bioihbjkbjnl/mcl2 huggingface dataset:
Anesthetic Depth Effects Upon Immune Competent Cells
Condition: Immunotoxicity; Anesthesia; Inert Gas Narcosis
MeSH terms: Inert Gas Narcosis
Study type: Interventional

Summary: 
      Anesthesia depth affects the proliferation of lymphocytes to NK-cells and memory T-cells
      effect and the phagocytosis activity of macrophages in healthy patients. ASA 1-3 subjects
      undergoing extended shoulder surgery under continuous regional anesthesia randomly were
      assigned to a deep or a shallow anesthesia level (BIS <35 or >55) for more than an hour.
      Immune response is measured by lymphocyte proliferation as well as neutrophil and monocyte
      phagocytosis activity.
    

Detailed description: 
      Blood samples were taken under minimal stress prior to anesthesia induction (T0), recovery
      (T1) and 12 weeks following hospital discharge (T2) from the respective anesthesia depth
      level. Bispectral index monitoring (BIS) was performed from the awake state to complete
      recovery in all subjects.

      Hemoglobin concentration, leukocyte and lymphocyte counts were determined by routine
      automated laboratory techniques. Lymphocyte proliferation was analyzed by SASPA flow
      cytometry analysis. In brief, 100 µl EDTA blood were stirred with 10 µl FITC and PE marked
      antibody mixture containing CD3, CD4, CD8, CD 16, CD45, CD28, CD27, CD 56.

      Monocyte and neutrophil phagocytosis activity was measured separately in macrophages of fresh
      heparinized whole blood using flow cytometric test kits.

      Proteomics of monocytes was done synchronously.
    

Intervention name(s): High dose propofol, fentanyl and sevoflurane; Low dose propofol, fentanyl and sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Deep Anesthesia; Shallow Anesthesia
Other intervention name(s): BIS lower than or equal to 45; BIS above 45
Intervention MeSH terms: Fentanyl; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling
Condition: Gastroenterology; Lesions
Study type: Observational

Summary: 
      All patients will receive standard medical care and no experimental interventions will be
      performed. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a
      well-established procedure commonly used for the investigation of lesions within or adjacent
      to the gastrointestinal (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal
      gland, lymph nodes, and subepithelial lesions). EUS-guided tissue sampling has been commonly
      performed with different size and types of aspiration and core biopsy needles.
    

Detailed description: 
      Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a well-established procedure
      commonly used for the investigation of lesions within or adjacent to the gastrointestinal
      (GI) lumen (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and
      subepithelial lesions). EUS-guided tissue sampling has been commonly performed with different
      size and types of aspiration and core biopsy needles. More recently, a novel
      through-the-needle microforceps has been introduced. The MorayTM microforceps fits through a
      19-gauge FNA needle and allows targeted tissue sampling under EUS visualization.

      Aim - To prospectively evaluate the safety and diagnostic yield of the through-the-needle
      microforceps for pancreatic and non-pancreatic solid, cystic and mixed solid/cystic lesions.
    

Intervention name(s): Endoscopic ultrasound- (EUS) guided tissue sampling
Intervention type(s): Other
Intervention description(s): EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.
Other intervention name(s): EUS-TS
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include all patients who are scheduled to undergo EUS-guided tissue sampling
        as part of their standard of care.
Efficacy and Tolerability of Idebenone in Boys With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      Idebenone is a synthetic analogue of coenzyme Q10 and is a powerful antioxidant and essential
      constituent of the process of energy production on the cellular level. It can protect
      mitochondria from oxidative damage and boost their impaired function. It is thought that this
      mechanism will slow decline in heart function that is part of the disease process of Duchenne
      Muscular Dystrophy (DMD). It is possible that patients may benefit in terms of muscle
      strength and respiratory function. This pilot trial is designed to investigate this.
    


Intervention name(s): idebenone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): idebenone 450 mg/day (150 mg three times a day)
Intervention MeSH terms: Idebenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duchenne Muscular Dystrophy; DMD; Duchenne
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following
      Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis
    

Detailed description: 
      To evaluate the potential of DSXS to suppress HPA axis function in patients with mild to
      moderate plaque psoriasis.

      To evaluate the efficacy parameters and adverse event (AE) profile of DSXS administered to
      patients with mild to moderate plaque psoriasis.
    

Intervention name(s): DSXS topical
Intervention type(s): Drug
Intervention description(s): topical treatment
Other intervention name(s): active
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Knowledge About Infertility; an Online Educational Tool
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of an online informational video
      in improving knowledge about infertility in couples experiencing problems conceiving. A pilot
      study will be conducted with first and second year medical students.
    

Detailed description: 
      This study is being conducted to assess how a short, online educational video changes
      knowledge about fertility and infertility in couples attending an infertility clinic for the
      first time. Participants will complete a questionnaire testing knowledge about infertility
      and general demographic information (age, gender, previous information sources on
      infertility, etc.) will be collected. Participants will then be directed to a short video on
      infertility. One week later, participants will return to the site to complete the infertility
      test questions a second time in order to test memory retention. The focus of both the
      questionnaire and educational video will be basic reproductive biology, infertility risk
      factors, etiologies and treatments and fertility myths.
    

Intervention name(s): educational video
Intervention type(s): Other
Intervention description(s): Educational video covering topics of basic reproductive biology, infertility etiologies, risk factors, treatments and common myths.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Infertility; Education; Risk Factors; Fertility knowledge; Fertility myths
Helping Employees Lose Pounds
Condition: Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of financial incentives and messaging tailored to
      individual goals and aspirations to promote and sustain weight loss. This is a 2-arm
      randomized controlled trial that will recruit eligible employees at a large university to
      participate in a 3-month weight loss program, followed by a 3-month follow-up period. The
      primary outcome will be change in autonomous motivation for weight loss.

      The study hypothesis is that intervention group participants will have a greater increase in
      autonomous motivation for weight loss than participants in the control group at 12 weeks.
    


Intervention name(s): Weekly Incentive
Intervention type(s): Behavioral
Intervention description(s): The tailored incentives intervention aims to assess the impact of tailored messaging and financial incentives on weight loss among obese employees.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Human Mass Balance and Biotransformation Study of [14C]TNP-2198
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to analyze absorption, metabolism, excretion, mass balance and
      biotransformation after a single oral dose of [14C]TNP-2198 in healthy male participants
    


Intervention name(s): [14C]TNP-2198
Intervention type(s): Drug
Intervention description(s): 600mg suspension containing 150μCi of [14C] TNP-2198
Other intervention name(s): Rifasutenizol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Do Antidepressants Induce Metabolic Syndromes METADAP Study
Condition: Major Depressive Disorder
MeSH terms: Metabolic Syndrome; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1
      antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes
      is a matter of concern.

      The main objective of this study is to assess the differential impact of antidepressants in
      terms of weight gain and metabolic syndromes.
    

Detailed description: 
      Since antidepressants and antipsychotics have common receptorial mechanisms of action (H1
      antagonism, 5HT2 antagonism), the impact of antidepressants in terms of metabolic syndromes
      is a matter of concern.

      The main objective of this study is to assess the differential impact of antidepressants in
      terms of weight gain and metabolic syndromes.

      Prospective 6-month naturalistic cohort study, comparing 4 classes of antidepressants (SSRIs,
      SNRIs, TCAs and others) to a control group (ECT and r-TMS), in 600 patients with a major
      depressive disorder requiring the beginning of either antidepressant or ECT/r-TMS treatment.
    

Intervention name(s): Tricyclic antidepressants
Intervention type(s): Drug
Intervention description(s): antidepressant version medical dispositive
Other intervention name(s): antidepressant version medical dispositive
Intervention MeSH terms: Antidepressive Agents; Antidepressive Agents, Tricyclic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major depressive disorder; Antidepressants; Weight gain; Metabolic syndromes
CoCo: Colour Coded Blood Pressure Control
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Insufficient blood pressure control is a frequent problem despite the existence of effective
      treatment. One of the causes is insufficient self-monitoring and a lack of adherence to
      therapy. Blood pressure self-measurement at home (Home Blood Pressure Measurement, HBPM) has
      positive effects on treatment adherence and is helpful in achieving the target blood
      pressure.

      Only a few studies have investigated whether the adherence for HBPM can be improved through
      simple measures and better blood pressure monitoring can be achieved.

      Objective Improvement of self-monitoring by means of blood pressure self-measurement and
      improved blood pressure control by using a new colour-coded blood pressure diary
    


Intervention name(s): "CoCo" colour coded blood pressure control
Intervention type(s): Behavioral
Intervention description(s): The patients in the intervention group will receive a colour-coded blood pressure record booklet. The corresponding colour coded areas are divided into three areas of green, yellow and red following a traffic light system. The green area covers blood pressure readings up to a maximum of 140/90 mmHg, the yellow area includes systolic readings over 140 to 180 mm Hg and diastolic readings over 90 to 110 mmHg. The red area covers systolic readings over 180 mmHg and diastolic readings over 110 mmHg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blood pressure; control; adherence; behaviour
Assessment of Efficacy and Safety of 3 Different Doses of co.Don Chondrosphere to Treat Large Cartilage Defects
Condition: Large Articular Cartilage Lesions of the Femoral; Condyle, Trochlea, Tibia or Retropatellar
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, randomised, open label, multicentre Phase II clinical trial to
      investigate the efficacy and safety of the treatment of large defects with 3 different doses
      of the autologous chondrocyte transplantation product co.don chondrosphere® (ACT3D-CS) in
      subjects with cartilage defects of the knee.

      After screening visit patients were booked for arthroscopy and had their cells harvesting
      from healthy cartilage. After the arthroscopy the patients were randomised in one of the
      three dose-groups. The cells are cultivated for 8-10 weeks in vitro to develope 3-dimensional
      spheroids, that are transplanted in an open knee procedure (treatment surgery)into the
      defect. Patients of all dose groups subsequently followed the same rehabilitation program and
      had post-surgery visits. The 12-month-visit is defined as final assessment. Then patients
      have follow-up assessments up to 60 months.
    

Detailed description: 
      see above
    

Intervention name(s): co.don chondrosphere®
Intervention type(s): Drug
Intervention description(s): co.don chondrosphere® are spheroids in suspension, developed from autologous chondrocytes.
The dose in group A is 3-7 spheroids/cm2 defect, in group B 10-30 spheroids/cm2 defect and in group C 40-70 spheroids/cm2 defect
Other intervention name(s): ACT3D-CS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: large cartilage defects; knee joint; femoral condyle, tibia, trochlear, retropatellar
Efficacy of Letrozole Versus Clomiphene Citrate on Ovulation Induction in Patients With Polycystic Ovarian Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      We aimed this study to determine and compare frequency of induction of ovulation in women
      with polycystic ovarian syndrome treated with Letrozole versus clomiphene citrate as
      published literature shows variations.
    

Detailed description: 
      Discrepancy between ovulation induction rate and pregnancy rate is related to anti-estrogenic
      effects on cervical mucus and endometrium and long acting gonadotrophins are more effective
      than clomiphene citrate. This study was aimed at comparing frequency of induction of
      ovulation in women with polycystic ovarian syndrome treated with Letrozole versus clomiphene
      citrate.
    

Intervention name(s): Letrozole
Intervention type(s): Drug
Intervention description(s): Letrozole as 5mg from day 3 to 7 of menstrual cycle
Other intervention name(s): Femara
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Biological Rhythms Impact of 12 Hours Shift Work
Condition: Shift-Work Sleep Disorder
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional

Summary: 
      Nonstandard time-schedules work are widespread in the world of work. Shift and night work
      have been shown to be responsible for a desynchronization of biological rhythms, associated
      with melatonin secretion impairment and sleep disturbances. However, while health
      consequences of night and shift work are widely recognized and represent a major public
      health concern (High Authority of Health 2012 Recommendations and National Agency for Public
      Health Food, Environment and Work 2016 Report), the mechanisms by which the circadian system
      is affected by shift work remain poorly understood. Indeed most of the studies in the fields
      are cross-sectional, based on few blood or urinary samples in a single work position, in
      workers whose shift work patterns are often misidentified and heterogeneous. Moreover, few
      studies have assessed melatonin secretion alterations in relation to objective sleep
      measurement (actigraphy). The aim of this study is to assess the dynamics of melatonin
      secretion adaptation in 12-hour shift work and to correlate these data to sleep-wake cycle
      recording.
    


Intervention name(s): melatonin and cortisol sampling
Intervention type(s): Other
Intervention description(s): The study will take place over 15 days during which the nurses will wear an actigraphic wristband and will fulfill a sleep log. During 3 periods of 24 hours selected during these 15 days, including a 12h day shift (Day 2), a 12h night shift (Day 8) and a rest (Day 13), the participants will collect their urine by 4 to 8 hour periods, note the corresponding urine volumes and for each period, sample a 5 mL tube which will be analyzed later (6-sulfatoxymelatonin and urinary cortisol assays). The subjects will complete questionnaires at the beginning of the study (Horne and Ostberg, Insomnia Severity Index, Epworth, Pichot, Hospital Anxiety and Depression) and the days corresponding to the urine sampling (Karolinska and St Mary Hospital).
Intervention MeSH terms: Hydrocortisone; Melatonin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: shift work; melatonin; sleep
Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The number of patients over 70 years old with cancer is increasing in France. This population
      is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a
      lot between subjects of the same age. Physicians hesitate to treat them with optimal doses
      because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty
      eight percent of gastric cancers are diagnosed in patients over the age of 70 in France.
      FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising
      treatment for digestive cancer. It increases the level of response and survival without major
      toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their
      conditions.

      The principal objectives are to demonstrate the efficacy of treatment, safety, survival and
      to find out if geriatric assessment data can help to better predict chemotherapy toxicity.
      The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic
      gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day
      1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of
      cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up
      and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and
      Lachs-Balducci screening.
    


Intervention name(s): Irinotecan associated to fluorouracil and leucovorin
Intervention type(s): Drug
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chemotherapy; gastric cancer; geriatric evaluation; efficacy; safety
Study of Chimeric Monoclonal Antibodies to Shiga Toxins 1 and 2
Condition: Shiga Toxin Producing Bacterial Infection
MeSH terms: Infections; Bacterial Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and efficacy of cαStx1 and cαStx2 administered
      concomitantly in children presenting early signs of Shiga Toxin-Producing Bacterial (STPB)
      Infection.
    

Detailed description: 
      Currently, there is no etiological treatment of STPB-induced HUS. Ideally, such treatment
      would be started in the early phase of the infection and would protect against both types of
      toxins and all of their variants. The chimeric anti-Shiga toxins 1 (cαStx1) and 2 (cαStx2)
      antibodies are intended to be administered as a single infusion and provide simultaneous
      protection against the two Shiga toxins (Stx1 and Stx2) by decreasing the incidence and
      severity of Shiga toxin-mediated clinical events including bloody diarrhea/hemorrhagic
      colitis and Hemolytic Uremic Syndrome (HUS) and associated sequelae.
    

Intervention name(s): cαStx1/cαStx2; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): cαStx1/cαStx2 administered concomitantly at a dose of 1 mg/kg (low dose cohort) or 3 mg/kg (high dose cohort)per antibody over 1 hour + standard of care; Placebo administered over 1 hour + standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shigamabs; Monoclonal; Antibodies; Shiga; Toxin; E.coli; HUS; Bloody; Diarrhea
Digital Therapeutic vs Psychoeducation for Management of Mild to Moderate Depression in Adolescents
Condition: Depression, Teen
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of the present randomized controlled study is to investigate if there is a
      difference in depression symptoms at 4-weeks among adolescents ages 16-17 years assigned to
      W-GenZD, a digital therapeutic, as compared to a psychoeducational control group.
    


Intervention name(s): W-GenZD
Intervention type(s): Device
Intervention description(s): W-GenZD is a program that delivers evidence based therapy for the symptoms of mild-moderate depression and anxiety in adolescents in brief "conversations" with a fully automated relational agent.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment