bioihbjkbjnl/mcl2 huggingface dataset:
SIMOX - Induction of Oxidative Stress
Condition: Oxidative Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to investigate if use of simvastatin is associated with the level
      of oxidative stress in humans. The association is examined by comparing changes in oxidative
      stress in a group treated with simvastatin with the change in a placebo group. The study is a
      randomized-based, double-blinded placebo-controlled study. Each treatment group consists of
      20 healthy male volunteers who consume simvastatin or placebo over 14 days. The induction of
      oxidative stress is measured by 8-oxoguanosine and 8- oxodeoxyguanosine, isolated from urine.
      A t-test will be performed to compare drug treatment with placebo. The results will be
      published.
    


Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 Simvastatin capsules of 20 mg every evening for 14 days; 2 placebo capsules every evening for 14 days
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Oxidative stress; Simvastatin
A Pharmacokinetic Study of an Experimental Paracetamol Formulation
Condition: Headache, Tension-Type
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 1

Summary: 
      This PK study is designed to show bioequivalence between the study treatments.
    


Intervention name(s): Experimental paracetamol; Paracetamol marketed formulation
Intervention type(s): Drug; Drug
Intervention description(s): experimental paracetamol with caffeine; marketed formulation containing caffeine
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Bioequivalence; Pharmacokinetics; Healthy volunteers; paracetamol; caffeine
Primary Ceramic-on-Ceramic Total Hip Replacement Versus Metal-on-Metal Hip Resurfacing in Young Active Patients
Condition: Indications for a Total Hip Prosthesis
Study type: Interventional

Summary: 
      Comparison of the functional result and speed of rehabilitation between two types of hip
      prostheses: primary ceramic-on-ceramic total hip replacement versus metal-on-metal hip
      resurfacing.
    


Intervention name(s): ceramic-on-ceramic total hip replacement versus metal-on-metal hip resurfacing
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair
Condition: Bicep Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The goal of this investigation is to determine if using BFR during postoperative therapy
      would lead to increased and expedited strength gains. Additionally, the investigators would
      like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration in
      the setting of bicep tendon tears, due to the altered tension-length relationship following
      surgery. The study will also look at patient reported outcomes metrics and pain scores to
      determine if BFR has a significant impact on the patient experience surrounding distal biceps
      tear and surgical repair
    


Intervention name(s): Blood Flow Restriction Therapy
Intervention type(s): Other
Intervention description(s): Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blood flow restriction; Rehabilitation; Physical therapy
ED Recovery Course Online RCT
Condition: Yoga-Based Recovery Course; Control
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether the Eat Breathe Thrive (EBT) Yoga for Eating
      Disorder Recovery online course is effective in supporting eating disorder recovery.
    

Detailed description: 
      We will conduct a block randomized controlled trial (RCT) comparing an intervention group and
      a waitlist control group. Participants in the intervention group will complete the Eat
      Breathe Thrive (EBT) Yoga for Eating Disorder Recovery online course. This course will be led
      by certified facilitators via Zoom and offered over the course of four weeks, comprising one
      two-hour session per week. The course will continue to recruit and enroll participants until
      sufficient power is reached for the study. At Pretest, Posttest 1, Posttest 2, and
      three-months Follow-Up, participants will complete a series of self-report measures (see
      point 12.3). Participants in the waitlist control group will only be engaged in the study
      assessment procedures. However, they will be given the opportunity to take part in the Yoga
      for Eating Disorder Recovery online course that was delivered to the intervention group, once
      Posttest 1 has been completed by both groups.
    

Intervention name(s): EBT yoga-based eating disorder course
Intervention type(s): Behavioral
Intervention description(s): Yoga for Eating Disorder Recovery online course. This course will be led by certified facilitators via Zoom and offered over the course of four weeks, comprising one two-hour session per week. The course will continue to recruit and enroll participants until sufficient power is reached for the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT- EBT Yoga-Based Course and Control group
Masking: None (Open Label)
Primary purpose: Supportive Care
Study on Adhesion Properties of Three Different Adhesives
Condition: Healthy
MeSH terms: Tissue Adhesions
Study type: Interventional

Summary: 
      This clinical investigation is a single centre, double blinded, case control study in healthy
      adult females. This study will be conducted in private rooms at Gentofte Hospital
      (Hjerte-medicinsk Forskning, post 835, Kildegårdsvej 28, 2900 Hellerup).

      The investigation centre will enroll 39 subjects including a 20% drop out within a four (4)
      months period. The subject will not be enrolled before approval of investigation protocol by
      the local ethics committee.

      The subjects need to meet the inclusion and exclusion criteria to be included in this
      clinical investigation. Each volunteer enrolled in the investigation can only participate
      once in a procedure. The testing period for each subject will be minimum 72 hours.

      The principal investigator's qualifications will be verified through his/her CV. The
      principal investigator is required to be a medical doctor with at least one year's experience
      in using similar medical adhesives (e.g. by being experienced in using electrodes where
      medical adhesives are included) and at least one year's experience with clinical research. In
      addition, the investigator must be trained in GCP before the study is initiated.

      If any subject withdraws from the study, they will not be replaced as drop-out rate is
      included in the sample size.

      Subjects must show up for two sessions, in the first session six adhesives will be placed
      below the subjects bra. The adhesives will be removed after minimum 72 hours at the second
      visit. While wearing the adhesives the subjects must keep the investigational area dry. 24,
      48 and 72 hours after placement of the adhesives, the subject is asked to completed a
      questionnaire.

      The eCRF must be completed for each subject that has signed the Informed consent form (ICF)
      and enrolled into this clinical investigation.
    


Intervention name(s): Application of adhesive
Intervention type(s): Other
Intervention description(s): Adhesive will be placed on the subjects skin below the bra. Placement of the adhesive will be randomized.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of a Diaphragmatic Breathing Training Program in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: COPD
Study type: Interventional

Summary: 
      Diaphragmatic dysfunction and alterations of thoracoabdominal motions are common in patients
      with chronic obstructive pulmonary disease (COPD). Several studies have described an
      impairment in diaphragmatic mobility of COPD patients compared to age matched control
      subjects and it has been associated with increase in dyspnea, exercise intolerance and
      mortality. COPD patients also experiment a higher activity of the accessory breathing
      muscles, which greatly increases the work of breathing and dyspnea sensation.

      Breathing strategies have been considered an important component of pulmonary rehabilitation
      and refer to a range of techniques, including/which includes the diaphragmatic breathing
      (DB). The principal aim of DB is to improve the participation of the abdominal motion while
      reducing the accessory muscles activity. The role of DB as an adjunctive treatment modality
      in the rehabilitation of COPD patients remains controversial. Despite the conflicting
      results, improvement of the abdominal motion and a reduction of thoracic excursion, during
      voluntarily DB, has been described as a common finding of several studies. The investigators
      hypothesized that a 4-week DBTP could induce higher participation of the diaphragm and this
      modification would relieve respiratory symptoms and improve exercise tolerance and the HRQoL.
      Therefore, in this randomized controlled trial the investigators aimed to test the effects of
      a short-term DBTP on thoracoabdominal motion, pulmonary function, diaphragmatic mobility,
      dyspnea, HRQoL and exercise tolerance in patients with mild to severe COPD.
    


Intervention name(s): Diaphragmatic breathing training
Intervention type(s): Other
Intervention description(s): The training group will participate in a diaphragmatic breathing program which will consist of three 45-min sessions each week (12 sessions totally). The program training will be individualized and supervised by the same physiotherapist. In each session, the patients will be initially instructed to perform 3 series of 10 maximally inspirations, predominantly with abdominal motion, while reducing upper rib cage motion in a supine position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: COPD, diaphragm, rehabilitation
Free Amino Acid-based Formula to Treat Children Cow's Milk Protein Allergy
Condition: Cow's Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      It is a study to assess the tolerance to a new commercially available infant formula in
      children affected by Cow's Milk Allergy.
    

Detailed description: 
      In the present study, the children will be followed-up during the treatment with the new
      formula for Cow's Milk Allergy. They will have monthly doctor's appointment, when the weight,
      height and symptoms will be evaluated, by a questionnaire and a physical examination.
    

Intervention name(s): Amix
Intervention type(s): Dietary Supplement
Intervention description(s): Treat the children with cow's milk allergy for 5 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Use of Micro Vibratory Stimulation Technique to Control the Pain of Digit Block Anesthesia
Condition: Pain, Analgesia
Study type: Interventional

Summary: 
      The investigators hypothesize that patients who receive 1% lidocaine injections for digit
      blocks of the finger will experience less pain when the injection is accompanied by the use
      of a micro-vibratory stimulator (MVS) compared with patients who receive injections without
      the MVS.
    

Detailed description: 
      Research Question/Hypothesis

      The investigators hypothesize that patients who receive 1% lidocaine injections for digit
      blocks of the finger will experience less pain when the injection is accompanied by the use
      of a micro-vibratory stimulator (MVS) compared with patients who receive injections without
      the MVS.

      Objectives

      The primary objective of this study is to compare the pain rating scale from an exposure
      group (digit block injection with the aid MVS) and the control group (traditional injection).
    

Intervention name(s): Microvibratory Stimulator; Microvibratory Stimulator'
Intervention type(s): Device; Device
Intervention description(s): Informed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise.; As above, Microvibratory Stimulator will be used as a sham device in parallel group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Therapeutic Play Applied by Using Toy Nebulizer and Toy Mask on Child's Fear and Anxiety Level
Condition: Therapeutic Play; Anxiety; Fear
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      In this study, it was aimed to examine the effect of therapeutic play applied with a toy
      nebulizer and toy mask before inhaler treatment on children's fear and anxiety.

      It is the hypothesis of the study that the therapeutic play applied by using a toy mask and a
      toy nebulizer before inhaler treatment in children will reduce the child's fear and anxiety.
    

Detailed description: 
      Acute diseases constitute the majority of applications made to pediatric emergency services.
      Inhaled drugs are frequently used in the treatment of childhood acute respiratory system
      diseases. Nebulizers are the preferred method of administering inhaled drugs. Medical
      procedures are one of the biggest fears of children, making it difficult to use nebulizers
      correctly and effectively. The negative reaction of the child to the mask and nebulizer
      during inhaler treatment causes incorrect inhalation patterns, reducing the safety and
      effectiveness of the treatment. This causes difficulties in relieving symptoms, increased
      hospital admission and hospitalization time, more treatment costs, and even negative
      consequences such as increased morbidity.

      Reducing the fear and anxiety seen in children due to the hospital environment and illness is
      important in terms of children's acceptance of the treatment process. One of the methods used
      for this purpose is therapeutic play. Pediatric nurses should fulfill their nursing roles and
      responsibilities by including therapeutic play in their care processes.
    

Intervention name(s): toy nebulizer and toy mask
Intervention type(s): Combination Product
Intervention description(s): The treatment was administered using therapeutic play.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The population of the randomized controlled experimental study was composed of children aged 3-8 years who applied to the pediatric emergency department due to respiratory system disease.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Toy Mask; Toy Nebulizer; Child; Nurse
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what
      the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics
      (what the medication does to the body) of TMC278 long acting (slowly effective after initial
      dosage and maintaining its effects over a long period of time) when administered as an
      intramuscular (ie, in to the muscle) injection in adult participants who are seronegative for
      human immunodeficiency virus type 1 (HIV-1).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), multi-arm (more
      than one treatment group), dose-ranging study (clinical study where different doses of study
      medication are tested against each other) to evaluate the safety, acceptability,
      pharmacokinetics, and ex vivo pharmacodynamics of a single and multiple intramuscular
      injections of long acting TMC278 to human immunodeficiency virus type 1 (HIV-1) seronegative
      (having a negative serum reaction) male and female participants. The study consists of 3
      phases including screening phase, treatment phase, and the follow up phase (approximately 4
      to 6 months after the first dose of study medication). In treatment phase, enrolled
      participants will be divided in to 2 arms, ie, Arm A (female participants) which will be
      further divided in to Arm 1A, Arm 2A, Arm 3A, Arm 4A, and Arm 5A with 12 female participants
      per arm; and Arm B (male participants) which will be further divided in to Arm 1B, Arm 2B,
      Arm 3B, Arm 4B, and Arm 5B with 6 male participants per arm. Safety evaluations will include
      assessment of adverse events, clinical laboratory tests, electrocardiogram, physical
      examination, and vital signs which will be monitored throughout the study. The total duration
      of study for each participant will be approximately 5 to 7 months.
    

Intervention name(s): TMC278, Long acting (LA)
Intervention type(s): Drug
Intervention description(s): TMC278 long acting will be administered IM to the participants as follows: a single dose of TMC278 600 mg will be administered at baseline in Arm 2A and Arm 2B; at Months 2 and 4 in Arm 5A and Arm 5B. A single dose of TMC278 900 mg will be administered at Months 2 and 4 in Arm 4A and Arm 4B. A single dose of TMC278 1200 mg will be administered at baseline in Arm 1A, Arm 1B; Arm 3A, Arm 3B, Arm 4A, Arm 4B, Arm 5A and Arm 5B; at Months 2 and 4 in Arm 3A and Arm 3B.
Other intervention name(s): TMC278
Intervention MeSH terms: Rilpivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; TMC278; Human Immunodeficiency Virus Type 1; HIV-1; Pharmacokinetics; Ex-vivo pharmacodynamics
Family Help Program: Nighttime Enuresis Treatment Program
Condition: Enuresis
MeSH terms: Enuresis; Urinary Incontinence; Nocturnal Enuresis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the
      effectiveness of the Strongest Families distance intervention compared to usual or standard
      care that is typically provided to children with mild to moderate Enuresis diagnoses. This is
      a single-centre trial based at the IWK Health Centre. The primary outcome is change in
      diagnosis.
    

Detailed description: 
      The purpose of the Family Help Program is to deliver, primary care mental health services to
      children and their families in the comfort and privacy of their own home. Approximately 46
      children (5-12 years of age)suffering from pediatric enuresis (at least 2 times a week) will
      be randomized.

      The intervention is delivered from a distance, using the urine alarm system accompanied by
      educational materials (manuals, video-tapes, audio-tapes) and telephone consultation with a
      trained paraprofessional "coach" who is supervised by a licensed health care professional.
      The telephone coach delivers consistent care based on written protocols, with on-going
      evaluation by a professional team.

      Fifty percent of the eligible participants will receive Family Help Program telephone-based
      treatment and 50% will be referred back to their family physician to receive standard care as
      determined by that physician. Those receiving standard care will be evaluated for outcome
      results and then compared to the Family Help treated participants. It is anticipated that
      Family Help treatment will be proven to be as or more effective than standard care.
    

Intervention name(s): FHP Night time ENuresis Intervention
Intervention type(s): Behavioral
Intervention description(s): Urine alarm/evidence-based psychological Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Mentalization-Based Group Therapy for Adolescents
Condition: Deliberate Self-Harm
MeSH terms: Self Mutilation; Self-Injurious Behavior
Study type: Interventional

Summary: 
      This is a prospective parallel group design of group-based Mentalization-Based Therapy for
      Adolescents (MBT-A) through a pilot randomised controlled trial comparing group-based MBT-A
      plus treatment as usual (TAU) to TAU alone. As a pilot study, we aim to determine: the
      effectiveness of our recruitment strategies; compliance with protocol/procedures; trends
      towards reduced self-harm.
    


Intervention name(s): Mentalization-Based Group Therapy for Adolescents
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent
Sclerotherapy of Internal Spermatic Veins in Patients With Varicocele and Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Varicocele
Study type: Interventional

Summary: 
      Patients with varicocele in whon early prostate cancer will be found will undergo venographic
      embolization of both spermatic veins. The study hypothesis is that this procedure will induce
      a gradual regression of the prostate volume that may decrease prostate cancer cells. Close
      follow-up will ensure that necessary therapy will be provided if needed according to clinical
      criteria. Results in terms of prostate size PSA level and tumor size will be recorded.
    


Intervention name(s): venographic occlusion of spermatic veins
Intervention type(s): Procedure
Intervention description(s): Through the femoral vein a catheter is inserted into the spermatic veins in succession and the veins are occluded.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer; venography; male patients; Localized microscopic prostate cancer up to Gleason 6 (3+3); PSA level <14; presence of varicocele