linjc16/ctgov huggingface dataset:
Vitamin E and Male Infertility

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to determine whether there is a correlation between the levels of Vitamin E in sperm and sperm DNA fragmentation. Previous research has shown that damage to the DNA in sperm may cause infertility or increase the chances of miscarriage, if the damage is extensive (eg. present in the overwhelming majority of sperm). Some studies suggest that DNA damage can be caused by oxidative stress. Antioxidants, such as Vitamin E, which are present in some foods, can prevent damage to cells from free radicals, which are naturally present by-products of metabolism. We ask whether there is a correlation between sperm DNA damage and Vitamin E

Detailed Description
-----------------
Sperm DNA damage is an emerging cause of male infertility that is likely to be more common among men with increased reactive oxygen species in the ejaculate. Vitamin E can protect the sperm membrane from oxidative damage and increased levels are associated with low levels of reactive oxygen species. This is a study of Vitamin E levels in the spermatozoa and sera of 48 infertile men, and 20 fertile men as a control group, to look for correlations between sperm vitamin E levels and the degree of sperm DNA fragmentation. Dietary intake of antioxidants will also be included.

Official Title
-----------------
Vitamin E and Male Infertility

Conditions
-----------------
Male Infertility

Intervention / Treatment
-----------------
* Other: behavior, procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile men with previously abnormal semen analyses. Control group: fertile adult males Exclusion Criteria: Proxceed use within 3 months of the start of study. Vitamin E supplements with > 45 IU daily

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: behavior, procedure|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlate vitamin E levels in spermatozoa with degree of DNA fragmentation in infertile men |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
male, infertility
Bevacizumab for Central Retinal Vein Occlusion Study

Study Overview
=================
Brief Summary
-----------------
Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.

Official Title
-----------------
A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)

Conditions
-----------------
Central Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: bevacizumab
* Drug: Sham bevacizumab injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CRVO with duration < 6 months Visual acuity of 20/800 to 20/50 Exclusion Criteria: CRVO with duration of > 6 months previous treatment with anti-angiogenic drugs
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 |
| --- | --- |
| Active Comparator: Intravitreal bevacizumab<br> | Drug: bevacizumab<br>* Intravitreal injection of 1.25 mg bevacizumab<br>|
| Sham Comparator: Sham injection<br> | Drug: Sham bevacizumab injection<br>* Sham intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients gaining 15 ETDRS letters or more |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in foveal thickness |  | 6 months | 
| Cases of neovascular glaucoma |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRVO, anti-VEGF, Macular edema
Emergent Expanded Access for ahSC Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury.

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this research study is to determine the safety of injecting ones own Schwann cells to augment sural nerve autografts after a severe, non-lacerating injury to the sciatic nerve has occurred.

Detailed Description
-----------------
The secondary purpose of this research project is to evaluate whether transplanted Schwann cells can enhance recovery of sensory and motor function. Emergency expanded access for a single patient was granted, as the patient was an ideal candidate for sural nerve repair augmented by autologous Schwann cells which could be harvested from a relatively small segment of sensory nerve. The cells were expanded using cell culture techniques and placed along with the sural nerve grafts wrapped by an FDA approved collagen matrix (Duragen). This study is being conducted at the Jackson Memorial and the University of Miami health systems. As a research subject the patient will be in this study for a total of 5 years from the date receiving Schwann cell transplant augmentation of sural nerve autografts.

Official Title
-----------------
Emergent Expanded Access to Use Autologous Human Schwann Cell Augmentation of Nerve Autograft Repair in a Single Patient With Severe Peripheral Nerve Injury

Conditions
-----------------
Sciatic Nerve Injury

Intervention / Treatment
-----------------
* Biological: Autologous human Schwann cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Single patient with severe sciatic nerve injury enrolled under emergency request

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Autologous human Schwann cells|Schwann cells harvested from the sural nerve will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix (Duragen).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Massage, Meditation, and Tai Chi for Chronic Lower Back Pain

Study Overview
=================
Brief Summary
-----------------
This clinical trial is a preliminary study designed to prepare for a full-scale, randomized clinical trial of the effectiveness of tai chi, mediation, and therapeutic massage for chronic lower back pain in adults.

Detailed Description
-----------------
Despite the common use of complementary and alternative therapies for back pain, little is known about how such therapies compare with each other or with conventional medical therapies in terms of effectiveness and cost. This study will lay the groundwork for a full-scale trial that will evaluate the relative effectiveness and costs of three promising relaxation-related techniques (massage, tai chi, and meditation) that are appropriate for both younger and older adults with chronic lower back pain. The pilot study will identify and resolve unanticipated problems and estimate the sample sizes required for an adequately-powered, full-scale trial. Participants with chronic lower back pain will be randomly assigned to one of the following groups: tai chi, massage, meditation, or continued usual care (control group). The participants assigned to each intervention will be divided equally between persons under and over age 65.

Official Title
-----------------
Relaxation-Related CAM Therapies for Chronic Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Tai chi
* Behavioral: Mindfulness-based Stress Reduction program
* Procedure: Therapeutic massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Chronic lower back pain

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 64 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Tai chi|nan|
|Behavioral: Mindfulness-based Stress Reduction program|nan|
|Procedure: Therapeutic massage|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Treatment of Patients With Donor Lymphocytes Sensitized by Antigens Expressed by the Host

Study Overview
=================
Brief Summary
-----------------
Allogeneic stem cell transplantation is the only effective treatment to patients resistant to conventional chemotherapy. Donor lymphocytes infusion (DLI) serve as a routine treatment of choice for patients relapsing following allogeneic stem cell transplantation. The present proposal is presented for introducing the use of immune rather than naive donor lymphocytes for patients with resistant relapse and resistant to DLI. DLI primed in-vitro against tumor cells of host origin or against host alloantigens presented by parental alloantigens in one way mixed lymphocytes culture can induce much more than potent graft-vs-leukemia and graft-vs-tumor effects, while down-regulating graft-vs-host disease (GVHD).

Official Title
-----------------
Treatment of Patients With Resistant Cancer/ Post Allogeneic Stem Cell Transplantation With Donor Lymphocytes Sensitized by Antigens Expressed by the Host

Conditions
-----------------
Hematological Malignancy, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Procedure: DLI sensitized against antigens expressed by the host.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with hematologic malignancy or metastatic solid tumor relapsing following allogeneic bone marrow or blood stem cell transplantation (alloBMT) or non-myeloablative stem cell transplantation resistant to DLI with no GVHD when taken off anti-GVHD prophylaxis. Patients with documented chimerism to confirm induction of host-vs-graft transplantation tolerance. Exclusion Criteria: Patients not consenting to participate in the study, or minors without approved parental consent. Patients with other diseases or complications that may limit their life span other than their basic disease. Pregnant or lactating women. Non-compliant patients or patients with poor performance status with life expectancy, e.g. 6 weeks.
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 |
| --- |
|Procedure: DLI sensitized against antigens expressed by the host.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Introducing more effective graft vs leukemia and graft vs tumor effects with immune donor lymphocytes in patients relapsing following allogeneic bone marrow or blood stem cell transplantation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upregulating of anti-tumor effects while minimizing anti-host responses |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic solid tumor
Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers

Study Overview
=================
Brief Summary
-----------------
This study will determine if HA dermal filler late occurring (> 4 weeks and <2 years) nodules are associated with bacterial contamination (independent of filler type) and to characterize the histological response.

Official Title
-----------------
Histological and Microbiological Evaluation of Late Occurring Nodules With Hyaluronic Acid Dermal Fillers

Conditions
-----------------
Dermal Nodule

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have only received HA fillers (no limitation on the brand(s)/product(s) of HA filler used; multiple product use is allowed). Present with an unresolved nodule (inflammatory or non-inflammatory) which was first observed > 4 weeks and > 2 years after most recent HA filler treatment and is determined to be greater than 3 millimeters (mm) in diameter by palpation Exclusion Criteria: Have received non-HA fillers (e.g. polyacrylamide, calcium hydroxyapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene, collagen) including mixes with HA fillers anywhere in the face. Are currently enrolled in a dermal filler clinical trial or previously enrolled in a dermal filler clinical trial with randomized treatment in which the type of dermal filler is unknown (i.e. non-HA filler arm of study). Have history of keloid or hypertrophic scarring Have received intralesional intervention for the nodule (e.g. hyaluronidase, corticosteroids, antibiotics, 5-fluorouracil). Are pregnant

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 |
| --- | --- |
| All Participants<br> | Other: No Intervention<br>* No Intervention is administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological Sampling | Histological lab assessment of biopsy sample for analysis of Hematoxylin and eosin (H&E), orcein, periodic acid-Schiff, gram stain and immunohistochemistry (IHC), with a histopathology assessment to identify possible presence and location of bacteria, mycobacteria, fungus, mold, and/or yeast and the immune/inflammation response within the biopsy. | 12 Weeks | 
| Microbiological Sampling | Microbiology lab assessment of biopsy sample for analysis of the presence and species of bacteria/mycobacteria within the biopsy. | 12 Weeks |
Impact of Antibiotic Prophylaxis in Per-oral Endoscopic Myotomy for Esophageal Motor Disorders

Study Overview
=================
Brief Summary
-----------------
No recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from Per-Oral Endoscopic Myotomy (POEM). The aim of our study was to evaluate the impact of antibiotic prophylaxis on the POEM's safety. This study was a comparative and multicentric retrospective analysis of a database prospectively maintained. Patients over 18 year's old with esophageal motor disorders confirmed by prior manometry, who underwent POEM were included. The primary endpoint was the occurrence of complications, as classified by Cotton, based on whether or not antibiotic prophylaxis was administered.

Official Title
-----------------
Impact of Antibiotic Prophylaxis and Conditioning Modalities in Per Oral Endoscopic Myotomy for Esophageal Motor Disorders

Conditions
-----------------
Esophagus Disorder, Esophageal Achalasia

Intervention / Treatment
-----------------
* Drug: Antibiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults patients presenting a major esophageal motor disorder confirmed by prior manometry according to the Chicago classification and treated by per-oral endoscopic myotomy after a multidisciplinary meeting decision Exclusion Criteria: Under-age patients were excluded

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 |
| --- | --- |
| POEM + Antibiotic prophylaxis<br>Cefazolin: 2g or Amoxicillin - clavulanic acid: 1g x 3 during 7 days | Drug: Antibiotics<br> <br> |
| POEM + No antibiotic prophylaxis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurence of postoperative complications, according to Cotton's classification | Depending on whether or not antibiotic prophylaxis was administered | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of the efficacy of the procedure | According to the Eckard score | 1 Month | 
| The occurence of perioperative and postoperative complications | According to Cotton's classification | 7 Days | 
| The C-Reactive Protein and white blood cells count sampled | Blood test the day after the procedure, level of CRP in mg/L | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antibiotic prophylaxis, per oral endoscopic myotomy
CYP2B6 Polymorphisms in Ketamine

Study Overview
=================
Brief Summary
-----------------
This research study will determine if genetic variation in CYP2B6 affects how the body metabolizes ketamine.

Official Title
-----------------
Role of CYP2B6 Polymorphisms in Ketamine Metabolism and Clearance

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-50 yr old CYP2B6*1/*1, CYP2B6*1/*6 or CYP2B6*6/*6 genotype (see table) (Note: subjects of other rare genotype but with one or more 516G>T, 785A>G, 983T>C or 1459C>T polymorphism may be enrolled at PI's discretion) Good general health with no remarkable medical conditions BMI <33 Provided informed consent Exclusion Criteria: Known history of liver or kidney disease Use of prescription or non prescription medications, herbals, foods or chemicals known to be metabolized by or affecting CYP2B6 Females who are pregnant or nursing Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction) Direct physical access to and routine handling of addicting drugs in the regular course of duty (this is a routine exclusion from studies of drugs with addiction potential)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine arm- *1/*1<br>1.*1/*1- oral racemic ketamine 0.4 mg/kg | Drug: ketamine<br>* 0.4 mg/kg oral racemic ketamine<br>|
| Experimental: Ketamine arm - *1/*6<br>2. *1/*6- oral racemic ketamine 0.4 mg/kg | Drug: ketamine<br>* 0.4 mg/kg oral racemic ketamine<br>|
| Experimental: Ketamine arm - *6/*6<br>3. *6/*6- oral racemic ketamine 0.4 mg/kg | Drug: ketamine<br>* 0.4 mg/kg oral racemic ketamine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype. | Ketamine metabolism, measured as the plasma norketamine/ketamine AUC ratio in CYP2B6*6 carriers (CYP2B6*6 hetero or homozygotes) compared to the wild-type CYP2B6*1/*1 genotype Ketamine, norketamine, and dehydronorketamine concentrations in plasma and urine were determined by enantioselective HPLC tandem mass spectrometry, using solid phase extraction, based on a modification of a published method. | up to 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ketamine polymorphisms