Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of abatacept in patients with diffuse systemic sclerosis (scleroderma)

Conditions: Scleroderma, Diffuse; Scleroderma, Systemic

Summary: systemic sclerosis (scleroderma) is an autoimmune connective tissue disease that involves the skin and other internal organs for which there are few effective treatment options. we hypothesize that treatment with abatacept, a new therapy recently approved for the treatment of rheumatoid arthritis, may reduce the progression of skin thickening and fibrosis in people with scleroderma.

systemic sclerosis is an autoimmune connective tissue disease of unknown etiology characterized by progressive fibrosis of the skin and internal organs, vascular damage, and autoantibody production. although the disease is relatively rare, it is associated with considerable morbidity and mortality. there have been improvements in survival over the past few decades; however, this has been related to better management of vascular manifestations of disease including renal crisis, pulmonary hypertension, gastroesophageal reflux disease, and raynaud's phenomenon. clinical studies of disease modifying therapies for cutaneous disease to date have been relatively unsuccessful. although the etiology of the disease remains unknown, several observations support the role of activated t cells in both the blood and skin of affected patients. abatacept, a recombinant fusion protein that blocks t cell activation, has recently been approved by the fda for rheumatoid arthritis. we hypothesize that inhibition of t cell activation with abatacept may be efficacious in the treatment of patients with diffuse systemic sclerosis. this is a randomized, double-blinded, placebo-controlled clinical trial of abatacept versus placebo in patients with diffuse systemic sclerosis. changes in validated measures of skin thickness and disease activity over 6-months of treatment will be compared between patients receiving abatacept and those receiving placebo. patients will be randomized 2:1 to receive abatacept. the protocol was amended during the study and the outcome measures "change in serum autoantibody profile" and "change in serum cytokine profile" were changed to exploratory outcomes.

Eligibility criteria:
inclusion criteria: * diagnosis of diffuse systemic sclerosis * age 18 years or older * adequate renal, pulmonary, and cardiovascular function * willingness to use effective contraception for the duration of the study if subject is of childbearing potential\&#xa; exclusion criteria: * other connective tissues diseases or overlap syndromes including mctd, sle, ra, eosinophilic fasciitis, and limited systemic sclerosis or morphea * use of disease modifying agents including methotrexate, cyclosporine,azathioprine, mycophenolate mofetil, minocycline, doxycycline, minocycline, thalidomide, penicillamine, tamoxifen, colchicine, or investigational agent within 90 days of screening visit * hiv, hepatitis b or hepatitis c infection * use of prednisone greater than 10mg daily for 28 days prior to screening visit * women who are breastfeeding or pregnant
florbetaben (bay94-9172) pet (positron emission tomography) imaging in mci (mild cognitive impairment) patients

Conditions: Alzheimer Disease; Amyloid Beta-Protein

Summary: the aim of the study is to investigate whether florbetaben (bay94-9172)positron emission tomography (pet) is able to distinguish between subjects with mild cognitive impairment (mci) progressing to alzheimer's disease (ad) from those with mci not progressing to ad.


Eligibility criteria:
inclusion criteria: * presence of mci defined as abnormal cognition on objective testing in the absence of dementia or significant functional loss. * absence of systemic or other neurological disease that may contribute to cognitive impairment or prevent follow-up over two years. * able to give written informed consent. * age \>/= 60 years of age * \>/= 7 years of education exclusion criteria: * mini mental state examination (mmse) score \< 24 at baseline * clinical dementia rating (cdr) score \> 0.5 at baseline * patients who receive regular medication of drugs which may adversely impact cognition (e.g. tricyclic antidepressants, antipsychotics and/or large doses of hypnotics or anxiolytics) * existing or history of cancer * history of severe head trauma, brain surgery or intracranial hematoma with permanent brain lesion * lifetime history of major affective disorder, schizophrenia, or schizo-affective disorder * contraindications to mri (magnetic resonance imaging) * relevant history, physical or imaging findings of neurological disease other than mci and mild depression * history of severe anaphylactic reaction or high risk of allergic reaction to drugs * patient has received another investigational drug in the preceding 14 days

Keywords: florbetaben amyloid beta-protein mci alzheimer's disease
study of high-dose letrozole therapy in postmenopausal patients with breast cancer

Conditions: Postmenopausal Women With Advanced Breast Cancer

Summary: to investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in postmenopausal patients with breast cancer, and to determine the blood concentrations of letrozole and hormones.


Eligibility criteria:
inclusion criteria: * patients with histologically documented breast cancer. * patients with hormone receptor (er and/or pgr) status of positive or unknown * patients who have been amenorrheic for the preceding 12 months or more. * patients who are 20 years or older and younger than 75 years. * patients with a history of postoperative adjuvant therapy or a history of endocrine therapy with tamoxifen for the treatment of progression or recurrence of the lesion. the endocrine therapy, however, should not exceed one regimen. * patients with progressing lesions. * patients with sufficient organ function to evaluate the safety * patients whose performance status (ps) is classified in 0～2. * patients who have no residual effects from previous treatments exclusion criteria: * patients with other concurrent or previous malignant disease (excluding uterine carcinoma in-situ). * patients with hypercalcemia and uncontrollable cardiac disease (including a history of serious cardiac disease) * patients who have previously received aromatase inhibitor. * patients who have lymphangitis-type lung metastasis or symptomatic brain metastasis. other protocol-defined inclusion / exclusion criteria may apply.

Keywords: aromatase inhibitor letrozole breast cancer
efficacy and safety of the distal radial approach

Conditions: Vascular Access Complication; Coronary Artery Disease

Summary: the aim of this non-inferiority trial is to determine if the distal radial access (dra) during percutaneous coronary intervention (pci) has an acceptable efficacy compared to the reference access through the conventional radial artery (tra) with a lower rate of radial artery occlusion (rao) in real life practice.

the conventional radial approach is the recommended vascular access for percutaneous coronary interventions. it is effective, feasible, but associated with a risk of occlusion of the radial artery. the distal radial approach is proposed as a new approach to reduce complications and preserve the radial artery. however, few clinical trials in real life were conducted in north african patients. this trial aims to evaluate the efficacy and safety of the distal radial approach versus the conventional radial approach. this trial is a non-inferiority, randomized controlled trial with two parallel arms: distal radial approach and conventional radial approach. two hundred and fifty patients scheduled for percutaneous coronary intervention will be included. the two main endpoints are the puncture success rate with a non-inferiority margin of 10% and the rate of 30-day occlusion of the punctured radial artery. secondary endpoints: catheterization success, crossover rate, procedure time, radial artery spasm, bleeding complications, quickdash score, pain score and operator satisfaction a single blind analysis will be led according to the per-protocol and intention-to-treat methods. avoiding occlusion of the puncture site allows to preserve the radial artery for subsequent coronary or cerebral percutaneous interventions as well as for coronary bypasses and hemodialysis fistulas. the results will provide the parameters related to the efficacy and safety of the distal radial approach, so improving clinical practice.

Eligibility criteria:
inclusion criteria: * over 18 years old. * hospitalized in the cardiology department of the military hospital of tunis. * elective percutaneous coronary intervention performed by experienced operators or fellows trained in the proximal and distal radial approach non-inclusion criteria: * not provided written informed consent * both radial arteries were used for prior catheterization * under oral anticoagulation * having coronary bypass surgery * hemodynamic instability * contra-indication to the radial approach: * orthopedic surgery: amputation * severe burns of both upper limbs. * radial artery pulse not palpable, negative modified allen test or barbeau classification type d * identified radial vascular anomaly: stenosis, fistula, tortuosity not allowing passage of the catheter exclusion criteria: * death within a short period of time after admission * pci by the same puncture site will be performed within 30 days after the first puncture * lost to follow-up

Keywords: radial artery coronary angiography percutaneous coronary intervention safety efficacy radial approach anatomical snuff box
imaging properties of pet radiotracer [18f]3f-phpg in patients with neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: the goal of this exploratory study is to test whether \[18f\]3f-phpg can be used reliably to map the locations of tumors in patients with neuroendocrine tumors. if so, the results of this study will be used to support further development of \[18f\]3f-phpg as a clinical tool for neuroendocrine tumor localization and staging.

subjects enrolled in this study will be recruited from the population of adult patients with neuroendocrine tumors, including pheochromocytoma and paraganglioma, being treated at the university of michigan hospital. the primary objective of the study is to obtain basic information on the biodistribution and pharmacokinetics of \[18f\]3f-phpg in cancer patients with neuroendocrine tumors. the secondary objective of the study is to compare the diagnostic performance of \[18f\]3f-phpg in cancer patients with neuroendocrine tumors with the fda approved radiopharmaceuticals \[123i\]metaiodobenzylguanidine (\[123i\]mibg) and \[68ga\]dota-tate in the same patients. a group of approximately 12 of the subjects scanned with \[18f\]3f-phpg will be recruited to undergo a whole-body \[123i\]mibg scan using planar scintigraphy with a gamma camera, following the standard clinical protocol used at the university of michigan. in addition, a single spect/ct scan of the primary neuroendocrine tumor will be acquired after the whole-body scan to provide a tomographic image for comparison with the positron emission tomography (pet) image acquired using \[18f\]3f-phpg. several subjects enrolled on this study will undergo \[68ga\]dota-tate scans off-study, as part of routine clinical management. existing \[68ga\]dota-tate scans will be obtained from consenting subjects' medical records. this is an exploratory study and thus all statistical data analyses will be exploratory in nature.

Eligibility criteria:
inclusion criteria: * current neuroendocrine tumor diagnosis * able to lie flat for 60 minutes * provision of informed consent exclusion criteria: * pregnancy or lactation * claustrophobia * inability to lie flat for 60 minutes * currently taking medications that may alter pet scans of neuroendocrine tumors with these tracers, including any of the following: * tricyclic antidepressants, which inhibit the norepinephrine transporter: desipramine, amitriptyline, imipramine * cold medications containing the sympathomimetic amines: phenylephrine, phenylpropanolamine, pseudoephedrine * nasal decongestants (some use phenylephrine as the active agent) * cocaine (which inhibits the norepinephrine transporter) * tetrabenazine (xenazine), which inhibits the vmat2 transporter * monoamine oxidase inhibitors (maoi) * some antihypertensive drugs: reserpine, labetalol, α-methyldopa, clonidine
plicated laparoscopic adjustable gastric banding study

Conditions: Weight Loss

Summary: compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable gastric banding in prospective clinical trial.

this is a prospective clinical trial comparing experimental plicated adjustable gastric banding versus standard adjustable gastric banding. all enrolled patients will choose to either standard (control group) banding or plication (study group) banding. each patient will complete a standardized survey rating their satisfaction from surgery, their satiety levels and green zone patient questionnaire at each visit.

Eligibility criteria:
inclusion criteria: * age older than 18 years * morbidly obese * bmi \>40 or * bmi \>35 plus co-morbid obesity related disease conditions * without contraindications to bariatric surgery: eg pregnancy, desire to become pregnant within the next 12 months, myocardial infarct within the last 6 months, cancer within last 5 years, end stage renal/liver disease * without any metabolic or medically correctable causes for obesity: eg untreated hypothyroidism, prader-willi exclusion criteria: * any patient not meeting the inclusion criteria * patients with any major medical problems contraindicating surgery * patients with a medically treatable cause of obesity * patients who elect to undergo a surgery other than plication adjustable gastric banding or standard adjustable gastric banding * alcohol or drug addiction * established infection anywhere in the body at the time of surgery * previous history of bariatric surgery, intestinal obstruction, or adhesive peritonitis * family or patient history of autoimmune disease

Keywords: gastric plication
a multiple dose trial of nnc 0151-0000-0000 in subjects with rheumatoid arthritis

Conditions: Inflammation; Rheumatoid Arthritis

Summary: this trial is conducted in europe. the aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of nnc 151-0000-0000 in subjects with rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * cz: age between 18 and 65 years (both inclusive) * a diagnosis of rheumatoid arthritis of at least three months before entry in trial * active rheumatoid arthritis (ra) * subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration exclusion criteria: * known or suspected allergy to trial product or related products * body mass index (bmi) less than 18.0 or more than 38.0 kg/m2 (inclusive)
study to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa (true-hs2)

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.


Eligibility criteria:
inclusion criteria: * diagnosis of hs for at least 6 months prior to screening visit. * mild to moderate hs (hurley i or ii) with the following at both screening and baseline visits: * a total an count of at least 4, with no draining tunnels and * affecting at least 2 distinct anatomical areas * agreement to not use topical and systemic antibiotics for treatment of hs during the vehicle-controlled period. * agreement to not use topical antiseptics, including washes and leave-on products on the areas affected by hs lesions during the vehicle-controlled period and weeks 16 to 20 of the extension period. * further inclusion criteria apply. exclusion criteria: * body surface areas to be treated exceed 20% bsa at screening or baseline * presence of draining tunnels at screening or baseline. * medical history including current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator. * laboratory values outside of the protocol-defined criteria. * pregnant or lactating participants, or those considering pregnancy during the period of their study participation. * further exclusion criteria apply.

Keywords: hidradenitis suppurativa skin disease ruxolitinb cream
camel whey protein gel for the treatment of aphthous ulcer

Conditions: Aphthous Stomatitis, Recurrent; Antioxidative Stress

Summary: higher prevalence of recurrent aphthous ulcer in young adults and the severity decreased with increasing age. the etiology of aphthous ulcer remains unclear. other possible factors include trauma, drug use, deficiency in vitamin b12, folic acid, iron, stress, hormonal changes and metabolic diseases. many topical agents such as local and systemic an- tibiotics, local antiseptics, topical nsaids, and topical corticosteroids are generally prescribed for symptomatic relief. several approved drug for- mulations such as pills, mouthwash, sprays and paste such as vitamin b12, chlorhexidine mouthwash, steroid lozenges and local anesthetics are primarily suggested for the treatment of aphthous ulcer. camel whey protein gel was fabricated to get benefits of its antiinflammatory, immunomodulator, antibacterial and antioxidant effects.

40 cases of recurrent aphthous ulcer patients as the research object,were randomly divide into the study group and the control group, each with 20 cases of both sexes with age ranging from 18 years to 50 years. inclusion criteria consisted of the following: (a) clinical examination and confirmed history of recurrent oral ulcer, (b) recurrence of the oral ulceration, and (c) patients in good condition with no serious systemic disease. eligible persons were excluded if they were administered antibiotics or glucocorticoids or accepted periodontal or dental treat- ments that interfered with the results of our experimental drugs. the control group will be subjected to placebo gel consisting of methyl cellulose gel whereas the study group will use camel whey protein dissolved in methyl cellulose gel base. the gel will be applied 1 day after ulcer appearance and will be stopped after ulcer disappearance

Eligibility criteria:
inclusion criteria: * clinical examination and confirmed history of recurrent oral ulcer, * recurrence of the oral ulceration * patients in good condition with no serious systemic disease. exclusion criteria: * if they were administered antibiotics or glucocorticoids * accepted periodontal or dental treat-ments that interfered with the results of our experimental drugs
tchcct-zhong-xing-emergency-department-airway

Conditions: Airway Complication of Anesthesia; Intubation;Difficult

Summary: to investigate which shapes of stylet, hand techniques and possible condition that improve intubation successful rate and reduce the elapsed intubation time.

challenging airway is always a big issue in emergency room. however, better hand technique, stylet shapes and conditions affecting intubation successful rate, elapsed duration need further investigations. we compare two endotracheal tube holding position, two holding places, with or without epiglottis lift technique in this study. all intubation processes in the study will be recorded.

Eligibility criteria:
inclusion criteria: * care givers with sufficient understanding of airway anatomy and management exclusion criteria: * n/a

Keywords: intubation epiglottis lift hold high position
aurelia: a study of avastin (bevacizumab) added to chemotherapy in patients with platinum-resistant ovarian cancer

Conditions: Ovarian Cancer

Summary: this randomized, open-label, 2-arm study will evaluate the efficacy and safety of avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. all patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. patients randomized to arm 2 of the study will receive avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. anticipated time on study treatment is until disease progression. patients will then receive standard of care, those in arm 1 (chemotherapy only) may opt to receive avastin (15 mg/kg iv 3-weekly). target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * female patients, \>/=18 years of age * epithelial ovarian, fallopian tube or primary peritoneal cancer * platinum-resistant disease (disease progression within \<6 months of platinum therapy) * eocg performance status of 0-2 exclusion criteria: * non-epithelial tumours * ovarian tumours with low malignant potential * previous treatment with \>2 chemotherapy regimens * prior radiotherapy to the pelvis or abdomen
six month clinical trial assessing efficacy and safety of inhaled insulin in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: to determine, in subjects with type 2 diabetes mellitus: 1. whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal exubera™ (inhaled insulin) plus a single bedtime ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed regular/nph insulin injections per day. 2. the toleration and safety of exubera™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * stable insulin regimen of at least 2 injections per day exclusion criteria: * any smoking within the last 6 months. smoking is not permitted at any time during this study. * subjects on insulin pump during 2 months prior to screening. * subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.