bioihbjkbjnl/mcl2 huggingface dataset:
Target Site Pharmacokinetics of Ertapenem After Multiple Doses in Diabetes Patients With Soft Tissue Infection
Condition: Soft Tissue Infection
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Background/rationale: Ertapenem is an innovative antimicrobial agent, which is approved in
      the European Union for diabetic foot infections of the skin and soft tissue. Although its
      antimicrobial spectrum and activity against ESBL-strains are promising to treat infected
      ulcers associated with diabetes, there is a lack of data on tissue pharmacokinetics of
      ertapenem in this patient population. However, for antimicrobial efficacy it is important to
      show that the antibiotic achieves sufficient concentrations at the site of infection, i.e. in
      tissue. A recent clinical study by Burkhardt et al. (Journal of Antimicrobial Chemotherapy,
      2006) using the microdialysis technique showed that the free tissue concentrations after a
      single dose of 1 g ertapenem are sufficient and adequate to kill most relevant bacteria,
      suggesting efficacy of ertapenem for soft tissue infections. It is well known that there is
      no accumulation of ertapenem in plasma after multiple doses of 1 g every 24 h in patients
      without significantly impaired renal function. The single dose study by Burkhardt et al. also
      suggests that only negligible drug accumulation can be expected in soft tissues of healthy
      young volunteers after multiple doses. However, it was shown for other antibiotics that
      tissue PK may be significantly different under pathologic conditions, leading to impaired
      penetration, but subsequent accumulation after multiple doses due to a longer tissue half
      life than in healthy volunteers. Since the properties of inflamed tissue may diverge from
      those of healthy tissue it is important to evaluate which concentrations of ertapenem are
      reached in inflamed tissue after multiple doses.

      Clinical study: In the present study we will measure the concentrations of ertapenem over
      time in plasma and infected tissue of 10 diabetes patients after multiple doses. The
      microdialysis technique will be used. The ertapenem concentrations will be measured in
      inflamed tissue and in non-inflamed subcutaneous tissue to identify the effect of
      inflammation on pharmacokinetics. The findings of the present study will help to confirm the
      efficacy of ertapenem for the indication of diabetic soft tissue infections.
    


Intervention name(s): Microdialysis
Intervention type(s): Procedure
Intervention description(s): PK measurements with microdialysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ertapenem tissue PK
Claudication Evaluation During Rowing ExerciseS
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Study type: Observational

Summary: 
      Check the feasibility of the collection of reliable measures of tcpO2 the lower limbs in
      arteriopathy when performing rowing on effort.
    

Detailed description: 
      Obtaining curve values of tcpO2 interpretable when recording the effort by rowing on rowing.

      Show the occurrence of ischemia in the lower limbs during recording effort by rowing on
      rowing
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with buttock pain and referred for an oximetry exercise test
      
Keywords: peripheral artery disease; transcutaneous oxygen pressure; claudication; rowing ergometer
A Study of EDP1815 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
Condition: Psoriasis; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      Evelo will investigate the safety and tolerability of EDP1815 and its potential to be a
      medicinal product in healthy volunteers and individuals with mild to moderate psoriasis and
      atopic dermatitis.
    

Detailed description: 
      This will be a randomized, double-blind, placebo-controlled clinical study with dose
      escalations to assess safety, tolerability, and pharmacodynamic effect of EDP1815. Since this
      clinical study is the first study in humans, the participants will be healthy volunteers or
      subjects with mild to moderate psoriasis or atopic dermatitis who are otherwise well.
      Investigation of EDP1815 in this patient population provides an opportunity to gain
      pharmacodynamic information using a range of tissue biopsies and composite clinical
      endpoints.
    

Intervention name(s): EDP1815; Placebo oral capsule; Placebo oral tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): EDP1815 is an orally administered monoclonal microbial; Placebo; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study is a double-blind dose escalation cohort study in healthy volunteers and participants with either mild to moderate psoriasis or mild to moderate atopic dermatitis. The study consists of 10 cohorts and will test doses of EDP1815 versus placebo. The safety and tolerability of EDP1815 will be tested in participants with psoriasis and atopic dermatitis alongside pharmacodynamic effects on the systemic immune system and observation of any clinical effects.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Haploidentical Transplantation With CD3/CD19 Depleted Grafts in Patients With Hematologic Malignancies
Condition: Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to study the feasibility and Toxicity of allogeneic
      haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a
      dose reduced conditioning.
    

Detailed description: 
      Transplantation of a CD3/CD19 depleted stem cell grafts after dose reduced conditioning for
      the treatment of treatment refractory or relapsed hematologic malignancies after preceding
      allogeneic or autologous hematopoietic cell transplantation.
    

Intervention name(s): Fludarabine; Thiotepa; Melphalan; OKT-3; CD3/CD19 depletion on CliniMACS
Intervention type(s): Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Fludarabine; Melphalan; Thiotepa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: haploidentical transplantation; immunomagnetic cell sorting; allogeneic hematopoietic cell transplantation; dose reduced conditioning
HFR A-equilibrium on Cardiovascular Stability
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of the present randomized controlled multinational trial is the comparison of a novel
      biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy,
      with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic
      overall and cardiovascular stability.
    

Detailed description: 
      Online hemodiafiltration (OL-HDF) has been recently associated with better patient survival
      in comparison with standard hemodialysis in some large observational studies (Canaud et al,
      KI, 2006; Vilar et al, CJASN , 2009) supporting the hypothesis that convection can improve
      patients outcomes. Moreover, it has been demonstrated in randomized controlled trials
      (Locatelli et al, Journal American Society of Nephrology, 2010) that OL-HDF significantly
      reduced the frequency of intradialytic hypotension. Nonetheless, the associated comorbidities
      and ageing of dialysis population require further devices able to improve treatment
      tolerance. Among these tools, the sodium profiling and biofeedback system seem to be
      promising to accomplish this task. But the correct intradialytic sodium balance is still far
      away today to be easily achieved. The use of an automated adaptive system dialysis to the
      sodium profiling has been investigated in a feasibility trial (Colì et al International
      Journal Artificial Organs, 2003). They also investigated the impact of such a device on
      treatment tolerance.

      The aim of this randomized multinational multicenter controlled trial is to evaluate the
      impact of sodium profiling applied to a endogenous hemodiafiltration technique on the
      intradialytic cardiovascular stability in comparison to standard no profiled endogenous
      hemodiafiltration.
    

Intervention name(s): Automated sodium profiling in endogenous hemodiafiltration; Standard sodium dialysate
Intervention type(s): Device; Device
Intervention description(s): Automated sodium profiling during endogenous reinfusion hemodiafiltration technique. The device processes the dialysate sodium and ultrafiltration rate during dialysis to achieve a preset sodium target at the end of the treatment. Sodium dialysate and maximal ultrafiltration rate are constraint within safety limits during dialysis.; Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration
Other intervention name(s): HFR-Aequilibrium; Standard HFR
Intervention MeSH terms: Dialysis Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with
      advanced lung cancer that is no longer responding to erlotinib or gefitinib.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the overall response rate (complete response and partial response) in
           patients with acquired erlotinib hydrochloride- or gefitinib-resistant advanced
           adenocarcinoma of the lung treated with dasatinib.

      Secondary

        -  To determine the progression-free survival and overall survival of patients treated with
           this drug.

        -  To determine the overall response rate in patients with EGFR T790M lung adenocarcinomas
           treated with this drug.

        -  To determine the progression-free survival and overall survival of patients with EGFR
           T790M lung adenocarcinomas treated with this drug.

        -  To determine the toxicity profile of dasatinib in these patients.

      OUTLINE: Beginning 1 week after completion of erlotinib hydrochloride or gefitinib therapy,
      patients receive oral dasatinib twice daily. Treatment continues in the absence of disease
      progression or unacceptable toxicity.

      Response is assessed by CT scan at 4 weeks, 8 weeks, and then every 8 weeks thereafter.
    

Intervention name(s): dasatinib
Intervention type(s): Drug
Intervention MeSH terms: Dasatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the lung; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer
To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH)
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      A proof of principle single-centre, randomized-controlled, examiner-blind, two treatment
      group study to investigate the efficacy of an experimental 15% w/w dissolvable strip in
      relieving dentine hypersensitivity (DH) after a single application and up to 4 hours after
      application compared to no treatment.
    

Detailed description: 
      This was a single-centre, randomized-controlled, examiner-blind, two treatment group (test
      and no treatment), parallel design, stratified (by maximum baseline Schiff sensitivity score
      of the two selected test teeth) study, in healthy participants with at least two sensitive
      teeth that meet all the criteria at the screening and the baseline pre-treatment visit.
      Participants were screened for study suitability at screening visit (Visit 1). At Visit 2
      (baseline; pre-treatment) 2 non-adjacent accessible teeth (incisors, canines, premolars) in
      different quadrants of the mouth and separated by at least 2 teeth (or equivalent edentulous
      space) were identified that demonstrated signs of sensitivity as measured by a qualifying
      tactile stimulus (Yeaple ≤ 20 gram [g]) and evaporative air assessment (Schiff sensitivity
      score ≥ 2) on the facial/cervical (ie, labial/buccal) tooth surface. Once the 2 test teeth
      were selected, the subjects were stratified (by maximum baseline Schiff sensitivity score of
      the 2 selected test teeth) and randomized to treatment or no treatment. DH was assessed at
      baseline (pre-treatment), and 10mins, 2 & 4 hours post-treatment.
    

Intervention name(s): Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate)
Intervention type(s): Device
Intervention description(s): Experimental dissolvable polymer strip containing Novamin (15% weight by weight[w/w] calcium sodium phosphosilicate).
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Randomised Double Blind Placebo Controlled Cross Over Design of the Efficacy of Topical Morphine for Inflammatory Pain in Children With Epidermolysis Bullosa
Condition: Epidermylosis Bullosa
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomised Double blind placebo controlled cross over design study of the efficacy of
      morphine for inflammatory pain in children with Epidermolysis Bullosa
    


Intervention name(s): topical opiod; morphine sulphate in intrasite gel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Long-Term Effects of HIV Exposure and Infection in Children
Condition: HIV Infections; HIV Seronegativity
MeSH terms: Infections
Study type: Observational

Summary: 
      As new drugs and vaccines are developed to prevent HIV disease progression and prolong
      survival of HIV infected patients, the short-term safety and effectiveness of these
      treatments are evaluated in research studies. However, the long-term effects, whether they
      are benefits or side effects, need to be studied as well. These long-term effects may have a
      greater impact on infants and children who are still growing and developing. The purpose of
      this study is to follow HIV-exposed and HIV infected infants, children, and adolescents who
      are seen at Pediatric AIDS Clinical Trials Group (PACTG) study sites. These patients will be
      observed for long-term benefits or any late harmful effects of medications or vaccines.
    

Detailed description: 
      The potential long-term benefits, toxicities, and other adverse outcomes of new anti-HIV
      therapies cannot be assessed within the time frame of most clinical trials. There is a need
      to better assess both positive and negative late outcomes and late treatment effects in
      growing children. This prospective, longitudinal study will evaluate the effects and their
      impact on children.

      Children in this study will include patients who are HIV infected, were exposed to HIV or
      anti-HIV drugs prior to or at the time of their birth, or children of patients followed at
      Pediatric AIDS Clinical Trial Group (PACTG) sites. Children will have a study visit every 3
      months through the first year of life. After age 1, children who are HIV infected will
      continue to have study visits every 3 months, while children who are HIV uninfected will have
      study visits once a year. Study assessments will include complete physical exam, medical
      history, Tanner staging, neurologic exam, growth and quality of life assessments, and
      laboratory tests such as hematology, chemistries, and urinalysis. Not all assessments will be
      performed at each study visit. Patients will be followed until age 24.
    

Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex
A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate
      the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in
      subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX)
      therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects
      will be enrolled into an open label extension period. Subjects will receive SB4 for an
      additional 48 weeks.
    


Intervention name(s): Enbrel (etanercept); SB4 (proposed biosimilar to etanercept)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Etanercept; Biosimilar
Pivotal Study of the iNAP® in Adults With OSA
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal
      Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with
      Obstructive Sleep Apnea (OSA)
    

Detailed description: 
      Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes
      significantly to hypertension, stroke, myocardial infarction and other health problems.
      Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular
      repositioning devices designed to increase the patency of the airway and to decrease airway
      obstruction, are used to treat OSA. To this end, the investigators are conducting a
      prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study
      to evaluate the efficacy and safety of iNAP® Sleep Therapy System (iNAP®), a tongue and soft
      palate retaining intraoral device, in adults with OSA.
    

Intervention name(s): iNAP® Sleep Therapy System
Intervention type(s): Device
Intervention description(s): The iNAP® provides a pressure gradient within the oral cavity, which pulls the tongue toward the upper palate and pulls the soft palate forward in a way that enhances the patency of the upper airway near the pharynx so that upper airway patency can be maintained to prevent sleep-disordered breathing.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Effect of Food on the Absorption and Bioavailability of PBI-200
Condition: Food Effect in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, open-label, randomized, three-way crossover study to assess the effect
      of food on the absorption and bioavailability of PBI-200.
    

Detailed description: 
      This is a single-dose, open-label, randomized, three-way crossover study to assess the effect
      of food on the absorption and bioavailability of PBI-200, administered orally under fasted
      and fed conditions.

      The study will enroll 18 healthy adult volunteers to ensure study completion of at least 12
      evaluable volunteers. The study will be conducted in 3 groups, with each group enrolling 6
      volunteers. As this is a crossover study, each volunteer will serve as their own control.
    

Intervention name(s): PBI-200
Intervention type(s): Drug
Intervention description(s): Single dose of PBI-200
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, open-label, randomized, three-way crossover design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Volunteer
Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson
Condition: Idiopathic Parkinson Disease; Parkinson's Disease and Parkinsonism
MeSH terms: Parkinson Disease; Parkinsonian Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an interventional study to treat 10 patients with a diagnosis of Parkinson's disease
      with neurological assessment from the Oxford Parkinson's Disease Quotient-39 (PDQ-39) and
      Movement Disorders Society Universal Parkinson's Disease Rating Scale (MDS-UPDRS), with
      autologous adipose tissue-derived stromal vascular fraction (SVF) cells by subdermal plane
      injection into the submuscular aponeurotic fascia of the face.

      This study assesses: 1) safety and 2) feasibility and 3) exploratory evidence of efficacy.
    

Detailed description: 
      Pre-procedure/intervention evaluation

      Patients had a medical history, physical exam, and medication review. Neurological
      examination used two instruments: PDQ-39 and the MDS-UPDRS, the latter including
      videorecording of a standardized motor examination. Subjects also completed the general
      health questionnaire SF-36 and have blood drawn for subsequent biomarker analysis (immune
      markers L-1beta, IL-2, IL-6, IL-10, and TNF-alpha). Patients had pre-operative laboratory
      studies (hemogram, coagulation profile, electrolytes, BUN, creatinine, and urinalysis) and
      anesthesia evaluation carried out 48 hours prior to procedures.

      Surgical and biochemical technique

      The autologous fat tissue was harvested via liposuction by a plastic surgeon. The fat was
      washed and processed with collagenase for 60 minutes at a temperature of 39-41ºC, in an
      incubator and by constant shaking with a rotary shaker. The digested adipose tissue was then
      centrifuged for 14 minutes in 3 steps and the cell fraction (SVF) contained in the fat was
      removed with a syringe. The cell count was performed using a Luna Stem cell counter (Logos
      Bio). SVF was injected the same day as the liposuction and adipose processing.

      A standardized total dose of 30x10e6 SVF cells was administered [Carstens 2017]. Injections
      of SVF cells bilateral (into the subdermal plane along the submuscular aponeurotic fascia) 1
      cc per site for a final dose of 0.3 million cells per site

      Post-surgical and management of complications

      Patients were observed for potentially adverse effects for 24 hours after the procedure.
      There were follow-up visits at seven days, 1-, 3-, 6- and 12 months postoperative and
      treatment period.
    

Intervention name(s): Adipose-derived stromal vascular fraction cells
Intervention type(s): Genetic
Intervention description(s): Published minimal clinically important differences (MCID) for PDQ-39; MDS-UPDRS; and levo-dopa equivalent dose and changes in the levels of blood proteins (L-1beta, IL-2, IL-6, IL-10, and TNF-alpha) in 10 patients after 12 months of treatment with SVF cells.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment