bioihbjkbjnl/mcl2 huggingface dataset:
Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcers
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12
      weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of
      Diabetic Foot Ulcer. The primary objectives of this study are: 1) to evaluate the
      effectiveness of EPIFLO in combination with standard wound therapy on wound healing as
      compared to standard wound therapy alone; and 2) Screening for potential safety issues.

      Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be
      enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen
      consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive
      debridement. Subjects will be randomized to either the Treatment arm or the Control arm.
      Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment
      Period, once two weeks after wound closure and once at the end of 12-week durability Period.
    


Intervention name(s): Epiflo; Moist Wound Therapy
Intervention type(s): Device; Other
Intervention description(s): During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.; During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
Other intervention name(s): Transdermal Continuous Oxygen Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with
      type 1 diabetes on postprandial plasma glucose concentrations
    


Intervention name(s): Pramlintide acetate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Placebo Comparator
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pramlintide,; insulin,; type 1 diabetes,; reduction in postprandial glucose,; pramlintide:insulin dose-ratio
Individualized Diet Improvement Program for Weight Loss and Maintenance, Cohort 2
Condition: Obesity; Overweight; Weight Loss; Diet Habit
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      This research is to develop a weight loss and weight maintenance program through dietary
      modifications for adults with obesity. Although scientific studies have shown the feasibility
      of rapid and safe dietary weight loss and subsequent weight maintenance, no efficacious
      dietary weight management program is widely available, and thus bariatric surgery remains the
      most reliable approach for weight loss/management. Safe and effective dietary weight loss and
      subsequent weight maintenance require flexible, individualized advice by an experienced
      dietitian/nutritionist.
    


Intervention name(s): Weight Management Intervention
Intervention type(s): Behavioral
Intervention description(s): Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observation of Rotation of an Intraocular Lens
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125
      AS IOL.

      At the end of surgery the orientation of the IOL is documented with a short video clip via
      the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6
      months after surgery. Rotational stability of the IOL is assessed using retroillumination
      images with a method to avoid bias from cyclorotation or head tilt.
    


Intervention name(s): cataract surgery
Intervention type(s): Procedure
Intervention description(s): cataract surgery with implantation of intraocular lens
Sampling method: Non-Probability Sample
Study population: 
        Eyes of patients with uni- or bilateral cataract applying for cataract surgery at the
        Department of Ophthalmology, Medical University Vienna.
      
Keywords: IOL rotation
A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, parallel-group, rater-blinded, randomized clinical study in subjects
      with advanced PD investigating the efficacy, PK, safety and tolerability of continuous SC
      infusion of 2 dosing regimens of ND0612H, a solution of LD/CD delivered via a pump system as
      a continuous SC infusion, compared to standard oral LD/CD. After screening, subjects will
      undergo 1 day of standard oral LD/CD inpatient dosing followed by 2 days of inpatient
      treatment with 1 of 2 randomly allocated (1:1 randomization ratio) dosing regimens of ND0612H
      continuous SC infusion. Subjects will then continue on a maintenance dose of the assigned
      ND0612H dosing regimen for the next 25 days. A safety visit will be performed 4 weeks after
      the last SC administration of the study drug for a total of about 2.5 months of participation
      for each subject enrolled into the trial.
    

Detailed description: 
      This phase IIa randomized, controlled, parallel-group study will be conducted in 36 subjects
      with advanced PD who are treated with oral LD/CD at a stable dose and have predictable
      morning "OFF" periods and at least 2.5 hrs of daily "OFF" periods. The study will investigate
      the efficacy, PK, safety and tolerability of continuous SC infusion of 2 dosing regimens of
      ND0612H. Regimen 1 will employ continuous infusion for 24 hrs using a low infusion rate at
      night and a higher rate at daytime with supplemental administration of oral immediate release
      (IR) LD/CD in the mornings. During the inpatient period of about 3 days, the site staff will
      manage the administration and replacement of the infusions. On Day 4 subjects will be
      discharged home after they and their study partners have received training on the
      administration of the infusion. Subjects will then continue on a maintenance dose of the
      assigned ND0612 dosing regimen for the next 25 days. A safety visit will be performed 4 weeks
      after the last SC administration of the study drug.
    

Intervention name(s): ND0612 (Levodopa/Carbidopa solution); ND0612 (Levodopa/Carbidopa solution) + morning oral IR-LD/CD
Intervention type(s): Drug; Drug
Intervention description(s): The total daily dose of levodopa/carbidopa 720/90 mg. Device: CRONO TWIN pump system.; The total daily dose levodopa/carbidopa from ND0612 538/67 mg. Morning dose of oral IR-LD/CD 150/15 mg. Device: CRONO TWIN pump system.
Other intervention name(s): Regimen 1 - 24-hr infusion; Regimen 2 - 14-hr infusion
Intervention MeSH terms: Levodopa; Carbidopa; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
MRI Findings in Inguinal Hernia
Condition: Inguinal Hernia; Pain
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      MRI imaging in clinically evident inguinal hernia is not routinely used. In other painful
      inguinal conditions (such as sportsmans hernia) inflammatory changes have been detected. The
      aim of the present study is to determine, whether similar inflammatory changes can be
      detected with MRI scan in inguinal hernia. Also, patient questionaires are used
      preoperatively and postoperatively to determine, if preoperative pain scores can be used as a
      predictive value for postoperative prolonged pain/neuralgia.
    


Intervention name(s): MRI scan
Intervention type(s): Procedure
Intervention description(s): MRI scan with a 1,5 T MRI scanner
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Phase IV Study With a 36-week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin Therapy When Added to the Therapy of Japanese Patients With Type 2 Diabetes With Inadequate Glycemic Control on Insulin.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Japanese male and female patients with Type 2 Diabetes and aged ≥ 20 years old, with
      inadequate glycemic control on insulin defined as Haemoglobin A1c ≥ 7.2% and < 11% will be
      enrolled into the wash-out phase or directly into the lead-in phase depending on whether the
      patient has been receiving an Oral antidiabetic drug (including Glucagon-Like Peptide-1
      agonists and excluding Thiazolidinedions) other than a Dipeptidyl Peptidase-4 inhibitor as
      part of the baseline treatment. Additional treatment with a concomitant Dipeptidyl
      Peptidase-4 inhibitor is allowed. And around 180 eligible patients in total will be
      randomized into the study with a 2:1 randomization scheme (i.e.120 patients into the
      dapagliflozin treatment group and 60 patients into the placebo treatment group. All subjects
      who completed a 16 weeks double-blind treatment period will shift to a 36 weeks open
      extension treatment period.
    


Intervention name(s): Dapagliflozin 5 mg; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin, a blood glucose lowering drug. Oral dose; Placebo tablet. Oral dose
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Japanese patients with type 2 diabetes with inadequate glycemic control on insulin
HSG and Tubal Patency Study
Condition: Tubal Patency
Study type: Interventional

Summary: 
      The investigators' research group is working to develop a highly effective, low cost
      non-surgical method of permanent contraception for women. To support this goal, we need to
      know more about the normal fallopian tube (tube that passes the egg from the ovary into the
      womb). The purpose of this study is to learn about how menstrual cycles and hormonal
      contraceptives affect tubal patency. Normally there is an opening between the tube and uterus
      to permit the flow of fluid and cells. If this opening is blocked, this can result in
      infertility. Tubal patency is when a woman's fallopian tubes are not blocked. Tubal patency
      is determined by an x-ray test called a hystero-(uterus)salpingo-(fallopian tube)graphy
      (HSG). HSG is a standard radiological imaging study that is used to determine if the
      fallopian tubes are open and free of disease. It is commonly done in women with an
      infertility diagnosis. The investigators usually do this test in the first 10 days of the
      menstrual cycle. Sometimes the tubes will appear to be blocked on the HSG when they are
      actually open. The timing of the HSG study during the menstrual cycle, or the use of hormonal
      contraception may make a difference in whether the tubes appear blocked on the HSG when they
      are actually patent.

      The results of the HSG test provide a good model for how our nonsurgical permanent
      contraception method might work. The investigators think that if the tubes are not patent,
      that our treatment will not work as well. Therefore, in this study we want to learn if
      menstrual cycle timing or current hormonal contraception use will affect the patency of the
      tubes as assessed by the HSG. The investigators want to examine the same women to see if
      tubal patency is changes during the menstrual cycle and during the use of a birth control
      pill and the birth control shot.
    


Intervention name(s): combined oral contraceptive; DepoProvera
Intervention type(s): Drug; Drug
Intervention description(s): combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption; injectable hormonal contraceptive
Other intervention name(s): pill, birth control pill, COC; Depo-medroxyprogesterone acetate, DMPA
Intervention MeSH terms: Medroxyprogesterone Acetate; Contraceptive Agents; Medroxyprogesterone; Contraceptives, Oral; Contraceptives, Oral, Combined
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hysterosalpingography, DMPA, combined oral contraceptive, tubal patency
Testing the Validity of the "Modified Confusion Assessment Method for the Emergency Department" (mCAM-ED)"
Condition: Delirium
MeSH terms: Delirium; Confusion; Emergencies
Study type: Observational

Summary: 
      The proposed Study validates the accuracy of the modified Confusion Assessment Method for the
      Emergency Department
    

Detailed description: 
      Delirium is a complex neuropsychiatric syndrome with sudden change in cognition such as
      disturbance in orientation or memory particularly in elderly patients in the context of acute
      illness. Multiple complications such as falls or increased duration of hospitalisation may
      result in delirium. Long-term consequences may result in increased mortality rates and higher
      admissions rates to nursing homes. In 2012, delirium prevalence in the Emergency Department
      (ED) of the University Hospital Basel was 9.5% in patients with 65 years and over. Although a
      systematic delirium management was introduced in 2012, without systematic screening delirium
      detection rates varies between 20 and 40% only. The risk of non-detection over the complete
      hospitalisation is high when early delirium detection did not occur in the ED. In a
      preliminary evaluation we could show the usefulness of the mCAM-ED
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to the emergency department being 65 years and over
      
Keywords: delirium detection
Sodium Benzoate and/or N-Acetylcysteine Added to TAU in Patients With Early Schizophrenia Spectrum Disorder.
Condition: Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to determine if the addition of Sodium Benzoate and / or NAC to TAU will be
      acceptable and tolerable and result in overall improvement of symptoms, social and cognitive
      functioning in patients with early schizophrenia spectrum disorder.
    


Intervention name(s): Sodium Benzoate; N-Acetylcysteine; Placebo; Sodium Benzoate Plus N-Acetylcysteine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sodium Benzoate will be administered at 1000mg daily; N-Acetylcysteine 1000 mgs twice daily dose; Placebo added to TAU; Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose
Intervention MeSH terms: Acetylcysteine; Sodium Benzoate; N-monoacetylcystine
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: This will be a 2x2 factorial design trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Schizophrenia; Sodium Benzoate; N-Acetylcysteine; NMDA receptor; Psychopharmacology; Anti-oxidant; Inflammation
Bendamustine and Rituximab for the Treatment of Splenic Marginal Zone Lymphoma
Condition: Marginal Zone B-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Study type: Interventional
Phase: Phase 2

Summary: 
      Splenic Marginal Zone Lymphoma (SMZL) is a well-defined low-grade B-cell lymphoma,considered
      as a rare neoplasm accounting for about 2% of all non-Hodgkin's lymphomas (NHL) and
      represents for most cases of otherwise unclassifiable chronic lymphoid B-cell cluster of
      differentiation antigen 5 (CD5)-lymphoproliferative disorders. SMZL is characterized by an
      almost exclusive involvement of the spleen and bone marrow and in about 25% of cases the
      disease pursues an aggressive course and most patients die of lymphoma progression within 3-4
      years.

      Retrospective studies have indicated that purine analogous achieved very high response rates
      in both naïve and pre-treated patients. Moreover, the introduction of the anti-cluster of
      differentiation antigen 20 (CD20) humanized antibody rituximab, either used alone or in
      combination with chemotherapy has been reported to be very effective in producing a rapid
      clearance of neoplastic cells.
    

Detailed description: 
      Prospective, multicenter, open-label, phase II study, designed to determine efficacy and
      safety of a Chemo-immunotherapy with the combination of bendamustine + rituximab in patients
      with splenic marginal zone lymphoma.

      Study Population: previously untreated (except for splenectomy and/or antiviral therapy for
      Hepatitis C Virus (HCV) infection) and symptomatic Splenic Marginal Zone patients.

      Objectives: evaluation of the efficacy and the safety of R-Bendamustine in symptomatic
      Splenic Marginal Zone Lymphoma patients.

      Primary Objective: efficacy of R-Bendamustine measured by Complete Response rate. Complete
      response rate defined as regression to normal size on CT of organomegaly (spleen, liver,
      lymph nodes); normalization of the blood counts and no evidence of circulating clonal cells,
      and no evidence or minor (≤ 5%) Bone Marrow (BM) infiltration detected by
      immunohistochemistry (IHC).

      Treatment: The R-Bendamustine regimen consisted of 28-day cycle. Patients achieving a
      complete response (CR) after 3 cycles received only one more cycle of R-Bendamustine, while
      those achieving a partial response (PR) received 3 additional cycles of R-Bendamustine; if
      less than PR patients were withdrawn from the study
    

Intervention name(s): Bendamustine and Rituximab
Intervention type(s): Drug
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanism of Action Study for Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to compare the mechanism of action between adalimumab and
      methotrexate in subjects with psoriasis.
    

Detailed description: 
      Both methotrexate and adalimumab are FDA-approved drugs for the treatment of moderate to
      severe psoriasis. The two treatments, methotrexate and adalimumab, both show efficacy for
      psoriasis, however their profiles differ. In the CHAMPION Study, more adalimumab-treated,
      moderate to severe psoriasis patients achieved a PASI 75 after 16 weeks compared to those
      treated with methotrexate (80% vs. 36%). The reason for this difference is poorly understood.
      No direct comparative mechanism of action studies in psoriasis patients between methotrexate
      and adalimumab (or any tumor necrosis factor blocker) has been reported.

      With etanercept, another tumor necrosis factor blocker, the in vivo mechanism has been
      studied with some scientific rigor. These studies demonstrate that etanercept down regulates
      multiple pro-inflammatory pathways (as shown in Table 1 of the protocol).

      To date, there are no similar studies with adalimumab or methotrexate.

      In order to understand the molecular and cellular basis for the differential clinical
      efficacy of adalimumab and methotrexate, it is essential to compare their mechanisms of
      action in psoriatic plaques. Biopsies will be performed, and we will study biomarkers in this
      proposal with immunohistochemistry, real-time polymerase chain reaction, and gene arrays.
    

Intervention name(s): Methotrexate; Adalimumab (Humira)
Intervention type(s): Drug; Drug
Intervention description(s): 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Methotrexate-treated patients will then receive 16 weeks of adalimumab at the end of study.; 2 cohorts (Randomized 1:1 adalimumab:methotrexate). Subjects will receive treatment on Day 1 (baseline visit) and then weekly or every 2 weeks for 16 weeks.
Other intervention name(s): Methotrexate (MTX); Folic Acid; Humira
Intervention MeSH terms: Folic Acid; Adalimumab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: tumor necrosis factor (TNF) inhibitor; tumor necrosis factor (TNF) blockade; Methotrexate; treatment; mechanism; psoriasis
Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Evaluate the effect of Synbiotic 365 (Version 5 and 7) on body composition in overweight and
      obese individuals as measured by change in body mass index (BMI) and the percentage of body
      fat from Day 0 to Day 84 when compared to placebo by Dual Energy X-ray Absorptiometry scan
      (DEXA) for body composition (Body Mass Index, Lean Body Mass, Body Fat, Fat Free Mass).
    


Intervention name(s): Rice Hulk; Synbiotic365 Ver 5; Synbiotic365 Ver 7
Intervention type(s): Other; Other; Other
Intervention description(s): Placebo; Active Comparator; Active Comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other