bioihbjkbjnl/mcl2 huggingface dataset:
Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody
Condition: Primary Hyperlipidemia and Mixed Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of
      evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.
    


Intervention name(s): Evolocumab; Atorvastatin; Placebo to Evolocumab; Placebo to Atorvastatin
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Administered by mouth; Administered by subcutaneous injection; Administered by mouth
Other intervention name(s): AMG 145; Repatha; LIPITOR®
Intervention MeSH terms: Atorvastatin; Evolocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Raised cholesterol; Cholesterol; Elevated Cholesterol; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases
Study of a Therapy Without Drugs, Supplementary to an Usual Treatment for the Pains Caused by Removing the Redon's Drain From a 7 to 17 Years Old Child in Pediatric Surgery.
Condition: Surgical Operation With the Settle of a Redon's Drain
Study type: Interventional

Summary: 
      The 3rd governmental plan of fighting against the pain favored the development and the
      evaluation of the efficiency of the non pharmacological methods. Its results always showes a
      lack of knowledge of these methods and the utility to pursue the researches.

      In the department of pediatric surgery of the university hospital of Limoges, the
      relaxing-touch is one of these methods which is more and more used. The healthcare staff
      noticed the beneficial effects of such an empirical method in terms of comfort and quality of
      life for the children.

      In 2011, a pilot study led in this department showed that, in spite of the usual treatment,
      the removal of the Redon's drain remains painful for 25 % of the children (score on the pain
      scale > or = 4). This result convinced the medical team to write a protocol of research from
      the following hypothesis: the implementation of a protocol of the Redon's drain removal
      associated to the relaxing touch and usual treatment could lead to a decrease of the acute
      pain for a 7 to 17 years old child.
    


Intervention name(s): Relaxing-touch method
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Opsin Receptors in Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      Melasma is a hyperpigmentation disorder that is probably exacerbated by visible light. Opsin
      receptors (OPN 1, 2, 3, 4 y 5) were described in the skin, being capable of activating
      melanogenesis induced by visible light. The aim of this study was to evaluate the expression
      of OPN in melasma skin and its changes following treatment with UV-Vis filter and 0.05%
      retinoic acid for 12 weeks.
    


Intervention name(s): Retinoic acid
Intervention type(s): Drug
Intervention description(s): To evaluate the role of Opsin receptors in melasma. The patients were treated with 0.05% Retinoic Acid, a regular therapy to treatment melasma, a ligand of Opsin receptors. Also, Uv-Visible light filter treatment as a posible opsin receptor blocker
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients with melasma divided in a UV-Visible light filter with 0.05% retinoic acid group and UV-Visible light filter alone
Masking: None (Open Label)
Primary purpose: Basic Science
Growth Hormone, IGF-1 and Medical Treatment in Acromegaly: Are There Effects on Gut Hormone Physiology and Postprandial Substrate Metabolism?
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Observational

Summary: 
      Acromegaly is a rare hormonal disorder leading to increased morbidity and mortality. In the
      vast majority of cases, a pituitary somatotroph cell adenoma causes excess growth hormone
      (GH) secretion, leading to hepatic insulin-like-growth factor 1 (IGF-1) hypersecretion. Both
      the disease as well as its treatment with long-acting somatostatin analogs (LA-SMSA) and/or
      pegvisomant affect glucose and lipid metabolism, possibly contributing to increased
      cardiovascular risk.

      In this pilot study, the investigators want to explore insulin sensitivity, postprandial gut
      hormone response, lipid handling and adipocytokine profile in the following 4 groups:

        -  controlled acromegalic patients on LA-SMSA (group 1)

        -  controlled acromegalic patients on combination treatment of LA-SMSA and pegvisomant
           (group 2)

        -  acromegalic patients without need for medical therapy after surgery (group 3)

        -  healthy control subjects (group 4)

      Furthermore, a longitudinal exploration will be performed in uncontrolled acromegalic
      patients (i.e. patients with serum IGF-1 levels above age-specific thresholds and/or symptoms
      due to active acromegaly (excessive sweating , arthralgia)) on LA-SMSA monotherapy (group 5).
      In this group, insulin sensitivity, postprandial gut hormone response, lipid handling and
      adipocytokine profile will be explored before introducing pegvisomant and three months after
      normalisation of IGF-1 levels.

      The investigators hypothesize that lipid and glucose handling will be less efficient in the
      controlled acromegalic patients on LA-SMSA than in controlled patients on combination therapy
      or after surgery, and that there will be no difference in substrate metabolism between
      healthy controls and controlled acromegalic patients on combination treatment or after
      surgery. Further, they hypothesize that introducing pegvisomant in uncontrolled acromegalic
      patients will improve their postprandial lipid and glucose handling.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Groups 1-3 and 5: outpatient clinic attendants Group 4: recruted from community (by
        placard)
      
Biospecimen description: 
      Serum
    
Keywords: Acromegaly; Acromegaly treatment; Long-acting somatostatin analogs; Pegvisomant; Insulin sensitivity; Gut hormones; Lipid metabolism; Adipokines
An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)
Condition: Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, single-arm, multicenter, Phase 4 study to explore the immunogenicity
      of the liquid formulation of Saizen® in subjects with Adult Growth Hormone Deficiency (AGHD),
      who are growth hormone (GH) treatment-naïve or who had prior GH treatment for GHD which was
      stopped at least 1 month prior to Screening and have no contraindication to the use of GH.
    


Intervention name(s): Saizen® solution for injection (referred as Saizen®)
Intervention type(s): Drug
Intervention description(s): Saizen® solution for injection will be administered subcutaneously daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
Other intervention name(s): Somatropin; Recombinant human growth hormone (r-hGH)
Intervention MeSH terms: Hormones
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult Growth hormone deficiency; Saizen®; Recombinant human growth hormone (r-hGH); Somatropin
Advancing HIV Prevention and Linkage to Care Among MSM With Gamification
Condition: HIV Infections; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This study is a pilot evaluation of 'Stick To It', a behavioral intervention based on the
      concept of gamification. The objective of the program is to encourage young men who have sex
      with men (MSM) to be regularly screened for HIV and sexually transmitted infections (STIs)
      and to adopt safer sexual behaviors, with the ultimate goal to decrease HIV and STI
      incidence. Gamification is the application of game elements, like points, badges, and
      rewards, to non-game settings.
    

Detailed description: 
      The investigators will conduct a quasi-experimental pilot study of 'Stick To It', a
      prevention intervention that uses gamification principles and mechanics. The intervention
      includes an online timer that reminds men to get tested, online quizzes, and peer
      recruitment; these activities are awarded with points redeemable for chances at prizes at
      participating clinics. The intervention was designed based on findings from interviews with
      health staff and focus groups with young MSM, and with input from a gamification consultant.
      The primary hypothesis is that the intervention will increase repeat HIV/STI testing among
      young MSM. The intervention will be implemented at two STI clinics in Oakland and Los
      Angeles, California in 2-week intervals for six months. The investigators will review medical
      records of exposed and unexposed young MSM attending the same STI clinics to compare uptake
      of quarterly HIV testing and self-reported behavior after six months.
    

Intervention name(s): Stick To It
Intervention type(s): Behavioral
Intervention description(s): The intervention is a prize system linked to points earned through online and real-world activities designed to incentivize young MSM to test for HIV and STIs every three months. Participants receive points for pre-determined activities, such as: answering online quizzes, inviting friends to participate, and getting tested for HIV/STIs. Points are redeemable in person at two AIDS Healthcare Foundation Men's Wellness Centers, where participants will be able to exchange their points for gumballs from a gumball machine; different color combinations of gumballs correspond to prizes of different values. Participants are reminded to get tested regularly via SMS messages; in addition, they can check when their next test is due by checking their testing timer on the stick2it.org website.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds
Condition: Burns Scald
Study type: Interventional

Summary: 
      Prospective randomized trial where two dressings has been compared for partial thickness
      scald burns in children 6 months to 6 years.
    

Detailed description: 
      Aim: The aim of this study was to compare two different treatment regimes for children with
      partial-thickness scald burns. Burns were treated with either a porcine xenograft (EZderm®,
      Mölnlycke Health Care, Gothenburg, Sweden) or a silver foam dressing (Mepilex® Ag, Mölnlycke
      Health Care, Gothenburg, Sweden).

      Methods: A prospective randomized clinical trial including 58 children admitted between May
      2015 and May 2018 for partial-thickness scalds to The Burn Centre in Linkoping, Sweden.
      Primary outcome was time to wound closure. Secondary outcomes were pain, need of surgery,
      wound infection, length of hospital stay, required dressings changes, and labour time.
    

Intervention name(s): Porcine xenograft (wound dressings); Silver foam (wound dressings)
Intervention type(s): Other; Other
Intervention description(s): commercial porcine xenograft, derived from acellular dermis from porcine.; commercial silver containing foam dressing
Other intervention name(s): EZderm from Mölnlycke Healthcare AB, Gothenburg, Sweden; Mepilex Ag from Mölnlycke Healthcare AB, Gothenburg, Sweden
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomised trial were children, after Guardians written consent,are randomized to one of two dressings.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: burns dressings healing
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in
      participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to
      receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and
      at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity
      of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg
      subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2,
      the participants were to be told they were receiving active study drug. The primary
      hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to
      placebo as measured by the proportion of participants achieving an Assessment in Ankylosing
      Spondylitis (ASAS) 20 response at Week 16.
    


Intervention name(s): Golimumab; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Golimumab 50 mg SC injection every 4 weeks; Placebo SC injection every 4 weeks
Intervention MeSH terms: Golimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails
Condition: Fracture Arm
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      To compare surgical outcomes from medial epicondyle fracture fixation with absorbable
      cartilage nails to those from traditional Kirschner wire fixation.
    

Detailed description: 
      From August 2007 to January 2012, 32 patients undergoing surgery for medial humeral
      epicondyle fractures in our hospital were randomized into group A (traditional Kirschner
      wire) or group B (absorbable cartilage nail). The same surgical team performed the
      operations, and patients were followed for over a year. Group A had open reduction with
      K-wire fixation, and group B was fixed with absorbable cartilage nails. The Bede scoring
      system was used to evaluate elbow function at follow-up.
    

Intervention name(s): absorbable cartilage nail; traditional Kirschner wires
Intervention type(s): Procedure; Procedure
Intervention description(s): The experiment group patients were fixed with absorbable cartilage nails; The control group were fixed with traditional Kirschner wires
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: medial epicondyle humerus; absorbable cartilage nail
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 4
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response
      at the site of Candin intradermal injection in the presence of a targeted immune pathway
      inhibitor.
    


Intervention name(s): Cosentyx; Candin
Intervention type(s): Drug; Drug
Intervention description(s): Cosentyx injection will be administered subcutaneously.; Candin will be administered interadermally along with NaCl solution.
Other intervention name(s): Secukinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study in Healthy Subjects to Assess How Dosing of Rifampin Affects What the Body Does to a Dose of GW679769 (Casopitant).
Condition: Nausea and Vomiting, Chemotherapy-Induced
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine what the body does while taking GW679769 alone and together with
      rifampin in healthy adult subjects.
    


Intervention name(s): GW679769 (Casopitant) oral tablets; Rifampin oral capsules
Intervention type(s): Drug; Drug
Intervention description(s): Casopitant tablets will be available with dose strength of 50 mg. Subjects will receive three 50 mg tablets for the dose of 150 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.; Rifampin capsules will be available with dose strength of 300 mg. Subjects will receive two 300 mg capsules for the dose of 600 mg. On Day 8 of Treatment Period 2, the dose of casopitant and rifampin is to be taken at the same time.
Other intervention name(s): GW679769 (Casopitant) oral tablets
Intervention MeSH terms: Rifampin; Casopitant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rifampin GW679769
Cognitive and Mood Effects of Docosahexaenoic Acid (DHA)-Rich and Eicosapentaenoic Acid (EPA)-Rich Fish Oil in Healthy Young Adults
Condition: Cognitive Function; Mood
Study type: Interventional

Summary: 
      To date, only a small handful of studies have assessed the effects of omega-3 polyunsaturated
      fatty acids (n-3 PUFAs) on cognitive function in healthy adults. The results from these
      studies are mixed, and have differed greatly in terms of methodology as regards sample size,
      treatment formulation and duration of the intervention. In order to address these issues, the
      present study aims to assess the effects of two different formulations of fish oil in
      parallel, and at doses consistent with the current recommended daily intake of oily fish,
      across a range of cognitive domains. The aim of the present investigation is therefore to
      specifically evaluate the effects of 12 weeks supplementation of DHA-rich fish oil and
      EPA-rich fish oil dietary supplements on cognitive function in healthy young adults
      maintaining a regular diet containing oily fish not more than once a week. Self-report mood
      assessments will form the secondary part of this investigation.
    


Intervention name(s): n-3 PUFAs; Placebo; n-3 PUFAs
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 g DHA-rich fish oil taken daily for 12 weeks; 1 g olive oil taken daily for 12 weeks; 1 g EPA-rich fish oil taken daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: n-3 PUFAs; Cognitive function; Healthy young adults; Fish oil; Mood
Dexamethasone Treatment of Congenital Adrenal Hyperplasia
Condition: Adrenal Hyperplasia, Congenital
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if dexamethasone given at night is a more effective
      treatment for congenital adrenal hyperplasia in young children than standard three times per
      day hydrocortisone. Our hypothesis is that nocturnal dexamethasone will lead to more
      efficient suppression of the hypothalamic-pituitary-adrenal axis. We performed a cross-over
      trial comparing hormonal control during two 24-hour hospitalizations, one on hydrocortisone
      and one on nocturnal dexamethasone.
    

Detailed description: 
      This is a Phase II clinical trial, intended to estimate the effect of instituting
      Dexamethasone therapy in comparison to prior standard therapy. Each subject provides his own
      baseline data. There is no control group. Patients with CAH who meet inclusion criteria will
      be admitted to the clinical research center for two 24 hour hospitalizations. Adrenal hormone
      profiles will be measured during each hospitalization. The patient will take his or her
      baseline hydrocortisone regimen during one hospitalization and a new regimen consisting of a
      single daily nocturnal dose of Dexamethasone during the second hospitalization.
    

Intervention name(s): dexamethasone; Hydrocortisone
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone will be given at a dose that equals 1/50 of the total daily hydrocortisone dose of the patient. It will be given in solution form at 10 PM for 3 days.; Subjects were given their baseline hydrocortisone regimen which was three times daily for 4 of the subjects and twice daily for one subject. Doses were given at 8 AM, 2 PM, and 8 PM. The 2 PM time point was skipped for the subject who received hydrocortisone twice daily. Doses ranged from 6.9 to 18.5 milligrams per meter squared per day and were based on each individual's baseline regimen.
Other intervention name(s): Decadron
Intervention MeSH terms: Dexamethasone; Hydrocortisone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of
      pyrimethamine and metformin IR after oral administration in healthy male volunteers.
    


Intervention name(s): Metformin and Pyrimethamine
Intervention type(s): Drug
Other intervention name(s): Diabex; Daraprim
Intervention MeSH terms: Metformin; Pyrimethamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metformin; Pyrimethamine; Drug interaction
Permissive Hypercapnia and Brain Development in Premature Infants
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      In the US, every year approximately 30,000 infants are born very prematurely, with birth
      weight less than 1000 grams. These infants usually require ventilators to help them breath
      normally during the first few weeks of life. Although the ventilator is lifesaving, it can
      also injure the very fragile lungs of these infants. Thus, a ventilation strategy, called
      permissive hypercapnia (high carbon dioxide), is widely used to prevent lung injury.
      Importantly, there is new research showing that high carbon dioxide may cause brain injury.
      In our proposed research, we will use magnetic resonance imaging methods to evaluate the
      brain in 40 very premature infants at term-equivalent age (Half of them had permissive
      hypercapnia ventilation, the other half did not) to see if permissive hypercapnia has adverse
      effect on brain development.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Premature infants with birth weight 401-1000 g (gestational age < 30 weeks)