bioihbjkbjnl/mcl2 huggingface dataset:
The Multicenter, Open-label, Single-use Autoinjector Convenience Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b)
      multiple domains related to subject's acceptability and satisfaction, and c) reliability of
      the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing
      multiple sclerosis (RMS).
    


Intervention name(s): Rebidose®
Intervention type(s): Device
Intervention description(s): The device is a ready to use single use auto injector containing Rebif® 44 mcg in a 0.5 mL prefilled syringe for sc injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Evaluation of Meibomian Gland Dysfunction Before and After Cataract Surgery
Condition: Cataract Patients
MeSH terms: Cataract; Meibomian Gland Dysfunction; Capsule Opacification
Study type: Interventional

Summary: 
      This study will compare cataract patients before and after phacoemulsification. Evaluations
      will be performed before and 1 and 3 months following cataract surgery, including parameters
      of dry eye syndrome and MGD. Dry eye syndrome parameters included TBUT, Schirmer's test type
      I, Oxford staining score, and the Ocular Surface Disease Index (OSDI) Questionnaire. MGD
      parameters consisted of lipid layer thickness (LLT), lid margin abnormality, meibum quality,
      meibum expressibility, MG orifice obstruction, MGD stage, and MG dropout.
    


Intervention name(s): Lipiview 2
Intervention type(s): Device
Intervention description(s): Tear film lipid layer thickness and meibomian gland dropout were measured by LipiView interferometer (TearScience Inc, Morrisville, NC)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Hysteroscopy Before in Vitro Fertilization - Does it Improve the Outcome?
Condition: Subfertility; Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      By randomizing sub-fertile women to either control or office-hysteroscopy in the circle prior
      to IVF or ICSI (intracytoplasmatic sperm injection

      ) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases
      pregnancy rates in the intervention group.
    

Detailed description: 
      Background A tenth of a population in Denmark today is the result of assisted fertility,
      including IVF and ICSI. In roughly 40 % of these subfertile women the reason is unknown.
      Standard initial procedures include transvaginal ultrasonography, with or without saline
      infusion to detect intrauterine abnormalities that might explain the infertile condition. The
      golden standard to detect intrauterine abnormalities is hysteroscopy. Such abnormalities can
      be detected in a fourth of this population. Earlier studies indicate that the hysteroscopy
      alone - without correcting any abnormalities, affects IVF/ISCI outcome positively.

      Aim By randomizing patients referred to the fertility clinic to ±office-hysteroscopy in
      circle prior to IVF/ISCI, we aim to enlighten whether mini-hysteroscopy with endometrial
      biopsy will increase the fertility by looking at pregnancy rates as our main outcome.

      Method Women signed up for second IVF/ISCI treatment will be recruited, after signed consent
      they are randomized to either office-hysteroscopy or nothing before standard treatment in the
      fertility clinic.

      Mini-hysteroscopy is a standard procedure in our gynecological outpatient clinic. The
      procedure is done without any anesthetics. Only women with normal intrauterine conditions
      will be enrolled in this protocol.

      When the fertility clinic has a positive serum-HCG (human chorionic gonadotropin

      ) and a positive transvaginal sonography, pregnancy is confirmed. If negative serum-HCG,
      negative pregnancy will be registered.
    

Intervention name(s): Office-hysteroscopy with biopsy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: IVF treatment; Office-hysteroscopy; Endometrial biopsy
Glans Penis Augmentation by Hyaluronic Acid for Treatment of Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized controlled cross-over study aims to evaluate the effect and safety of glans
      penis augmentation using Hyaluronic acid in the treatment of premature ejaculation in compare
      with placebo .
    


Intervention name(s): Hyaluronic Acid
Intervention type(s): Drug
Intervention description(s): Glans penis augmentation using multiple puncture technique as described by Abdallah et al. (2012) with minor modifications. HA is injected at two circular levels: one at the level of corona of glans penis and a second circular level is mid-way between the corona and urethral meatus. Six injections are injected at coronal level and four are injected in the second level, each injection is of 0.2 ml and is injected into deep dermis.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients with premature ejaculation according to the definition of Fourth International Consultation on Sexual Medicine 2015
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: premature ejaculation; IELT; hyaluronic acid; glans penis augmentation
Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft in Periodontal Intrabony Defects
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      A clinical and radiographic evaluation of 2 regenerative techniques, bioresorbable membrane
      and bone allograft for management of periodontal intrabony defects.
    

Detailed description: 
      Twenty-two patients suffering from advanced chronic periodontitis were included in this
      randomized controlled clinical trial. Each subject contributed had two- or three-walled
      intrabony defects. Patients were randomly assigned into two groups; bioresorbable membrane or
      bone allograft. Clinical parameters were recorded at baseline and at 3 and 6 months
      postoperatively. Radiographic parameters were recorded at baseline and at 6 months
      postoperatively.
    

Intervention name(s): Demineralized bone matrix in putty form; Amnion chorion membrane
Intervention type(s): Biological; Biological
Intervention description(s): it is a type of bone graft from human cadavers.; A bioresorbable allograft membrane for guided tissue regeneration from amnion and chorion parts of the placenta from pregnant females for guided tissue regeneration.
Other intervention name(s): DBM; bioresorbable membrane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)
Condition: Asthma, Bronchial
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent
      asthma.
    


Intervention name(s): MK0476, montelukast sodium / Duration of Treatment: 1 Year; Comparator : fluticasone propionate / Duration of Treatment: 1 Year
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluticasone; Xhance; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Metabolic Effects of a Pre-meal Protein Drink With or Without Added Amino Acids at a Subsequent Composite Meal
Condition: Diabetes Mellitus, Type 2; Satiety Response
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study was to investigate the efficacy of intake of whey or soy protein
      isolates, respectively, with or without supplementation of amino acids, on post-meal insulin
      secretion and glycaemic regulation. Additionally, the effect on plasma amino acids, gut
      hormones and ghrelin in plasma, as well as subjective satiety was investigated.
    

Detailed description: 
      Hyperglycaemia in type 2 diabetes (T2D) is associated with an increased risk of
      cardiovascular diseases, and it has been suggested that reduction of postprandial glycaemia
      is just as important as lowering fasting blood glucose levels to reach optimal metabolic
      control and reduce risk of complications in T2D. Observational studies indicate that milk
      consumption reduces the risk of developing T2D, obesity and cardiovascular disease, and a
      possible protective mechanism has been ascribed to the protein fraction. It has previously
      been demonstrated that addition of whey proteins, co-ingested with carbohydrates, stimulates
      insulin secretion and reduces postprandial glycaemia in both healthy subjects as well as in
      T2D patients. The effect is mediated through the insulinogenic properties of whey that
      appears to stem from a generation of a particular amino acid (AA) pattern in postprandial
      blood after ingestion of whey proteins. In the presently described project it is hypothesized
      that exchanging part of the whey protein for insulinogenic AA might be useful to optimize an
      insulinogenic effect. Additionally, soy protein has been suggested to have beneficial effects
      on insulin resistance and obesity as well on satiety. The possible effect of soy protein on
      insulin response and glycaemic regulation is therefore also of interest.

      A randomized, single blind, within-subject trial was performed. The test meals were provided
      as breakfasts on 7 different occasions in random order with approximately 1 week between each
      test. The test subjects were instructed to drink the protein drink immediately prior to
      eating the standardized sandwich meal. Altogether, the protein drink and the sandwich meal
      were to be consumed within 12 min.
    

Intervention name(s): Protein drink; Reference meal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Test drink providing 9g protein; Control meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Whey protein; Soy protein; Insulinogenic amino acids; Incretins; Glycaemia; Insulinaemia
Efficacy and Safety Study of Total Glucosides of Paeony Combined With Acitretin to Treat Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      This is a randomized, double blind, placebo parallel-controlled, multi-center clinical trial.
      Patients with psoriasis vulgaris were randomly divided into the experiment group （treated
      with TGP combined with acitretin capsules) and control group （treated with placebo combined
      with acitretin capsules）.The treatment lasted 12 weeks. The efficacy and safety were
      evaluated at the baseline, as well as 2, 4, 8 and 12 weeks after the beginning of
      treatment.The investigator's hypothesis TGP combined with Acitretin Capsulesin is more safe
      and effective than Acitretin Capsulesin to treat Psoriasis Vulgaris.
    


Intervention name(s): Total glucosides of paeony & Acitretin Capsules; Acitretin Capsules
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acitretin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Total Glucosides of Paeony(TGP); Acitretin Capsules; Psoriasis Vulgaris
Zambia SiVET MMR Tdap-IPV
Condition: High Risk for HIV
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Participants will receive vaccination for measles, mumps, and rubella (MMR) and tetanus,
      diphtheria, pertussis, and inactivated polio (Tdap-IPV). The study schedule design is to
      simulate a vaccine efficacy trial to see if single women can participate in studies that
      mimic actual HIV vaccine studies.
    

Detailed description: 
      This study will evaluate if women at high risk for HIV infection residing in Lusaka, Zambia
      and Ndola, Zambia are willing to participate and can be retained in future HIV vaccine
      trials. 150 women will be enrolled that are either sex workers or single women that were
      identified at infant vaccination clinics (at risk due to a recent pregnancy indicating
      unprotected sexual contact outside of marriage or cohabitation). Two licensed vaccines will
      be administered as proxies for HIV vaccine administration. The clinic and laboratory
      procedures will simulate HIV vaccine trial procedures and will therefore inform recruitment
      and retention strategies and HIV incidence among high risk women in future HIV vaccine
      trials.
    

Intervention name(s): Tdap - IPV Vaccine; MMR Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, combined with inactivated poliomyelitis vaccine (0.5 ml) will be administered intramuscularly.; A live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly.
Other intervention name(s): Adacel Quadra; TRIMOVAX
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Screening
Keywords: AIDS; Immunology; Public Health; Female sex workers; Single mothers
IVF Outcome After Bariatric Surgery
Condition: Infertility; Obesity
MeSH terms: Infertility
Study type: Observational

Summary: 
      This case-control study compares IVF results and live birth rates in women undergoing IVF
      with a history of bariatric surgery as compared to 2 age-matched control groups composed of
      (A) non-operated women matched on cases' post-operative BMI (controls 1) and (B) non-operated
      severely obese women (controls 2).
    

Detailed description: 
      A preliminary study in the participating center showed a trend to lower ovarian response to
      stimulation and live birth rates after bariatric surgery compared to weight-matched patients.
      However, statistical significance was not reached, as the sample size was small.

      The aim of the research project is to study the ovarian response and live birth rates of this
      bariatric surgery population, with a sufficient number of patients, in order to reach higher
      statistical power. This case-control study will involve 3 IVF (in-vitro fertilization)
      centers in France . All patients undergoing IVF with a history of bariatric surgery will be
      included from January 2012. Each case will be matched for BMI and age to the 2 next patients
      without bariatric surgery history and undergoing IVF and to one non-operated severely obese
      woman. Surgery procedures include sleeve gastrectomies and by-passes. The IVF results and
      live birth rates will be compared between the three groups.
    

Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Women underoing IVF and having undergone bariatric surgery
      
Keywords: Assisted Reproductive Technology; Obesity; Bariatric Surgery; Infertility; Fertility Preservation
Formulations of Liposomal Local Anesthetics
Condition: Underdosing of Local Anesthetics, Initial Encounter
Study type: Interventional
Phase: Phase 1

Summary: 
      This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated
      ropivacaine formulation for dental anesthesia.
    

Detailed description: 
      This blinded cross-over study aim to evaluate the efficacy of liposome-encapsulated 0, 5%
      ropivacaine for dental anesthesia after maxillary infiltration.
    

Intervention name(s): Ropivacaine
Intervention type(s): Drug
Intervention description(s): 1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.
Other intervention name(s): 0,5% ropivacaine encapsulated in liposomes; 0,5% ropivacaine with epinephrine 1:200.000; 2% lidocaine with epinephrine 1:100.000
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Ropivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: liposomes; ropivacaine; dental anesthesia; dentistry
Effect of Antioxidant on Endurance Performance in Healthy Men
Condition: Exercise Tolerance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance
    

Detailed description: 
      Regular physical exercise has many beneficial effects, but it has been reported that
      strenuous exercise could elevate the production of free radical and other reactive oxygen
      species (ROS) which eventually injure the tissues and decrease the muscle function.So many
      kinds of antioxidant supplementations have been tried to decrease the muscle fatigue and
      enhance the exercise performance. polyphenolic flavonoids abundant in fruits and leafy
      vegetables have strong antioxidant effect. oligomerized litchi fruit extract has strong
      antioxidant capacity and higher bioavailability compared to that of grape seed polyphenol.
      The aim of this study was to determine whether oligomerized litchi fruit extract could induce
      endurance exercise performance more than Vit C + Vit E mixture or placebo could do.
      Therefore, we designed double blind randomized controlled trial, setting the change of
      running time to exhaustion under submaximal treadmill test as the primary endpoint.
    

Intervention name(s): Oligomerized litchi fruit extract; VItamin C + Vitamin E mixture; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 100mg at once twice a day for 1 month; Vitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month; twice a day for 1 month
Other intervention name(s): oligonol; brand name of oligomerized litchi fruit extract
Intervention MeSH terms: Vitamins; Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Two Investigational Pneumococcal Vaccines in Healthy Adults
Condition: Pneumococcal Infections; Streptococcus Pneumoniae Infections; Pneumococcal Pneumonia
MeSH terms: Infections; Communicable Diseases; Pneumonia; Pneumonia, Pneumococcal; Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, tolerability, and immunogenicity of two
      investigational pneumococcal vaccines at three dose levels in healthy adults.

      Primary Objective:

      - To evaluate the safety and tolerability of two investigational pneumococcal vaccines.

      Observational Objective:

      - To evaluate the immunogenicity of the investigational pneumococcal vaccines.
    

Detailed description: 
      An initial cohort of 6 participants will receive a single dose of one of two investigational
      pneumococcal vaccines. After safety evaluation of that cohort, additional cohorts will
      receive 2 injections 30 days apart of same investigational pneumococcal vaccine at same or
      increased dose level. All participants will be monitored for safety for 30 days after each
      vaccination.
    

Intervention name(s): Pneumococcal Vaccine Formulation 1; Pneumococcal Vaccine Formulation 2; Pneumococcal Vaccine Formulation 3; Pneumococcal Vaccine Formulation 4; Pneumococcal Vaccine Formulation 5; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, intramuscular (1 middle dose); 0.5 mL, intramuscular (2 low doses); 0.5 mL, intramuscular (2 middle doses); 0.5 mL, intramuscular (2 middle doses); 0.5 mL, intramuscular (2 high doses); 0.5 mL, intramuscular
Other intervention name(s): Tris buffered saline
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pneumococcal Infections; Streptococcus Pneumoniae Infections; Pneumococcal Vaccine
Vitamin K-absorption From Dairy
Condition: Healthy
Study type: Interventional

Summary: 
      Lactic acid bacteria produce a mixture of higher menaquinones, including menaquinone-9 (MK-9)
      and menaquinone-10 (MK-10). Vitamin K1 (phylloquinone) is normally present in chloroplasts in
      green vegetables. A new dairy product is developed containing both vitamin K1 and
      K2-vitamins. However, the extent to which the various forms of vitamin K are absorbed from
      such a mixture is not known. In this study the absorption profile of phylloquinone and
      menaquinones from this new dairy product containing several K-vitamins is investigated. This
      study describes a dietary intervention experiment for one single cocktail containing several
      K-vitamins as part of a dairy product.
    


Intervention name(s): vitamin K-rich dairy product
Intervention type(s): Dietary Supplement
Intervention description(s): several forms of vitamin K: phylloquinone, menaquinone-7,-8,-9,and -10.
Intervention MeSH terms: Vitamin K
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitamin K; Bio-availability
Changes in Serum Vitamin D Level After Different Loading Doses of Cholecalciferol
Condition: Hypovitaminosis D
MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      it is a clinical trial to observe increase in serum vitamin D level and clinical symptoms
      after 3 different doses of cholecalciferol given either intramuscularly or oral.
    

Detailed description: 
      A prospective, interventional study was conducted in Department of Rheumatology, BSMMU,
      Dhaka, Bangladesh from October 2015 to January 2017. One hundred and five clinically healthy
      adults of age 21-39 with serum vitamin D concentration were enrolled in the study. Serum
      vitamin D level was estimated by chemiluminescent micro particle immunoassay method at
      baseline and 3 months after the intervention. The participants were divided into three groups
      using random number table. Group A was given 6 lakh IU of cholecalciferol IM stat dose, group
      B was given 6 lakh IU of cholecalciferol orally with a glass of milk stat dose and group c
      was given 2 lakh IU of cholecalciferol orally once a month for 2 months followed by tablet
      cholecalciferol 1000 IU daily.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single center, interventional, open labelled study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypovitaminosis D; cholecalciferol; mehadose