bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Adjuvant Transarterial Chemoembolization (TACE) for Preventing Tumor Recurrence After Liver Resection
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to analyze the therapeutic effect of adjuvant TACE after
      resection.Patients receiving curative resection (R0) were randomized to postoperative TACE
      group and no TACE group. The time to recurrence ,the overall survival as well as the
      incidence of complications after therapy was observed to confirm the role of adjuvant TACE.
    

Detailed description: 
      Although resection of hepatocellular carcinoma is potentially curative, local recurrence is
      common with the recurrence rate higher than 50% during 5 years. So to reduce the recurrence
      rate of HCC, some interventions had been tried in clinic, including transarterial
      chemoembolization (TACE), immunotherapy, and interferon treatment etc. But few of these
      adjuvant therapies had been proved effective and their long term efficacy and clinical
      application remained further explored.

      TACE had been prove to be effective in patients with advanced stage of HCC in randomized
      controlled trials and meta-analysis, but the role of adjuvant TACE after liver resection is
      controversial. The results getting from different randomized control trials varied
      significantly because of the bias of patient selection, different study design，the small size
      of sample, different drug used in chemotherapy and lack of proper stratification…,so a big
      sample size, well patients selected and well designed randomized controlled trial is needed
      to further confirm the role of the postoperative TACE.

      Patients with HCC who received curative liver resection (R0) were randomly assigned 1:1 by
      the doctors to receive no adjuvant TACE(control group) or TACE(treatment group). All patients
      in the treatment group received adjuvant TACE 45 days after liver resection. The outcomes of
      patients were evaluated during the 3-years follow up.
    

Intervention name(s): epirubicin and lipiodol
Intervention type(s): Drug
Intervention description(s): using the technology of Seldinger,The drugs (30 mg epirubicin mixed with 5 ml lipiodol) are given via hepatica propria artery.
Other intervention name(s): transarterial chemoembolization
Intervention MeSH terms: Epirubicin; Ethiodized Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: hepatocellular carcinoma; adjuvant therapy; TACE; time to recurrence; overall survival
Reliability, Validity Of The Turkish Version Of The Back Performance Scale
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      In this study, we performed the validity and reliability of the Turkish version of Back
      Performance Scale.
    

Detailed description: 
      Low back pain (LBP) is defined as the pain that occurs in the area between the lower border
      of the scapula and the buttocks and sometimes radiates to the lower extremities. In the
      community, lower back pain is the second most common health problem after cold. 15% of LBP
      cases are chronic. Appropriate use of assessment questionnaires is one of the most important
      steps in the evaluation of the functional level of the patient and in deciding on an
      effective treatment protocol. The purpose of study is to determine the Turkish version,
      validity and reliability of Back Performance Scale. 180 patients with chronic low back pain
      were included in the study. Test-retest and internal consistency analysis were conducted to
      determine the reliability of the questionnaire. Test-retest results evaluated using the
      Intraclass Correlation Coefficient method.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with chronic back pain between the ages of 18-65
      
Keywords: validity; reliability; low back pain
Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.
Condition: Endometrial Diseases
MeSH terms: Uterine Diseases
Study type: Observational

Summary: 
      To evaluate the endometrial and isthmic microbiota in patients with isthmocele after
      C-Section, and if this microbiota is similar or not with better reproductive outcomes.
    

Detailed description: 
      A total of 45 subjects undergoing in vitro fertilization treatment. Fifteen patients without
      isthmocele will be included in the control group and 30 patients affected with isthmocele in
      the other group, divided in 2 subgroups: 15 with 1 previous C-Section, and 15 with 2 or more
      previous C-Section. Paired samples of endometrial fluid (EF) and isthmic fluid (IF) will be
      obtained simultaneously the day of egg retrieval. Patients will follow a protocol for
      all-freezing embryos or oocytes.
    

Intervention name(s): ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): All the patients will have a transvaginal ultrasound evaluation during the first visit to the clinic to evaluate the presence or not of isthmocele.
Other intervention name(s): transvaginal scan, ultrasound
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female patients undergoing IVF treatment.
      
Biospecimen description: 
      samples for Endometrial fluid (EF) and isthmocele fluid (IF) will be collected the day of the
      oocyte pick up after IVF stimulation for freeze-all oocytes or embryos.
Tech-TYA: eHealth Platform to Deliver Group Intervention for YA Cancer Survivors
Condition: Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to adapt a web-based platform to deliver a group intervention
      for young adult cancer survivors.
    

Detailed description: 
      In the first part of this study, the investigators adapted a website to deliver an
      evidence-based intervention for improving HRQOL for young adult cancer survivors, and then
      conducted usability testing sessions with young adult cancer survivors to get feedback on the
      website. In the second part of the study, the investigators will conduct a single-arm pilot
      trial in which the website will be used to deliver the intervention via weekly group meetings
      with a trained facilitator over the course of 10 weeks.
    

Intervention name(s): Cognitive-Behavioral Stress Management and Health Education
Intervention type(s): Behavioral
Intervention description(s): Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Neoplasms; Quality of life; Young adults
Comparing Everolimus and Sirolimus in Renal Transplant Recipients
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      This study is being done to compare the effectiveness and safety of two different kidney
      transplant immunosuppression drugs, Zortress (the study drug) and Rapamune (which is used in
      the current standard immunosuppression regimen).
    

Detailed description: 
      Zortress is FDA approved, is used as standard of care at some other institutions, and may
      also be given as standard of care if it is believed to be the best immunosuppression regimen
      for a particular kidney transplant recipient. The rationale for testing Zortress vs. Rapamune
      is to determine which of these drugs is more effective in preventing chronic rejection of the
      transplanted kidney. Because these two drugs are related to each other there is no current
      literature addressing the replacement of Rapamune with Zortress in an immunosuppression
      regimen, therefore the goal of this study is to compare these two immunosuppression drugs.
    

Intervention name(s): Everolimus; Sirolimus
Intervention type(s): Drug; Drug
Intervention description(s): 0.75mg twice a day, Orally, starting on day of transplant; 5mg, Orally, starting on day of transplant; decreasing to 3mg
Other intervention name(s): Zortress; Rapamune
Intervention MeSH terms: Sirolimus; Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney; Kidney transplant; Renal failure; End Stage Renal Disease; kidney transplant recipient
A Clinical Study to Evaluate Efficacy and Safety of a Cosmetic Product in the Treatment of Facial Lines
Condition: Fine Lines; Wrinkles; Photoaging
Study type: Interventional

Summary: 
      This randomized, double-blind, placebo-controlled clinical trial was conducted to assess the
      efficacy and safety of an anti-aging serum to improve the appearance of expression lines as
      well as overall skin health of aging skin after 12 weeks of twice-daily use in female
      subjects, aged 35-60, compared to placebo. A total of 55 subjects completed study
      participation which included 33 subjects in the active group and 22 subjects in the placebo
      group.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled clinical trial is being conducted to assess
      the efficacy and safety of the anti-aging serum when used over the course of 12 weeks by
      women with mild to moderate fine lines, wrinkles and overall photodamage on the global face.

      Efficacy and tolerability will be assess through clinical grading at baseline, weeks 4, 8,
      and 12. Efficacy evaluation on fine lines and wrinkles through clinical grading will also be
      performed at 15 minutes post product application. Self-assessment questionnaires and VISIA
      photography will be completed at baseline, weeks 4, 8, and 12. 3D PRIMOS photography will be
      performed at baseline, weeks 8 and 12.

      A total of 55 subjects completed study participation which included 33 subjects in the active
      group and 22 subjects in the placebo group.
    

Intervention name(s): Facial cleanser; Facial moisturizer; Sunscreen
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Facial cleanser to be used by study participants; Bland moisturizer to be used by study participants after serum in the evening.; Sunscreen to be applied after application of serum in the morning.
Other intervention name(s): Neutrogena Sheer Zinc SPF 30
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: anti-aging; serum
Valsalva Maneuver and Control in Reducing Pain During Spinal Injection
Condition: Brachytherapy
Study type: Interventional

Summary: 
      The study aimed to compare the effectiveness of Valsalva maneuver as non pharmacological
      approach and control in reducing pain during spinal injection.
    

Detailed description: 
      This was an experimental study on 70 subjects with 35 subjects treated with Valsalva maneuver
      and 35 subjects treated as control from January to April 2019. Research subjects were female
      who underwent brachytherapy for the first time with spinal anesthesia. The effectiveness in
      reducing pain was assessed by using Visual Analogue Scale (VAS) and patient movement during
      the surgery.
    

Intervention name(s): Valsalva maneuver; Control
Intervention type(s): Other; Other
Intervention description(s): pressure during Valsalva maneuver was measure using sphygmomanometer; patient was not given any intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: valsalva maneuver; control; pain; spinal injection
Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects
Condition: Post-stroke Gait Assessments
Study type: Observational [Patient Registry]

Summary: 
      Many neurological patients express enhanced deficits while walking in a dark room (or during
      the night): the supraspinal structures involved in this navigational deficit have not been
      identified yet. In this project, the investigators will study post-stroke gaits of human
      patients and compare them to those of a control population during a goal-oriented task
      performed in different visual conditions.

      The investigators want to test the hypothesis that during simple goal-oriented locomotor
      tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express
      navigational deficits.
    


Intervention name(s): Kinematic measurements
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The selected patients will be described by following parameters:

          -  Parameters in relation to the person: age, gender.

          -  Parameters in relation to the pathology: NIHSS, exact localisation, time since start
             of the symptoms, FIM (functional independence measure) visual field (ophthalmological
             examen), visual acuity (ophtalmological examen), visual neglect (Bells Cancellation
             Task), visuo-spatial short term working memory (Corsi span), visual motor integration
             (3-D cub subtest MoCA)

          -  Parameters in relation to hospital stay: length of stay.
Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis
Condition: Nephritis, Lupus
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release
      Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).
    


Intervention name(s): Tacrolimus Sustained-release Capsules (ADVAGRAF)
Intervention type(s): Drug
Intervention description(s): Started: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment.
Other intervention name(s): ADVAGRAF: Tacrolimus Sustained-release Capsules
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nephritis, Lupus; Tacrolimus
Evaluation of D-chiro-inositol Treatments
Condition: Inositol; Testosterone; Insulin; Ovulation; Asprosin
Study type: Interventional

Summary: 
      Healthy women will take tablets containing 600 mg D-chiro-inositol twice per day for one
      month. We will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia,
      estradiol, testosterone.
    


Intervention name(s): D-chiro-inositol
Intervention type(s): Dietary Supplement
Intervention description(s): D-chiro-inositol 600 mg twice per day on an empty stomach for one month
Intervention MeSH terms: Inositol
Intervention model: Single Group Assignment
Intervention model description: Human healthy women
Masking: None (Open Label)
Primary purpose: Supportive Care
Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the safety of the gynaecological formulation in normal
      conditions of use.
    


Intervention name(s): Dermacyd Breeze Pocket BR (Lactic Acid)
Intervention type(s): Drug
Intervention description(s): Dermacyd Breeze Pocket BR (Lactic Acid) during 21 consecutive days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study in Two Panels of Healthy Adult Participants to Assess Single-Dose Immediate-Release and Single-Dose Dispersible Formulations of Pretomanid
Condition: Multi-drug Resistant Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study
      in healthy adult subjects.
    

Detailed description: 
      This is a single-dose, open-label, randomized, four-period, four-treatment, crossover study
      in healthy adult subjects. Each panel of 24 subjects will be randomized according to the same
      4-sequence, 4- period Williams design, in which each participant will receive four
      single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an
      FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10
      hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast
      of at least 10 hours. The two panels will be investigated concurrently.
    

Intervention name(s): Pretomanid
Intervention type(s): Drug
Intervention description(s): Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
Treatment C (test) = single 50-mg dispersible tablet, orally administered.
Treatment D (test) = single 10-mg dispersible tablet, orally administered.
Other intervention name(s): PA-824
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each panel of 24 subjects will be randomized according to the same 4-sequence, 4-period Williams design, in which each participant will receive four single-dose treatments. Subjects in Panel 1 will receive all treatments after consuming an FDA standard high-fat, high-calorie breakfast following an overnight fast of at least 10 hours. Subjects in Panel 2 will receive all treatments directly following an overnight fast of at least 10 hours. The two panels will be investigated concurrently.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MDR-TB (multi-drug resistant tuberculosis); Extensively Resistant Pulmonary Tuberculosis; XDR-TB (extensively drug resistant tuberculosis; pretomanid; PA-824
Effect of Positive End-expiratory Pressure on Optimal Balloon Volume During Esophageal Pressure Monitoring
Condition: Mechanical Ventilation
Study type: Observational

Summary: 
      Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The
      volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure.
      The optimal balloon volume is directly dependent on surrounding pressure. In the present
      study,the investigators will observe the optimal volume of esophageal balloon during the
      different PEEP in bench and clinical study.
    

Detailed description: 
      The esophageal pressure (Pes) is used as a surrogate for pleural pressure to obtain
      transpulmonary pressure. Catheter with air balloon is the most commonly used method to
      measure the Pes. The optimal injected volume of the balloon is the key factor in accurate
      measurement of Pes. The recoil pressure of the balloon turns up while the balloon is
      over-filled, resulting in over-estimation of the PES; on the other hand, an under-filled
      balloon also cannot properly transmit the surrounding pressure of balloon. However, the
      researchers showed the optimal balloon volumes is related to the surrounding pressure and
      even is not correspond with manufacturer's recommendations. Theoretically, when balloon
      transmural pressure(PTM) is zero, representing the balloon in a condition with equivalent
      pressure inside and outside of the balloon, it was defined as optimal volume. However, in
      clinical settings, it is difficult to determine the balloon PTM, and therefore the optimal
      volume cannot be obtained, because the surrounding pressure of the balloon cannot be
      conveniently measured.

      In the present study, the investigators will develop a simple method to obtain the optimal
      balloon volume and observe the effect of positive end-expiratory pressure on optimal balloon
      volume during esophageal pressure monitoring. The investigators want to validate the accuracy
      of method in the bench study and clinical feasibility in mechanical ventilated patients.
    

Intervention name(s): Positive end-expiratory Pressure
Intervention type(s): Procedure
Intervention description(s): Positive end-expiratory pressure will be used during mechanical ventilation.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        postoperative patients receiving mechanical ventilation
      
Keywords: optimal balloon volume; positive end-expiratory pressure
Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension; Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to investigate treatment of postoperative pulmonary hypertension by
      iloprost inhalation in children with congenital heart defects. It was a controlled
      single-blind randomized multi-center prospective study in order to explore the efficacy of
      this method in the treatment and prevention of pediatric pulmonary hypertension after
      corrective open-heart surgery for congenital heart defects.
    

Detailed description: 
      Primary objectives:

        1. To evaluate the effect of iloprost inhaled on postoperative PH after biventricular
           repair for CHD.

        2. To verify the benefits of iloprost inhaled in improving the hemodynamics after
           biventricular repair for CHD.

      Secondary objectives:

        1. To investigate the preventive effect of iloprost inhaled on the life-threatening PHC
           occurring immediately after complex congenital heart surgery or occurring just after
           weaning off cardiopulmonary bypass.

        2. To explore the potential of iloprost inhaled to reduce the early mortality after PHC and
           to decrease the use of ECMO/VAD.
    

Intervention name(s): iloprost nebuliser solution; distilled water
Intervention type(s): Drug; Drug
Intervention description(s): Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days; 1-2 ml aerosolized distilled water inhalation per session
Other intervention name(s): Ventavis; Treeful
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pulmonary hypertension, pulmonary hypertensive crisis