bioihbjkbjnl/mcl2 huggingface dataset:
A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in
      adult subjects with atopic dermatitis
    


Intervention name(s): OPA-15406; Tacrolimus; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days; 0.1% concentration of tacrolimus.
Other intervention name(s): Protopic
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic Dermatitis, Eczema
Sculptra Aesthetic Post-Approval Study
Condition: Nasolabial Fold Contour Deficiencies; Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      Study is designed to assess the long-term safety of Sculptra Aesthetic in immune-competent
      subjects as a single regimen for correction of nasolabial fold (NLF) contour deficiencies and
      other facial wrinkles.
    


Intervention name(s): injectable poly-L-lactic acid Sculptra Aesthetic
Intervention type(s): Device
Other intervention name(s): Sculptra Aesthetic
Intervention MeSH terms: Mannitol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RO6889450 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, single center, adaptive single ascending dose (Part 1) and multiple
      ascending dose (Part 2) study is designed to assess the safety, tolerability,
      pharmacokinetic, and pharmacodynamics following an oral administration of RO6889450 versus
      placebo in healthy volunteers. The anticipated duration of this study is approximately 18
      weeks.
    


Intervention name(s): Placebo; RO6889450
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Volunteers
MR Elastography for the Herniated Intervertebral Disc
Condition: Intervertebral Disc Herniation
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      Low back pain is a major cause of disability, especially in the working-age population. A
      total of 149 million working days are lost every year as a consequence of back pain.
      Intervertebral disc (IVD) degeneration is thought to play a major role in chronic back and
      neck pain. Decades of bench-top research in tissue mechanics have shown clear relationships
      between changes in mechanical properties and abnormal changes IVD structure and composition.
      Our overall hypothesis is that measurements of IVD mechanical properties can provide valuable
      information about its structure and composition for early diagnosis of degeneration,
      quantification of degeneration progress, and evaluation of treatment strategies. Magnetic
      Resonance Elastography (MRE) is an imaging method to quantify mechanical properties from soft
      tissues. The objectives of this study are to evaluating repeatability and collecting base
      line data from healthy individuals; and to apply MRE to patients with disc herniation.
    


Intervention name(s): Custom Magnetic Resonance Elastography Device
Intervention type(s): Other
Intervention description(s): Magnetic Resonance Elastography is an imaging method to measure mechanical properties of tissues.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This double-blinded, randomised and controlled trial evaluates the efficacy of
      oxygen-enriched ELO drinking water as an adjuvant modality in diabetes care for enhancement
      of glycemic control in patients with Type 2 diabetes mellitus. Adults with type 2 diabetes
      will be randomized to drink 1.5 L of either ELO water or normal drinking water for 24 weeks.
      The primary outcome is improvement in glycaemic control.
    

Detailed description: 
      Global diabetes mellitus prevalence is rapidly increasing. In 2015, IDF reported that
      Singapore has 12.8% of its population diagnosed with diabetes mellitus, of which more than 90
      percent are type 2 diabetes with underlying insulin resistance. With the aging population and
      increasing prevalence of obesity and sedentary lifestyles, the prevalence is expected to
      continue to rise.

      In vitro studies demonstrated that hypoxia creates a state of insulin resistance through HIF
      (Hypoxia Inducible Factor) transcription factor expression in adipocytes. Insulin sensitivity
      was shown to improve in type 2 diabetes patients and overweight non diabetic patients placed
      in a hyperbaric oxygen chamber.Increased water intake has been associated with lower HbA1c in
      the general population , and also with lower post-prandial glucose in type 2 diabetic
      individuals.

      This study aims to evaluate the effects of 1.5 L daily of ELO water, a drinking water
      enriched with molecular oxygen in a stable form, with a similar volume of bottled drinking
      water, on glycaemic control in adults with type 2 diabetes in Singapore.
    

Intervention name(s): ELO Water; Placebo drinking water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): oxygen-enriched water; bottled drinking water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oxygen-enriched water
Neurodynamics vs. Stretching in Soccer Players With Short Hamstring Syndrome
Condition: Hamstring Contractures
MeSH terms: Contracture
Study type: Interventional

Summary: 
      Comparison of the effects of passive stretching vs. sciatic nerve gliding in soccer players
      presenting with short hamstring syndrome.
    

Detailed description: 
      Soccer players from three teams in the region of Murcia (Spain) were recruited and randomly
      divided into three groups: control group, experimental group 1 and experimental group 2.

      In the control group passive shoulder mobilization will be applied, in experimental group 1
      sciatic nerve gliding will be applied and in experimental group 2 passive hamstring
      stretching will be applied.

      Treatments will be performed once a week for 4 weeks and measurements will be taken at week 1
      and 4.
    

Intervention name(s): Sciatic nerve slippage.; Passive stretching of the hamstring muscles.; passive shoulder mobilization.
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Sciatic nerve slippage.; Passive stretching of the hamstring muscles.; passive shoulder mobilization.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Control group. Experimental group 1. Experimental group 2.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Peripheral nervous system; Muscle stretching exercises; Hamstring muscles; Sciatic nerve; Elasticity
Trial to Evaluate the Efficacy of Simvastatin for Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      Tobacco smoking is the number one preventable cause of disease worldwide. Unfortunately,
      there are few smoking cessation agents and their effectiveness has been shown to be
      relatively limited and is associated with potential unwanted effects. Therefore, the
      discovery of new medications that can facilitate abstinence and reduce relapse to cigarette
      use represents a pressing necessity. In the attempt to find molecules that could reduce
      drug-seeking behavior, we discovered that simvastatin reduces cocaine and nicotine, but not
      food, seeking behavior in rats. This discovery of a new therapeutic application for an
      already marketed class of compounds may greatly facilitate the translation from preclinical
      to clinical setting. In this project, we aim at investigating whether simvastatin is an
      effective smoking cessation agent in humans.

      The study design is a multicenter, randomized, double blind 2 parallel groups, clinical trial
      with an intention-to-treat analysis. Smokers will randomly be assigned to receive simvastatin
      or placebo for 3 months. 200 smokers (100 receiving simvastatin and 100 receiving placebo)
      will be recruited through already established networks of general practitioners. The primary
      outcome of the efficacy of simvastatin will be the rate of smoking abstinence during the last
      month of the 3-month treatment period, defined as reported continuous abstinence from smoking
      and confirmed by expired air carbon monoxide and urinary cotinine concentration. The last
      assessment will be done 6 months after the predefined quit date.

      The results of this proof-of-concept study may open new perspectives in the treatment of
      tobacco use and dependance.
    


Intervention name(s): simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pipeline for Uncoilable or Failed Aneurysms
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      To determine the safety and effectiveness of Pipeline Embolization Device for the treatment
      of uncoilable or failed wide-necked intracranial aneurysms (IA).
    

Detailed description: 
      Patients with large or giant aneurysms of the internal carotid artery treated with PED.
      Angiographic follow-up occurs at 3 and 5 years.
    

Intervention name(s): Pipeline Embolization Device (PED)
Intervention type(s): Device
Intervention description(s): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neurovascular embolization; therapeutic embolization
Arthroscopic Biological Augmentation With Subacromial Bursa for Bursal Side Partial-thickness Rotator Cuff Tears
Condition: Partial Thickness Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The investigators aimed to compare the results of acromioplasty + arthroscopic debridement
      and acromioplasty + augmentation with subacromial bursa.
    


Intervention name(s): Augmentation with subacromial bursa + acromioplasty; Rotator cuff debridement + acromioplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Two intervention was planned. Rotator cuff debridement + acromioplasty group is mentioned as Group A (18 patients) and augmentation with subacromial bursa + acromioplasty is Group B; Two intervention was planned. Rotator cuff debridement + acromioplasty group is mentioned as Group A (18 patients) and augmentation with subacromial bursa + acromioplasty is Group B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: partial thickness; bursal side; rotator cuff; full thickness; subacromial bursa
Investigation of Stent-grafts in Aortic Dissection (INSTEAD)
Condition: Aortic Dissection
MeSH terms: Aortic Dissection
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of INSTEAD is to compare long-term (5 years) outcomes of endograft prosthesis
      versus medical management in patients with dissection of the thoracic aorta.
    

Detailed description: 
      Patients > 18 years with type B aortic dissection were randomized to either thoracic aortic
      endoprosthesis (stent-grafting) or antihypertensive management (medical treatment). Only
      stable patients without spontaneous false lumen thrombosis 14 days after index dissection
      were considered eligible for study inclusion. Long-term outcome measures included all-cause
      mortality, aorta-specific mortality and a cluster endpoint (reflecting progression of
      disease, conversion and additional interventions); the analysis is based on 140 randomized
      cases followed for at least 5 years.
    

Intervention name(s): endoprosthesis
Intervention type(s): Device
Intervention description(s): Thoracic aortic stentgraft
Other intervention name(s): Talent endoprosthesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dissection; Aorta; Surgery
An STD Prevention Intervention for Men Newly Released From Jail
Condition: Sexually Transmitted Diseases; Risk Behavior
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      Study participants who are exposed to the intervention will: 1)report more condom use during
      sexual episodes; 2) have fewer new and repeat STD infections 3)demonstrate greater risk
      reduction, communication, and anger management skills; 4) report fewer substance use
      behaviors, and 5)report more health care seeking activities, than the participants in the
      control group
    

Detailed description: 
      The MISTERS study is a randomized control trial of a cognitive-behavioral skill building
      multi-session intervention that targets men who are newly released from jail and have a
      history of drug use. Men 45 days or less post release with self reported HIV negative and
      substance use histories were randomized into either a 5-session intervention or control
      group. Study participation included four time-sensitive interviews and STD testing at three
      time periods. The interview questions included demographics, STD history and knowledge,
      sexual risk behaviors, as well as an assessment of anger management, communication, and
      condom use skills.
    

Intervention name(s): The MISTERS Intervention for Post Jail Release Men
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sexually transmitted diseases; Risk Behavior
Postpartum Care Timing: A Randomized Trial
Condition: Postpartum; Pregnancy Related
Study type: Interventional

Summary: 
      The purpose of this study is to determine if shortening the time to initial postpartum visit
      from six weeks to two weeks can improve clinic visit attendance and decrease usage of the
      emergency department.
    

Detailed description: 
      Postpartum care is an integral component to completing the maternal peripartum experience and
      transitioning the patient to well-women care. The American Congress of Obstetrics and
      Gynecology has recently highlighted the importance of this "fourth stage" of pregnancy
      suggesting earlier and more comprehensive visits compared to the standard 6-week postpartum
      visit. Specifically they describe that "all women should ideally have contact with a maternal
      care provider within the first three weeks postpartum" however this is largely derived from
      expect opinion and retrospective data. The current rate of postpartum visit attendance is as
      low as 66%, especially in women with scant prenatal care. In the investigators
      government-funded clinic, the postpartum clinic attendance in 2017 was 69% and many of the
      patients have co-morbidities, notably a 25% rate of psychiatric illness. Additionally, in
      this population, the investigators have identified a high rate of Emergency Department (ED)
      usage (8.7%) within 30 days of delivery suggesting that perhaps an earlier routine visit is
      ideal and can prevent the use of the ED. The aim therefore is to evaluate the utility of an
      early postpartum visit at two weeks in addition to a standard six-week visit with a
      randomized control trial.
    

Intervention name(s): Postpartum Visit at 6 Weeks; Postpartum Visit at 2 Weeks
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The patient will be scheduled for a routine postpartum visit at the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.; The patient will be scheduled for an earlier postpartum visit in addition to the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breastfeeding; Contraception; Emergency; Department
The Effect of Educational Intervention on Delivery Type Selection in Pregnant Women at Kermanshah, Iran
Condition: Pregnancy
Study type: Interventional

Summary: 
      In an experimental research, 100 nulliparous pregnant women who had referred to health care
      centers in Kermanshah were randomly selected and after taking Written Informed Consent
      letter, assigned into case and control groups. instruction based on TPB was provided just for
      the case group. Afterwards, post-test was taken by both groups and the results were analyzed.
    

Detailed description: 
      In an experimental research, 100 nulliparous pregnant women with the gestational age of 28-36
      weeks who had referred to health care centers in Kermanshah (western Iran) were randomly
      selected and after taking Written Informed Consent letter, assigned into case and control
      groups. The inclusion criteria consisted of nulliparous pregnant women with the gestational
      age of 28-36 weeks, women under 35 years old, and no contraindications for normal childbirth.
      Exclusion criteria included the absence of women in continuous training sessions, premature
      delivery, and maternal unavailability during the completion of the questionnaires.

      Three Training sessions each lasted for one hour during twenty days were hold for the case
      group. The first session was conducted to affect their attitude and provide favourable
      attitude towards natural delivery. The second session was allocated to presenting feasible
      methods for reducing pain in order to enhance mothers' perceived behavioral control. In the
      3rd session the methods were exercised practically so that they could better employ them
      whenever needed during the parturition. As a result, the mothers' selection of the sort of
      delivery was checked out. In order to influence the subjective norm, pregnant women were also
      asked to transfer their knowledge to their husbands. The control group also received only
      routine training sessions by the midwives in the health care centers.

      In each one-hour training session; 45 minutes was dedicated to listening to lectures, having
      colloquies, and discussing methods via using teaching aids such as pamphlets, and manuals.
      The last 15 minutes was allocated to summarizing the issues and answering mothers' questions.

      At the end of the training sessions, the post-test was administered for both groups and the
      data were analyzed.
    

Intervention name(s): Education based on TPB
Intervention type(s): Behavioral
Intervention description(s): Three Training sessions were given to the case group; each lasted for one hour, during a period of twenty days. During each one-hour training session a period of 45 minutes was dedicated to listening to lectures, having discussions, and discussing methods of using teaching aids such as pamphlets and manuals. The last 15 minutes was used to summarize issues and answer questions.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion
Condition: Entropion
MeSH terms: Entropion
Study type: Interventional

Summary: 
      This study aims to assess the combination of anterior lamellar recession (ALR) with
      blepharoplasty, suprasternal fixation, and internal eyelash bulb extirpation of aberrant
      lashes posteriorly located in patients with any grade of upper eyelid trachomatous
      cicatricial entropion
    


Intervention name(s): Modified anterior Lamellar Recession
Intervention type(s): Procedure
Intervention description(s): ALR is one of the procedures used to treat cicatricial entropion and trichiasis. Few studies present the effect of modifications to this procedure in trachomatous entropion and trichiasis. Because trachoma is common in our country, there is a probability that the number of surgeries for TT will rise.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Developmental Effects of Infant Formula Supplemented With LCPUFA
Condition: Cognitive Development; Growth
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects on visual development, growth, cognitive
      development, tolerance, and blood chemistry parameters in term infants fed one of four study
      formulas containing various levels of DHA and ARA.
    


Intervention name(s): DHA and ARA; Control
Intervention type(s): Other; Other
Intervention description(s): various levels of DHA and ARA
Keywords: infant formula; visual development
Peripheral Blood CD34-positive Cells Enumeration as Predictor of Stem Cell Harvest
Condition: Blood Stem Cell Harvest Failure
Study type: Observational

Summary: 
      Stem cell mobilization procedures after chemotherapy and G-CSf performed at our Institution
      between 2002 and 2013 were reviewed in order to define prognostic factors for optimal harvest
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent mobilization