linjc16/ctgov huggingface dataset:
Obtaining Undifferentiated Cells From Testis Biopsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to isolate and culture stem cell from adult human testicular biopsies for future transplantation in fertility preservation.

Detailed Description
-----------------
Testicular biopsies were obtained from azoospermic patients as part of their diagnosis and work-up after obtaining a signed informed consent. A portion of each sample was mechanically dissected in PBS with 1% Pen/Strep. For enzymatic digestion samples were incubated with 0.5g/ml Collagenase type 1A for 20min and TripLE Select for 15min at 37ºC on a shaker and then filtered with 30µm and centrifuged at 1,000rpm. The pellets were seeded and incubated in embryonic stem cell media (hESC) with glial cell line-derived neurotrophic factor (GDNF 4ng/mL) for 5-7 days at 37ºC (1st culture). To identify and isolate SSCs they were marked with CD49f antibody and FACS sorted. Positive cells were cultured in gelatine plates containing hESC media with leukaemia inhibitory factor (LIF1000U/mL) (2nd culture).

Official Title
-----------------
Isolation, Culture and Characterization Stem Cells From Testis Biopsy

Conditions
-----------------
Azoospermia

Intervention / Treatment
-----------------
* Other: analyse and proliferate the cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -azoospermic patients

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

Sexes Eligible for Study
-----------------
Male

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

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 |
| --- | --- |
| No Intervention: tissue from biopsies<br> | Other: analyse and proliferate the cells<br>* Obtention of excess tissue from testicular biopsies and maintained in 4ºC until procedures. Digestion of the biopsies through controlled enzymes Replication of the cells Selection undifferentiated cells Expansion of the purification cells population Characterization of the cell population Assessment of pluripotent and germinal cell potential. Possible maturation of the cells.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of potential germinal and pluripotent of the isolated cultures. | •The spermatogonial cells isolated from testicular biopsies of azoospermic patients will be matured in vitro for thegeneration of sperm for infertility treatment. * Undifferentiated cells of the testis biopsy will be characterized as degrees of plasticity for proof that they are capable of regeneration spermatogenesis. | one month |
Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm

Study Overview
=================
Brief Summary
-----------------
Part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to variation of the biological response to clopidogrel . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled trial. It could be an option for APT due to more reproducible response with less interindividual variability and reduced monitoring. The aim of this study is to demonstrate the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing neurovascular stenting for cerebral aneurysm.

Official Title
-----------------
Ticagrelor Versus Clopidogrel for Platelet Inhibition in Patients Undergoing Neurovascular Stenting for Intracranial Aneurysm

Conditions
-----------------
Cerebral Aneurysm

Intervention / Treatment
-----------------
* Drug: Clopidogrel
* Drug: Ticagrelor
* Drug: aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unruptured cerebral aneurysm elective endovascular treatment stenting required dual antiplatelet therapy required 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clopidogrel-aspirin<br>clopidogrel: 75mg and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery. | Drug: Clopidogrel<br>* clopidogrel: efficacy and safety in cerebral aneurysm stenting<br>Drug: aspirin<br> <br> |
| Experimental: ticagrelor-aspirin<br>Ticagrelor: 90 mg bid and aspirin 250 mg once a day for 15 weeks; prescribed 3 weeks before surgery | Drug: Ticagrelor<br>* ticagrelor:efficacy and safety in cerebral aneurysm stenting<br>Drug: aspirin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition |  | 4 months |
Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants <3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).

Official Title
-----------------
A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age.

Conditions
-----------------
Candidiasis

Intervention / Treatment
-----------------
* Drug: caspofungin acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates and infants <3 months of age Patient has a body weight greater than or equal to 500 grams Patient has documented or highly suspected Candida infection Exclusion Criteria: Patient is greater than 3 months of age Patient has a body weight of less than 500 grams Patient does not meet certain laboratory testing criteria Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days Patient has documented HIV infection of any stage Patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: caspofungin acetate|Duration of Treatment 28 Days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters of drug exposure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  |
Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes

Study Overview
=================
Brief Summary
-----------------
Although haemostasis aimed to maintain bloodless surgical field for better exposure for the surgeon, cosmetic impact, and decreased breakdown of repair, there is no trials regarding the impact of haemostasis techniques on surgeon satisfaction during surgery and patients reported outcomes.

Official Title
-----------------
Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes. A Prospective Randomized Study

Conditions
-----------------
Hypospadias, Hypospadias, Coronal, Hypospadia, Repair, Tourniquet

Intervention / Treatment
-----------------
* Procedure: Tourniquet
* Procedure: Non-tourniquet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: distal penile hypospadias were eligible for tubularized incided plate (TIP) urethroplasty repair Exclusion Criteria: coagulopathy sickle cell disease or sickle cell trait circumcised patient history of previous failed surgery severe chordee (>30 degree after degloving).

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 36 Months

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Experimental: Tourniquet<br>tubularized incided plate (TIP) urethroplasty plus tourniquet | Procedure: Tourniquet<br>* tubularized incided plate (TIP) urethroplasty plus tourniquet<br>|
| Experimental: Non-tourniquet<br>tubularized incided plate (TIP) urethroplasty plus non-tourniquet | Procedure: Non-tourniquet<br>* tubularized incided plate (TIP) urethroplasty plus non-tourniquet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess Intraoperative blood loss | by blood loss in milliliter in used gauze piece | 12 months | 
| bipolar diathermy use | by number of bipolar diathermy usage | 12 months | 
| Surgeon satisfaction about haemostasis | Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported satisfaction | by hypospadias objective scoring evaluation (HOSE) questionnaire | 24 months | 
| Long term complication rate | number of surgery related complication after 5 years post operative | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourniquet, Hypospadias
An Observational Study of Efficacy and Safety of Modern Insulin in Diabetes Patients Switched From Anti-diabetic Treatment

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical conditions in the Gulf countries.

Official Title
-----------------
Efficacy and Safety Study in Subjects Using Levemir® (Insulin Detemir), NovoMix®30 (Biphasic Insulin Aspart 30) and/or NovoRapid® (Insulin Aspart) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin detemir
* Drug: biphasic insulin aspart 30
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or type 2 diabetes Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid® Selection will be at the discretion of the individual physician Exclusion Criteria: Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid® Previous enrolled in this study Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>* Other names: Levemir®;|
| B<br> | Drug: biphasic insulin aspart 30<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>|
| C<br> | Drug: insulin aspart<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major hypoglycaemic events reported |  | during 24 weeks of treatment | 
| Change in HbA1c |  | during 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving HbA1c below 7.0% |  | at 12 & 24 weeks | 
| Change in FPG |  | at 12 & 24 weeks | 
| Change in PPG |  | at 12 & 24 weeks | 
| Body weight |  | at 12 & 24 weeks | 
| Change in number of hypoglycaemic events in the last 4 weeks before routine visits |  | at 12 & 24 weeks | 
| Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits |  | at 12 & 24 weeks | 
| Number of adverse drug reactions (ADR) |  | at 12 & 24 weeks |
Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD.

Official Title
-----------------
A Multicenter, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance and Safety/Tolerability of SSR180711C for 4 Weeks, Using Donepezil as Calibrator, in Patients With Mild Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: SSR180711C
* Drug: donepezil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients with diagnosis of mild AD Exclusion Criteria: Concomitant or previous treatment by acetylcholinesterase inhibitors and/or memantine Medical condition which may interfere with the study History of epileptic seizures Lens opacity Lack of reliable caregiver The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 90 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>dose 1 | Drug: SSR180711C<br>* duration of treatment: 4 weeks<br>|
| Experimental: 2<br>dose 2 | Drug: SSR180711C<br>* duration of treatment: 4 weeks<br>|
| Experimental: 3<br>dose 3 | Drug: SSR180711C<br>* duration of treatment: 4 weeks<br>|
| Placebo Comparator: 4<br> | Drug: placebo<br>* duration of treatment: 4 weeks<br>|
| Active Comparator: 5<br> | Drug: donepezil<br>* duration of treatment: 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive performance |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive, global, functional and behaviorial assessments |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer, cognitive
Psychological Morbidity and Facial Volume in HIV Lipodystrophy: Quantification of Treatment Outcome

Study Overview
=================
Brief Summary
-----------------
The hypotheses of this study were that: HIV lipodystrophy is associated with psychological morbidity relating to body image, anxiety and depression. Treatment of HIV lipodystrophy using autologous fat transfer, polylactic acid or Bio-alcamid, is associated with an improvement in psychological morbidity and anatomical volume of treated areas. The DI3D system is a valid and reproducible method of recording and measuring facial 3-D volume.

Detailed Description
-----------------
as above

Official Title
-----------------
Psychological Morbidity and Facial Volume in HIV Lipodystrophy:

Conditions
-----------------
HIV-Associated Lipodystrophy Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV facial lipoatrophy concurrent antiretrovirals Exclusion Criteria: known psychological disorder skin allergies significant medical problems precluding anaesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| autologous fat transfer<br>patients received fat transfer for HIV lipodystrophy | |
| polylactic acid<br>treatment with polylactic acid (PLA) for HIV lipodystrophy | |
| bio-alcamid<br>bio-alcamid injections | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of 3-D facial volume | 3-D facial camera | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychological outcome | derriford appearance scale hospital anxiety and depression scale | 2 years |
Double-S: a Wearable Device for Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to use a minimally invasive erectile device for patients suffering from erectile dysfunction.

Detailed Description
-----------------
The purpose of the study is to use a minimally invasive erectile device support to provide to patients suffering from erectile dysfunction the possibility to achieve satisfactory penetrating intercourse. The goal of this is to help men who have issues with erectile function (e.g.after radical prostatectomy for prostate cancer, vascular or metabolic erectile dysfunction non-responsive to phosphodiesterase-5 inhibitor medications, etc.) to have medication-free mechanical support for their penis in order to obtain sexual penetration satisfactorily.

Official Title
-----------------
Double-S: a Wearable Device for Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Device: Double-S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males >18 years old suffering from any cause moderate to severe erectile dysfunction (e.g. ED after radical prostatectomy and/or radiation therapy for prostate cancer and or other pelvic malignancies affecting the sexual potency; emotional and psychological ED; organic vascular and/or metabolic ED etc.) having a female partner willing to participate in the study Exclusion Criteria: not willing to attempt sexual vaginal intercourse with their partner inability to wear/operate the external penile device for any reason

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double-S arm<br>Participants will be asked to use the wearable penile device during intercourse. | Device: Double-S<br>* Wearable device for intercourse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in modified International Index of Erectile Dysfunction score | score 0 to 30 with higher score meaning better erectile function | baseline and up to 1 month post-baseline |
Obstetrical Risk Factors for the Development of Urinary and/or Fecal Incontinence

Study Overview
=================
Brief Summary
-----------------
Evaluation of Obstetrical Risk Factors for the development of Urinary and/or Fecal Incontinence according to a questionaire The questionaire will be filled by the study investigators after the women participating in the study sign their consent. The study is based solely on a questionaire and does not include any physical examination, blood exam or intervention. The study will be performed on the premises of Maaynei Hayeshua medical center. The inclusion criteria include women above the age of 18 who arrive to Maaynei Hayeshua Medical center for any reason. The data will be transferred to a computerized data base and analyzed statistically.

Official Title
-----------------
Obstetrical Risk Factors for the Development of Urinary and/or Fecal Incontinence

Conditions
-----------------
Obstetric Risk Factors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women of age 18 or above Exclusion Criteria: women under the age of 18 men

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
incontinence, obstetric risk factors, women, of age 18, above