bioihbjkbjnl/mcl2 huggingface dataset:
Survey of Symptoms After a COVID Vaccination in Employees
Condition: Symptoms Recoding SARS-CoV-2 After Vaccination
Study type: Observational

Summary: 
      Background:

      SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) has had us firmly in its
      grip for more than two years. In January 2021, the quality and risk management unit of the
      LKH (Landeskrankenhaus) -Univ. Klinikum Graz commissioned to carry out vaccinations for
      employees and subsequently for high-risk patients.

      In the vaccination line, which was open for 85 days in 2021/22, the vaccines from Astra
      Zeneca, Biontech-Pfizer and Moderna were vaccinated. There were hardly any complications. The
      primary immunization, booster vaccination and booster vaccination were carried out.

      Despite the small number of incidents in the sense of an immediate reaction, there were
      numerous sick leave.

      Methods:

      For this reason, in the course of the booster vaccination, starting from October 2021 to
      January 2022, every vaccinated person was asked to fill out a questionnaire. Participation
      was voluntary and was supported by the works councils of the Medical University and the
      LKH-University clinic Graz approved. The survey served to retrospectively record how many
      employees developed symptoms in response to the respective vaccination.

      With this approach it will be possible to subject the responses to an in-depth statistical
      analysis in order to obtain a data-based contribution to the side effects of vaccines
      categorized with different vaccination schemes.
    


Intervention name(s): questionnaire
Intervention type(s): Other
Intervention description(s): questionnaire
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Employees of the University Clinic Graz who get a booster vaccination.
      
Keywords: SARS-CoV-2; Symptoms
A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects
Condition: Healthy; Pharmacokinetics of ASP0456
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single
      ascending dose of ASP0456 in non-elderly healthy subjects.
    


Intervention name(s): ASP0456; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): linaclotide
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: ASP0456; Pharmacokinetics; safety; tolerability
PE-1 in the Diagnosis of Pancreatic Exocrine Insufficiency
Condition: Pancreatic Exocrine Insufficiency
MeSH terms: Exocrine Pancreatic Insufficiency
Study type: Interventional

Summary: 
      The aim of this study was to evaluate and determine the clinical performance of Fecal
      Pancreatic Elastase 1 Test in the diagnosis of pancreatic exocrine insufficiency.
    

Detailed description: 
      Fecal Pancreatic Elastase 1 (PE-1)Test has high diagnostic accuracy in pancreatic exocrine
      insufficiency (PEI), has become a painless noninvasive diagnostic modality in clinical
      practice, and has been widely used in clinical practice.

      However, in China, the diagnostic ability of the PE-1 test in the Chinese population has not
      been demonstrated and has not been reported. Meanwhile, pancreatin stimulation, 13C-mixed
      triglyceride breath test, and N-benzoyl-L-tyrosyl-p-aminobenzoic acid test required drugs,
      which cannot pass the examination of the drug administration and were not allowed to be
      carried out to diagnose PEI in China. In addition pancreatin stimulation is an invasive test
      has certain risks for subjects and 72-hour fecal fat quantification was mainly used for the
      diagnosis of severe PEI. Therefore, This study adopted strict clinical diagnosis as a
      comparative method for PE-1 test to judge the ability of PE-1 test to diagnose PEI in the
      Chinese population.

      This study aims to clarify the application efficacy of PE-1 test in PEI through a
      multi-center, prospective clinical study comparing PE-1 test with strict clinical diagnosis.
      To study the accuracy of PE-1 test in the diagnosis of PEI.
    

Intervention name(s): Fecal pancreatic elastase 1 test
Intervention type(s): Diagnostic Test
Intervention description(s): Fecal pancreatic elastase 1 test are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PE-1; Pancreatic exocrine insufficiency
Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine
Condition: Encephalitis, Japanese; Measles; Mumps; Rubella
MeSH terms: Measles; Rubella; Mumps; Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine
      (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not
      adversely affect immunogenicity or safety.
    

Detailed description: 
      When incorporating a new vaccine in the Expanded Programme on Immunization (EPI), it is
      important to provide evidence that it can be introduced concurrently with other routine
      pediatric vaccines without significantly impairing the immune response to any vaccine while
      maximizing coverage and minimizing cost. This non-inferiority study aims to compare CD-JEV
      and MMR responses in a population of children in a country where MMR introduction is ongoing
      or planned. This information will help the ministries of health evaluate the addition of
      CD-JEV into routine EPI.
    

Intervention name(s): Live attenuated SA 14-14-2 Japanese Encephalitis vaccine; Measles, mumps, rubella vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Single 0.5 mL dose of World Health Organization prequalified live, attenuated SA 14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products, Chengdu, China, administered by subcutaneous injection; Single 0.5 mL dose of live, attenuated measles-mumps-rubella vaccine (Schwarz measles virus, RIT 4385 mumps strain, and Wistar RA 27/3 rubella virus) manufactured by GlaxoSmithKline, Inc., administered by subcutaneous injection.
Other intervention name(s): CD-JEV; CD.JEVAX®; RS.JEV®; MMR; Priorix®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
Condition: Constipation
MeSH terms: Constipation; Fistula
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To evaluate the clinical efficacy of Naturetti (capsules) , considering the following
      criteria:

        -  Evacuation frequency during the treatment and follow-up period

        -  Consistency of stools during the treatment and follow-up period

        -  Global evaluation, regarding increase in frequency of evacuation and shape of stools.

      Secondary Objective:

        -  Number of days without evacuation

        -  Proportion of evacuation with pain

        -  Proportion of evacuation with strain

        -  Proportion of evacuation with incomplete sensation

        -  Proportion of blocked stools

        -  Proportion of manual maneuvers to facilitate defecation

        -  Proportion of subjects that adhere to the diet recommended

        -  Proportion of the patients who have to use rescue medication

        -  Level of constipation improvement, according to the patient evaluation

        -  To evaluate clinical tolerability of the study medication by the continuous use

        -  To evaluate the occurrence of adverse events related to the study drug

        -  To identify any drug interaction.
    


Intervention name(s): SENNA+CASSIA; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: capsule Route of administration: oral Dose regimen: once a day; Pharmaceutical form: Capsule Route of administration: oral Dose regimen: once a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Exercise on Post-Covid Symptoms
Condition: COVID-19
Study type: Interventional

Summary: 
      The study aimed to investigate the effects of strengthening and relaxation exercises on pain,
      anxiety, and sleep quality. 76 post-covid patients were randomized into experimental and
      control groups. Experimental group patients performed strengthening and relaxation exercises
      3 times a week for 8 weeks. Control group patients did not perform any program. All
      participants were assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36),
      Pittsburgh sleep quality index (PSQI) before and after the study.
    

Detailed description: 
      After COVID-19, musculoskeletal pain, anxiety, and sleep problems can continue. The study
      aimed to investigate the effects of strengthening and relaxation exercises on pain, anxiety,
      and sleep quality. The study was performed at Gaziosmanpaşa Education and Research Hospital
      with 76 post-covid patients that were randomized into experimental and control groups.
      Experimental group patients performed strengthening and relaxation exercises 3 times a week
      for 8 weeks. Control group patients did not perform any program. All participants were
      assessed with McGill Pain Scale short form (SFMPQ), short-form 36 (SF-36), and Pittsburgh
      sleep quality index (PSQI) before and after the study.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Strengthening and Relaxation Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Influence of Specific Collagen Peptides on Recovery After Exercise Induced Muscle Damage
Condition: Recovery
Study type: Interventional

Summary: 
      The present study aims at investigating the potential influence of specific collagen peptides
      on recovery after exercise induced muscle damage with focus on long-term effects.
    


Intervention name(s): Collagen; Concurrent training
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants ingest 15 grams of either specific collagen peptides or Placebo daily; Both arms undergo a 12-week trainingintervention 3x/week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Collagen peptides; Concurrent training; Ultrasound; MVC; RFD
MRI Exploration of Protein Digestion
Condition: Gastric Digestion
Study type: Interventional

Summary: 
      The goal of this study is to assess the feasibility of using MRI for in vivo monitoring of
      gastric milk digestion (protein coagulation and breakdown). The study will be in healthy
      normal-weight individuals aged between 18 and 45 years.

      The main questions it aims to answer are:

        1. Is there a significant effect of time on the postprandial magnetization transfer ratio
           (MTR) of the stomach contents?

        2. Can a difference in postprandial MTR of the stomach contents between the test products
           be detected?

      Participants will visit after an overnight fast two times and then have MRI scans of the
      stomach before and after the consumption of 500 mL of pasteurized or high-pasteurized skim
      milk.
    

Detailed description: 
      Rationale: Gastric digestion is the first step in the breakdown of dietary proteins, and is
      therefore essential for the further breakdown in the intestines and subsequent absorption of
      amino acids. Food processing, such as heating can modify the structure and digestibility of
      proteins. Digestion of dietary protein, and how this is affected by heating is often studied
      using in vitro digestion models that mimic the digestive tract. However, outcomes from these
      models need to be verified using in vivo digestion data from humans. Such data can in turn be
      used to improve digestion models. Magnetic resonance imaging (MRI) may be used to
      non-invasively monitor both in vitro and in vivo protein digestion, and hence, may bridge the
      gap between in vitro digestion models and real-life digestion physiology. The investigators
      have recently established candidate MRI markers for gastric protein digestion using in vitro
      models (MT and CEST MRI). As a next step, their potential for in vivo application needs to be
      established. Therefore, the aim of this research is to do a feasibility study in humans.

      Objective: Assess the feasibility of using MT MRI for in vivo monitoring of gastric milk
      digestion (protein coagulation and breakdown).

      Study design: Randomized cross-over study with two treatments.

      Study population: 12 healthy volunteers, 18-45 years old.

      Intervention: Participants will ingest 300 mL of commercial pasteurized skim milk (SM, heated
      for 20 s at 72 °C) and of high pasteurized skim milk (heated for 30 min at 80 °C). MRI scans
      of the stomach will be made at baseline, at t = 5 min and at 15-minute intervals up until t =
      95 minutes after the start of ingestion. In addition, verbal ratings of hunger, fullness and
      nausea will be collected.
    

Intervention name(s): skim milk
Intervention type(s): Other
Intervention description(s): pasteurized or high-pasteurized skim milk
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of MFPP
Condition: Myofascial Pelvic Pain
MeSH terms: Pelvic Pain
Study type: Interventional

Summary: 
      Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major
      contributor of female chronic pelvic pain. However, the effect of the patient's
      self-myofascial release (SMFR) is not clear. Current study is to investigate the effect of
      SMFR combined with biofeedback and electrical stimulation (BES) therapy compared with BES
      alone in patients with MFPP.
    

Detailed description: 
      68 patients was enrolled and randomly allocated into two groups: BES-SMFR group (n=34) and
      BES group (n=34). Every patient received 4 weeks treatment, and was evaluated at baseline
      (T0), 4-week post-intervention (T4) and 12-week follow-up (T12). The primary outcome was pain
      intensity. The secondary outcomes were degree in activation of MTrPs, surface
      electromyography (sEMG) levels, and Patient Global Impression of Improvement (PGI-I).
    

Intervention name(s): BES-SMFR; BES
Intervention type(s): Procedure; Procedure
Intervention description(s): For the BES intervention, it was performed using the same Vishee neuro-muscle stimulator as the sEMG assessment with a vaginal probe was inserted into the vagina and placed close to the PFMs. At the same time, patients could learn about their neuromuscular activity through the biofeedback instrument, abdominal breathing for 5 sec was necessary when PFMs were overactive. BES was performed once every 2 days for 4 weeks.; First, a standardized and structured vaginal examination was performed by digital palpation to identify pelvic floor active MTrPs, and then pain mapping was developed for the patient's use. Second, patients were required to participate in intensive training regarding myofascial release techniques. Following the training, SMFR was regularly performed by at home for 5 minutes daily for 4 weeks. SMFR was confirmed with patients at all their follow up visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy
Condition: Tolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the efficacy and safety of the administration of lidocaine spray in
      oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the
      other half will receive a placebo.
    


Intervention name(s): Lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Lidocaine; Endoscopy; Tolerance
Bioequivalence Study
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if tablets manufactured at different sites have the
      same bioavailability, that is yield similar blood levels/concentrations of the drugs and are
      handled by the body similarly
    

Detailed description: 
      Primary Purpose:

      Other: Protocol designed to demonstrate the bioequivalence of the fixed dose combination of 5
      mg Saxagliptin and 1000 mg Metformin Extended Release Tablet manufactured in Mt. Vernon,
      Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured
      in Mt. Vernon, Indiana and the bioequivalence of the fixed dose combination of 5 mg
      Saxagliptin and 500 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana
      and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt.
      Vernon, Indiana in healthy human subjects under fed conditions
    

Intervention name(s): Saxagliptin/Metformin
Intervention type(s): Drug
Other intervention name(s): Kombiglyze XR
Intervention MeSH terms: Metformin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Beauty Image Efficacy Study
Condition: Skin Aging
Study type: Interventional

Summary: 
      The objective is to evaluate the effects of oral supplement of a blend containing collagen
      peptides, phosphatidylserine, Saussurea involucrata and lutein (Beauty Image) on the
      improvement of skin aging in terms of hydration, gloss, melanin content, roughness and
      wrinkling, and anti-UV performance.
    


Intervention name(s): Beauty Image; Placebo Control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1.97g/package; 2 packages one day for 8 weeks; Placebo Control; 1.97g/package; 2 packages one day for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label study for patients who participated in the BPS-MR-PAH-203 study and
      have volunteered to continue treatment for PAH with Beraprost Sodium Modified Release
      (BPS-MR) tablets.
    

Detailed description: 
      Eligible patients who participated in BPS-MR-PAH-203 and who elect to continue receiving
      study drug in an open-label extension.Each patient will return to the clinic following
      enrollment in the study at 3, 6, and 12 months, and annually thereafter for assessment.
      Patients will be called by study personnel to assess adverse events and concomitant
      medications at Month 9, and at 3 month intervals following the annual visit.

      At the End of Study visit, patients discontinuing study drug will be down-titrated off of
      BPS-MR at the discretion of the Investigator, at a maximum decrement of one tablet (60µg)
      b.i.d. per day and a minimum decrement of one tablet (60µg) b.i.d. per week. Likewise,
      patients who withdraw early from the study will be down-titrated off of BPS-MR in the same
      manner. Upon completion of down-titration, patients will return to the clinic for a final
      Closeout visit.

      Currently enrolled patients may be invited to participate in an optional four times daily
      (QID) dosing substudy of BPS-MR with total daily dose of BPS-MR achieved previously in the
      main study. Patients will return to the clinic for baseline visit, week 12, and then will
      follow the visit schedule provided to them in BPS-MR-PAH-204 main study.
    

Intervention name(s): Beraprost Sodium Modified Release
Intervention type(s): Drug
Other intervention name(s): BPS-MR Tablets, 60mcg; Beraprost Sodium Modified Release Tablet, 60mcg
Intervention MeSH terms: Epoprostenol; Beraprost
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MMPPC Outpatient Clinical Protocol 2016
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This study trials a prototype artificial pancreas system that consists of a Roche insulin
      pump, a Dexcom continuous glucose monitor (CGM), and an experiential MMPPC (multiple model
      probabilistic predictive control) algorithm housed on an android cell phone. The system doses
      insulin based on CGM sensor glucose levels and the experimental algorithm.

      The aim of this clinical study is to determine the efficacy of the MMPPC controller in
      adolescents and adults with type 1 diabetes in a hotel setting.
    

Detailed description: 
      This study trials a prototype artificial pancreas system that consists of a Roche insulin
      pump, a Dexcom continuous glucose monitor (CGM), and an experiential MMPPC (multiple model
      probabilistic predictive control) algorithm housed on an android cell phone. The system doses
      insulin based on CGM sensor glucose levels and the experimental algorithm. The algorithm runs
      through a glucose control platform called the DiAs (Diabetes Assistant)

      The aim of this study is to determine the safety and feasibility of the MMPPC controller in
      adults and adolescents with type 1 diabetes testing the use of predefined tuning parameters
      to provide adaptability to patient. We will assess the safety of the system with both
      unannounced meals, and meals using a meal announcement with a premeal insulin bolus based on
      the subject's estimated carbohydrate content of the meal
    

Intervention name(s): MMPPC algorithm artificial pancreas
Intervention type(s): Device
Intervention description(s): An artificial pancreas system using the MMPPC algorithm, Roche insulin pump, and Dexcom CGM
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Intervention model description: Use the MMPPC system for 72 hours in a hotel setting
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: artificial pancreas