bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Interdental Brushing on the Evolution of Supra-gingival Bacterial Flora (BACTERIB)
Condition: Healthy
Study type: Observational [Patient Registry]

Summary: 
      In France, two-thirds of adults over 35 years of age have at least a periodontal disease. The
      etiology is the accumulation of dental plaque, especially in interdental spaces. The cleaning
      of interdental spaces is particularly complex. This accumulation of dental plaque is at the
      origin of a modification of the bacterial flora in favor of periodontopathogenic bacteria.
      These pathogens can induce within the periodontal tissues an immune and inflammatory reaction
      that cause tissue degradation. The majority of studies focus on people over 30 years of age
      with gingivitis or periodontitis. However, young adults, in whom the initial or even
      reversible stages of periodontal disease are the most frequent, should be the preferred
      target of preventive measures for this pathology.

      The main objective of this study is to quantify, in healthy patients, the evolution of the
      supragingival bacterial flora, in the interdental spaces, following the daily passage of
      brushes with the adapted diameter and single passage. The secondary objective is to evaluate
      the qualitative change in the bacterial flora (proportions of periodontal bacteria /
      commensal bacteria) following the interdental cleaning.
    


Intervention name(s): Use of interdental brushes
Intervention type(s): Other
Intervention description(s): No intervention they just use interdental brushes as it should be done routinely
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        - Subjects aged from 18 to 35 years in good health
The Effects of Prolonged Standing Compared to Prolonged Sitting on Postprandial Lipemia
Condition: Metabolic Syndrome; Atherosclerosis
MeSH terms: Atherosclerosis; Metabolic Syndrome
Study type: Interventional

Summary: 
      The effects of 12 hours of prolonged standing will be compared to prolonged standing on a
      high fat tolerance test the following day. Plasma triglycerides, insulin, and glucose will be
      measured in a crossover study design.
    


Intervention name(s): Prolonged Standing; Prolonged Sitting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subject will stand for 12 hours and undergo a high fat tolerance test the subsequent day; Subject will sit for 12 hours and undergo a high fat tolerance test the subsequent day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetic and Pharmacodynamic Properties of BIOD-123 and BIOD-125 Compared to Humalog® in Subjects With Type 1 Diabetes Including Assessments of Injection Site Toleration
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and
      compare them to Humalog.
    

Detailed description: 
      The primary objective is to assess the speed of absorption of BIOD-123 and BIOD-125 and
      compare them to Humalog.

      The secondary objectives are to assess other pharmacokinetic characteristics of BIOD-123 and
      BIOD-125 and compare those to Humalog®, to assess pharmacodynamic characteristics of BIOD-123
      and BIOD-125 and compare those to Humalog®, and to evaluate the safety and tolerability of
      BIOD-123 and BIOD-125 compared to Humalog®
    

Intervention name(s): BIOD-123; BIOD-125; Humalog
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Anterior Mediastinum Teratoma: A Case Report
Condition: Teratoma
MeSH terms: Teratoma
Study type: Observational

Summary: 
      The investigators report a case of a 39-year-old man who presented an anterior mediastinal
      cystic mature teratoma. Those kind of tumor contain elements derived from more than one of
      the three primary germ layers (ectoderm, mesoderm, endoderm), frequently arranged in a
      haphazard manner. They arise from totipotent cells and, therefore, are primarily found in
      gonads, and more rarely in primitive cells kidnapped in other parts of the body. The tissues
      are immature to well differentiated and foreign to the anatomic site. Mature teratomas are
      either cystic or solid, although the cystic presentation predominates in gonadal sites.
      Benign teratomas are the most common mediastinal germ cell tumor, accounting 70% of the
      mediastinal germ cell tumors in children and 60% of those in adults. Immature teratomas are
      potentially malignant tumors; their prognosis is influenced by the anatomic site of the
      tumor, patient age, and the fraction of the tumor that is immature. Treatment of benign
      mediastinal teratoma includes complete surgical resection, with results in a excellent
      long-term cure rates. Complete resection of teratomas should be the goal of treatment.
    


Intervention name(s): right thoracotomy
Intervention type(s): Procedure
Intervention description(s): complete surgical resection
Observational model: Case-Only
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Keywords: Teratoma; Mediastinum
A Study of Seltorexant in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioequivalence of Test 1 and/or Test 2
      seltorexant tablet formulations with respect to Reference seltorexant tablet formulation in
      healthy participants receiving a single dose under fasted conditions.
    


Intervention name(s): Seltorexant
Intervention type(s): Drug
Intervention description(s): Seltorexant will be administered orally as per assigned treatment sequence.
Other intervention name(s): JNJ-42847922
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Hemodynamic Measurements During Cesarean Section With Spinal Anesthesia
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of low dose versus standard dose spinal
      anesthesia with and without intravenous phenylephrine-infusion on blood pressure, cardiac
      output and systemic vascular resistance.
    

Detailed description: 
      Hypotension during cesarean section with spinal anesthesia is common. We compare low dose
      versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion.
    

Intervention name(s): Phenylephrine
Intervention type(s): Drug
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Hemodynamic; Hypotension; Spinal; Anesthesia; Healthy pregnant women for elective cesarean section
The Impact of SPC on Advanced Breast Cancer Patients
Condition: Breast Cancer; Palliative Care; Quality of Life; Cancer, Breast
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The aim of this prospective, observational study is the evaluation of the effectiveness of a
      14-day Specialist Palliative Care therapy in participants with advanced breast cancer carried
      out in a stationary palliative care unit in Poland. The length of the entire study will be 36
      months.
    


Intervention name(s): Specialist Palliative Care
Intervention type(s): Procedure
Intervention description(s): In the research, Specialist Palliative Care was provided according to the guidelines established by Mid-Western Health Board in a Report of the National Advisory Committee on Palliative Care as well as according to recommendations of Polish Society of Palliative Medicine and Polish National Healthcare Fund. In order to ensure interdisciplinary and integrated palliative care, a team of specialists was appointed. Team members were engaged in the process of treatment of each patient during the time of the study and applied their specialist skills according to the needs of the patients
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with advanced stage breast cancer refered for a SPC treatment at palliative care
        department in Poland, Będzin.
      
Keywords: Breast Cancer; palliative care; life quality; performance status; esas
Sequential Versus Single O2 Levels on Human Embryo Development
Condition: Embryo Culture
Study type: Interventional

Summary: 
      Myriads of elements affect human embryo culture in vitro. These include, but not limited to,
      air quality, culture media, culture temperature, incubator humidity, pH, and O2 levels. O2
      tension has been thoroughly investigated and, to date, 5% O2 level is superior to 20%.
      Reports showed that lowering the O2 from Day 3 of embryo culture seems to be physiological.
    


Intervention name(s): Sequential O2 Culture
Intervention type(s): Other
Intervention description(s): We investigate the effect of sequential O2 levels on human embryo culture after Intracytoplasmic sperm injection (ICSI)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Age Comparisons of Exercising Muscle O2 Supply in Healthy Adults: Effects of Esmolol Infusion
Condition: Aging
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will test the central hypothesis that postmenopausal women will demonstrate
      increased oxygen extraction in active leg muscle during leg cycling exercise while receiving
      an infusion of Esmolol, a fast-acting β1 selective antagonist, when compared to premenopausal
      women
    

Detailed description: 
      This study will test the central hypothesis that postmenopausal women will demonstrate
      increased oxygen extraction in active leg muscle during leg cycling exercise while receiving
      an infusion of Esmolol, a fast-acting β1 selective antagonist, when compared to premenopausal
      women. β1 selective antagonists (or "β1 blockers") are used to lower heart rate and improve
      O2 supply-to-demand balance in patients with coronary artery disease. By using esmolol to
      attenuate the central sympathetic response to exercise (increased heart rate and cardiac
      output) we can examine peripheral mechanisms of O2 delivery. The current project will
      evaluate how older postmenopausal women adjust active muscle O2 supply to an acute reduction
      in systemic O2 delivery during large muscle dynamic exercise when compared to younger
      premenopausal women.
    

Intervention name(s): Esmolol infusion; Saline infusion; Pre exercise baseline; Isometric handgrip exercise; Semi-recumbent cycling
Intervention type(s): Drug; Drug; Other; Other; Other
Intervention description(s): The Esmolol loading dose will be 0.5 mg/kg fat free mass/min administered over the first 3 minutes, followed by a maintenance dose of 0.25 mg/kg fat free mass/min for the remainder of the protocol (maximum of 60 minutes).; Saline will be rate/volume matched to the calculated esmolol dose.; Subject rests quietly while drug infusion begins (3 min loading dose followed by 10 min of maintenance dose) until heart rate and blood pressure stabilize.; The subject will grip at 40% of their maximum and maintain that grip for 90 seconds. Once at rest and once during heavy intensity cycling.; Subjects will pedal for 2-4 minutes at a very light intensity (20W), followed immediately by 5 minutes at a moderate intensity (at a workload intended to elicit 85% of the oxygen consumption observed at the lactate threshold), and 5 minutes of cycling at a heavy intensity (at a workload estimated to elicit oxygen consumption half way between those observed at the lactate threshold and respiratory compensation point). Subjects will then continue cycling at the heavy intensity for 90 seconds while performing isometric handgrip exercise.
Other intervention name(s): Esmolol Hydrochloride; Normal saline solution
Intervention MeSH terms: Esmolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Esmolol hydrochloride; Exercise
A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the
      treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone.
      Adapalene and clindamycin have been reported to have a better effect in acne treatment when
      used together. This new formulation is also easier to use as it combines two products into a
      single gel and only needs to be used once a day.
    


Intervention name(s): Adapalene-Clindamycin Combination Gel; Adapalene Gel; Clindamycin Gel
Intervention type(s): Combination Product; Drug; Drug
Intervention description(s): 5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks; Differin 0.1% Gel, applied nightly for 12 weeks; Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks
Other intervention name(s): Differin; Clindamycin
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
Condition: Pediatric Pain; Chronic Pain, Widespread; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Chronic Pain
Study type: Interventional

Summary: 
      The broad aim of this study is to implement and evaluate the efficacy of Graded Exposure
      Treatment (GET Living) to target elevated pain-related fears in children with chronic pain at
      the Stanford Pediatric Pain Management Clinic (PPMC). The investigators will evaluate the
      effectiveness and acceptability of this intervention for children with high levels of
      pain-related fear and functional disability. If proven efficacious, it will allow for the
      dissemination of this innovative treatment model to others working with children and
      adolescents with chronic pain.
    

Detailed description: 
      The treatment intervention to be tested in this clinical trial is Graded in-vivo Exposure
      Treatment (GET Living) compared to Multidisciplinary Pain Management (MPM) in adolescents
      with chronic musculoskeletal pain. Participants will be randomized into GET Living or MPM,
      and will be instructed to not seek new treatments for pain for the duration of the study.
      Both treatments consist of 12 1-hour patient sessions delivered twice a week across 6- weeks
      and 3 parent-only sessions.
    

Intervention name(s): Graded Exposure Therapy (GET Living); Multidisciplinary Pain Management (MPM)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The protocol consists of 12 interdisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Phase I-III are conducted with the psychologist, physical therapist, adolescent, and parent (as developmentally appropriate). Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment.; The protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological CBT sessions and Physical Therapy sessions. Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adolescents will be randomized to either GET Living or TPM and stratified on fear (moderate/high; FOPQ-C: moderate [35-49] high [50-96]) and disability (moderate/high; moderate [13-29] severe [30-60]), to minimize the possibility of imbalance between the two treatment arms. To allow the use of small blocks while minimizing the probability of a blinded staff member predicting the next assignment we will use blocks of size two and four and randomly choose block sizes.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Tryptophan and Behavior Therapy for Cocaine Abuse - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of tryptophan vs. placebo, and voucher
      payments vs. a control condition, in the treatment of cocaine dependence.
    

Detailed description: 
      This clinical trial uses a 2 by 2 design to compare tryptophan to placebo, and voucher
      incentives vs. a control condition, in the outpatient treatment of cocaine dependence- using
      a relapse prevention model of treatment intervention.
    

Intervention name(s): Tryptophan
Intervention type(s): Drug
Intervention MeSH terms: Tryptophan
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Clinical Trial to Evaluate the Influence of Genotype on the Pharmacokinetics/Pharmacodynamics of Clopidogrel
Condition: Influence of Genotype of Drug Metabolizing Enzyme or Transporter on the Pharmacokinetics/Pharmacodynamics of Clopidogrel; Influence of Aspirin on the Pharmacokinetics/Pharmacodynamics of Clopidogrel
Study type: Interventional
Phase: Phase 4

Summary: 
      This study has an open-label, five-period, single-sequence design. The purpose of this study
      is as follows;

        1. Primary

             -  To evaluate the influence of genotype of drug metabolizing enzyme or transporter on
                the pharmacokinetics/pharmacodynamics of clopidogrel

             -  To evaluate the influence of aspirin on the pharmacokinetics/pharmacodynamics of
                clopidogrel

        2. Secondary

             -  To explore the representative biomarkers for the variable
                pharmacokinetics/pharmacodynamics of clopidogrel

             -  To evaluate the influence of genotype of drug metabolizing enzyme or transporter on
                the drug-drug interactions between aspirin and clopidogrel

             -  To explore the representative biomarkers for the drug-drug interactions between
                aspirin and clopidogrel
    


Intervention name(s): Clopidogrel+Aspirin
Intervention type(s): Drug
Intervention description(s): Clopidogrel 75 mg, Aspirin 100 mg
Intervention MeSH terms: Aspirin; Clopidogrel
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clopidogrel,; Aspirin,; Pharmacogenomics
Effectiveness and Safety of Probiotic in Regulating Chronic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      To evaluate the effectiveness and safety of the use of probiotics as food supplements in
      regulating the intestinal habit of subjects with chronic constipation, in comparison with
      placebo.
    


Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The experimental phase of this study had last 84 days, and each patient will make 4 visits (d1, d28, d56, d84).; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Probiotics；Chronic constipation
Safety, Tolerability, and Pharmacokinetics (PK) of CTP-499
Condition: Diabetic Nephropathy
MeSH terms: Diabetic Nephropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      CTP-499 following single dose administration.
    

Detailed description: 
      This is a double-blind, single ascending dose administration study of four doses of CTP-499.
      Following dosing safety and tolerability will be assessed. Blood and urine samples will be
      taken for pharmacokinetics (PK) and bioavailability. Safety assessments will include
      monitoring of adverse events, vital signs (blood pressure, pulse rate, respiratory rate and
      oral temperature), clinical laboratory findings, 12-lead ECGs, and physical examination
      findings.

      The plasma concentration time data for CTP-499 and its metabolites will be analyzed using
      noncompartmental methods. Actual dosing and sampling times will be used for analysis. The
      primary pharmacokinetics parameters are: Cmax, Tmax, T1/2, AUClast and AUCinf for plasma;
      relative bioavailability; and Ae and CLr for urine.
    

Intervention name(s): CTP-499; CTP-499
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg, 1200 mg, 1800 mg and 2400 mg; 400 mg immediate release capsule
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; Healthy volunteers
Optimization and Harmonization of Advanced MRI Sequences
Condition: Dementia Frontal; Dementia Alzheimers; Lewy Body Variant of Alzheimer Disease; Neuro-Degenerative Disease
MeSH terms: Alzheimer Disease; Dementia; Neurodegenerative Diseases; Lewy Body Disease
Study type: Observational

Summary: 
      Development of a shared multimodal MRI protocol for the definition and quantification of
      imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.
    

Detailed description: 
      Development of a shared multimodal MRI protocol for the definition and quantification of
      imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.
    

Intervention name(s): AD FDT DBL GROUP
Intervention type(s): Diagnostic Test
Intervention description(s): All participants will undergo an MRI session. The MRI protocol will include the clinical diagnostic protocol defined within the Network and research sequences as specified above (T1 3D, DTI, FLAIR 3D, QSM).
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients and controls recruited based on the inclusion criteria carry out clinical and
        neuropsychological tests
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to evaluate the effect of treatment with romosozumab for 6 months
      compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as
      assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.
    


Intervention name(s): Romosozumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection once a month (QM); Administered by subcutaneous injections once a month
Other intervention name(s): AMG 785; Evenity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Osteoporosis.; Osteoporosis-Postmenopausal.; Bone Diseases-Metabolic.; Bone Diseases.; Musculoskeletal Diseases.