bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Look at How Safe Insulin NNC0471-0119 is and How it Works in People With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is looking at the safety of the new medicine, insulin NNC0471-0119, its
      concentrations in the blood and effect on blood sugar for the treatment of type 1 diabetes.
      Insulin NNC0471-0119 will be compared to faster aspart. The purpose of this study is to test
      how insulin NNC0471-0119 is tolerated by participants body, how it is transported in
      participants bloodstream, how long it stays there and how the blood sugar is lowered compared
      to faster aspart. Participants will get either the new insulin NNC0471-0119 or faster
      aspart-which treatment participants get is decided by chance. It is the first time insulin
      NNC0471-0119 is tested in people. Faster aspart is a globally used medication for treatment
      of diabetes mellitus. Participants will get one single injection in a fasting state which
      will take place at the study site. The medicine will be injected under the skin in the
      stomach. The study will last for about 13-53 days, depending on individual visit schedule.
      Participants will have four clinic visits with the study doctor, one of which will require an
      in-house visit period of 3 days. During the in-house visit, two intravenous cannulas will be
      inserted for sampling of blood and infusion of insulin. Participants cannot be in the study
      if the study doctor thinks that there are risks to their health. Women: Women cannot take
      part if they are of childbearing potential.
    


Intervention name(s): NNC0471-0119; Fast-acting insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be randomised to either of five dose levels 0.3, 0.6, 1.2, 2.4 or 3.6 of NNC0471-0119 nanomol per kilogram body weight, which will be administered as a single dose. NNC0471-0119 will be administered subcutaneously (s.c., under the skin) in fasting state.; Participants will get a fixed dose of 0.2 units of fast-acting insulin aspart (Fiasp®) per kilogram body weight, administered subcutaneously (s.c., under the skin) in fasting state.
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once
      daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg
      (FTC/TDF) once daily in subjects currently being treated with adefovir dipivoxil (Hepsera)
      for chronic hepatitis B who have persistent viral replication (detectable hepatitis B virus
      deoxyribonucleic acid [HBV DNA]).

      Subjects with confirmed (within 4 weeks) plasma HBV DNA ≥ 400 copies/mL during double blind
      treatment at Week 24 or any time thereafter have the option of receiving 12 weeks of
      open-label FTC/TDF which may be continued through the end of the 168-week treatment period if
      there is a virologic response (HBV DNA < 400 copies/mL). Alternatively, subjects with
      confirmed HBV DNA < 400 copies/mL at or any time after Week 24 of double-blind treatment may
      continue blinded therapy up to Week 168 at the discretion of the investigator. If, in the
      investigator's opinion, it is felt that continued blinded treatment beyond 24 weeks in
      subjects with confirmed HBV DNA ≥ 400 copies/mL is not beneficial, the subject may
      discontinue the study and begin commercially available HBV therapy rather than initiate
      open-label FTC/TDF.
    


Intervention name(s): tenofovir DF; emtricitabine /tenofovir DF
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg tablet, once daily (QD); emtricitabine 200 mg/tenofovir DF 300 mg once daily (combination tablet)
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Effects of Pioglitazone in Type II Diabetic Patients Previously Treated With Insulin
Condition: Type 2 Diabetes Mellitus; Insulin Resistance
MeSH terms: Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of the study is to demonstrate whether a switch from insulin therapy to an oral
      therapy with pioglitazone/glimepiride will lead to a deterioration of glycemic control
      (increase in HbA1c by more than 0.5 %) within a 6 month observation period.
    

Detailed description: 
      To demonstrate that reconverting type 2 diabetic patients from insulin treatment to oral
      treatment using pioglitazone in combination with or without glimepiride is possible without
      deterioration of blood glucose control.

      Primary aim is to maintain glycaemic control (HbA1c) defined as an increase in HbA1c of not
      more than 0.5 % after 6 months of treatment (visit 7) compared to baseline HbA1c value
      (screening visit V1).
    

Intervention name(s): pioglitazone and glimepiride
Intervention type(s): Drug
Intervention description(s): switch from any insulin treatment to 30 mg pioglitazone and 3 mg glimepiride.
Other intervention name(s): Actos - pioglitazone; Amaryl - glimepiride
Intervention MeSH terms: Pioglitazone; Glimepiride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes; insulin treatment; ß-cell function
Family-based Crisis Intervention With Suicidal Adolescents in the ED
Condition: Suicide
MeSH terms: Suicide
Study type: Interventional

Summary: 
      The Family Based Crisis Intervention (FBCI) is an emergency psychiatry intervention designed
      to sufficiently stabilize suicidal adolescents within a single ED visit so that they may
      return home safely with their families. This study is a randomized clinical trial of FBCI v.
      TAU in an urban Emergency Department.
    

Detailed description: 
      In current practice, treatment as usual (TAU) for suicidal adolescents includes evaluation,
      with little or no intervention provided in the Emergency Department (ED), and disposition,
      usually to an inpatient psychiatry unit. The Family Based Crisis Intervention (FBCI) is an
      emergency psychiatry intervention designed to sufficiently stabilize suicidal adolescents
      within a single ED visit so that they may return home safely with their families. The
      intervention works intensively with both the adolescent and the family, so that the caregiver
      has the knowledge and skills to help the adolescent after discharge.

      In this study, suicidal adolescents (ages 13-18) and their families presenting for
      psychiatric evaluation to a large pediatric ED were randomized to receive FBCI or treatment
      as usual (TAU). Patients and caregivers completed self-report measures of suicidality, family
      empowerment, and satisfaction with care provided at pre-test, post-test, and 3 follow up
      time-points over a one-month period. Clinicians contacted the adolescent and caregiver at
      these timepoints to administer the questionnaires and assure safety planning was being
      carried out.
    

Intervention name(s): Family-Based Crisis Intervention
Intervention type(s): Behavioral
Intervention description(s): This intensive ED-based intervention with suicidal adolescents and their families includes cognitive behavioral skill building, psychoeducation, enhancing therapeutic readiness, safety planning, and co-creation of a joint crisis narrative.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: family-based crisis intervention; adolescent suicide
Safety of Epidural Fentanyl and Adrenalin During Childbirth
Condition: Pregnancy; Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Investigation of pharmacokinetic effects of combining fentanyl and adrenalin in the epidural
      solution given to women in childbirth
    

Detailed description: 
      Healthy women with indication for labor epidural at the Labor Clinic, Rikshospitalet
      University Hospital, may be included. A randomized, placebocontrolled, double
      blind,comparison of epidural with and without adrenalin. Outcome: Length of birth, quality of
      pain relief, total amount of epidural solution injected, and plasma concentration of
      fentanyl.
    

Intervention name(s): adrenalin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): adrenalin 2 microgram pr ml placebo; Saline instead of adrenaline in the epidural mixture
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: labor analgesia; fentanyl; epinephrine
Study of Platelet-rich Plasma in Treating Patients With Tibiofemoral Cartilage Degeneration
Condition: Cartilage Degeneration
Study type: Interventional

Summary: 
      Recently an articular cartilage repair has been given much attention in the orthopaedic
      field. Cartilage regeneration capacity is very limited. Optimal approach seems to be a
      delivery of natural growth factors. Autologous platelet-rich plasma (PRP) contains
      proliferative and chemoattractant growth factors. The objective of the present study was to
      determine if PRP can increase tibiofemoral cartilage regeneration and improve knee function.
    

Detailed description: 
      Fifty consecutive and strictly selected patients, affected by Grade II or III chondromalacia,
      underwent one year treatment (9 injections) with autologous PRP in a liquid form with 2,0 to
      2,5-fold platelets concentration. Outcome measures included hte Lysholm, Tegner, IKDC, and
      Cincinnati scores. Magnetic resonance imaging was used to evaluate cartilage thickness and
      degree of degeneration.
    

Intervention name(s): platelet rich plasma injection
Intervention type(s): Biological
Intervention description(s): The approximate 2.0 to 2.5-fold platelet concentration (taking into consideration the mean human blood platelet count of 200 000 /μl) was achieved in all specimens. Mean platelet concentration in PRP was 459 000 /μl (range, 407 000 /μl to 513 000 /μl).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet-Rich Plasma; Knee; Tibiofemoral Chondromalacia; Injection
Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study
Condition: Growth Hormone; Advanced Maternal Age; PGT-A
Study type: Interventional
Phase: Phase 3

Summary: 
      This retrospective cohort study aims to investigate the effects of recombinant human growth
      hormone (rh-GH) on the euploid status of preimplantation blastocysts in AMA patients.

      Infertile patients aged 38-46 years old were recruited for study if they fulfill the
      inclusion criteria and do not have the exclusion criteria.

      Treatment group: Women received growth hormone (GH) supplement during antagonist protocol for
      ovarian stimulation.

      Control group: Women received antagonist protocol for ovarian stimulation. The primary
      outcome is the euploidy rate of blastocysts per stimulation cycle and per testing cycle.
    


Intervention name(s): Growth hormone; GnRH antagonist
Intervention type(s): Drug; Drug
Intervention description(s): Growth hormone is supplemented during the ovarian stimulation till the day of trigger; GnRH antagonist protocol for ovarian stimulation
Intervention MeSH terms: Hormones
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed
      and improved glycemic control. However, previous U-healthcare service had some limitations,
      which needs specific devices to check blood glucose and send it to central system. Voice
      inception technique based U-healthcare service is expected to improve glycemic control
      without specific devices.

      To evaluate the clinical efficacy of this system, researchers plan to compare the improvement
      of glycemic control, self-management, and quality of life between U-health care group
      (intervention) and conventional treatment group (control).
    

Detailed description: 
      Ubiquitous healthcare for chronic disease such as diabetes is intensively developing field.
      Nowadays, various methods are tried to find the most effective and easiest way for supplying
      U-health care.

      Here, researchers are going to investigate the efficacy and safety of voice inception
      technique based U-healthcare service.
    

Intervention name(s): U-health care
Intervention type(s): Device
Intervention description(s): voice inception technique based U-healthcare service
Other intervention name(s): U-health care group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Comparison of Minimal Approach With Conventional Approach for Distal Radial Fractures
Condition: Closed Frykman Type II Fracture of Right Radial Head
MeSH terms: Fractures, Bone; Radius Fractures
Study type: Interventional

Summary: 
      The objective of this study is to compare a minimal invasive approach with the conventional
      flexor carpi radialis approach for volar plating of distal radial fractures.
    

Detailed description: 
      The objective of this study is to compare a minimal invasive approach with the conventional
      flexor carpi radialis approach for volar plating of distal radial fractures.

      From January 2011 to September 2012, 157 patients with distal radial fractures were allocated
      into group A (n=83) and B (n=74). Patients in group A were treated through a 1.5 to 2-cm long
      incision, and patients in group B were treated through the conventional flexor carpi radialis
      approach. All fractures were fixed with volar plates. Patients were assessed range of motion
      of the wrist, grip strength of the hand, and pronation strength of the wrist. Results were
      analyzed with the Statistical Package for Social Sciences 13.0. A P < 0.05 was statistically
      significant.
    

Intervention name(s): Incision
Intervention type(s): Procedure
Intervention description(s): The objective of this report is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Distal radial fracture; pronator quadratus; mini-approach; volar plating; open reduction and internal fixation
Application of Megavoltage Imaging to Reduce Artifact After Seed Implants
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      This is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure
      in patients treated with interstitial permanent seed implants for low and intermediate risk
      prostate cancer. All patients will received the same standard of care treatment but will
      receive an additinoal CT image of the prostate.
    


Intervention name(s): MVCT
Intervention type(s): Radiation
Intervention description(s): Patients will receive an additional MVCT scan at their one month follow up visit.
Keywords: Prostate; Cancer
Efficiency of Two Dimensional High Definition vs Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery
Condition: Rectal Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Introduction: The usual surgical technique for large adenomatous tumors and rectal cancer is
      anterior resection of the rectum or abdominoperineal resection. These techniques are
      associated with high mortality and morbidity and with genitourinary dysfunctions.

      To solve these problems, transanal endoscopic microsurgery (TEM) was designed. Through its
      3-D vision system using a rectoscope, this procedure allows access to rectal tumors located
      up to 20 cm from the anal verge. It is associated with minimal morbidity and has few
      repercussions for anal continence.

      The use of 2-D high definition cameras and screens obtains images of a similar quality to 3-D
      images. This means that from the surgical point of view the procedure known as TEO (transanal
      endoscopic operation) seems as practicable as classic TEM.

      Main aim: To assess the effectiveness of 2-D high definition vision systems (TEO) versus
      conventional 3-D (TEM) in endoscopic surgery of rectal tumors, with respect to surgical
      facility, postoperative morbidity, quality of the surgical specimens, and cost.

      Design: Prospective, controlled, randomized study of the efficacy of the use of 2-D high
      definition endoscopic systems versus 3-D (TEM) in transanal endoscopic surgery.

      Disease studied: Rectal adenomas and adenocarcinomas "in situ" suitable for local surgery.

      Main variable evaluated: Cost per procedure assuming similar surgical efficacy and equal
      postoperative morbidity.

      Study population and total number of patients: Patients diagnosed with rectal tumor treated
      with curative intent (rectal adenomas and adenocarcinomas "in situ"). The total sample
      calculated for the trial was 36 patients, 18 in each group (TEO and TEM).

      Timing and expected finish date: After approval by the CEIC, the expected date for the
      inclusion of the first patient was August 2010. The study is expected to last 18-24 months.
    


Intervention name(s): 2-D high definition vision systems, transanal endoscopic operation (TEO); Transanal endoscopic microsurgery (TEM)
Intervention type(s): Procedure; Procedure
Intervention description(s): Transanal endoscopic operation (TEO). Through its 2-D vision system using a rectoscope, this procedure allows access to rectal tumors located up to 20 cm from the anal verge; Transanal endoscopic microsurgery (TEM). 3-D vision system using a rectoscope, allowing access to rectal tumors located up to 20 cm from the anal verge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transanal endoscopic microsurgery; Transanal endoscopic operations; Rectal adenomas; Transanal endoscopic surgery; Rectal adenocarcinomas "in situ"
A Study of Safety and Immunogenicity of a Malaria Vaccine Candidate
Condition: Prophylaxis Against Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      Shanghai Wanxing Bio-Pharmaceuticals is currently evaluating one malaria vaccine candidate,
      PfCP2.9 adjuvanted with Montanide ISA 720. This trial is designed to test the safety and
      immunogenicity of 3 doses and 2 vaccination schedules.

      This blood stage candidate malaria vaccine is being developed for the routine immunization of
      infants and children living in malaria-endemic areas.
    

Detailed description: 
      This is a double blind, randomized, controlled Phase I study of PfCp2.9, an experimental
      malaria vaccine candidate, adjuvanted with Montanide ISA 720.

      The primary objective of this study is to assess the safety and reactogenicity of the vaccine
      in healthy Chinese adult volunteers.
    

Intervention name(s): Plasmodium falciparum Chimeric Prot. 2.9 - Montanide ISA 720
Intervention type(s): Biological
Intervention MeSH terms: Monatide (IMS 3015)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: malaria
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 3

Summary: 
      Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium
      falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's
      Medicines and Healthcare products Regulatory Agency.

      CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a
      public-private partnership with the Medicines for Malaria Venture (MMV), World Health
      Organisation (WHO-TDR) and academic partners from the London School of Hygiene and Tropical
      Medicine, University of Liverpool and the Liverpool School of Tropical Medicine as a
      treatment for acute uncomplicated P. falciparum malaria.

      The combination of chlorproguanil-dapsone-artesunate (CDA) is being developed to supersede
      chlorproguanil-dapsone for the same indication, but the addition of an artemisinin
      derivative, artesunate, should provide additional population benefits over
      chlorproguanil-dapsone alone. The artemisinins have been demonstrated to rapidly reduce
      parasite load and have activity against the sexual stages of the P.falciparum lifecycle. The
      addition of a second agent to the chlorproguanil-dapsone combination should also protect
      against the selection of resistant strains of P.falciparum.

      Artemether-lumefantrine is the only available fixed-dose Artemisinin-based Combination
      Therapy actually available and is considered as the gold standard for the treatment of P.
      falciparum malaria. This study will therefore aim to demonstrate the non-inferiority of the
      combination of CDA to artemether-lumefantrine in terms of efficacy at 28-days. The key
      secondary objectives will compare the Parasite Clearance Times (PCT) and the Fever Clearance
      Times (FCT) between CDA and artemether-lumefantrine.
    


Intervention name(s): chlorproguanil-dapsone-artesunate; artemether-lumefantrine
Intervention type(s): Drug; Drug
Other intervention name(s): chlorproguanil-dapsone-artesunate
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Dapsone; Chlorproguanil; Proguanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Malaria CDA COARTEM Africa pediatrics children