bioihbjkbjnl/mcl2 huggingface dataset:
Resiliency in Total Joint Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The investigators primary objective is to determine how does participation in StreaMD affect
      patient reported outcomes after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty
      (TKA)?
    

Detailed description: 
      Osteoarthritis is a leading cause of disability in the US. By conservative estimates, about
      54 million adults in the US have doctor-diagnosed arthritis. The number of people expected to
      have arthritis by the year 2040 is more than 78 million. Total joint arthroplasty is
      considered the treatment of choice for end-stage osteoarthritis. Currently, more than 1
      million hip and knee replacements are performed each year in the US. By 2030, primary THR is
      projected to grow 171% and primary TKR is projected to grow by up to 189%, for a projected
      635,000 and 1.28 million procedures, respectively. The incidence of pre-operative
      psychological distress in this group of patients is reported between 30% and 60% and
      preoperative psychological distress is associated with poorer pain and functional outcomes
      after surgery. Resilience, characterized by an ability to bounce back or recover from stress,
      is increasingly recognized as a psychometric property affecting many outcomes' domains
      including outcomes after TJA. Better resilience could improve patients overall satisfaction
      with the procedure.
    

Intervention name(s): StreaMD
Intervention type(s): Other
Intervention description(s): Patients who are randomized to the intervention arm will be signed up for the automated text messaging program. Patients will receive automated text messages related to their surgery during the study period and can also ask questions through the text messages program, where automated messages will be sent based on the questions asked.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Total Hip Arthroplasty; Total Knee Arthroplasty; Patient Reported Outcomes; Resilience
Study to Characterize the Efficacy of a Dual Active Dentifrice for the Relief of Dentin Hypersensitivity
Condition: Dentin Hypersensitivity; Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This exploratory study will characterize the efficacy profile of an experimental dual active
      5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single
      active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.
    

Detailed description: 
      This will be a single center, 8-week, randomized, controlled, examiner-blind, two treatment
      arm, parallel design, stratified (by maximum Baseline Schiff sensitivity score of the two
      selected test teeth), Phase II, exploratory clinical study in healthy participants with DH.
      It is hypothesized that the combination of two antisensitivity active ingredients with
      complementary modes of action (potassium nitrate: nerve desensitization; stannous fluoride:
      dentin tubule occlusion) will deliver superior anti-sensitivity efficacy, compared to either
      active alone.
    

Intervention name(s): Potassium Nitrate; Stannous Fluoride
Intervention type(s): Other; Other
Intervention description(s): The test dentifrice contains 5% w/w potassium nitrate.; The test and control dentifrices contain 0.454% w/w stannous fluoride (1100 ppm fluoride).
Intervention MeSH terms: Fluorides; Tin Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single center, 8-week, randomized, controlled, parallel design, exploratory clinical study in healthy participants with dentin hypersensitivity. Eligible participants will be stratified by the maximum Baseline Schiff sensitivity score of their two selected test teeth).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Glucosamine as a Novel Adjunctive Therapy in Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional
Phase: Phase 4

Summary: 
      Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of
      chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect and
      was administrated orally in osteoarthritis and atopic dermatitis therapy. Given the Oral
      lichen planus (OLP) T-cell-mediated pathogenesis; this drug seems to be a promising
      therapeutic option. The investigators compared clinical effectiveness of Glucosamine combined
      with two topical corticosteroid regimens to that of topical corticosteroid alone in
      symptomatic OLP and investigated therapeutic mechanism by examining treatment effect on
      expression of inhibitor kappa kinase alpha (IKKα) and interleukin-8 (IL-8) in OLP lesions.
    

Detailed description: 
      Thirty patients with Erosive or Atrophic OLP were randomly assigned into Three equal groups
      to receive combination of topical steroid (triamcinolone acetonide 0.1 %) four times per day
      and (glucosamine sulfate 500 mg) orally three times per day for 8 weeks (Group I),
      combination of topical steroid twice daily and glucosamine sulfate 500 mg orally three times
      per day for 8 weeks (Group II), or topical steroid alone four times per day for 8 weeks
      (Group III) all patients were followed up for another treatment free 4 weeks observational
      period. Photographs of the most severe lesion were taken (Marker lesion) in each patient and
      analyzed for Total Ulcerative Area (TUA), Total Atrophic Area (TAA), and Total Reticular Area
      (TRA), patients were also assessed using clinical scores (CS) and visual analogue scale
      (VAS). Pre-treatment and post-treatment specimens were immunohistochemically stained to
      detect expression of IKKα and IL-8.
    

Intervention name(s): Glucosamine sulfate; triamcinolone acetonide
Intervention type(s): Drug; Drug
Intervention description(s): Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect; Topical corticosteroid
Other intervention name(s): Kenalog in orabase
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oral lichen planus; Glucosamine; IL-8
Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to determine if repetitive transcranial magnetic stimulation
      (TMS) will alleviate symptoms of major depressive disorder (MDD) in pregnant women.

      TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more
      effectively with one another. Effective neuron communication is thought to lead to the
      lessening of depressive symptoms. In this study subjects require daily TMS treatment for
      approximately four weeks.
    

Detailed description: 
      We hypothesize that there will be a decline in the Hamilton Rating Scale for Depression
      (HDRS-17) scores from the beginning to end of treatment. We expect that this decrease will be
      significantly greater in subjects receiving active transcranial magnetic stimulation (TMS)
      compared to those receiving placebo TMS. Treatment response will be defined as greater than
      50% reduction in HDRS-17 score.

      We also hypothesize that levels of Brain Derived Neurotrophic Factor (BDNF), a protein
      thought to regulate mood and cognitive functioning, will increase in subjects who respond to
      TMS treatment. We expect BDNF levels to increase by greater than or equal to 20% in those who
      respond to TMS. As previously stated, TMS response will be defined as a significant decrease
      (50% or greater) in the HDRS-17 from baseline to end of treatment.
    

Intervention name(s): Active Transcranial Magnetic Simulation; Sham Transcranial Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): Subjects will be given active TMS 5 days per week for 4 weeks for a total of 20 sessions. Each session will last approximately 10 minutes.; Subjects will be given sham TMS 5 days per week for 4 weeks for a total of 20 sessions. The sham coil contains a shielding mechanism which diverts the magnetic field away from the patient. The sham treatment will last approximately 10 minutes.
Other intervention name(s): Neuronetics 2100 CRS TMS System; The eSham System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Pregnancy; Brain Derived Neurotrophic Factor; Transcranial Magnetic Stimulation
Neoadjuvant PD-1 Monoclonal Antibody in Cisplatin-ineligible High Risk Upper Tract Urothelial Carcinoma
Condition: Neoadjuvant Immunotherapy of Cisplatin-ineligible High Risk Upper Urinary Tract Urothelial Carcinoma
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Neoadjuvant therapy of cisplatin-based chemotherapy has been proved to improve prognosis of
      muscle invasive UTUC patients in several studies. This study is designed to investigate the
      safety and efficacy of neoadjuvant PD-1 monoclonal antibody in patients with locally advanced
      upper urinary tract urothelial carcinoma (UTUC) which are ineligible for cisplatin.
      Tislelizumab, an anti-programmed death protein-1 (PD-1) monoclonal antibody, was engineered
      to minimize binding to FcγR on macrophages to abrogate antibody-dependent phagocytosis, a
      mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. The safety,
      tolerability, and efficacy of tislelizumab in patients with PD-L1 positive urothelial
      carcinoma who progressed during/following platinum-containing therapy was proved in a phase 2
      trial (CTR20170071). This trial focuses on the efficacy of Tislelizumab to induce
      pathological down-staging of locally advanced UTUC in neoadjuvant setting.
    

Detailed description: 
      Neoadjuvant therapy of cisplatin-based chemotherapy has been proved to improve prognosis of
      muscle invasive UTUC patients in several studies. This study is designed to investigate the
      safety and efficacy of neoadjuvant PD-1 monoclonal antibody in patients with locally advanced
      upper urinary tract urothelial carcinoma (UTUC) which are ineligible for cisplatin.
      Tislelizumab, an anti-programmed death protein-1 (PD-1) monoclonal antibody, was engineered
      to minimize binding to FcγR on macrophages to abrogate antibody-dependent phagocytosis, a
      mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. The safety,
      tolerability, and efficacy of tislelizumab in patients with PD-L1 positive urothelial
      carcinoma who progressed during/following platinum-containing therapy was proved in a phase 2
      trial (CTR20170071). This trial focuses on the efficacy of Tislelizumab to induce
      pathological down-staging of locally advanced UTUC in neoadjuvant setting.
    

Intervention name(s): Tislelizumab
Intervention type(s): Drug
Intervention description(s): Patients will receive 2-4 cycles of Tislelizumab (200mg per cycle) before surgery（radical nephroureterectomy, segmental ureteral resection, endoscopic ablation）
Other intervention name(s): anti-PD-1 monoclonal antibody
Intervention MeSH terms: Tislelizumab
Intervention model: Single Group Assignment
Intervention model description: Patients will receive 2-4 cycles of Tislelizumab (200mg per cycle) prior to surgery（radical nephroureterectomy, segmental ureteral resection, endoscopic ablation）
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neoadjuvant therapy; radical nephroureterectomy; Tislelizumab; Cisplatin-ineligible
Effect of Exercise With or Without Breakfast, on Metabolism, Appetite and Cognition
Condition: Energy Balance,; Appetite,; Cognitive Function.
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of eating breakfast in combination with
      exercise on fat usage, appetite and brain performance later in the day.
    


Intervention name(s): Breakfast & exercise
Intervention type(s): Drug
Intervention description(s): 1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Risk Analysis for Cardiovascular Autonomic Neuropathy
Condition: Cardiovascular Autonomic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Nervous System Diseases
Study type: Observational

Summary: 
      This is a large-scale, community-based, cross-sectional study to evaluate environmental and
      genetic risk factors for cardiovascular autonomic neuropathy in general Chinese population.
    

Detailed description: 
      A large-scale, community-based, cross-sectional study was conducted to explore the extent to
      which risk factors associated with cardiovascular autonomic neuropathy (CAN) in general
      Chinese population. A total of more than 2000 participants were recruited by using multiple
      stages sampling (first cluster sampling and then simply sampling). Data involved in
      demographic information, clinical biomarkers such as glucose and lipids profiles, medical and
      therapy history were collected. Every participants was complete DNA extracted and genotyped.
      Cardiovascular autonomic functions were measured by using short-term heart rate variability
      (HRV) to evaluate the outcome of CAN. Univariate and multiple variables analysis have been
      performed to examine potential environmental and genetic risk factors of CAN. In addition,
      clinical risk model, simply screening model and non-linear system model such as artificial
      neural network was created, respectively.
    

Intervention name(s): not intervention
Intervention type(s): Other
Intervention description(s): This is a cross-sectional study, no intervention was performed.
Other intervention name(s): This is a cross-sectional study, no intervention was performed.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        We recruited participants from rural and urban communities in Shanghai. Survey participants
        with undiagnosed CAN, aged 30-90 years, were included in this study. Our study invited a
        total of 3,012 subjects to a screening visit between 2011 and 2012.
      
Biospecimen description: 
      DNAs were extracted and genetyped.
    
Keywords: risk analysis; general Chinese population; cardiovascular autonomic neuropathy
A 28-Day Study of Diclazuril in the Treatment of Cryptosporidiosis in Patients With AIDS
Condition: Cryptosporidiosis; HIV Infections
MeSH terms: Cryptosporidiosis
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of diclazuril capsules as a treatment for cryptosporidial
      related diarrhea in AIDS patients who have been treated in the double-blind study # JRD
      64,433/1101 and have relapsed, or de-novo patients who have been diagnosed with
      cryptosporidial related diarrhea and who meet the inclusion and exclusion criteria of this
      protocol.
    


Intervention name(s): Diclazuril
Intervention type(s): Drug
Intervention MeSH terms: Diclazuril
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; Cryptosporidiosis; Diarrhea; diclazuril; Coccidiostats; Acquired Immunodeficiency Syndrome
Group Cognitive Behavioral Therapy to Treat Depression in an Epilepsy Clinic Setting
Condition: Epilepsy; Depressive Disorder
MeSH terms: Epilepsy; Depressive Disorder
Study type: Interventional

Summary: 
      This study involves a form of group therapy called Cognitive Behavioral Therapy or CBT for
      depressed patients with Epilepsy. The CBT groups will be tailored for an epilepsy clinic
      population. There are 12 sessions of therapy in the study held once a week for 12 weeks.
    

Detailed description: 
      Depression is frequent in PWE and often missed for unclear reasons. Busy neurology clinics
      and their overworked physicians often lack psychiatric backup that may make inquiring about
      psychological issues problematic. In the psychiatric community, awareness of the need for
      depression intervention in the primary care clinic has been recognized for many years and
      several treatment models exist. This study will attempt to use one such model, i.e.
      Cognitive-Behavioral Therapy (CBT) using a group format and tailoring its use for an epilepsy
      clinic population.
    

Intervention name(s): Cognitive Behavioral Therapy (CBT) in a Group Format
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HIV Screening Take-up: Evaluating Incentives and Opt-out Strategies
Condition: HIV
Study type: Interventional

Summary: 
      Over twenty percent of HIV-positive persons in the United States are unaware of their
      infection, leading the Institute of Medicine to recently urge further work to compare the
      effectiveness of HIV screening strategies. This study will use a randomized trial to compare
      several variants of emergency-room-based HIV-testing policies in order to determine how HIV
      test acceptance rates can be increased. The testing policies will be designed using
      principles from behavioral economics, varying the choice architecture and offering small
      monetary incentives. This will be the first study to measure differences in take-up rates
      across a variety of promising but largely untested approaches within a unified randomized
      trial. Three defaults will be tested: traditional opt-in (test only those patients who
      request testing), opt-out (routinely testing unless patients decline), and active-choice
      testing (patients are required to state whether they want to be tested). The study will also
      be the first to test the effect of small monetary incentives ($1, $5, $10) on test take-up.
      An additional novel study contribution will be to test the hypothesis that compliance with
      large requests (accept an HIV test) increases after making a small request or pre-commitment
      - this "foot in the door" technique has not been previously studied in this setting. The
      factorial design will permit a direct comparison of all interventions, as well as
      interactions. The study will contribute a nuanced empirical understanding of how testing
      protocols from behavioral economics theory affect the effectiveness and efficiency of
      screening programs in an actual scaled- up setting (San Francisco General Hospital). This
      will assist in implementing and assessing recent CDC guidelines on HIV screening, while also
      more generally advancing scientific knowledge related to applying behavioral economics in
      comparative effectiveness research.
    


Intervention name(s): Monetary Incentive; Questionnaire Timing; HIV Test Offering
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): $1, $5, or $10 incentive; Timing of the questionnaire--either before or after testing is offered.; HIV Test will be offered as opt-in, opt-out, or active choice.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Patient-reported Outcomes in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Patient-reported health economic outcomes for patients enrolled in S1543003 and S1543004
      protocols
    


Intervention name(s): bifeprunox
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
Condition: Walking Impairment; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group
      study of ADS-5102 extended release (ER) capsules, an investigational formulation of
      amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS.
      ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher
      plasma amantadine concentrations in the early morning, sustained throughout the afternoon,
      and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to
      deliver its primary treatment effect during the day, and potentially reduce the adverse
      events of immediate-release amantadine when the patient is asleep.
    


Intervention name(s): ADS-5102; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral capsules to be administered once daily at bedtime for 4 weeks; Oral capsules to be administered once daily at bedtime for 4 weeks
Other intervention name(s): amantadine HCl extended release
Intervention MeSH terms: Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female
      Subjects
    

Detailed description: 
      This is a Phase 1 study in healthy volunteers to evaluate the potential effect of multiple
      doses of paroxetine on the pharmacokinetics and safety of HBI-3000. Each subject serves as
      his/her own control: Period 1 vs. Period 2.
    

Intervention name(s): HBI-3000; Paroxetine
Intervention type(s): Drug; Drug
Intervention description(s): small molecule, multi-ion channel blocker; serotonin uptake inhibitor, CYP2D6 inhibitor
Other intervention name(s): Sulcardine sulfate
Intervention MeSH terms: Paroxetine
Intervention model: Single Group Assignment
Intervention model description: Experimental: HBI-3000, 350 mg, 50 mL intravenous infusion (IV) over 30 minutes on Day 1 of Period 1 and approximately 15 days later on Day 1 of Period 2
Paroxetine: 20 mg dose twice a day on Days 1 and 2 of Period 2, and once a day on Days 3 through 7 inclusive of Period 2
Masking: None (Open Label)
Primary purpose: Treatment