linjc16/ctgov huggingface dataset:
Repository for Sepsis and Postresuscitation Samples

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to find a new therapeutic strategy by investigating the serial serum samples of patients with sepsis or postresuscitation state.

Official Title
-----------------
Repository for Samples Collected From Sepsis and Postresuscitation Patients in Emergency Intensive Care Unit

Conditions
-----------------
Cardiac Arrest, Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 16 years old Admitted to ICU Diagnosed as having sepsis or as postresuscitation status Definition of sepsis: 2 or more SIRS criteria + infection is suspected Definition of postresuscitation status: Survived from non-traumatic cardiac arrest Exclusion Criteria: refusal to participate DNAR status

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Postresuscitation group<br>Adults (age over 16 years old) who have survived from nontraumatic cardiac arrest and admitted to ICU. | |
| Sepsis group<br>Adults (age over 16 years old) who satisfy the sepsis criteria (SIRS>=2 and infection is suspected for a cause) and admitted to the ICU. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-month mortality | All cause mortality within 1-month | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality | All cause mortality during hospitalization | until hospital discharge, an expected average of 2 weeks | 
| ICU length of stay |  | Until ward transfer or discharge, an expected average of 7 days | 
| Favorable neurologic outcome | Favorable neurologic outcome is used for outcome measure in postresuscitation patients only. Favorable neurologic outcome means cerebral performance category 1 and 2. This outcome is measured at discharge and 6-month after admission. | at discharge, an expected average of 2 weeks and at 6-month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Arrest, Sepsis, Biological Markers, Anti-Inflammation Agents, Antioxidants
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)

Study Overview
=================
Brief Summary
-----------------
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.

Official Title
-----------------
A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)

Conditions
-----------------
Breast Cancer, Breast Reconstruction, Nipple Reconstruction

Intervention / Treatment
-----------------
* Device: Nipple reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient presents with a history of breast cancer, having previously completed either uni- or bi-lateral breast removal and reconstruction. Patient presents with a desire to obtain nipple reconstruction Patient is at least 18 years of age And other inclusion criteria Exclusion Criteria: Patient is not medically fit enough for surgery under local anesthesia Patient is currently smoking, using tobacco products, or nicotine products (i.e. patch, gum, or nasal spray) Patient is pregnant, breastfeeding or planning further pregnancy during the study period Patient has physical allergies or cultural objections to the receipt of porcine products And other exclusion criteria

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: Nipple Reconstruction Cylinder<br> | Device: Nipple reconstruction<br>* Biodesign® Nipple Reconstruction Cylinder<br>* Other names: Biodesign;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Patient Satisfaction | Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biodesign, Nipple Reconstruction, Breast Cancer, Mastectomy
Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Upper airway resistance during sleep can present with a range of symptoms from simple snoring (SS) through to severe obstructive sleep apnea (OSA). Pharyngeal narrowing or collapse leads to reduction or cessation in airflow during sleep, and is associated with loud snoring. The investigators hypothesized that regular singing exercises could strengthen pharyngeal muscles and/or increase their resting tone, and lead to an improvement of symptoms and thus quality of life in patients with all forms of snoring.

Official Title
-----------------
A Single Blinded Prospective Randomized Controlled Trial to Investigate Whether Singing Exercises Can Improve Symptoms of Snoring and Sleep Apnea

Conditions
-----------------
Snoring, Upper Airway Resistance Syndrome, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Behavioral: Singing exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years old or over history of simple snoring or sleep apnoea with RDI 10-40 Exclusion Criteria: severe sleep apnoea RDI >40 morbid obesity BMI > 40 unable to provide written informed consent

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Singing exercises<br> | Behavioral: Singing exercises<br>* A 3 month self-guided treatment based on a specially designed 3CD box set, which patient performed every day ('Singing for Snorers': UK)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth sleepiness scale |  | Entry to study (day one), and after 3 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loudness of snoring | Visual analogue scale rating | Entry to study (day one), and 3 months after intervention | 
| Frequency of snoring | Visual analogue scale rating | Entry to study (day one), and 3 months after intervention | 
| SF-36 quality of life assessment tool |  | Entry to study (day one), and 3 months after intervention | 
| Compliance with exercises | Applied only to intervention group. Rated on visual analogue scale of 100mm from 'never' to 'every day' | After 3 months of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Snoring, Sleep apnea, Pharyngeal muscle tone
INVITE Study: Invasive Instrumentation in Trauma Patients in the Shock Room

Study Overview
=================
Brief Summary
-----------------
This study is an online survey asking for invasive instrumention in trauma patients of an emergency department

Detailed Description
-----------------
The INVITE study is an online survey for medical doctors asking for invasive instrumention (e.g., arterial line, entral venous line, etc.) in trauma patients of an emergency department

Official Title
-----------------
Invasive Instrumentation in Trauma Patients in the Shock Room: A Online-survey for Anaesthesia Departments in Germany

Conditions
-----------------
Multiple Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multiple trauma treated in the emrgency department 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 |
| --- | --- | --- |
| Insertion of central venous catheter  survey |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polytrauma, emergency medicine
Primary Birmingham Hip Resurfacing Arthroplasty Using a Metal-on-Metal Couple in the Young Active Patient

Study Overview
=================
Brief Summary
-----------------
To prospectively obtain data about the clinical and radiological results of the resurfacing technique as primary hip prosthesis in young active patients

Official Title
-----------------
Primary Birmingham Hip Resurfacing Arthroplasty Using a Metal-on-Metal Couple in the Young Active Patient

Conditions
-----------------
Indications for a Total Hip Prosthesis

Intervention / Treatment
-----------------
* Device: Primary Birmingham hip resurfacing arthroplasty using a metal-on-metal couple


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total hip prosthesis Exclusion Criteria: -

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Primary Birmingham hip resurfacing arthroplasty using a metal-on-metal couple|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and radiological results |  |  |
A Social Media Intervention for Risky Drinking

Study Overview
=================
Brief Summary
-----------------
This study is being completed to pilot prevention methods to promote wellness and reduce risky behaviors, including the use of substances such as alcohol and other drugs. This study will help the study team learn about ways of delivering this information that is both appealing and helpful to young adults.

Official Title
-----------------
A Social Media Intervention for High-intensity Drinking in a National Sample of Emerging Adults

Conditions
-----------------
Drinking Behavior

Intervention / Treatment
-----------------
* Behavioral: Social media messaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reside in the United States of America (USA) Be able to read English, view, and click on a social media advertisement. Self-reported past-month high-intensity drinking (HID) Regular Snapchat use (at least 3 days/week). Exclusion Criteria: If they fail identity verification based on: 1) internet protocol address (IP), 2) survey time completion, 3) repeat attempts, and 4) survey responses.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Link to an educational website about alcohol; link to resources. | |
| Experimental: Social media messaging<br>Health coaching via social media for 8 weeks | Behavioral: Social media messaging<br>* A motivational interviewing-based intervention delivered via private health coaching on social media for 8 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Acceptability | Study-specific acceptability rating completed by participants (% with a positive rating, higher % is better): Item wording: Overall, how did you feel about Snapchatting with the team? Response options: Disliked it a lot, Disliked it, Neutral, Liked it/Liked it a lot There are no statistical analyses because pre-registered primary outcomes are descriptive in nature. | 2 months | 
| Feasibility of the Intervention (Engagement) | % of participants engaging in the intervention (at least one reply) There are no statistical analyses because pre-registered primary outcomes are descriptive in nature. | During the 8 week intervention delivery period | 
| Feasibility of the Intervention (Completion) | % of participants who remain connected to intervention account at 8 weeks (end of intervention) There are no statistical analyses because pre-registered primary outcomes are descriptive in nature. | 8 weeks |
Multiple Dose Study Evaluating the Safety and Tolerability of NSA-789

Study Overview
=================
Brief Summary
-----------------
This is a multiple dose study of NSA-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with Alzheimer's Disease

Official Title
-----------------
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects and Subjects With Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease, Healthy Subjects

Intervention / Treatment
-----------------
* Drug: NSA-789
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with Alzheimer's Disease) Women must be surgically sterile or postmenopausal Subjects with Alzheimer's Disease must be generally healthy, but may have a stable, chronic illness if well controlled. Exclusion Criteria Healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study. Subjects with Alzheimer's Disease may not be on any cholinesterase inhibitors such as donepezil (Aricept®) or rivastigmine (Exelon®) within 4 weeks of the start of 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Other: placebo<br> <br> |
| Experimental: NSA-789<br> | Drug: NSA-789<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event monitoring as specific tests that will be done to monitor safety (ECGs, certain laboratory tests, vital signs) and tolerability |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic and pharmcodynamic parameters |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Disease, schizophrenia
Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients receive either daily choline chloride in their total parenteral nutrition (TPN) solution or their usual TPN. The TPN is given intravenously over a 12 hour period beginning at approximately 9 PM nightly. Therapy continues for 24 weeks. Adjustments in the daily dose of choline provided may be required based on plasma free choline levels and patient tolerance. Additionally, all patients record the type and amount of their food intake on a daily basis. Patients are followed every 2 weeks during the first 6 weeks, then every 4 weeks beginning with week 12 for the remainder of the 24 weeks, and then again at week 34. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Fatty Liver

Intervention / Treatment
-----------------
* Drug: choline chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Receiving nightly total parenteral nutrition (TPN) for greater than 70% of nutritional needs for a minimum of 8 weeks prior to study entry; Receiving no greater than 38 kcal/kg/day/ideal body weight; Receiving lipid emulsion as part of TPN regimen Expected to require TPN for at least 34 weeks after study entry Hepatic steatosis documented by prestudy CT scan Consistent daily amount of intravenous amino acids, dextrose, or lipid received for 3 weeks prior to study entry --Prior/Concurrent Therapy-- No concurrent cholinergic medications --Patient Characteristics-- Hepatic: Albumin at least 3.5 g/dL; No hepatic failure; PT no greater than 2 times upper limit of normal Renal: No renal failure requiring hemo- or peritoneal dialysis Other: No AIDS; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: choline chloride|nan|

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
-----------------
gastrointestinal disorders, hepatic steatosis, rare disease
Male Reproduction COVID Sequelae Study (MARCOS).

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of COVID-19 Vaccination on semen parameters and to determine how long these possible changes may last following vaccination.

Official Title
-----------------
Corona Virus Disease 19 (COVID-19) Vaccine and Impact on Fertility Study

Conditions
-----------------
Infertility, Male

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving COVID-19 vaccines Male age 18-50 years old Exclusion Criteria: Adults unable to consent Women Prisoners Men who have been receiving Testosterone replacement therapy or anabolic steroids within the last year Men with a history of Azoospermia Men with a genetic or other medical condition known to be associated with decreased semen parameters (i.e. Klinefelter's syndrome, Y-Chromosome Microdeletion (YCMD), post-chemotherapy treatment, etc.) Positive COVID-19 test within the last 3 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 vaccine group<br>Participants scheduled to receive the COVID-19 vaccine will be evaluated on its effect on semen parameters for up to 6 months post vaccination. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm concentration | As measured from semen samples. | up to 6 months | 
| Sperm motility | As measured from semen samples. | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19 Vaccine