bioihbjkbjnl/mcl2 huggingface dataset:
Morbidity After Diagnosis and Treatment of Breast Cancer Patients
Condition: Breast Cancer; Shoulder; Lymphedema; Fatigue
MeSH terms: Breast Neoplasms; Lymphedema
Study type: Observational

Summary: 
      This study will examine the frequency and severity of problems in women with breast cancer
      for 2 years following initial medical treatment, including:

        -  Physical impairments, such as loss of strength or flexibility, increased weight and
           swelling.

        -  Symptom distress, such as pain, fatigue and weakness.

        -  Functional limitations and disabilities, such as loss of independence in activities of
           daily living (e.g., grooming, bathing, dressing, driving a car), work and social and
           recreational activities.

      It will identify factors associated with these problems and try to determine their
      relationship to them.

      Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible
      for this study. Women who have a breast biopsy negative for cancer will also be enrolled as
      control subjects. Participants will be drawn from patients referred to the National Naval
      Medical Center for diagnosis and treatment during 2001-2003.

      Participants will be evaluated over a 2-year period during an initial baseline visit (before
      medical treatment or biopsy) and follow-up visits at 1, 3, 6, 12, 18 and 24 months following
      procedures:

        -  Interview about past medical history and present illness, social and recreational
           activities, functional independence at work and during activities of daily living.

        -  Completion of questionnaires including health survey, upper limb disability
           questionnaire, and physical activity questionnaire. (Questionnaires are completed only
           at baseline and 12 and 24 months after medical treatment begins.) The questionnaires
           take about 30 to 40 minutes to complete.

        -  Upper body examination, including pain measurement using a 10-point scale, active and
           passive range of motion measures, manual muscle testing measures using a 10-point scale,
           timed upper limb lift test, and measures of upper limb volume and girth.
    

Detailed description: 
      Patients and healthy participants will undergo an interview at the beginning of the study and
      1,3,6,9, 12, 18 and 24 months and answer questions about their medical history; family
      history; current problem and treatment; pain history; and social, physical and recreational
      activities. At the visit, they will also undergo an upper body physical exam by a physical
      therapist. Patients and the healthy participants will also fill out questionnaires about arm
      disability, quality of life, and physical activity at the beginning of the study and at 12,
      18, and 24 months.
    

Observational model: Cohort
Time perspective: Prospective
Keywords: Shoulder; Breast Cancer; Physical Therapy; Lymphedema; Quality of Life; Breast Cancer Surgery; Healthy Volunteer; HV; Normal Control
An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study was to investigate the mortality and macrovascular morbidity as
      well as the incidence of malignancies over time, in high-risk diabetic participants who
      previously received long-term treatment with either pioglitazone or placebo in combination
      with their usual medication for glycaemic management.
    

Detailed description: 
      This was a European,multicenter,observational study of participants who were previously
      treated with pioglitazone or placebo in addition to their existing anti diabetic medication.
      This 10-year observational study was conducted as a follow-up of PROactive study
      (NCT00174993) to investigate the CV and macrovascular effects observed with pioglitazone over
      time during PROactive.In this study,high risk T2DM patients previously enrolled in PROactive
      were analyzed for long-term incidence,nature, and pattern of all malignancies in pioglitazone
      and placebo-treated groups.This study enrolled 3599 participants.No treatment was prescribed
      by this protocol and participants will be managed in accordance with normal medical
      practice.The planned total duration of the study was 10 years,with data being analyzed and
      reported every 2 years.Participants were assessed at nominal visits every 6 months and every
      effort was made to obtain as much of the required information as possible.
    

Intervention name(s): No Intervention; No Intervention
Intervention type(s): Other; Other
Intervention description(s): Participants who previously received Pioglitazone in the PROactive study (NCT00174993).; Participants who previously received pioglitazone-matching placebo in the PROactive study (NCT00174993).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        High-risk T2DM participants previously treated with pioglitazone and placebo in PROactive
        study (NCT00174993) were included in this study.
      
Keywords: Drug Therapy
Evaluation of the Use of Various Assessments of Common Cold Symptoms for Proof of Efficacy of ColdZyme Mouth Spray
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      This study evaluates the use of various assessments of common cold symptoms for proof of
      efficacy of ColdZyme Mouth Spray on naturally acquired common colds. Half of the participants
      will receive ColdZyme® Mouth Spray while the other half may use optional care as needed.
    


Intervention name(s): ColdZyme
Intervention type(s): Device
Intervention description(s): ColdZyme® Mouth Spray is a CE-marked medical device with the following composition: glycerol, water, cod trypsin, ethanol (<1 %), calcium chloride, trometamol and menthol.
ColdZyme® Mouth Spray consists of a 20 ml bottle, pump, spray nozzle and protective cap.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics, Immunogenicity, Safety and Tolerability of MEDI3506 in Health Chinese Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the pharmacokinetics, immunogenicity, safety and tolerability of
      investigational drug MEDI3506 with single dose in Healthy Chinese participants.
    

Detailed description: 
      A phase I, randomised, double-blind, placebo-controlled parallel-group study to evaluate the
      pharmacokinetics, immunogenicity, safety, and tolerability of single dose of MEDI3506 in
      healthy Chinese Participants
    

Intervention name(s): MEDI3506; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): MEDI3506; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: MEDI3506; Healthy Volunteers
Cabergoline in Nonfunctioning Pituitary Adenomas
Condition: Pituitary Adenoma; Nonfunctioning Pituitary Adenoma
MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinically nonfunctioning pituitary adenoma remains the only pituitary tumor subtype for
      which no effective medical therapy is available or recommended. We will evaluate the use of
      cabergoline in a clinical trial, in order to define the efficacy of this treatment in
      nonfunctioning pituitary adenoma.
    

Detailed description: 
      Nonfunctioning pituitary adenomas (NFPA) are common tumors of sellar region characterized by
      the absence of clinically hormonal pituitary secretion. These adenomas are typically not
      diagnosed until they become very large and cause compressive neurologic symptons (e.g. visual
      impairment or cranial nerve palsy). Most of them are able to synthesized gonadotropins but
      not secreted it.

      Transsphenoidal surgical resection is the first-choice therapy in NFPA. However, complete
      removal is difficult and tumor rest is very common. In these cases, the pragmatic use of
      radiotherapy is effective to reduce residual tumor growth or recurrence, but it is related
      with severe side effects. Another possibility is the clinical observation, or wait-to-see
      approach, but it is associated with tumor progression: 40% in 5-10 years. The efficacy of
      some medical treatment are not defined yet.

      Since the identification of dopaminergic and somatostatinergic receptors in NFPA, the
      pharmacological treatment of the NFPA has been considered as a possibility for treatment. To
      date, clinical use of dopamine agonist (DA) in NFPA patients has been evaluated in some
      studies. However, these studies present modest and inconclusive results and the DA role in
      the NPFA management remains undefined.

      In this study, the investigators plan a clinical trial designed to investigate the efficacy
      of cabergoline in NFPA individuals with remaining tumor after primary neurosurgery. These
      results could help to define the efficacy of DA in NFPA management.
    

Intervention name(s): Cabergoline
Intervention type(s): Drug
Other intervention name(s): dostinex
Intervention MeSH terms: Cabergoline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Single Center, Open Label and Randomized Clinical Trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pituitary Adenoma; Dopaminergic Agonist; Nonfunctioning Pituitary Adenoma; Cabergoline
Effects of Ground Level Gait Training With Body Weight Support (BWS) and Functional Electrical Stimulation (FES)
Condition: Hemiparesis; Stroke
MeSH terms: Paresis; Body Weight
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of gait training on ground level,
      combining BWS and FES in people following chronic stroke.
    

Detailed description: 
      The body weight support system (BWS) associated to a treadmill as well as to a functional
      electrical stimulation (FES) of the common peroneal nerve, has been proposed as a strategy
      for gait training in people following stroke. Moreover, it has also considered that the
      ground level is the most common locomotion surface, and that there is little information
      about the effects of gait training, on this kind of surface, in people with hemiparesis.
    

Intervention name(s): gait training on ground level using BWS; gait training on ground level using BWS associated to FES
Intervention type(s): Device; Device
Intervention description(s): An A1-B-A2 system was applied in which A1 and A2 corresponded to gait training on ground level using Body Weight Support (BWS). Each training phase was performed during 45 minutes, three times a week, for six weeks.; An A1-B-A2 system was applied in which B corresponded to the training associated to Functional Electrical Stimulation. Each training phase was performed during 45 minutes, three times a week, for six weeks.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kinematic; hemiparesis; gait; Body weight support; Functional electrical stimulation
Competitive Carriage of Neisseria Spp(Lactamica 2)
Condition: Neisseria Lactamica
Study type: Interventional

Summary: 
      In the future it is likely that we will replace the current schedule of injected vaccines
      with interventions that interrupt transmission of infections in more subtle ways. The agent
      that causes meningococcal disease (Neisseria meningitidis) colonises the nasopharynx of
      individuals. In most people, the bacterium is harmless and survives for months in the
      nasopharynx, however in a minority of people the bacteria can cause invasive disease.

      Simply reducing colonisation amongst target groups may protect them, and the rest of the
      population as well. In a previous study we investigated cross protective antibodies, and
      found incidentally that inoculating adult volunteers with Neisseria lactamica, a harmless
      'cousin' of N. meningitidis, possibly prevents N. meningitidis carriage. If true this could
      lead to novel mechanisms of reducing colonisation in targeted groups, possibly in the form of
      a nasal medication. The proposed study large experimental challenge study funded by
      Meningitis UK that will aim to establish if N. lactamica does or does not inhibit
      colonisation by N. meningitidis. We will also determine whether N. lactamica displaces
      existing N. meningitidis carriage, and whether there are individuals who are innately
      resistant to any Neisseria carriage. The study will recruit 300 volunteers between the ages
      of 1830yrs from the two universities in Sheffield. It will involve placing droplets of
      N.lactamica bacteria into the nose of half our group of volunteers, and a harmless water like
      solution into the nose of the other half of volunteers. We will carry out nose swabs at
      intervals over a six month period to establish if the pattern of N.meningitidis carriage is
      effected by N.lactamica colonisation. If the findings are positive we will perform future
      mechanistic investigations. A62.
    


Intervention name(s): lactamica; Placebo
Intervention type(s): Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating
Condition: Smoking; Binge Eating; Behavior
MeSH terms: Bulimia; Binge-Eating Disorder
Study type: Interventional

Summary: 
      This study will evaluate the extent to which we can engage and manipulate putative targets
      within the self-regulation domain within and outside of laboratory settings in samples of
      smokers and overweight/obese individuals with binge eating disorder. This is the fourth phase
      of a study that aims to identify putative mechanisms of behavior change to develop an
      overarching "ontology" of self-regulatory processes.
    


Intervention name(s): Laddr
Intervention type(s): Behavioral
Intervention description(s): Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not "diagnosis-specific" but rather enables integrated care for any combination of individuals' goals, needs, and preferences.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate the Pharmacokinetics of AFQ056 in Subjects With Hepatic Impairment Compared to Healthy Subjects
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics of AFQ056 in subjects with mild, moderate, severe
      hepatic impairment compared with healthy control subjects.
    


Intervention name(s): AFQ056
Intervention type(s): Drug
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: AFQ056; Hepatic impairment; Hepatic impaired
DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS
Condition: Popliteal Artery Stenosis; Atheroma
MeSH terms: Plaque, Atherosclerotic
Study type: Observational

Summary: 
      The purpose of this study was to compare the results of directional atherectomy with
      antirestenotic therapy (DAART technique) and angioplasty/Supera stenting for the treatment of
      popliteal atherectomy lesions.
    

Detailed description: 
      Atherectomy offers a way to improve the chances to avoid stent placement, although it did not
      show superiority in terms of vessel patency or limb salvage compared with POBA. Nevertheless,
      atherectomy can modify the plaque morphology and the mechanical properties of the baseline
      disease, which allows better drug penetration and diffusion into the vessel wall.

      Moreover, the combination of directional atherectomy devices and drug coated balloons
      (directional atherectomy with antirestenotic therapy, DAART), theoretically might further
      improve the clinical outcomes of drug coated angioplasty. The "leave nothing behind"
      strategies have gained support among interventionalist. Many studies claim that atherectomy
      improves results when combined with adjunctive DCB.

      The Supera stent, when compared with other self-expanding nitinol stents, has proven to
      deforms less with knee flexion and exhibits less strain. It mimics the natura structure and
      movement of the anatomy and optimizes luminal gain maintaining a round open lumen in
      challenging anatomies, as the popliteal artery. Mechanical scaffolding is often required
      owing to elastic recoil and flow-limiting dissections in complex popliteal lesions.

      The purpose to this study was to retrospectively evaluate the efficacy of both techniques for
      endovascular treatment of atherosclerotic lesions of the popliteal artery.
    

Intervention name(s): DAART; ATP/Supera stenting
Intervention type(s): Device; Device
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with lifestyle limiting intermittent claudication, ischemic rest pain, ischemic
        ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the
        popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at
        least a 12-months of follow-up
      
Keywords: Popliteal artery; Drug-coated balloon; Supera stent; Directional atherectomy
Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioavailability, safety, tolerability and
      pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended
      in liquid.
    

Detailed description: 
      A single-dose, three period, complete cross-over study to evaluate the relative
      bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet
      formulations of ABT-072 when compared to that of the original capsule formulation suspended
      in liquid as a reference.
    

Intervention name(s): ABT-072
Intervention type(s): Drug
Intervention description(s): See arm description for more information
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Phase 1; Bioavailability
Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients
Condition: Gastric Adenocarcinoma
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Gastric cancer have poor prognosis and majority of patients resistant to 5-FU/DDP based
      first-line chemotherapy in China. There was no recommended second-line chemotherapy for
      advanced gastric cancer. Taxane is promising in gastric cancer. Nanoparticle Albumin-Bound
      Paclitaxel (Abraxane，ABI-007) has good convenience to use and been approved in breast cancer
      in many countries. The investigator then initiated a prospective phase Ib/IIa clinical trial
      with nab-paclitaxel plus TS-1 as the second-line treatment in advanced gastric cancer to
      observe the safety and efficacy.
    

Detailed description: 
      This study is a two-stage design. Stage 1

      The investigator should evaluate two recommend dose and tolerability of nab-paclitaxel plus
      S-1 after one course of treatment as 3+1 design:

      nab-paclitaxel should be given intravenously on days 1 and 8 at a dose as follows, Treatment
      should be repeated every 3 weeks: Treatment arm A：125 mg /m2; Treatment arm B：100 mg /m2;
      Treatment arm C: 80 mg /m2; S-1 should be given orally twice a day as follows for 14
      consecutive days, followed by a 1-week rest. Treatment should be repeated every 3 weeks. BSA
      < 1.5 m2，40mg，bid;BSA ≥ 1.5 m2，50mg，bid.

      The investigator should determine whether to continue the original regimen; compare the
      safety and pharmacokinetic results with original profile of combination therapy to select the
      best therapy programs (RD, recommended dose).

      Stage 2 According to two-stage design (Simon,1989), re-entry subjects to the recommended dose
      group to a total of 25 valid cases. If 11 patients achieve response, then enter the second
      phase of total 66 patients.
    

Intervention name(s): Nanoparticle Albumin-Bound Paclitaxel
Intervention type(s): Drug
Intervention description(s): this study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced; resistant to prior chemotherapy
To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste
Condition: Oral Hygiene
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study will be to compare the Gingival Bleeding and Gingival
      Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice
      compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be
      conducted at Silverstone Research Group. Participants will be recruited from their database
      and by use of an external recruitment agency.
    


Intervention name(s): Sodium bicarbonate plus sodium fluoride; Sodium fluoride
Intervention type(s): Drug; Drug
Intervention description(s): Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride; Toothpaste containing 1100 ppm fluoride as sodium fluoride
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment