bioihbjkbjnl/mcl2 huggingface dataset:
Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4)
Condition: Somatisation Disorder; Somatoform Disorders
MeSH terms: Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in
      patients with long lasting health problems with no known medical explanation, defined as
      multi-organ Bodily distress syndrome (BDS). ACT treatment is given as two different types of
      treatment, a 9-session group therapy and a 1-day workshop followed by an individual
      consultation, and both are compared to standard treatment, which is one single advisory
      consultation. The study includes 180 patients.
    

Detailed description: 
      The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in
      patients with multi-organ Bodily distress syndrome (BDS). BDS is a unifying diagnosis that
      encompasses a group of closely related conditions such as somatization disorder,
      fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The project consists of
      a three-armed randomized controlled trial of ACT treatment given as a supplement to standard
      treatment as either 9-session group therapy or as a 1-day workshop followed by an individual
      consultation, compared to standard treatment, which is one single advisory consultation.

      Primary outcome is patient-rated improvement measured by Clinical Global Improvement Scale
      (CGI-I). Secondary outcome is functional level (physical, mental and social) measured by the
      SF-36 Physical Component Summary (PCS). The study includes 180 participants.
    

Intervention name(s): Acceptance and Commitment Therapy
Intervention type(s): Behavioral
Intervention description(s): Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bodily Distress Syndrome; Medically unexplained symptoms; Functional somatic symptoms; Functional somatic syndromes; Treatment; Acceptance and Commitment Therapy
Safety, Tolerability, and Pharmacokinetics of Single Dose TenoMiR as a Treatment for Tennis Elbow
Condition: Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is testing a drug called TenoMiR that is being developed for the treatment of
      tennis elbow (lateral epicondylitis). The study drug is a new compound that works by
      improving the quality of the collagen which helps repair damage to the elbow. The study drug
      is being developed in the hope of providing a more reliable treatment than those currently
      available and can be given at the time of first diagnosis, so that recovery can begin as soon
      as possible.
    

Detailed description: 
      TenoMiR a chemically synthesised mimic of microRNA-29a (miR29a) which has improved stability,
      activity and cellular uptake while being non-immunogenic, has been created to restore miR29a
      levels back to pre-injury levels.

      TenoMiR is unique in directly targeting the key changes in collagen production associated
      with tendinopathy. Unlike other therapies, TenoMiR has a well-defined mode-of-action that is
      supported by a wealth of scientific data. Moreover, treatment with TenoMiR does not require
      invasive biopsies and can be delivered at the point of initial diagnosis initiating recovery
      at the very earliest time.
    

Intervention name(s): TenoMiR (Low Dose); TenoMiR (Medium Dose); TenoMiR (High Dose); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Mimic of miR29a; Mimic of miR29a; Mimic of miR29a; 0.9% saline
Other intervention name(s): CWT-001; CWT-001; CWT-001
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Controlled, Randomised, Double Blind, Single Centre Trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fall Prevention Study Among Seniors in Bomlo
Condition: Fall
Study type: Interventional

Summary: 
      Recruiting seniors age 65-85 at risk of falling in Bomlo municipality. Clinical tests
      performed by physiotherapist. If risk of falling is confirmed, participants will be
      randomized to either intervention group with fall-preventing exercize program or to a control
      group. Follow-up over 5 years.
    

Detailed description: 
      Participants randomized to either exercise group or control group. Tests for balance and
      strength performed by physiotherapist at inclusion, and after three and six months and one
      year for both groups. Further follow-up and further inclusion of participants had to be
      terminated due to the pandemic in Mach 2020, when group activities were no longer allowed.
    

Intervention name(s): Physical exercize
Intervention type(s): Behavioral
Intervention description(s): 10 weeks group exercize followed by community-based voluntary exercize
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: None (Open Label)
Primary purpose: Prevention
Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects
Condition: Intra-subject Variability of Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives:

      To evaluate the intra-subject variability of the pharmacokinetics (PK) of single oral capsule
      doses of 20 mg lomitapide.
    

Detailed description: 
      This study will be a single centre, open-label study. It will comprise of 2 single oral doses
      with at least a 14-day washout between doses. Following the first dose subjects will be
      discharged from the unit for the remainder of the washout period. Subjects will be
      re-admitted to the unit on Day -1 (Period 2) and following an overnight fast they will be
      administered the second dose on Day 1 (Period 2). Subjects will be discharged from the unit
      following the 168 h PK blood draw.
    

Intervention name(s): lomitapide
Intervention type(s): Drug
Intervention description(s): 20 mg dose
Other intervention name(s): Juxtapid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Correction of Anterior Open Bite With Skeletally Anchored Extrusion Arch
Condition: Anterior Openbite Malocclusion
MeSH terms: Malocclusion; Open Bite
Study type: Interventional

Summary: 
      This study will aim to evaluate the effect of skeletally anchored extrusion arch on the
      dentofacial structures in patients with anterior open bite (AOB).
    

Detailed description: 
      This study will be a prospective clinical study. All the patients will be treated with 0.022
      inch slot Roth metal brackets. Orthodontic bands will be cemented to the maxillary first
      molars. Both maxillary and mandibular teeth, will be sectionally leveled and aligned with
      superelastic Ni-Ti archwires.

      A buccal stiff sectional wire from the first molar to the canine will be added for anchorage
      reinforcement. Extrusion will be done by inverting a 0.017 × 0.025-inch Connecticut intrusion
      archwire and inserting it in the molar auxiliary tubes upside-down and miniscrew will be tied
      to the molar bands to act as additional indirect anchorage.
    

Intervention name(s): extrusion of the anterior teeth
Intervention type(s): Procedure
Intervention description(s): sectional leveling and alignment of the teeth, then using of the extrusion arch as an overlay wire to treat the open bite
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of BI 653048 H3PO4 Oral Drinking Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  Investigation of safety and tolerability of BI 653048 H3PO4 following the administration
           of single rising doses of an aqueous solution in healthy male subjects

        -  Pharmacokinetic and pharmacodynamic characteristics of BI 653048, including the
           investigation of dose proportionality

        -  Investigation of relative bioavailability of capsules versus aqueous solution
    


Intervention name(s): BI 653048 H3PO4 solution; BI 653048 H3PO4 low dose capsule; BI 653048 H3PO4 high dose capsule; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Respiratory Proprioceptive Neuromuscular Facilitation Technique in Chronic Pulmonary Obstructive Disease Patients.
Condition: COPD
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of PNF technique combined with aerobic
      exercises among COPD patients in a clinical setting. Previous literature has evaluated this
      technique in ventilated patients but in clinical setting specifically in Pakistan, this
      invention therapy has not been implied in COPD patients.
    

Detailed description: 
      Chronic Obstructive Pulmonary Disorder manifested as breathlessness, respiratory difficulties
      and persistent cough is one of the biggest causes of mortality around the world. 2.1% of
      Pakistani population has COPD. Proprioceptive neuromuscular facilitation is used as
      management technique in which muscle stretching promotes chest wall mobility and restores
      regular breathing rhythm. In previous studies, PNF technique combined with aerobic exercises
      has been utilized to improve Pulmonary functions in COPD patients. But the sample size of
      these studies was small and participants were ventilated patients, hence not targeting the
      diaphragm. Our study shall evaluate the impact of PNF technique combined with aerobic
      training on the Pulmonary function of COPD patients in the clinical setting.
    

Intervention name(s): Conventional; PNF
Intervention type(s): Other; Other
Intervention description(s): The participants of controlled group will be given the treatment protocol after baseline measurements controlled breathing techniques (3session per week 10mins for 6 weeks) & Aerobic exercise(3 session per week for 6 weeks) with 10sec hold into 10reps.outcome measures will be recorded through a digital spirometer & measurement of 6MWT & chest expansion.; The participants of experimental group will be given the Intervention protocol after baseline measurements. Additionally these 30 participants will also receive PNF technique exercises consisting of Thoracic Vertebral pressure, Anterior Basal stretch, and Intercostal stretch for 20-25 minutes in 3 sessions per week, and outcomes Measures will be recorded through a digital spirometer and measurements of 6 minutes walk test and chest Expansion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Peak Expiratory Flow Rate (PEFR); Pulmonary function; PNF techniques
Bioequivalence Study Comparing A New 80 Mg Atorvastatin Tablet To A 80 Mg Atorvastatin Commercial Tablet
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial
      atorvastatin tablets (Lipitor®).
    


Intervention name(s): Atorvastatin; Atorvastatin
Intervention type(s): Drug; Genetic
Intervention description(s): A single 80 mg dose of marketed 80 mg atorvastatin tablets; A single dose of new formulation of 80 mg atorvastatin tablets
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioqeuivalence, Pharmacokinetics, Atorvastatin
Comparison of Parker Flex-Tip Endotracheal Tube to Standard Endotracheal Tube
Condition: Endotracheal Intubation
Study type: Interventional

Summary: 
      Patients presenting for elective surgery requiring tracheal intubation will be randomized to
      one of two different endotracheal tubes (ETT).
    

Detailed description: 
      The post-operative complication of a sore throat after endotracheal intubation is
      unfortunately common, with estimates ranging from 15-50%. Most estimates are in the order of
      35-45%.(McHardy 1999, Higgins 2002) There is evidence that many patients do not report sore
      throat and/or vocal changes unless directly asked because surgical pain is more prominent and
      many patients may be unaware that intubation completed as part of the general anesthetic.
      (Harding 1987)

      The Parker FlexTip® endotracheal tube (ETT) is formulated with a softer plastic at the distal
      tip as well as a laterally curved profile to reduce trauma during ETT advancement. (Makino
      2003) This ETT has been shown to be faster during fibreoptic intubation, but complication of
      sore throat was not examined. (Kristensen 2003)

      Our previous study (Jones 2007) demonstrated that modification of anesthetic techniques could
      reduce the incidence of post-operative sore throat in patients undergoing naso-tracheal
      intubation. We will now study the Parker Flex-Tip ETT to see if its use can also reduce the
      incidence of sore throat in patients undergoing oro-tracheal intubation.
    

Intervention name(s): FlexTip ETT (Parker FlexTip/GlideScope FlexTip); Control - standard flexible ETT (Mallinckrodt)
Intervention type(s): Device; Device
Intervention description(s): FlexTip ETT used for endotracheal intubation; Control - standard flexible ETT
Mallinckrodt Hi-Lo cuffed tracheal tube, Catalog # 86114, Mallinckrodt, ST. Louis, MO, 63134
Other intervention name(s): Parker FlexTip; GlideScope FlexTip
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: endotracheal tube
A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease
Condition: Huntingtons Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042)
      compared with placebo in participants with manifest Huntington's disease (HD)
    


Intervention name(s): RO7234292; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intrathecal injection; Intrathecal injection
Other intervention name(s): Tominersen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HD, RG6042, intrathecal, ASO, antisense oligonucleotide
Interventions of Smoking Cessation During Pregnancy
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this clinical trial is to test whether offering pregnant smokers a high intensity
      intervention for smoking cessation increases the rate of smoking cessation at the third
      trimester of pregnancy, compared to low intensity intervention for smoking cessation that is
      the usual care, control condition.
    

Detailed description: 
      This is a randomized controlled trial that compares the efficacy of a proactive
      pregnancy-tailored high intensity intervention for smoking cessation, with a usual care low
      intensity intervention, that is the control condition.

      Intervention group participants will receive a high intensity intervention, which includes:
      30 minutes of cognitive-behavioural intervention delivered by a trained health care
      professional through out the first 24 weeks of gestation and a self-help manual especially
      tailored for smoking cessation during pregnancy. Control group participants will receive 5
      minutes of low intensity intervention.

      Participants' smoking status will be biochemically validated with urine cotinine and nicotine
      both at the baseline and at the 32nd week of gestation, expired carbon monoxide (CO) will be
      measured only at the baseline. After childbirth the infants' birth weight, the premature
      birth and any other complications in pregnancy and childbirth will be recorded. No medication
      is going to be used.
    

Intervention name(s): Low intensity intervention; Higher intensity intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.; Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.
Other intervention name(s): Experimental group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Pregnancy; Smoking cessation; Cognitive-Behavioural interventions
APEX Study: Effects of Allopurinol on Coronary and Peripheral Endothelial Function in Patients With Cardiac Syndrome X
Condition: Syndrome X
MeSH terms: Microvascular Angina; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Morbidity of patients with cardiac syndrome X (typical anginal-like chest pain and normal
      coronary arteriograms) is high with continuing episodes of chest pain and frequent hospital
      readmissions. Management of this syndrome represents a major challenge to the treating
      physician. Evidence for the important role of endothelial dysfunction and oxidative stress in
      the pathogenesis of cardiac syndrome X has been recently strengthened by the finding that
      basal superoxide production predicts future cardiovascular events in this patient group. The
      investigators have recently shown that high-dose allopurinol abolishes vascular oxidative
      stress and improves endothelial function in patients with chronic heart failure, which makes
      allopurinol a prime candidate to reduce oxidative stress in syndrome X. The hypothesis to be
      tested in this study is whether allopurinol offers dual benefits of improving vascular
      function and reducing myocardial ischaemia in patients with cardiac syndrome X. This study
      may discover a novel way to improve endothelial function and anginal symptoms which are often
      debilitating in these patients.
    


Intervention name(s): allopurinol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): allopurinol 300mg twice a day; placebo
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cardiac syndrome X; endothelial function
Pharmacogenetics of Naltrexone for Stimulant Abuse
Condition: Substance Use Disorders; Methamphetamine Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This investigation will be the first study assessing genetic modulation of naltrexone's NTX
      effects upon the abuse liability of a stimulant drug (methamphetamine). The study team will
      assess the ability of oral NTX to block the reinforcing and positive subjective effects of
      intranasal (IN) methamphetamine (30mg/70kg). This investigation could identify an important
      Gene x Pharmacological interaction, contributing to the personalization of stimulant abuse
      pharmacotherapy.
    

Detailed description: 
      A recent meta-analysis concluded that the OPRM1 A118G SNP (rs1799971) significantly moderates
      the treatment efficacy of Naltrexone (NTX) in treating alcohol abuse, increasing the
      treatment efficacy by over 2-fold among G-allele carriers (AG/GG). The proposed application
      would be the first to investigate the moderating effect of this genotype in the efficacy of
      NTX to treat stimulant abuse. More specifically, the study team proposes to investigate the
      interaction between NTX and intranasal (IN) methamphetamine (30mg/70kg). Participants who
      meet DSM criteria for mild-to-severe stimulant use disorder (N=up to 70) will complete 4
      testing sessions where drug effects are tested following pretreatment with NTX (0, 50 mg).
      Naltrexone pretreatment effects upon the abuse liability of IN methamphetamine will be
      assessed using self-report measurements of positive subjective effects and drug
      self-administration. Medication effects on these validated predictors of abuse potential will
      be compared between A118G A allele homozygotes (AA) and G-allele carriers (AG/GG; an
      anticipated 25% of the total sample), in order to assess genetic moderation of treatment
      outcome.
    

Intervention name(s): Intranasal Methamphetamine
Intervention type(s): Drug
Intervention description(s): Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will complete two testing sessions in which the effects of oral naltrexone (0 mg & 50 mg) will be tested in combination with intranasal methamphetamine. Participants will complete two testing sessions (naltrexone 0 mg + Methamphetamine & naltrexone 50 mg + methamphetamine), in randomized order.
Masking: Single (Participant)
Primary purpose: Basic Science