bioihbjkbjnl/mcl2 huggingface dataset:
Zinc as Enhancer in Immune Recovery After Stem Cell Transplantation for Hematological Malignancies
Condition: Stem Cell Transplant Complications
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT)
      are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at
      the moment of the graft. Patients of the Control group take only standard antimicrobial
      prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of
      Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. Laboratory tests are
      performed on peripheral blood samples.
    

Detailed description: 
      Patients affected by multiple myeloma undergone autologous stem cell transplantation (SCT)
      are enrolled at the moment of stem cell collection. They are randomized 1:1 in two groups at
      the moment of the graft. Patients of the Control group take only standard antimicrobial
      prophylaxis after SCT; the Sample group takes in addition a daily oral supplementation of
      Zinc Sulfate (600 mg/die) from day +5 until day +100 after SCT. The aim of the study is to
      investigate the immune reconstitution in presence of Zinc, focused on thymic reconstitution.
      Laboratory tests are performed on peripheral blood samples, collected at 4 time-points: two
      before transplant (at the moment of the enrollment and the day before conditioning) and two
      after transplant (day +30 and +100).
    

Intervention name(s): Zinc Sulfate Oral Product; Levofloxacin 500Mg Oral Tablet; Fluconazole 200mg tab; Acyclovir 400 MG
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once daily from day +10 until day +30 after stem cell transplantation; twice daily from day +10 until day +30 after stem cell transplantation; twice daily from day +10 until day +30 after stem cell transplantation
Intervention MeSH terms: Levofloxacin; Fluconazole; Acyclovir; Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Case-control study, open, without placebo
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: zinc
A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability
Condition: Procedural Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      A prospective dose escalation, nine period cross-over trial assessing the safety,
      pharmacokinetics, bioavailability and pharmacodynamics of escalating doses of Remimazolam
      when administered intranasally as powder and solution in healthy subjects and compared to an
      intravenous control
    

Detailed description: 
      The design will be a randomized, double-blind, comparative, placebo- and active-controlled
      nine-period crossover study in healthy male volunteers. Subjects will be randomized and will
      receive each of the 9 treatments which will be separated by a minimum of 48 hours.The first
      treatment arm will always be the intravenous remimazolam. Eligible subjects will then be
      randomized to treatment sequence prior to study drug administration in treatment period 2.
      Each subject will participate in the study for up to 51 days, from Screening until Follow-up.
    

Intervention name(s): Remimazolam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): For induction and maintenance of sedation; Control arm
Other intervention name(s): CNS7056
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prehypertension Among Medical Students in Visakhapatnam and Association With Cardiovascular Risk Factors
Condition: Prehypertension; Cardiovascular Risk Factors
MeSH terms: Prehypertension
Study type: Observational

Summary: 
      Student Investigator = Thakkallapalli Zeeshan Muzahid. The study aims to assess the
      prevalence of prehypertension among medical students of Andhra Medical College,
      Visakhapatnam, India and its association with other cardiovascular risk factors - overweight
      /obesity, diabetes, lipid profile.
    

Detailed description: 
      275 medical students will be studied and a history taken and examination done with special
      emphasis on recording of Blood Pressure, measurement of height and weight (& Body Mass Index)
      and Waist Circumference in all. Glucose Tolerance Test and Fasting Lipid profile will be
      measured in a random selection of 30 prehypertensives and 30 normotensives.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Graduate Medical Students
      
Keywords: Prehypertension; Prevalence; Cardiovascular Risk Factors
Longitudinal Changes of [18F]PI-2620 Positron Emission Tomography in Subjects With Cognitively Normal, Mild Cognitive Impairment and Alzheimer's Disease
Condition: Cognitively Normal; Mild Cognitive Impairment; Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall goal of this imaging trial is to evaluate crosssectional difference and
      longitudinal changes of [18F]PI-2620, a tau targeted positron emission computed tomography
      radioligand, in cognitively normal individuals, and subjects with mild cognitive impairment
      and Alzheimer's disease.
    


Intervention name(s): [18F]PI-2620
Intervention type(s): Drug
Intervention description(s): Imaging for evaluating the accumulation of abnormal tau protein in the brain
Other intervention name(s): FluoroTau
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: [18F]PI-2620; tauopathy; positron emission computed tomography
Clinical Evaluation of An Approved Contact Lens
Condition: Tear Film Characteristics
Study type: Interventional

Summary: 
      This is an 8-visit, bilateral, dispensing clinical study to evaluate the change in tear fluid
      pH and tear film osmolarity in an FDA-cleared contact lens in new contact lens users over a
      14-day period.
    


Intervention name(s): Marketed Contact Lens
Intervention type(s): Device
Intervention description(s): Narafilcon A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Study of Intra-articular Hyaluronic Acid in the Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to prove the non-inferiority of the intra-articular injection of
      hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to
      Synvisc®.
    


Intervention name(s): Sinovial® (syringe containing sodium hyaluronate solution); Synvisc® ( syringe containing Hylan G-F 20 solution)
Intervention type(s): Device; Device
Intervention description(s): 2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.; 2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.
Other intervention name(s): Sinovial®: Class III medical device(CE mark n° 0499); Synvisc®: class III medical device (CE mark n° 0088)
Intervention MeSH terms: Pharmaceutical Solutions; Hyaluronic Acid; Hylan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CBT Depression Intervention for Co-Occurring Chronic Headache
Condition: Depression; Headaches Chronic; Migraine Disorders
MeSH terms: Migraine Disorders; Headache Disorders; Headache; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Having co-occurring depression and chronic headaches is challenging and can greatly impact
      one's professional, personal, family, and social life. People living with chronic headaches
      are often at a greater risk of having comorbid psychiatric disorders (depression, anxiety),
      reduced quality of life, and impaired functioning because of under-diagnosis, misdiagnosis or
      under-treatment of both chronic conditions.

      This study is a pilot clinical trial that will compare the effectiveness of a brief
      cognitive-behavior therapy (CBT) depression intervention to a care as usual (control) group.
      The aim of the study is to determine how well the CBT intervention will reduce the frequency,
      severity and level of disability of both the headaches and depression symptoms.
    

Detailed description: 
      STUDY LOCATIONS:

      (A) University of Georgia College of Education in Athens, GA

      (B) Henry Ford Hospital - Main campus in Detroit, MI.

        -  For the MI participants, you must be willing to travel to Detroit for the intervention
           if you choose to participate and are assigned to the treatment group.

      **Please contact me with any questions about the study.**

      Background: This research focuses on emphasizing alternative treatment approaches to
      underserved and marginalized groups. This study is a randomized pilot intervention to treat a
      community sample with co-occurring depression and chronic pain (i.e. headaches/migraines) -
      since they are at an increased risk for impaired functioning, comorbid psychiatric disorders
      and reduced quality of life.
    

Intervention name(s): CBT Individual Psychotherapy
Intervention type(s): Behavioral
Intervention description(s): The 4-session CBT treatment will include receipt of a manualized cognitive behavioral intervention, delivered individually, to treat the depression symptoms (e.g. cognitive restructuring, behavioral activation) and teach adaptive coping strategies to manage their depression. Ideally, the intervention will also positively affect their chronic headaches (i.e. reduction of headache frequency, severity and level of disability). Each session is approximately 60 minutes with specific, reflective and guided activities related to a specific module within the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic headaches, migraines, depression
Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine whether combination treatment (adding
      methylprednisolone to Avonex) reduces progression of disability over 4 years compared to
      Avonex alone. The study will also investigate whether combination therapy has any impact on
      the incidence of relapse and brain atrophy as measured by MRI.
    

Detailed description: 
      Approximately 340 therapy-naïve MS patients with relapsing-remitting form of the disease will
      be randomized to receive Avonex alone or Avonex plus methylprednisolone (MP). Patients will
      receive MP as 500 mg po for 3 days every month or matching placebo. The patients are followed
      on a 3-monthly basis for 4 years with disability as the primary parameter of efficacy over
      that time.
    

Intervention name(s): Interferon-beta-1a (Avonex) plus methylprednisolone
Intervention type(s): Drug
Intervention description(s): oral administration given on 3 consecutive days, monthly as described in protocol.
Other intervention name(s): Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Methylprednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Combination therapy for multiple sclerosis
Effect on Blood Chemistry and Inflammatory Marker of Omega-3 Enriched Total Parenteral Nutrition
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and
      docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil
      emulsions have not been commercially available until very recently. The Objective of this
      study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total
      parenteral nutrition in healthy Korean male subjects. This study is designed as a randomized,
      open-label, 2-treatment, 2-way crossover trial. Blood samples will be collected every 1 hour
      from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and
      insulin.
    

Detailed description: 
      Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and
      docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil
      emulsions have not been commercially available until very recently. The Objective of this
      study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total
      parenteral nutrition in healthy Korean male subjects.

      This study is designed as a randomized, open-label, 2-treatment, 2-way crossover trial. The
      16 subjects will be randomly assigned to 1 of 2 sequences of the two treatments: Combiflex®
      lipid peri or Winuf® peri will be infused via peripheral venous catheter for 6 hours at 3
      ml/kg/h. Blood samples will be collected every 1 hour from 0 to 12 hours after starting an
      intravenous infusion for triglyceride, glucose, and insulin. Cholesterol, HDL-cholesterol,
      LDL-cholesterol, AST, ALT, and total bilirubin as liver function biomarkers, and hsCRP as
      inflammatory biomarker will be analysed at 0, 6 and 12 hour after starting an intravenous
      infusion.
    

Intervention name(s): Combiflex® lipid peri; Winuf® peri
Intervention type(s): Drug; Drug
Intervention description(s): total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil; total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Omega-3; Blood lipid profiles; DHA; EPA; Triglyceride; Glucose; Insulin; LDL; TPN
Safety and Immunogenicity With Two Different Serotype 2 Potencies of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Adults in Singapore
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the post-vaccination neutralizing antibody response
      against each dengue serotype by vaccine group.
    

Detailed description: 
      The vaccine being tested in this study was Takeda's Tetravalent Dengue Vaccine Candidate
      (TDV). TDV is being tested to protect people against dengue fever. This study looked at
      safety and the titers of antibodies to dengue fever induced in people who were administered a
      high-dose of TDV (HD-TDV) compared to TDV.

      The study enrolled 351 patients. Before being assigned to a treatment group participants were
      screened for previous exposure to the dengue virus using a Dengue immunoglobulin G (IgG)
      enzyme-linked immunosorbent assay (ELISA). Participants were randomly assigned in 1:1 ratio
      (by chance) to one of the two treatment groups-which remained undisclosed to the participant
      and study doctor during the study (unless there is an urgent medical need):

        -  HD-TDV 0.5 mL subcutaneous injection

        -  TDV 0.5 mL subcutaneous injection

      All participants received a single injection on Day 1. Participants were asked to record any
      symptoms that may or may not be related to the vaccine or the injection site in a diary card
      for 28 days after vaccination.

      This multi-center trial was conducted in Singapore. The overall time of participation in this
      study was 12 months. Participants made multiple visits to the clinic, including a final visit
      1 year after receiving their dose of TDV.
    

Intervention name(s): Takeda's Tetravalent Dengue Vaccine Candidate (TDV); Takeda's High-Dose Tetravalent Dengue Vaccine Candidate (HD-TDV)
Intervention type(s): Biological; Biological
Intervention description(s): TDV subcutaneous injection; High-dose TDV subcutaneous injection
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine
Quit Smoking With Nicotine Patch and Exercise/Health Education (Females Only)
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      This research study is for FEMALE cigarette smokers who want to quit smoking.

      Participants will be provided with brief quit-smoking education at the beginning of the study
      and will receive the nicotine patch for 10 weeks, free of charge.

      Participants will be assigned to either an exercise program or a general health education
      program. The exercise and health education programs will take place over 14 weeks, with
      follow-up appointments 3, 6, and 12 months after the end of the 14-week program.

      There is no fee for any part of this study and participants will be compensated for their
      time.
    

Detailed description: 
      Participants must complete telephone screening process first.

      All eligible participants must attend an orientation session when the investigators will
      explain the study in detail. After this session, interested participants will complete a
      consent form and the investigators will collect blood pressure, resting heart rate, body mass
      index (height/weight), and a carbon monoxide sample to confirm eligibility. The investigators
      will then explain the physician consent process (all eligible and interested participants
      must obtain consent from a physician or clinic that they have seen in the past year to
      confirm that it is safe for them to participate).
    

Intervention name(s): Moderate intensity exercise; Health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Brisk walking on a treadmill for 56 minutes 3x per week.; Videos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Preoperative Oral Carbohydrate Loading in Gynecologic Surgery
Condition: Postoperative Recovery
Study type: Interventional

Summary: 
      The advantage of carbohydrate loading in minimally invasive surgeries are not well
      established. We designed this study to evaluate whether preoperative oral carbohydrate
      improve postoperative recovery after laparoscopic gynecologic surgeries.
    

Detailed description: 
      This study will be conducted in the female adult patient scheduled for laparoscopic
      gynecologic surgery for benign or premalignant condition. Patients with American Society of
      Anesthesiologist physical status classification I-II, not pregnant or on lactation will be
      included. Patients with underlying disease that will delay gastric emptying (GERD, history of
      gastrointestinal surgery, diabetes), or contraindicated to NSAID or opioid, psychiatric or
      mental disorders, alcoholism, or drug abuse will be excluded.

      Participants will be randomized into 2 group: the control group and the study group.
      Randomization will be conducted via random block with stratification generated by the
      http://www.randomization.com with 1:1 allocation. The sequence will be kept in opaque, sealed
      envelopes until the day before the study date. One investigator, not involved in the outcome
      assessment, opened the envelope on the day before the surgery, and allocated participants in
      each group.

      After having regular diet until the evening before surgery, participants allocate in the
      control group were kept fasted from midnight until surgery. Participants in the study group
      will receive 800 mL of carbohydrate beverage (12.8% carbohydrates, 50 kcal/100 mL, 290
      mOsm/kg). The participants in the study group will freely drink carbohydrate beverage
      starting from the evening before surgery up to 2 hours before surgery.

      The postoperative quality of recovery (QoR) score, time to readiness to discharge, patient
      satisfaction, postoperative nausea and vomiting, change in body weight, and insulin
      resistance will be assessed.
    

Intervention name(s): NO-NPO (Daesang WelLife Co., Ltd., Korea)
Intervention type(s): Dietary Supplement
Intervention description(s): 800 mL of carbohydrate beverage consists of 12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage
Condition: Post-partum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The current study aimed to investigate the effectiveness of the Mostafa Maged maneuver
      compared to Bimanual uterine compression in controlling postpartum hemorrhage during vaginal
      delivery.

      The study subjects were categorized into two groups. The first group was managed by the
      Mostafa Maged maneuver , whereas the second group was managed by routine bimanual uterine
      compression.

      investigators attempted to determine the duration of each maneuver required until the
      investigator became exhausted, as well as whether or not oxytocin was administered later in
      each maneuver .
    


Intervention name(s): Mostafa Maged maneuver; Bimanual uterine compression
Intervention type(s): Procedure; Procedure
Intervention description(s): While the patient is on the lithotomy position , The first step in the Mostafa Maged maneuveur step is placing the right hand to the posterior fornix of vaginal canal trying to put pressure on the cervix and the lower part of uterus compressing the anterior and posterior walls of the lower uterine segment. The second point is placing the left hand over the fundus of the uterus and the posterior wall of the uterus from the abdominal part of the pregnant mother (the side of the abdominal skin). The third step is trying to grasp the whole uterus by the two hands abdominally and vaginally against the symphysis pubis as if the uterus is containing or surrounding the symphysis pubis bone, and in this way, getting the anterior and posterior walls of the uterus against each other (compression achieved); the clinician places one hand on the abdomen and the other hand inside the vagina then compresses the uterus between the two hands.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mostafa Maged maneuver; Bimanual uterine compression; vaginal delivery; postpartum hemorrhage