bioihbjkbjnl/mcl2 huggingface dataset:
RTA 408 Lotion in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human study of a topical dermal lotion formulation of RTA 408, a
      novel small molecule which suppresses oxidative stress and inflammation. In this study, the
      safety, local pharmacodynamics (PD), and systemic pharmacokinetics (PK) of RTA 408 will be
      evaluated following topical application of RTA 408 Lotion to healthy volunteers. This study
      will be conducted in three parts. In Part A of the study, healthy volunteers will have RTA
      408 Lotion Vehicle and RTA 408 Lotion (0.5%, 1%, and 3%) applied to a small skin surface area
      (four individual 4-cm2 sites; 16 cm2 total area) twice daily for 14 days to assess the local
      skin tolerability, local PD, and systemic PK of these treatments. Part B will be conducted
      after completion of Part A and will assess the safety, tolerability, local PD, and systemic
      PK of RTA 408 Lotion applied topically twice daily for 14 days to a larger skin surface area
      (~100 cm2). Part C will be conducted after completion of Part B and will assess the safety,
      tolerability, local PD, and systemic PK of RTA 408 Lotion applied topically twice daily for
      28 days to a larger skin surface area (~500 cm2). The maximum tolerated drug concentration in
      Part A will be used in Part B and Part C.

      Approximately 32 healthy adult volunteers will be enrolled in this study with 12 volunteers
      in Part A and 10 volunteers each, in Parts B and C.
    

Detailed description: 
      Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a
      wholly owned subsidiary of Biogen.
    

Intervention name(s): RTA 408 Lotion 0.5%, 1%, 3%; Lotion vehicle/placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RTA 408; RTA 408 Lotion; Oxidative stress; Inflammation; Volunteers
Durolane SJ for Treatment of Rhizarthrosis
Condition: Rhizarthrosis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The main objective of the trial is to assess the clinical changes in terms of physical
      examination, VAS Scale and the Quick-DASH questionnaire, and the biomechanical parameters in
      terms of mobility of the TMC joint, the grip strength of the hand and lateral pinch strength
      in patients with rhizarthrosis after administration of viscosupplementation.

      The secondary objectives of the trial will be to assess the safety of the treatment with
      viscosupplementation, and the correlation between the clinical and biomechanical changes at
      the end of the trial.
    

Detailed description: 
      This is a prospective, open, non-comparative study in 36 subjects with rhizarthrosis,
      comparing signs and symptoms before and after a single injection of DUROLANE SJ in the
      affected hand.

      Subjects were assessed pre-treatment and at 1, 3, and 6 months post-treatment. This study is
      associated with a post marketing commitment with the European Notified Body, BSI, to confirm
      DUROLANE SJ's effectiveness in rhizarthrosis.
    

Intervention name(s): Durolane SJ
Intervention type(s): Device
Intervention description(s): DUROLANE® is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate-buffered saline at a concentration of 20 mg/mL .
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy of different sodium fluoride (NaF)
      containing toothpastes in prevention of dental caries. Change from baseline fluoride data at
      various time points up to four hours after a single brushing with NaF containing toothpastes
      will be evaluated.
    

Detailed description: 
      Topical fluorides in a wide variety of delivery systems have been proven to be clinically
      effective in the prevention of dental caries. It is generally agreed that fluoride has its
      anti-caries effect mainly by decreasing the rate of enamel demineralization and enhancing the
      rate of enamel remineralization. There is a general consensus that level of fluoride in
      plaque fluid, may be directly related to the anti caries effects of fluoride. Also, fluoride
      levels in the oral fluids decrease rapidly after topical fluoride application, mainly due to
      the diluting and washing effect of saliva followed by periodic swallowing. To evaluate
      fluoride content, plaque samples will be collected from the interproximal surfaces of the
      posterior teeth of participants using a standardized approach. Plaque fluid fluoride will be
      calculated using a micro analytical method and in comparison to a standard fluoride curve
      constructed on the same day of the analysis.
    

Intervention name(s): Sodium Fluoride (NaF); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Different fluoride toothpastes containing between 1400ppmF - 1450ppmF of fluoride as NaF; Fluoride free toothpaste (0ppmF)
Other intervention name(s): fluoride
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: toothpaste; plaque fluid; fluoride
Influence of Tracheal-bronchial Anatomy Changes on Multi-detector Computed Tomography Scan of the Chest Upon Placement of Left-Sided Double Lumen Endotracheal Tube
Condition: Intubation, Intratracheal; Multidetector Computed Tomography
Study type: Observational

Summary: 
      One-lung ventilation (OLV) is used for thoracic surgical procedures to facilitate surgical
      exposure. Lung isolation is performed using a double-lumen endotracheal tube (DLT) and
      optimal position is achieved with the use of fiberoptic bronchoscopy. The most common
      technique used to place a left-sided DLT is the blind method technique, which consists of
      direct laryngoscopy and rotation of the DLT into the trachea with the aim to intubate the
      entrance of the left main bronchus. The DLT will be rotated counterclockwise blindly after
      the tip of the DLT passes the vocal cords under direct laryngoscopy. However, in some
      occasions, the tip of the DLT migrates into the right bronchus because the alignment between
      the trachea and right bronchus is more vertical. The identification of the misplacement can
      be challenging, which could lead to the failure of lung isolation. In order to avoid the
      unsuccessful lung isolation, Investigators are interested in identifying the factors that
      potentially influence the incorrect tube DLT placement diverting into the opposite bronchus.
    

Detailed description: 
      Recently, multi-detector 3-dimensional computed tomography (MDCT) scan of the chest is
      becoming a routine study for patients requiring thoracic surgical procedures. On the day of
      thoracic surgery, the participant will be intubated with a left-sided DLT and investigators
      will confirm the correct insertion of the left-sided DLT at first pass under direct
      laryngoscopy. This information will be recorded and saved. After the study is completed,
      investigators will review the MDCT of the chest to review any abnormal findings and correlate
      it with the success of the insertion of the left-sided DLT into the left bronchus.
      Investigators will conduct a pilot study to determine the most influential anatomical change
      that leads to the DLT misplacement at the first pass based upon the changes of the
      tracheal-bronchial anatomy on MDCT.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patient undergoing scheduled thoracic surgery at University of Iowa Hospital
      
Keywords: Double-lumen endotracheal tube; Multidetector Computed Tomography
3D Ultrasound Measurement of Junctional Zone Thickness and Its Relation to Implantation Success
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      100 patients aged 21-40 years old, diagnosed as primary or secondary infertility . These
      patients are then assigned to receive fertility treatment (ovulation induction, ICSI,
      intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to
      measure the junctional zone thickness and followed up after treatment to determine the rate
      of implantation.
    


Intervention name(s): 3D ultrasound
Intervention type(s): Radiation
Intervention description(s): ultrasound to measure the thickness of the junctional zone at day 21 of the cycle
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 patients aged 21-40 years old, diagnosed as primary or secondary infertility due to the
        following causes of infertility; ( Pelvic Inflammatory disease, dysovulation , tubal
        infertility, unexplained infertility, combined infertility or due to male factor ).
      
Keywords: junctional zone; implantation; three D ultraosund; Assisted Reproductive Technology; Pregnancy
Shoe Modification and Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This trial will assess the ability of shoe inserts to relieve pain and disability in people
      with knee osteoarthritis (OA) in the inner (medial) aspect of the knee.
    

Detailed description: 
      Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain
      and disability. Its prevalence increases with age, leading to about 65-85% of those age 65
      years and older having OA. Involvement of the knee with OA is the main reason for significant
      functional impairment as it alters ambulation through pain and stiffness. Nonpharmacological
      management of knee OA includes the use of orthotic supports such as wedged insoles for varus
      or valgus knee deformities to relieve pain and improve function in the early stages of this
      joint disease. Although these interventions are desirable because they are simple and
      inexpensive, we do not have a clear understanding about their efficacy in relieving pain and
      disability in people with knee OA. We also do not know whether there is a relationship
      between changes in joint biomechanics that occur with wedged insoles and changes in function
      and progression of OA. Furthermore, information is lacking regarding which patients would
      benefit from wedged insoles. Answering these questions will be critically important in the
      development of guidelines for the prescription of wedged insoles in knee OA. Patients in this
      study will be evaluated at baseline and after wearing the lateral-wedged insoles immediately
      and after wearing the insoles for four weeks. The participants will wear lateral-wedged
      insoles for the painful knee(s) for as many hours and for as many days of the week as they
      can tolerate. Some subjects may use a neutral position insole for an asymptomatic knee.
    

Intervention name(s): Shoe insert; walking shoes
Intervention type(s): Device; Other
Intervention description(s): Subjects with knee OA underwent gait analysis and knee pain and function assessment at baseline while wearing walking shoes and after four weeks of wearing walking shoes with lateral-wedged insoles.; walking shoes
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lateral wedge inserts; shoe inserts
Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      • To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial
      atorvastatin tablets (Lipitor®).
    


Intervention name(s): Atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): A single 10 mg dose of marketed 10 mg atorvastatin tablets; A single 10 mg dose of new formulation of 10 mg atorvastatin
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence, pharmacokinetics, atorvastatin
Mono Antiplatelet and Colchicine Therapy
Condition: Acute Coronary Syndrome; Drug-Eluting Stents
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of aspirin-free, P2Y12
      inhibitor single antiplatelet and colchicine treatment in patients with acute coronary
      syndrome treated with drug-eluting stents.
    

Detailed description: 
      After successful drug-eluting stent implantation for acute coronary syndrome, screening for
      study subject enrollment is performed. For those who submitted written informed consent,
      aspirin is stopped the day after the intervention, and colchicine 0.6mg once daily is
      started. The P2Y12 inhibitor, prasugrel or ticagrelor, for single antiplatelet therapy
      remains. For the duration of hospital stay, platelet reactivity using VerifyNow test and
      C-reactive protein are measured. Aspirin may be restarted at the discretion of the
      investigator based on results of the platelet function test. C-reactive protein is remeasured
      30 days after the intervention. Clinical follow-up is performed 30 days and 90 days after the
      intervention.
    

Intervention name(s): Aspirin; Colchicine
Intervention type(s): Drug; Drug
Intervention description(s): Aspirin is discontinued the day after drug-eluting stent implantation; Colchicine is started the day after drug-eluting stent implantation
Other intervention name(s): Aspirin stop; Colchicine start
Intervention MeSH terms: Aspirin; Colchicine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet Aggregation Inhibitors; Colchicine
Time to Perform Lung Function Test in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Time to perform lung function test after chest physiotherapy in cystic fibrosis.

      The investigators study FEV1(forced expiratory volume in one second) and FVC (forced vital
      capacity).
    

Detailed description: 
      The patients perform spirometry before, direct after, 30 minutes, 1 hour, 2 hours, and 3
      hours after physiotherapist. The investigators want to study the FEV1 and FVC.
    

Intervention name(s): Lung function test
Intervention type(s): Procedure
Intervention description(s): Lung function test.
Other intervention name(s): Lung function test.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung function; Physiotherapy
The Effect of Two Probiotic Products on the Intestinal Barrier Function in Patients With Irritable Bowel Syndrome
Condition: IBS
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      This study will investigate the effects of supplementation with two different probiotic
      products (Lactobacillus reuteri strains) on the intestinal barrier function, gut health and
      stress symptoms in diarrhoea-predominant irritable bowel syndrome (IBS-D) patients.
    

Detailed description: 
      After having given their written informed consent, subjects will complete screening
      procedures to evaluate their eligibility for the study (visit 1). Study participants will
      undergo two baseline visits (visits 2 and 3, 3 weeks apart) to account for individual
      variations, and will then be randomly assigned to 6-week intake of one of two Lactobacillus
      reuteri strains, or placebo in a ratio of 1:1:1 (stratified by sex). Participants will attend
      a study visit three weeks into the intervention (visit 4) and at the end of the intervention
      (visit 5, week 6). The intestinal permeability will be assessed using a standardized
      multi-sugar test at visit 2, visit 3, visit 4, and at end of intervention (visit 5). Blood,
      saliva and faecal samples will be collected at visit 2-5. In addition, gastrointestinal
      symptoms will be recorded at those visits (using Gastrointestinal symptom rating scale-IBS,
      GSRS-IBS; IBS severity scoring system, IBS- SSS). Quality of life using the 5Q-5D-5L and
      Hospital Anxiety and Depression Scale (HADS) scores will also be recorded at those visits. In
      addition, at visit 3 and visit 5, the IBS-Quality of life (IBS-QoL) and the Perceived Stress
      Scale (PSS) will be completed. In a daily diary, participants will record stool frequency and
      consistency from visit 2 until end-of-study visit 5. Dietary habits of the patients will be
      assessed via a food frequency questionnaire (FFQ) and a 3-day food diary before the
      intervention (between visit 2 and 3).
    

Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 5x10^8 colony forming units (CFU) of each probiotic strain, two capsules per day over six weeks; Similar in shape and taste to intervention capsules but without the probiotic components, two capsules per day over six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
An Investigational Study to Evaluate Experimental Medication BMS-986165 Given as a Tablet and Solution in Healthy Male Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate BMS-986165 given as a tablet in healthy male
      participants.
    


Intervention name(s): BMS-986165
Intervention type(s): Drug
Intervention description(s): Oral administration of tablet and 15-minute intravenous BMS-986165 solution for infusion
Intervention MeSH terms: Deucravacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Blood Pressure and Metabolic Effects of Nebivolol in Hypertensive Patients With Impaired Glucose Tolerance or Impaired Fasting Glucose
Condition: Hypertension
MeSH terms: Hypertension; Glucose Intolerance
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being done to see if the blood pressure and metabolic effects of an approved
      drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and
      placebo in hypertensive patients.
    

Detailed description: 
      This study is double blind (neither you nor the physician will know when you are receiving
      placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol
      or hydrochlorothiazide).

      All participants will also receive lisinopril, an angiotensin converting enzyme, or losartan,
      an angiotensin receptor blocker. All medications are approved and marketed for the treatment
      of hypertension.This study is being conducted in about 500 patients at approximately 80
      research centers in the United States.

      The study consists of approximately 9 study visits over a period of 5 months. During these
      visits, patients will undergo routine health exams and some special laboratory tests such as
      an oral glucose tolerance test.
    

Intervention name(s): Nebivolol with concomitant losartan or lisinopril; HCTZ with concomitant losartan or lisinopril; Placebo with concomitant losartan or lisinopril
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.; Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.; Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Intervention MeSH terms: Losartan; Lisinopril; Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nebivolol; BYSTOLIC ™; hydrochlorothiazide; lisinopril; Prinivil (TM); Zestril (TM); losartan; Cozaar (TM); Impaired Fasting Glucose; Impaired Glucose Tolerance; hypertension
Effectiveness of Divalproex Sodium (Depakote) in Treating Children With Temper Outbursts and Severe Mood Swings
Condition: Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote)
      versus placebo in treating children with temper outbursts and severe mood disorders.
    

Detailed description: 
      Depakote has been used to treat seizures in children for more than 20 years. The purpose of
      this study is to determine the effectiveness of divalproex sodium (Depakote) in treating
      children with temper outbursts and severe mood disorders.

      This study will last 12 weeks. Participants will be randomly assigned to receive either 250
      mg Depakote or placebo. The dose of medication will increase at the end of Week 1 to 500 mg
      of either depakote or placebo; participants will remain on this dose through Week 5. At Week
      6, participants will cross-over and receive the other treatment (either depakote or placebo),
      which they will take through Week 12. Study visits will occur weekly and will include a
      physical exam, blood and urine tests, and self-reports of adverse events. In addition,
      caregivers will complete reports about mood swings throughout the study.
    

Intervention name(s): Divalproex Sodium (Depakote)
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Behavioral Disorders