bioihbjkbjnl/mcl2 huggingface dataset:
Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study
Condition: Brain Injury
MeSH terms: Brain Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Severe brain injuries induce alteration of state of consciousness. These functional
      limitations can be significantly alleviated by treatment neurorehabilitation, particularly if
      this is established early. It has been shown that treatment of vertical integration in
      patients in a vegetative state or minimally conscious state can improve the level of
      supervision and positive influence on rehabilitation. Therefore, there are sufficient
      indications that anticipate the treatment of vertical integration, since the phase of
      hospitalization in ICUs, may improve the functional outcome of the patient.
    

Detailed description: 
      Early verticalization and stepping with the equipment Hocoma Erigo, during monitoring of
      vital parameters. The device Erigo is already CE marked and, for the purposes of the study,
      will be used in accordance with the intended use of the same mark (after-market clinical
      investigation).
    

Intervention name(s): Early rehabilitation treatment on Erigo Hocoma; Early rehabilitation treatment on Erigo Hocoma
Intervention type(s): Other; Other
Intervention description(s): 5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 °; Early verticalization treatment with Erigo Hocoma, a tilt table with stepping system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brain injury; coma; intensive care; early rehabilitation
LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate user satisfaction and tolerability in
      young women (18-29 years of age) using the LCS12 compared with young women using a COC
      (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use
      of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional,
      extension phase. Safety data only will be collected during the extension phase of the study.

      Secondary objectives are to observe the tolerability, discontinuation rates, adverse event
      profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]),
      and bleeding profiles with the two birth-control methods. Additionally, data on missed
      tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system
      (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician
      satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal
      threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of
      subjects) will be collected. Finally, in the COC group, information will be collected on the
      psychosocial impact of missed or delayed pill intake.
    


Intervention name(s): Levonorgestrel IUD (LCS, BAY86-5028); Yasmin (EE30/DRSP, BAY86-5131)
Intervention type(s): Drug; Drug
Intervention description(s): LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 18 months with optional extension to 36 months for subjects in this group only.; Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one pill / day without any breaks for the entire study duration of 18 months.
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The ImageKids Study: Developing the pMEDIC and the PICMI
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      The overall objectives of this study are to develop two indices capable of measuring
      intestinal damage, and, separately, inflammatory disease activity in Pediatric Crohn's
      disease by means of Magnetic Resonance Imaging with Enterography protocol (MRE) and pelvic
      MRI.
    

Detailed description: 
      The PICMI Score and the pMEDIC are aimed to be discriminative (at one point in time),
      evaluative (measuring damage progression over time) and predictive. The indices will be used
      as endpoint measures in clinical research and also in clinical practice to identify those who
      are at risk for rapid disease progression and surgery.
    

Intervention name(s): MRE
Intervention type(s): Device
Intervention description(s): Developing the Pediatric Crohn's Disease Intestinal Damage Score (pMEDIC score) and the Pediatric MRE-Based Activity Index (PICMI)
Other intervention name(s): MRI; Pelvic MRI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Crohn's Disease; MRE; Pelvic MRI; P-MRI; colonoscopy; gastroscopy
Safety of and Immune Response to the PENNVAX-B DNA Vaccine With and Without IL-12 in HIV-uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      An effective vaccine may be the only way to stop the HIV pandemic. The purpose of this study
      is to determine the safety of and immune response to the DNA vaccine, PENNVAX-B with or
      without an IL-12 adjuvant when given using electroporation.
    

Detailed description: 
      An effective and safe vaccine must be developed in order to halt the HIV pandemic. The
      purpose of this study is to assess the safety and immune response to the HIV DNA vaccine,
      PENNVAX-B when given with and without an IL-12 adjuvant and delivered via electroporation.

      Participants in this study will be randomly assigned to one of three groups and will visit
      the study clinic 9 times over 9 months. Group 1 will enroll first. Participants in this group
      will receive 3 mg of the PENNVAX-B or placebo vaccine at Months 0, 1, and 3. Once safety data
      has been examined for Group 1, Group 2 will begin enrollment. Group 2 participants will
      receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or placebo at Months 0, 1, and
      3. Once Group 1 and Group 2 safety data have been collected Group 3 will begin enrollment.
      These participants will also receive 3 mg of PENNVAX-B vaccine plus 1 mg of IL-12 adjuvant or
      placebo at Months 0, 1, and 3.

      At clinic visits participants will have physical exams and blood and urine collected. After
      receiving study injections, participants will be observed in the clinic for at least 30
      minutes. In addition, participants will be asked to monitor symptoms for 3 days after each
      injection.
    

Intervention name(s): PENNVAX-B; IL-12 DNA plasmids
Intervention type(s): Biological; Biological
Intervention description(s): DNA vaccine encoding the Gag, Pol, and Env proteins of HIV; Adjuvant for HIV vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV Seronegativity; HIV Preventive Vaccine
Comparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery
Condition: Orthopedic Surgery
MeSH terms: Vomiting
Study type: Interventional

Summary: 
      Postoperative nausea and vomiting (PONV) is related with extended hospital day and risk
      factor of aspiration pneumonia. Postoperative patient controlled intravenous analgesia is
      related with postoperative nausea and vomiting. Selective 5-HT3 antagonist, Palonosetron, is
      the most recent medication for prevention of PONV. Purpose of our study is comparison of PONV
      preventive effect of palonosetron and combination of palonosetron and dexamethasone.
    


Intervention name(s): palonosetron; palonosetron with dexamethasone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexamethasone; Palonosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: palonosetron, dexamethasone, PONV (postoperative nausea and vomiting)
The Effects of Coffee
Condition: Healthy Subjects
Study type: Observational

Summary: 
      In this study, participants will be eligible to participate in a paid research study that
      will examine the effects of regular coffee drinking. The study takes approximately 2 hours
      total, 55 min. on 2 separate days. Participants will be asked to do computer tasks and drink
      only coffee provided to them during the study.
    

Detailed description: 
      The purpose of the experiment is to evaluate how coffee affects different individuals while
      completing computer tasks. If an individual agrees to participate, particpants will be asked
      to come to the laboratory to drink coffee on 2 days. During each visit, participants will be
      asked to drink coffee, complete forms, and perform computer tasks. To be eligible to
      participate, participants must be medically healthy.
    

Observational model: Defined Population
Time perspective: Other
Keywords: coffee; caffeine; healthy subjects
The Sinonasal Outcome Test - 22, Validated for Danish Patients
Condition: Chronic Rhinosinusitis
Study type: Observational

Summary: 
      Introduction: Chronic rhinosinusitis (CRS) is a significant health problem increasing in both
      incidence and prevalence. It calls into attention consensus about diagnosing, assessing
      symptoms and treatment of patients with CRS. Therefore a validated Danish measure of
      health-related quality of life in sinonasal disease is needed.

      Method: The Sinonasal Outcome measure 22 (SNOT-22) was translated into Danish and
      reproducibility was evaluated by test-retesting 40 patients with CRS. The statistical
      analyses used, were Pearson´s correlation coefficient, Cronbach´s alfa, Kappa and
      Bland-Altman´s Plot. Reproducibility was also tested looking at subscales within the SNOT-22.

      Result: The results show good internal correlation with Cronbach´s alfa at 0.83 in the
      initial test and 0.92 in the retest. Pearson was 0.70 (p<0.001) revealing good correlation
      between the initial scores and the retests scores. Kappa was calculated for each item with a
      mean value of 0.61 showing substantial agreement. Paired t-test revealed no significant
      difference in the subscales.

      Conclusion: The Danish version of SNOT-22 is recommended for Danish clinicians and researches
      as a patient-reported measure of outcome in sino-nasal disorders such as rhinosinusitis and
      nasal polyposis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with chronic rhinosinusitis diagnosed by a medical doctor
      
Keywords: Chronic Rhinosinusitis; Sinonasal Outcome test 22
Equine-assisted Intervention on Psychosocial Adjustment in Patients With Psychiatric Disorders
Condition: Equine-assisted Therapy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of a brief equine-assisted intervention
      on the social adjustment, assertiveness, self-esteem and coping strategies in adult patients
      with psychosocial dysfunction, hospitalized and followed in psychiatry, as compared to
      standard care.
    


Intervention name(s): Equine-assisted intervention
Intervention type(s): Behavioral
Intervention description(s): Usual care including an equine-assisted intervention carried out on foot, next to the horse, in 3 sessions of 3 hours each, spread over 4 weeks. This program is based on self-awareness, communication, assertiveness and adaptability.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychiatry; Psychosocial adjustment
Role of Intrauterine Insemination in Patients With Endometriosis I-II
Condition: Endometriosis I-II
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Intrauterine insemination (IUI) is an ART that provides good results in selected patients,
      improving their reproductive prognosis. Endometriosis I y II, according to ASRM
      classification, remains an indication to perform IUI. This indication is on continuous
      debate, considering that different studies have shown controversial results about it, due to
      the poor reproductive outcomes in this group of patients
    


Intervention name(s): Intrauterine insemination
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We analyzed the database (SIVIS) containing information on IUI treatment cycles carried out
        at the IVI-Clinics between 2011 and 2017.
A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of ketoconazole and rifampicin on the pharmacokinetics of fimasartan.
    


Intervention name(s): Fimasartan, Ketoconazole, Rifampicin
Intervention type(s): Drug
Intervention description(s): Fimasartan (1 day)
Ketoconazole (3 days) Ketoconazole + Fimasartan (1 day)
Rifampicin (9 days) Rifampicin + Fimasartan (1 day)
Intervention MeSH terms: Rifampin; Ketoconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Evaluation of iFR vs FFR in Stable Angina or Acute Coronary Syndrome
Condition: Angina Pectoris; Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Angina Pectoris; Angina, Stable; Infarction
Study type: Interventional

Summary: 
      Previous trials have demonstrated that the use of physiological assessment of stenosis
      severity using fractional flow reserve (FFR) is superior to angiographic assessment in
      percutaneous coronary intervention (PCI) and improves clinical outcome. Despite the clinical
      utility, FFR is used only in 10-15% of patients today. The main reasons for the low adoption
      rate of FFR are the prolonged procedural time, Adenosine related discomfort and cost
      associated with Adenosine.

      Instantaneous Wave-Free ratio (iFR®) is a novel method to assess coronary lesions for
      functional significance. The main benefits of the method compared to FFR are that the
      measurement is instantaneous and does not require Adenosine infusion. Thus, the patient does
      not experience any discomfort from the measurement and procedural time could be shortened
      compared to when using FFR. This could potentially increase the adoption rate of physiologic
      assessment of coronary lesions.

      The aim of this trial is to compare the clinical outcome of patients assessed by iFR® with
      patients assessed by FFR.

      Furthermore, the trial will be conducted as a registry based randomized clinical trial (RRCT)
      which is a novel strategy to conduct clinical trials. The randomization will occur online in
      the Swedish angiography and angioplasty registry (SWEDEHEART) using a web based platform.
    


Intervention name(s): iFR; FFR
Intervention type(s): Device; Device
Intervention description(s): Treatment guided by Instantaneous wave-free ratio (iFR®); Intervention guided by Fractional Flow Reserve
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Instantaneous wave Free Ratio; Fractional Flow Reserve
A Study to Evaluate Oral VT-1161 in the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Condition: Recurrent Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in
      vivo pharmacology studies have demonstrated that VT-1161 is highly active against Candida
      albicans and also non-albicans Candida species that cause vulvovaginal candidiasis. VT-1161
      is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect
      profile that limits the use of commonly prescribed antifungal agents for the treatment of
      recurrent yeast infections.
    


Intervention name(s): VT-1161; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis
Condition: Non-invasive Lipolysis
Study type: Interventional

Summary: 
      This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect
      safety and efficacy data on the TempSure Firm. The intended use of the TempSure device is to
      use the Firm handpieces for non-invasive lipolysis.
    

Detailed description: 
      Up to 12 subjects will be enrolled at up to 3 study centers. Subjects will attend a
      screening/pretreatment visit which may be performed on the same day as the treatment visit.
      Subjects may receive 1 treatment on the abdomen with the TempSure firm. Subjects will undergo
      abdominoplasty surgery at one of 4 predetermined timepoint after an abdomen treatment: day 0
      (within 24 hours after treatment), 10 days (+/- 3 days), 20 days (+/- 3 days), or 30 days
      (+/- 7 days). This will be determined by the availability of the subject and/or an as needed
      basis and this will be decided by the Investigator and the Sponsor.
    

Intervention name(s): TempSure Firm
Intervention type(s): Device
Intervention description(s): The TempSure firm will be used on the abdomen for non-invasive lipolysis.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 4 different arms, each with different time frames based on thei subjects' availability. Each group uses the same device and treatment parameters, with the only difference being when follow up measures are taken.
Masking: None (Open Label)
Primary purpose: Treatment
Biological Functions of Carotenoids in Humans
Condition: Oxidative DNA Damage
Study type: Interventional

Summary: 
      This study will examine the the efficiency fo absorption of major plant pigments,
      carotenoids, (lutein, beta-carotene and lycopene)and will measure the biological functions of
      carotenoids in healthy women in response to an 8-week period of carotenoid supplementation.

      The antioxidant capacity (in both the aqueous and lipid compartments), DNA oxidation (single
      cell gel electrophoresis), Insulin-like Growth Factor (IGF-1), Insulin-like Growth Factor
      Binding Protein-3 (IGFBP-3), (gene expression profile (high-density filter-based cDNA
      microarrays), lipid peroxidation (MDA analysis and Isoprostane determination), and
      antioxidant nutrient levels (carotenoids, tocopherols, ascorbic acid and uric acid) in the
      circulation will be measured every other week throughout the study period.
    


Intervention name(s): mixed carotenoids
Intervention type(s): Drug
Intervention MeSH terms: Carotenoids
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon
      alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with
      viral load and viral kinetics will be investigated in patients with chronic hepatitis C
      genotype 1 who were non-responders to previous standard combination therapy with pegylated
      interferon and ribavirin. Patients will be randomized to receive either weekly or twice
      weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after
      a washout period of 6 weeks.
    


Intervention name(s): peginterferon alfa 2a [Pegasys]; peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sc weekly; iv weekly; sc twice weekly; iv twice weekly
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SweetDreams Sleep Study for Children With Autism
Condition: Autism Spectrum Disorder; Insomnia
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This proposal will acquire preliminary data on the feasibility and effectiveness of an
      innovative and scalable strategy for improving access to effective sleep health care for
      preschool-aged children with Autism Spectrum Disorder (ASD). The investigators will develop
      and test an on-line delivery adaptation of the existing behavioral sleep interventions for
      preschool aged children.
    

Detailed description: 
      Access to effective treatments for sleep disorders is a persistent challenge. This is due to
      the lack of trained clinicians as well as caregiver resources to seek out and utilize such
      critical services. The SweetDreams intervention will solve this problem with on-line delivery
      of educational materials and treatment strategies for an evidence-based intervention. It will
      be readily available to caregivers at any time and through multiple outlets such a computer,
      tablet, and telephone, modes of delivery favored by and effective for parents of children in
      this age group.

      This adaptation will address key challenges to sleep health care for children with ASD: (1)
      Learning differences of children with ASD by incorporating intervention principles from the
      TEACHH model; (2) Overcome the challenge of treatment access due to the limited number of
      qualified providers by developing didactic videos for online and mobile device delivery
      (referred to as SweetDreams); and, (3) Responding to the NIH emphasis on developing "more
      effective interventions…by targeting interventions to the identified needs of community
      members," SweetDreams will use a dynamic process involving extensive collaboration with
      children, parents, developmental pediatricians, and other experts on youth with ASD.
    

Intervention name(s): SweetDreams
Intervention type(s): Device
Intervention description(s): SweetDreams is a mHealth adaptation of existing evidence-based sleep interventions. It is a user friendly and developmentally appropriate modularized 4-week web-based intervention available on computer, tablet or mobile phones.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep; autism