bioihbjkbjnl/mcl2 huggingface dataset:
The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect
Condition: Skin Condition
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      To assess Chenopodium Formosanum and Fagopyrum Esculentum Extract on skin anti-aging
    


Intervention name(s): Placebo drink; Chenopodium Formosanum and Fagopyrum Esculentum Extract drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): consume 2 bottle (30 mL) per day for 56 days; consume 2 bottle (30 mL) per day for 56 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Bioavailability of Clormadinone/Ethinyl Estradiol Tablets 2 mg/0.02 mg With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be performed at a single site with 38 subjects. Participantswill take 2
      tablets of the test product and reference product in 2 periods and 2 sequences (either test
      after reference or reference after test). There will be a washout of at least 14 days between
      each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Clornadinone and Ethinyl estradiol of 2 tablet formulations with Clormadinone 2 mg and
      Ethinyl estradiol 0.02 mg and to demonstrate bioequivalence of both formulations in terms of
      rate and extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Andrómaco S.A.

        -  Reference Product: Evafem 20 [Trademark], product of Grünenthal. The 90% confidence
           intervals for the intra-subject coefficient of variation (Test versus Reference Product)
           for the main pharmacokinetic parameters area under the plasma concentration-time curve
           from time zero to time t (AUC0-t) and from time zero to 72 hours (AUC0-72), and maximum
           plasma concentration (Cmax) for total Clormadinone and Ethinyl estradiol will be
           determined.

      Participants will be confined in the study site for approximately 36 hours during each study
      period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic
      (PK) blood samples will be obtained. 16 blood samples will be taken up to 24 hours after the
      administration in each period. Participants will return to the site to provide additional
      blood samples at 48 h, and 72 h postdose. The washout period between the two study periods
      will be at least 14 days. The samples from each participant will be analyzed with 2 methods
      of high performance liquid chromatography-tandem mass spectrometry bioanalytical assays to
      quantify total Clormadinone and Ethinyl estradiol in plasma.

      The safety objective is to evaluate the tolerability of both formulations in women by
      collecting adverse events.
    

Intervention name(s): Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Test Product Coated Tablets; Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Reference Product Coated Tablets
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Evafem 20 (Trademark)
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Exercise in Gulf War Illness (GWI)
Condition: Gulf War Illness; Persian Gulf Syndrome
MeSH terms: Syndrome; Persian Gulf Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to determine if submaximal exercise by bicycle stress tests with
      pulmonary measurement of VO2MAX plus maximal isometric hand grips on 2 consecutive days
      causes a higher level of "exertional exhaustion" in GWI compared to healthy veterans (HVets).
    

Detailed description: 
      Subjects sat on upright bicycles for preexercise symptoms, respiratory gases, EKG, and vital
      sign measurements.

      Submaximal exercise began at low resistance with increases every 30 to 60 seconds until 70%
      predicted heart rate was reached by 5 minutes. Subjects maintained their pace until 25
      minutes, then resistance was increased incrementally to increase to 85% predicted heart rate
      (approximately sufficient to reach anaerobic threshold).

      Symptoms, respiratory gases, EKG, and vital signs were measured every 5 minutes, at peak of
      exercise, and 5 minute intervals after exercise.

      The identical exercise protocol was used approximately 24 hr later. Secondary outcomes were
      assessed by comparisons from before exercise to after the second bicycle exercise stress
      test.
    

Intervention name(s): Submaximal bicycle exercise stress tests performed 24 hr apart
Intervention type(s): Diagnostic Test
Intervention description(s): Submaximal bicycle exercise stress tests were performed for 25 min at 70% predicted heart rate, then ramped up to 85% predicted heart rate. Subjects could stop when they felt they had reached their maximum effort if before reaching 85% predicted heart rate.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All veterans who served in the Armed Forces between August 1990 and July 1991
      
Biospecimen description: 
      Plasma, serum, urine, cerebrospinal fluid (CSF), and buccal swab samples retained for testing
      as described in protocol.
    
Keywords: Persian Gulf War; Gulf War Syndrome; GWI; Gulf War Illness; Exercise; Chronic Fatigue; Fibromyalgia; Veterans; Irritable Bowel Syndrome; Migraine headaches; Neuropathy
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Condition: Analgesia; Pain Management; Acute Pain
MeSH terms: Acute Pain
Study type: Observational

Summary: 
      In our clinic, routine suprainguinal fascia iliaca block (SIFIB) has been administered for
      postoperative analgesia in patients undergoing knee arthroplasty. Recently, we have
      introduced the IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee)
      block to this regimen, and the aim of this retrospective study is to determine whether the
      addition of the IPACK block enhances the quality of analgesia.

      Knee arthroplasty, also known as knee joint replacement surgery, is a common procedure
      performed to alleviate pain and improve joint function in patients with knee osteoarthritis
      or other knee-related conditions. Postoperative pain management is crucial for patient
      comfort and overall recovery.

      In this study, we aimed to compare the two techniques mentioned earlier, namely the SIFIB
      (Suprainguinal Fascia Iliaca Block) and the SIFIB+IPACK, by examining the data of patients
      who underwent knee arthroplasty under spinal anesthesia at our clinic between January 1,
      2023, and September 1, 2023.
    


Intervention name(s): SIFIB (suprainguinal fascia iliaca block); IPACK (Interspace between the popliteal artery and capsule of the posterior knee ); Patient controlled anagesia device
Intervention type(s): Procedure; Other; Device
Intervention description(s): Ultrasound guided Suprainguinal Fascia Iliaca Block for Knee Arthroplasty Patients; Ultrasound guided IPACK (Interspace between the popliteal artery and capsule of the posterior knee ) Block for Knee Arthroplasty Patients; Those who were administered opioids with PCA as rescue analgesic in the postoperative analgesia plan on the selected dates will be included in the study.
Other intervention name(s): PCA
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        data of patients underwent total knee arthroplasty under spinal anesthesia between
        01.01.2023 and 01.09.2023
      
Keywords: analgesia; IPACK; SIFIB
POTS-CFS Study: Orthostatic Intolerance in the Context of Pediatric ME/CFS
Condition: Chronic Fatigue Syndrome in Adolescence; Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance
MeSH terms: Fatigue Syndrome, Chronic; Orthostatic Intolerance; Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome
Study type: Observational

Summary: 
      Pilot-case-control study on exertion and orthostatic intolerance of adolescents with myalgic
      encephalomyelitis/ chronic fatigue syndrome (ME/CFS) compared to age-matched healthy controls
      (HC).
    

Detailed description: 
      ME/CFS is a complex disease. Symptoms include orthostatic intolerance (OI) such as postural
      tachycardia syndrome (PoTS). PoTS in ME/CFS can significantly impair everyday function and
      social participation. Yet, data in affected adolescents are rare and inconsistent.

      This pilot-case-control study study aimed at characterizing OI in adolescents aged 14-17
      years with ME/CFS and age-adapted HC, comparing the results with other clinical features of
      both such as exertion intolerance, fatigue, and health-related quality of life, and
      suggesting a standardized tool for diagnostics.

      ME/CFS was diagnosed according to the Clinical Canadian Criteria (CCC 2003), criteria of the
      former Institute of Medicine (IOM 2015), the diagnostic work sheet developed by Rowe 2017,
      and/or the pediatric case suggested by Jason 2006. Questionnaires were used to evaluate
      symptoms (e.g. post-exertional malaise, fatigue, anxiety, depression), and health-related
      quality of life. A standardized specific interview was performed to assess the medical
      history of OI (HOI). Heart rate (HR) and blood pressure were evaluated every minute during a
      passive 10-min standing test (NASA lean test) in the morning with empty stomach and without
      morning medication.

      Data were evaluated according to the PoTS criteria defined in 2019 at the National Institutes
      of Health Expert Consensus Meeting and by the International Classification of Diseases
      (ICD-11) (8D89.2). Frequency and type of OI, including PoTS, were examined in both groups and
      outcomes compared to parameters from questionnaires. Based on the results, novel standards
      for OI diagnostics were suggested.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescents with ME/CFS and healthy controls
To Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid Burden
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare PET measurements of fibrillar amyloid burden using
      [18F]AZD4694.
    


Intervention name(s): [18F]AZD4694
Intervention type(s): Drug
Intervention description(s): [18F]AZD4694 PET Ligand administered at Visit 1, 30 days following screening and at visit 4 for some of the participants.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PET; Alzheimer's disease; diagnostic
Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response
Condition: Rectal Cancer; Organ Preservation
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      This was a propensity-score matched observational analysis, comparing the oncological outcome
      of surgical resection vs watch and wait apporach for rectal cancer patients with a cCR.
    

Detailed description: 
      Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant
      chemoradiotherapy followed by a clinical complete response from the year 2010 to 2018 were
      included. Sequential subjects were identified from a prospective maintained database in the
      Sun Yat-sen University Cancer Center. Clinical experts on rectal cancer from other 5 regional
      medical centers in China were also invited to participate, and provided data of cCR patients.
      Standardized forms for data collection were sanded to researchers in each center. Patients
      received radical resection will constituted our surgery group. Those refused surgery
      constituted the observation group who went on with the watch and wait approach. A
      propensity-score matched observational analysis will be used to compare the oncological
      outcome of these two groups.
    

Intervention name(s): standard TME surgery
Intervention type(s): Procedure
Intervention description(s): radical resection for rectal cancer
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pathologically confirmed stage II/III rectal adenocarcinoma patients who received
        neoadjuvant chemoradiotherapy followed by a clinical complete response were included and
        divided into two groups according to the treatment followed.
      
Keywords: Rectal Cancer; clinical complete response
A Study in Healthy Men to Test How BI 1291583 is Processed in the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to

        -  Assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces
           following a dose of BI 1291583 (C-14)

        -  Provide plasma and urine samples for pharmacokinetic investigations

        -  Provide plasma, urine, and faeces samples for metabolic profiling and structural
           identification of metabolites
    


Intervention name(s): BI 1291583 mixed with [C-14] BI 1291583
Intervention type(s): Drug
Intervention description(s): BI 1291583 mixed with [C-14] BI 1291583
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Probiotic Use on Immune Cell Function in Children
Condition: Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      Probiotics are microorganisms that are believed to provide health benefits when consumed. The
      term probiotic is currently used to name ingested microorganisms associated with beneficial
      effects to humans and animals. Probiotics are popularized in the lay literature for many
      different clinical problems. They have been studied in infants and children as a preventive
      or treatment for a variety of infections. Studies on the medical benefits of probiotics have
      yet to reveal a cause-effect relationship, and their medical effectiveness has yet to be
      conclusively proven for most of the studies conducted thus far. The putative benefit of
      probiotics in the prevention of infection relates to potential benefits to the innate and
      adaptive immune systems of infants.

      The goals of this investigation are to study immune system cell function and microbiome in
      children who are taking probiotics.

      To accomplish this goal, we propose a pilot study for which we will obtain blood and
      nasopharyngeal and stool samples prior to and post probiotic use in children greater than 12
      months-36 months over a 27-38 day period
    


Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): All children will receive a daily dose of probiotic (10⁹ cfu of L.acidophilus NCFM and B. lactis, Bi-07), a commercially available probiotic. Parents will give probiotic in 1 ounce of milk or water once a day for 30 days in an open label fashion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immune system; Probiotics
A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of VX-548 in treating
      acute pain.
    


Intervention name(s): VX-548
Intervention type(s): Drug
Intervention description(s): Tablets for oral administration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transplantation of Human Embryonic Stem Cell-derived Progenitors in Severe Heart Failure
Condition: Ischemic Heart Disease
MeSH terms: Heart Failure; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the feasibility and safety of a transplantation of
      cardiac-committed progenitor cells derived from human embryonic stem cells in patients with
      severe heart failure.
    

Detailed description: 
      Heart failure due to coronary artery disease is a major problem because of its high
      prevalence, increased incidence and associated costs. When conventional
      medical/interventional treatments fail and if cardiac transplantation is contra-indicated,
      alternate options need to be considered. Transplantation of stem cells has emerged as one of
      them. While the optimal cell type still remains debatable, there is compelling evidence that
      cells whose phenotype closely matches that of the recipient tissue look sound candidates. In
      this context, human embryonic stem cells are attractive because of the possibility to drive
      their fate in vitro, prior to transplantation, towards a cardiac phenotype. We have developed
      a process for achieving such a commitment and generating cardiac-directed cells. The
      objective of this study is to assess both the feasibility and safety of this approach. In
      addition, the disadvantages of multiple intramyocardial injections have now been recognized.
      We have then taken advantage of the surgical setting of the trial (which entails concomitant
      coronary artery bypass or a mitral valve procedure) to switch from injections to the
      epicardial delivery of a fibrin gel into which the progenitor cells have been embedded.
      Coverage of this cell-loaded patch by an autologous pericardial flap is finally designed to
      provide trophic factors to the underlying cellular graft with the hope of improving its
      viability.
    

Intervention name(s): Human embryonic stem cell-derived CD15+ Isl-1+ progenitors
Intervention type(s): Biological
Intervention description(s): Epicardial delivery of a fibrin patch embedding human embryonic stem cell-derived CD15+ Isl-1+ progenitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postinfarction heart failure; Transplantation of human embryonic stem cell-derived cardiac progenitors; Tissue-engineered cellular graft; Fibrin hydrogel
Postoperative CCRT With Docetaxel vs Cisplatin in High Risk Oral Cavity Cancer
Condition: Oral Cavity Squamous Cell Carcinoma
MeSH terms: Carcinoma, Squamous Cell; Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized,controled, phase II, open label study of postoperative concurrent
      chemoradiotherapy with Docetaxel versus Cisplatin for high-risk squamous cell carcinoma of
      the oral cavity cancer.The primary purpose of this study is to evaluate the efficacy of
      concurrent chemoradiotherapy with docetaxel in OCC patients.
    


Intervention name(s): Docetaxel; Cisplatin; IMRT
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 20mg/m2/w; 100mg/m2/q3w; a total dose of 60Gy in 30fractions over 6 weeks
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral cavity squamous cell carcinoma; concurrent chemotherapy; High-Risk
Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties
Condition: Hyperglycemia; Dietary Modification
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      It is not known whether different lentil varieties have the same efficacy in lowering blood
      glucose. Similarly, the carbohydrate component of lentils responsible for lowering blood
      glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol
      bioactive.
    

Detailed description: 
      The overall aim of this work is to produce credible evidence for substantiating a food health
      claim for post prandial blood glucose lowering by lentil. Although several studies have shown
      that lentil consumption results in a lowering of post prandial blood glucose, it is not known
      whether different lentil varieties have the same efficacy. Similarly, the carbohydrate
      component of lentils responsible for lowering blood glucose is not known, nor is the
      bioavailability of lentil metabolites and polyphenol bioactive. The investigators hypothesize
      that the slowly digestible starch content of lentil is inversely related to in vivo glycemic
      response. The specific aims of this study are: (i) to identify the putative component(s) in
      lentil that might account for its blood glucose lowering effect, and (ii) to identify
      differences in blood glucose reduction among lentil varieties. These aims will be achieved in
      a three-step process. Firstly, in vitro studies will be pursued to determine the carbohydrate
      fractions of 20 new and emerging Canadian lentil varieties. Secondly, these results will be
      used to choose 8 lentil varieties with different slowly digestible starch content for a human
      Glycemic Index study. Thirdly, identification of lentil metabolites will be achieved by
      collecting extra capillary blood (200uL)and urine samples at fasting and 120min for
      measurement of polyphenols and metabolites using established HPLC and metabolomics
      techniques.
    

Intervention name(s): Lentil Variety; White Bread
Intervention type(s): Other; Other
Intervention description(s): Participants will consume 8 varieties of lentils that are cooked by boiling; Participants will consume white bread on at least two different test days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: glucose; glycemic index; lentil; polyphenols; metabolites; bioavailability
Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, double-blind, placebo controlled, parallel group, dose-escalating,
      randomised study designed to assess and compare the safety and tolerability, PK, and
      immunogenicity of GNbAC1 administered as a single dose at 4 different dose levels of 36, 60,
      85 and 110 mg/kg.
    


Intervention name(s): GNbAC1; GNbAC1 Placebo
Intervention type(s): Drug; Other
Intervention description(s): Monoclonal Antibody infused i.v.; Equivalent to GNbAC1 Buffer
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Temelimab