bioihbjkbjnl/mcl2 huggingface dataset:
Brain Imaging and Treatment Studies of the Night Eating Syndrome
Condition: Night Eating Syndrome
MeSH terms: Syndrome; Night Eating Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in
      the treatment of the Night Eating Syndrome.
    

Detailed description: 
      This proposal explores the implications of our two recent major discoveries: the striking
      efficacy of the Selective Serotonin Reuptake Inhibitor (SSRI) sertraline in the control of
      the Night Eating Syndrome (NES) and the unprecedented elevation in the level of serotonin
      transporter (SERT) binding in the midbrain of persons with NES. Our overall theory is that
      NES is associated with a syndrome-specific increase in SERT derived from a genetic
      vulnerability which is affected by life stress. This increased SERT activity produces a fall
      in post-synaptic serotonin levels. The investigators hypothesize that these decreased
      serotonin levels result in a significant phase delay in circadian food intake manifested by
      evening hyperphagia, nighttime ingestions and morning anorexia. SSRIs that block this
      increased SERT activity increase synaptic serotonin levels and restore the circadian rhythm
      of food intake.
    

Intervention name(s): escitalopram oxalate
Intervention type(s): Drug
Intervention description(s): The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding will be conducted which will compare SERT binding in 31 night eaters with that of 10 control subjects. The first procedure will be to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls. Medication will be administered starting at 10 mg daily, with increase up to 20 mg, as indicated and tolerated, for up to three months. Visits will occur at baseline and weeks 1, 2, 4, 6, 8, 10, and 12.
Other intervention name(s): Lexapro
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adjuvant TACE to Reduce the HCC Recurrence After Resection
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second
      leading cause of cancer-related death. Surgical resection is still the main radical approach
      for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further
      improvement of prognosis of HCC patients. The conventional risk factors of recurrence
      including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the
      microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after
      hepatectomy. The investigators' previous study showed that the recurrence rate is more than
      50% for the patients with >5cm solitary tumor and MVI. The MVI was confirmed as the only
      independent risk factor for the overall and disease-free survival of HCC patients in multiple
      variables analysis. It is important to reduce the recurrence and prolong the survival of
      patients after hepatectomy with effective adjuvant therapy. TACE has been utilized as an
      adjuvant therapy after hepatectomy, but its significance is still unknown. Then, the
      investigators design the current prospective randomized clinical trial to evaluate the effect
      of adjuvant TACE to reduce the recurrence in HCC patients at high risk (>5cm solitary tumor
      and MVI) after resection, compared to vigilant follow-up.
    

Detailed description: 
      The patients with solitary tumor more than 5cm and microvessels invasion after radical
      hepatectomy were randomized to receive adjuvant TACE（1~2 cycles, 4~6 weeks) or follow-up. The
      main endpoint: overall survival (OS), disease-free survival(DFS), and safety were compared
      between this two groups.
    

Intervention name(s): Adjuvant TACE; Follow-up
Intervention type(s): Procedure; Procedure
Intervention description(s): 1~2 cycles TACE were performed as adjuvant therapy after radical hepatectomy; Patients received just follow-up to monitor the recurrence of HCC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carcinoma,Hepatocellular; Chemoembolization; Adjuvant therapy; Hepatocellular; Microvessels invasion
Overweight Children - Musculoskeletal Consequences
Condition: Pediatric Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose was to investigate the consequences of pediatric overweight on the
      musculoskeletal system, postural control and proprioception, and to analyze prospectively the
      influence of ball games and nutrition counseling.
    


Intervention name(s): Ball games program; Nutrition counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): twice a week different ball games 90min; 9 units of 90min each of nutrition counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening
Condition: Child Development; Developmental Disabilities; Ambulatory Care; Screening
MeSH terms: Developmental Disabilities
Study type: Interventional

Summary: 
      The purpose of this research study is to test the effectiveness of telephone-based early
      childhood developmental screening and care coordination, compared to usual care in a primary
      care pediatrics clinic. Investigators randomized 152 participants to one of two study arms,
      with the intervention families receiving developmental screening over the phone, and control
      families receiving usual care with their pediatricians.
    

Detailed description: 
      Although the American Academy of Pediatrics (AAP) recommends universal early childhood
      developmental screening as part of routine well-child care, there have been many studies
      documenting that many pediatricians do not follow the AAP guidelines. One intervention that
      has the potential to improve care, especially for low-income families, is centralized,
      telephone-based developmental screening, and care coordination for families whose children
      have developmental or behavioral concerns. 2-1-1 Los Angeles developed such an intervention
      and this study aims to test its effectiveness, in partnership with a local community clinic,
      using a randomized, controlled study design. Investigators partnered with the Clinica Oscar A
      Romero, a federally-qualified health center in Los Angeles, serving predominantly low-income
      Latino families. Investigators hope to enroll up to 300 families in the study. Eligible
      families will have children ages 12 to 42 months of age who receive well-child care at the
      clinic. As investigators obtain informed consent and enroll families, they will randomize
      study participants into intervention and control groups. Intervention group families will be
      transferred to 211 Los Angeles to complete developmental screening over the phone, while
      control group families will go to their pediatricians for well-child care as usual.
    

Intervention name(s): Telephone-based developmental screening and care coordination
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized individually at the time of enrollment, to receive either telephone-based developmental screening and care coordination, through 2-1-1 Los Angeles, in addition to usual care, or usual care alone. Primary outcomes were measured at 6 months after enrollment.
Masking: None (Open Label)
Primary purpose: Health Services Research
Illness Management and Parental Adjustment to Cancer Treatment
Condition: Solid Tumor; Leukemia; Lymphoma; Brain Tumor
MeSH terms: Neoplasms; Brain Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to test the efficacy of a clinic-based intervention designed to
      reduce illness uncertainty for parents of children who have been recently diagnosed with
      cancer.
    

Detailed description: 
      The proposed trial will test the efficacy of the parent-focused clinic-based Parent
      Uncertainty Management Intervention (PUMI) to improve the outcomes of children newly
      diagnosed with cancer and their parents. Participants will be randomly assigned to receive
      equivalent doses of either the PUMI or an Education/Support (ESO) group. Theoretically driven
      by Mishel's model of illness uncertainty, the PUMI will teach parents about uncertainty
      prevention and management through the use of medically-specific communication, information
      management, and problem-solving skills via in-clinic sessions and an online portal. Parents
      and children will complete measures online at baseline, 1-week, and 3-, 6-, and 12-month
      follow-ups.
    

Intervention name(s): IMPACT; ESO
Intervention type(s): Behavioral; Other
Intervention description(s): • The intervention is 6 sessions lasting approximately 45 minutes reviewing ways to help prevent and respond to illness uncertainty. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist.; This control is 6 sessions lasting approximately 45 minutes providing education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist.
Other intervention name(s): Parent Uncertainty Management Intervention; Education/Support Only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Intervention; Illness Uncertainty; Childhood Cancer; Solid Tumor; Leukemia; Lymphoma; Brain Tumor; Randomized clinical trial; Parental uncertainty management intervention; Parent; Oncology; Pediatric
Disposition of 14C-LY2452473 Following Oral Administration in Healthy Human Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose study of radiolabeled [14C]-LY2452473 in healthy male volunteers to
      study the absorption, distribution, metabolism, and elimination of LY2452473.

      This study is for research purposes only and is not intended to treat any medical condition.
    


Intervention name(s): LY2452473
Intervention type(s): Drug
Intervention description(s): Administered orally as a liquid suspension
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Absorption; Distribution; Metabolism; Excretion; Mass balance; Metabolic profile; Radiolabeled study; 14C
Treatment of High Altitude Polycythemia by Acetazolamide
Condition: High Altitude Polycythemia
MeSH terms: Altitude Sickness; Hypoventilation; Polycythemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The prevalence of High Altitude Polycythemia (or Chronic Mountain Sickness) is between 8 and
      15% in the high altitude regions of South America. There is no pharmacological treatment
      available. After a first preliminary study in 2003 demonstrating the beneficial effects of
      acetazolamide in reducing hematocrit in these patients, after 3 weeks of treatment, we want
      to confirm this effect and implement a treatment protocol of 3 month-duration.
    

Detailed description: 
      Chronic mountain sickness (CMS) is characterized by an excessive number of red cells in the
      blood of persons living permanently above the altitude of 2,500m. The symptoms of this very
      incapacitating disease are : headaches, chronic asthenia, digestive troubles, sleep
      disturbances. The hemoglobin concentration is higher than 21 g/dl of blood. In addition,
      patients show a pulmonary hypertension of variable degree, as well as a systemic
      hypertension.

      This disease affects essentially males, but women are also concerned after menopause. The
      evolution of the disease is always very dramatic, towards a cardiac failure and cerebral
      vascular stroke. The prevalence is between 8% and 15% on the Andean Altiplano . No
      pharmacological treatment is available.

      A preliminary study was performed (Richalet et al. AJRCCM, 2005) that demonstrated the
      efficiency of acetazolamide (a carbonic anhydrase inhibitor) in reducing the hematocrit and
      the erythropoetin concentration,and increasing nocturnal oxygen saturation in patients
      suffering from CMS, after 3 weeks of treatment.

      We plan to perform a double-blinded placebo-controlled study to evaluate the efficiency of a
      3-month treatment with daily 250 mg acetazolamide to reduce the hematocrit and hemoglobin
      concentrations and ameliorate the clinical symptoms of 55 patients suffering from CMS and
      living at high altitude (Cerro de Pasco, Peru).
    

Intervention name(s): acetazolamide
Intervention type(s): Drug
Intervention MeSH terms: Acetazolamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: high altitude; hypoxia; pulmonary hypertension; polycythemia; hypoventilation
Contact Lenses and Infiltrative Keratitis
Condition: Keratitis
MeSH terms: Keratitis
Study type: Interventional

Summary: 
      To quantify and compare baseline tear proteins and ocular response in contact lens wearers
      with a history of corneal infiltrative events, to those without a history of complications.
      This will be accomplished via measurement of select anti-inflammatory tear proteins before,
      during and after contact lens wear.
    


Intervention name(s): senofilcon A
Intervention type(s): Device
Other intervention name(s): Acuvue Oasys
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Contact lenses
Safety, Tolerability and Pharmacokinetics of Genz-682452 in Healthy Men
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to assess the tolerability, safety and pharmacokinetic
      parameters of Genz-682452 in healthy adult males, in two parts.

      Part 1 (GZFD00111TDU12766): double-blind, randomized, placebo-controlled, sequential
      ascending single dose study;

      Part 2 (GZFD00211FED12767): open-label, randomized, 2-sequence, 2-period, 2-treatment
      crossover study with a minimum wash-out period; to obtain preliminary information on the
      pharmacokinetics, tolerability and safety of Genz-682452 after single oral doses in fed and
      fasted conditions.

      Subjects are not allowed to participate in more than 1 part of the study.
    


Intervention name(s): Genz-682452; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules for oral administration.; Placebo to Genz-682452
Intervention MeSH terms: Venglustat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to <18 Years of Age
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3/4, randomized, observer-blind, multi-center study, stratified study evaluated
      the immune (antibody) response, efficacy and safety of a cell-derived quadrivalent subunit
      influenza virus vaccine (Seqirus QIVc) in comparison with a non-influenza comparator,
      meningococcal serogroup A, C, W-135, and Y (Menveo®, GlaxoSmithKline Biologicals, S.A.) in
      healthy pediatric subjects ≥2 Years to <18 Years of Age
    

Detailed description: 
      This Phase 3/4, randomized, observer-blind, multi-center, stratified study evaluated the
      efficacy, safety, and immunogenicity of a cell-derived quadrivalent subunit influenza virus
      vaccine (Seqirus QIVc) compared to a non-influenza comparator vaccine in healthy male and
      female participants between 2 to <18 years of age. A total of 4514 children/teens were
      randomized, receiving either QIVc or the non-influenza comparator vaccine. The comparator was
      (meningococcal [Groups A, C, W-135, and Y] oligosaccharide diphtheria CRM197 conjugate
      vaccine [Men ACWY]). Randomized enrollment was stratified in a 1:1 ratio via an Interactive
      Response Technology (IRT) system which assigned the participants into two age cohorts: 2 to
      <9 years of age and 9 to <18 years of age. Subjects between 2 to <9 years of age were further
      stratified by previous influenza vaccine status ("previously vaccinated" or "not previously
      vaccinated").
    

Intervention name(s): QIVc; Non-influenza Comparator Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains; Non-influenza comparator vaccine for intramuscular use
Other intervention name(s): Flucelvax Quadrivalent
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 3/4
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza vaccine
Bone Mineral Density Substudy - An Ancillary Study to MTN-003
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Observational

Summary: 
      The MTN-003 HIV prevention study include the use of microbicides, substances that kill
      microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil
      fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to
      determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on
      bone mineral density (BMD).
    

Detailed description: 
      The effect of tenofovir on bone mineral density (BMD) has not yet been studied and is of
      potential concern. The purpose of this study is to determine the changes in BMD among
      individuals receiving TDF and FTC/TDF compared with a placebo.

      This substudy will enroll individuals currently participating in MTN-003. The expected
      duration of participation for each participant is approximately 48 months. Study treatment
      will be provided by MTN-003. Study treatment will not be provided by this substudy.

      Study visits will occur every 6 months after enrollment. A nutrition assessment, physical
      activity history, and urine and blood collection will occur at all visits.
    

Intervention name(s): Emtricitabine/tenofovir disoproxil fumarate; Emtricitabine/tenofovir disoproxil fumarate placebo; Tenofovir disoproxil fumarate; Tenofovir disoproxil fumarate placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200 mg/300 mg tabletas a part of MTN-003; placebo tablet as a part of MTN-003; 300 mg tablet as a part of MTN-003; placebo tablet as a part of MTN-003
Other intervention name(s): FTC/TDF; Truvada; FTC/TDF placebo; Truvada placebo; TDF; TDF placebo
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Sexually active, HIV-uninfected women who are currently enrolled in MTN-003
      
Biospecimen description: 
      Urine and blood samples
    
Keywords: Microbicide; HIV Seronegativity; Bone Mineral Density
A Study to Investigate the Effect of CYP3A4 Inhibition on the Single Dose Pharmacokinetics of ASTX660 and the Effect of a Single Dose of ASTX660 on the Pharmacokinetics of the CYP3A4 Substrate Midazolam
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      In Part 1, the primary objective is to investigate the effect of multiple doses of
      itraconazole, an inhibitor of CYP3A4, on the pharmacokinetic (PK) profile of a single dose of
      ASTX660.

      In Part 2, the primary objective is to investigate the effect of a single dose of ASTX660 on
      the pharmacokinetics of the CYP3A4 substrate midazolam and its metabolite, 1-hydroxy
      midazolam.

      Safety and tolerability of a single dose of ASTX660 in the absence and presence of multiple
      doses of the CYP3A4 inhibitor itraconazole and in the presence of a single dose of the CYP3A4
      substrate midazolam will also be evaluated.
    


Intervention name(s): ASTX660; Midazolam; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Form: capsule; Route of administration: oral; Form: syrup; Route of administration: oral; Form: capsule; Route of administration: oral
Intervention MeSH terms: Itraconazole; Midazolam
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
N-Acetylcysteine and L-carnitine in Pcos
Condition: PCOS
Study type: Interventional
Phase: Phase 2

Summary: 
      N-Acetylcysteine and L-carnitine were used in pcos patients
    

Detailed description: 
      N-Acetylcysteine was compared to L-carnitine in clomiphene citrate in Pcos women to detect
      the hormonal and metabolic effect
    

Intervention name(s): N-Acetylcysteine; L-carnitine
Intervention type(s): Drug; Drug
Intervention description(s): N-Acetylcysteine in clomiphene resistant pcos women; L-carnitine in clomiphene resistant pcos women
Other intervention name(s): motova plus
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Endocrine Regulation of Lipolysis in Obesity and Diabetes
Condition: Obesity; Diabetes
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Adipose tissue (AT) dysfunction is a commonly observed feature of metabolic dysfunction in
      obesity and diabetes. An important characteristic when examining AT function is the capacity
      to break down stored lipids (i.e. lipolysis) and its regulation. In the present study, the
      aim was to investigate whether atrial natriuretic peptide-mediated lipolysis is altered in
      different adipose tissue depots (subcutaneous and visceral adipose tissue) of obese subjects
      with or without type 2 diabetes, compared to age-matched lean men. Eventually, the knowledge
      gained from this research will contribute to a better understanding of the present adipose
      tissue dysfunction and to the optimization of exercise programs for people with obesity and
      diabetes.
    


Intervention name(s): adipose tissue sampling
Intervention type(s): Other
Intervention description(s): adipose tissue (subcutaneous and visceral adipose tissue) sampling during abdominal surgery and phenotype determination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)