Kornimate/medical-research-clean huggingface dataset:
transperineal fusion biopsy versus transrectal

Conditions: Prostate Cancer

Summary: comparison of the efficacy and safety of 2 types of prostatic biopsies: transperineal biopsy versus transrectal biopsy.

interventional, comparative, randomized, controlled study in 2 parallel groups, open-label, longitudinal, multicenter, aimed at demonstrating the non-inferiority of targeted transperineal biopsies compared to targeted transrectal biopsies in terms of diagnostic efficiency.

Eligibility criteria:
inclusion criteria: * patient having had a multiparametric prostatic mri with the realization of 3 sequences (t2, diffusion, perfusion) interpreted by a local referent radiologist in prostate mri or whose pi-rads score is confirmed by rereading by a local referent radiologist in prostate mri in case prostate mri performed outside the center; * patient with at least one pi-rads 4-5 lesion on mri; * patient eligible for prostate, transperineal and transrectal biopsies, targeted and systematized; * patient with negative pre-biopsy antibacteriological urine examination ; * patient with prostate specific antigen (psa) level ≤ 20 ng / ml; * patient capable of understanding the information related to the study, answering questionnaires in french, reading the instructions and having expressed their consent to participate in the study. exclusion criteria: * patient who has already had a prostate biopsy; * patient with stage ≥ ct3a prostate cancer according to tnm classification version 8 * patient with negative mri or whose lesions have a pi-rads score \<4; * patient with impassable rectal stenosis; * patient with a dermatological disease preventing perineal access; * patient with rectal amputation; * patient presenting with a urinary tract infection; * patient on anticoagulant treatment at an effective oral dose, not relayed; * patient participating in another clinical trial, or in a period of exclusion from another clinical trial
green coffee extract supplementation and oxidative stress, systemic and vascular inflammation

Conditions: Metabolic Syndrome

Summary: metabolic syndrome (mets) is defined as the collection of risk factors contributing to type 2 diabetes mellitus and cardiovascular disease. mets is accompanied by oxidative stress and low-grade inflammation. green coffee is rich in polyphenols called chlorogenic acids (cga) which possess anti-inflammatory and anti-oxidative characteristics. thus, we carried out this trial to examine green coffee extract (gce) effects on oxidative stress, systemic and vascular inflammation in patients having mets


Eligibility criteria:
inclusion criteria: * body mass index of over 25, waist circumference \>102 cm in men or \>88 cm in women,fasting blood glucose \>100 mg/dl, triglycerides (tg) \> 150 mg/dl, high density lipoprotein cholesterol (hdl-c) \ 130 mmhg and diastolic blood pressure (dbp) \>85mmhg exclusion criteria: * insulin administration for diabetes control, having hypo- or hyperthyroidism, renal failure or other chronic diseases, regular coffee consumption, pregnancy, breastfeeding, taking estrogen, progesterone, corticosteroids, weight loss supplements and obeying unusual weight loss plans
feasibility of modified mindfulness training on antenatal depression and perceived stress in pregnant women with male child preference

Conditions: Antenatal Depression

Summary: this study will assess the feasibility of a modified mindfulness training intervention aimed at reducing antenatal depression and perceived stress in pregnant women with male child preference. the findings aim to support mental health interventions in maternity care.

utilizing the adapt-itt framework, this study will tailor mindfulness-based interventions to address unique cultural stressors, particularly those affecting maternal mental health due to male child preference.

Eligibility criteria:
inclusion criteria: * pregnant women in the first and second trimester * score ≥10 on the edinburgh postnatal depression scale (epds) exclusion criteria: * psychiatric illness history, use of psychiatric medication

Keywords: mindfulness training antenatal depression male child preference perceived stress
effect of 12 weeks of acupuncture on amh and coh in low responder patients

Conditions: Hypogonadism; Ovarian; Female Infertility

Summary: the investigators want to study whether 12 weeks of acupuncture has any effect on amh and the ovarian reserve in women with low ovarian reserve (low responders). amh is measured before and after 12 weeks of acupuncture and the clinical response to controlled ovarian hyperstimulation before and after the acupuncture is compared.

amh is measured cycle day 2 or 3 before and after 12 weeks of acupuncture and the levels are compared. furthermore, secondary outcomes from ivf treatments before and after the intervention are compared.

Eligibility criteria:
inclusion criteria: * ivf/icsi treatment * 18-40 years * amh measured \< or = 10 pmol/l * maximum of 8 oocytes collected at last treatment before inclusion- exclusion criteria: * (use of testicular sperm) * more than 4 acupuncture treatments within the last 3 months before inclusion -

Keywords: acupuncture ivf amh ovarian reserve
immunogenicity and safety of a booster dose of the spikogen vaccine in kidney transplant recipients after two doses of sinopharm vaccine

Conditions: COVID-19

Summary: this is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant sars-cov-2 spike protein subunit vaccine (spikogen) produced by cinnagen co. in kidney transplant recipients after two doses of sinopharm's inactivated virus vaccine. a total of 100 adult individuals receive a single dose of the spikogen covid-19 vaccine at 1 to 3 months after the second dose of the sinopharm covid-19 vaccine. the injection is given in the deltoid muscle of the non-dominant arm. for immunogenicity assessments, blood samples will be collected one month after the booster injection. for safety assessments, all participants will be followed up for one month. study hypotheses include: 1. a booster dose of the spikogen covid-19 vaccine induces strong immunogenicity against sars-cov-2 in adult kidney transplant recipients who were fully vaccinated with sinopharm covid-19 vaccine. 2. a booster dose of the spikogen covid-19 vaccine is safe and tolerable in adult kidney transplant recipients who were fully vaccinated with sinopharm covid-19 vaccine.


Eligibility criteria:
inclusion criteria: * male or female ≥18 years * willing and able to comply with all study requirements, including scheduled visits, intervention, and laboratory tests * kidney transplant recipients who had received two doses of sinopharm vaccine after transplantation * females must not be pregnant or breastfeeding * at least six months should have passed from the time of transplantation * between 1 to 3 months should have passed from the second dose of sinopharm vaccine exclusion criteria: * subjects with signs of active sars-cov-2 infection at the screening visit * subjects with a history of sars-cov-2 infection based on a positive pcr test result after the second dose of the primary vaccination * subjects with an active cmv infection that requires treatment * subjects who have received rituximab within 6 months prior to the screening visit * subjects who have received intravenous immune globulin (ivig) within 6 months prior to the screening visit * subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products. * subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study. * subjects who have experienced transplant rejection within 30 days prior to the screening visit * subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion.

Keywords: covid-19 sars-cov-2 recombinant protein spike advax-sm advax vaccine adjuvant kidney transplant
effect of perioperative clopidogrel responsiveness on ischemic outcome in patients with acute coronary syndrome undergoing off-pump coronary artery bypass surgery

Conditions: Acute Coronary Syndrome (ACS)

Summary: the whole blood thrombelastograph (teg®) platelet mapping™ assay measures clot strength, maximal amplitude (ma), reflecting maximal platelet function, and detects the reduction in platelet function, presented as percentage inhibition, by both aspirin and clopidogrel. a study reported that the teg® can be used as routine monitoring of the variability in adp receptor inhibition and of antiplatelet therapy. therefore, using teg platelet mapping assay, we could find out the perioperative clopidogrel responsiveness of the patients with acs undergoing opcab. the purpose of this study is to determine whether the rate of the major adverse cardiac events (mace, a combined endpoint of mi, revascularization and cardiac death) is higher in the patients with high degree of clopidogrel resistance, who are scheduled to undergo the opcab due to acs.


Eligibility criteria:
inclusion criteria: 1. the patients with acs undergoing opcab 2. the patients over 20 years of age 3. the patient who have been taking \[100 mg of aspirin\] and \[75 mg of clopidogrel or 180 mg of ticagrelor\] for more than one week and who continue within 3 to 5 days prior to surgery exclusion criteria: 1. re-operation or emergency operation 2. the patients with bleeding tendency of decreased liver function 3. left ventricular ejection fraction \< 40% by echo 4. preoperative hematocrit \ 1.4 mg/dl 5. abnormal preoperative prothrombin time or activated partial thromboplastin time 6. preoperative use of other po antiplatelet drugs or po anticoagulants

Keywords: off-pump coronary artery bypass surgery, clopidogrel responsiveness, ischemic outcome
noninvasive ventilation facemasks favoring carbon dioxide washout

Conditions: Respiratory Insufficiency

Summary: the objective of this randomized cross-over trial is to assess the physiological effects of three different facemasks for noninvasive ventilation (nivairo, visairo, optiniv) in patients with acute hypercapnic respiratory failure


Eligibility criteria:
inclusion criteria: acute respiratory failure with * paco2 ≥ 45 mmhg; * arterial ph \< 7.35; * signed written informed consent exclusion criteria: * respiratory rate \< 12 bpm; * immediate need for intubation; * haemodynamic instability (systolic blood pressure \ 5 mmol/l) and/or clinically diagnosed shock; * metabolic acidosis; * recent head surgery or anatomy that prevent the application of facemasks; * any contraindications to oesophageal balloon insertion and/or electrical impedance tomography (eit) belt placement. * any contraindications to facemask noninvasive ventilation.
effect of an investigational compound on tolerability of extended release niacin (0524a-023)(completed)

Conditions: Hypercholesteremia; Hyperlipidemia

Summary: this is a 12-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the efficacy of mk0524 to improve the tolerability of extended-release niacin. there will be 6 scheduled clinic visits and 3 treatment arms.


Eligibility criteria:
inclusion criteria: * patient is appropriate candidate for niacin therapy * patients with evidence of ischemic cardiovascular disease must be on a statin and have ldl-c \<130 mg/dl at v1 * patients with diabetes mellitus and no evidence of ischemic cardiovascular disease must have ldl-c \<130 mg/dl at v1 * non-diabetic patients with 2 or more risk factors for coronary heart disease and no ischemic cardiovascular disease must have ldl-c \<160 mg/dl at v1 * patient has tg \<500 mg/dl (5.65 mmol/l) at v1 * a patients historic serum or plasma lipid values measured within 6 months from visit 1 may be used to meet lipid inclusion criteria * all other patients do not require specific lipid entry criteria exclusion criteria: * patients with unstable doses of medications * pregnant or lactating women, or women intending to become pregnant are excluded * patients with diabetes mellitus that is poorly controlled, unstable or newly diagnosed * patients with: chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary disorder or hepatic disease, hiv positive, gout (within 1 year)

Keywords: primary hypercholesteremia mixed hyperlipidemia
effects on the pain of an infiltration by acid hyaluronic association and corticoids versus only corticoids in the rhizarthrosis.

Conditions: Rhizarthrosis

Summary: the rhizarthrosis, or the degenerative osteoarthritis of the trapezo-metacarpal joint, is a frequent degenerative osteoarthritis. the treatment associates not pharmacological measures, such as resting relative of the joint, the orthosis of rest, glazing and pharmacological measures such analgesic, anti-inflammatory not steroidal per bones or premises, even infiltrations cortisone or by hyaluronic acid. no study has, for the moment, tested the interest of the combination of cortisone and hyaluronic acid in rhizarthrosis. in view of the current publications, we propose to carry out a study on two arms, with corticosteroids in reference arm; the experimental arm is the combination of hyaluronic acid and cortisone.


Eligibility criteria:
inclusion criteria: * adults, ≥ 40 years * pain located at the root of the thumb (near the wrist) and awakened by direct pressure and movement * pain resistant to well-conducted medical treatment, with analgesics, nsaids, icing with pain (analog visual scale) ≥ 4 for more than 3 months * radiological findings (kapandji face + profile incidence) typical of rhizarthrosis, stage ii or iii of eaton and litter, with at least 2 of the following 5 radiological elements observed on the trapeziometacarpal joint: * marginal osteophyte * pinching of the joint space * sclerosis of the subchondral space * subchondral kyst * absence of osteopenia * patient with the ability to understand the protocol and signed informed consent * patient receiving social security exclusion criteria: * known allergy to any of the products (corticosteroids or hyaluronic acid) including its excipients (methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol) * change of analgesic treatment within 4 weeks before inclusion. * patients with symptomatic bilateral rhizarthrosis * scaphoid-trapezial arthrosis * local or general infection * severe coagulation disorders, ongoing anticoagulant therapy * severe and / or uncontrolled hypertension * earlier local surgery * associated inflammatory rheumatism * tendinopathy of de quervain, thumb to jump associated * infiltrations earlier than 6 months * diabetes imbalanced * live vaccines * severe water and / or sodium retention (hypernatremia), particularly in cases of heart failure, decompensated liver failure (edema and ascites failure) * pregnant or lactating women * immunocompromised or hemodialysis patients * patients under guardianship, trusteeship, or deprived of liberty * patients participating in another clinical research protocol involving a drug or medical device * patients unable to follow the protocol, according to the judgment of the investigator
efficacy of botulinum toxin for the treatment of dystonia associated with parkinson's disease and atypical parkinsonism

Conditions: Parkinson Disease; Atypical Parkinsonism; Dystonia

Summary: dystonia is a disabling symptom affecting both patients with idiopathic parkinson's disease (pd) and atypical parkinsonism (ap). botulinum toxinum (bont), by blocking muscle contraction, is a possible treatment for focal dystonia. the benefit of bont treatment has been proven in some focal dystonia associated with pd or ap. the investigators aim to give an overview of the efficacy of bont in a variety of focal dystonia in a large cohort of parkinsonian patients.


Eligibility criteria:
inclusion criteria: * diagnosed parkinson's disease or atypical parkinsonism * age \> 18 years * reported dystonia * at least 1 injection with botulinum toxin realized exclusion criteria: * refusal to participate in the study

Keywords: botulinum toxinum dystonia parkinson disease atypical parkinsonism
verbal and written instruction versus verbal and written plus simulation in patients with breast cancer and their caregivers

Conditions: Breast Cancer

Summary: the purpose of this study is to compare two different ways of teaching people how to give injections at home. the first is what we do now, which is teaching patients and/or their caregivers verbally and by giving written instructions. the second is what we do now (verbal and written instructions) along with a demonstration and practice using a needle and an injection pad that feels similar to skin and fat. this is being done to find the best method for teaching people to give an injection at home.


Eligibility criteria:
inclusion criteria: * english speaking * over 18 years of age * no history of performing injections * patient must be receiving pegfilgrastim during adjuvant or neoadjuvant chemotherapy * patient will have the pegfilgrastim administered at home either by self administering or by a caregiver. exclusion criteria: * patient or caregiver desire to inject (with saline) during or immediately following the injection teaching * prior self-injection or injection administration experience of any type * patients with history of anaphylaxis or other severe reactions to latex * patients that required pegfilgrastim injection be administered in clinic

Keywords: injection teaching 13-057
anc & malaria diagnostic in pregnancy

Conditions: Malaria

Summary: the program's overall objective is to assess the impact of a package of interventions aimed at reducing malaria-related mortality and morbidity in pregnant women and newborns by ensuring access to a package of interventions designed to optimise the detection and treatment of malaria during pregnancy as well as improving the early detection and treatment of malaria during the third trimester.

this is a cluster-randomised study in which the health facility is the unit of randomisation. 16 health facilities will be randomised to intervention and control. at the community level women will be encouraged to access anc early in the pregnancy, attend follow-up antenatal visits throughout the pregnancy and deliver at the facility. the current recommended standard of care will be provided to all women attending antenatal and obstetric care. in the intervention area, obstetric, medical, drug-exposure histories will be collected at anc visits. in addition, in the last trimester of the pregnancy (\> 28 weeks of pregnancy), women will be systematically evaluated with selected diagnostic test for whether they have malaria parasites and treated effectively. skilled birth attendants at the facility will be trained in emergency obstetric and neonatal care and the assessment of neonates for danger signs, low birth weight and external/observable birth defects. in the control area, women will be provided with standard practice of care. in both areas, women will be diagnosed and treated at delivery if they are positive.

Eligibility criteria:
inclusion criteria: * located in the geographical location of dafra \& do district * have a minimum attendance of 200 pregnant women per year exclusion criteria: * other public health facilities, private clinics and dafra district hospital will be excluded from the study.

Keywords: malria diagnosis malaria prevention in pregnancy anc services improvement
comparison of doubled quadrupled versus quadrupled allograft tissue constructs for anterior cruciate ligament (acl) reconstruction

Conditions: Anterior Cruciate Ligament; Injury

Summary: the purpose of this study is to compare two different soft tissue allografts, double bundle tibialis anterior allograft or quadruple bundle hamstring allograft, used in repairing a torn anterior cruciate ligament (acl) of the knee.


Eligibility criteria:
inclusion criteria: * acl injury is the primary limitation to activities of daily living. exclusion criteria: * multiple current ligamentous injuries to the knee. * revision reconstruction of the acl. * uncorrected instability of the acl on the opposite knee.

Keywords: anterior cruciate ligament tear acl ligament knee allograft
proton/photon rt - benign meningiomas(p92-13)

Conditions: Benign Meningioma

Summary: the purpose of this study is to determine the best radiation dose for participants with meningioma that has grown back after previous surgery, or which the surgeon has been unable to remove completely. this research study is designed to determine whether a higher dose of radiation will decrease the likelihood that the tumor will grow back, compared to the probability of re-growth that occurs after standard radiation doses.

* after initial interview and physical examination, an immobilization device (head mask, neck support, back support, etc.) will be made for the participant. a treatment planning ct will be performed and a radiation treatment plan will be based on this ct scan. * the radiation dose will usually be given once a day, five days per week. the radiation treatment will take between 7 and 8 1/2 weeks, including treatment planning. * treatment doses will vary, and the dose each participant will receive will be made on the basis of random assignment. participants will either receive the usual dose of 55.8 cge in 31 treatments or 1.8 cge, or 63 cge in 35 treatments of 1.8 cge.

Eligibility criteria:
inclusion criteria: * age 18 or over * histological documentation of benign meningioma * documentation by imaging studies (ct and/ or mri) or residual or recurrent intracranial tumor * karnofsky performance status of ≥ 70 * study specific informed consent exclusion criteria: * malignant meningiomas * prior cranial irradiation, except treatment of localized skin cancer of the face or scalp * patients having a concurrent primary cancer (except skin) * patients having another cancer controlled \< 3 years * pregnant patients

Keywords: sphenoid region parasellar area photon radiation therapy proton radiation therapy