bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection
Condition: Staphylococcal Infections
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Tigecycline is being developed as an agent that overcomes tetracycline-resistance mechanisms
      and provides activity against emerging multi-drug resistant pathogens. The purpose of this
      protocol is to determine the linkage between time related clinical measures of infection
      response and time to bacterial eradication in patients with intravascular catheter infections
      caused by Staphylococcus epidermidis and other coagulase negative staphylococci.
    

Detailed description: 
      Tigecycline, a glycylcycline antibiotic and an analog of the tetracycline minocycline,
      demonstrates a broad spectrum of antibacterial activity by inhibiting multiply resistant
      gram-positive, gram-negative, anaerobic, and "atypical" bacteria. It is being developed as an
      agent that overcomes tetracycline-resistance mechanisms and provides activity against
      emerging multi-drug resistant pathogens. These attributes may provide clinicians with a
      valuable therapeutic alternative. The purpose of this protocol is to determine the linkage
      between time related clinical measures of infection response and time to bacterial
      eradication in patients with intravascular catheter infections caused by Staphylococcus
      epidermidis and other coagulase negative staphylococci. The study is being conducted in two
      phases. The first treats patients who have removal of the catheter at the time of treatment,
      and the second treats patients who have the catheter remaining in situ during tigecycline
      treatment.
    

Intervention name(s): Tigecycline
Intervention type(s): Drug
Intervention description(s): All patients will receive tigecycline infusions approximately every 12 or 24 hours. The usual regimen of tigecycline is (an initial intravenous (IV) dose of 100 mg followed by 50 mg approximately every 12 hours). Patients with severe hepatic dysfunction may, at the investigator's discretion with CPL Associates approval (call enrollment hotline) may be given a total daily dose of 50 mg (one 50 mg dose or 25 mg approximately every 12 hours). Tigecycline infusions will be administered over approximately 30 minutes in 100 mL of normal saline.
Intervention MeSH terms: Tigecycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tigecycline; Staphylococcal Infections; Catheter
Clinical Management of Anxiety and Access to Health Care
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Dental and health anxiety are common and potentially distressing problems, for both patients
      and health care providers. Anxiety has been identified as a barrier to regular dental visits
      and as an important target for enhancement of oral health-related quality of life. possible
      groups, (1) high dental anxiety and (2) low dental anxiety. The study aimed to develop and
      evaluate a computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT) that
      could be easily implemented in dental healthcare settings.

      A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental
      procedures, and cognitive restructuring was developed. A randomized controlled trial was
      conducted (N=151) to test its efficacy. Consenting adult dental patients who met inclusion
      (e.g., high dental anxiety) and exclusion criteria were randomized to one of two groups, (1)
      immediate treatment (IT) (n=74) or (2) a waitlist control (WL) (n=77).
    

Detailed description: 
      Analyses of covariance (ANCOVAs) based on intention to treat analyses were used to compare
      the two groups on dental anxiety, fear, avoidance, and overall severity of dental phobia.
      Baseline scores on these outcomes were entered into the analyses as covariates.
    

Intervention name(s): Computerized Dental Anxiety Treatment
Intervention type(s): Behavioral
Intervention description(s): The Computerized Dental Anxiety Treatment Program consists of treatment modules that are be delivered through a computer. The modules use Cognitive Behavioral Therapy (CBT) to assist the participant in preparing a personal plan for managing his/her dental anxiety. The program incorporates a range of CBT techniques, including cognitive restructuring, exposure, and motivational interviewing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Ductus Venosus Doppler at 16 Weeks in Monochorial Pregnancy
Condition: Twin Pregnancy, Monochorionic; Pregnancy Followed
Study type: Observational

Summary: 
      Studies shows that the realization of the Ductus venosus Doppler may improve the screening of
      the twin-twin transfusion syndrome. In this study, we want to compare the outcome of
      monochorial pregnancy when this Doppler was performed during the ultrasound at16 weeks, and
      when it wasn't. In order to do that, we will compile past reports (January 2015/ January
      2018) of all monochorial pregnancy handled in the hospital of Montpellier and Kremlin
      Bicêtre. We will establish if the Doppler was done or not, if the twin-twin transfusion
      syndrome appears and the neonatal outcome.
    


Intervention name(s): Ductus venosus Doppler
Intervention type(s): Other
Intervention description(s): Ductus venosus Doppler
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Monochorial pregnancy followed in the hospital of Montpellier or Bicêtre
      
Keywords: Ductus venosus Doppler
Clinical and Biological Outcomes of Human Milk and Formula Intake After Gastroschisis Repair
Condition: Gastroschisis
MeSH terms: Gastroschisis
Study type: Interventional

Summary: 
      The purpose of this study is to determine which type of food results in a shorter hospital
      stay and better overall outcome for babies born with gastroschisis.
    


Intervention name(s): Enteral Intake - Human Milk; Enteral Intake - Formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Comparing formula and human milk; Comparing formula and human milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Patients with a primary unilateral inguinal hernia are randomized to Lichtenstein's operation
      or Prolene Hernia System to repair their groin hernia. Follow up for three years with a total
      number of 4 clinical examinations. End point is postoperative pain and recurrences.
    


Intervention name(s): Lichtenstein's operation; Prolene Hernia System
Intervention type(s): Procedure; Procedure
Intervention description(s): Lichtenstein's operation to repair primary unilateral inguinal hernia; Prolene Hernia System to repair primary unilateral inguinal hernia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Surgery; Lichtenstein; Prolene Hernia System; Postoperative pain; Recurrence
Trial to Evaluate the Pharmacokinetics and Safety Profile of BAY94-9027 Following Single and Multiple Dose Administration
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to describe the pharmacokinetics (PK) of BAY94-9027(the test
      drug). Pharmacokinetics means that we will measure how well the study drug corrects the
      factor VIII levels in your blood and how long it takes for the levels to fall back to your
      baseline level. The study is also designed to determine if the pharmacokinetics of BAY94-9027
      change following repeat dosing over 8 weeks, determine if BAY94-9027 is safe, tolerable, and
      effective for the treatment of severe hemophilia A and define the appropriate dose of
      BAY94-9027. Two doses of BAY94-9027 will be studied.

      The first 8 subjects enrolled in the study (cohort 1) will receive a low dose (25 IU/kg) and
      will be treated 2 days a week for 8 weeks (total of 16 doses). The second 8 subjects (cohort
      2) will receive a higher dose and will be treated 1 day a week for 8 weeks (total 8 doses).
      All subjects will receive a single dose of rFVIII (Bayer Kogenate FS) to determine the PK by
      measuring blood levels for 2 days before they start the study drug BAY94-9027. Factor VIII
      blood levels for BAY94-9027 will be measured for 7 days after the first and last dose to see
      describe the PK. Safety & tolerability assessment include vital signs, coagulation and
      hematological parameter, clinical chemistry, measurement of FVIII inhibitor and polyethylene
      glycol (PEG) antibodies will be done during the course of the study.
    


Intervention name(s): BAY94-9027 + Recombinant Factor VIII (Kogenate FS, BAY14-2222); BAY94-9027 + Recombinant Factor VIII (Kogenate FS, BAY14-2222))
Intervention type(s): Biological; Biological
Intervention description(s): Single dose of Kogenate FS and 16 doses of BAY94-9027 given 2 times a week for 8 weeks. Both drugs to be given intravenously.; Single dose of Kogenate FS and 9 doses of BAY94-9027 given once a week for 8 weeks. Both drugs to be given intravenously.
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Safety
Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity
Condition: Inflammation; Insulin Sensitivity
MeSH terms: Insulin Resistance; Obesity, Abdominal; Hypersensitivity; Inflammation
Study type: Interventional

Summary: 
      Rationale: It is well established that increased intake of saturated fatty acids (SFA) is
      associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by
      dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to
      clarify the association between dietary fatty acids and metabolic risk markers beyond lipid
      profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy
      replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However, limited
      evidence is available on the effects of dietary fatty acids on insulin sensitivity and
      secretion. The current study is designed to investigate the effects of SFA versus MUFA versus
      CARB on insulinemic response and lipid metabolism in healthy individuals with central
      obesity.

      Study design: A randomized, crossover, single blind design study was carried out. The
      subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day
      during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein
      content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy
      intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based
      on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of the total
      energy intake. The CARB diet provided approximately 34 g/day experimental fat based on a 2000
      kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from total fat with the
      exchange from oleic acid (C18:1).

      Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence
      insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid
      metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be
      comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin
      sensitivity, endothelial and vascular function and inflammation
    


Intervention name(s): A 2000 kcal test meal; A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Inflammation; Insulin sensitivity; Interleukin-6 (IL-6); C-peptide; Saturated fatty acid (SFA); Monounsaturated fatty acid (MUFA); Carbohydrate (CARB)
High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Purpose: The purpose of this study will be to examine the feasibility and acceptability of a
      6-week high intensity interval training (HIIT) program in patients with knee OA symptoms
      ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body
      metabolism induced by 6-weeks of HIIT.

      Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA

      Procedures (methods): All participants will be assigned to the single-arm of the study in
      which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will
      be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability,
      feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes
      will include whole body metabolism markers, inflammation, and a set of physical function
      including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness,
      isometric knee extensor and flexor strength (factors associated with physical function and
      symptomatic knee OA progression), and body composition.
    


Intervention name(s): High intensity interval training
Intervention type(s): Behavioral
Intervention description(s): Each training session will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
Other intervention name(s): Stationary bike
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose-finding Study of OPC-41061 in Treatment of Cardiac Edema (Congestive Heart Failure)
Condition: Heart Failure, Congestive; Edema
MeSH terms: Heart Failure; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      This drug is being developed to treat cardiac edema. The primary purpose of this study is to
      investigate the dose response for body weight in seven-day repeated oral administration of
      OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion
      secondary to CHF despite taking furosemide at 40 mg/d or more. This study is being conducted
      in Japan.
    


Intervention name(s): OPC-41061(Tolvaptan)
Intervention type(s): Drug
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: OPC-41061; Tolvaptan; Heart Failure; Edema; Extracellular volume expansion
Codeine Phosphate/Guaifenesin ER Tablet 30 mg/600 mg Steady State Clinical Study
Condition: Cough
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this pivotal study are:

        1. to evaluate bioavailability of an extended-release and immediate release Codeine
           Phosphate/Guaifenesin tablet at steady state following multiple oral administration

        2. to assess the safety and tolerability of this Codeine Phosphate/Guaifenesin extended
           release formulation.
    

Detailed description: 
      This study will be a single-center, Two-site open-label, randomized, multiple-dose,
      two-treatment, two-period crossover design. During the course of the study, thirty eight (38)
      healthy adult volunteers will receive multiple doses of Codeine Phosphate/ Guaifenesin
      extended-release tablet 30 mg/600 mg and multiple doses of an IR Codeine Phosphate/
      Guaifenesin immediate-release tablet 20 mg/400 mg tablet in two separate treatment periods.

      Volunteers will enter the clinic the day prior [approximately 12 hours] to each dosing and
      will be confined in the clinic for 7 nights for each treatment period. The extended release
      tablet (test) will be administered as two tablets two times a day, 12 hours apart, and the
      immediate release tablet (reference) will be administered as one tablet six times a day, 4
      hours apart. Pre-dose blood samples will be collected prior to morning dose on Days 1, 2, 3,
      4, 5, 6 and 7. On Day 7, Two extended release tablets will be given once in the morning and
      the immediate release tablet will be given three times, in the morning and 4 and 8 hours
      later. Serial blood samples will be collected on Day 7 for up to 12 hours post morning dose.

      On Day 7 volunteers will be released from the study site after the 12-hour blood collection
      if clinically appropriate and will return to the study site to start the next treatment after
      a minimum of 7 days of wash-out period, which begins the morning after the last dose taken of
      the previous Period.
    

Intervention name(s): Codeine Phosphate/Guaifenesin ER Tablet; Codeine Phosphate/Guaifenesin IR Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Provide two Codeine Phosphate and Guaifenesin ER Tablet every 12 hours for 6 1/2 days.; Provide one Codeine Phosphate and Guaifenesin IR Tablet every 4 hours for 6 1/2 days
Other intervention name(s): Lot 100171; Lot 100168
Intervention MeSH terms: Phenylpropanolamine; Codeine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Conjugated linoleic acids (CLAs) comprise a family of linoleic acid (18:2n-6; LA) isomers
      that are formed by biohydrogenation and oxidation processes in nature. The main form of CLA,
      cis-9, trans-11-18:2, can be produced directly by bacterial hydrogenation in the rumen or by
      delta-9 desaturation of the co-product vaccenic acid (trans-11-18:1) in most mammalian
      tissues including man. The second most abundant isomer of CLA is the trans-10, cis-12-18:2
      form. Observations clearly emphasize that differences exist between mammalian species in
      their response to CLAs with mice being the most sensitive. The majority of studies on body
      compositional effects (i.e. fat loss, lean gain), on cancer and cardiovascular disease
      attenuation, on insulin sensitivity and diabetes and on immune function have been conducted
      with a variety of animal models. Recent studies indicate that some but not all of the effects
      observed in animals also pertain to human volunteers. Reports of detrimental effects of CLA
      intake appear to be largely in mice and due mainly to the trans-10, cis-12 isomer.
      Suggestions of possible deleterious effects in man due to an increase in oxidative lipid
      products (isoprostanes) with trans-10, cis-12 CLA ingestion require substantiation.
      Unresponsiveness to antioxidants of these non-enzymatic oxidation products casts some doubt
      on their physiological relevance. We hypothesized that supplementation with CLA + an
      antioxidant (vitamin E) in patients with diabetes mellitus may have beneficial effects on
      glycemic control and insulin sensitivity.
    


Intervention name(s): Tonalin SG1000T FFA
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Diabetes mellitus; CLA; Antioxidant; Glycemic control
Laparoscopic Management of Periappendicular Abscess
Condition: Appendicitis; Abdominal Abscess
MeSH terms: Appendicitis; Abscess; Abdominal Abscess
Study type: Interventional
Phase: Phase 2

Summary: 
      According to retrospective studies the conservative management of periappendicular abscess is
      associated with decreased complication and re-operation rate compared with open appendectomy.
      Large abscesses require percutaneous drainage. Sometimes percutaneous drainage is not
      possible because of anatomical position of the abscess and surgical treatment is needed. The
      purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the
      first-line treatment in patients with periappendicular abscess.

      The hypothesis of the study is that laparoscopic management of periappendicular abscess is
      suitable for the first-line treatment and it does not increase time of hospitalization or
      complication rate compared with conservative management.
    


Intervention name(s): Laparoscopic appendectomy; Conservative management with percutaneous drainage
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic appendectomy and laparoscopic drainage of the abscess. If appendectomy is not possible due to technical difficulties only laparoscopic drainage is performed. Patients are treated with the same antimicrobial therapy as the control group (intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day).; Patients are treated with intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day. If the abscess is at least 3 cm in diameter percutaneous ultrasound guided drainage is performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopy; Drainage; Appendectomy
Study in Patients With Mild to Moderate Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot
      study to obtain data on size and variance of treatment effects in subjects with mild to
      moderate Psoriasis.
    

Detailed description: 
      This was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot
      study to obtain data on size and variance of treatment effects in subjects with mild to
      moderate Psoriasis. The target sample size of 60 was selected as a practical figure for
      recruitment purposes in one centre over 3 months.After a 2 week washout during which only
      emollients were applied to their psoriasis, patients attended for baseline assessment of
      psoriasis severity and blood tests.Subjects attended every 4 weeks for 12 weeks for clinical
      assessment and blood tests.Each patient once eligible{see inclusion & exclusion criteria} was
      allocated to either active treatment or placebo in identical packing for a total of 12 weeks.
    

Intervention name(s): B. Infantis 35624
Intervention type(s): Dietary Supplement
Intervention description(s): One sachet daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pilot study