bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
Condition: Complicated Urinary Tract Infection
MeSH terms: Infections; Urinary Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the
      treatment of complicated urinary tract infections as compared to a comparator group.
    


Intervention name(s): NXL104/ceftazidime; Imipenem/Cilastatin
Intervention type(s): Drug; Drug
Intervention description(s): 125mg/500mg TID; 4 x daily
Intervention MeSH terms: Imipenem; Ceftazidime; Avibactam; Cilastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic
      (PD) profiles to determine the safety and tolerability of single and multiple doses of
      pantoprazole in infants aged 1 through 11 months.
    


Intervention name(s): pantoprazole sodium enteric-coated spheroid suspension
Intervention type(s): Drug
Intervention description(s): pediatric suspension taken daily x 7 days
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GERD; Infant
Clinical Evaluation of the VIPUN Balloon Catheter 0.1
Condition: Healthy; Motility Disorder; Gastric Emptying
Study type: Interventional

Summary: 
      The primary aim of this investigation is to assess the safety, feasibility and performance of
      the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will
      also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric
      motility and emptying. Furthermore, this investigation will examine whether gastric motility
      and emptying as measured in this study are correlated.
    


Intervention name(s): VIPUN Balloon Catheter 0.1 deflated; Codeine Phosphate; Placebo; VIPUN Balloon Catheter 0.1 inflated
Intervention type(s): Device; Drug; Drug; Device
Intervention description(s): deflation balloon; 58.8 mg codeïne phosphate; Sirupus Simplex; VIPUN Balloon Catheter 0.1 inflated
Intervention MeSH terms: Codeine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A single-blinded, monocenter, randomized crossover investigation in healthy volunteers.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
PillCam Colon Capsule Endoscopy for Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The
      aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate
      patients with ulcerative colitis and reach high consistency to conventional colonoscopy.
    

Detailed description: 
      Symptomatic patients with confirmed ulcerative colitis (UC) were enrolled in this prospective
      single-center study. No sooner had patients gone through Pillcam colon capsule (PCC)
      endoscopy solution than they got conventional colonoscopy which is recognized as the "gold
      standard" examination technique. The extent of mucosal damage and inflammatory lesions during
      both modalities were recorded for comparison. In addition, the regimen of bowel preparation,
      completion rate, colonic cleanliness, compliance or adverse events were analyzed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        academic hospital endoscopist of digestive department
      
Biospecimen description: 
      regular biopsy was taken during conventional colonoscopy according to the activity and
      position of ulcerative colitis involved.
    
Keywords: Pillcam colon capsule endoscopy; conventional colonoscopy; ulcerative colitis; endoscopic manifestation; colonoscopy
A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate whether, after two 8-week treatment
      periods, male patients with erectile dysfunction (ED) in China prefer 20 milligram (mg)
      tadalafil or 100 mg sildenafil. This trial consists of two treatment periods of 8 weeks each
      and an extension phase of 8 weeks, for a total of 24 weeks.
    


Intervention name(s): Tadalafil; Sildenafil
Intervention type(s): Drug; Drug
Intervention description(s): Administered Orally; Administered Orally
Other intervention name(s): Cialis; LY450190
Intervention MeSH terms: Sildenafil Citrate; Tadalafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Isotretinoin on The Gonads and Hirsutism
Condition: Adverse Effects of Medical Drugs
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators consider that there are some rising concerns about the use of isotretinoin
      by women of reproductive age with depleted ovarian reserve, hence it is important to detect
      the effect of isotretinoin on ovarian reserve.

      There has not been a well-designed study evaluating its effects on the human ovarian reserve,
      hormone levels and menstrual cycles in women with polycystic ovary syndrome (PCOS). For this
      reasons, this study was administered to determine whether there is an effect of isotretinoin
      on the gonads and hirsutism in women with acne and PCOS.
    


Intervention name(s): oral isotretinoin
Intervention type(s): Drug
Other intervention name(s): roaccutane
Intervention MeSH terms: Isotretinoin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: isotretinoin; PCOS; acne vulgaris
The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF
Condition: Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency
Study type: Interventional

Summary: 
      A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration
      in patients with HBV-related Acute-on-chronic liver failure.
    

Detailed description: 
      Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease
      with high mortality. In this study, the investigators intend to assess the efficacy and
      safety of Thymosin-α1 in patients with HBV-related Acute-on-chronic liver failure.
    

Intervention name(s): Thymosin-α1
Intervention type(s): Drug
Intervention description(s): 1.6 mg s.c injection once per day for 7 days, then 1.6 mg s.c injection twice a week for 11 weeks.
Other intervention name(s): Zadaxin
Intervention MeSH terms: Thymalfasin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function
Condition: Heart Failure; Atrial Fibrillation
MeSH terms: Heart Failure; Atrial Fibrillation
Study type: Observational [Patient Registry]

Summary: 
      This is an investigator-started study. The trial is coded as no. GC&PJ-Dig-Iva2009-2012.

      The authors have no conflict of interest and there was no financial sponsoring The study was
      planned according to the Good Clinical Quality standards using an intention-to-treat
      analysis. The protocol was approved from the ethics committee. Selected patients gave their
      written informed consent. The family practitioners agreed and obtained the collected data and
      analysis. Analysis of collected data was performed by a single-blinded author (without
      knowledge of the used test drug and time of collection of data).

      Study Hypothesis: Compare the effect of digoxin and ivabradine in chronic heart failure with
      permanent atrial fibrillation (ischemic etiology).

      Multiple Time Frames: Primary Outcome is measured before and after each medical intervention.

      Measurements at baseline and after 3 month of therapy (twice, with the 2 different drugs):

      Measurements Severity of dyspnea. Digoxin serum concentration. ECG: Heart rate at rest and
      during 6-min walking test. Cardiac function (echocardiography): systolic function (ejection
      rate, left trial size,diastolic function.

      Participants were followed (ambulatory observation) for at least 3 months
    

Detailed description: 
      Selected patients had chronic coronary artery disease which had been treated with
      percutaneous dilatation & stenting and/or aortocoronary bypass. The severity of myocardial
      ischemia had induced heart failure with diastolic dysfunction and preserved systolic
      function, and permanent AF.

      1 Inclusion criteria:

      Dyspnea class III NYHA.

      Abnormal left ventricular relaxation with preserved (≥52%) ejection fraction (LVEF).

      Patients either in sinus rhythm or with permanent atrial fibrillation.

      2. Exclusion criteria:

      Unstable angina pectoris.

      Reduced systolic cardiac function (LVEF<52%).

      Normal diastolic function.

      Diabetes requiring insulin.

      Moderate or severe renal or hepatic dysfunction.

      Technically insufficient echocardiography.
    

Intervention name(s): Digoxin and ivabradine
Intervention type(s): Drug
Intervention description(s): No more details
Other intervention name(s): Medical therapy in heart failure with atrial fibrillation.; Drugs used: digoxin and ivabradine.
Intervention MeSH terms: Digoxin
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with ischemic heart disease and heart failure with preserved systolic function,
        dyspnea grade III NYHA. Either in sinus rhythm (and possible paroxismal atrial
        fibrillation) or with permanent atrial fibrillation.
      
Keywords: Digoxin; Ivabradine; Cardiac failure; Economics
Therapeutic Effects of Line Dancing in People With MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The objective of this study is to analyze the effects of line dancing on balance, anxiety,
      depression and quality of life for people with multiple sclerosis (PwMS).
    

Detailed description: 
      Purpose: The objective of this study is to analyze the effects of line dancing on balance,
      anxiety, depression and quality of life for people with multiple sclerosis (PwMS).

      Methods: This study was conducted prospective parallel-group design study. 31 PwMS were
      randomized two groups. The dance group undertook 60-minute sessions twice a week for four
      weeks and the control group did not do any particular training during this period. The
      outcome were measured using the Berg Balance Scale (BBS), Hospital Anxiety and Depression
      Scale (HADS), and Multiple Sclerosis Quality of Life-54 (MSQoL-54) by an evaluator blinded to
      the study.
    

Intervention name(s): line dancing
Intervention type(s): Other
Intervention description(s): The intervention included 60-minute sessions, two days a week for four weeks for a total of eight sessions. All sessions were administered by the physiotherapist who has 26 years of experience in dance therapy. The dance was performed on a one to one basis with minimal support from the therapist. The line dancing sequence, which was specially created for this training program, was designed as a structured goal-oriented dance. Line dancing movements/steps are comprised of moving forward and backward, or sideways and turns and scuff. In addition, the fact that one foot is always in contact with the ground makes it ideal for patients with multiple sclerosis, who may have balance problems.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: line dance; balance; anxiety; depression; quality of life; Multiple Sclerosis
Effect of EMST Systemic Inflammation and Oxidative Stress in Patients With Moderate OSAS
Condition: Obstructive Sleep Apnea; Oxidative Stress; Respiratory Muscle Training
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Inflammation
Study type: Interventional

Summary: 
      It was aimed to investigate the effect of expiratory muscle strength training (EMST) applied
      at different intensities on systemic inflammation and oxidative stress in patients with
      moderate obstructive sleep apnea syndrome (OSAS). In the study, 32 male patients diagnosed
      with moderate OSAS will be included in the study. Participants will then be divided into 2
      groups by block randomization. In the three-blind planned study; the first group will receive
      high-intensity %60 maximum expiratory pressure (MEP) EMST training, and the second group will
      be given low-intensity 30% of MEP, EMST training for 12 weeks. Disease-related symptoms,
      disease severity apnea-hypopnea index (AHI), oxidative stress index (OSI) and systemic
      inflammation level, exercise capacity, respiratory muscle strength, sleep quality, daytime
      sleepiness, and fatigue severity will be evaluated before and after the study.
    

Detailed description: 
      Primary outcome measures are; disease severity, oxidative stress index and systemic
      inflammation.

      Secondary outcome measurements are; disease-related symptoms, exercise capacity, respiratory
      muscle strength, sleep quality, daytime sleepiness, and severity of fatigue.
    

Intervention name(s): Expiratory muscle trainig
Intervention type(s): Other
Intervention description(s): This exercise will be used to strengthen forced expiratory muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Oxidative Stress
Evaluating the Safety and Efficacy of the Pico Laser With a Specialized Lens Array for the Treatment of Wrinkles
Condition: Wrinkles
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of the treatment of wrinkles
      using a 755nm Alexandrite Laser.
    


Intervention name(s): 755nm Alexandrite Laser
Intervention type(s): Device
Intervention description(s): 755nm Alexandrite Laser for the treatment of Wrinkles
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Shoulder Motion Guided Patient Diagnostic and Treatment Classification
Condition: Rotator Cuff Shoulder Syndrome and Allied Disorders
Study type: Observational

Summary: 
      The investigators purpose is to determine the ability of a low cost, currently available
      imaging technique to predict shoulder movement disorders and the location of shoulder disease
      based on motion analysis of subjects with known shoulder disorders.
    

Detailed description: 
      Shoulder disorders account for the second largest number of musculoskeletal cases in the
      United States with a large health care burden. The current standard for diagnosis of shoulder
      disorders is a clinical exam, visual motion assessment and in some cases, costly magnetic
      resonance (MR) imaging. However, specific tissue pathologies are not always accurately
      identified, and often not directly linked to the magnitude of dysfunction. There is a need
      for categorizing or sub-grouping patients based on the underlying movement dysfunctions with
      which they present. Video fluoroscopy is a common clinical tool that can improve the accuracy
      of motion analysis. The investigators are using 2-D fluoroscopy, combined with 3-D MR imaging
      to measure shoulder motion. From the motion analysis we can predict areas of potential soft
      tissue disease, and compare these to disease locations from MR imaging. The investigators
      hypotheses is that our motion based predicted disease locations will be significantly
      associated with disease locations from MR imaging.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with shoulder pain and rotator cuff disease, as well as age and gender matched
        controls.
A Dose-proportionality Study of Five Tablet Strengths of ER OROS Paliperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the dose proportionality of the 3-, 6-, 9-, 12-, and
      15-mg tablets of ER OROS paliperidone. Additionally, the safety and tolerability of the
      treatments in healthy volunteers will be assessed.
    

Detailed description: 
      This study is designed as a single-center, open-label, randomized, 5 treatment-period,
      crossover study in healthy male adults. The study consists of a screening phase and an
      open-label treatment phase during which each volunteer will receive 5 treatments of study
      drug in a random order and separated by a washout period of 10 to 14 days. Treatments will
      consist of a single oral dose of: A) 1 tablet containing 3 mg ER OROS paliperidone; B) 1
      tablet containing 6 mg ER OROS paliperidone; C) 1 tablet containing 9 mg ER OROS
      paliperidone; D) 1 tablet containing 12 mg ER OROS paliperidone; E) 1 tablet containing 15 mg
      ER OROS paliperidone. All treatments will be administered after an overnight fast. Volunteers
      are to remain in bed for 4 hours after dosing and are strongly advised to remain in bed for
      up to 36 hours. Five different ER OROS paliperidone tablet strengths (3, 6, 9, 12, and 15 mg)
      will be developed with the intent to market. Since ER OROS paliperidone is an extended
      release formulation, this study is designed to show dose-proportional pharmacokinetics of all
      these dose strengths. Safety and tolerability will be monitored throughout the study.
      Treatments will consist of a single oral dose of: A) 1 tablet containing 3 mg ER OROS
      paliperidone; B) 1 tablet containing 6 mg ER OROS paliperidone; C) 1 tablet containing 9 mg
      ER OROS paliperidone; D) 1 tablet containing 12 mg ER OROS paliperidone; E) 1 tablet
      containing 15 mg ER OROS paliperidone
    

Intervention name(s): ER OROS Paliperidone
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Mood disorders; Antipsychotic drugs; ER OROS Paliperidone
The Effect of a Phospholipid Drink on Cognitive Performance Under Acute Stress
Condition: Cognitive Performance (Focus)
Study type: Interventional

Summary: 
      The study will explore the effects of a 6-week phospholipid drink intervention on the
      cognitive performance and physiological and subjective stress parameters of males following a
      repeated psychosocial/physical stressor.
    

Detailed description: 
      The study conforms to a randomised, double-blind, placebo controlled, parallel groups design
      examining cognitive performance and physiological/subjective stress responses after a
      psychosocial/physical stressor before and after a six week daily intake of an phospholipid
      containing drink vs. placebo.

      The study will examine:

      Cognitive performance following acute stress prior to, and following 6-weeks intake of a
      phospholipid containing drink or a placebo analogue.

      Physiological and subjective stress responses following acute stress prior to, and following
      6-weeks intake of a phospholipid containing drink or a placebo analogue
    

Intervention name(s): Phospholipid drink; Placebo milk drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participant in an intervention parallel group will consume a drink with added phospholipids; Participant in an intervention parallel group will consume a drink without added phospholipids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Memory; Attention
Validity of Profile Fitness Mapping Low Back Questionnaire
Condition: Low Back Pain; Pain; Assessment, Self; Disability Physical
MeSH terms: Back Pain; Low Back Pain
Study type: Observational [Patient Registry]

Summary: 
      As patients improve on one parametric result, the results on the other parametric may worsen,
      but the total score may not be affected. For this reason, it would be useful to make
      measurements that evaluate all the parameters of the patients. Thus, it would be more
      advantageous to score both pain and symptoms separately, as well as activity limitations.
      Therefore, neck specific surveys are needed to meet this need.

      For this reason, this study was planned to determine the validity of the questionnaire named
      "Profile Fitness Mapping Low Back Questionnaire" in patients with low back pain.
    

Detailed description: 
      The translation of the original version of "Profile Fitness Mapping Low Back Questionnaire"
      to Turkish will be translated by two independent professional translators. Afterwards, a
      person without a medical history and a native English speaker will be translated into English
      again. Once the translation stages are complete, the translators will be brought together to
      discuss the two versions of the questionnaire. Then the final state will be translated into
      the main language of the questionnaire and the compliance will be checked.

      First of all, people who have been suffering from low back pain for at least six months will
      complete the "Profile Fitness Mapping Low Back Questionnaire", "Oswestry Disability Index"
      and "SF-36 health related quality of life questionnaire".

      Seven days after the questionnaire, the "Profile Fitness Mapping Low Back Questionnaire" will
      be completed again.
    

Intervention name(s): Questionnaire
Intervention type(s): Other
Intervention description(s): Profile Fitness Mapping Low Back Questionnaire
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients have neck pain more than six months
      
Keywords: validity; low back pain; functional; pain; questionnaire