bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I, Safety Study of Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in Chinese Children
Condition: Mumps
MeSH terms: Mumps
Study type: Interventional
Phase: Phase 1

Summary: 
      Mumps is an acute infectious respiratory disease caused by the mumps virus (MuV), which
      occurs mainly in children and adolescents. Its main clinical symptoms were parotid gland
      suppurative swelling and pain with fever. The pathological changes and harm caused by mumps
      was not only confined to the parotid gland, on the contrary, the social harm caused by
      serious complications cannot be ignored. As mumps is a vaccine-preventable infectious
      disease, vaccination is a fundamental strategy for controlling mumps. So far, there are 13
      genotypes of MuV. Based on the analysis of molecular epidemiology, the main epidemic strain
      of MuV in China was the F genotype. The commonly used vaccine strains represented only a
      small number of known genotypes, e.g. Jeryl-Lynn (JL) and Rubini strains, which belong to
      type A, Urabe strain belongs to type B, and L-Zagreb strains belongs to type D. Virus seed of
      Live Attenuated Mumps Vaccine (Human diploid cell) developed by the institute was SP-A
      strain, which was the first separation and preparation of the attenuated mumps viruses in
      China. SP-A belongs to F genotype, which was the domestic epidemic genotype. In addition, the
      cell substrate prepared for vaccine was human diploid cell (KMB-17 strain), which is much
      safer to use. The preliminary test results showed that the vaccine possessed good
      immunogenicity and good antigenic cross-reactivity. The application of this vaccine will
      provide more effective means to prevent and control of mumps epidemic.
    


Intervention name(s): 3.50±0.25logCCID50/ml; 4.25±0.25 logCCID50/ml; 5.00±0.25 logCCID50/ml; 0 logCCID50/ml; Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.; Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.; Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.; 0 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.; Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in children (2-4 years old) and infants (8-23 months old) on day 0.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Live Attenuated Mumps (F-genotype) Vaccine
Dose Finding Study to Treat High Phosphate Levels in the Blood.
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks
      treatment period
    

Detailed description: 
      The study consists of a screening period of approximately 1 week, a wash out period of up to
      3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period
      and a follow-up period of up to 2 weeks, during which patients are put back on their pre
      washout phosphate lowering medication.

      The wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in
      s-phosphate levels.

      There are 7 parallel treatment arms in the study with bid and od treatment regimens.

      Laboratory efficacy endpoints and safety assessments will be evaluated at various times
      throughout the study.

      The target population of the study is: male or female patients, above18 years of age with End
      Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a
      minimum of 3 months.
    

Intervention name(s): AZD1722; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AZD1722, oral tablet; Placebo bid, double dummy technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: S-phosphate, hyperphosphatemia, hemodialysis, ESRD
Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A prospective, single-center, open-label, phase 1 study evaluating the pharmacokinetics (PK)
      of ustekinumab administered via the RaniPill™ capsule ("RT-111").
    

Detailed description: 
      The RaniPill device is a capsule-like ingestible device, which injects a microneedle
      containing a micro tablet (payload/drug) into the intestinal wall. This is a single-center,
      prospective, open-label, phase 1 study.

      Healthy Volunteers, 18-65 years of age, of any race, recruited from the general population
      and assigned to one of the following groups:

        -  Group 1 (SC Control): Stelara®, 0.5mg via SC injection (N= up to 15)

        -  Group 2: RT-111-0.50 mg (N= up to 20)

        -  Group 3: RT-111-0.75 mg (N=up to 20)
    

Intervention name(s): Stelara; RT-111 (0.5mg); RT-111 (0.75mg)
Intervention type(s): Drug; Combination Product; Combination Product
Intervention description(s): A commercial formulation of ustekinumab for SC control (0.5mg); RaniPill capsule containing ustekinumab with a dose of 0.5mg; RaniPill capsule containing ustekinumab with a dose of 0.75mg
Intervention MeSH terms: Ustekinumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of ARB-001467 in Subjects With Chronic HBV Infection Receiving Nucleos(t)Ide Analogue Therapy
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a phase 2a, single blind, randomized, placebo controlled, study evaluating the
      safety, anti-viral activity, and pharmacokinetics (PK) following multiple doses of
      intravenous ARB-001467
    

Detailed description: 
      Approximately 24 subjects will be enrolled in three cohorts: two cohorts of HBeAg-negative
      subjects and one cohort of HBeAg-positive subjects and 12 HbeAg-negative subjects will be
      enrolled in cohort 4. All subjects will be non-cirrhotic, with chronic hepatitis B virus
      (HBV) infection, and will have been receiving nucleos(t)ide-analogue (NA) therapy with
      entecavir or tenofovir for at least 12 months.
    

Intervention name(s): ARB-001467; Placebo
Intervention type(s): Drug; Other
Intervention description(s): An IV infusion of ARB-001467; An IV infusion of placebo
Other intervention name(s): 0.9% sodium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
Condition: Geographic Atrophy
MeSH terms: Geographic Atrophy; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The Phase Ia, open-label, multicenter study will consist of a single-dose, dose-escalation
      study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal
      (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA).
    


Intervention name(s): FCFD4514S
Intervention type(s): Drug
Intervention description(s): Intravitreal escalating dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GA
Treatment of Overweight Children and Adolescents
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The intervention program "Obeldicks light" is developed for overweight children aged 8-16
      years. This intervention is gender - and age specific.

      The 6-month intervention is based on nutrition course, behaviour therapy and exercise
      therapy. The evaluation compromised quality of structure, process and results of the
      intervention. 300 participants in a randomised controlled group design will be evaluated at 4
      time points: baseline, end of intervention, 6 months after end of intervention and 12 months
      after end of intervention.Primary outcome measure is change of weight status as standard
      deviation score of BMI. Drop-outs will be interviewed to improve the intervention.
    


Intervention name(s): behavioral intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
Condition: Liver Diseases; Hepatic Encephalopathy; Hepatic Insufficiency
MeSH terms: Liver Diseases; Hepatic Encephalopathy; Hepatic Insufficiency; Liver Failure; Brain Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Branched chain Amino Acids enhances the
      uptake of ammonia in muscle tissue.
    

Detailed description: 
      Branched-chain amino acids (BCAA; leucine, valine, isoleucine) are used to prevent hepatic
      encephalopathy in cirrhotic patients. The main effect of BCAAs is believed to take place in
      muscles where BCAAs provide carbon-skeletons for the TCA-cycle. This enhances the conversion
      of alfa-ketoglutarate to ammonia via glutamine.

      We intend to study the effect of oral administered BCAA on the metabolism of ammonia and
      amino acids across the leg-muscles by means of catheters inserted into the femoral artery (A)
      and vein (V). Muscle blood flow (F; L/min) will be determined by constant infusion of
      indocyanine green and indicator dilution principle. Arterial blood flow and A and V
      concentrations of ammonia and amino acids will be measured before an oral load of BCAA (0.45
      g BCAA/kg body weight) and after 1 and 3 hours. The metabolism of ammonia will also be
      estimated by means of 13N-NH3 PET scans.

      Hypothesis: BCAA increases the uptake of ammonia in muscle tissue and lowers arterial
      ammonia.
    

Intervention name(s): Branched chain amino acids
Intervention type(s): Dietary Supplement
Intervention description(s): Branched chain amino acids 0.45g/kg BW. Oral supplement. Administered once on study day
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Ammonia; Citric acid cycle; Branched Chain Amino Acids
Appendectomy by Low Impact Laparoscopy vs Routine Laparoscopy : a Randomized Prospective Monocentric Trial
Condition: Appendicitis; Appendectomy
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      Introduction: Surgery performed under low insufflation pressure combined with
      micro-laparoscopy (incisions 4X smaller than incisions in conventional laparoscopy) is called
      "low impact laparoscopy" or LIL. It significantly reduces postoperative pain and reduces the
      average length of stay.

      This technique, currently underdeveloped has never been evaluated in the literature for
      appendectomy.

      Main objective of the study: to obtain a reduction in postoperative pain when using the
      low-impact laparoscopy technique for appendectomies.

      Secondary objectives: to study the feasibility of LIL in appendectomies, to obtain a
      reduction in the average length of stay, a reduction in the consumption of analgesics, a
      reduction in costs, and a more rapid resumption of activities.

      Material and methods :

      This is a prospective, single-center, double-blind study. The inclusion criterion is the
      presence of acute uncomplicated appendicitis. The number of subjects to be included in each
      group is evaluated at 25. The subjects are divided into two groups preoperatively:

        -  Conventional group: insufflation pressure at 12mmHg and conventional instrumentation

        -  LIL group: insufflation pressure at 7mmHg and micro-laparoscopy instrumentation.

      Identical dressings are put in place at the end of the procedure in order to hide from the
      patient the protocol in which he was included.

      Pain assessment is recorded daily during the first postoperative week. The consumption of
      analgesics is also recorded. Then on the 7th day, 15th day and 30th postoperative day. During
      hospitalization, readings are taken by the nurse. At home, the data is entered by the patient
      via the Link4Life smartphone application.

      Conclusion: LIL applied to appendectomy has never been evaluated in the literature. It would
      allow a reduction in postoperative pain, the average length of stay for patients as well as
      improved rehabilitation.
    


Intervention name(s): Conventional group; Low impact laparoscopy group
Intervention type(s): Procedure; Procedure
Intervention description(s): Insufflation pressure at 12mmHg and conventional instrumentation; Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cervical Stabilization Exercises in Patients With Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effectiveness of cervical stabilization exercises
      on cervical positioning error in spondyloarthritis patients.
    

Detailed description: 
      The position sense and kinesthesia are defined as proprioception. In other words,
      proprioception allows being aware of positions of the body parts in the space. Muscles,
      tendons, joint capsules are source of proprioception.

      Possible damage to these structures due to inflammation may cause diminished proprioception
      sense. Decreased proprioception was shown for cervical region in axial spondyloarthritis
      patients in a recent study.

      Different exercise programs may help increasing proprioception. Therefore, the aim of the
      present study is investigate the effects of cervical stabilization exercises on cervical
      proprioception accuracy.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Home exercises were performed three times in a week for six weeks. Home exercises included range of motion exercises, coordination exercises and strengthening exercises. Repeats and durations of the exercises increased every week to provide progression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arthritis; Exercise; Proprioception
Value-based Cognitive Behavioral Therapy for Prevention of Chronic Whiplash-associated Disorders
Condition: Musculoskeletal Disorders; Whiplash
MeSH terms: Musculoskeletal Diseases; Whiplash Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a specifically tailored value-based
      cognitive behavioural therapy program (V-CBT) is able to prevent the development of
      persistent disability, pain, and psychological distress if delivered within the first three
      months after a whiplash injury.
    

Detailed description: 
      The primary objective of the present study is to test whether a specifically tailored
      value-based cognitive-behavioural therapy program (V-CBT) is able to prevent the development
      of persistent disability, pain, and psychological distress if delivered within the first
      three months after a whiplash injury. Methods. The current study is a two-armed randomized
      controlled study with a crossover design. Group A is scheduled for V-CBT within one week of
      randomization and group B with a delayed onset 3 months after randomization.
    

Intervention name(s): Value-based cognitive-behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): The intervention is a manualized program specifically tailored for prevention of disability and psychological distress after whiplash injuries. The intervention is delivered by two trained clinical psychologists og consists of 10 weekly one-hour individual sessions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: whiplash, prevention, pain, cognitive-behavioural therapy
Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
Condition: Moderate-to-Severe Atopic Dermatitis; Dermatitis, Dermatitis Atopic; Eczema, Skin Diseases, Skin; Diseases Genetic, Genetic; Diseases Inborn, Skin; Disease, Eczematous Skin; Hypersensitivity, Immediate; Hypersensitivity, Immune System Diseases; Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Eczematous; Hypersensitivity; Immune System Diseases; Hypersensitivity, Immediate
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to demonstrate the efficacy of dupilumab as a
      monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe atopic
      dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab
      as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe AD.
    


Intervention name(s): Dupilumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.; Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
Other intervention name(s): REGN668
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the potential effects of 28 days of nevirapine treatment on the steady-state
      pharmacokinetics of nelfinavir and of stavudine (d4T), and to further evaluate the
      pharmacokinetics of nevirapine in combination with nelfinavir, and d4T compared to the
      historical controls treated with nevirapine but without nelfinavir or d4T. To determine the
      efficacy of long-term combination therapy of nevirapine, nelfinavir and d4T on viral load in
      patients who are non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease
      inhibitor naive, and have <= 6 months prior d4T exposure at the time of screening.
    

Detailed description: 
      The trial is an open-label study in patients with HIV-1 infection who are naive to treatment
      with NNRTI and protease inhibitor classes of antiretroviral drugs and have <= 6 months prior
      exposure to d4T at the time of screening. Part I of this trial is an investigation of
      potential pharmacokinetic interaction between nevirapine and nelfinavir in HIV-1-infected
      adults treated with d4T. Part II is an investigation of the long-term antiviral activity of
      the combination of nevirapine and nelfinavir on viral load as measured by HIV-1 RNA.
    

Intervention name(s): Nelfinavir mesylate; Nevirapine; Stavudine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Nevirapine; Stavudine; Nelfinavir
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1; Drug Therapy, Combination; Nevirapine; Stavudine; RNA, Viral; Nelfinavir; Anti-HIV Agents; Viral Load
General Anesthesia and Autonomic Nervous System in Children
Condition: Anesthesia, General
Study type: Observational

Summary: 
      The objective of the ANESPEDIA study is to describe in a pediatric population (aged from 4 to
      8 years old) receiving elective surgery, the impact of general anesthesia on autonomic
      nervous system and their kinetics of early postoperative course (24 hours).
    

Detailed description: 
      Some physiological factors such as sport activity or pathological as sepsis, certain chronic
      diseases or diabetes are known to modulate the overall autonomic activity and the intrinsic
      capacity of the individual to regulate its sympathovagal balance. These influences can alter
      the physiological autonomic balance sometimes with positive consequences on the Cardiac
      frequency-breathing control, blood pressure adjustment depending on the position of the
      individual, on the status of blood volume, but sometimes deleterious with bad regulation of
      sinus cardiac activity and respiration rate.

      General anesthesia is recognized as one of the factors that can modify more or less
      sustainable the sympathovagal autonomic balance. While many studies described the effects of
      anesthesia on the autonomic nervous system, most data are done in adult subjects. For the
      child who sees intrinsically autonomic physiological changes related to its maturative
      status, assessment of the impact of anesthesia in the pediatric population in per and
      postoperative was never realized.
    

Intervention name(s): Autonomic nervous system activity
Intervention type(s): Device
Intervention description(s): Autonomic nervous system activity (parasympathetic activity) will be measured by electrocardiogram (holter) during 24 hours postoperative
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children from 4 to 8 years enjoying a scheduled surgery without any infection or trauma
        context and performed under general anesthesia
      
Keywords: General anesthesia; Autonomic nervous system; Children
Bioavailability of BI 1356 Administered With and Without Food to Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the food effect on the relative bioavailability and pharmacokinetics of a 5 mg
      BI 1356 tablet administered as a single dose
    


Intervention name(s): BI 1356
Intervention type(s): Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment