linjc16/ctgov huggingface dataset:
Weaning And Variability Evaluation (WAVE)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if variability in heart and breathing rates can be used to predict successful weaning. We are collecting data to determine whether or not subtle differences in heart rate and respiratory function will help physicians to decide if a patient is ready to be weaned.

Detailed Description
-----------------
In this prospective observational pilot study, mechanically ventilated patients weaning or near extubation (i.e. within 1-5 days) were selected to undergo continuous heart rate (EKG waveform at 500 Hz) and respiratory rate (expired CO2 waveform at 100 Hz) recording. The data was collected as per standard practice by the bedside monitor (Phillips Intelivue MP70). A portable CPU with TrendfaceTM software was used to download the data for variability analysis. All decisions on timing of SBTs and extubation were left to the discretion of the treating team who were unaware of the variability results. SBT's were repeated daily from trial onset until extubation patient permitting.

Official Title
-----------------
Weaning And Variability Evaluation

Conditions
-----------------
Extubation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been requiring mechanical ventilation for >48 hours. At least partial reversal of the condition precipitating invasive ventilation. Stabilization of other organ system failures (i.e. no worsening). The patient is able to tolerate pressure support ventilation ≤14 cm H2O (SpO2 ≥ 90% with FiO2 ≤ 40% and PEEP ≤ 10 cm H2O) The patient is hemodynamically stable (off vasopressors or on low levels of vasopressors). Stable neurological status (no deterioration in the last 24 hors, intact respiratory drive and ICP < 20). The patient has intact airway reflexes (adequate cough with suctioning and a gag reflex). Exclusion Criteria: Allergy to skin adhesives or a contraindication to placing electrocardiogram adhesives (e.g. severe psoriasis). Do not reintubate order documented on chart or anticipated withdrawal of life support. Tracheostomy Known or suspected severe myopathy or neuropathy (i.e. myasthenia gravis, Guillain-Barré syndrome) or quadriplegia. Severe heart failure or Grade IV left ventricular function. Prior extubation during ICU stay.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Continuous heart rate and respiratory rate waveforms |  | at time of sponataneous breathing trial (at least 48 hours after intubation and within 24 hours of extubation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extubation, weaning, mechanical ventilation
The Evaluation of Cow Milk-Based Formulas

Study Overview
=================
Brief Summary
-----------------
Infants will be fed infant formula and blood drawn to measure fatty acid levels in the blood.

Official Title
-----------------
The Evaluation of Cow Milk-Based Formulas - Study A

Conditions
-----------------
Term Infants

Intervention / Treatment
-----------------
* Other: Marketed infant formula with DHA and ARA
* Other: Milk-based infant formula with DHA and ARA
* Other: Milk-based formula with DHA, ARA, prebiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, term infant 10 to 18 days of age Exclusion Criteria: Breast fed infants Infants with formula intolerance

Ages Eligible for Study
-----------------
Minimum Age: 10 Days
Maximum Age: 18 Days

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marketed infant formula with DHA and ARA<br>Marketed milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) | Other: Marketed infant formula with DHA and ARA<br> <br> |
| Experimental: Milk-based infant formula with DHA and ARA<br>Experimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) | Other: Milk-based infant formula with DHA and ARA<br> <br> |
| Experimental: Milk-based formula with DHA, ARA, prebiotics<br>Experimental milk-based infant formula containing docosahexaenoic acid (DHA) and arachidonic acid (ARA) and prebiotic blend | Other: Milk-based formula with DHA, ARA, prebiotics<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red Blood Cell (RBC) ARA and DHA |  | 120 Days of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phospholipid fatty acids, tolerance |  | 120 Days of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant, formula, LC PUFA
Study of Gulf War Illness (GWI) by Comparing GWI and Healthy Veterans

Study Overview
=================
Brief Summary
-----------------
Determine if: genetic differences of CNDP1 gene the previously defined GWI/Chronic Fatigue Syndrome (GWI/CFS) cerebrospinal fluid proteome contents psychometric other variables can differentiate between veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms and those without these complaints.

Official Title
-----------------
CNDP1 Polymorphisms in Gulf War Illness (GWI)

Conditions
-----------------
Gulf War Illness, Persian Gulf War Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to: Persian Gulf waters and adjacent land areas Other global locations U.S. only Status prior to 1990 and 1991: Active duty National Guard Reserves Exclusion Criteria: Current active duty military personnel Any one who was not active duty military personnel between August 1, 1990 and July 31, 1991 HIV/AIDS; pregnancy or lactation; potential hepatitis; drug addiction; chronic inflammatory, infectious, or autoimmune medical illnesses not associated with GWI; incarceration; dementia, other cognitive limitation; or reliance on a care-giver in order to respond to the questionnaires and other study tests. Amputations of one or both hands and forearms will be permitted but hand grip tests will not be tested
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 |
| --- | --- |
| 1<br>GWI: veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms | |
| 2<br>HC: healthy veterans of the 1990-1991 Persian Gulf War | |

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
-----------------
CNDP1, carnosine dipeptidase 1, Persian Gulf War, Gulf War Syndrome, GWI, Gulf War Illness, Exercise, Chronic Fatigue, Fibromyalgia, Veterans, Irritable Bowel Syndrome, Migraine headaches, Neuropathy, Multiple Chemical Sensitivity
Correlation Analysis of Hearing Thresholds, Validated Questionnaires and Psychoacoustic Measurements in Tinnitus Patients

Study Overview
=================
Brief Summary
-----------------
Objective: To evaluate the correlation between audiometric thresholds, pitch matching (PM), minimum masking level (MML), Tinnitus Handicap Inventory (THI) and the Beck Depression Inventory (BDI) in tinnitus patients. Subjects: 48 patients with tinnitus as the main complaint from OTOSUL, Otorrinolaringologia Sul-Fluminense, Volta Redonda, RJ, Brasil and Centro de Tratamento e Pesquisa em Zumbido, Belo Horizonte, MG, Brasil. Method: Subjects performed tonal audiometry, Pitch Matching (PM) and Minimum Masking Level (MML) for tinnitus. They also fulfilled the Tinnitus Handicap Inventory (THI) and Beck Depression Inventory (BDI). Data was statistically compared for correlation between audiometric thresholds, psycho-acoustic measures and questionnaires.

Official Title
-----------------
Correlation Analysis of Hearing Thresholds, Validated Questionnaires and Psychoacoustic Measurements in Tinnitus Patients

Conditions
-----------------
Tinnitus, Hearing Loss, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tinnitus for more than 6 months sensorineural hearing loss normal otoscopy Exclusion Criteria: conductive or mixed hearing losses A-r, A-d, B and C tympanograms tinnitus treatment in the last 6 months pregnant woman Vestibular Schwannoma

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tinnitus patients<br>Group of 48 tinnitus patients | |

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
-----------------
tinnitus, depression, audiometry, measurement
Effect of Gabapentin on Idiopathic Subjective Tinnitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus.

Detailed Description
-----------------
Tinnitus is the perception of sound in the absence of acoustic stimulation. It can be subjective or objective. . Despite numerous researches,no effective treatment for people who suffer from tinnitus has yet been stablished. As there are many evidences suggesting that loss of inhibition in the central nervous system may be responsible for many aspects of auditory dysfunction,including tinnitus; and as Gabapentin (Neurontin), a gama-aminobutyric acid (GABA) analogue, is an effective medication in conditions where inhibition in the CNS is impaired; we guess that Gabapentin might be useful for treating idiopathic subjective tinnitus.

Official Title
-----------------
Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus

Conditions
-----------------
Subjective Tinnitus

Intervention / Treatment
-----------------
* Drug: Gabapentin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with subjective idiopathic tinnitus Exclusion Criteria: tinnitus with known underlying cause pregnant women and patients younger than 18 or older than 75 years patients with impaired renal function

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Randomly,half of the subjects are given Gabapentin. | Drug: Gabapentin<br>* Gabapentin, 600 mg bid for the first two weeks, increased to a maximum dose of 1800 mg per day during the next 6 weeks if necessary.<br>* Other names: Neurontine;|
| Placebo Comparator: 2<br>Randomly,half of the subjects receive placebo. | Drug: placebo<br>* placebo is given with the same definition as Gabapentin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the sensation of Tinnitus by the patient or complete resolution of tinnitus;by the patient's scoring it from one to ten, before and after prescribing Gabapentin. |  | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relieve of complications of tinnitus, such as sleep difficulties. |  | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tinnitus, gabapentin
Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture

Study Overview
=================
Brief Summary
-----------------
A prospective, multicenter and controlled study to observe the efficacy and safety of coated metal ureteral stent in the treatment of radiation induced ureteral stricture.

Official Title
-----------------
Efficacy and Safety of Coated Metal Ureteral Stent in the Treatment of Radiation Induced Ureteral Stricture, A Prospective, Mutlcenter and Controlled Study

Conditions
-----------------
Ureteral Stricture, Hydronephrosis, Radiation Exposure

Intervention / Treatment
-----------------
* Device: Coated metal ureteral stent(CMUS)
* Device: Double-J stent(DJS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ureteral stricture and hydronephrosis. Previous history of radiation therapy. Must be able to tolerate surgery. Exclusion Criteria: Combine with hypertonic neurogenic bladder (except for patients with long-term indwelling catheter). Colon resection surgery patients.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CMUS group<br>Coated metal ureteral stent is indwelled. | Device: Coated metal ureteral stent(CMUS)<br>* Coated metal ureteral stent aims to treat the patients with refractory ureteral stricture, such as radiation induced ureteral stricture. In this study, CMUS is indwelled to observe the efficacy and safety in the treatment of radiation induced ureteral stricture compared with Double-J stent.<br>|
| Other: DJS group<br>Double-J stent is indwelled | Device: Double-J stent(DJS)<br>* Double-J stent is commonly used for treatment of kinds of ureteral stricture. In this study, DJS is indwelled as a controlled group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency rate | Number of patients evaluated with hydronephrosis | Up to 36 months | 
| Indwelling time | Number of months of the implant in the ureter | Up to 36 months | 
| Device related serious adverse events | Number of device related serious adverse events | Up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coated metal ureteral stent, safety, efficacy, radiation induced ureteral stricture
Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas

Study Overview
=================
Brief Summary
-----------------
To test the feasibility of collecting cell-free DNA (cfDNA) samples from DLBCL patients before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method.

Detailed Description
-----------------
Primary Objective: • To determine the feasibility and clinical utility of ctDNA in identifying actionable alterations and minimal residual disease for lymphoma patients across community centers in Texas. Secondary Objectives: To provide useful prognostic information before treatment, assess molecular response at interim time points and residual disease at the end of therapy, and identify tumor-specific mutations Levels of cfDNA and its association with both EFS and OS in patients receiving therapy

Official Title
-----------------
Feasibility and Clinical Utility of Cell-free DNA (cfDNA) in Identifying Actionable Alterations and Minimal Residual Disease for Lymphoma Patients Across Community Centers in Texas

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Diagnostic Test: cell-free DNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female patients who are at least 18 years of age on the day of informed consent signing. Patients must have a histologically documented diffuse large B-cell lymphoma requiring therapy. Provision of written informed consent for the study. Pregnant women not included Cognitively impaired adults are not included. Exclusion Criteria: None

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cell-free DNA (cfDNA) samples<br>cell-free DNA (cfDNA) samples from DLBCL participants before and after treatment. cfDNA is DNA traveling in your blood outside of a cell and is easily collected from blood samples drawn using the vein puncture method. Blood will be drawn 3 times (by vein) | Diagnostic Test: cell-free DNA<br>* Given by IV (vein)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | through study completion; an average 1 year |
Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program for eligible participants with a previously treated B-cell cancer who are ineligible for an ongoing pirtobrutinib clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

Official Title
-----------------
Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers

Conditions
-----------------
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Lymphocytic, Small, Lymphoma, Mantle-Cell, Waldenstrom Macroglobulinemia, Ritcher's Transformation, Syndrome

Intervention / Treatment
-----------------
* Drug: Pirtobrutinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed with: CLL or SLL and have received treatment with the following five classes of therapy: Chemotherapy, anti-cluster of differentiation (anti-cd) 20 antibody, covalent Bruton's tyrosine kinase (BTK) inhibitor, B-cell lymphoma-2 (BCL-2) inhibitor, and phosphatidylinositol 3-kinase (PI3K) inhibitor MCL that has been previously treated with a covalent BTK inhibitor Richter's Transformation (RT) with previous Richter's directed-therapy Waldenstrom macroglobulinemia (WM), previously treated with chemotherapy, anti-CD20 antibody and a covalent BTK inhibitor Are not eligible for an ongoing pirtobrutinib clinical trial Exclusion Criteria: Inadequate organ function Significant cardiovascular disease History of allogenic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified Tcell (CAR-T) therapy within 60 days Tested positive for human immunodeficiency syndrome (HIV) or known active hepatitis B or C virus or cytomegalovirus (CMV) infection Active, uncontrolled autoimmune cytopenia Clinically significant active malabsorption syndrome Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pirtobrutinib|Administered orally.|

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
-----------------
BTKi, BTK Inhibitor, Bruton's tyrosine kinase inhibitor, Hematologic Disease, B-cell receptor