bioihbjkbjnl/mcl2 huggingface dataset:
The Multi-stakeholder Assessment of Economic and Managerial Determinants and Impacts of Telemedicine
Condition: Telemedicine
Study type: Interventional

Summary: 
      The study aims to conduct a comprehensive evaluation involving multiple stakeholders to
      assess the factors influencing and the consequences of telehomecare in comparison to
      traditional care models. The integration of technology into the healthcare sector
      necessitates significant changes in care of patients, organizational structures, production
      processes, organizational responsibilities, and the management of service delivery processes.

      The delivery of telemedicine services through integrated devices represents a method of
      service production that demands active involvement from patients or, in the case of pediatric
      patients, their caregivers. This collaborative process of patient engagement in healthcare
      services is referred to as "co-production." In this research, telehomecare will be examined
      as an illustrative instance of co-producing healthcare services.

      Co-production implies that the inputs into a production process are contributed not only by
      the organization producing a good or service but also by the users. In the case study,
      co-production occurs through the interaction between patients/caregivers and professionals
      during telehealth visits for device-mediated monitoring activities. Throughout the televisit,
      patients/caregivers play a crucial role in collecting and sharing the necessary parameters
      with professionals using the device, thereby serving as essential actors in the care process.

      The investigators explored the impact of a transitional care program, utilizing an
      user-friendly mobile medical device, to support an early discharges in a pediatric setting.
      Clinical outcome and economic advantages are considered. This study will contribute to
      implement knowledge on the role of telemedicine on HaH healthcare in pediatrics.
    

Detailed description: 
      This is a single-center, two-arm, randomized, open-label, parallel-group study that was
      conducted at Buzzi Children's Hospital, a hospital in a metropolis located in Milan (Italy).
      The different arms consisted of an experimental group with an early discharge adopting
      telehomecare and a standard care group with in-person physical care until the end of
      hospitalization.
    

Intervention name(s): Telemedicine
Intervention type(s): Other
Intervention description(s): The telehomecare solution involves an early discharge with continued home monitoring through the use of telemedicine utilizing an user-friendly mobile. Additionally, there were a clinical reassessment in person 72 hours after discharge to evaluate the outcomes and results of the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
The Effects of Exercise Intensity on Mood and Wellbeing
Condition: Healthy; Exercise; Mood
Study type: Interventional

Summary: 
      The study will adopt a between-within group design where participants will exercise at 1 of 4
      intensities for 30 minutes at SportsPark Reading. Mood, mental health (e.g., state anxiety
      and immediate depressive feelings) and physiological parameters (heart rate, blood pressure
      and body temperature) will be assessed before and after exercise intervention to compare the
      acute change across time for each intensity condition (no exercise (control), low, moderate,
      high).
    


Intervention name(s): Spin Bike Exercise; Control
Intervention type(s): Other; Other
Intervention description(s): 30 minute spin bike class led by a qualified instructor.; 30 minute completing seated activities (e.g., wordsearches)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Trial for Peroperative Procedure and Postoperative Pain After Rectal Misoprostol or Rectal Hyoscine Administration
Condition: Hysteroscopic Surgery; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Dilatation of the cervix is necessary before operative hysteroscopic procedures. This
      dilatation with Hegar dilators has certain difficulties and is associated with pain. Cervical
      priming with various substances soften the cervix, ease the entry for the operation and
      decrease complications such as uterine perforation.

      The investigators aimed to compare rectally administered "misoprostol" and" hyoscine butyl
      bromide" with sham protocol.
    

Detailed description: 
      The study is planned as a double blind randomised controlled one centre study. It will take
      part at a operative gynaecological department of a university hospital. Women who apply to
      the university clinic who have a medical indication for hysteroscopic surgery will be
      recruited after informed consent.

      Patients included in the study will be allocated to three groups. The intervention arms will
      be two arms and one sham group. The randomisation will be performed to three groups by a
      third party who is not involved in the surgical procedures.

      Upon initial evaluation, a form evaluating age and other sociodemographic characteristics
      will be filled out before the scheduled hysteroscopy procedure. After completion of the
      initial form, rectal tablets will be administered according to the allocated group; two hours
      previously to the procedure. Hysteroscopy will be under general anaesthesia with a 10 mm
      hysteroscope during the follicular phase of the menstrual cycle.

      During the procedure the duration of the cervical entry and total duration of the operation
      will be noted. Additionally basal dilatation will be noted.

      Two hours after the procedure pain will be documented according to the Visual Analogue Scale
      which is a ten point scale. A value of "1" indicates "no pain". A value of "10" indicates
      "excruciating" pain.
    

Intervention name(s): Misoprostol; Hyoscine butyl bromide
Intervention type(s): Drug; Drug
Intervention description(s): Rectal administration 2 jours before the procedure; Rectal administration 2 jours before the procedure
Other intervention name(s): Cytotec; Buscopan
Intervention MeSH terms: Scopolamine; Bromides; Misoprostol; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three group parallel design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: misoprostol; hyoscine butyl bromide; cervical dilatation; cervical ripening; hysteroscopy; pain
Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair
Condition: Cleft Palate
MeSH terms: Cleft Palate
Study type: Interventional

Summary: 
      The purpose of this investigator-initiated study is to determine whether acetaminophen is an
      effective pain reliever for primary cleft palate repair in children and possesses opioid
      sparing effects. Additionally, the investigators will determine if patients who receive
      acetaminophen have less opioid related side-effects. The study will have three study groups
      based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral
      acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine)
      alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the
      intraoperative period and 24 hours after surgery for all patients within the study and
      converted to morphine equivalents.
    


Intervention name(s): Oral acetaminophen; Ofirmev®; Opioid only
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.; Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.; Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cleft palate surgery; post-operative pain management; Acetaminophen
Examining Persistence in Smokers With Schizophrenia
Condition: Smoking Cessation; Schizophrenia; Schizo Affective Disorder
MeSH terms: Schizophrenia; Mood Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      All participants will receive free weekly counseling (8- weeks) and free nicotine patches
      (10-weeks). They will complete assessment measures commonly used in smoking cessation
      studies. We hope to show that this treatment is feasible in this small pilot study before
      comparing it to a more established treatment in a future randomized clinical trial.
    

Detailed description: 
      This study is a non-randomized trial of a new psychosocial treatment for smoking cessation
      (for smokers with schizophrenia) that is based on cognitive behavioral therapy for smoking
      cessation - a commonly used approach. Participants will receive free weekly counseling (8-
      weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly
      used in smoking cessation studies. We hope to show that this treatment is feasible in this
      small pilot study before comparing it to a more established treatment in a future randomized
      clinical trial.
    

Intervention name(s): counseling
Intervention type(s): Behavioral
Intervention description(s): individual, weekly, smoking cessation counseling + over-the-counter nicotine patch
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Men to Find the Best Formulation for Once Daily Intake of Nintedanib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to assess single dose drug exposure of several newly
      developed formulation prototypes of Nintedanib compared to Ofev® following oral
      administration.
    


Intervention name(s): Ofev®; Nintedanib formulation 1; Nintedanib formulation 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ofev®; Nintedanib formulation 1; Nintedanib formulation 2
Other intervention name(s): Nintedanib
Intervention MeSH terms: Nintedanib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Growth Hormone (GH) in Congenital Adrenal Hyperplasia
Condition: Adrenal Hyperplasia, Congenital
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction; Hyperplasia
Study type: Observational

Summary: 
      Congenital adrenal hyperplasia (CAH) is a genetic rare disease, which alters the adrenal
      production of gluco and mineralo corticoids. The treatment consists in supplementing children
      using hydrocortisone. Despite care for these children has improve substantially across
      decades, short adult height still remains an important consequence of the disease. About 20 %
      of patients have an AH below 2 standard deviations compared to their expected height.

      In the OPALE model study, the investigators have collected data from a cohort of 496 French
      patients, born between 1970 and 1991 and with a known genotype. Using their age, sex, growth,
      disease, bone maturation and pubertal data, they have built a model which allows to predict
      their AH using data available at 8 years of age. This model has shown that the currently used
      formula to calculate the predicted AH (Bayley Pineau's method) is not applicable to children
      with CAH.

      In this project, the investigators plan to use the prediction model to compare the AH in
      patients who have received GH treatment to their predicted AH using the model.

      The hypothesis is that GH improves the AH in such patients. Existing cohorts have shown
      improved growth celerity, and growth expectation using the Bayley-Pineau formula), but this
      has not been shown on the actual AH.

      This study will allow to reinforce the investigators' hypothesis.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with genetically proven CAH, classical form, or simple virilizing, with 21
        hydroxylase, or 11ᵝ hydroxylase, or 3βol-dehydrogenase deficit, born between 1970 and 1998,
        having received GH treatment for a minimal one year duration.
      
Keywords: congenital adrenal hyperplasia; short stature; growth hormone treatment
Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Early-stage breast cancer patients treated with breast conservative surgery are enrolled in
      this study if they meet defined criteria. Patients are randomized into two groups:
      conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is
      that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar
      efficacy and toxicity.
    


Intervention name(s): radiotherapy
Intervention type(s): Radiation
Intervention description(s): one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.
the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer patients; breast conservation surgery; hypofractionated radiotherapy
Safety and Efficacy Study for the Treatment of Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if Engensis (VM202) is safe and effective in
      treating painful diabetic neuropathy.
    

Detailed description: 
      Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries
      a high risk of pain, trophic changes and autonomic dysfunction. There is currently no
      effective treatment for diabetic neuropathy, and good glycemic control is the only way to
      minimize the risk of occurrence. Clearly, it would be desirable to prevent, impede, or
      reverse the disrupting and often life-threatening manifestations of peripheral neuropathy by
      stimulating growth or regeneration of peripheral nerve axons.
    

Intervention name(s): Low Dose: 16 mg Engensis (VM202); High Dose: 32 mg Engensis (VM202); Control- Placebo (normal saline)
Intervention type(s): Biological; Biological; Other
Intervention description(s): Subjects in the Low Dose Group (8mg VM202 / leg) will receive the following intramuscular injections in each calf:
Day 0 - 32 injections / calf:
• 16 injections of 0.5mL of VM202 / calf - (4 mg of VM202 / calf)
Day 14 - 32 injections / calf:
• 16 injections of 0.5mL of VM202 / calf - (4 mg of VM202 / calf); Subjects in the High Dose Group (16 mg VM202 / leg) will receive the following intramuscular injections in each calf:
Day 0
• 32 injections of 0.5mL of VM202 / calf (8 mg of VM202 / calf)
Day 14
• 32 injections of 0.5mL of VM202 / calf (8 mg of VM202 / calf); subjects will receive thirty-two (32) 0.5 mL injections of normal saline on Day 0 and Day 14.
Other intervention name(s): Gene Therapy; Gene Therapy; Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nerve pain; diabetic nerve pain; throbbing; burning; painful feet; tingling; numbness; Engensis (VM202)
Aminophylline for Patients With Post-Dural Puncture Headache
Condition: Post-dural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Its
      clinical manifestations are pain in the forehead and the occipital region, or diffuse
      headache. The pain is dull or fluctuating, becoming worse when standing and better when lying
      down, and is often accompanied by symptoms including a stiff neck, tinnitus, hearing loss,
      photophobia, and nausea, which cause great suffering to the patients1. According to
      epidemiological data, approximately 10% to 30% of the patients who undergo lumbar puncture
      suffer from PDPH within 48 hours of the procedure.Currently, commonly used treatments for
      PDPH include rehydration, the administration of corticotropin, caffeine, or sumatriptan, and
      the application of an epidural blood patch. The efficacy of theophylline has been proven in a
      placebo-controlled study in which 17 PDPH patients received an intravenous (IV) injection of
      200 mg theophylline. The Visual Analogic Scale scores 4 hours after treatment were
      significantly different compared with those of the placebo group5. At present, the clinical
      application of theophylline has been replaced by aminophylline and doxofylline, and it is
      difficult to purchase theophylline in most hospitals in China and other countries.

      The Aminophylline for Patients With Post-Dural Puncture Headache trial, is a
      prospective,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and
      safety of an IV injection of aminophylline on post-dural puncture headache.Eligible patients
      were randomized in a blinded fashion(1:1) to receive IV injection of aminophyllineor or
      sterile isotonic saline.The investigators estimate that this trial will demonstrate that an
      IV injection of aminophylline could be the preferred method for the clinical treatment of
      PDPH.
    


Intervention name(s): Aminophylline; isotonic saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aminophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: post-dural puncture headache; Aminophylline
The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the
      role of neuroactive steroids in individuals with cocaine use disorder (CUD).
    

Detailed description: 
      This experimental study aims to examine the effects of PREG on a) repeated cocaine craving,
      mood and neurobiological reactivity to brief, guided imagery exposure to stress, drug cues
      and neutral situations in the laboratory and b) daily cocaine intake, craving, cognition and
      mood in men and women with CUD; and c) sex differences in all of these outcomes. The study's
      hypothesis is that PREG vs PLA will dose-specifically decrease stress-induced and drug-cue
      induced cocaine craving, improve mood and cognitive performance, and normalize hypothalamic
      pituitary adrenal (HPA) axis response to stress and drug-cue imagery, and reduce cocaine
      intake and craving in daily life in individuals with CUD.
    

Intervention name(s): PREG 300/500 mg; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 2 doses of PREG (300/500 mg/day); placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants will be randomly assigned to 2 doses of PREG (300/500 mg/day) vs placebo (PLA) treatment (N=20/group) over 8 weeks.
Masking: Single (Participant)
Primary purpose: Treatment
Methylphenidate to Improve Balance and Walking in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Methylphenidate is an amphetamine-like psychomotor stimulant drug currently approved for the
      treatment of attention-deficit hyperactivity disorder (ADHD), postural orthostasis
      tachycardia syndrome and narcolepsy. It is also often prescribed off label to people with MS
      to improve fatigue. It is proposed that methylphenidate may also improve imbalance and
      walking deficits in MS by improving concentration and central integration, one of the primary
      mechanisms thought to underlie imbalance and walking deficits in MS.
    

Detailed description: 
      The proposed pilot study will examine the effects of methylphenidate on imbalance and walking
      in 24 subjects with MS and imbalance. The subjects will be randomly assigned to receive
      either an escalating does of methylphenidate, 20mg, 40mg or 60mg, divided into two doses each
      day, or matched placebo for 2 weeks at each dose. If a subject does not tolerate dose
      escalation they will be instructed to discontinue use of the drug. The maximum safely
      tolerated dose for each subject will be noted. Changes from baseline in subject's walking
      speed, balance, vestibular function, cognitive function, and fatigue will be assessed at each
      dose.
    

Intervention name(s): Methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each; Escalating matched dose of placebo
Other intervention name(s): Ritalin
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple sclerosis; postural balance; walking