bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RO5310074 in Patients With Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind. placebo-controlled study will assess the safety, tolerability,
      pharmacokinetics and pharmacodynamics of multiple doses of RO5310074 in patients with
      psoriatic arthritis who have or have had an inadequate response to oral disease-modifying
      antirheumatic drugs (DMARDs) or non-steroidal anti-rheumatic drugs (NSAIDs). Patients will be
      randomized in cohorts to receive either 6 intravenous doses of RO5310074 or placebo.
      Anticipated time on study treatment is 12 weeks.
    


Intervention name(s): Placebo; RO5310074
Intervention type(s): Drug; Drug
Intervention description(s): multiple doses; multiple ascending doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Smart Heart Study: Cognitive Benefits of Cardiac Rehabilitation
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      The proposed study will be the first to examine whether changes in blood flow patterns within
      the brain account for the possible cognitive benefits of CR. A clearer understanding of this
      possibility may provide key insight into the way CVD affects the brain, help identify
      effective treatments, help a greater number of patients return to work, and improve quality
      of life.
    

Detailed description: 
      Based on recent patient referrals, we expect that 30 participants will subsequently enroll in
      CR and 30 will not. CR patients will complete standardized neuropsychological tests (45-60
      minutes) and Transcranial Doppler (30-40 minutes) during their first and last week in the CR
      program. Patients who do not enroll in CR will undergo testing at similar intervals to serve
      as a matched control group. Standard medical records will be collected for participants in
      both groups to obtain demographic and medical information. CR-specific medical records will
      also be collected to obtain information about possible mechanisms for cognitive benefits
      (e.g. improved stress test performance, reduced blood pressure, etc.). All participants will
      be compensated for their time.
    

Intervention name(s): Observational
Intervention type(s): Behavioral
Intervention description(s): No intervention
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Those with cardiovascular disease
      
Keywords: Cardiac Rehabilitation; Cognitive functioning; Cardiovascular disease
Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in
      patients with Chronic Idiopathic Constipation (CIC).
    

Detailed description: 
      This is an open-label extension study of plecanatide in the treatment of patients with CIC
      who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).

      The planned duration of each patient's study participation is up to 411 days, including up to
      33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks
      after the last dose of study drug.
    

Intervention name(s): Plecanatide
Intervention type(s): Drug
Intervention MeSH terms: Plecanatide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plecantaide; Chronic Idiopathic Constipation; Chronic; Idiopathic; Constipation; Synergy; CIC; CIC study; CIC OLE; CIC OLE study; OLE; OLE CIC; OLE CIC3; Open label; Open label study; Long term; Long term study; Extension; Extension study
A Single-Center, Clinical Study to Evaluate the Safety of a Non-Fragranced Personal Lubricant in Healthy Female Subjects
Condition: Erythema; Edema
MeSH terms: Erythema
Study type: Interventional

Summary: 
      To evaluate the safety of a personal lubricant when used as indicated as a personal lubricant
      in the vagina and vulvar/perineal areas at least four times weekly for two weeks in a
      population of healthy females
    


Intervention name(s): Miami w/o frag Personal lubricant
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Patellar Tendinopathy - The Effect of Load Magnitude in Exercise-based Treatment
Condition: Patellar Tendinopathy; Jumper's Knee
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The purpose of this project is to investigate if the magnitude of a loading based 12 weeks
      rehabilitation regime for patellar tendinopathy influence the clinical outcome, tendon
      structure and function.

      The investigators hypothesize that a greater magnitude (90% of 1RM) of loading will yield a
      more positive clinical outcome, tendon structure and function in patients with patellar
      tendinopathy compared to a lower magnitude of loading (55% of 1 RM) when total exercise
      volume is equal in both groups.
    

Detailed description: 
      Randomized controlled intervention study with one year follow-up
    

Intervention name(s): Heavy slow resistance training; Moderate slow resistance training
Intervention type(s): Other; Other
Intervention description(s): Resistance training for knee extensors. The exercise will be performed at 90% of 1 RM and slowly (6 s/repetition).; Resistance training for knee extensors. The exercise will be performed at 55% of 1 RM and slowly (6 s/repetition).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Retrospective Review a Comprehensive Case Database of HoLEP Procedure Performed by a Single Surgeon
Condition: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      Persistent detrusor overactivity (DO) after transurethral prostatectomy results in
      symptomatic failure in more than one third of the patients. Storage symptoms are major
      complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate
      (HoLEP). To investigate the effect of DO in the patients with Benign Prostatic Obstruction
      (BPO), the investigators evaluated the changes in the storage symptoms following HoLEP in
      conjunction with the prescription of the anticholinergic drugs.
    

Detailed description: 
      Eighty men with urodynamically proven BPO underwent HoLEP at our hospital. All patients were
      evaluated preoperatively with International Prostate Symptom Score (IPSS), International
      Continence Society male questionnaire short form (ICS-SF), 3-day frequency - volume charts
      (FVC), transrectal ultrasonography, and uroflowmetry with postvoid residual urine volume. The
      patients were divided into two groups; BPO without DO (Non-DO group) and BPO with DO (DO
      group). We assessed the patients postoperatively at 2 weeks, 1, 3 and 6 months after surgery.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients underwent Holmium Laser Enucleation of the Prostate by a single surgeon
      
Keywords: Holmium Laser Enucleation of Prostate
mCVI® Lighting Conditions Clinical Study
Condition: Algorithm Verification
Study type: Observational

Summary: 
      This single center prospective clinical study is to verify the algorithm of mCVI® in 4
      different lighting conditions to accurately capture pulse rate and respiratory rate in 10
      healthy subjects in comparison to commercially-available Masimo pulse oximeter devices. This
      is a non significant risk device.
    

Detailed description: 
      In this prospective clinical study the mCVI® device is a mobile application used to simply
      verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate
      while spontaneously breathing. There is no facial recognition technology. There is no
      immediate feedback given to the research team to act upon or provide for further clinical
      care decisions. In real time, the mCVI® device will be compared to two commercially-available
      Masimo pulse oximeter devices in a single visit.
    

Intervention name(s): There is no intervention
Intervention type(s): Other
Intervention description(s): There is no intervention
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers
Evaluation of Fetal Cardiac Function in Rheumatic Heart Disease (RHD) Patients
Condition: Fetal Distress
MeSH terms: Rheumatic Heart Disease; Heart Diseases; Fetal Distress
Study type: Observational

Summary: 
      The goal of this study is to evaluate fetal myocardial performance in patients with heart
      diseases in comparison to normal pregnant patients.
    

Detailed description: 
      Cardiac diseases affect 1-4% of pregnancies of industrialized countries,and the number of
      patients who develop cardiac problems during pregnancy is increasing.

      Congenital heart diseases, ischemic heart and cardiac arrhythmias are the most dominant
      causes. In developing countries, rheumatic heart disease remains prevalent. Pregnancy induces
      haemodynamic changes with increased intravascular volume which may not only poses a risk of
      maternal death but also of serious morbidity such as heart failure, stroke and cardiac
      arrhythmia.

      The fetus is not spared.Previous reports revealed a significant reduction in fetal growth
      rates associated with maternal heart disease.There is also association with preterm delivery
      and reduced birth weight. The presence of maternal cyanosis and a reduced cardiac output are
      the most significant predictors.

      Accurate and reliable measurement of fetal cardiac function could be valuable for making the
      diagnosis and for fetal surveillanceThe most suitable parameters for assessing fetal cardiac
      function will mainly be determined by the cause of the dysfunction. Abnormal values of
      ejection fraction or cardiac output are usually found in the late stages of deterioration,
      and therefore more sensitive parameters have been proposed for earlier diagnosis and
      monitoring of fetal cardiac dysfunction. In most cases of cardiac dysfunction, diastolic
      parameters (such as DV or IRT) are the first to be altered, reflecting impaired relaxation
      and compliance due to a stiffer or less effective heart. Similarly, parameters reflecting
      longitudinal function (such as annular displacement or velocities) are typically affected in
      the early stages as compared to radial function (such as ejection fraction).

      The goal of this study is to evaluate fetal myocardial performance in patients with heart
      diseases in comparison to normal pregnant patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women with compensated rheumatic heart disease and pregnant women with normal
        pregnancy with the same inclusion/exclusion criteria listed below.

        Inclusion criteria:

          1. Age of the patient: 15-40 years old.

          2. Compensated rheumatic heart disease.

          3. singleton Singleton pregnancy.

          4. Normal placental location.

        Exclusion criteria:

        The patients have hypertension, diabetes or any other medical disorders affecting
        pregnancy.
Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of BI
      655130 in healthy male subjects following IV administration of multiple rising doses. The
      study will also explore safety and tolerability following a single IV administration.
    


Intervention name(s): BI 655130; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
ToleroMune House Dust Mite Follow on Study
Condition: House Dust Mite Allergy; Rhinoconjunctivitis
MeSH terms: Dust Mite Allergy
Study type: Observational

Summary: 
      House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and
      fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is
      associated with poorer lung function, greater medication requirements and more asthma
      symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is
      evidence that HDMA leads to the development of asthma, in addition to exacerbating
      pre-existing asthma in HDM-sensitised patients.

      ToleroMune HDM is currently being developed for the treatment of HDM allergy.

      The Purpose of this optional observational follow-on study is to evaluate the continued
      efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline
      approximately two years after the completion of the baseline EEC visit in TH002 following
      challenge with HDM allergen in an EEC.
    

Detailed description: 
      Subjects who completed all dosing visits and the post treatment challenge (PTC) in study
      TH002 will be invited to attend the Screening visit for TH002a. Subjects will attend for 3
      visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be
      performed 3-10 days later.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects previously randomised in study TH002 and completed all dosing visits and the PTC
      
Keywords: House Dust Mite Allergy; Rhinoconjunctivitis; Environmental Exposure Unit; Immunotherapy; ToleroMune HDM
Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Ovarian Cancer (Cyto-chip 2)
Condition: Peritoneal Carcinoma; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma; Peritoneal Neoplasms
Study type: Observational

Summary: 
      Epithelial ovarian carcinoma (EOC) is one of the main cause of death from cancer in women in
      the Western world. It is often diagnosed at an advanced stage and the disease remains
      confined to the peritoneal cavity for much of its natural history. Despite a high rate of
      response to first-line therapy, about 20% of EOC are naturally resistant to platinum and
      about 2/3 of patients with initial response will recur within 5 years. Most tumour
      recurrences will develop resistance to systemic platinum over time. The prognosis of these
      patients with persistent or recurrence disease remains poor despite salvage therapy including
      alternative systemic chemotherapy and further cytoreductive surgery (CRS). Since twenty
      years, centers have pursued comprehensive CRS combined with Hyperthermic Intraperitoneal
      Chemotherapy (HIPEC) for the management of peritoneal surface malignancies (PSM). This
      combined approach is the standard of care for the management of some rare peritoneal disease
      such as pseudomyxoma peritonei or peritoneal mesothelioma. EOC should be an ideal target for
      this loco-regional treatment, as most of its evolution remains confined to intraperitoneal
      cavity and because of its sensitivity to chemotherapy. Intraperitoneal chemotherapy has been
      shown to have significant efficacy in frontline EOC in 3 large randomized studies. Recently,
      French clinical guidelines have been edited to recommend CRS+HIPEC in patients with ovarian,
      tubal or primitive carcinomatosis FIGOI IIIC, initially not resectable (Grade B). HIPEC adds
      some advantages to this intraperitoneal chemotherapy: the hyperthermia effect with its direct
      cytotoxicity demonstrated in vitro, the synergistic effect with some anticancer agents and,
      the deliverance immediately following CRS, avoiding the problem of "cancer cell entrapment"
      by postoperative or posttherapeutic adhesions that limits distribution of chemotherapy agents
      to all sites. The use of HIPEC for EOC was reported into relatively small case-series from
      single institutions. Results from a single centre cannot be extrapolated to other centres
      because of the heterogeneity of patient's selection and HIPEC techniques.
    


Intervention name(s): Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Intervention type(s): Procedure
Intervention description(s): Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
Other intervention name(s): Cytoreductive surgery alone
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ovarian peritoneal metastases.
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics including dose proportionality, and
      pharmacodynamics of BI 187004 CL within a predefined dose range
    


Intervention name(s): Placebo to BI 187004 CL; BI 187004 CL
Intervention type(s): Drug; Drug
Intervention description(s): 1 single dose per subject as oral solution; 1 single dose per subject as oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A RCT of CenteringPregnancy on Birth Outcomes
Condition: Pregnancy; Preterm Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether CenteringPregnancy group prenatal care can
      improve preterm birth rate and other birth outcomes, maternal psychosocial and behavioral
      outcomes, and decrease the racial difference in selected birth outcomes among African
      American and White women, compared to individual prenatal care.
    

Detailed description: 
      This is a randomized controlled trial to compare biomedical, behavioral and psychosocial
      outcomes by race among pregnant women who participate in CenteringPregnancy group prenatal
      care, to women in the traditional individual prenatal care and to investigate whether
      improving women's stress, activation and engagement will explain the potential benefits of
      CenteringPregnancy on outcomes and health disparities. The trial will be conducted in a large
      prenatal care center in South Carolina. Eligible White and Black women will be recruited
      before 20 weeks of gestational age with low risk pregnancy.
    

Intervention name(s): CenteringPregnancy
Intervention type(s): Behavioral
Intervention description(s): 8-12 pregnant women whose due dates are in the same month will receive ten 2-hour group prenatal care sessions according to the standard curriculum provided by the Centering Healthcare Institute.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Racial disparities
Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
Condition: Hypercholesterolemia; Hypertriglyceridemia
MeSH terms: Hypercholesterolemia; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and
      other lipid levels in patients with low HDL-C
    


Intervention name(s): Gemcabene 150 mg; Gemcabene 300 mg; Gemcabene 600 mg; Gemcabene 900 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Blinded capsules and tablets, 150 mg, once daily, 84 days; Blinded capsules and tablets, 300 mg, once daily, 84 days; Blinded capsules and tablets, 600 mg, once daily, 84 days; Blinded capsules and tablets, 900 mg, once daily, 84 days; Blinded capsule and tablets, once daily, 84 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lipid Regulator; TG
Randomized Trial of Psychotherapy for Persistently Depressed Primary Care Patients
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study. The purpose of this study is to determine whether adding 4 months of
      behavioral therapy to primary care physician medication treatment(relative to medication
      treatment alone) improves outcomes for persistently depressed primary care patients.
    


Intervention name(s): behavior therapy; Medication prescribed by PCP
Intervention type(s): Behavioral; Drug
Intervention description(s): 10 sessions over 4 months; Can include any antidepressant medication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depression; Primary care
DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
Condition: Diabetic Foot Ulcer; Lower Extremity Wound
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes
      of DermACELL AWM in dermal regeneration.
    

Detailed description: 
      This clinical evaluation with DermACELL AWM will explore its use in the treatment of complex
      soft tissue defects involving muscle, fascia, tendon, or bone exposure (Wagner Classification
      3 and 4).

      A total of 50 subjects will be treated with DermACELL AWM in the operating room for coverage
      of deep soft tissue defects in the lower extremity. Subjects will then be followed in the
      outpatient clinic for up to 16 weeks.

      The specific aim of the study is to assess the ability of the product to sustain an optimal
      dermal layer. The time (days) required for wound bed preparation (granular bed after
      placement of DermACELL AWM) and safety data will be collected.
    

Intervention name(s): DermACELL AWM
Intervention type(s): Other
Intervention description(s): Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology
Intervention model: Single Group Assignment
Intervention model description: Prospective, multicenter post market product evaluation of study product for deep wounds of the lower extremity
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic Foot Ulcer; DFU; Lower Extremity Wound; Skin Substitute