bioihbjkbjnl/mcl2 huggingface dataset:
Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL
Condition: Lymphoma, Large-Cell, Diffuse; Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Diffuse large B-cell lymphoma is a most prevalent non-Hodgkin's lymphoma. Recently the
      clinical results have been improved with new drugs and new modalities such as
      cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks. Bortezomib
      is well known to be effective for multiple myeloma and has been being tried for other
      malignancies including lymphoma. The investigators will incorporate Bortezomib to CHOP every
      2 weeks to further improve the clinical efficacy in diffuse large B-cell lymphoma.
    

Detailed description: 
      Intended number of patients: 63 patients in total

        -  Phase I: 9 patients for 3 levels

        -  Phase II: 50 patients plus 3 patient from Phase I at MTD level

        -  Plus 4 patients: considering 5% follow-up loss rate

      Study design and methodology:

      For phase I, 9 patients; 3 levels of bortezomib (1.0, 1.3 and 1.6 mg/m2), 3 patients at each
      dose level.

      If escalation of bortezomib beyond 1.0 mg/m2 is not possible, the trial will be stopped.

      For phase II, 53 patients (3 from phase I at MTD level); Reject when complete response rate
      equal or less than 12/19 or 37/53 by Simon two-stage optimal phase II design.

      Treatments:

        -  Bortezomib:

      For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks.

      For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks.

        -  CHOP2: cyclophosphamide 750mg/ m2 day 1, vincristine 1.4 mg/ m2 (max. 2 mg) day 1,
           doxorubicin 50 mg/ m2 day 1, prednisolone 100 mg days 1-5, every 2 weeks.

        -  G-CSF: Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks.
    

Intervention name(s): Bortezomib; Cyclophosphamide; Doxorubicin; Vincristine; Prednisolone; Lenograstim
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Bortezomib:
For phase I, 3 dose levels (1.0, 1.3 or 1.6 mg/m2), days 1 and 4, every 2 weeks.
For phase II, suggested dose of Bortezomib through phase I, days 1 and 4, every 2 weeks.; cyclophosphamide 750mg/m2 day 1, every 2 weeks; doxorubicin 50 mg/m2 day 1, every 2 weeks; vincristine 1.4 mg/m2 (max. 2 mg) day 1, every 2 weeks; prednisolone 100 mg days 1-5, every 2 weeks; Lenograstim 5 microgram/kg subcutaneously days 4-13 every 2 weeks
Other intervention name(s): velcade; cytoxan; adriamycin; Oncovin; Pd; Neutrogin; G-CSF
Intervention MeSH terms: Prednisolone; Cyclophosphamide; Doxorubicin; Vincristine; Bortezomib; Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diffuse large B-cell lymphoma; Bortezomib; CHOP; Lenograstim
ConfidenHT System for Diagnostic Electrical Mapping of Renal Nerves
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      To evaluate the safety and performance of the ConfidenHT System
    

Detailed description: 
      To evaluate the safety and performance of the ConfidenHT System for diagnostic mapping of
      renal nerves; functional distribution of renal nerves and the effect of renal nerve
      stimulation on the blood pressure
    

Intervention name(s): ConfidenHT system
Intervention type(s): Device
Intervention description(s): ConfidenHT Medical system
Other intervention name(s): ConfidenHT Medical system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: RDN
The Effect of Probiotic Intake on Intestinal Permeability in Healthy Adults
Condition: Intestinal Barrier Function
Study type: Interventional

Summary: 
      In this double blind, crossover study participants will take a placebo for 3 weeks each. Gut
      permeability will be assessed weekly using food-grade sugar molecules. On the second week,
      participants will take aspirin, which will make their intestine permeable to the sugars.
      Participants will be asked to provide urine and stool samples to assess gut permeability and
      microbial communities. No change in permeability to the small sugar probes is anticipated
      with the probiotic.
    


Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This probiotic is commercially available and contains L. helveticus R0052 (0.2 x 10^9 CFU/capsule) and L. rhamnosus R0011 (3.8 x 10^9 CFU/capsule) as active ingredients and ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide, and maltodextrin as excipients.; The placebo contains ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide and maltodextrin.
Other intervention name(s): Lacidofil STRONG
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, double-blind, placebo-controlled crossover in which participants receive one of the study supplements (probiotic or placebo) for a 3-week intervention period each will be used.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Probiotic; Intestinal Permeability; Leaky Gut
A Double-blind Randomized Placebo-controlled Study Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the present study is at the first stage: a comparative assessment of the safety of
      the two methods of vaccine administration, at the second - an assessment of the safety and
      state of post-vaccination immunity at different times after vaccination
    

Detailed description: 
      In the first stage estimate of safety of vaccine after its single administration to the nasal
      cavity by the drip method or by spray - dispenser during the period of observation in 30 days
      with the participation of 24 volunteers, divided into 2 groups of 12 people for each method
      of administration

      After interim analysis of safety data is subject to the consent of the local ethics Committee
      of the Research Centre about the possibility of further studies of the drug - will be started
      the second phase of the study, which, along with continued security research, provides the
      definition of the parameters of immunogenicity of the study drug. The second phase of the
      study will included 200 participants, including 100 people will receive the study drug and
      100 will be a control group of observation - that is, will get a placebo.
    

Intervention name(s): GamFluVac; Placebo
Intervention type(s): Biological; Other
Intervention description(s): The drug is a vaccine that induces high-level immunity against influenza A viruses; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: influenza; vaccine; Immunologic Factors; Respiratory Tract Infections; vector vaccines
Cardiovascular Function in COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of the study are to explore the effect of treatment with tiotropium +
      olodaterol fixed dose combination (FDC) compared to fluticasone propionate + salmeterol FDC
      on:

        -  reversal of left ventricular diastolic dysfunction assessed with cardiac magnetic
           resonance (CMR) imaging,

        -  measures of arterial stiffness assessed by CMR and pulse wave analysis (PWA),

        -  reduction of hyperinflation assessed with body plethysmography and

        -  post dose spirometry.
    


Intervention name(s): Tiotropium; Olodaterol; Fluticasone propionate; Salmeterol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fixed Dose Combination; Fixed Dose Combination; Fixed Dose Combination; Fixed Dose Combination
Other intervention name(s): INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO; INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO
Intervention MeSH terms: Fluticasone; Xhance; Tiotropium Bromide; Salmeterol Xinafoate; Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Inhibition Effects of Probiotics on Pathogens Associated With VAP
Condition: Ventilator Associated Pneumonia
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Study type: Observational [Patient Registry]

Summary: 
      This study evaluates that P. aeruginosa, A. baumannii, K. pneumonia and Staph aureus which
      are obtained from patients' tracheal aspiration culture who treated with mechanical
      ventilation will be compared with Lactobacillus (LAB) members and nisin bactriocin in the
      laboratory. The aim is to investigate the probiotics' antimicrobial properties and effects on
      these bacteria's growth rate.
    

Detailed description: 
      Ventilator associated pneumonia (VAP) is one of the most commonly seen hospital-acquired
      infections that occurs in patients who receive mechanical ventilation. VAP usually occurs
      48-72 hours after mechanical ventilation and is related increased incidence of
      multidrug-resistant infections, increased antibiotic use, extended mechanical ventilation
      time, increased patient stay in the intensive care unit (ICU), and increased patient stay in
      the hospital. One recent intervention is the probiotic therapy which is a nonantibiotic
      strategy for maintenance of the host's aerodigestive microbial balance and VAP
      prevention.Common causative pathogens of VAP include Gram negative bacteria such as
      Pseudomonas aeruginosa, Klebsiella pneumoniae, and Acinetobacter species, and Gram-positive
      bacteria such as Staphylococcus aureus. In this study, these Gram negative pathogens obtained
      from mechanical ventilated patients' tracheal aspiration culture and reference bacteria
      strains will be compared with Lactobacillus (LAB) members and nisin in the laboratory.
      Probiotics' antimicrobial properties and effects on these bacteria's (obtained from patients
      and reference strains) growth rate will be investigated.
    

Intervention name(s): Lactobacillus bacteria
Intervention type(s): Other
Intervention description(s): Antimicrobial effects of Lactobacillus bacteria (LAB) and nisin bacteriocin on pathogen bacteria and commercial strains of the same bacteria's growth rate will be investigated.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who mechanically ventilated at least 48 hours will be included. Patients' tracheal
        aspirate cultures will be used for study. Pseudomonas aeruginosa, Acinetobacter baumanii,
        Staphylococcus aureus and Klebsiella pneumoniae will be isolated from tracheal aspiration
        cultures.Antimicrobial effects of Lactobacillus members will be investigated on the
        bacteria's growth rate in the laboratory.
Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the effects of the NOMAC-E2 combined oral
      contraceptive (COC) on bone mineral density (BMD).
    


Intervention name(s): NOMAC-E2; LNG-EE
Intervention type(s): Drug; Drug
Intervention description(s): Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).; Levonorgestrel and Ethinyl Estradiol Tablets, 0.150 mg Levonorgestrel and 0.030 mg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 for 26 consecutive 28-day menstrual cycles (2 years).
Other intervention name(s): SCH 900121; SCH 900121
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effectiveness of a Proprioceptive Neuromuscular Proprioceptive Neuromuscular Facilitation
Condition: Proprioceptive Neuromuscular Facilitation
Study type: Interventional

Summary: 
      Introduction: Paddle tennis is a popular sport which can cause lower limb injuries due to
      impaired flexibility, such as ankle dorsiflexion. To improve this, methods such as
      proprioceptive neuromuscular facilitation (PNF), eccentric exercises and electrical
      stimulation (NMES) can be used. Objective: To compare the effectiveness of a PNF program with
      one of eccentric exercise plus NMES in the weight bearing lunge, lateral step down and drop
      jump test in amateur paddle tennis players. Methods: Pilot randomized clinical trial
      involving 20 male amateur paddle tennis players.

      Participants were randomly divided into two groups of ten. One group received a PNF protocol,
      while the another group was given an Eccentric+ NMES exercise protocol. During the study,
      range of dorsal ankle flexion (ROMDf) was measured, as well as the vertical jump and lateral
      step down capacity of the participants.
    


Intervention name(s): eccentric exercises and electrical stimulation; proprioceptive neuromuscular facilitation
Intervention type(s): Other; Other
Intervention description(s): Eccentric exercises and strengthening currents to improve ankle dorsiflexion in professional padel players.; proprioceptive neuromuscular facilitation to improve ankle dorsiflexion in professional padel players.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proprioceptive neuromuscular facilitation;; Paddle tennis; Ankle dorsiflexion range; Eccentric exercise; Neuromuscular electrostimulation
Brain Markers of Treatment Response in Post-Traumatic Stress Disorder (PTSD)
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine if treatment of post-traumatic stress disorder in
      combat veterans with paroxetine changes brain responses as measured by functional magnetic
      resonance imaging and if brain responses can predict who will get better with treatment.
    


Intervention name(s): Paroxetine
Intervention type(s): Drug
Intervention description(s): Paroxetine 20-40mg po QD for 12 weeks
Other intervention name(s): Paxil (brand name)
Intervention MeSH terms: Paroxetine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Metabolism and Pharmacokinetics of [14C]-BIBF 1120 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the metabolic profile,

      to obtain the mass balance after oral administration,

      to determine the concentration of [14C]-radioactivity in blood cells, plasma, urine and
      faeces,

      to determine BIBF 1120 and BIBF 1202 concentrations in plasma, urine, and faeces, if
      feasible,

      to determine the protein binding of [14C]-radioactivity,

      to determine the pharmacokinetics of BIBF 1120, BIBF 1202 and total radioactivity after a
      single oral administration of [14C]-BIBF 1120 in healthy volunteers
    


Intervention name(s): BIBF 1120 ES
Intervention type(s): Drug
Intervention MeSH terms: Nintedanib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dual-task Gait Performance in People With Knee Osteoarthritis Before and After Knee Replacement Surgery
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Knee Osteoarthritis (OA) is one of the most common conditions causing disability and
      limitation in the elderly population, with 13% of women and 10% of men over the age of 60
      suffering from symptomatic knee osteoarthritis. Pain and other symptoms of OA significantly
      affect the quality of life, manifesting itself in pain, decreased range of motion, functional
      limitation and change in gait patterns.

      Total Knee Replacement Surgery (TKR) is the most common solution for patients with advanced
      cartilage erosion and is considered a successful surgery with high satisfaction rates (about
      80%). The surgery becomes necessary when pain limits the daily functioning and impairs the
      quality of life and after the failure of conservative treatment.

      Still, patients undergoing TKR suffer in the first period after surgery from pain, decreased
      balance and proprioceptive impairment. Despite the improvement in pain and function, the
      rates of falls after surgery do not change drastically and remain high.

      About a third of older adults fall each year, leading to fractures, functional decline and in
      some cases death. Walking is a complex task, and with advancing age walking becomes less
      automatic and requires additional attention. Among adults, it is known that an increased risk
      of falls is associated with reduced ability to perform complex walking tasks, such as walking
      while talking or crossing obstacles.

      After TKR, most falls occur while walking due to slipping / tripping. In addition,
      proprioceptive impairment, pain and poor balance are associated with an increased risk of
      falling after TKR. The mechanism underlying these effects may be increased allocation of
      cognitive resources to walking. Thus, this study will examine the ability of people before
      and after TKR to perform complex walking tasks, in order to examine the change in attention
      allocation to walking following surgery. It is hypothesized that after surgery, the ability
      to walk while performing an additional task will be lower than prior to surgery.
    


Intervention name(s): Gait analysis pre- and post- surgery
Intervention type(s): Behavioral
Intervention description(s): None (observational)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Candidates for TKR surgery at HaEmek Medical Center.
      
Keywords: Total knee replacement; Cognitive load; Gait; Proprioception; Dual task
Efficacy of Azadirachta Indica (Homoeopathic Medicine) in Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      Acne is one of the most common skin problems in teenagers and adolescents. There are many
      lesser known homoeopathic medicines which have been mentioned in the literature for treatment
      of acne but their potential has not been properly assessed /documented and therefore these
      medicines don't form a part of many prescriptions. As a part of this study,efficacy of
      Azadirachta Indica will be studied in the treatment of Acne vulgaris
    


Intervention name(s): Azadirachta Indica
Intervention type(s): Drug
Intervention description(s): To start with subjects will be prescribed Azadirachta Indica in 6 potency to be taken in form of pills 4 times a day for seven days. Dosage and frequency will be changed, if required, based on the condition of subject and their response according to homoeopathic principles.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Homoeopathy; Homeopathy; Azadirachta Indica
COMPARISON OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The purpose is to compare the effects of piezosurgery and conventional rotary instruments on
      postoperative pain, swelling, trismus and patients' comfort after mandibular third molar
      surgery.
    

Detailed description: 
      The investigators plan a prospective and split mouth study. Thirty patients will be randomly
      selected. Inclusion criteria were being older than 18 of age, having asymptomatic bilateral
      mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully
      covered with mucosa and bone, and being otherwise medically healthy.

      One side of the patients will be randomly selected and labeled as "experimental group". In
      experimental group, impacted third molar will be extracted using piezosurgery. The other side
      will be accepted as "control group". In the control group, impacted third molar will be
      extracted using conventional rotary instruments.There will at least one month between two
      surgeries. The investigators will compare postoperative pain, swelling, trismus and patients'
      comfort.
    

Intervention name(s): Piezosurgery group
Intervention type(s): Other
Intervention description(s): Piezosurgery technique will be examined about impacted third molar surgery.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Trismus; piezosurgery; pain; swelling
Cefaly® Device in the Treatment of Patients With Fibromyalgia.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The objective of this pilot open trial was to assess the efficacy and safety of external
      trigeminal nerve stimulation (e-TNS) with the Cefaly® device in fibromyalgia.
    

Detailed description: 
      The main objective of this clinical pilot trial was to evaluate the use of external
      trigeminal nerve stimulation (e-TNS) with the Cefaly® neurostimulator device as a new
      therapeutic treatment for fibromyalgia.
    

Intervention name(s): Cefaly
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment