Kornimate/medical-research-clean huggingface dataset:
phase 1/2 clinical study of tpx-115 in patients with partial-thickness rotator cuff tear

Conditions: Rotator Cuff Injuries

Summary: rotator cuff tear is one of the most common shoulder diseases and conservative treatment is commonly used for tears involving ≤50% of tendon thickness. since conventional conservative treatments are not fundamental to repair tendon tissue, there is a growing need of new therapy to improve structural outcome. this study assesses the safety and efficacy of allogeneic fibroblasts on partial-thickness rotator cuff tear. the primary outcome is change in american shoulder and elbow surgeons (ases) score at 24 weeks after tpx-115 injection. secondary outcomes include changes from baseline in visual analogue score (vas) pain score, functional evaluations including range of motion (rom), constant score (cs), ases score and simple shoulder test (sst) at 4, 12 and 24 weeks after administration and structural evaluation using mri at 24 weeks after injection.


Eligibility criteria:
inclusion criteria: participants must; 1. be 19 years of age or older. 2. have partial-thickness rotator cuff tear, ≤50% of tendon thickness or of ellman grade i, ii assessed by mri. 3. have unilateral shoulder pain lasting more than 3 months despite conservative treatment and vas pain score ≥5 at screening. 4. understand fully the study and voluntarily sign the informed consent for participation in the study. exclusion criteria: participants with any of the following conditions will be excluded unless stated otherwise; 1. have partial-thickness rotator cuff tear larger than 50% of tendon thickness or of ellman grade iii, or full-thickness rotator cuff tear confirmed by mri. 2. have prior medical history of shoulder surgery on the torn rotator cuff or the upper part of shoulder within 6 months prior to screening visit (shoulder trauma, fracture, upper cervical spine surgery, etc.). 3. have had subacromial or intra-articular injections on the affected shoulder within 3 months prior to screening visit. 4. have had received systemic steroid or immunosuppressive agents within 4 weeks prior to screening visit. 5. have been diagnosed with the following diseases. * inflammatory joint diseases * other shoulder diseases which may cause shoulder pain or functional disorder * autoimmune diseases * active hepatitis b or c * hiv ab positive * malignant tumors within the last 5 years * coagulopathy * genetic disorders related to fibroblasts of collagen * other serious diseases deemed to affect the results of the study 6. have allergies to bovine proteins or gentamicin. 7. be pregnant, breastfeeding, planning pregnancy or unwilling to use of contraceptive suggested in this study. 8. have participated in other clinical trials and received investigational agents within 4 weeks of this study 9. be deemed inadequate for the study by investigators.
femoral venous pulsatility and right heart dysfunction in heart surgery: an observational study

Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery; Right Heart Failure; Right Ventricular Dysfunction

Summary: right heart failure during cardiac surgery is associated with increased perioperative morbidity and mortality. in this context, it is imperative to develop simple diagnostic tools to detect right heart failure. the purpose of this observational study is to determine if ultrasound doppler of the femoral vein can detect and predict right ventricular failure after cardiac surgeries requiring cardiopulmonary bypass. it is expected that an elevated pulsatility of the femoral vein before the induction of general anesthesia is associated with perioperative right heart failure.


Eligibility criteria:
inclusion criteria: * adults (at least 18 years old) * able to consent * undergoing elective cardiac surgery at the montreal heart institute * surgery requiring cardiopulmonary bypass * peri-operative trans-oesophageal echography planned exclusion criteria: * critical preoperative state, defined as vasopressor requirement, mechanical support including intra-aortic balloon, mechanical ventilation or cardiac arrest necessitating resuscitation * know condition that could interfere with femoral venous assessment or interpretation (such as femoral vein thrombosis, femoral instrumentation, ecmo, etc.) * planned cardiac transplantation, implantation of a ventricular assist device or surgery for a congenital condition * pregnancy

Keywords: pulsatile femoral vein doppler flow
clinical evaluation of the treatment of spider angioma

Conditions: Spider Angioma

Summary: to evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.

the purpose of this study is to evaluate the safety and efficacy of the 532 nm ktp laser within the cutera excel v system for the treatment of spider angiomas.

Eligibility criteria:
inclusion criteria: 1. males or females, 5 to 65 years of age (inclusive). 2. fitzpatrick skin types i-iv 3. subject must be able to read, understand and sign the informed consent form. 4. if subject is a minor (\<18 years old in illinois), assent must be obtained from the subject and a parental consent form must be signed by the parents or legal guardian. 5. subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions. 6. willing to have limited sun exposure for the duration of the study, including the follow-up period. 7. willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes 8. agree not to undergo any other procedure for the treatment of spider angioma during the study. exclusion criteria: 1. pregnant. 2. history of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation. 3. having a known anti-coagulative condition or taking anticoagulation medications, including aspirin. 4. history of seizure disorders due to light. 5. systemic use of isotretinoin (accutane®) within 6 months of study participation. 6. excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study. 7. participation in a study of another device or drug within 3 months prior to enrollment or during the study. 8. in the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.
max - shock clinical trial

Conditions: Cardioversion; Atrial Fibrillation

Summary: can electrical cardioversion (ecv) for af be improved. it is the preferred method to restore sinus rhythm in patients with af in whom a rhythm-control strategy is pursued. hypothesis: ecv success rates will be greater with a biphasic defibrillator with maximum energy of 360j (® physio-control) compared to a biphasic defibrillator with maximum energy of 200j (® zoll)

published estimates of ecv success using modern biphasic defibrillators vary considerably but most are limited by small sample sizes. our pre-intervention ecv success rate of 91.8% was stable over \>2.5 years and is comparable to a previous study from our institute11 and to recent estimates from moderately sized studies using contemporary technology. for instance, the euro heart survey on af reported an ecv success rate of 91% in 424 patients2 and the biphasic energy selection for transthoracic cardioversion of atrial fibrillation (best af) trial reported 89% success in 380 patients.3 the variability in starting shock energy and shock energy escalation observed at our centre prior to implementing the oafcp is also consistent with reported practices elsewhere. a recent survey of 57 european centres found that nearly two-thirds of hospitals started with a 100 j biphasic shock for af whereas the remaining third started with 200 j.1 considerable differences in electrode placement were also reported in this survey with 58.7% of centres using an anterolateral position and the remainder using an anteroposterior approach.1our investigators and others have previously shown that physicians seldom apply sufficient force even when prompted to do so and even when using handheld paddles.10,16,17 ecv practices at our institute prior to implementing the oafcp were therefore likely representative of those at most centres.

Eligibility criteria:
inclusion criteria: * patients age \> 18 years. * persistent atrial fibrillation. * scheduled for elective cardioversion at uohi * patient is within the circle of care of uohi electrophysiology staff exclusion criteria: * known left-atrial appendage thrombus. * contraindication to appropriate anticoagulation. * patient is included in another randomized clinical trial. * patient does not meet all of the above listed inclusion criteria.

Keywords: defibrillator
epione guided lung evaluation

Conditions: Lung Cancer

Summary: interventional clinical study to obtain performance and safety data of the epione® device when used for percutaneous procedures in the lung.

the objectives are: * to evaluate the technical success of the device * to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence) * to evaluate the safety of the device 25 subjectsare planned and will undergo an intervention, during which the clinician will use the epione device

Eligibility criteria:
inclusion criteria: * patient ≥18 years old, * patient for whom a percutaneous ct-guided intervention in lung has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians, * patient with a signed informed consent form. * patient covered by a social security system. exclusion criteria: * patient unable to undergo general anesthesia, * pregnant or nursing female, confirmed before the intervention * patient already participating in another clinical study

Keywords: percutaneous ct-guided ablation biopsy abcess drainage fiducial placement lung robotics
pelvic floor function evaluation of singleton primiparae after vaginal delivery and cesarean section

Conditions: Pelvic Floor Disorders

Summary: objective of this longitudinal observational cohort study was to analyze incidence of pelvic floor dysfunction (pfd) symptoms, including pelvic organ prolapse (pop), urinary incontinence (ui), and fecal incontinence (fi), seven to twelve years after delivery, in two groups of singleton primiparae after vaginal delivery (vd) and cesarean section (cs).

pelvic floor disorders (pfd) usually refers to three definable groups of symptoms that include pelvic organ prolapse (pop), urinary incontinence (ui), and fecal incontinence (fi). the prevalence of these conditions increases with age, but in general, pfd affect 20-50 % of women throughout their lives. thus, pfd are common and have significant societal impact. another important pfd risk factor is childbearing. specifically, these disorders are more common among multiparas. vaginal delivery (vd) has been considered the main contributing factor because of pelvic floor muscle, fascia, and nerves damage.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * cephalic presentation * delivery in term (gestational week 38-42) * no other childbirth during study period exclusion criteria: - operative vaginal delivery (vacuum extraction or forceps delivery)

Keywords: childbirth pelvic organ prolapse urinary incontinence fecal incontinence
a national registry of patients with hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: a registry of patients with the diagnosis of hepatocellular carcinoma.

the purpose of this research is to study the factors which might cause hepatocellular carcinoma (a form of cancer arising within the liver) and compare these factors in patients from different ethnic groups and from different parts of the united states. the researchers will also conduct a survey of the stage of the cancer (how far advanced it is) and what treatments are used for this difficult-to-treat tumor.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of hepatocellular carcinoma exclusion criteria: * patients can not be under 18 years of age
randomised efficacy study of two artemether-lumefantrine oral formulations for the treatment of uncomplicated p. falciparum malaria

Conditions: Malaria, Falciparum

Summary: the purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(coartem®) or artemether/ lumefantrine suspension (co-artesiane®) in western kenya


Eligibility criteria:
inclusion criteria: * children aged between 6 and 59 months * minimum body weight of 5kg * presence of fever (temp \>/= 37.5°c) or a history of fever in the last 24 hours * presence of asexual p. falciparum monoinfection * initial parasite density of between 2,000 and 200,000 asexual parasites/µl of blood * not suffering from severe and complicated forms of malaria * able to take drugs under study by the oral route * parent or guardian gives informed written consent to participate in study exclusion criteria: * severe and/or complicated malaria (who, 2000 classification), including severe anaemia (hb =/\ 200,000 µl) * patients treated with mefloquine, halofantrine within the 7 days before day 0 or with quinine salts and artemisinin derivatives within 3 days before day 0, or artemether-lumefantrine 30 days before day 0 * patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria * patients with vomiting and/or diarrhoea * signs of severe malnutrition (defined as follows: children with weight/height ratio below 3 standard deviations or below 70% of the median of the who standardized reference values, or still with symmetrical oedema affecting both feet) * presence of general danger signs in children below 5 years or other signs of serious and complex plasmodium falciparum, as stated in the present who definitions * patients with known history of heart disease or arrhythmia * history of allergy to artemether/lumefantrine or quinine

Keywords: artemether/lumefantrine suspension p. falciparum malaria children uncomplicated plasmodium falciparum malaria
a dose frequency optimization,trial of nivolumab 240 mg every 2 weeks vs nivolumab 480 mg every 4 weeks in subjects with advanced or metastatic non-small cell lung cancer who received up to 12 months of nivolumab at 3 mg/kg or 240 mg every 2 weeks

Conditions: Lung Cancer

Summary: the primary objective of this study is to compare pfs (progression-free survival) rate at 6 months and at 1 year after randomization, of nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (stage iiib/iv) nsclc (non-sq and sq).


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histologically or cytologically documented squamous or non-squamous non-small cell lung cancer (nsclc) (stage iiib/iv), or recurrent or progressive disease following multimodal therapy * patients must have received pre-study nivolumab for up to 12 months and have 2 consecutive tumor assessments confirming complete response (cr), partial response (pr), or stable disease (sd) * measurable disease before start of pre-study nivolumab treatment * eastern cooperative oncology group (ecog) performance status (ps) 0-2 exclusion criteria: * carcinomatous meningitis * untreated, symptomatic central nervous system (cns) metastases * symptomatic interstitial lung disease other protocol defined inclusion/exclusion criteria could apply
safer warfarin treatment

Conditions: Atrial Fibrillation; Venous Thrombosis; Pulmonary Embolism; Heart Valve Prosthesis

Summary: the study is a national multicenter prospective observational study, including 200 patients. the main purpose of this study is to explore in more detail the influence of genetic variability (cyp enzymes and vitamin k dependent proteins) and dietary vitamin k status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. the hypothesis is that genetic variability concerning cyp enzymes and vitamin k dependent proteins predict dosing and adverse events during warfarin treatment. the main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin k status to make the anticoagulation therapy with warfarin more secure.


Eligibility criteria:
inclusion criteria: * caucasian * \>18 years of age * included in the study at the onset of warfarin treatment * target inr (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves) * standard indications for warfarin treatment exclusion criteria: * non-caucasian * clinical significant liver affection * heart failure, nyha class iii-iv * non-compliant - not able to accomplish protocol demands * not able to give informed consent * long-term antibiotic therapy * malabsorption conditions and inflammatory bowel disease

Keywords: warfarin genotyping vitamin k dosing adverse events initial phase of treatment algorithm
effects of exercise during gestation on maternal and foetal health

Conditions: Pregnancy

Summary: the main objective of this project is to assess the effects of a novel and supervised exercise intervention in overweight pregnant and their newborn. methods/design: the present study is a randomized controlled trial. sixty overweight pregnant interested in participate in the intervention program will be randomly assigned to either exercise (3 sessions/week), or to usual care (control) group (30 pregnant per group). the primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic profile. secondary outcomes measure are: i) body composition; ii) dietary patterns; iii) physical fitness; iv) objectively measured physical activity and sedentary behaviour; v) sleep quality; vi) mental health, quality of life and positive health; vii) haematology and biochemical analysis; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x) bone health biomarkers; xi) adiposity-related proteins expression. the data will be analysed on an intention-to-treat basis and per protocol.


Eligibility criteria:
inclusion criteria: * overweight pregnant woman with a normal pregnancy course. * answer "no" to all questions on the parmed-x for pregnancy\*. * to be able to walk without assistance. * to be able to read and write enough. * informed consent: to be capable and willing to provide consent. \*in addition, specific inclusion criteria for data analysis are: gestational age at delivery of 37-42 weeks with single foetus, spontaneous vaginal delivery or instrumental vaginal and caesarean without maternofoetal pathology (or other indication that does not involve maternofoetal risk, such as disproportion, failed induction, no foetal progression or non-cephalic presentation), newborn with appropriate weight, apgar score\>7 in the 1st and 5th minute of life, cord blood ph (normal\>7.20) and normal monitoring results. exclusion criteria: * acute or terminal illness. * malnutrition. * inability to conduct tests for assessing physical fitness or exercise during pregnancy. * underweight, normal-weight or obesity. * pregnancy risk factors (such as hypertension, type 2 diabetes, etc.). * multiple pregnancies. * chromosopathy or foetal malformations. * uterine growth restriction. * foetal death. * upper or lower extremity fracture in the past 3 months. * presence of neuromuscular disease or drugs affecting neuromuscular function * be registered in other exercise program * perform more than 300 minutes of at least moderate physical activity per week * unwillingness to either complete the study requirements or to be randomised into control or intervention group.

Keywords: pregnant women quality of life exercise sleep fetal research diet, mediterranean physical fitness oxidative stress inflammation
pelvic drains after radical hysterectomy in treating patients with uterine, cervical, or vaginal cancer

Conditions: Cervical Cancer; Endometrial Cancer; Infection; Perioperative/Postoperative Complications; Vaginal Cancer

Summary: rationale: the use of pelvic drains may help to prevent complications following radical hysterectomy and pelvic lymphadenectomy. it is not known whether receiving pelvic drains during surgery is more effective than receiving no pelvic drains during surgery in patients with uterine, cervical, or vaginal cancer. purpose: randomized phase iii trial to determine if the use of pelvic drains following radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with uterine, cervical, or vaginal cancer.

objectives: i. evaluate postoperative complications associated with the use or omission of pelvic drains following radical hysterectomy and node dissection that includes suturing of the vaginal cuff and no peritonealization. outline: this is a randomized, two-arm study. all patients receive radical hysterectomy (rutledge-piver ii-iii type) and pelvic lymphadenectomy, without pelvic and parietal peritonealization, with suturing of the vaginal cuff and closure of fascia and cutaneous layers; lumboaortic node dissection is optional. patients are randomized during surgery to one of two arms: those on arm i receive pelvic drains and those on arm ii do not. those in arm i have drains applied in the pelvis, and lymph is collected by vaginal and/or transabdominal drains located in both retroperitoneal fossa. drains are removed when the loss is less than 50 ml in 24 hours. patients in both arms are followed at 2-3 months and 12 months after surgery. projected accrual: 214 patients will be accrued for this study within 2 years.

Eligibility criteria:
disease characteristics: histologically proven cervical, vaginal, or endometrial carcinoma for which abdominal radical hysterectomy (rutledge-piver ii or iii type) and pelvic node dissection is indicated the following are excluded: extensive intraoperative retroperitoneal blood loss (more than 3000 ml) excessive postsurgical hemorrhage or oozing of the wound area requiring postoperative drainage concurrent urinary or bowel injury/deviation or surgical procedures for urinary incontinence (burch etc.) application of prophylactic abdominal mesh for subsequent radiotherapy patient characteristics: age: not specified performance status: who 0-2 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior neoadjuvant chemotherapy endocrine therapy: not specified radiotherapy: no prior radiotherapy surgery: see disease characteristics

Keywords: stage i cervical cancer stage ii cervical cancer stage i vaginal cancer stage ii vaginal cancer stage i endometrial carcinoma stage ii endometrial carcinoma infection perioperative/postoperative complications