Kornimate/medical-research-clean huggingface dataset:
radiofrequency ablation vs doppler-guided haemorrhoidal artery ligation in the treatment of haemorrhoidal disease

Conditions: Haemorrhoids; Internal Haemorrhoids; Grade II/III Haemorrhoids

Summary: surgical treatment of grade ii/iii internal haemorrhoidal disease is indicated in the case of medical and/or instrumental treatment failure. minimal invasive alternatives to haemorrhoidectomy have been introduced in the last decades to treat grade ii/iii haemorrhoids. doppler-guided haemorrhoidal artery ligation (dghal) represents a good therapeutic option in this condition with good short and mid-term outcomes but postoperative recurrence rates up to 35% at 5 years. recently, a technique of radiofrequency ablation (rfa) has been introduced with promising outcomes. a recent systematic review reported a significant improvement of preoperative symptoms and a recurrence rate \< 5%. to date, there is no study comparing dghal to rfa in the treatment of grade ii/iii haemorrhoids. the aim of this study is to demonstrate the non-inferiority in terms of failure rate of haemorrhoidal radiofrequency ablation compared to doppler-guided haemorrhoidal artery ligation, associated with mucopexy, in the treatment of grade ii and iii haemorrhoidal disease


Eligibility criteria:
inclusion criteria: * major patient, * with symptomatic grade ii or iii haemorrhoidal disease, * requiring surgical management, * patient able to understand the protocol and having given written informed consent to participate in the study, * patient affiliated to the social security system or entitled to it. exclusion criteria: * hemostasis disorders * associated external haemorrhoidal disease (thrombosis) * history of surgical procedure for treatment of haemorrhoids (instrumental treatment is not a contra-indication) * associated proctological pathology (anal fissure, chronic suppuration, external rectal prolapse) * history of colorectal cancer * history of inflammatory bowel disease * history of rectal resection * patient participating in another interventional clinical research protocol involving a drug or clinical investigation of a medical device * patient who is pregnant, breastfeeding or able to procreate without effective contraception\* at the time of inclusion * patient under guardianship, curators or deprived of liberty. * patient under court protection. * oral contraceptive (pill), monthly vaginal ring, weekly transdermal patch, subcutaneous implant, intrauterine devices (iud), or sterilisation.

Keywords: haemorrhoids radiofrequency doppler-guided haemorrhoidal artery ligation
study evaluating rimonabant efficacy in insulin-treated diabetic patients(arpeggio)

Conditions: Type 2 Diabetes Mellitus

Summary: primary: effect on hba1c over 48 weeks in insulin-treated patients with type 2 diabetes secondary: effect on glucose, total daily insulin dose, body weight, waist circumference, hdl-cholesterol, triglycerides - safety, tolerability

the total duration of the study will be up to 360 days including screening period (up to 14 days) and double-blind treatment period (approximately 11 months).

Eligibility criteria:
inclusion criteria: * male or female patients aged greater than or equal to 18 years. * diagnosis of type 2 diabetes as defined by who criteria. * type 2 diabetes treated with insulin for at least 3 months (insulin dose of at least 30 u/day for at least 4 weeks). * hba1c greater than or equal to 7%. * having signed the informed consent form. exclusion criteria: general: * weight loss \> 5 kg within 3 months prior to screening visit. * pregnancy or lactation. * absence of medically approved contraceptive methods for females of childbearing potential. * administration of other investigational drugs within 30 days prior to screening visit. * previous participation in a rimonabant study. * presence or history of allergic reaction or intolerance to multiple drugs. related to endocrine and metabolic disorders: * presence of any clinically significant endocrine disease according to the investigator.note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit. * fasting c-peptide \< 1.0 ng/ml. related to other disorders: * presence of any severe medical or psychological condition that in the opinion of the investigator would compromise the patient's safety or successful participation in the study. * presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer. related to laboratory findings: * positive test for hepatitis b surface antigen and/or hepatitis c antibody. * abnormal tsh level (tsh \> uln or \< lln). * positive urine pregnancy test. related to previous or concomitant medications: * antidiabetic drugs other than insulin within 3 months prior to screening visit. * drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).

Keywords: type 2 diabetes mellitus
impact on influenza vaccination rates of a telephone text message recall from the attending physician

Conditions: Influenza Viral Infections

Summary: this study is a clinical trial designed to assess the impact on influenza vaccination rates among people aged over 65 of a telephone text message recalling them to be vaccinated by their gp. twenty-two gps will be randomly selected in each arm (recall versus usual care, 1:1). each gp will include a maximum of 210 patients by random selection from their patient list. a difference of 4 percentage points is expected between the two arms at the end vaccination campaign in the vaccination rate.

this is an open-label trial with 2 arms: an interventional or "recall" arm and a "usual care" or control arm. cluster randomization at the physician level was chosen to avoid contamination within the same patients group. physicians will be randomized at the start of the vaccination campaign in one of the two arms (1:1), and all patients eligible (with a maximum of 210 per doctor) to be vaccinated will be recalled or not, depending on their gps arm.

Eligibility criteria:
inclusion criteria: the inclusion criteria for physicians are: * to be a gps * to be based in ile-de-france (paris region, france) * to be a user of the eo medical software the patients inclusion criteria are: * belonging to the list of attending physicians of the participating gps * being 65 years of age or older * having a medical file in the gp's eo medical software * having been selected at random if the number of patients aged 65 or over exceeds 210 patients (for 44 participating gps). exclusion criteria: * patients for which their attending physicians considers participating inappropriate (e.g. palliative care)

Keywords: reminder vaccination campaign influenza
effects of progesterone on smoked nicotine induced changes in hormones and subjective ratings of stimulant drug effects

Conditions: Nicotine Dependence

Summary: the clinical studies propose to study the abuse-related effects of nicotine after progesterone administration during the follicular phase in women of reproductive age. concurrent analysis of hypothalamic-pituitary-adrenal hormones should help to clarify the role of the hpa axis in the abuse-related effects of nicotine.

these clinical studies will analyze the interactions between progesterone, nicotine, alterations in endocrine hormones, mood and cardiovascular measures. the studies also intend to examine the contribution of menstrual cycle phase. it is hypothesized that this novel focus on nicotine's rapid hormonal, cardiovascular and subjective effects will be important for developing novel biologic approaches to treatment for nicotine abuse and dependence as well as advancing our understanding of the neurobiology of nicotine reinforcement.

Eligibility criteria:
inclusion criteria: * women between the ages of 18 and 40 who currently smoke at least 15 cigarettes every day, and who fulfill dsm-iv diagnostic criteria for nicotine dependence will be eligible for participation. * no evidence of clinically significant disease based upon complete medical history and physical examination supervised by dr. arthur siegel (chief of internal medicine). * absence of dsm-iv axis i disorders other than nicotine dependence (305.10) as measured by the structured clinical interview (scid). * routine laboratory blood tests including complete blood count, electrolytes, bun and creatinine, liver function tests, hepatitis panel and urinalysis will be performed. laboratory parameters must be within the normal range. hbsag must be negative but subjects who have hepatitis serology consistent with previous exposure to hepatitis a, hepatitis b, or hepatitis c, but who do not have clinical and biochemical evidence of acute infection, will be acceptable. * hematocrit levels ≥ 35% for females. * serum pregnancy test (hcg beta subunit) results must be negative within 24 hrs of the study session day. * normal ekg. * a body mass index (bmi-ratio of weight (w) to height (h) squared; w/h2=kg/m2) of between 18.0 and 27.0 for women. * subjects must be able to read and understand instructions, as well as provide a valid informed consent. exclusion criteria: * participants with any lifetime dsm-iv axis i disorder other than nicotine dependence. * participants with clinically significant medical disorders. * women who are pregnant as determined by laboratory testing for serum beta hcg. * women who use hormonal contraceptive medications will not be accepted, because this would confound the hormonal measures. * women with a mean bmi of outside the range 18.0-27.0. * participants who describe themselves as seeking treatment will not be selected but will be referred to local smoking cessation programs. * subjects with peanut/peanut oil allergies will be excluded. * participants diagnosed with lactose intolerance will be excluded.
erector spinae plane blocks (esp) for postoperative pain in lumbo-sacral spine surgery

Conditions: Erector Spinae Plane Block; Lumbar Spine Surgery

Summary: the goal of this study is to evaluate the analgesic efficacy of bilateral erector spinae plane (esp) blocks after lumbar and lumbo-sacral spine surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. we are aiming to investigate how esp blocks, performed under ultrasound guidance at the t12 vertebral level, contribute to postoperative pain control. this will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until patient discharge from hospital. these primary outcome measures will be compared between a treatment group of participants, who will receive esp blocks and a control group who will receive a sham block. our primary hypothesis is that esp blocks significantly reduce postoperative pain and opiate requirements


Eligibility criteria:
inclusion criteria: * spine surgery at or below the l1 vertebral level * midline surgical approach exclusion criteria: * previous lumbar or lumbo-sacral surgery with or without hardware placement * evidence of dura pathology (including csf leak) * spine tumor * non-english speaking
factors affecting patients with myofascial temporomandibular disorders

Conditions: Myofascial Temporomandibular Disorder; Bruxism, Sleep; Sleep Disturbance; Jaw Spasm; Headache

Summary: the aim of the study was to assess and compare the relationship between jaw function, neck disability, sleep quality, fatigue, and headache in patients with myofascial temporomandibular disorder (tmd) with sleep bruxism (sb) and without (non-sb).

the study was conducted on tmd patients who were willing to participate in the study between january and december 2020. the case-control study included patients diagnosed with myofascial tmd by dental practitioners at regional hospitals referred for physiotherapy. total of 200 myofascial tmd patients, comprising 91 identified as sb and 109 as non-sb were included in the study. the jaw function limitations scale (jfls), neck disability index (ndi), pittsburgh sleep quality index (psqi), fatigue severity scale (fss), and headache impact test-6 (hit-6) scales and indexes were used for both groups. the effect of sleep bruxism (sb) on jaw function, neck problems, sleep quality, fatigue, and tension headache were evaluated. the interactions of these factors and the importance of taking sb into consideration when evaluating and treating patients with tmd were examined.

Eligibility criteria:
inclusion criteria: * diagnosis of myofascial tmd according to diagnostic criteria for temporomandibular disorders (dc/tmd) * pain for more than 6 months * no therapeutic interventions reported for tmd or the neck in the last 6 months * intellectual capacity to provide informed consent exclusion criteria: * not meeting the dc/tmd criteria * diagnosis of psychiatric disease * history of surgery related to the cervical region and/or tmj * cervical and/or tmj malignancy * trauma history * proven specific pathologies such as fracture, or rheumatoid disease * history of facial paralysis * pregnancy

Keywords: temporomandibular disorders sleep bruxism neck disability sleep headache
near infrared spectroscopy (nirs) and superior mesenteric artery (sma) doppler patterns as predictor of feeding tolerance in very low birth weight (vlbw) intrauterine growth restricted (iugr) and non iugr infants

Conditions: Infant, Very Low Birth Weight; Infant Malnutrition; Feeding Disorder of Infancy or Early Childhood; Splanchnic Oximetry; Splanchnic Oxygenation

Summary: this study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (iugr) or non-iugr stratification:population will be stratified in two groups: iugr infants (approximately 10 children) and non-iugr infants (approximately 10 children). primary endpoint:to evaluate the changes in the intestinal perfusion determined by feeding in vlbw infants fed by 3 hours nasogastric nutrition (cn) or by bolus (bn). secondary endpoint: * to compare if changes in the intestinal perfusion induced by feeding are different between iugr and non-iugr infants; * to compare growth and nutritional status of the 2 groups by randomized arm. * to evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (\< 72 hours of life) values of doppler flow velocimetry and of near infrared spectroscopy (nirs). after birth, in the first 24 hours of life, and in the transitional period, between the 48th and 72nd hours of life, all infants' intestinal perfusion will be evaluated with nirs and a doppler of the superior mesenteric artery will be executed. * to test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance (need of interruption of enteral feeding). design: this is a randomized, non-pharmacological, single-center, cross-over study including 20 vlbw babies. duration of the study: 24 months. inclusion criteria * weight at birth ranging: 700 - 1501 grams; * gestational age up to 25 weeks and 6 days; * written informed consent from parents or guardians exclusion criteria * major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract) * significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, dic) * pre-existing cutaneous disease not allowing the placement of the probe


Eligibility criteria:
inclusion criteria: * weight at birth ranging: 700 - 1501 grams; * gestational age up to 25 weeks and 6 days; * written informed consent from parents or guardians. exclusion criteria: * major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract) * significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, dic) * pre-existing cutaneous disease not allowing the placement of the probe

Keywords: vlbw iugr nirs enteral nutrition superior mesenteric artery doppler
recombinant human angiotensin-converting enzyme 2 (rhace2) as a treatment for patients with covid-19

Conditions: COVID-19

Summary: recombinant human angotensin-converting enzyme 2 (rhace2) as a treatment for patients with covid-19 to block viral entry and decrease viral replication.


Eligibility criteria:
inclusion criteria: 1. hospitalized male or female 2. diagnosed to be covid-19 positiv 3. signed inform consent form exclusion criteria: 1. any patient whose clinical condition is deteriorating rapidly 2. known history of positive hepatitis b surface antigen, hepatitis c antibody or hiv antibody 3. history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation 4. pregnant females as determined by positive serum or urine hcg test prior to dosing 5. lung transplantation 6. pre-existing renal failure, i.e. requiring renal replacement therapy with hemodialysis or peritoneal dialysis 7. there are other uncontrolled co-morbidities that increase the risks associated with the study drug administration, that are assessed by the medical expert team as unsuitable 8. patient in clinical trials for covid-19 within 30 days before icf 9. immunocompromised patients (chemotherapy, hiv, organ transplants, stem cell transplants)
efficacy and safety study of msrd-100 in subjects with atopic dermatitis >=3 months of age and older

Conditions: Atopic Dermatitis

Summary: this is a double-blind, randomized, vehicle-controlled, multi-center, parallel group phase 3 study of msrd-100 in the treatment of atopic dermatitis in subjects aged 3 months and up

this is a 4-week efficacy, safety and tolerability study of msrd-100 applied twice daily for 4 weeks compared to its vehicle among subjects ≥3 months of age in the treatment of atopic dermatitis covering ≥5% body surface area. the study will consist of up to 4 visits which includes screening - visit 1 (screening), baseline - visit 2 , visit 3 (day 14), and an end of treatment/final study visit - visit 4 (day 28). study ids m169981001 and m169981002 are two identical studies being run in parallel with different study sites.

Eligibility criteria:
key inclusion criteria: 1. subjects who are male or female, ≥3 months of age on the date of baseline visit. 2. subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the hanifin and rajka diagnosis criteria for atopic dermatitis. 3. subjects must have an investigator global assessment (iga) score of ≥2 at baseline. 4. subjects who have atopic dermatitis covering ≥5% body surface area (bsa) excluding the eyelids, perioral area, around the nostrils, and in the diaper area (for subjects who wear diapers or plastic pants). 5. subjects who have atopic dermatitis with a sign and symptom score ≥ 2 on the following three signs and symptoms: erythema, infiltration/papulation, and erosion/oozing/crusting present in at least one body surface area affected. key exclusion criteria: 1. unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline. 2. concurrent conditions and history of other diseases. 3. used any of the following treatments within the indicated washout period before the baseline visit or those who would require the following during the study. 4. subjects who require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease.

Keywords: dermatitis, atopic eczema dermatitis pruritus genetic diseases, inborn hypersensitivity hypersensitivity, immediate immune system diseases skin diseases, eczematous skin diseases, genetic skin diseases itching rash steroid
topical avastin for treatment of corneal neovascularization

Conditions: Corneal Neovascularization

Summary: the purpose of this study is to determine the effectiveness and safety of topical bevacizumab (avastin) for treatment of corneal neovascularization.

primary outcomes measures included neovascular area (na), defined as the area of the corneal vessels themselves; vessel caliber (vc), defined as the mean diameter of the corneal vessels; and invasion area (ia), defined as the fraction of the total cornea into which the vessels extend. the occurrence of ocular and systemic adverse events was closely monitored throughout the course of the study.

Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age * clinical stable corneal neovascularization (as defined above) * ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits. * all female patients of childbearing potential will be excluded. a female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries. exclusion criteria: * current or recent (≤ 1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye * current or recent (≤ 3 months) intravitreal drug injection to the study eye; recent (≤ 1 month) change in dose and frequency of topical steroids and/or non-steroidal anti-inflammatory agents * uncontrolled hypertension defined as systolic blood pressure of ≥ 150 mmhg or diastolic blood pressure of ≥ 90 mmhg; history of a thromboembolic event, including myocardial infarction or cerebral vascular accident * patients age 75 or older; history of renal abnormalities * recent (≤ 3 months ) or planned surgery * history of coagulation abnormalities, including end stage liver disease or current anticoagulation medication other than aspirin (warfarin, heparin, enoxaparin, or similar anticoagulant agent) * all female patients of childbearing potential (a female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries) * any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study