linjc16/ctgov huggingface dataset:
Efavirenz to Nevirapine Switch and Low-Density Lipoprotein (LDL)-Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.

Official Title
-----------------
Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study

Conditions
-----------------
HIV Infections, Hypercholesterolemia, Antiretroviral Therapy

Intervention / Treatment
-----------------
* Drug: Nevirapine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions 14 days apart Severe dyslipidemia with Low-Density Lipoprotein cholesterol (LDL-c) >3.4 mmol/L in the presence of at least one of the 3 following coronary heart disease (CHD) risk factors: age>45 among males or age>55 among females, hypertension, current smoking, family history of CHD Low-Density Lipoprotein cholesterol (LDL-c)>4.1 mmol/L regardless of CHD risk factors. Exclusion Criteria: Protease inhibitors use within the previous 6 months, Prior exposure to nevirapine Asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative AST or ALT>1.25N if hepatitis virus B or C were positive Fasting glycemia>1.26g/L, Current CHD Triglycerides>4.6 mmol/L Introduction of lipid lowering drugs, corticoïds, retinoïds and betablockers within the previous 3 months.

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in LDL cholesterol between baseline and week 52 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Efavirenz, Nevirapine, Dyslipidemia
Low Power ThULEP for Prostate Size More Than 80 gm

Study Overview
=================
Brief Summary
-----------------
Feasibility and Efficacy of lower power thulium enucleation of prostate more than 80 grams

Detailed Description
-----------------
Intra operative outcome and postoperative follow up of IPSS score and IEFF score at 6 months.

Official Title
-----------------
Low Power Thulium Enucleation of Prostate More Than 80 Grams

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Procedure: ThuLEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BPH patients with failed medical treatment Refractory retention Hematuria Bladder stones Renal impairment due to BPH Exclusion Criteria: Neurogenic patients stricture urethra
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 |
| --- | --- |
| Other: ThuLEP group<br> | Procedure: ThuLEP<br>* Minimal invasive prostate intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of complete adenoma removal ( enucleation time in minutes) |  | During operation | 
| International prostate symptoms score IPSS less than 7 which is good outcome |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function- 5 score more than 12 which is a good outcome |  | 12 months |
A Blinded, Four-Way Crossover in Healthy Subjects to Assess EEG After Administration of Ketamine, Placebo and AZD6765

Study Overview
=================
Brief Summary
-----------------
This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.

Detailed Description
-----------------
A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) parameters after the administration of ketamine, two doses of AZD6765 and Placebo

Official Title
-----------------
A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) Parameters After the Administration of Ketamine, Two Doses of AZD6765 and Placebo

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD6765
* Drug: AZD6765
* Drug: Ketamine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 18-30 Non-smoker for at least 4 weeks Exclusion Criteria: Any clinically relevant acute or chronic disease History of substance abuse Hypersensitivity to ketamine

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD6765 75 mg<br> | Drug: AZD6765<br>* 75 mg<br>|
| Experimental: AZD6765 150 mg<br> | Drug: AZD6765<br>* 150 mg<br>|
| Active Comparator: Ketamine 0.5 mg/kg<br> | Drug: Ketamine<br>* 0.5 mg/kg<br>|
| Placebo Comparator: 125 mL sterile NaCl 0.9%<br> | Drug: Placebo<br>* 125 mL sterile NaCl 0.9%<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qEEG assessed through the gamma bands |  | Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pupil Size - to assess the relationship between qEEG and pupil size |  | Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h, and 8h | 
| Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus. |  | Day 1 of each treatment period at Predose, 1h, 3h, and 8h | 
| Bond/Lader scales and eVAS - to assess the subject's alertness, calmness and contentment |  | Day 1 of each treatment period at Predose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, and 8h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy, Effect of a single dose on gamma-band qEEG
A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.

Study Overview
=================
Brief Summary
-----------------
To evaluate safety with the use of Systane Ultra in contact lens wearers. A comparison to a currently marketed contact lens rewetting drop will be included as a control.

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Systane Ultra
* Other: Sensitive Eyes Rewetting Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be between 18 and 65 years of age. Provide written Informed Consent. Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality, or a Rigid Gas Permeable (RGP) contact Lens Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye. Sodium fluorescein (NaFl) corneal staining score sum of < 2 in both eyes (NEI scoring system). Must be willing to maintain pre-enrollment systemic medication regimens during the study. Must be available for study visits and to fill out study questionnaires. Exclusion Criteria: Has modified their systemic medications within 30 days prior to enrollment. Has a history of allergy to any study product ingredients Is unwilling or unable to meet the study visit timeline. Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear. Is currently using any topical eye medications (not including rewetting drops, artificial tear products or Restasis).

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systane Ultra<br>Systane Ultra | Other: Systane Ultra<br>* Re-wetting ocular eye drop<br>|
| Sensitive Eyes<br>Sensitive Eyes | Other: Sensitive Eyes Rewetting Drops<br>* Re-wetting ocular eye drop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events and Visual Acuity |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Eye, re-wetting drops
Chronic Pain in Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The objective is to identify modifiable clinical factors and neurobiological pathways that lead to the development of chronic pain in patients with early rheumatoid arthritis. Participants will undergo quantitative sensory testing, a type of testing that involves assessing response to well-defined, quantifiable painful stimuli, at 0, 3, and 12 months. A subset of participants will also undergo magnetic resonance imaging at 0 and 12 months to assess neuroimaging markers that have previously been shown to be involved in chronic pain.

Official Title
-----------------
CNS Pain Mechanisms in Early Rheumatoid Arthritis: Implications for the Acute to Chronic Pain Transition

Conditions
-----------------
Arthritis, Rheumatoid, Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for QST: Age ≥18 years Meet either the 1987 or 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA Persistent joint symptoms ≤ 2 years Active inflammatory disease If taking opioids on an as needed (prn) basis, must be able to hold opioid for 12 hours before study procedures If taking NSAIDs, must be able to hold NSAIDS for 24 hours before study procedures If taking a central-acting pain medication, must be on a stable dose and able to stay on a stable dose throughout study Exclusion Criteria for QST: Routine, scheduled opioid use Routine, scheduled prednisone dose >10 mg or its equivalent Peripheral neuropathy Peripheral vascular disease Raynaud's phenomenon requiring treatment, manifested by claudication or ischemic rest pain Uncontrolled blood pressure Additional Inclusion Criteria for neuroimaging: Age <75 years old Right-handed Ability to lie on their back for the duration of the MRI scans Additional Exclusion Criteria for neuroimaging: Severe claustrophobia precluding MRI Body mass index >40 kg/m2 Pregnant Contraindications to MRI

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 |
| --- | --- |
| Patients with early rheumatoid arthritis<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Survey Criteria | Minimum value 0, maximum value 31; higher scores indicate worse outcomes | 12 months |
Fresolimumab In Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if fresolimumab is safe in treating people with systemic sclerosis (scleroderma) and to investigate the effect of fresolimumab in the skin of these individuals.

Official Title
-----------------
OPEN LABEL TRIAL OF ANTI-TGF-BETA MAB, FRESOLIMUMAB, IN SYSTEMIC SCLEROSIS - A PHASE ONE BIOMARKER TRIAL

Conditions
-----------------
Diffuse Systemic Sclerosis

Intervention / Treatment
-----------------
* Drug: Fresolimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet ACR criteria for diffuse systemic sclerosis < 24 months since onset of first SSc manifestation other than Raynaud's phenomenon Modified Rodnan Skin Score ≥ 15 Male or female adult ( ≥ 18 years of age) Able and willing to give written informed consent and comply with study protocol Exclusion Criteria: Moderate or severe pulmonary disease w/ FVC < 80% or DLCO < 70% or ground glass and fibrosis > 20% of lung fields by HRCT Treatment with investigational drug within 4 weeks of screening Ongoing use of high dose steroids (> 10mg/day) or unstable steroid dose in past 4 weeks Treatment with immunosuppressive, cytotoxic, or antifibrotic drug within 4 weeks of screening Positive for HIV, HBV, and/or HCV Known active infection (bacterial, viral, fungal, mycobacterial, or other); not including fungal infection of nail beds or any major infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening Patients w/ history of malignancy or premalignant lesion History of keratoacanthoma or squamous cell carcinoma Moderate to severe hepatic impairment SSc renal crisis within 6 months or creatinine > 2.0 Lack of IV access for medication administration Moderate or severe cardiac disease with significant arrhythmia, heart failure, or unstable angina Anemia (Hb < 8.5 gm/dL) Thrombocytopenia or blood clotting disorder Patients with organ transplant (including allogeneic bone marrow transplant)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fresolimumab<br> | Drug: Fresolimumab<br>* intravenous fresolimumab 1mg/kg, first 8 patients; 5 mg/kg following 8 patients<br>* Other names: anti-TGF-beta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety of fresolimumab in patients with scleroderma |  | 24 weeks | 
| To investigate the effect of fresolimumab on TGF-beta responsive gene expression in skin after treatment with fresolimumab compared to pre-treatment TGF-beta responsive gene expression. | TGF-beta regulated skin gene expression | 7 weeks |
Effect of Aerosol Filtering on Infectious Diseases in Day Care

Study Overview
=================
Brief Summary
-----------------
Effect of aerosol flitration and removal on typical infectious diseases such as upper respiratory tract infectinos is studied in day care. Many filtration methods such as filters and electrical filtering are used to remove aerosol particles from room air.

Official Title
-----------------
Effect of Aerosol Filtering on Infectious Diseases in Day Care

Conditions
-----------------
Upper Respiratory Tract Infection, Diarrhea

Intervention / Treatment
-----------------
* Other: Air purification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is expected to be in the same day care unit for the duration of the study Exclusion Criteria: Subject is known not to be in the same day care unit for the duration of the study
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Two of the four participating day care units are allocated in arm 1 | Other: Air purification<br>* Aerosol particles are removed from room air by several methods<br>|
| Other: Arm 2<br>Two of the four participating day care units are allocated in arm 2 | Other: Air purification<br>* Aerosol particles are removed from room air by several methods<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident infections | Incident infections among subjects | During the study periods 11/22-4/23 and 11/23-4/24. These are identical for every subject. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days absent from work | Days absent from work by the parents of sick children | During the study periods 11/22-4/23 and 11/23-4/24. These are identical for every subject. |
Myo-inositol Plus Melatonin in Perimenopausal Women

Study Overview
=================
Brief Summary
-----------------
Menopause is the milestone of a more broaden condition that can last up to 10 years. The first menopausal symptoms usually appear around the age of 42 and are characterized by a gradual decline in thyroid and gonadal function with a progressive increase of plasmatic luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels. Recent studies have shown that myo-inositol and melatonin play a major role in ovarian homeostasis. In particular, it has been demonstrated that myo-inositol and/or melatonin supplementation lead to an increase of oocyte quality. Additional studies focused on postmenopausal women have shown that myo-inositol is able to ameliorate the metabolic syndrome that often affects these patients, thus reducing the risk of cardiovascular diseases (CVDs). The aim of the present study is to evaluate whether myo-inositol and melatonin might play a positive role in regulating hormonal levels during menopausal onset.

Official Title
-----------------
Effects of Myo-inositol Plus Melatonin in Perimenopausal Women

Conditions
-----------------
Perimenopause

Intervention / Treatment
-----------------
* Dietary Supplement: Myo-Mel
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FSH between 15 and 50 IU/ml on the 5th day of the menses Oligomenorrhea Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 42 Years
Maximum Age: 48 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myo+Mel<br>Patients are treated with 2g of myo + 3mg of melatonin daily | Dietary Supplement: Myo-Mel<br> <br> |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I study now a multi-center phase II-trial was conducted.

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically-confirmed epithelial ovarian cancer of FIGO stage IIB - IV life expectancy of more than three months ECOG performance status less than 3 laboratory parameters within the normal range, including a glomerular filtration rate (GFR) greater than 60 ml/min, serum creatinine levels below 1.6 mg/dl, liver transaminases less than two times the normal levels, bilirubin concentrations below 1.5 mg/dl, adequate bone marrow function as indicated by a neutrophil count greater than 1,500/µl, and a platelet count greater than 100,000/µl. written informed consent Exclusion Criteria: suffering from secondary malignancy or underlying serious, uncontrolled concurrent medical or psychiatric disease radiotherapy within 4 weeks for study entry

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: Paclitaxel, Carboplatin<br> | Drug: Paclitaxel<br> <br> Drug: Carboplatin<br> <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
-----------------
Ovarian neoplasms, paclitaxel, carboplatin, clinical trials, phase II, first-line chemotherapy, weekly therapy schedule