bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Itraconazole as Secondary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation or Chemotherapy With Prior Invasive Fungal Infection
Condition: Invasive Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Invasive fungal infections (IFI) remain the major cause of death among neutropenic patients
      receiving chemotherapy for leukemia, or submitted to stem cell transplantation. Patients with
      a history of invasive fungal infection (IFI) are at high risk of developing relapse and fatal
      complications.

      Prompt intensive antifungal therapy, have improved responses and survival, allowing an
      increase of antifungal treatments, including secondary antifungal prophylaxis.

      Few studies have addressed the role of previous IFI in the feasibility of stem cell
      transplant, or the secondary prophylaxis with antifungal drugs in preventing recurrence of
      infection after transplantation. However, given the lack of prospective studies, the role of
      secondary antifungal prophylaxis remains unclear.

      Itraconazole is a wide-spectrum triazole antifungal agent active against Candida albicans,
      non-albicans, Aspergillus spp., Blastomyces dermatitidis, Blastomyces coccidioides,
      Cryptococcus neoformans, Sporothrix schenkii, Paracoccidioides brasiliensis, Histoplasma spp.
      and various kinds of yeast fungi and mycetes.

      The role of itraconazole IFI prophylaxis treatment has been proved by many interventional
      studies. In this prospective, multicentric study of secondary prophylaxis, itraconazole will
      be given at standard dose to patients undergoing allogeneic stem cell transplantation or
      chemotherapy with prior invasive fungal infection, to assess the efficacy and safety of
      itraconazole secondary prophylaxis.
    


Intervention name(s): Itraconazole
Intervention type(s): Drug
Intervention description(s): Itraconazole will be administered intravenously 2×200 mg/d(200mg twice a day, with 12 hours interval, and should be completed in no less than 60 minutes each time) in the first two days of treatment as a loading dose, then 200mg/d intravenously (200mg once a day with 24 hours interval and completed in no less than 60 minutes) until the end of the at-risk period.
In transplant patients, the end of "at-risk period" is defined as a stable engraftment of 1*109/L neutrophil cells; in patients who have undergone chemotherapy, it is defined as the resolution of neutropenia (neutrophil cells> 0.5*109/L).
If needed, the patients will take itraconazole solution orally after intravenous administration.
Other intervention name(s): Sporanox IV and Oral solution
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hematological malignancy; previous proven or probable invasive fungal infection
Tranexamic Acid as an Intervention in Placenta Previa
Condition: Interventional Drug in Placenta Previa
MeSH terms: Placenta Previa
Study type: Interventional

Summary: 
      Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide
      perinatal mortality and maternal morbidity in pregnant women
    

Detailed description: 
      Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide
      perinatal mortality and maternal morbidity in pregnant women. No medication is of specific
      benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some
      circumstances in order to administer antenatal corticosteroids. A review article concluded
      that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis
      beyond 48 hours is not clinically indicated.
    

Intervention name(s): Tranexamic acid injection; Glucose water 5%
Intervention type(s): Drug; Other
Intervention description(s): Active group will receive 1gm Tranexamic acid 12 hourly for 48 hours; Placebo group 30ml will be received 12 hourly for 48 hours
Other intervention name(s): Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India; Glucose B.Braun
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization for both groups to the 2 groups will be done using Randomization Allocation Software program and whom will add the numbers on each syringe will be a pharmacist not involve in the study and will have the cods belong to the type of the intervention with him until the end of the research .
Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Placenta previa; Tranexamic acid; intervention; Double blind
A Pilot Study of Lithium in Progressive Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether lithium carbonate is safe, well-tolerated,
      and effective at treating progressive forms of multiple sclerosis.
    

Detailed description: 
      In progressive multiple sclerosis (MS), patients experience worsening disability through a
      combination of inflammatory and neuro-degenerative processes. To test whether low-dose
      lithium carbonate ameliorates disability accumulation in progressive MS, patients with
      progressive MS were randomly assigned to take lithium in either the first or second year of a
      two-year trial. The trial was designed as a cross-over study to maximize exposure to lithium
      to for two reasons: 1) To increase the number of persons with MS exposed to lithium for
      purposes of assessing safety and tolerance; and 2) To increase the power to detect changes in
      the primary radiological outcome (change in brain volume) and also in secondary clinical
      outcomes (disability, mood, fatigue, cognition).
    

Intervention name(s): Lithium Carbonate
Intervention type(s): Drug
Intervention description(s): Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.
Other intervention name(s): Standard care (observation)
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each study participant agreed to a two-year enrollment commitment. Each subject was asked to take lithium for one year and to be observed for one year. Randomization was used to determine the sequence of lithium vs. observation (year 1 or year 2).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Lithium
Temperature-dependent Changes in Cardiovascular Parameters During Warm Water Footbaths in Healthy Women
Condition: Warm Footbath; Cardiovascular System; Autonomic Nervous System
Study type: Interventional

Summary: 
      A study to explore whether different temperatures of warm water footbaths have different
      effects on the cardiovascular system, the autonomic nervous system and the general well-being
      of healthy women.
    

Detailed description: 
      This is a blinded, four-arm randomized controlled trial with crossover design to explore the
      effects of warm water footbaths with different water temperatures on cardiovascular stress,
      reaction of the autonomic nervous system and a feeling of comfort and warmth in healthy
      female volunteers. Cardiovascular and ANS measurements are performed continuously throughout
      the interventions and the participants rate their feelings of warmth, general well-being and
      the footbath-related comfort with questionnaires.
    

Intervention name(s): 38°C warm water footbath; 40°C warm water footbath; 42°C warm water footbath; 38-42°C rising temperature footbath
Intervention type(s): Other; Other; Other; Other
Intervention description(s): A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 38°C, followed by a ten-minute post-intervention rest period.; A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 40°C, followed by a ten-minute post-intervention rest period.; A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 42°C, followed by a ten-minute post-intervention rest period.; A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water. Water temperature starts at 38°C and is increased by 1°C every 6 minutes, resulting in 42°C after 30 minutes. The footbath is followed by a ten-minute post-intervention rest period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Warm water footbath; Temperature-dependent effects; Cardiovascular System; Autonomic Nervous System; Heart Rate Variability; Healthy female volunteers
A Study to Evaluate Efficacy of IP on Alertness and Mental Fatigue
Condition: Mental Fatigue
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      The current study is design to asses the effect of E-AG-01/ E-AG-02/ E-AG-03 on mental
      alertness as compared to placebo.
    

Detailed description: 
      Intake of caffeinated drinks is known to improve energy levels, alertness, and concentration
      levels. Caffeine is a stimulant of central nervous system and therefore is probably the most
      commonly used psychoactive substance in the world. Caffeine intake is preferred by many
      individuals because moderate amount of caffeine consumption postulates certain beneficial
      effects on nervous system as well as on general well-being, like increase in the level of
      alertness and diminution in exhaustion especially in low arousal circumstances (e.g. working
      at night), improvements in performance on vigilance tasks and simple tasks that require
      sustained response. Along with these virtues caffeine intake is associated with certain
      demerits also. High dose of caffeine that is more than 400 mg a day in healthy adults may be
      associated with adverse events such as psycho motor agitation, insomnia, headache,
      gastrointestinal complaints depending on several other lifestyle parameters.

      Since caffeine intake is habitual, withdrawal of caffeine poses certain concerns on
      performance like its negative impact on mood levels following its withdrawal.

      Hence there is always a need to find an alternative to caffeine which has the same attributes
      of caffeine but is not associated with its habit forming stance. In order to fulfill this
      unmet need Enovate Biolife has designed a novel natural caffeine free ingredient which
      postulates to enhance the mental alertness and combats mental fatigue similar as caffeine
      without causing adverse effects associated with caffeine.
    

Intervention name(s): AG-01; AG-05; AG-06; AG-07
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Product to increase mental alertness; Product to increase mental alertness; Product to increase mental alertness; Product to increase mental alertness
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Medico-economic Evaluation of ENTERRA Therapy
Condition: Gastroparesis; Vomiting; Nausea
MeSH terms: Gastroparesis; Nausea; Vomiting
Study type: Interventional

Summary: 
      The aim of this clinical trial is to assess the symptomatic efficacy and the impact on the
      utilization of healthcare resources of a treatment by gastric electrical stimulation (ENTERRA
      ®) in patients with refractory nausea and/or vomiting leading to a nutritional impairment.
      Eligible patients will be those with refractory symptoms either idiopathic, postsurgical or
      due to diabetes mellitus. The duration of the study will be 28 months for each patient.

      After a run-in period of 4 months during which a prospective assessment of healthcare
      resources utilization and of the severity of the symptoms will be obtained, patients will be
      implanted. The follow-up period after implantation of the device will last 24 months in every
      patients and will be divided in two parts: a) After the first postoperative month during
      which the device will remained on the "OFF" position, the first phase of the study will be a
      randomized double-blind cross-over study with 2 periods of 4 months during which the device
      will be activated or not. After the 9th month of follow up, the trial will be an open trial
      and the device will be activated in all patients.

      During the whole trial, patients will record all types of healthcare resources utilizations
      (hospitalizations, drug treatments, endoscopic procedures…) while the symptomatic efficacy of
      the treatment will be assessed by standard questionnaires at the following visits scheduled
      at 1, 5, 9, 12, 18, 24 months. The glycemic control will be determined at each visit in
      diabetic patients. A delayed gastric emptying will not be a selection criteria but we have
      planned to analyze the clinical results of the treatment in taking into account a delayed or
      normal gastric emptying during the pre-implantation period. Moreover, gastric emptying
      studies have been scheduled at 5, 9, 12 and 24 months to test the impact of gastric
      electrical stimulation on gastric emptying.
    


Intervention name(s): Implantation of ENTERRA therapy
Intervention type(s): Device
Intervention description(s): Gastric electrical stimulation using Enterra Therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Drug-refractory gastroparesis; diabetes mellitus induced gastroparesis; Gastric electrical stimulation; Long-term multicenter study
Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine if the frequency of blood glucose testing in patients with type 2 diabetes who
      are being treated with diet and exercise alone or diet and exercise plus oral agents will
      impact the HbA1c level.
    

Detailed description: 
      To determine the impact of SMBG frequency on blood glucose control in patients receiving
      systematic diabetes management education through Type 2 Diabetes BASICS at International
      Diabetes Center.
    

Intervention name(s): frequency of self monitoring blood glucose
Intervention type(s): Behavioral
Intervention description(s): Evaluate the impact of self monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: referred to; comprehensive; diabetes; education; program
Clinical Outcomes of Maitland's Mobilization in Patients With Myofacial Chronic Neck Pain
Condition: Myofascial Pain Syndrome of Neck
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Neck Pain
Study type: Interventional

Summary: 
      Myofacial neck pain is a common musculoskeletal problem caused by presence of trigger points
      and local and referred pain patterns. Chronic neck pain is responsible for the involvement of
      joints, ligaments, fascia and connective tissue as well. The objective of this study was to
      assess the impacts of Maitland's mobilization in patients with myofacial chronic neck pain.
      Maitland's mobilization is one of the most common manual therapy approaches used by
      physiotherapists. Maitland's techniques involve the application of passive and accessory
      oscillatory movements to spinal and vertebral joints to treat pain and stiffness.

      In this randomized, placebo treatment controlled trial, 30 patients consecutively aged 25-45
      years meeting inclusion criteria were isolated into two groups. The study group was treated
      with Maitland's mobilization consistently for 8 weeks while the control group got placebo
      treatment for a similar time frame. Visual analog Scale (VAS), Neck disability index (NDI)
      and cervical range of motion (ROM) questionnaire was filled by patients before, intermediate
      and after the intervention to evaluate the severity of pain, functional ability and range of
      motion.
    


Intervention name(s): Maitland's mobilization; Traditional Physical therapy
Intervention type(s): Other; Other
Intervention description(s): Maitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness.It has Five grades; BASELINE TREATMENT INCLUDES TENS and Hot PACKS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck Pain; Manual mobilization; Isometric exercise; Triger points; Visual analog scale
A Low Glycemic Index Diet as Prevention of the Catch-up Fat Phenomenon
Condition: Dietary Intervention
Study type: Interventional

Summary: 
      The catch-up fat phenomenon is an evolutionary conserved physiological response to a
      starvationrefeeding cycle. It is characterized by long-term suppression of thermogenesis,
      reduced body protein regain and an increase in fat mass above basal level during refeeding.
      Clinically, it characterises weight cycling in overweight patients which is associated with
      increasing fat mass (visceral fat) and increased morbidity (e.g. insulin resistance,
      inflammation). In this project, the physiological, cellular and molecular mechanisms of this
      phenomenon will be investigated in humans, mice and C. elegans. It is hypothesized that
      refeeding a low GI (=glycemic index)- diet after weight loss prevents the catchup fat
      phenomenon and its sequelae. This translational research will provide comprehensive insights
      into the catch-up fat phenomenon as well as provide a suitable strategy of its prevention.
    

Detailed description: 
      In a human intervention study, changes in physiological, metabolic, and neuroendocrine
      functions in response to weight cycling will be investigated under controlled conditions in
      normal weight subjects. The mechanisms of the catch-up fat phenomenon are analysed starting
      from stable energy balance followed by overfeeding, weight loss and weight regain following
      weight loss (refeeding). Changes in body composition (including ectopic fat), metabolism
      (resting energy expenditure, substrate oxidation rates, insulin resistance) and plasma
      hormone concentrations will be assessed. Fat tissue probes will be used to characterise key
      enzymes and signalling pathways, redox status and whole genome expression. Modulation of the
      hormonal response to weight cycling is brought about by varying macronutrient content and
      glycemic index of the diets. We hypothesize that, insulin and leptin resistance are explained
      by increased insulin secretion during the refeeding period. Both, adaptive thermogenesis as
      well as insulin and leptin resistance can be ameliorated by attenuation of the increase in
      insulin and leptin secretion during refeeding a low GI diet after weight loss.
    

Intervention name(s): dietary intervention by varying GI diets
Intervention type(s): Other
Intervention description(s): The human study intends to characterise the partitioning of weight gain during refeeding and to affect the catch-up fat phenomenon by the glycemic index (GI) of the diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: partitioning of weight gain; refeeding; catch-up fat phenomenon; glycemic index
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to document the long-term safety and tolerability of
      teriflunomide in Multiple Sclerosis (MS) participants with relapse.

      The secondary objective was to document the long-term efficacy on disability progression,
      relapse rate and Magnetic Resonance Imaging (MRI) parameters.
    

Detailed description: 
      Participants completing the EFC6049 (HMR1726D/3001) study were given the opportunity to
      continue in the extension study;

        -  participants receiving teriflunomide 7 mg or 14 mg were blindly maintained on the same
           dose of teriflunomide.

        -  participants receiving placebo were randomized at a 1:1 ratio to teriflunomide 7 mg or
           14 mg.

      The study period per participant was broken down as follows:

        -  Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide was
           commercially available in the country where participant lived,

        -  Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up
           if participant continued on teriflunomide treatment by obtaining its commercial form
           after end of the study.

      The total duration of the extension was 292 weeks (about 6 years) from the first participant
      enrolled or until teriflunomide is commercially available in the country where participant
      lived.
    

Intervention name(s): Teriflunomide (HMR1726)
Intervention type(s): Drug
Intervention description(s): Tablet, oral administration QD.
Other intervention name(s): Aubagio
Intervention MeSH terms: Teriflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Oral treatment