bioihbjkbjnl/mcl2 huggingface dataset:
Pulmonary Tele-rehabilitation and Progressive Muscle Relaxation on Discharged Covid-19 Patients
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The aim of this study is to investigate efficacy of internet based pulmonary rehabilitation
      and progressive muscle relaxation program on functional capacity, depression and anxiety,
      dyspnea, fatigue, sleep quality and quality of life in covid19 patients after hospital
      discharge
    

Detailed description: 
      Novel coronavirus disease 2019 (covid19) could cause respiratory and physical dysfunction,
      anxiety and depression, fatigue and affect sleep quality and quality of life in infected
      patient after hospital discharge. there is expect that pulmonary rehabilitation can improve
      these symptoms and prevent complications in these cases. It seems that Progressive muscle
      relaxation exercise could improve pulmonary rehabilitation effect. Due to social isolation of
      Covid 19 patients after hospital discharge, internet base rehabilitation will be used in this
      study. participants will be randomized in two pulmonary tele-rehabilitation groups after
      hospital discharge. One group will be received pulmonary rehabilitation include education,
      breathing exercises, aerobic and upper and lower limbs muscle strengthening exercises.
      Another group will be perform progressive muscle relaxation in addition of these exercise.
      Treatment duration is 6 week with 5 days/week frequency. Two exercise sessions per week will
      be supervised with expert physiotherapist via videoconferencing.

      Outcomes will be measured at baseline, within two week and at the end of six week exercises
      program.
    

Intervention name(s): Pulmonary telerehabilitation; progressive muscle relaxation training
Intervention type(s): Other; Other
Intervention description(s): pulmonary telerehabilitation program include breathing exercise,aerobics exercise and upper and lower limbs muscle strengthening exercise; summarized Jacobson progressive muscle relaxation training method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
Condition: Autistic Disorder; Behavioral Symptoms
MeSH terms: Autistic Disorder; Behavioral Symptoms; Problem Behavior
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will provide long-term safety data for patients who are taking aripiprazole for up
      to 1 year. Most patients enrolled in this study will have participated in a short-term study
      with aripiprazole (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]).
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Tablets, Oral, 2, 5, 10, or 15 mg, once daily, 52 weeks
Other intervention name(s): Abilify; BMS-337039
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Serious behavioral problems in children and adolescents with AD; behavioral problems
Optimizing Risk Messages for Waterpipe Tobacco Cessation in Young Adults
Condition: Hookah Smoking
Study type: Interventional

Summary: 
      The objective of this study is to examine whether messages conveying the harms and
      addictiveness of waterpipe (i.e., hookah) tobacco delivered by mobile phone multimedia
      messaging (MMS) are effective for promoting hookah tobacco cessation among young adults ages
      18 to 30 years.
    

Detailed description: 
      The purpose of this study is to test the effects of messages communicating the risks (i.e.,
      health harms, addictiveness) of hookah tobacco delivered via mobile multimedia messaging for
      promoting hookah tobacco cessation. The study will also compare two messaging approaches, a
      standard untailored approach where all participants receive the same message content, and a
      tailored messaging approach where message content is personalized to baseline measures of
      hookah tobacco use behavior and beliefs and interactively to exchanges that occur via mobile
      messaging sent and received during the exposure period. The study includes young adults ages
      18 to 30 who are current hookah tobacco smokers. Eligible participants are young adults ages
      18 to 30 years who have smoked hookah tobacco at least once in the past month, smoke hookah
      tobacco on at least a monthly basis, and have access to the internet and a personal mobile
      phone to complete study procedures. Study participants will complete a baseline survey
      online, and all participants will receive standard information about the risks of hookah
      tobacco. Then participants will be randomly assigned to one of three groups: control group,
      untailored message group, tailored message group. Participants in the untailored and tailored
      message group will receive messages sent to their mobile phones communicating the risks of
      hookah tobacco for a 6 week period. All participants will complete follow-up surveys online 6
      weeks after baseline, 3 months later, and 6 months later.
    

Intervention name(s): Hookah tobacco risk messages
Intervention type(s): Behavioral
Intervention description(s): Mobile multimedia messages consisting of text and imagery conveying the risks of hookah tobacco use.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized trial with 3 groups: 1) Control group that receives no study messages; 2) Untailored message group that receives general messages about the risks of hookah tobacco; 3) Tailored message group that receives messages about the risks of hookah tobacco that are personalized to their hookah tobacco use behavior and beliefs.
Masking: None (Open Label)
Primary purpose: Prevention
A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)
Condition: Arterial Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary study objective is to assess the safety of afamelanotide while the secondary
      objective is to assess whether the therapy affects the size of the penumbra, by increasing
      blood flow, restoring oxygen supply to the brain, and reducing the amount of cerebral oedema
      (fluid) which is seen as a result of the stroke. Positive findings would indicate that the
      drug is able to support brain tissue-at-risk and provide overall neuroprotection and benefit
      to stroke patients.
    


Intervention name(s): Afamelanotide
Intervention type(s): Drug
Intervention description(s): Six adult patients with clots located in the higher segments of the brain and who are ineligible for alternative treatments will be enrolled in the study and evaluated for six weeks. The study will assess patients' brain injury with computed tomography (CT) scans and magnetic resonance imaging (MRI), as well as using recognised methods of clinical evaluation to measure changes in patients' neurological and cognitive function following treatment.
Intervention MeSH terms: Afamelanotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rheumatoid Arthritis Coping Enhancement
Condition: Rheumatoid Arthritis; Obesity; Pain
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      This study will test an enhanced lifestyle behavioral weight management program that
      integrates pain coping strategies with a lifestyle intervention that we expect to enhance
      obese RA patient's ability to cope with pain-related weight challenges. In the proposed
      study, up to 120 obese (RA-BMI > 28) rheumatoid arthritis patients will be consented in order
      to randomly assign 80 patients to one of two conditions: 1) an Enhanced Lifestyle Weight
      Management protocol or 2) standard care control. Patients randomized to the Enhanced
      Lifestyle Weight Management condition will participate in a 12-week protocol in which
      training in coping skills to increase self-efficacy and decrease the impact of RA pain on
      behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss
      factors will be integrated into a lifestyle behavioral weight loss intervention.
    


Intervention name(s): Enhanced Lifestyle Weight Management
Intervention type(s): Behavioral
Intervention description(s): The Enhanced Lifestyle Weight Management program was a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of RA pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors were integrated into a lifestyle behavioral weight loss intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to one of two arms.
Masking: Single (Participant)
Primary purpose: Other
Keywords: rheumatoid arthritis; pain; obesity
COVID-19 Quarantine on Musculoskeletal Status in Hemophilia
Condition: Hemophilia Arthropathy
MeSH terms: COVID-19; Joint Diseases; Hemophilia A
Study type: Observational

Summary: 
      Background. The recurrence of hemarthrosis in patients with congenital coagulopathies favors
      the development of a progressive, degenerative and intra-articular lesion (hemophilic
      arthropathy) that mainly affects the knees, ankles and elbows. Pain is one of the main
      clinical manifestations of hemophilic arthropathy. As a consequence of the COVID-19 pandemic,
      the Government of Spain, among others, established a total confinement for two months, in
      order to avoid contagion of the population Objective. To assess the effect of COVID-19
      confinement on bleeding frequency, pain perception, and range of motion in patients with
      hemophilic arthropathy.

      Study design. Prospective observational study. Method. 27 patients with hemophilia A and B
      will be included in this study. Patients will be recruited from the Spanish Hemophilia
      Federation (Fishemo) specialized center for hemophilia patients. The dependent variables will
      be: the frequency of bleeding (through a self-report), the perception of pain (measured with
      the visual analog scale and a pressure algometer), the joint state (with the Hemophilia Joint
      Health Score), and the range of joint movement (measured with a goniometer). Two evaluations
      will be carried out: pre-treatment (carried out in the month of February, as a periodic
      evaluation) and post-treatment (at the end of the period of confinement in Spain).

      Expected results. The aim is to observe the sequelae caused by confinement and a sedentary
      lifestyle in patients with hemophilic arthropathy, through changes in joint status, pain and
      range of motion.
    


Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Hemophilic arthropathy patients who will not receive any intervention. The dependent variables (frequency of hemarthrosis, pain, joint state and range of movement) in the joints will be evaluated: elbows, knees and ankles.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with hemophilic arthropathy routinely treated at the specialized hemophilia
        center of the Spanish Federation of Hemophilia (Fishemo).
      
Keywords: Hemophilic arthropathy; Joint pain; Joint health; Range of motion; Hemarthrosis; COVID-19
Effect of Fibrin Sealant on Early Wound Healing
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this randomized controlled clinical trial is to compare wound healing after the
      use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for
      their periodontal (gum)problems are selected and invited. Two regions will be operated in a
      selected patient. One region will receive fibrin sealant (test site) and the other region
      will get sutures (control site). Wound healing will be assessed by evaluating inflammatory
      markers, Interleukin 1beta and interleukin 8, from a non invasively collected gum fluid.

      Hypothesis. Fibrin sealant use will result in less inflammation seen through reduced levels
      of interleukin (1beta and 8) compared to use of sutures.
    


Intervention name(s): Fibrin Sealant; Suture
Intervention type(s): Drug; Drug
Intervention description(s): Fibrin Sealant 4ml (Baxter Tisseel); Black silk 000
Other intervention name(s): TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated; Ethicon
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: fibrin sealant; tissue adhesive; wound healing; interleukin 1 beta; interleukin 8
Deambulatory Epidural During the Labour
Condition: First Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      Assess the impact of instrumentation and caesarean related to dyskinesia by reducing the
      concentration of local anesthetic and therefore the motor block.
    

Detailed description: 
      Prospective, randomized and double-blind study performed on primiparous parturient divided
      into two distinct groups.
    

Intervention name(s): Levobupivacaine 0.1% + Sufentanil 0.2µg/ml; Levobupivacaine 0.07% + Sufentanil 0.3µg/ml; Lumbar epidural analgesia
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Levobupivacaine 0.1% + Sufentanil 0.2µg/ml; Levobupivacaine 0.07% + Sufentanil 0.3µg/ml; Introduction of a catheter in lumbar epidural space
Other intervention name(s): control group; ambulatory group; labor analgesia
Intervention MeSH terms: Sufentanil; Dsuvia; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: epidural; primiparous patient; deambulation
Safety Study of BMS-816336 in Healthy Male Subjects
Condition: Diabetes Mellitus, Non-Insulin-Dependent; Dyslipidemia
MeSH terms: Dyslipidemias; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics
      following single oral doses of BMS-816336 in healthy male subjects.
    


Intervention name(s): BMS-816336; BMS-816336; BMS-816336; BMS-816336; BMS-816336; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days; Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days; Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days; Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days; Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days; Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure
Condition: Copd; IMT
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The aim of this study is to examine the effectiveness of inspiratory muscle training (IMT)
      before bronchoscopic procedure in Chronic Obstructive Pulmonary Patients (COPD). Patients
      with a diagnosis of COPD, who are listed for a bronchoscopic procedure and referred to the
      pulmonary rehabilitation (PR) clinic, will be randomly divided into two groups. Standard PR
      exercise program will be applied to both groups. In addition to the standard program, IMT
      will be applied to one of the groups. The effect of IMT on exercise program gains will be
      examined.
    

Detailed description: 
      -  Cases diagnosed with COPD by a chest diseases specialist at Yedikule Chest Diseases and
           Thoracic Surgery Training and Research Hospital will be included in the study.

        -  The cases meeting the inclusion criteria will be randomized and divided into two groups,
           called the standard rehabilitation group (PRGr) and the inspiratory muscle training
           group (IMTGr).

        -  Initial exercise sessions and all evaluations of all cases will be performed in the
           hospital. The 2nd and 3rd training repetitions will be held at their homes via online
           synchronized videoconferencing. The exercise video will be sent to the smart phones of
           the cases who have completed 3 training sessions. Participants will be called once a
           week by phone and exercise follow-up will be carried out.

        -  All subjects will continue to exercise 5 days a week for 2 months. The standard PR
           consists of breathing exercises, peripheral muscle strength and self walking training.
           In addition, IMT was applied to IMTGr.
    

Intervention name(s): Inspiratory muscle training; Standard pulmonary rehabilitation programme
Intervention type(s): Other; Other
Intervention description(s): Respiratory muscle strengthening training will be given with a resistive threshold inspiratory muscle strengthening device.; The standard PR consisted of breathing exercises, peripheral muscle strengthening and self walking training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: IMT; COPD; pulmonary rehabilitation; bronchoscopic procedure; Bronchoscopic lung volume reduction; valve; coil; balloon
Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi center open label study intended to provide photo documentation and time to
      response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to
      severe non-nodular inflammatory acne vulgarism.
    

Detailed description: 
      This was a 12-week, multi-center, open label, two-arm study. Subjects will be assigned to
      treatment with 1% or 2% BPX-01 gel. Subjects will apply 1g of the gel as a thin film to the
      entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA,
      and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy.
      Photographs will be taken to document treatment effect.

      Safety will be assessed with the vital signs, brief physical examination, clinical laboratory
      tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation,
      incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri,
      incidence of product related facial staining and collection of adverse events.
    

Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): BPX-01 1 or 2% topical gel will be applied to face once daily
Other intervention name(s): BPX-01
Intervention MeSH terms: Minocycline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial to Assess the Bioavailability of Quetiapine Versus Seroquel® in Subjects With Schizophrenia or Bipolar Disorder
Condition: Bipolar Disorder; Schizophrenia
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part trial.

      The primary objective of Part A is to estimate the ratio of geometric means of
      pharmacokinetic (PK) parameters and their within-subject variability for the 300mg quetiapine
      tablet formulation A and the 300mg quetiapine tablet formulation B compared to 300mg
      Seroquel.

      The primary objective of Part B is to estimate the ratio of geometric means of PK parameters
      and their within-subject variability for the selected tablet formulation from Part A of 25mg
      quetiapine compared to 25mg Seroquel.
    


Intervention name(s): Seroquel IR 300mg; Seroquel IR 25mg; Quetiapine Formulation A 300mg; Quetiapine Formulation B 300mg; Quetiapine Formulation 25mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered during Part A, administered orally BID with water, over 5 days.; Administered during Part B, as a single, 25mg dose taken with water.; Administered during Part A, administered orally BID with water, over 5 days.; Administered during Part A, administered orally BID with water, over 5 days.; Administered during Part B, as a single, 25mg dose taken with water.
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a two-part, crossover study. In Part A, participants will be randomized into one of three treatment sequences, each receiving Seroquel immediate release (IR) 300mg, Quetiapine Formulation A 300mg and Quetiapine Formulation B 300mg. In Part B, participants will be randomized into one of two treatment sequences, each receiving Seroquel IR 25mg and Quetiapine 25mg, the formulation of which will be established in Part A.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Seroquel; Digital Medicine Quetiapine; Pharmacokinetics; Bioavailability
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride
      and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone
      hydrochloride and metformin hydrochloride) Tablets 15 mg/850 mg of Takeda Pharmaceuticals
      America, Inc. USA. Dosing periods of studies were separated by a washout period of 14 days.

      Study Design:

      Randomized, Two-Way Crossover, Single-Dose, and Open-Label
    


Intervention name(s): Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Pioglitazone
Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus
Condition: Diarrhea; Rotavirus Infection
MeSH terms: Rotavirus Infections; Diarrhea
Study type: Interventional

Summary: 
      Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be
      clinically important in time of hospitalization and reduction of duration of diarrhea
      secondary to rotavirus?
    

Detailed description: 
      Nitazoxanide has demonstrated a cytoprotective effect against rotavirus, reducing duration
      time of diarrhea in comparison to placebo in previous studies. In the current study, based in
      those results, we design a randomized single-blind controlled trial, in order to asses the
      effectiveness of nitazoxanide and probiotics in comparison with a control group
    

Intervention name(s): Nitazoxanide; Probiotic mix preparation; Oral hydration solutions
Intervention type(s): Drug; Drug; Other
Intervention description(s): Nitazoxanide 15mg/Kg/day twice day for 3 days; Probiotic preparation 1 gram twice a day for 5 days; Oral hydration solutions as needed
Other intervention name(s): Noxom; Givotan; Probiotic; Rehsal 60; 2.5% Glucosaline
Intervention MeSH terms: Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: nitazoxanide; Probiotics; Diarrhea; Rotavirus; Children