bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) Following Hysterectomy
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of Transcutaneous Electrical Nerve
      Stimulation (TENS) in patients after abdominal hysterectomy surgery.
    

Detailed description: 
      The aim of this study is to evaluate the efficacy of the Transcutaneous Electrical Nerve
      Stimulation (TENS) on postoperative pain and quality of recovery in patients following
      abdominal hysterectomy surgery under general anesthesia.
    

Intervention name(s): TENS
Intervention type(s): Device
Intervention description(s): Transcutaneous Electrical Nerve Stimulation will be apply
Other intervention name(s): Transcutaneous Electrical Nerve Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute pain; Transcutaneous Electric Nerve Stimulation; Anesthesia Recovery Period
Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
Condition: Schizophrenia; Schizophreniform Disorders; Bipolar I Disorder
MeSH terms: Body Weight; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effect of ALKS 3831 compared to olanzapine on body weight in
      young adults with schizophrenia, schizophreniform, or bipolar I disorder who are early in
      their illness
    

Detailed description: 
      In the US adolescent subjects starting at age 16 will be enrolled. In the EU, subjects age 18
      and older will be enrolled.
    

Intervention name(s): ALKS 3831; Olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): Olanzapine + samidorphan, daily oral dosing; Daily oral dosing
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alkermes; ALKS 3831; Olanzapine; Samidorphan; Schizophrenia; Schizophreniform; Bipolar I
Validation of Edema-invariant Multi-shell High Angular Resolution Diffusion Imaging (msHARDI)-Based Tractography With Intra-operative Cortical Stimulation
Condition: Brain Lesions
Study type: Observational

Summary: 
      Currently, standard-of-care tractography is based on information obtained from diffusion
      tensor imaging (DTI). DTI is a diffusion magnetic resonance imaging (dMRI) technique that is
      routinely obtained on neurosurgical patients to assist in pre-operative planning. The primary
      objective of the proposed study is to determine the ability of msHARDI-based tractography to
      discern fibers in edematous brain regions.
    


Intervention name(s): MRI; Neurocognitive battery
Intervention type(s): Other; Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with brain lesions near eloquent cortex
      
Keywords: Eloquent cortex
Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening
Condition: Attention Deficit-Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Attention-deficit/hyperactivity disorder (ADHD) is a neuropsychiatric disorder characterized
      by problems with sustaining attention, organization, planning, procrastination, daydreaming,
      restlessness, impulsivity and hyperactivity.This is an outpatient study for subjects between
      the ages of 18-60, who have an Attention deficit hyperactivity disorder (ADHD) diagnosis
      meeting all inclusion criteria and not meeting any of the exclusion criteria.
    

Detailed description: 
      One purpose of this trial is to extend the evidence basis for Mydayis in adult ADHD to
      include efficacy with a clinical ADHD symptom measure validated for DSM-5 adult ADHD. Another
      purpose of this trial is to re-examine the clinical efficacy of Mydayis later in the day on
      ADHD symptoms; the data on ADHD symptoms via the TASS 1 (Spencer et al. 2008) is a decade old
      and has not been examined in subsequent trials.
    

Intervention name(s): MYDAYIS; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MYDAYIS treatment will be given at a minimum dose of 12.5mg/day and will increase in increments of 12.5mg, up to 37.5mg, based upon clinical response and tolerability.; During the two-week, placebo lead-in, all patients will receive 12.5mg of placebo at Visit 1 and Visit 2.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
WES of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data
Condition: Neurofibromatosis Type 2; Vestibular Schwannoma; Acoustic Neuroma
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Neurilemmoma; Neuroma; Neuroma, Acoustic; Neurofibromatosis 2
Study type: Observational [Patient Registry]

Summary: 
      Whole exome sequencing (WES) of 50 sporadic and 50 Neurofibromatosis Type2 (NF2)-associated
      vestibularis schwannomas (VS) in children and young adults. The aim is to gain insight into
      the complete genome of the NF2 associated VS compared to sporadic VS (control group). These
      data are to be correlated with the clinic, ie the auditory function (audiogram, acoustically
      evoked potentials) and the clinical picture as well as the tumor growth rate and general data
      such as sex, age, side, etc.
    

Detailed description: 
      Whole exome sequencing (WES) of 50 sporadic and 50 Neurofibromatosis Type2 (NF2)-associated
      vestibularis schwannomas (VS) in children and young adults. The aim is to gain insight into
      the complete genome of the NF2 associated VS compared to sporadic VS (control group). These
      data are to be correlated with the clinic, ie the auditory function (audiogram, acoustically
      evoked potentials) and the clinical picture as well as the tumor growth rate and general data
      such as sex, age, side, etc.

      The analysis of genetic changes should provide a better insight into the oncogenesis of these
      tumors. The distinct genetic characteristics between NF2-associated and sporadic VS suggest a
      different oncogenesis of these tumors.

      The correlation of the genetic characteristics with the partly very different clinical
      appearance and a very different dynamics of the disease, in particular the tumor volume in
      the course, identifies the underlying modifiers of the disease course.

      Based on these genetic modifiers, patients can be stratified and individual clinical therapy
      decisions can be made.

      By demonstrating these genetic profiles in the peripheral blood, prospective conclusions can
      be drawn about expected disease progression before intervention as well as for therapy
      monitoring
    

Intervention name(s): Whole exome sequencing
Intervention type(s): Diagnostic Test
Intervention description(s): Whole exome sequencing
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        -  Study population: Operated NF2-associated VS

          -  Control group: Operated sporadic VS
      
Biospecimen description: 
      Tumor tissue Blood
    
Keywords: Whole exome sequencing; Neurofibromatosis Type 2; Acoustic Neuroma; Vestibular schwannoma
Pharmacokinetics of Once Daily Darunavir/Ritonavir in HIV-infected Children
Condition: Human Immunodeficiency Virus; Children
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Observational

Summary: 
      Darunavir/ritonavir is one of the preferred antiretroviral agents as part of combination
      antiretroviral therapy for treatment of HIV-infected adults according to international
      guidelines. For children 3-12 years old, FDA has approved once daily dosing of
      darunavir/ritonavir. Dosing recommendations for children 6-12 years old have been approved
      based on a modelling and simulation procedure by the company.

      This pharmacokinetic study is designed to validate the proposed dosing recommendation for
      once daily darunavir/ritonavir in HIV-infected children aged 6-12 years old.
    

Detailed description: 
      The EMA and FDA recommended weight band dosing for once daily DRV/r dosing in children 3 -12
      years of age has been derived from pharmacokinetic modelling. Results from population
      pharmacokinetic modelling and simulation in these children predict similar DRV plasma
      exposures compared to treatment-naïve adults, but has not been formally studied in the target
      population. Although no clinical trial was conducted to collect exposure-safety data, the
      predicted exposures from the once daily dosing is supported by exposures observed in a
      paediatric clinical trial where twice-daily dosing was administered. To validate the weight
      band based dosing recommendations, we want to evaluate the pharmacokinetics of DRV/r
      administered once daily, using DRV tablets, in HIV-infected children.

      Darunavir/ritonavir is one of the preferred antiretroviral agents as part of combination
      antiretroviral therapy for treatment of HIV-infected adults according to international
      guidelines. For children 3-12 years old, FDA has approved once daily dosing of
      darunavir/ritonavir. Dosing recommendations for children 6-12 years old have been approved
      based on a modelling and simulation procedure by the company.

      This pharmacokinetic study is designed to validate the proposed dosing recommendation for
      once daily darunavir/ritonavir in HIV-infected children aged 6-12 years old.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected children (6-12 years) using once daily darunavir/ritonavir.
      
Biospecimen description: 
      Plasma samples
Exercise and Radiotherapy, a Good Combination?
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Every year, almost 3000 Norwegian women are diagnosed with breast cancer. Various symptoms of
      short-and long-term side effects may be experienced, such as physical deterioration, reduced
      quality of life and fatigue. At St.Olavs Hospital, Trondheim University Hospital, all
      out-patients undergoing post operative radiotherapy are currently offered participation in
      group exercise training sessions. The main purpose of this study is to evaluate these
      out-patient group exercise sessions.
    


Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): One hour, twice a week, for 5 weeks: warming-up with aerobic exercises, endurance exercises, strength exercises for large muscle groups, body awareness, range-of- motion exercises for the shoulders and stretching and relaxation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise therapy; oxygen consumption
PK and PD Interaction Between Tegoprazan and NOACs After Multiple Oral Dosing in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the effects of combination therapy of tegoprazan and novel oral
      anticoagulants (NOACs) on the pharmacokinetic and pharmacodynamic properties of NOACs in
      healthy adults.
    

Detailed description: 
      A randomized, open-label, multiple-dose, two-arm, two-period crossover study

      [Cohort 1] To evaluate the effects of combination therapy of tegoprazan and edoxaban on the
      pharmacokinetic and pharmacodynamic properties of edoxaban in healthy adults.

      [Cohort 2] To evaluate the effects of combination therapy of tegoprazan and apixaban on the
      pharmacokinetic and pharmacodynamic properties of apixaban in healthy adults.

      [Cohort 3] To evaluate the effects of combination therapy of tegoprazan and rivaroxaban on
      the pharmacokinetic and pharmacodynamic properties of rivaroxaban in healthy adults.
    

Intervention name(s): Tegoprazan 50mg; Edoxaban 60mg; Apixaban 5mg; Rivaroxaban 20mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration of one tablet of tegoprazan 50 mg once daily; Oral administration of one tablet of edoxaban 60 mg once daily; Oral administration of one tablet of apixaban 5 mg twice daily; Oral administration of one tablet of rivaroxaban 20 mg once daily
Other intervention name(s): K-CAB Tab. 50 mg; Lixiana Tab. 60mg; Eliquis Tab. 5 mg; Xarelto Tab. 20 mg
Intervention MeSH terms: Rivaroxaban; Apixaban; Edoxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-arm, two-period crossover
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a Fasting Mimicking Diet on Sperm Quality
Condition: Sub Fertility, Male; Fertility Disorders; Sperm Count, Low
MeSH terms: Infertility; Oligospermia; Infertility, Male
Study type: Interventional

Summary: 
      This study investigates the effect of repetitive cycles of a Fasting Mimicking Diet (3x5 days
      in six months) on sperm quality in men
    

Detailed description: 
      This 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a
      novel supportive treatment in male infertility due to reduced sperm quality according to
      WHO5-criteria. The participants will be randomized in two groups. The intervention group
      follows a regime of a periodic fasting mimicking diet (3x5 days in six months, every 6-8
      weeks, accompanied via a mobile application), whereas the patients on the waiting list
      continue their normal diet. Spermiograms are taken about every 2 months following the WHO-5
      criteria. In addition, qualitative interviews will be conducted including individual and
      focus group interviews with a subgroup of participants.
    

Intervention name(s): Fasting Mimicking Diet
Intervention type(s): Behavioral
Intervention description(s): The mobile application "Salufast" provides standardised fasting packages for 5 days of approx. 500 kcal and accompanies the participants during all fasting days.
Other intervention name(s): Fasting; Dietary Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This explorative study is conducted in form of a randomized, controlled trial design with a fasting intervention and a waiting list, which continues the usual diet.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: fasting; natural therapies; fasting mimicking diet; caloric restriction; dietary restriction; dietary intervention; lifestyle modification; spermiogram; sperm motility; liquefaction time; sperm morphology; total sperm count; sperm density
Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to investigate the effect of omalizumab on the number of tissue eosinophils
      and other markers of airway inflammation and remodeling, including thickness of the lamina
      reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway
      inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists.
      This study will also investigate the correlation between systemic and pulmonary inflammation,
      and the correlation between clinical outcomes and changes within the tissue, to assist in the
      future identification of patients with tissue eosinophilia and their response to treatment,
      without the need for invasive bronchoscopy.
    


Intervention name(s): omalizumab at a dose of 0.016mg/kg/IU/mL; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma, adults, anti-immunoglobulin E ( IgE), omalizumab, airway inflammation, airway remodeling, allergy
Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV Participants
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks
      of treatment with sovaprevir, ACH-0143102, and ribavirin (RBV) in genotype-1 (GT-1),
      treatment-naive, hepatitis C virus (HCV) participants.
    


Intervention name(s): Sovaprevir; ACH-3102; Ribavirin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Nonstructural protein 3/4A protease inhibitor.; Nonstructural protein 5A inhibitor.
Other intervention name(s): ACH-0141625
Intervention MeSH terms: Ribavirin; Odalasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; Genotype 1; Hepatitis C; Liver Diseases; Hepatitis; Ribavirin; Antiviral Agents; Anti-infective Agents; Protease Inhibitors; NS5a Inhibitors; Viral
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
Condition: Overweight; Microbiota; Endotoxemia; Metabolic Syndrome; Non-Alcoholic Fatty Liver Disease; Insulin Resistance
MeSH terms: Endotoxemia; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight; Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      It has been suggested that the actual obesity epidemy is related to chronic overconsumption
      of added or free sugars. The increasing popularity of artificial sweeteners attest the
      population willingness to reduce added sugars intake and to use alternatives to alleviate
      health impact of free sugar overconsumption. However, recent findings suggest that artificial
      sweeteners may rather contribute to obesity epidemy and its associated adverse health
      effects, potentially via a negative impact on gut microbiota. It has been shown in various
      studies that, for the same amount of sucrose, unrefined sugars (such as maple syrup) are
      associated with favorable metabolic effects. The polyphenols contained in maple syrup,
      especially lignans, could contribute to these positive effects. Indeed, the strong impact of
      those biomolecules on the modulation of gut microbiota and on gastro-intestinal and metabolic
      health has been demonstrated in several studies. It is therefore highly relevant to test the
      hypothesis that the substitution of refined sugar by an equivalent amount of maple syrup (5%
      of daily energy intake) result in a lesser metabolic deterioration, by the modulation of
      maple syrup on gut microbiota, than the one observed with refined sugar.
    


Intervention name(s): Maple syrup; Placebo
Intervention type(s): Other; Other
Intervention description(s): Substitution of refined sugar by an equivalent quantity of maple syrup (5% of daily energy intake) in the participant diet. A dietitian will help study subjects to target added sugar sources in their usual diet and suggest ways to substitute it with maple syrup.; Substitution of refined sugar by an equivalent quantity of maple-flavored sucrose syrup (5% of daily energy intake) in the participant diet. A dietitian will help study subjects to target added sugar sources in their usual diet and suggest ways to substitute it with the placebo (sucrose syrup).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Aino ECG Ambulatory Study
Condition: Arrhythmias, Cardiac; Atrial Fibrillation and Flutter
MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac
Study type: Observational

Summary: 
      The study includes collection of data from patients referred to a therapeutic evaluation in
      Tays Sydänkeskus Oy (Heart Center Co, Tampere University Hospital) or another unit of
      Sydänkeskus (hereafter the Heart Hospital) due to suspected cardiac arrhythmia. Data
      collection takes place outside the hospital in normal daily conditions. The monitoring is
      started during the outpatient visit at Heart hospital polyclinic or when leaving home from
      cardiac ward and it continues for 2 days. Reference information about the occurrence of
      arrhythmia episodes and the reference ECG data are obtained from simultaneously worn Holter
      device.

      During the two days the study device and the reference device are worn continuously. Wearing
      the devices does not affect the daily routines of the participant except there is no
      possibility to take a shower. The arrhythmia episodes are labelled in post-hoc signal
      analysis and annotations visually confirmed by a cardiologist. The participants are
      instructed to take ECG recordings with the wrist device every time the device gives a
      notification and also whenever the participant feels arrhythmia symptoms. There will be at
      least four intermittent ECG records taken on each day.
    


Intervention name(s): Wrist-word optical heart rate and ECG measurement device
Intervention type(s): Device
Intervention description(s): Aino ECG: wrist-word optical heart rate and ECG measurement device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The source population of the study includes patients referred to a therapeutic evaluation
        or treatment in Tays Heart Hospital due to suspected cardiac arrhythmia. A portion (up to
        one third) of the subjects may be having on-going atrial fibrillation at the beginning of
        the measurement and may suffer from persistent or permanent atrial fibrillation.
Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      Investigation of arginine and NO metabolism in healthy subjects is important as a reference
      for alterations in arginine-NO metabolism in patients. Moreover, this study will indicate the
      changes during aging and gender-related differences. Although data on arginine metabolism
      exist in literature, data are limited to young healthy male subjects. Since patients with
      suspected changes in arginine metabolism, e.g. sepsis and cancer patients are often elderly
      and also women, knowledge of arginine metabolism in these groups is needed.
    


Intervention name(s): stable isotope infusion for measurement of metabolism
Intervention type(s): Other
Intervention model: Single Group Assignment
Primary purpose: Basic Science
Keywords: volunteers