bioihbjkbjnl/mcl2 huggingface dataset:
Study to Determine the Safety, Tolerability, Pharmacokinetics, Food Effect and Pharmacodynamics of Single and Multiple Ascending Doses of P7435 in Healthy, Overweight or Obese Subjects
Condition: Healthy
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      -  This is a single centre, phase I, randomized, double-blind, placebo-controlled,
           crossover, dose escalating study of P7435 using single and multiple doses, to be
           conducted in healthy male and female (Non child bearing) subjects having BMI between 19
           to 40 kg/m2.

        -  The study will be conducted in 2 parts as follows: Part A will consist of the Single
           Ascending Dose (SAD) study and Part B will consist of the Multiple Ascending Dose (MAD)
           study.
    


Intervention name(s): P7435; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Evaluation of the QuantiFERON-TB Test.
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Observational

Summary: 
      To compare the results of the investigational test to the currently approved QuantiFERON-TB
      Gold In-Tube test.
    

Detailed description: 
      The objective of the study was to enroll patients who have clinical signs/symptoms strongly
      indicating TB and who are receiving of have to start the treatment for active TB, and test
      the variants of the CST001 assay to support the evaluation of clinical sensitivity.
    

Intervention name(s): CST001
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with bacteriologically confirmed and untreated TB disease.
      
Keywords: Tuberculosis; TB
Niclosamide Role in Diabetic Nephropathy
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is randomized, controlled, parallel, prospective clinical study will be conducted
      on 60 patients diagnosed with type 2 diabetes mellitus at least five years ago. Patients will
      be recruited from Tanta University Hospital, Tanta, Egypt.

      Accepted patients will be randomized into 2 groups as the following:

      Control group: 30 patients will receive maximum tolerated dose of ACEI plus placebo pills for
      six months Treatment group: 30 patients will receive maximum tolerated dose of ACEI plus
      niclosamide tablets 1 gram once daily for six months The primary end point will be the change
      in Urinary albumin to creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR)
      after six months of treatment
    


Intervention name(s): Niclosamide; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Niclosamide tablets 1 gram once daily; lactose tablets
Intervention MeSH terms: Niclosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes - Niclosamide - Diabetic kidney disease
Rituxan With or Without Methotrexate in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to help determine the effectiveness of rituxan (with or without
      methotrexate) in the treatment of psoriatic arthritis.
    

Detailed description: 
      The purpose of this study is to evaluate safety and efficacy of rituximab, with and without
      methotrexate, in joints, enthesium and skin in psoriatic arthritis patients with inadequate
      response to methotrexate who have either not tried anti-TNF therapy or have had inadequate or
      failed response to anti-TNF therapy. To explore biologic mechanism of action via histological
      and immunohistochemical evaluation of pre and post treatment biopsies of psoriatic plaques.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15). The first infusion of rituximab should be administered IV at an initial rate of 50 mg/hr. If a hypersensitivity or infusion related reaction does not occur, escalate the infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
Other intervention name(s): Rituxan
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rituximab; Rituxan; Psoriatic Arthritis; Arthritis
A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug levels of cendakimab delivered
      subcutaneously in healthy participants.
    


Intervention name(s): Cendakimab
Intervention type(s): Drug
Intervention description(s): Specified Dose on Specified Days
Other intervention name(s): CC-93538; BMS-986355; RPC4046
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Cendakimab
Mechanisms of Neural Mobilization in the Treatment of Chronic Pain
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Chronic Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to determine the effect of a manual therapy technique (neural
      mobilization) on measures of clinical pain and function, experimental pain sensitivity, and
      on the function of the median nerve in individuals with carpal tunnel syndrome. The
      investigators hypothesized that individuals receiving a neural mobilization technique known
      to directly stress the median nerve would demonstrate greater improvements in clinical pain
      and function, experimental pain sensitivity, and median nerve function than those receiving a
      sham technique.
    


Intervention name(s): neural mobilization; sham neural mobilization; healthy controls
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): manual therapy technique known to directly stress the median nerve; sham technique mimicking the neural mobilization which is not specific to the median nerve; People without carpal tunnel syndrome for comparison
Other intervention name(s): upper limb tension test with median nerve bias
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: manual therapy; carpal tunnel syndrome; central sensitization
Implementation of Academic Detailing Interventions on Prescribing of Antimicrobial Drugs in Primary Health Care
Condition: Upper Respiratory Tract Infections; Acute Respiratory Tract Infection; Viral Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Virus Diseases
Study type: Interventional

Summary: 
      World increase in mortality from consequences of antimicrobial resistance (AMR) represents a
      significant public health problem. Irrational prescribing of antimicrobial drugs (AMD) in
      general population is one of the main causes of development AMR. This is also contributed by
      fact that up to 90% of total antimicrobial consumption in Europe is related to the general
      population. Problem of AMR has been recognized by World Health Organization and Council of
      European Union, which support the establishment of the antimicrobial stewardship team
      (A-team). A-team provides co-ordinated interventions that promote rational use of AMD. To
      date, no study has been carried out in which A-team from hospital environment goes to primary
      health care for the purpose of rationalization prescribing of AMD by primary health care
      practitioners. Project for implementation of hospital A-team in primary health care in
      Koprivnica-Križevci County was initiated using academic detailing method aimed at
      rationalization of the consumption of AMD.
    


Intervention name(s): Academic detailing intervention
Intervention type(s): Behavioral
Intervention description(s): Academic detailing or educational outreach is a method based on scientific data with the help of educated A-team members in the form of direct (face-to-face) interactions, prescribing practices change and adherence improves according to the application of currently valid therapeutic guidelines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Antimicrobial resistance; Hospital A-team; Academic detailing intervention; Antimicrobial prescribing; Primary care
hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Dietary intervention studies thus far have failed to be replicable or causal.This is
      particularly relevant regarding plastic-derived chemicals (PDCs),This first-of-a-kind dietary
      intervention study explores a potential causal relationship between human serum levels of BPA
      and High-Sensitivity C-Reactive Protein (hsCRP)
    

Detailed description: 
      Dietary intervention studies thus far have failed to be replicable or causal. The results,
      therefore, have failed to provide clinicians and the general public with consistent and
      useful information on which to base reliable food-related health decisions. This is
      particularly relevant regarding plastic-derived chemicals (PDCs), such as Bisphenol A, now
      that the federal CLARITY-BPA program has failed to achieve scientific consensus.
      Investigators propose a novel human dietary protocol that is both replicable and causal,
      based upon BPA's demonstrated inflammatory effects in humans. This first-of-a-kind dietary
      intervention study explores a potential causal relationship between human serum levels of BPA
      and High-Sensitivity C-Reactive Protein (hsCRP), a proven clinical indicator of inflammation.
      Investigators used the equivalent of a USDA-defined "typical diet" followed by a PDC-reduced
      diet to compare blood levels of hsCRP. This proof-of-concept investigation is the first to
      use an easily accessible, medically-accepted clinical laboratory test to directly measure
      human health effects of PDC reduction. Unexpected new complications discovered during the
      investigation indicate that these results may yet be inconclusive for direct causal
      relationship. However, the novel lessons and techniques developed as a result of those
      discoveries offer further specific and improved methods and best practices that can enable
      future dietary interventions to produce replicable, causal results.
    

Intervention name(s): hsCRP serum measurement of inflammation
Intervention type(s): Diagnostic Test
Intervention description(s): hsCRP inflammation change as result of non-contaminated diet
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Autogenic Drainage Effect on Blood Gases and Prevention of Pulmonary Complication After Upper Abdominal Surgery
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Purpose: This study will find out the effect of Autogenic drainage on the prevention of
      pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper
      abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients
      will be divided into two groups, study group (A) include patients that receive first
      traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and
      splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional
      physiotherapy (localized breathing exercise, diaphragmatic breathing and splinted coughing)
    

Detailed description: 
      Purpose: This study will find out the effect of Autogenic drainage on the prevention of
      pulmonary complications after upper abdominal surgery. Method: Sixty patients post upper
      abdominal surgeries will be included, their ages ranged from 50 to 60 years old. The patients
      will be divided into two groups, study group (A) include patients that receive first
      traditional physiotherapy (localized breathing exercise, diaphragmatic breathing, and
      splinted coughing) then autogenic drainage (B)-Group B: patients that receive traditional
      physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)
    

Intervention name(s): autogenic drainage
Intervention type(s): Procedure
Intervention description(s): breathing control using expiratory airflow to mobilize secretions from smaller to larger airways. Secretions are cleared independently by adjusting the depth and speed of respiration in a sequence of controlled breathing techniques during exhalation in addition to traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autogenic drainage; blood gases; Pneumonia,; upper abdominal surgery; Postoperative pulmonary Complications
The Effects of Alkalised Cocoa on Human Vascular Function
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The primary propose of this study is to determine how processing, in particular alkalisation,
      alters the vascular effects of high-flavanols foods such as cocoa
    

Detailed description: 
      A randomised, triple blind, cross-over design human intervention studies will be conducted in
      10 healthy human volunteers to test the impact of alkalisation on the absorption, metabolism
      and vascular reactivity of cocoa flavanols. Participants will be requested to consume a
      standardised high flavanol-rich cocoa, non-alkalised (1745 mg of flavanols), a low-flavanol
      cocoa, heavily alkalised (1.3 mg of flavanols) and a flavanol-rich cocoa, medium alkalisation
      (410 mg of flavanols). The three intervention diets are otherwise matched for macro- and
      micronutrient content. Vascular measurements will be performed by using Flow Mediated
      Dilation (FMD), Laser Doppler imaging (LDI) and Digital Volume Pulse (DVP). Blood and urine
      samples will be taken to measure the concentration of flavonoids from the cocoa drinks and
      markers of blood vessel function. A number of other biochemical and physiological measures
      will be recorded including blood glucose, lipoproteins, cytokine levels and blood pressure.
    

Intervention name(s): Processed High-flavanol
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Flavanol; Cocoa; Vascular function; Absorption; Metabolism; Alkalisation
Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
Condition: CD20+, B-cell Lymphomas; Mantle Cell Lymphoma; Non-Mantle Cell Low Grade B Cell Lymphomas (SLL/CLL); Transformed Lymphoma/DLBCL/PMBCL; Hodgkin's Disease; Gray Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is being done to determine if combining an investigational drug called
      Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose
      chemotherapy.
    

Detailed description: 
      Everolimus is a pill that interferes with lymphoma cell growth by blocking a cellular pathway
      important in causing cancer cells to grow, called mTor. Rituximab is an intravenous
      medication that specifically attacks a protein commonly found on lymphoma cells called CD20.

      Rituximab is already widely used to treat multiple forms of lymphoma. Moreover, continuing
      rituximab after the completion of chemotherapy is already commonly used to help patients stay
      in remission longer. Everolimus has been shown in many types of relapsed lymphoma to decrease
      the size of lymph nodes by itself. Everolimus is approved by the Food and Drug Administration
      (FDA) for the treatment of advanced kidney cancer and subependymal giant cell astocytoma. It
      is not approved for use in lymphoma. The use of everolimus in this research study is
      investigational. The word "investigational" means that everolimus is not approved for
      marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of
      everolimus in this study.

      The combination of everolimus and rituximab for 1 year after high dose therapy is also new.
      We believe the combination of these medications right after your chemotherapy will be more
      effective in attacking your remaining cancer before they have time to re-grow.

      The usual treatment of lymphoma after high-dose chemotherapy is observation. After your body
      has fully recovered from the effects of the chemotherapy, you will receive everolimus daily
      for one year and IV rituximab four times during that year.
    

Intervention name(s): Everolimus; Rituximab
Intervention type(s): Drug; Biological
Intervention description(s): The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL.; 375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions)
Other intervention name(s): RAD001; Rituxan
Intervention MeSH terms: Rituximab; Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional
Phase: Phase 1

Summary: 
      This proposal is based on findings from our previous work involving ferumoxytol-enhanced
      cardiac magnetic resonance angiography. The resolution of the pulmonary vasculature based on
      our previous imaging protocol was exceptional (PMID: 26786296). In the Partners Healthcare
      System between January 1, 2014 and January 1, 2015 there were 541 patients evaluated in
      Partners Healthcare-affiliated hospitals with a diagnosis of pulmonary embolism and acute or
      chronic kidney disease at the same visit between 01/01/2014 and 01/01/2015. Ventilation
      perfusion scanning was performed in 201 patients during this same time interval. Up to 63% of
      these patients in one year did not receive the diagnostic test of choice.
    

Detailed description: 
      Thromboembolic events in patients with chronic kidney disease are out of proportion to age
      matched controls occurring 2.34 times more frequently than in non-CKD patients (PMID
      19561505). At the same time, patients with kidney disease are not offered the gold standard
      for pulmonary embolus diagnosis, i.e. CT angiography, for concern of acute dialysis to treat
      contrast-induced nephropathy. Ventilation perfusion scintigraphy (V/Q) is the preferred
      diagnostic test for patients with advanced CKD (glomerular filtration rate <30mL/min/m2) and
      suspicion of pulmonary embolus, but can not be utilized if pulmonary parenchyma contains
      interstitial edema or alveolar occlusion due to pneumonia. If diagnostic tools for pulmonary
      embolus are not available, patients are subject to the risk of empiric treatment to avoid
      life-threatening complications of untreated pulmonary embolus. For those patients with CKD
      that undergo CT angiography, they are placed at risk of initiating dialysis. If this occurs
      multiple financial costs are associated with dialysis catheter placement and acute
      hemodialysis. If a patient instead is evaluated with gadolinium-based contrast modalities,
      there is the risk of nephrogenic systemic fibrosis and the morbidity associated with this
      iatrogenic disease process.

      Ferumoxytol-enhanced MRI could avoid the risk of iodinated contrast and gadolinium contrast
      and accelerate the diagnosis and treatment of patients with pulmonary embolus.
    

Intervention name(s): Ferumoxytol
Intervention type(s): Drug
Intervention description(s): ferumoxytol-enhanced magnetic resonance angiography for the diagnosis of pulmonary embolus
Other intervention name(s): Feraheme
Intervention MeSH terms: Ferrosoferric Oxide
Intervention model: Single Group Assignment
Intervention model description: single-arm, open label
Masking: None (Open Label)
Primary purpose: Diagnostic
Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP)
Condition: Purpura; Idiopathic Thrombocytopenic Purpura
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Recombinant Human Thrombopoietin (rh-TPO)
      in combination with Rituximab are effective and safe in the management of
      Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).
    

Detailed description: 
      Rituximab was given intravenously at a dose of 100 mg weekly for 4 consecutive weeks (Day 1,
      8, 15, 22). Rh-TPO (TPIAOTM, a product of Sunshine Pharmaceutical Co Ltd, China, approved by
      China State Food and Drug Administration) was given subcutaneously at a dose of 1.0
      μg/kg（300u/kg）for 14 days (Day 1-14). Platelet count (PC) was monitored every three or four
      days until day 22, followed by tests every week. Platelet transfusion was administered to
      patients with active bleeding symptoms or to those whose PC<10×10^9/L. Patients were followed
      for 3 months, and any adverse effects were recorded during the period of treatment and during
      the follow-up.
    

Intervention name(s): rhTPO in combination with Rituximab
Intervention type(s): Drug
Intervention description(s): Rituximab was given intravenously at a dose of 100 mg weekly for 4 consecutive weeks (Day 1, 8, 15, 22). Rh-TPO (TPIAOTM, a product of Sunshine Pharmaceutical Co Ltd, China, approved by China State Food and Drug Administration) was given subcutaneously at a dose of 1.0 μg/kg（300u/kg）for 14 days (Day 1-14).
Other intervention name(s): Recombinant Human Thrombopoietin; Recombinant Human TPO; rhTPO combine with Rituximab; Recombinant Human Thrombopoietin combine with Rituximab; Recombinant Human TPO combine with Rituximab
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Purpura; Idiopathic Thrombocytopenic Purpura
Pharmacokinetics and Tolerability of Meloxicam Injected Intramuscularly vs. Tablet in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the pharmacokinetics and tolerability of an intramuscular 15 mg
      meloxicam injection in comparison to the 15 mg oral tablet
    


Intervention name(s): Meloxicam ampoule; Meloxicam tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment