bioihbjkbjnl/mcl2 huggingface dataset:
"VRTierOne" as a Method Supporting the Post-stroke Rehabilitation
Condition: Stroke; Depression
MeSH terms: Stroke; Depression
Study type: Interventional

Summary: 
      Thanks to using VR googles and the phenomenon of total immersion "VR Tier One" allows to
      completely separate the patient from the hospital environment, provides an intense visual,
      auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming
      and mood-improving effect or, in another part of the game, it can motivate and cognitively
      activate the patient. The additional aim of the game is to help the patients regain their
      emotional balance, let them recognize their resources in order to bring them to power in the
      rehabilitation process and trigger the natural recovery mechanisms.
    

Detailed description: 
      The goals of the project:

        1. The evaluation of the influence of virtual therapeutic game on the mood and wellbeing of
           the patients undergoing post-stroke rehabilitation.

        2. The evaluation of the influence of virtual therapeutic game on the acceptance of the
           illness and self-efficacy assessment of the patients undergoing post-stroke
           rehabilitation.

        3. The evaluation of the influence of virtual therapeutic game on the effectiveness of
           post-stroke rehabilitation process in relation to locomotive function as well as basic
           and instrumental activities of daily living.

        4. The analysis of possible side effects appearing while using virtual reality therapy.
    

Intervention name(s): VR Tier One; Control
Intervention type(s): Device; Other
Intervention description(s): 10 sessions of 20 minutes virtual terapeutic game
Thanks to using VR googles and the phenomenon of total immersion VR Tier One terapy game allows to completely separate the patient from the hospital environment and provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or it can motivate and cognitively activate the patient. The additional aim of the game is to help the patients regain their emotional balance, let them recognize their resources in order to bring them to power in the rehabilitation process and trigger the natural recovery mechanisms.; 10 sessions of 20 minutes of Schultz Autogenic Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; post-stroke rehabilitation; virtual reality; depression; mental health
Glycemic and Insulinemic Response of Pasta Products in Comparison to Asian Foods
Condition: Diabetes
Study type: Interventional

Summary: 
      The aim of the study is to determine the glycaemic and insulinaemic index of pasta products
      and local foods. It is hypothesized that different pasta cuts and wholegrain composition of
      pasta and local foods have different GI depending on the nature of the carbohydrate content
      and the food structure within each food.
    

Detailed description: 
      There will be a total of 9 test sessions and each session will last up to 3.5 hours. The
      order of sessions will be determined with an online randomizer. At each test session, the
      following procedures will be performed: two finger-prick blood samples, five minutes apart to
      measure baseline blood glucose and insulin concentrations Subject will be served the test
      food and to consume within15 minutes Following the test meal, blood samples will be collected
      at the following time points: 15, 30, 45, 60, 90, 120, 150 and 180min for glucose
      measurements and insulin measurements will be collected at 30, 60, 90, 120, 150 and 180min.
    

Intervention name(s): Glucose Reference 1; Glucose Reference 2; Glucose Reference 3; Semolina Penne; Wholegrain Penne; Semolina Spaghetti; Wholegrain Spaghetti; Jasmine Rice; Asian Noodles
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Glucose contains 50g of available carbohydrates; Glucose contains 50g of available carbohydrates; Glucose contains 50g of available carbohydrates; Semolina Penne contains 50g of available carbohydrates; Wholegrain Penne contains 50g of available carbohydrates; Semolina Spaghetti contains 50g of available carbohydrates; Wholegrain Spaghetti contains 50g of available carbohydrates; Jasmine Rice contains 50g of available carbohydrates; Asian Noodles contains 50g of available carbohydrates
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in
      approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will
      enroll to take open-label AR11 BID and undergo dose optimization activities for 8 weeks.
      Patients who achieve a stable dose during the dose optimization period will continue
      participation and will be randomized to take double-blind medication (AR11 or placebo) orally
      twice daily for 1 week. At the end of each double-blind treatment period, patients will be
      evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP
      assessments.
    

Detailed description: 
      This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in
      approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will
      enroll in the study to take open-label AR11 twice daily and undergo dose optimization
      activities for 8 weeks. Patients who achieve a stable dose during the dose optimization
      period will continue participation and will be randomized to take double-blind medication
      (AR11 or placebo) orally twice daily for 1 week. At the end of the first double-blind
      treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom
      setting utilizing SKAMP and PERMP assessments. At the end of the second double blind
      treatment period, patients will be evaluated for ADHD symptoms in a second laboratory
      classroom setting utilizing SKAMP and PERMP assessments.
    

Intervention name(s): AR11; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): amphetamine sulfate; matching Placebo
Intervention MeSH terms: Amphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; AR11; classroom design; amphetamine sulfate
Human Chorionic Gonadotropin (hCG) Priming Prior to Controlled Ovarian Hyperstimulation (COH) in Poor Responder In Vitro Fertilization (IVF) Patients
Condition: Ovarian Response
Study type: Interventional
Phase: Phase 4

Summary: 
      There is a decline in androgen concentration with ovarian aging. Also, ovarian response to
      COH in IVF cycles diminishes with ovarian aging. Recent evidence suggest that testosterone or
      DHEA may improve ovarian response in poor prognosis patients by increasing intraovarian
      androgen concentration. A physiological way to induce androgen synthesis within the ovary is
      to stimulate theca cells androgen production by hCG stimulation. By doing this in the
      previous cycle we might expect a better response to COH.
    


Intervention name(s): human chorionic gonadotropin; placebo
Intervention type(s): Biological; Biological
Intervention description(s): 200 IU, sc, every 5 days, 4 doses; diluent, every 5 days, s.c., 4 doses
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: androgens; hCG; low response; IVF; Ovarian response in women with previous low response
Clinical Performance Comparison of Two Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the clinical performance of two contact lenses.
    


Intervention name(s): senofilcon A; lotrafilcon B
Intervention type(s): Device; Device
Intervention description(s): soft contact lens, 2-week replacement indicated; soft contact lens with a 4-week replacement indicated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the preventative antiviral activity of CD388, as
      compared to saline placebo, when administered as a single dose to healthy adult participants
      in a human viral challenge model of influenza.
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo-controlled, proof-of-concept study
      in healthy adult male and female participants 18 to 55 years of age, inclusive. The primary
      goal of this Phase 2a study is to assess the prophylactic antiviral activity against
      influenza, safety, tolerability, and pharmacokinetics (PK) of CD388 via a human viral
      challenge (HVC) model, and to explore the impact of dose levels on efficacy. Each participant
      will receive a single administration of CD388 or placebo; multiple dose levels of CD388 may
      be evaluated.
    

Intervention name(s): Saline placebo; CD388
Intervention type(s): Drug; Combination Product
Intervention description(s): Sterile normal saline for injection; CD388 liquid for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Diffusion Weighted Magnetic Resonance Imaging for the Characterization of Solitary Pulmonary Lesions
Condition: Thorax Cancer
MeSH terms: Body Weight
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study, is to investigate the value of diffusion weighted imaging on the
      differential diagnosis of solitary pulmonary lesions.
    

Detailed description: 
      When a patient is diagnosed with a lung lesion, the differential diagnosis is important,
      since the treatment is determined by the lesion character. The goal in the evaluation of
      solitary pulmonary lesions is to distinguish malignant lesions from benign lesions in as
      non-invasive a manner as possible. As computed tomography is widely used, the diagnosis of
      solitary pulmonary lesions has become easier. The size, features of the edges, shape,
      internal structure (calcification, fat content, cavitation, etc.), density, satellite nodule,
      growth rate and contrast involvement of the lesion are important properties which help to
      distinguish benign lesions from malignant ones. However, as the distinction is not absolute
      at all times, other imaging methods such as positron emission tomography and magnetic
      resonance are preferred. The importance of this issue is the high five-year survival rate in
      early-diagnosed lung cancer cases.

      Diffusion is the randomized microscopic motion of water molecules. It is known that diffusion
      is a sensitive parameter of tissue characterization at a microscopic level. Nowadays,
      diffusion is measured in vivo with diffusion weighted MRI and ADC measurements.

      Diffusion weighted imaging has a wide use on oncologic patients for the purpose of diagnosis.
      In addition, it is used in the distinction of acute cerebral infarction and epidermoid or
      arachnoid cysts. Recently, it has also been used in the characterization of cystic or solid
      lesions in the thoracic cavity. In this study, the investigators aimed to evaluate the
      accuracy of differentiation of solitary pulmonary lesions.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Magnetic resonance imaging (MRI) was applied to a total of 46 patients between January 2011
        and July 2011, who presented.
      
Keywords: diffusion weighted magnetic resonance imaging
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Study D5553C0003 is a 28-week, randomized, double-blind, active-controlled, multicenter,
      Phase 3 efficacy and safety study with 24-week and 52-week extension phases of simultaneous
      administration of exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg once daily (QD)
      compared to EQW 2 mg alone and dapagliflozin 10 mg QD alone in patients with Type 2 diabetes
      who have inadequate glycemic control on metformin.
    


Intervention name(s): Exantide with Dapagliflozin; Exentide; Dapagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 mg weekly suspension injection and 10 mg Dapagliflozin; 2 mg; 10 mg once daily Dapagliflozin
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Exenatide; Dapagliflozin; Diabetes medication; Treatment efficacy; Placebo; Metabolism; Cardiovascular metabolic
Growth Hormone Deficiency and Empty Sella Cardio-Metabolic Risk Factors in Obesity: a Cross-Sectional Study
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Obesity is a disease not always attributable to nutritional imbalance, frequently associated
      with changes in key hypothalamic-pituitary (HP) axes. The regain of weight loss after
      hypochaloric diets has been ascribed to these HP disregulations. The aim of the study is to
      explore pituitary morphology and its association with pituitary function and metabolic
      phenotype in outpatient obese individuals evaluated in the period 2010-2013 at the Department
      of Experimental Medicine of the University of Rome La Sapienza, with features of HP disease
      in a cross-sectional .
    


Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Obese
Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine
      after 8 weeks of treatment in patients that have tried one available treatment without
      getting the full benefit
    

Detailed description: 
      The study will consist of a screening period of up to 14 days before the Baseline Visit,
      followed by an 8-week Treatment Period with vortioxetine or desvenlafaxine. A Safety
      Follow-up Visit will be performed approximately 4 weeks after the Primary Outcome/Withdrawal
      Visit.

      At Baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an
      8-week, double-blind Treatment Period.
    

Intervention name(s): Vortioxetine; Desvenlafaxine
Intervention type(s): Drug; Drug
Intervention description(s): 10 or 20 mg/day, capsules, orally; 50 mg/day capsules, orally
Intervention MeSH terms: Vortioxetine; Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The O'Neil Long Acting Naltrexone Implant (OLANI) Pharmacokinetic (PK)/Safety Study in Healthy Volunteers
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the pharmacokinetic profile and safety of the O'Neil Long Acting
      Naltrexone Implant (OLANI) overtime in healthy volunteers. All participants will be treated
      in an open label manner. No randomization will occur. It is hypothesized that the OLANI will
      provide sustained therapeutic doses of naltrexone (NTX) for periods up to 6 months via a
      single subcutaneous application of 2 OLANIs.
    

Detailed description: 
      Naltrexone (NTX) is a nonspecific pure opioid antagonist with a high affinity for the
      µ-opioid receptor. It blocks the effects of opioids by competitive binding at opiate
      receptors. NTX is used primarily in the management of opiate and alcohol dependence. It is
      available in the United States (US) as 2 formulations; a once daily oral formulation (Revia)
      and a once monthly intramuscular injection (Vivitrol). While NTX is a potent antagonist and
      efficiently blocks the effects of exogenous opiates such as heroin, the success of NTX for
      the treatment of opiate dependence has been limited by poor patient compliance. Therefore,
      the development of a sustained release NTX formulation (in excess of 1 month) would be of
      great benefit for the treatment of opioid use disorder.
    

Intervention name(s): naltrexone implant
Intervention type(s): Drug
Intervention description(s): 1.8 g implant containing 60% naltrexone
Other intervention name(s): OLANI; O'Neil Long Acting Naltrexone Implant
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: naltrexone; opioids; opioid use disorder; OLANI implant
Haiti Rural School Feeding Study: Effect of Vita Mamba on Anemia and Hemoglobin Concentrations
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This study applied a matched cluster, controlled design, using community cluster as the unit
      of randomization. Communities were first matched during the formative research phase and
      randomized into treatment (Vita Mamba + deworming) or control (deworming) groups, using a
      simple experimental 1:1 design. The principal investigator generated the random allocation
      sequence and assigned the cluster to groups. Children were followed longitudinally for Hb
      concentration and anthropometric measures were taken at baseline (November 2014) and endline
      (June 2015). Parents were surveyed at baseline for household-level socioeconomic and
      demographic information; environmental conditions including water, hygiene, and sanitation;
      and child diet and morbidities.

      All children in the intervention schools received the Vita Mamba once per school day from
      November 2014 to June 2015, for approximately 26 weeks. Children in both groups received
      Albendazole at baseline in November 2014. Compliance was monitored by teachers and tracked by
      collection of empty packages. Lessons learned from another school feeding trial by the study
      team were applied to increase compliance such as opening the packages for the children
      immediately prior to consumption to discourage selling or sharing later with family members.
      Vita Mamba was developed for the urban school trial by the research team with representatives
      from Edesia (a US-based nonprofit manufacturer of ready-to-use foods with expertise in
      research and development) and Nutriset (the parent company in the PlumpyField network). Meds
      & Food for Kids, a nonprofit manufacturer of ready-to-use foods in Haiti using locally
      produced peanuts, produced the Vita Mamba for this trial. Vita Mamba (50 g) contains 260 kcal
      and meets >75% of the Recommended Dietary Allowance (RDA) for critical micronutrients (S1
      Table).
    


Intervention name(s): Vita Mamba peanut butter paste
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
To Evaluate SSD8432/ Ritonavir in Adults With COVID-19
Condition: COVID-19 Patients
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, double-blind, Phase 1b clinical trial to evaluate the safety,
      Pharmacodynamics, and Pharmacokinetic of SSD8432 combined with ritonavir tablets in adults
      with COVID-19.
    

Detailed description: 
      This is a randomized, double-blinded, placebo-controlled, dose-climbing Phase Ib clinical
      trial, designed to evaluate the safety, pharmacodynamics, and pharmacokinetics of SSD8432/
      ritonavir versus placebo in asymptomatic, mild, and common type adult COVID-19 subjects.

      This clinical trial is planned to enroll 32 asymptomatic infected, mild or common type adult
      COVID-19 subjects, divided into 2 cohorts according to different doses of SSD8432:

      Cohort 1: 16 subjects, 12 subjects will receive low-dose SSD8432/ ritonavir, and 4 subjects
      received placebo; Cohort 2: 16 subjects, 12 subjects will receive high-dose SSD8432/
      ritonavir, and 4 subjects received placebo.
    

Intervention name(s): SSD8432 dose 1/Ritonavir; SSD8432 dose 2/Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1:SSD8432/ritonavir or placebo, on day 1 ~day5，BID；; Cohort 2:SSD8432/ritonavir or placebo, on day 1 ~day5，BID；
Other intervention name(s): SIM0417 dose 1/Ritonavir; SIM0417 dose 2/Ritonavir
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide in Migraineurs
Condition: Headache; Migraine; Vasoactive Intestinal Peptide; Ultrasonography, Doppler, Transcranial
MeSH terms: Headache
Study type: Interventional

Summary: 
      We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that
      VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To
      test this hypothesis, we performed a double blind placebo-controlled crossover study in
      migraineurs and studied the effect on headache and cerebral and systemic hemodynamic
      parameters.
    

Detailed description: 
      We hypothesized that infusion of VIP may induce headache/migraine in migraineurs and that
      VIP-induced headache may be associated with dilation of intra- and extracranial vessels. To
      test this hypothesis, we performed a double blind placebo-controlled crossover study in
      migraineurs and studied the effect on headache and cerebral and systemic hemodynamic
      parameters. The subjects were randomly allocated to the infusion of 8pmol/kg/min VIP or
      placebo (isotonic saline), duration 25min. Headache intensity, mean velocity of blood flow in
      the middle cerebral artery (VmMCA), superficial temporal artery diameter, end-expiratory CO2
      and vital signs were recorded at baseline and then every 10 min until 120 min after start of
      the infusion. The patients received a headache diary for the following 12 hours after
      infusion.
    

Intervention name(s): Vasoactive intestinal peptide
Intervention type(s): Drug
Intervention MeSH terms: Vasoactive Intestinal Peptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Migraine; VIP; Transcranial Doppler; Headache