bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effectiveness of the POWER Through Choices Program
Condition: Pregnancy; Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of the POWER Through Choices (PTC)
      curriculum in increasing contraceptive use and delaying sexual initiation among youth living
      in group foster care homes.
    

Detailed description: 
      Youth in foster care are at especially high risk for teen pregnancy and associated sexual
      risk behaviors. The POWER Through Choices (PTC) program is a 10-session sexuality curriculum
      that aims to increase contraceptive use and delay sexual initiation by empowering youth to
      make healthy, positive choices about their sexual behaviors. This study uses a cluster
      randomized design to compare the effectiveness of PTC to usual programs and services provided
      to youth living in group foster care homes. Study participants will be youth living in group
      foster homes recruited in four locations: Kern County, CA; Cook County, IL; Baltimore County,
      MD; and Oklahoma (statewide). The study is being conducted as part of the national Evaluation
      of Adolescent Pregnancy Prevention Approaches funded by the Office of Adolescent Health in
      the U.S. Department of Health and Human Services.
    

Intervention name(s): POWER Through Choices
Intervention type(s): Behavioral
Intervention description(s): 10-session group-based sexual education curriculum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Teen pregnancy; Sexually transmitted infections; Sexual risk behaviors
Maintenance Therapy Using Lenalidomide in Myeloma
Condition: Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Maintenance treatment of myeloma.
    


Intervention name(s): lenalidomide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral drug; oral placebo
Other intervention name(s): REVLIMID
Intervention MeSH terms: Lenalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Myeloma; Revlimid; Maintenance therapy; Autologous Stem Cell Transplantation
A Study to Test the Safety and Tolerability of a New Medication in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      A 1-year outpatient study to test the safety and tolerability of a new medication in the
      treatment of schizophrenia
    

Detailed description: 
      Study will evaluate long-term safety and tolerability of a new compound in the treatment of
      patients with schizophrenia as assessed by adverse events (AEs), measures of extra pyramidal
      symptoms (EPS; Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Scale [BAS], and
      Simpson-Angus Rating Scale [SAS]), vital sign measurements, electrocardiograms (ECGs),
      clinical laboratory evaluations.
    

Intervention name(s): Lurasidone 80mg tablet
Intervention type(s): Drug
Other intervention name(s): Lurasidone
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Latuda; Lurasidone
Effects of Yoga on Objective and Self-reported Health Indicators Among Female and Male Individuals
Condition: Stress, Psychological, Physiological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether inversions (specific yoga postures in which
      the heart is higher than the head) and other dynamic and static yoga postures affect heart
      rate variability, oxygen uptake, blood pressure, blood parameters and other objective
      measures of health, and a variety of subjective and objective measures of health in female
      and male individuals in Sweden.
    

Detailed description: 
      This randomized, controlled trial involving 44 male and females in Sweden will investigate
      whether yoga inversions and semi-inversions and other dynamic and static yoga postures will
      affect the following variables: heart rate variability, oxygen uptake, anthropometric
      variables, common symptoms in general practice, sleepiness, sleep quality and
      recovery/recuperation after sleep, blood pressure, blood lipids, blood proteins, blood sugar,
      salivary cortisol, hand grip strength, relaxation and recovery perceived stress, self-rated
      health, rating of perceived exertion, satisfaction with life, and work-family conflict.

      Participants will be divided into an intervention group and a passive control group. The
      intervention group will participate in six to ten weeks of yoga classes. The classes will be
      held 1-2 times a week for approximately one hour each and will include yoga poses and
      breathing techniques. The control group will not participate in any intervention but will
      conduct their lives as usual.

      The variables will be assessed at baseline; at the end of the intervention; and three, six,
      and twelve months after the end of the intervention.
    

Intervention name(s): Yoga intervention
Intervention type(s): Other
Intervention description(s): 6 weeks of yoga postures, once a week for 60 minutes in a group session with a yoga teacher.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: heart rate variability; oxygen uptake; heart rate recovery; perceived stress; sleep; blood pressure; body mass index; body weight; hand grip strength; sleep quality; subjective health complaints; blood lipids; salivary cortisol; blood sugar; HbA1C; Adiponectin; Leptin; Adipolipoproteins; blood proteins; cytokines; insomnia; sleeplessness; yoga
Foscarnet Treatment of Serious CMV Retinitis Infection in Patients With Acquired Immunodeficiency Syndrome
Condition: Cytomegalovirus Retinitis; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Cytomegalovirus Retinitis; Retinitis; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      To explore the safety and usefulness of foscarnet, an antiviral agent, in the treatment of
      cytomegalovirus (CMV) retinitis. Untreated CMV retinitis is a rapidly progressive, blinding
      disease in AIDS patients. The manner in which foscarnet breaks down in the body and the
      effect of increasing periodic intravenous doses are also studied. Foscarnet is active in
      vitro (test tube) against herpes viruses, including CMV, by inhibiting the virus DNA
      polymerases, enzymes necessary for virus replication, without affecting cellular DNA
      polymerases. Opportunistic CMV disease in AIDS is usually seen as retinitis, colitis,
      esophagitis, hepatitis, pancreatitis, encephalitis, or pneumonia. Ganciclovir has been used
      to treat AIDS patients with CMV disease but can cause severe neutropenia (very low neutrophil
      cell counts). Foscarnet does not suppress the production of neutrophils or other leukocytes
      (myelosuppression) and has shown in vitro activity against HIV.
    

Detailed description: 
      Foscarnet is active in vitro (test tube) against herpes viruses, including CMV, by inhibiting
      the virus DNA polymerases, enzymes necessary for virus replication, without affecting
      cellular DNA polymerases. Opportunistic CMV disease in AIDS is usually seen as retinitis,
      colitis, esophagitis, hepatitis, pancreatitis, encephalitis, or pneumonia. Ganciclovir has
      been used to treat AIDS patients with CMV disease but can cause severe neutropenia (very low
      neutrophil cell counts). Foscarnet does not suppress the production of neutrophils or other
      leukocytes (myelosuppression) and has shown in vitro activity against HIV.

      Treatment is given for a total of 10 weeks with a 2-week induction regimen followed by
      randomization to daily maintenance foscarnet for 8 weeks. If induction therapy is tolerated
      without unexpected toxicity, patients are allowed to self-administer foscarnet at home via
      central venous catheter and may receive up to 11 days of induction therapy by
      self-administration on an outpatient basis. Foscarnet will be administered in open-label
      fashion so that both investigator and patient will know the dose. Within the study, there are
      8 patients who upon entering the 2nd week of maintenance foscarnet therapy are treated with
      zidovudine (AZT).
    

Intervention name(s): Foscarnet sodium
Intervention type(s): Drug
Intervention MeSH terms: Foscarnet; Phosphonoacetic Acid
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Retinitis; AIDS-Related Opportunistic Infections; Foscarnet; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Antiviral Agents
The Maraviroc Darunavir/Ritonavir Once Daily Pharmacokinetic Study
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open label, prospective, two phase pharmacokinetic study. Subjects
      currently attending for HIV care at St. Mary's Hospital, London will be eligible.
    

Detailed description: 
      The study will describe the steady state pharmacokinetic parameters and short term safety of
      maraviroc/darunavir/ritonavir dosed at 150/800/100 mg once daily with and without
      tenofovir/emtricitabine 245/200 mg once daily in HIV-1 infected subjects.

      Fifteen HIV-1 infected subjects will be recruited. Eligible subjects will currently be
      receiving antiretroviral therapy comprising:

        -  tenofovir/emtricitabine 245/200 mg daily plus

        -  darunavir/ritonavir 800/100 mg daily

      On day 1, subjects will modify their current antiretroviral therapy to the following:

        -  tenofovir/emtricitabine 245/200 mg daily plus

        -  darunavir/ritonavir 800/100 mg daily plus

        -  maraviroc 150 mg daily On day 10 subjects will undergo an intensive pharmacokinetic
           visit.

      On day 11, subjects will modify their current antiretroviral therapy to the following:

        -  darunavir/ritonavir 800/100 mg daily plus

        -  maraviroc 150 mg daily (i.e. tenofovir/emtricitabine will be discontinued) On day 20
           subjects will undergo an intensive pharmacokinetic visit. Following completion of this
           study phase, subjects will recommence their usual antiretroviral treatment regimen and
           attend for a study follow up visit.
    

Intervention name(s): Maraviroc; Truvada; Darunavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Maraviroc 150 mg daily; daily until 10. day then stop; daily until 10. day then stop
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Maraviroc; Darunavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV
A Study of Mirikizumab in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of the study drug known as
      mirikizumab. The study will investigate how the body processes the study drug. It will last
      up to about 4 months for each participant.
    


Intervention name(s): Mirikizumab - IV; Mirikizumab - SC; Placebo - IV; Placebo - SC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered IV; Administered SC; Administered IV; Administered SC
Other intervention name(s): LY3074828; LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Non-drug Study to Assess the Suitability of Assessment Scales in Japanese Individuals With Down Syndrome Aged 6-30
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Observational

Summary: 
      To evaluate the suitability (i.e. number of tests completed and number of participants
      completing the tests, variance estimate of baseline and of the change from baseline values)
      of neurocognitive tests and functioning scales in view of their use in future multicenter,
      multinational clinical efficacy trials testing a putative cognitive enhancer for individuals
      with Down syndrome aged 6-30.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        People with Down syndrome
Exercise as Cardio Protective Modulates in Diabetic Patients
Condition: Diabetes Mellitus; Exercise
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      -  Physical exercise for 6 months produced significant improvement in adiponectin, hs-CRP,
           and nitric oxide (NO) and was significantly correlated with adiposity markers, lipid
           profile and glycemic control factors in both obese and non-obese diabetic patients.

        -  Patients with good physical activity reported a significant decrease in BMI, CHD risk
           scores, reduced hs-CRP, an increase in the levels of adiponectin and nitric oxide.

        -  In patients with type 2 diabetes mellitus, adiposity markers, lipid profile, hs-CRP, and
           adiponectin were significantly improved following moderate exercise interventions
    

Detailed description: 
      To elucidate the potential role of exercise as anti-adiposity and anti-cardio protective
      modulates, we thought to investigate the effect of supervised aerobic training of moderate
      intensity on adiposity markers, nitric oxide level, plasma adiponectin, hs-CRP, and its
      association with CHD risk score in obese and non-obese patients with type 2 diabetes.
    

Intervention name(s): Supervised aerobic exercise
Intervention type(s): Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Fifty subjects diagnosed with type 2 diabetes for more than 5 years aged 45-70 years were
        invited in the period from 2013 to 2014 to participate in this study. Patients were
        diagnosed according to the criteria of American diabetes association.32 Based on the values
        of BMI, the patients were classified into two groups, obese diabetic group (n= 25, BMI ≥ 30
        kg/m2) and non-obese group (n= 25, BMI ≤ 30 kg/m2).
      
Biospecimen description: 
      Blood samples were obtained from all subjects at 0800 h after an overnight fast before and
      after the training program Venous blood samples (5 mL) were collected into plain tubes, the
      samples were allowed to clot for half an hour following which samples were centrifuged for 15
      minutes at 2000 rpm. Samples were given a coded study identification number and were stored
      frozen at 80°C until analysis.
A Study to Compare the Safety and Imaging Pattern of Cyclotron-produced Technetium (CTC) vs. Generator-produced Technetium (G-PERT) in People With Thyroid Disorders Who Need Surgery
Condition: Thyroid Gland Diseases
MeSH terms: Thyroid Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      A 99mTc Pertechnetate (G-PERT) scan is a nuclear medicine test that can create an image of
      the thyroid gland and other organs. G-PERT is approved by Health Canada for the direct
      imaging and measurement of thyroid uptake.

      Doctors and researchers at the University of Alberta have developed a new method of producing
      99mTc Pertechnetate (called CTC). It is made in a cyclotron at the Medical Isotope and
      Cyclotron Facility (MICF) at the University of Alberta, Edmonton, Alberta. This new
      production method will provide another source of 99mTc Pertechnetate. The aim of this study
      is to confirm that CTC is safe and can be used interchangeably with G-PERT.
    

Detailed description: 
      The clinical trial will be a Phase III, prospective, crossover, image interpretation blinded,
      single site study. All subjects will receive Tc-99m pertechnetate (one CTC and one G-PERT
      administration separated by at least 48 hours) and subsequently be imaged for thyroid uptake
      and whole body biodistribution. The order of the scans will be randomized. The thyroid image
      will be interpreted for uptake / no uptake in the thyroid, and the whole body biodistribution
      image will be interpreted for uptake / no uptake in selected anatomical sites. Interpretation
      of thyroid imaging results will be compared with other clinical findings (such as
      pre-surgical ultrasound, fine needle aspirate, and post-surgical pathology results, when
      available). All imaging assessments will be conducted by 1 blinded Nuclear Medicine
      physician. A safety evaluation will be conducted on all subjects receiving CTC, consisting of
      vital signs, haematology and SMA-12 serum biochemistry profile (pre-injection and
      post-imaging), and, for both CTC and G-PERT, an adverse event assessment (until the subject
      leaves the Nuclear Medicine department) after each administration.
    

Intervention name(s): CTC; G-PERT
Intervention type(s): Drug; Drug
Intervention description(s): After injection of CTC, a whole body and thyroid scan will be performed.; After injection of G-PERT, a whole body and thyroid scan will be performed.
Other intervention name(s): Cyclotron-produced technetium; Generator-produced technetium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults
Condition: Malaria; Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will evaluate whether relatively non-immune populations in endemic countries can
      effectively generate significant cellular and humoral immune responses that confer protection
      against P. falciparum infection after inoculation of aseptic, purified, vialed, metabolically
      active, non-replicating (live, radiation attenuated) Plasmodium falciparum sporozoites (PfSPZ
      Vaccine) administered intravenously (IV).
    

Detailed description: 
      This is a single center, Phase 1, dose escalating, randomized, double blind, controlled
      trial. Seventy-three healthy male volunteers, aged 18 to 35 years will be recruited. The
      study will have 5 study groups that will include 49 volunteers who will be intravenously
      injected with PfSPZ Vaccine, 8 control volunteers who will receive normal saline and 16
      additional control volunteers who will be recruited at the time of controlled human malaria
      infection (CHMI) at 3 and 24 weeks. The control volunteers will help better assess the
      occurrence of AEs compared to background disease patterns that occur in this tropical area,
      and the performance of the vaccine.
    

Intervention name(s): PfSPZ Vaccine; Normal Saline (Placebo); PfSPZ Challenge
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Aseptic, purified, vialed, metabolically active, non-replicating (live, radiation attenuated) cryopreserved Plasmodium falciparum sporozoites (PfSPZ); Live, infectious, aseptic, purified, vialed, cryopreserved Plasmodium falciparum sporozoites (PfSPZ) for CHMI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria; Plasmodium falciparum malaria; PfSPZ Vaccine; PfSPZ Challenge; Controlled human malaria infection (CHMI)
Periodic Limb Movement and Genetic Generalized Epilepsy
Condition: Epilepsy Generalized Idiopathic Not Intractable
MeSH terms: Epilepsy; Epilepsy, Generalized
Study type: Observational

Summary: 
      The study aimed to study the correlation between periodic limb movement occurring during
      sleep and the different parameters of genetic generalized epilepsy
    

Detailed description: 
      Although periodic limb movements are prevalent among patients with epilepsy, the exact
      relationship between these movements and epilepsy remains elusive. Objective: The aim of this
      work was to study the periodic limb movements among patients with genetic generalized
      epilepsy in relation to different clinical characteristics and seizure recurrence. Methods:
      Sixty individuals participated in this study: thirty of them were newly diagnosed with
      genetic generalized epilepsy and thirty were healthy individuals. Sleep quality was assessed
      using the Pittsburgh Sleep Quality Index questionnaire, and a standard polysomnographic study
      was conducted to all subjects. All patients then received sodium valproate in therapeutic
      doses and were followed up for six months. Electroencephalogram (EEG) was done after the
      follow-up period and seizure recurrence was assessed. Accordingly, patients were classified
      into three groups according to clinical seizure recurrence and follow-up EEG findings.

      Periodic limb movement index and frequency were compared among the patients' groups and were
      correlated with different clinical characteristics.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thirty patients and thirty volunteer healthy controls were recruited. Patients were newly
        diagnosed with genetic generalized epilepsy according to the ILAE 2010 criteria who did not
        previously receive AEDs. The clinical seizures were either eye-witnessed by physicians or
        video-recorded to ensure they were true epileptic seizures. Age of participants ranged from
        9 to 29 years. All patients recruited in this study had at least two unprovoked seizures
        occurring >24 hours apart. Patients with pre-existing psychiatric illnesses those with
        seizures due to toxic or metabolic causes ), infections, or structural causes, and those
        using hypnotic drugs were excluded. The control subjects were healthy volunteers who were
        not related to the patients and had no family history of epilepsy.
      
Keywords: Generalized epilepsy, idiopathic, periodic limb movement