bioihbjkbjnl/mcl2 huggingface dataset:
Medical Review: Hand Surgery After Local Block Versus Non-block
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Observational

Summary: 
      In this study, the effects of local block vs non block will be assessed with respect to
      postoperative outcomes (such as pain score, and recovery profiles) in outpatients after hand
      surgery.
    

Detailed description: 
      Analyzing medical records and through a telephone questionnaire, in a retrospective and
      prospective review respectively.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatients undergoing hand surgery
      
Keywords: pain management; ambulatory surgery; opioid; local anesthesia; hand surgery; postoperative pain
6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Three New Generation Drug Eluting Stent
Condition: Recurrent Angina After Coronary Stent Placement
Study type: Interventional

Summary: 
      Aim of this study is to compare at 6 months follow-up, endothelization and malapposition,
      evaluated by means of optical coherence tomography, in terms of number of struts not
      endothelized or malapposed, after the implantation of three new generation stent: Cre8,
      Biomatrix and Xience.
    

Detailed description: 
      This is a randomized study aimed at evaluating in 60 patients with either acute coronary
      syndromes or stable coronary artery disease submitted with PCI and stenting, endothelization
      and malapposition at 6 months follow-up (primary endpoint), evaluated by means of optical
      coherence tomography in terms of number of struts not re-endothelized or malapposed, after
      the implantation of three new generation stent: Cre8, Biomatrix and Xience. Further clinical
      follow-up will be performed to evaluate MACE at 12 months follow-up.
    

Intervention name(s): optical coherence tomography at 6 months
Intervention type(s): Device
Intervention description(s): 6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: optical coherence tomography; malapposition; endothelization
ADRN Barrier/Immunoprofiling Exploratory Pilot Study
Condition: Dermatitis; Dermatitis, Atopic; Eczema; Non-atopic Healthy Controls
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Observational

Summary: 
      The purpose of this study is to look at how defects in the skin barrier and immune response
      affect risk for skin infections.

      Participants will be classified into 4 groups based on Atopic Dermatitis (AD)/Non-Atopic (NA)
      status and Staphylococcus aureus (S. aureus) colonization (negative or positive):

        -  AD S. aureus negative

        -  AD S. aureus positive

        -  NA S. aureus negative and

        -  NA S. aureus positive.
    

Detailed description: 
      Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with
      severe itching. People with atopic dermatitis have defects in the skin barrier as well as
      defects in the immune system which fights off skin infections. People who have atopic
      dermatitis often have complications from viral and bacterial skin infections, such as
      recurring Staphylococcus aureus (S. aureus), or Staph infections.

      The study will compare the skin barrier and immune response of people with and without atopic
      dermatitis in relation to whether Staph bacteria is growing on their skin.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants enrolled in the ADRN Registry study (NCT01494142) who fulfill eligibility
        criteria for this (ADRN04) study
      
Biospecimen description: 
      Whole blood, skin tissue
    
Keywords: Dermatitis; Staphylococcus; Staphylococcus aureus; Dermatitis, Atopic; Non-atopic controls
A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and
      safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects.

      The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level
      cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese
      subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group)
      who will receive IP (see below).
    


Intervention name(s): CC-90001
Intervention type(s): Drug
Intervention description(s): CC-90001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Subjects; CC-90001; Japanese; Caucasian; Safety; Pharmacokinetics
Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see how safe an investigational new drug (T89) is and how
      well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.
    

Detailed description: 
      This is a single centre, double-blind, randomized, placebo controlled, single- and multiple-
      dose-escalation study.

      After informed consent is obtained, subjects were evaluated with a medical history
      questionnaire, physical examination, blood and urine collections for clinical laboratory
      safety tests, urine drug screen, serum pregnancy test for each women, vital signs and ECG.
      The subjects who fulfill the inclusion criteria but no exclusion criteria were provisionally
      enrolled. For participation in this trial, subjects were instructed to avoid any
      prescription, over-the-counter (OTC), and alternative / complementary medications or
      significant changes in diet without advance permission from principal investigator. The
      subjects were instructed to discontinue alcohol, caffeine and bromine containing
      beverage/food. 20 subjects were enrolled and divided into three Groups: Group A, Group B and
      Group C.
    

Intervention name(s): T89 Group A; Placebo Group A; Placebo Group B; T89 Group B; Placebo Group C; T89 Group C
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 150mg single dose on day 1; 150mg single dose; 300mg single dose; 300mg single dose; 225mg bid; 225mg bid
Other intervention name(s): Dantonic®; Salvtonic®; Compound Danshen Dripping Pills; Dantonic®; Salvtonic®; Compound Danshen Dripping Pills; Dantonic®; Salvtonic®; Compound Danshen Dripping Pills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: T89 Safety in Healthy Japanese population
Randomised Trial of Eutectic Mixture of Local Anaesthetics Cream and Oral Sucrose Solution for Venepuncture
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral
      sucrose solution compared to oral sucrose solution alone before venepuncture in preterm
      infants.
    

Detailed description: 
      Venepuncture is a painful procedure commonly performed in premature infants.
      Nonpharmacological intervention (oral sucrose solution) can reduce neonatal pain. EMLA cream
      is an oil in water emulsion of an eutectic mixture of prilocaine and lignocaine; it is an
      local anesthetic cream. Very few reports have looked at the efficacy of EMLA in preterm
      infants.

      This randomized bicentric trial will investigate the efficacy of topical EMLA cream with oral
      sucrose solution compared to oral sucrose solution alone before venepuncture in preterm
      infants.
    

Intervention name(s): venepuncture
Intervention type(s): Procedure
Intervention description(s): venepuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Venepuncture; Pain; Emla cream; Oral sucrose solution; Premature infant; Premature infant admitted to the care baby unit were; included in the study.; Programed venepuncture is performed with analgesia.
Iliac Vein Stenting in Advanced Chronic Venous Insufficiency
Condition: Iliac Vein Obstruction; May-Thurner Syndrome; Cockett Syndrome
MeSH terms: Venous Insufficiency; May-Thurner Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      About 90 % of vascular symptoms affecting the lower limbs consist of venous diseases. Its
      highest incidence occurs from the second decade of life, affecting significantly the
      economically active population. Chronic Venous Insufficiency treatment aims to relieve
      symptoms, treat and prevent complications, prevent recurrences and provide cosmetic
      satisfaction with minimal side effects. It's current treatment includes some classic postural
      measures (leg elevation), elastic stockings and bandages compression therapy and possible
      medication (phlebotonics). The results in the medium and long term are unfavorable, since a
      large number of patients do not get better or evolves with recurrence of symptoms. Nowadays
      many, no prospective , not randomized , international studies have shown favorable results
      with endovascular treatment of obstruction in the iliac vein territory in patients with
      advanced Chronic Venous Insufficiency . The purpose of this prospective, double-blinded
      randomized study is to evaluate the results obtained with endovascular treatment, through the
      use of angioplasty and stenting in this group of patients when compared with clinical
      treatment .
    


Intervention name(s): Phlebotonic; Stent; Limb elastic compression support; Unna boot dressing
Intervention type(s): Drug; Device; Procedure; Procedure
Intervention description(s): Aminaftone -- 75 mg BID; Iliac Vein Stenting; CEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages; CEAP 6 > Unna boot dressing
Other intervention name(s): Aminaftone; Wallstent; Venosan compression stockings; Atamed elastic bandages
Intervention MeSH terms: Aminaftone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Iliac; Vein; Stent
Relative Bioavailability of Bromhexine Given as Granules and Syrup in Healthy Volunteers (Clinical Phase I Study)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the current study is to investigate relative bioavailability of bromhexine
      hydrochloride given as granules and syrup
    


Intervention name(s): Bromihexine hydrochloride syrup; Bromihexine hydrochloride granules
Intervention type(s): Drug; Drug
Intervention description(s): syrup; granules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy
Condition: Endometriosis Ovary
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with
      three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep
      pelvic endometriosis (subperitoneal).

      Surgical management of endometriomas is justified in cases of significant clinical symptoms
      (like pain), especially in cases of resistance to medical treatment. Currently, laparoscopic
      cystectomy surgery is the recommended technique to treat ovarian endometrioma. However, it is
      now well demonstrated that this surgery significantly reduces the ovarian reserve.

      Ethanol sclerotherapy is an alternative technique used to treat ovarian endometriomas.
      Several studies demonstrated the effectiveness and safety of this treatment, particularly in
      terms of preserving fertility. Regarding these reassuring data, many clinicians changed their
      practices and propose this technique as a first-line surgery.

      Ovarian reserve comprises two elements: size of the primordial follicle stock and quality of
      the ovocytes. Antimüllerian hormone (AMH) has been shown to be the best marker of fertility.

      The aim of this study is to observe changes in AMH levels after endometrioma sclerotherapy.
      This study is conducted in the Hospices Civils de Lyon, in 3 different sites.
    


Intervention name(s): Blood test
Intervention type(s): Biological
Intervention description(s): additional blood test will be done 3 and 12 months after endometrioma sclerotherapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: endometrioma; sclerotherapy; ovarian reserve; antimüllerian hormone
Validating the "Foods for Health" Portfolio of Functional Food Products
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objective of this research project is to investigate the ability to affect cardiovascular
      disease (CVD) risk factors through a novel, easily implemented functional food-based
      approach. The goal of the proposed project is to evaluate the effect of a range of
      proprietary products specifically formulated to deliver convenient pre-packaged
      condition-specific foods to positively impact blood cholesterol levels in statin intolerant
      and/or statin unwilling participants. The specific aim of this project is to evaluate the
      changes in serum low-density lipoprotein (LDL)-cholesterol, triglyceride (TG) glucose,
      insulin and high-sensitivity C-reactive protein (hsCRP) concentrations over a 4 week regimen
      using healthy tasty foods which are self-selected by a statin intolerant patient group.
    


Intervention name(s): Portfolio of functional foods; Control foods
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Evaluation of AN777 on Elderly Subjects During Bed Rest and Recovery
Condition: Aged
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objectives are to evaluate the effect of AN777 on muscle strength loss that
      occurs during bed rest, and to investigate whether AN777, in association with resistance
      training, will support muscle strength recovery following bed rest in healthy elderly
      subjects.
    


Intervention name(s): Experimental Nutritional Powder Formula; Placebo comparator
Intervention type(s): Other; Other
Intervention description(s): Powder twice a day; Powder twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Elderly volunteers
Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis
Condition: Diabetes Mellitus Type 1 and 2; Diabetes Mellitus Complications; Gastroparesis; Gastrointestinal Motility Disorder
MeSH terms: Gastroparesis; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Complications
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK)
      profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and
      delayed gastric emptying.
    


Intervention name(s): RM-131; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 μg subcutaneously once; Matching placebo volume subcutaneously once
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type 1 and 2; Delayed Gastric Emptying; Gastroparesis; Gastrointestinal Motility Disorder
Text Messages and Physical Activity Among Teens
Condition: Physical Activity
Study type: Interventional

Summary: 
      The purpose of this study is to assess whether text messages can be used as a way to increase
      the amount of physical activity teens get each day.
    

Detailed description: 
      This research will develop an innovative intervention that promotes physical activity to
      14-17 year olds (roughly high school aged youth). It is guided by Self Determination Theory
      and seeks to enhance adolescents' feelings of physical activity autonomy, competence, and
      relatedness, key psychological needs related to motivation to be physically active. The
      physical activity to be promoted is walking, which has broad appeal and can be performed as
      part of usual-day activities. Since youth are heavy users of cell phones and texting, the
      intervention will send theoretically-grounded text messages designed to enhance physical
      activity.
    

Intervention name(s): TXT Me
Intervention type(s): Behavioral
Intervention description(s): text messages, physical activity, self determination theory, extrinsic motivation, intrinsic motivation, pedometers, walking, prompts
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity; exercise; walking; pedometers; goal setting; text messages; motivation; intrinsic motivation; extrinsic motivation; self determination theory; prompts
Intestinal Inflammatory and Metabolic Responses to a High Fat Meal and Plant Polyphenol Blend
Condition: Anthocyanins
Study type: Interventional

Summary: 
      This study will investigate the beneficial effects of supplementation with a plant polyphenol
      blend rich in anthocyanins on parameters of inflammation and metabolic responses following a
      challenge with a high-fat (HF) meal.

      The investigators will use a randomized crossover study to investigate the effects of: 1)
      placebo (control); 2) plant polyphenol blend rich in anthocyanins; on systemic inflammatory
      markers (endotoxemia, cytokines, NF-κB), glucose and lipid metabolic responses following
      consumption of a high-fat (HF) meal in healthy subjects. The high-fat meal (320 g) consists
      of English muffin bread, sausage, egg and cheese, obtained from US market and completed with
      palm fat. The total energy content of the high-fat meal is 1,026 Kcal with 70.5 g of fat
      (29.8 g of saturated fat), 270 mg of cholesterol, 65 g carbohydrate, 5.2 g sugar, and 33 g
      protein with a total of 62% energy originated from fat, 25% from carbohydrates and 13% from
      protein. The high-fat meal will be standard and it will not be adjusted for large and small
      participants.
    


Intervention name(s): Plant polyphenol blend; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal; A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized placebo-controlled cross-over design study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Pediatric Metabolic Syndrome Study
Condition: Metabolic Syndrome; Overweight and Obesity; Cardiovascular Risk Factor
MeSH terms: Overweight; Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The Pediatric Metabolic Syndrome Study is an observational study being conducted at the
      Medical University of South Carolina to investigate cardiometabolic risk parameters in obese
      subjects ages 4 to 21. A detailed assessment is performed on eligible subjects including
      fasting labwork, anthropometrics, nutrition analysis, body composition testing,
      echocardiography, and carotid IMT measurements.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        obese 4 to 21 yo subjects
      
Keywords: pediatric metabolic syndrome
Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg
      twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis
      (AS) and previous failure to usual practice therapies in Spain.
    


Intervention name(s): etanercept; etanercept/placebo
Intervention type(s): Drug; Drug
Intervention description(s): Etanercept 50 mg twice a week (BIW) for 12 weeks; Etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Effect of etanercept in subjects with ankylosing spondylitis
Dry Needling Versus Stretching for Muscle Extensibility
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Currently
      several authors have shown the presence of active myofascial trigger points (MTrP) in the
      muscles surrounding the hip joint that reproduce the symptoms of the patients with hip OA.

      Despite of the beneficial effects that have shown may conservative non-pharmacological
      treatments, there is a lack of studies evaluating the effects of the conservative treatments
      on muscle extensibility.

      According to the new paradigm about the presence of MTrPs, the investigators decided to
      conduct a randomized clinical trial to compare the effects of DN intervention and stretching
      protocol on muscle extensibility in patients with hip OA.
    


Intervention name(s): Dry needling
Intervention type(s): Other
Intervention description(s): Dry needling of the active MTrPs following the technique described by Hong et al (1994,1995)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: physiotherapy; stretching; dry needling