linjc16/ctgov huggingface dataset:
Health and Quality of Life One Year After Discharge From the Intensive Care Unit (ICU)

Study Overview
=================
Brief Summary
-----------------
The goal is to capture the Quality of life and survival of patients one year after the stay at ICU. Data will be collected during the stay in the ICU and evaluated. One year after the ICU stay patients will be send a Quality of Life questionnaire they need to fill out and return. All data will be evaluated together.

Detailed Description
-----------------
no detailled description necessary

Official Title
-----------------
Health and Quality of Life One Year After Discharge From the ICU: in Time Not Limited Quality Control After Intensive Medical Treatment

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Behavioral: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are at least 5 days or longer without interruption at the ICU Exclusion Criteria: patients with less than 4 days at the ICU
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| all patients<br>questionnaire for patients with ICU stay at least 5 days or longer without interruption at the ICU | Behavioral: questionnaire<br>* Investigation on all study patients, no Intervention, no groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 1 year after ICU discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QoL and Survival one year after ICU stay
Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)

Study Overview
=================
Brief Summary
-----------------
Overall improvement, severities and changes of specific clinical symptoms were surveyed in outpatients with depression or in a depressed state to evaluate the efficacy and safety of PAXIL tablets in patients in whom the PAXIL dose was increased and those treated with a constant dose.

Official Title
-----------------
Special Drug Use Investigation for PAXIL Tablet (20mg-Clinical Symptom Progression)

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who is 18 years or more Subjects diagnosed with depression or in a depressed state Exclusion Criteria: Subjects who have been treated with paroxetine prior to this investigation Subjects with hypersensitivity to paroxetine Subjects taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs Concomitant use in subjects taking pimozide

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed PAXIL<br>Patients with depression or depressed state prescribed PAXIL during study period | Drug: Paroxetine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice |  | 12 weeks | 
| Efficacy evaluation based on Beck Depression Inventory - Second Edition (BDI-II) | The investigator asked the patient to fill out a set of self-administered BDI-II forms at each time of the patient's visits to the medical center (Patients were to make visits around 1, 2, 4, 8 and 12 weeks after starting PAXIL). | 12 weeks | 
| Efficacy evaluation based on overall improvement | The investigator comprehensively assessed the general condition of the patient at each time of the patient's visits to the medical center and rated the condition on a seven-grade eight-category scale (7 grades of markedly improved, moderately improved, slightly improved, unchanged, slightly worsened, worsened and severely worsened; a category of unassessable). | 12 weeks | 
| Efficacy evaluation based on severities of specific symptoms | The investigator rated the severities of depressed mood, anxiety, feeling irritated, hypobulia, physical symptoms and sleep disorder on a four-grade scale (none, mild, moderate and severe) based on the interview and the results of BDI-II at each time of the patient's visits to the medical center (patients were to make visits around 1, 2, 4, 8 and 12 weeks after starting PAXIL). | 12 weeks |
Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex

Detailed Description
-----------------
This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and severe) on the pharmacokinetics of Tenofovir Exalidex

Official Title
-----------------
An Open-Label Study to Investigate the Effect of Renal Impairment on the Pharmacokinectics of Tenofovir Exalidex

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: Tenofovir Exalidex (TXL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 years of age and over Capable of giving written informed consent Capable of completing study requirements Exclusion Criteria: Positive result for HIV, HBV, or HCV History or medical condition which could impact patient safety Current or past abuse of alcohol or drugs Participation in another clinical trial within the past 30 days

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Tenofovir exalidex (TXL)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Subjects<br>Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL) | Drug: Tenofovir Exalidex (TXL)<br>* Drug: Tenofovir Exalidex (TXL)<br>* Other names: lipid conjugate TFV;|
| Experimental: Severe RI<br>Severe Renal Impairment subjects Tenofovir Exalidex (TXL) | Drug: Tenofovir Exalidex (TXL)<br>* Drug: Tenofovir Exalidex (TXL)<br>* Other names: lipid conjugate TFV;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers | Measuring Cmax : the peak plasma concentration | up to six days post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the adverse events for TXL in RI subjects | review of Adverse events | up to six days post dose | 
| Evaluation of safety labs for TXL in RI subjects | review of safety labs | up to six days post dose |
Micro Plug Set - Post Market Clinical Follow-up (PMCF) Plan

Study Overview
=================
Brief Summary
-----------------
This is an observational, post market clinical follow-up (PMCF) intended to evaluate the residual risks of the Micro Plug Set which is intended for use during arterial embolization of the peripheral vasculature. This PMCF will collect data pertaining to any adverse events as well as the identification of any unanticipated risks up to the first 12 months following device implant.

Official Title
-----------------
Dr. Amplatz Micro Plug - Post Market Clinical Follow-up (PMCF) Plan

Conditions
-----------------
Trauma Injury, Bleeding

Intervention / Treatment
-----------------
* Device: Micro Plug Set


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is scheduled for arterial embolization in the peripheral vasculature. Subject is greater than 18 years of age Exclusion Criteria: Subject is unable to give informed consent Subject is pregnant or breastfeeding Subject has allergy to nickel Patient requires neurologic or cardiac use of an occlusion device, contrary to the Micro Plug Set Instructions For Use.

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: Micro Plug Set|The Micro Plug Set is indicated for arterial embolization in the peripheral vasculature.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of serious device-related and procedure-related adverse events | Rate of serious device-related and procedure-related adverse events | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful delivery of the device | Rate of successful delivery of the Micro Plug device to the intended position. | 1 day |
TWIST Human Gene and Cleft Lips and Palates

Study Overview
=================
Brief Summary
-----------------
This study uses a sequence analysis for TWIST and other craniofacial development genes, among patients presenting with facial clefting.

Official Title
-----------------
TWIST Human Gene and Cleft Lips and Palates

Conditions
-----------------
Cleft Lip

Intervention / Treatment
-----------------
* Other: None: molecular genetics diagnosis procedure only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged from 1 month to 18 years: Parents agree to enrollment or patients, themselves, agree to enrollment when able to do so Healthcare insurance holders Display facial clefting Grown patients over 18 years of age: Agree to enrollment Display facial clefting Healthcare insurance holders Exclusion Criteria: Patients declining enrollment Patients without healthcare insurance

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None: molecular genetics diagnosis procedure only|None: molecular genetics diagnosis procedure only|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to show, among patients displaying facial clefting, the TWIST mutations and the mutation in genes involved with TWIST in craniofacial development |  | Not relevant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to show, among patients displaying facial clefting and mutations in such genes, possible mutations in the same genes |  | Not relevant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Facial clefting, twist, craniofacial development genes, Human cleft lip and palate, cleft lip and palate
Minimally Invasive Lateral Approach for Sinus Augmentation: a Split-mouth Randomized Clinical Trial.

Study Overview
=================
Brief Summary
-----------------
It is assumed that the minimally invasive lateral approach and the traditional lateral sinus lift procedure will result in better outcomes in terms of height of augmented bone. It is also assumed that the minimally invasive lateral approach will reduce surgical complications and patient's discomfort in comparison with a traditional lateral sinus lift procedure.

Detailed Description
-----------------
16 patients edentulous in maxillary posterior area will be treated with a bilateral sinus lift procedure. Once a patient will be enrolled in the study impressions will be taken. After the wax-up, a radiographic stent will be prepared. Special attention will be given to position radio-opaque references in the positions where the implants will be inserted according to a prosthodontic guided insertion. Pre-surgical CT scan will be executed after placing the stent in its proper position in patient's mouth. After that, if no surgical contra-indications will be detected at CT evaluation, patients will be enrolled for surgical interventions.

Official Title
-----------------
Minimally Invasive Lateral Approach for Sinus Augmentation: a Split-mouth Randomized Clinical Trial.

Conditions
-----------------
Bone Involvement in Diseases Classified Elsewhere

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patient edentulous in the maxillary posterior area on both left and right side( not completely edentulous). - residual bone height in the maxillary premolar and molar region less than 4mm. Exclusion Criteria: - history of systemic diseases that would contraindicate surgical treatment
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 |
| --- | --- |
| minimally invasive approach test<br>minimally invasive lateral approach | |
| control lateral traditional approach<br>standard surgical approach | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height of augmented bone |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post surgical patient's discomfort |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lateral approach, bone augmentation , sinus floor elevation
Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Investigate the efficacy and safety of colchicine therapy in improving hepatic function and reducing hepatic fibrosis (scarring) in children with hepatic cirrhosis.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive colchicine orally twice daily for 24 months. After the first month, the dose of colchicine will increase and remain at that dose for the duration of study. Patients are evaluated every 6 months during study.

Conditions
-----------------
Cirrhosis, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: colchicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Advanced hepatic fibrosis or cirrhosis in children Not pregnant

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: colchicine|nan|

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
-----------------
hepatic cirrhosis, gastrointestinal disorders, rare disease
EHR Embedded Comparative Effectiveness Studies--CPS

Study Overview
=================
Brief Summary
-----------------
Randomize Everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in EHR systems to do comparative effectiveness research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical Center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.

Detailed Description
-----------------
EHR Embedded Comparative Effectiveness Studies-CPS will be held in the Center for Pain and Spine at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either activity restriction or no activity restriction following lumbar discectomy.

Official Title
-----------------
Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems

Conditions
-----------------
Degenerative Spondylolisthesis

Intervention / Treatment
-----------------
* Behavioral: Activity Restriction
* Behavioral: Activity as Tolerated


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (>18) able to consent Sufficient fluency in English Indications for discectomy Able to restrict activities or to resume activities as tolerated Exclusion Criteria: Pregnant women Prisoners Children (<18).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Activity Restriction<br>Discharge orders for activity restriction | Behavioral: Activity Restriction<br>* Standard post-operative activity instructions (i.e., no bending, twisting, or lifting more than 10 lbs for 4 weeks, no return to work until cleared to do so).<br>|
| Activity As Tolerated<br>Discharge orders written for activity as tolerated | Behavioral: Activity as Tolerated<br>* Instructions advising activity as tolerated and return to work based on patient discretion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors for patient participation in EHR imbedded study | Patient Survey | Baseline | 
| Receipt of treatment | Patient Survey | 6 months post-enrollment | 
| Satisfaction with Treatment | Patient Survey | 6 months post-enrollment |
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Aging Frailty

Detailed Description
-----------------
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Aging Frailty. This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Frailty. Patients with Frailty will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Aging Frailty

Conditions
-----------------
Frailty

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Aging Frailty Understanding and willingness to sign a written informed consent document Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Pregnancy Clinically significant abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety. Continued drug abuse Pre-menopausal women not using contraception Previous organ transplant Hypersensitivity to sulfur
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: Treatment Group<br>Single intravenous infusion of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frailty, stem cell treatment, Anti Aging
Embryo DNA Repair Capacity Project

Study Overview
=================
Brief Summary
-----------------
The mail aim of the present study is to use molecular methods to analyze the ability of human preimplantation embryos to repair their DNA

Detailed Description
-----------------
The main aim of the present study is to investigate the DNA repair pathways of preimplantation embryos, examining the events that take place following induction of a DSB at a unique targeted site. The investigators aim to address questions concerning the functionality of the DNA repair mechanism(s) in developing embryos, before and after genome activation.

Official Title
-----------------
Investigation of Cellular DNA Repair Capacity in Human Preimplantation Embryos

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Genetic: double strand break


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gamete donors: be at least 21 years of age, in good health and eligible to donate their games through the standard gamete donation programs IVF couples: any couples proceeding with a routine IVF cycle Exclusion Criteria: less than 21 years of age inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 42 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gamete donors<br>healthy male and female game donors to undergo routine gamete donation process | Genetic: double strand break<br>* an induction of a double strand break will be made in the embryos generated for this research and the repair mechanism observed<br>|
| Infertile Couple<br>Couples undergoing routine IVF to treat their infertility | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| repair of double strand break in DNA | targeted deep sequencing to identify the presence of the double strand break in the DNA and subsequent repair ability of the embryo | up to 12 days |