bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Myofascial Release at the Cervicothoracic Region in Patients With Rotator Cuff Repairs
Condition: Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      this study was conducted the patients with rotator cuff tears who underwent rotator cuff
      repair surger.The patients were randomly divided into 2 groups and a total of 20 subjects
      were randomized in a single block order using RandomAllocation Software 1.0.0 by simple
      randomization.All evaluation and treatment was done by the same physiotherapist.The first
      group was included in the traditional treatment program after rotator cuff repair, while the
      second group was included in the myofascial release program, 2 sessions a week between the
      4th and 7th weeks, in addition to the traditional treatment.
    

Detailed description: 
      Patients in the 2 groups undergoing rc repair were also included in a similar physiotherapy
      program.Immobilization with a sling was made for 4-6 weeks after surgery. In addition to
      physiotherapy in group 2, myofascial release therapy was applied to the upper trapezius,
      sternocloidomastoideus, pectoral muscles (major, minor) 2 days a week between the 4th and 7th
      weeks after surgery, in addition to the conventional treatment. Myofascial treatment took
      30-45 minutes per session.
    

Intervention name(s): myofascial release technique; physiotherapy
Intervention type(s): Other; Other
Intervention description(s): myofascial release group took myofascial release (MFR) therapy sessions twice a week for 4 weeks between 4 and 7 weeks. MFR was applied to upper trapezius, SCM, pectoralis major-minor and sternocostal fascia. muscle was replaced elongated position and pressure was applied for 60-120 second.; patients used sling up to 4 weeks. They did first 4 weeks passive/ assistive range of motion exercise. In 6-8 weeks they did active exercises. 8-12 weeks they did progressive resistive exercises.
Other intervention name(s): classic physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised controlled study this study was conducted with rotator cuff tear patients who underwent arthroscopic rotator cuff treatment.
The patients' pain intensity, joint range of motion, flexibility of shoulder muscles, grip and muscle strength, shoulder function evaluations and physical characteristics, age, differences between body mass index were evaluated with Mann Whitney-U test.Measurements before and after treatment were evaluated with the Wilcoxon test. Friedman test was performed for the measurements made at postoperative 3, 7, and 12 weeks before in-group treatment. Bonferoni correction was done for possible differences.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myofascial release; rotator cuff tears; physiotherapy; rotator cuff repair
Effectiveness of a Mindfulness and Compassion Intervention for Pregnant Women and Their Partners for the Prevention of Stress and Depression During Pregnancy and Breastfeeding
Condition: Pregnancy, Childbirth and Postpartum
MeSH terms: Depression
Study type: Interventional

Summary: 
      The aim of this study is to assess a mindfulness and compassion group intervention for
      pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of
      stress, negative affect and depression in pregnancy and breastfeeding. This group
      intervention will also be compared with a Treatment as usual (TAU) group consisting in a
      childbirth education class taught by the Health Center midwife. The principal hypothesis is
      that the mindfulness and compassion intervention will be more effective than TAU.
    

Detailed description: 
      The aim of this study is to assess a mindfulness and compassion group intervention for
      pregnant women and their partners (8 weeks) for the prevention, reduction and treatment of
      stress, negative affect and depression in pregnancy and breastfeeding.

      There will be two groups:

        1. A face to face mindfulness and compassion intervention for pregnant women in their
           second trimester of pregnancy and their partners in group format (8 weeks) based in the
           Mindfulness Based Childbirth and Parenting program from Nancy Bardacke. This group will
           also receive in their third trimester of pregnancy the childbirth education classes
           taught by midwives (6-8 weeks) that every pregnant woman normally attends to in the
           National Health Care System in Spain (TAU).

        2. A control group that will receive only the childbirth education class by midwives (TAU)
           group consisting in a childbirth education class taught by the Health Center midwife at
           the third trimester of pregnancy.

      Each group will be composed of 60 participants with a total sample of 120. The principal
      hypothesis is that the mindfulness and compassion intervention will be more effective than
      TAU in the decrease of stress, negative affect and depression and in the increase of positive
      affect during pregnancy and breastfeeding.

      The differences between the intervention and control group will be analyzed. Finally, a
      qualitative study will be conducted.
    

Intervention name(s): Mindfulness
Intervention type(s): Behavioral
Intervention description(s): TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Mindfulness; Compassion; Depression during Pregnancy and Postpartum; Prevention; Stress
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      ascending single- and multiple-doses of TAK-020 in healthy participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-020. TAK-020 is being tested to evaluate
      safety and tolerability of single doses and 7 days multiple doses of TAK-020 in healthy
      volunteers. This study will look at the PK characteristics (how the drug acts throughout the
      body) of the drug and safety and tolerability (lab results, vital signs, ECG, and side
      effects) in healthy participants who take TAK-020.

      The study will enroll a total of approximately 120 participants. This study is designed to
      consist of 2 sequential parts: Part 1-a SRD, and Part 2-a MRD. Healthy participants for Part
      1 will be enrolled into 9 cohorts. Each cohort will have 8 randomized participants with
      receiving a single dose of TAK-020, and 2 receiving matching placebo under fasted conditions.
      In Cohorts 1-9 doses of 0.1, 0.5, 2.5, 4.4, 8.8, 17.5, 35, 70 and 105 mg will be evaluated.

      Healthy participants for Part 2 will be enrolled into 7 cohorts. Each cohort will have 8
      randomized participants, with participants receiving one dose of TAK-020 on Day 1, followed
      by a washout on Day 2, then daily dosing on Days 3-9 of TAK-020 with 2 participants receiving
      matching placebo under fasted conditions. In Cohorts 1-4 doses of 3.75, 5.75, 13 and 25 mg
      will be evaluated. For Cohorts 5-7, the subsequent dose level is to be determined based on
      data from Part 1 and review of safety, tolerability and PK data from Part 2 Cohorts 1-4.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 45 days. Participants in Part 1 will make multiple visits
      to the clinic including a period of confinement to the clinic and will be contacted by
      telephone 14 days after the last dose of study drug for a follow-up assessment. Participants
      in Part 2 will make multiple visits to the clinic including a period of confinement to the
      clinic and will be observed at the clinic 17 days after the last dose of study drug for a
      follow-up assessment.
    

Intervention name(s): TAK-020; TAK-020 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-020 oral solution; TAK-020 placebo-matching oral solution
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy
Condition: Need for Bowel Preparation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall
      colon cleansing in preparation of colonoscopy
    


Intervention name(s): Prepopik® ½ Sachet x 2 (9-12 years); Prepopik® 1 Sachet x 2 (9-12 years); Oral polyethylene glycol (PEG) based preparation (9-12 years); Prepopik® 1 Sachet x 2 (13-16 years); Oral polyethylene glycol (PEG) based preparation (13-16 years)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): Prepopik®; Prepopik®; Prepopik®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate
Condition: Postmenopausal Women
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after
      breakfast, to a 35 mg immediate-release tablet, administered according to labeling
      instructions.
    

Detailed description: 
      To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen
      C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately
      after a typical breakfast, to that of a 35 mg immediate-release tablet, administered
      according to labeling instructions (ie, at least 30 minutes prior to breakfast) in
      postmenopausal women after 13 weeks of treatment.
    

Intervention name(s): risedronate; risedronate; risedronate; risedronate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks; 35mg delayed release risedronate tablet following breakfast, once a week for 13 weeks; 50mg delayed release risedronate tablet following breakfast, once a week for 13 weeks; 50mg delayed release risedronate tablet before breakfast, once a week for 13 weeks
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Botox vs Occlusal Splint for Masseter Pain
Condition: Pain, Face
MeSH terms: Facial Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized clinical trial will compare the standard treatment (occlusal splint) and
      botox for the treatment of face muscular pain in adults. Fifty patients will be invited and
      selected, and allocated to the experimental group, according to the randomization sequence
      previously performed. For the splint group, a rigid splint will be worn by the patient every
      night. For the botox group, 60u of botox will be injected in 3 regions of the masseter
      muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning
      of the study. Oral health related quality of life, pain, and cervical neck position will be
      evaluated. Paired t-test and chi-square will be used for statistical analysis.
    


Intervention name(s): Botox Injectable Product; Occlusal splint
Intervention type(s): Drug; Device
Intervention description(s): 60u will be used at 3 sites of masseter muscle, on each side of the face; In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
Condition: Mal de Debarquement Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      The goal of this study is to determine whether external neuromodulation using repetitive
      transcranial magnetic stimulation (rTMS) can reduce the perception of self-motion that is
      experienced by individuals with mal de debarquement syndrome (MdDS). Mal de debarquement is
      translated as the "sickness of disembarkment," and refers to the chronic feeling of rocking
      dizziness that occurs after exposure to passive motion. Treatment for MdDS is limited and
      morbidity is high. The goal of the study is to determine whether rTMS can suppress the
      rocking dizziness of MdDS.
    

Detailed description: 
      Participants will maintain web-based diaries of their symptoms for two weeks prior to
      treatment with rTMS. Up to 20 treatments with rTMS with either anatomically or functionally
      determined targets will be administered. Post treatment diaries will continue for up to 12
      weeks after rTMS administration.
    

Intervention name(s): Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MdDS; TMS; fMRI; EEG
The Concomitant Cryomaze Procedure Using Nitreous Oxide Cryoprobe: Comparison With Argon Based Cryoprobe
Condition: Atrial Fibrillation; Valve
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The aim of this study is compare the surgical convenience and early and long-term outcomes of
      cryomaze procedure using nitrous oxide with using Argon gas.

      The investigators will analyze the pathologic findings of atrial tissue after cryoablation
      using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation
      burden 3 months and 1 year postoperatively and atrial activity will be checked.
    

Detailed description: 
      The investigators have used the Medtronic ATS cryoprobe (Argon based) since 2009 for cryomaze
      procedure for treatment of atrial fibrillation combined with valvular heart disease.

      However, sometimes, it was inconvenient due to excess flexibility, wide lesion related to
      excess low temperature and time-consuming detachment from atrium after cryoablation. The
      investigators introduced Atricure cryoprobe (Nitreos Oxide based) in hope of overcoming these
      shortcomings of ATS probes last year.

      Up to date, the investigators have been satisfactory in terms of the surgical convenience. On
      the other hand, we have the questionability of transmural lesion of Atricure probe because of
      the higher temperature of Atricure probe compared with ATS probe.

      The aim of this study is compare the surgical convenience and early and long-term outcomes of
      cryomaze procedure using nitrous oxide with using Argon gas.

      The investigators will analyze the pathologic findings of atrial tissue after cryoablation
      using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation
      burden 3 months and 1 year postoperatively and atrial activity will be checked.
    

Intervention name(s): Cryomaze procedure using Nitrous oxide; Cryomaze procedure using Argon
Intervention type(s): Device; Device
Intervention description(s): Cryomaze procedure using Nitrous oxide; Cryomaze procedure using Argon
Other intervention name(s): Atricure cryoprobe; ATS medtronic probe
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; maze operation; cryoablation
Clinical Study for Comparative Assessment of Efficacy and Safety of Angal S, Topical Spray and ANTI-ANGIN® FORMULA, Topical Metered Spray in Treatment of Patients With Uncomplicated Acute Infectious and Inflammatory Diseases of the Pharynx, Accompanied by a Sore Throat
Condition: Sore Throat
MeSH terms: Pharyngitis; Pharyngeal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate no less therapeutic efficacy and safety of the
      Angal S, topical spray [Menthol], 0,5 mg + 2 mg (Sandoz dd, Slovenia) compared to ANTI-ANGIN®
      FORMULA, topical metered spray, 0,12 mg + 0,24 mg (LLC "Valeant", Russia) in treatment of
      patients with uncomplicated acute infectious and inflammatory diseases of the pharynx,
      accompanied by a sore throat.
    


Intervention name(s): Angal S, topical spray [Menthol]; ANTI-ANGIN® FORMULA, topical metered spray
Intervention type(s): Drug; Drug
Intervention description(s): 0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution; 0,12 mg + 0,24 mg (LLC "Valeant", Russia) administered as one to two consecutive presses on the actuator button, up to 6 times per day, , for a maximum 5 days or until full illness resolution
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Angal S; ANTI-ANGIN FORMULA; Sore Throat; no less therapeutic efficacy
A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis
Condition: Lupus Nephritis; Systemic Lupus Erythematosus
MeSH terms: Nephritis; Lupus Nephritis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 1b/2, multi-center study in which patients will receive KZR-616, administered
      as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
    

Detailed description: 
      The study consists of 2 parts:

      Part 1, Phase 1b, is an open-label multiple dose escalation study to evaluate the safety and
      tolerability of KZR-616 in patients with systemic lupus erythematosus (SLE) with and without
      lupus nephritis. The Phase 1b part of this study fully enrolled October 2020.

      Part 2, Phase 2, is an open-label study to evaluate the efficacy and safety of KZR-616 in
      patients with active proliferative lupus nephritis (LN) to assess the number of patients with
      a 50% reduction in UPCR after 24 weeks of weekly SC injections with KZR-616 when compared to
      baseline.
    

Intervention name(s): KZR-616
Intervention type(s): Drug
Intervention description(s): Subcutaneous Injection of KZR-616
Other intervention name(s): KZR-616 Lyophile
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunoproteasome inhibition; selective proteasome inhibition; proteasome; lupus nephritis; lupus; nephritis; active proliferative lupus nephritis; open-label; systemic lupus erythematosus; lupus erythematosus
Dual-task Assessment and Rehabilitation for Individuals With Residual Symptoms After mTBI
Condition: Brain Injury Traumatic Mild; Concussion, Brain
MeSH terms: Brain Injuries; Brain Concussion; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      This research aims to develop an intervention that combines mTBI-specific motor and cognitive
      challenges into a progressive and challenging rehabilitation program. We plan to develop and
      refine a combined motor and cognitive intervention using healthy athletic young adults (n=12)
      and people with a positive history of non-resolving mTBI (n=12). We will conduct limited
      feasibility testing by conducting 6 week training sessions with each subject group. We also
      plan to identify best measures for determining readiness for duty or full function by
      incorporating and testing 3 dual-task assessment measures using state-of-the-art wearable
      sensors to quantify movement.
    


Intervention name(s): Cognitive and Motor Dual-task Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention will take place 3 times per week for 6 weeks (60 minutes/session) and employs motor and cognitive challenges. It is based on known motor and cognitive deficits after mTBI and is structured using a theoretical framework published in another domain of neurologic disease. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. Each station will have 3 levels of difficulty with optional cognitive progressions. Subjects will spend 8 minutes at each station with a 2 minute transition/rest period between stations and will be progressed in motor and cognitive difficulty as able.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Opioid Free Anesthesia in Breast Cancer Surgery
Condition: Opioid Free Anesthesia
Study type: Interventional

Summary: 
      A comparison of incidences of postoperative nausea and vomiting (PONV) , postoperative pain
      severity and recovery parameters in breast cancer patients receiving opioid or opioid-free
      general anesthesia.
    

Detailed description: 
      Breast cancer is one of the most common oncologic diagnosis in women. Surgery is
      traditionally performed under general anesthesia with opioid-based analgesia. It is
      associated with higher incidences of PONV, more severe acute postoperative pain and increased
      incidences of chronic pain. The possibility of higher risk of metastasis has also been
      reported.

      The purpose of our study is to compare the opioid-free general anesthesia with the
      opioid-based general anesthesia with respect to the quality of recovery, postoperative pain
      and cancer recurrence and metastasis.
    

Intervention name(s): paravertebral block; opioid free anesthesia; sham block; opioid general anesthesia
Intervention type(s): Procedure; Drug; Procedure; Procedure
Intervention description(s): Paravertebral block will be performed at T2,T4 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.4% ropivacaine 20ml at each injection site.; propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.; Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.; propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained .
Other intervention name(s): nerve block; opioid free; local infiltration; traditional general aneshesia
Intervention MeSH terms: Analgesics, Opioid; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment