bioihbjkbjnl/mcl2 huggingface dataset:
Phase I/II Trial of KRN7000 in Patients With Chronic Hepatitis C Infection
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase I/II trial of KRN7000 in patients with chronic hepatitis C.

      Study objectives: To evaluate and compare the safety and tolerability of 3 ascending doses of
      a-GalCer.

      The primary efficacy parameter: HCV-RNA response at the end of treatment. Secondary efficacy
      parameter: Serum ALT response. Further objectives of the study are to evaluate the effect of
      a-GalCer on serum cytokines IFNg and TNFa and on iNKT cells.

      Number of dose levels: 3 Investigational product: KRN7000 Route of administration:
      intravenous Dosages and frequency: 0.1, 1, 10 mcg/kg, monthly injection, 3 times (day 0, day
      28 and day 56)
    

Detailed description: 
      Phase I/II trial of KRN7000 in patients with chronic hepatitis C.

      This study is a multicenter double-blind randomized placebo-controlled phase I/II
      dose-escalation trial. The protocol is conducted in The Netherlands, Belgium and Germany.
      Patients with chronic hepatitis C who met the inclusion criteria are assigned to receive
      a-GalCer (KRN7000 ((2S, 3S,
      4R)-1-O-(a-D-galactopyranosyl)-N-hexacosanoyl-2-amino-1,3,4-octadecanetriol), Kirin
      Pharmaceutical Co., Ltd., Gunma, Japan) or placebo intravenously, thrice with intervals of 4
      weeks. Cohorts of 12 patients are entered at each of the three dose levels (0.1, 1 and 10
      mg/kg body weight). Three patients per dose level are randomized to the placebo arm.

      Dose escalation to the next cohort are decided after evaluation by a safety review board of
      all the safety data collected on all the patients who had completed 3 weeks after the first
      injection in the preceding dose cohort. After completion of 8 weeks of treatment, with
      injections at 0, 4 and 8 weeks, patients are monitored without further therapy for an
      additional 16 weeks.

      Study objectives: The objective of the study is to evaluate and compare the safety and
      tolerability of 3 ascending doses of a-GalCer. The primary efficacy parameter is the response
      at the end of treatment, based on serum hepatitis C virus ribonucleic acid (HCV RNA) levels.
      As a secondary efficacy parameter serum ALT levels are evaluated. Further objectives of the
      study are to evaluate the effect of a-GalCer on serum cytokines IFNg and TNFa and on iNKT
      cells.
    

Intervention name(s): KRN7000
Intervention type(s): Drug
Intervention MeSH terms: KRN 7000
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic hepatitis C; KRN7000; a-GalCer; immunotherapy; Natural Killer T cells; interferon
Hemoglobinopathy Nursing Program and Pediatric Nursing Students
Condition: Hemoglobinopathies; Thalassemia; Sickle Cell Disease; Nurse's Role
MeSH terms: Anemia, Sickle Cell; Thalassemia; Hemoglobinopathies
Study type: Interventional

Summary: 
      Hemoglobinopathies are the most common life threatening, monogenic disorders in the world.
      The most common causes of hemoglobinopathies are sickle cell disease and thalassemia. Aim:
      This study aimed to evaluate the effect of a hemoglobinopathy nursing program on pediatric
      nursing students' performance.
    


Intervention name(s): Hemoglobinopathy Nursing Program
Intervention type(s): Other
Intervention description(s): "Hemoglobinopathy Nursing Program" is more informative for "Groupe 1" than "Group 2"
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and
      tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to
      placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the
      pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system,
      blood pressure and heart rate) in healthy male subjects.
    


Intervention name(s): QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Contains magnesium stearate, silica dental type, anhydrous lactose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Effects of Serotonin Agonist Citalopram on Multimodal Esophageal Stimulation in Healthy Volunteers
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      To investigate the effect of citalopram, a selective serotonin reuptake inhibitor, on
      esophageal sensitivity.
    


Intervention name(s): Citalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg citalopram intravenously; Saline solution
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Mobile Health App to Reduce Diabetes in Latina Women With Prior Gestational Diabetes II
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      The investigators will conduct a pre-post study to evaluate the effectiveness of the Hola
      Bebe intervention on improving self-efficacy for healthy eating and physical activity, and on
      weight loss among Hispanic women with recent GDM. The Hola Bebe app provides a unique
      opportunity to provide an effective, culturally tailored lifestyle modification program. The
      investigators will provide training to health educators at the two participating sites to
      ensure consistency and fidelity of implementation.
    

Detailed description: 
      The study builds on the investigators' previous research in which the investigator developed
      a culturally-tailored Spanish and English app for Latinas with recent GDM based on Social
      Cognitive Theory and Behavioral Economics.

      The app-based program included 12 audio/visual behavioral and educational modules on healthy
      eating and physical activity, motivational texts, weight tracking, personalized action plans,
      tiered badges, videos (easy at-home exercises, user-friendly, easy-to-follow recipes, and
      building a balanced plate), and an online community to communicate with other participants.
      All content was in plain-language Spanish and English, with Spanish and English audio
      voice-over. Graphics were dynamic and incorporated culturally sensitive.
    

Intervention name(s): Hola Bebe
Intervention type(s): Behavioral
Intervention description(s): Participants will receive the handout "It's never too early to prevent diabetes" and will meet with the health educator at their CHC and download the Hola Bebe app. The health educator will advise participants to watch one module and complete an action plan for each of the first 12 weeks of study and encourage participants to weigh themselves weekly. The app includes the following features:1) educational/ behavioral audio visual modules, with automatic prompting to complete an action plan at the end of each module; 2) a motivational message library so that participants can chose which motivational texts they wish to receive, how often and time of day; 3) a community forum where participants can interact with each other and ask questions to the health educator; 4) tracking of weights to allow participants to see a graphic of their weight over time by inputting weekly weights; and 5) awards program where participants can earn badges for completing modules.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics
Condition: Feeding Behavior
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of Semielevated Side-Lying (ESL) and
      Semielevated Supine Position (ESU) positions used in bottle-feeding of very preterm infants
      upon their physiological characteristics and feeding performances.
    

Detailed description: 
      Semielevated supine position (ESU) is a position frequently used in neonatal intensive care
      units. In this position, infant is laid and fed on its back and the head is elevated to an
      angle of 45-60° in order to reduce the respiratory load of lungs. The ESL position, head of
      the infant is elevated to an angle of 45-60° and the infant is fed in the side-lying
      position. Since this position mimics the breast-feeding position, very preterm infants are
      supported to utilize the advantages of breast-feeding. A randomization was provided in the
      sample group consisting of totally 80 infants and while 38 infants were included in the ESL
      (experimental) group, 42 infants were included in the ESU (control) group.In the power
      analysis repeated at the end of the study, the power of the study was determined as 87% at a
      reliability of 95%.
    

Intervention name(s): Semielevated Side-lying Position-ESL; Semielevated Supine Position
Intervention type(s): Other; Other
Intervention description(s): The infants in the experimental group (n = 38) were held in the ESL position. In this position, their head and trunk were elevated to an angle of 45-60◦ with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infantswere held in the side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and their head and neck were held at the same level by the researcher; whereas, their chin was held in the flexion posture mildly facing the floor. The researcher supported their head, neck, and shoulder with her left hand and controlled the bottlewith her right hand.; The ESU position was applied to the infants in the control group (n=42). In this position, their head and trunk were elevated to an angle of 45-60◦ with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and they was laid in the supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas their chin was held in the flexion posture mildly facing the floor. The researcher supported their head, neck, and shoulder with her left hand and controlled the bottlewith her right hand.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Feeding; preterm infant; physiological characteristics; position; ESL; ESU
1-1-12 Wash-in for Desflurane Low Flow Anesthesia
Condition: Anesthesia
Study type: Observational

Summary: 
      We propose a new wash-in technique for desflurane low flow anesthesia with fresh gas flow of
      O2:N2O 1:1 L/min with desfluraene 12%.

      The objective of this study is to identify time to achieve alveolar concentration of
      desflurane at1, 2, 3, 4, 5 and 6%.
    

Detailed description: 
      The benefits of low flow anesthesia are economic, less pollution, more heat and humidity
      preservation but it requires appropriate wash-in phase. The current wash-in protocols are
      complicated and time consuming. We propose a new 1-1-12 desflurane wash-in protocol which is
      more simple and predictable.

      The objective of this study is to identify time to achieve alveolar concentration of
      desflurane at 1, 2, 3, 4, 5 and 6% with 1-1-12 wash-in protocol.

      All patients will receive iv propofol 2 mg/kg as induction agent and succinyl choline 1.5
      mg/kg for intubation. Then the ventilation will be controlled to achieve end-tidal CO2 30-35
      mmHg with O2:N2O 1:1 L/min with desflurane 12%. Time to achieve alveolar concentration of
      desflurane at 1, 2, 3, 4, 5 and 6% will be recorded and analyzed. After that, the
      concentration of desflurane and anesthetic technique will be adjusted to requirement of
      anesthesiologist.
    

Intervention name(s): 1-1-12 wash-in
Intervention type(s): Procedure
Intervention description(s): wash-in phase during start of low flow anesthesia
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing general anesthesia with endotracheal intubation and controlled
        ventilation
      
Keywords: low flow anesthesia; wash-in; desflurane
Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA
Condition: Joint Diseases; Arthritis Knee; Arthroplasty Complications
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Osteoarthritis is the most common cause of chronic joint disease, and its incidence has
      increased due to the high average life expectancy, in addition to the high incidence of
      obesity. Total knee arthroplasty is currently an accepted treatment for severe degenerative
      conditions and there are various implant systems with special features depending on component
      geometry, degree of fit of the articular surfaces, and fixation techniques. A tibial
      component with mobile polyethylene has been developed as an alternative to fixed polyethylene
      because it has theoretical advantages in terms of increasing the range of motion, reducing
      wear conditions, and reducing the incidence of anterior knee pain when the articular surface
      of the patella is not resurfaced.
    

Detailed description: 
      The study is a randomized controlled clinical trial where the sample will be collected within
      one year from the date of approval of the Scientific Research Council at Damascus University.
      The sample consists of a group of patients who will undergo a total primary knee arthroplasty
      without patellar resurfacing following primary arthritis knee. The patients will be randomly
      divided into two groups. The first will be a primary total knee arthroplasty with a mobile
      bearing, and the second group with a fixed bearing. Then the patients will be followed for at
      least one year.

      The data of the patients included in the study will be collected before the surgical
      operation, then the surgery; followed up for at least two years after it, and then compared
      between the two groups in terms of a range of motion and functional and clinical results
      according to the Knee Society Score (KSS) and the anterior knee pain scale, and patient
      satisfaction assessment according to the Forgotten Joint Scale (FJS).
    

Intervention name(s): Total knee arthroplasty with a Mobile Bearing system.; Total knee arthroplasty with a Fixed Bearing system.
Intervention type(s): Procedure; Procedure
Intervention description(s): The prostheses will be cruciate scarifying cemented DePuy Synthes PFC Sigma with a Mobile Bearing system without resurfacing the patella.; The prostheses will be cruciate scarifying cemented DePuy Synthes PFC Sigma with a Fixed Bearing system without resurfacing the patella.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mobile bearing; Fixed bearing; Knee Arthroplasty
Effect of Healthy Lunch and Snack Meal on Reaction Time and Well-being of Physicians and Nursing Staff (Go-No-Go)
Condition: Nutrition Intervention
Study type: Interventional

Summary: 
      The aim of this study is to investigate the impact of increased availability of healthy food
      and drink during working hours on reaction time and well-being in physicians and nursing
      staff.

      Hospital medical staff often works long and hectic hours, without adequate meal or rest
      breaks in order to provide 24-hour care. This is a concern, as not only the staff's
      well-being is important to the individual welfare, but it is also vital to the quality and
      safety of the care their patients receive. The investigators believe that by focusing on
      physicians and nursing staffs nutrition the investigators will see a positive effect on staff
      performance and well-being - and thus ultimately possibly on patient safety.

      Hypothesis: The provision of healthy lunch and snack meal during working hours for a period
      of 4 weeks will improve reaction time and well-being compared to habitual diet in physicians,
      nurses and nursing assistants.
    

Detailed description: 
      The study is designed as a randomised controlled 2 x 4 weeks cross-over trial, initiated with
      a 1-week run-in period. The study sample will consist of 60 volunteer physicians, nurses and
      nursing assistants from Herlev University Hospital in Copenhagen, Denmark. A healthy lunch
      and snack meal meeting the current danish diet recommendations will be delivered daily during
      all working days in the intervention period. During the control period, the participants are
      requested to maintain their habitual dietary intake at work. Reaction time will be assessed
      by reaction time test Go/No-Go, a subtest of Test-battery for Attention Performance. Changes
      in mood will be measured by the Profile of Mood State questionnaire. In addition, dietary
      intake, level of physical activity and palatability of the intervention diet will be
      registered.
    

Intervention name(s): Dietary treatment
Intervention type(s): Other
Intervention description(s): Dietary treatment with healthy lunch and snack meal during working hours
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Diet treatment; Mental Health; Reaction time; State of moods; Working hours; Medical Hospital Staff
The Safety and Efficacy of Divalproex Sodium Extended-Release Tablets in Migraine Prophylaxis: A Study in Adolescents
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Depakote ER is safe and effective in the
      reduction of occurrence of migraine headaches in adolescents.
    


Intervention name(s): divalproex sodium
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Migraine; Depakote ER
Set up for in-Vivo Measurement of Dynamic Intraocular Pressure (IOP)
Condition: Intraocular Pressure
Study type: Interventional

Summary: 
      In this modern era, surgeons prefer to perform emulsification through small micro incisions.
      To accomplish this safely, surgeons raise irrigation bottle heights or use forced infusion
      systems.We believe that this sustained rise in the IOP during micro-incision
      phacoemulsification for a substantial period could be detrimental to the ocular structures.
      Therefore, intra-operative IOP pertaining to micro-incision cataract surgery is an emerging
      concern.

      Conventional systems for measuring IOP generate an isolated graph of continuous pressure
      recording. Interpretation of the IOP fluctuations from these graphs requires a two step
      superimposition approach to characterize the IOP changes.
    

Detailed description: 
      The aim of the present study was to describe a new setup for intra-operative monitoring of
      IOP in a clinical setting and validate it by correlating IOP differences arising with
      different phacoemulsification parameters in eyes undergoing microincision coaxial
      phacoemulsification.
    

Intervention name(s): phacoemulsifcation; phacoemulsifcation
Intervention type(s): Device; Device
Intervention description(s): A sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit; A sensor (Blumenthal cannula) connected to a transducer, a signal amplifier, an IOP recording device, and a display unit
Other intervention name(s): high aspiration flow rate,; high vacuum; low flow rate; low vacuum; low bottle height
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: IOP measurement; IOP fluctuation; in-vivo IOP measuring device; intraocular pressure measurement
Antiretroviral-Sparing Concept With HIV-specific T Cell Precursors With High Proliferative Capacity (PHPC)
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      PHPC-02 is a phase II, randomized, placebo-controlled trial designed to investigate whether
      therapeutic immunization during highly active antiretroviral therapy (HAART) induces
      elevations of HIV-specific T cell precursors with high proliferative capacity (PHPC) in
      HIV-1-infected individuals, and whether the quantity of PHPC correlates with the viral load
      set point following analytical treatment interruption (ATI). Subjects will be randomized to
      receive either DermaVir Patch (8 subjects per cohort) or DermaVir Patch Placebo (8 subjects
      per cohort) every four weeks for three applications while receiving maximally suppressive
      HAART. HAART will be discontinued at Week 9 for an ATI period of 20 weeks.
    

Detailed description: 
      16 subjects on maximally suppressive HAART were randomized to receive three doses of either
      DermaVir or Placebo immunotherapy.

      Subjects receive three DermaVir/Placebo treatments over eight weeks (Weeks 0, 4 and 8) while
      receiving HAART. HAART is discontinued for a 20 week ATI.

      Resumption of HAART during ATI is subjects experience:

        -  A confirmed CD4+ cell decrease by > 50%

        -  A confirmed CD4+ cell decrease to less than 350 counts/mL

        -  A confirmed VL increase > 300,000 copies

        -  Emergence of CDC AIDS related event(s)

        -  Signs or symptoms of clinically significant immunosuppression

        -  The subject or the subject's clinician wishes to restart HAART

        -  The subject becomes pregnant
    

Intervention name(s): DermaVir; Placebo; HAART
Intervention type(s): Biological; Biological; Drug
Intervention description(s): DermaVir is a synthetic nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing 15 HIV proteins that assemble to HIV-like particles. DermaVir is topically administered with DermaPrep medical device to target the nanomedicine to Langerhans cells of the skin.These Langerhans cells migrate to the lymph node to induce cytotoxic T cells that can kill HIV-infected cells; Dextrose/glucose solution; Three or more antiretroviral drugs that can fully suppress HIV RNA
Other intervention name(s): LC002; LC002 Placebo; Highly active antiretroviral therapy
Intervention MeSH terms: Anti-Retroviral Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
      
Biospecimen description: 
      peripheral blood mononuclear cells (PBMC) and plasma
    
Keywords: HIV; Vaccine; Immune Therapy; DermaVir; Treatment experienced