bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Physical Activity an Stress in Children
Condition: Obesity; Children; Physical Activity; Stress; Snacking
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the impact of physical activity in obese and
      nonobese prepubertal children on:

        1. biological stress responses during a psychosocial stress test

        2. snacking and feeling of hunger in response to the same psychosocial stress test

        3. the moderating factor of attachment on the biological stress responses and on snacking

      Children will be investigated on one study day during 3.5 hours.
    

Detailed description: 
      Hypotheses In this study, 3 primary hypotheses will be tested.

        1. Moderate physical activity during 25 min in children decreases the cortisol levels in
           response to the Trier Social Stress Test TSST-C (for children).

        2. Moderate physical activity during 25 min in children decreases the snacking (calorie
           consumption when corrected for expenditure and switch in quality of food intake) in
           response to the Trier Social Stress Test TSST-C (for children).

        3. A secure attachment will be a moderating factor for the general increase in cortisol and
           the snacking in response to the psychosocial stress test (Trier Social Stress Test
           TSST-C).

      Secondary objectives:

        1. To test if the impact of physical activity on stress responses and snacking differs
           between obese and non-obese children

        2. To test the impact of physical activity on the cardiovascular stress reactivity (blood
           pressure, heart rate) and the perceived stress (scale) in response to the Trier Social
           Stress Test TSST-C?

        3. To test if the stress reactivity and its modulation by physical activity is different in
           anxious and in impulsives/labile children

        4. To test if serious life events and parental worries and parental educational style
           influence the stress reactivity
    

Intervention name(s): Acute physical activity intervention; placebo
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 25 min of physical activity. The placebo arm will have 25 min of reading.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Children; Physical activity; Stress; Snacking
Diffusion-weighted Imaging Study in Cancer of the Ovary
Condition: Ovarian Cancer; Peritoneal Metastases
MeSH terms: Neoplasm Metastasis; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Observational

Summary: 
      This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring
      treatment response in ovarian cancer metastases and assess its potential in monitoring
      treatment response. This will involve standardising DW-MRI for the abdomen and pelvis across
      multiple centres and platforms, assessing reproducibility of the measurement in patients
      planned for neoadjuvant chemotherapy and assessing its utility as an early response biomarker
      in patients with platinum-sensitive relapse due to receive therapy with carboplatin. Scanning
      measurements will be correlated with histopathological markers in tumour samples in order to
      link the biomarker with response mechanisms.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with primary or relapsed ovarian cancer
      
Biospecimen description: 
      Tumour samples taken at surgery for histological analysis
Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical Study
Condition: Parkinson Disease; Movement Disorders; Neuro-Degenerative Disease; Nervous System Diseases; Brain Diseases
MeSH terms: Parkinson Disease; Nervous System Diseases; Movement Disorders; Brain Diseases; Neurodegenerative Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is an extension to the HP-CD-CL-2002 clinical study. It evaluates the long-term
      safety and tolerability of CDNF in patients with Parkinson's disease when dosed directly into
      the brain using an implanted investigational drug delivery system (DDS). Long-term safety of
      the DDS is also being evaluated. All patients will receive monthly infusions of either mid-
      or high-dose of CDNF for a period of 6 months.
    

Detailed description: 
      A patient's participation in the study will last for six months and will include nine visits:

      Screening (1 visit, same as HP-CD-CL-2002 End-of-Study visit) Dosing visits: CDNF (6 visits)
      DAT-PET (1 visit) End-of-study visit (1 visit)

      Study examinations and assessments

        -  Physical examination: pulse rate, blood pressure, temperature, body weight and height,
           body mass index (BMI), neurological exam

        -  ECG (electrocardiography) and blood and urine tests

        -  Pregnancy tests for women of childbearing age

        -  Completion of a patient diary to record mobility and time asleep

        -  Parkinson's Kinetigraph (PKGTM) Data Logger: a watch-type movement recording device

        -  Questionnaires, rating scales and forms: quality of life, mood, memory, impulse control,
           mental health

        -  Assessment of the port and the skin around the port

        -  Cerebrospinal fluid sampling by lumbar puncture

        -  Magnetic resonance imaging (MRI)

        -  Positron emission tomography scans (PET)

      For more information: https://treater.eu/clinical-study/
    

Intervention name(s): Cerebral Dopamine Neurotrophic Factor; Renishaw Drug Delivery System
Intervention type(s): Drug; Device
Intervention description(s): Repeated intracerebral infusions; Stereotactically implanted device
Other intervention name(s): CDNF; DDS
Intervention MeSH terms: Dopamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, Double-Blind, Active Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson; CDNF; Drug Delivery System; Intracerebral
Evaluating the Safety of and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults in Uganda
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The RV 156A clinical trial is evaluating an experimental HIV vaccine in people who are not
      infected with HIV. Participants in that study are randomly assigned to receive either the HIV
      vaccine or placebo. This study will enroll people who are participating in the RV 156 study.
      In this study, researchers will evaluate the safety of and immune response to a different
      experimental HIV vaccine in people who participated in the RV 156 study.
    

Detailed description: 
      RV 156A is a single site, phase 1 open label study with accrual restricted to participants in
      RV 156. Participants in the RV 156 study were randomly assigned to receive three injections
      of either placebo or the VRC-HIVDNA009-00-VP vaccine. All participants in this study will
      receive one injection of a different experimental HIV vaccine, VRC-HIVADV014-00-VP. The
      purpose of this study is to evaluate the safety and immunogenicity of the VRC-HIVADV014-00-VP
      vaccine in people who participated in the RV 156 study. Researchers will examine the
      differences in the immune response to the VRC-HIVADV014-00-VP vaccine between people who
      received placebo in the RV 156 study and people who received the VRC-HIVDNA009-00-VP vaccine
      in the RV 156 study.

      A projected number of up to 29 volunteers will be enrolled from the Makerere University site
      in Uganda. At study entry, all participants will undergo a physical examination, medical
      history review, vital sign measurements, and blood and urine collection. They will also
      receive counseling for HIV prevention and pregnancy prevention. Participants will then
      receive one injection of the VRC-HIVADV014-00-VP vaccine in their upper arm. They will remain
      in the clinic for 30 to 45 minutes for observation and monitoring. For 3 days after the
      vaccination, participants will record their temperature and any adverse symptoms in a diary.
      Additional study visits will occur at Days 3, 14, 28, 42, 84, 168, 252, and 336. At each
      visit, participants will undergo the same study procedures that they completed at the study
      entry visit.
    

Intervention name(s): VRC-HIVADV014-00-VP Vaccine
Intervention type(s): Biological
Intervention description(s): All participants will receive one injection in their upper arm of 1 x 10^10 particle units (PU)/mL of VRC-HIVADV014-00-VP at study entry.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Electric Impedance Tomography Before and After Dilatative Tracheotomy
Condition: ICU Patients; Tracheotomy Required
Study type: Observational

Summary: 
      The changes of local pulmonary ventilation should be registered with an electric impedance
      tomography (EIT) before and after a dilatative tracheotomy. The hypothesis is that the EIT
      cannot show changes in local ventilation due to the tracheotomy.
    


Intervention name(s): EIT belt
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ICU patients undergoing an elective dilatative tracheotomy. Before and after tracheotomy
        the results of EIT will be compared.
Treatment of Fragile-X Associated Tremor/Ataxia Syndrome (FXTAS) With Allopregnanolone
Condition: Fragile X-associated Tremor/Ataxia Syndrome
MeSH terms: Ataxia; Cerebellar Ataxia; Tremor; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the safety and efficacy of Allopregnanolone as a
      possible treatment for symptoms of Fragile X-associated Tremor/Ataxia Syndrome (FXTAS).
    

Detailed description: 
      This study includes a screening visit with several assessments, followed by an open-label
      medication trial of Allopregnanolone for 12 weeks and an end-point evaluation to assess for
      changes. Assessments include blood draws for genetic and safety laboratory testing,
      neurological and physical exam and medical history, cognitive testing, and motor testing.

      Study record was updated in October 2018 to include adverse events and outcome measure
      reporting. Study record was updated in November 2018 in response to requests to (1) specify
      time frame of reported outcome measures, (2) clarify that the RASS was a safety monitoring
      tool, not a prespecified outcome measure, and as such will not be reported as an outcome
      measure, and (3) upload a version of the study protocol and statistical analysis plan with
      the required title page and statistical analysis plan information.
    

Intervention name(s): Allopregnanolone
Intervention type(s): Drug
Intervention description(s): Allopregnanolone is an endogenous inhibitory pregnane neurosteroid. It is synthesized from progesterone, and is a potent positive allosteric modulator of the action of γ-aminobutyric acid at GABAA receptor. Subjects will receive up to 12 infusions in the study. Subjects will all begin with 2.0 mg dosage. If tolerated, the next infusion will be 4.0 mg, and if that is tolerated, the next infusion will be 6.0 mg. Subject infusions will remain stable at the highest dosage tolerated for the remainder of the study. Each infusion will consist of 2.0 mg, 4.0 mg, or 6.0 mg aliquots of the 0.5 mg/ml allopregnanolone in 6% sulfobutylether-β-cyclodextrin with 0.9% sodium chloride injection solution.
Other intervention name(s): 5α-pregnan-3α-ol-20-one; 3α,5α-tetrahydroprogesterone; brexanolone
Intervention MeSH terms: Pregnanolone; Brexanolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)
Condition: Pregnancy; Neonates
Study type: Observational

Summary: 
      The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286)
      treatment for the induction of multifollicular growth in women undergoing Controlled Ovarian
      Stimulation (COS) prior to in vitro fertilization (IVF) or Intracytoplasmic Sperm Injection
      (ICSI) is safe for pregnant participants and their offspring.
    

Detailed description: 
      This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal
      outcomes of all women who were treated with corifollitropin alfa and became pregnant during
      the base Trial 38833. For this follow-up trial (38834), no investigational products will be
      administered and no study specific assessments are required, but information will be obtained
      as per standard clinical practice.
    

Intervention name(s): Corifollitropin alpha (MK-8962, Org 36286) 100 ug; Corifollitropin alpha (MK-8962, Org 36286) 150 ug; Triptorelin; Recombinant follicle stimulating hormone (recFSH); Human chorionic gonadotprophin (hCG).
Intervention type(s): Drug; Drug; Drug; Biological; Biological
Intervention description(s): Subcutaneous administration of corifollitropin alpha at a dose of 100 ug; Subcutaneous administration of corifollitropin alpha at a dose of 150 ug; Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase).; From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG.; HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.
Intervention MeSH terms: Triptorelin Pamoate; Hormones; Follicle Stimulating Hormone
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with an ongoing pregnancy at least 10 weeks after embryo transfer in Trial 38833 were
        enrolled in this trial.
      
Keywords: Neonatal outcome; Congenital malformations; In-Vitro fertilization; Controlled ovarian stimulation; Follow-up
Crossover Study to Compare the Pharmacokinetics of Subcutaneous and Intravenous Ceftriaxone Administration
Condition: Pharmacokinetics in Healthy Adults
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The proposed study aims to assess the time above MIC (4 mg/mL), and the
      pharmacokinetics/pharmacodynamics and bioavailability of 1 g ceftriaxone administered by
      constant rate subcutaneous infusion over 2 hours compared with 1 g of ceftriaxone
      administered as a constant IV infusion over 0.5 hours. In addition, the study will compare
      the results obtained after 1 g ceftriaxone intravenous or subcutaneous administration with 2
      g ceftriaxone administered subcutaneously
    


Intervention name(s): ceftriaxone
Intervention type(s): Drug
Intervention MeSH terms: Ceftriaxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants
Condition: Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

Summary: 
      The purpose of this study is to understand the changes in skin microflora, skin barrier
      function, and skin biochemical constituents in response to direct contact with model
      surfactants used in personal care articles. The results from this study will provide insights
      into the complex interaction between the skin microbiome and the epidermis after exposure to
      surfactants.
    


Intervention name(s): PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%; Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%; Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%; Silwet* DA-63 (Momentive) 1.5%; Sodium lauryl sulfate (Sigma Aldrich) 1.0%; Water (control)
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention MeSH terms: Castor Oil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Microcirculation of Patients With Kidney Transplant
Condition: Microcirculation
Study type: Observational

Summary: 
      This study measures the sublingual microcirculation of patients with kidney transplant using
      MicroScan. The data will be compared with data of health volunteers and end stage renal
      disease patients on hemodialysis.
    

Detailed description: 
      This study measures the sublingual microcirculation of patients with kidney transplant using
      MicroScan. The data will be compared with data of health volunteers and end stage renal
      disease patients on hemodialysis. The microcirculation date includes total small vessel
      density, perfused small vessel density, proportion of perfused vessels, microvascular flow
      index, and heterogeneity index.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with kidney transplant
Gene Therapy in Treating Patients With Primary Brain Tumors
Condition: Brain and Central Nervous System Tumors
MeSH terms: Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Inserting the gene for herpes virus into a person's cells may improve the body's
      ability to fight cancer or make the cancer more sensitive to chemotherapy using antiviral
      drugs such as ganciclovir.

      PURPOSE: Phase I trial to study the effectivenesss of gene therapy in treating patients with
      primary brain tumors.
    

Detailed description: 
      OBJECTIVES: I. Assess the response to a stereotactically administered recombinant adenovirus
      vector carrying the herpes simplex virus thymidine kinase gene (H5.010RSVTK) followed by
      intravenous ganciclovir in patients with recurrent malignant glioma. II. Estimate the maximum
      tolerated dose of H5.010RSVTK in these patients. III. Describe the toxic effects of
      H5.010RSVTK. IV. Assess the efficiency of gene transfer and duration of transgene expression
      in these patients. V. Assess quantitative and qualitative glucose metabolic activity of
      tumoral sites by positron emission tomography. VI. Analyze the immunologic response to
      adenovirus transduction in these patients. VII. Determine the benefit and toxicity of
      multiple doses of H5.010RSVTK in patients with resectable tumors.

      OUTLINE: This is a dose-finding study. All patients receive stereotactically injected
      H5.010RSVTK (a recombinant adenovirus vector containing the herpes simplex virus thymidine
      kinase gene). Cohorts of 3-6 patients receive escalating doses of H5.010RSVTK until the
      maximum tolerated dose is reached. Ganciclovir is then given on the third post-injection day.
      Patients with unresectable tumors receive ganciclovir for 14 consecutive days. Patients with
      resectable tumors receive ganciclovir for 7 consecutive days before undergoing craniotomy
      with optimal debulking and injection of a second dose of the adenovirus vector followed by
      ganciclovir for 14 more days. Patients are followed monthly for survival.

      PROJECTED ACCRUAL: A total of 18 patients (9 with resectable tumors and 9 with unresectable
      tumors) will be entered over 3 years.
    

Intervention name(s): gene therapy; chemotherapy; ganciclovir; conventional surgery
Intervention type(s): Biological; Drug; Drug; Procedure
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult giant cell glioblastoma; adult gliosarcoma
A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of escalating
      multiple subcutaneous (SC) doses of MEDI-563 in adult subjects with asthma.
    

Detailed description: 
      This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-escalation,
      multicenter study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity
      of multiple subcutaneous doses (25, 100, or 200 milligram [mg]) of benralizumab (MEDI-563) in
      adult subjects with asthma.
    

Intervention name(s): Placebo; Benralizumab 25 mg; Benralizumab 100 mg; Benralizumab 200 mg
Intervention type(s): Other; Biological; Biological; Biological
Intervention description(s): Placebo matched to benralizumab (MEDI-563) injection subcutaneously on Day 0, 28, and 56.; Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.; Benralizumab (MEDI-563) injection 100 mg subcutaneously on Day 0, 28, and 56.; Benralizumab (MEDI-563) injection 200 mg subcutaneously on Day 0, 28, and 56.
Other intervention name(s): MEDI-563; MEDI-563; MEDI-563
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Benralizumab; MEDI-563
Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling
Condition: Alcohol Consumption
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      The main purpose of this study is to see whether heavy drinking will interfere with a
      specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead
      to liver injury in some patients who drink heavily.
    


Intervention name(s): Placebo; 10 mg Obeticholic Acid (OCA)
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.; 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other