bioihbjkbjnl/mcl2 huggingface dataset:
Functional Evaluation of Kefir Drink on Antifatigue and Exercise Exercise Performance-2
Condition: Exercise Performance; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Purpose: The aim of the present study was to evaluate potential beneficial effects of Kefir
      drink (Synbio Tech Inc., Kaohsiung City, Taiwan) on fatigue and ergogenic functions following
      physiological challenge. Methods: 16 male subjects, 8 in each group, were divided into two
      groups according to the principle of maximal oxygen uptake, which were (1) first-stage
      placebo and second-stage Kefir group (hereinafter referred to as group A). (2) The first
      phase of Kefeier, the second phase of the placebo group (hereinafter referred to as group B),
      after 4 weeks of supplementation, the performance and fatigue resistance tests were carried
      out in sequence, including: treadmill aerobic endurance exhaustion time, and fixation
      Exercise time and intensity challenge changes in blood lactate, blood urea nitrogen
      concentration and creatine kinase activity, as well as differences in body composition before
      and after supplementation. After the first phase of the test is completed, the four weeks of
      emptying are performed. And after adding the crossover sample, perform four weeks of
      supplementation and testing again.
    


Intervention name(s): Kefir; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 28 days supplementation kefir drink (prepared by inoculating pasteurized 9.2% reconstituted skim milk with powder kefir starter culture and fermented at 37 °C for 16 h. The fermented milk was then pasteurized at 100 °C for 30 min and freeze dried. The powder kefir starter culture used for inoculation was composed of defined lactic acid bacteria strains which contains Lactobacillus fermentum DSM 32784 (LF26), L. helveticus DSM 32787 (LH43), L. paracasei DSM 32785 (LPC12), L. rhamnosus DSM 32786 (LRH10), and Streptococcus thermophilus DSM 32788 (ST30)), 200ml/day; Maltodextrin, same calorie as kefir, 200ml/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open label, fixed sequence study of the effect of multiple dose
      PF-06650833 on single dose OC PK in healthy female subjects.
    


Intervention name(s): PF-06650833; Ethinyl estradiol (EE) and levonogestrel (LN)
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg by mouth (PO) Once daily (QD) for 11 days; Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
Other intervention name(s): Oral contraceptive (OC)
Intervention MeSH terms: Ethinyl Estradiol; Contraceptive Agents; Contraceptives, Oral; Estradiol
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Trial of BTT1023 in Patients With Primary Sclerosing Cholangitis
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study to determine the safety and preliminary efficacy of a human
      monoclonal antibody (BTT1023) which targets the vascular adhesion protein (VAP-1) and its use
      in the treatment of patients with primary sclerosing cholangitis (PSC).
    

Detailed description: 
      Primary sclerosing cholangitis is a progressive immune mediated biliary disease characterised
      by bile duct inflammation and fibrosis, and accompanying hepatic fibrosis. For patients with
      elevated alkaline phosphatase (ALP) in particular, progressive disease is predicted, that
      currently results in a need for liver transplantation in the majority. No current medical
      therapy has as yet been shown to be effective in altering the natural history of disease. For
      this reason patients with PSC with elevated ALP values will be recruited to this study, to
      evaluate the impact of Vap-1 blockade by BTT1023, in an early phase study focused on
      biochemical efficacy and safety.

      This is an early phase study of BTT1023 in immune mediated liver disease, with the rationale
      to identify biochemical efficacy of effect (reduction in ALP) and safety, in an orphan
      disease indication for PSC that presently lacks any other medical therapy. The study design
      therefore focuses on identifying early biochemical efficacy signals to justify larger scale,
      randomised controlled studies over longer duration.
    

Intervention name(s): BTT1023
Intervention type(s): Drug
Intervention description(s): IV (in the vein) Investigational Medicinal Product (IMP)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BUTEO; Primary sclerosing cholangitis; PSC; VAP-1; BTT1023; Human monoclonal antibody
Ischemia Modified Albumin (IMA) Expression in the Male and Female Population
Condition: Group Identification
MeSH terms: Ischemia
Study type: Observational

Summary: 
      The study has as general objective to analyze in the adult population, (male and female) the
      presence of a very common protein, in its normal form and modified, isolated from the blood
      of patients and called albumin. The opportunity to observe the distribution of this protein
      in the population, provides the basis to be able to perform this type of assay also in the
      population of patients with pathologies, in the near future, with the aim of increasing
      knowledge on the subjective tolerability to orthopedic implants.
    

Detailed description: 
      100 patients, waiting for elective surgical intervention (such as hip replacement or primary
      knee ligament reconstruction, arthroscopy), distributed evenly by gender and age (50 men, 50
      women including 25 postmenopausal and 25 in bearing age) and afferent to the Department of
      Surgery Prosthetic hip and knee of our Institute, will be enrolled. At execution time of
      blood sampling routine, a further specimen of whole blood (7 ml) will be added which will be
      sent to the Medical technology laboratory for IMA dosage. In addition, total albumin,
      ferritin, transferrin and serum iron will be analyzed from clinical pathological laboratory.
      The investigators will be able to analyze the IMA and normalized IMA distributions with
      respect to gender factor and correlation with the three listed blood tests (ferritin,
      transferrin and serum iron).
    

Intervention name(s): blood exams
Intervention type(s): Other
Intervention description(s): in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        25 males under 45y, 25 males over 45y, 25 fertile females and 25 infertile females
      
Biospecimen description: 
      Serum vials
The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor
Condition: Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The purpose of this study is to verify the effect of neurofeedback-assisted mindfulness
      training for workers. Subjects who can participate in the screening are assigned to one
      neurofeedback-assisted mindfulness training group, mindfulness only training group, and
      self-treatment group. The neurofeedback-assisted mindfulness group and the mindfulness group
      meet with psychologist and have education for the mindfulness training with or without
      neurofeedback respectively, a total of 4 times, once a week. On the other hand, the
      self-treatment group provides self-education by providing the stress education kit.
    

Detailed description: 
      After screening, Pre-evaluation is conducted on the subjects who agreed to participate in the
      study. Pre-assessment includes questionnaires related to stress, emotional labor, resilience,
      sleep, etc., and includes stress-related physiological measures using HRV, 2 lead EEG. After
      the pre-evaluation, the neurofeedback-assisted mindfulness and mindfulness training group
      will have education sessions with a psychologist for 30 minutes at a time, once a week, for a
      total of 4 sessions (one month for a period). The education includes the instruction of the
      application including mindfulness training, with or without neurofeedback, and the review for
      the accomplishment of the training. Participants should follow the instruction and the
      training schedule which is arranged in advance. On the other hand, for a self-care control,
      the education sessions are not provided and self-learning materials are provided once a week.
      The purpose of the study is to find the effectiveness of mindfulness training on reduction of
      stress and severity of emotional labor. Especially, mindfulness training group with
      neurofeedback might be expected to show the highest improvement in various clinical scales
      and biomarkers including EEG and HRV.
    

Intervention name(s): stress management and meditation
Intervention type(s): Behavioral
Intervention description(s): mindfulness training using mobile application
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy individuals recruited through advertisement
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: resilience; emotional labor; mindfulness; neurofeedback
Protein Ingestion and Skeletal Muscle Atrophy
Condition: Muscle Atrophy
MeSH terms: Muscular Atrophy; Atrophy
Study type: Interventional

Summary: 
      The effect of different protein intakes on skeletal muscle atrophy during short term
      unilateral leg immobilisation.
    


Intervention name(s): Lower limb immobilisation (leg brace) with varying levels of protein intake
Intervention type(s): Other
Intervention description(s): Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Salivary Drug Concentration Exploratory Study of Cetylpyridinium Chloride Buccal Tablets
Condition: Pharyngitis Acute; Gingivitis
MeSH terms: Gingivitis; Pharyngitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a single-arm, open-label study to explore the salivary concentration of
      Cetylpyridinium Chloride Buccal Tablets after single-dose administration in Healthy Subjects
    

Detailed description: 
      Primary Objective: To observe the concentration of the investigational product in the saliva
      of healthy subjects.

      Secondary purpose: To observe the safety of the investigational product in healthy subjects.
    

Intervention name(s): Cetylpyridinium Chloride Buccal Tablets
Intervention type(s): Drug
Intervention description(s): Subjects administrated single dose of Cetylpyridinium Chloride Buccal Tablet
Intervention MeSH terms: Cetylpyridinium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: salivary drug concentration
A Study to Compare the Pharmacokinetic Profiles of DW224aa and DW224a
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare and explore pharmacokinetics of zabofloxacin, the
      main component of DW224aa(Test drug) and DW224a(Reference drug).
    


Intervention name(s): Experimental DW224aa; Experimental DW224a
Intervention type(s): Drug; Drug
Intervention description(s): DW224aa tablet, single dose; DW224a capsule, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
The Evaluation of the Effect of Preoperatively Applied Throat Lozenge
Condition: Anesthesia; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Purpose:The aim of this study is to evaluate the effect of preoperative throat lozenge on
      pain relief in the postoperative period of the mucosal damage caused by intubation in
      patients who underwent operations in the head and neck region under general anesthesia.

      Methods: 60 patients were included in this study who were hospitalized in the inpatient
      service of the Oral and Maxillofacial Surgery department, This study was single-blind and
      performed by the same practitioner. Throat lozenge (strepsilis) was given to patients 30
      minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9
      minutes).The postoperative sore throat was evaluated by VAS scale (0=no pain, 10=unbearable
      pain), and cough and hoarseness were evaluated with a four-point Likert scale (0=absent,
      3=severe) at 1, 4, 6, 12, and 24 hours.
    

Detailed description: 
      Before the operation, blood sugar, urea, creatinine, electrolytes, prothrombin time, active
      partial thromboplastin time, and liver enzyme levels were determined in all patients.
      Hemoglobin and hematocrit determinations were made. Electrocardiography and chest radiographs
      were taken. Patients whose biochemical tests were within normal limits were included in our
      study.

      The study was single-blind and performed by the same practitioner. Throat lozenge
      (strepsilis) was given to 30 patients, and sugar dragee in the same size and shape was given
      to 30 patients 30 minutes before the operation (the dissolution rate of the lozenge was
      proven to be 6-9 minutes). In order not to cause any complications, sugar patients were
      sucked and told not to chew.

      Before the initiation of general anesthesia, height, weight, intubation time, mallampati
      score and ASA classification, the name of the operation, the start and end time of the
      operation, smoking, tube number, and whether spasms occurred were recorded. Patients taken to
      the service in the postoperative period were rested by wearing an oxygen mask. Postoperative
      sore throat VAS scale (0 = no pain, 10 = unbearable pain), cough, and hoarseness were
      assessed at 1, 4, 6, 12, and 24 hours with a four-point Likert scale (0 = absent, 3 =
      severe).
    

Intervention name(s): strepsilis; Placebo
Intervention type(s): Other; Other
Intervention description(s): Throat lozenge (strepsilis) was given to patients 30 minutes before the operation (the dissolution rate of the lozenge was proven to be 6-9 minutes).; Sugar dragee in the same size and shape was given to 30 patients 30 minutes before the operation. In order not to cause any complications, sugar patients were sucked and told not to chew.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Pain; Anesthesia and Analgesia; Orthognathic Surgery
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
Condition: Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with
      body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot
      participate. The purpose of this study is to find out whether a medicine called BI 456906
      helps people lose weight.

      Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The
      fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin
      once a week. Placebo injections look like BI 456906 injections but do not contain any
      medicine.

      Participants are in the study for about a year. During this time, there are about 20
      in-person visits to the study site. At the study site visits, doctors measure participants'
      body weight. Results are compared between the BI 456906 groups and the placebo group. The
      doctors also regularly check the general health of the participants.
    


Intervention name(s): BI 456906; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 456906; Placebo
Other intervention name(s): Survodutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Zinc Sulphate vs. Zinc Amino Acid Chelate
Condition: Diarrhea; Acute Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute respiratory infection and acute diarrhea are among the most prevalent diseases of
      childhood increase the burden of morbidity and mortality in children under 5 years.

      Among the possible strategies for its prevention is important to count on good nutritional
      status for use in developing a good immune response to infections. Zinc deficiency has been
      shown to favor the development of infections and has been considered a real public health
      problem.

      Within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that
      has shown evidence of being better absorbed and tolerated.

      We propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in
      the prevention of acute diarrheal disease and acute respiratory infection.
    


Intervention name(s): Zinc sulfate as dietary supplementation; Zinc amino acid chelate as dietary supplementation; Milk without fortification without zinc
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Zinc sulfate as dietary supplementation; Zinc amino acid chelate as dietary supplementation; Milk without fortification
Other intervention name(s): Milk without zinc
Intervention MeSH terms: Zinc; Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Child, Preschool; Dietary Zinc; Zinc sulfate; zinc-glycine chelate
SECOX as Neoadjuvant Therapy in Patients With Locally Advanced HCC
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the resectability after treatment with SECOX
      (sorafenib, capecitabine, oxaliplatin) as neoadjuvant therapy in patients with locally
      advanced hepatocellular carcinoma
    


Intervention name(s): Sorafenib; Capecitabine; Oxaliplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PO; PO; IV
Other intervention name(s): Nexavar
Intervention MeSH terms: Capecitabine; Oxaliplatin; Sorafenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Omega-3 Supplementation on Serum Level and Gene Expression of IGF-1and IGFBP-3 in Men With CVD.
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is the comparison between the effects of supplementation with omega 3
      or placebo for 8 weeks in serum level of IGF-1 and IGFBP-3 and gene expression of IGF-1 in
      patients with cardiovascular disease.
    


Intervention name(s): Omega-3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 cap 1 g Omega-3 per day for 2 months; 4 cap 1 g Placebo(paraffin) per day for 2 months
Other intervention name(s): n-3 fatty acids; n-3 PUFA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atherosclerotic; IGF-1; IGFBP-3
The Effects of Yoga on Body Image in College Women
Condition: Body Image; Eating Disorder; Obesity; Yoga
MeSH terms: Obesity; Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of a regular yoga practice on body image
      in college women.
    

Detailed description: 
      A randomized controlled design will be used to study the effects of a regular yoga practice
      on body image in young adult women. Fifty female freshman, sophomores, and juniors between
      the ages of 18 and 26 years will be recruited from the University of Delaware student
      population, specifically targeting those new to yoga. Age, academic standing, availability
      and prior yoga experience will be evaluated.

      Consented individuals will be randomized to one of two conditions: (1) yoga (offered 3 times
      per week) for 10 weeks; or (2) a control group. Baseline assessments, midpoint assessments,
      and end-of-study assessments will be conducted on all participants. Participants will be
      compensated for their attendance at assessment visits.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention description(s): The yoga classes will be adapted to all levels of experience, mobility, and body size. Specific breathing techniques and body positive language will be incorporated into a body-positive yoga training done by Ms. Lisa Diers, RDN, E-RYT, YACEP. Less focus will be placed on precision of the poses, instead focus will be on body feelings, except where physically dangerous. Thus, the overall focus will be on listening to one's own body. List of messages will be carefully designed to be related to eating and weight, but to not be directly discussed. Ms. Diers will travel to Delaware to lead the intervention training for yoga instructors prior to the study taking place.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention