bioihbjkbjnl/mcl2 huggingface dataset:
Paracetamol on Postoperative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      The drugs with both high potency and low side effects are preferred in the prevention of
      postoperative nausea and vomiting (PONV) which is a common problem. This prospective
      randomized study aimed to compare the efficacy of paracetamol on PONV in adults undergoing
      maxillofacial surgery.
    

Detailed description: 
      One hundred-twenty patients are randomly divided into two groups; the paracetamol group who
      received the IV infusion of paracetamol (1.5 ml/kg); and the metoclopramide group who
      received the IV infusion of saline (1.5 mg/kg). The presence of vomiting and the actions
      indicative of nausea, such as repeated gagging or spitting, within 24h following general
      anesthesia are defined as PONV. All PONV episodes and postoperative pain scores are recorded
      during 24h postoperatively. The postoperative 0-4h and 4-24h are defined as early and late
      postoperative period, respectively. Intravenous 4 mg ondansetron as rescue antiemetic drug is
      administered in case of two or more vomiting episodes.
    

Intervention name(s): Perfalgan; Control
Intervention type(s): Drug; Drug
Intervention description(s): For postoperative pain; For postoperative nausea and vomiting
Other intervention name(s): Paracetamol; Saline
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: PONV; Paracetamol
Phase I/II Study of SyB L-0501RI in Combination With Rituximab to Treat Lymphoma
Condition: Lymphoma, B-cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      For SyB L-0501RI administered by an intravenous rapid infusion in combination with rituximab,
      the safety will be investigated in previously untreated patients with low-grade B-cell
      non-Hodgkin's lymphoma (Lg-B-NHL) or mantle cell lymphoma (MCL), and the safety and
      tolerability will be investigated in patients with recurrent/refractory diffuse large B-cell
      lymphoma (DLBCL).
    


Intervention name(s): SyB L-0501RI
Intervention type(s): Drug
Intervention description(s): The specified dose of SyB L-0501RI and rituximab will be administered by intravenous rapid infusion over 10 minutes on specified days.
Other intervention name(s): Rituximab
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma, B-cell, Diffuse, SyB L-0501RI
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is planned to assess the safety and pharmacokinetic profile in normal
      healthy subjects in US for WCK 771 with doses ranging from 600 mg to 1000 mg BID for 5 days.
      In the proposed Phase I MAD study, a subject will be administered 600mg, 800mg, and 1000mg
      WCK 771 BID for 5 days (Ten doses) or an identical placebo as intravenous infusion.
    


Intervention name(s): WCK 771 IV Infusion; Placebo IV Infusion
Intervention type(s): Drug; Other
Intervention description(s): subjects will receive intravenous infusion of WCK 771; subjects will receive matching placebo intravenous infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
REGENERA Implant in Excised Non-Malignant Breast Lesions
Condition: Benign Breast Disease
MeSH terms: Breast Diseases; Fibrocystic Breast Disease
Study type: Interventional

Summary: 
      The purpose of this First-in-Human pilot study is to evaluate the safety and performance of
      REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions
      treated with excision or lumpectomy in whom the tissue removed is replaced by REGENERA.
    

Detailed description: 
      This is a pre-market, single center, interventional, open label, non-comparative, pilot
      first-in-human study on adult female patients with localized non-malignant breast lesion.
      This study will include an enrollment period of 12 months and 6 months study duration per
      patient.

      The primary objective of this study is to demonstrate the safety profile of a new breast
      implant (REGENERA) in excision or lumpectomy of non-malignant breast lesions.

      The secondary objectives of this study are:

        -  To assess the safety of the implant procedure

        -  To assess the feasibility of the implant procedure

        -  To evaluate the performance of REGENERA breast implant:

             -  In replacing the removed tissue

             -  In potential interference with current diagnostic standard of care imaging
                procedures

             -  On patient's quality of life and satisfaction

             -  On investigator's satisfaction.
    

Intervention name(s): REGENERA
Intervention type(s): Device
Intervention description(s): REGENERA breast implant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Lumpectomy; Bio-absorbable
Zometa Study in Pediatric Acute Lymphoblastic Leukemia
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for
      one fourth of all childhood cancers & 74 % of childhood leukemia. Based upon drug registry
      data, children prescribed more than three courses of systemic glucocorticoids yearly faced a
      20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids
      were discontinued, and fracture rates returned to expected for age by 1 year after treatment
      (Journal Of Clinical Endocrinology & Metabolism 2009). The investigators will study the role
      of bisphosphonates in the prevention of secondary osteoporosis in children & adolescents
      treated for ALL in the Children's Cancer Hospital -Egypt.
    


Intervention name(s): zolendronic acid; calcium & vitamin D
Intervention type(s): Drug; Drug
Intervention description(s): patients will receive calcium & vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of
Initial dose: (0.025) mg /kg
Subsequent doses ( 0.05) mg /kg.
Maximum dose of 4 mg.; patients will receive calcium & vitamin D Dose of Calcium : 1500- 2000 gram elemental Calcium daily . Dose of Vitamin D ( calcitriol; one alpha) 800-1000 International Unit
Other intervention name(s): bisphosphonates
Intervention MeSH terms: Vitamin D; Diphosphonates; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ALL; zoledronic acid; Osteoporosis
The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Treatment options that increase immune function, such as Osteopathic Manipulation Treatment
      (OMT) lymphatic techniques, may provide improved short or long term performance of the immune
      system. However, the efficacy of OMT to boost immune function among people living with HIV
      has not yet been examined in a controlled study. Our experiment is designed to examine the
      short (45 minutes) term impact of OMT on the white blood cells counts of HIV positive men who
      are either antiretroviral therapy (ART) naïve or have not taken ART for at least 12 months
      prior to enrollment in the study.
    


Intervention name(s): Osteopathic Manipulative Treatments
Intervention type(s): Procedure
Intervention description(s): opening the thoracic inlet
pectoral traction for 1 minute bilaterally
rib raising for a total of 4 minutes- 2 minutes on each side of the thoracic spine ]
thoracic pump at a rate of 60 times per minute for a total of 5 minutes bilaterally
abdominal pump at a rate of 30 times per minute for a total of 5 minutes bilaterally.
Primary purpose: Supportive Care
Keywords: Human Immunodeficiency Virus (HIV); complementary therapies
Comparison of Modified With Conventional Adaptive Servoventilation Processes
Condition: Periodic Breathing; Cheyne-Stokes Respiration
MeSH terms: Respiratory Aspiration; Cheyne-Stokes Respiration
Study type: Interventional

Summary: 
      The objective of this study is to compare the modified adaptive servoventilation control
      algorithm of the with the standardised algorithms of routinely-used servoventilation
      processes (AutoSet CS2) in terms of the effect on obstructive and central events. The aim is
      to normalise breathing during sleep and hence eliminate the sleep-related breathing disorder,
      resulting in even more effective treatment of nocturnal breathing disorders in patients with
      cardiovascular diseases and sleep apnoea, to ensure optimum therapy success.
    

Detailed description: 
      Patients with cardiovascular disorders frequently suffer from sleep-related respiratory
      disorders (SRRD), such as obstructive sleep apnea (OSA) or a specific form of central sleep
      apnea, Cheyne-Stokes breathing (CSB, periodic breathing). However there is also a significant
      incidence of complex nocturnal breathing disorders, with both obstructive and central
      components. Sleep-related breathing disorders of this kind cause decreases in arterial oxygen
      saturation through brief hypopneas and apneas. Disturbed breathing also causes the patient to
      wake frequently during the night (arousals), usually during the hyperventilatory phase of
      CSB. Repeated arousals cause fragmentation of sleep, and therefore a deep sleep deficit. This
      leads to increased sleepiness during the day and impaired cognitive performance.

      Previous studies have shown that Cheyne-Stokes breathing can be treated effectively with
      adaptive servoventilation. An enhancement to the routinely used algorithm (AutoSet CS2) has
      been created which allows the algorithm to differentiate between obstructive events and
      Cheyne-Stokes breathing, and better respond to apneas and hypopneas to eliminate the
      sleep-related breathing disorder and normalise breathing during sleep.
    

Intervention name(s): Adaptive Servo-controlled Ventilation (ASV)
Intervention type(s): Device
Intervention description(s): Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed
Other intervention name(s): AutoSet CS2; Adapt SV
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
CardioTOxicity Induced by andRogeNICS and Their Antagonists (TORNICS)
Condition: Heart Diseases
MeSH terms: Heart Diseases; Cardiotoxicity
Study type: Observational

Summary: 
      Anti-androgenic therapies relying on peripheral and/or central blockade for the treatment of
      prostate cancer seems to have an impact on the cardio-vascular system. This study
      investigates reports of cardiovascular toxicities for treatment including Anatomical
      Therapeutic Chemical (ATC) classification: sex hormones (G03), hypothalamic hormones (H01C)
      and sex hormones used in treatment of neoplastic diseases (L02) in the French
      pharmacovigilance database and European Clinical Trials (EudraCT) database.
    

Detailed description: 
      Hormone replacement therapies and contraceptive pills are responsible of a wide range of
      cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart
      disease. The difference of incidence and type of cardio-vascular events between men and women
      are strongly related to sex hormones. Androgenic agonists and antagonists are used in various
      indication including prostate cancer or hormone replacement therapies. This study
      investigates the main characteristics of patients affected by cardiovascular side effects (of
      which ventricular arrhythmia's, QT prolongation and Torsade de Pointe) imputed to drugs
      classified as G03, H01C and L02 according to ATC. A causality assessment according to both
      Begaud's method and the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) is
      systematically applied.
    

Intervention name(s): Hormonal therapies: G03, H01C and L02 in the ATC classification
Intervention type(s): Drug
Intervention description(s): Hormonal therapies including all therapies classified G03, H01C and L02 in the ATC classification
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The population is selected in the French pharmacovigilance database and EudraCT database
        from 01/01/1985 to 14/04/2017 and included patients treated with hormonal therapies
        included in the ATC classification references: G03, H01C and L02.
      
Keywords: Cardiotoxicity; Androgens; Hormone Replacement Therapy; Testosterone; Androgen Antagonists
Reduction of Topical Anesthetic Onset Time Using Ultrasound
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Children ages 3-7 who are undergoing blood drawing receive either standard care, topical
      medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the
      onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure
      is evaluated.
    


Intervention name(s): SonoPrep
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Half-life of Plasma Phytosterols in Very Low Birth Weight Preterm Infants With Parenteral Nutrition-associated Cholestasis
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Observational

Summary: 
      Parenteral nutrition-associated cholestasis (PNAC) is one of the most common complications
      resulting from administration of parenteral nutrition in neonates. Excess intravenous intake
      of vegetable oil-based lipid emulsions containing phytosterols is felt to be a major
      contributing factor. To date, no information is available on plasma phytosterols half-lives
      in very-low-birth-weight (VLBW) preterm infants with PNAC. In a prospective cohort study,
      plasma phytosterols (campesterol, stigmasterol and sitosterol) of VLBW preterm infants with
      PNAC will be measured by gas chromatography-mass spectrometry (GC-MS) during PN
      administration and also after the stop of intravenous lipid infusion. Plasma phytosterols
      half-lives will be calculated from the monoexponential decay curves. Blood samples will be
      weekly collected from 1st to 12th week of life during routine metabolic tolerance analysis or
      gas-analysis in order to avoid burden of additional phlebotomy. Samples will be collected in
      ethylenediaminetetraacetic acid-tubes and immediately centrifugated. Plasma will be stored in
      pyrogallol added-tubes at -20°C until analysis. Saponification reaction will be done using
      5-alpha-cholestane as internal standard.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Preterm infants (24 < gestational age < 32 weeks; 500 g ≤ birth weight < 1250 g) with
        parenteral nutrition-associated cholestasis.
The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
Condition: Vitamin A Deficiency
MeSH terms: Night Blindness; Vitamin A Deficiency
Study type: Interventional

Summary: 
      The study comprises an open-label randomized controlled trial investigating the efficacy of
      consuming a daily ration of pro-vitamin A biofortified cassava on vitamin A status of
      Nigerian children, aged 3-4 years old (n=200).
    

Detailed description: 
      Objective: The primary objective is to assess the efficacy of daily consumption of
      pro-vitamin A rich cassava during 10 weeks on body retinol pools of 3-4 year old children in
      Nigeria after high-dose vitamin A supplementation. The secondary objectives are: 1) To
      investigate the effect of daily consumption of pro-vitamin A rich cassava on functional
      indicators such as nutritional anaemia and gut integrity; 2) To investigate the effect of
      zinc deficiency and genetic polymorphisms in the Beta-Carotene Oxygenase 1 (BCO1) and related
      genes on the efficacy of pro-vitamin A rich cassava consumption; 3) To compare the skin
      colour in the palm of the hand of each participant with their serum retinol levels using a
      handheld non-invasive spectrophotometer.

      Study design: Open-label (single-blinded) randomized controlled trial with two parallel
      groups Study population: Pre-school children, aged 3-4 years living in Osun State area,
      South-Western Nigeria. Children (n=750) will be screened for eligibility. Out of these, n=250
      will undergo a 4-week run-in phase. n=200 children will be randomly allocated to two
      different treatments: 1) Yellow cassava providing ~50% of the recommended daily allowance
      (RDA) for vitamin A; 2) White cassava.

      Main study parameters/endpoints: The primary outcome was the difference in body retinol pools
      between groups 1 and 2 at the end of intervention; however, due to the inability to assess
      body retinol pools, the modified primary outcome is the difference in serum retinol
      concentrations between groups 1 and 2. Other outcome measures include: other vitamin A status
      indicators (β-carotene, retinol binding protein, transthyretin), inflammatory markers, iron
      status indicators, anthropometrics, gut integrity, and thyroid function.
    

Intervention name(s): Pro-vitamin A biofortified cassava; White cassava
Intervention type(s): Other; Other
Intervention description(s): Pro-vitamin A biofortified cassava is the product of international conventional breeding programs (non-GMO) in order to increase the pro-vitamin A content of cassava for improved nutritional intake; Conventional white cassava
Other intervention name(s): Yellow cassava; Biofortified cassava; Cassava; Manihot esculenta
Intervention MeSH terms: Vitamin A; Provitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pro-vitamin A; Cassava; Vitamin A deficiency; Retinol Isotope Dilution; Preschool children; Nigeria
A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma(ENKTL)
Condition: Extranodal Natural Killer/T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, single-arm, phase II study to evaluate the efficacy and safety of
      CS1001 monotherapy for Relapsed or Refractory Extranodal Natural Killer/ T Cell Lymphoma
      (ENKTL)
    

Detailed description: 
      Eligible subjects with rr-NKTL after prior asparaginase-based chemotherapy or chemo
      radiotherapy are planned to receive CS1001 1200 mg intravenous infusion every three weeks
      until progression of disease, intolerable toxicity, consent withdrawn, death. The primary
      endpoint of this trial is objective response rate (ORR), as assessed by independent
      radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma:
      Lugano 2014 Classification.
    

Intervention name(s): CS1001
Intervention type(s): Biological
Intervention description(s): monoclonal antibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ENKTL
A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings
Condition: Self-Injurious Behavior
MeSH terms: Self-Injurious Behavior
Study type: Interventional

Summary: 
      The current research is being undertaken as part of a professional doctorate in clinical
      psychology, which aims to evaluate the feasibility of a group programme to address self-harm
      within 23 days, to provide evidence for a controlled trial. The intervention will include
      four group sessions conducted over 2 weeks, based on Dialectical Behavioural Therapy.
      Specifically the aims are to determine 1) means and a standard deviation for two pre and post
      treatment outcome measures in order to estimate sample size for the main study, 2) the need
      for an inpatient intervention for self-harm measured by number of participants eligible and
      accepting of the treatment, 3) retention of participants for 4 groups given the predicted
      short stays of patients on wards, and 4) the acceptability of the research process for this
      client group through feedback.
    


Intervention name(s): Dialectical Behavioural Therapy (DBT) based skills groups
Intervention type(s): Behavioral
Intervention description(s): Dialectical Behavioural Therapy (DBT) involves skills that help people manage their emotions and tolerate distress. This therapy is found effective in reducing self-harm behaviour for outpatients with Borderline Personality Disorder.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Melanocortin 4 Receptor Mutations and Obesity-associated Diseases
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Mutations in the melanocortin 4 receptor (MC4R) are the most common form of monogenic
      obesity, and can explain 2-6% of severe obesity.

      Studies have shown that mutations in MC4R are associated with increased fat mass,
      height-for-age, appetite and insulin resistance among children. In adults, mutations in MC4R
      are less penetrant for these phenotypes but it has been observed that individuals with MC4R
      mutations have a smaller than expected blood pressure for their degree of obesity.

      The purpose of this study is to explore the association between functional MC4R mutations and
      obesity, insulin resistance and blood pressure.
    


Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Men and women aged 18-70 years
      
Biospecimen description: 
      Whole blood
    
Keywords: Obesity; MC4R; Blood pressure; Blood glucose
Peer Interactions and Food Are Substitutable in Youth
Condition: Activity Choices; Caloric Intake; Social Time
Study type: Observational

Summary: 
      This study examines the effects of increasing the cost of social interactions and food on
      overweight and non-overweight youth. Using a computerized operant task youth will earn points
      exchangeable for food and social activity.

      The investigators predict that both overweight and non-overweight children will substitute
      food for interactions with an unfamiliar peer when this alternative is made expensive. Also,
      the investigators predict that both overweight and lean participants will defend their choice
      to spend time with a friend even when this alternative is made expensive.
    


Sampling method: Probability Sample
Study population: 
        Boys and girls ages 9-11.
      
Keywords: Food reinforcement; social reinforcers; overweight; children