linjc16/ctgov huggingface dataset:
Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.

Official Title
-----------------
Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure

Conditions
-----------------
Heart Failure, Congestive, Sleep Apnea Syndromes

Intervention / Treatment
-----------------
* Device: ApneaLink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe heart failure (as determined via Echocardiogram or treating physician) Exclusion Criteria: Clinically significant asthma requiring therapy Significant (parenchymal) lung disease Severe pulmonary hypertension Hypercapnia (PCO2 > 60mmHg) Cardiogenic Shock Severe chronic renal failure Narcotic abuse/intravenous drug use (including heart failure due to alcohol abuse or chemotherapy, HIV+ and Hepatitis C) Methicillin- resistant Staphylococcus aureus infection Tracheotomy Enrolled in any concurrent study that may confound the results of this study Nocturnal positive airway pressure or oxygen Inability or refusal to sign patient consent form Inability or refusal to adhere to protocol requirements

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ApneaLink|A two channel sleep screening device for the assessment of Sleep Disordered Breathing.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea- Hypopnea Index |  | Overnight |
Psychotraumatology in Somatic Medicine

Study Overview
=================
Brief Summary
-----------------
Psychotraumatology is clinically highly relevant, especially in the medical-somatic disciplines. Despite progress in recent decades, the clinical care is still inadequate - with unfavorable health effects for affected patients. There are avoidable burdens for involved clinicians and the health care system as a whole, also in terms of costs. With this background, our long-term project combines different research levels. Besides clarifying the clinical phenomenon, it aims to examine 1) the influence of traumatization on the physician-patient interaction as well as 2) the current psychological stress of the patients. Furthermore, 3) moderating factors on the side of the physicians, such as professional experience on the physician-patient interaction will be examined.

Official Title
-----------------
Psychotraumatology in Somatic Medicine - Gynecological Consultation

Conditions
-----------------
Trauma, Psychological; Somatic

Intervention / Treatment
-----------------
* Diagnostic Test: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen Exclusion Criteria: Severe mental disorder (e.g. dissociative disorder) Insufficient knowledge of German

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Questionnaires|Questionnaire study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of physician-patient relationship | German version of the questionnaire Patient Reactions Assessment Instruments (PRA-D; Brenk-Franz et al., 2016) | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early traumatization | German version of the questionnaire Childhood Trauma Questionnaire (CTQ, Bernstein und Fink, 1998) | Day 0 | 
| Current traumatization | German version of the questionnaire Impact of Event Scale-Revised (IES-R; Weiss & Marmar, 1997) | Day 0 | 
| Anxiety & Depression | German version of the questionnaire Hospital Anxiety and Depression Scale (HADS; Herrmann et al., 1995; Hermann-Lingen et al., 2011) | Day 0 | 
| Dissociative symptoms | German questionnaire on dissociative symptoms (FDS-20; Spitzer et al., 2021) | Day 0 | 
| General distress | German version of the questionnaire distress thermometer (BTH; Mehnert et al., 2006) | Day 0 |
Glutamine Popsicles in Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients

Study Overview
=================
Brief Summary
-----------------
Nutrition is an important part of the recovery process after having a head injury so that subjects can gain strength and fight off infection. Liquid nutrition formulas are often given to patients through a tube that has been placed into the intestines for feeding when they are unable to eat on their own. Some reports suggest that nutrition with extra amounts of the amino acid called glutamine may decrease infections and hospital stay in severely injured patients. The purpose of this study is to evaluate if giving extra amounts of an amino acid called glutamine with liquid nutrition formulas will decrease the risk of infection and length of stay in the intensive care unit after having a head injury.

Official Title
-----------------
Evaluation of Glutamine Popsicles in Adult/Pediatric Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients

Conditions
-----------------
Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantion

Intervention / Treatment
-----------------
* Drug: nutritional supplement
* Drug: glutamine popsicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males Nonpregnant females Receiving chemotherapy for BMT/HSCT Exclusion Criteria: Documented hepatic dysfunction History of cirrhosis History of acute renal failure (creatinine clearance < 25 mL/min) Gastrointestinal malabsorptive disorder

Ages Eligible for Study
-----------------
Minimum Age: 4 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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nutritional supplement|nan|
|Drug: glutamine popsicle|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grade of mucositis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for intravenous versus oral nutritional supplementation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone marrow transplant (BMT), hematopoietic stem cell transplant (HSCT)
Evaluation of PET/CT of Cephalic Arteries for the Diagnosis of Giant Cell Arteritis

Study Overview
=================
Brief Summary
-----------------
Giant cell arteritis (GCA) is the most common vasculitis in adults. The diagnosis of GCA is evoked by the association of clinical signs and biological anomalies (inflammatory syndrome) in patients over 50 years of age. On the other hand, starting a treatment implies being certain of the diagnosis which requires performing a temporal artery biopsy under local anesthesia. This examination is therefore an invasive procedure for patients whose sensitivity is not optimal. This is why imaging techniques (echo-Doppler or MRI of the temporal arteries) have been developed to look for signs of vasculitis without the need to perform a biopsy. However, these examinations lack sensitivity (=falsely concluding the absence of GCA) and specificity (=falsely concluding the presence of GCA). Recently, advances in imaging, and in particular positron emission tomography (PET), have made it possible to visualize the cephalic arteries, including the temporal artery. The aim of this study is therefore to evaluate the sensitivity and specificity of PET of the cephalic arteries for the diagnosis of GCA and to compare them with those of echo-Doppler and MRI of the temporal arteries.

Official Title
-----------------
Evaluation of PET/CT of Cephalic Arteries for the Diagnosis of Giant Cell Arteritis

Conditions
-----------------
Giant Cell Arteritis

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient for which the diagnosis of GCA is suspected and who underwent a cervical PET/CT Exclusion Criteria: previously diagnosed GCA, glycemia > 7 mmol/L, PET CT performed more than 72 h after introduction of glucocorticoids, age < 50 years

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients<br> | Other: Data collection<br>* Data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity / specificity of cervical PET/CT for the diagnosis of GCA | diagnosis retained by the clinician without question after 6 months of follow-up and treatment for at least 6 consecutive months | 6 months |
Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

Study Overview
=================
Brief Summary
-----------------
This study is to collect blood and urine samples to help identify and validate protein biomarkers of recovery from moderate or severe acute kidney injury (AKI).

Official Title
-----------------
Identification and Validation of Biomarkers of Acute Kidney Injury Recovery

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:a. Males and females 21 years of age or older Receiving care in an intensive care unit Expected to remain in the ICU for at least 48 hours after enrollment Use of indwelling urinary catheter as standard care at the time of enrollment Subject must have acute kidney injury (KDIGO stage 2 or stage 3) at the time of the first sample collection First sample must be collected within 36 hours of meeting KDIGO stage 2 criteria Written informed consent provided by patient or legally authorized representative (LAR) Exclusion Criteria: Prior kidney transplantation Comfort-measures-only status Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment History of human immunodeficiency virus (HIV) or hepatitis virus (based upon available medical records) infections (NOTE: HIV or hepatitis testing need not be performed for enrollment in this study.) Special populations, pregnant women, prisoners or institutionalized individuals Patient meets any of the following: Active bleeding with an anticipated need for > 4 units PRBC in a day Hemoglobin < 7 g/dL Any other condition that in the physician's opinion would contraindicate drawing serial blood samples for clinical study purposes

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

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 |
| --- | --- | --- |
| Validation of biomarkers for Acute Kidney Injury Recovery in Blood or Urine. | This study is a multi-center study intended to enroll enough subjects to validate biomarkers for acute kidney injury recovery. Subjects enrolled will be those with known moderate to severe AKI. The study is to determine the outcome of Major Adverse Kidney Event (MAKE) and Major Adverse Cardiac Event (MACE) during a period of up to 7 days. | Day 1-7 of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| None at this time | There are no secondary outcomes measures planned at this time | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Renal
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Study Overview
=================
Brief Summary
-----------------
Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Detailed Description
-----------------
The primary purpose of this study is to provide continuing access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Official Title
-----------------
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)

Conditions
-----------------
Breast Neoplasm Malignant Female

Intervention / Treatment
-----------------
* Drug: Gedatolisib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently enrolled in the B2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the Investigator Previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures No evidence of progressive disease, as determined by the Investigator Provide written informed consent prior to enrolling and receiving treatment Exclusion Criteria: Permanently discontinued from treatment in Study B2151009, or discontinued from Study B2151009 for any reason Women who are pregnant, intend to become pregnant, or nursing

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gedatolisib|Gedatolisib is a potent, reversible dual inhibitor that selectively targets phosphoinositide 3 kinase (PI3K) and mammalian target of rapamycin (mTOR) in biochemical and cellular assays.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Infant Fecal Insult Study

Study Overview
=================
Brief Summary
-----------------
The rationale for the study is to better understand the dynamics of skin microflora following skin barrier disruption in an adult dermatitis model. The results from this study will provide insights in the complex interaction between skin microbiome and epidermis under normal and disease conditions

Official Title
-----------------
Fecal Insult Study: An Exploratory Study to Evaluate the Microbial Consortia and Skin Barrier Function After Exposure to Artificial Fecal Irritants

Conditions
-----------------
Dermatitis

Intervention / Treatment
-----------------
* Other: Artificial Fecal Insult
* Other: Phosphate Buffered Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subjects with Fitzpatrick Skin Types I, II or III Exclusion Criteria: Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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: Artificial Fecal Insult<br>protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline) | Other: Artificial Fecal Insult<br>* protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline<br>Other: Phosphate Buffered Saline<br>* 200 microliters of phosphate buffered saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of microbes present on skin after exposure to artificial fecal insult | Microbes will be identified by metagenomic sequencing | up to 7 days | 
| Relative abundance of microbes present on skin measured in picograms of DNA |  | up to 7 days |
Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to test the pharmacodynamics of insulin analogs and their dependence on external and physiological alterations. We plan to compare the pharmacodynamics of insulin analog delivery in regular conditions and in the presence of increased perfusion of the delivery site, achieved by way of local warming and movement

Official Title
-----------------
Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: with heat and massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant age between 18- 65 years old Type I or Type II diabetes HbA1c 6-12% Does not suffer from sever hypertension, kidney, liver or heart disease Does not suffer from active Ischemic heart disease Is willing to sign the consent form Exclusion Criteria: Participants age < 18 or > 65 Pregnancy Breast feeding women Un-controlled diabetes, HbA1c values > 12% range Suffers from active Ischemic heart disease Alcohol addiction Is not prepared to signed the informed consent

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with treatment<br> | Device: with heat and massage<br>* For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin blood level with and with out the intervention |  | at the end of every daily study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin, diabetes, post prandial glucose level, pharmacokinetics, pharmacodynamics
Intradermal, Fractional Dose of HPV Vaccines:

Study Overview
=================
Brief Summary
-----------------
This randomized phase IV trial compares fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, 12 months, and 24 months.

Official Title
-----------------
Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.

Conditions
-----------------
HPV Infection, HPV Vaccine

Intervention / Treatment
-----------------
* Biological: HPV vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 27-45 years at enrollment Not intending to receive the HPV vaccine series for the duration of the study participation Willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule Exclusion Criteria: Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9) Currently pregnant or breastfeeding Immune deficiency or other immune disorder HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer) Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes, Known allergy to vaccine components Prior history of HPV-associated cancer

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bivalent HPV vaccine<br>One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously | Biological: HPV vaccine<br>* Gardasil 9 Bivalent HPV VLP Vaccine, one-fifth dose Nonavalent HPV VLP Vaccine, one-fifth dose<br>|
| Experimental: Nonavalent HPV vaccine<br>One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously | Biological: HPV vaccine<br>* Gardasil 9 Bivalent HPV VLP Vaccine, one-fifth dose Nonavalent HPV VLP Vaccine, one-fifth dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV antibody detection after fractional HPV vaccination | HPV antibody response after delivery of a single, intradermal, fractional dose of the HPV-2 or HPV-9 vaccines | 12 months |