bioihbjkbjnl/mcl2 huggingface dataset:
Pentoxifylline as an Adjunctive in Treatment of Negative Symptoms in Chronic Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study to evaluate the efficacy and safety of pentoxifylline, the novel
      phosphodiesterase inhibitor, as an adjunctive to risperidone in alleviating the negative
      symptoms of schizophrenia.
    

Detailed description: 
      there is some evidence for the role of phosphodiesterase (PDE) signaling system in
      pathophysiology of schizophrenia making this system a potential target for therapeutic
      agents. PDEs are a family of enzymes that hydrolyse cyclic nucleotides and thus play a key
      role in regulating intracellular levels of the second messenger cyclic adenosine
      monophosphate (cAMP) and cyclic guanosine monophosphate. Pentoxifylline (PTX) is a methylated
      xanthine derivative and a PDE inhibitor that is FDA-approved for the treatment of patients
      with intermittent claudication on the basis of chronic occlusive arterial disease of the
      limbs. It is known to inhibit platelet aggregation, increase erythrocyte flexibility or
      deformability, and reduce blood viscosity. The rationale for its use in schizophrenia is that
      it competitively inhibits PDEs, resulting in increased cAMP levels, the activation of protein
      kinase A (PKA), the inhibition of IL and TNF-α synthesis, and reduced inflammation.
      Furthermore, there is growing evidence to support the inflammatory hypothesis of
      schizophrenia, the investigators will also explore whether cytokine levels mediate the
      response from pentoxifylline treatment.
    

Intervention name(s): Placebo oral tablet; Pentoxifylline
Intervention type(s): Drug; Drug
Intervention description(s): Placebo tablets PLUS Risperidone 2 mg tablet up to 6 mg/day; Pentoxifylline tablet PLUS Risperidone 2 mg tablet up to 6 mg/day
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Home Sleep and Metabolism
Condition: Overweight; Sleep
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Bedtimes and wake-up times vary from person to person. The aim of this research is to examine
      the associations between sleep habits and metabolism in healthy people. In this study, the
      investigators will collect information on sleep-wake habits and how the body uses energy.
    


Intervention name(s): sleep
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The proposed study is a multi-centre, open-label crossover study to assess the safety and
      acceptability of a silicone elastomer vaginal ring (containing no drug) when inserted for a
      12 week period in 200 healthy, sexually active women.
    


Intervention name(s): intravaginal ring
Intervention type(s): Device
Intervention description(s): silicone elastomer intravaginal ring containing no drug product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV-1; HIV seronegativity
The Impact of Sucrose Ingestion During Exercise on Liver and Muscle Glycogen Concentration.
Condition: Liver and Muscle Glycogen Use During Exercise.
Study type: Interventional

Summary: 
      Carbohydrate is stored in the body as glycogen, which is mainly found in the liver and
      muscle. During endurance exercise, muscle glycogen is used as fuel for the working muscles
      and liver glycogen is broken down to provide glucose to maintain blood glucose (sugar)
      levels. Both liver and muscle glycogen are important for the ability to perform
      intense/prolonged endurance exercise. Therefore, nutritional strategies which can maximise
      the availability of glycogen in muscle and liver can benefit endurance exercise capacity.

      The carbohydrates typically found in sports drinks are glucose and sometimes fructose. If
      glucose only is ingested during exercise, then the maximum rate at which can be absorbed from
      the intestine into the blood stream is ~1 g/min. However, if different sources of
      carbohydrate (fructose) are used, which are absorbed through a different pathway, absorption
      of carbohydrate can be up to ~1.8 g/min. With more carbohydrate available as a fuel, this
      translates into an improvement in performance.

      Sucrose is a naturally occurring sugar that is made up of a single glucose and single
      fructose molecule. Therefore, theoretically, this can use the two different pathways of
      absorption and also maximise carbohydrate delivery. It is not yet known however, what impact
      this has on our liver and muscle glycogen stores during exercise. Therefore the aim of this
      study is to assess whether sucrose ingestion influences liver and muscle glycogen depletion
      during endurance exercise.
    


Intervention name(s): Glucose ingestion; Sucrose ingestion
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Glucose ingestion during exercise at 1.8 g/min; Sucrose ingestion during exercise at 1.8 g/min
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
Condition: Relapsing Forms of Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria
      toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have
      been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon
      (IFN).

      Secondary objective is to evaluate the immune response to vaccination with 23-valent
      pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response]
      and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T
      cell-dependent neoantigen response].
    


Intervention name(s): dimethyl fumarate; tetanus diphtheria toxoids vaccine; 23-valent pneumococcal polysaccharide vaccine; meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent); non-pegylated interferon
Intervention type(s): Drug; Biological; Biological; Biological; Drug
Intervention description(s): Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera.; Administered as described in the treatment arm; Administered as described in the treatment arm; Administered as described in the treatment arm; Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.
Other intervention name(s): DMF; BG00012; Tecfidera; Td; Tenivac; Pneumovax 23; PPSV23; MCV4; Menveo; IFN
Intervention MeSH terms: Interferons; Dimethyl Fumarate; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vaccine; pneumococcal; meningococcal; tetanus diphtheria; immune response
A Validation Study of Near Infrared Fluorescence Imaging of Lymphatic Vessels in Humans.
Condition: Focus of Study is: Near Infrared Fluorescence Imaging
Study type: Observational

Summary: 
      The aim of this study is to examine the use of Near Infrared Fluorescence imaging on
      lymphatic vessels in humans.

      Different parameters that reflect lymphatic function will be tested for intra and inter
      individual reproducibility.

      We use 10 healthy test subjects and examine their lymphatic system. All subjects are healthy
      men between the ages of 20 and 30.

      When the fluorescent dye "indocyanine green", has been injected into the skin on the patients
      feet, it will be transported through the lymph vessels, resulting in clear visualization of
      the vessels, using a laser and a EM-CCD camera.

      On both legs we examine the frequency of vessel contraction and the velocity of lymph moving
      in vessels. We furthermore use several methods to quantify the vessel function such as the
      refill time of a vessel, (manually emptied vessel and refill time of 10 cm of a vessel), and
      pumping pressure (at what pressure lymph can pass a blood pressure cuff).

      We investigate the activity of vessels over time, and after several interventions such as
      exercise, and water baths of the foot at different temperatures.

      The patients are examined for approximately 4 hours and wil be examined again 14 days later.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants are young healthy males.
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
Condition: Obsessive Compulsive Disorder
MeSH terms: Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      To evaluate the long-term impact of treatment with sertraline on aspects of cognitive,
      emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16
      years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive
      compulsive disorder.
    

Detailed description: 
      Purposive sample: patients are not randomly selected, that is, he or she must meet certain
      inclusion criteria in order to qualify as a potential study participant.
    

Intervention name(s): sertraline; psychotherapy
Intervention type(s): Drug; Behavioral
Intervention description(s): Non interventional study - drug, dose, duration etc as per USPI and clinician discretion; Non-interventional study- as above
Intervention MeSH terms: Sertraline
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The accessible population is children meeting inclusion/exclusion criteria from US centers
        in various clinical settings, including the Child and Adolescent Psychiatry Trials Network
        (CAPTN). From these, the study-eligible population (all children age 6 to 16 (inclusive)
        with an anxiety, depressive, or obsessive-compulsive disorder, who are exposed to
        sertraline under real-world conditions) will comprise an inception cohort of enrolled
        subjects beginning treatment for one of the study-qualifying disorders with sertraline or
        psychotherapy.
      
Keywords: prospective; cohort; sertraline; long-term impact; cognition; emotional and physical development; pubertal maturation
CBT for Adolescents With Excessive Worry
Condition: Excessive Worry
Study type: Interventional

Summary: 
      This case series aims to test the feasibility and acceptability of streamlined cognitive
      behavioral therapy (CBT) for adolescents with excessive worry. The treatment protocol focuses
      on reducing intolerance of uncertainty and the hypothesis is that this will help reduce
      worry.
    

Detailed description: 
      This pilot study aims to test a new form of Cognitive Behavioral Therapy for adolescents with
      excessive worry. The investigators will include 12 participants with excessive worry and test
      the treatment which focuses on reducing intolerance of uncertainty (IU) in order to reduce
      worry.

      Participants will be randomized to either one, two or three weeks of weekly baseline
      measurements prior to starting treatment, and will thus work as their on controls in this
      case series design.

      Primary outcome measures will be collected at 12 weeks after treatment start. Participants
      will be followed up at three months after treatment.
    

Intervention name(s): Cognitive behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): CBT focused on reducing intolerance of uncertainty
Other intervention name(s): CBT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Excessive worry; Worry; Adolescents; Intolerance of uncertainty
Effect of Carbohydrate Consumption on Fatigue and Muscle Damage in Jiu-Jitsu Athletes
Condition: Fatigue; Exercise-induced Muscle Damage
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The study is a randomized, double-blinded, placebo-controlled trial that will include the
      participation of 14 Jiu-Jitsu athletes between 18 and 33 years. The aim of the study is to
      evaluate the effects of carbohydrate consumption on fatigue and exercise-induced muscle
      damage in Jiu-Jitsu athletes.
    

Detailed description: 
      Brazilian Jiu-Jitsu (BJJ) is a sport characterized by intermittent high-intensity efforts
      separated by periods of low intensity. Muscular strength is considered one of the most
      important physical components to be developed, especially in the upper limbs through dynamic
      and static actions. The activities of high intensity (relation effort-pause) carried out by
      the upper and lower limbs during BJJ can induce muscle fatigue. In order to minimize the
      glycogen depletion and to guarantee the availability of energy substrate to the athlete
      during the physical exercise, the carbohydrate intake before moderate intensity exercises
      should be between 5-7 g / kg of weight / day. The intervention group will receive a 30g
      maltodextrin beverage and the placebo group a non-carbohydrate drink. There will be 3 combat
      simulations of 8 min each, with intervals of 10 min between fights. Athletes will be
      instructed to remain with their usual intake during the study. The outcomes will be: manual
      grip strength (dynamometer), upper limb strength (KGST), lower limb strength (vertical jump),
      subjective exertion perception (Borg scale), pain perception (Nilsson scale), blood markers
      of muscle damage (CK and LDH), lactate, and glycemia.
    

Intervention name(s): Carbohydrate (maltodextrin); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): maltodextrin flavored; non-caloric drink
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
In Vitro Optimization of Oxytocin-induced Myometrial Contractility by Propranolol
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The rates of cesarean deliveries (CD) and postpartum hemorrhage (PPH) are on the rise, with
      failed induction and augmentation of labor as major contributing factors. Oxytocin is
      commonly used for labor induction, as well as during the third stage of labor to minimize the
      risk of primary PPH. At delivery, it is imperative that the uterus responds effectively to
      parenteral oxytocin. Poor response to oxytocin following delivery is commonly due to
      prolonged labor with oxytocin augmentation that is known to "desensitize" the myometrium.
      Despite the option of several second line uterotonic agents, none of them are as effective as
      oxytocin in controlling PPH. Given that poor uterine muscle contraction is the root cause of
      both failed induction or augmentation (leading to a CD in labor) and uterine atony (leading
      to PPH), there is an urgent and clinically important need to investigate novel methods to
      enhance oxytocin-induced myometrial contractions.

      Propranolol, a beta adrenergic receptor agonist, has the potential to improve myometrial
      contractions by virtue of its ability to inhibit catecholamine production. The investigators
      plan to investigate the effects of propranolol in both naive and desensitized myometrium, in
      order to better understand its potential role in improving labor induction and reducing the
      risk of PPH following oxytocin exposure during labor.

      The investigators hypothesize that propranolol is likely to potentiate the action of oxytocin
      upon human myometrium, to ultimately help improve the success of labor induction/augmentation
      and treatment of PPH.
    

Detailed description: 
      Myometrial samples will be used to investigate the effect of propranolol on uterine
      contractions when exposed to high and low doses of oxytocin (to simulate PPH treatment and
      labor induction respectively).

      The tissue will also be frozen at the end of the experiment, and Western blotting will be
      used to investigate the effect of propranolol on the expression patterns and cellular
      distribution of the oxytocin receptor and beta-adrenergic receptor and their signaling
      pathways in desensitized myometrium.
    

Intervention name(s): Oxytocin; Propranolol
Intervention type(s): Drug; Drug
Intervention description(s): Oxytocin in solution, ranging from 10 -12M to 10 -5M; Propranolol in solution, 10-6M
Other intervention name(s): pitocin
Intervention MeSH terms: Propranolol; Oxytocin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: propranolol; oxytocin; uterine contraction
Phase 1 TAK-925 Study in Healthy Adult and Elderly Volunteers and Participants With Narcolepsy
Condition: Healthy Participants and Patients With Narcolepsy
MeSH terms: Narcolepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate safety, tolerability, and pharmacokinetics of
      TAK-925 when a single dose of TAK-925 is administered to healthy adult participants, healthy
      elderly participants and patients with type 1 narcolepsy.
    

Detailed description: 
      Orexins are neuropeptides that play a role in the regulation of sleep and wakefulness. In
      type 1 narcolepsy, there is a loss of orexin producing neurons in the brain. The
      investigational drug, TAK-925, is an orexin 2 receptor agonist that is being tested in
      healthy adult participants, healthy elderly participants and patients with narcolepsy in
      order to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single intravenous
      administration.

      The study will enroll approximately 20 healthy participants and 16 healthy elderly
      participants in Part 1 of the study and approximately 20 patients with narcolepsy in Part 2.

      In Part 1, the study consists of 4 cohorts of 8 or 4 participants each. Participants will be
      randomly assigned (by chance, like flipping a coin) to one of the following treatment groups
      to receive TAK-925 or placebo:

      - Part 1, Cohort 1; TAK-925 (Dose Level 1, 3, 5), Cohort 2; TAK-925 (Dose Level 2, 4, 6),
      Cohort 3 and 4; TAK-925 (Dose Level 5)

      For Cohort 1-4, healthy adult and elderly participants will be administered TAK-925 or
      placebo once in each cohort or dose level. The dose at the start (Cohort 1 dose level 1) is 7
      mg of TAK-925 and following doses in Cohorts 1-4 will be determined based on available data
      from previous Cohorts/dose levels.

      In Part 2 of the study, the study consists of 3 cohorts of 4 to 12 patients with narcolepsy.
      Patients will be randomly assigned to one of the treatment groups of Cohort 5-7 and will be
      administered TAK-925 or placebo once in each cohort. The dose of TAK-925 in Cohort 5-7 is TBD
      and will be decided based on available data from Part 1 and previous Cohorts.

      - Part 2, Cohort 5-7

      This multi-center trial will be conducted in Japan. Participants will make multiple visits to
      the clinic. Visits in Part 1 will include a screening period (Day -28 to -2), Check-in on Day
      -1, Treatment period (Day 1 and 2), and follow-up visit on Day 7. In Part 2 of the study, the
      visits include a screening period (Day -42 to -2), Check-in on Day -1, Cross-over period (Day
      1 to 4), and follow-up visit on Day 7.
    

Intervention name(s): TAK-925; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-925 Intravenous Infusion; TAK-925 Placebo Intravenous Infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      EPIDUO™ (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, marketed by GALDERMA LABORATORIES,
      L.P., is a safe and effective topical therapy used for the treatment of acne vulgaris.
      Actavis Mid-Atlantic LLC has developed a generic formulation of adapalene and benzoyl
      peroxide topical gel 0.1%/2.5%,and the current study is designed to evaluate the safety and
      efficacy of this formulation to determine if it is bioequivalent to EPIDUO™.
    


Intervention name(s): adapalene 0.1% and benzoyl peroxide 2.5% topical gel; EPIDUO; Placebo (Vehicle Gel)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dosage form: topical gel Dosage: A pea-sized amount was applied to each affected area of the face Frequency: once daily in the evening Duration: 12 weeks; EPIDUO (adapalene 0.1% and benzoyl peroxide 2.5%) Gel; Vehicle Gel
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne; adapalene/benzoyl peroxide; Epiduo; Mild to severe acne vulgaris