking medication or supplements with a known side effect of affecting physiologic responses to exercise (e.g., acetaminophen, beta blockers, statins, aspirin) Any form of tobacco or nicotine use in the past six months Current musculoskeletal injury impacting physical activity A positive pregnancy test at any point in the study Study physician discretion based on any other medical condition or medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized counterbalanced study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 40:20<br>Walking for 40 minutes, resting for 20 | Other: Work to rest cycles of 40:20 minutes<br>* Walking in a hot environment for 2 hours with repeated 40 minutes of work and 20 minutes of rest<br>|
| Experimental: 20:10<br>Walking for 40 minutes, resting for 20 | Other: Work to rest cycles of 20:10 minutes<br>* Walking in a hot environment for 2 hours with repeated 20 minutes of work and 10 minutes of rest<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in core body temperature | Core body temperature is measured using a rectal thermistor | Upon completion of 2 hours of the work protocol | 
| Change in heart rate | Heart rate is measured using a telemetry strap | Upon completion of 80 minutes of work |
Optical Imaging For Assessment of Foot Perfusion

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.

Detailed Description
-----------------
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. SFDI is a non-contact optical imaging technology that measures tissue functional (blood volume, tissue oxygen saturation) and structural information (scattering index) across a large field of view. Our hypothesis is that SFDI parameters can eventually become a quantitative tool to assess foot health and identify patients at risk for ulcer formation. This phase of the study is designed to correlate SFDI outputs to current clinical risk categories

Official Title
-----------------
Optical Imaging For Assessment of Foot Perfusion

Conditions
-----------------
Diabetes, Ulcer Foot

Intervention / Treatment
-----------------
* Device: SFDI Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Pregnant/lactating women Rheumatoid arthritis

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| 0<br>Control - no diabetes | Device: SFDI Imaging<br>* Imaging with SFDI device<br>* Other names: OxImager;|
| 1<br>Diabetes | Device: SFDI Imaging<br>* Imaging with SFDI device<br>* Other names: OxImager;|
| 2<br>Diabetes w/neuropathy | Device: SFDI Imaging<br>* Imaging with SFDI device<br>* Other names: OxImager;|
| 3<br>Diabetes with vascular disease | Device: SFDI Imaging<br>* Imaging with SFDI device<br>* Other names: OxImager;|
| 4<br>Diabetes w/healed ulcer | Device: SFDI Imaging<br>* Imaging with SFDI device<br>* Other names: OxImager;|
| 5<br>Diabetes with current ulcer | Device: SFDI Imaging<br>* Imaging with SFDI device<br>* Other names: OxImager;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical risk category | risk assessment based on clinical signs | immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer incidence | Ulcer formation | 1 year |
Same-day Cervical Preparation Before Dilation and Evacuation

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized trial is to compare same-day cervical preparation using Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before D&E at 16.0 to 20.0 weeks. Primary objective: To compare D&E operative time. We hypothesize that same-day Dilapan-S™ plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative time. Secondary objectives: To compare treatment groups for the following: Pre-operative cervical dilation; need for mechanical dilation and ease of dilation if required; ability to complete D&E without further cervical preparation; ease of D&E; complications; pain; side effects; patient and provider satisfaction.

Official Title
-----------------
Same-day Cervical Preparation With Dilapan-S™ Plus Buccal Misoprostol Compared to Overnight Dilapan-S™ Before Dilation and Evacuation at 16 to 20 Weeks' Gestation: A Randomized Controlled Trial

Conditions
-----------------
Cervical Dilation Prior to Dilation and Evacuation

Intervention / Treatment
-----------------
* Device: Same-Day Dilapan-S
* Device: Overnight Dilapan-S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older Seeking pregnancy termination from 16 0/7 to 19 6/7 weeks of gestation on the day of enrollment. Eligible for pregnancy termination at PPNYC Able to give informed consent English speaking Exclusion Criteria: Active bleeding or hemodynamically unstable at enrollment Signs of chorioamnionitis or clinical infection at enrollment Signs of spontaneous labor or cervical insufficiency at enrollment Spontaneous intrauterine fetal demise Allergy to Dilapan-S™ or misoprostol

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Same-day Dilators<br>Participants will have Dilapan-S cervical dilators placed 4-6 hours prior to D&E and will receive 400 mcg buccal misoprostol pills 3 hours prior to D&E. | Device: Same-Day Dilapan-S<br>* Dilapan-S cervical dilators placed the same day as the D&E procedure<br>|
| Active Comparator: Overnight dilators<br>Participants will have Dilapan-S cervical dilators placed the day prior to their D&E procedure and will receive buccal placebo pills (vitamin B12) 3 hours prior to D&E. | Device: Overnight Dilapan-S<br>* Dilapan-S cervical dilators placed the day prior to D&E procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | From initiation of D&E procedure to completion of D&E procedure, Study Day 2 |
Safety Study of Dexmedetomidine in Septic Patients

Study Overview
=================
Brief Summary
-----------------
Septic patients in Intensive Care Unit always need mechanical ventilation and conscious-sedation. But the recommended dose 0.2-0.7μg/kg/h could not run well because of wide range. The purpose of this study is to find the effective dose of dexmedetomidine adult septic patients of mechanical ventilation .

Detailed Description
-----------------
Inclusion Criteria: Age: between 18 years mechanical ventilation RASS≥2 A diagnosis of sepsis within 48 hours Exclusion Criteria: Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users Primary Outcome Measures: Dose of dexmedetomidine Secondary Outcome Measures: RASS score Requirement for rescue intervention, RASS will be recorded per hour.

Official Title
-----------------
The Effective Dose of Dexmedetomidine for Moderate Sedation of Adult Intubated Septic Patients in the ICU.

Conditions
-----------------
Sepsis, Agitation

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intubated patients RASS≥2 A diagnosis of sepsis within 48h Exclusion Criteria: Cardiac disease Cardiac rhythm abnormalities liver dysfunction coma severe hypotension muscle relaxant users

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: dexmedetomidine,sepsis,ED50<br>Intervention Name: dexmedetomidine dosage form: intravenous injection dosage：0.2-0.7μg/kg/h frequency: 1 duration:12 hours | Drug: Dexmedetomidine<br>* Septic patients are randomly received 1 of 6 doses( 0.2,0.3,0.4,0.5,0.6,0.7μg/kg/h) dexmedetomidine.<br>* Other names: precedex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of dexmedetomidine |  | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RASS score Requirement for rescue intervention, RASS will be recorded per hour. |  | 1 hour |
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in MDS Patients

Study Overview
=================
Brief Summary
-----------------
This is a biological study for adult MDS patients who undergo HSCT procedure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant to study genomic and transcriptomic changes.

Detailed Description
-----------------
This is a biological study for adult MDS patients who undergo HSCT procedure.The research is focused on the study of biological mechanisms of disease relapse after HSCT in MDS to provide the rationale to develop pre-emptive strategies in patients with high risk of transplant failure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant by using Single-cell sequencing. To study genomic and transcriptomic changes in CD34+ blast cells at disease relapse after HSCT will be used TARGET-seq in parallel with unbiased whole-transcriptome analysis.

Official Title
-----------------
Molecular Mechanisms of Disease Relapse After Allogenic Stem Cell Transplantation in Patients With Myelodysplastic Syndrome

Conditions
-----------------
Myelodysplastic Syndromes

Intervention / Treatment
-----------------
* Other: bone marrow withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of MDS according to 2016 WHO criteria Aged 18y or older Patients who will receive allogeneic stem cell transplantation (HSCT) Signed written informed consent according to ICH/EU/GCP and national local laws Exclusion Criteria: Second HSCT procedure.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biological evaluation<br>evaluation of molecular changes in CD34+ blast cells at the time of relapse after allo-HSCT. | Other: bone marrow withdrawal<br>* bone marrow samples evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD34+ blast cells modifications | Difference in frequency distribution of CD34+ blast cells mutations between transplant and relapse. | at 24 months |
Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania

Study Overview
=================
Brief Summary
-----------------
Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children living with HIV who are orphaned. This phase 2 trial aims to determine whether attending the intervention improves outcomes compared to standard care. We aim to test the hypothesis that attendance at MWT improves psychological symptoms, self-esteem, emotional and behavioural difficulties, and self-efficacy compared to standard care.

Official Title
-----------------
An Evaluation of a Psychosocial Intervention for Orphans With HIV Infection: a Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Other: Memory Work Therapy
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 14-18 years HIV positive Orphaned Naïve to the intervention Exclusion Criteria: Adults Children under 14 HIV negative Parent(s) living Previously attended the intervention

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 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 |
| --- | --- |
| Experimental: Intervention: Memory Work Therapy<br>Residential week intervention consisting of memory box, memory book, tree of life, Active Citizen book, all activities facilitated. | Other: Memory Work Therapy<br> <br> |
| Active Comparator: Control: standard care<br>Usual care services. | Other: Standard care<br>* Pediatric clinic, ART<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change: Brief Symptom Inventory | The BSI measures psychological symptom patterns | T0( study entry), T1 (2 weeks), T2 (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change: Rosenberg Self-Esteem Scale | A measure of self esteem | T0 (study entry), T1 (2 weeks), T2 (6 weeks) | 
| Change: Goodman's strengths and difficulties questionnaire | Measures mental health in children and young people | T0 (study entry), T1 (2 weeks) T2 (6 weeks) | 
| Change: Self-efficacy questionnaire for children | measure emotional and social self-efficacy. | T0 (study entry), T1 (2 weeks), T2 (6 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Children, orphans
Mouse Allergen and Asthma Intervention Trial

Study Overview
=================
Brief Summary
-----------------
The MAAIT is a randomized, controlled trial of a home intervention to reduce mouse allergen exposure in mouse allergic children with asthma and mouse allergen exposure. Participants will be randomized to either the Integrated Pest Management (IPM) Group or the Education Group. The IPM Group will receive professional mouse abatement, education, two HEPA filters, allergen-proof mattress and pillow encasements, and targeted cleaning. The Education Group will receive education about IPM at the beginning of the trial and then after completion of the trial, will receive the IPM intervention. Participants will be followed for 12 months.

Official Title
-----------------
Mouse Allergen and Asthma Intervention Trial

Conditions
-----------------
Asthma, Mouse Allergy, Mouse Allergen Exposure

Intervention / Treatment
-----------------
* Other: Integrated Pest Management
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persistent asthma exacerbation, previous 12 months evidence of mouse sensitization high levels of mouse allergen in home ages 5-17 years Exclusion Criteria: intermittent asthma no exacerbation in previous 12 months not sensitized to mouse low or undetectable mouse allergen in home other lung disease aside from asthma

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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: Education Group<br>This group will receive IPM education at baseline, and then the full IPM intervention after completing the study. | Other: Education<br>* This group will receive education about mouse IPM.<br>|
| Experimental: IPM Group<br>This group will receive the full IPM intervention at baseline. | Other: Integrated Pest Management<br>* The IPM intervention will include professional mouse abatement, two HEPA filters, targeted cleaning, education about IPM, and allergen-proof mattress and pillow encasements. The intervention will be delivered at baseline to the IPM Group, and then repeated if recurrent or persistent mouse infestation is present.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in asthma symptoms | days of asthma symptoms | 0, 3, 6, 9, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, mouse allergen, environmental intervention
Embryo Implantation After Induced Endometrial Injury

Study Overview
=================
Brief Summary
-----------------
Some studies have revealed that an induced endometrial injury could improve embryo human implantation in patients with implantation failure. The purpose of this study is to determine whether the induced endometrial injury could be beneficial for regular patients undergoing IVF

Detailed Description
-----------------
Endometrial induced injury has been suggested that could improve embryo implantation in cases of patients with recurrent implantation failure. The mechanisms that induce that improvement remain unknown. We want to analyse if the endometrial induce injury could be useful in cases of standard patients who require assisted reproductive techniques. For that purpose we will start a randomized controlled trial with the ideal background in implantation in ART, the egg donation programme.

Official Title
-----------------
Evaluation of Induced Endometrial Injury in the Subsequent IVF Cycle.

Conditions
-----------------
Sterility

Intervention / Treatment
-----------------
* Procedure: Scratching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19-44 aged women 19-29.9 Kg/m2. 1st or 2nd fresh embryo transfer ( egg donation). 1 or 2 blastocysts available. written agreement. > or = 6 mms endometrial thickness. Exclusion Criteria: Premature ovarian failure. Endometrial pathology. Insufficient endometrial development. Hydrosalpinx Mullerian malformations.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 44 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scratching<br>induced endometrial injury | Procedure: Scratching<br>* Endometrial biopsy<br>* Other names: Endometrial induced injury;|
| No Intervention: No scratching<br>None intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing implantation rate (OIR) |  | 12 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live born rate (LBR) |  | 9 months after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scratching, Endometrial biopsy, Ongoing embryo implantation, Assisted reproductive techniques