Kornimate/medical-research-clean huggingface dataset:
carotid body removal for the treatment of resistant hypertension: a pilot study

Conditions: Hypertension

Summary: this is a pilot study to assess the effectiveness, safety and feasibility of carotid body removal in patients with high blood pressure (hypertension) resistant to medical treatment. patients with high blood pressure are at significant risk of medical complications including stroke and heart disease. the principle research question is whether removal of the carotid body will lead to an improvement in the blood pressure of this patient group.


Eligibility criteria:
inclusion criteria: * resistant htn criteria with either confirmed sleep disordered breathing. definition of htn:office sbp ≥ 160 mmhg and daytime mean abpm ≥ 140 mm hg * definition of sleep disordered breathing: sdb defined as mild to moderate obstructive, central or mixed sleep apnea defined as 5 \< ahi \< 30 with o2 desaturation not exceeding 80% during the night. exclusion criteria: * calculated gfr \< 30 * carotid body located outside the defined carotid septum * obstructive carotid atherosclerotic disease * oxygen desaturation at rest below 92% * known structural lung disease (medical interview) * requirement for oxygen therapy to maintain oxygen saturation * patients wish to participate in mountain climbing, skin diving or free diving * pregnancy or anticipation of pregnancy * palliative care/chemotherapy * acute coronary syndrome or unstable angina \< 6 months prior to procedure * use of exogenous insulin and history of hypoglycemic unawareness * stroke or transient ischaemic attack (tia), or myocardial infarction \< 6 months prior to procedure * expected life expectancy less that 24months due to other disease * intravenous drug use * excessive use of alcohol or sedatives (alcohol intake \>28 units/week) * obesity (bmi \> 40) * upper airway or facial abnormalities * large neck circumference (\>43.2 cm men; \>40.6 cm women) * febrile illness within two weeks of participation * unable to attend for follow up appointments at 1, 3 and 6 months post operatively.
hcv-rna kinetics during sorafenib for hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Cancer

Summary: this research study is a phase iv clinical trial. phase iv trials are used to further test and monitor the safety of a drug approved by the fda and to see if the drug has any other indications that can be used to treat different diseases. sorafenib is a new drug, which is approved under the brand name nexavar for the treatment of liver cancer. it is also currently being tested in various other cancers. sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. by slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors. the researchers of this study would like to study the effects of sorafenib on hepatitis c by drawing additional research blood samples from people infected with hepatitis c who are receiving sorafenib treatment for liver cancer. these tests will measure certain proteins in the blood (hcv-rna) which may indicate if sorafenib has any effect on the hepatitis c virus.

this is a prospective, open-label, non-interventional trial to evaluate hcv-rna levels during treatment with sorafenib in patients with advanced hepatocellular carcinoma. participants will receive sorafenib 400mg orally twice daily. hcv-rna (hepatitis c virus - ribonucleic acid) levels will be measured at baseline, week 2 of sorafenib, week 4 of sorafenib, week 6 of sorafenib, week 8 of sorafenib, week 12 of sorafenib, and 2 weeks after discontinuing sorafenib. hcv-rna levels will be measured by drawing about 2 tablespoons of blood during the study period, tumor assessments will be done by mri (magnetic resonance imaging) or ct (computed tomography) scans at baseline and every 8 weeks.

Eligibility criteria:
inclusion criteria: * histologically and/or radiologically confirmed advanced hcc * detectable hcv rna with anti-hcv-positivity * life expectancy of at least 3 months * willing to use adequate contraception exclusion criteria: * pregnant or breastfeeding * undetectable hcv rna * uncontrolled hypertension * active or clinically significant cardiac disease * thrombolic, embolic, venous or arterial events within 6 months of informed consent * pulmonary hemorrhage/bleeding event (nci-ctcae grade 2 or higher) within 4 weeks before study entry * previously untreated or concurrent cancer except cervical cancer in situ, treated basal cell carcinoma or superficial bladder tumor * presence of non-healing wound, ulcer or bone fracture * history of organ allograft * known or suspected allergy or hypersensitivity to any of the study drugs * any malabsorption condition * inability to comply with the protocol and/or not willing or not available for follow up * major surgery within 30 days prior to start of study drug

Keywords: hepatitis c positive
pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy

Conditions: Sarcoma, Soft Tissue

Summary: a randomized double blind phase iii trial of pazopanib versus placebo in patients with soft tissue sarcoma whose disease has progressed during or following prior therapy


Eligibility criteria:
inclusion/exclusion criteria: * high or intermediate grade of soft tissue sarcoma; low grade tumours allowed provided there is disease progression. * metastatic and measurable disease (recist); * subjects can have received maximum of 4 prior lines of systemic therapies (including up to 2 combination regimens) for advanced disease. (neo) adjuvant/maintenance treatments are not counted for this criterion; * last dose of prior therapy can be given upto 14 days prior to start of study if all ongoing toxicity from prior anticancer therapy are grade 1 or resolved (except alopecia). * must have failed anthracycline-based therapy and available standard chemotherapies at the treating institution except if medically contraindicated or refused by patient; * no treatment with anti-angiogenesis inhibitors; * age \> 18 years * who ps 0-1; * no leptomeningeal or brain metastases, normal bone marrow, liver, renal and cardiac functions; * no prior history of malignancies other than sarcoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix or breast or the patient has been free of any other malignancies for \> 3 years) * adequate bone marrow function; adequate blood clotting results; adequate hepatic and renal function; * no poorly controlled hypertension; * clinically normal cardiac function; * no clinically significant gastrointestinal abnormalities including malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment. * no cerebrovascular accidents 1 * no transient ischemic attack, deep vein thrombosis or pulmonary embolism within past six months; * no active bleeding or bleeding diathesis; * no hemoptysis within six weeks of study drug; * no major surgery or trauma within 28 days of therapy treatment; * concomitant medication restriction; * no known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib * ability to swallow \& retain oral medication * adequate contraception must be used; * no psychological familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomization in the trial.

Keywords: metastatic soft-tissue sarcoma pazopanib soft tissue sarcoma placebo
diaport closed-loop artificial pancreas

Conditions: Type 1 Diabetes Mellitus

Summary: the primary purpose of this pilot study is to test an artificial pancreas system which uses the intra-peritoneal (ip) route for insulin delivery in type 1 diabetic patients.

during this study, the investigators would like to evaluate the intra-peritoneal insulin delivery as a potential breakthrough method for delivering insulin within the artificial pancreas system. the intent is to exploit the rapid action achieved by ip insulin to compensate for meals and for management of the basal insulin needs. patients will come for two closed-loop admissions of 24 hours. the first closed-loop will be performed using subcutaneous route, whereas the second one will be performed using the intra-peritoneale route.

Eligibility criteria:
inclusion criteria: * patient must be aged between 18 (inclusive) and 65 years old * patient must have been clinically diagnosed with type 1 diabetes mellitus for at least one year * patient must have been identified as presenting an indication for the diaport® system, i.e. showing poor glucose control under sc insulin delivery as shown by a sustained hba1c level \> 8% and/or high blood glucose variability including recurrent hypoglycemic events. patient will be eligible for the study because he/she will have a diaport implanted. * patient must demonstrate proper mental status and cognition for the study * patient must be affiliated or beneficiary of a social medical insurance * patient has signed informed consent form prior to study entry exclusion criteria: * unwilling to perform repeated glucose checks, consume standardized meals, and/or take insulin as instructed * evidence of cardiovascular event during the previous 6 months, non stabilized retinopathy, or clinically significant screening laboratory abnormalities * pregnancy, breast feeding, or intention of becoming pregnant * medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions. * patient is actively enrolled in another clinical trial or was part of study within 30 days or whose annual study income is over 4 500€ * persons deprived of freedom, adults protected by law or vulnerable persons

Keywords: type 1 diabetes, diaport, artificial pancreas, zone mpc algorithm, ap system, intraperitoneal insulin
transcutaneous vagus nerve stimulation in patients with chronic heart failure

Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Midrange Ejection Fraction

Summary: to verify the efficacy of transcutaneous vagus nerve stimulation (tvns) on and autonomic balance in patients with chronic heart failure and reduced (hfref) or mildly reduced (hfmref) left ventricular ejection fraction. the study hypothesis is that tvns increases baroreflex gain, with consequent benefits on sympathovagal balance (at short- and mid-term), and on quality of life and bio-humoral parameters (at mid-term).

pilot phase: comparing the effects of right- (10-minute) vs. left-sided tvns (10-minute) on brs and heart rate variability (hrv) in a subset of patients. short-term phase: comparing the effects of active- (10-minute) vs. sham-tvns (10-minute) on brs, hrv, and sympathetic nerve activity. mid-term phase: comparing the effects of active- (4-week) vs- sham-tvns (4-week) on brs, hrv, biomarkers, exercise performance, and cardiac function.

Eligibility criteria:
inclusion criteria * aged ≥18 years; * ability to consent to enrollment; * diagnosis of chronic heart failure (chf= and left ventricular ejection fraction \<50% according to the latest european guidelines. exclusion criteria * history of acute coronary syndrome within 3 months of enrollment; * clinical need to modify chf therapy during the study; * history of recurrent syncope, orthostatic hypotension, severe bradycardia (average heart rate \<50 bpm), or second or third-degree atrioventricular block; * neurological conditions characterized by dysautonomia (e.g., parkinson's disease); * unstable major psychiatric disorders or treatment with psychoactive drugs or drugs that can act on the autonomic nervous system (e.g., antidepressants, antipsychotics, opioids, benzodiazepines); * uncontrolled thyroid disorders; * active neoplasia; * severe renal insufficiency (estimated glomerular filtration rate \<15 ml/min/1.73 m2); * moderate or severe chronic obstructive pulmonary disease (fev1/fvc \<70% of predicted and fev1 \<70%); * liver insufficiency (ast/alt \>100 u/l and/or gamma-gt \>150 u/l); * participation in other clinical studies in the 3 months preceding; * women in pregnancy, breastfeeding, or of childbearing age not following adequate contraception (the woman must agree to abstain from heterosexual intercourse or use at least two effective contraceptive measures such as bilateral tubal ligation, male sterilization, use of hormonal contraceptives that inhibit ovulation, intrauterine devices releasing hormones, copper intrauterine devices; all barrier devices must be used in combination with a spermicidal cream).
exercise therapy and jaw-mobilizing device for trismus in head and neck cancer patients

Conditions: Head and Neck Cancers; Trismus; Radiotherapy Side Effects

Summary: this study evaluates the effects of exercise therapy combined with a jaw-mobilizing device on enhancing quality of life in head and neck cancer patients undergoing radiotherapy.

this study investigates the efficacy of exercise therapy combined with a jaw-mobilizing device (et-jmd) in improving maximal mouth opening (mmo), preventing trismus, enhancing quality of life (qol), and alleviating trismus-related symptoms in head and neck cancer (hnc) patients undergoing radiotherapy.

Eligibility criteria:
inclusion criteria: * age ≥ 20 years. * ability to communicate in mandarin or taiwanese, without significant reading, hearing, or writing impairments, and capable of completing questionnaires independently or with researcher assistance. * diagnosed with head and neck cancer and scheduled for initial radiotherapy to the head and neck region. * clear consciousness without severe cognitive or psychiatric disorders. * presence of intact central incisors (#11, #41) on the right side or (#21, #31) on the left side of both the upper and lower jaws. * baseline maximal mouth opening (mmo) ≥ 25 mm. * willingness to participate in the study with signed informed consent. exclusion criteria: * known temporomandibular joint disorders. * postoperative wound healing complications diagnosed by a physician that prevent participation in mouth-opening rehabilitation exercises.

Keywords: head and neck cancer trismus radiotherapy-induced mouth opening limitation
s-1 and radiotherapy for elderly esophageal cancer patients

Conditions: Esophageal Cancer; S-1; Radiotherapy

Summary: to investigate the efficacy and toxicity of s-1 with concurrent radiotherapy in older patients with esophageal cancer.

older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including concurrent chemoradiotherapy. in this phase ii trial, the efficacy and toxicity of s-1 with concurrent radiotherapy will be investigated in this setting.

Eligibility criteria:
inclusion criteria: 1. cytologically or histologically confirmed esophageal carcinoma; 2. ecog performance status: 0-1; 3. no treatments prior to enrollment; 4. at least one measurable lesion on ct, mri or esophageal barium exam; 5. normal functions of heart, lung, liver, kidney and bone marrow; 6. blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/l and platelet (plt) ≥100×109/l, creatinine ≤1.5 unl; 7. informed consent signed. exclusion criteria: 1. prior treatments of chemotherapy or irradiation; 2. poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable; 3. contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis; 4. participating in other clinical trials; 5. clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities; 6. the subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

Keywords: esophageal cancer radiotherapy elder s-1
a plaque test study with leo 35299 in psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: the purpose of the study is to evaluate the anti-psoriatic effect of leo 35299 in different formulations, compared to daivonex® ointment and daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by kj dumas and jr scholtz.


Eligibility criteria:
inclusion criteria: 1. following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out. 2. age 18 years or above. 3. males, or females of non-child bearing potential. 4. subjects with, in the opinion of the investigator, stable psoriasis based on total plaque score evaluated at screening visit and at visit 2 (baseline). exclusion criteria: 1. male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application. 2. female subjects who are pregnant, of child-bearing potential or who are breast feeding. 3. systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months(adalimumab, alefacept, infliximab), 4 months(ustekinumab) or 4 weeks/5 half-lives (which-ever islonger) for experimental biological products prior to randomisation and during the study. 4. systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within the 4-week period prior to randomisation and during the study. 5. subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study: - potent or very potent (who group iii-iv) corticosteroids. 6. subjects using of phototherapy within the following time periods prior to randomisation and during the study: * puva (4 weeks) * uvb (2 weeks) 7. subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study: * who group i-ii corticosteroids (except if used for treatment of scalp and/or facial psoriasis) * topical retinoids * vitamin d analogues * topical immunomodulators (e.g. macrolides) * anthracen derivatives * tar, * salicylic acid. 8. subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis 9. subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview 10. subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments) 11. subjects with current participation in any other interventional clinical, based on interview of the subject
thalidomide 100 mg/day versus thalidomide 400 mg/day in relapse refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the objective of this study is to show that thalidomide at a dose of 100 mg/d (with remedial treatment with dexamethasone if a progression occurs) is equivalent in terms of efficacy with thalidomide at 400 mg/d (with remedial treatment with dexamethasone if a progression occurs) in the treatment of refractory or relapsed multiple myeloma after at least two courses of treatment. the use of thalidomide at 100 mg/d should reduce the side effects and improve the safety of the treatment.


Eligibility criteria:
inclusion criteria: * patient over 18 years who has been informed about the potential risks and side effects of the treatment and having signed an informed consent to take part in the various aspects of the study. * having a refractory or relapsed multiple myeloma after at least two courses of treatment. * the patients with a refractory or relapsed multiple myeloma after a single course of treatment that included an alkylating drug, can be included if there is no alternative treatment. * concerning the thalidomide: agreement to use and introduction of effective contraception by all the patients: 1. for women of childbearing potential * oral estroprogestogen contraception introduced at least 1 month before the first administration of thalidomide, and continued until the first menstruation following the end of the treatment, and their partners use a condom. * qualitative serum test for beta-hcg negative: to be done on day 2 or 3 of the menstrual cycle just before the 1st prescription of thalidomide; in a context of spaniomenorrhea or amenorrhea the test should be done within 3 days after the 1st prescription of thalidomide. 2. for post-menopausal women * 1st situation: known sterility due to: * total hysterectomy; * total ovariectomy; * total salpingectomy * 2nd situation: natural menopause * amenorrhea for at least 1 year and * negative progestagen test and * plasma fsh \> 50 iu/l 3. for men: throughout the duration of the treatment and for 3 months after the end of the protocol (i.e. one spermatogenesis cycle), sexual intercourse must always be protected by using a condom. exclusion criteria: * pregnant or breast-feeding women or those of childbearing potential who are not using an effective method of contraception or the lack of protection during sexual intercourse in men. * patients who have already received treatment with thalidomide. * contraindication to thalidomide. * patient who has an absolute contraindication to dexamethasone. * patient with a history of deep vein thrombosis and who is not taking effective oral anticoagulation (the anticoagulant must be continued throughout the entire study). * performance index more than or equal to 3, unless the patient is bedridden as a result of the progress of the myeloma. * any situations that do not permit adequate follow-up of the study.

Keywords: multiple myeloma, thalidomide, dose, dexamethasone