bioihbjkbjnl/mcl2 huggingface dataset:
Initial Dosing of BI 655130 in Palmoplantar Pustulosis Patients
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to investigate the safety and efficacy of BI 655130 in
      patients with PPP following multiple intravenous administrations compared to placebo.
    


Intervention name(s): Spesolimab (low dose); Placebo; Spesolimab (high dose)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 12 weeks treatment; 12 weeks treatment; 12 weeks treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.
Condition: Partial Edentulism in the Maxilla or in the Mandible
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to
      implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate
      up to five years after implant loading. The hypothesis is that there will be no clinically
      relevant differences in marginal bone level alterations one year after functional loading.
    


Intervention name(s): OsseoSpeed EV; OsseoSpeed TX
Intervention type(s): Device; Device
Intervention description(s): OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm; OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Internet-based ERITA Added to TAU in Young People With Non-Suicidal Self-Injury (TEENS) Feasibility Trial
Condition: Non-suicidal Self-injury
MeSH terms: Wounds and Injuries; Self-Injurious Behavior
Study type: Interventional

Summary: 
      There has been a significant increase in non-suicidal self-injury the last decades especially
      among young people and treatment initiative are sparse. We aim to assess the feasibility of
      methods, procedures, and safety of internet-based Emotion Regulation Individual Therapy for
      Adolescents (ERITA) as add on to treatment as usual (TAU) in 13-17-year-old patients with
      non-suicidal self-injury referred to psychiatric services.
    

Detailed description: 
      Non-suicidal self-injury has disseminated almost epidemically through the last decades in
      young persons. There is no evidence of any experimental treatment for non-suicidal
      self-injury in adolescents, superior to treatment as usual. Patients with stigmatizing
      illness such as non-suicidal self-injury may find internet-based interventions more
      acceptable. The study is a feasibility trial, with a randomization procedure in a parallel
      group design. Patients will be recruited from Child- and Adolescent Mental Health Services
      (age 13 to 17 years). The experimental intervention is internet-based, and therapist guided;
      ERITA consists of online Emotion Regulation Individual Therapy for Adolescents (ERITA) as
      add-on to treatment as usual. Treatment as usual is provided by multidisciplinary teams in
      nine outpatient clinics within Child and Adolescent Mental Health Services in the Capital
      Region of Denmark. Feasibility of recruitment and trial procedures will be monitored as well
      as explorative clinical outcomes.
    

Intervention name(s): Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)
Intervention type(s): Behavioral
Intervention description(s): Please see description of experimental arm (arm one)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, feasibility trial including a randomization procedure in a parallel group design with blinded outcome assessment.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-suicidal Self-injury; Internet-based intervention
Ultrasound Guided Anterior Quadratus Lumborum Block
Condition: Postoperative Pain; Ultrasound
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Percutaneous nephrolithotomy (PNL) is frequently used today for renal stones. percutaneous
      nephrolithotomy (PNL) procedure has become the treatment of choice for many patients with
      symptomatic renal stones . Patients undergoing PNL suffer from acute postoperative pain,
      despite a multimodal analgesic regime.

      This is a randomised controlled trial efficacy of the anterior Quadratus Lumborum Block (QLB)
      in terms of analgesic efficacy in patients who undergo percutaneous nephrolithotomy.
    

Detailed description: 
      Many analgesic procedures such as NSAID, opioid and regional anesthesia procedures are used
      as a part of multimodal analgesia for postoperative Percutaneous nephrolithotomy pain.

      In this study we will use the ultrasound -guided anterior Quadratus Lumborum Block . Local
      anesthesic will be injected between quadratus lumborum muscle and psoas muscle with
      ultrasound.Analgesic effect of this block will be detected by using morphine consumption and
      visual analogue scale .
    

Intervention name(s): Morphine Sulfate; Group P; Group A
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): patient-controlled analgesia (PCA) morphine; Group P:patient-controlled analgesia (PCA) morphine; Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 Bupivacaine
Other intervention name(s): Morphine; Bupivacaine
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective,randomized,single blind
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: quadratus lumborum block; pain; ultrasound; percutaneous nephrolithotomy
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of Two Controlled Release Pregabalin Tablets As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of two
      pregabalin controlled release tablets as compared to multiple doses of the pregabalin
      immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of two
      pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate
      release capsule and 3) evaluate the safety and tolerability of multiple doses of two
      pregabalin controlled release tablets as compared to multiple doses of the pregabalin
      immediate release capsule.
    

Detailed description: 
      Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of two
      pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate
      release capsule
    

Intervention name(s): Pregabalin controlled release, 165 mg; Pregabalin controlled release, 330 mg; Pregabalin immediate release, 150 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two tablets of 165 mg controlled release (administered concurrently) once daily for four days.; 330 mg controlled release tablet administered once daily for four days.; 150 mg immediate release capsules administered every 12 hours for four days
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregabalin; pharmacokinetics; bioavailability; bioequivalence
Human Laboratory Study Of Varenicline in Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to test the ways that a drug called varenicline helps smokers to
      quit smoking. Varenicline is also called Chantix® and is approved by the United States Food
      and Drug Administration (FDA) to help people quit smoking. We will test how varenicline works
      by having you quit smoking and complete tasks that assess how you think and feel. We predict
      that varenicline help reduce anxiety, improve attention and concentration, and reduce how
      satisfying cigarettes are.
    

Detailed description: 
      The purpose of this study is to understand the therapeutic mechanisms of varenicline, a novel
      nicotinic analogue, through focused measures of potential psychological and physiological
      mediators. Varenicline is an FDA-approved pharmacotherapy for smoking cessation that is
      believed to provide relief from craving and withdrawal through agonism and antagonism of some
      central nervous system nicotinic acetylcholinergic receptors. However, no controlled studies
      have established the physiological and psychological processes that mediate the efficacy of
      varenicline in humans. The main goal of the proposed pilot study is to evaluate and compare
      the effects of varenicline on subjective, cognitive, and physiological outcomes, using a
      randomized, placebo-controlled, double-blind between-groups design. The study will combine
      both brief clinical trial methodology with human laboratory approaches. A secondary goal is
      to validate the utility of the laboratory paradigms for the identification of future smoking
      cessation agents.
    

Intervention name(s): Placebo; Varenicline
Intervention type(s): Drug; Drug
Intervention description(s): Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).; Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
Other intervention name(s): Chantix; Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Tobacco; nicotine; smoking; varenicline; human laboratory study; stress tolerance; startle response; cognitive assessment; progressive ratio
Effect of Prone Position onV/Q Matching in Non-intubated Patients With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      A prospective physiologic study, in participants with COVID-19-related pneumonia requiring
      supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (HFNC)) less than 24
      hours. The investigators assessed the effect of prone position on ventilation inhomogeneity
      and ventilation/perfusion mismatch by electrical impedance tomography (EIT).
    

Detailed description: 
      Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the
      participant's chest at the fifth or sixth intercostal space and connected it to an EIT
      monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany).

      Baseline data were collected during supine position (timepoint SP1), including demographic
      and anthropometric data, a baseline arterial blood gas measurement, and ventilation
      parameters including type of supplemental oxygen, respiratory rate, fractional concentration
      of oxygen in inspired air (FiO2). The participants received instructions of end expiratory
      occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 5%
      NaCl solution was injected via the central venous catheter. Subsequently, each participant
      was helped into the prone position and data collection，end expiratory occlusion and 10% NaCl
      solution injection were preformed again after approximately 30 min (timepoint PP1). The
      participant was then encouraged to maintain the prone position for at least 3 h before being
      helped back into the supine position. Clinical data collection, end expiratory occlusion and
      injection of a bolus of 10 mL of 5% NaCl solution were repeated again 1 h after resupination
      (timepoint SP2).
    

Intervention name(s): prone position
Intervention type(s): Other
Intervention description(s): patient was helped into the prone position, patient received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 5% NaCl solution was injected via the central venous catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; prone position; ventilation and perfusion matching
Effect of GSK376501 on CYP450 Activity in Healthy Adult Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is meant to assess potential inhibitory effects of GSK376501 on CYP450 isoenzymes
      3A4, 2C8, 2C9. subjects will receive probe compounds and systemic levels of these substrates
      will be compared pre and post dosing of GSK376501.
    


Intervention name(s): GSK376501; Midazolam; Rosiglitazone; Flurbiprofen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK376501 oral tablet will be available with dosing strengths of 75 milligrams administered once daily. Biconvex, It will be a round, white film-coated tablets with both plain sides and no identifying markings.; Midazolam oral syrup will be available with a dose of 5 milligrams administered once daily. It will be a clear, red to purplish-red, cherry-flavored syrup.; Rosiglitazone oral tablet will be available with dosing strengths of 4 milligrams administered once daily. It will be a orange colored tablet debossed with SB on one side and 4 on the other.; Rosiglitazone oral tablet will be available with dosing strengths of 50 milligrams administered once daily. It will be a blue, oval, film coated tablet.
Intervention MeSH terms: Rosiglitazone; Flurbiprofen; Midazolam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects,; Cytochrome P450 isoenzymes,; Repeat Dose; GSK376501,
The Effect of Mindfulness-Based Practices and Deep Relaxation Exercises in Pregnant Women
Condition: Anxiety; Pregnancy Related
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Pregnancy is a transitional period during which important physical, biological and
      psychological changes are experienced for women, and the probability of encountering factors
      that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy
      is associated with negative birth outcomes and can be reduced with relaxation exercises.
      However, mindfulness-based approaches affect pregnancy outcomes positively. Data collected
      with the "Personal Description Form", and "The Pregnancy-related Anxiety
      Questionnaire-Revised 2".
    

Detailed description: 
      Pregnancy is a transitional period during which important physical, biological and
      psychological changes are experienced for women, and the probability of encountering factors
      that may cause stress, anxiety and low quality of life is high. Maternal stress in pregnancy
      is associated with negative birth outcomes and can be reduced with relaxation exercises.
      However, mindfulness-based approaches affect pregnancy outcomes positively. The aim of this
      study, which was conducted to determine the effects of mindfulness practices and deep
      relaxation exercises on the level of pregnancy-related anxiety, is to create intervention
      programs compatible with the prenatal period and to contribute to the improvement of
      pregnancy outcomes. First of all, a total of 111 pregnant women (37 mindfulness based stress
      reduction program, 37 deep relaxation exercises and 37 control) are planned to be included in
      the study. However, we recalculated the power analysis with a reference study after obtaining
      approval and before starting the study. With the calculation we made with the reference
      study, we determined our final sample number as 102 pregnant women (34 individuals for the
      mindfulness meditation group, 34 individuals for the deep relaxation exercises group, and 34
      individuals for the control group). Data collected with the "Personal Description Form", and
      "The Pregnancy-related Anxiety Questionnaire-Revised 2". Mindfulness and deep relaxation
      practices was applied by midwives who are experts in their fields who are certified in these
      fields.
    

Intervention name(s): Mindfullness Based Stress Reduction (MBSR) intervention; Deep Relaxation Exercises intervention; No Intervention
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Mindfullness Based Stress Reduction (MBSR) intervention: Monitoring anxiety levels with mindfulness program; Deep Relaxation Exercises intervention: Monitoring anxiety levels with deep Relaxation Exercises intervention; No Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Postural Instability in Progressive Supranuclear Palsy
Condition: Progressive Supranuclear Palsy; Parkinson's Disease
MeSH terms: Parkinson Disease; Paralysis; Supranuclear Palsy, Progressive
Study type: Observational

Summary: 
      The purpose of this study is to better understand why individuals with Progressive
      Supranuclear Palsy (PSP) fall. Understanding the mechanism of gait and balance dysfunction in
      individuals with PSP may provide us with important early diagnostic tools, allowing for
      earlier identification of mobility problems and to better evaluate medical therapies aimed at
      improving motor disability.

      The investigators will recruit 10 PSP, 10 PD and 10 healthy controls for the study. All
      subjects will be asked to come to the OHSU clinic at the Center for Health and Healing for an
      initial screening visit. They will meet with the primary investigator to conduct a brief
      interview and physical examination. In addition, they will be asked to answer questions
      regarding current and past medical illness, how often they fall and what kinds of medications
      they are on.

      Subjects who agree to participate will come to the Oregon Clinical and Translational Research
      Institute (OCTRI) at OHSU for balance testing. Subjects will be asked to stand or sit on a
      movable platform with eyes open or closed. Prior to standing on the platform, the
      investigators will place 6 small sensors on body which are held in place by velcro straps
      (one on each wrist, ankles, chest and lower back). The platform will then be moved (tilt or
      slide) while subjects try to keep their balance. During all of the balance tests described
      above, body movements will be recorded from the sensors on the subjects' body. This data is
      directly recorded by a computer and analyzed to help us gain better understanding of the
      subjects' posture and their ability to remain up right.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        OHSU Movement Disorders Clinic Volunteers from the community (Portland, Oregon and
        surrounding areas)
      
Keywords: Progressive Supranuclear Palsy; PSP; Falls; Gait; Balance; Parkinson's Disease; PD
Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the
      efficacy of a single dose of Autologous Protein Solution (APS) in patients with
      Osteoarthritis (OA) of the knee.
    

Detailed description: 
      A double-blind, multicenter, randomized, saline-controlled trial (RCT) that will evaluate the
      efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic
      osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with
      prior treatment.
    

Intervention name(s): nSTRIDE APS; Saline
Intervention type(s): Device; Device
Intervention description(s): single intra-articular injection; single intra-articular injection
Other intervention name(s): Autologous Protein Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autologous Protein Solution; APS; intra-articular injection; osteoarthritis
Effects of Therapeutic Tapping in Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Dysmenorrhea is more common among women of reproductive age, as it affects their quality of
      life and limit their daily activities and normal functioning. The estimates of dysmenorrhea
      from research conducted all around the world varied widely, from 20% to 90%. This study is
      planned to determine the effects of KT on clinical symptoms, QOL and academic performance of
      students with Primary dysmenorrhea.
    

Detailed description: 
      Literature suggested that kinesio tape technique, one of the effective physiotherapy
      technique, used for Primary dysmenorrhea, to stimulate muscle movements, assist weak muscles
      (fascia and soft tissue), reduce discomfort and muscle cramps, facilitate proprioceptive
      input, boost lymph and blood flow, and relieve pain. This will be a randomized controlled
      trial, with three groups.

      Participants in the experimental group will receive therapeutic tape on the sacral and
      suprapubic regions with the Star shape and ligament with general physical therapy session.
      Sham group (ST) group will receive sham taping with general physical therapy session.
      Participants in Control group (CG) will receive only general physical therapy session.

      All groups will be assessed at baseline, at 8th week and 12th week for clinical symptoms, QOL
      and academic performance.
    

Intervention name(s): KinesioTape; Sham Tape; General Physio session
Intervention type(s): Other; Other; Other
Intervention description(s): The kinesio tape technique, one of the physiotherapy techniques, is an elastic thin band, water-resistant, air-permeable framework to stimulate muscle movements, assist weak muscles (fascia and soft tissue), reduce discomfort and muscle cramps, facilitate proprioceptive input, boost lymph and blood flow, and relieve pain. Participants in the KT group will receive therapeutic tape on the sacral and suprapubic regions with the Star shape and ligament technique (From initial 4 h to 72 h of the menstruation cycle); This group will receive KT tapping without stretch on the sacral and suprapubic region.; General physical therapy session including Hot pack (3-5min) and General body stretching(stretching of neck & upper trapezius, arm & shoulder girdle, triceps brachii, teres major & minor, quadriceps muscle iliopsoas muscle, adductors muscle, hamstrings muscle) 30-45 sec each, for 7-10 min, (0-4 week) ,45-60sec each, for 10-15 min(4-8week), 15-20 min(8-12week) will be repeated 2 times/day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment