bioihbjkbjnl/mcl2 huggingface dataset:
A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, healthy volunteers will receive a single intravenous dose of either
      PF-06438179 or infliximab (United States) or infliximab (European Union). During the course
      of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the
      blood, and by comparing these levels among the different administration arms of PF-06438179
      and the licensed infliximab products. Safety, tolerability, and immunologic response will
      also be evaluated throughout.
    


Intervention name(s): PF-06438179; Remicade; Remicade
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1; Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1; Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
Other intervention name(s): Infliximab-Pfizer; Infliximab (European Union); Infliximab (United States)
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Bioequivalence; Biosimilarity; Similarity; PK; Phase 1; Infliximab; Healthy Volunteers; Single-dose; Immunology
Open-Label, Dose-Escalating Study Assessing Safety, Tolerability, Efficacy, of RP103 in Mitochondrial Disease
Condition: Inherited Mitochondrial Disease, Including Leigh Syndrome
MeSH terms: Leigh Disease; Mitochondrial Diseases; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate safety, tolerability and efficacy of cysteamine bitartrate delayed-release
      capsules (RP103) administered up to 1.3 g/m²/day in two divided doses, every 12 hours, for up
      to 6 months in patients with inherited mitochondrial disease.
    

Detailed description: 
      This is an open-label, dose-escalation study to assess the safety, tolerability, efficacy,
      pharmacokinetics and pharmacodynamics of cysteamine bitartrate delayed-release capsules
      (RP103) for treatment of children with inherited mitochondrial disease.

      Prior to treatment, patients will undergo a Screening Visit. If eligible, each participant
      will return for the Day 1 study visit and begin dosing. Every 2 weeks over the subsequent 8
      weeks, participants will alternate between returning to the clinic for detailed assessments
      (Weeks 4 and 8) and receiving a telephone call from the Investigator team to assess safety
      and RP103 dose (Weeks 2 and 6) and the potential need for an immediate unscheduled study
      visit. Thereafter, participants will continue to return to the clinic every 4 weeks for
      detailed assessments at Weeks 12, 16, 20, and 24 (the Study Exit visit).

      The Study Exit visit will occur at Week 24, and participants will be offered the opportunity
      to continue on to an extension study (RP103-MITO-002 [NCT02473445]) until results of the
      present study are known.
    

Intervention name(s): Cysteamine Bitartrate
Intervention type(s): Drug
Intervention description(s): Cysteamine Bitartrate Delayed-release capsules
Other intervention name(s): RP103
Intervention MeSH terms: Cysteamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leigh Syndrome; Leber's hereditary optic neuropathy; myoclonic epilepsy; mitochondrial encephalomyopathy; Kearn-Sayre syndrome; POLG-related disorders; Neurogastrointestinal encephalopathy
Biodegradable Synthetic Scaffold as a Substitute for hAM in Limbal Epithelial Cells Transplant in LSCD Patients
Condition: Limbal Stem Cell Deficiency
MeSH terms: Limbal Stem Cell Deficiency
Study type: Interventional

Summary: 
      The purpose of this clinical study is to undertake a pilot safety and efficacy study of a
      synthetic biodegradable membrane as a substitute for using donor human amniotic membrane
      (hAM) for the treatment of limbal stem cell deficiency (LSCD) by combining this with freshly
      excised limbal tissue in theatre as a one stage procedure
    

Detailed description: 
      This study will involve the used of a synthetic biodegradable Poly Lactide-co-Glycolic Acid
      (PLGA) biodegradable, synthetic carrier membrane (PLGA) membrane as a substitute for using
      donor human amniotic membrane (hAM) for the treatment of limbal stem cell deficiency (LSCD)
      by combining this with freshly excised limbal tissue in theatre as a one stage procedure.

      This has the potential to simplify the current procedure and make it safer and accessible to
      more surgeons and eventually benefit more patients. The use of PLGA membrane, in place of hAM
      for limbal transplants, is a novel technique and has a lot of promise and potential, which
      will potentially benefit patients at large and significantly bring down costs for the limbal
      transplants while reducing the disease transmission risks of using human donor tissue.
    

Intervention name(s): PLGA scaffold
Intervention type(s): Device
Intervention description(s): Poly-Lactic-co-Glycolic Acid (50:50) biodegradable, synthetic scaffold
Other intervention name(s): Purasorb PDLG 5004
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LSCD; SLET; Donor Human Amniotic Membrane (hAM); PLGA
Investigation of Potential Drug-drug Interaction of Volasertib With Itraconazole in Patients With Various Tumours
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the present study is to investigate the influence of
      co-administration of itraconazole and volasertib on the pharmacokinetic profile of volasertib
      without co-administration of itraconazole. Secondary objectives are to investigate safety,
      tolerability and preliminary therapeutic effects following intravenous administration of
      volasertib.
    


Intervention name(s): volasertib; itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Solution for infusion; capsules
Other intervention name(s): Orungal®
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Behavior Therapy (CBT) for Children With Functional Gastrointestinal Disorders
Condition: Functional Gastrointestinal Disorders (FGID); FGID According to the Rome III Criteria; Irritable Bowel Syndrome (IBS); Functional Abdominal Pain; Functional Dyspepsia
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Dyspepsia; Abdominal Pain
Study type: Interventional

Summary: 
      The purpose of the trial is to develop a treatment protocol to be used in trials studying
      internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The
      study size is not based on power calculations but the estimated sample necessary to develop a
      treatment protocol. This study will include 20-30 children with FGID and their parents who
      will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of
      exposure-based CBT. The study uses a pre- post-design with no control group.
    


Intervention name(s): Cognitive behavior therapy
Intervention type(s): Other
Intervention description(s): Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional gastrointestinal disorders; FGID; Recurrent abdominal pain; Abdominal pain; pain-predominant functional gastrointestinal disorders; Pediatric pain
Lifestyle-Related Health Outcomes in Prediabetes and Diabetes
Condition: Obesity; Prediabetic State; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
Study type: Interventional

Summary: 
      This study looks as how a health education intervention strategy effects health outcomes in
      overweight and obese adolescents.
    

Detailed description: 
      This study aims to do the following:

        1. To evaluate whether a health education and coaching strategy in overweight and obese
           adolescents (≥85th percentile) with high risk for type 2 diabetes is superior to usual
           care (single nutrition consultation) for weight management, clinical health outcomes
           (measures of glucose tolerance), lifestyle behavior outcomes (diet and physical
           activity) and outcomes of importance to patients such as satisfaction with the health
           care team, treatment goals, and psychosocial functioning.

        2. To evaluate whether a health education and coaching strategy in obese adolescents with
           diabetes (type 1 or type 2) is superior to usual care (single nutrition consultation)
           for weight management, clinical health outcomes (measures of diabetes control),
           lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to
           patients such as satisfaction with the health care team, treatment goals, and
           psychosocial functioning.

        3. At baseline, before the interventions described in Aims 1 and 2, to identify key diet
           and physical activity factors, patient characteristics, or biomarkers which are
           predictive of diabetes risk.

        4. At baseline, before the interventions described in Aims 1 and 2, can associations
           between glycemia, cardiometabolic risk factors, and diet and physical activity behaviors
           in overweight and obese adolescents who are at risk for type 2 diabetes be identified
           using the Bright Futures questionnaire, a survey for lifestyle behavior which is
           normally used in the clinic setting.
    

Intervention name(s): Health Education and Coaching Strategy; Dietary consult
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Utilizing health education and health coaching to intervene with adolescents who are at high risk for type 2 diabetes or prediabetes regarding nutrition and physical activity. A 16-week curriculum will be utilized and phone-based coaching visits will be performed.; A routine clinic-based dietary consult will be performed (approximately 1-hour).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: at risk for type 2 diabetes; currently has type 2 diabetes
Efficacy Study of the OV-Watch™ Personal Fertility Monitor for Women Using Clomiphene Citrate.
Condition: Infertility; Anovulation; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Infertility; Anovulation
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict
      ovulation while women are taking clomiphene citrate.
    

Detailed description: 
      At any given time, there are 10-15% of American couples with infertility. A problem with
      ovulation (releasing an egg) is one of the most common causes of female infertility. The
      frequency and timing of intercourse is important because the best chance of pregnancy occurs
      around the time of ovulation. The days that pregnancy is most likely to occur with
      intercourse is referred to as the "fertile window".

      The fertile window lasts for 6 days. It starts 4 days before ovulation and continues through
      the day after ovulation. Intercourse on the day of ovulation gives the highest chance of
      getting pregnant. However, intercourse up to 4 days before ovulation can still result in
      pregnancy because sperm can survive for up to 6 days in the reproductive tract of a woman.

      Urinary testing for the luteinizing hormone (LH) surge is the most common method for
      predicting ovulation. The LH surge precedes ovulation by about 36 hours. When LH is detected,
      this gives a couple only 2 days to have intercourse that may result in fertilization.

      The OV-Watch is an FDA approved device that has been shown to predict ovulation 5 days in
      advance for women who ovulate regularly. This wristwatch-like device is worn daily to detects
      changes in sweat ions. The device allows for earlier detection of the fertile window, giving
      the couple more opportunities to conceive.

      For women who do not ovulate on their own or ovulate irregularly, medication can be taken to
      help make eggs and ovulate. Clomiphene citrate is the most commonly used medication for this.
      We plan to study the effectiveness of the OV-Watch in women who are undergoing ovulation
      induction with clomiphene citrate and will compare the results to standard urinary LH
      testing.
    

Intervention name(s): OV-Watch
Intervention type(s): Device
Observational model: Defined Population
Time perspective: Prospective
Keywords: OV-Watch; fertility monitor; ovulation induction; clomiphene citrate; anovulation; infertility
The Effect of Glutamatergic Modulation on Cocaine Self-administration
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Repeated drug consumption may progress to problematic use by triggering neuroplastic
      adaptations that attenuate sensitivity to natural rewards while increasing reactivity to
      craving and drug cues. Converging evidence suggests that glutamate modulation may work to
      correct these adaptations and rapidly restore motivation for delayed non-drug rewards
      relative to immediate drug use. Using an established laboratory model aimed at evaluating
      behavioral shifts in the salience of cocaine now vs. money later, the investigators will test
      the effect of CI-581a on cocaine self-administration as compared to the active control.
    


Intervention name(s): CI-581a; CI-581b
Intervention type(s): Drug; Drug
Intervention description(s): a 50 minute infusion 24 hours prior to cocaine self-administration session; a 50 minute infusion 24 hours prior to cocaine self-administration session
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Impact of Incorporating an Exergame Activity Application in a Treatment Regimen for Overweight Children
Condition: Body Mass Index; Blood; Sugar, High; Lipid Disorder; Body Image
MeSH terms: Overweight; Lipid Metabolism Disorders; Hyperglycemia
Study type: Interventional

Summary: 
      80 children aged 5-13, BMI≥85%, will be recruited to a program for the treatment of
      overweight children.The intervention group will use the app "Just Dance Now" and The control
      group will be exposed to the usual program without the app. Measurements will be performed at
      the beginning of the program, the end and 3 months after completion of the intervention.
    

Detailed description: 
      80 children aged 5-13, BMI≥85%, will be recruited to the five-month program, at two centers
      for the treatment of overweight children. The intervention group will use the app "Just Dance
      Now" and part of a weekly exercise session will be dedicated to a group app activity. The
      control group will be exposed to the usual program without the app.

      Measurements of BMI, blood sugar and lipid profiles, as well as physical examination, and
      questionnaires regarding attitude and response to physical activity will be performed at the
      beginning of the program, the end and 3 months after completion of the intervention.
      Participation in the sessions will be documented and home activity recorded using a weekly
      log. ANOVA two-way repeated measures will be used to assess improvements in outcome measures.
    

Intervention name(s): Control; Exergame activity_EXG; Application activity
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Five-month interdisciplinary program, including: twice a week one-hour group exercise activity sessions, 3-5 group meetings with a dietician, 12-13 parent sessions with a social worker, and a healthy cooking workshop, each child will take part in individual sessions including: two appointments with a pediatrician, three sessions with a dietician and two sessions with a physical therapist serving as a consultant for physical activity.; In addition to the treatment given to the control group (as described above), the EXG group will obtain home access to the app "Just Dance Now" and part of a weekly exercise session will include a group activity with the app.; The application - "Just Dance Now" will be downloaded to the cellular phone of the child or parent. Exercise using the app will be used by cell phone connection to the child's home computer and as part of exercise group activity.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Exergame; Cellular apps; Smartphone; Overweight; Obesity; Children; Physical activity; Fitness; Motivation; BMI
Phase III Study of Intramuscular TAK-816 in Healthy Infants
Condition: Healthy Volunteers; Haemophilus Influenzae Type b, Prevention
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of intramuscular
      TAK-816 in healthy Japanese infants.
    

Detailed description: 
      The vaccine being tested in this study is called TAK-816. TAK-816 was being tested to
      evaluate its safety and immune response after intramuscular (IM) injection with TAK-816. This
      study evaluated adverse events and the seroprotection rate and geometric mean titer (GMT) of
      anti-polyribosylribitol phosphate (PRP)-antibodies in participants who were administered
      TAK-816 IM.

      The study enrolled 31 participants. All participants received 3 doses of TAK-816 IM at 4-week
      intervals as part of the primary vaccination and 1 booster vaccination 52 weeks after the
      third dose of the primary vaccination.

      This multi-center trial was conducted in Japan. The overall time to participate in this study
      was 64 weeks. Participants made multiple visits to the clinic including a final visit 4 weeks
      after last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-816
Intervention type(s): Biological
Intervention description(s): TAK-816 intramuscular injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Drug therapy; Safety and immunogenicity of Hib vaccine
Clinical Characteristics of Acute Pulmonary Embolism in Chinese Population
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Observational [Patient Registry]

Summary: 
      There are no special clinical characteristics of acute pulmonary embolism in Chinese
      population.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Acute pulmonary embolism in Chinese population
      
Biospecimen description: 
      BNP，D-dimer
Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Type 1 diabetes (T1D) is associated with increased risk of poor cardiometabolic health.
      Regular exercise is recommended for optimal management of comorbidities in T1D. Unique
      barriers to exercise exist for T1D, including fear of hypoglycemia, unpredictable glycemic
      excursions with exercise, and inadequate knowledge about exercise. Unlike traditional
      moderate intensity continuous training (MICT) which requires extended periods of time, high
      intensity interval training (HIIT) requires minimal time (~10 minutes of exercise per
      session), with the potential to rapidly stimulate mitochondrial biogenesis and metabolism.
      The extent to which these exercise strategies alter metabolomic signatures of carbohydrate,
      fat, and amino acid metabolism in T1D is unknown. The overall goal of the proposed project is
      to identify the acute metabolic effects and physiological modifiers of HIIT compared to MICT
      and control (CON) using metabolomic profiling and cardiometabolic assessments in 14 adults
      with T1D. Using a randomized cross-over approach, the primary aim is to compare the
      metabolomics response immediately post, 1 hr post, and glycemic control through 48 hrs after
      HIIT, compared to MICT matched for total energy expenditure, versus a no exercise CON. An
      additional aim will be to characterize the influence of biological sex and physiological
      outcomes (i.e. body composition, lean mass, visceral fat) on the metabolomics profile of
      these subjects. Outcomes from the present study, with existing data from our team, will lay
      the foundation for a larger diet and exercise lifestyle intervention that will ultimately
      lead to changes in clinical practice to co-manage glycemia and cardiometabolic comorbidities.
    


Intervention name(s): High Intensity Interval Exercise; Moderate Intensity Continuous Exercise
Intervention type(s): Other; Other
Intervention description(s): One session of high intensity interval exercise; One session of calorically matched moderate intensity exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Impact of an Oral Health Intervention
Condition: Eating Disorder
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      This pilot study will assess the effectiveness of an original oral health education program
      on affecting the behaviors of patients diagnosed with eating disorders.
    


Intervention name(s): Smiles Matter Oral Health Education Series
Intervention type(s): Behavioral
Intervention description(s): Three sessions scheduled 2 weeks apart consisting of 15-20 minutes of didactic learning, 10 minutes of a group/personal exercise, and 10 minutes of questions that the patients have on the topic discussed that day
Intervention model: Single Group Assignment
Primary purpose: Other
Keywords: Anorexia nervosa; Bulimia
Effect of Noise Blocking During General Anesthesia on Postoperative Pain
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      To investigate the effect of noise blocking during general anesthesia on postoperative pain
      in patients undergoing laparoscopic abdominal surgery. The aim of this study was to determine
      whether noise blocking can reduce postoperative pain, analgesic use, and its possible effects
      on intraoperative electrocorticogram.
    


Intervention name(s): Wear noise-cancelling earphones
Intervention type(s): Device
Intervention description(s): Intervention of wearing noise-canceling earphones after general anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomly divided into intervention group（noise blocking） and control group（No noise blocking）
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: noise blocking; Postoperative Pain