Kornimate/medical-research-clean huggingface dataset:
a first time in human study in healthy male volunteers for compound gsk557296.

Conditions: Obstetric Labour, Premature; Premature Ejaculation

Summary: a study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug gsk557296.


Eligibility criteria:
inclusion criteria: * healthy males who are 18 to 45 years of age * body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician * non-smokers exclusion criteria: * alcohol consumption averaging more than 7 drinks per week * positive for hepatitis c antibody, hepatitis b antigen or hiv * any use of prescription drugs or non prescription drugs

Keywords: healthy subjects, safety, tolerability, pharmacokinetics
effect of etoricoxib to treat chronic low back pain (0663-042)

Conditions: Recurrent Low Back Pain

Summary: study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.


Eligibility criteria:
inclusion criteria: * low back pain for previous 3 months and majority of days in last month * regular use of acetaminophen or nsaid to treat low back pain in past month * judged to be in otherwise good health exclusion criteria: * low back pain that is due to secondary causes * radicular/myelopathic pain * surgery for low back pain within the past 6 months * active lawsuit or claim pertaining to their low back pain * disease that may confound the results of the study or pose risk to the patients * corticosteroid use in past month * previous participation in an mk0663 study
pathway ch-1 long-term follow-up

Conditions: Chronic Cluster Headache

Summary: the objective of the study is to demonstrate the long-term safety and performance of the ati neurostimulation system when used for stimulation of the sphenopalatine ganglion (spg) in cluster headache subjects.


Eligibility criteria:
inclusion criteria: * subject has been implanted with an ati neurostimulator as a part of the pathway ch-1 trial. * subject has completed the pathway ch-1 open label final office visit and remains implanted with an ati neurostimulator. * subject has the ability to read, comprehend and to reliably record information as required by the protocol. * subject is able to provide written informed consent prior to participation in the study. exclusion criteria: * subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'on.' * subject is not suitable for the study for any reason in the judgment of the investigator.
a phase ib/ii study of js015 combination therapy in advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a phase ib/ii, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary efficacy of js015 combination therapy in patients with advanced solid tumors. the recommended dose for phase ii trial （rp2d） will be determined based on the safety, tolerability, pharmacokinetics and efficacy.


Eligibility criteria:
inclusion criteria: 1. patients who meet the following criteria for each indication cohort: 1. esophageal cancer cohort, patients with histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable or with distant metastasis, who progressed during or after prior first-line pd-(l)1 antibody and platinum-based chemotherapy; 2. gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with locally advanced unresectable or distant metastases, her2-negative, who progressed during or after prior first-line pd-(l)1 antibody and platinum-based chemotherapy; 3. 1l gastric cancer cohort, patients with histologically or cytologically confirmed gastric/gastroesophageal junction adenocarcinoma with her2-negative results and no prior systemic antitumor therapy; 4. colorectal cancer cohort, patients with histologically confirmed adenocarcinoma of the colon or rectum, who progressed during or after first-line 5-fu-based combination therapy; 5. pancreatic cancer cohort, patients with histologically or cytologically confirmed locally advanced unresectable or distant metastatic pancreatic ductal adenocarcinoma, who have not received any previous systemic antitumor therapy 2 . eastern cooperative oncology group (ecog) 0 or 1; 3. life expectancy \>=12 weeks; 4. at least one measurable lesion according to recist 1.1; 5. adequate organ function; exclusion criteria: 1. leptomeningeal metastases and /or active brain metastases; 2. pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated management (puncture, drainage, etc.); 3. history of interstitial lung disease or a previous history of noninfectious pneumonia with corticosteroid therapy, or evidence of active pneumonia on screening imaging; 4. history of immunodeficiency; 5. history of serious cardiovascular and/or cerebrovascular diseases; 6. history of abdominal or tracheo-esophageal fistula, gastrointestinal (gi) perforation, or intra-abdominal abscess within 6 months before the first dose of administration
effect of tirzepatide on brown adipose tissue in obesity

Conditions: Obesity

Summary: this study is testing whether a new anti-obesity medicine called tirzepatide can increase the activity of special fat cells in the body that help burn energy. these fat cells are known as brown and beige fat. the study includes women with obesity and will last 24 weeks. participants will receive either tirzepatide or a placebo (a look-alike injection with no active drug). researchers will measure the amount and activity of brown fat using medical imaging (pet/ct, mri, and thermal camera), and examine fat tissue samples to look for changes in gene activity and structure that show beige fat activation. the study will also evaluate how these fat changes affect body weight, energy use, hormone levels, blood sugar, and other health markers. the goal is to learn whether tirzepatide helps improve metabolism by increasing energy-burning fat in addition to reducing appetite.


Eligibility criteria:
inclusion criteria: * female sex * age between 18 and 50 years * bmi between 30 kg/m² and 40 kg/m² at pre-screening * prior comprehensive non-pharmacological and non-surgical management of obesity, including a history of at least 12 months of intensive lifestyle intervention with a maximum weight reduction of less than 5% * stable body weight within the three months preceding study enrollment (defined as weight fluctuations within 5%) * no prior pharmacological or surgical interventions for obesity * euthyroid state * eumenorrhea or oligomenorrhea * ability to comprehend the study objectives and procedures * willingness to provide informed consent and to comply with the study protocol, including the use of highly effective contraception during the study period, with signed consent and agreement provided in duplicate * commitment to use highly reliable contraception and absence of plans for pregnancy within the 8 months following enrollment exclusion criteria: * pregnancy or lactation * postmenopausal * amenorea * type 2 diabetes * reliance on natural contraception methods * non-compliance with previous therapeutic regimens * personal history of malignancy * personal or family history of medullary thyroid carcinoma * personal history of pancreatitis * personal history of cholelithiasis * personal history of major depressive episodes or suicidal ideation * personal history of acute coronary events or hemodynamically significant coronary artery disease * psychiatric disorders * current treatment with sympathomimetics or sympatholytics * excessive alcohol consumption

Keywords: obesity tirzepatide brown adipose tissue beige adipose tissue adipose tissue browning energy expenditure
ablation vs amiodarone for treatment of afib in patients with chf and an icd

Conditions: Heart Failure

Summary: 1. to determine if catheter-based atrial fibrillation (af) ablation is superior to amiodarone treatment for symptomatic persistent/permanent af in icd/crtd patients with an impaired left ventricular function. 2. hypothesis: af ablation is better than amiodarone for subjects with symptomatic persistent or permanent af and impaired lv function in terms of recurrence of af, quality of life, 6-minute walk distance, ef and total number of hospitalizations.


Eligibility criteria:
inclusion criteria: 1. patients with an dual chamber icd or crtd (with an existing functional atrial lead) with remote monitoring capabilities and ef \<= 40% within the last 3 months by echocardiogram, nuclear imaging, mri or cardiac catheterization, 2. persistent or chronic symptomatic af resistant to anti-arrhythmic medication other than amiodarone. resistant defined as recurrent af of greater than 5 minutes duration at least once per month. 3. therapeutic anticoagulation for at least three weeks prior to initiation of therapy 4. ability to complete 6 minute walk test. 5. age \>= 18 years old. (females must be either post-menopausal \>12 months, practicing a protocol-acceptable method of birth control \[defined as injectable or implantable hormonal contraceptives, oral contraceptives, intrauterine device, diaphragm plus spermicide\], or have had a hysterectomy, bilateral oophorectomy, or tubal ligation performed at least 6 months prior to enrollment). 6. all patients optimized on chf medications including beta-blocker and ace-inhibitor or angiotensin-receptor blocker. 7. patients receiving low dose amiodarone- \<200 mg for 2 or less months exclusion criteria: the exclusion criteria are: 1. reversible causes of af such as pericarditis, hyperthyroidism, 2. presently with valvular heart disease requiring surgical intervention 3. presently with coronary artery disease requiring surgical intervention 4. early post-operative af (within three months of surgery) 5. previous maze or left atrial instrumentation 6. prolonged qt interval 7. hypothyroidism 8. liver failure 9. life expectancy \<= 2 years 10. social factors that would preclude follow up or make compliance difficult. 11. contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin 12. enrollment in another investigational drug or device study. 13. patients with severe pulmonary disease i.e. copd or asthma 14. documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction 15. any ophthalmologic disorders (other than requiring glasses for vision correction)

Keywords: atrial fibrillation ablation
acute comfort and blurring profile evaluation of marketed lubricant eye drops

Conditions: Dry Eye

Summary: to evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients


Eligibility criteria:
inclusion criteria: * documented diagnosis of dry eye exclusion criteria: * use of topical ocular drops within 2 hours preceding enrollment

Keywords: dry eye, artificial tears,
genetic study of the fbn1 gene and fibrillin-1 abnormalities in choctaw native americans and other patients with systemic sclerosis

Conditions: Systemic Sclerosis

Summary: objectives: i. determine whether defects in fibrillin-1 cellular processing are present in the tsk1 mouse model that carries a known fbn1 gene rearrangement and in a population of choctaw native american patients with systemic sclerosis who have a strong genetic predisposition to the disease. ii. determine the ultrastructural features of fibrillin-1 in these patients. iii. screen the fbn1 gene for mutations beginning at the regions homologous to the tsk1 duplication and latent transforming growth factor binding proteins in these patients and in an unaffected choctaw control group. iv. determine the correlation between fibrillin-1 abnormalities and clinical presentation, autoantibodies, and ethnicity.

protocol outline: patients undergo punch skin biopsy obtained from the upper arm or back. studies of fibrillin-1 synthesis and cellular processing, and fbn1 mutational analysis, linkage analysis, and genetic mapping are performed on the tissue samples. patients from all major us ethnic groups (caucasian, hispanic, african americans) will be recruited for the study in the next 2 years.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of systemic sclerosis in accordance with the american college of rheumatology preliminary criteria positive for systemic sclerosis antibodies (e.g., anticentromere, antitopo, antifibrillarin, or antirna polymerase)

Keywords: arthritis & connective tissue diseases rare disease systemic sclerosis
predicting infant extubation using diaphragm surface electromyography

Conditions: Infant, Newborn, Disease

Summary: this study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

this study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

Eligibility criteria:
inclusion criteria: * intubated and mechanically ventilated on nicu exclusion criteria: * major congenital abnormalities
gastroesophageal reflux disease (gerd) before and after gastric bypass

Conditions: Gastroesophageal Reflux Disease; Morbid Obesity

Summary: the hypothesis of this study was that gastric bypass (gbp) ameliorates gastroesophageal reflux disease (gerd) in morbidly obese patients.

the investigators studied the impact of this surgical procedure on gerd in patients with morbid obesity. esophageal syndromes were evaluated according to the montreal consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for portuguese language along with esophageal syndromes with injury assessed through upper endoscopy. esophageal acid exposure was determined through 24h ph monitoring. increased acid exposure was characterized when total esophageal ph \< 4 for at least 4% of the total monitoring time.

Eligibility criteria:
inclusion criteria: * morbid obesity * acceptance to undergo open gastric bypass exclusion criteria: * prior gastroesophageal surgery * achalasia

Keywords: gerd gastric bypass
preoperative infusion of levosimendan in patients undergoing cardiac surgery

Conditions: Cardiac Disease; Cardiac Failure; Cardiac Surgery; Inotropes; Ejection Fraction

Summary: the aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery

patients with severely reduced left ventricular ejection fraction (lvef) face a high risk of morbidity and mortality after cardiac surgery. impaired cardiac function preoperatively predisposes patients to low cardiac output syndrome. levosimendan acts by a different mechanism than traditional inotropes and its preoperative use could improve the outcome of patients with cardiac failure. specifically, it promotes vasodilation of coronary, pulmonary and systemic vessels, has an anti-inflammatory and anti-oxidant effect and enhances cardiac contractility by improving the response of the myofilaments to intracellular calcium. the aim of this retrospective study will be to investigate the effect of the preoperative administration of levosimendan on the outcome of patients with compromised cardiac function undergoing cardiac surgery.

Eligibility criteria:
inclusion criteria: * elective cardiac surgery * cardiac surgery under cardiopulmonary bypass * low ejection fraction (\<40%) exclusion criteria: * age \<18 years old * urgent operation * glomerular filtration rate\<30 ml/min * hepatic dysfunction preoperatively * side effects (hypotension, tachycardia, st segment abnormalities during levosimendan administration * redo surgery

Keywords: levosimendan low output syndrome
a study of nivolumab and ipilimumab and nivolumab alone in combination with trans-arterial chemoembolization (tace) in participants with intermediate stage liver cancer

Conditions: Cancer, Hepatocellular

Summary: the purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with trans-arterial chemoembolization (tace) to tace alone in participants with intermediate liver cancer.


Eligibility criteria:
inclusion criteria: * participant has intermediate-stage hepatocellular carcinoma (hcc) whose tumor characteristics exceed the beyond milan and up-to-7 (bmu7) criteria and is eligible for trans-arterial chemoembolization (tace) * participant has no extrahepatic spreading (ehs), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (mvi) * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 exclusion criteria: * known fibrolamellar hcc, sarcomatoid hcc, or mixed cholangiocarcinoma and hcc * prior liver transplant or participants who are on the waiting list for liver transplantation * active, known, or suspected autoimmune disease other protocol defined inclusion/exclusion criteria apply
audio vestibular functions in covid 19 patients in sohag governate

Conditions: COVID19

Summary: there is evidence that up to 30% of covid-19 patients was reported with neurological manifestations such as impaired consciousness, headache, and dizziness have been reported in covid-19 patients in addition, olfactory and taste alterations are common symptoms in patients affected by covid-19.this study will be conducted to evaluate the effect of the novel coronavirus on audio-vestibular functions in confirmed covid19 patients.


Eligibility criteria:
inclusion criteria: - well educated patients age: range between 20 to 50 years no previous history of hearing loss or otoneurologic disease well confirmed covid 19 patients: patients who were diagnosed with coronavirus from * symptoms: fever, cough, generalized malaise, dyspnea. * laboratory finding: abnormalities have been observed in complete blood count (cbc), high c-reactive protein and ferritin, elevated d-dimer. * imaging: chest ct scan: bilateral ground glass opacities, crazy paving, and consolidation. * nasopharyngeal swab for sars-cov-2 polymerase chain reaction testing (rt-pcr). exclusion criteria: * previous history of hearing loss or otoneurological disease
a single intravitreal injection of raav2-nd4 for the treatment of leber's hereditary optic neuropathy

Conditions: Leber Hereditary Optic Neuropathy

Summary: this study is meant to evaluate the safety and efficacy of raav2-nd4 treatment for leber hereditary optic neuropathy with the g11778a mutation in mitochondrial dna.

leber's optic hereditary neuropathy (lhon) is a maternally inherited ocular disorder primarily associated with mutations in mitochondrial dna. the disease is a common cause of blindness in both eyes of affected teenagers and young adults. there is currently no approved effective treatment for lhon. in 2011, the first lhon gene therapy investigator-initiated study was conducted (registered in december 2010 with clinicaltrials.gov identifier nct01267422) to explore the safety and efficacy of gene therapy for lhon. the gene therapy was a recombinant adeno-associated virus serotype 2 containing human mitochondrial nd4 (mt-nd4) gene (raav2-nd4). by 36 months of follow-up, six out of nine patients who received the raav2-nd4 intravitreal injection experienced clinically significant vision improvement and no adverse events were observed. this is an open-label, single-arm, multi-center study to further evaluate the safety and efficacy of raav-nd4 in the treatment of lhon patients with g11778a mutation. all patients will be treated with a single intravitreal injection raav-nd4, with dose 1 × 10\^10 vg/0.05 ml in one of the eyes.

Eligibility criteria:
inclusion criteria: 1. patients carry the mitochondrial point mutation at 11778, which is consistent with the diagnostic criteria for lhon. 2. no apparent eye sight improvement in lhon patients or any other treatment within the past year. 3. eyesight of both eyes is below 0.3. 4. patients signed written informed consent. 5. patients are between the ages of 10 and 65 years old and able to tolerate the gene therapy procedure which includes local anesthesia. 6. patients are willing to follow the doctor's instructions and to consult the doctor at prescribed times. 7. patient's physical examination results are all normal, including liver function, kidney function, routine blood test, routine urine test, complete immunological test, and humoral immune response. exclusion criteria: 1. patients who are wearing a cardiac pacemaker, suffering from severe heart, lung or kidney function failure, various hemorrhagic diseases, acute infectious diseases, high fever, or convalescing after heart surgery or who are pregnant are excluded. 2. patients who are participating in other clinical studies are excluded. 3. patients who suffer from a diagnosed mental problem are excluded. 4. patients who suffer from chronic diseases such as diabetes and hypertension are excluded. 5. patients who show abnormal test results such as positive aav2 humoral immune response (positive means that the aav2 neutralizing antibody assay of patient was significant different when comparing free serum with 1:20 serum concentrations) and abnormal human t lymphocyte subsets cd3+, cd3+/cd4+ and cd3+/cd8+ prior to gene therapy surgery are excluded.

Keywords: lhon,g11778a mutation, raav2-nd4，gene therapy
postoperative analgesic effects of using dexmedetomidine for ultrasound guided thoracic paravertebral block

Conditions: Pain

Summary: we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine for ultrasound guided thoracic paravertebral block in thoracotomy

paravertebral block is commonly used in the treatment for acute and chronic pain.the duration of paravertebral block could theoretically be prolonged with neurolytic agents. dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.

Eligibility criteria:
inclusion criteria: * asa 1-2 * 18-65 aged * patient undergoing thoracotomy exclusion criteria: * chronic opioid consumption * bupivacaine and dexmedetomidine allergies * coagulopathy * infection at the needle insertion side * chronic liver and kidney disease