linjc16/ctgov huggingface dataset:
Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity

Study Overview
=================
Brief Summary
-----------------
Innlandet Hospital in Gjøvik is a center for patients suffering from morbid obesity in Hedmark og Oppland, Norway. Patients with either BMI > 40 kg/m2 or with BMI > 35 kg/m2 and complications who opt for gastric bypass surgery, go through a standard program including a thorough clinical examination and information on the operation, followed by a learning and coping program that consists of standard dietary advise for weight loss and includes weekly visits during 8 weeks. This research project concerns a subgroup in the patient population described above: morbidly obese patients with irritable bowel syndrome (IBS). In this group it will be investigated how an 8 week preoperative milk-free diet affects digestive functions and weight loss. It is known that milk may cause stomach complaints and may make it more difficult to loose weight.

Official Title
-----------------
Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity

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

Intervention / Treatment
-----------------
* Dietary Supplement: milk-free


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: morbid obesity Exclusion Criteria: no consent contraindications to surgery

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: milk-free<br>morbidly obese patients with irritable bowel syndrome (IBS) eligible for gastric bypass surgery | Dietary Supplement: milk-free<br>* milk-free diet during 8 preoperative weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms | Gastrointestinal symptom rating scale (GSRS-IBS) in validated Norwegian translation | 8 weeks | 
| IgG antigen against milk | analysed at BMLab, Sandvika | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric bypass, Questionnaires, Diet, Milk
Genetic Epidemiology of Adult Onset Glioma

Study Overview
=================
Brief Summary
-----------------
To establish a clinic based case control study for examination of potential risk factors for primary adult brain tumors.

Detailed Description
-----------------
Genetic epidemiology of adult glioma to establish potential risk factors for primary adult brain tumors.

Official Title
-----------------
Genetic Epidemiology of Adult-Onset Glioma

Conditions
-----------------
Adult-Onset Glioma

Intervention / Treatment
-----------------
* Other: Mouth Swab, Toe Nail Clippings, Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary glioma of any stage diagnosed within 4 months

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Mouth Swab, Toe Nail Clippings, Questionnaires|The objective of this study is to establish a clinic based case control study for examination of potential risk factors for primary adult brain tumors.|

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
-----------------
Glioma
BIOtinidase Test In Optic-Neuropathy

Study Overview
=================
Brief Summary
-----------------
Biotinidase is an enzyme that recycles biotin, a water-soluble vitamin essential as a coenzyme for four carboxylases that are involved in gluconeogenesis, fatty acid synthesis, and in the catabolism of several branch-chain amino acids. Biotinidase deficiency (BD) is an autosomal recessively inherited disorder. Patients with profound BD (<10% of mean normal serum biotinidase activity) presents, usually during early childhood, with neurological (seizures, hypotonia, ataxia, developmental delay, vision problems, and/or hearing loss) and non-neurological findings (metabolic acidosis, respiratory difficulties, alopecia and/or skin rash) that may progress to coma or death if untreated. Three cases of adult-onset biotinidase deficiency with reversible optic neuropathy have recently been described in France, where there is no neonatal screening of BP. Once treated with Biotin, patients' vision was fully restored. This study aims to assess the prevalence of BP among a population of patients with idiopathic optic neuropathy, and to assess the efficacy of Biotin supplementation on visual impairment in these patients.

Official Title
-----------------
BIOtinidase Test In Optic-Neuropathy

Conditions
-----------------
Biotin Deficiency, Optic Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with bilateral optic neuropathy symptoms beginning before 50 years old diagnosed for more than 1 months etiology unknown Exclusion Criteria: none
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 |
| --- | --- | --- |
| prevalence of biotin deficiency among patients with idiopathic optic neuropathy | measure of biotinidase activity (nkat/l unit) | baseline |
Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Valvular Heart Surgery

Study Overview
=================
Brief Summary
-----------------
One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

Detailed Description
-----------------
One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death. High-mobility group protein B1 (HMGB1) is a protein which is encoded by the HMGB1 gene in human. HMGB1 is secreted by immune cells (like macrophages, monocytes and dendritic cells). Activated macrophages and monocytes secrete HMGB1 as a cytokine mediator of Inflammation. There are many studies suggesting the relationship between HMGB1 and acute coronary syndrome, myocardial ischemic/reperfusion injury, atherosclerosis, heart failure and other cardiac disease as a marker for inflammatory response. However, there are no other study evaluating HMGB1 as a prognostic factor after valvular surgery, so far.

Conditions
-----------------
Valvular Heart Disease

Intervention / Treatment
-----------------
* Procedure: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 20 patients undergoing aortic valve surgery or more than single valve surgery Exclusion Criteria: age < 20 patients undergoing single mitral valve surgery history of open heart surgery emergency surgery history of steroid medication infective disease and/or malignant tumor coronary artery bypass surgery or aortic replacement surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| MGB1 in valvular heart surgery<br>Evaluation of the high mobility group box 1 as a prognostic biomarker in patients undergoing valvular heart surgery | Procedure: Blood sampling<br>* Blood sampling 5ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concentration of HMGB1 | The relationship between concentration of HMGB1 and post op prognosis in patients undergoing valvular heart surgery | collect blood sample right before the surgery after induction of anesthesia |
Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Versus Tecnica Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. RCT

Study Overview
=================
Brief Summary
-----------------
Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional single-shot subarachnoid anesthesia

Detailed Description
-----------------
This study aims to investigate whether a different hemodynamic effect is related to the injection o titrated local anesthetic for subarachnoid anesthesia versus the conventional single shot injection. The data to be recorded are blood pressure and pulse rate at different timing. As secondary outcomes the investigators will record the anesthetic level achieved using the Bromage score.

Official Title
-----------------
Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Nel Confronto Con la Tecnica Tradizionale Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. Trial Randomizzato Controllato

Conditions
-----------------
Anesthesia; Adverse Effect, Anesthesia, Local

Intervention / Treatment
-----------------
* Procedure: subarachnoid block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 20-40 kg/m2 ASA 1-3 undergoing total hip arthroplasty no controindications to subaracnhoid block able to understand and sign a written informed consensus METs > o = 4 Exclusion Criteria: baseline SBP < 100 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T group<br>Subaracnhoid block levobupivacaine 0.5%, 10 mg (2 ml) via subarachnoid injection plus 1mg for each metameric level needed to achieve the T10 level sensory block (evaluation with pinprick test at 10 minute after the firts injection and at 4 minute from the second injection) | Procedure: subarachnoid block<br>* subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty<br>|
| Active Comparator: S group<br>levobupivacaine 0.5%, 15 mg (3 ml) via subarachnoid injection | Procedure: subarachnoid block<br>* subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SBP change | SBP will be recorded at baseline and every 5 minutes after the subarachnoid block for 1 hour | 60 minute |
The Significance of MRI in the Development of Diagnostics and Treatment of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how MRI changes the treatment and diagnostics of ductal breast cancer. 100 women with newly diagnosed breast cancer will participate the study.

Conditions
-----------------
Mammary Ductal Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tumor size less than 2cm Ductal carcinoma unifocal Exclusion Criteria: Previous breast cancer
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br> | |
| MRI<br> | |

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
-----------------
Carcinoma ductale mammae
DaVinci Registry(Distinctly Assess Vision in Coronary Intervention)

Study Overview
=================
Brief Summary
-----------------
Prospective Internet-Registry, Postmarketing-Surveillance, Registration and Follow-up of patients after Multi-Link VISION™ - Stent Implantation

Detailed Description
-----------------
A Non-Randomized prospective evaluation of the Multi-Link Rx Vision TM Coronary Stent System in the treatment of patients with De novo native coronary artery lesions

Official Title
-----------------
Distinctly Access Vision In Coronary Interventions

Conditions
-----------------
Coronary Disease

Intervention / Treatment
-----------------
* Device: Multilink Vision™ Stent (CE-labeled)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women and Men Age >18 years, Intention to treat all stenosis with Multi-Link VisionTM Stents, documented patient consent Exclusion Criteria: No Multi-Link Vision™ Stent implanted, life expectation >9 M, cardiogenic shock, STEMI, NSTEMI or unstable angina pectoris with pathologic markers within the last 48 hours, intolerance of Clopidogrel/ Tiklopidin

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 |
| --- | --- |
| 1<br>Patients who have received a Vision stent and who have diabetes and/or complex lesions. | Device: Multilink Vision™ Stent (CE-labeled)<br>* Patients who have diabetes and/or complex lesions and who have had a Multilink Vision™ Stent placed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TVF |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of death |  |  | 
| Time to first MI |  |  | 
| TVR |  |  | 
| CABG |  |  |
COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.

Official Title
-----------------
A 12 Week Randomized, Double-Blind, Force-Titration, Parallel Group, Multi Centre, Phase IIIb Study to Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects With Raised LDL-C and a 10 Year Risk of CHD >10%

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of 3 or more coronary heart disease risk factors as defined by the protocol. Fasting low density lipoprotein cholesterol level of > 130 mg/dL. Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease. Not previously taken statins. Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1 Active arterial disease eg Unstable angina, or recent arterial surgery Blood lipid levels above the limits defined in the protocol Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rosuvastatin | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|
| Active Comparator: 2<br>Atorvastatin | Drug: Atorvastatin<br> <br> * Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoprotein cholesterol levels following treatment in subjects with metabolic syndrome. |  | At 6 & 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of other lipids and lipoproteins |  | At 6 & 12 weeks | 
| Modification of insulin resistance, inflammatory markers & glucose metabolism |  | At 6 & 12 weeks | 
| Safety: adverse events & abnormal laboratory markers |  | At 6 & 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, hypercholesterolemia, low density lipoproteins, metabolic syndrome, Rosuvastatin
Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients

Study Overview
=================
Brief Summary
-----------------
To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.

Official Title
-----------------
Phase IV, Non Randomized Study in ARV Experienced Patients Under Switch Therapy With Kaletra

Conditions
-----------------
Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Drug: lopinavir/ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV Infected subjects Subjects failing in current HIV treatment, or Subjects with a viral load < 400 copies/mL and not tolerating their current HIV treatment. Exclusion Criteria: Subject is currently participating in another clinical study or has participated in another clinical study within 30 days prior to screening visit Subject is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 17 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: lopinavir/ritonavir<br>* lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment<br>* Other names: Kaletra;|
| Active Comparator: 2<br> | Drug: lopinavir/ritonavir<br>* lopinavir/ritonavir 400 mg/100 mg bid 48 weeks of treatment<br>* Other names: Kaletra;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | Baseline, Week 4, Week 24 and Week 48 | 
| CD4 |  | Baseline, Week 24 and Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Monitoring |  | Baseline, Week 4, Week 24 and Week 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kaletra
Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

Study Overview
=================
Brief Summary
-----------------
The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.

Detailed Description
-----------------
This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.

Official Title
-----------------
Comparison of the HSO iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

Conditions
-----------------
Aphakia, Cataract

Intervention / Treatment
-----------------
* Device: iSert 251 intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated Have clear intraocular media Have potential Best Corrected Visual Acuity of 20/40 or better Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse Exclusion Criteria: Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period Are monocular Have current ocular infection Are taking systemic steroids or other anti-metabolites Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.

Ages Eligible for Study
-----------------
Minimum 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational intraocular lens<br>iSert 251 intraocular lens | Device: iSert 251 intraocular lens<br>* aphakic intraocular lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | BEST Spectacle-Correction (ETDRS) Distance Visual Acuity | 4 to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications and Adverse Events | Number of Participants with Complications or Adverse Events | 4 to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraocular lens, IOL, cataract, Hoya, surgical, optics, ocular, visual acuity