linjc16/ctgov huggingface dataset:
Assisted Nerve Blocks

Study Overview
=================
Brief Summary
-----------------
The study investigates assisted nerve blocks using an ultrasound machine.

Conditions
-----------------
Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for nerve blocks Exclusion Criteria: patient not able to provide the informed consent allergy to local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Feasability of assisted nerve blocks |  | 24h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nerve Blocks
Natural Killer Cells Reconstitution Kinetics Post Haploidentical Transplantation

Study Overview
=================
Brief Summary
-----------------
Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution.

Detailed Description
-----------------
Patients with hematological malignancies suitable for allo-HSCT but without HLA-identical related or unrelated donors were candidates for the HLA-haploidentical HSCT. Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution. Peripheral blood will be collected by day15, 30, 60, 90, 180, and 1 year post transplantation.

Official Title
-----------------
Natural Killer Cells Reconstitution Kinetics Post T Cells Repleted Haploidentical Transplantation

Conditions
-----------------
Natural Killer Cell Mediated Immunity

Intervention / Treatment
-----------------
* Drug: MMF
* Drug: MMF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation Exclusion Criteria: NR or refractory AML/ALL before transplantation donors from mother or collateral related

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 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 |
| --- | --- |
| experimental group<br>MMF withdrawal by engraftment post haplo-SCT | Drug: MMF<br>* MMF withdrawal by engraftment post haplo-SCT<br>|
| control group<br>MMF withdrawal by 2 month post haplo-SCT | Drug: MMF<br>* MMF withdrawal by 2 month post haplo-SCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune Reconstitution differences between two group |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of Infection differences between two group |  | 1 year | 
| Cumulative incidence of acute GVHD differences between two group |  | 100 day | 
| Cumulative incidence of chronic GVHD differences between two group |  | 1 year | 
| Cumulative incidence of TRM differences between two group |  | 1 year | 
| Cumulative incidence of relapse differences between two group |  | 1 year | 
| DFS differences between two group |  | 1 year | 
| OS differences between two group |  | 1 year |
Family Health After Predictive Huntington Disease (HD) Testing

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify health management concerns and needs of family members of asymptomatic and symptomatic persons with mutation in the gene for Huntington Disease (HD).

Detailed Description
-----------------
This is an observational study with three phases. In Phase 1, focus groups consisting of family members of persons with HD Gene mutation will be conducted and data collected to be analyzed through content analysis to identify salient themes and key issues. In Phase 2, a survey instrument will be developed and field-tested in order to describe the health care needs, management strategies, and needs for health and social services of relative/significant others of asymptomatic and symptomatic persons with the mutation in the gene for HD. In Phase 3, the survey will be distributed to family members of asymptomatic and symptomatic persons with mutation in the gene for HD and frequencies and comparisons of survey responses according to respondent characteristics will be reported.

Official Title
-----------------
Family Health After Predictive Huntington Disease Testing

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Genetic: Mutation in the gene


Participation Criteria
=================
Eligibility Criteria
-----------------
Family members of asymptomatic and symptomatic persons with mutation in the gene for Huntington Disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>All Participants hav a family member with Huntington Disease | Genetic: Mutation in the gene<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of a positive HD test or presence of HD on a family members perceptions of: health problems, emotional and functional health status, resources/strategies for managing problems, helpfulness, and services needed to help family members cope. |  | Over 6 yr span | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the health care needs, management strategies, and needs for health and social services of a broader sample of relatives/significant others in families in which a person has a gene mutation for HD. |  | Over 6 yr span | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Care Management, Family, Huntington's Disease
IUD Self-Removal Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot study designed to test the effectiveness of several techniques for intrauterine device (IUD) self-removal and to understand patient preferences regarding IUD self-removal and indicators of success as well as understanding the impacts of IUD self-removal on other clinical care.

Detailed Description
-----------------
The Investigators propose to test a novel method for self-removal of IUDs in an effort to increase the proportion of patients who are able to successfully and safely remove their IUD when desired. Participants will attempt self-removal in office, where a provider will be able to remove the IUD if unsuccessful. Participants will be instructed on current and novel techniques and the investigators will examine indicators of success as well as patient and provider preferences.

Official Title
-----------------
IUD Self-Removal: A Study to Pilot the Feasibility of a Novel Technique

Conditions
-----------------
IUD

Intervention / Treatment
-----------------
* Other: Instructions for IUD Self-Removal Provided to Participant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting at clinic for IUD removal or exchange Willing and able to give consent with literacy in English or Spanish Exclusion Criteria: Participants who are referred for a complicated IUD removal such as a stingless IUD, prior failed IUD removal attempt, or an IUD failure.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IUD Self-Removal<br> | Other: Instructions for IUD Self-Removal Provided to Participant<br>* The provider will offer any individual presenting for in-person IUD removal or exchange (removal-replacement) the option for self-removal. The participant will be provided a 'how to' instruction sheet with information on positioning and what to expect. The participant will first attempt removal with clean hands if desired, then utilizing non-sterile, clean gloves (not explicitly tested in prior studies) and if that fails, the use of a menstrual cup (a novel technique). If not successful, the provider will perform standard IUD removal in the clinic.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of IUD Self-Removal Techniques | Proportion of participants who successfully remove their IUDs | Immediately after IUD Removal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IUD Removal
A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)

Study Overview
=================
Brief Summary
-----------------
The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women. The safety and tolerability of UC1010 is also evaluated in study part 1. In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment groups are compared to one placebo group.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Parallel-group Study on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UC1010 Administered Subcutaneously, Single-dosing in Healthy Women (Part 1) and Multiple Dosing in PMDD Women (Part 2) - Phase I/II Study

Conditions
-----------------
Premenstrual Dysphoric Disorder

Intervention / Treatment
-----------------
* Drug: UC1010
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Part 1 -Essentially healthy Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles Exclusion Criteria: steroid hormonal treatment during the previous three months treatment with psychopharmaceuticals or other treatment for PMS history of or a significant medical condition ongoing be pregnant or plan a pregnancy within the study period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- |
| Active Comparator: UC1010 low dose<br> | Drug: UC1010<br> <br> |
| Active Comparator: UC1010 high dose<br> | Drug: UC1010<br> <br> |
| Placebo Comparator: Vehicle<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premenstrual symptom severity |  | Daily Record of Severity of Problems (DRSP) measured during 4-5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | During 1.5 month (starting from first dose) |
A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants

Study Overview
=================
Brief Summary
-----------------
A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants Background: Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human milk and preterm formulas contain DHA and AA, but at lower concentrations than required to approximate utero accretion rate. Objective: To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age. Design: A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal centers. Subjects and methods: Infants with birth weight < 1.5 kg are randomized to either an intervention or a control group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100 ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek, USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for fatty acid pattern using high performance liquid chromatography.

Conditions
-----------------
Infant, Low Birth Weight

Intervention / Treatment
-----------------
* Procedure: Supplement of fatty acid (DHA and AA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth weight < 1500 g Born at one of 4 participating neonatal centers in Norway Exclusion Criteria: Cerebral haemorrhage (stage 3 or 4) Major congenital malformations that are supposed to affect growth and development Illness that require prolonged parenteral nutrition (>4 weeks)

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

| Intervention/Treatment |
| --- |
|Procedure: Supplement of fatty acid (DHA and AA)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive development |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth |  |  | 
| Adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fatty acids, Human milk, Infant development, Very low birthweight infants
Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Montelukast Chewable Tablet under fed conditions

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Montelukast Sodium 5 mg Chewable Tablets Under Fed Conditions

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Montelukast
* Drug: Singulair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to montelukast or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Montelukast<br>5 mg Chewable Tablet | Drug: Montelukast<br>* 5 mg Chewable Tablet<br>* Other names: Singulair;|
| Active Comparator: Singulair<br>5 mg Chewable Tablet | Drug: Singulair<br>* 5 mg Chewable Tablet<br>* Other names: Montelukast;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 9 days |
TolerUp Enteral Feeding Protocol

Study Overview
=================
Brief Summary
-----------------
This prospective, observational, multi-center study will follow children with cerebral palsy who decided to switch to an enteral product that contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance.

Official Title
-----------------
A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy

Conditions
-----------------
Gastrointestinal Tolerance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cerebral palsy Fed with an enteral product that does not contain partially hydrolyzed protein and medium chain triglycerides and decided to be switched to an enteral product contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance Fed by tube, using enteral tube feeding as sole source of nutrition A signed and dated informed consent by subject's legally acceptable representative Exclusion Criteria: Chronic diseases other than cerebral palsy (e.g. diabetes mellitus, renal, liver, endocrine diseases, malignancy) Intestinal obstruction Dialysis treatment Requirement of artificial ventilation Requirement of parenteral nutrition Normal nutrition in addition to enteral tube feeding Allergy or intolerance to any ingredient of the study product Currently participating in another clinical or non-clinical study

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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 |
| --- | --- | --- |
| Gastro-Intestinal Tolerance | healthcare professional assessed | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometrics | change in weight from baseline measurement | Baseline to 6 months | 
| Care Giver Satisfaction of Enteral Product | survey administered by healthcare professional | Baseline to 6 months |
An Observational Study of Patients With Coronavirus Disease 2019

Study Overview
=================
Brief Summary
-----------------
This is an observational study of patients with COVID-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.

Detailed Description
-----------------
Data from up to 5,000 adult patients in the US will be captured from eligible patients enrolled following admission to the hospital. Participants will have de-identified medical records collected from hospital admission to discharge, including but not limited to critical care monitoring, details on mechanical ventilation, laboratory data, imaging reports, medications, and all procedures. Diagnosis and patient management will follow each hospital's standard of care and no specific treatments, procedures or laboratory tests will be dictated by enrollment in TARGET-COVID-19.

Official Title
-----------------
An Observational Study of Patients With Coronavirus Disease 2019

Conditions
-----------------
COVID-19, Coronavirus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (age ≥18 years) who are or have been hospitalized and diagnosed with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection. SARS-CoV-2 confirmed diagnosis (e.g. polymerase chain reaction [PCR] or other clinically utilized test). Exclusion Criteria: N/A

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 |
| --- | --- | --- |
| Natural history of COVID-19: Characteristics of COVID-19 |  | 12 months | 
| Natural history of COVID-19: Participant demographics |  | 12 months | 
| Natural history of COVID-19: Treatment use |  | 12 months | 
| Time point of clinical response |  | 12 months |