bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      This study is a prospective randomized controlled clinical study. After the novel Achilles
      tendon rupture repaired , patients were randomly divided into 4 groups according to
      immobilisation duration of 0, 2, 4, and 6 weeks, respectively. All patients underwent the
      same suture technique with a similar rehabilitation protocol and were examined clinically at
      2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks to study the difference in efficacy among the
      groups.
    

Detailed description: 
      This prospective randomized controlled clinical study is designed to compare the treatment
      outcomes of different immobilisation duration by dividing the patients into four groups
      according to immobilisation duration of 0, 2, 4, and 6 weeks after a similar suture
      technique. The primary outcome was the time of return to light sports activity (LSA).
      Secondary outcomes included range of motion (ROM) and single-legged heel rise height (SHRH).
      Data on operation time, complications, visual analogue pain scale (VAS), American Orthopaedic
      Foot and Ankle Society (AOFAS) hindfoot score, and Achilles tendon Total Rupture score (ATRS)
      were also collected. Demographic baseline data were analysed using one-way analysis of
      variance; outcome parameters were analysed using Kruskal-Wallis H test, and complications
      were analysed using Fisher's exact test. Statistical significance was considered at P ≤ 0.05.

      The inclusion criteria were patients aged 18 to 60 years with an acute closed single-legged
      complete ATR who underwent open surgery with our suture technique.

      The excluded criteria were patients with prior ATR and those without rehabilitation or
      follow-up outcomes. Other situations that affected patients' lower limb functions or tendon
      healing (e.g. autoimmune disease, diabetes mellitus, systemic corticosteroid treatment) were
      also excluded.
    

Intervention name(s): immobilisation duration
Intervention type(s): Device
Intervention description(s): immobilisation duration of 2,4,6 week after suture of Achilles tendon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Duration of immobilisation
Comparing Nose & Mouth Breathing During Exercise
Condition: Healthy
MeSH terms: Mouth Breathing
Study type: Interventional

Summary: 
      The purpose of this study is to compare physiological responses in cardiovascular variables
      between nose and mouth breathing at rest and during exercise.
    

Detailed description: 
      Breathing patterns can affect the cardiovascular system. Little is known about how nose
      versus mouth breathing affects cardiovascular variables (blood pressure, heart rate, etc.) at
      rest and during exercise. It has been suggested that breathing through the nose can cause
      calmness and lower blood pressure. However, research is needed to examine the extent to which
      breathing through the nose affects cardiovascular variables at rest and during exercise.
      Therefore, we will compare cardiovascular variables between nose-only and mouth-only
      breathing. The rate of breathing will be fixed (using an audible metronome) for both
      breathing conditions (nose-only vs mouth-only) based on an individual's free breathing (i.e.,
      no breathing cues) breathing rate.
    

Intervention name(s): Nose-only breathing; Mouth-only breathing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will breathe only through their nose (mouth closed) during rest and submaximal exercise.; Participants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Non-contact Endoscopy at Covid-19 Outbreak
Condition: Gastrointestinal Disease; Infectious Disease
MeSH terms: Communicable Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      The COVID-19 outbreak and spread throughout the world now constitutes a global public health
      emergency. Direct contact between doctors and patients in daily practice bears potential risk
      of Covid-19 infection, and telemedicine, or non-contact medicine, in this circumstance,
      offers an ideal solution. Remote controlling capsule endoscopy system for gastric examination
      was recently developed and applicated in clinical practice.
    

Detailed description: 
      The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon
      Technologies, China) adds a remote control workstation and a audio-visual exchange system to
      the original well-establish MCE system, which consists of a robotic magnetic arm, a
      workstation (now bypassed) and a capsule endoscope, and boasts a 90% sensitivity and 94%
      specificity for diagnosing gastric focal lesions. This feasibility study aims to evaluate the
      technical success, clinical success and adverse events of the first clinical application of
      non-contact MCE system.
    

Intervention name(s): Non-contact MCE system
Intervention type(s): Device
Intervention description(s): After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the study subject positions himself (herself) on the examination bed in Room A, while the operating doctor sits in Room B at the remote control workstation instructing her to swallow the capsule via the audio-visual exchange system. After the capsule entering the stomach, the doctor manipulated the two joysticks on the remote control workstation, mobilizing the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric examination.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072
Condition: Hyperlipidemias; Hypertension
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2071 and
      AD-2072 in healthy male volunteers.
    

Detailed description: 
      To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination
      compared with the administration of AD-2071 and AD-2072.
    

Intervention name(s): AD-2071 10/20mg; AD-2072 80/5mg; AD-2071 10/20mg + AD2072 80/5mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AD-2071 10/20 mg tablet; AD-2072 80/5mg tablet; AD-2071 10/20 mg + AD-2072 80/5mg tablet
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Using a Text-message System to Engage Depressed Adolescents in Cognitive-behavioral Therapy Homework
Condition: Major Depressive Disorder; Cognitive Behavior Therapy; Text Messaging
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The primary goal of the pilot is to test the feasibility and utility of using a
      text-messaging system to engage adolescents in improved homework adherence during
      cognitive-behavioral therapy (CBT) for major depressive disorder.
    

Detailed description: 
      Adolescent major depressive disorder leads to recurrent episodes, increased rates of
      attempted and completed suicides, and persistent social impairment between episodes (Weissman
      et al 1999). Cognitive behavioral therapy (CBT) is an accepted first-line therapy for
      mild-moderate depression in adolescents. Integral to CBT is "homework" as it enhances mastery
      of newly learned coping strategies, facilitates generalization of skills to novel situations,
      increases self-efficacy, and ultimately reduces vulnerability to relapse (Detweiler et al
      1999). Adherence to homework is a recognized problem in adults, and is similarly problematic
      in adolescents. One method of implementing CBT homework in a manner that is centric to
      current youth culture is through text messaging. By using a modern modality that many
      adolescents rely on for daily communication, there is the likelihood that they will find it
      more engaging than traditional modalities. Thus the potential that a text message system can
      help improve homework compliance in adolescents is significant, because improved homework
      adherence may ultimately be linked to improved clinical outcomes for these disorders with
      high rates of chronic morbidity and mortality.
    

Intervention name(s): Paper and pen homework; Text message system homework.
Intervention type(s): Behavioral; Device
Intervention description(s): Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks.; Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent's cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; CBT; Texting; SMS
Ph 1 Study of ADI PEG 20 in Pediatric Subjects Who Are Argininosuccinate Synthetase (ASS) Deficient
Condition: Argininosuccinate Synthetase Deficient
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study of pegylated arginine deiminase (ADI-PEG 20) in pediatric patients
      who deficient in the expression of tumor argininosuccinate synthetase, and have failed prior
      treatments. The study hypothesis is that this drug will be safe in pediatric patients.
    

Detailed description: 
      This phase 1 study will use a classic 3 dose levels by 3 patients per dose level design. Once
      the maximum tolerated dose is reached, additional patients may be enrolled at that dose
      level.
    

Intervention name(s): ADI-PEG 20
Intervention type(s): Drug
Intervention description(s): 4.5, 9 and 18 mg/m2 dosage weekly dosing intramuscular until progressive disease
Other intervention name(s): pegylated arginine deiminase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arginine; Arginine deiminase; Argininosuccinate synthetase; Phase 1; Pediatric; Failed other treatments; Pediatric patients
Demographic, Clinical, Laboratory and Genetical Characteristics of Patients With Beta Thalassemia Intermedia
Condition: Thalassemia
MeSH terms: Thalassemia; beta-Thalassemia
Study type: Observational

Summary: 
      The definition of Thalassemia Intermedia is not generally accepted and the specific clinical
      and laboratory characteristics varies between patients. Some patients are blood transfusion
      dependent and others are occasionally transfused. Also the mutations in the beta globin gene
      are diverse. Another mutations including mutations in the alfa globin gene and in the xmn1
      gene can affect the clinical course of this disease. The purpose of this study is to
      summarize the characteristics of patients with Thalassemia Intermedia treated at the
      Pediatric Hematology Unit at the HaEmek Medical Center in Israel
    

Detailed description: 
      The characteristics that will be recorded from the medical files include: demographic data,
      included gender and ethnic origin, family history, age at diagnosis, number and frequency of
      blood transfusions including age of first transfusion and physical examination findings.

      The laboratory data included iron metabolism parameters, mutation in the alfa and beta gene
      and the presence of the xmn1 polymorphism.
    

Intervention name(s): Laboratory analysis.
Intervention type(s): Genetic
Intervention description(s): The blood transfusions given to the patients are in accord to physician decision and not related to the study
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with beta Thalassemia Intermedia.
      
Biospecimen description: 
      DNA samples will be obtained to analyze the beta and alfa globin genes and the xmn1
      polymorphism.
    
Keywords: Beta globin gene; Alfa globin gene; xmn1 polymorphism
An Analysis of Kinesio® Tape on Myofascial Pain Syndrome of the Iliotibial Band
Condition: Myofascial Trigger Point Pain
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      Participants will report for two research sessions. Prior to arrival, membership to a club
      sports team will be confirmed via email. The first session will require one hour, while the
      second will require 30 minutes. Maximum amount of time expected is one and a half hours, over
      two sessions in 48 hours. The 1st and 2nd sessions will be separated by 48 hours. Upon
      arrival for session 1, informed consent will be obtained along with the following demographic
      information: age, sex, height, weight, dominant leg, and sport. Next, the participant will
      complete the Musculoskeletal Questionnaire (MQ) in regard to the last 12 months. Participants
      will then be assessed for trigger points in their dominant side iliotibial band via
      palpation. Diagnostic criteria for trigger point will be modeled after Travell and Simons:
      taut band, pain upon palpation, referred pain, and a local twitch response. Up to four
      trigger points will be marked on the subject's skin with marker or pen. Pain pressure
      threshold will be obtained via algometer, using the terminology "Tell me the first moment you
      experience pain by verbalizing 'pain' ". Then, three pain pressure threshold readings will be
      taken per trigger point and then averaged by the researcher. Kinesiology tape will then be
      applied to the identified trigger points using the Fascial Technique. Pain pressure threshold
      will be obtained again with the same protocols 10 minutes after the tape is applied. The
      participant will be asked to wear the tape for 48 hours. Upon arrival for session 2, the
      application of the tape will be confirmed. With the participant's choice to continue in the
      study, a third and fourth measurement of pain pressure threshold will be obtained: one with
      the tape remaining on, and another 10 minutes after removal of the tape. Again, three pain
      pressure threshold readings will be taken per trigger point and then averaged by the
      researcher.
    


Intervention name(s): Kinesio® Tape
Intervention type(s): Other
Intervention description(s): Fascial taping technique for myofascial trigger points on the iliotibial band
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Attention biases in threat processing have been assigned a prominent role in the etiology and
      maintenance of anxiety disorders. Attention Bias Modification Treatment (ABMT) utilizes
      computer-based protocols to implicitly modify biased attentional patterns in anxious
      patients. This is a double-blind randomized controlled trial of ABMT for clinically anxious
      10-18 year-olds. Participants will be assessed using clinical interviews and parent- and
      self-rated questionnaires before, in the middle and after twelve sessions of ABMT or control
      groups, and again at ten-week follow-up. Outcome measures will be anxiety symptoms and
      depression as measured by gold standard questionnaires as well as structured clinical
      interviews with youth and their parents. Attentional threat bias, Attentional control and
      interpretation of ambiguous information will also be measured to explore potential mediators
      of ABMT's effect on anxiety. The investigators expect the findings to inform pathways to
      treatments for anxious children and to provide initial information on mechanisms of ABMT
      efficacy.
    


Intervention name(s): Attention Bias Modification treatment (ABMT); Exposure only +ABMT; Attention training only +ABMT; Placebo group
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral face stimuli.; Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial.; Attention training via repeated trials of a dot-probe task using non-emotional stimuli.; Identical discrimination task including a single non-emotional stimulus in each trial.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: attention bias modification treatment; attention training; anxiety disorders; clinical trials
A Multicenter, Relapse Prevention Study With Levomilnacipran Extended Release (ER) in Participants With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Recurrence; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the efficacy, safety and tolerability of levomilnacipran
      extended-release (ER) compared with placebo in the prevention of depression relapse in major
      depressive disorder (MDD).
    


Intervention name(s): Levomilnacipran ER; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.; Dose-matched placebo taken orally once daily.
Other intervention name(s): FETZIMA®
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fetzima; Relapse-prevention; Placebo-controlled
Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the iTBS is an effective treatment of the
      negative symptoms of schizophrenia.
    

Detailed description: 
      This study will evaluate whether the intermittent Theta Burst Stimulation (iTBS), a new high
      frequency TMS protocol is efficient in the treatment of the Negative Symptoms of
      schizophrenia.

      Neuroimaging studies demonstrate that hypoactivity in the left dorsolateral prefrontal cortex
      (LDLPFC) was associated with negative symptoms.

      The investigators hypothesize that iTBS applied to LDLPFC will improve negative symptoms and
      will improve activity of the LDLPFC measured with Magnetic Resonance Spectroscopy (MRS).
    

Intervention name(s): active iTBS; sham iTBS
Intervention type(s): Procedure; Procedure
Intervention description(s): Intermittent Theta Burst Stimulation (iTBS) over Left dorsolateral prefrontal cortex.
80% MT, 20 sessions of 6 minutes, 2 per day; iTBS placebo (placebo coil)
Other intervention name(s): TMS; rTMS; TBS; iTBS; placebo TMS; placebo rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: iTBS; Negative Symptoms
Study of an Extended Release (ER) Tablet, Single and Repeated Dosing
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to study the safety and tolerability of increasing doses of AZD1305 and how
      the medication is metabolised by the body (how it is taken up, distributed, and how it
      disappears from the body). The study is performed in healthy volunteers.
    


Intervention name(s): AZD1305; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ER tablet, administered as single and repeated doses.; Tablet, administered as single and repeated doses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: AZD1305; safety; pharmacokinetics; multiple ascending doses; Safety and pharmacokinetics
Promotora-Led Physical Activity Intervention Trial for Latinas in Texas
Condition: Physical Activity
Study type: Interventional

Summary: 
      The purpose of this study it to determine if a promotora-led intervention that takes a
      comprehensive, multi-level, community-based approach to promoting physical activity (PA) is
      effective among a particularly underserved segment of Latinas. We hypothesize that Latinas in
      the promotora-led PA Intervention will significantly increase minutes per week of
      moderate-to-vigorous physical activity (MVPA) compared to Latinas in the attention-control
      group.
    


Intervention name(s): Health education; Telephone Counseling; Newsletter; Environmental Change
Intervention type(s): Behavioral; Behavioral; Other; Other
Intervention description(s): Group health education sessions delivered by a promotora approximately 90 minutes in length. In the PA arm, health education incorporates at least 30 minutes group exercise.; Brief (10 minute) telephone counseling calls delivered by promotoras using motivational interviewing techniques. The counseling calls will emphasize behavior change strategies, including self-monitoring, goal setting, reinforcement, problem solving, stimulus control, and enlisting social support.; Educational, motivational and informational newsletters tailored for each community and hand-delivered by promotoras to participant homes.; Create a site atmosphere that promotes PA and increases the number of PA program offerings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: physical activity; prevention; health disparities; behavior; community based intervention