bioihbjkbjnl/mcl2 huggingface dataset:
Study of Bortezomib Combined With ACVBP in Peripheral T-cell Lymphoma
Condition: Peripheral T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and the safety profile and toxicity of
      a combination of Velcade™ (bortezomib) with a standard chemotherapy regimen (ACVBP
      [doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone]) in the treatment of
      previously untreated patients with peripheral T-cell lymphoma (PTCL).
    

Detailed description: 
      This is a multicentric, open-label, non-randomized, non-competitive clinical study,
      evaluating the efficacy and safety of V-ACVBP chemotherapy in previously untreated patients
      aged from 18 to 65 years with peripheral T-lymphoma.

      It is anticipated that 60 subjects will be enrolled over two years (from June 2005 to May
      2007).

      The duration of the treatment period is approximately 28 weeks and patients are followed
      until death.

      The total duration of the study is expected to be 5 years (from June 2005 to May 2010).
    

Intervention name(s): Velcade; Doxorubicin; Prednisone; Cyclophosphamide; Vindesine; Bleomycin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1.5 mg/m², D1, D5, 4 cycles; 75 mg/m², D1, 4 cycles; 60 mg/m², D1-D5, 4 cycles; 1200 mg/m², D1, 4 cycles; 2 mg/m², D1, D5, 4 cycles; 10 mg, D1, D5, 4 cycles
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Bortezomib; Bleomycin; Vindesine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peripheral T-cell lymphomas; bortezomib; ACVBP regimen
Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis
Condition: Multiple Sclerosis, Pharmacokinetics
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Serum and cerebrospinal fluid will be obtained from 20 patients with relapsing-remitting
      multiple sclerosis treated with teriflunomide tablets 14 mg daily
    

Detailed description: 
      Teriflunomide concentration in cerebrospinal fluid and serum will be determined in 12
      patients with multiple sclerosis. They have been treated for at least 6 months and the
      sampling from blood and by spinal tap is done before dose at 8 am in 10 patients and at 12 am
      in 10 patients. The dependence from age, sex, and blood-brain barrier (BBB) integrity will be
      evaluated.The ratio between serum and cerebrospinal fluid will determine the passage over the
      BBB.
    

Intervention name(s): Teriflunomide 14 MG
Intervention type(s): Drug
Intervention description(s): Blood and cerebrospinal fluid is obtained from teriflunomide treated patients with multiple sclerosis
Intervention MeSH terms: Teriflunomide
Intervention model: Single Group Assignment
Intervention model description: Pharmacokinetic
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Evaluate the Efficacy of an Over-the-counter (OTC) Sunscreen Lip Balm
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the 8-hour moisturization efficacy of OTC sunscreen
      lip balm after a single treatment application.
    

Detailed description: 
      A single-center, randomized, controlled, intra-individual comparison, open label clinical
      study to determine the 8-hour moisturization efficacy of a sunscreen lip balm. Skin hydration
      will be assessed before (Baseline) and after (2, 4, 6 and 8 hours post-treatment) a single
      treatment with test product, compared to 'no treatment' as control, using a corneometer.
      Study treatments will be randomly assigned to 2 test sites delineated on the skin of the
      participant's volar forearms (one test site on each arm). A 1-week conditioning phase will
      precede the test day, during which participants will use the soap provided for personal
      washing.
    

Intervention name(s): ChapStick Lip Moisturizer Original
Intervention type(s): Drug
Intervention description(s): Sunscreen lip balm.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Tasimelteon in Subjects With Mild or Moderate Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to understand whether there is any difference in the
      amount of tasimelteon (including its breakdown products) in the blood in individuals with
      mild or moderate liver disease compared to individuals who have normal liver function.
    

Detailed description: 
      The study will employ an open-label, parallel-group design. Up to 32 subjects will be
      enrolled in 3 groups: Group 1 will consist of 8 subjects with mild hepatic impairment; Group
      2 will consist of 8 subjects with moderate hepatic impairment; Group 3 will consist of up to
      16 healthy subjects matched by gender, age, smoking status, and body mass index, to Groups 1
      and/or 2. For each group, there will be a 21-day screening period, a baseline period, a
      single-dose treatment period with an on-site observation period of 36 hours, and a study
      completion evaluation conducted after the last PK blood sample is drawn. Each subject will
      receive a single 20-mg dose of tasimelteon, after which safety assessments will be performed.
    

Intervention name(s): tasimelteon
Intervention type(s): Drug
Intervention description(s): 20 mg tasimelteon capsules, PO single dose
Other intervention name(s): VEC-162; BMS-214778
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Liver disease; pharmacokinetics
Multicentre, Double-blind Study Versus Placebo on Impact and Safety of Extramel® 140 IU on Perceived Stress, Physical and Intellectual Fatigue, Pain Perception if Present, and the Impact on the Quality of Life
Condition: Life Stress; Fatigue; Pain; Quality of Life
MeSH terms: Fatigue; Stress, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      Objectives of this Multicentre, double-blind study versus placebo were to evaluate impact and
      safety of the daily administration of Extramel® 140 IU SOD for 12 weeks on perceived stress,
      physical and intellectual fatigue, pain perception, if present, and the impact on the quality
      of life of 70 subjects included with 60 that can be evaluated.
    


Intervention name(s): Extramel 10 mg - 140 UI SOD; Placebo - Excipient only
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects took one capsule of Extramel® 140 IU, or its corresponding placebo, daily over 12 weeks.
Each volunteer was seen for the 3 visits:
visit V1, so-called inclusion visit (D0),
visit V2 at 28 days, tolerance of +/- 3 days, (D28) and
visit V3 at 84 days, tolerance of +/- 3 days, (D84).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Super-Oxyd-Dismutase; SOD; melon juce; perceived stress
Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture?
Condition: Ankle Injuries; Fracture
MeSH terms: Fractures, Bone; Ankle Fractures; Ankle Injuries
Study type: Interventional

Summary: 
      After a patient has fractured an ankle that then requires surgery, the recommendation is to
      remain in bed, with the operated leg elevated on pillows for 48 hours. This is a
      precautionary measure, as yet unsubstantiated by research, which is thought to minimize ankle
      swelling that can inhibit the healing of the surgical wound. However, prolonged bed rest can
      lead to other complications such as blood clots in the lungs or leg veins, or chest
      infections such as pneumonia. Prolonged bed rest is also known to cause weakness and a loss
      of fitness such that recovery may be slower. In this research the investigators will be
      randomly allocating patients to mobilize within 24 hours post operatively or to rest in bed
      for 48 hours with their leg well elevated. The investigators will measure length of stay and
      wound healing and integrity at 14 days. This study aims to investigate whether getting
      patients out of bed within 24 hours of surgery can accelerate recovery and reduce acute
      hospital length of stay without affecting wound healing. If bed rest for 2 days is not
      necessary, there will be benefits for the patient in terms of general health and ability, and
      for the hospital in terms of cost savings through shorter lengths of stay and patient through
      put. The investigators already know that early mobilization is beneficial following other
      types of orthopedic surgery such as hip fractures. This study aims to investigate if early
      mobilization following surgical management of ankle fractures is safe with specific regard to
      wound integrity and wound outcomes. This study will also investigate the effect of earlier
      mobilization on the length of time spent in the acute hospital and for those discharged
      directly home, the amount and type of support required. If early mobilization is found to be
      safe for wound healing and results in shorter in-hospital stays, this research will provide
      the confidence to endorse a change to current clinical practice.
    


Intervention name(s): Early mobilization; Standard mobilization
Intervention type(s): Procedure; Procedure
Intervention description(s): pt to get out of bed and mobilize with physiotherapist within 24 hours of surgery. they will be allowed toilet privileges and will go home when safe (as per medical staff and allied health); this group will rest in bed with their leg elevated above their heart for 48 hours post surgery to ankle fracture and will then mobilize with physiotherapist with aim to discharge home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: ankle; fracture; mobilisation; bed rest; internal fixation
Effect of Bristle-less Toothbrush (PeriClean) on Gum Recession
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      This study tests if a bristle-less tooth brush has any measurable effect on gum recession in
      patients who are seen regularly for preventive dental care compared to a regular soft
      tooth-brush.

      Subjects are recruited from patients attending the Western University of Health Sciences
      Dental Center and asked to continue regular preventive dental care while using either the
      test or control brush for a year and using floss and toothpaste supplied by the researchers.
      The exams include measurement of plaque, pockets and gum recession every 3 months, and
      involve photographs and impressions of the teeth and gums to record any changes that occur.
    

Detailed description: 
      Purpose: This randomized clinical trial tested if a novel bristle-less tooth brush design is
      more effective in preventing gingival recession in adults receiving periodontal maintenance
      than a soft tooth brush with nylon bristles.

      Materials and methods: The investigators will recruit 23 subjects with gingival recession who
      received regular periodontal maintenance care at Western University of Health Sciences Dental
      Center, and who did not exhibit signs of acute dental and systemic disease, occlusal
      discrepancies and parafunctional habits. The investigators will randomly assign these
      subjects to two groups, one using a soft nylon-bristled tooth brush, and the other group
      using the experimental tooth brush that contains a brush head with short, soft, rubbery
      cones. Both groups will receive regular maintenance and periodontal exams by blinded
      examiners every 3-4 months measuring probing depth, bleeding on probing, plaque indices, and
      gingival recession. In addition, gingival recession will also be determined using a measuring
      guide on study models obtained with polyvinylsiloxane impressions. For added control of
      confounding variables, both groups will be supplied with abrasivity tooth paste and waxed
      floss while receiving repeated oral hygiene instruction and phone follow-up.
    

Intervention name(s): Tooth brush without nylon bristles; Tooth brush with soft nylon bristles
Intervention type(s): Other; Other
Intervention description(s): Subjects will use a bristle-less tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months; Subjects will use a soft bristled tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
Other intervention name(s): PeriClean Toothbrush; Oral B soft brush
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Observational

Summary: 
      This is a multicenter,open-label,prospective study of Aripiprazole use in patients with
      schizophrenia and bipolar disorder.
    

Detailed description: 
      This is a multicenter,open-label,prospective study of Aripiprazole use in patients with
      schizophrenia and bipolar disorder.

      Qualified schizophrenia patients will be enrolled to an 12-week treatment phase of
      Aripiprazole by physician's assessment.

      Qualified bipolar disorder patients will be enrolled to an 8-week treatment phase of
      Aripiprazole by physician's assessment.

      This study will be continued for 6 years. The final report of Aripiprazole PMS will be
      submitted to KFDA on December 28, 2009.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): The recommended starting and target dose for Abilify is 10 or 15mg/day administered on a once-a-day schedule without regard to meals.
(Administer 10 to 30 mg/day according to the patient's condition)
Intervention MeSH terms: Aripiprazole
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according
             to DSM-IV criteria

          -  Age: more than 18 years of age
      
Keywords: Aripiprazole; Schizophrenia; Bipolar Disorder
Vitamin K2 for Reduction the Calcium at Carotid Bifurcation in Patients With Subcritical Lesions
Condition: Carotid Plaques
Study type: Interventional

Summary: 
      Clinical study single center, prospective, randomized, controlled (vs. no supplement),
      open-label, blinded assessor (the doctor who will perform the Doppler ultrasound at 6 and 12
      months will not know the treatment given to the patient, because the diagnostic test in
      question is considered operator-dependent), a "parallel group", which aims is evaluate the
      reduction in the level of calcium in the carotid artery and the carotid atherosclerotic
      plaques, on a sample of 60 subjects presenting subcritical calcified lesions of the carotid
      bifurcation with a range of 40-60%.
    


Intervention name(s): Nutraceutical product based on vitamin K2 (PLAK2)
Intervention type(s): Other
Other intervention name(s): PLAK2
Intervention MeSH terms: Vitamin K; Vitamin K 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Safety and Protective Efficacy of BCG Vaccination Against Controlled Human Malaria Infection
Condition: Malaria; Plasmodium Falciparum
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The Bacillus Calmette-Guérin (BCG) vaccine, a live attenuated Mycobacterium bovis vaccine,
      has been used to prevent tuberculosis for almost a century, and it is still the most used
      vaccine in the world. There is also circumstantial and indirect evidence that BCG vaccination
      can protect against malaria. Investigators hypothesize that BCG vaccination can offer
      protection against malaria in the Controlled Human Malaria Infection (CHMI) model.

      A total of 20 healthy male and female volunteers will participate in this randomized,
      single-blind clinical trial. Volunteers will be randomized to receive either BCG vaccination
      (BCG vaccine SSI) (group 1, n=10) or no treatment (group 2, n=10). Five weeks after
      vaccination of group 1 volunteers, all volunteers will undergo a CHMI administered by the
      bites of five P. falciparum infected Anopheles mosquitoes.
    


Intervention name(s): BCG vaccination
Intervention type(s): Biological
Intervention description(s): BCG vaccine InterVax
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Study Evaluating the Pharmacokinetic and Mass Balance of Single Dose [14C] AZD9291 in Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the pharmacokinetic and Mass Balance of single dose [14C] AZD9291 in
      healthy male volunteers
    

Detailed description: 
      A Single-centre, Non-Randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally
      Administered [14C]-AZD9291 in Healthy Male Volunteers
    

Intervention name(s): AZD9291
Intervention type(s): Drug
Intervention description(s): Volunteer will receive a single oral dose of 20 mg [14C]-AZD9291 as a solution on Day 1
Intervention MeSH terms: Osimertinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I, healthy, pharmacokinetics, Mass balance
A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single center, open-label, randomized, parallel group, dose finding study to
      evaluate safety and efficacy of recombinant human luteinizing hormone (r-hLH, LHadi®),
      compared with urinary human chorionic gonadotrophin (u-hCG, Profasi®), both given
      subcutaneously, in inducing ovulation in infertile women undergoing stimulation of follicular
      growth with recombinant human follicle stimulating hormone (r-hFSH, Gonal-F®).
    


Intervention name(s): r-hFSH; r-hLH; u-hCG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daily r-hFSH treatment will be administered subcutaneously at a starting dose according to the site's standard practice from Day 3-5 of menstrual cycle up to follicular development or 28 days. Dose can be altered according to ovarian response (reduced to 75 IU/day; increased to 225 IU/day).; Ovulation triggering will be performed using a single injection of r-hLH injection subcutaneously at a dose of 825 or 2750 or 5500 or 11,000 or 22,000 IU as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter >= 18 mm, not more than 5 follicles with diameter >= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L).; Ovulation triggering will be performed using a single injection of 5000 IU of u-hCG as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter >= 18 mm, not more than 5 follicles with diameter >= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L).
Other intervention name(s): Gonal-f®; LHadi®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infertility; Ovulation induction; Recombinant human Luteinizing Hormone (r-hLH); Urinary human Chorionic Gonadotrophin (u-hCG); Recombinant human Follicle Stimulating Hormone (Gonal-f®)
Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the
      safety of CRN04894 in healthy volunteers as well as the relationship between exposure and
      pharmacodynamic (PD) parameters.
    


Intervention name(s): CRN04894 Oral Solution; Placebo Oral Solution
Intervention type(s): Drug; Drug
Intervention description(s): CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.; Placebo
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Green Tea Mouthwash on Generalized Plaque- Induced Gingivitis
Condition: Plaque Induced Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This investigation will study the effect of green tea mouthwash as an adjunctive therapy to
      mechanical treatment on gingival health, and whether it has any side effects. This study also
      aims at increasing the awareness among health professionals and the community regarding the
      benefits of natural herbal products such as green tea on oral health, opposed to common
      chemical products. This may provide an efficient alternative for people who are sensitive to
      certain chemical products or who have limited sources of income and cannot afford expensive
      treatment of dental problems.
    


Intervention name(s): green tea mouthwash; green tea mouthwash; placebo
Intervention type(s): Other; Other; Other
Intervention description(s): green tea bags in 100 ml warm water for 5 min; , in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.; Plain water
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment