bioihbjkbjnl/mcl2 huggingface dataset:
Depot-medroxy Progesterone Acetate Injectable Contraceptives in Lactating Women 1st Week Versus 6 Week Postpartum Initiation
Condition: Complications of DMPA Injectable Contraceptives
Study type: Interventional

Summary: 
      This study aims to identify the effect of using Depot-medroxy progesterone acetate injectable
      contraceptives on lactating women mother and infant in 1st week versus 6th week postpartum
      initiation.

      This study is open labeled -randomized clinical trial was used. It was conducted at woman's
      health hospital, Assuit University. This study applied on 120 lactating women, who divided
      into two equal group I (who used DMPA injectable in the 1st week postpartum) and group II
      (who used DMPA injectable in the 6th week postpartum). Each group included 60 lactating
      women). Follow up was carried out after 3 months from the first dose to determine the changes
      in the studied women's menstrual period, weight, breast feedings…etc.
    


Intervention name(s): Depot-medroxy Progesterone Acetate Injectable Contraceptives
Intervention type(s): Device
Intervention description(s): Depot-medroxy progesterone acetate injectable contraceptives
Intervention MeSH terms: Medroxyprogesterone Acetate; Contraceptive Agents; Medroxyprogesterone; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Operative Treatment of Ankle Fractures
Condition: Ankle Fracture, Trimalleolar; Ankle Fracture - Lateral Malleolus; Ankle Fracture, Bimalleolar
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

Summary: 
      Patients who underwent operative treatment of an ankle fracture with or without following
      removal of the osteosynthetic material are examined by a specific ankle provocation test, a
      questionnaire and X-Rays to evaluate the clinical, functional and radiological outcome
      compared to a healthy control group
    

Detailed description: 
      The study includes all patients operated from 09.12.2012 to 31.12.2020. Patients will undergo
      an X-Ray at least two years after primary surgery or at least one year after removal of the
      osteosynthetic material. The patients operated from 09.12.2012 to date are therefore a
      retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. This
      method is used to achieve the highest possible number of patients in a define period of time
      with no alteration of surgical technique.

      All patients in the retrospective cohort are contacted at least 2 years after surgery (or 1
      year after removal) via phone call or letter, informed about the study and asked to
      participate. In case of informed consent, they are invited to the study site. They are asked
      to complete the questionnaires and they undergo X-Ray of the affected and the non-affected
      ankle.

      All patients in the prospective cohort are informed about the study and asked to participate
      in the outpatient clinic. In case of informed consent, they are invited to the study site at
      least 2 years after surgery. They are asked to complete the questionnaires and they undergo
      na X-Ray of the affected and non-affected ankle.
    

Intervention name(s): Specific provocation test
Intervention type(s): Diagnostic Test
Intervention description(s): To compare the results the investigators invite a healthy control group matching in age and gender with the intervention cohort. The control group is informed about the study and asked to participate in the outpatient clinic. In case of informed consent, the participants are invited to the study site. The participants undergo the same provocation test of the ankle, and are asked to complete the specific provocation test. In case of substantial underachievement in the provocation test (<60% of maximum) an X-Ray of both ankles in a.p. and lateral projection is performed. The aim is to radiologically analyse the ankles, and to rule out any morphological reasons for the above mentioned underperformance.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Use of Whole Body Vibration in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the efficacy of a 3-month program consisted of the
      use of whole body vibration (WBV) in patients with fibromyalgia in order to determine whether
      this intervention would be effective to short and medium-term improvement of symptoms in
      these patients.
    

Detailed description: 
      This was a single blind randomized controlled trial. Forty patients of FM group were assigned
      randomly to 2 study groups: 20 patients will be part of the experimental group (EG) that will
      perform a neuromuscular treatment using the vertical whole body vibration platform and
      another 20 will constitute the control group (CG). All these subjects will sign the
      corresponding informed consent for their participation in the study, according to the ethical
      criteria established in the Helsinki Declaration. The study took place between January and
      Juny 2019. Two groups of variables were analyzed in the present study three times: before,
      after and follow-up after three months of the intervention.
    

Intervention name(s): Whole body vibration platform
Intervention type(s): Device
Intervention description(s): A neuromuscular treatment using a rotational whole body vibration platform.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this clinical,two groups of participants receive different interventions. One group receives a training with a whole body vibration plattform and the other is the control group.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study To Investigate If MRI Scanning Is Effective At Seeing What Hayfever Drugs Do In Nasal Passage.
Condition: Seasonal Allergic Rhinitis; Sinusitis
MeSH terms: Rhinitis; Sinusitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Observational

Summary: 
      The purpose of this study is to establish whether MRI scanning is a sensitive measure of the
      effects of existing drug treatments on nasal dimensions following challenge with intranasal
      allergen in subjects with hayfever. If successful this technique could be applied to increase
      confidence for internal decision making and ultimately may be used to assess how effective a
      new drug treatment is.
    


Intervention name(s): pseudoephedrine hydrochloride; cetirizine hydrochloride
Intervention type(s): Drug; Drug
Other intervention name(s): pseudoephedrine hydrochloride
Intervention MeSH terms: Cetirizine; Pseudoephedrine; Ephedrine
Keywords: anti-allergy.; seasonal allergic rhinitis (SAR),; intranasal allergen challenge,; MRI,
A Study of LY3090106 in Japanese and Caucasian Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of a study drug known as LY3090106
      in healthy Caucasian and Japanese participants. Side effects and tolerability will be
      documented. Blood samples will be taken to compare how the body handles the drug. The study
      will last about 12 weeks, not including screening or additional follow-up.
    


Intervention name(s): LY3090106; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy and Safety Study of Meloxicam Versus Mefenamic Acid in Patients With Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      To access the efficacy and safety of Meloxicam 7.5 mg and 15 mg once daily compared with
      Mefenamic acid 500 mg t.i.d. over a treatment period of 3-5 days, during an observation
      period of 3 menstrual cycles, for the symptomatic relief of primary dysmenorrhea
    


Intervention name(s): Meloxicam 7.5 mg; Meloxicam 15 mg; Mefenamic acid 500 mg; Placebo matching 7.5 mg meloxicam; Placebo matching 15 mg meloxicam; Placebo matching 500 mg mefenamic acid
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Meloxicam; Mefenamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study to Evaluate the Efficacy of Poppi Apple Cider Vinegar Prebiotic Soda to Improve Gut Health In Participants
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      This exploratory observational trial provides the opportunity to gather information on the
      effect of daily consumption of Poppi Apple Cider Vinegar Prebiotic Soda on gut health and
      digestion.
    

Detailed description: 
      Individuals aged 18+ with a BMI under 30 and self-reported regular issues with IBS and/or
      poor digestion symptoms, including bloating, gassiness, heartburn, abdominal pain,
      constipation or associated symptoms (self-reported), but otherwise healthy will be chosen to
      participate in the study (see "4. Participant Definition"). Participants will be advised to
      discontinue any other oral supplement targeting the gut, including antibiotics, during the
      study and at least 3 months prior to.

      Participants will be asked to complete the baseline survey on gut and skin health before the
      study starts.

      Participants will also be asked to discontinue any additional soda consumption during the
      study.

      Each day in the morning, for lunch, or in the afternoon, participants will drink one 12 fl
      oz. can of Poppi ACV prebiotic soda.

      After 2 full weeks (day 14 of the study period) of drinking Poppi daily, participants will
      complete the 2-week follow up survey of gut and skin health.

      After four weeks (day 28) of the study period, participants will complete the 4-week
      end-of-study follow up survey of gut and skin health. Making the whole study period four
      weeks.

      The gut health surveys completed at baseline, week two and week four will be evaluated to
      determine the impact of Poppi ACV prebiotic soda on symptoms of poor gut
      health/digestion/IBS, including bloating, gas, heartburn, constipation and abdominal pain, as
      well as skin health.
    

Intervention name(s): Drink Poppi Soda
Intervention type(s): Dietary Supplement
Intervention description(s): Drink Poppi Vinager Soda
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bloating; abdominal pain; gassiness; heartburn
Tesamorelin Effects on Liver Fat and Histology in HIV
Condition: Human Immunodeficiency Virus (HIV); Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV)
      infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of
      patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of
      NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and
      fibrosis.

      NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group
      has previously shown that HIV-infected individuals with increased visceral adiposity
      generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing
      hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is
      FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous
      study, treatment with tesamorelin in HIV-infected individuals selected for abdominal
      adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin
      on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The
      investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the
      inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.
    


Intervention name(s): tesamorelin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): inactive substance that looks like tesamorelin
Other intervention name(s): Egrifta
Intervention MeSH terms: Tesamorelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human immunodeficiency virus (HIV); Nonalcoholic fatty liver disease (NAFLD); Nonalcoholic steatohepatitis (NASH); Growth hormone releasing hormone; tesamorelin
Assessment of Cerebral Vasoreactivity Using Near-infrared Spectroscopy (NIRS) in Infants (VARO)
Condition: Hypercapnia
MeSH terms: Hypercapnia
Study type: Interventional

Summary: 
      The purpose of this study is to show that a permissive hypercapnia during mechanical
      ventilation in children under general anaesthesia will improve cerebral perfusion.
    

Detailed description: 
      Mechanical ventilation interferes with cerebral perfusion via the changes in intrathoracic
      pressure and/or as a consequence of hypocapnia. This latter occurs frequently following
      traditional ventilation strategies with relatively high tidal volume and respiratory rate.
      New trends in anesthesia intend to promote protective lung ventilation by keeping a
      normocapnic or even mildly hypercapnic state. However, cerebral vascular vasotonicity is
      carbon dioxide (CO2)-dependent with hypocapnia potentially leading to vasoconstriction and
      subsequent decrease in cerebral blood flow. Changes in cerebral vasoreactivity can be
      assessed by the near infrared spectroscopy (NIRS) device. This monitoring evaluates the
      changes in various parameters (deoxygenated hemoglobin, oxygenated hemoglobin, the tissue
      oxygenation index (TOI) and the tissue hemoglobin index (THI)) that act as surrogate for
      cerebral vasoconstriction.

      We, therefore designed this prospective observational comparative effectiveness study in
      order to characterize the potential beneficial effect of permissive hypercapnia on cerebral
      perfusion in infants.
    

Intervention name(s): Normocapnia; Mild Hypercapnia
Intervention type(s): Other; Other
Intervention description(s): Normoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa); Decrease in minute ventilation in order to increase ETCO2 to 6.5 kPa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: spectroscopy, near-infrared; Infant; Anesthesia, general
Study to Determine the Ability of Seresis to Act as a Skin Protection Agent in Healthy Young Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to detect the efficacy of Seresis® in reducing the damage produced on the skin by
      Matrix-metalloproteinases (MMP) and by oxidative stress (marker: heme oxygenase-1 expression)
      activated by UV radiation
    


Intervention name(s): Seresis®; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Preoperative Warming of Patients on Postoperative Hypothermia and Shivering
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      The investigators want to evaluate the effect of prewarming on the rate of postoperative
      hypothermia and shivering and to compare sublingual versus tympanic temperature assessment
      during the perioperative period in patients.

      Patients will be randomly assigned to 4 groups with different duration of prewarming. Body
      temperature will be recorded regularly by sublingual and tympanic (by thermocouple)
      measurement. Incidence of hypothermia (temp. < 36°C) and shivering will be assessed
      postoperatively.
    

Detailed description: 
      Inadvertent perioperative hypothermia causes many serious complications. Therefore,
      prevention from, detection and therapy of hypothermia is essential. The appropriate methods
      of temperature assessment are still under debate as well as the effect and necessary duration
      of active prewarming of patients to avoid postoperative hypothermia and shivering.

      The aim of our study is to evaluate the effect of prewarming on the rate of postoperative
      hypothermia and shivering and to compare sublingual versus tympanic temperature assessment
      during the perioperative period in patients undergoing elective minor surgery.

      The investigators plan to include patients scheduled for routine minor surgery of
      approximately 1h duration. Patients will be randomly assigned to 4 groups with different
      duration of active prewarming. Body temperature will be recorded regularly by sublingual and
      tympanic (by thermocouple) measurement. Incidence of hypothermia (temp. < 36°C) and shivering
      will be assessed postoperatively.
    

Intervention name(s): duration of preoperative active warming
Intervention type(s): Procedure
Intervention description(s): duration of prewarming by "forced air warming"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hypothermia, accidental; prewarming; body temperature monitoring; preoperative warming; sublingual temperature assessment; tympanic temperature assessment
Cross-sectional Study of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      This study is designed to collect data on precipitating factors, diagnosis, morbidity,
      therapy, quality of life, and symptom severity, etc. informations in patients with
      fibromyalgia.
    

Detailed description: 
      Patients fulfilling 1990 ACR criterion for fibromyalgia will be recruited in Fibromyalgia
      outpatient service which is belonged to the Department of Rheumatism. Except collecting
      patients' demographic and social characteristic informations, rheumatologist also carry out a
      comprehensive evaluation including patient current history, current medication use, and
      tender point examination for a diagnosis or confirmation of fibromyalgia and treatment
      recommendations. Patients with fibromyalgia will be asked to fill a set of questionnaires to
      evaluate their quality of life, symptoms severity, quality of sleep and emotion. The study
      will be conducted in Beijing, China.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients fulfilling 1990 ACR criterion for fibromyalgia be seen in the Fibromyalgia
        Outpatient Service which belonged to the Department of Rheumatism, Guang'anmen Hospital,
        Beijing China.
ADenosine Vasodilator Independent Stenosis Evaluation II - ADVISE II
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      To assess the clinical value of iFR to characterize, without concomitant administration of
      hyperemic agents and outside a specified range of iFR values, coronary stenosis severity as
      determined with fractional flow reserve (FFR)
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient receiving a standard of care FFR measurment in the cath lab setting.
The Cold Fluids Study
Condition: Hemodynamic Instability
Study type: Interventional
Phase: Phase 4

Summary: 
      In this single center crossover study the aim is to investigate the effect of Ringer's
      lactate solution at high and low temperatures on physiological response in healthy adults.18
      healthy volunteers will be included. Inclusion criteria is; Age between 18-64. Exclusion
      criteria is; Pre-existing medical problems, Pregnancy (validated through a certified
      pregnancy test), Body mass index >35 kg/m2, Medication use apart from allergy medication,
      contraceptives, or non-steroidal anti-inflammatory drugs.

      Participants will be randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C,
      59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. Fluids will be
      administered through a peripheral vein. After a minimum "washout period" of 24 hours,
      subjects are switched to receive infusion at the other aforementioned temperatures.

      Primary outcome is

        -  The increase in MAP at 15 minutes after infusion of the fluid bolus. Secondary outcome
           is

        -  Time until return of MAP to baseline value after infusion.
    


Intervention name(s): Ringer's Lactate
Intervention type(s): Drug
Intervention description(s): On the first trial day healthy volunteers are randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of SHP465 in Children Aged 4 to 5 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability
      of SHP465 in children aged 4 to 5 years with ADHD after multiple daily doses of 6.25
      milligram (mg) SHP465
    


Intervention name(s): SHP465
Intervention type(s): Drug
Intervention description(s): SHP465 capsule will be administered at a dose of 6.25 mg, orally once daily for 4 weeks. SHP465 is comprised of sulfate salts of dextroamphetamine and amphetamine, with dextroamphetamine saccharate and amphetamine aspartate monohydrate, which provide a composite enantiomer ratio of 3:1 d-amphetamine to l-amphetamine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SHP465; ADHD; Hyperactivity