Kornimate/medical-research-clean huggingface dataset:
proof of mechanism in elt

Conditions: Premature Ejaculation

Summary: the purpose of this study is to determine if the administration of gsk958108 can delay ejaculation in patients with primary premature ejaculation as measured by the ejaculatory latency time (elt) using the masturbation model and sexual visual stimulation, and to evaluate the safety and tolerability of gsk958108 in healthy men with pe


Eligibility criteria:
inclusion criteria: * heterosexual male subject with self-reported moderate or severe primary premature ejaculation with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation * baseline ejaculation latency time \< 3 minutes * subjects must agree to use a contraception methods as per protocol * body weight \> or = 50 kg and body mass index within the range 19.0-29.9 kg/m2 * subject with normal visual acuity (with appropriate correction if needed) * subject able to cooperate in all study procedure including the eye examination with use of mydriatics exclusion criteria: * erectile dysfunction * history of migraine * current clinically relevant abnormality * history of psychiatric illness or suicidal attempts or behaviours * history of any eye disorder or colour blind, excluding myopia and presbyopia * cardiac conduction disorder or other clinically significant cardiac disease * positive at pre-study drug/alcohol screen and to hepatitis or hiv tests * regular consumption of alcohol * history of sensitivity or intolerance to drugs * consumption of red wine, seville oranges, grapefruit or grapefruit juice \[and/or pummelos, exotic citrus fruits, grapefruit hybrids\] from 7 days prior to the first dose of study medication * subject has received or is continuing to receive any treatment for premature ejaculation in the four weeks prior to the study start * use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements prior to the first dose of study medication * participation in another clinical trial in the previous month * exposure to more than four new experimental drugs within the previous 12 months * where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period. * unwillingness or inability to follow the procedures outlined in the protocol.
construction of the therapeutic alliance between inpatient psychiatric patients and nurses

Conditions: Psychiatric Diseases

Summary: clarify the determinants of the construction of a therapeutic alliance (at) between paramedical staff (nurses and caregivers ) and adult patients in a functional unit of full-time general psychiatric whether the quality of therapeutic alliance influences the continued support outpatient , after completion of full-time hospitalization.

this is a prospective, observational, multicenter inpatient units parisian full time of the etablissement public health white house (spread over 4 sites). the study seeks to collect, on the one hand the level of at obtained at the end of hospitalization in general adult psychiatry and, secondly, to understand how this one was built. the at will be measured: * firstly by the self-administered questionnaire star-p, translated into french by the "translation / back-translation" method. * secondly through semi-structured qualitative interviews, conducted at discharge by a health care setting or a specially trained and who did not participate directly in the patient's care included. indeed, the questionnaires allow, through scales to measure the at quantitative way through proposals (items) presented as so, and look for associations with some predefined decisive. however, it is difficult to explore more complex combination of mechanisms. conducting interviews can meet this goal. an interview grid will be conducted and organized around the search for representations and affects related relational patient / nurse(s) and caregiver(s) in the context of hospital care. the interviews will be recorded and fully transcribed. a thematic analysis will be conducted to identify the objects and themes. the inclusions in this qualitative analysis will stop when reaching the saturation process. in this type of study, it is generally necessary to include thirty people to reach saturation. finally, semi-structured group interviews (focus group) will be conducted by co-investigators and doctoral student psychologist caregivers with the discussion topic imposed: the at construction. they will be directed to paramedics caregivers (nurses and caregivers) are not part of the investigation team conducting research but actively involved in care. their goal will be to harvest their representations regarding the quality of the therapeutic relationship they're trying to build with patients. a focus group will be conducted by site (4 sites), with 5 to 12 volunteers per group.

Eligibility criteria:
inclusion criteria: * adult patient (\>18 years old) * adult psychiatric inpatients exclusion criteria: * patients carrying perversion disorder or paranoia * patients trust whose legal representative refuses participation in the survey * patients non covered by the french health system * non consenting patients

Keywords: severe mental illness nursing therapeutic alliance psychiatric diseases
effect of oral supplementation with curcumin on insulin sensitivity in subjects with prediabetes

Conditions: PreDiabetes

Summary: this study evaluates the effects of oral supplementation with curcumin on the insulin sensitivity in subjects with prediabetes. the half of participants will receive curcumin and bioperine in combination, while the other half receive placebo.

the therapeutic strategies for prediabetes to this day are based on the change of habits, mainly food and exercise plans. it has been advice, in specific circumstances, to grant a pharmacological regimen. curcumin or curcuma longa ((1e,6e)21,7-bis(4-hydroxy-3-methoxyphenyl)-1,6- heptadiene-3,5-dione), is the main ingredient of the hindu condiment, turmeric, which is obtained from the rhizome plant. in new studies, it has been documented that the oral consumption of curcumin (curcuma longa) in pre-diabetic and diabetic patients has a positive effect as an antidiabetic agent thanks to its anti-inflammatory, antioxidant, antithrombotic, cardio and neuroprotective effects. in animal models, it has been shown that oral curcumin consumption is capable of increasing insulin sensitivity in liver, muscle and adipose tissue, increases glucose uptake in muscle and insulin secretion, which is reflected in the reduction of hyperglycemia, glycosylated hemoglobin, decrease of the homeostatic model assessment of insulin resistance (homa-ir) and decrease of serum lipids. curcumin has been included in the oriental diet since ancient times and is used in traditional medicine, which is why it is considered safe, since its consumption is approved by the fda (federal drugs administration). a 12g per day dose has shown no side effects in humans. therefore, it is proposed that the consumption of curcumin in pre-diabetic patients can improve glucose tolerance and decrease insulin resistance parameters.

Eligibility criteria:
inclusion criteria: * men and women with age between 18 and 60 years old. * with prediabetes diagnosis, according to the american diabetes association : 1. fasting serum glucose: 100-125 mg/dl 2. glycosylated hemoglobin (hba1c): 5.7-6.4% 3. post-prandial glucose: 140-199 mg/dl after an oral dose of 75 g of glucose. exclusion criteria: * subjects with any type of diabetes. * subjects with body mass index \> 35 kg/m2 * pregnant women. * volunteers who ingest drugs that alter blood glucose levels, antiplatelet agents, angiotensin-converting enzyme inhibitors, angiotensin ii receptor antagonists, fibrates, statins. * subjects with serum creatinine \> 2 mg/dl or in renal replacement therapy. * subjects that normally consume food supplements. * subjects with acute infections or with chronical diseases (cancer, rheumatoid arthritis, etc.).

Keywords: curcumin insulin sensitivity homa
long-term use: cgm system assessment in adult athletes with diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate cgm glycemic control using the dexcom g4 system as well as system performance during high levels of activity and home use by adult athletes with insulin-requiring diabetes mellitus, over an extended period of time.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. diagnosis of diabetes mellitus exclusion criteria: 1. extensive skin changes/diseases 2. known allergy to medical adhesives 3. pregnancy 4. dialysis
treatment of polycythaemia vera and essential thrombocythaemia: influence on the clot structure

Conditions: Polycythemia Vera; Thrombocythemia, Essential

Summary: myeloproliferative neoplasms (mpn) such as polycythemia vera (pv) and, essential thrombocythaemia (et) are rare clonal myeloid neoplasms associated with an increased risk of both venous and arterial thrombosis. thrombotic complications are the main determinant of morbidity and in a less extend mortality. routine haemostasis analysis (tp, aptt) are usually normal and are useless to demonstrate a hypercoagulable state. however, previous evidence suggests that global coagulation tests such as thrombin generation or thromboelastometry are able to detect signs of procoagulant imbalance in mpn. similarly, current data seems to demonstrate that fibrin clot properties (clot permeability, turbidimetry, clot lysis time) properties is altered suggesting an hypercoagulable state. goals of pv and et treatments are to control blood count to reduce the risk of thrombotic events. moreover, new drugs such as janus kinase inhibitors (jaki) were recently licensed for pv and are under investigations on clinical trial for et. it is currently unknown if treatments that were used for et and pv, and especially jaki are able to modify the hypercoagulable state that is observed in those diseases, and if there is difference between drugs. to evaluate impact of mpn treatment on prothrombotic haemostatic profile, we propose to evaluate global coagulation and fibrin clot properties in mpn, depending on the treatment.


Eligibility criteria:
inclusion criteria: * all men and women, older than 18 years, with a diagnosis of pv or et (primary or secondary) according to the 2008 world health organization (who) classification. exclusion criteria: * lack of participant's consent; * concomitant treatment with anticoagulant drugs (anti-vitamin k, heparin or direct oral anticoagulant drugs); * active cancer other than non-melanoma skin cancer (defined as cancer diagnosis \<5 years or treatment \<2 years); * recent infection (\<30d); * recent surgery (\<30d); * recent hospitalization (\<30d); * recent thromboembolic or cardiovascular event (\<3m).
investigation on appropriate duration of dabigatran use after catheter ablation for paroxysmal atrial fibrillation in patients with low thromboembolic risk

Conditions: Atrial Fibrillation; Thromboembolism

Summary: the purpose of this study is to investigate the appropriate duration of dabigatran use after radiofrequency catheter ablation for paroxysmal atrial fibrillation in patients with low thromboembolic risk. according to the most recent guideline, anticoagulation is recommended to continue at least 2 months after the procedure. however bleeding risk with anticoagulant is also problematic. post-procedural thrombosis is considered due to acute inflammation or char formation at the site of ablation, and these reaction occurs mostly within 1 month after the procedure. also, the risk of thromboembolism is low in patients with cha2ds2-vasc score less than 1. the investigators hypothesized that dabigatran use for the first 1 month after the rfca for patients with paroxysmal af and low thromboembolic risk would be sufficient for efficacy and safety compared to conventional dabigatran use for 2 months.


Eligibility criteria:
inclusion criteria: * paroxysmal af undergoing catheter ablation * cha2ds2-vasc score \<= 1 * informed consent exclusion criteria: * persistent af * cha2ds2-vasc score \> 2 * prior cva * prior atnicoagulant * severe hf * abnormal liver or renal function * history of severe bleeding

Keywords: dabigatran
hector-study to evaluate the efficacy of octreotide in patients with inoperable hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: a preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can prolong survival time in patients with primary liver cancer. due to methodological deficiencies of the preliminary study the results will be re-checked by the comparison of octreotide with an pseudo-drug (so-called placebo) primarily regarding to the survival time and secondarily concerning costs, side effects, patient cooperation and quality of life as well as specific conditions in the tumor tissue in both groups with 108 patients with primary liver cancer.

a pilot study showed that octreotide can prolong survival time of patients with hcc. due to methodological deficiencies the results of this pilot study will be re-evaluated by comparison of octreotide versus placebo primarily regarding to the global survival time and secondarily concerning the costs, side effects, patient compliance and quality of life as well as the somatostatin receptors in the tumor tissue and its prognostic relevance in both groups with 108 patients with hepatocellular carcinoma. an interim analysis was done after occurrence of the half of the events (deaths). no significant effect could be shown.

Eligibility criteria:
inclusion criteria: * inoperable patients * histologically confirmed hcc or patients who refuse surgery and who otherwise (e.g. due to the advanced tumor stage) are not applicable for palliative local therapy (e.g. pei, tace, rfta). * age: 18 years or older exclusion criteria: general: * patient with symptomatic cholecyst-/choledocholithiasis * patient with severe psychiatric disease. * participation in another clinical trial within the last 4 weeks. * simultaneous participation in another clinical examination. * legally incapacitated patient, who is not able, to understand nature, meaning and consequence of the study. * continuous drug or alcohol abuse. * patient with known hiv infection and antiretroviral therapy. * patient with not controllable infection disease. * pregnancy. study- and indication-specific exclusion criteria: * secondary malignant tumor without complete remission. * secondary malignant tumor with complete remission but current adjuvant therapy. * preliminary or current therapy with tamoxifen * pretreatment of the hcc. * first-time diagnosis \> 6 months before inclusion into the study. * severe hepatic encephalopathy, refractory to any treatment. * patients with operable hcc. * contraindication to i.m. injections. * hypersensitivity to octreotide.

Keywords: hepatocellular carcinoma; sandostatin-lar; rct
transcranial alternating current stimulation in back pain- pilot sudy

Conditions: Chronic Low Back Pain

Summary: chronic pain is a severe disabling problem within society, affecting 25-30% of the united states population.. transcranial alternating current stimulation (tacs) has the potential to provide a treatment option that is safe, scientifically-supported, low-cost, and easy-to-administer method to effectively reduce symptoms in patients suffering from chronic pain. the purpose of this study is to test the feasibility of using tacs to treat patients with chronic pain, and to collect pilot efficacy as well as eeg and ekg biomarker data for optimizing the design of subsequent large-scale studies. the treatment rationale is to renormalize the presumed pathological structure of alpha oscillations in the prefrontal cortex (pfc) of patients with chronic pain.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 * diagnosed with nonspecific chronic low back pain by clinician * bmi is less than 30 * suffered from chronic pain for \> 6 months * self-report pain measures \>4 * meets criteria for low depression and suicide risk as defined by the hamilton-depression rating scale * capacity to understand all relevant risks and potential benefits of the study (informed consent) * not currently taking opioids, benzodiazepines, and anticonvulsant medications exclusion criteria: * radicular pain * traumatic brain injury, any brain devices/implants, including cochlear implants and aneurysm clips * history of major neurological or psychiatric illness, including epilepsy * (for females) pregnancy or breast feeding * diagnosis of eating disorder (current or within the past 6 months), obsessive compulsive disorder (lifetime), or attention-deficit hyperactivity disorder (currently under treatment)

Keywords: tacs transcranial alternating current stimulation low back pain chronic pain alpha oscillations heart rate variability
radiofrequency applications and alcoholic neurolysis of genicular nerve for the treatment of knee osteoarthritic pain

Conditions: Radiofrequency; Alcohol; Genicular Nerve; Knee Osteoarthritis; Pain

Summary: this study aims to investigate the efficacy of radiofrequency ablation and alcoholic neurolysis of genicular nerve on alleviating pain and improving the function of advanced knee osteoarthritis patients.

knee osteoarthritis (oa) is a major cause of pain and disability. patients with moderate to severe knee oa often suffer from excruciating pain with chronic inflammation and reduced range of motion. conventional treatment of knee oa includes nonpharmacologic therapies and pharmacologic therapies. analgesics, low-potency opioids, narcotic analgesics, and nonsteroidal anti-inflammatory drugs (nsaids) are commonly used in pharmacologic therapies. radiofrequency ablation (rfa) has been used for the treatment of chronic pain that has been unresponsive to conservative therapies. it acts by disrupting the transmission of pain signals using thermal lesion production to interrupt nociceptive signals. the nerve block is conventionally performed by local anesthesia alone or in combination with corticosteroid. nerve ablation causes iatrogenic neural degeneration aiming only for sensory or sympathetic denervation without motor deficits. the nerve ablation methods currently available are performed by either thermal ablation using rfa or chemical ablation using alcohol or phenol.

Eligibility criteria:
inclusion criteria: * age \> 18 years old. * both sexes. * patients with knee osteoarthritis. * previous conservative treatments longer than 3 months. * visual analog scale (vas)≥ 4. * radiological osteoarthritis grades 3 and 4 according to the kellgren-lawrence grading system (0 = none, 1 = doubtful, 2 = minimal, 3 = moderate, and 4 = severe). exclusion criteria: * patient refusal. * history of knee surgery. * radiculopathy. * anticoagulant therapy. * injection with steroids or hyaluronic acids during the previous 3 months. * serious neurologic or psychiatric disorders.
thrombolysis in ischemic spinal cord stroke

Conditions: Motor Weakness in Two or Four Limbs; Damage in the Anterior Spinal Artery (ASA); Temperature and Superficial Sensation; Urinary Retention or Bowel Disorder

Summary: ischemic stroke of the spinal cord is a rare disease accounting for about 1% of all ischemic events in the central nervous system (cns). in most cases the consequences are catastrophic, with a high rate of severe functional disability and mortality rate up to 30%. ischemic stroke of the spinal cord can arise from: 1. dissection of the aorta. 2. aneurism in the aorta. 3. atherosclerotic disease of the aorta or vertebral arteries. 4. spinal surgeries. 5. spinal avm. 6. embolism from cardiac origin. 7. occlusion of radicular artery. onset is usually sudden, reaching maximal intensity in hours until the patient becomes paralyzed in two or in all four limbs. in most cases the damage is in the anterior spinal artery (asa). the disease is expressed with motor weakness accompanied by disturbance of temperature and superficial sensation, urinary retention or bowel disorder, with preserved position and vibration sense. the differential diagnosis of ischemic spinal cord includes diseases such as acute myelitis of the spinal cord or acute demyelinating polyneuropathy like guillan barree syndrome (gbs). therefore in order to reach the appropriate diagnosis in most cases an urgent mri of the spinal cord is necessary upon arrival in the emergency department. one of the treatments to acute ischemic stroke is providing thrombolysis. as tested and validated in numerous studies for ischemic events in the brain, until today no validated study in ischemic spinal stroke using thrombolysis has been completed.


Eligibility criteria:
inclusion criteria: 1. patients with vascular risk factors 2. patients with sudden weakness of the lower or upper limbs together with bowel disorder. 3. window treatment - not over 6 hours since the start of the event till the start of the treatment. 4. patient without dissection of the aorta in the abdomen. 5. patient without contraindication to ivtpa. 6. patient with no etiology found after clarification. exclusion criteria: 1. refusal to sign an icf. 2. reason for weakness is known. 3. patient with contraindication ivtpa. -