Kornimate/medical-research-clean huggingface dataset:
dose-adjusted adjuvant fec compared to standard fec for breast cancer

Conditions: Breast Cancer

Summary: this is an open randomized phase iii study. the primary objective of this study is to compare fec adjuvant chemotherapy in operable breast cancer given either as fixed doses calculated according to the patients surface area or with doses adjusted according to leukopenia after course one in order to achieve hematological equitoxicity. the main aim of the study is to test whether chemotherapy dosage aimed at hematological equitoxicity will improve the effect of adjuvant chemotherapy.

group a, fecstandard(standard fec) is given 7 courses of 5-fluorouracil-epirubicin (farmorubicin)-cyclophosphamide with doses based on the patient's surface area. leukocyte nadir values at day 10, 12 or 13 and 15 are measured. dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia. group b fectailored(tailored fec) receives course one at identical doses to group a. leukocyte nadir values at day 10,12 or 13 and 15 are measured. doses of subsequent courses are adjusted to achieve grade 3 leukopenia (leukocyte nadir 1.0 to 2.0) in patients experiencing only grade 0 to 2 leukopenia after course one. dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia . patients achieving only grade 0-2 leukopenia at the first course will be randomized into continued treatment at standard doses (group a) or to doses tailored to achieve grade 3 leukopenia (group b). the primary comparisons will be made between these two groups of patients. patients with grade 3-4 leukopenia after the first course not be randomized but followed according to the protocol and received treatment as group a, fecstandard.

Eligibility criteria:
inclusion criteria: * node positive or 2) high-risk node negative# * no major cardiovascular morbidity * female age 18-60 * ecog/who performance status \<1 * histologically proven invasive breast cancer * written or oral witnessed informed consent according to the local ethics committee requirements * start of adjuvant chemotherapy within 8 weeks after surgery exclusion criteria: * distant metastases (m1) * locally advanced cancer * nonradically operated (positive resection margins) * pregnancy or lactation * leukocyte count \< 3.5 x109 /l * platelets \< 100 x109 /l * other serious medical condition * previous or concurrent malignancies at other sites, except basal cell carcinoma and carcinoma cervicis uteri in situ

Keywords: breast cancer
study of aro-apoc3 in healthy volunteers, hypertriglyceridemic patients and patients with familial chylomicronemia syndrome (fcs)

Conditions: Hypertriglyceridemia; Familial Chylomicronemia

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of aro-apoc3 in healthy adult volunteers and in patients with severe hypertriglyceridemia and familial chylomicronemia syndrome (fcs).


Eligibility criteria:
inclusion criteria: * women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception * willing to provide written informed consent and to comply with study requirements * normal electrocardiogram (ecg) at screening * hypertriglyceridemic patients must have a history of fasting serum triglycerides of at least 300 mg/dl (3.38 mmol/l) at screening or verifiable diagnosis of fcs exclusion criteria: * clinically significant health concerns * regular use of alcohol within one month prior to screening * use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study * recent use of illicit drugs * use of more than two tobacco/nicotine containing or cannabis products per month within 6 months prior to drug administration (applicable only to normal healthy volunteers) note: additional inclusion/exclusion criteria may apply, per protocol
the effects of whole body vibration on postural control in patients with ataxia

Conditions: Ataxia

Summary: to investigate the effects of whole body vibration on postural control and on the level of satisfaction regarding how to reach the goals of the patients with ataxia

patients will be randomly assigned to 2 groups, group 1 will take only exercise therapy, group 2 will take exercise therapy and whole body vibration together. after 1 week wash-out period, patients assigned other therapy period. all assessments will be repeated before and after each therapy period. exercise therapy will consist of selected balance, coordination and walking exercises according to the individual needs of patients. whole body vibration (20-30 hz, minimum amplitude) will be applied to cases in the form of 4 sets (1 min application and 1min rest.) cases will take the treatment 1-hour, 3 days in a week for 8 weeks. the evaluation parameters consists of demographic information, computerized dynamic posturography, international cooperative ataxia rating scale, trunk impairment scale, berg balance scale, barthel index and goal assessment scale.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ataxia * ataxic patients who are able to walk 25 m independently exclusion criteria: * clinical diagnosis of systemic problems (diabetes mellitus, hypertension) * clinical diagnosis of cognitive impairment
effect of instrumented assisted soft tissue mobilization on pain, function and proprioception in patients with shoulder impingement syndrome

Conditions: Shoulder Impingement

Summary: this study will be conducted to investigate instrumented assisted soft tissue mobilization on pain, function and proprioception in patients with shoulder impingement syndrome

shoulder impingement is a clinical syndrome in which soft tissues become painfully entrapped in the area of the shoulder joint. patients present with pain on elevating the arm or when lying on the affected side. shoulder pain is the third most common musculoskeletal complaint in orthopedic practice, and impingement syndrome is one of the more common underlying diagnoses. on the pathophysiological level, it can have various functional, degenerative, and mechanical causes. the impingement hypothesis assumes a pathophysiological mechanism in which different structures of the shoulder joint come into mechanical conflict. the decision to treat conservatively or surgically is generally made on the basis of the duration and severity of pain, the degree of functional disturbance, and the extent of structural damage. the goal of treatment is to restore pain-free and powerful movement of the shoulder joint.instrument-assisted soft tissue mobilization (iastm) is a popular treatment for myofascial restriction which is applied using specially designed instruments to provide a mobilizing effect to soft tissue (e.g., scar tissue and myofascial adhesion) to decrease pain and improve range of motion (rom) and function. eighty patients will be allocated randomly into two equal groups; the experimental one will receive iastm and the control will receive traditional therapy for eight weeks.

Eligibility criteria:
inclusion criteria: * patients with impingement syndrome from both genders. * age range from 25-40 years * body mass index 18.5-24.9 kg/m2 * subjects are non-smokers. * shoulder impingement symptoms lasting at least 6 weeks exclusion criteria: 1. hand truma, present pain or other kinds of complaints in the hand area. 2. history of deformities, fractures, or surgery of the tested upper extremity joints affecting hand grip strength within the last 6 months. 3. presence of cardiopulmonary, hormonal disorder, central or peripheral neurological deficits or any condition that can influence the results.

Keywords: instrumented assisted soft tissue mobilization shoulder impingement syndrome
clinical and pathologic studies in non-hodgkin's lymphoma and hodgkin's disease

Conditions: Lymphoma, Non-Hodgkin; Hodgkin's Disease

Summary: the purpose of this study is to characterize the molecular and cell biology of the tumor cells in lymphoma.

this research involves the study of lymphoma cells in order to better understand how the disease grows and spreads. this study may lead to the development of special materials that could be used, in the future, to treat lymphoma or to follow the response of lymphoma to treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of hodgkin's disease or non-hodgkin's lymphoma, any cellular classification, any stage, any grade. * adult or pediatric patients receiving lymph node excision for purposes other than cancer therapy (i.e. tonsillectomy, sleep apnea). * a routine procedure for tissue collection is planned. * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * patients without nhl or hodgkin's disease
reset-ssc: an open-label study to evaluate the safety and efficacy of caba-201, a cd19-car t cell therapy, in subjects with systemic sclerosis

Conditions: Systemic Sclerosis; Scleroderma

Summary: reset-ssc: a phase 1/2 open-label study to evaluate the safety and efficacy of caba-201, a cd19-car t cell therapy, in subjects with systemic sclerosis

systemic sclerosis (ssc), also known as scleroderma , is a rare autoimmune disorder characterized by autoantibody production and abnormal b cell function. though the cause of ssc is not well understood, it is thought to involve b cells that cause the body to attack different tissues in one's own body, causing skin and organ fibrosis. this study is being conducted to evaluate the safety and efficacy of an investigational therapy, caba-201, a cd19-car t cell therapy, that can be given to patients with ssc who have active disease. a single dose of caba-201 in combination with cyclophosphamide (cy) and fludarabine (flu) will be evaluated.

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤75 * a clinical diagnosis of ssc, based on the 2013 american college of rheumatology and european league against rheumatism classification criteria. * early active disease * evidence of significant skin, pulmonary, renal, or cardiac involvement exclusion criteria: * contraindication to leukapheresis * history of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites * active infection requiring medical intervention at screening visit * current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections. * concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures * severe lung or cardiac impairment * previous car t cell therapy * prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant other protocol-defined inclusion/exclusion criteria may apply.

Keywords: caba-201 autoimmune disease anti-cd19 car-t therapy systemic sclerosis scleroderma
comparison study of surgical staplers for the treatment of hemorrhoids

Conditions: Hemorrhoids

Summary: the purpose of this study is to demonstrate that the covidien eea™ hemorrhoid and prolapse stapling set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.


Eligibility criteria:
inclusion criteria: * the subject is able to understand and sign informed consent form * the subject is between 18-85 years of age. * the subject has (symptomatic) grade 2-3 hemorrhoids and is eligible for stapled hemorrhoidopexy exclusion criteria: * the procedure is needed as revision hemorrhoid surgery. * any female patient, who is pregnant, suspected pregnant, or nursing. * the participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date. * the participant is unable or unwilling to comply with the study requirements, follow-up schedule. * the participant has a 1 year history of drug or alcohol abuse. * the participant has a history of venous thrombosis or pulmonary embolism. * the participant has a history of coagulopathy. * the participant has taken aspirin, anti-coagulation and/or anti platelet therapies (e.g. warfarin, lovenox) within 7 days prior to the planned date of surgery. * the participant has a history of fecal incontinence * the participant has had injection therapy, infrared laser treatment or rubber band ligation for treatment of hemorrhoids within 1 month of screening * the participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Keywords: hemorrhoid hemorrhoid stapler
albuterol dpi (a006) clinical study-b2: efficacy, dose-ranging and initial safety evaluation

Conditions: Asthma

Summary: the main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of a006, an albuterol dry powder inhaler (dpi), in the dose range of 25 to 180 mcg per dosing in comparison to a dpi placebo control and an albuterol metered dose inhaler (mdi) active control. this study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.

the main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of a006, an albuterol dry powder inhaler (dpi), in the dose range of 25 to 180 mcg per dose in comparison to the dpi placebo control and the active (reference) control. the study results of this study together with that of a006-b study will be utilized to determine the optimum final dose range of a006 for further clinical studies. the study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma but are otherwise generally healthy.

Eligibility criteria:
inclusion criteria: * generally healthy, male and female adults, 18-55 years of age at screening * with mild-to-moderate persistent asthma for at least 6 months prior to screening and having used a beta-agonist(s) inhaler * demonstrate a forced expiratory volume (fev1) at 50-85 percent of predicted normal during screening baseline measurement * demonstrate an airway reversibility of greater than or equal to 15 percent within 30 minutes of inhaling 2 inhalations of proventil mdi during screening visit * demonstrate peak inspiratory flow rate (pif) within 80-150 l/min (after training), at least 2 times consecutively * demonstrate ability to use a dpi and mdi inhaler properly after training * females must be not pregnant, not lactating, and using a clinically acceptable form of birth control * properly agree to participate in the trial exclusion criteria: * a smoking history of more than or equal to 10 years or having smoked within 6 months of screening visit * upper respiratory tract infections within 2 weeks or lower respiratory tract infection within 4 weeks prior to screening visit * asthma exacerbations that required emergency care or a hospital stay within 4 weeks prior to screening visit * any current or recent respiratory tract infections that might affect the response to the study drug as determined by the investigator, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema and other significant respiratory diseases besides asthma * current clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant or other illnesses that could impact the study as determined by the investigator * known intolerance or hypersensitivity to any ingredients of the study drug dpi or proventil mdi (i.e.: albuterol, sulfate, lactose, milk protein, hfa-134a, oleic acid and ethanol)

Keywords: asthma mild-to-moderate persistent asthma mild asthma moderate asthma persistent asthma
comparison of forced air and conductive patient heating systems during ambulatory surgeries

Conditions: Hypothermia

Summary: comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.

patients will be randomized into either the forced air group (fa) or conductive heat group (ch). randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes. fifty patients will be recruited with 25 patients being randomized into each group. in patients assigned to the fa group, a bair hugger (arizant medical, inc., eden prairie, minnesota) forced-air cover will be positioned over the upper body (if lower extremity surgery) or lower body (if upper extremity surgery). the forced-air blower will be set and activated per standard practice usually after prepping and draping. in patients assigned to the ch group, a vitaheat (vitaheat, inc, aurora, il) conductive heating device will be placed under the torso of the patient. the device will be set and activated per standard practice usually just after positioning of the patient on the operating table. patients in both groups will be otherwise draped per surgical routine. ambient temperature will be maintained near 20°c. temperatures will be recorded using a temporal artery thermometer.

Eligibility criteria:
inclusion criteria: * patients undergoing orthopaedic outpatient surgeries over 18 years old exclusion criteria: * allergic to material of bair hugger

Keywords: orthopaedics post-operative warming
sequential vs upfront intensified neoadjuvant chemotherapy in patients with large resectable or locally advanced breast cancer.

Conditions: Breast Cancer

Summary: 2 different treatment schedules may be used for neoadjuvant chemotherapy in breast cancer using adriamycin, cyclophosphamide and taxotere. the most optimal sequence- concurrent or sequential- is however unclear. the aim of the study is to compare the efficacy and tolerability of neoadjuvant chemotherapy with ac followed by t(adriamycin, cyclophosphamide, taxotere) versus tac ( with upfront t) in patient with large resectable or locally advanced breast cancer.


Eligibility criteria:
inclusion criteria: * women presenting with large resectable or locally advanced breast cancer (t2 ≥3 cm, t3, or t4, and/or ln positive) * measurable disease (breast and/or lymph nodes) * no prior surgery other than biopsy and no prior chemotherapy or radiation therapy * age ≥18 years and age ≤70 years * karnofsky performance score ≥70% * estrogen and/or progesterone receptor analysis performed on the primary tumour in the biopsy material * in case the tumor is er/pgr ³ 50% positive, (neo)adjuvant hormonal therapy in stead of chemotherapy should be considered (e.g. in team ii study) * her2/neu receptor analysis performed on the primary tumour in the biopsy material * adequate bone marrow function (within 14 days prior to registration): wbc ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l * adequate liver function (within 4 weeks prior to start treatment): bilirubin ≤1.5 x upper limit of normal (unl) range, alat and/or asat ≤2.5 x unl, alkaline phosphatase ≤5 x unl * adequate renal function (within 4 weeks prior to start treatment): the calculated creatinine clearance should be ≥50 ml/min * patients must be accessible for treatment and follow-up * written informed consent according to the local ethics committee requirements exclusion criteria: * patients with advanced pulmonary disease of any cause (oxygen dependent)- peripheral neuropathy \> grade 2 whatever the cause * serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrythmias * evidence of distant metastases (m1) * patients with a history of breast cancer * patients with a history of another malignancy (except basal cell skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry- pregnant or lactating women, or potentially fertile women not using adequate contraception

Keywords: large resectable breast cancer locally advanced breast cancer neoadjuvant therapy
clinical evaluation of injectable alb-prf in the management of intrabony defect in stage-iii periodontitis patients

Conditions: Intrabony Periodontal Defect

Summary: clinical evaluation of injectable albumin platelet rich fibrin versus platelet rich fibrin in the management of intra-bony defect in stage-iii periodontitis patients. the goal of this clinical trial is to compare injectable albumin platelet rich fibrin versus platelet rich fibrin in the management of intra-bony defect in stage-iii periodontitis patients. the main question aims to answer are: will albumin platelet rich fibrin (alb-prf) as adjunct to minimally invasive surgical technique (mist) be superior in terms of improvement in clinical parameters compared to the use of prf with mist.


Eligibility criteria:
inclusion criteria: 1. stage iii periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (cal) ≥5mm and probing pocket depth (ppd) ≥6 mm with no defect extending to a root furcation area. 2. vital teeth. 3. no history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months. 4. no periodontal therapy carried out in the past 6 months. 5. ability to sign an informed consent form. 6. patients age ≥18 years old. 7. patients who are cooperative, motivated, and hygiene conscious. 8. systemically free according to cornell medical index. exclusion criteria: 1. patient undergoing orthodontic treatment. 2. pregnant females or breast feeding. 3. smokers. 4. teeth mobility greater than grade i.

Keywords: albumin platelet rich fibrin (alb-prf) minimally invasive surgical technique (mist) stage 3 periodontitis intrabony defect
couple-focused intervention for breast cancer patients

Conditions: Breast Cancer

Summary: the goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions developed to reduce the psychological distress on women and their partners during and after the breast cancer experience. the first group, an enhanced couple-focused group (ecg), incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills) as well as basic relationship communication and support skills (e.g., expressing support needs constructively). the second group, a couples' support group (sg), is a non-structured group where general topics are discussed. the investigators will evaluate the impact of each group condition on patients' psychological adaptation, social and role functioning, and cancer treatment adherence. the investigators will also evaluate whether patient and partner perceptions of relationship support, relationship intimacy, stress management skills, and intervention group support mediate the groups' effects on each other's psychological adaptation. the investigators hypothesize that ecg will have stronger positive effects on patient general and cancer-related distress and well-being than sg. the investigators hypothesize that group support will mediate greater improvements in patient psychological functioning in both groups but that the effects of group support will be significantly stronger in sg than ecg.


Eligibility criteria:
inclusion criteria: * patient has a primary diagnosis of stage 0 (ductal carcinoma in situ), 1, 2, or 3a breast cancer * patient has had breast cancer surgery within the last twelve months * patient and partner married or cohabitating * patient and partner 18 years of age or older * patient and partner speak and read english * patient and partner can provide meaningful informed consent * patient and partner do not have any chronic physical or cognitive illness that would preclude participation in the group sessions * couple lives within 2 hour commuting distance to the center from which they are recruited exclusion criteria: - patient is male

Keywords: women couples counseling groups support intervention marriage