bioihbjkbjnl/mcl2 huggingface dataset:
Comparing Efficacy of Azithromycin and Probiotics for Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      the goal of this clinical trial is to measure the efficacy of probiotics for treatment of
      acne vulgaris, to compare it with azithromycin and to measure the synergistic effect of
      azithromycin and probiotics for treatment of acne vulgaris
    

Detailed description: 
      this study aims to answer this research question: in patients of acne vulgaris, is use of
      probiotics as efficacious as azithromycin in treating acne lesions & improving quality of
      life? total 75 patients were divided into 3 groups. group A received azithromycin, group B
      received probiotics and group C received both drugs. a topical cream was also advised to all
      groups. outcome was measured as reduction in total lesion count and improvement in patients'
      quality of life via reduction in Dermatology Life Quality Index score.
    

Intervention name(s): Azithromycin; Probiotic Formula; Benzoyl Peroxide 4 % Topical Cream
Intervention type(s): Drug; Drug; Drug
Intervention description(s): antibiotic; probiotics; topical cream
Other intervention name(s): "Zetro" by "Getz Pharma"; "Hi-Flora" by "Unicare Bioceuticals"; "Benoxyl" by "Glitz pharma"
Intervention MeSH terms: Azithromycin; Benzoyl Peroxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of the Vaccine ALVAC-HIV vCP205 in HIV-Negative Adult Volunteers in Uganda
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if it is safe to give ALVAC-HIV vCP205, a possible HIV
      vaccine, and to study the immune responses in adult HIV-1 uninfected volunteers.

      Uganda has been severely affected by HIV infection and AIDS and has been selected to
      participate in HIV-vaccine development. The HIV viruses commonly isolated from Uganda are 2
      kinds that are not used in making current vaccines. Current vaccines generate several kinds
      of immune responses. Researchers would like to see if a response to the kind of virus in a
      current vaccine will also protect people from the viruses commonly found in Uganda.
    

Detailed description: 
      The African country of Uganda is severely affected by HIV infection and AIDS and has been
      selected by the World Health Organization to participate in HIV-vaccine development. The
      predominant HIV-1 strains isolated from Ugandans are members of clade A and clade D. The only
      vaccines available for human testing are based on envelope proteins from clade B and clade E
      viruses. ALVAC-HIV vCP205 is a second generation vaccine that can induce a humoral and
      cellular response against several antigens. The current study will attempt to extend these
      findings to determine if the vCP205 vaccine, when administered to Ugandans, can induce
      cytotoxic T-lymphocyte (CTL) responses that are reactive against the HIV strains prevalent in
      Uganda.

      Volunteers are randomized into 1 of 3 groups and receive either the candidate HIV-1 vaccine
      ALVAC-HIV vCP205, the experimental canarypox rabies vaccine ALVAC-RG, or placebo-ALVAC.
      Neither the volunteer nor his/her health care professional knows which preparation is being
      given. Volunteers receive 4 injections over a period of 6 months and are followed for up to
      24 months. Clinical observations and monitoring of hematological, chemical, and immunologic
      parameters are done. Safety is evaluated by monitoring for local and systemic adverse
      reactions during the course of the trial. Comparative immunogenicity analyses are based on
      CTL responses to HIV and measures of binding and HIV-specific antibody responses. At each
      visit, volunteers are counseled on how to avoid HIV exposure and pregnancy.
    

Intervention name(s): ALVAC-HIV MN120TMG (vCP205); ALVAC-RG Rabies Glycoprotein (vCP65)
Intervention type(s): Biological; Biological
Intervention MeSH terms: polysaccharide-K
Masking: Double
Primary purpose: Prevention
Keywords: HIV Antibodies; HIV-1; AIDS Vaccines; HIV Seronegativity; Uganda; Cross Reactions; HIV Preventive Vaccine
A Local Experiential Study With Sitagliptin (an Antihyperglycemic Drug) in 30 Patients With Type 2 Diabetes Mellitus (0431-178)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess, over a 4-week treatment period, the safety and efficacy of the
      addition of sitagliptin to metformin in participants with type 2 diabetes mellitus (T2DM) who
      failed to achieve glycemic control on metformin monotherapy.
    


Intervention name(s): Sitagliptin phosphate; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin 100 mg tablet by mouth once daily for 4 weeks.; Stable dose of metformin tablet(s) by mouth (at least 1000 mg/day) for 4 weeks.
Other intervention name(s): MK-0431; Januvia; Glucophage
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Homeopathy for Persistent Insomnia in Patients With Cancer
Condition: Chronic Insomnia; Cancer
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Persistent insomnia is highly prevalent complaint in cancer survivors, but is seldom
      satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective
      intervention may offer a practicable solution. The aim of this study was to investigate the
      clinical effectiveness of homeopathy for insomnia.
    


Intervention name(s): Homeopathy Medicine
Intervention type(s): Other
Intervention description(s): Homeopathy, or homeopathic medicine, is a holistic system of treatment. Individualized homeopathy remedy was based on the most characteristic and clear mental symptoms. Secondly, general symptoms were taken into account.C-potencies were provided and manufactured according to the Homeopathic Pharmacopoeia and Hahnemann's methodology. Each individualized homeopathic remedy were be prescribed in C-potencies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Clinical Performance and Stability of Different Types of Implant Supported Overdenture
Condition: Complete Edentulism
Study type: Interventional

Summary: 
      A Total number of 36 implants were installed in 6 patients having mandibular single denture.

      The patients were divided into two groups according to the definitive prosthesis.

      Group I received ball and socket retained mandibular implant overdenture while Group II
      received cement retained implant supported fixed bridges.
    

Detailed description: 
      Implant's stability, clinical performance (gingival index, pocket depth, plaque index and
      bleeding on probing) and patient's satisfaction were performed after 15, 30,60 and 90 days
      after prosthesis delivery
    

Intervention name(s): Osstell ( Osstell AB, Goteborg, Sweden).; periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein; questionnaire for patient satisfaction
Intervention type(s): Device; Device; Other
Intervention description(s): Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery; Clinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery; A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.
Other intervention name(s): - Assessment of implants clinical performance
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups.Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Implant stability; Pocket depth; Patient Satisfaction; Overdentures
Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery
Condition: Mitral Regurgitation; Mitral Stenosis; Tricuspid Regurgitation
MeSH terms: Mitral Valve Insufficiency; Tricuspid Valve Insufficiency; Mitral Valve Stenosis
Study type: Observational

Summary: 
      Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's
      outcome regarding acute kidney injury. Although cardiopulmonary bypass (CPB), an essential
      procedure for cardiac surgery, dilutes patient's blood components, possible impact of
      applying acute normovolemic hemodilution (ANH) and CPB on s-Cr has not been well
      investigated.

      In patients undergoing cardiac surgery employing moderate hypothermic CPB (age 20-71 years,
      n=32), ANH will be randomly applied to 15 patients (Group-ANH) but not in 17 patients
      (Group-C) before initiating CPB. For ANH procedure consisting of 5 ml/kg of blood salvage and
      administering 5 ml/kg of balanced hydroxyethyl starch (HES) 130/0.4 for 15 min will be
      started at 30 min after anesthesia induction and before CPB application for surgery. In both
      groups, moderate hypothermic CPB will be initiated by using 1600-1800 ml of bloodless priming
      solution. The changes of hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr will be
      determined before ANH (T1), after the first ANH of 2.5 ml/kg (T2), and after the second ANH
      of 2.5 ml/kg (T3), 30 sec and 60 sec after the initiation of CPB (T4, T5), immediately and 1
      hour after the weaning from CPB (T6, T7) and at the end of surgery (T8). S-Cr will be
      determined by using a point-of-care test device (StatSensor™ Creatinine, Nova Biomedical,
      USA).
    


Intervention name(s): Acute normovolemic hemodilution (ANH); hydroxyethyl starch (HES 130/0.6)
Intervention type(s): Procedure; Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective cardiac surgery due to valvular heart disease
      
Keywords: cardiac surgery; acute normovolemic hemodilution
Comparison of the Effects of QLB 2 and QLB 3 on Post-operative Analgesia in Cesarean Section Surgery
Condition: Analgesia; Acute Pain; Chronic Pain
MeSH terms: Chronic Pain; Acute Pain
Study type: Interventional

Summary: 
      This study evaluates the post-operative analgesic effects of quadratus lomborum block 2 and 3
      (QLB 2, 3) in patients having cesarean section with spinal anesthesia. Spinal anesthesia will
      be performed to all patients for the surgery.
    

Detailed description: 
      In this study, patients are divided into two groups. After the spinal anesthesia is performed
      and cesarean section surgery is over; QLB 2 block will be performed to patients in Group A ;
      while QLB 3 block will be performed to patients in Group B.

      In addition, patient controlled analgesia (PCA) will be used in the first 24 hours
      postoperatively.

      Group A - Patients in group A will have QLB 2 block after the surgery. In addition, patient
      controlled analgesia (PCA) will be used in the first 24 hours postoperatively.

      Group B - Patients in group B will have QLB 3 block after the surgery. In addition, patient
      controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
    

Intervention name(s): Regional anesthesia
Intervention type(s): Other
Intervention description(s): The effects of QLB 2, 3 interfascial plane blocks on post-operative analgesia after cesarean section surgery
Other intervention name(s): Quadratus Lumborum Block 2; Quadratus Lumborum Block 3
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated randomization codes.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Regional Anesthesia; Acute and chronical pain; Quadratus Lumborum Blocks; Cesarean Section; Spinal Anesthesia
Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects
Condition: Xerostomia
MeSH terms: Xerostomia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the consumer perception of an experimental
      mouthwash formulation in population with dry mouth
    


Intervention name(s): Biotene mouthwash; Bottled mineral water
Intervention type(s): Other; Other
Intervention description(s): Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds.; Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a non-randomized, open-label, one-sequence, two-period within-subject study to
      investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female
      volunteers using itraconazole as a CYP3A inhibitor. The study was conducted at 1 site in the
      Netherlands.
    


Intervention name(s): Balovaptan; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): In Period 1, balovaptan was administered orally once daily (qd) on Days 1 to 10.
In Period 2, balovaptan was administered qd on Days 6 to 20.; In Period 2, 200 mg itraconzole was administered bid for 4 days and qd on Days 5-20, approximately 12 hours apart. On Days 6-20, 200 mg itraconazole was administered qd.
Intervention MeSH terms: Itraconazole; Balovaptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Aging and Aerobic Fitness Level on Heat Dissipation
Condition: Risk of Heat Stress
MeSH terms: Heat Stress Disorders
Study type: Interventional

Summary: 
      In the context of global aging, the health risk factors associated with exercising or working
      in the heat for aging population are exacerbated by the rising in global surface
      temperatures. The purpose of this investigation is to determine at what age the heat loss
      decrements occur and to examine if aerobic fitness level can affect the heat loss capacity in
      neutral environmental conditions.
    

Detailed description: 
      All trials were conducted to indoor gyms with the same environmental temperature and relative
      humidity, 26 - 30oC and 40-50% respectively, to ensure no difference in body temperature were
      due to the external thermal stress. The participants were instructed to refrain from intense
      exercise as well as alcohol and caffeine consumption for 24 hours prior to experimental trial
      and to had a light meal 2h before their arrival.

      Upon arrival, participants would have to wear running shoes, light and short running shorts
      and light cotton socks. Participants received comprehensive instructions about the shuttle
      run test and the whole process of measurements. Firstly participants answered the
      International Physical Activity Questionnaire (IPAQ). Thereafter, anthropometrics data
      (weight and height) were evaluated as well as the body temperature in external ear canal and
      axillary. All participants followed five minutes warming up and then performed to 20 m
      shuttle run test until their volitional limit. Once the participants could no longer run, the
      test was over and the number of laps was recorded. After the end of the shuttle run, were
      evaluated the body temperature and the weight of each participants. No fluids consumptions
      were permitted until the second weighing. They were weighed twice, at baseline and at the end
      of the running test with a precision weight scale (Kern DE 150K2D, KERN & SOHN GmbH,
      Balingen, Germany).

      Environmental data including air temperature and relative humidity were measured continuously
      using a portable weather station (LCD Digital Temperature & Humidity Meter HTC-1). The
      weather station was placed 1 meter above the ground according to the manufacturer's
      guidelines.
    

Intervention name(s): Shuttle run test
Intervention type(s): Behavioral
Intervention description(s): At the shuttle run test, participants were required to run between two lines 20 meters apart, while keeping pace with audio signals emitted from a pre-recorded CD. The frequency of the sound signals increases in such way that running speed was increased by 0.5 km h-1 each minute from the starting speed 8.5 km h-1.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: heat loss; aging; aerobic fitness level; heat stress
Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants
Condition: Healthy
Study type: Interventional

Summary: 
      This is a multicentric, randomized, blinded, controlled trial to study the effects of a new
      infant formula on the changes in the newborn body composition over time: weight gain,
      anthropometric data, incidence of infections, digestive tolerance (flatulence, vomiting and
      regurgitation), feces (consistency and frequency), behavior (restlessness, colic, nocturnal
      awakenings), count of probiotic strains of the intestinal microbiota in feces, safety and
      tolerability of the investigational products (measured as number, frequency and severity of
      adverse events in all branches of the study)
    


Intervention name(s): Nutribén Innova® 1; Nutribén®; Breastfeed
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Infants are fed solely with infant formula supplemented with an inactive probiotic and omega 3 fatty acids over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's; Infants are fed solely with infant formula over the first 6 months of their life, from then on the infants are fed with the study formula and the usual supplementary food, recommended to the baby's age.; Infants are breastfeeding solely over the first 6 months of their life, from then on the infants are fed as recommended by their caregiver, as if they are not participating in a research study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Infant formula, body composition, safety
Single Dose Study Of PF-04308515 And Prednisone On Carbohydrate
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effect of a single dose of PF-04308515 or prednisone on
      calculated measures of glucose tolerance and insulin resistance by using a modified oral
      glucose tolerance test.
    


Intervention name(s): PF-04308515; PF-04308515; Prednisone; PF-04308515; PF-04308515; Prednisone; Prednisone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT); 10 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test(OGTT); 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT); X mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT); Y mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT); 5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT); 20 mg (5 mg tablets) predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy People; Glucocorticoids; Prednisone
Study Evaluating Safety & Immunogenicity of rLP2086 Vaccine in Adolescents
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate the safety of an investigational meningitis vaccine and the immune response
      to it in adolescents
    


Intervention name(s): rLP2086; rLP2086; rLP2086; rLP2086
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Vaccine administered at 0, 1, and 6 months; Vaccine administered at 0, 1, and 6 months; Vaccine administered at 0, 1, and 6 months; Vaccine administered at 0, 1, and 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adolescent; Meningococcal; Safety