bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Dietary Restriction of Animal Protein and Fat on Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Patients will be randomized into the control or intervention group. Based on patient
      preference, the intervention group will be trained for one hour in either individual or group
      format on vegan diet. They will also be directed to www.pcrm.org and www.drmarymd.com for low
      glycemic, animal free, low fat food options and support. The control group will continue
      their normal omnivorous diet program. Twenty-four hour food recalls will be obtained at the
      start and end of the trial, and once a week for the 6 weeks of the trial by telephone.
      Patients will undergo a final interview at the end of the 6 week study period. The
      intervention group should strive to obtain 90% of their calories from plants. They will be
      encouraged to eat freely and not count calories. Patients will undergo additional individual
      consultation as needed to promote compliance and answer specific questions.

      Over the 6 weeks, the Patient Global Improvement of Change (PGIC) and the 36 item short form
      health survey (SF-36) will be performed weekly by telephone. Patient will perform a Visual
      Analog Scale (VAS) of their pain level randomly daily on their own. C-reactive protein levels
      will be assessed at the beginning and end of the study at Munson Medical Center Laboratories
      as a secondary measure of diet changes.

      There have been no published prospective randomized controlled trials assessing whether a
      vegan diet would benefit osteoarthritis. The specific aim of this study is to determine if a
      vegan diet will result in subjective reduction in perceived pain and limitations to function
      in patients with osteoarthritis.
    


Intervention name(s): Limitation of Animal Fat and Protein in the Diet; Control
Intervention type(s): Other; Other
Intervention description(s): Animal products were proscribed and the use of unrefined foods was encouraged. Participants were asked to limit high-fat plant foods, such as nuts, avocados, and refined oils. There was no restriction in energy intake, were encouraged to eat freely and not count calories.; Participants assigned to the control group will be instructed to follow their usual diets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arthritis; Pain; Function; Diet; Vegan; Vegetarian; Restriction
A Pilot Study of Hemoporfin PDT in Children With Port-wine Stain
Condition: Port-wine Stain
MeSH terms: Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study aims to evaluate the efficacy and safety of hemoporfin photodynamic therapy
      (PDT) with different light doses for port-wine stain (PWS） in 7-14 years old children. The
      population pharmacokinetics of hemoporfin in children will be investigated as well.
    


Intervention name(s): Hemoporfin PDT
Intervention type(s): Drug
Intervention description(s): Photodynamic therapy is performed using hemoporfin. Hemoporfin（5mg/kg）is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Randomized Trial Evaluating Performance of the Trevo Retriever Versus the Merci Retriever in Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      To determine if the Trevo Retriever is as good or better than the Merci Retriever in
      restoring blood flow to the brain of a patient experiencing an acute ischemic stroke in a
      large vessel.
    

Detailed description: 
      The TREVO 2 protocol was designed to assess the safety and effectiveness of the Trevo
      Retriever device and determine if it is substantially equivalent to the predicate Merci
      Retriever. The trial utilized a Primary Effectiveness Endpoint of revascularization and a
      composite Primary Safety Endpoint that included procedure-related serious adverse events
      occurring within 24 hours of the procedure. Subjects who presented to enrolling centers with
      large ischemic strokes were screened for eligibility in the study. If a subject met
      eligibility criteria, then Informed Consent was obtained prior to commencing the angiogram.
      If all inclusion/exclusion criteria were confirmed, including the angiographic criteria, then
      the subject was randomized.The Primary Effectiveness Endpoint was successful
      revascularization of the target occlusion, using the TICI score. Success was determined by
      the central Core Lab.The Primary Safety Endpoint is a composite endpoint, described in the
      protocol as the "Incidence of procedure-related serious adverse events (PRSAEs) through 24
      hours post procedure (-6/+12 hours) defined as: vascular perforation or intramural arterial
      dissection, symptomatic ICH, embolization to a previously uninvolved territory, access site
      complication requiring surgical repair or blood transfusion, intra-procedural mortality,
      device failure (in vivo breakage), or any other complications judged by the Clinical Events
      Committee (CEC) to be related to the procedure."
    

Intervention name(s): Mechanical Thrombectomy
Intervention type(s): Device
Intervention description(s): Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemia; Stroke; Ischemic Stroke; Mechanical Thrombectomy; Brain; Brain clot; Cerebrovascular disease; Recanalization; Revascularization
Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections
Condition: Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of
      HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for
      7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized
      on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g.
      q12h for up to 14 days.
    

Detailed description: 
      multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of
      HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for
      7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized
      on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g.
      q12h for up to 14 days.

      The main criteria for evaluation will be:

        -  Efficacy

        -  Safety

        -  Microbiologic eradication
    

Intervention name(s): Daptomycin; Vancomycin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vancomycin; Daptomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cSSSI; MRSA
Efficacy Study of Strattera for Treating Attention Disorders in Traumatic Brain Injury (TBI)
Condition: Traumatic Brain INjury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Cognition Disorders
Study type: Interventional

Summary: 
      Atomoxetine is the only medication that is currently approved by the FDA for the treatment of
      attention deficit hyperactivity disorder in adults. It has gained recent interest as an
      alternative medication for treating attentional problems related to traumatic brain injury
      (TBI), but it's effectiveness in this population has not been studied. There are a number of
      advantages of Atomoxetine over traditional neuro-stimulant medications currently used for
      attentional disorders after traumatic brain injury. This study will use a randomized
      double-blind placebo-controlled crossover design to investigate the efficacy of atomoxetine
      to improve attention, behavioral function, and depression in adults with TBI
    


Intervention name(s): atomoxetine; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention; Traumatic Brain INjury; Atomoxetine; Strattera
A Study of Escalating Doses of Romidepsin in Association With CHOP in the Treatment of Peripheral T-Cell Lymphomas
Condition: Peripheral T Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is an open label, multicenter study with two phases:

        -  A dose escalation phase of Romidepsin administered IV at day 1 and 8 or at day 1 without
           day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone
           (CHOP)administered every 3 weeks for 8 cycles in patients with T-cell lymphoma.

        -  An expansion phase in order to assess the safety and the efficacy of the association of
           the recommended dose of Romidepsin associated with CHOP in a population of patients with
           T-cell lymphoma.
    

Detailed description: 
      The primary objective of the study is to determine the feasibility of the combination and the
      recommended dose (RD) of Romidepsin when administered in association with CHOP in a
      population of patients with newly diagnosed Peripheral T-cell lymphoma (PTCL) as measured by
      the toxicities during treatment.

      Secondary objectives:

        -  To assess the safety of the association Romidepsin and CHOP,

        -  To assess the efficacy of the association of Romidepsin and CHOP: response rate and
           complete response rate, progression-free survival, response duration and overall
           survival.
    

Intervention name(s): Romidepsin and CHOP; Romidepsin and CHOP; Romidepsin and CHOP; Romidepsin and CHOP
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma; Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma; Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma; Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
Intervention MeSH terms: Romidepsin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Rising Dose Study of BI 144807 Powder in Bottle in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-man trial forms the basis for potential clinical development of BI 144807 in
      the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics,
      and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male
      volunteers.
    


Intervention name(s): BI 144807 Placebo; BI 144807
Intervention type(s): Drug; Drug
Intervention description(s): Placebo that represents BI drug; single dose (low to high dose)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics and bioequivalence of
      isotretinoin formulations after administration of single doses to normal, non-smoking,healthy
      males under fasting conditions
    

Detailed description: 
      An open label, randomized, single dose, oral bioequivalence study of Isotretinoin capsules 20
      mg of Dr. Reddy's Laboratories Limited,under fasting conditions
    

Intervention name(s): Isotretinoin
Intervention type(s): Drug
Intervention description(s): Isotretinoin Capsules,20 mg
Other intervention name(s): ACCUTANE
Intervention MeSH terms: Isotretinoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of Two Doses of Monovalent Inactivated Influenza Vaccine That is Adjuvanted With MF59C.1 (MF59) and Uses a Surface Antigen From a Potential Pandemic Virus Strain Candidate (H5N1) in Adult and Elderly Subjects Using Four Different Vaccination Schedules
Condition: Pre-pandemic Influenza Vaccine
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The present study will evaluate the immunogenicity, safety and immunogenicity of two doses of
      monovalent inactivated influenza vaccine that is adjuvanted with MF59C.1 (MF59) and uses a
      surface antigen from a potential pandemic virus strain candidate (H5N1) in Adult Subjects.
    


Intervention name(s): Monovalent inactivated influenza vaccine
Intervention type(s): Biological
Intervention description(s): Two doses of monovalent inactivated influenza adjuvanted vaccine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza vaccine
The Effect Site Concentration of Remifentanil for Conscious Sedation During Awake Nasotracheal Fiberoptic Intubation
Condition: Cervical Disc Herniation; Cervical Spinal Stenosis; Cervical Spine Damage
MeSH terms: Spinal Stenosis; Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 4

Summary: 
      Remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive
      function. It can be used for conscious sedation during awake nasotracheal fiberoptic
      intubation. Target-controlled infusion is more reliable technique for maintaining optimal
      infusion rate than manual controlled infusion. The aim of this study is to determine the
      effect site concentration of remifentanil for successful conscious sedation during awake
      nasotracheal fiberoptic intubation.
    


Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): After topical airway anesthesia with 10 % lidocaine in nostril and oropharyx, 1.5~2.0 mg of IV midazolam is injected. Awake nasotracheal fiberoptic intubation is performed with target-controlled infusion of remifentanil. Initial effect site concentration is 3.0 ng/ml. Smooth intubation is defined as absence of persistent cough with head elevation and defensive movement of extremities. In case of smooth intubation, effect site concentration is decreased by 0.5 ng/ml for the subsequent case. If intubation is not smooth, effect site concentration is increased by 0.5 ng/ml for the subsequent case. EC50 of remifentanil is determined using Dixon's up-and-down method.
Intervention MeSH terms: Remifentanil
Primary purpose: Prevention
Tylenol Levels in Bariatric Patients
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The current study is designed to measure and evaluate the pharmacokinetic profiling of
      acetaminophen in the young obese patient population.
    

Detailed description: 
      This will be a descriptive study carried out by study staff from the anesthesiology
      department. The patient population will include obese patients scheduled for robot-assisted
      or laparoscopic bariatric surgery. There will be no change in our usual anesthetic care for
      these patients. Volume of distribution and elimination half-life of acetaminophen in serum
      samples are the primary measurements of the study. If detected, a significant reduction in
      opioid requirements may lead to improved patient satisfaction and decreased opiate side
      effects.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of 30 patients presenting to the OR for robotic assisted
        or laparoscopic bariatric surgery.
      
Biospecimen description: 
      Serum Samples
    
Keywords: Obesity; Bariatrics; Acetaminophen; robot-assisted or laparoscopic bariatric surgery; Pharmacokinetics
Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to compare the steady state pharmacokinetics of lacidipine
      with and without the co-administration of telmisartan and to compare the steady state
      pharmacokinetics of telmisartan with and without the co-administration of lacidipine
    


Intervention name(s): Lacidipine; Telmisartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan; Lacidipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Gene Therapy for X-linked Chronic Granulomatous Disease (CGD) in Children
Condition: Chronic Granulomatous Disease
MeSH terms: Granuloma; Granulomatous Disease, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to evaluate the side effects and risks after infusion of retroviral
      gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned
      (busulphan) children with chronic granulomatous disease (CGD). Also gene corrected and
      functional active granulocytes in the peripheral blood and the engraftment in the bone marrow
      of the patients will be monitored an documented.
    


Intervention name(s): retroviral SF71-gp91phox transduced CD34+ cells
Intervention type(s): Genetic
Intervention description(s): autologous ex-vivo transduced (SF71-gp91phox)CD34+ cells
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Granulomatous Disease in children (=or< 18 years)
"Bilateral Training in Stroke Patients"
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The objective of this study was to evaluate the effects of bilateral training for upper
      extremity in stroke patients and to compare these effects between right and left stroke
      patients. A Quasi Experimental Study conducted on community stroke survivors. A total of 24
      stroke patients were included and divided into Group A (Right hemiplegia) (n=12) and Group B
      (Left hemiplegia) (n=12). Chronic stroke patients (>3 months), aged 30-70 years with left or
      right sided diagnosed stroke patients were included while patients on medication that could
      affect the cognitive functions or with any other cognitive impairments who are not able to
      follow commands were excluded. Both groups received the same intervention of with bilateral
      arm training involving 5 functional tasks to improve the functional activities of daily
      living in upper extremities. Fugl-Meyer Assessment-Upper Extremity Tool (FMA-UE) and
      Wolf-Motor Function Test (WMFT) were used to assess as outcome measures.The measurements were
      obtained at baseline and after 6th week of training. Data was analyzed using SPSS version 21.
    


Intervention name(s): Bilateral training (BAT)
Intervention type(s): Other
Intervention description(s): Each group received bilateral training) for upper extremities for 3 days per week for 01 hour/day for up to 6 weeks. Tasks included functional tasks such as stacking cones and cups, positioning the cup upright, throw a ball into basket, carrying a wooden block and buttoning and unbuttoning of shirt with counting. Each task was performed for 10 minutes and had a rest break of 1 minute.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and Irbesartan
Condition: Type 2 Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, multi-center, randomized, open-label, parallel-arm controlled study,
      for which a total of 216 patients with type 2 diabetic nephropathy (Stage II-IV) will be
      enrolled. The subjects will be randomized to three groups in 1:1:1 ratio. One group receive
      Alfacalcidol 0.25ug/day and Irbesartan 150mg/day for 16 consecutive weeks. The second group
      receive Alfacalcidol 0.25ug/day alone for 16 consecutive weeks. The third group receive
      Irbesartan 150mg/day alone for 16 consecutive weeks. All subjects will be followed up for 4
      weeks after medication is over. A total of 4 visits have been scheduled for this study at
      week 0, week 8, week 16, week 20.
    


Intervention name(s): Alfacalcidol; Irbesartan
Intervention type(s): Drug; Drug
Other intervention name(s): Alfacalcidol Soft Capsules; Irbesartan Pills
Intervention MeSH terms: Alfacalcidol; Hydroxycholecalciferols; Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetic nephropathy; Alfacalcidol