linjc16/ctgov huggingface dataset:
Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass

Study Overview
=================
Brief Summary
-----------------
to compare the results of SASI to SAS-J in treatment of morbid obesity

Detailed Description
-----------------
200 of patients indicated for obesity surgery will be divided into 2 groups : Group 1, will be operated by SASI and Group 2, will be operated by SAS-J

Official Title
-----------------
Single Anastomosis Sleeve Ileal Bypass Versus Single Anastomosis Sleeve Jejunal as a Treatment of Morbid Obesity

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: SASI
* Procedure: SAS-J


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity patients fit for laparoscopic surgery give approval to share in the study Exclusion Criteria: patients refused to share in the study patients unfit for surgery patients aged less than 18 and older than 60 patient with previous upper abdominal surgery either for obesity or other diseases revisional bariatric procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SASI<br> | Procedure: SASI<br>* Single-Anastomosis Sleeve ileal (SASI) Bypass<br>|
| Experimental: SAS-J<br> | Procedure: SAS-J<br>* Single-Anastomosis Sleeve Jejunal (SAS-J) Bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nutritional deficiency | the effect of the 2 procedures on nutritional status by doing the following investigations to collectively give idea about deficiency this investigation including: Hb% ( in mg/dL), vitamin D (in ng/mL) , vitamin B ( in pg/mL), Serum Ca (in mg/dL) serum Zinc (in μg/dL) serum Iron ( in mcg/dL) serum Folate (in μg/L) and serum albumin ( in g/dL) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comorbidities | change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer | 1 year | 
| complications | early and late complications | 1 year | 
| weight loss | the effect of the 2 procedures on weight measured by percentage of excess weight loss | 12 months |
Magnetic Resonance Imaging Evaluation of the Tissular Oxygen Saturation in Brain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the tissular oxygen saturation in brain by magnetic resonance imaging on subjects and to correlate the results with near infrared spectroscopy measurements.

Conditions
-----------------
Stroke, Cerebral Tumor

Intervention / Treatment
-----------------
* Other: imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers or Patients with cerebral lesion Exclusion Criteria: claustrophobia MRI exclusion criteria

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

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient<br>Imaging | Other: imaging<br> <br> |
| Other: healthy subject<br>Imaging | Other: imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI measurements of local oxygen saturation in the brain |  | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Oxygenation, nirs
Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV Vaccine in Female Subjects Aged 10-14 Years

Study Overview
=================
Brief Summary
-----------------
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immunogenicity and the safety of the HPV vaccine in female subjects aged 10 - 14 years in Korea.

Detailed Description
-----------------
Study participants will receive either HPV or hepatitis A vaccine, study duration will last for 7 months and involve a total of 4 visits.

Official Title
-----------------
Evaluate the Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a 0,1,6 Mth Schedule in Healthy Female Subjects Aged 10-14 Yrs

Conditions
-----------------
Infections, Papillomavirus

Intervention / Treatment
-----------------
* Biological: HPV-16/18 L1/AS04


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: A female subject between, and including, 10 and 14 years of age at the time of the first vaccination. Written informed assent from the subject and informed consent from the parent or guardian of the subject should be obtained prior to enrolment. Subjects must have a negative urine pregnancy test. Healthy subject before entering the study as established by medical history and clinical examination. Subject must be of non-childbearing potential. Exclusion criteria: Pregnant or breastfeeding. Previous vaccination against HPV. Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes, or autoimmune disease.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HPV-16/18 L1/AS04|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate antibody responses against HPV-16 and HPV-18 in all HPV vaccine recipients at Month 7. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and reactogenicity throughout the study period. |  |  |
Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators want to have a collection of fresh primary or recurrent tumor tissue for establishment of patients-derived xenografts in order to: generate a biobank of in vivo patient xenografts representing the different subgroups of tumors for head and neck cancer perform genetic and transcriptional profiling of the primary, metastatic tumors and xenograft tumors evaluate the efficacy of new targeted agents, whether or not in combination with standard treatment options evaluate biomarkers of drug sensitivity study primary and secondary (acquired) resistance in these models

Official Title
-----------------
Establishment of Primary Patient-derived Xenograft Models of Tumor From Patients With Head and Neck Cancer for Preclinical Evaluation of Targeted Therapies.

Conditions
-----------------
Squamous Cell Carcinoma of the Head and Neck

Intervention / Treatment
-----------------
* Procedure: Local biopsy in the tumor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In the first phase, all patients with primary or recurrent/ metastatic disease of head and neck cancer can be included pre-operatively or before a tumor biopsy after obtaining informed consent Data on stage, grade, histology, adjuvant treatment, responses, relapse should be available Follow-up data should be available Patients with recurrent disease are allowed Written informed consent

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 |
| --- |
|Procedure: Local biopsy in the tumor|A tumor biopsy of 0.5 cm2 or more will be collected from every patient during surgery or endoscopy after informed consent and if there is enough material after review by the pathologist.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with immunohistochemistry (KI67) on FFPE (fixation followed by paraffin embedding) slides | Identification of the biomarkers of new cancer therapies for head and neck | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with genetic techniques | Characterization of the biomarkers of new cancer therapies for head and neck cancer on the patient-derived xenografts with genetic techniques | 10 years |
Change of Retinally-Induced Aniseikonia in Patients With Epiretinal Membrane After Vitrectomy

Study Overview
=================
Brief Summary
-----------------
Epiretinal membrane is common disease, affecting 5 10 % incidence over 60 years old population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but nowadays with technical improvement and surgical instrument renovation, it seems to have been changed the surgical indication. Therefore, we plan to evaluate the changes of binocular visual acuity, aniseikonia in patients with epiretinal membrane.

Conditions
-----------------
Epiretinal Membranectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic epiretinal membrane who had impaired vision or metamorphopsia, want to undergo vitrectomy Age more than 20 years and less than 90 years old Exclusion Criteria: secondary epiretinal membrane due to retinal surgery, impaired visual acuity less than 20/40 in the normal eye(Snellen chart) due to severe cataract glaucoma patients complication during vitrectomy (ex. Retinal tear, silicone oil injection, …) other retinal disease except epiretinal membrane other ocular surgery history within 3 months intellectual problems or illiterate whom could not obtained informed consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| ERM<br>idiopathic epiretinal membrane patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Stereopsis tested by TNO test (arc of second) | Stereopsis is normal binocular vision. Its presence or absence is an important indicator of the state of binocularity. The TNO test is graded to provide retinal disparities ranging from 15 to 480 second of arc. | from Initial screening day before surgey to postoperative 6 months | 
| Titmus test (arc of second) |  | from Initial screening day before surgey to postoperative 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epiretinal membrane, stereopsis, aniseikonia
TNF-Alpha Inhibition for Treatment of Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
It is widely believed that inflammation contributes to the pathogenesis of AD. TNF has been implicated in both AD and neurological inflammation. Anti-TNF therapy is therefore surmised to be of potential benefit for treating AD.

Detailed Description
-----------------
Etanercept, a biologic anti-TNF fusion protein, will be administered weekly or biweekly by perispinal injection to a maximum of 15 study subjects for a period of one month, followed by a 5 month and a 6 month possible study extension, with serial testing of cognition and function monthly.

Official Title
-----------------
Etanercept for Alzheimer's-Type Memory Loss Pilot Study

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

Intervention / Treatment
-----------------
* Drug: etanercept given by perispinal administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NINCDS-ADRDA Criteria for Alzheimer's disease CT or MRI consistent with AD Exclusion Criteria: active infection CHF demyelinating disease uncontrolled diabetes mellitus vascular dementia clinically significant neurologic disease other than AD Hachinski >4 history of lymphoma TBC wbc<2500 platelets<100,000 HCT<30 pregnancy premenopausal, fertile not on acceptable birth control change in neuroactive medication within 4 weeks of study initiation

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

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: etanercept given by perispinal administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADAS-Cog |  |  | 
| SIB |  |  | 
| MMSE |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Category fluency |  |  | 
| other neuropsychological tests |  |  |
Effect of Yohimbine on Colon Transit

Study Overview
=================
Brief Summary
-----------------
This study is being done to learn if yohimbine, a naturally occurring drug, affects the speed at which food travels through the stomach, intestines and colon, and if yohimbine affects the amount of liquid you can drink in a short period of time. Understanding how yohimbine works on the gut may help develop new treatments for patients with constipation. Yohimbine has been approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use as proposed in this study is considered investigational.

Official Title
-----------------
Effect of Oral Yohimbine on Colonic Transit: Randomized, Placebo-Controlled Trial

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

Intervention / Treatment
-----------------
* Drug: Yohimbine, oral


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy male or non-pregnant, non-breastfeeding female volunteers, -18-65 years old; Able to provide written informed consent before participating in the study; Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Yohimbine, oral|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonic transit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Small bowel transit time |  |  | 
| Gastric emptying time |  |  | 
| Maximum tolerated volume ingested during satiation testing |  |  | 
| Average stools per day |  |  | 
| Stool consistency |  |  |
Metabolic Effects of Chronic Ketosis (KETO-CHF Metabolic)

Study Overview
=================
Brief Summary
-----------------
Heart Failure (HF) is a major public health issue because the disease affects 1-2% of the Western population and the lifetime risk of HF is 20%. Despite major improvements in the management and care of patients with HF, the 1-year mortality in patients with HF is 13% and >50% of HF patients are admitted during a 2.5 year period. Furthermore, patients with HF have markedly decreased physical capacity and quality of life. Thus, there is a need for new treatment modalities in this group of patients. It is well established that patients with heart failure have metabolic disturbances, including disturbed glucose metabolism with increasing insulin resistance, increased lipolysis, and disturbances in skeletal muscle homeostasis. Presently there are no data on the clinical metabolic effects of long-term oral ketone-supplementation in patients with chronic HF. In this study we aim to investigate the effect of 14 days modulation of circulating ketone body levels on endogenous protein, glucose, and fatty acid metabolism in patients with HFrEF.

Official Title
-----------------
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Metabolic Effects

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Dietary Supplement: Ketone monoester
* Dietary Supplement: Placebo drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic heart failure with NYHA II-III Left ventricular ejection fraction ≤40% Negative urine-HCG for women with childbearing potential Exclusion Criteria: Known diabetes or HbA1c ≥48 mmol/mol Significant cardiac valve disease Severe stable angina pectoris Age <18 years

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketone monoester (3-OHB)<br> | Dietary Supplement: Ketone monoester<br>* Commercially available ketone supplement<br>|
| Experimental: Placebo Treatment<br> | Dietary Supplement: Placebo drink<br>* Isocaloric placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in lipolysis rate | Measured as differences in palmitate flux | 14 days of dietary supplement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in protein metabolism | Measured with a urea tracer | 14 days of dietary supplement | 
| Changes in glucose kinetic | Measured by glucose tracer | 14 days of dietary supplement |
Study of Genetic and Molecular Defects in Primary Immunodeficiency Disorders

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Identify the molecular defects responsible for primary immunodeficiency disorders. II. Explore the mutations within each syndrome to better understand the genetics of these disorders. III. Study the function of the Wiskott-Aldrich syndrome proteins (WASP). IV. Design methods to identify carriers and for prenatal diagnosis. V. Explore new avenues for therapy.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are studied systematically to determine the extent of their immune deficiency and to confirm a specific diagnosis. Patients with a known immunodeficiency syndrome are studied in detail to identify the gene mutation, to assess the effect of the mutation on the gene product, and to establish cell lines for further in vitro assessment of the genetic defect. The function of Wiskott-Aldrich syndrome proteins (WASP) in hematopoietic cells is studied. Family members of patients with X-linked disorders are studied to identify carrier females.

Conditions
-----------------
X-Linked Agammaglobulinemia, X-Linked Hyper IgM Syndrome, Wiskott-Aldrich Syndrome, Leukocyte Adhesion Deficiency Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Primary immunodeficiency disease, e.g.: Leukocyte adhesion deficiency syndrome Wiskott-Aldrich syndrome X-linked agammaglobulinemia X-linked hyper IgM syndrome

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wiskott-Aldrich syndrome, X-linked agammaglobulinemia, X-linked hyper IgM syndrome, genetic diseases and dysmorphic syndromes, immunologic disorders and infectious disorders, leukocyte adhesion deficiency syndrome, primary immunodeficiency disease, rare disease