linjc16/ctgov huggingface dataset:
Healthy Term Infants Fed Milk-Based Formulas

Study Overview
=================
Brief Summary
-----------------
This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.

Official Title
-----------------
Healthy Term Infants Fed Milk-Based Formulas With A Supplemental Carotenoid

Conditions
-----------------
Infants

Intervention / Treatment
-----------------
* Other: Standard Milk-based Formula Containing Carotenoid
* Other: Investigational Milk-based Formula Containing Carotenoid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant is in good health Infant is a singleton from a full term birth with a gestational age of 37-42 weeks Infant's birth weight was > 2490 g ( 5 lbs 8 oz) Infant is between 14 and 28 days of age Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study Exclusion Criteria: An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development. Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance

Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 28 Days

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Milk-based Formula Containing Carotenoid<br>milk-based ready to feed infant formula | Other: Standard Milk-based Formula Containing Carotenoid<br>* Fed ad libitum<br>|
| Experimental: Investigational Milk-based Formula Containing Carotenoid<br>investigational milk-based ready to feed infant formula | Other: Investigational Milk-based Formula Containing Carotenoid<br>* Fed ad libitum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotenoid Concentration | Plasma sample | Change from Baseline to end of Study Period A ( 21 Days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotenoid Concentration | Plasma sample | Change from Baseline to end Study Periods A ( 21 Days) and B ( 21 Days) |
PET and MRI Imaging of Brain Tumors Using [18F]PARPi

Study Overview
=================
Brief Summary
-----------------
This study is to collect data about how 18FPARPi can be used together with PET/positron emission tomography and MRI/magnetic resonance imaging scans to take pictures of brain cancer

Official Title
-----------------
Pilot Study of [18F]PARPi PET/MR Imaging in Patients With New and/or Suspected Recurrent Brain Tumors

Conditions
-----------------
Brain Tumor, Brain Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: PET/MR with [18F]PARPi
* Drug: [18F]PARPi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with new or suspected recurrent brain tumors (including suspected recurrent brain tumors showing growth from any preceding scan) Age >/= 18 years Minimum at least one brain lesion size >/= 1.5cm diameter Scheduled to undergo treatment at MSK Willingness to sign informed consent Able to receive intravenous gadolinium contrast per MSK Department of Radiology guidelines Exclusion Criteria: Any contraindication to 3T MRI (PET/MR scanner is 4.0 Tesla) Pregnancy or breast-feeding women

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 |
| --- | --- |
| Participants with Brain Cancer<br>Participants with new or suspected recurrent brain tumors | Diagnostic Test: PET/MR with [18F]PARPi<br>* One PET/MR study (with up to 3 scan times) with [18F]PARPi<br>Drug: [18F]PARPi<br>* Injection of <100ug of [18F]PARPi prior to 1 PET/MR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax measurements | [18F]PARPi updtake in lesions will be quantified by standard SUVmax measurements from PET/MR scans | Up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain cancer, 18FPARPi, PET scan, MRI, Memorial Sloan Kettering Cancer Center, 19-311
Population PK of Antibiotics, Sedative and Analgesics, and Antiplatelet Drugs During ECMO

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to optimize the dosage regimen of drugs in patients during during Extracorporeal Membrane Oxygenation (ECMO) by population pharmacokinetic modeling.

Official Title
-----------------
Population Pharmacokinetics of Antibiotics, Sedative and Analgesics, and Antiplatelet Agents During Extracorporeal Membrane Oxygenation (ECMO)

Conditions
-----------------
Pharmacokinetics, Extracorporeal Membrane Oxygenation

Intervention / Treatment
-----------------
* Other: Residual blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are taking levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel while underdoing Extracorporeal Membrane Oxygenation Exclusion Criteria: Pregnant women Receiving a therapy that can affect blood concentration due to a drug-drug interaction with levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel

Ages Eligible for Study
-----------------
Minimum Age: 19 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 udergoing ECMO<br>Population who have been taking antibiotics or antiplatelets or sedatives/analgesics during Extracorporeal Membrane Oxygenation | Other: Residual blood<br>* Residual blood samples(1 2 cc) at each sampling time are collected from all subjects while using ECMO for drug concentration assays(LC-MS/MS etc.).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters | Volume of distribution | Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO | 
| Pharmacokinetic parameters | Clearance | Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO | 
| Pharmacokinetic parameters | Absorption rate (if oral drugs) | Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extracorporeal Membrance Oxygenation, Pharmacokinetic medeling, Antiplatelet agents, Sedatives, Antibiotics
Male Reproductive Health of Floating Population: a Large-Scale Survey in Dongguan

Study Overview
=================
Brief Summary
-----------------
To determine the prevalence of sexual problems particularly premature ejaculation and erectile dysfunction among men working in factories of Dongguan city, using the self-rating scales like International Index of Erectile Function, and to investigate the characteristics or risk factors associated with these sexual problems in floating population through regression analysis.

Detailed Description
-----------------
In China, the floating population is a special group of people who work and live outside their hometowns and without residence cards of that area they reside. Sexual problems are common in floating population, majority of whom are in their sex active age. There is a lack of studies concerning these sexual problems, so we conduct this survey to investigate the sexual dysfunctions among men, especially the floating population, and to find out whether most of these sexual problems are related to their social lives, medical illnesses, and psychological status.

Official Title
-----------------
Prevalence of Reproductive Health Problems and Their Social, Psychological and Physical Association Among Men in Floating Population: a Large-Scale Cross-Sectional Study in Dongguan City

Conditions
-----------------
Sexual Behavior, Erectile Dysfunction, Premature Ejaculation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have reached 18 years old live in Dongguan more than 6 months floating population with or without residence card Exclusion Criteria: younger than 18 years old live in Dongguan less than 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| men of floating population<br>males who live in Dongguan more than 6 months and without residence cards | |
| men of non-floating population<br>males who live in Dongguan more than 6 months and with residence cards | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of sexual problems | Determine the prevalence of sexual problems among men of floating population in Dongguan. | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between risk factors and sexual problems | Association between social, psychological and physical factors and sexual problems. | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male Reproductive Health, Floating Population, Sexual Behavior, Erectile Dysfunction, Premature Ejaculation
Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices

Study Overview
=================
Brief Summary
-----------------
To see if removing the omentum in addition to a gastric bypass improves diabetes is better than just a gastric bypass.

Official Title
-----------------
Randomized Controlled Trial of Laparoscopic Gastric Bypass Plus Omentectomy Versus Laparoscopic Gastric Bypass Alone in Improving Diabetic Indices

Conditions
-----------------
Diabetes, Interleukins, Cytokines

Intervention / Treatment
-----------------
* Procedure: laparoscopic gastric bypass plus omentectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing laparoscopic gastric bypass, >18 yo, understands english Exclusion Criteria: previous lower pelvic surgery, self-pay patients, previous weight loss surgery,

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: 1<br>surgery plus omentectomy | Procedure: laparoscopic gastric bypass plus omentectomy<br> <br> |
| No Intervention: 2<br>standard gastric bypass | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diabetic indices |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interleukin and cytokine levels, weight loss |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, diabetes, cytokines
Studying Biomarkers in Samples From Younger Patients With Wilms Tumor

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood, tissue, or bone marrow from patients with cancer in the laboratory may help doctors to learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies biomarkers in samples from younger patients with Wilms tumor.

Detailed Description
-----------------
OBJECTIVES: To analyze 250 favorable-histology Wilms tumor (FHWT) samples from patients registered on NWTS4 for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by subtelomeric multiplex ligation-dependent probe amplification (MLPA), and to determine their association with relapse-free and overall survival. To develop a robust multiplex MLPA test using multiple synthesized probes to those targets identified as significantly associated with relapse in Aim 1. To validate the multiplex MLPA test designed and tested in Aim 2 on an independent set of 1727 FHWT and 250 anaplastic WT registered on NWTS-5. OUTLINE: Archived DNA samples are analyzed for gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q by MLPA. Assay results are then researched for accuracy, clinical validity, sensitivity, precision, and potential analytical interferences.

Official Title
-----------------
Validation of Copy Number Changes by MLPA as Predictors of Relapse in Wilms Tumor

Conditions
-----------------
Kidney Cancer

Intervention / Treatment
-----------------
* Genetic: DNA analysis
* Genetic: nucleic acid amplification
* Other: diagnostic laboratory biomarker analysis
* Other: medical chart review


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: DNA samples from FHWT patients registered on: NWTS-4 NWTS-5 with focal and diffuse anaplasia tumors PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA analysis|nan|
|Genetic: nucleic acid amplification|nan|
|Other: diagnostic laboratory biomarker analysis|nan|
|Other: medical chart review|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of copy number changes (gain of 1q and 15q, and loss of 1p, 16q, 17p, and 22q) in FHWT by the MLPA assay |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wilms tumor and other childhood kidney tumors
Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger

Study Overview
=================
Brief Summary
-----------------
In this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of A1 pulley. Results will be compared regarding functional, clinical and cosmetic outcome.

Official Title
-----------------
Comparative Clinical Study of Ultrasound-Guided A1 Pulley Release vs Open Surgical Intervention in the Treatment of Trigger Finger

Conditions
-----------------
Surgical Release of Ai Pulley Trigger Finger

Intervention / Treatment
-----------------
* Procedure: Surgical release A1 pulley for Trigger finger of the hand


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months. Exclusion Criteria: Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease. Patients with multiple trigger fingers

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 |
| --- | --- |
| Active Comparator: Open surgical release A1 Pulley<br> | Procedure: Surgical release A1 pulley for Trigger finger of the hand<br> <br> |
| Active Comparator: Ultrasound guided close release A1 pulley<br> | Procedure: Surgical release A1 pulley for Trigger finger of the hand<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of triggering expressed as the success rate per digit. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time for taking postoperative pain killers |  | 12 weeks | 
| Range of motion recovery |  | 12 weeks | 
| QuickDASH test scores (Greek version) |  | 12 weeks | 
| Time to return to normal activities (including work) |  | 12 weeks | 
| Cosmetic results |  | 12 weeks |
A Study To Find The Best Doses Of SU011248 And Gemcitabine When Given Together To Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with gemcitabine in patients with advanced solid tumors

Official Title
-----------------
A Phase 1 Study Of SU011248 And Gemcitabine In Patients With Advanced Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: SU011248; Gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists Patient has good performance status (ECOG 0 or 1) Exclusion Criteria: Prior treatment with either gemcitabine or SU011248 Hypertension that cannot be controlled by medications

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: SU011248; Gemcitabine<br>* Dose finding study using SU011248 (sunitinib) daily by oral capsule in 4/2 (administered for 4 out of every 6 weeks) or 2/1 (administered for 2 out of every 3 weeks) schedule with gemcitabine administered on Days 1, 8, 22 and 29 on Schedule 4/2 and Days 1 and 8 on Schedule 2/1 until progression or unacceptable toxicity<br>* Other names: Sutent, sunitinib, SU11248, Gemzar;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximally tolerated dose of SU011248 (dosed on Schedule 4/2 or 2/1) when given in combination with gemcitabine |  | From screening until at least 28 days beyond discontinuation of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pharmacokinetics of SU011248 and gemcitabine when these drugs are co-administered |  | From screening until at least 28 days beyond discontinuation of study treatment | 
| To preliminarily assess the antitumor activity of SU011248 and gemcitabine in patients with measurable disease |  | From screening until at least 28 days beyond discontinuation of study treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solid tumor malignancy, SU011248, sunitinib, neoplasms
Ivermectin as a Novel Therapy in COVID-19 Treatment

Study Overview
=================
Brief Summary
-----------------
Efficacy of Ivermectin in COVID-19 treatment

Detailed Description
-----------------
Clinical Study Evaluating the Efficacy of Ivermectin in COVID-19 treatment

Official Title
-----------------
The Efficacy of Ivermectin in COVID-19 Treatment

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Drug: Ivermectin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Adult Patients aging from 20 to 65 years-old with COVID-19 confirmed by pharyngeal swab PCR. Exclusion Criteria: Allergy or contraindication to the drugs used in the study. Pregnant and lactating mothers. Patients with cardiac problems.
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 |
| --- | --- |
| Experimental: Ivermectin<br>Ivermectin plus standard of care treatment Dose 2 tablets 12mg per day for 3 days | Drug: Ivermectin<br>* Ivermectin treatment<br>* Other names: iverzine, ivermectin;|
| No Intervention: Standard of care<br>Standard of care treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with mortality | Improvement of survival | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Effect on the length of hospital stay | 1 month | 
| The need for mechanical ventilation | Need for mechanical ventilation | 1 month |