bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy of UP165 on Sleep Quality and Mood State in Healthy Adults
Condition: Sleep Disturbance
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      A randomized, double blind, placebo controlled, parallel group study to evaluate the efficacy
      of UP165 on sleep quality and mood state in healthy adults
    


Intervention name(s): UPI65 (Low Dose); UP165 (High Dose); Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Red colored Capsules; Red colored Capsules; Red colored Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double blind, placebo controlled, parallel group
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Sleep Quality
Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy
Condition: Allergic Rhinitis; Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess safety, tolerability and demonstrate a dose response
      signal using Total Symptom Score (TSS), based on challenges with grass pollen in an
      Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose of
      SUBLIVAC FIX Phleum (SP) after 10 months of treatment compared to placebo.

      The study has 4 treatment groups: 3 different doses of SP and placebo will be tested.
    

Detailed description: 
      The current dose range finding study with SP has been designed to test three different
      concentrations of SUBLIVAC FIX Phleum (SP) that includes 3 doses (10,000 AUN/mL; 40,000
      AUN/mL; 80,000 AUN/mL) and placebo to demonstrate a dose response signal and to estimate the
      minimal effective dose of SP. The study will be conducted in the target population of
      seasonal allergic subjects in a fully validated Environmental Exposure Chamber (EEC) system.
      The EEC system is a facility that has temporal uniformity of airborne allergen (pollen)
      exposure to subjects. Use of the EEC ensures exposure to relatively consistent levels of
      allergen. This facility has been used in a number of immunotherapy trials and is an improved
      challenge model of AR compared to the previously used nasal provocation test. Treatment
      duration of this study is extended to 10 months.
    

Intervention name(s): SUBLIVAC FIX Phleum Prat.
Intervention type(s): Biological
Intervention description(s): sublingual daily administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sublingual immunotherapy; Dose range finding; Grass pollen; Allergic rhinitis/rhinoconjunctivitis; Immunogenicity
Estimation of the MCID for Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Background: The effect of exercise on knee osteoarthritis (OA) is often evaluated with
      patient-reported scales. The Minimal Clinically Important Difference (MCID) values of these
      scales are needed to understand the change in patients after treatment and to manage the
      treatment.

      It is also one of the most important data in calculating the MCID sample size. Aim: In the
      literature, MCID studies for exercise applied to knee OA are limited especially for those who
      did not undergo surgery. Thus new studies are needed.

      Method: 100 patients who were diagnosed with knee osteoarthritis will be recruited for the
      study. Participants will be included in an exercise program tailored to their needs for 15
      sessions. WOMAC, OKS, LEFS scales will be used also knee range of motion will be assessed in
      the baseline, after treatments and in the 4th month follow up.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): All patients will be included in the exercise program for their symptoms regarding knee osteoarthritis for 15 sessions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: knee osteoarthritis; mcid; exercise; rehabilitation
A Study to Evaluate the Safety of Augment™ Bone Graft
Condition: Defect of Articular Cartilage
MeSH terms: Cartilage Diseases
Study type: Interventional

Summary: 
      Is Augment Bone Graft plus Allograft safe to use for the treatment of osteochondral defects
      of the knee?
    

Detailed description: 
      Subjects will be 18 to 40 years with an osteochondral defects of the knee.They will be
      candidates for allograft and Augment Bone Graft will be added to the procedure. The safety of
      Augment Bone Graft plus allograft for osteochondral defects of the knee will be evaluated by
      type, frequency, severity and relatedness of adverse events to the device for a minimum of 24
      weeks.Magnetic Resonance Imaging will be performed at 1,12 and 42 weeks to evaluate device
      integrity and surgical treatment of osteochondral defects. Computed tomography will be done
      at week 1 and week 24 to determine the healing status of the osteochondral defect.
    

Intervention name(s): Augment Bone Graft
Intervention type(s): Device
Intervention description(s): Augment Bone Graft physically fills bone defects by providing a biocompatible scaffold for new bone formation.The material is comprised of a matrix of beta tricalcium phosphate and a highly purified recombinant human platelet-derived growth factor.
Other intervention name(s): Bone Graft
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observational Prospective Study.at the End of the Study the Patients Will be Classified According to PH,Serum Bicarbonate and Serum Sodium Into 6 Groups and Statistical Analysis Will be Performed Using Spss
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis
Study type: Observational

Summary: 
      1-to identify the prognostic value of serum bicarbonate and serum electrolytes at time of
      admission and their association with development of complications ,length of hospital stay
      ,prognosis and mortality in hospitalized cirrhotic patient
    

Detailed description: 
      the purpose of this study will be explore the impact of data obtained for the arterial blood
      gas parameters and serum bicarbonate and electrolytes at the time of hospital admission on
      adverse clinical outcomes ,duration of length of hospital stay and mortality in patients with
      cirrhosis .Furthermore incorporation these parameters into model of end stage liver disease
      could help to improve the prognostic value of MELDscore in comparison to the prognostic value
      of traditional equation of original MELD and child score
    

Intervention name(s): arterial blood gases and serum electrolytes
Intervention type(s): Diagnostic Test
Intervention description(s): arterial bloog gases parameters serum potassium serum sodium serum calcium
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        the study protocol will be approved by ethical committee of sohag university of medicine
        written informed consent will be obtained from all participants
Characterization of Secondary Hyperalgesia in Healthy Volunteers
Condition: Experimental Pain in Healthy Males
MeSH terms: Hyperalgesia
Study type: Interventional

Summary: 
      In this prospective trial we aim to investigate the intra-individual and inter-individual
      variance in secondary hyperalgesia following pain elicited by the experimental pain model:
      Brief Thermal Sensitization.

      Furthermore we wish to investigate how precise the psychological tests, Pain Catastrophizing
      Scale and Hospital Anxiety and Depression Scale predict the size of the area of secondary
      hyperalgesia.
    


Intervention name(s): Brief thermal sensitization; Long thermal stimulation; Heat-pain-detection threshold
Intervention type(s): Other; Other; Other
Intervention description(s): A small area of the skin of the study participants are heated to 45 degree celsius for 3 minutes, followed by evaluation of secondary hyperalgesia.; A small area of the skin of the study participants are heated to 45 degrees celsius for 1 minute. During the 1 minute period, the study participant will continually report pain on an electronic visual analog scale.; The threshold for heat pain are evaluated by heating a small area of the study participants skin. When the study participant feels pain, the temperature (degrees celsius) is registered.
4 threshold measurements per session. Heat pain threshold is defined as the average temperature of the 4 measurements.
Other intervention name(s): Experimental thermal pain model; Experimental pain model; Experimental pain model
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pain; Secondary hyperalgesia; thermal sensitization; Catastrophization; Anxiety
The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
Condition: Community Acquired Pneumonia (CAP)
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      Azithromycin has high rates of clinical response and eradication, wide spectrum of activity,
      so we suppose the development of the azithromycin injectable formulation in Japan would
      deliver benefit to patients of community acquired pneumonia.
    


Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention description(s): The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.
Intervention MeSH terms: Azithromycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple ascending dose study; the purpose of this study is to examine the safety,
      tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic
      Patients who are currently maintained on a stable dose of an antipsychotic medication.
    


Intervention name(s): SPD489 (Lisdexamfetamine dimesylate); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.; Placebo Capsule(s) for oral use taken once daily for 30 days
Other intervention name(s): Vyvanse, LDX
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Schizophrenia
HairMax LaserComb Open Label Study to Treat Seborrheic Dermatitis
Condition: Seborrheic Dermatitis
MeSH terms: Dermatitis; Dermatitis, Seborrheic
Study type: Interventional

Summary: 
      The purpose of this study is to test whether the stimulation of vascularization and cellular
      metabolism on the scalp by use of the HairMax LaserComb will produce improvement in the
      condition of scalp seborrheic dermatitis.
    

Detailed description: 
      This is an open label pilot study to evaluate the effects of the low-level laser light on
      seborrheic dermatitis of the scalp. Dandruff assessment scores for scalps with seborrheic
      dermatitis will be assessed at baseline with monthly evaluations during treatment, until
      final assessment at end of treatment at week 12.

      The trial will involve 10 patients aged 18 years and older with a diagnosis of seborrheic
      dermatitis. Patients will use the LaserComb device three times per week on non-consecutive
      days for 12 weeks. No other seborrheic dermatitis products will be used during treatment. The
      investigator will conduct measurements of dandruff at each study visit, as a measure of
      efficacy.

      The trial consists of 4-5 study visits (screening/baseline, week 4, week 8 and week 12).
      Dandruff evaluation and adverse event assessments will be performed at each visit.

      Safety analysis will be assessed based on the reports of adverse events during the study.
    

Intervention name(s): HairMax LaserComb
Intervention type(s): Device
Intervention description(s): LaserComb to be used 3 times weekly on non-consecutive days, according to User Manual instructions. Use is preferably following a shower, prior to using any styling products on the hair or scalp. Hair may be wet or dry during treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: seborrheic dermatitis
Study of Sodium Bicarbonate in Kidney Transplant Recipients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to compare the effect of sodium bicarbonate versus no sodium
      bicarbonate treatment on urinary ammonia levels and urinary transforming growth factor-beta1
      (TGF-beta1) excretion in renal transplant patients with low-to-normal serum bicarbonate
      levels (20 - 28 mmol/L).
    

Detailed description: 
      Renal allograft survival ten years after transplant is only about 50%. In people with
      non-transplant chronic kidney disease (CKD), sodium bicarbonate treatment seems to delay
      progressive decline in kidney function in those with low serum bicarbonate levels (metabolic
      acidosis). This may be because sodium bicarbonate reduces renal ammonia production and hence
      fibrosis. Observational evidence suggests that people with CKD and low-normal serum
      bicarbonate levels might also benefit from sodium bicarbonate treatment. TGF-beta1 levels
      seem to be an important predictor of chronic allograft nephropathy, and alkalinizing agents
      may have an effect on TFG-beta1 excretion.

      Retrospective analysis of participants in the African American Study of Kidney Disease and
      Hypertension showed the lowest risk of CKD progression was among those having baseline serum
      bicarbonate levels in the range of 28-30 mmol/L. Recent studies in people with pre-transplant
      CKD have suggested that increasing low serum bicarbonate levels (< 22 mmol/L) with
      alkalinizing agents such as sodium bicarbonate and sodium citrate may reduce CKD progression.

      Design: this is an open-label randomized study testing the effect of a six-month intervention
      with sodium bicarbonate 650 mg orally thrice daily versus no sodium bicarbonate treatment on
      renal ammonia excretion and urinary TGF-beta1.

      Visits will occur at baseline, 3 months, and 6 months. At each follow-up visit, the study
      coordinator or principal investigator will review a medical questionnaire with the
      participant and collect a sample of blood and urine for analysis of urinary TGF-beta1,
      metabolic panel, pH, urinary net acid excretion, urinary bicarbonate and urinary ammonia.
    

Intervention name(s): Sodium bicarbonate
Intervention type(s): Drug
Intervention description(s): Sodium bicarbonate 650mg by mouth three times daily for 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bicarbonate; Chronic allograft nephropathy; Urinary TGF-beta; Urinary acid excretion
Study of Mind-Body Skills Groups for Adolescents With Depression in Primary Care
Condition: Depression; Depressive Disorder
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The Center for Mind -Body Medicine has developed a mind-body skills group program that
      incorporates meditation, guided imagery, breathing techniques, autogenic training,
      biofeedback, genograms, and self-expression through words, drawings, and movement. These
      mind-body skills are designed to increase self-awareness and self-regulation. This program
      has been shown to significantly improve depression symptoms in children and adolescents with
      posttraumatic stress disorder in Gaza, but it has not yet been tested in a US adolescent
      population. The purpose of this study is to determine the feasibility of using mind-body
      skills groups to reduce depression in adolescents and to investigate the effects of the
      program on factors such as self-efficacy, mindfulness and rumination which are likely to
      mediate improvement.
    


Intervention name(s): mind-body-skills group
Intervention type(s): Behavioral
Intervention description(s): mind-body skills group program incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Depression; Adolescent; mind-body-skills; group therapy; primary care
Individual and Family Motivational Interviews for Substance Using Truant Teens
Condition: Substance Use; Risky Sexual Behavior
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This application will provide a test of one potential model for adding substance use
      assessment and brief intervention into a truancy court program. The primary goal of this
      study is to determine whether a motivational intervention will reduce substance use among
      adolescents referred to truancy court for school attendance problems. In this treatment
      development application, an open trial with 20 families referred by truancy court will first
      be conducted. This trial will be used to adapt an existing motivational intervention to
      include material relevant to school attendance and performance. Then 100 families
      participating in the Rhode Island Truancy Court Program with adolescents between the ages of
      13-16 years who report using substances will be randomly assigned to receive the experimental
      intervention plus standard truancy court procedures or psychoeducation plus standard truancy
      court procedures. The 2-session intervention protocol consists of an individual motivational
      interview plus the Family Check-Up (Dishion & Kavanagh, 2003), a family based motivational
      interview. The experimental protocol provides a thorough assessment of both individual and
      family strengths and weaknesses with respect to substance use prevention and school
      attendance/performance. Follow-up interviews will be conducted at 3 and 6 months.
    


Intervention name(s): Family Check-up/ Individual MI; Individual and family psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The 2-session intervention protocol consists of an individual motivational interview plus the Family Check-Up (Dishion & Kavanagh, 2003), a family based motivational interview. The experimental protocol provides a thorough assessment of both individual and family strengths and weaknesses with respect to substance use prevention and school attendance/performance.; Families in PE will return for the same number of visits as the IMI and FCU sessions of the IMI/FCU condition. An interventionist will review a set of educational materials with the parents regarding teen SU use, truancy and risk behaviors and parenting a teenager. A similar set of materials will be reviewed with the adolescent
Other intervention name(s): (Family Check-up); (Psychoed)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: substance use; adolescents; intervention; truancy; sexual risk behavior
Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post SARS-CoV-2 Patients
Condition: Post-COVID-19 Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      Chronic fatigue, weakness, dyspnea, headaches, cognitive dysfunction, stress, sadness,
      anxiety, sleep disturbances, and orthostatic intolerance are among the symptoms of acute
      Covid-19 in patients, and these symptoms persist for more than 12 weeks after recovery.
      Extended Covid-19 syndrome, also known as Post-Covid-19 syndrome, is described as
    

Detailed description: 
      Therapeutic exercises are an evidence-based method for the maintenance of musculoskeletal,
      cardiovascular and neurological well-being and the prevention and treatment of chronic
      diseases. The effects of therapeutic exercises on the human body varied according to the
      frequency, intensity, duration and type of exercise.

      Increasing physiological and psychological recovery after exercise can lead to results such
      as better performance and reducing the risk of injury. Therefore, various methods are used to
      facilitate post-exercise recovery.

      The best-known and most widely used post-exercise recovery method is active cooling, also
      known as active rest or cool-down. Active cooling; It is defined as any activity that
      includes voluntary, low/moderate intensity exercise or movement performed within one hour of
      exercise. Passive rest, on the other hand, is defined as no or minimal voluntary/intentional
      exercise movement.
    

Intervention name(s): non-invasive auricular vagus stimulation; Placebo Non Invasive Vagus Stimulation
Intervention type(s): Device; Device
Intervention description(s): The only cutaneous nerve of the N. vagus, ramus auricularis, receives sensation from the posterior surface of the auricle, the posterior part of the external auditory canal and the adjacent part of the eardrum. Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. This device non-invasively stimulates the auricular branch of the vagus nerve without any action. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased.; Placebo Non Invasive Vagus Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and drug levels of
      BMS-986337 in healthy participants and in healthy Japanese participants.
    


Intervention name(s): BMS-986337; BMS-986337 Placebo; Famotidine
Intervention type(s): Drug; Other; Biological
Intervention description(s): Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteers