Kornimate/medical-research-clean huggingface dataset:
telehealth in improving quality of life in patients during post radiation therapy visits

Conditions: Malignant Neoplasm

Summary: this pilot clinical trial studies how well telehealth works in patients during post radiation therapy visits. a telehealth virtual office visit can be performed from the patient's home or workplace, decreasing time spent traveling to visit site, time spent in waiting room, and cost to patient. studying telehealth may improve quality of life in patients during post radiation therapy visit.

primary objectives: i. to examine feasibility of conducting a trial comparing a telehealth visit and an in person office visit. secondary objectives: i. to examine patient satisfaction, patient assessment of physician communication during a telehealth visit. ii. to examine patient distrust in the healthcare system following a telehealth visit. iii. to examine physician ability to perform a patient assessment during a telehealth visit. iv. to examine physician perceptions of telehealth visits. v. to examine monetary and time cost to patients for telehealth visit. vi. to calculate clinic savings derived from telehealth visits. outline: patients undergo their first post-treatment visit as a virtual telehealth visit using the jeffconnect application.

Eligibility criteria:
inclusion criteria: * patients currently undergoing or planned to start radiation treatment with curative, adjuvant or palliative intent * karnofsky performance status (kps) score \>= 60 * patients must be capable to read and speak english and provide study specific informed consent prior to study entry * patients must have access to a computer or smartphone and internet connection at home on which they would be willing to do a telehealth study * pennsylvania or new jersey residents \*telehealth visits for new jersey residents will only be performed by physicians with a current medical license issued by the state of new jersey. exclusion criteria: * kps \< 60% * no access to a computer, smartphone or internet * unable to read and/or speak english * decisionally impaired patients * patients not residing in pennsylvania or new jersey
the effects of periodontal therapy on gingival crevicular fluid nlrp3,caspase-1,il-1β levels in children with gingivitis

Conditions: Gingivitis

Summary: this study aims to determine the levels of nlrp3, caspase-1 and il-1β concentrations in the gingival crevicular fluid of paediatric patients with gingivitis and their changes after periodontal treatment.

after being informed about the study and potential risks, necessary periodontal measurements will be performed and gingival crevicular fluid will be collected from all patients who gave written informed consent, and patients with gingivitis will be followed up on the 7th and 30th day after periodontal treatment.

Eligibility criteria:
inclusion criteria: inclusion criteria for the group with gingivitis; * systemically healthy * 11-14 years old * permanent dentition * no need for endodontic and restorative treatment * gingivitis with gingivitis * have verbally and in writing agreed to participate in the study and are willing to attend follow-up appointments regularly participants will be included in the study. inclusion criteria for the healthy group; * systemically healthy * 11-14 years old * permanent dentition * no need for endodontic and restorative treatment * periodontally healthy * have verbally and in writing agreed to participate in the study and are willing to attend follow-up appointments regularly participants will be included in the study. exclusion criteria * in need of endodontic and restorative treatment * systemically unhealthy * patients who do not give verbal or written consent

Keywords: nlrp3 caspase-1 il-1β gingivitis gcf
a long-term study of tirzepatide (ly3298176) in adults with type 1 diabetes and obesity or overweight

Conditions: Type 1 Diabetes; Obesity; Overweight

Summary: the main purpose of this study is to find out how well and how safely tirzepatide works long-term in adults who have type 1 diabetes and obesity or overweight. participation in the study will last about 20 months.


Eligibility criteria:
inclusion criteria: * have type 1 diabetes and on insulin treatment for at least one year prior to screening * have an hba1c value of 7.0% to 10.5% inclusive, at screening * have a body mass index (bmi) of ≥25 kilograms per square meter (kg/m2) at screening * are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study exclusion criteria: * have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (dka)) during the period of 180 days prior to screening and until randomization. * have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization. * are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * have had chronic or acute pancreatitis * have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening
efficacy of pentoxifylline and alpha lipoic acid in pcos resistant to clomiphene citrate

Conditions: Clomiphene Citrate; Resistant Ovary Syndrome; Polycystic Ovary Syndrome

Summary: this study evaluate the addition of ptx and ala to clomiphene citrate in the treatment of polycystic ovary.

clomiphene, ptx and ala each used in treatment of pco but they do so by different mechanisms. clomifene is in the selective estrogen receptor modulator (serm) family of medication. it works by causing the release of gonadotropin-releasing hormone by the hypothalamus, and subsequently gonadotropin from the anterior pituitary. ptx and ala are used in treatment of pco due its anti-oxidant effect.

Eligibility criteria:
inclusion criteria: 1. patients will be diagnosed as having pcos according to the rotterdam criteria for diagnosis of pcos 2. age between 18 and 39 years. 3. period of infertility \>1 years. 4. patients who have previously received clomiphene citrate (cc) and being diagnosed as having cc resistance 5. body mass index (18-30) kg/m2. exclusion criteria: 1. history of pelvic surgery or infertility factor other than anovulation 2. endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and cushing syndrome, as detected by history, examination, or investigations. 3. known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin k deficiency. 4. consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date. 5. male factor infertility (sperm count \< 5 million per milliliter, normal morphology \<4%). 6. elevated serum prolactin, t.s.h and f.s.h. 7. patients diagnosed with diabetes mellitus 8. patients who are hypersensitive to pentoxifylline or other xanthines such as caffeine, theophylline and theobromine or to any ingredient in the formulation or component of the container. 9. patients with acute myocardial infraction, severe coronary artery disease. 10. patients with hemorrhage or at risk of increased bleeding and patients with peptic ulcers.

Keywords: pentoxifylline alpha lipoic acid polycystic ovary clomiphene
work place adjusted intelligent physical exercise reducing musculoskeletal pain in shoulder and neck (vims) - industrial workers

Conditions: Non-specific Pain of the Neck and Shoulder

Summary: the purpose of this study is to investigate the effect of specific resistance training on neck/shoulder pain in industrial workers.


Eligibility criteria:
inclusion criteria: * industrial worker exclusion criteria: * trauma, life threatening diseases, pregnancy
radiation therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. radiation therapy may be an effective treatment for prostate cancer. purpose: phase i trial to study the effectiveness of radiation therapy in treating patients who have stage ii or stage iii prostate cancer.

objectives: i. determine the maximum tolerated dose of radiotherapy using 3-dimensional (3d) conformal techniques in patients with stage ii or iii adenocarcinoma of the prostate. ii. determine the morbidity of high-dose 3d conformal therapy in these patients. outline: this is a dose escalation study. patients undergo 3-dimensional conformal radiotherapy 4-5 days a week for at least 8 weeks. cohorts of 20-40 patients receive escalating doses of radiotherapy until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which no more than 10% of patients experience dose-limiting toxicity. patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter. projected accrual: a minimum of 40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: locally advanced (t2c-t3) adenocarcinoma of the prostate including: bulky tumors confined to prostate (stage ii) tumors extending beyond capsule (stage iii) psa no greater than 20 ng/ml no regional lymph node involvement (by ct scan or surgical sampling) no distant metastases patient characteristics: age: 18 and over performance status: karnofsky 60-100% life expectancy: not specified hematopoietic: wbc greater than 4,000/mm3 platelet count greater than 100,000/mm3 hemoglobin greater than 11 g/dl hepatic: not specified renal: not specified other: no major medical or psychiatric illness that would preclude study no metallic pelvic prosthesis prior concurrent therapy: biologic therapy: no prior biologic therapy chemotherapy: no prior chemotherapy endocrine therapy: prior hormonal therapy allowed radiotherapy: no prior radiotherapy (including pelvic irradiation) surgery: no prior radical surgery for carcinoma of the prostate

Keywords: adenocarcinoma of the prostate stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer
efficacy and safety of recombinant factor viii (greengene) in patients with hemophilia a

Conditions: Hemophilia A

Summary: the purpose of this study is to study the evaluation of efficacy and safety of greengene (recombinant factor viii).


Eligibility criteria:
inclusion criteria: * hemophilia a patients at least 12 years of age * at least 150 treatment exposure-days to previous fviii products * fviii≤2% at screening or diagnosis (fviii≤1% for pk study) * cd4 lympocyte cell count\>400/㎕ * patients willing to cooperate for the study * patient's or legal guardian's consent to participate in the study exclusion criteria: * fviii inhibitor(neutralizing antibody to fviii)≥0.6 bethesda units * coagulation disorders other than hemophilia a (e.g. idiopathic thrombocytopenic purpura, von willebrand disease) * platelet count≤100,000㎣ * subjects with clinical evidence of symptomatic hiv disease regardless of hiv-seroposive/seronegative * subjects with rfviii antibody, mouse igg antibody, or cho antibody * creatinine levels more than 2 times of reference rage, got and gpt levels more than 3 times of reference range, diabetes mellitus or other metabolic disorder * subjects with diastolic blood pressure≥100mmhg not controlled with antihypertensive medications * anemia(hemoglobin\<12g/dl) * subjects with severe or life-threatening bleeding just before entry into the trial * subjects with a history of treatment failure due to formation of inhibitor to fviii * subjects with a history of severe hypersensitive reactions to fviii concentrate * subjects requiring pre-medication for fviii infusion(e.g. antihistamines, etc)

Keywords: hemophilia a factor viii recombinant
randomized trial comparing colesevelam vs. ezetimibe

Conditions: Type 2 Diabetes Mellitus

Summary: a 24-week, randomized, open-label study investigating the efficacy, safety and tolerability of colesevelam 3.75 g daily compared to ezetimibe 10 mg daily, as an add-on to baseline statin therapy in patients with type 2 diabetes mellitus (t2dm) who are not at target for glycated hemoglobin (hba1c) (\> 7.0%) and low-density lipoprotein (ldl) cholesterol (\> 2.0 mmol/l).

this study will enroll 200 adult patients with t2dm who are not at target for hba1c and ldl cholesterol. patients who are on baseline statin therapy will be randomly assigned in a 1:1 ratio to colesevelam 3.75 g daily for 24 weeks, or ezetimibe 10 mg daily for 24 weeks. if a patient has statin intolerance, they may be on a fibrate and/or niacin, or on no lipid lowering therapy. the primary efficacy objectives are 1. to demonstrate that colesevelam 3.75 g daily is non-inferior to ezetimibe 10 mg daily as add-on to statin therapy for patients achieving a composite target of hba1c (≤ 7.0%) and ldl cholesterol (≤ 2.0 mmol/l) at week 24, and 2. to compare the proportion of patients achieving a composite target of hba1c (≤ 7.0%) and ldl cholesterol (≤ 2.0 mmol/l) at week 24. this study will also assess the primary composite outcome in a sub-group of patients on sodium/glucose cotransporter 2 inhibitor (sglt2i) therapy.

Eligibility criteria:
inclusion criteria: 1. diagnosis of type 2 diabetes \> 6 months 2. hba1c level between 7.1 to 10.0% (inclusive) within three months of study enrollment 3. ldl cholesterol \> 2.0 mmol/l within three months of study enrollment 4. receiving a stable dose of statin for a minimum of three months, which the investigator does not plan to change over the 24-week trial period. if patient has documented statin intolerance, may be on a fibrate and/or niacin, or on no lipid lowering therapy 5. stable diabetes medications for previous three months (apart from adjustment of insulin dose) 6. informed consent exclusion criteria: 1. use of a second lipid lowering therapy other than statin within three months of study enrolment, unless on a fibrate and/or niacin if patient has statin intolerance 2. triglycerides ≥ 5.0 mmol/l or incalculable ldl cholesterol 3. significant liver enzyme or ck elevation defined as ck or alt ≥ 3x upper limit of normal (uln) 5) pregnant or breast feeding or planning to become pregnant or breast feed during the study 6) chronic kidney disease (ckd) stage ≥4 or estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m-squared 7) severe gastroparesis or history of significant bowel resection 8) current use of any investigational product

Keywords: diabetes hyperlipidaemia colesevelam ezetimibe ldl cholesterol glycated hemoglobin
cardio-oncology registry

Conditions: Cancer; Cardiac Disease; Metabolic Syndrome; Arrhythmia; Heart Diseases

Summary: cardio-oncology is an emerging field. most of the data available have been issued from either retrospective analysis, industry data or pharmacovigilance data. these data sources include a number of bias. confucius is a single tertiary centre prospective registry including all patients who have been referred for cardio-oncology assessemnt. the objectives are to provide a comprehensive vue of cardoi-oncology, enable to detect early signals of cardiotoxicity and enhance ancillary projetcts aiming at specific populations (e.g., type of cancer) and/or drugs.


Eligibility criteria:
inclusion criteria: * referred to cardio-oncology exclusion criteria: * refusal to participate

Keywords: cancer heart cardiovascular cardio-oncology onco-cardiology phamacology precision medicine
hip osteoarthritis and foot orthoses trial (hoot)

Conditions: Hip Osteoarthritis

Summary: this trial is a randomized feasibility trial to determine the feasibility of comparing two different shoe inserts and on pain, quality of life and physical activity associated with hip osteoarthritis.

participants will be randomized to one of two groups - contoured prefabricated foot orthoses or flat shoe inserts (the comparator). participants will be asked to use the inserts daily for a six week period. adherence to the intervention will be monitored using a daily diary, as well as adverse events and co-interventions. the primary outcome is feasibility domains (demand, implementation, acceptability, practicality) with secondary outcomes of change in hip-related pain and quality of life and physical activity levels. the primary time-point will be 6-weeks.

Eligibility criteria:
inclusion criteria: primary symptomatic and radiographic hip oa, in accordance with the american college of rheumatology (i) aged \> 45 years; (ii) pain in the hip or groin for more than 3 months; (iii) average pain intensity over the past week of \> 3 out of 10 (numerical rating scale) during functional tasks like walking, climbing stairs or climbing in/out of a car; (iv) radiographic confirmation of hip osteoarthritis with a kellgren-lawrence score ≥ 2 within the last 12 months; (v) mild to moderate disability indicated by; 1. able to reciprocally ascend and descend 10 stairs unaided, 2. able to safely walk one city block, and 3. able to jog five meters if required exclusion criteria: (i) other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional (doctor, physiotherapist, podiatrist etc) in the last 6 months; (ii) have received active treatment for their hip pain by a health professional (eg physiotherapist) in the last 3 months; (iii) history of hip trauma or surgery on the affected side; (iv) corticosteroid use (oral or intra-articular injection) in the past 3 months (v) neurological impairment or condition affecting lower limb function (vi) conditions or factors affecting ability to take part in the intervention, e.g., unavailable for a 6 week intervention period, routine use of gait aids, uncontrolled hypertension, or morbid obesity (body mass index \> 40); (vii) use of foot orthoses in the previous 12 months (viii) systemic inflammatory disease (e.g. rheumatoid arthritis); (ix) unable to write, read or comprehend english.
brief internet intervention for hazardous alcohol use to people seeking online help for depression

Conditions: Depression; Problem Drinking

Summary: hazardous alcohol consumption is common among people suffering from depression. there are effective internet interventions that target hazardous alcohol consumption or depression separately but none that combine these online interventions without the involvement of a therapist. this study aims to evaluate the effects of combining an internet intervention targeting hazardous alcohol consumption with one for depression on drinking and depressive symptoms.

a double-blinded, parallel group randomized controlled trial will be used. participants with current depression who also drink in a hazardous fashion (n=986) will be recruited for a study to 'help improve an online intervention for depression.' participants will be assigned, by chance, to receive moodgym or to receive moodgym plus a brief internet intervention for hazardous alcohol consumption - check your drinking (cyd). participants will be contacted 3- and 6-months after receiving the interventions to assess changes in drinking and depression status. it is predicted that participants receiving the cyd intervention in addition to moodgym will reduce their alcohol consumption to a greater extent than those who just received moodgym. further predictions include the impact of receiving check your drinking on improvements in depressive symptoms.

Eligibility criteria:
inclusion criteria: * 18 years of age or over * score 10 or more on the patient health questionnaire (phq-9) * score 8 or more on the alcohol use disorder identification test (audit) exclusion criteria: * current suicidal ideation on the phq-9
face reconstruction by allotransplantation of composite tissues

Conditions: Reconstruction of the Face

Summary: to show the feasibility of face transplantation in patients

most facial defects can be reconstructed with autologous tissues using standard plastic surgical techniques. however, when the circular facial muscles (eg. orbicularis oculi and orbicularis oris) are destroyed by burns, ballistic traumas, tumors, or congenital deformities there are no conventional surgical solutions. the study was designed following the advice of the french national ethics advisory committee for life sciences and health (ccne). the objectives are to study the feasibility and efficacy of face cta transplantation, functional results, and influence on quality-of-life, as well as the management of immunosuppression.

Eligibility criteria:
inclusion criteria: * age 18 through 65 years * signed written informed consent * patient with a loss of substance of the median third of the face by traumatisms or not carrying the totality of the lips with or without the nasal pyramid. * validation of the feasibility by a committee of expert in plastic surgery and maxillofacial * patient with a positive psychologic evaluation * patient with an anatomical evaluation and assessment pretransplantation positive normal infectious assessment * good compliance and capacity of adaptation to the assessment difficulties * patient with renal, hepatic, hematologic ,cardiac normal * patient profiting from a social security cover * patient informed patient, having signed a free assent lit with inclusion in the study exclusion criteria: * patient minor under supervision or deprived of freedom by court order or administrative. * person remaining in a medical or social establishment * pregnant. or breast-feeding women * patient presenting a sever cardiac pathology having a risk of decompensation into pre, per and post operational * patient presenting a hepatic pathology * any cancer that has been in complete remission for \> 5 years malignancies tumoral lesion of the face with 2 years deadline of remission respected renal insufficiency chronic clearance of creatin \< 60l ml/mn * chronic respiratory insufficiency * patient presenting an active infection which can be worsened by the immunosuppression * patient presenting an active infection which can be worsened by the corticoid * patient with affection being able to compromise post-operative survival * patient with digestive ulcer * no known hiv infection * serology hepatitis b with circulating dna highlighted quantitatively * personality emotional unstable * schizophrenic or not schizophrenic psychosis

Keywords: allotransplantation:composite tissue face transplantation
the effect of a red rice and olive extract nutrition supplement on cholesterol levels in patients with metabolic syndrome

Conditions: Hypercholesterolaemia

Summary: this randomised controlled trial studies the effect of a commercially available nutritional supplement on cholesterol levels in people with metabolic syndrome and elevated cholesterol levels.


Eligibility criteria:
inclusion criteria: * metabolic syndrome according to atpiii criteria 3 of the following: * waist circumference \>88cm (in females) or \>102cm (in males) * triglycerides \>150mg/dl * hdl \<40 (50)mg/dl in males (females) * blood pressure\>130/85 or treatment for aht * glucose \>110mg/dl exclusion criteria: * pregnancy * treatment with cholesterol lowering drugs