bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between Land-based and Water-based Exercises for Knee Osteoarthritis: Randomized Controlled Trial
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      Forty six patients with knee osteoarthritis will be randomly allocated into two groups:
      water-based exercises and land-based exercises. Both of them will receive a strengthening
      exercise protocol for lower limb muscles. A blind investigator will assess the patients
      before and immediately after, 3 months and 6 months following the interventions. The main
      outcomes will be pain, function and strength.
    

Detailed description: 
      Forty six patients with knee osteoarthritis will be randomly allocated into two groups:
      water-based exercises and land-based exercises. Both of them will receive a strengthening
      exercise protocol for lower limb muscles. A blind investigator will assess the patients
      before and immediately after, 3 months and 6 months following the interventions. The main
      outcomes will be pain, function, physical performance and strength.
    

Intervention name(s): water-based exercises; land-based exercises
Intervention type(s): Other; Other
Intervention description(s): water-based exercise strengthening protocol for lower limb muscles; land-based exercise strengthening protocol for lower limb muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
WatchPAT Device Validation Study Compared to Polysomnography
Condition: Sleep Apnea Syndromes; Sleep Disorder; Sleep
MeSH terms: Sleep Apnea Syndromes; Sleep Wake Disorders
Study type: Interventional

Summary: 
      Validation study of a novel sleep Device compared to a traditional sleep study.
    

Detailed description: 
      This is an investigator-initiated validation study for the WatchPAT 200 device compared to
      the gold standard polysomnography procedure (sleep study). To evaluate the accuracy of the
      WatchPAT device compared to an in-laboratory Polysomnogram (PSG), measurements including
      obstructive apnea hypopnea index (OAHI), apnea hypopnea index (AHI), oxygen desaturation
      index (ODI) and other relevant sleep parameteres and indices will be compared. Ultimately,
      the diagnostic agreement of the WatchPAT device in detecting between normal sleep and mild
      sleep apnea architecture will be assessed.
    

Intervention name(s): WatchPAT Intervention
Intervention type(s): Device
Intervention description(s): Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Polysomnogram; Sleep Disordered Breathing
The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis
Condition: Hepatic Encephalopathy; Liver Cirrhosis; Sleep Disturbance
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Dyssomnias; Parasomnias; Fibrosis
Study type: Interventional

Summary: 
      Sleep disturbances are common among patients with liver cirrhosis, but the reasons are not
      well understood. In this project the investigators evaluated whether an increase in blood
      ammonia in patients with cirrhosis had an impact on sleep quality and the function of retinal
      ganglion cells measured by pupillary response to blue light.
    


Intervention name(s): Amino Acid Challenge (AAC)
Intervention type(s): Dietary Supplement
Intervention description(s): The AAC contains 54 g banana flavoured amino acid mixture added 200-300 mL of water. The AAC simulates the composition of haemoglobin in approximately 400 mL of blood.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this proof of concept study is to use functional magnetic resonance imaging
      and behavioral assessments to investigate the effect of citalopram on restricted repetitive
      behaviors in people with autism spectrum disorders.
    


Intervention name(s): Citalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pill, 5-20mg once a day for twelve weeks; Placebo pill once a day for twelve weeks
Other intervention name(s): Celexa
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Restricted repetitive behaviors; restricted interests; Aspergers; Autism
A Study to Evaluate Safety and Efficacy of DC-TAB in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate safety and clinical efficacy of DC-TAB in multiple
      sclerosis.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled, exploratory, dose-ranging Phase
      IIa study in multiple sclerosis patients to evaluate the safety, tolerability, T-cell
      tolerance inducing effect, clinical effects and pharmacokinetics of intravenous DC-TAB, a
      solution of recombinant human alpha B-crystallin.

      At entry, patients were randomized to one of the treatments, placebo, 7.5 mg DC-TAB, 12.5 mg
      DC-TAB or 17.5 mg DC-TAB in a 1:1:1:1 fashion. Patients received a single intravenous bolus
      injection which was repeated twice with 2-month intervals during the 6-month monitoring
      period. The goal of such injection was to induce antigen-specific T-cell tolerance. The study
      consisted of two parts, a treatment period of 24 weeks, and a follow-up period of an
      additional 24 weeks. Patients returned to the hospital weekly during the first month, and
      monthly thereafter.

      The primary analysis was performed on data collected in the treatment period, and was
      performed after all patients had completed 24 weeks into the study. An additional analysis
      was performed once all patients had completed the full 48 weeks of the study. Patients and
      site study personnel remained blinded throughout the study.

      After 12 and 24 patients completed 4 weeks into the study, and after 24 patients had
      completed 12 weeks of follow-up, a partially blinded safety review was conducted by an
      independent drug safety monitoring board to verify safety of the intervention in MS patients.
    

Intervention name(s): recombinant human alpha B-crystallin; Placebo comparator
Intervention type(s): Biological; Other
Intervention description(s): intravenous injections; intravenous injection
Other intervention name(s): HspB5; CRYAB; DC-TAB; phosphate-buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alpha B-crystallin; immune tolerance
Cohort of Patients With a Symptomatic Rotator Cuff Tear Treated Without Surgical Repair
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      In accordance with national guidelines surgical repair of rotator cuff tear is the first-line
      strategy only in young patients, depending on tear size, fatty infiltration of rotator cuff
      muscles and articular status. In appropriate situations, a satisfactory result is expected in
      more than 80% of cases with a very good long-term outcome. On the other hand, the first-line
      strategy in older patients is conservative as the main objective is the treatment of pain and
      stiffness of the shoulder which can be achieved at least in the short-term with general and
      local medications and physiotherapy. In addition, poor prognostic factors such as massive
      tears and muscle fatty infiltration or atrophy, are more frequently present in those
      patients, leading to poor results of surgical treatment and a high risk of iterative tear
      after repair.

      Because of a lack of evaluation, there is currently no identified prognostic factor of
      medical treatment and on the other hand no clinical situation in which a surgical repair is
      mandatory. Therefore, investigator designed this study as an observatory with the follow up
      of patients with a symptomatic rotator cuff tear treated conservatively.
    

Detailed description: 
      Patients are regularly monitored in rheumatology consultation at 3 months, 6 months, 1 year,
      2 years, 30 months, 3 Years, 42 months, 4 years, 54 months and 5 years supplemented by simple
      radiological monitoring and an MRI followed by 1 year, 2 years and 5 years.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients having a full-thickness tear of the rotator cuff confirmed by MRI
      
Keywords: Rotator cuff tear; MRI
Inducing Systemic Immunity and Regressions in Metastatic Melanoma
Condition: Metastatic Malignant Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether
      autologous cytokines injected into cutaneous metastases would induce a systemic immune
      response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that
      had never been injected. Such immune responses were observed, and often the never-injected
      metastasis regressed completely. 20% of patients remained free of disease for greater than 5
      years.
    

Detailed description: 
      Lymphocytic infiltrates were seen in never-injected nodules only after several weeks of
      injections elsewhere. No adverse events were seen. The tumor-infiltrating lymphocytes were
      able to kill autologous melanoma ex vivo. Some patients who experienced complete regressions
      of all metastases lived without disease for over 10 years.
    

Intervention name(s): Autologous cytokines
Intervention type(s): Biological
Intervention description(s): Sterile autologous cytokines were injected weekly into multiple metastatic nodules while other nodules in the patient were never injected and were monitored for the development of dense lymphocytic infiltrates as evidence of an induced immune response.
Other intervention name(s): cytokine/chemokine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Multi-Method Early Intervention Program for Inhibited and Anxious Preschoolers
Condition: Behavioral Inhibition; Anxiety
Study type: Interventional

Summary: 
      This project aims to develop and evaluate a novel early intervention program that targets the
      specific risk factors implicated in the development and persistence of shyness, social
      reticence, and withdrawal in children. The project includes a program development phase,
      Phase I (pilot test of full study procedures using developed treatment protocol), and Phase
      II (randomized controlled trial/RCT). Outcomes that will be assessed include change in child
      behavioral inhibition and parenting, using parent and teacher reports and observational data.
      Families are assessed at three time points: baseline, post-treatment (or at approximately 8
      weeks for the control group), and 2 month follow-up.
    


Intervention name(s): Parent Psychoeducation; Turtle Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6-session parent psychoeducation group on child anxiety, following their children's lead, and encouraging approach behaviors.; The Turtle Program involves a child social and emotional skills group (Social Skills Facilitated Play) and a modification of Parent-Child Interaction Therapy in which parents are provided in-vivo coaching in following their children's lead and encouraging approach behaviors within the peer context. The child group provides a forum of same-age peers to learn to develop social and emotion regulation skills. The Turtle Program is administered over an 8-week period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age
Condition: Group B Streptococcal Infections
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study
      evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged
      18 to 49 years of age with no history of group B streptococcal vaccination will be randomized
      to receive either a single intramuscular dose of multivalent group B streptococcus vaccine
      (various formulations at 3 dose levels) or a placebo (saline control).
    


Intervention name(s): Multivalent group B streptococcus vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Various formulations at three dose levels; Saline Control
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant
Condition: Antipsychotic Induced Weight Gain; Non-alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Weight Gain
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetics (PK) of miricorilant
      in the presence and absence of the strong cytochrome P450 [(CYP) 2C19] inhibitor,
      fluvoxamine, in healthy participants. Participants will receive a single dose of miricorilant
      under fed conditions with a standard breakfast after an overnight fast alone and in
      combination with once-daily doses of fluvoxamine. Blood samples will be collected at regular
      intervals for PK and safety analysis between admission and discharge from the clinical unit.
    


Intervention name(s): Miricorilant; Fluvoxamine
Intervention type(s): Drug; Drug
Intervention description(s): Miricorilant 6 x 100 mg coated tablets; Fluvoxamine 50 mg tablet
Other intervention name(s): CORT118335
Intervention MeSH terms: Fluvoxamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effectiveness of Perioperative CPAP to Reduce Obstructive Sleep Apnea Related Adverse Events
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Objective of the study: To determine whether Perioperative Auto-CPAP treatment prevent
      postoperative worsening of OSA and improve nocturnal oxygen saturation in surgical patients
      with moderate and severe OSA.
    

Detailed description: 
      The patients will be approached by the study coordinators at the preoperative clinic. If the
      patient is interested in participating the study, STOP-Bang and Epworth questionnaires will
      be implemented to determine the risk for OSA.If the patients are classified as high risk of
      having OSA, they are scheduled for an overnight sleep study at home. The patients with
      Apnea-Hypopnea Index (AHI)>15 from the sleep study will be randomized into two study groups:
      Perioperative CPAP group or control group (routine care). In the perioperative CPAP group,
      patients will be treated with auto-CPAP for 2-3 nights preoperatively and 5 nights
      postoperatively. All patients will undergo sleep study on the third postoperative night and
      be monitored by a pulse oximeter for 2-3 nights preoperatively and 5 nights postoperatively.
    

Intervention name(s): auto-titrated CPAP; Control
Intervention type(s): Device; Device
Intervention description(s): Patients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.; Patients in this group will receive routine care, undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for oxygen saturation level for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia
Assessing Function in Pediatric Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the FIM™ as a measure of daily function in children
      with sickle cell disease hospitalized with vasoocclusive pain. Currently, the standard for
      pain assessment is a rating of pain intensity, as determined by observation (for younger
      children) or self-report (for older children and adolescents). However, these measures of
      pain intensity are not effective in recurrent or chronic pain states, and in sickle cell
      disease in particular. Pediatric patients who are hospitalized with vasoocclusive pain often
      do not report a decrease in pain intensity; however, other indications of clinical status,
      such as ambulation, less use of opiates from the patient-controlled analgesia (PCA) pump,
      increased food intake, and transition to oral pain medication, signify that the patient may
      be improving. As a result of our inability to get an accurate picture of the patients'
      condition, we would like to have a summary of improvement that would reflect these changes in
      clinical status and reflect the reduced impact of sickle cell pain on the patient's life. In
      this study, we plan to evaluate a standardized functional assessment measure in pediatric
      patients with sickle cell disease. It is hypothesized that FIM™ scores will correlate with
      other indicators of clinical status, such as movement, quality of sleep, use of IV opiates
      from the patient-controlled analgesia (PCA) pump, and use of intravenous vs. oral pain
      medications. It is also hypothesized that the FIM™ will demonstrate adequate responsiveness
      to change in functional status within a 3-7 day hospitalization by a progressive increase in
      scores and associations with other indicators of clinical improvement.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents with sickle cell disease
Retina Microvascularisation and Cardiovascular Heart Disease Prediction
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      Earlier studies have found that retinal photography could be very useful for evaluating the
      condition of microcirculation and the risk of cardiovascular diseases in patients. The
      architectural changes in retinal vascularisation strongly correlates with macrovascular
      remodeling. Also, recent founding suggests a possible close anatomical parallel between both
      the macrovascular and the microvascular blood.

      Our objectives are to assess (1) in which age and sex subgroups, if any, retinal vascular
      alteration in arterioles and venules can be predictive for cardiovascular morbidity and
      mortality; and (2) whether variations in arteriolar or venular caliber will predict better
      cardiovascular pathogenesis in normal and patient population. If the association between the
      diameter of the retinal vessels and the risks of cardiovascular disease is verified during
      this study, the impact on prevention would be enormous. The retinal microvascular change
      could become a powerful biomarker in the early detection of the cardiovascular pathogenesis
      and death risk
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        (50 to 70 years old) with history of coronary heart disease (CHD) or one or more risk
        factors.
      
Keywords: Retinal Microvascularisation; Fundus; mfERGs; CHF; Cardiovascular Disease; Coronarography; Macrovascularisation; The objectives are to assess if if any retinal vascular disorder in arterioles and venules can be predictive for cardiovascular morbidity and mortality
A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective for this study is to evaluate the safety of lebrikizumab compared with
      Topical Corticosteroids (TCS) alone in patients with persistent moderate to severe Atopic
      Dermatitis (AD) that is inadequately controlled with TCS.
    


Intervention name(s): Lebrikizumab; Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)
Intervention type(s): Drug; Drug
Intervention description(s): Lebrikizumab Dose Level 1 subcutaneous monotherapy was administered SC once every 4 weeks for a total of 3 doses.; Triamcinolone acetonide 0.1% cream will be supplied as single 454-g jars to be used on the body. Hydrocortisone 2.5% cream will be supplied as single 28-g tubes to be used on the face and intertriginous areas as indicated.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Hydrocortisone; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study of Fecal Microbiota Transplantation in the Treatment of Antibiotic-associated Diarrhea
Condition: Fecal Microbiota Transplantation; Antibiotic-associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      Antibiotic-associated diarrhea (AAD) refers to the occurrence of other unexplained diarrhea
      symptoms after the use of antibiotics, often combined with abdominal pain, bloating and
      bloody stool. Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant
      the microbiota from the feces of healthy people into the intestinal tract of patients. To
      explore the overall efficacy and safety of FMT in the treatment of AAD.
    


Intervention name(s): Fecal Microbiota Transplantation
Intervention type(s): Procedure
Intervention description(s): Fecal Microbiota Transplantation (FMT) is a therapeutic method to transplant the microbiota from the feces of healthy people into the intestinal tract of patients. This treatment aims to improve a range of diseases associated with the gut microbiota by restoring the balance of the gut microbiota.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment