bioihbjkbjnl/mcl2 huggingface dataset:
The Montefiore Metoclopramide Study
Condition: Nausea; Extrapyramidal Symptoms
MeSH terms: Nausea
Study type: Interventional
Phase: Phase 4

Summary: 
      Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea,
      vomiting, and migraine headaches in Emergency Departments. However, little research has
      focused on the optimal dose of metoclopramide for treatment of nausea in the emergency
      department. We propose a randomized, double-blind, placebo controlled trial to investigate
      the optimal dose of metoclopramide for treatment of nausea.
    

Detailed description: 
      The most effective dose of metoclopramide for treatment of nausea in the emergency department
      setting has not been thoroughly investigated. One pilot study among emergency department
      patients in Australia found no statistical difference between 10 mg and 0.4
      milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10
      milligrams of metoclopramide is no more effective than placebo. In contrast, investigations
      focusing on chemotherapy patients and post-operative patients suggest that higher dosage
      metoclopramide is more effective in treating nausea and vomiting. This emergency department
      study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of
      metoclopramide by using the visual analog scale.

      In addition to evaluation of dose, we will evaluate one of the most common side affects of
      metoclopramide, akathisia. Akathisia is characterized by a subjective component of
      restlessness and an objective component in the form of the inability to remain motionless.
      Anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia
      when dopamine function is impaired in the basal ganglia. In fact, the use of diphenhydramine
      has been shown to reduce the incidence of akathisia in patients receiving a different
      anti-emetic, prochlorperazine. However, no research has focused on the use of
      anti-cholinergic medications to reduce metoclopramide induced akathisia. This investigation
      will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced
      akathisia in ED patients being treated for nausea/vomiting.
    

Intervention name(s): metoclopramide 10 mg; Diphenhydramine 25 mg; Placebo; Metoclopramide 20 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): an anti-emetic medication; used for prophylaxis against akathisia; placebo; Metoclopramide 20 mg
Intervention MeSH terms: Diphenhydramine; Promethazine; Metoclopramide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metoclopramide; Nausea; Akathisia; Emergency department
Postoperatory Recovery in Thoracic Surgical Procedure, Fast-track Protocol vs. Conventional Care
Condition: Thoracic Surgery
MeSH terms: Aortic Dissection
Study type: Interventional

Summary: 
      The aim of this study was to compare the functional capacity of exercise by six-minute walk
      test before and after thoracic surgical procedure in subjects who have undergone the
      Fast-track protocol with those who were under conventional care. Researchers want to find out
      if Fast-track is a strategy to enhance functional capacity after thoracic surgery.
    

Detailed description: 
      Fast track programs represents a new approach to the management of patients undergoing
      surgery. It is perioperative care pathway designed to achieve early recovery and helps to
      minimize postoperative morbidity and mortality.

      These multimodal approaches focuses on enhancing recovery and reducing of surgical stress by
      minimal invasive surgery, optimized pain relief, early nutrition and ambulation.

      In postoperative, the bed rest leads to the increase in muscle loss and weakness, impairs
      pulmonary function, predisposes to venous stasis and thromboembolism, increases infection
      complications and reduces functional capacity.

      However, information on the results of Fast-track protocols in functional capacity of
      exercise during hospital stay is sparse.

      The six-minute walk test is use to measure of functional capacity of exercise in different
      populations and to detect changes after interventions. The distances traveled in two
      six-minute walk test (preoperative and postoperative) will be compared between the two groups
      (Fast-track and Conventional).

      In this trial the investigators will consider Fast-track protocol to be feasible to enhance
      functional capacity of exercise after thoracic surgery.
    

Intervention name(s): Fast-track protocol
Intervention type(s): Other
Intervention description(s): Preoperatory management, epidural anesthetic management, avoiding the need opioid in postoperatory analgesia and use of an standardized postoperatory management protocol to an early oral intake and early mobilization. At the postoperative recovery room, after extubation and fully awake, patients started physiotherapy exercises, as physical exercises of moving up upper and lower extremities accompanied by deep breathing exercises. After than, the patients standed up beside the bed and if there was no complications, patients performed ambulation. The physiotherapist aided the patients during all period.
Other intervention name(s): Early rehabilitation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: postoperative care; exercise test; early ambulation; Fast-track
Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa
Condition: Primary Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess if shorter combinations of SSG plus single dose AmBisome®,
      Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating
      visceral leishmaniasis in Eastern Africa.
    

Detailed description: 
      The current study intends to look at potential feasible short course combination therapies as
      well as evaluate (and possibly register) miltefosine in its conventional dose against VL in
      Sudan and Kenya.
    

Intervention name(s): Liposomal amphotericin B (AmBisome®) and sodium stibogluconate; Liposomal amphotericin B + miltefosine; Miltefosine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11; AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11; Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B; Miltefosine; Antimony Sodium Gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase II; Randomised clinical trial; Visceral Leishmaniasis
Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single-centre prospective randomised study comparing the virological and
      histological response of HBV infection to lamivudine in combination with interferon versus
      lamivudine alone.
    


Intervention name(s): Lamivudine plus Polyethylene glyco-interferon alfa-2b; Lamivudine
Intervention type(s): Drug; Drug
Other intervention name(s): Lamivudine plus Polyethylene glyco-interferon alfa-2b
Intervention MeSH terms: Interferons; Interferon-alpha; Lamivudine; Interferon alpha-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HBeAg-positive; chronic; Hepatitis B; lamivudine; seroconversion; Chronic Hepatitis B
Bioavailability of Iron From Savoury Food Product
Condition: Healthy; Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The study is designed to assess the bioavailability of iron from 4 different iron fortified
      savoury food products
    


Intervention name(s): Savoury food product
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: female; subjects
Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known
Condition: Leukemia; Neoplasms
MeSH terms: Leukemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The present trial will be performed according to an open design to determine the maximum
      tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in
      paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than
      18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy
      (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric
      cancer patients
    


Intervention name(s): volasertib
Intervention type(s): Drug
Intervention description(s): intravenous administration on day 1of a treatment course
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Maximizing Language Development in Children With Hearing Loss
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of early intervention on language skills
      for children with hearing loss.
    


Intervention name(s): Early language intervention
Intervention type(s): Behavioral
Intervention description(s): Parents will practice the specific set of strategies (visual, interactive, tactile, responsive) during sessions that occur weekly and last 1 hour for a total of 26 sessions, over 6 months. Each session will include four segments: (a) the therapist will review the intervention strategies taught in the workshop (10 min), (b) the therapist will model the intervention strategy with the child (10 min), (c) the parent will practice the strategy with her child with coaching from the therapist across four different routines and activities of the parent's choice (30 min), and (d) the therapist will provide feedback to the parent, summarize the session, and answer the parent's questions (10 min).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hearing Loss; Cochlear Implant; Deaf; Hearing Impairment; Hard of Hearing
Melatonin in Adults With SMS
Condition: Smith Magenis Syndrome
MeSH terms: Smith-Magenis Syndrome; Syndrome
Study type: Interventional

Summary: 
      Sleep-Wake and behavioral disorders in Smith Magenis Syndrome (SMS) are strongly linked to an
      inversion of the nychtemeral secretion of melatonin. This inversion have been described in
      children with SMS. However its evolution during adulthood remains unknown. The aim of this
      study is to assess 24hours melatonin levels in 10 adults with SMS in order to optimize
      medication in adults with SMS
    

Detailed description: 
      SMS is one of the rare syndromes in which the inversion of melatonin secretion is regular,
      which is an exceptional situation for the study of the influence of genetic factors on the
      regulation of sleep / wake rhythm. Recently, point mutations of the RAI1 gene (Retinoic Acid
      Induced 1) have been identified in individuals with the clinical features of SMS with a
      reversal of the secretion rate of melatonin ,highlighting the role of RAI1 in SMS sleep
      disorders.

      Daytime secretion of melatonin is associated with significant drowsiness and plays a major
      role in diurnal behavior disorders, especially in younger people. Conversely, the absence of
      nocturnal melatonin is a causal factor in the shortening and fragmentation of nocturnal sleep
      .

      Basically, little is known about the mechanisms that explain the inversion of the secretion
      rate of melatonin in SMS.

      These aspects, and in particular the nycthemeral reversal of the melatonin cycle, have been
      described in a population of children and we do not know how these disturbances evolve in
      adulthood
    

Intervention name(s): Hourly dosing of the nychtemeral secretion of melatonin
Intervention type(s): Biological
Intervention description(s): Hourly dosing of the nychtemeral secretion of melatonin links and with sleep disorders and behavior of adult patients with SMS
Intervention MeSH terms: Melatonin
Intervention model: Single Group Assignment
Intervention model description: To specify the evolution of the nycthéméral cycle of the secretion of melatonin in 10 adult subjects carrying a SMS
Masking: None (Open Label)
Primary purpose: Screening
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining radiation therapy with chemotherapy may kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus
      radiation therapy in treating patients who have primary CNS lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of methotrexate and cytarabine chemotherapy in
      combination with whole-brain radiation therapy for patients with non-AIDS related primary
      central nervous system lymphoma. II. Assess the response rate and safety of this chemotherapy
      regimen.

      OUTLINE: Patients receive the first course of chemotherapy as soon as possible after
      diagnosis and staging. Methotrexate (MTX) IV is administered over 40-60 minutes on days 1 and
      15. Cytarabine (AraC) is administered intrathecally on days 1 and 15. The second course of
      chemotherapy begins on day 29 or after bone marrow recovery. Radiation therapy begins no
      later than 3 weeks after completing chemotherapy. Patients are followed until death.

      PROJECTED ACCRUAL: A maximum of 50 patients will be accrued.
    

Intervention name(s): cytarabine; methotrexate; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Cytarabine; Methotrexate
Primary purpose: Treatment
Keywords: primary central nervous system non-Hodgkin lymphoma
A Phase Ia/Ib Study of IBI315 in Patients With HER2-expressing Advanced Solid Tumor
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this phase I study is to evaluate the safety and potential efficacy
      and to determine the recommended phase 2 dose (RP2D) of IBI315, a HER2/PD-1 bi-specific
      antibody in patients with advanced solid tumors
    

Detailed description: 
      This phase Ia/Ib, open-label, multicenter study has two stages. The Ia stage is a
      dose-escalation study that will focus on safety, tolerability, efficacy and RP2D . Patients
      with HER2-expressing advanced solid tumor who failed from previous standard of care will be
      enrolled in the phase Ia study. DLT observation period is 28 days.
    

Intervention name(s): IBI315; IBI315
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive IBI315 until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.; Patients will receive IBI315 RP2D until disease progression,intolerability, informed consent withdraw, or otherreasons leading to treatment discontinue.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and the Pharmacokinetic Study of Characteristics of MKT-N2 (Montelukast) and Singulair® (Montelukast Sodium)to Treat Asthma
Condition: Asthma and Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The Purpose of A center, Randomized, Open label, single dose, Placebo-controlled,
      2-Treatment, 2-Way, 2-Period Crossover Study to Compare the Safety and the Pharmacokinetic
      Characteristics of MKT-N2 (Montelukast) and Singulair® (montelukast sodium) tablet 10mg in
      Healthy Male Korean Subjects
    


Intervention name(s): Montelukast; Montelukast sodium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10
Condition: Amyloid Cardiomyopathy, Transthyretin-Related
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy
      adult subjects
    

Detailed description: 
      Up to 48 healthy volunteers will be given a single dose of AG10 or placebo and be monitored
      for safety and tolerability over a 5-day period. Up to 48 healthy volunteers will be given
      multiple doses of AG10 or placebo and be monitored for safety and tolerability over a 15-day
      period.
    

Intervention name(s): AG10 oral tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Active single ascending dose; Placebo single dose
Other intervention name(s): Eidos Therapeutics AG10; Matching placebo
Intervention MeSH terms: Coal Tar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients
Condition: Coronary Disease
MeSH terms: Coronary Disease; Coronary Artery Disease
Study type: Interventional

Summary: 
      It is known that organized cardiac rehabilitation is effective in improving exercise capacity
      in coronary heart disease patients. Less is known about the long-term results after cardiac
      rehabilitation. Earlier studies have shown that many patients quit exercising when no longer
      attending formal rehabilitation. The investigators wish to investigate the effect of a
      maintenance program after ending a rehabilitation program, and to compare this to usual care.
      The investigators hypothesis is that the maintenance program will result in higher exercise
      capacity and more physical activity compared to usual care.
    


Intervention name(s): Exercise training; Control
Intervention type(s): Behavioral; Other
Intervention description(s): The patients will meet for organized exercise training once monthly and also exercise testing every third month.; The patients will receive the usual care provided by the hospitals and the community health services
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; heart; coronary disease; rehabilitation
Effects of Assisted Sit-up Exercise vs Swiss Ball Pikes on Postpartum Low Back Pain.
Condition: Postpartum Disorder; Lumbar Pain Syndrome; Activation, Patient
MeSH terms: Puerperal Disorders; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The aim of this study is to evaluate and compare the effectiveness of assisted sit-up
      exercise and swiss ball pikes on the treatment of pain and disability of postpartum low back
      pain. The current study will compare the use of assisted sit-up exercise and swiss ball
      pikes. The current study is novel in a way that there is limited literature about treating
      postpartum low back pain with physical strengthening exercises. These two methods will be
      employed to see if they improve ranges along with accompanying pain and disability.
    

Detailed description: 
      This study will be a randomized clinical trial. Subjects with postpartum low back pain
      meeting the predetermined inclusion and exclusion criteria will divide into two groups.
      Pre-assessment will be done using the Numeric Pain Rating Scale & Roland-Morris Questionnaire
      as subjective measurements. Subjects in one group will be treated with assisted sit-up
      exercise and the other will be treated with swiss ball pikes. Each subject will receive a
      total of 12 treatment sessions, with 2 treatment sessions per week. Post-treatment reading
      for numeric pain rating scale and Roland-Morris questionnaire will be recorded after the end
      of the 4th, 8th, and 12th treatment session.
    

Intervention name(s): assisted sit-up exercises; swiss ball pikes exercises
Intervention type(s): Other; Other
Intervention description(s): Group A patients will be instructed to perform assisted sit-up exercises by lying on their back and lifting their torso. They will use their body weight to strengthen and tone the core stabilizing abdominal muscles. This exercise will perform a minimum of five and maximum of 10 repetitions, two times a day and two days a week. Isometrics, back stretching, and strengthening exercises will be given as a common intervention for both groups before starting treatment session.; Group B patients will be instructed to perform swiss ball pikes by getting into the pushup position, the rest of the tops of their feet on a swiss ball. Each patient should keep her legs as straight as possible, bend her hips and try to pull her feet towards their chest so that the ball rolls forward. Hold at the top for three to four seconds, then slowly roll back to the starting position. This exercise will perform a minimum of one or two and a maximum of 10 repetitions, two times a day and two days a week. Both exercises will be performed for 12 weeks in both groups. Isometrics, back stretching, and strengthening exercises will be given as a common intervention for both groups before starting the treatment session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Drug Interaction Study With Rosuvastatin
Condition: Immunosuppression For Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of concomitant administration of
      BMS-986020 on the single dose Pharmacokinetics (PK) of Rosuvastatin in healthy subjects.
    


Intervention name(s): BMS-986020; Rosuvastatin
Intervention type(s): Drug; Drug
Other intervention name(s): Lysophosphatidic acid (LPA1) Antagonist; Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Parallel Assignment
Masking: None (Open Label)