bioihbjkbjnl/mcl2 huggingface dataset:
Laparoscopic Hernia Repair With Lateral Umbilicus Ligament for Children
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Observational

Summary: 
      The role of laparoscopic surgery in pediatric inguinal hernia repair is clear. Laparoscopic
      hernia repair is especially advantageous for bilateral diseases and minimally invasive
      technique in children because it avoids vas injury. However, the problem of recurrent rate
      has not been resolved. The aim of this study was to refine the current criteria used the
      lateral umbilicus ligament covering the internal hernia opening region, and eliminated
      recurrence in laparoscopic inguinal hernia (LIH) repair in children. The investigators
      hypothesized that the lateral umbilicus ligament covering the internal hernia opening region
      after the laparoscopic purse-string knot would result in lower recurrence and the same
      operation relative complication
    

Detailed description: 
      The primary outcome measure was the recurrence rate after surgery, and the secondary outcome
      measures included degree of postoperative pain, the amount of postoperative analgesia,
      procedural duration, number of days to recovery normal activity, surgical complications,
      cosmetic results, and patient satisfaction. The outcome was recorded at the outpatient visits
      10 days, 6 months, 1 year, 3 years and 5 years after the surgery. The cosmetic result was
      scored (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3) by the patients or
      parents, the attending nurse, and the surgeon (maximum points = 9). The patient satisfaction
      was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3). The
      long axis of the testes was measured.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients between 2 years and 17 years of age undergoing laparoscopic inguinal hernia
        repair at our institution by a single surgeon from January, 2000 to August, 2005 were
        prospectively followed for outcome.
      
Keywords: Inguinal hernia; Laparoscope; Lateral us ligament; Recurrence; Pediatric; unilateral inguinal hernia
Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the
      safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and
      single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy
      subjects.
    


Intervention name(s): ASC43F
Intervention type(s): Drug
Intervention description(s): One dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: ASC43F; Phase 1; Thyroid hormone receptor beta agonist; FXR agonist; ASC41; ASC42
Oophorectomy Followed by Chemotherapy Versus Chemotherapy Alone in Colorectal Cancer Patients
Condition: Stage IV Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective phase III trial to define the role of oophorectomy in metastatic
      colorectal cancer patients with ovarian metastasis.
    

Detailed description: 
      A recent study demonstrated that colorectal cancer with ovarian metastases were less
      responsive to chemotherapy compared to extraovarian metastases. The survival impact of
      oophorectomy has not been defined yet in this clinical setting. The incidence of microscopic
      ovarian metastasis has been reported to be approximately 10%. Therefore, the investigators
      propose a prospective study of oophorectomy followed by standard chemotherapy versus standard
      chemotherapy alone to determine whether oophorectomy increases survival.
    

Intervention name(s): Oophrectomy
Intervention type(s): Procedure
Intervention description(s): Both oophrectomy
Other intervention name(s): No other intervention needed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: oophrectomy; survival
Characteristics and Dynamics of TCR Repertoire in Patients With Hematological Malignancies After Allo-HSCT
Condition: Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation; Graft Vs Host Disease; Recurrence
MeSH terms: Hematologic Neoplasms; Graft vs Host Disease; Recurrence
Study type: Observational [Patient Registry]

Summary: 
      Graft-versus-Host Disease (GVHD) and relapse, which is mainly due to lack of
      Graft-versus-Leukemia (GVL), are the most frequent and severe complications of allogeneic
      hematopoietic stem cell transplantation (allo-HSCT). T cells expanded from mature T cells in
      the graft play a dominant role in development of GVHD and GVL early after allo-HSCT. Recent
      applications of high-throughput sequencing (HTS) to the T cells repertoire open a new avenue
      for us to look deeply into how these T cells dynamically adjust in the context of the
      recipient's environment.

      The main goal of this research study is to set up a mathematical model based on T cell
      receptor (TCR) sequencing to enable prediction for the key immunologic outcomes early
      post-transplantation. This study will deepen the understanding of the molecular mechanisms
      driving the most deadly post-transplantation complications, and serve as convincing evidence
      upon which to choose a better donor and a more proper transplantation approach.

      This observational trial will perform HTS for TCR β-chain complementarity determining region
      3 (CDR3) repertoires of grafts and peripheral blood samples from recipients
      post-transplantation and analyze the relationship between dynamics of TCR CDR3 repertoires
      and clinical outcomes early post-transplantation, especially including GVHD and relapse. The
      investigators want to know how the antigen environment in recipients drives dynamics of
      mature T cells from grafts in order to use the new discovered rules to better predict and
      treat the disease process.
    


Intervention name(s): Myeloablative Hematopoietic Stem Cell Transplantation
Intervention type(s): Other
Intervention description(s): Myeloablative hematopoietic stem cell transplantation from many kinds of donors, including matched related donor, matched unrelated donor, haploidentical related donor.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergone myeloablative hematopoietic stem cell transplantation about 1 year ago.
      
Keywords: TCR Repertoire; Next Generation Sequencing; ALL; AML; MDS; Myeloablative
Effects of Mineral Water Consumption on Serum Lipid Parameters
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effect of a specific mineral water on serum
      lipid concentrations in healthy subjects.
    


Intervention name(s): Mineral water (Hita, Oita, Japan); Mineral water (Aso-gun, Kumamoto, Japan)
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Pentoxifylline and Systemic Inflammation in Hemodialysis Patients
Condition: Inflammation; End-stage Renal Disease; Hemodialysis
MeSH terms: Kidney Failure, Chronic; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of
      TNF-α, IL-6, and CRP in patients on hemodialysis.
    

Detailed description: 
      Patients were randomly selected from the total HD patients of our hospital. Once included,
      patients were randomly allocated (by a computer-generated randomization list) to a study or
      control group. Over a period of 4 months, patients of the study group received one PTX tablet
      (400 mg) orally once a day (at dinner time), whereas controls received one starch identical
      tablet on the same schedule.

      All patients had three HD sessions per week, with the same kind of single-use dialysis
      membrane and dialysate. Monthly visits were scheduled for clinical and biochemical
      evaluations. A blood sample was taken at baseline and every month for measurement of complete
      blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual
      methods). In serum samples at 0, 2 and 4 months, TNF-α and IL-6 concentrations were measured
      by ELISA using high sensitivity kits (Amersham Pharmacia Biotech, Buckinghamshire, UK).
      Additionally, in the same serum samples, CRP concentrations were measured by nephelometry
      using high sensitivity kits (Dade Behring, Marburg, Germany) in a Nephelometry Analyzer II
      (Dade Behring, Marburg, Germany). All laboratory measurements, including inflammation
      markers, were performed in the Central Laboratory (Hospital de Especialidades, CMNO), by the
      same personnel blinded to patient's details.

      Treatment compliance was recorded by counting tablets left in the container at the end of
      each monthly visit.
    

Intervention name(s): Pentoxifylline; starch tablets
Intervention type(s): Drug; Drug
Intervention description(s): Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time); Over a period of 4 months, patients of the control group received one starch tablet orally once a day (at dinner time)
Other intervention name(s): trental; placebo
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: inflammation; pentoxifylline; hemodialysis
Sevoflurane's Effect on Mitral Valve Annular Velocity in Cardiac Surgery
Condition: Valvular Heart Disease
MeSH terms: Heart Diseases; Heart Valve Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine sevoflurane's dose-dependent effect on left
      ventricular (LV) function in cardiac surgery. The change of tissue Doppler imaging (TDI) of
      lateral mitral valve annular velocity at three different sevoflurane concentrations would be
      analyzed by using intraoperative transesophageal echocardiography (TEE)in cardiac surgery
      patients.
    

Detailed description: 
      Following data would be determined after 10 min-exposure to each dosage of sevoflurane with
      1.0, 2.0 and 3.0 inspired vol% (T1, T2 and T3, respectively) during remifentanil-based
      anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=14):

        1. TDI of lateral mitral annulus at systole (S'), early filling (E') and atrial contraction
           (A')

        2. transmitral flow Doppler at early filling (E), atrial contraction (A), deceleration
           time;

        3. LV-ejection fraction (EF)

        4. bispectral index (BIS)

        5. phenylephrine-infusion rate

        6. other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean
           blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central
           venous pressure (CVP), pulmonary capillary wedge pressure (PCWP), mixed venous O2
           saturation (SvO2), cardiac index (CI) and stroke volume index (SVI)
    

Intervention name(s): Sevoflurane dosage titration
Intervention type(s): Drug
Intervention description(s): comparisons of the effect of the 10 min-inhalation of each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3)
Other intervention name(s): sevorane
Intervention MeSH terms: Sevoflurane
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cardiac surgery; sevoflurane; tissue Doppler
Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose
      to healthy males.
    


Intervention name(s): hot water; Black tea and phenolic acids
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Hot water and placebo capsule; Black tea extract and capsule with phenolic acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Black tea; phenolic acids
Dietary Quality During Adolescence is Associated With Mother's Dietary Quality During Pregnancy
Condition: Eating Behavior
Study type: Observational

Summary: 
      We will examine the association between diet quality in offspring at age 14 years and
      maternal diet quality during pregnancy in the Danish National Birth Cohort
    

Detailed description: 
      Background: Dietary exposures in fetal life may have long lasting impact on the individual's
      susceptibility for several non-communicable diseases. Although offspring's own dietary habits
      become increasingly independent from parental influence other external factors are likely to
      exist. Further insights are needed to interpret and separate potential influence from
      exposures in pregnancy from later dietary habits on later disease risk.

      Objectives: We will examine the association between diet quality in offspring at age 14 years
      and maternal diet quality during pregnancy in the Danish National Birth Cohort (DNBC).

      Design: A total of 19620 DNBC offspring-mother pairs will be matched by offspring dietary
      intake assessed at age ~14 years with a 150-item food frequency questionnaire (FFQ) and
      dietary intake assessed with a 300-item FFQ during mid-pregnancy (1996-2003). A Healthy
      Eating Index (HEI) will be developed as an indicator for diet quality based on current Danish
      Food-Based Dietary Guidelines including 8 components; fruit and vegetables, fish, dietary
      fibers, red meat, saturated fatty acids, sodium, sugar-sweetened beverages, and added sugar.
    

Intervention name(s): Observational
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Around 95,000 children born during 1996-2003 in Denmark were recruited for The Danish
        National Birth Cohort
      
Keywords: diet quality; pregnancy; adolescence; longitudinal study; food frequency questionnaire
Low Intensity Resistance Training With Partial Blood Flow Restriction for Quadriceps Strengthening
Condition: Knee Osteoarthritis; Symptomatic Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The objective of the proposed research is to assess the efficacy of an eight-week, efficient
      and tolerable, low-intensity resistance-training program with concurrent application of
      partial blood flow restriction (PBFR) for improving quadriceps strength and volume in women
      with risk factors for incident symptomatic or progressive knee OA. This specific aim will be
      achieved through a randomized, controlled trial, comparing low intensity training with and
      without PBFR. There have been numerous reports of exercise interventions in people with knee
      osteoarthritis. However, this research is novel in that it will be the first to use a low
      intensity regimen that will minimize forces on the knee while still having the potential to
      lead to clinically meaningful strength gains in older adults with risk factors for incident
      symptomatic or progressive knee OA.
    


Intervention name(s): partial blood flow restriction; Low intensity exercise without partial blood flow restriction
Intervention type(s): Other; Other
Intervention description(s): Partial Blood Flow Restriction (PBFR) Low-Intensity Exercise: using the Biodex 3 Dynamometer in isotonic mode at 10% (first 3 weeks), 15% (following 3 weeks) and 20% (final 3 weeks) of their 1RM for each side, while receiving PBFR in each exercising limb. The padded belts (65 mm in width and 650 mm in length) of the Kaatsu Master™ PBFR device (Sato Sports Plaza, Tokyo, Japan) will be applied to the proximal thigh as near to the hip joint as is comfortable. Before training each leg, subjects will be seated in a chair where an initial belt pressure of 37-40 mmHg will be applied. The belt then will be iteratively pressurized for 30 seconds and then relaxed for 10 seconds in increments of 20 mmHg from 100 mmHg to the final pressure of 160 mmHg. During exercise, the cuff pressure will be continuously controlled and monitored by the PBFR apparatus; Low-Intensity Exercise: using the Biodex 3 Dynamometer in isotonic mode at 10% (first 3 weeks), 15% (following 3 weeks) and 20% (final 3 weeks) of their 1RM for each side in each exercising limb without partial blood flow restriction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: knee osteoarthritis; isokinetic knee extensor strength; quadriceps volume; symptomatic knee osteoarthritis
A 5-way Treatment Period Trial of Single Doses of Intranasal GSK256066 in Patients With Rhinitis
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      This current study is planned as a dedicated pharmacodynamic (effect of drug on the body)
      study to investigate the dose response in rhinitic subjects at doses where GSK256066 has been
      proven to work (200mcg) or expected to (50mcg) work. This study also aims to investigate the
      lower end of the predicted therapeutic range.
    


Intervention name(s): GSK256066
Intervention type(s): Drug
Intervention MeSH terms: 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Seasonal allergic rhinitis,; hayfever
An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen
Condition: Metrorrhagia
MeSH terms: Metrorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl
      estradiol, an oral contraceptive tablet, given in an extended regimen
    

Detailed description: 
      This is an open-label study evaluating the bleeding profile of norgestimate/ethinyl estradiol
      tablets administered as an extended regimen (84 consecutive days of active tablets followed
      by seven days medication free) following a traditional regimen of two 28-day cycles (21 days
      of active tablets, followed by seven days of placebo tablets) of norgestimate/ethinyl
      estradiol tablets. All patients will receive norgestimate/ethinyl estradiol tablets in a
      traditional regimen for two 28-day cycles. Following the Traditional Treatment Phase, all
      patients will receive norgestimate/ethinyl estradiol tablets in an Extended Regimen Treatment
      Phase, consisting of 84 days of treatment with norgestimate/ethinyl estradiol tablets. Safety
      evaluations include physical examinations, adverse event reporting and vital signs. The
      hypothesis of the study is that a triphasic extended regimen would not result in breakthrough
      bleeding and spotting when the progestin dose drops. Traditional Regimen: two 28 day cycles
      of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week,
      placebo daily for 1 week. Extended Regimen: four uninterrupted cycles of norgestimate 180 mcg
      daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, 1 week medication-free.
      In both Treatment Regimens patients receive ethinyl estradiol 25 mcg in each active tablet.
      The study is 147 days, Traditional days 1-56 and Extended days 57-147
    

Intervention name(s): Norgestimate/Ethinyl Estradiol tablet
Intervention type(s): Drug
Intervention MeSH terms: Ethinyl Estradiol; Norgestimate; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral contraceptive; breakthrough bleeding; spotting
Evaluation of the Effectiveness of a Web-based Treatment Program for Depression for the Reduction of Depressive Symptoms
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      200 persons with depression are recruited via internet depression forums devoted to
      depression and are randomly assigned either to the online program deprexis or to a wait-list
      control condition. All participants receive free-of-charge online access to deprexis either
      immediately or with an eight week delay.

      Prior to intervention and eight weeks later, both groups are assessed via an anonymous online
      survey which was implemented using the software package OPST®. The survey consists of
      different questionnaires. The Beck Depression Inventory (BDI) represents the primary outcome.
      It is assumed that the severity of depressive symptoms will improve to a significantly
      greater extent in the deprexis than in the wait-list control condition in the course of eight
      weeks.
    

Detailed description: 
      Deprexis is a web-based intervention that can be obtained online (www.deprexis.com). Deprexis
      encompasses 10 content modules with a strong focus on evidence-based cognitive-behavioral
      techniques, either from its so-called first (behavior-oriented), second (cognitive-oriented)
      or third wave (e.g. mindfulness and acceptance): (1) psychoeducation, (2) behavioral
      activation, (3) cognitive modification, (4) mindfulness and acceptance, (5) interpersonal
      skills, (6) relaxation, physical exercise and lifestyle modification, (7) problem solving and
      (8) expressive writing and forgiveness, (9) positive psychology and (10) dreamwork and
      emotion-focus interventions. The ten modules are framed by one introductory and one summary
      module. Communication is carried out online via simulated dialogues. Patients have to respond
      to narrative text messages from the virtual therapists in multiple-choice response fashion,
      enabling them to express doubt, to affirm a particular message or to request more
      information. Text messages are aided with drawings, photographs and animations. The program
      is adaptive and selects exercises and contents on the basis of the subject's response. The
      modules are sequential and each module refers and builds upon previous one. Modules can (and
      should be) repeated within the intervention period.
    

Intervention name(s): Deprexis; Wait-list
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral: Deprexis (10 sessions) delivered online versus wait-list control group; Behavioral: the wait-list group receives Deprexis after 8 weeks
Other intervention name(s): web-based treatment program for depression; web-based treatment for depression after 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Online-Therapy; Deprexis; Self-help