bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Comorbid Personality Disorder on the Treatment of Bipolar I Disorder
Condition: Bipolar I Disorder; Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine the impact of comorbid personality disorder on the outcome of
      treatment among patients with bipolar I disorder.
    

Detailed description: 
      The major aim of this proposal is to examine the impact of comorbid personality disorder on
      the outcome of treatment among patients with bipolar I disorder.

      The specific aims are to create a research and supervisory team and to identify potential
      moderators of treatment response and mediators of outcome over the course of treatment.

      Members of the team will meet weekly to begin a treatment development process for enhancing
      Interpersonal Social Rhythm Therapy (IPSRT) for these patients. Additional assessment
      measures will be utilized to examine the proposed mediators and moderators of treatment.
    

Intervention name(s): Interpersonal Social Rhythm Therapy (IPSRT)
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1 Study of ANJ900 Chinese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and
      female Chinese subjects. Subjects will participate in 3 treatment periods and will be
      randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of
      7 days between doses.
    

Detailed description: 
      This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and
      female Chinese subjects. Subjects will participate in 3 treatment periods and will be
      randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of
      7 days between doses.

      All subjects will receive each of the following treatments:

        -  Treatment 1: A single dose of 1800 mg ANJ900 in the fasted state.

        -  Treatment 2: A single dose of 1800 mg ANJ900 in the fed state.

        -  Treatment 3: A single dose of 1000 mg metformin IR in the fasted state. Potential
           subjects will be screened to assess their eligibility to enter the study within 14 days
           prior to the first dose administration. Subjects will be admitted into the study site on
           Days 1, 7, and 14 and will be confined to the study site until discharge on Days 3, 10,
           and 17 respectively.
    

Intervention name(s): ANJ900; Metformin IR
Intervention type(s): Drug; Drug
Intervention description(s): Metformin hydrochloride delayed-release tablets; metformin hydrochloride
Other intervention name(s): Met DR; Met IR
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims at evaluating the therapeutic effects of both Nitazoxanide and Escitalopram
      as adjuvant therapies in patients with Rheumatoid Arthritis and to evaluate their impact on
      STAT3/ JAK2, TLR /IL -1β signaling pathways.
    

Detailed description: 
      This study is a randomized, controlled prospective study to evaluate the potential
      therapeutic effects of the broad -spectrum antimicrobial (Nitazoxanide) and selective
      serotonin reuptake inhibitor (Escitalopram) on synovial inflammation and angiogenesis when
      administered as add-on treatments to the current DMARDs treatments for rheumatoid arthritis
      patients.

      A total of 90 RA patients recruited from Outpatient Clinic of Physical Medicine, Rheumatology
      and Rehabilitation at Mansoura University hospitals, Mansoura, Egypt will be included in the
      study. They will be diagnosed with RA according to the American College of
      Rheumatology/European League Against Rheumatism criteria 2010 (the ACR/EULAR 2010 criteria).

      RA Patients who will meet the inclusion criteria will be enrolled in the study.

      They will be classified into three groups:

      Group 1: 30 RA patients who will receive the traditional therapy of rheumatoid arthritis for
      12 weeks and serve as the control group.

      Group 2: 30 RA patients who will receive traditional therapy plus Nitazoxanide 1 gm/day for
      12 weeks.

      Group 3: 30 RA patients who will receive traditional therapy plus Escitalopram 10 mg/day for
      12 weeks.

      Clinical Examinations and laboratory parameters will be performed and measured at the
      beginning of the study and 3 months after randomization to evaluate the efficacy of
      Nitazoxanide and Escitalopram in the treatment of rheumatoid arthritis.
    

Intervention name(s): Placebo; Nitazoxanide 500Mg Oral Tablet; Escitalopram 10mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo will be administered to the control group for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.; All subjects will receive Nitazoxanide 500gm twice daily for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.; All subjects will receive Escitalopram 10 mg/day for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Intervention MeSH terms: Nitazoxanide; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nitazoxanide; Escitalopram; STAT3/ JAK2 signaling pathway; TLR-4 /IL -1β signaling pathway
A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication
Condition: Helicobacter Pylori
Study type: Interventional
Phase: Phase 4

Summary: 
      We aim to assess and compare the effectiveness of clarithromycin- and furazolidone-based
      regimens as primary therapies in eradicating H. pylori.
    

Detailed description: 
      Helicobacter pylori plays a pivotal role in many diseases such as peptic ulcer disease and
      MALT lymphomas. And the prevalence of H. pylori is increasing in some parts of the world.

      However, the eradication becomes increasingly difficult due to the growing antibiotic
      resistance. Bismuth-containing quadruple regimens are now recommended to serve as first-line
      therapies. Bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple
      regimens are both in the list of the first regimens. And recent antimicrobial susceptibility
      tests showed us that the clarithromycin was increasingly resisted while furazolidone remained
      hardly resisted. The comparison between the effects of bismuth-clarithromycin-containing and
      bismuth-furazolidone-containing quadruple regimens is not so clear.
    

Intervention name(s): Furazolidone; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): bismuth-furazolidone-containing quadruple regimens; bismuth-clarithromycin-containing quadruple regimens
Intervention MeSH terms: Clarithromycin; Furazolidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter Pylori; furazolidone; clarithromycin; bismuth-containing quadruple regimen
Different Strategies in Frozen IVF/ICSI Cycles
Condition: Pregnancy Rates
Study type: Observational

Summary: 
      In the absence of robust contemporary data, investigators decided to perform a multicenter
      cohort study of various IVF centers, to compare the different modalities used for pregnancy
      rates following frozen-thawed embryo transfer (FET) treatment cycles in normoovulatory
      patients undergoing IVF/ICSI.
    

Detailed description: 
      In general, the type of FET protocol for each patient is selected by the attending physicians
      at their own discretion. In all centers, patients with ovulatory cycles are typically
      prescribed an NC-FET or mNC-FET, whereas patients with oligomenorrhoea or amenorrhoea are
      prescribed an artificial cycle to prepare the endometrium for FET.

      Ovarian stimulation protocol

        1. The antagonist protocol

        2. The long 21 /2 agonist protocol Laboratory technique

      a. IVF or b. ICSI Embryo freezing using only vitrification will be performed in days 3 or
      5/6. Embryo transfer will be conducted at days 3 or 5/6. The maximum number of embryos
      transferred will be two, as in accordance to the Hellenic legislation.

      The following modalities will be analyzed, patients with:

        1. Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG without
           luteal support (Group 1)

        2. Natural cycle, spontaneous ovulation or ovulation triggering by exogenous hCG with
           luteal support (progesterone) (Group 2)

        3. Hormone Replacement cycle (cyclacur) plus GnRHa suppression with luteal support
           (progesterone) (Group 3)

        4. Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support
           (progesterone) (Group 4)

      Of note, the conversion between different supplementation methods may be testimated as
      follows: 0.75 mg of micronised estradiol (oral administration) = 1.25 g of estradiol gel
      (transdermal administration) = 1 mg of estradiol valerate (oral or vaginal adminstration).
    

Intervention name(s): Hormone Replacement cycle 1; Hormone Replacement cycle 2
Intervention type(s): Drug; Drug
Intervention description(s): Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone); Hormone Replacement cycle with GnRHa suppression
Intervention MeSH terms: Hormones
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Following clinical evaluation along with previous medical and reproductive history,
        participants will be categorized according to the subfertility factor and further
        demographic parameters (age, Body Mass Index (BMI), smoking status, basal FSH levels,
        parity, antral follicle count (AFC) in the fresh cycle, type (primary/secondary) and
        duration of subfertility and number of unsuccessful IVF/ICSI attempts (fresh and/or frozen)
        will be recorded along with the respective hormonal profiles.
A Study to Evaluate MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors
Condition: Select Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic
      agents in adult subjects with select advanced solid tumors.
    

Detailed description: 
      This is a Phase 1 multicenter, open-label study to evaluate the safety, pharmacokinetics,
      pharmacodynamics, immunogenicity, and antitumor activity of MEDI0562 in combination with
      immune therapeutic agents in adult subjects with select advanced solid tumors.
    

Intervention name(s): MEDI0562; Tremelimumab; Durvalumab
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.; Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.; Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
Intervention MeSH terms: Durvalumab; Tremelimumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced solid tumors; MEDI0562; durvalumab; tremelimumab; OX40; PD-L1; CTLA-4; immuno-oncology; Cancer
Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults
Condition: Mobility Limitation
MeSH terms: Mobility Limitation
Study type: Interventional

Summary: 
      This research study is looking at the effects of a whey protein nutritional supplement on
      changes in muscle mass, strength and physical function in response to a 6 month program of
      strength training exercise.
    


Intervention name(s): Whey protein; Maltodextrin placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): powdered, 46g supplement dissolved in fluids, twice daily; powdered, 46g supplement dissolved in fluids, twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Whey protein; Resistance exercise; Physical activity; Mobility disability; Physical function; Muscle mass; Muscle strength; Older Adults; Mobility-Limited
The Combination Effect of Platelet-rich Plasma and Hyaluronic Acid for Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for
      osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far.
      Hence, investigator assess a prospective randomized double-blind controlled trial.
    

Detailed description: 
      Patients with single or bilateral OA knee will be enrolled and randomized into intervention
      and control group. One dose of PRP is applied into both groups. One week later, one dose of
      HA is injected in intervention group and one dose of normal saline is injected in control
      group. Outcome measurements included visual analog scale (VAS)、Lequesne's severity
      index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test
      (Biodex) and analysis of synovial fluid at different follow-up frame (1st month, 3rd month,
      6th month and 1 year after treatment).
    

Intervention name(s): platelet rich plasma + Hyaluronic acid; platelet rich plasma + normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.; The normal salin as the placebo intervention was injection control group.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Platelet rich plasma; Osteoarthritis of knee; Hyaluronic acid
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 in Otherwise Healthy Controlled Asthmatic Subjects
Condition: Healthy; Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics including posology, and
      pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic
      subjects
    


Intervention name(s): Placebo to BI 1021958 qd; BI 1021958 bid; Placebo to BI 1021958 bid; BI 1021958 qd
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): tablet; tablets; tablets; tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Caffeine Versus Placebo for Spinal Headaches
Condition: Post Dural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional

Summary: 
      Caffeine will be studied against placebo in patients with positional headache after a lumbar
      puncture (aka "spinal headache").
    

Detailed description: 
      Pain will be assessed at set intervals using a Visual Analog Scale. Blood patch therapy will
      be offered to all those still in pain at the end of one hour after drug administration.
    

Intervention name(s): Caffeine; saline
Intervention type(s): Drug; Drug
Intervention description(s): Caffeine 500 mg IV; Normal saline
Other intervention name(s): Treatment group; Placebo control group
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: headache; caffeine; pain
Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.
Condition: Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin
MeSH terms: Erythema
Study type: Interventional

Summary: 
      Study objective To assess the performance of different application regimens of Actinica® on
      protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned
      healthy subjects (phototype I to III).

      Study centers A total of 20 subjects will be enrolled in 1 site in France.

      Methodology This will be a monocentre, randomised, controlled, investigator-blind,
      intra-individual comparative clinical investigation.

      There will be a total of 6 visits for each subject. Each subject will participate for a
      period of maximum 35 days.

      Study population Healthy subjects, male or female, at least 18-60 years old, with phototype
      I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion
      criteria.

      The clinical investigation will be conducted in 2 parts.

      Part 1 - SPF determination:

      To determine the SPF of Actinica® with application of two different amounts (0.8 and 2
      mg/cm2).

      Part 2 - Sun exposure:

      To assess the performance of the different application regimens of Actinica® on protection
      from UVR-induced erythema throughout 1 day of sun exposure.
    


Intervention name(s): Actinica, 0.8 mg/cm2, 1 application; Actinica, 0.8 mg/cm2, 2 applications; Actinica, 2 mg/cm2, 1 application; Actinica, 2 mg/cm2, 2 applications
Intervention type(s): Device; Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Effects of Caffeine on Physical Performance of Ice Hockey Players
Condition: Caffeine; Athletic Performance
Study type: Interventional

Summary: 
      To date, only one study has evaluated the effect of caffeine supplementation on athletic
      performance in ice hockey players finding a lack of ergogenic effect. This lack of effect is
      surprising as caffeine has been suggested to be an effective and safe nutritional supplement
      to improve physical performance in both trained and untrained individuals. Therefore, the aim
      of the present study is to evaluate the effect of acute caffeine ingestion (3mg/kg body
      mass). Thirteen elite adult ice-hockey male players will perform specific ice hockey
      performance tests in two separate days. On both occasions players will ingest 330 ml of water
      with lemon powertabs isostar® (86 kcal / 19g of carbohydrates) tablets, which will include in
      one of these days 3 mg/kg body mass of anhydrous caffeine. Players will perform a 35-m
      sprint, an agility test (Weave agility - slalom with puck), and a reaction test.
    


Intervention name(s): Caffeine; Placebo drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will ingest a drink with 3mg/kg of body weight mixed with carbohydrates; Participants will ingest the exact same drink without caffeine
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be given a bottle with either caffeine and carbohydrates or just carbohydrates. All participants will complete ice-hockey specific athletic tests in both conditions.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ultrasound Guided Radial Artery Catheterization
Condition: Arterial Catheterization, Peripheral
Study type: Interventional

Summary: 
      Comparing an novel technique ( oblique view) during ultrasound guided radial artery
      catheterization versus Transverse and longitudinal views
    


Intervention name(s): radial artery Catheterization
Intervention type(s): Procedure
Intervention description(s): Insertion of radial artery catheter for sampling and blood pressure measurement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Metabolic Availability of Tryptophan From White Maize
Condition: Healthy
Study type: Interventional

Summary: 
      Our objective is to determine the metabolic availability of Tryptophan in white maize using
      the indicator amino acid oxidation (IAAO) technique in adult men.
    

Detailed description: 
      Our objective is to determine the metabolic availability of Tryptophan in white maize. Seven
      young, healthy, male adults will receive graded levels (13.2, 26.4, 39.7, 52.9) of tryptophan
      requirement of 3.78 mg/kg/d as a crystalline amino acid (AA) mixture and a porridge of white
      cornmeal protein respectively.
    

Intervention name(s): Tryptophan
Intervention type(s): Other
Intervention description(s): Tryptophan will be supplied at 13.2, 26.4, 39.7, or 52.9% of requirement; sourced from crystalline amino acid and white cornmeal maize.
Intervention MeSH terms: Tryptophan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: protein quality