bioihbjkbjnl/mcl2 huggingface dataset:
Coital Pharmacokinetics/Pharmacodynamics (PK/PD) of Tenofovir Gel
Condition: Pharmacokinetics of 1% Tenofovir Gel Following Coitus; Pharmacodynamics of 1% Tenofovir Gel Following Coitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Objectives:

        -  To assess the impact of coitus (and semen) on the pharmacokinetics of tenofovir 1% gel
           in female genital tract secretions, vaginal and cervical tissue and rectal tract
           secretions

        -  To assess the impact of coitus (and semen) on pharmacodynamics of luminal drug by
           measuring the anti-HIV-1 activity in CVL samples

      Study Summary:

      MTN-011 will enroll heterosexual monogamous, sexually active couples, in which both partners
      are healthy and HIV-negative. The female participants must be between the ages of 21-46
      (inclusive) and currently using effective non-barrier contraception. Male participants must
      be 21 years of age or older. This Phase 1 expanded safety study will assess tenofovir PK in
      the genital tract secretions (CVL), rectal (rectal sponge) and both intracellular and
      extracellular tissue compartments (vaginal biopsy) in the absence of, or following coitus.
      Pharmacodynamics (antiviral activity) will also be assessed in CVL. MTN-011 will study the
      timing in which coitus might have the greatest impact on these variables, which is when gel
      is applied shortly prior to coitus in the absence of a drug reservoir.

      MTN-011 will examine PK/PD in response to a single dose of 1% tenofovir gel applied shortly
      before sex and compare to PK/PD assessments following a single gel application without sex.
      Additionally, data obtained from a visit in which participants do not dose with gel and do
      not have sex will serve as an additional control for the pharmacodynamic (PD) studies of the
      antiviral activity in CVL. If tenofovir retains its antiviral activity following sex, then
      the anti-HIV activity in CVL collected at the visit in which female participants dose with
      gel and have sex should be comparable to that of CVL collected at the visit in which females
      dose with gel and then do not engage in intercourse and significantly greater than the
      endogenous anti-HIV activity in CVL obtained at the visit in which participants do not dose
      with gel but do have sex and the visit in which no gel is administered and sex does occur.
      Data analysis performed after the completion of enrollment and follow-up procedures will
      demonstrate if there is an impact of coitus and semen on PK/PD when a single 1% tenofovir
      dose is applied shortly prior to sex.
    


Intervention name(s): 1% Tenofovir Gel
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Pharmacokinetic, Pharmacodynamic and Safety Evaluation After Single Oral Administration of KRN1493
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, open, single ascending dose, parallel study to evaluate the pharmacokinetics,
      pharmacodynamics and safety of KRN1493 after single oral administration in healthy Korean
      male volunteers.
    

Detailed description: 
      Eligibility for participation of this study was determined from demographic information,
      medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
      within 3 weeks before study drug administration. Subjects suitable for this study were
      admitted to the Clinical Trials Center, Seoul National University Hospital on the day before
      dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed study drug
      orally with 240 ml water around at 9 a.m. of Day 1 and they were fasted until 4 hours
      post-dose. Subjects performed scheduled procedures including clinical laboratory tests,
      electrocardiograms and pharmacokinetic samplings. During admission, subjects were served low
      calcium diets. Subjects were discharged on Day 2, and visited Clinical Trials Center on Day
      3, Day 4 and Day 5. Study participation was terminated on post-study visit (Day 7 - 10).
    

Intervention name(s): KRN1493
Intervention type(s): Drug
Intervention description(s): KRN1493 25mg tablet 2,3 or 4 tablets single oral administration
Intervention MeSH terms: Cinacalcet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer
Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in
      bladder cancer.
    

Detailed description: 
      To test the combination of oxaliplatin chemotherapy in combination with taxotere chemotherapy
      in patients with advanced bladder cancer who have failed one prior chemotherapy.
    

Intervention name(s): Oxaliplatin; Taxotere
Intervention type(s): Drug; Drug
Intervention description(s): Calculated per patient; Calculated per patient
Other intervention name(s): Eloxatin; Docetaxel
Intervention MeSH terms: Docetaxel; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Functional Treatment on Mandibular Asymmetric Growth
Condition: Temporomandibular Joint Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      Temporomandibular joint (TMJ) arthritis is known to alter the mandibular development in
      children diagnosed with juvenile idiopathic arthritis. In a number of cases a genuine
      breakdown of cartilage and bone is seen in the affected joint which leads to asymmetric
      mandibular growth in the affected side. In cases of unilateral TMJ involvements severe
      mandibular asymmetric mandibular growth deviations are seen. We hypothesize that these growth
      deviations can be minimized and controlled by the use functional orthodontic appliance
      therapy.
    

Detailed description: 
      This is a retrospective study design with the aim to evaluate the clinical procedures we have
      used the last 15 years to treat JIA patients with unilateral TMJ arthritis. More
      specifically, the purpose is to evaluate the mandibular growth in all JIA patients with
      unilateral TMJ arthritis and an asymmetric mandibular growth pattern treated with
      non-surgical distraction splint therapy between 1994 and 2010 at the dep. of Orthodontics,
      Aarhus University, Denmark. The evaluation is based on radiological examinations at the
      beginning of their non-surgical distraction treatment as well as after the patients have
      finished their distraction-splint therapy.
    

Intervention name(s): Distraction splint therapy
Intervention type(s): Device
Intervention description(s): After the diagnosis of unilateral TMJ arthritis with clinical asymmetric mandibular growth deviations the JIA patients are offered treatment with a distraction splint. The appliance consists of an acrylic splint (distraction splint) covering the occlusal surfaces of the teeth in the upper or lower dental arch. The height of the splint is thereafter gradually increased every 6th to 10th weeks in order to optimize the mandible growth in the affected side and thereby reduce the overall asymmetric mandibular growth pattern(non-surgical distraction of the TMJ and mandibular condyle).
Other intervention name(s): functional appliance
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Juvenile Idiopathic arthritis patients diagnosed with unilateral temporomandibular joint
        arthritis and an asymmetric mandibular growth pattern
      
Keywords: Mandibular growth temporomandibular arthritis
Comparison of MAG and Fish Oil Efficacy
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      A potential application for unstructured monoacylglycerol (MAG) containing long chain
      polyunsaturated fatty acids (LC-PUFA)can be to provide essential fatty acids to humans who
      chronically consume lipases inhibitor such as Orlistat® for weigh lowering reasons. Indeed,
      it is predictable that chronic consumption of Orlistat® led to a depletion of essential fatty
      acids with time, therefore unstructured MAG containing LC-PUFA can be an option as a source
      of LC-PUFA for patients under Orlistat® treatment and hypothetically for subjects with other
      type of maldigestion/malabsorption. Potential applications of such concept are therefore
      related to disease conditions comprising low lipid digestion due to lipase activity
      insufficiency.

      In the present study, in order to see the response information for eicosapentanoic acid (EPA)
      delivery, EPA will be provided either as a mixture of free monoacylglycerols or as
      triacylglycerol (TAG). The erythrocyte and plasma fatty acid composition from subjects under
      Orlistat® consumption will be analyzed.
    


Intervention name(s): Fish oil enriched with EPA; MAG-EPA oil; Orlistat
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: EPA; LC-PUFA; Orlistat; Obesity
A Clinical Study to Measure the Effect of OP-101 After Being Administered Subcutaneous in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to measure the Safety, Tolerability, and Pharmacokinetics of OP-101 After
      Subcutaneous Administration in Healthy Volunteers
    


Intervention name(s): OP-101
Intervention type(s): Drug
Intervention description(s): Subcutaneous injection of OP-101 in healthy volunteers
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Can Synbiotic Use Effect Gut Bacteria and the Immune Response in Older People
Condition: Aging
Study type: Interventional

Summary: 
      The objectives of this study are to use a nutritional change in the diet to improve gut
      health in older people. Ageing can result in major changes in the composition and activities
      of the bacteria in your gut, leading to a higher incidence of gastrointestinal infections,
      decreased intestinal motility and impaired bowel function as people get older. This can
      result in constipation or diarrhoea, increased levels of inflammation and reduced immune
      response to infection. Therefore, individuals aged 65 or over could benefit from safe and
      effective interventions that maintain a healthy balance of gut bacteria as well as restoring
      the immune response. Bacteria in the gut are known to promote health. Eating foods containing
      beneficial bacteria for example (probiotics) or food which contain substrates for the
      bacteria to grow on (prebiotics) can improve the balance of gut bacteria. The investigators
      will use a synbiotic with known anti-inflammatory properties, comprising a probiotic
      Bifidobacterium longum strain and inulin (Synergy 1), The synbiotic has been previously shown
      to be beneficial in reducing inflammation and to increase levels of beneficial bacteria in
      the gut in two studies in patients with inflammatory bowel disease. The investigators would
      now for these reasons, like to determine the effects of our Synbiotic on the gut bacteria and
      immune function of older individuals in a double-blinded, crossover, placebo controlled,
      randomised investigation involving 40 volunteers for three months. The trial is designed so
      that participants will be assigned to receive the Synbiotic preparation or the placebo for
      the first four weeks, this will be followed by four weeks without treatment, and then they
      will switch to the opposite preparation for another four weeks.
    


Intervention name(s): Synbiotic (Synergy 1/B. longum); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Combination of a prebiotic Synergy 1 and a probiotic Bifidobacterium longum; maltodextrose
Intervention MeSH terms: Sulfalene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Older people; Synbiotic; Prebiotic; Probiotic; Bacteria; Immune
Mindfulness-Based Stress Reduction for Adults With Low-Risk Chest Pain Associated With Anxiety
Condition: Chest Pain; Anxiety; Mindfulness
MeSH terms: Chest Pain; Anxiety Disorders
Study type: Interventional

Summary: 
      This Emergency Department based study investigates the feasibility and effectiveness of a
      mindfulness based stress reduction (MBSR) training program referral for patients with chest
      pain at low risk for acute coronary syndrome but associated with anxiety. Outcomes assessed
      for eligible patients randomized to MBSR vs. usual care include mental health (longitudinal
      Generalized Anxiety Disorder - 7 (GAD-7) scores), quality of life (PROMIS Global Short Form),
      and ED resource utilization (return Emergency Department (ED) visits).
    

Detailed description: 
      To determine the effect of an MBSR training program for patients with low-risk chest pain
      associated with anxiety on mental health (longitudinal GAD-7 scores, quality of life (PROMIS
      Global Short Form), and ED resource utilization (return ED visits). The working hypothesis is
      that early referral to MBSR will help patients better regulate their thoughts, feelings, and
      bodily sensations related to their anxiety symptoms and have a significant positive effect on
      patient-centered outcomes such as mental health, quality of life as well as decreased ED
      resource utilization. To this end the investigators will randomize patients identified via a
      two step process (HEART Score <4 and GAD-7 score > 9 to usual care referrals versus MBSR. The
      investigators will then follow these participants for outcomes including change in GAD-7
      scores, PROMIS Global Short Form, ED utilization among other outcomes at 6 weeks, 3 months, 6
      months, and 1 year.
    

Intervention name(s): MBSR Referral; Usual Care Referral
Intervention type(s): Behavioral; Other
Intervention description(s): Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.; Referral to PCP or Psychiatry
Other intervention name(s): MBSR
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chest Pain; Anxiety; Mindfulness; Emergency Service, Hospital
A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this clinical research study is to learn if BMS-512148, added to insulin and
      one or two anti-diabetes medications (metformin and/or pioglitazone or rosiglitazone), can
      help reduce the blood sugar levels compared to insulin and one or two anti-diabetes
      medications (metformin and/or pioglitazone or rosiglitazone) alone, in subjects with type 2
      diabetes. The safety of this treatment will also be studied.
    


Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, once daily, up to 12 weeks; Tablets, Oral, 0 mg, once daily, up to 12 weeks
Other intervention name(s): BMS-512148
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
First in Human SAD and MAD Study of Inhaled TD-0903, a Potential Treatment for ALI Associated With COVID-19
Condition: Acute Lung Injury (ALI) Associated With COVID-19; Inflammatory Lung Conditions Associated With COVID-19
MeSH terms: COVID-19; Lung Injury; Acute Lung Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study in healthy subjects to evaluate the safety, tolerability and
      pharmacokinetics of single (Part A and B) and multiple (Part B) doses of inhaled TD-0903.
    


Intervention name(s): TD-0903; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study drug to be administered by inhalation; Placebo to be administered by inhalation
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: double-blind, randomized, placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute lung injury; ALI; COVID-19; Coronavirus Disease 2019; inflammatory lung conditions; Inflammatory lung disease
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
Condition: Atrophic Vaginitis
MeSH terms: Vaginitis; Atrophic Vaginitis; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the longterm safety and efficacy of the vaginal
      application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on
      atrophic vaginitis in postmenopausal breast cancer patients who have been treated with
      aromatase inhibitors.
    


Intervention name(s): Gynoflor
Intervention type(s): Drug
Intervention description(s): Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Shoulder Muscle Massage Shoulder Stiffness
Condition: Massage Effect
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators investigated the effect and predictors of effectiveness of massage in the
      treatment of patients with posterior shoulder stiffness. This is a randomized controlled
      trial study- massage and control (hand touch) two times a week for 4 weeks. A total of 60
      patients with posterior shoulder tightness were randomized into 2 groups; 52 of them
      completed this study (29 for the massage and 23 for the control). Patient sex, age, body mass
      index, glenohumeral internal rotation range of motion (ROM), duration of symptom, functional
      status, and muscle stiffness were recorded. Additionally, for the massage group, patients
      with glenohumeral internal rotation improvement of 20 degrees after massage were considered
      responsive, and the others were considered nonresponsive. The influences of the
      aftermentioned factors on the effectiveness of massage were analyzed by multivariate
      logistric regression. The overall mean internal rotation ROM increased significantly after
      massage (from 31.9° to 54.9°; P < 0.001) compared to the control (from 28.7° to 34.9°; P >
      0.05). There were 22 patients in the responsive group and 7 in the nonresponsive group. Among
      the factors, duration of symptoms, FLEX-SF score, and posterior deltoid stiffness were
      significant predictors of effectiveness of massage. Massage was an effective treatment for
      subjects with posterior shoulder stiffness, but was less effective in patients with longer
      duration of symptoms, higher functional limitation, and less posterior deltoid stiffness.
    


Intervention name(s): massage
Intervention type(s): Other
Intervention description(s): For the massage group, a physical therapist with 8 years of clinical experience in manual therapy provided the massage on the posterior deltoid, infraspinatus, and teres minor of the involved shoulder for 18 minutes [about 6 minutes for each muscle and order was random] two times a week for 4 weeks. The techniques of massage included petrissage for 3 minutes and rolling for 3 minutes of soft tissues
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stiff shoulder; massage; muscle stiffness
A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
Condition: Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive
      patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of
      telacebec (Q203).
    


Intervention name(s): Telacebec (Q203); Rifafour e-275
Intervention type(s): Drug; Drug
Intervention description(s): High, Mid, Low dose of telacebec; RHZE (R=rifampicin: H=isoniazid: Z=pyrazinamide: E=ethambutol)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interprofessional Training to Improve Diabetes Care: The ReSPECT Trial
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The investigators' study focuses on improving the care of diabetes, a complex chronic
      illness, by providing important insights into interprofessional training and its potential
      role in fostering the necessary interdisciplinary management needed for chronic conditions
      and in addressing the gap between best practice and actual care provided.
    

Detailed description: 
      The complexity of diabetes management challenges the acute care-oriented healthcare system.
      Some experts suggest part of the problem is that the healthcare system fosters a separate
      silos decision making model. While there is increasing recognition that quality diabetes care
      is best provided in an interdisciplinary manner, interprofessional training models are
      limited, as is understanding of the links between interprofessional training, actual
      practice, and patient outcomes. Advancing our understanding of interprofessional training
      models is critical because most of the complications associated with diabetes (e.g.,
      amputations, renal failure, strokes) can be prevented or delayed with proper management. The
      investigators' objective is to better understand the processes and mechanisms by which
      interprofessional training impacts on chronic care management (practice patterns) and the
      ways it translates into improved patient outcomes.
    

Intervention name(s): Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT)
Intervention type(s): Behavioral
Intervention description(s): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for diabetes mellitus (DM) patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans.
Other intervention name(s): ReSPECT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes; Telemedicine; Shared Medical Appointments