bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of
      vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or
      large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2
      compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining
      total 25 OH vitamin D level.

      The investigators plan to conduct a controlled trial to compare the effect of various vitamin
      D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level
      between 20 to 50 nmol/L.
    


Intervention name(s): ergocalciferol 2000 IU orally, daily; ergocalciferol 25000 IU oraly every 2 weeks; ergocalciferol 50000 IU orally every 4 weeks; ergocal1000 IU & cholecal 1000 IU orally daily; cholecalciferol 2000 IU orally daily; Cholecalciferol 25000 IU orally every 2 weeks; Cholecalciferol 50000 orally every 4 weeks; placebo orally everyday
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ergocalciferol 2000 IU orally, daily; ergocalciferol 25000 IU oraly every 2 weeks; ergocalciferol 50000 IU orally every 4 weeks; ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day; cholecalciferol 2000 IU orally everyday; Cholecalciferol 25000 IU orally every 2 weeks; Cholecalciferol 50000 orally every 4 weeks; placebo orally everyday
Other intervention name(s): ergocalciferol; ergocalciferol; ergocalciferol; ergocalciferol and cholecalciferol; cholecalciferol; Cholecalciferol; Cholecalciferol; placebo
Intervention MeSH terms: Cholecalciferol; Vitamin D; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D2, vitamin D3, 25 Oh vitamin D2, 25 Oh vitamin D3
HealthSmart: Promoting Healthy Lifestyles for Young Adult Cancer Survivors Using Educational Videos
Condition: Environmental Exposure to Ultraviolet Light
Study type: Interventional

Summary: 
      To assess the efficacy of the two SunSmart intervention videos to change sun protection
      attitudes and behaviors
    

Detailed description: 
      SunSmart is a novel video intervention designed to prevent secondary skin cancer in young
      adult cancer survivors by increasing their adherence to recommended sun protection.

      This study will assess two versions of the SunSmart video intervention. These are: 1) The
      INFORMATION VIDEO providing basic information about UV risks, including secondary skin cancer
      and the benefits of sun protection (SP), as well as specific SP recommendations and steps to
      integrate SP as part of routine self-care for the healthy cancer survivor; and 2) THE
      INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an
      additional embedded video segment emphasizing negative appearance consequences of UV
      exposure. Primary aim of the study is to assess the impact of the video intervention on sun
      protection intentions and behavior in young adult cancer survivors compared to a control
      intervention. Secondary aims are to describe the impact of the appearance information when
      included in the SunSmart intervention, to investigate the extent to which the intervention
      changes sun protection through hypothesized mediating variables, and to describe the
      consistency of sleep behaviors over time in cancer survivors.
    

Intervention name(s): THE INFORMATION + APPEARANCE VIDEO; Information SunSmart video; Sleep hygiene video
Intervention type(s): Other; Other; Other
Intervention description(s): THE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure.; The INFORMATION SunSmart video providing basic information about UV risks, including secondary skin cancer and the benefits of SP, as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor; Contain information on better sleep hygiene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to view one of two SunSmart educational videos or a control video on sleep hygiene. In the three months following the video intervention, participants' sun protection attitudes and behaviors are assessed. An additional measure of sun protection behaviors 12-months later will be provided by participants who participate in the optional 1-year follow-up.
Masking: None (Open Label)
Primary purpose: Other
Alveolar Ridge Preservation With Different Grafting Strategies
Condition: Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional

Summary: 
      The aim of the present study was to compare the half-packed grafts that are covered with
      either a collagen or a nonresorbable membrane to the conventional alveolar ridge preservation
      procedures involving full-packed grafts and collagen membrane. The primary purpose was to
      evaluate the bone dimensional changes between the groups, and the secondary objective was to
      assess the potential contributing factors to clinical, radiographic and implant-related
      outcomes under different alveolar ridge preservation procedures.
    

Detailed description: 
      Regarding different surgical approaches in alveolar ridge preservation, limited studies
      directly compare collagen and non-resorbable membrane, and the comparison between half- and
      full- grafting strategy in clinical and radiographic outcomes was still lacking. The
      comparable effect of dimensional preservation between groups was shown except for more
      radiographic bone gain in full-grafting group. Contributing factors, including thin bone
      thickness , vertical root fracture related sockets, non-molar sites and large BPD might
      attenuate the effect of ARP. At implant placement, similar results in bone quality and
      keratinized mucosal width was found in all groups, while thicker vertical mucosal thickness
      was obtained when using nonresorbable membrane. All surgical modalities in alveolar ridge
      preservation yield stable peri-implant health 1 year after implant placement.
    

Intervention name(s): Alveolar ridge preservation
Intervention type(s): Procedure
Intervention description(s): Different grafting strategy of alveolar ridge preservation with different sealing materials
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alveolar ridge preservation; sealing material; resorbable membrane; non-resorbable membrane; dental implants
Resistance Band Training Versus Nordic Hamstring Exercise on Hamstring Strength Among Football Players
Condition: Intervention; Injury Prevention
Study type: Interventional

Summary: 
      The major aim of this project to compare the effects of Resistance band training and Nordic
      hamstring exercise on hamstring strength among football players.
    

Detailed description: 
      Hamstring strength is important in football players and plays an important role in their
      sprint gait cycle. Football players should develop sprinter-like musculature in order to
      benefit their body strength and power hence preventing from hamstring strain injuries.
      Professional and recreational sports like Football, hamstring muscle strength training is
      commonly used to increase and balance lower body strength and power.
    

Intervention name(s): Nordic Hamstring Exercise; Hamstring Curl with Resistance band
Intervention type(s): Other; Other
Intervention description(s): To perform Nordic Hamstring Exercise, the subject was in kneeling position on the mat, arms by the side or in front of the chest, knee in 90-degree flexion and ankles well stabilized with the help of a therapist which is positioned behind the subject. Then subject was asked to lean forward by using the hamstring muscles by extending while trying to resist the forward fall, he should lean forward from the knee and not from the hip. The only time one can put his hands in front of him is when he can't rely on his legs and then push himself back to starting position and them repeat the procedure again.; Traditional Hamstring Curl by using Resistance band.
Resistance Band: Thera-band Green, 4.6 kg resistance at 100% elongation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups with randomization, Assignment: Nordic Hamstring exercise versus Hamstring Curl with Resistance band
Masking: Single (Participant)
Primary purpose: Other
Keywords: Nordic Hamstring exercise; Modified sphygmomanometer; Manual muscle Testing; Resistance band
Vaccination Study of Abatacept (BMS-188667) for Normal Healthy Volunteers
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the ability of healthy subjects to build anitbodies to tetanus and
      pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is
      being developed for the treatment of Rheumatoid Arthritis and which can affect the immune
      system.
    


Intervention name(s): Tetanus + pnemococcal vaccines alone; Abatacept + vaccines; Abatacept + vaccines; Abatacept + Vaccines
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0 mg + vaccines, Single dose, 28 days.; Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 70 days.; Parenteral, IV, 750 mg abatacept + vaccines, Single dose, 56 days.; parenteral, IV, 750 mg abatacept + vaccines, Single dose, 84 days.
Other intervention name(s): Orencia; Orencia; Orencia
Intervention MeSH terms: Abatacept; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis
Sodium Picosulphate/Magnesium Citrate and Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy
Condition: Colon Cleansing for Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon
      preparation affects the quality of colon cleansing. The study is aimed at comparing the
      efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and
      low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor
      bowel preparation.
    


Intervention name(s): sodium picosulphate magnesium citrate; low-volume PEG -ascorbic acid
Intervention type(s): Drug; Drug
Intervention description(s): Use of the product in colon cleansing before colonoscopy. Two sachets each containing 10 mg of sodium picosulfate, 3.5 g magnesium oxide and 12.0 g citric acid. The 2 doses are taken diluted in a glass water.; THe product is used as colon cleanser before colonoscopy. It is supplied as a powder for oral use, to be reconstituted with 2 L of water and drunk as a solution. It consists of 100.0 g macrogol 3350 plus electrolytes (7.5 g sodium sulphate, 2.7 g sodium chloride, 1.0 g potassium chloride) and 4.7 g ascorbic acid.
Other intervention name(s): Citrafleet, IBI Lorenzini, Aprilia, Italy; Moviprep, Norgine Ltd, Harefield, UK
Intervention MeSH terms: Ascorbic Acid; Magnesium citrate; Picosulfate sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Colon preparation; Colonoscopy; Polyethylene glycol; Sodium Picosulphate
Outpatient Administration of R-DHAP in Relapsed/Refractory Non-Hodgkin Lymphoma
Condition: Relapsed Non Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this study is to evaluate the efficacy and safety of a combination of the
      anti-CD20 monoclonal antibody Rituximab, Dexamethasone, daily high dose Cytarabine twice, and
      Carboplatin; delivered in an outpatient setting.
    

Detailed description: 
      The R-DHAP (Rituximab, Dexamethasone, Cytarabine, and Cisplatin) schedule includes high-dose
      cytarabine every 12 hours and requires careful monitoring of renal toxicity because of
      cisplatin. These conditions limit the use of this protocol in an outpatient setting.

      The S phase of lymphoma cells is longer than 12 hours, then cytarabine can be used daily
      without reduction of the antineoplastic effect. Carboplatin does not have remarkable renal
      toxicity so is not necessary to monitor blood chemistry or IV fluids during its
      administration.

      The study hypothesis is that modifications to the original R-DHAP protocol, using cytarabine
      on a daily basis and the substitution of cisplatin by carboplatin can preserve the efficacy,
      reducing the incidence of renal events. The investigators hypothesize that those
      modifications can make the schedule more suitable for an outpatient administration in
      relapsed or refractory non-Hodgkin lymphoma patients.

      After 3 cycles of chemotherapy, the overall response and the incidence of adverse events will
      be evaluated.

      In order to achieve the purpose of this trial, 130 participants will be included.
    

Intervention name(s): Rituximab; Carboplatin; Cytarabine Injection; Dexamethasone; Filgrastim 0.3 MG/ML
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Rituximab 375 mg/m²; Carboplatin AUC5; Cytarabine 2000 mg/m² qd 2 days; Dexamethasone 40 mg; One subcutaneous injection daily for 5 days
Other intervention name(s): MabThera; Neupogen
Intervention MeSH terms: Cytarabine; Dexamethasone; Rituximab; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Pantoprazole in Children With GERD
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to characterize the PK profile, safety and tolerability of
      single and multiple doses of pantoprazole in children aged 1 through 11 years with
      endoscopically proven GERD.
    


Intervention name(s): pantoprazole for approximately 9 weeks.
Intervention type(s): Drug
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastrointestinal Reflux Disease
Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This single-arm, open-label study will assess the safety and tolerability of one daily tablet
      of a commercially available cardiovascular health dietary supplement by questionnaire and
      blood markers in adults with borderline to mild hypertension over a 6 month period. Although
      the cardiovascular health dietary supplement being investigated has been on the market for
      over 20 years, prospective safety data and blood markers of end organ function have not
      previously been reported.
    

Detailed description: 
      Hypertension is an important overall risk factor for developing cardiovascular disease in the
      United States, and is a leading risk factor for cardiovascular events, including myocardial
      infarction and stroke, and cardiovascular-related mortality with advancing age. Based on
      population based studies and clinical trials, both systolic blood pressure (SBP) and
      diastolic blood pressure (DBP) elevations are continuous, strong and independent risk factors
      for cardiovascular disease.

      The product being studies is a cardiovascular health dietary supplement that has been
      commercially available since 1993. It is currently sold to healthcare practitioners as well
      as directly to consumers. Some healthcare providers use the product as part of a plan to
      treat high blood pressure in their patients. This is the first study collecting prospective
      safety data on this product.
    

Intervention name(s): Cardiovascular health dietary supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Herbal/mineral dietary supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Workplace Interventions on the Treatment of Low-back Pain
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      The study evaluates the effect of workplace interventions on work ability promotion among
      workers with back problems. The half of participant will receive Information, advice and
      guidance for back problems in addition to participatory workplace actions organized by
      Occupational Health Physiotherapist. The other half will receive only Information, advice and
      guidance without workplace intervention.
    

Detailed description: 
      Musculoskeletal symptoms, especially back pain, account for the majority of days lost.

      In order to enhance the health and working careers of people with MSD, it is important that
      work can be arranged in such a way that they can remain in work life despite MSD.In the field
      of work ability promotion, various stakeholders; the worker, employer, professionals in
      occupational health services (OHS) interact to optimize actions and practices to prevent
      absences from work and promote remaining at work. This study aims to investigate
      participatory working practices and modles of co-operation among OHS and workplaces.
    

Intervention name(s): Workplace intervention
Intervention type(s): Other
Intervention description(s): The study contains normal services of occupational health. Both intervention groups are based on voluntary will, and the normal care and services are guaranteed. In the intervention group new working method which improve co-operation between occupational health services and workplaces.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: musculoskelelal disorder; occupational health service
Donepezil 10 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the rate and extent of absorption of donepezil 10
      mg tablet (test) versus Aricept® (reference), administered as a 1 x 10 mg tablet under
      fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA Bioequivalence Statistical Methods
    

Intervention name(s): Donepezil; Aricept®
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg Tablet; 10 mg Tablet
Other intervention name(s): Donepezil (generic name)
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Healthy Subjects; Donepezil
Safety Escalating Repeat IV, in Stroke Patients
Condition: Ischaemic Attack, Transient
MeSH terms: Ischemic Attack, Transient
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to is to test increasing repeat doses of GSK249320 compared to
      placebo in patients with stroke.
    

Detailed description: 
      GSK249320 is a humanised monoclonal antibody (mAb) that binds with high specificity to
      myelin-associated glycoprotein (MAG) and antagonises or neutralises MAG-mediated inhibition
      and has been shown to improve functional recovery after stroke in pre-clinical models,
      possibly by promoting neuroregeneration and plasticity. The present study is the first in
      patients with stroke. The main aim of this study is to select tolerated doses of GSK249320
      that can be used in future trials to evaluate its efficacy in improving clinical function in
      patients recovering from stroke. This clinical trial is designed as a placebo-controlled,
      single-blind, multicenter study to investigate the safety, pharmacokinetics (PK) and
      pharmacodynamics (PD) of escalating repeat IV doses of GSK249320. Three sequential dose
      escalation cohorts (1, 5 and 15 mg/kg) are planned, with 8 patients on placebo and 8 on
      active in cohort 1 and 4 patients on placebo and 8 on active in cohorts 2 and 3. Each patient
      will receive 2 repeat IV doses 9 ± 1 days apart and assessments will extend to at least 16
      weeks.
    

Intervention name(s): GSK249320; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): I.V. infusion; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Ixmyelocel-T Treatment of Patients With Osteonecrosis of the Femoral Head
Condition: Osteonecrosis
MeSH terms: Osteonecrosis; Legg-Calve-Perthes Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if Ixmyelocel-T grafting with demineralized bone
      matrix bound in autologous plasma after core decompression surgery is superior to core
      decompression with demineralized bone matrix bound in autologous plasma in preventing
      progression of osteonecrosis to a more severe disease stage (Stage II to III or higher) from
      the time of surgery until 24 months later, in patients with University of Pennsylvania
      (UPenn) Stage IIB or C disease at diagnosis.
    

Detailed description: 
      This study is an event-driven, multi-center, prospective, independent observer-blinded,
      controlled, randomized Phase III clinical trial enrolling patients diagnosed with University
      of Pennsylvania (Steinberg) Classification Stage IIB or C osteonecrosis of the femoral head.

        -  The first patient group is the Treatment Group and will receive core decompression and
           treatment with BRCs and demineralized bone matrix bound in autologous plasma, and

        -  The second patient group is the Control Group and will receive core decompression and
           demineralized bone matrix bound in autologous plasma, without any BRCs.

        -  Enrollment: With an anticipated drop-out rate of 10% in up to twenty (20) sites, a total
           of approximately 135 patients will be enrolled and randomized to obtain 120 evaluable
           patients (75 for the TRC treatment group and 45 for the Control treatment group).

        -  Primary endpoint: The percentage of patients progressing to a more severe UPenn disease
           stage (Stage II to III or higher) between 0 and 24 months will be the primary efficacy
           variable to demonstrate TRC therapy is superior to Control therapy.
    

Intervention name(s): Ixmyelocel-T; Standard of Care Only
Intervention type(s): Biological; Other
Intervention description(s): Core decompression of the femoral head to remove necrotic tissue with Ixmyelocel-T given to treatment arm only.; Core decompression of the femoral head to remove necrotic tissue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteonecrosis