bioihbjkbjnl/mcl2 huggingface dataset:
Risedronate Sodium in Post Menopausal Osteoporosis
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to compare subject satisfaction of once a week dosing of 35 mg
      Actonel to once daily dosing of 5 mg Actonel in postmenopausal osteoporotic women.

      The secondary objectives are to measure compliance (50 % drug taken), and persistence, [and
      urinary NTx (N-telopeptides) (optional)].
    


Intervention name(s): risedronate sodium
Intervention type(s): Drug
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Glucosanol™ in Reducing Post-prandial Glucose Levels in Overweight Subjects
Condition: Hyperglycemia, Postprandial
MeSH terms: Overweight; Hyperglycemia
Study type: Interventional

Summary: 
      Glucosanol had previously been proven to be effective in aiding weight loss and weight loss
      maintenance. Studies have also shown that Glucosanol (also known as Phaseolamin), was
      effective in aiding weight loss and also has evidence on reducing post-prandial glucose
      levels. This study is to enrich the existing evidence on dose-dependent post-prandial glucose
      effects of Glucosanol
    


Intervention name(s): Glucosanol 500mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Breastfeeding Support System
Condition: Preterm; Breastfeeding; Breast Milk; Breastfeeding Support System
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      This study was conducted to investigate the effect of a breastfeeding support system on
      breast milk quantity and mother-infant attachment in preterm infants. This randomized
      controlled experimental study was conducted in the Level III Neonatal Intensive Care Unit
      (NICU) of a hospital in eastern Turkey between January and June 2022. The population of the
      study consisted of preterm infants and their mothers who received treatment and care in the
      NICU between the dates of the study. The study sample consisted of 70 preterm infants (35
      experimental, 35 control) and their mothers who met the research criteria.
    


Intervention name(s): Routine nursing care; breastfeeding support system
Intervention type(s): Other; Other
Intervention description(s): Preterm infants in the control group did not receive any intervention other than the routine feeding protocol applied in the clinic. Body weights of the babies were measured and recorded in the morning before the first feeding. The amount of breast milk to be given for feeding according to the clinic protocol was determined by the physician and the babies were fed with a bottle. The mothers of preterm infants were asked to fill out the Mother-Infant Attachment Scale before and after the feeding of their infants. These interventions were continued until the baby was fully breastfed.; Body weight of preterm infants in the experimental group was measured and recorded in the morning before the first feeding. The mothers of preterm infants were asked to fill out the Mother-Infant Attachment Scale in the pre-procedure period. The amount of breast milk that the preterm infant should receive during feeding was determined by the physician. Before feeding, the neonatal nurse ensured sterile preparation of the milk and transferred it to the Breastfeeding Support System. The mothers were then prepared for the procedure. Accordingly, the breastfeeding support system was explained to the mother by the specialized neonatal nurse. When the preparation of the mother and baby was completed, the baby was placed on the mother's breast. After feeding, the mother was asked to fill out the Mother-Infant Attachment Scale the again. These interventions were continued until the baby was fully transferred to the mother's breast.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Intubating Condition After Magnesium Pre-treatment
Condition: Easy of Laryngoscopy Manipulation; Vocal Cord Position or Movement; Patient Reaction to Intubation and Cuff Inflation; Mean Arterial Pressure; Heart Rate
Study type: Interventional

Summary: 
      Magnesium had an inhibitory effect on neuromuscular transmission and caused a decrease in
      muscle fiber membrane excitability. It reduces the amount of acetylcholine that is released
      at the motor nerve terminal by decreasing the calcium conductance of presynaptic
      voltage-dependent calcium channels. After pre-treatment with magnesium, an increased speed of
      onset and a prolongation of the recovery period of neuromuscular blockade have been observed
      with other non-depolarizing neuromuscular blocking agent (NMBA) such as atracurium,
      vecuronium and rocuronium. Rocuronium is the currently preferred NMBA used as an alternative
      to succinylcholine for rapid tracheal intubation. As an alternative to succinylcholine, high
      doses of NMBA have been tested for rapid sequence intubation. This excessively high dose of
      rocuronium, however, prolongs the duration of the neuromuscular block and this may not be
      warranted in every surgical setting.

      The reduction of onset time of rocuronium by magnesium pre-treatment can make intubation
      condition more rapid and much better clinically. It will thus be interesting to compare
      intubation conditions of a standard intubation dose of rocuronium after magnesium
      pre-treatment with high dose of rocuronium or standard dose of rocuronium.
    


Intervention name(s): magnesium sulphate; normal saline; normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The patients of group M receive 50 mg/kg of magnesium sulphate in 100 ml of isotonic saline over 10 min immediately before anaesthesia induction. After induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg), rocuronium 0.6 mg/kg is given over 5 s in a running infusion.; Patients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.6 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg).; Patients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.9 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg).
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
Condition: Dravet Syndrome; Lennox Gastaut Syndrome
MeSH terms: Epilepsies, Myoclonic; Lennox Gastaut Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with
      Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol
      (CBD).
    


Intervention name(s): ZX008 0.2 to 0.8 mg/kg/day; Cannabidiol
Intervention type(s): Drug; Drug
Intervention description(s): ZX008 drug is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free.; Cannabidiol
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dravet Syndrome; LGS
MAST - Magnesium for Sickle Cell Acute Crisis in Children
Condition: Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if intravenous magnesium sulfate treatment is
      effective in reducing the length of stay and pain in children with sickle cell disease
      suffering an acute vaso-occlusive episode.
    

Detailed description: 
      Sickle cell disease is a group of complex, chronic disorders characterized by hemolysis,
      acute vaso-occlusive episodes (crises), unpredictable acute complications that can be
      life-threatening, and the variable development of chronic organ damage. Administration of
      magnesium sulfate has the potential to reduce hemolysis since it induces negatively charged
      chloride ions and water entry to the cell. To date only one non-randomized, non-blinded,
      single arm study with only 19 children evaluated the effect of magnesium on length of stay in
      the hospital of children with sickle cell disease.

      In this randomized, double blind, two-arm placebo controlled study, children with sickle cell
      disease admitted for a vaso-occlusive crisis will receive intravenous magnesium sulfate or
      placebo every 8 hours during their stay in the hospital , along with pain management. We will
      measure length of stay (LOS), pain, adverse effects, and the total amount of narcotics
      required for pain control.
    

Intervention name(s): Magnesium Sulfate; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous Magnesium Sulfate (100 mg/Kg, Max 2 gram/dose) 8 hourly.; Intravenous Placebo (Normal Saline in equivalent amount to magnesium sulfate 100 mg/Kg, Max 2 gram/dose) 8 hourly.
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Anemia, Sickle Cell; Magnesium Sulfate; pediatric
Dairy Proteins and Postprandial Appetite Regulation and Energy Expenditure
Condition: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of dairy proteins (whey and casein) on
      postprandial appetite regulation and energy expenditure.
    

Detailed description: 
      Several studies have shown that a high protein intake is associated with a increased loss of
      body weight and body fat as compared to a diet with a normal or low protein content. The
      effect seems to be due to a higher diet induced thermogenesis and increase satiety.

      Milk has a high content of proteins. It contains two very different types of protein: whey
      and casein. Whey is a soluble protein whereas casein clots into the stomach, which delays its
      gastric emptying and thus probably results in a slower release of amino acids. It is
      therefore very likely that the two types of protein affect the thermogenesis and appetite
      regulation differently.

      The aim of the present study is to examine the effect of dairy proteins (whey and casein) on
      postprandial energy expenditure, substrate oxidation and appetite regulation.

      The study will have a cross-over design including four meals each including a test drink
      (milk, casein drink, whey drink or water).
    

Intervention name(s): dairy proteins
Intervention type(s): Dietary Supplement
Intervention description(s): Protein drinks with 3.5% protein. The protein source will be whey, casein or whey and casein (20:80; normal content in the milk). In the arm with water no protein will be added.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Dairy proteins; Appetite regulation; Energy expenditure
Evaluating the Capacity of High-sensitivity Serum CRP Levels to Predict Bronchial Hyper Responsiveness in School Age Children
Condition: Hyperreactive Airway
MeSH terms: Bronchial Hyperreactivity
Study type: Observational

Summary: 
      Background:

      Bronchial hyper responsiveness (BHR) assessed by methacholine challenge test (MCT) may aid in
      the diagnosis of asthma, while negative MCT can help to exclude the diagnosis. Laboratory
      measures that predict the results of MCT are expected to reduce the number of procedures. The
      possible capacity of High sensitive C-reactive protein (hs-CRP), a marker of systemic
      inflammation, to predict negative or positive MCT in children has not been evaluated.

      Aim: to evaluate the capacity of hs-CRP to predict positive or negative MCT in school aged
      children and to compare it with markers of airway inflammation: Fractional exhaled Nitric
      Oxide (FeNO) and markers of allergic sensitization (IgE and peripheral blood eosinophils).

      Design: Prospective study evaluating these parameters in patients with positive and negative
      MCT.

      Participant selection: The study population included subjects (age range 6 to 18 years)
      referred for Methacholine Challenge Test (MCT)

      Sample size: 130 participants in the two groups. Intervention: Each subject will undergo
      evaluation including a respiratory questionnaire, methacholine challenge test with
      determination of PC20(the provocative concentration that reduced FEV1 by 20% from baseline),
      exhaled nitric oxide (eNO). Venous blood will be analyzed for complete blood count +
      eosinophils, IGE levels, hs-CRP. All measurements will be evaluated in a single 3 hour visit,
      with no follow up study visits.

      Primary end point: hs-CRP levels as add on tool to predict negative or positive MCT in
      children Secondary outcome parameters: All other parameters are the secondary end points.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        subjects (age range 6 to 18 years) referred for Methacholine Challenge Test (MCT)
      
Keywords: C reactive protein; Airway hyperreactivity; Body mass index
Use of Exhaled Particles to Assess Lung Pharmacokinetics
Condition: Healthy; Lung Pharmacokinetic
Study type: Interventional

Summary: 
      This research project in humans aims at increasing the general understanding of lung
      pharmakokinetic by sampling exhaled particles. The central hypothesis of this study is that
      pharmacokinetics of Salbutamol (model drug) can be monitored in exhaled particles.
    

Detailed description: 
      The aim of the present study is to increase the general understanding of lung pharmakokinetic
      by systematically sampling exhaled particles at pre-specified quantities to reproduce and
      extent existing pilot data. For comparison, samples of blood plasma and nasal filter samples
      (nasosorption) will be collected for pharmakokinetic analyzes. Nasosorption will be performed
      to explore the possibility of detecting drug concentrations in nasal filter paper samples.

      Salbutamol will be administered by inhalation and orally in a cross-over study design and
      both application routes shall be comparised regarding the detection of pharmakokinetic data.
      The aim of the study is not to generate safety or efficacy data of the selected licensed
      drugs. The choice of drugs is based on general considerations regarding therapy of airway
      diseases and the physical-chemical properties of the compounds. It is not driven by the
      compounds per se.
    

Intervention name(s): Inhalation Spray; Tablet
Intervention type(s): Drug; Drug
Intervention description(s): 400 mcg salbutamol administered per metered dose inhaler; 8 mg salbutamol administered per tablet for ingestion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Sequential Therapy for Hypogonadotropic Hypogonadism
Condition: Hypogonadotropic Hypogonadism; Kallmann Syndrome
MeSH terms: Kallmann Syndrome; Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      The traditional therapy for induction of spermatogenesis in male hypogonadotropic
      hypogonadism requires both HCG and human menopausal gonadotropin (HMG) or FSH until pregnancy
      occurs. Because of the high cost of hMG or FSH preparations and poor compliance, the
      investigators raise a new sequential therapeutic approach which can make the treatment more
      economic and tolerable. The zinc supplement will be also evaluated in patients in this study.
      This randomized, parallel, open, and multi-center study will compare the efficacy of
      traditional therapy with new therapy and evaluate the safety of the new protocol.
    


Intervention name(s): Traditional intervention for HH using HCG and FSH; Sequential intervention for HH using HCG and FSH; Sequential intervention for HH using HCG and FSH plus zinc
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Human chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year;; Human chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months; Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily
Other intervention name(s): Tranditional; Sequential; Sequential plus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypogonadotropic Hypogonadism; Kallmann Syndrome; LH; FSH
Neotrofin for Treatment of Chemotherapy-Induced Peripheral Neuropathy
Condition: Peripheral Nervous System Diseases; Chemotherapy-Induced Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Nervous System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and efficacy of Neotrofin in treating the peripheral
      neuropathy that results from chemotherapy for cancer.
    


Intervention name(s): leteprinim potassium (Neotrofin)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The Automated Insulin Delivery (AID) System is an investigational insulin delivery device
      being developed for use for participants with diabetes. The purpose of this study is to
      assess the safety of the AID system and to test whether the AID System functions as it was
      designed to.

      This study will last approximately 12-18 days, not including screening. Screening is required
      within 28 days prior to the start of the study.
    


Intervention name(s): AID System; Insulin Lispro
Intervention type(s): Device; Drug
Intervention description(s): AID system; Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Other intervention name(s): LY8888AU; LY275585
Intervention MeSH terms: Insulin Lispro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Novel Intervention for Amphetamine-type Stimulants Addiction
Condition: Amphetamine Addiction
MeSH terms: Amphetamine-Related Disorders; Behavior, Addictive
Study type: Interventional

Summary: 
      The repetitive transcranial magnetic stimulation (rTMS) will be used to treat
      amphetamine-type stimulant (ATS) addiction.
    

Detailed description: 
      The Glutamate and GABA deficits in prefrontal cortex play a vital role in ATS addiction and
      relapse, and proposed repetitive transcranial magnetic stimulation (rTMS) as a novel
      interventions. Focused on evaluating Glutamate/GABA functions in prefrontal cortex and
      functional connectivity with deep brain regions, neuropsychological tests, biochemical tests,
      magnetic resonance spectroscopy (MRS) and functional MRI will be used to investigate the
      neurobiological mechanism of ATS addiction and relapse. These methods will also be used to
      evaluate the efficacy of the novel intervention and investigate the mechanisms. The study
      will be very helpful to develop novel interventions in clinical practice and decrease
      ATS-related harm for both the patients and their families.
    

Intervention name(s): repetitive transcranial magnetic stimulation (rTMS); sham repetitive transcranial magnetic stimulation (rTMS)
Intervention type(s): Radiation; Radiation
Intervention description(s): Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day; Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Amphetamine-type stimulants; prefrontal-striatal circuits; rTMS; Glutamate/GABA; motivational and cognitive intervention