bioihbjkbjnl/mcl2 huggingface dataset:
Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain
Condition: Lumbar Facet Joint Pain; Lumbar Medial Branch Neurotomy
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      Prospective study to analyse pain reduction with two types of canulae and two types of
      placements for lumbar medial branch radiofrequency denervation.
    

Detailed description: 
      Patients who suffer from lumbar zygapophyseal joint pain often receive radiofrequency medial
      branch denervation as treatment. Many types if canulae exist, and many types of placing them
      in relation to the Medial Branch nerves (MB). The EARL study tries to compare the analgesic
      effect of thin canulae (22 gauge) placed perpendicular to MB to thicker canulae (18 gauge)
      placed parallel to MB.
    

Intervention name(s): PAIN REDUCTION ON VAS/NRS
Intervention type(s): Other
Intervention description(s): Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective comparative study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lumbar facet joint pain; Lumbar Medial Branch Neurotomy; Chronic Low Back Pain
Efficacy, Safety and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Patients With Active, Moderate-to-severe Crohn's Disease.
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a proof of concept, multi-center, randomized, double-blind, placebo-controlled,
      parallel-group phase 2 dose-ranging study of BI 655066/ABBV-066 (risankizumab), an IL-23 p19
      antagonist monoclonal antibody, in patients with moderately to severely active Crohn's
      disease.
    


Intervention name(s): risankizumab IV; risankizumab SC; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): risankizumab administered by IV infusion; risankizumab administered by SC injection; Placebo for risankizumab administered by IV infusion
Other intervention name(s): BI 655066; ABBV-066; BI 655066; ABBV-066
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ABBV-066; BI 655066; risankizumab
Oxidative Stress as an Acute Exercise-induced Mechanism of Stem and Progenitor Cell Mobilization
Condition: Healthy
Study type: Interventional

Summary: 
      It is already known from literature that exercise mobilizes stem and progenitor cells into
      the peripheral blood. However, the exact mechanisms thereof remain to be fully elucidated.

      The investigators hypothesize that exercise-induced oxidative stress could be at least one of
      the responsible mechanisms and therefore want to study the exercise-induced stem and
      progenitor cell mobilization in a group of healthy young men when they exercise with,
      compared to when they exercise without antioxidative supplementation.

      The primary outcome is numbers of stem and progenitor cells in the peripheral blood after an
      acute bout of exercise. As a secondary outcome, numbers of apoptotic mature and immature
      cells in the blood will be analysed.
    


Intervention name(s): Antioxidative supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Each participant conducts two identical cycling tests, first without and a week later with antioxidative supplementation
Intervention model: Single Group Assignment
Intervention model description: Each participant enrolled in the study will be part of the supplementation and control condition group in a non-randomized order
Masking: None (Open Label)
Primary purpose: Basic Science
Escitalopram for the Treatment of Self-Injurious Skin Picking
Condition: Impulse Control Disorders
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effectiveness of escitalopram in treating
      self-injurious skin picking.
    

Detailed description: 
      Purpose: Self-injurious skin picking is a problem documented to occur in 2 % of dermatology
      patients (Gupta, Gupta and Haberman, 1986) , and approximately 4% of the general population
      (Keuthen et al., 2000). It is widely under recognized, with medical sequelae that can include
      scarring, infections, lesions, and potentially life-threatening outcomes (O'Sullivan et al.,
      1999). In a prior study, fluoxetine was shown to be superior to placebo in treating
      self-injurious skin picking in a modest-sized double blind trial (Simeon et al., 1997).
      Similarly, open-label trials of other SSRIs, including sertraline (Kalivas, Kalivas and
      Gilman, 1996) and fluvoxamine (Arnold et al., 1999) resulted in reductions in skin-picking
      behavior. Escitalopram is a new SSRI that may have superior efficacy for the treatment of
      major depression and fewer side effects than other SSRIs. This study aims to assess the
      efficacy of escitalopram in patients who suffer from self-injurious skin-picking.

      Comparisons: Subjects' initial scores on the CGI, HAM-D, SPTS, SPS, SPIS, BDI, BAI, QLESQ, &
      BDDQ will be compared to subjects' final scores.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin Picking; Escitalopram; Lexapro; Body Focused Repetitive Behaviors; Obsessive Compulsive Spectrum Disorders
Recovery Therapy Trial
Condition: Schizophrenia; Psychotic Disorders; Mood Disorders
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders; Mood Disorders
Study type: Interventional

Summary: 
      This project will systematically apply a specialist version of Cognitive Behaviour Therapy
      (CBT), known as Recovery Therapy, to a random sample of patients with psychotic disorders.
      Previously, the therapy has been developed and efficacy established, but the extent of
      applicability to (unselected) mental health service patients is unknown. The main aim is to
      establish the extent to which this therapy is acceptable and effective for mental health
      service clients. A secondary aim is to develop guidelines for the conduct of such therapy in
      public mental health settings.
    


Intervention name(s): Recovery Therapy (Cognitive Behaviour Therapy for psychosis)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Therapy; Psychotic Disorders; Treatment Outcome
GLP1R Polymorphisms and Response to GLP1
Condition: Diabetes
Study type: Interventional

Summary: 
      Glucagon-like Peptide-1 (GLP-1) is an important incretin hormone which acts as a powerful
      insulin secretagogue. Defects in GLP-1 synthesis and secretion are thought to be part of the
      pathogenesis of type 2 diabetes. Furthermore GLP-1 based therapy is an important part of the
      therapeutic armamentarium for the treatment of type 2 diabetes. The GLP-1 receptor (GLP1R) is
      the principal site of action of GLP-1 and GLP-1 receptor agonists like exenatide and
      liraglutide. The gene coding for this receptor, GLP1R, is highly polymorphic and contains
      numerous non-synonymous Single Nucleotide Polymorphisms (nsSNPs) which could potentially
      alter response to endogenous or exogenous GLP-1 or GLP-1R agonists. Indeed there is some in
      vitro data to support this concept. We propose to utilize a hyperglycemic clamp to test the
      insulin secretory response to infused GLP-1 in healthy volunteers to determine the effect of
      genetic variation in GLP1R on response to GLP-1.
    


Intervention name(s): GLP-1
Intervention type(s): Drug
Intervention description(s): GLP-1 infused at 0.75 pmol/kg/min from 121-180 minutes, GLP-1 infused at 1.55 pmol/kg/min from 181-240 minutes,
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: GLP-1; Insulin Secretion
Helminth-induced Immunomodulation Therapy (HINT) in Relapsing-remitting Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis of this study is that helminth-induced immunomodulation therapy (HINT) will be
      safe and effective when administered orally in patients with relapsing-remitting multiple
      sclerosis (RRMS).
    

Detailed description: 
      Phase 1 of the HINT trial was completed with enrollment of 5 subjects. HINT Phase 2 is now
      closed to enrollment of 15 subjects. Recruitment sites are the UW-Madison and the Marshfield
      Clinic.
    

Intervention name(s): Helminth ova
Intervention type(s): Biological
Intervention description(s): 2500 ova per dose (liquid form)
Other intervention name(s): Therapy with Helminths
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
L-Arginine Metabolism in Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Essential hypertension is characterized by impaired endothelial function. Data derived from
      normotensive subjects with a genetic predisposition to arterial hypertension suggest that
      endothelial dysfunction is a cause rather than a consequence of the condition. Given that, in
      normotensive offspring of hypertensive parents, impaired endothelium dependent vasodilation
      can be restored by supplementation of the nitric oxide (NO) precursor L-arginine, a defect in
      the L-arginine/NO pathway can be postulated. The investigators at the University of
      Erlangen-Nuremberg, hypothesize that impaired endothelial function in essential hypertension
      is associated with alterations in L-arginine metabolism and transport. This study will
      determine whether metabolism and transport of L-arginine are altered in patients with
      essential hypertension and whether these potential alterations can be targeted
      therapeutically.
    


Intervention name(s): L-Arginine
Intervention type(s): Drug
Intervention description(s): oral administration of L-arginine for 4 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Essential hypertension
Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional

Summary: 
      Percutaneous tibial nerve stimulation is introduced as regular treatment option for fecal
      urge continence at the Cantonal Hospital St. Gallen. During this introduction phase
      efficiency und adverse events will be monitored in this observational study.
    

Detailed description: 
      Before treatment patients will have a proctological exam, a proctoscopy, endosonography and
      anorectal manometry. Incontinence scores (Wexner, Vaizey, Hanley) and quality of life scores
      (FIQL, VAS) will be recorded.

      Treatment consists of 4 phases with decreasing frequency of percutaneous tibial nerve
      stimulations (pTNS).

      During phase 1 weekly stimulations of 30 mins are applied for 12 weeks. After 6 and 12 weeks
      incontinence scores are recorded. Additionally after the end of phase 1 quality of life is
      measured and an anorectal manometry is preformed.

      Phase 2 lasts for 8 weeks, with 2-3 stimulations/month Phase 3 lasts for 8 weeks, with
      stimulations every 3 weeks Phase 4 consists of one stimulation in one month.

      After phase 4 incontinence scores und quality of life are measured.
    

Intervention name(s): Percutaneous tibial nerve stimulation (pTNS)
Intervention type(s): Procedure
Intervention description(s): A 34 gauge needle in placed close to the tibial nerve about 2-3 cm above the ankle. A self-adhesive surface electrode is placed on the skin. Needle and surface electrode are connected to an electric stimulator and the stimulating current (0 - 10 mA) is increased in 20 steps. When the patient feels a tingling sensation in the foot, stimulating current is set back for one step and the treatment is started (30 min stimulation).
Other intervention name(s): pTNS; peripheral tibial nerve stimulation; peripheral neuromodulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fecal Incontinence; Fecal Urge Incontinence; Percutaneous tibial nerve stimulation
A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, open-label study will evaluate the effect of food, and the effect of
      omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be
      assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of
      danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of
      omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.
    


Intervention name(s): danoprevir; omeprazole; ranitidine; ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral doses of danoprevir; oral doses of omeprazole; oral dose of ranitidine; oral doses of ritonavir
Intervention MeSH terms: Ritonavir; Omeprazole; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the effect of LCQ when added to metformin.
    


Intervention name(s): LCQ908A; LCQ908A; LCQ908A; LCQ908A; LCQ908A; Placebo; Sitagliptin; metformin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes
Remineralization Effect of Fluoride Varnishes on Permanent Molars
Condition: Remineralization
Study type: Interventional

Summary: 
      The aim of this study was to evaluate and compare the efficacy of NaF, NaF with TCP, NaF with
      CPP-ACP, and NaF with CXP varnishes on newly erupted first permanent molar teeth. The study
      was carried out in 40 healthy, high caries risk children (DMFS >8), aged six to seven years
      with newly erupted permanent first molars who referred to the Pediatric Dentistry Clinic of
      Kırıkkale University Faculty of Dentistry, Kırıkkale, Turkey. A total of 140 teeth were
      divided randomly into four groups and the varnishes were applied to the determined teeth at
      baseline, one and three months. The same varnish was used, if there is more than one first
      molar to be applied of the same patient. The groups were comprised as follows:

      Group 1: Duraphat Varnish containing 5% NaF (Colgate-Palmolive, NSW, Australia) (n = 35),
      Group 2: Clinpro™ White Varnish containing 5% NaF with TCP (3M ESPE, MN, USA) (n = 35), Group
      3: Embrace ™ Varnish containing 5% NaF with CXP (Pulpdent, MA, USA) (n = 35), Group 4: MI
      Varnish containing 5% NaF with CPP-ACP (GC, Tokyo, Japan) (n = 35). All dental treatments of
      the patients were completed before the varnish application and oral hygiene instructions were
      given to all children at the start of the study.

      Patients were called for follow up appointments at 1, 3 and 6 months, and in the follow-up
      period DIAGNOdent device (laser fluorescence scanning) was used to monitor mineralization
      changes. LF measurements were made at baseline (T0), after one month (T1) three months (T2)
      and six months (T3). Within and between group comparisons were analysed statistically.
    


Intervention name(s): Sodium Fluoride; Tricalcium Phosphate; Xylitol-coated calcium and phosphate; Casein phosphopeptide amorphous calcium phosphate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sodium Fluoride varnish was applied to the targeted teeth at baseline, one and three months.; Varnish with Tricalcium Phosphate was applied to the targeted teeth at baseline, one and three months.; Varnish with Xylitol-coated calcium and phosphate was applied to the targeted teeth at baseline, one and three months.; Varnish with Casein phosphopeptide amorphous calcium phosphate was applied to the targeted teeth at baseline, one and three months.
Intervention MeSH terms: Calcium, Dietary; Listerine; Calcium; Fluorides; Sodium Fluoride; Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1 study in healthy volunteers (female and male) to evaluate through SAD and MAD, the
      safety, PK, PD and immunogenicity of ARGX-113 administered intravenously.
    

Detailed description: 
      The phase 1 in healthy volunteers include:

      SAD with 5 doses of test product and placebo

      MAD with 2 doses and two dosing intervals of the test product and placebo

      The safety, pharmacokinetics, pharmacodynamics and immunogenicity of the test product are
      evaluated.
    

Intervention name(s): ARGX-113; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: SAD MAD
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Condition: Meningococcal B Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the immunogenicity, safety and tolerability of a
      new vaccine that might prevent meningococcal B disease. The study will be conducted in
      healthy toddlers aged between 12 and 24 months.
    


Intervention name(s): rLP2086 vaccine; Pediatric HAV vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 60 mcg or 120mcg at 0, 2 and 6 months; 0.5-mL dose at months 0 and 6. Normal saline at month 2.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Phase 2 Immunogenicity; Safety; Tolerability Study; rLP2086 Vaccine; Healthy Toddlers; Neisseria meningitidis; Duration of Immunogenicity
The Effect of Low-Intensity Resistance Exercise Training
Condition: Delayed Onset Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      It was to compare the effect of low-load resistance training with blood flow restriction
      (LL-BFR) and high-intensity resistance training (HI-RT) on muscle strength, endurance and
      volume, functional performance, and delayed onset muscle soreness (DOMS).

      The study included 13 young women. It is a controlled study designed for individuals to
      perform two different exercise protocols unilaterally. The persons were randomly allocated
      into two groups as LI- BFR (Group I, n = 13) and HI-RT (Group II, n = 13). Both groups
      received training for 6 weeks and 3 days a week. Blood flow restriction was performed only in
      group I.
    

Detailed description: 
      Both sides triceps muscle thickness, triceps and biceps strength and endurance, functional
      performances (upper extremity Y balance test (UQYBT)), delayed-onset muscle soreness (DOMS)
      were evaluated before and after training.
    

Intervention name(s): Low Intensity Exercises with Blood Flow Restriction; High Intensity Resistant Exercise
Intervention type(s): Other; Other
Intervention description(s): In the exercise protocol, people exercised resistance between 20% and 30% of 1 MaxRepetition with free weight. In addition, blood flow was restricted in 70% of the arterial occlusion pressure of the individual with the help of a cuff during exercise.; People included in the study did resistance exercise with free weight at 70-80% of 1 MT.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Self Controlled Randomised Trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: muscle hypertrophy; triceps brachii; muscle strength