bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Date Fruit Consumption in Later Pregnancy
Condition: Labor Long
Study type: Interventional

Summary: 
      EFFECT OF DATE FRUIT CONSUMPTION IN LATER PREGNANCY ON LENGTH OF GESTATION LABOR AND DELIVERY
      OF NULLIPAROUS WOMEN
    

Detailed description: 
      This randomized, controlled study was conducted at the Gynecology and Obstetrics department
      of Pak Emirates Military Hospital for Six months duration from Jan 2021 to June 2021. Ethical
      consent for the study was taken from the Ethical Committee. All participants have signed the
      written consent. Healthy primigravida's at more than 37 weeks of gestation with no prenatal
      complications (low-risk pregnancies) or chronic diseases were invited to contribute in the
      analysis.

      The criteria of exclusion included all primigravida and non-primigravida with prenatal
      problems. Prenatal complications included placenta praevia, rupture of membranes, multiple
      pregnancies, diabetes, hypertension and additional health problems, fetal abnormalities,
      fetal growth restriction or any contraindication to delivery by vagina.

      The females who met the eligibility criteria were contacted and provided information related
      to the analysis. In the preliminary phase of contact with potential volunteers, the study was
      presented as a participant's usage of dates to expedite delivery. The randomization
      arrangement was performed by means of sealed envelopes numbered from 1 to 10, equally
      allocated by randomization to the date-consumers and the group of control. Therefore, they
      will be allocated to dates consumer or control group recipients.
    

Intervention name(s): Dates group
Intervention type(s): Other
Intervention description(s): Seven dates to be provided to patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dates; labour; period of gestation; delivery
A Comparison of the Perception of a Needle Injection Pain Between Cancer Patients Receiving Opioid Therapy Versus Opioid-naive Patients
Condition: Cancer Patients
Study type: Interventional

Summary: 
      Opioid-induced hyperalgesia (OIH) is most broadly defined as a state of nociceptive
      sensitization caused by exposure to opioids. In humans, the evidence of OIH is strong but
      conflicting. Previous clinical studies mostly used experimental or non-standardized surgical
      stimuli to assess OIH. We therefore sought to certify a presence of OIH using a standardized,
      clinical pain stimuli in cancer patients receiving opioid therapy and opioid-naive patients.
    


Intervention name(s): The local anesthetic injection
Intervention type(s): Procedure
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Opioid induced hyperalgesia
Effectiveness of Standing Frame on Constipation in Children With Cerebral Palsy
Condition: Cerebral Palsy; Quadriplegia; Diplegia; Constipation
MeSH terms: Paralysis; Cerebral Palsy; Quadriplegia; Constipation
Study type: Observational

Summary: 
      Children with Cerebral Palsy and quadriplegia or severe diplegia suffer from highly reduced
      mobility and consequent constipation. Clinicians frequently recommend standing-frames to
      exercise the support reaction in this population, sharing the opinion that the upright
      position may facilitate intestinal transit, although no evidence supports this assumption.

      The investigators conducted this single-subject research to determine the effects of the
      standing-frame on the frequency of evacuation in chronically constipated children with CP and
      quadriplegia.

      Moreover, the investigators studied its effects on the frequency of induction of evacuation,
      the characteristics of the stool and the pain suffered by the child due to constipation
      and/or evacuation.
    


Intervention name(s): standing-frame
Intervention type(s): Device
Other intervention name(s): stander
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In this study we included children with CP, in the manifestation of severe diplegia or
        quadriplegia, who do not currently use the standing-frame. The population of interest might
        be referred to the Unit for severe disability in developmental age or to one of the
        neuro-psychiatric and rehabilitation Units of the area of Modena and Reggio Emilia, (5.000
        km2 of surface and 1.250.000 inhabitants)
      
Keywords: Standing-frame; Chronic constipation; Cerebral palsy; Quadriplegia; Severe diplegia
A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
Condition: Migraine; Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-center, single-dose, open-label, 5-period crossover (in each part), pharmacokinetic
      and safety study.
    

Detailed description: 
      36 subjects received a single dose of STS101, 1.0 mg DHE mesylate IM injection, and 2 mg DHE
      mesylate nasal spray in a randomized, 5-period crossover manner.
    

Intervention name(s): Dihydroergotamine; Dihydroergotamine; Dihydroergotamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dihydroergotamine intranasal powder; Dihydroergotamine intramuscular injection; Dihydroergotamine intranasal spray
Other intervention name(s): Dihydroergotamine Mesylate; Dihydroergotamine Mesylate; Dihydroergotamine Mesylate
Intervention MeSH terms: Dihydroergotamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dihydroergotamine; dihydroergotamine mesylate; migraine
Traumatic Brain Injury and Yoga
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      This long-term goal of this project was to advance best practices in occupational therapy in
      conjunction with yoga. To address the long-term goal, this research team developed a pilot
      yoga intervention. The intervention was designed to focus on balance, balance confidence,
      body responsiveness, pain, physical ability and quality of life. Assessments were then chosen
      to address these areas pre and post yoga intervention. A manual and protocol were developed
      for the intervention and then the intervention was implemented with a group of individuals
      with chronic traumatic brain injury.
    

Detailed description: 
      This was an 8-week yoga intervention, focused on demonstrating the preliminary feasibility
      and efficacy of yoga for individuals with chronic traumatic brain injury. The study was a
      mixed-methods longitudinal study. Assessments were conducted 8 weeks prior to the yoga
      intervention and then just following the 8 week yoga intervention. The objectives of this
      feasibility and efficacy study was to 1) further develop, standardize, and manualize the yoga
      for the traumatic brain injury intervention and 2) assess change in balance, balance
      confidence, body responsiveness, pain, physical ability, and quality of life.
    

Intervention name(s): Assigned Interventions
Intervention type(s): Other
Intervention description(s): Yoga Group: designed for chronic TBI was provided two times a week for 8 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: yoga; Traumatic Brain Injury
Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
Condition: Presbyopia; Refractive Error
MeSH terms: Presbyopia; Refractive Errors
Study type: Interventional

Summary: 
      The aim of this study is to assess the visual performance of multiple optimised prototype
      soft contact lens designs compared to commercially available contact lenses.
    

Detailed description: 
      Prospective, double-masked, crossover, bilateral wear, dispensing clinical trial where
      participants will wear multiple prototype (test) and commercial (control) lenses.

      Multiple prototype contact lens designs will be assessed against commercial control lenses
      during the study, where each design will be worn for up to a week. There will be a minimum 1
      night washout period between lens designs.
    

Intervention name(s): Etafilcon A; Etafilcon A; Nelfilcon A; Nesofilcon A; Nelfilcon A; Etafilcon A; Somofilcon A; 58% Poly-HEMA; Omafilcon A
Intervention type(s): Device; Device; Device; Device; Device; Device; Device; Device; Device
Intervention description(s): Prototype lens material; Control lens for presbyope group; Control lens for presbyope group; Control lens for presbyope group; Control lens for non-presbyope group; Control lens for non-presbyope group; Control lens for presbyope group; Control lens for presbyope group; Control lens for non-presbyope group
Other intervention name(s): 1-Day Acuvue Moist Multifocal; Dailies Aqua Comfort Plus Multifocal; Biotrue ONEday for Presbyopia; Dailies Aqua Comfort Plus; 1-Day Acuvue Moist; Clariti 1 Day Multifocal; SEED 1dayPure moisture Multistage; Proclear Multifocal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Presbyopia; Refractive error; Contact lens
Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy
Condition: Diagnostic Esophagogastroduodenoscopy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Diagnostic esophagogastroduodenoscopy is an uncomfortable and stressful procedure for most of
      the patients. Various methods are available for sedation during this procedure. Because of
      some side effects related to intravenous administration of sedatives, oral administration of
      these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in
      treatment of anxiety. Hence, we determine the efficacy of oral and sublingual alprazolam as
      for sedation during this procedure. We hypothesize that sublingual alprazolam is more
      effective than that oral form and both forms more effective than placebo in reducing anxiety
      and pain/discomfort related to the procedure.
    


Intervention name(s): Oral alprazolam; Sublingual alprazolam; Oral placebo; Sublingual placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pain; Discomfort; Anxiety; Satisfaction; Compliance
Dose-Finding Safety and Efficacy Trial of Org50081 (Esmirtazapine) in the Treatment of Vasomotor Symptoms (46101/P06459/MK-8265-012)
Condition: Menopause; Vasomotor Symptoms
Study type: Interventional
Phase: Phase 3

Summary: 
      The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A
      receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be
      effective in reducing the number and intensity of hot flushes in preliminary trials. Also
      several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been
      investigated to manage hot flushes, confirming the role of the serotonergic system. In the
      present trial, the efficacy and safety of four different doses of esmirtazapine compared to
      placebo was investigated in women with moderate to severe vasomotor symptoms associated with
      the menopause. The primary study hypothesis was that esmirtazapine would show superior
      efficacy to placebo.
    


Intervention name(s): esmirtazapine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Esmirtazapine maleate; SCH 900265; Org 50081
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Zika and Neurodevelopment Among Infants in Grenada
Condition: Zika Virus Infection; Neurocognitive Deficit; Development, Child; Neurodevelopmental Abnormality
MeSH terms: Zika Virus Infection
Study type: Interventional

Summary: 
      Implement a randomized controlled trial, evidence-based, culturally adapted, environmental
      enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika
      Exposed Children.
    

Detailed description: 
      The intervention group received up to twelve 1-hour weekly visits by trained and experienced
      Grenadian parent and infant relationship specialists who provided home-based interventions as
      part of the Saving Brains Grenada project.

      The environmental enrichment intervention is a brain-based program that teaches parents about
      brain development in young infants and skills for building a strong social-emotional
      connection that stimulates brain development and maximizes neurocognitive function. A
      detailed intervention manual was developed and used as a guide for the intervention
      specialists. Neurocognitive outcomes in the intervention and control group were assessed pre
      and post intervention by a separate and blinded assessment team.
    

Intervention name(s): Conscious Discipline-Based Environmental Enrichment Intervention
Intervention type(s): Behavioral
Intervention description(s): Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
Condition: Complicated Urinary Tract Infection; Acute Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a multi-center, multi-national, double-blind, randomized, comparator-controlled
      study of plazomicin administered intravenously compared with levofloxacin, a standard
      approved intravenous therapy for complicated urinary tract infection (cUTI) and acute
      pyelonephritis (AP).
    


Intervention name(s): levofloxacin; plazomicin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Levofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: urinary tract infection; UTI; cUTI; pyelonephritis; AP; ACHN-490
Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin
      alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS
      patients
    

Detailed description: 
      Polycystic ovary syndrome (PCOS), one of the most common endocrine disorders affecting women
      on reproductive age , seems to be associated with an increased incidence of cardiovascular
      disease. At present, insulin-sensitizing drugs, such as metformin, represent one of the most
      important line treatment for hyperinsulinemic PCOS women. Metformin is able to produce
      favourable outcomes on the metabolic derangements in insulin-resistant normal weight and
      obese PCOS patients. Oral contraceptives represent the traditional medical therapy for the
      long-term treatment of PCOS women, in order to obtain regular menstrual cycles and to improve
      the clinical signs of hyperandrogenism.Based on the above mentioned evidences, the aim of the
      present study was to evaluate the effects of DRPS/EE alone versus metformin alone versus
      DRPS/EE plus metformin on the CD4+CD28null T cells frequency and on endocrino-metabolic
      parameters, in hyperinsulinemic PCOS patients
    

Intervention name(s): Metformin; Yasmin;; Metformin plus Yasmin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500 mg of Metformin per 3/die; 1pill/day for cycles of 28 days (21 pills followed by 7 no-pill days); 0.03 mg EE plus 3 mg of DRPS combined with 500 mg of metformin three times daily
Intervention MeSH terms: Metformin; Drospirenone and ethinyl estradiol combination; Ethinyl Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PCOS
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3-3'Ddelta30) in Healthy Adults
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and
      subtropical regions of the world. The purpose of this study is to evaluate the safety of and
      immune response to a new dengue virus vaccine in healthy adults.
    

Detailed description: 
      Dengue viruses cause dengue fever and the more severe dengue hemorrhagic fever/shock
      syndrome. More than 2 billion people living in tropical and subtropical regions of the world
      are at risk of dengue virus infection, which is the leading cause of hospitalization and
      death in children in several tropical Asian countries. This study will evaluate the safety
      and immunogenicity of a live attenuated dengue virus vaccine called rDEN3-3'D4delta30. This
      vaccine is derived from rDEN4delta30, another dengue virus vaccine candidate that has been
      shown to be safe and immunogenic in Phase I and II trials in healthy adults.

      There will be two groups in this study. Participants in Group 1 will be randomly assigned to
      receive rDEN3-3'D4delta30 vaccine or placebo at study entry. The dosing for Group 2 will be
      determined by a safety review of all participants in Group 1. If less than 90 % of the Group
      1 participants seroconvert to DEN3 participants in Group 2 will receive a higher dose of
      rDEN3-3'D4delta30. If at least 90 % of Group 1 participants seroconvert to DEN3, participants
      in Group 2 will receive a lower dose of rDEN3-3'D4delta30.

      All participants will be required to monitor their temperature three times each day for the
      first 16 days following each vaccination. Study visits will occur 30 minutes following each
      vaccination and every other day after vaccination until Day 16, followed by four additional
      visits at selected days through Day 180. Blood collection, vital signs measurement, and a
      targeted physical exam will occur at each study visit. Some participants will be asked to
      undergo a skin biopsy or additional blood collection at selected visits.
    

Intervention name(s): rDEN3-3'D4delta30; rDEN3-3'D4delta30; rDEN3-3'D4delta30
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Live attenuated 10^3 dose of rDEN3-3'D4delta30 vaccine.; Live attenuated 10^5 dose of rDEN3-3'D4delta30 vaccine.; Live attenuated 10^1 dose of rDEN3-3'D4delta30 vaccine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique
Condition: Drug Mechanism; Healthy
Study type: Interventional

Summary: 
      The main objective is to assess whether a novel electrochemical tool is reliable in detecting
      concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples. We will
      recruit 12 healthy volunteers aged 18-45. They will get 1 g oral paracetamol. Paracetamol
      concentration will be detected from abovementioned samples at timely intervals for 24 hours,
      analyzed with the novel electrochemical method and compared to gold standard
      mass-spectrometry analysis.

      Despite of extensive use, the mechanism of action of parasetamol is not completely
      understood. The central serotonergic system may play a role. Endocannabinoid system is a
      group of lipid mediators, that possibly is involved in mediating paracetamol effect to the
      serotonergic system. Serum lipidomic assessment can be used to study endocannabinoid
      metabolics. In this study we will try to assess changes in endocannabinoid system by looking
      into serum lipidomics in order to understand the mechanism of action of paracetamol.
    


Intervention name(s): Paracetamol; Paracetamol concentration measurements and lipidomic assessment
Intervention type(s): Drug; Diagnostic Test
Intervention description(s): 1 g oral paractamol; Paracetamol concentration is measured from saline-, urine-, venous blood- and fingerprick- samples at timely intervals. Also serum lipidomic assessment is performed from venous blood samples.
Intervention MeSH terms: Acetaminophen
Intervention model: Single Group Assignment
Intervention model description: Healthy volunteers
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: electrochemical; Paracetamol; Lipidomics; Endocannabinoid system
Evaluating the Safety and Tolerability of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in
      HIV-positive adults who were virologically suppressed and who were on antiretroviral therapy
      (ART).
    

Detailed description: 
      Ruxolitinib is a medication approved by the U.S. Food and Drug Administration (FDA) to treat
      myelofibrosis, a disorder in which bone marrow is replaced by scar (fibrosis) tissue. Many of
      the cytokines affected by myelofibrosis are also affected by HIV. Because of this,
      ruxolitinib may also be a possible treatment for HIV. The purpose of this study was to
      evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were on ART
      and who were virologically suppressed. Researchers evaluated the effect ruxolitinib had on
      inflammation and immune activation.

      This study enrolled HIV-positive adults who were on select ART regimens and who had viral
      suppression. ART was not provided by the study; participants continued to receive ART from
      their own health care providers. Participants were randomly assigned to receive either
      ruxolitinib (Arm A) or no study treatment (Arm B) in 2:1 ratio. Participants in Arm A
      received ruxolitinib twice a day for 5 weeks. All participants attended study visits at entry
      (Day 0) and Weeks 1, 2, 4, 5, 10, and 12. These visits included physical examinations,
      clinical assessments, blood collection, adherence assessments, oral swab collection, and
      pregnancy testing for female participants. At Weeks 1 and 4, participants in Arm A took part
      in pharmacokinetic (PK) sampling, which involved having blood drawn several times over 6 to 8
      hours.
    

Intervention name(s): Ruxolitinib
Intervention type(s): Drug
Intervention description(s): 10 mg orally twice daily for 5 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment