bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Study to Evaluate the Microbiology and Safety of C16G2 Administered to Adult and Adolescent Dental Subjects
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate if C16G2 Gel administered over a certain period of
      time either with a toothbrush or a custom dental tray can effectively kill bacteria in the
      mouth that cause dental cavities.
    

Detailed description: 
      This multi-center, multiple-arm study will evaluate the microbiological activity and safety
      of C16G2 Gel in male and female dental subjects, 12 to 75 years of age. The study will be
      conducted in a randomized, double-blind, placebo-controlled and open-label manner and enroll
      adolescent (12-17 years of age) and adult subjects (18-75 years of age).

      A total of approximately 128 study subjects will be enrolled into up to 7 study arms. Study
      drug (C16G2 Gel or Placebo) will be administered via manual brush gel application (MBGA) or
      tray gel application (TGA). Two C16G2 concentrations will be evaluated. Four study arms will
      be conducted in a double blind manner, with a treatment allocation ratio of 4:1
      (C16G2:Placebo), three study arms will be conducted in an open-label manner. Before dosing,
      eligible subjects will undergo professional dental prophylaxis on Day 0. Clinic visits for
      all study arms will include Visit 1 (Screening/Days -21 to 0), and a varying number of dosing
      and follow-up visits.
    

Intervention name(s): C16G2 Gel; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Antimicrobial peptide; Placebo
Other intervention name(s): Antimicrobial peptide
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Immunogenicity of BCG, Delivered Intradermally in Healthy Volunteers
Condition: TB
Study type: Interventional

Summary: 
      To assess the immunogenicity of M. bovis BCG (SSI strain), given intrademally in the standard
      dose used in clinical practice and to measure the development of the immune response in the
      first six months after administration. M. bovis BCG is a fully licensed vaccine that has been
      in routine clinical use for the last 50 years. It is the most widely administered vaccine in
      the world today and has an excellent safety record.
    

Detailed description: 
      Volunteers for the study will be recruited through advertisements. Each volunteer will have
      received an information sheet concerning the study and will have agreed to participate in
      writing.

      Volunteers will be given at least 48 hours between reading the information leaflet and
      agreeing to participate. Female volunteers will have a pregnancy test prior to enrollment.
      Volunteers will give signed consent for their GP's to be notified about their participation
      in the trial. The GP will be faxed a letter on the day of screening and asked to reply if
      they know of a reason why the volunteer should not take part. The signed consent form will
      also be faxed with the letter.

      A week after the screening visit and after a negative Heaf test, subjects will receive a
      single intradermal injection of 106 cfu M. bovis BCG in 0.1ml just inferior to the insertion
      of the deltoid muscle. Blood tests will be taken at the screening visit and day of
      immunisation, 1 and 2 weeks, and 1, 2, 3 and 6 months after the immunisation. 75mls will be
      taken on the screening visit, and 60mls will be taken on all subsequent visits. Screening
      samples will be tested for full blood count, biochemical screen and immunological assays to
      determine vaccine immunogenicity. Peripheral blood mononuclear cells will be prepared for
      cellular immunological assays to be performed without or following cryopreservation. Other
      serological measures of immune response, i.e.

      antibody titres, will be assayed on frozen plasma samples. All blood tests will be taken
      within 1-3 days of the due date as described in the schedule above.
    

Intervention name(s): BCG (SSI Strain)
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: TB; Vaccine; BCG
Individualized Carbohydrate Intake Strategy to Improve Blood Glucose Control
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The objective of this study is to test whether an individualized carbohydrate intake based on
      weight and pre physical activity glucose level is more effective than usual camp care to
      improve glucose control in children and adolescents engaging in team sports (basketball,
      soccer, hockey) during a summer camp.

      At the enrollment interview, in addition to collecting patient's information (age, sex,
      diabetes duration, recent A1c, type of treatment, insulin doses body weight, concomitant
      diseases, diabetes complications and history of severe hypoglycemia), a continuous glucose
      monitoring system (FreeStyle Libre) will be installed by a nurse. At least, eight sports
      sessions per participant are planned for this study. In a randomized order, the
      individualized carbohydrate intake will be applied during at least 4 interventions sport
      sessions while at least 4 with matching types of sports will be used as control sessions. Two
      sport sessions are routinely scheduled at the camp each day; from 9h:30 to 10h:30 and from
      11h:00 to 12h:00. For intervention sessions that involve individualized carbohydrate intake,
      the FreeStyle Libre will be scanned 0-10 minutes before the start of the team sport.
      Carbohydrates will then be given in the amount of 0.5g/kg for glucose levels between 4.5 to
      7.0 mmol/L and 0.25g/kg for glucose levels between 7.1 to 10.0 mmol/L and none will be given
      if glucose levels are between 10.1 and 15.0 mmol/L. When glucose levels are below 4.5 mmol/L
      or above 15.0 mmol/L, the camp staff will take care of hypoglycemia/hyperglycemia treatment.
      During control sessions, as per camp routine care, there will be no measurement of glucose
      levels before the start of physical activity.
    


Intervention name(s): Physical activity; FreeStyle Libre; SenseWear Armband
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will engage in team sports exercise twice a day: from 9h:30 to 10h:30 and from 11h:00 to 12h:00.; Glucose levels will be measured by the FreeStyle Libre; Energy expenditure during physical activity sessions will be measured with the SenseWear Armband.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Physical activity; Carbohydrates; Hypoglycemia
Evaluation of Different Anesthesia for Uterine Curettage
Condition: Uterine Curettage; Abortion, Induced
Study type: Interventional

Summary: 
      Anesthesia during uterine curettage is a problem. Paracervical block is used in general for
      such an operation, though, the anesthetic efficacy is incomplete. Propofol is the
      short-lasting intravenous anesthetic administrated popularly. Sevoflurane is a new
      inhalational anesthetic well-known for it's "easy come, easy go" property. The investigators
      hypothesized that propofol, sevoflurane and paracervical block had different anesthetic
      efficacy during uterine curettage. Which one is the optimal selection for such operation
      needed to be evaluated.
    


Intervention name(s): Lidocaine; Propofol; Sevoflurane
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Paracervical injection of 2% Lidocaine to block associated nociception input; Propofol 3mg/kg will be injected intravenously; 1 mg/kg will be added additionally for incomplete anesthesia; Sevoflurane 8% for anesthesia induction, 2-3% as the maintenance
Other intervention name(s): Lignocaine; Diprivan; Sevorane
Intervention MeSH terms: Lidocaine; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Local anesthetic; Propofol; Sevoflurane
UF-BMT-HSCT-001: A Non-Interventional Study Evaluating Diet in HSCT Survivors
Condition: Hematopoietic Neoplasm
MeSH terms: Hematologic Neoplasms
Study type: Observational

Summary: 
      This is a single center, cross-sectional, non-interventional study aimed at the nutritional
      intake of long-term health of allogeneic or autologous hematopoietic stem cell transplant
      (HSCT) survivors.
    

Detailed description: 
      Higher rates of comorbidity among hematopoietic stem cell transplant (HSCT) survivors support
      the need for lifestyle interventions that target this vulnerable population. Comprehensive
      evaluation of the nutrient intake will provide adequate information necessary for develop of
      a targeted nutritional intervention in order to achieve specific nutritional need and improve
      long-term health of HSCT survivors. The cross-sectional design of this study has been
      selected for the timely collection of subject reported nutrient intake data. The intended
      study is strictly observational.
    

Intervention name(s): Dietary intake -Food Frequency Questionnaire; Receptivity to Participating in Diet Interventions
Intervention type(s): Other; Other
Intervention description(s): Dietary intake will be assessed using 2014 full-length food frequency questionnaire. The Block 2014 questionnaire combines a full-length food frequency questionnaire with a brief physical activity screening tool. The food and beverage list includes 127 items in the past 1 month, plus additional questions to adjust for fat, protein, carbohydrate, sugar, and whole grain content.; Study participants will rate their interest in learning more about dietary interventions to stay healthy using items developed specifically for this study. The items will be rated on a 3-point Likert-type scale from 3 (extremely interested) to 1 (not at all interested).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both males and females who have a medical history of allogeneic or autologous hematopoietic
        stem cell transplant (HSCT), irrespective of the disease. For the purpose of this study,
        HSCT survivor is defined as subjects one or more years after allogeneic or autologous HSCT
        without disease relapse, active graft-versus-host disease, or active infection.
the Effect of Transcutaneous Electrical Acupoint Stimulation on the Quality of Oocyte on Poor Ovarian Response(POR)
Condition: Poor Ovarian Response
Study type: Interventional

Summary: 
      Patients in experimental group will be given transcutaneous electrical acupoint stimulation
      (TEAS) treatment for 12 weeks prior to controlled ovarian stimulation (COS).The patients will
      be given three times acupuncture every week except menstruation.Patients in no intervention
      group will not be given any interventions for 12 weeks prior to COS. The primary outcome
      measure is the number of MII eggs obtained in the COS cycle. The secondary outcome measures
      are the lab and clinical reproductive outcomes.
    

Detailed description: 
      The patients will be randomly recruited into two groups. Patients in experimental group will
      be given TEAS treatment for 12 weeks prior to COS.The patients will be given three times
      acupuncture every week except menstruation. One treatment lasts for 30 minutes. The acupoints
      used for the TEAS treatment included head acupoint Baihui(DU20), abdominal acupoint Zhongji
      (RN3), Guanyuan (RN4), Zigong(EX-CA1), leg acupoint Sanyinjiao(SP6), waist acupoint Shenyu
      (BL23) and Guanyuanyu(BL26). Patients in no intervention group will not be given any
      intervention for 12 weeks prior to COS. When at least one dominant follicle is greater than
      18 mm then injection a GnRH agonist (Triptorelin, Ferring, Switzerland) 0.2mg. 36 hours later
      transvaginal oocyte retrieval will be taken. After 3 hours of incubation, each egg will be
      transferred with a density of about 100,000/mllive sperm. The fresh embryo transfer is
      performed 72 hours after embryo culture in vitro. The whole embryos will be frozen.

      The primary outcome measure is the number of MII eggs obtained in the COS cycle. The
      secondary outcome measures are the lab and clinical reproductive outcomes,including basic
      endocrine, serum Anti-Mullerian Hormone （AMH）, antral follicle counts, fertilization rate,
      cleavage rate, number of D3 embryos, the clinical pregnancy rate and early abortion rate.
    

Intervention name(s): TEAS
Intervention type(s): Other
Intervention description(s): Patients in the experimental group will be given TEAS treatment for 12 weeks prior to COS. The patients will be given three times acupuncture every week except menstruation. The acupuncture acupoint locations are as follows: head acupoint Baihui(DU20), abdominal acupoint Zhongji (RN3), Guanyuan (RN4), Zigong(EX-CA1), leg acupoint Sanyinjiao(SP6), waist acupoint Shenyu (BL23) and Guanyuanyu(BL26).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcutaneous electrical acupoint stimulation; quality of oocyte; ovarian reserve; poor ovarian response; in vitro fertilization-embryo transfer
A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is designed to evaluate the long-term safety and tolerability of VX-509 in
      subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll
      subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).
    

Detailed description: 
      VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In
      autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This
      cascade ultimately contributes to abnormal immune response that results in chronic
      inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage
      and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the
      treatment of RA.

      This study will follow a "treat to target" (T2T) paradigm. T2T strategies have been followed
      in non-rheumatologic fields for decades. T2T trials have been conducted for RA from the late
      1990's, and have substantiated the concept that treating to a target is associated with a
      better outcome than standard of care treatment. This has led to recommendations by experts to
      use T2T strategies in clinical practice.
    

Intervention name(s): VX-509
Intervention type(s): Drug
Intervention description(s): VX-509 dose may be increased every 8 weeks in a stepwise fashion from 100 to 150 mg and from 150 to 200 mg, as needed (determined by ongoing disease activity by CDAI)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Painless Local Anaesthesia With Bicarbonate Admixture
Condition: Local Infiltration; Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examines whether the injection of local anesthesia mixed with sodium bicarbonate
      in the ratio of 3:1 creates a less burning sensation and is as effective regarding the
      anesthetic effect as in the ratio of 9:1.
    

Detailed description: 
      Therefore the investigators compare two groups with 24 healthy individuals in each group in a
      cross-over study. One group receives four injections (two in each forearm) and one group
      receives only two injections (one in each forearm)

      The four injections of group 1 are:

        -  IMP1: Lidocaine and sodium bicarbonate ratio 3:1

        -  IMP 2: Lidocaine and sodium bicarbonate ratio 9:1

        -  IMP 3: Lidocaine

        -  IMP 4: Sodium cloride 0.9% (=placebo)

      The two injections of group 2 are IMP1 and IMP2.

      After each injection the individual has to rate their pain sensation on a NRS scale and
      afterwards the anesthetic effect gets tested by a standardized laser application.
    

Intervention name(s): Lidocaine and sodium bicarbonate; Lidocaine and sodium bicarbonate; Lidocaine; Sodium cloride 0.9%
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Lidocaine and sodium bicarbonate ratio 3:1; Lidocaine and sodium bicarbonate ratio 9:1; Lidocaine injection; Placebo
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Alemtuzumab and CHOP in T-cell Lymphoma
Condition: Lymphoma, T-Cell, Peripheral
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine efficacy and safety of the monoclonal antibody
      MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma.
    

Detailed description: 
      First International phase III T-cell lymphoma study Indication:Newly diagnosed non-cutaneous
      peripheral T-cell lymphoma Study objectives:Determination of the efficacy and safety of the
      monoclonal antibody MabCampath® (alemtuzumab) combined with two-weekly CHOP supported by
      G-CSF Primary Endpoint: Event-Free-Survival (EFS) Study Design: International open-label,
      multicentre, randomized Phase III Study

      Study Medication: Patients are randomized to six cycles of two-weekly CHOP plus G-CSF with or
      without alemtuzumab given subcutaneously 30 mg day 1 in combination with chemotherapy cycles
      1-4. Patients in CR, CRu and PR after the 6 cycles of CHOP14 combined or not with alemtuzumab
      will receive a consolidation with high-dose chemotherapy followed by autologous stem cell
      transplantation.

      Patient Population: Patients > 18 yrs with newly diagnosed non-cutaneous, non-leukemic PTCL,
      except alk-protein positive and negative anaplastic large cell lymphoma Planned Sample Size:
      308 young patients (18-60 yrs) registered and randomized Total Number of Centers: This study
      will be proposed to main European and Australian Study Groups.
    

Intervention name(s): CHOP14 chemotherapy (cyclophosphamide, hydroxydaunorubicin, vincristin, prednison) plus G-CSF, combined with alemtuzumab; CHOP14 chemotherapy (see specification under Arm B) plus G-CSF
Intervention type(s): Drug; Drug
Intervention description(s): Cyclophosphamide 750 mg/m2 i.v. on day 1 Hydroxydaunorubicin 50 mg/m2 i.v. on day 1 Vincristin 1 mg/m2 i.v. day 1 (max. 2mg) Prednisone 50 mg/m2 p.o. day 1 to 5 Alemtuzumab 30 mg s.c.on day 1 of CHOP-14 cycles 1-4; 6 cycles of CHOP every 2 weeks
Intervention MeSH terms: Cyclophosphamide; Alemtuzumab; Doxorubicin; Liposomal doxorubicin; Vincristine; Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; MabCampath; Campath; CHOP-14; CD52 expression
Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea
Condition: Hypertension
MeSH terms: Sleep Apnea Syndromes; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the
      effect of treatment of OSAS on the resistant hypertension have no been established. In a
      double-blind randomized clinical trial patients with resistant hypertension with at least
      moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight
      weeks in an ambulatory set. The investigators want to determine any difference on
      hypertension control between the 2 management strategies.
    

Detailed description: 
      This is a double blind, randomized, placebo controlled trial. Participants were consecutive
      patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use
      of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and
      without white coat phenomenon. All participants should have a diagnosis of at least moderate
      OSAS, defined by AHI > 15 in a portable monitoring sleep exam. Participants were assigned to
      active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure
      (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP
    

Intervention name(s): active CPAP; sham-CPAP
Intervention type(s): Device; Device
Intervention description(s): auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients; The sham-CPAP was the same equipment used for active CPAP (Respironics Remstar-Auto, Murraysville, PA) fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al. The differences between the two were undetectable except for the pressure generated in the facial mask in the sham-CPAP that was no greater than 1cm H2O.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Resistant Hypertension; Sleep apnea syndrome; Treatment
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Memory Consolidation in Healthy Adults
Condition: Memory Consolidation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3
      polyunsaturated fatty acid dietary supplements on overnight verbal and visual memory
      consolidation as well as morning alertness before and after 26 weeks of supplementation
    


Intervention name(s): Olive Oil Placebo; EPA-rich; DHA-rich
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 6 months placebo supplementation; 6 months placebo supplementation; 6 months placebo supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science