linjc16/ctgov huggingface dataset:
Hemodynamic Effects of Physiotherapy in the Early Postoperative Period

Study Overview
=================
Brief Summary
-----------------
Physiotherapy will be applied to the patients who undergo thoracotomy operation after 24 hours of intensive care stay. Physiotherapy program includes breathing exercises, incentive spirometer training, ambulation. Oxygen saturation, heart rate and blood pressure values will be recorded before and after the training session. Changes in the follow-up parameters will be discussed.

Official Title
-----------------
Hemodynamic Effects of Physiotherapy in the Early Postoperative Period

Conditions
-----------------
Physiotherapy, Postoperative, Lung Diseases

Intervention / Treatment
-----------------
* Other: physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Between 18-75 age Hemodynamically stable Being conscious Exclusion Criteria: Excessive pain Neurological complications Posttraumatic and musculoskeletal problems to prevent exercise Do not want to be included in the study Fever above 38 degrees

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early physiotherapy group<br>breathing exercise incentive spirometry training ambulation coughing | Other: physiotherapy<br>* Physiotherapy program includes breathing exercises, incisive spirometer study, grade ambulation. Oxygen saturation, heart rate and blood pressure values will be recorded before and after the session. Changes in the follow-up parameters will be discussed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline oxygen saturation | The hearth rate response will be measured before and after exercise training with pulse oximeter. | 30 minutes | 
| Change from baseline hearth rate response. | The hearth rate response will be measured before and after exercise training with intensive care ECG | 30 minutes | 
| Change from baseline systolic and diastolic blood pressure response. | Blood pressure will be measured before and after exercise training with monometer from the arm | 30 minutes |
Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.

Detailed Description
-----------------
Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Anamorelin HCl Dose Range Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: anamorelin HCl
* Drug: anamorelin HCl
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage IIIB or IV NSCLC eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab Exclusion Criteria: mixed large and small cell histologies for lung cancer significant obesity, BMI > 30

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Active 50 mg<br> | Drug: anamorelin HCl<br>* 50 mg tablet<br>* Other names: ST-1291;|
| Experimental: 2 Active 100 mg<br> | Drug: anamorelin HCl<br>* 100 mg tablet<br>* Other names: ST-1291;|
| Placebo Comparator: 3 Placebo<br> | Drug: placebo<br>* placebo tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand grip strength and body weight |  | Twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life and Biomarker |  | Twelve weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC
Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue

Study Overview
=================
Brief Summary
-----------------
The main objective of the study is to assess the effectiveness of the sheathed speculum in providing adequate visualization and access to the cervix in patients with excessive vaginal tissue. The secondary objective is to rate the patient's comfort evaluation during the sheathed speculum examination.

Detailed Description
-----------------
This is a descriptive clinical trial designed to assess the efficacy of a sheathed speculum in providing adequate visualization and access to the cervix in women with excessive vaginal tissue. Eligible, consented subjects who fail their initial speculum examination (because their cervix is not visualized due to the collapse of loose lateral vaginal walls) will have a sheathed speculum examination instead of the standard-of-care exam whereby the clinician fabricates a solution at the bedside (condom with tip cut placed on speculum, concomitantly using an additional instrument like a lateral-wall retractor, glove with tip of thumb placed over the speculum, using the largest speculum available)

Official Title
-----------------
Using a Sheathed Speculum to Visualize and Access the Cervix In Women With Excessive Vaginal Tissue

Conditions
-----------------
Vaginal Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 64 years BMI greater than 30 (or see next line) Collapsing vaginal tissue preventing the visualization of the cervix (meeting this criterion in the absence of a BMI >30 would also qualify the patient for the study). Able to provide written informed consent Exclusion Criteria: Patients unwilling to participate in the study or provide consent Presence of significant acute pelvic pain syndromes (ie exacerbation of dyspareunia, chronic pelvic pain or pelvic floor dysfunction, atrophic vaginitis, interstitial cystitis, endometriosis) which, in the opinion of the examining clinician, could potentially confound the patient's responses to the questionnaire Presence of active genital herpes Presence of significant condyloma acuminata (may be an investigator decision) Any other patient deemed inappropriate for the study by the consenting or examining investigator.

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

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

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 |
| --- | --- | --- |
| Number of patients with adequate visualization and access to cervix or vaginal vault |  | At time of speculum exam |
Thin EBUS Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a single-center pilot study at the Medical University of South Carolina (MUSC) to evaluate the safety and efficacy of the TCP-EBUS scope (Thin EBUS). This study will consist of a standard of care bronchoscopy and will be followed for approximately 3 months. While the device is not FDA approved, it is the same technology but a thinner version of the SCP-EBUS bronchoscope.

Official Title
-----------------
Clinical Evaluation of the Thin TCP-EBUS Bronchoscopy System

Conditions
-----------------
Lung; Node

Intervention / Treatment
-----------------
* Device: Slimscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide informed consent. >21 years of age or older. Target lesion(s) within the middle third of the lung, which will be determined radiographically prior to scheduling the procedure by the bronchoscopist or radiologist, or by being located at least 2 airway generations from the main carina as seen radiographically. Target lesion(s) location documented on CT scan report. Indicated for bronchosocpy. Bronchoscopic procedure scheduled within 30 days of the CT scan report. Exclusion Criteria: Not suitable for flexible bronchoscopy as determined by the treating physician prior to the procedure. Currently on anticoagulation medications with INR >1.5. Currently using DOAC and does not suspend use at least 7 days prior to the index procedure Currently using Plavix and does not suspend use for at least 7 days prior to the index procedure.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Procedural group<br> | Device: Slimscope<br>* Slimscope thin EBUS endoscope is inserted and used to visualize lung nodules.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to visualize lung nodule | Study team will determine whether or not the lung nodule was able to be visualized by the scope. | Throughout the procedure (approximately 1 hour) |
NI-0401 in Patients With Acute Renal Allograft Rejection

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.

Official Title
-----------------
A Phase IIa, Open-Label, Dose-Titration, Multicenter Study to Assess the Safety and Preliminary Efficacy of NI-0401 in Patients With Acute Cellular Renal Allograft Rejection

Conditions
-----------------
Acute Renal Transplant Rejection

Intervention / Treatment
-----------------
* Drug: NI-0401


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion Criteria: evidence of cellular rejection in a renal biopsy according to Bannff 97 criteria rise in Serum Creatinine concentration by >20% compared to baseline value Main Exclusion Criteria: previous therapy with anti-CD3 mAB(OKT3) or anti-lymphocytes polyclonal antibodies (ATG, Atgam) patients with cardiac insufficiency or fluid overload severe HLA sensitization (>50% panel reactive antibodies prior transplantation) defined concomitant disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NI-0401<br>5 daily infusions of escalating doses of NI-0401 | Drug: NI-0401<br>* 5 daily infusions with escalating doses of NI-0401<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nature,frequency,intensity,causality and seriousness of adverse events |  | Studay day 1 to week 6 |
Follow-up of Adolescent Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Very little information is available about extremely obese (body mass index [BMI] > 40 kg/m2) adolescents. The purpose of the Follow up of Adolescent Bariatric Surgery (FABS) study is to collect information obtained during the clinical care of obese adolescents from all over the country that can be used by researchers to study obesity, the complications of obesity, and the outcomes of obesity treatment during adolescence. This information will be used to describe the experience of the obese adolescent, including how obesity during adolescence and its treatment impacts health and well-being. The information may also be used to study causes of obesity, to determine the predictors of successful obesity treatment and for other obesity related research. Because of the importance of understanding the outcome of obesity and obesity treatments (surgical and non-surgical) on the patient over time, the data included in the study will be collected before, during and after any treatments rendered. For those who do not undergo a treatment which results in major weight change, it will be critical to determine the natural history of adolescent severe obesity as the adolescent transitions into adulthood. Finally, another important purpose of the FABS research study is to obtain patients' consent to be contacted for possible participation in future research studies. SPECIFIC AIMS: To describe the natural history of morbid obesity among adolescents who seek treatment for their obesity To describe major outcomes following bariatric surgery in adolescents evaluated at 3, 6, 12, and annually for 10 years post-operatively and compare these to outcomes to patients managed non-surgically To organize a national cohort of severely obese adolescents who agree to be contacted in the future for research studies

Official Title
-----------------
Follow-up of Adolescent Bariatric Surgery

Conditions
-----------------
Morbid Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients seeking treatment for Obesity at Cincinnati Exclusion Criteria: Currently Enrolled in Teen LABS Study.
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 |
| --- | --- | --- |
| BMI |  | Annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Co-morbidities |  | Annual | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMI > 40, Obesity, Adolescents, Weight Loss Surgery
Posterior Cingulate Function in Persons With Risk Factors for Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use fMRI techniques to explore a certain part of the brain associated with Alzheimer's disease known as the posterior cingulate. Determining the functionality of this brain region may help us diagnose AD more accurately, thus allowing earlier treatment.

Detailed Description
-----------------
The posterior cingulate is a key brain region suggested by recent studies to be affected in people at risk for Alzheimer's Disease (AD). Because the PC is affected very early in the course of AD and the region may have reduced function even prior to the onset of symptoms, further understanding of its functional role and its relationship to other brain regions may be helpful in detecting AD earlier and in monitoring disease progression and treatment. This project examines the role of the PC and its connections to other brain regions using functional magnetic resonance imaging (fMRI), a technique that allows us to examine the brain at work during tests of memory and decision-making. The main goal is to see if functional connections between brain regions are modulated by risk for AD.

Official Title
-----------------
Posterior Cingulate Function in Persons With Risk Factors for Alzheimer's Disease

Conditions
-----------------
Magnetic Resonance Imaging, Alzheimer's Disease, Dementia, Adult Children, Risk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cognitively healthy (Controls Only) Parents survived past age 70 and did/do not have memory problems. Exclusion Criteria: Claustrophobia Metallic or electronic implants

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells

Study Overview
=================
Brief Summary
-----------------
This research is being done to understand how changes in DNA may put people at risk for developing coronary artery disease. Stem cells will be made using cells from blood and/or skin biopsy samples. We are trying to understand which specific changes in DNA negatively impact a person's health.

Official Title
-----------------
Evaluating Cardiovascular Phenotypes Using Induced Pluripotent Stem Cells

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases: Previously enrolled in the CAD module of the Genebank at Scripps Clinic Registry Eligible to have their blood drawn Be reliable, cooperative and willing to comply with all protocol-specified procedures Able to understand and grant informed consent Controls: Previously enrolled in the Healthy Elderly Active Longevity (HEAL) Cohort Eligible to have their blood drawn Be reliable, cooperative and willing to comply with all protocol-specified procedures Able to understand and grant informed consent Exclusion Criteria: Unwilling or unable to grant informed consent. Have a significant medical condition that in the Investigator's opinion may interfere with subject's study participation.

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 |
| --- | --- |
| Cases<br>Subjects previously enrolled in the Scripps Genebank Study | |
| Controls<br>Subjects previously enrolled in the Scripps Healthy Elderly Active Longevity (HEAL) Cohort | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iPSC development | Develop methods of iPSC generation from patients with genomic risk. | five years |
Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

Study Overview
=================
Brief Summary
-----------------
To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.

Official Title
-----------------
Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

Conditions
-----------------
Feeding Intolerance

Intervention / Treatment
-----------------
* Other: Marketed cow milk-based premature infant formula
* Other: Marketed extensively hydrolyzed casein infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Premature infant 28 to 33 weeks gestational age, inclusive, at birth Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day Birth weight is greater than or equal to 700g to 1750g Appropriate birth weight for gestational age Singleton or twin birth Signed Informed consent Exclusion Criteria: Infant's mother plans to exclusively breast feed 5 minute APGAR score is less than or equal to 4 Major surgery that required general anesthesia prior to randomization Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization Grade III or IV intraventricular hemorrhage diagnosed prior to randomization Infant is currently participating in another clinical study
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marketed cow milk-based premature infant formula<br> | Other: Marketed cow milk-based premature infant formula<br> <br> |
| Experimental: Marketed extensively hydrolyzed casein infant formula<br> | Other: Marketed extensively hydrolyzed casein infant formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enteral intake (ml/kg/day) |  | Daily for 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight (g) |  | Daily for 14 days | 
| Feeding Tolerance | Gastric residuals, regurgitation(>1 ml), fecal output (number of stools per day) | Daily for 14 days | 
| Respiratory status | Apnea and/or bradycardia events, use of supplemental oxygen, use of mechanical ventilation | Daily for 14 days | 
| Gut Inflammation | Fecal calprotectin, alpha and beta defensins, TNF alpha, gastric ultrasound | Once at Study Day 14 | 
| Confirmed or suspected sepsis or necrotizing enterocolitis |  | Daily for 14 days | 
| Date of hospital discharge |  | Once at hospital discharge | 
| Growth | length (cm) and head circumference (cm) | Study Days 1, 7, and 14 |