bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
Condition: Glomerulonephritis
MeSH terms: Glomerulonephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA
      nephropathy.
    


Intervention name(s): Ramipril
Intervention type(s): Drug
Intervention description(s): 2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
Intervention MeSH terms: Ramipril
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Connective Tissue Massage in Patients With Migraine
Condition: Migraine With Aura; Migraine; Migraine Without Aura; Connective Tissue Diseases
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura; Connective Tissue Diseases
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effectiveness of connective tissue massage in
      patients with migraine
    


Intervention name(s): Connective Tissue Massage; Education
Intervention type(s): Other; Other
Intervention description(s): Connective tissue massage (CTM) is a manipulative technique that facilitates the diagnosis and treatment of a wide range of pathologies. Observation and subsequent manipulation of the skin and subcutaneous tissues can have a beneficial effect upon tissues remote from the area of treatment.; Education patients were informed about migraine triggers, migraine prevention and coping strategies and exercise options. The exercises were demonstrated by the physiotherapist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised in Non-specific Low Back Pain
Condition: Low Back Pain; Physical Activity
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study compares the efficacy of a supervised rehabilitation program vs a non supervised
      rehabilitation program on pain, disability, quality of life and kinesiophobia in patients
      with non-specific low back pain.
    

Detailed description: 
      Low back pain is one of the most common problems of population, being a priority for health
      systems. It has got a high prevalence and recurrence, affecting in a social and economic way,
      and, it is one of principal causes of laboral absenteism. A randomized clinical trial will be
      conducted comparing a supervised physical therapy rehabilitation program vs a non supervised
      rehabilitation program.

      Objective: to compare the efficacy of a supervised rehabilitation program vs a non supervised
      rehabilitation program in patients with non-specific low back pain.

      Methods: Sixt-four subjects with chronic non-specific low back pain will be assigned to
      supervised rehabilitation program or non supervised rehabilitation program during 4 weeks (5
      sessions/week). Outcomes measures will be the following: disability, pain intensity, fear of
      movement, quality of life, McQuade Test, and lumbar mobility flexion.
    

Intervention name(s): Supervised exercise program; Non supervised exercise program
Intervention type(s): Other; Other
Intervention description(s): It will consist in a supervised exercise program, including the following exercises:
Diaphragmatic breathing.
Transverse abdomLateral leg raise for gluteus mediuminis muscle activation.
Pelvic swing.
Gluteus bridge.
Spinal mobility.
Spinal extensor muscles strengthening
Frontal plank
Side plank.
Lateral leg raise for gluteus medium; It will consist in a non supervised exercise program, including the following exercises:
Diaphragmatic breathing.
Transverse abdomLateral leg raise for gluteus mediuminis muscle activation.
Pelvic swing.
Gluteus bridge.
Spinal mobility.
Spinal extensor muscles strengthening
Frontal plank
Side plank.
Lateral leg raise for gluteus medium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; physical therapy; randomized clinical trial; exercise program
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893 in Healthy Adult Subjects
Condition: Staphylococcus Aureus
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, first time in human study enrolling approximately 33 healthy adult
      subjects (18-65 yrs) from one study site. The purpose of this study is to evaluate the
      safety, tolerability and PK of MEDI4893 in healthy adult volunteers administered as a single
      IV dose compared with placebo, across 4 cohorts. The 4 dose cohorts will enroll sequentially.
      Subjects will be followed for safety from the time of Informed Consent through 360 days post
      dose.
    

Detailed description: 
      This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to
      evaluate the safety, tolerability and pharmacokinetics of MEDI4893, an extended half-life
      human monoclonal antibody against Staphylococcus aureus alpha toxin, in healthy adult
      subjects. Approximately 33 subjects will be enrolled across 4 fixed dose cohorts at 1 study
      site . This study will last approximately 389 days, constituting a screening period of up to
      28 days, 1 day of investigational product administration, and a 360 day safety follow up
      period.
    

Intervention name(s): Placebo; MEDI4893
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; Human immunoglobulin G1 kappa monoclonal antibody
Other intervention name(s): Active comparator
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Telemedicine Education for Rural Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The investigators will implement an interactive school-based telemedicine education program
      for rural low-income, minority children with asthma, their caregivers, and school nurses in
      the Delta region of Arkansas.

      Specific aims:

        1. The investigators will examine changes in asthma symptoms control and other health
           outcomes such as activity levels and family/child emotional health in the intervention
           group compared to a usual care group.

        2. The investigators will examine changes in asthma knowledge, self-efficacy, and quality
           of life in the intervention participants and their caregivers compared to a usual care
           group.
    

Detailed description: 
      The investigators will conduct a prospective study to examine the impact of an interactive,
      telemedicine asthma intervention among children living in the rural Delta region of Arkansas.
    

Intervention name(s): Telemedicine Education; Usual care
Intervention type(s): Other; Other
Intervention description(s): Student Asthma Education. Each student will engage in 6 age-appropriate sessions on various aspects of asthma health.
Caregiver Asthma Education. The primary caregiver will engage in 2 asthma education sessions.
School Nurse Asthma Education. School nurses will participate in 2 sessions.
Primary Care Provider (PCP) Communication. The PCP of the intervention group participant will be notified of his/her patient's baseline asthma assessment. They will receive updates summarizing each telemedicine intervention.; Participants will receive asthma care by their PCP with no education sessions or PCP communications by the research staff.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Low-income; Quality of life; Children
Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy,
      safety, and tolerability of brexpiprazole + sertraline combination treatment in adult
      subjects with Post-Traumatic Stress Disorder.
    


Intervention name(s): Brexpiprazole; Sertraline; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Up to 3 mg pill; Up to 150 mg pill; Pill
Other intervention name(s): Rexulti; Zoloft
Intervention MeSH terms: Sertraline; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PTSD
The Effect of Tea on Vascular Function and Insulin Sensitivity
Condition: Insulin Resistance
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      The aim of this research is to explore changes in peripheral/cerebrovascular function and
      insulin sensitivity after a 7-day combination of physical activity reduction (-50% steps per
      day) and overfeeding (+50% kcal per day, comprising 65% fat) in healthy male volunteers, and
      examine whether daily intake of tea can prevent such changes.
    

Detailed description: 
      The aim of this study is to explore the impact of a 7-day 'unhealthy' lifestyle that combines
      physical activity reduction (-50% steps per day) and overfeeding (+50% kcal per day,
      comprising 65% fat) on peripheral (conduit artery and skin microvessels) and cerebrovascular
      function and insulin sensitivity in healthy male participants. Moreover, the investigators
      will explore whether the detrimental impact of this lifestyle can be mitigated by daily tea
      consumption (equivalent to 6 cups/day). To explore this hypothesis, the investigators will
      perform measurements of these parameters before and after 7-days of reduced physical activity
      and overfeeding, with and without the combination of daily tea ingestion.
    

Intervention name(s): Green tea; Placebo tea
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention product is regular green tea brewed with hot water in a large quantity. The tea obtained is dried and the powder, with added sugar, is distributed over sealed aluminium sachets (1 gram of powder per sachet). The product has been cleared for consumption by Unilever's Microbiology Department and the independent Safety and Environmental Assurance Centre of Unilever.; A product of similar colour and taste, but not the presumed actives of tea (polyphenols), is used as placebo. The product has been cleared for consumption by Unilever's Microbiology Department and the independent Safety and Environmental Assurance Centre of Unilever.
Other intervention name(s): Camillia sinesis
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: tea; cardiovascular; vascular; metabolism; microcirculation; physical inactivity; polyphenols; conduit artery; endothelial function; cerebrovascular; insulin sensitivity
A Combination Therapy In Patients With Social Anxiety Disorder
Condition: Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy, safety and tolerability of a combination
      of Vestipitant and Paroxetine in patients with Social Anxiety Disorder (SAD)
    


Intervention name(s): vestipitant/paroxetine
Intervention type(s): Drug
Intervention MeSH terms: Paroxetine; Vestipitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: anxiety; Social Anxiety Disorder; SAD
Enhancing Complex Care Through an Integrated Care Coordination Information System
Condition: Nurse Based Care Management; Health Information Technology
Study type: Interventional
Phase: Phase 3

Summary: 
      Cluster randomized controlled trial comparing care coordination incentives to pay for
      performance (quality measure) incentives in clinics on utilization, cost, quality, and
      patient experience.
    


Intervention name(s): Data collection; Data Collection
Intervention type(s): Other; Other
Intervention description(s): Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).; Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Care coordination, primary care; nurse care management; practice facilitation
A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase Ib, open-label, multi-centre study to determine the safety, tolerability and
      pharmacokinetics (PK) of capivasertib when given in combination with novel agents
      (enzalutamide or abiraterone) to inform the selection of capivasertib dose regimens for each
      combination for further clinical evaluation when given to patients with metastatic castration
      resistant prostate cancer (CRPC). The study design allows an exploration of different doses
      with intensive safety monitoring to ensure the safety of the patients.
    

Detailed description: 
      The study will be conducted on multiple centers (≤10) in USA and Spain. The study design
      allows an exploration of different doses with intensive safety monitoring to ensure the
      safety of the patients.

      The two planned combination treatments during Part A of this study are:

      Part A1: Capivasertib and enzalutamide Part A2: Capivasertib and abiraterone Part B will
      include any optional dose expansion cohorts based on Safety Review Committee (SRC) review of
      data from Part A of this study.

      The study will include up to approximately 87 evaluable patients, divided among the 4 study
      parts as follows:

      Part A1: Up to approximately 36 patients (up to four dose levels with up to approximately 9
      patients per dose level).

      Part B1: Up to approximately 12 patients. Part A2: Up to approximately 27 patients (up to
      three dose levels with up to approximately 9 patients per dose level). Part B2: Up to
      approximately 12 patients.
    

Intervention name(s): Capivasertib; Enzalutamide; Abiraterone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive multiple oral dose of capivasertib.; Patients will receive 160 mg oral dose of enzalutamide.; Patients will receive 1000 mg oral dose of abiraterone.
Other intervention name(s): AZD5363
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will include up to approximately 87 evaluable patients, divided among the 4 study parts.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic; Castration Resistant; Prostate Cancer
Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 in Healthy Adults
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To provide safety, tolerability, pharmacokinetic, and immunogenicity data for MEDI-524
      administered initially as a single dose to healthy adults in a dose escalation safety study
      before testing in the targeted pediatric population.
    


Intervention name(s): MEDI-524 (Numax-TM); MEDI-524 (Numax-TM); MEDI-524 (Numax-TM); MEDI-524 (Numax-TM); MEDI-524 (Numax-TM)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Grp.1: 3 mg/kg IV (single dose); Grp. 2: 15 mg/kg IV (single dose); Grp. 3: 30 mg/kg IV (single dose); Grp. 4: 3 mg/kg IM (single dose); Grp.5: 3 mg/kg IM (two doses)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Dry Needling on Stiffness in Latent Trigger Points
Condition: Trigger Points
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether application of Dry Needling (DN) is
      effective for reduced on Stiffness in Latent trigger point (LTrP) of upper trapezius. The
      secondary purposes are to determine the correlation on two elastography for stiffness measure
      (Shear-wave elastography and Strain elastography). Randomized controlled trial, in parallel
      with cross-control design. Two groups with LTrP in upper trapezius, and will be randomly
      selected to DN group or Sham-Dn group.
    


Intervention name(s): Intervention-Dry Needling; Control-Dry Needling
Intervention type(s): Device; Device
Intervention description(s): Deep Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle.
1 session in upper trapezius muscle moving the needle up and down ten times.; Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles
1 session in upper trapezius muscle moving the needle up and down ten times.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Latent trigger point; Stiffness; Dry Needling
Yoga for Youth With IBD: a Pilot Feasibility Study
Condition: Inflammatory Bowel Diseases; Yoga; Adolescents; Crohn Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      An 8-week yoga intervention to determine the feasibility and acceptability of yoga as a
      supplemental therapy in the management of inflammatory bowel disease in the adolescent
      population.
    

Detailed description: 
      Youth with IBD experience abdominal pain, diarrhea, weight loss, and psychological suffering
      related to their disease process. While many biologic and non-biologic therapies are
      available to target the inflammatory component of IBD, youth with IBD could benefit from a
      more holistic therapy that addresses psychological wellness, which has been shown, in turn,
      to reduce disease burden. It is known that stress (multiple varieties) leads to IBD flares.
      It is also known that mind-body intervention reduces stress. The mind-gut connection is
      widely discussed in medical circles, however, current therapies have not capitalized on it.
      The investigators would like to know if an easily accessible mind-body intervention (yoga)
      can improve wellness, lower stress levels, and reduce intestinal inflammation in youth with
      IBD.

      The study will be an 8-week feasibility pilot. Participants will be asked to participate in
      online yoga videos and in-studio yoga sessions. Participants will be asked to complete
      multiple surveys throughout the intervention and continue receiving standard care from their
      primary gastroenterology team.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention description(s): Yoga for 30 minutes three times weekly for 8 weeks in addition to three, 1-hour in-studio yoga sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inflammatory bowel disease; adolescent; yoga; mind-body
A Study Comparing CoQ10 Levels While Taking 3 Different Statins
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin
      or Rosuvastatin.
    

Detailed description: 
      Statins are known effectively treat high cholesterol and heart disease. However, statins may
      lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be
      responsible for side effects such as myalgia.

      Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins
      do, while still lowering cholesterol.

      In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking
      3 different FDA-approved statins, in equipotent doses.
    

Intervention name(s): Pitavastin 4mg; Atorvastatin 20mg; Rosuvastatin 5mg
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Livalo; Lipitor; Crestor
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LDL, HDL
Study Will Test the Theory That Training With the Facial-Flex Exercise Device Will Improve Snoring in Patients
Condition: Primary Snoring; Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Snoring
Study type: Interventional

Summary: 
      The study will test the hypothesis that training with the Facial-Flex exercise device for six
      weeks will improve snoring in patients with primary snoring or very mild sleep apnea.
    

Detailed description: 
      Subjects will be studied before and after 6 weeks of Facial-Flex training using portable
      monitoring. There will be 8 patient visits and 2 additional trips to the sleep center to
      return the portable sleep monitor.
    

Intervention name(s): Facial-Flex
Intervention type(s): Device
Intervention description(s): Oral exercise device
Other intervention name(s): Facial Exerciser; Facial Dynamic Resistance; Neck Exerciser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep Study; Snoring; Sleep Apnea; Muscle Laxity; Oral Appliance; Facial Muscles; Neck Muscles; Upper Airway; Muscle Strength; Dynamic Resistance; Oral Exercise; Facial Toning; Facial Muscle Strength; Strap Muscles of the Neck; Apnea-Hypopnea