bioihbjkbjnl/mcl2 huggingface dataset:
Improving Therapeutic Learning in Depression: Proof of Concept
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite advances in both pharmacotherapy and psychotherapy for major depression, non-response
      and partial-response remain relatively common outcomes, motivating the search for new
      treatments. This study is concerned with the development of one such novel treatment, the
      augmentation of exposure-based cognitive-behavior therapy (CBT) with d-cycloserine (DCS).
    

Detailed description: 
      Investigators will study the efficacy of DCS for augmenting therapeutic learning relevant for
      the treatment of depression (i.e., outside the extinction learning where DCS has been shown
      to have success). Specifically, the study investigates the role of DCS in enhancing
      declarative memory in depressed individuals, as evaluated by standardized tests and the
      retention of cognitive therapy session material. Investigators will also study an active
      comparison agent, modafinil, which appears to offer cognitive enhancing effects among both
      sleep-deprived and non-sleep-deprived individuals, but also appears to have drug-state (e.g.,
      mood and side) effects that are not characteristic of DCS augmentation. Therefore,
      drug-context effects may affect memory retention over time. Hence, the study will evaluate
      memory enhancement effects both during the period of drug action as well as one week later
      when no drug is taken. Overall, investigators will examine cognitive function and memory
      performance over 4 study sessions in 96 men and women with major depression, who, in a
      double-blind fashion, will be randomly assigned to either: (1) 250mg DCS, (2) 100mg
      modafinil, or (3) placebo administered on Study Weeks 2 and 3. The memory tests include both
      items unique to a given study week and memory tasks that are repeated over time that allow
      assessment of memory and retention effects across one-week periods.
    

Intervention name(s): 250 mg DCS; 100 mg Modafinil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drug; Drug; Drug
Other intervention name(s): d-cycloserine
Intervention MeSH terms: Cycloserine; Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cognitive behavior therapy (CBT); d-cycloserine (DCS); Modafinil
Imaging Tau in Alzheimer's Disease and Normal Aging
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to learn about tau tangles in Alzheimer's disease. A type of
      positron emission tomography (PET) scan is used to measure the abnormal accumulation of
      protein called tau in the brain. These are thought to be involved in Alzheimer's disease. The
      investigators will also perform brain MRI and to tests to measure the participant's memory
      and thinking.
    

Detailed description: 
      This study is being done to determine the relationship between tau tangles and cognitive
      impairment in elderly subjects with and without Alzheimer's disease (AD). Subjects will
      undergo screen that includes neuropsychological testing and brain MRI. This study uses a
      special type of scan called a PET scan to take pictures of the brain. During the PET scan, a
      special radioactive dye called 18F-MK-6240 is injected into the body. 18F-MK-6240 sticks to
      abnormal tangles made of the protein tau. Subjects will have the option to have lumbar
      puncture performed to measure CSF concentrations of biomarkers.
    

Intervention name(s): 18F-MK-6240; Lumbar Puncture (optional)
Intervention type(s): Drug; Procedure
Intervention description(s): 18F-MK-6240 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.; Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
Other intervention name(s): [18F]-MK6240
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 18F-MK-6240; Cognitive Impairment; Alzheimer's
A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled,
      parallel-group study to evaluate the efficacy and safety of omalizumab administered
      subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged
      12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite
      standard-dose H1 antihistamine treatment.
    

Detailed description: 
      Type I Error Rate Control Plan

      Primary Outcome Measure

      In order to maintain an overall type I error rate of 0.05 (2-sided) across the 3 omalizumab
      dose levels, the testing of the primary Outcome Measure was conducted in the following
      hierarchical order. A p-value < 0.05 is only considered statistically significant if
      statistical significance was claimed at the previous stage.

        -  Stage 1: Omalizumab 300-mg group vs. placebo

        -  Stage 2: Omalizumab 150-mg group vs. placebo

        -  Stage 3: Omalizumab 75-mg group vs. placebo

      Secondary Outcome Measures

      A hierarchical analysis of the following secondary Outcome Measures was performed for each
      dose found to be significant in the primary Outcome Measure. A p-value < 0.05 is only
      considered statistically significant if statistical significance was claimed at the previous
      stage.

        -  Stage 1: Change from baseline to Week 12 in the urticaria activity score over 7 days
           (UAS7)

        -  Stage 2: Change from Baseline to Week 12 in the weekly number of hives score

        -  Stage 3: Time to minimally important difference (MID) response in the weekly itch
           severity score by Week 12

        -  Stage 4: Percentage of participants with a UAS7 score ≤ 6 at Week 12

        -  Stage 5: Percentage of weekly itch severity score MID responders at Week 12

        -  Stage 6: Change from Baseline to Week 12 in the weekly size of the largest hive score

        -  Stage 7: Change from Baseline in the overall dermatology life quality index (DLQI) score
           at Week 12

        -  Stage 8: Change from Baseline in the overall dermatology life quality index (DLQI) score
           at Week 12

        -  Stage 9: Percentage of complete responders (UAS7 = 0) at Week 12
    

Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.; Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Combination Treatment With Doxazosin Plus TolterodineSR 2 mg Versus 4mg in Men With an Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH)
Condition: Overactive Bladder; Benign Prostatic Hyperplasia
MeSH terms: Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      OAB occurs in approximately 50% to 75% of men with BPO and up to 38% of men with BPO continue
      to suffer from OAB after relief the obstruction.Symptoms of OAB are more bothersome than the
      voiding complaints of slow stream and hesitancy. However, the patients with both BPO and OAB
      are often not treated with muscarinic receptor antagonists due to concern that they will
      experience acute urinary retention.

      Tolterodine is a potent and pure muscarinic receptor antagonist that was developed
      specifically for the treatment of overactive bladder. Recently, studies revealed that
      tolterodine was effective, safe and well tolerated in adults with OAB and urodynamically
      confirmed BPO.However, the optimal dosage of antimuscarinic for the treatment of OAB
      coexisting BPO was not yet fully assessed. In real clinical situation, some patients complain
      voiding difficulty after addition of antimuscarinics and want to stop antimuscarinics.It is
      probable that a lower dosage of antimuscarinics combined with alpha-adrenergic antagonists
      can be used safely in OAB patients with BOO, with the same efficacy.

      This study is designed to investigate the optimal doses of tolterodine SR in combination with
      doxazosin in men with both BOO and OAB based on efficacy, safety, and tolerability.
    


Intervention name(s): doxazosin plus tolterodine SR
Intervention type(s): Drug
Intervention description(s): doxazosin plus tolterodine SR(2 mg, qd)for 12 weeks or (4 mg, qd) for 12 weeks
Other intervention name(s): Cadura XL 4mg or 8mg; Detrusitol SR 2mg
Intervention MeSH terms: Doxazosin; Tolterodine Tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Overactive bladder; Benign prostate hyperplasia; Doxazosin; Tolterodine
Postural Garment Versus Exercises for Women With Cervical Pain
Condition: Posture; Cervical Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study aim to compare a new postural garment (Posture Plus Force ®) versus exercises in
      women with non specific cervical pain. The investigators focus on nurses and allied health
      professionals due to the importance of posture in work related musculoskeletal disorders.
    

Detailed description: 
      OBJECTIVE: To investigate the effects of a postural garment versus exercises in nurses with
      non-specific cervical pain.

      DESIGN: Randomized cross over clinical trial with a 3 months sequence treatment and a 3
      months washout period..

      PARTICIPANTS: Nurses and allied health professionals with cervical pain aged 21 to 55 years.

      INTERVENTIONS:

      Participants are allocated at random to receive interventions in two groups:

        -  P+ : a postural garment (Posture Plus Force - FGP srl ® - Italy) to be worn from 2 to 4
           hours per day, during 90 days.

        -  Ex: five physiotherapy sessions to learn stretching and strengthening exercises (20
           minutes) with instructions to continue at home on a daily basis for 90 days.

      The subjects in each group will be cross over after three months of wash out period.

      MAIN OUTCOME MEASURES:

      The primary outcomes are postural control and pain intensity. Pictures on sagittal and
      frontal plane as well as measurements of static posturography with a scan (SpinalMouse ®) are
      conducted at T0 (pre-intervention), T1 immediately after garment fitting for P+ group and
      after the 5th session for Ex group, T30, T60 and T90 at day 30, day 60 and day 90 of
      follow-up. Pain is measured by visual analogue scale (VAS) on the same assessment days.

      STATISTICAL ANALYSIS:

      Statistical analysis is conducted following intention-to-treat principles, and the treatment
      effects calculated using linear mixed models.
    

Intervention name(s): Exercises; Posture garment
Intervention type(s): Other; Device
Intervention description(s): 5 sessions of exercises of 20 minutes each. Participants have to do a set of cervical, dorsal and abdominal stretching and strengthening exercises. Participants receive instructions to continue at home on a daily basis for 3 months and record compliance in a logbook.; Participants are provided with the appropriate size of a posture garment which includes thoracic and abdominal tensional bands. They are instructed to wear it 2 to 4 h per day for a 3 month period and record compliance in a logbook daily.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants are randomised to receive one intervention during the initial 3 month phase of the study and receive the other intervention during the second 3 month phase of the study, after a wash out 3 month period.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: posture; cervical pain; exercise
Knee Brace and Biomechanical Footwear in the Treatment of Knee Osteoarthritis.
Condition: Osteoarthritis,Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study investigates the effects of unloader knee brace, biomechanical footwear device and
      exercise therapy on pain, physical function and quality of life in patients with knee
      osteoarthritis. The aim is to find more effective treatment strategies to delay or prevent
      heavy knee replacement surgeries.
    

Detailed description: 
      The aim of this study is to investigate the effects of exercising, and using a knee brace and
      exercising, and using of biomechanical footwear device on clinically important symptoms,
      physical function and quality of life in patients with osteoarthritis of the knee. The
      hypothesis is that the groups of using knee brace and biomechanical footwear can alleviate
      pain, improve physical function and quality of life more efficiently, than the group doing
      home exercises only.

      The subjects (n = 120) will be randomized into three groups mentioned above, after which they
      will start to do exercises, or to use a knee brace and do exercises, or to use biomechanical
      footwear at home according to the instructions for 4 months. Physical function, symptoms and
      quality of life will be measured before and after 4-month intervention. In addition, at
      12-month time point follow-up surveys will be addressed with regard to symptoms and quality
      of life, as well as to cost-effectiveness of the study.
    

Intervention name(s): Home-based exercise; Knee brace; Biomechanical footwear device
Intervention type(s): Other; Device; Device
Intervention description(s): Home-based exercises three times per week.; Progressive use of knee brace each day during activities of daily living.; Progressive use of footwear each day during activities of daily living.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee brace; biomechanical footwear; exercise; RCT
Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence
Condition: Urinary Incontinence; Stress Urinary Incontinence; Urge Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urinary Incontinence, Urge
Study type: Interventional

Summary: 
      This multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid
      fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence.
    

Detailed description: 
      Both 2940 nm Er:YAG (Erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are
      cleared by the Food and Drug Administration (FDA) for ablation, vaporization, coagulation of
      soft tissue and for skin resurfacing. Fractional delivery of laser is a well-established
      method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue
      intact in order to decrease healing time. The layers of skin and vaginal mucosal tissue
      exhibit similarities that suggest the clinical results seen with skin resurfacing may be
      translated to the vaginal tissue. Improved vaginal tissue tone and increased collagen
      formation in the lamina propria beneath the urethra may lead to improved urinary control.
      This multi-centered, 18-month prospective clinical trial will determine the safety and
      long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (Hybrid Fractional
      Laser) as an alternative non-surgical, non-hormonal treatment for improvement of symptoms of
      urinary incontinence.
    

Intervention name(s): Hybrid Fractional Laser
Intervention type(s): Device
Intervention description(s): Consecutive and coincident fractional 2940 nm and 1470 nm lasers
Other intervention name(s): diVa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mediterranean Diet, Trimethylamine N-oxide (TMAO) and Anti-oxidants in Healthy Adults
Condition: Mediterranean Diet; Trimethylamine N-oxide; Cardiovascular Risk Factor
Study type: Observational

Summary: 
      Trimethylamine N-oxide (TMAO) is a small organic compound naturally present in fish and
      seefood or generated by the bacterial breakdown of dietary phosphatidylcholine and
      carnitine-containing foods within the human gut microbiome. Elevated serum TMAO was
      previously reported to be associated with an elevated risk for cardiovascular events.

      Aim of this study was to investigate the association between plasma levels of TMAO with the
      Mediterranean diet in a cohort of healthy adults.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects (n=84) aged 21-50 years with a BMI of 20-29.9 kg/m2, chosen among hospital
        volunteers and employees from the same geographical area. A sample size of n=40 was
        determined from a power analysis of a within-subject design to detect a 10% difference of
        plasma TMAO concentration at alfa<0.05 and β =0.8. Participants were screened by the use of
        a blood chemistry profile, cell count, and health history questionnaire.
EFFECT OF CRYOLIPOLYSIS ON HORMONAL PROFILE AND MENSTRUAL REGULARITYIN OBESE WITH PCOS
Condition: Obese Women With PCOS
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The effecting study to determine the impact of cryolipolysis on obese women with pcos
    

Detailed description: 
      Polycystic ovary syndrome(PCOS) is the most common endocrine disorder in women of
      reproductive age. Women with this syndrome may have infrequent menstrual periods or
      amenorrhea and excess androgen levels. The ovaries develop numerous small follicles and fail
      to ovulate on a regular basis, with subsequent subfertility in those women that wish to
      conceive.The etiology of PCOS is unclear. Early diagnosis and treatment may reduce the risk
      of long-term complications such as type 2 diabetes and heart disease ,PCOS affects 5-20% of
      women of reproductive age worldwide. The condition is characterized by hyperandrogenism,
      ovulatory dysfunction and polycystic ovarian morphology (PCOM) with excessive androgen
      production by the ovaries being a key feature of PCOS. PCOS is classified into four separate
      phenotypes (A-D), according to the presence or absence of three characteristics:
      hyperandrogenism (either biochemical or clinical), ovulatory dysfunction and polycystic
      ovarian morphology. Only phenotype A requires all three features of PCOS to be present. The
      various diagnostic criteria currently available for PCOS include a greater or fewer number of
      PCOS phenotypes. AE-PCOS, Androgen Excess-PCOS Society; NIH, National Institutes of Health
      ,the trial made on 2group ,control group and study group for 3 months
    

Intervention name(s): Cryolipolysis device
Intervention type(s): Device
Intervention description(s): -Cryolipolysis device
1max cool shaping device ( inform china korean technology).Is used for fat lipolysis ,with no harm to the skin.The device consist of Cool sculptor applicator head , cool gel pad its alarge gel pad it should be adherent to the area to be treated before applying the cool sculptor applicator to protect the skin from bruising or ecchymosis. The device uses vacuum suction which can be adjusted according to the patient tolerance. Duration of session 45min at each of treatment session ,1session every 2weeks for 3months.
Other intervention name(s): max freeze device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Impact of cryolipolsis on hormonal Profile in obese women with Pcps
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: obesity, pcos ,cryolipolysis
The Effect of Combination Therapy Using Li-ESWT and PDE-5 Inhibitor in Patients With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      to compare the effect of combination of li-eswt and pde-5 inhibitor to pde-5 alone in
      erectile dysfunction patients
    

Detailed description: 
      Comparing the effect of Combination therapy (Li-ESWT combined with PDE5-inhibitor) vs SIngle
      therapy (PDE5-inhibitor) in mild to moderate Erectile Dysfunction patients.

      Parameters used for comparation are EHS score, IIEF-5 score, VEGF level and PSV
    

Intervention name(s): Li-ESWT; Tadalafil 2.5Mg Tab
Intervention type(s): Procedure; Drug
Intervention description(s): Li-ESWT twice weekly for 4 weeks; tadalafil 2.5mg once daily
Other intervention name(s): Shockwave Therapy; Standard First Line Therapy
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators intend to show that DDAVP improves platelet activity from baseline to 60
      minutes after treatment start.
    


Intervention name(s): DDAVP injection (desmopressin acetate)
Intervention type(s): Drug
Intervention description(s): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes
Intervention MeSH terms: Deamino Arginine Vasopressin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intracerebral hemorrhage; platelets
A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the safety and efficacy for two regimens of etanercept in patients
      with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly
      regimen and a 50mg once weekly regimen.
    

Detailed description: 
      This study will compare the safety and efficacy for two regimens of etanercept in patients
      with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly
      regimen and a 50mg once weekly regimen.
    

Intervention name(s): etanercept
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis