bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Multi-dose of HB0034 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate the safety and tolerability of HB0034 in healthy
      subjects following multiple-dose.
    

Detailed description: 
      This is a multi-dose escalation study of HB0034 to evaluate the safety, tolerability,
      pharmacokinetics, and immunogenicity of HB0034.
    

Intervention name(s): Recombinant Humanized Anti-IL-36R Monoclonal antibody and Placebo
Intervention type(s): Drug
Intervention description(s): HB0034 and Placebo
Other intervention name(s): no other names
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
Condition: Infectious Skin Disease; Bacterial Skin Disease
MeSH terms: Skin Diseases, Bacterial; Skin Diseases, Infectious; Skin Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of
      complicated skin and skin structure infections (cSSSI).
    

Detailed description: 
      The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used
      safely and effectively for this indication. Data from in vitro and animal studies support
      this hypothesis.

      In PTK 0796-CSSI-0702 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be
      compared to an antibiotic approved for this indication by FDA. Initial treatment will be
      administered intravenously with the option for subsequent oral treatment.
    

Intervention name(s): PTK 0796; Linezolid
Intervention type(s): Drug; Drug
Intervention description(s): PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg; Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets
Intervention MeSH terms: Linezolid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CSSSI
Comparison Between NEOSORB Plus and NEOSORB
Condition: Skin Reaction to Suture Material
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to investigate whether NEOSORB Plus antibacterial suture (chlorhexidine
      diacetate coated PGLA910) is not inferior to NEOSORB suture (PGLA910) in the points of
      intraoperative handling.
    

Detailed description: 
      1. Enrollment

             1. Urologic surgery which needs fascia and subcutaneous tissue repairs

             2. Clean and clean-contaminated surgery

             3. Patients aged more than 18 years and under 80 years

        2. Randomization

             1. NEOSORB Plus (chlorhexidine diacetate coated PGLA910) or NEOSORB (PGLA910) suture

             2. Stratification by operative methods: Open surgery vs. laparoscopic or
                robot-assisted laparoscopic surgery

        3. Follow-up with 30 days

             1. Primary endpoint: intraoperative handling during operation

             2. Secondary endpoint: wound healing assessment on postoperative 1st (+1) days and
                11th (± 4) days

             3. Safety evaluation: counting adverse events within postoperative 30 days
    

Intervention name(s): NEOSORB PLUS; NEOSORB
Intervention type(s): Device; Device
Intervention description(s): Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910); Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)
Other intervention name(s): Antibacterial suture material; Non-antibacterial suture material
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Hands-on-Healing vs. Touch for Fatigued Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This randomized controlled trial examines the efficacy of hands-on-healing for fatigue and
      immune function in breast cancer survivors. Participants may be randomized to one of three
      groups: hands-on-healing, touch alone, or a control group.
    

Detailed description: 
      Please see our website at http://healing.ucsd.edu for detailed information on the study.
    

Intervention name(s): Hands-on-Healing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cancer; Fatigue; Breast Cancer; Healing; Energy Healing; Complementary; Alternative; Immune; Cytokine; Hormone; Cortisol; Placebo; Mock Healing
Acute STROke Complicating TAVI - Management and Outcomes
Condition: Stroke; Aortic Valve Stenosis; Periprocedural Complication
MeSH terms: Stroke; Aortic Valve Stenosis
Study type: Observational

Summary: 
      Periprocedural complications of trans catheter aortic valve implantation, and particularly
      the occurrence of stroke has a marked impact on survival and quality of life. The
      characteristics of periprocedural stroke complicating TAVI, and particularly of interventions
      aimed to treat stroke complicating TAVI have not been systematically described. We therefore
      aimed is to explore the incidence and characteristics of acute stroke complicating TAVI and
      to describe the safety and efficacy of emergent interventions to treat acute stroke
      complicating TAVI.
    


Intervention name(s): Mechanical thrombectomy; Thrombolytic Agent
Intervention type(s): Procedure; Drug
Intervention description(s): Percutaneous intervention aimed to retrieve/treat clot affecting the cerebral circulation.; Drug aimed to dissolve thrombus affecting the cerebral circulation
Intervention MeSH terms: Fibrinolytic Agents
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with periprocedural stroke complicating TAVI
      
Keywords: periprocedural stroke; transcatheter aortic valve implantation; transcatheter aortic valve replacement
Pilot Study for the Urinary Incontinence Treatment
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Non invasive study to improve the urinary incontinence, through pelvic floor muscles
      exercises
    

Detailed description: 
      A non invasive study to improve the urinary incontinence performed in 36 women from two
      groups: 18 menopausal women and 18 fertile women. The participants have to do pelvic floor
      muscles exercises with a restorative pelvic floor device every day for two months using the
      Magic Kegel app download in their mobile devices
    

Intervention name(s): Magic Kegel app
Intervention type(s): Device
Intervention description(s): Pelvic floor muscles recover exercises with a specific device and Magic Kegel App
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Urinary Incontinence; Pelvic Floor
To Evaluate the Safety, Tolerability, Pulmonary Deposition, Pharmacokinetics and Pharmacodynamics of Ciprofloxacin Inhale in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD, GOLD II-III)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted in a single-center, randomized, single-blinded,
      placebo-controlled, dose escalation design with two dose groups.Multiple-dose inhalation of
      Ciprofloxacin inhale 50 and 75 mg or placebo will be administered to 16 Japanese patients
      with COPD in totalPatients with moderate to severe COPD, stage II or III according to GOLD
      criteria, will participate in the study.The study will consist of 2 steps as indicated below;
      starting at Step 1 (50 mg) and escalating doses up to Step 2 (75 mg), after the tolerability
      of the dose in the previous step is confirmed. In each step, the study will be conducted as
      multiple dose study with b.i.d. regimen for 10 days (between day 2 and 11) in a randomized,
      single-blind, placebo-controlled design. In addition, before and after the multiple dose
      administration, single administration will be conducted in each subject (day 0 and 12).
    


Intervention name(s): Ciprofloxacin (Cipro InhaIe, BAYQ3939); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ciprofloxacin Inhale 50 and 75 mg 2 times a day (BID) for 10 days; Placebo TID for 10 days
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Chronic Obstructive; Phase I; Pharmacokinetics; Microbiology
Perioperative Fluid Therapy in Pediatric Patients Undergoing Penile Hypospadias Repair
Condition: Volume Overload
MeSH terms: Hypospadias
Study type: Interventional

Summary: 
      Optimization of perioperative fluid management is important for preventing adverse events,
      such as hypovolemia, cardiogenic shock, volume overload, and pulmonary edema, in both adult
      and pediatric patients. If the intravascular (IV) fluid volume is not optimized, pediatric
      patients are at risk of dehydration or volume overload. Perioperative IV fluid therapy is
      important during and after induction of general anesthesia (GA).The aim of this study is to
      investigate the difference between conventional and restrictive fluid replacement regimens
      using lung ultrasound in pediatric patients undergoing penile hypospadias repair, as a
      surgery with minor fluid loss.
    


Intervention name(s): lung ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Lung ultrasound with a curvilinear probe (DDED) is performed in all patients in a supine position on the lateral wall of the chest at approximately the level of the lower ribs using an ultrasound probe at a frequency of 4-12 MHz (AcusonX300, Siemens Korea, Seoul, South Korea). The mean number of B-lines detected on the ultrasound image and the percentage of patients who showed B-lines on their images were recorded. The mean of three measurements is used. Inter-observer variability is estimated to be 0.766 (95% confidence interval 0.675-0.847).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Conventional regimen; restrictive regimen; lactated Ringer's solution; lung ultrasound; fluid management
Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa (proof of concept), randomized, double blind, placebo-controlled,
      multicentre clinical trial to evaluate the safety and efficacy of daily PBF-677 oral
      treatment during 28 days in Ulcerative colitis (UC) patients who are not receiving
      immunosuppressants and present mild-to-moderate activity of the disease. Enrolled patients
      would receive standard high doses of 5-ASA (4g), according to current clinical guidelines,
      and are randomized to receive also PBF-677 or placebo.
    

Detailed description: 
      This Proof-of-concept clinical trial is carefully designed to establish the safety profile of
      PBF-677 over 28 days in mild to moderate ulcerative colitis population and explore the
      relationship between the 200 mg PBF-677 dose and induction of remission, according to
      clinical parameters (Partial Mayo Score) and a faecal surrogate biomarker of mucosal
      inflammation (Calprotectin). The trial also will explore the PBF-677 pharmacokinetics (PK)
      profile during 28 days of administration.

      This small-scale study has been designed to detect a signal that PBF-677 is safe and active
      on decreasing levels of faecal calprotectin, as well as preliminary evidence of ameliorate
      the Partial Mayo Clinical Score in colitis patients who are in flare of the disease.

      The Population Under Study will be: Around 30 subjects. Adults (18-75 years old)
      non-immunosuppressed patients with mild to moderate active ulcerative colitis disease.
    

Intervention name(s): PBF-677; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): oral small molecule, antagonist of Adenosine A3 receptor (AA3R); Oral capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double blind, placebo controlled, multicenter clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Yoga on Phase Angle and Quality of Life in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      In this study,we aimed to examine the effects of Hatha yoga on PA and QoL in patients with
      breast cancer.

      Patients will be randomized to receive the yoga group and the control group.Hatha yoga will
      be practiced twice a week for 10 weeks for intervention group.The PA of the patients will be
      assessed using a body analysis instrument and QoL was evaluated with an EORTC-Q questionnaire
      both before treatment and at week 10.
    


Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): Each class started with a check-in period during which any questions or concerns could be raised, after which the patients were given 5 minutes for seated meditation and 10 minutes for Shavasana (lying down in a restorative position).
The following poses were instructed during the course: standing poses with mountain pose (tadasana), chair pose (utkatasana), extended triangle pose (utthita trikonasana), extended side angle pose (utthita parshvakonasana), warrior 1 (virabhadrasana 1), warrior 2 (virabhadrasana 2) and tree pose (vrikshasana). The intervention was applied twice a week for 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase Angle; Hatha Yoga; Breast Cancer; Quality of Life
Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess preliminary parameters of safety and efficacy of a single dose of
      BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.
    

Detailed description: 
      This was an exploratory, double-blind, randomized, placebo-controlled, multicenter, adaptive
      parallel-group design study in four parts in patients with acute COPD exacerbation. In Part
      I, patients were randomized to receive either a single dose of 75mg BCT197, placebo or 40 mg
      oral prednisone in the ratio of 1:1:1. In Part II patients were randomized to receive either
      a single dose of 20 mg BCT197 or placebo in the ratio of 5:1. Patients in Parts I and II
      received their single dose on Day 1 of the study. In Parts III and IV patients were
      randomized to receive either BCT197 or placebo in a ratio of 5:1 at a dose of 20mg (Part III)
      or 75 mg (Part IV) with patients receiving a single dose on both Day 1 and Day 6 of the
      study.
    

Intervention name(s): BCT197; Prednisone placebo; BCT197 placebo; Prednisone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): capsules; capsules; capsules
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; Exacerbation; Pulmonary Inflammation
To Compare the Blood Level of Marketed Japanese Valsartan Tablet Formulation vs Global Valsartan Tablet Formulation in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess how the body changes the blood level of single dose of
      valsartan 160 mg tablet Japanese formulation and valsartan 160 mg tablet global formulation
      under fasting condition in healthy volunteers.
    


Intervention name(s): Valsartan
Intervention type(s): Drug
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relative bioavailability, formulation, Japanese, valsartan, healthy subjects
Before and After Erythrocyte Suspension Transfusion
Condition: Anemia; Oxidative Stress
Study type: Interventional

Summary: 
      Hypoperfusion, hypoxia and ischemia occurs in circulation as a result of anemia. All of these
      situations lead to oxidative stress and endothelial dysfunction in the organism. In this
      study, the investigators aimed to investigate the oxidant-antioxidant balance and asymmetric
      dimethylarginine (ADMA) levels in patients that have symptomatic anemia in need of
      erythrocyte suspension (ES) transfusion. To the best of the investigators knowledge, there
      have been few studies in the literature on anemia and total oxidant, total antioxidant and
      ADMA levels. We aimed to observe changes in oxidative - antioxidant ADMA levels before and
      after ES transfusion.
    


Intervention name(s): Before Erythrocyte Suspension (ES); After Erythrocyte Suspension (ES)
Intervention type(s): Other; Other
Intervention description(s): ES transfusion needs of the patients were determined according to clinical signs and symptoms. Vital signs were closely monitored and recorded before, during and after transfusion. Infusion was performed slowly for the first 15 minutes in terms of allergic reaction, and then the transfusion rate was adjusted according to the patient's clinic.; Venous blood samples were obtained from patients who needed ES transfusion before transfusion. Control venous blood samples were obtained from the patients who did not develop any complications for 24 hours after starting of the transfusion and became hemodynamically stable.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Erythrocyte suspension; Total antioxidant status; Total oxidant status; Asymmetric dimethylarginine
Perioperative Chemotherapy Plus Cetuximab Versus Chemotherapy Alone for High Risk Resectable Colorectal Liver Metastasis
Condition: Colorectal Cancer Stage IV; Metastasis
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study was designed to analyze the prognosis and recurrence predictive factors of high
      risk patients (Clinical Risk Score≥3) of resectable colorectal liver metastasis.

      The efficacy of perioperative chemotherapy plus cetuximab and chemotherapy alone was compared
      for these patients.
    

Detailed description: 
      Resection could prolong the survival of colorectal liver metastasis patients, however,the
      curative resection rate was still low and more than 2/3 of the patients would experience
      tumor recurrence.This study was designed to formulate a more accurate and individual
      evaluation system via the multivariate analysis.

      Up to now, there was no data to demonstrate the addition of cetuximab to perioperative
      chemotherapy could decrease recurrence and prolong survival for RAS wild-type, high
      risk(Clinical Risk Score≥3) resectable colorectal liver metastasis patients. This study was
      also designed to elucidate this question and to observe the objective response rate(ORR) and
      the safety data of the regime.
    

Intervention name(s): Cetuximab plus FOLFIRI/FOLFOX; FOLFIRI/FOLFOX/CapeOX
Intervention type(s): Drug; Drug
Intervention description(s): cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy; to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)
Other intervention name(s): Erbitux; C225; XELOX
Intervention MeSH terms: Leucovorin; Cetuximab; Fluorouracil; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal liver metastasis; preoperative; chemotherapy; targeted therapy
Communicating Smoking Risks Through Graphic Warning Labels
Condition: Lung Cancer; Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Smoking is the largest preventable health risk in the U.S. The Family Smoking Prevention and
      Tobacco Control Act of 2010 mandated the placement of larger pictorial warnings on cigarette
      packs as well as nine new statements of smoking risks. This trial tests the effectiveness of
      the warnings proposed by the Food and Drug Administration by providing cigarettes with the
      proposed labels to 320 smokers across two sites (Philadelphia, PA and Columbus, OH). In
      addition, the trial tests the effects of different warning label components.
    


Intervention name(s): Picture warning; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Warning contains picture proposed for each text statement by FDA
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Verticality Perception Assessed by the Haptic Vertical
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators previously shown that a rotating optokinetic stimulus results in shifts of
      the subjective visual vertical in healthy human subjects. However, the origin of these shifts
      is still poorly understood. Both torsional displacement of the eyes and a shift in the
      internal estimate of direction of gravity have been proposed as potential explanations. Here
      the investigators use a vision-independent setup to differentiate between these two
      hypotheses, predicting no impact of a rotating stimulus on the subjective haptic vertical if
      torsion triggers the shift.
    


Intervention name(s): changes in whole-body roll position and visual/haptic stimuli presented
Intervention type(s): Other
Intervention description(s): In different whole-body roll positions subjects will be presented a luminous line or a rod in combination with a moving or stationary background. Participants will be asked to align the line or the rod along perceived direction of gravity.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: vestibular; spatial orientation; vision; optokinetic