bioihbjkbjnl/mcl2 huggingface dataset:
Different Proprioceptive Neuromuscular Facilitation (PNF) Technique in Patients With Knee Osteoarthritis
Condition: Muscle Weakness; Balance Disorders; Knee Pain; Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Muscle Weakness
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of 6-week physiotherapy and
      rehabilitation programs involving different 'Proprioceptive Neuromuscular Facilitation' (PNF)
      techniques in patients with knee osteoarthritis on pain, proprioception, postural control,
      muscle strength, range of motion and knee functions
    

Detailed description: 
      The results obtained from this study will contribute to the selection of PNF technique which
      is most suitable for physiotherapies working on knee osteoarthritis in clinics as well as
      demonstrating the efficacy of PNF which has been studied in the literature very few times.

      As a result of this study, the evidence value of the PNF technique will be determined in the
      physiotherapy and rehabilitation program of patients with knee osteoarthritis, and the
      efficacy of this technique, which is theoretically adopted, will be demonstrated
      scientifically. It will also determine the most ideal of the two PNF techniques to be applied
      in patients with knee osteoarthritis
    

Intervention name(s): Hotpack; Ultrasound; Combine Exercise; Repeated Contraction Exercise; Standart Exercise Therapy
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Hotpack applied 20 minutes for knee 3 session for 6 weeks; Ultrasound applied 10 minutes for knee 3 session for 6 weeks; Proprioceptive Neuromusculer Facilitation Technique İnclude eccentric and concentric contractions 3 session for 6 week; Proprioceptive Neuromusculer Facilitation Technique include concentric contractions 3 session for 6 week; Quadriceps, hamstring and hip muscle strength exercise. Hamstring stretch exercise.
3 session for 6 week
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Dietary Interventions Evaluating Transport of Uric Acid Across the Tubules
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether low fat dairy diet reduces serum uric acid
      levels.
    

Detailed description: 
      Uric acid plays a role not only in the pathogenesis of gout but is also a predictor of
      cardiovascular disease, hypertension and renal disease in man. We have identified the human
      urate ion channel transporter (hUAT), located in the proximal convoluted tubule of the kidney
      that is involved in both the secretion and reabsorption of urate across the tubule. This
      channel has a unique lectin binding site that in in-vitro studies, has been found to be
      modulated by glucose, galactose and lactose. We have also identified a mutation (G/A
      polymorphism) in our laboratory, that in in-vitro studies has demonstrated diminished hUAT
      channel activity. Cross-sectional studies have earlier shown that uric acid levels vary with
      serum glucose levels. Studies have also reported that a low-fat dairy diet reduces the
      incidence of gout, while others have shown that this diet reduces blood pressure
      significantly when compared with a non-dairy diet. We hypothesize that the effect of blood
      glucose levels in lowering uric acid levels is through the regulation of hUAT channel
      activity. We also hypothesize that a low-fat dairy diet reduces serum uric acid levels
      through hUAT regulation leading to a decrease in the incidence of gout and a reduction in
      blood pressure levels. In our proposed randomized, controlled, cross-over trial in healthy
      adult volunteers, we aim to study the effect of a low-fat dairy diet and a non-dairy diet on
      serum uric acid levels, the renal fractional excretion of uric acid and blood pressure. We
      will also study the effect of an acute intravenous infusion of glucose on these parameters.
      DNA analysis for hUAT mutations of study subjects will be done to assess if there is a
      blunted response of hUAT activity in subjects with the polymorphism as compared to normal
      individuals.
    

Intervention name(s): Low fat dairy diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Basic Science
Keywords: Uric acid; Dairy; Diet
Innovations in HIV Testing
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The investigators propose to improve HIV prevention and care through expanding HIV testing
      options to include self-testing for young women, their peers and their sex partners, and by
      facilitating linkage to care.
    

Detailed description: 
      The investigators propose to improve HIV prevention and care through expanding HIV testing
      options to include self-testing for young women, their peers and their sex partners, and by
      facilitating linkage to care. In this study the investigators proposed two phases. The first
      phase, previously completed, is formative and involved two parts: 1) conducting formative
      qualitative research to understand perceptions of HIV testing and HIV self-testing in the
      study population and 2) conducting observed HIV self-testing to better understand any
      challenges with self-testing and the materials needed to make the process clear. The second
      phase of the study is a randomized controlled trial where the investigators will randomize
      approximately 400 young women to receive either 1) CHOICE of self-testing or clinic-based HIV
      Counseling and Testing (HCT) or 2) clinic based HCT. Once young women have been randomized,
      they will be asked to recruit up to 4 peers or male sex partners to test with the method of
      their randomization group.
    

Intervention name(s): Oraquick HIV Self Test; Clinic Based HIV Counseling and Testing (HCT)
Intervention type(s): Other; Other
Intervention description(s): This is an oral swab in home HIV test.; Receiving Counseling and Testing for HIV at the clinic.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants randomized to (1) Choice - they get to choose (1a) self-test vs (1b) HCT (HIV testing and counseling at clinic) or (2) they are randomized to HCT.
Masking: None (Open Label)
Primary purpose: Screening
Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients
Condition: Post-surgical Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel
      design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected
      during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the
      need for rescue medication (oxycodone).
    

Detailed description: 
      Primary Objective:

      To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in
      subjects undergoing an elective Bunionectomy .

      Secondary Objectives

        -  To evaluate the safety and tolerability of a single intraoperative administration of
           CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.

        -  To evaluate the PK profile of a single intraoperative administration of CA-008 vs.
           placebo in subjects undergoing an elective Bunionectomy .

        -  To explore the efficacy of various doses of CA-008 administered intraoperatively in
           subjects undergoing an elective Bunionectomy .
    

Intervention name(s): CA-008; Placebo; Ketorolac; Acetaminophen; Oxycodone; Bupivacaine Hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single-dose wound infiltration prior to surgical incision closure; single-dose wound infiltration prior to surgical incision closure; 30mg IV administered intraoperatively; 1000mg IV administered intraoperatively; 5mg PO prn post-surgery; 0.5% infiltration pre-surgery
Other intervention name(s): Vocacapsaicin
Intervention MeSH terms: Acetaminophen; Ketorolac; Oxycodone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a
      day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with
      Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to
      provide control of their IBS-D symptoms.
    


Intervention name(s): Eluxadoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eluxadoline 100 mg oral tablets BID with food.; Placebo matching eluxadoline oral tablets BID with food.
Other intervention name(s): VIBERZI™
Intervention MeSH terms: Eluxadoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 1 Clinical Trial of RHN-001 in Healthy Adult Volunteers
Condition: Safety; Tolerability; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical Trial is to assess the safety, tolerability and Pharmacokinetic
      profile of 750 mg single oral dose of RHN-001 and 1500 mg of RHN-001 administered orally in
      fasted and fed conditions in healthy adult volunteers.
    

Detailed description: 
      The study is planned to be conducted in Two Phases (Cohort A and Cohort B). The first phase
      will be carried out in two Cohorts i.e., a single oral dose of investigational drug 750 mg or
      placebo under fasting (Cohort A1) and a single oral dose of investigational drug 750 mg or
      placebo under fed conditions (Cohort A2).

      The second phase of the study will also be carried out in two cohorts i.e., a single oral
      dose of 1500 mg or placebo under fasting (Cohort B1) and a single oral dose of 1500 mg or
      placebo under fed conditions (Cohort B2).

      Blood samples will be obtained from the volunteers at different time-points i.e. 0.0 hour
      (before dosing), 15.0 minutes, 30.0 minutes, 1.0 hour, 2.0, 3.0, 4.0, 8.0, 12.0 and 24.0
      hours post-dose in each cohort.

      Urine samples (10 mL) for PK analysis will be collected after dosing for 24 hours whenever
      the subjects feel to urinate during their stay at the clinical trial site.
    

Intervention name(s): RHN-001 (one tablet 750mg); RHN-001 (750mg * 2 Tablets)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects in A1 and A2 will receive 750mg RHN-001 or matching placebo tablets in Fasted state and Fed states respectively with 240 mL ambient temperature water.; Subjects in B1 and B2 will receive 1500mg RHN-001 (750mg tablet) or matching placebo tablets in Fasted state and Fed states respectively with 240 mL ambient temperature water.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is planned to be conducted in Two Phases (Cohort A and Cohort B). The first phase will be carried out in two Cohorts i.e., single oral dose of investigational drug 750 mg or placebo under fasting (Cohort A1) and single oral dose of investigational drug 750 mg or placebo under fed conditions (Cohort A2). The second phase of the study will also be carried out in two cohorts i.e., single oral dose of 1500 mg or placebo under fasting (Cohort B1) and single oral dose of 1500 mg or placebo under fed conditions (Cohort B2). The second phase of the study will be carried out after the safety assessments of period one.
Blood and urine samples will be collected from volunteers till 24 hours post dose in each Cohort for pharmacokinetic assessment of the drug and its active metabolites.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Phase 1 study; Anti inflammatory; healthy volunteers
Quetiapine in the Treatment of Psychotic Depression - a Pilot Study
Condition: Psychotic Depression
MeSH terms: Depression; Depressive Disorder; Mental Disorders; Psychotic Disorders; Bipolar Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Atypical antipsychotics have been found not only to be beneficial in the treatment of
      psychotic disorders, but even for depressive symptoms in patients with schizophrenia.
      Remarkably, preliminary data suggest that the atypical antipsychotic quetiapine has
      antidepressive properties. Until now, there is limited knowledge concerning the efficacy of
      quetiapine in major depressive illness and especially in psychotic depression. In our own
      clinical practice, several patients with psychotic depression were successfully treated with
      quetiapine as add-on therapy or as monotherapy. On the background of that, the convincing
      effects of quetiapine in bipolar depression, single-case reports and pilot studies concerning
      its effectiveness in depressive mood states in psychotic disorders as well as our clinical
      experiences, it is to assume that a treatment with quetiapine over a 6 weeks period show
      similar effects in major depressive episode with psychotic features, i.e. psychotic
      depression. In this pilot study we plan to investigate 20 patients with psychotic features of
      depression under treatment with quetiapine.
    


Intervention name(s): Quetiapine
Intervention type(s): Drug
Intervention description(s): Dosage form: tablets Dosage: between 300 mg/die and 600 mg/die Frequency: once daily Duration: 6 weeks
Other intervention name(s): Seroquel Prolong
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quetiapine; Psychotic depression
Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose
      combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 850
      mg administered together
    


Intervention name(s): Linagliptin/Metformin FDC; Linagliptin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pediatric Bipolar Disorder Study at UCLA
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      The UCLA Semel Institute for Neuroscience in Los Angeles, CA, is conducting a study looking
      at similarities and differences in how the brain works between bipolar disorder and attention
      deficit hyperactivity disorder (ADHD).
    

Detailed description: 
      Children between the ages of 7 and 17 years old, with a diagnosis of Bipolar I, Bipolar II,
      or Bipolar NOS, are currently being recruited for this study looking at similarities and
      differences in how the brain works between bipolar disorder and attention deficit
      hyperactivity disorder (ADHD). The study involves a comprehensive evaluation at intake,
      cognitive assessment, EEG, and functional MRI, done over the course of 2 or 3 visits. This
      study does not provide treatment. However, with participants' consent, the assessment
      information can be shared with the child's clinician or psychiatrist and a letter with the
      results from cognitive testing can be prepared, which can be useful in school planning.
      Referrals for treatment can also be provided.
    

Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Bipolar Disorder
      
Keywords: bipolar disorder; child bipolar disorder; adolescent bipolar disorder; pediatric bipolar disorder; fMRI; MRI; EEG; neurocognitive tasks
Effect of Preoperative Pregabalin on Propofol Induction Dose
Condition: Anesthesia, General; Laparoscopic Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary issue is to determine whether preoperatively administered pregabalin decreases
      the necessary dose of propofol during induction of general anesthesia. The investigators
      secondary issue is to test if preoperatively administered pregabalin decreases anxiety.
    


Intervention name(s): Pregabalin
Intervention type(s): Drug
Intervention description(s): Preoperative administration of pregabalin vs placebo 1 hour before surgery
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthesia, General; Propofol; Pregabalin; Preoperative care; Laparoscopic surgery
A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose
      Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy
      Male Subjects
    

Detailed description: 
      This study is a pilot phase 1, randomized, double-blind, two-arm, parallel group, single-dose
      study, which is designed to evaluate the safety, immunogenicity, PK and PD of CT-P41 and
      EU-approved Prolia in healthy male subjects. Approximately 30 male subjects will be enrolled
      and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment
      group, all subjects will receive a single 60 mg dose of either CT P41 or EU-approved Prolia
      by subcutaneous injection via a PFS on Day 1, followed by 134 days of safety, immunogenicity,
      PK, and PD measurements.
    

Intervention name(s): CT-P41; EU-approved Prolia
Intervention type(s): Biological; Biological
Intervention description(s): 60 mg/mL single dose, Solution for injection in PFS; 60 mg/mL single dose, Solution for injection in PFS
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare the pharmacokinetic profile to establish the
      better controlled liberation of the test product (Tramadol HCL OAD tablets of 200 mg,
      Labopharm) and its bioavailability in relation with the commercialised reference (Zytram®
      tablets of 200 mg, Zambon), single dose administered.
    


Intervention name(s): Tramadol Contramid OAD; Zytram
Intervention type(s): Drug; Drug
Intervention description(s): 1 Tramadol Contramid OAD 200 mg tablet as a single dose; 1 Zytram 200 mg tablet as a single dose
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly
Condition: Shingles
MeSH terms: Herpes Zoster
Study type: Interventional

Summary: 
      Vaccination is the most effective way of preventing infectious diseases. Despite the success
      of vaccines in general, vaccines induce diminished antibody responses and lower protection in
      the elderly in particular. This could be explained by a defect in the early responses of an
      ageing immune system. A better understanding of the basic immunological mechanisms that
      mediate vaccine efficacy is incomplete. Such information is critical and could greatly
      decrease both the cost and the time to new vaccine development particularly for the geriatric
      population.

      In this trial, the investigators will study the immunologic differences of the FDA approved
      licensed shingles vaccine between a younger and an older group. Thirty three healthy
      volunteers between the ages of 25-40 and forty four healthy volunteers between the ages of
      60-79 will be enrolled in the study. Each participant in the study will be given one shingles
      shot. Blood work will be obtained one month before vaccination, on the day of vaccination,
      one day, three days, seven days, fourteen days, one month, three months and six months after
      vaccination. Throughout the duration of the study, the participants will be monitored for
      safety.
    

Detailed description: 
      RATIONALE: Zoster vaccine is known to induce diminished antigen-specific T cell responses and
      lower protection in the elderly. Here we hypothesize that this is due to intrinsic defects in
      innate responses to the live attenuated virus, which translates into sub-optimal functional
      adaptive immune responses. Therefore, early innate signatures of vaccination should correlate
      with, and predict the immunogenicity of Zoster vaccine in the young and elderly.

      STUDY DESIGN: Double center, open label study in which adult healthy volunteers will be
      vaccinated with Zoster vaccine. Blood samples will be collected on day D-30 (pre-
      vaccination) D0 (at vaccination) and D1, D3, D7, D14, D30, D90 and D180 (post vaccination) to
      study innate and adaptive immunity responses. Even though Zoster vaccine is considered safe,
      volunteers are asked to report and record any local or systemic AEs for 7 days
      post-vaccination. Also AEs will be reported for 30 days post-vaccination any SAE for 180 days
      post vaccination. AEs developing the day of the blood draw will also be reported
    

Intervention name(s): ZOSTAVAX
Intervention type(s): Biological
Intervention description(s): shingles vaccine, one dose
Other intervention name(s): shingles vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: shingles vaccine; immune responses