bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Molecular Hydrogen Administration on Performance and Body Response on Exercise in National-level Fin-swimmers
Condition: Athletic Performance; Muscle Fatigue; Oxidative Stress
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aim of this randomized, double-blind, placebo-controlled crossover trial is to evaluate
      the effect of hydrogen-rich water consumption on performance, recovery, psychological and
      biochemical outcomes in elite Czech fin-swimmers.
    

Detailed description: 
      Twelve Czech national and international-level fin-swimmers participate in this trial.
      Participants take molecular hydrogen via drinking hydrogen-rich water (HRW) or placebo three
      days before (1260 ml/day) and during testing day (2520 ml). All participants participate in
      two testing session and receive HRW and placebo in random order. Each session includes two
      training units in a 25-m indoor swimming pool and a 24-hour monitored recovery. The first
      training unit takes place in the morning between 9 and 11 AM and includes three high
      intensity interval sets. The afternoon training unit includes a continuous 400-m competitive
      performance. The washout period between testing sessions is 7 days. The variables assessed
      are as follows: swimming times, heart rate variability, lower limb explosive strength, rating
      of perceived exertion, subjective perceived muscle soreness, creatine kinase, blood lactate,
      and protein carbonyls. Statistical analysis is based on analysis of variance for repeated
      measures with factors: water (HRW and placebo), time, and interaction. Fisher's post-hoc
      tests is used for pairwise comparisons. The significance level is set at 0.05.
    

Intervention name(s): Hydrogen rich water; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Hydrogen-rich water with molecular hydrogen concentration 0.9 ppm.; Tap water with molecular hydrogen concentration 0.0 ppm.
Other intervention name(s): Aquastamina-R, Nutristamina, Ostrava, Czech Republic; Aquastamina-Placebo, Nutristamina, Ostrava, Czech Republic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effect of Kinesiotaping and Night Splinting in Patients With Carpal Tunnel Syndome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) which is defined as a symptomatic compression neuropathy of the
      median nerve at the level of the wrist.

      Different types of splints are used for improving the function and decreasing the pain
      intensity and symptoms in the rehabilitation of patients with CTS.

      However effectiveness of treatment by taping has never been investigated in physiotherapy and
      rehabilitation.

      The aim of this study was to compare the short-term effect of conventional physiotherapy
      only, and also kinesio taping and night splinting in patients with CTS.
    

Detailed description: 
      Carpal tunnel syndrome (CTS) which is defined as a symptomatic compression neuropathy of the
      median nerve at the level of the wrist.It is considered as the most common disabling
      neuromuscular condition of the upper extremities.

      Night splints are used in conjunction with the conservative intervention to improve the
      function and decrease the pain intensity and paresthesia in the rehabilitation of patients
      with carpal tunnel syndrome. However effectiveness of treatment by kinesiotaping has never
      been investigated.

      The aim of this study was to compare the short-term effect of conventional physiotherapy
      only, and also kinesio taping and night splinting in addition to conventional physiotherapy
      in the rehabilitation of patients with CTS.
    

Intervention name(s): Kinesiotaping; Night Splinting; Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): A total of 20 sessions physiotherapy sessions including hot pack, ultrasound, kinesiotaping and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.times per day 3sets of ten repetitions) will be applied.; A total of 20 sessions physiotherapy sessions including hot pack, ultrasound, night splinting and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.; A total of 20 sessions physiotherapy sessions including hot pack, ultrasound and exercise program (tendon and nerve gliding exercises=2 times per day 3 sets of ten repetitions) will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: carpal tunnel syndrome; night splinting; kinesiotaping; physiotherapy and rehabilitation
Relationship Between PTEN and Glycemic Variability and Outcome in Critically Ill Patients
Condition: Critical Illness; Hyperglycemia
MeSH terms: Hyperglycemia; Critical Illness
Study type: Observational

Summary: 
      Glycemic variability in critically ill patients is a recognized negative prognostic factor.
      The molecular mechanisms determining inter-patients variability in glucose metabolism during
      stress are not fully understood. The Phosphatase and Tensin homolog (PTEN) is known to
      influence glucose homeostasis by interfering in intracellular insulin signaling.

      Aim of this study is to ascertain whether differential expression of PTEN in critically ill
      patients correlates with glycemic variability and clinical outcome.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Truma patients admitted to general ICU
      
Keywords: ICU; Hyperglycemia; Length of stay
Surgery or Chemoradiation for Esophageal Cancer
Condition: Esophageal Cancers
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare outcomes in patients with operable squamous carcinoma of
      the esophagus who have received either surgery or definitive chemoradiation (CRT).
    


Intervention name(s): Esophagectomy; Definitive chemoradiation
Intervention type(s): Procedure; Radiation
Intervention description(s): The patients will receive standard open esophagectomy with two-field lymphadenectomy; 3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in a three-dimensional conformal mode (total of 50-60 Gy given in 25-30 fractions) will be given over a period 5-6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: squamous cell carcinoma; esophagectomy; chemoradiotherapy; chemoradiation; Squamous cell carcinomas of the esophagus
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ir-CPI in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this First-in-Human study is to assess the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of Ir-CPI, a novel dual inhibitor of FXIIa and FXIa,
      following IV administration of single ascending doses in healthy male volunteers.
    


Intervention name(s): Ir-CPI - Dose 1; Ir-CPI - Dose 2; Ir-CPI - Dose 3; Ir-CPI - Dose 4; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours; 6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours; 6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours; 6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours; For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Antithrombotic; Intrinsic coagulation pathway
Bioavailability Study of MGL-3196 Tablets Compared to Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics of MGL-3196 capsules with
      MGL-3196 tablets in healthy male subjects and female subjects not of child-bearing potential.
    


Intervention name(s): MGL-3196 Tablet; MGL-3196 Capsule
Intervention type(s): Drug; Drug
Intervention description(s): MGL-3196 in Tablet form; MGL-3196 in Capsule form
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study was to document the pharmacokinetic parameters of both
      levetiracetam and its metabolite, ucb L057, after a single dose of 20 mg/kg of levetiracetam
      in epileptic pediatric subjects, aged 1 month to less than 4 years.
    


Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Levetiracetam; Keppra
Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride
Condition: Pharyngitis
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to in order to verify any differences between the 2 treatment groups in terms of
      duration of analgesic effects after the first drug intake and time to remission of symptoms
      and signs of pharyngitis
    


Intervention name(s): Benzidamine hydrochloride; Ketoprofen lysine salt
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketoprofen; Ketoprofen lysine; Benzydamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Observational

Summary: 
      to evalute if therapeutic alliance is related to adherence in JIA
    

Detailed description: 
      The therapeutic alliance is the agreement that is being built between doctor and patient
      during the construction process of care. So active collaboration based on a shared assessment
      of issues and agreement on possible solutions. Initially described in psychiatry, this
      analytical concept has been extended to several chronic diseases in particular requiring more
      often a strong link between doctor and patient. His measure is important since it has been
      demonstrated by several previous studies that the therapeutic alliance is predictive of the
      therapeutic effects of treatment. This alliance, however, was little studied in juvenile
      idiopathic arthritis, its connection with the observance or the quality of life has never
      been evaluated.

      The chronic nature of juvenile idiopathic arthritis (JIA) requires a strong ability of the
      child to follow his treatment, where the role of parents going to be important and where the
      relationship built with the caregiver is also essential.

      Adherence is a complex concept for which there is no ideal measure. Direct evaluation
      criteria such as bioassays prove still incomplete and difficult to implement in observational
      studies. Indirect measures have been developed through self-administered questionnaires and
      literature showed their relatively good correlation with actual catches. The innovative
      hypothesis of this research is that a better therapeutic alliance is associated with better
      adherence child in JIA.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with Juvenile idiopathic arthritis (JIA) and aged from 8 to 18 years, that have
        been akready seen more than 2 times in consultation by the same practitioner.

        Treatment is based on the non-steroidal anti-inflammatory drugs, corticosteroids or
        immunosuppressant therapy and due to chronic nature of JIA, it requires a strong ability of
        the child to follow his treatment. The role of parents going to be important and the
        relationship built with the caregiver is essential. As much as in adults, and can be more
        complex way the question of adherence / therapeutic adherence.
Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions
Condition: Prevention; Rehabilitation
MeSH terms: Deglutition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The research is about a prospective study conducted in patients suffering from dysphagia and
      cervical spine disorders and how they are interrelated. Three questionnaires have been given
      to patients with neurologic deficits, the first of these investigates the occurence of
      dysphagia in the three stages of swallowing, the second looks into the quality of life
      following a stroke or other neurologic damage and the third analyses how cervical spine
      disorders can affect every day life. After the bedside examination, VFSS or FEES, the
      patients are submitted to swallowing and cervical resistance exercises in fixed time periods
      after their hospitalisation. The results will be collected and evaluated using the
      statistical programme SPSS.
    


Intervention name(s): Videofluroscopic swallow study (VFSS); cervical spine isometric exercises; Fiberoptic endoscopic esophageal study (FEES)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Barium, radiation; patients with cervical scoliosis will execute isometric exercises of the cervical spine; food for swallowing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: spine injuries; brain lesions; dysphagia
Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of two recombinant HIV vaccines in HIV
      infected young adults on stable anti-HIV therapy.
    

Detailed description: 
      By helping to control viral replication, HAART has dramatically improved the prognosis for
      HIV infected individuals. However, because of extensive side effects, some of which may be
      acute and life-threatening, many patients find it difficult to tolerate a HAART regimen.
      HAART-associated long-term morbidity or mortality contribute to this difficulty.
      Administering an HIV therapeutic vaccine might allow HIV infected individuals to delay or
      interrupt treatment, avoiding the side effects associated with antiretroviral exposure. This
      study will evaluate the safety of two injections of two recombinant therapeutic vaccines in
      HIV infected young adults who are currently on stable HAART.

      This study will last 72 weeks. All participants will receive two rMVA vaccines (env/gag and
      tat/rev/nef-RT) at study entry and at Week 4 and two rFPV vaccines (env/gag and
      tat/rev/nef-RT) at Weeks 8 and 24. Safety will be assessed immediately after each
      immunization and at 1 hour and 48 hours postimmunization. There will be 16 study visits over
      72 weeks. A physical exam, blood collection, and administration of an adherence module will
      occur at most visits. An electrocardiogram (ECG) will occur at study entry and Weeks 2 and
      10. Urine collection will occur at study entry and Weeks 4, 8, and 24.
    

Intervention name(s): rMVA-HIV (env/gag [TBC-M358] + tat/rev/nef-RT [TBC-M335)]); rFPV-HIV (env/gag [TBC-F357] + tat/rev/nef-RT [TBC-F349])
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant experimental therapeutic vaccine using the modified vaccinia Ankara vector given at study entry and Week 4; Recombinant experimental therapeutic vaccine using fowlpox vector given at Weeks 8 and 24
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment Experienced; HIV Therapeutic Vaccine
The Effect of Genetic Variation in TMPRSS6 Gene (SNP rs855791) on Oral Iron Absorption: an Iron Stable Isotope Study
Condition: Iron Metabolism Disorders
MeSH terms: Metabolic Diseases; Iron Metabolism Disorders
Study type: Interventional

Summary: 
      Iron deficiency is considered the most common nutritional deficiency worldwide and affects
      children and women in both non-industrialized as well as industrialized countries. The main
      regulatory molecule of iron metabolism is hepcidin, a hormone produced in the liver that
      regulates intestinal iron absorption, placental transport, recycling of iron by macrophages
      and release from stores. The expression of hepcidin is regulated by many mediators, one of
      which is Matriptase-2 - a transmembrane protease. Complete loss of function leads to the rare
      disease iron-refractory iron deficiency anemia (IRIDA). Matriptase-2 is encoded by the gene
      TMPRSS6 and the single nucleotide polymorphism (SNP) rs855791 causes a non-synonymous
      substitution (V736A) that reduces the activity of the protease to inhibit hepcidin
      transcription. Genome wide association studies have identified the TMPRSS6 SNP rs855791 has a
      strong association with red blood cell and iron parameters in the general population.

      The objectives of the study is to measure oral iron absorption and systemic iron utilization
      into red blood cells (RBC) using oral isotopic labels in subjects homozygotes for common
      variants of the TMPRSS6 gene with the SNP rs855791 (A736V); AA vs. VV subjects.

      The aim is to conduct an iron absorption study in 80 Taiwanese women of reproductive age,
      non-pregnant, non-anemic, investigating the effect of the genetic variants of the SNP
      rs855791. The participants will be split in two groups of equal size; wild type AA vs.
      mutation VV. Iron absorption and systemic utilization will be assessed by two test meals
      containing stable isotopes of iron.The primary outcome of the trial is the oral iron
      absorption from a test meal as compared between the two genotypes AA vs. VV. Secondary
      outcomes are the comparison iron status markers between the two genotypes.
    


Intervention name(s): Testmeal A; Testmeal B
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The tesmeal A is is plain rice, with a seaweed sauce, fortified with labelled iron as stable iron isotope as ferrous sulfate; The tesmeal B is plain rice, with a seaweed sauce, fortified with labelled iron as stable iron isotope as ferrous sulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Taperloc Complete Microplasty vs Taperloc Complete Standard: Randomized Controlled Study on Bone Mineral Density
Condition: Osteoarthritis; Avascular Necrosis; Traumatic Arthritis; Rheumatoid Arthritis; Legg-Perthes Disease
MeSH terms: Arthritis; Legg-Calve-Perthes Disease; Necrosis
Study type: Interventional

Summary: 
      The primary purpose of this study is to measure the postoperative changes in bone mineral
      density, comparing the Taperloc Complete Reduced Distal Microplasty stem and the standard
      length Taperloc Complete Reduced Distal stem.
    

Detailed description: 
      The Taperloc Microplasty cementless stem is designed to transmit load to the proximal femur,
      thereby preserving bone density, and preventing long term instability and loosening secondary
      to proximal bone resorption. The primary aim of this study is therefore to compare the
      postoperative changes in bone density with the Taperloc Microplasty stem, using the standard
      length Taperloc stem as a control.

      In addition, the Taperloc stem has historically had a neck angle of 138°. There have been
      criticisms that this neck angle is too high for the typical Korean population. The newer
      Taperloc Complete system (both Microplasty and standard length) has a neck angle of 133°. A
      secondary aim is Occurrence ratio of thigh pain difference between Microplasty and standard
      stem in Korean Population
    

Intervention name(s): Taperloc Complete Microplasty; Taperloc Complete Standard
Intervention type(s): Device; Device
Intervention description(s): Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.; Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Condition: Hepatobiliary Disorders; Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases; Liver Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once
      daily versus placebo in subjects with non-alcoholic steatohepatitis
    


Intervention name(s): Semaglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg); Once daily administration subcutaneously ( s.c., under the skin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment