bioihbjkbjnl/mcl2 huggingface dataset:
Protocol to Monitor the Neurological Development of Infants With Exposure in Utero From Birth to 15 Months in Tanezumab Clinical Studies
Condition: Osteoarthritis; Cancer Pain; Recurrent Low Back Pain
MeSH terms: Low Back Pain; Cancer Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      A4091065 is a multicenter, prospective, cohort study with enhance physical an
      neurodevelopmental surveillance to characterize the outcomes related to the development of
      infants up to the age of 15 months who were potentially exposed to tanezumab, placebo or
      comparator via maternal exposure or in utero in any tanezumb study.
    

Detailed description: 
      A4091065 is a long term observational follow up study of subjects from tanezumab
      interventional studies A4091056, A4091057, A4091058, A4091059, A4091061 or A4091063
    

Intervention name(s): Investigational medical product (IMP) administered in parent study
Intervention type(s): Drug
Intervention description(s): IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Exposure in utero in tanezumab program
Chronic Inflammation and Exercise Responsiveness
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to determine how chronic inflammation influences skeletal muscle
      protein metabolism and metabolic function in humans. The investigators will evaluate acute
      responsiveness to a single bout of exercise in men and women who are either lean or
      overweight/obese. The investigators will explore the relationship between circulating
      inflammatory markers and anabolic, proteomic, and transcriptional responses to acute
      exercise. The investigators will measure skeletal muscle protein synthesis in the
      postabsorptive state and in response to a single bout of exercise.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Men and women between the ages of 30-55 years will be recruited for this study. Fifteen
        individuals will be lean, defined as a body mass index (BMI) between 19 and 24 kg/m2.
        Thirty individuals will be overweight/obese, defined as a BMI between 25 and 45 kg/m2.
Does Preoperative Sleep Quality Affect the Postoperative Emergence Delirium in Children Undergoing Strabismus Surgery
Condition: Postoperative Delirium; Strabismus; Sleep Disorder
MeSH terms: Delirium; Sleep Wake Disorders; Emergence Delirium; Strabismus
Study type: Observational

Summary: 
      Sleep is important in maintaining the physiological function of the human body. Recently
      several studies have reported that preoperative sleep quality is associated with
      postoperative emergence delirium (ED) The ED is a common in pediatric patients undergoing
      general anesthesia with sevoflurane, but studies on the association of sleep quality have
      been rare. The investigators, therefore, aimed to investigate the relationship between
      postoperative delirium and pre and postoperative sleep quality in pediatric patients
      receiving strabismus surgery through this study
    

Detailed description: 
      This study aimed on pediatric patients aged 4-12 years, undergoing elective strabismus
      surgery. Informed consent was obtained from both parents and children on the day of
      pre-anesthetic evaluation visit. The child and his or her parents were questioned on
      preoperative patient's sleep quality based on Pittsburg Sleep Quality Index (PSQI). Surgery
      was performed under the same anesthesia as usual. After the operation, extubation was
      performed and patient was moved to post anesthesia recovery room (PACU). During the stay in
      PACU, one investigator measured degree of ED by Watcha and PAED (Post anesthesia emergence
      delirium ) scale to minimize bias. One day after the surgery, the investigator mede a phone
      call to the parents of the patient to obtain information for postoperative PSQI.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subject of this study is pediatric patients aged 4~12 years, undergoing elective strabismus
        surgery.
      
Keywords: Postoperative delirium; Sleep quality; Pediatric anesthesia; Strabismus surgery
SupportBP 2.0:Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      A 3-arm randomized pilot trial aimed at comparing the effectiveness of different approaches
      to recruiting patients to participate in a 6-month remote monitoring program for the
      management of hypertension (HTN).
    

Detailed description: 
      The investigators will utilize the Way to Health (WTH) platform to develop and evaluate a new
      remote monitoring enrollment model that is integrated with routine clinical care at Penn
      Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients
      with poorly controlled HTN the investigators will:

        1. Compare the effect of sending eligible patients a blood pressure cuff with the mailed
           invitation letter and opt-out framing versus the more conventional method of phone calls
           following mailed letters.

        2. Evaluate the feasibility and effectiveness of a remote monitoring program with
           individualized stepped escalation for hypertension management.
    

Intervention name(s): Opt-In Recruitment; Opt-Out Recruitment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients in the opt-in recruitment arm will receive a letter describing the program and inviting them to participate in the remote monitoring program. Along with the letter they will receive an informational brochure and a copy of the informed consent form. Patients in this arm will then receive a recruitment phone call explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will mail a blood pressure cuff and begin the remote monitoring program for the patient 6 days later.; Patients assigned to opt-out recruitment will receive a blood pressure cuff with instructions in the mail along with a letter describing the program and opt-out framing regarding their participation, as well as a brochure and a copy of the informed consent form. Patients in this arm will receive a recruitment phone call similar to recruitment arm A, explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will begin the remote monitoring program for the patient immediately.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: blood pressure; remote monitoring
A Histological Study Evaluating Silk Voice and Crosslinked Hyaluronic Acid
Condition: Vocal Fold Palsy; Vocal Cord Paralysis; Vocal Cord Atrophy
MeSH terms: Vocal Cord Paralysis; Paralysis
Study type: Interventional

Summary: 
      The primary study goal is to evaluate the histological characteristic of Silk Voice to
      evaluate the potential for Silk Voice to deliver long-term results to patients.
    

Detailed description: 
      The primary study goal is to evaluate the histological characteristic of Silk Voice at a
      surrogate implantation site to evaluate the potential for Silk Voice to deliver long-term
      results to patients. Information obtained from this study will help clinician determine Silk
      Voice's treatment duration and whether Silk Voice is appropriate for their patient.
    

Intervention name(s): Silk Voice
Intervention type(s): Device
Intervention description(s): Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each subject enrolled will receive implantation of both Silk Voice and control material.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: silk, vocal fold
Fish Intervention and Learning Abilities
Condition: Cognitive Enhancement
Study type: Interventional

Summary: 
      In the FINS study we test - in a randomized non blinded intervention study- the hypothesis
      that increased intake of salmon will improve cognitive performance of children aged 4 years
      to 6 years in the Munich area (Germany), who habitually consume little fish.
    

Detailed description: 
      Long chain polyunsaturated fatty acids (LC-PUFA) of the n-3 series, eicosapentaenoic acid
      (EPA) and most prominently docosahexaenoic acid (DHA), are considered important for neural
      development during pre- and postnatal development.
    

Intervention name(s): Fish Meals; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Meals containing salmon; No fish meals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Test; Omega-3 Fatty acids
Changes in Body Adiposity by Dual Probiotic Strains Positively Correlated With Changes in Lp-PLA2 Activity in Overweight Adults
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective was to evaluate the effect of the consumption of dual probiotic strains
      containing Lactobacillus curvatus (L. curvatus) HY7601 and Lactobacillus plantarum (L.
      plantarum) KY1032 on weight loss, body adiposity and inflammatory markers including
      lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in overweight subjects.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled study was conducted on 120 subjects with age
      between 20 and 65 years, nondiabetic (fasting blood glucose <126 mg/dL and 2-hour blood
      glucose <200 mg/dL), and overweight (25 kg/m2 ≤ body mass index (BMI) < 30 kg/m2). Over a 12
      week test period, the probiotic group consumed 2 g of powder twice a day containing L.
      curvatus HY7601 and L. plantarum KY1032, while the placebo group consumed the same product
      without probiotics for 12 weeks.
    

Intervention name(s): Probiotic group; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The 2 g of probiotic powder contained 0.1 g of Lactobacillus curvatus HY7601, 0.1 g of Lactobacillus plantarum KY1032, 1.24 g of crystalline cellulose, 0.5 g of lactose, and 0.06 g of blueberry-flavoring agent.; The 2 g of placebo powder contained 1.34 g of crystalline cellulose, 0.6 g of lactose, and 0.06 g of blueberry-flavoring agent.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Probiotic; Weight loss; Lp-PLA2
Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use
      testing, in a controlled indoor environment
    


Intervention name(s): BAY987517; BullFrog Gel Sunscreen Land Sport SPF-50
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161); Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Assessing the Safety of Dapivirine Gel and Film Formulations
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to determine the safety of dapivirine gel and dapvirine film for healthy,
      HIV-uninfected women aged 18-45 years using the product for 7 daily doses.
    


Intervention name(s): Dapivirine Vaginal Film; Dapivirine Vaginal Gel
Intervention type(s): Drug; Drug
Intervention description(s): Dosage form: vaginal film Dosage: 1.25mg Frequency: 7 daily doses; Dosage form: vaginal gel Dosage: 0.5%, 2.5g Frequency: 7 daily doses
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV Infections; Anti-HIV agents; HIV-1
Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection
Condition: Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Observational

Summary: 
      The purpose of this observational study is to compare two approved treatment regimen(s)
      containing boceprevir and telaprevir, as part of standard of care for the treatment of
      hepatitis C.
    

Detailed description: 
      The objective of the study is to compare the effect of adding 2 oral hepatitis C virus (HCV)
      protease inhibitors, telaprevir versus boceprevir, as part of current standard treatment
      regimen with (pegylated-interferon-alpha + ribavirin) for HCV Genotype-1 infection. Data will
      be obtained from medical records of consenting patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population of adults aged 18-64 years, diagnosed with HCV genotype 1, with an HCV RNA
        >100,000. They should have had a liver biopsy within 5 years before enrollment. Lab work to
        determine eligibility includes an absolute neutrophil count of at least 1200 per cubic
        millimeter, a platelet count of at least 90,000 per cubic millimeter and a hemoglobin level
        of at least 12 g per deciliter
      
Keywords: Hepatitis C infection; Hepatitis C Virus; HCV
A Study to Examine the Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of TMC435 in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics (what the body does to a
      medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7
      days in healthy Chinese participants.
    

Detailed description: 
      This is an open-label (both [participants and investigator] know what treatment participants
      will receive) and randomized (study medication is assigned by chance) study. The study
      consists of 3 phases: a screening phase (within 21 days prior to administration of study
      medication), a treatment phase (from day -1 [1 days before the administration of study
      medication] to Day 10 including pharmacokinetics sample collection), and follow-up phase (up
      to 16 days after the last dose of study medication or after dropout [other than withdrawal of
      consent]). Approximately 32 healthy participants will be equally divided into 2 groups (Group
      1 and Group 2) to receive TMC435 for 7 days. Safety will be evaluated by the assessment of
      adverse events, clinical laboratory tests, vital signs, and physical examination which will
      be monitored at various timepoints throughout the study. The total duration of study
      participation for each participant will be approximately 47 days.
    

Intervention name(s): TMC435 100 mg; TMC435 150 mg
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive TMC435 100 mg capsule once daily from Day 1 to Day 7 after food.; Participants will receive TMC435 150 mg capsule once daily from Day 1 to Day 7 after food.
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Chinese participants; TMC435; Multiple oral doses; Pharmacokinetics; Safety; Tolerability
Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability of the high concentration
      liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the
      same HCLF of gantenerumab produced with the G3 process in healthy participants following
      single SC dose administration.
    

Detailed description: 
      This multi-center, randomized, open-label, single dose, parallel-group study will assess the
      relative bioavailability and the safety and tolerability of gantenerumab produced with the G4
      process in comparison to gantenerumab produced with the G3 process. All participants will
      receive single SC dose of gantenerumab (manufactured by either the G3 or G4 process) on Day
      1. The total duration of the study for each participant will be up to 21 weeks: Screening (up
      to 8 weeks); In-clinic period (Days -1 to 3); Out-patient period (Days 4 up to 68); and
      Safety Follow-up (up to 90 days after dosing).
    

Intervention name(s): Gantenerumab
Intervention type(s): Drug
Intervention description(s): Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).
Other intervention name(s): RO4909832
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction
Condition: Myocardial Infarction; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1

Summary: 
      Following a Heart attack the acute loss of heart muscle cells results in a cascade of events
      causing an immediate decrease in cardiac function that has the potential to persist long
      term. Despite revascularization of the infarct related artery circulation and appropriate
      medical management to minimize the stresses on the heart walls, a significant percentage of
      patients experience permanent cardiac dysfunction and consequently remain at an increased
      life-time risk of experiencing adverse cardiac events, including death.

      There is a great potential for stem cell therapy, using a variety of cell precursors
      (particularly hematopoietic,)to contribute to new blood vessel formation (and possibly
      limited heart muscle formation) and muscle preservation in the myocardial infarct zone. The
      administration of cells via an infusion through the infarct related artery appears to be
      feasible and result in a clinical effect in some studies.

      Therefore, we propose to evaluate the safety and efficacy of a CD34+ selected stem cell
      product (AMR-001), administered through the infarct related coronary artery 6 to 9 days after
      successful infarct related artery stent placement.

      The primary objective of the study is to determine the feasibility and safety of
      prospectively identifying patients at risk for clinically significant cardiac dysfunction
      following a myocardial infarction and the ability to isolate and infuse via the affected
      coronary circulation an autologous bone marrow derived CD34+ cell product at four dose
      levels.

      The secondary objective of the study is to assess the effect on cardiac function and infarct
      region perfusion. A concurrent patient group meeting eligibility but not receiving CD34+
      cells will be evaluated similar to the treated group to assess the rate of significant
      spontaneous improvement in cardiac function without CD34+cell infusion.
    


Intervention name(s): Intra-coronary infusion
Intervention type(s): Drug
Intervention description(s): In our study there will be four dosing cohorts (5, 10, 20 and 30 x 106) of CD34+ cells.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myocardial infarction; bone marrow; cd34+; stem cells
A Single-Dose, Open-Label, Study to Evaluate the Sustainability of the Effects of SYN-010 in Patients With IBS-C
Condition: Irritable Bowel Syndrome With Constipation (IBS-C)
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      A Single-Dose, Open-Label, Extension Study to Evaluate the Sustainability of the Effects of
      SYN-010 in Patients with Irritable Bowel Syndrome with Constipation
    

Detailed description: 
      This is a Phase 2, multi-center, open-label study. Up to sixty subjects with irritable bowel
      syndrome with constipation who are between the ages of 18 and 65, inclusive, will be
      enrolled. Subjects must have completed the previous SB-2-010-001 study. The entire duration
      of the study may be up to 57 days (from enrollment to the post end-of-study [EOS] visit
      telephone call).
    

Intervention name(s): SYN-010
Intervention type(s): Drug
Intervention model: Single Group Assignment
Intervention model description: Subjects from the study SB-2-010-001 (NCT02495623) were given either SYN-010 21 mg, SYN-010 42 mg, or Placebo. The subjects were offered the opportunity to roll over into SB-2-010-002 and receive SYN-010 42 mg. Some of the analyses were done from day one of SYN-010-001.
Masking: None (Open Label)
Primary purpose: Treatment