bioihbjkbjnl/mcl2 huggingface dataset:
AZD9291 First Time In Patients Ascending Dose Study
Condition: Advanced Non Small Cell Lung Cancer; Advanced (Inoperable) Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will treat patients with advanced NSCLC who have already received at least one
      course of specific anti-cancer treatment but the tumour has started to re-grow following that
      treatment. This is the first time this drug has ever been tested in patients, and so it will
      help to understand what type of side effects may occur with the drug treatment, it will
      measure the levels of drug in the body, it will also measure the anti-cancer activity. By
      using these pieces of information together the best dose of this drug to use in further
      clinical trials will be selected.
    

Detailed description: 
      A Phase I/II, Open-Label, Multicentre Study to Assess the Safety, Tolerability,
      Pharmacokinetics and Anti-tumour Activity of Ascending Doses of AZD9291 in Patients with
      Advanced Non Small Cell Lung Cancer who have Progressed Following Prior Therapy with an
      Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent (AURA)
    

Intervention name(s): AZD9291
Intervention type(s): Drug
Intervention description(s): Starting dose 20 mg, administered once daily. If tolerated subsequent cohorts will test increasing doses of AZD9291, until a maximum tolerated dose or maximum feasible dose is defined
Intervention MeSH terms: Osimertinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oncology,; Non Small Cell Lung Cancer,; Metastatic,; EGFR sensitivity mutation,; T790M resistance mutation
Clinical Trial With Catheter Locking TauroSept® (Taurolidine 2%) or Saline Solution 0,9%
Condition: Catheter Related Blood Stream Infections
MeSH terms: Infections; Sepsis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient than
      saline solution 0.9% as a catheter lock solution in preventing catheter related blood stream
      infections in patients with home parenteral nutrition.
    

Detailed description: 
      Home Parenteral Nutrition has become a mainstay in the support of patients with chronic
      intestinal failure. It requires the presence of a central venous catheter to assure adequate
      venous access. Catheter Related BloodStream Infections (CRBSIs) are frequent. Most CRBSIs
      originate from contamination of the catheter hub and subsequent growth of microorganisms
      embedded within the biofilm that rapidly develops on the inner catheter surface. The best
      preventive measure against the development of CRBSIs is observation of strict hygiene
      guidelines when inserting and manipulating a central venous catheter and in addition to this
      the instillation of antimicrobial solutions like TauroSept® or saline solution 0.9% into the
      catheter lumen (antimicrobial lock). This measure is currently widely used in clinical
      practice.
    

Intervention name(s): TauroSept®
Intervention type(s): Device
Intervention description(s): 5 ml of TauroSept® will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily.
The duration of TauroSept® administration in this trial will be 12 months.
Other intervention name(s): Taurolidine 2%
Intervention MeSH terms: Taurolidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Decision Aids Upper and Lower Extremity
Condition: Upper Extremity Dysfunction; Lower Extremity Problem
Study type: Interventional

Summary: 
      This study aims to assess differences in choice of treatment (and the rationale behind it),
      physical function, pain intensity, satisfaction, and decision regret between orthopedic
      patients who review a decision aid during their visit and those that do not. Decision aids
      for 23 different conditions are included.
    

Detailed description: 
      Patients visiting an orthopeadic surgeon in one of our 4 affiliated offices in a large urban
      area in the United States are invited to participate over a 4 month period. All
      English-speaking patients, between 18 and 89 years old, visiting an orthopeadic surgeon with
      a new problem, for which either invasive or non-invasive treatment is possible and a DA is
      available are asked to participate in this study. Exclusion criteria are non-English speakers
      or a clear preference for a treatment option by surgeon or patient. Patients will be randomly
      assigned to either the intervention or the control group in a 1:1 ratio using an Excel random
      number generator. Patients in the intervention group go over the DA during the visit, once
      the surgeon has identified the diagnosis. After the diagnosis is set, the surgeon steps out
      of the visit and steps back in when the patients has reviewed the DA. The surgeon and the
      patient go over the treatment options and a decision will be made. After the visit, all
      patients, both in the intervention and control group, are asked to fill out a survey. Two
      weeks after enrollment a research assistant calls all patients for a follow up questionnaire.
    

Intervention name(s): Decision aid
Intervention type(s): Other
Intervention description(s): The decision aids aim to inform the patients about the diagnosis and the treatment options. They aim to help the patient prioritize and make an informed decision.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized in an intervention group that reviews a decision aid and a control group that does not.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Decision aids
A Weight Loss Trial for Emotional Eating
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a new weight loss treatment which
      incorporates behavioral weight loss skills and skills for learning how to identify, manage,
      and cope with emotions helps with weight loss and emotional eating in people who are
      overweight and eat in response to emotions.
    


Intervention name(s): Behavioral Weight Loss; Enhanced Behavioral Weight Loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly group meetings addressing behavioral weight loss skills including calorie counting, exercise, behavior modification, environmental changes, and coping with triggers.; Weekly group meetings that combine behavioral weight loss skills (calorie counting, exercise, behavior modification, environmental changes) with skills to decrease emotional eating by learning ways to manage and cope with emotions without eating.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Intranasal Oxytocin on Cigarette Smoking
Condition: Nicotine Dependence; Tobacco Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Socioemotional processing dysfunctions (i.e., disruptions in affective, cognitive, and neural
      processes that encode, interpret, and respond to socially and emotionally relevant stimuli)
      have been implicated in tobacco smoking and relapse, however this potential target for
      medication development has not been systematically examined. Evidence from animal and human
      laboratories indicate that administration of intranasal oxytocin enhances socioemotional
      processing and may be efficacious for the treatment of drug addiction, including nicotine
      dependence. In order to evaluate the potential efficacy of intranasal oxytocin for smoking
      cessation, this laboratory-based proposal will examine whether intranasal oxytocin attenuates
      smoking lapse, nicotine withdrawal, and socioemotional processing disruptions in regular
      smokers following overnight abstinence.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Pitocin; Ocean Spray saline spray
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Role of Cervical Consistency Index and Uterocervical Angles in Medical Termination
Condition: Second Trimester Abortion; Uterocervical Angle; Cervical Consistency Index
Study type: Observational [Patient Registry]

Summary: 
      The main aim of the investigator study is the success of predictivity cervical consistency
      index (CCI), anterior uterocervical angle (aUCA) and posterior uterocervical angle (pUCA) in
      second trimester terminations.
    

Detailed description: 
      This prospective clinical study includes 136 pregnant women with a diagnosis of in utero ex
      fetus who were hospitalized for medical termination in the gynecology service of Health
      Sciences University Bursa High Specialization Training and Research Hospital Gynecology and
      Obstetrics Clinic as a single center. The participants were divided into 2 groups as those
      whose treatment was completed in the first 24 hours (who were completely aborted and removed
      the fetal material and its attachments ) and those who aborted within 24-48 hours when
      additional cycles were needed. Furthermore who applied to additional treatment methods were
      recorded (cervical balloon, hysterotomy ) during these periods. In all pregnant women;
      characteristic features, abortion times, doses of misoprostol used, anterior- posterior
      uterocervical angle, cervical length, cervical consistency indexes and gestational weeks were
      saved.
    

Intervention name(s): abortus within 24 hours or 24-48 hours
Intervention type(s): Other
Intervention description(s): second trimester medical termination
Other intervention name(s): misoprostol
Intervention MeSH terms: Misoprostol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        white people same demographics no socio- cultural difference
      
Keywords: medical termination; uterocervical angle; abortion; second trimester
A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of single dose intravenous rifampin on
      the single-dose PK of orally administered TAK-906.
    

Detailed description: 
      The drug being tested in this study is called TAK-906. TAK-906 is being tested to evaluate
      the effect of single dose intravenous rifampin on the single-dose PK of oral TAK-906 in
      healthy adult participants.

      The study will enroll approximately 12 participants. Participants will be randomly assigned
      to one of the two treatment sequences AB or BA:

        -  Sequence AB: TAK-906 25 mg, followed by a washout period of at least 7 days, then
           Rifampin 600 mg and TAK-906 25 mg

        -  Sequence BA: Rifampin 600 mg and TAK-906 25 mg, followed by a washout period of at least
           7 days, then TAK-906 25 mg

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is 49 Days. All participants will make final visit 14 days after
      receiving their last dose of study drug for follow up assessment.
    

Intervention name(s): TAK-906; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): TAK-906 capsule.; Rifampin infusion.
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Study of UB-312 in Healthy Participants and Parkinson's Disease Patients
Condition: Parkinson's Disease; Parkinsonism
MeSH terms: Parkinson Disease; Parkinsonian Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 44-week, randomized, placebo-controlled, double-blind, single-center, phase 1
      clinical trial consisting of a dose-escalation Part A study in healthy participants, followed
      by a Part B in participants with Parkinson's disease with a selected doses from Part A.
    

Detailed description: 
      This is a first-in-human Phase 1 study to determine the safety, tolerability, and
      immunogenicity of UB-312 in healthy participants and in participants with Parkinson's disease
      (PD). UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine and may provide an active
      immunotherapy option for treating synucleinopathies including the most prevalent form, PD.

      The study consists of two parts. Part A of the study with healthy participants will consist
      of dose escalation and cohort staggering for up to seven planned dose levels or placebo. Part
      B of the study will consist of two cohorts of participants with Parkinson's disease (PD).
      Dosing for Part B will be based on safety, tolerability and immunogenicity from Part A. All
      eligible participants will be enrolled in a 44-week study consisting of 20 weeks of treatment
      and 24 weeks of follow-up.
    

Intervention name(s): UB-312; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): A synthetic peptide-based vaccine; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mood Management Phone Counseling in Smoking Cessation
Condition: Cigarette Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      Information obtained from this study will help us to have a better idea of how phone
      counseling may facilitate the process of quitting smoking for individuals with a history of
      recurrent depression.
    

Detailed description: 
      Adult smokers with a history of recurrent major depression (MDD) report higher levels of
      depressive symptoms when presenting for smoking cessation treatment and have poor smoking
      outcomes relative to other smokers. Carefully conducted clinical trials have supported the
      efficacy of cognitive-behavioral mood management treatment for depression in improving
      smoking cessation outcomes in this high-risk group. Although efficacious, these intensive
      group treatments require significant resources and thus may have limited impact outside of
      specialized smoking cessation programs. In the present study we will develop and obtain
      preliminary data on the efficacy of proactive telephone counseling for smoking cessation that
      integrates cognitive-behavioral mood management skills training for depression (MM). Smokers
      with a history of recurrent MDD will be randomly assigned to the proactive telephone
      counseling for smoking cessation with mood management (MM) or a standard proactive telephone
      counseling (ST) comparison condition. We expect that this program of research will result in
      the development of a specialized, efficacious treatment with broad reach into a significant
      subpopulation of smokers at greatest risk for difficulties quitting, and will therefore have
      important clinical and public health significance in decreasing the overall prevalence of
      cigarette smoking.
    

Intervention name(s): Mood Management Phone Counseling for Smoking Cessation
Intervention type(s): Behavioral
Intervention description(s): Phone counseling addressed mood management and smoking cessation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Phone Counseling
Pelvic Floor Contraction in Different Positions Among Women With and Without Stress Urinary Incontinence
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Observational [Patient Registry]

Summary: 
      Examination of pelvic floor contraction in different positions among women with and without
      stress urinary incontinence (SUI) will be conducted via diagnostic ultrasound. This will
      enable clinicians and researchers to establish an appropriate protocol for pelvic floor
      muscle examination and treatment.
    

Detailed description: 
      The main goal of this study is to compare the ability of the pelvic floor muscles to contract
      in different positions among women suffering from SUI to healthy women. Secondary objectives:
      is to compare subjective reports of the difficulty to contract the pelvic floor muscles
      between the two groups, and to examine the connection between the severity of urinary leakage
      and the ability to contract pelvic floor muscles.

      The study will include 50 female participants in the ages of 18-45. Research group will
      include 25 participants suffering from SUI in accordance with the International Consultation
      on Incontinence Questionnaire Short Form (ICIQ-SF) and 25 healthy participants (grade 0 on
      the ICIQ-SF questionnaire).

      The examination will be performed with an abdominal ultrasound device in supine, sitting,
      standing and squatting. The Height of the bladder base will be measured during rest period
      and maximal contraction. The extent and direction of bladder base movement would indicate the
      quality of pelvic floor performance. Next, the length of contraction time will be measured.
      The participant would hold the maximal contraction as long as possible in order to examine
      muscular endurance. Rest will be given between tests. After finishing the tests in all four
      postures, the participants will be questioned about the degree of difficulty contracting the
      pelvic floor.

      Significance of the study: The importance of the research is about granting the clinicians
      and researchers additional tools in order to help establishing a protocol for pelvic floor
      muscle activity examination and treatment.
    

Intervention name(s): ultrasound examination
Intervention type(s): Diagnostic Test
Intervention description(s): ultrasound examination of pelvic floor muscle will be conducted. In addition questionnaires regarding demographic characteristics and SUI will be performed.
Other intervention name(s): transabdominal ultrasound assessment
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Women, between ages 18-45 with and without USI.
A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos)
Condition: COPD
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort®
      Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
    

Detailed description: 
      A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to
      Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort®
      Turbuhaler® as an Active Control in Subjects with Moderate to Very Severe Chronic Obstructive
      Pulmonary Disease

      This study includes the following 3 sub-studies: 12-hour Pulmonary Function Test (PFT),
      Pharmacokinetic (PK) Profile, and Hypothalamic-pituitary-adrenal Axis.
    

Intervention name(s): BGF MDI 320/14.4/9.6 μg; GFF MDI (PT003) 14.4/9.6 μg; BFF MDI (PT009) 320/9.6 μg; Symbicort® Turbuhaler® (TBH) Inhalation Powder
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI]); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI); Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
Other intervention name(s): BGF; GFF; BFF
Intervention MeSH terms: Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study With Heptral in Subjects With Liver Disease Due to Alcohol Consumption
Condition: Intrahepatic Cholestasis Associated With Alcoholic Liver Disease
MeSH terms: Liver Diseases; Cholestasis; Liver Diseases, Alcoholic; Cholestasis, Intrahepatic
Study type: Interventional
Phase: Phase 3

Summary: 
      A research study of an approved drug called Heptral®, ademetionine, to treat adults with
      intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum)
      in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with
      liver disease has shown that ademetionine is effective.
    


Intervention name(s): Ademetionine IV+tablet; Ademetionine tablet
Intervention type(s): Drug; Drug
Intervention description(s): IV ademetionine (500 mg/vial) for 2 weeks followed by oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 6 weeks; oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 8 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intrahepatic Cholestasis