linjc16/ctgov huggingface dataset:
Bilateral Allotransplantation of Upper Limbs

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to realize a bilateral transplantation of upper limbs. The first objective is functional but there are aesthetic and psychologic imperatives too. This open and descriptive study needs compatible donor and recipient. The sample should be realized simultaneously and the transplantation should be made by two coordinated teams according to this sequence : osteosynthesis, vascular anastomosis, sutures of tendons and nervous sutures. An immunosuppressant treatment should be initialized from the beginning of the intervention and continued for life. Rejections should be screened by regular clinical and histological examinations.

Conditions
-----------------
Patients Private of Their Upper Limbs

Intervention / Treatment
-----------------
* Procedure: bilateral allotransplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Donor: State of brain death Compatibility with recipient about sex, size, age and color Blood compatibility; integrity of upper limbs Recipient: Double amputation of hands or forearms with traumatic origin Personal motivation Good health condition Delay from 2 months to 34 years between amputation and transplantation Exclusion Criteria: Donor: Uncompatibility with sample Lesion on upper limbs Neoplasia Hepatitis B or C Positive CMV serology Recipient: Uncompatibility with immunosuppressant treatment Psychosis Carcinosis Cardiovascular diseases Addiction to alcohol or smoking Pregnancy Feeding

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

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

| Intervention/Treatment |
| --- |
|Procedure: bilateral allotransplantation|bilateral allotransplantation of upper limbs|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional rehabilitation of patients by bilateral allotransplantation of upper limbs, evaluated by measure of the function of the transplanted extremities |  | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetic and psychologic |  | 6 years |
Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates

Study Overview
=================
Brief Summary
-----------------
This prospective study will compare the pharmacokinetic exposure to liposomal amphotericin B between critically ill patients and non-critically ill (hematology) patients in an early and late exposure day.

Detailed Description
-----------------
This phase IV, open label, non-randomized, monocenter pharmacokinetic study will be carried out in critically ill and non-critically ill (hematology) patients receiving multiple dose treatment with L-AmB. The pharmacokinetic exposure to liposomal amphotericin B in plasma, urine, BAL and ascitic fluid will be compared between the two population groups in an early and late exposure day. Correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.

Official Title
-----------------
Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates

Conditions
-----------------
Pharmacokinetics, Liposomal Amphotericin B, Critically Ill Patients

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment with L-AmB Admitted to an ICU or Hematology ward Exclusion Criteria: DNR 2 or 3 Pregnant or lactating women Previous documentation of intolerance/sensitivity to L-AmB

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 |
| --- | --- |
| Critically ill patients<br>Patients admitted on ICU. | Other: Sample collection<br>* Plasma, urine, BAL and ascitic fluid sample collection.<br>|
| Hematology patients<br>Patients admitted on the hematology ward. | Other: Sample collection<br>* Plasma, urine, BAL and ascitic fluid sample collection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma exposure and PK parameters | To document and compare plasma exposure and PK parameters in an ICU vs. non ICU hematology patient cohort in the early and late phase of L-AmB treatment. | July 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Covariates | To document correlating covariates and to stimulate the pharmacokinetics of L-AmB to provide a rationale for optimal dosing strategy in critically ill patients. | July 2020 |
First Time Mothers and Anal Incontinence Six Years Postpartum

Study Overview
=================
Brief Summary
-----------------
Previous studies show that incontinence is relatively common during pregnancy and after delivery. Experiencing incontinence during pregnancy or in the first year after delivery increases the risk of long term incontinence. There is scarce documentation of the long term prevalence of anal incontinence (AI) in Norway. This study aims to explore prevalence and risk factors for incontinence approximately six years after delivery among the 1718 who participated in two previous studies exploring the prevalence and predictors of anal incontinence in late pregnancy and during the first year after first delivery, and the effect of pelvic floor muscle exercises as treatment for anal incontinence after delivery. Increased awareness and knowledge about risk factors and long term prevalence of anal incontinence among health professionals as well as pregnant and parous women may give indications about which women to target for preventative measures to reduce the risk of new onset of postpartum AI during pregnancy and after delivery. Further, increased knowledge may aid in planning individualized follow-up during pregnancy and the first year as well as in the long term among women with existing AI symptoms.

Official Title
-----------------
First Time Mothers and Anal Incontinence Six Years Postpartum

Conditions
-----------------
Fecal Incontinence, Urinary Incontinence, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants in previous studies Exclusion Criteria: Women not participating in previous studies

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal incontinence | St. Mark's score measuring frequency and severity of anal incontinence | Anal incontinence six years postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary incontinence | ICI-Q UI SF measuring frequency and severity of urinary incontinence | urinary incontinence six years postpartum |
DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study Results will be defined as: Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years. Primary endpoints: Primary Patency at 12 months, TLR (clinical driven), Secondary endpoints: Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,

Official Title
-----------------
Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries

Conditions
-----------------
Peripheral Vascular Diseases

Intervention / Treatment
-----------------
* Device: DEB
* Device: POBA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critical limb ischemia. Rutherford class 4-6 Crural disease, long lesions, more than 2 cm. Life expectancy > 1year > 18 years Exclusion Criteria: Pregnancy Patients disapproval Allergy to drug or contrast

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: Drug eluting balloon angioplasty<br>Intervention with DEB angioplasty in long lesions of crural arteries | Device: DEB<br>* Intervention with drug eluting balloon.<br>|
| Active Comparator: Plain old balloon angioplasty<br>Intervention with plain old balloon angioplasty POBA in long lesions of crural arteries | Device: POBA<br>* Intervention with old technology as comparison<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency of treated crural vessels | Evaluation with MRA (Magnetic Resonans Angiography) at 12 months, regarding binary restenosis or occlusion in the treated arterial segment. Proportion of treated segments that remains open. | 12 months | 
| Clinical driven target lesion revascularization (TLR) | Porportion of patients that needs retreatment in in the monitored arterial segment | 12 months |
Markers of Executive Attention Development in Preschoolers

Study Overview
=================
Brief Summary
-----------------
This project aims to identify precursors of executive attention that can serve as early markers of ADD.

Official Title
-----------------
Markers of Executive Attention Development in Preschoolers

Conditions
-----------------
Attention Deficit Disorder

Intervention / Treatment
-----------------
* Device: EEG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal schooling Parental consent Exclusion Criteria: - Psychotropic drug

Ages Eligible for Study
-----------------
Minimum Age: 48 Months
Maximum Age: 60 Months

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 |
| --- | --- |
| Term<br> | Device: EEG<br>* EEG<br>|
| Preterm<br> | Device: EEG<br>* EEG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude in µV of EEG changes relative to baseline when expected stimulus is omitted in a tactile stimulation sequence |  | at 4 years old |
Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

Study Overview
=================
Brief Summary
-----------------
Patients with coronary artery disease have an abnormal cardiac metabolism. The hypothesis of this study is that shifting cardiac metabolism from free fatty acids to glucose will improve myocardial ischemia

Detailed Description
-----------------
The present study will evaluate the effect of free fatty acid inhibition with Trimetazidine on silent myocardial ischemia and total ischemic burden in coronary artery disease patients with type II diabetes. Patients will undergo ambulatory ECG monitoring at baseline and will be randomized to receive on top of thei standard anti-anginal therapy trimetazidine or placebo for 6 months. Patients will repeat the ambulatory ECG monitoring at the end of the study

Official Title
-----------------
Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease

Conditions
-----------------
Coronary Artery Disease, Type II Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Trimetazidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: coronary artery disease type II diabetes mellitus - Exclusion Criteria: unstable coronary artery syndromes impaired liver and kidney function -

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total ischemic burden |  |  | 
| silent ischemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptomatic myocardial ischemia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, diabetes mellitus
Review of Kidney Biopsies of Dent Disease Patients

Study Overview
=================
Brief Summary
-----------------
This study is being done to obtain pathology reports from all patients in the Dent disease registry who have had a kidney biopsy. The investigator will collect the biopsy slides and reports in an attempt to determine if they have any common findings.

Detailed Description
-----------------
If the patient agrees to be in the study, the patient will be asked to participate in the following: Sign a consent form indicating the patient's willingness to participate. Provide a signed medical release form allowing the investigator to request your official kidney biopsy reports, and also allowing the investigator to request the original slides for review. At the end of the study, all slides will be returned to the referring facility. The investigator will also review your medical record

Official Title
-----------------
Systematic Review of Clinical Biopsies of Dent Disease Patients

Conditions
-----------------
Dent Disease

Intervention / Treatment
-----------------
* Procedure: Renal Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients in the Dent Disease Registry with a previous renal biopsy. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dent Disease patients<br>Patients with diagnosed Dent Disease | Procedure: Renal Biopsy<br> <br> * Other names: All patients in the Dent Disease Registry with a previous renal biopsy.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy changes | The primary outcome will be to determine the number of glomeruli, percent globally sclerotic glomeruli, percent focally sclerotic glomeruli, and the severity of interstitial fibrosis (none, mild, moderate, severe) and interstitial crystals (none, mild, moderate, severe) | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dent, Dents, Dent Disease, Renal Biopsy, Kidney Biopsy, Clinical Biopsy
A Single Patient Will be Treated With Individual Patient TCR-Transduced PBL

Study Overview
=================
Brief Summary
-----------------
A single patient will be treated with Individual Patient TCR-Transduced PBL

Detailed Description
-----------------
Background: -Please refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F. Objective: -Under Individual Patient Expanded Access, to treat a patient with metastatic breast cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize mutated neoantigens in the autologous cancer. Eligibility: Must have measurable, metastatic disease as assessed per RECIST v1.1 criteria. Must sign the informed consent document. Willing to sign Durable Power of Attorney Form. Must have all regulatory approvals prior to start of treatment. Design: Please refer to NCI-SB protocol 18-C-0049, Amendment F. The patient will be treated with a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by the infusion of autologous transduced PBL and then high-dose aldesleukin. The patient will also receive pembrolizumab on Day -2 prior to cell administration and additional doses every 3 weeks following cell infusion until the time of disease progression.

Official Title
-----------------
Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab

Intervention / Treatment
-----------------
* Drug: Individual Patient TCR-Transduced PBL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Individual Patient TCR-Transduced PBL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
NuvaRing vs. Oral Contraceptive Pills (OCP) for In-Vitro Fertilization (IVF) Pre-treatment

Study Overview
=================
Brief Summary
-----------------
The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and medications are delivered locally. It has been proven to be as safe and effective as the combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. Following a single vaginal insertion, steroid concentrations remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to better compliance, tolerability and acceptance by patients requiring ovarian suppression prior to COH for IVF.

Official Title
-----------------
A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles

Conditions
-----------------
Infertility, In-vitro Fertilization

Intervention / Treatment
-----------------
* Drug: NuvaRing
* Drug: marvelon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients less than 38 years of age. Healthy women starting their first IVF/ICSI cycle. No contraindication to Combined Oral Contraceptive (COC) use. Appendix 1 Consent to randomization. Exclusion Criteria: Any contraindication to COC use. Hypersensitivity to Nuva ring or any of its components. Language barrier to consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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: NuvaRing<br>NuvaRing for IVF pre-treatment | Drug: NuvaRing<br>* NuvaRIng 21 days for IVF pre-treatment.<br>|
| Active Comparator: Combined oral contraceptive pill<br>OCP for IVF pre-treatment | Drug: marvelon<br>* marvelon 21 daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description) | abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain | patients were followed for the duration of an in-vitro fertilization cycle- 2 months |