Kornimate/medical-research-clean huggingface dataset:
study to assess the non-inferiority of pamorelin® 11,25mg sc injected versus pamorelin® 11,25mg im injected in patients suffering from advanced prostate cancer (pamoject)

Conditions: Prostate Cancer

Summary: the active ingredient of pamorelin® 11,25 mg is triptorelin. triptorelin is a substitute for a natural hormone produced in the body called gonadotrophin-releasing hormone (gnrh). gnrh is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. the growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. hormonotherapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation pamorelin® 11,25 mg administered via subcutaneous (sc) injection as compared to pamorelin® 11,25 mg administered via standard intramuscular (im) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24.


Eligibility criteria:
inclusion criteria: * histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy * life expectancy of more than 9 months * documented testosterone levels of ≥ 125 ng/dl measured by any laboratory or on site within the previous 6 months exclusion criteria: * has a history of hypersensitivity to the investigational medicinal product or drugs with a similar chemical structure * has previously received a gnrh analogue, estrogens or a steroidal anti -androgen within the last year preceding the study * concomitant anti-coagulation treatment * patient who underwent an orchidectomy or who is scheduled to receive an orchidectomy during the course of this study * patient with known spinal medullar compression
prevalence of pompe's disease in respiratory clinics

Conditions: Pompe's Disease

Summary: pompe's disease is a very rare condition which causes weakness of the respiratory muscles and may therefore cause symptoms of breathlessness or even respiratory failure, requiring the use of a ventilator at night. recently a treatment for this condition has become available as well as a simple diagnostic test. however, we believe it is possible that there are patients with this condition who are presently undiagnosed attending respiratory clinics. we would like to complete an observational study of patients with respiratory muscle weakness of an unknown cause, who are attending respiratory clinics at two london centres, to determine whether patients attending these services have undiagnosed pompe's disease.

participation in the study will involve taking measurements of respiratory muscle strength, lower limb strength and collecting blood samples to test for enzymes which relate to pompe's disease. these measures will be completed during a routine clinic visit. participation will also involve the study coordinator accessing medical notes to gain information about disease history. the study aims to collect information about the number of patients attending respiratory clinics with undiagnosed pompe's disease and the characteristics of these patients so that other specialist services could use these criteria to identify patients who may benefit from investigations and treatment. if any participants are diagnosed with pompe's disease and could benefit from treatment medical staff would refer them for treatment at local uk centres.

Eligibility criteria:
inclusion criteria: patients presenting to home mechanical ventilation or other respiratory clinics: who are over 18 years old with unexplained respiratory muscle weakness with breathlessness and/or type ii respiratory failure which may be treated by a ventilator which is: unexplained by a known pulmonary disease, radiological abnormality or distortion of body hiatus (e.g scoliosis or massive obesity defined as bmi \> 50 kg/m2), associated with a restrictive ventilatory defect or associated with unexplained muscle weakness. exclusion criteria: respiratory muscle weakness confirmed to be due to another cause known to have pompe's disease at time of referral
exploratory study to evaluate the effects of the probiotics l. rhamnosus gr-1 and l. reuteri rc-14

Conditions: Vaginosis, Bacterial

Summary: the purpose of this study was to determine whether l. rhamnosus gr-1 and l. reuteri rc-14 delivered via capsules to the vagina of post-menopausal women over a three day course of treatment can restore and maintain a lactobacilli-dominated microbiota. exploratory analysis of microbial ecology, human microarrays and multiplex immunological assessments are included to characterize potential effects.


Eligibility criteria:
inclusion criteria: * willing and able to read, understand, and sign the informed consent form (icf); * post-menopausal females between the ages of 40 and 80 years old (subjects who have not had a menstrual period for the last 12 months); * currently in a mutually monogamous sexual relationship or not sexually active; * agree to be sexually abstinent 72 hours prior to each study visit. also, agree to refrain from intercourse for 48 hours after treatment administration; * agree to abstain from the use of any other intravaginal product (e.g. gels, foams, lubricants, douches, etc.) throughout the study period, from the time of screening until day 47; * willing and capable of following all study instructions; and * good general health. exclusion criteria: * use of vaginal lubricants, or any products applied vaginally within three months prior to visit 1and throughout the duration of study participation; * a history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy; * a medical condition which might compromise immune system functions (such as cancer, leucopenia, hiv-positive, or organ transplant); * antibiotics and/or antifungal medication use within the last four (4) weeks; * oral probiotic supplement use within 3 months prior to visit 1 and throughout the duration of the study; * significant changes in diet during the course of the study based on self-report; * induced menopause due to surgical or medical interventions, such as bilateral oophorectomy, hysterectomy, chemotherapy or radiation treatment; * currently undergoing local or systemic estrogen therapy who are not willing to alter therapy during the course of the study; * a nugent score of 0 - 3 or greater than 6; * history of drug or alcohol abuse; * currently diagnosed with or being treated for a genital infection or urinary tract infection; * individuals with a sexually transmitted disease (self-reported or detected by the principal investigator); * at enrollment, have any social or medical condition, or psychiatric illness that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives; * participation in a clinical trial involving an investigational product/device within the past three months; subjects who are scheduled to participate in another clinical study concurrently; and * known intolerance or allergy to l. rhamnosus gr-1® or l. reuteri rc-14® or to any product excipients.
non-invasive monitoring of cerebral autoregulation in perioperative neonatal cardiac surgery

Conditions: Congenital Heart Disease in Children; Extracorporeal Circulation; Complications

Summary: cardiac surgery under extracorporeal circulation (ecc) in newborns with congenital heart disease causes significant morbidity and mortality. the perioperative period is a period of major vulnerability implicated in the appearance of these sequelae, and it is therefore essential to monitor brain function during ecc. the quality of cerebral oxygenation in the perioperative period is routinely monitored non-invasively by infra-red spectroscopy, which makes it possible to estimate cerebral tissue oximetry from a surface electrode (nirs). the association between time spent outside the limits of cerebral autoregulation and the occurrence of perioperative encephalopathy is not known. the purpose of this study is to determine whether disturbances in brain autoregulation during the operative period are associated with the occurrence of postoperative encephalopathy in children operated on for congenital heart disease in the neonatal period. the main objective of the research is to determine the association between time spent outside individually determined cerebral autoregulation limits and the appearance of brain lesions suggestive of low brain output. secondary objectives will investigate the association between time spent outside autoregulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria and will study factors predictive of the development of postoperative encephalopathy.


Eligibility criteria:
inclusion criteria: * any newborn (0-28 days) with congenital heart disease, hospitalized in the preoperative period at the nantes university hospital, for whom a decision is made to perform an operation under extracorporeal circulation, suitable to be transported for an mri without risk, advice taken from the treating team. exclusion criteria: * emergency cardiac surgery * preoperative extracorporeal assistance * preoperative intubation * preoperative administration of inotropes * pre-operative instability contra-indicating pre-operative mri * dependence on a pace maker contra-indicating mri imaging. * parental consent refusal * non-affiliation to a health security insurance
efficacy and safety of pyronaridine-artesunate for the treatment in uncomplicated falciparum malaria

Conditions: Malaria, Falciparum

Summary: this study is a prospective, single arm, open-labelled clinical trial. the total number subjects will be 145 patients to receive pyronaridine-artesunate once daily for 3 days. dosing will be according to the body weight. all patients will have a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). a negative blood slide will be defined as parasite count negative per 1000 wbc in two consecutive days. the sample on day 3 will be taken as close as possible to 72h after the initial blood smear. participant will follow up for 42 days to assess the drug efficacy and safety (day 7, 14, 21, 28, 35 and 42).


Eligibility criteria:
inclusion criteria: * adults and children ≥ 20 kg * symptomatic of malaria infection, i.e. history of fever within 24 hours and/or presence of fever \>37.5°c. * microscopic confirmation of asexual stages of p. falciparum (p. falciparum and mixed infection in pailin only) * capability of taking an oral medication * written informed consent given to participate in the trial * willingness and ability to adhere to follow-up visit schedule exclusion criteria: * pregnancy or lactation (urine test for β hcg to be performed on any woman of child bearing age, that is 18 to 45 y/o) * female aged 12-18y * parasitemia \> 150 000/µl). * signs or symptoms indicative of severe malaria: * impaired consciousness (blantyre coma score \<5) * severe anaemia (hct\<15%) * bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venepuncture sites * respiratory distress * severe jaundice * known hypersensitivity to artemisinins - defined as history of erythroderma/other severe cutaneous reaction, angioedema or to pyronaridine * history of splenectomy * known history or evidence of clinically significant disorders, such as: * known active hepatitis a, e.g. by detection of anti hav-igm. * known hepatitis b surface antigen (hbsag) carrier. * known hepatitis c antibody (hcv ab). * liver function tests (ast/alt levels) more than 2.5 times the upper limit of normal range.
preventing mental health problems after childhood severe malaria

Conditions: Malaria

Summary: this is a randomized trial in which caregivers of children suffering from malaria will be assigned to two treatment conditions to prevent mental health problems in the children. a psycho-education arm (control) and a behavioral arm (intervention). pre- and post-intervention assessments for behavioral problems in the child and mother will be carried out.

this study is designed to prevent mental health problems in children after an episode of severe malaria. the effect of the intervention on the mother's psychological wellbeing will also be assessed. both caregivers and children will be assessed on the ward before being randomly assigned to the treatment arms. the interventions in both arms will be done in three phases with the third phase being done at home after discharge. post-intervention assessments will be done on both the caregivers and mothers 6 months after discharge.

Eligibility criteria:
inclusion criteria: * aged 1.5 to 4 years * admitted with severe malaria necessitating admission and intravenous treatment * signed informed consent from the caregiver. severe malaria in this study will include; cerebral malaria, severe malarial anemia, malaria with impaired consciousness (but not in coma or cm) and malaria with multiple seizures. exclusion criteria: * living more than 50km from the hospital * pre-existing developmental delays based on the ten questions questionnaire
prospective registry of pacemaker patients concerning percentage of right ventricular pacing, lvef and nyha class

Conditions: Atrial Fibrillation; Bradycardia; Heart Block; Sick Sinus Syndrome

Summary: this registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. frequency and distribution of right ventricular pacing, nyha class and left ventricular ejection fraction shall be documented.


Eligibility criteria:
inclusion criteria: * implanted pacemaker for more than 6 months, vvi/ddd, written consent exclusion criteria: * pacemaker implanted for less than 6 months, no right ventricular pacing possibility (aai), no consent

Keywords: pacemaker nyha class ejection fraction heart failure
relationship between cardiopulmonary exercise testing and ca-p in chronic kidney disease (ckd)

Conditions: Ckd-Mbd

Summary: reductions in exercise capacity associated with exercise intolerance augment cardiovascular disease risk and predict mortality in chronic kidney disease. this study utilized cardiopulmonary exercise testing to (a) investigate mechanisms of exercise intolerance; (b) unmask subclinical ca and p and vitamin d abnormalities that may precede cardiovascular disease in chronic kidney disease.

cardiopulmonary exercise testing will carry out in stage 3-5 chronic kidney disease patients ; estimated glomerular filtration rate \<60 ml/min/1.73 m2) and biochemistry will be added (ca p via d pth fgf23).

Eligibility criteria:
inclusion criteria: * ckd patients with gfr \<60 non-dialysis * age\<18 exclusion criteria: * htn * not signing consent * active coronary disease
uveitis in relation to perceived stress: a prospective study

Conditions: Uveitis

Summary: the purpose of this study is to conduct a prospective analysis to determine the relationship between disease activity of noninfectious uveitis and stress.

patients presenting at the new york eye and ear infirmary (nyeei) who meet the inclusion criteria will be recruited prospectively. patients diagnosed with non-infectious uveitis will be asked to self-administer the perceived stress scale (pss) - 10, following informed consent. patient demographics will also be collected. the presence of inflammation will be then be assessed by the investigator. patients will be asked to complete the pss-10 again at all subsequent standard-of-care visits within a 6-month timeframe. pss-10 scores are obtained by reversing the scores on the four positive items (4, 5, 7 and 8), then summing across all 10 items. patient and the investigator will be masked to the pss scores.

Eligibility criteria:
inclusion criteria: * at least 18 years of age with a diagnosis of non-infectious uveitis * able to self-administer the perceived stress scale (pss) - 10 exclusion criteria: * diagnosis of infectious uveitis
wrist denervation vs exercise in wrist osteoarthritis

Conditions: Osteoarthritis Wrist

Summary: a randomized controlled trial comparing partial wrist denervation to a self-managed exercise therapy program in 140 patients with wrist osteoarthritis.

backgroud: high quality evidence regarding the effectiveness of non-operative and operative treatments in wrist osteoarthritis are lacking. aim: to analyze: 1. does partial wrist denervation and self-managed exercise therapy improve patient-reported outcomes, pain, grip strength and range of motion (rom) in wrist oa? 2. is any of the two treatment concepts partial wrist denervation and self-managed exercise therapy more efficient than the other in terms of patient-reported outcomes, pain relief, grip strength and range of motion? method: a multicenter parallel group, two-arm, randomized, controlled, assessor blinded, trial of 140 patients. the study is conducted at the departments of hand surgery at södersjukhuset stockholm and malmö university hospital. group1: self-managed exercise therapy program containing: * patient education: * exercise therapy program: the exercise therapy program is designed by sara larsson (physiotherapist at the department of hand surgery in malmö, sweden), influenced by previous studies on wrist stability and proprioception. focus is on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. the program consists of neuromuscular exercises that focus on coordination, wrist stability and strength. group 2: surgery will be performed under local anesthesia (+ blood-less field or wide-awake local anesthesia no torniquet (walant) according to the surgeon's preference) through a single dorsal incision. ain and pin neurectomy will be performed as described by berger (berger, 1998). primary outcome: patient rated wrist evaluation (prwe) score (0-100) (macdermid et al., 1998) 12 months after intervention.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * chronic wrist pain (≥6 months) due to scapholunate advanced collapse (slac) / scaphoid non-union advanced collapse (snac) grade 1-3 osteoarthritis. * radiological signs of osteoarthritis on posteroanterior and lateral radiograph. exclusion criteria: * previous pin or ain neurectomy. * rheumatoid arthritis or other chronic inflammatory arthritis. * symptomatic osteoarthritis in the distal radio-ulnar (dru), scapho-trapezio-trapezoid (stt) or thumb carpometacarpal (cmc) joints. * ongoing infection. * inability to co-operate with the follow-up protocol. * systemic or intra-articular glucocorticoids or intraarticular prp or hyaluronic acid injections in the affected joint within 3 months prior to enrollment.
bibf 1120 versus bevacizumab in metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the primary objective of this study is to evaluate pfs rate at 9 months of bibf 1120 in combination with mfolfox6 compared with mfolfox6 combined to bevacizumab in first line patients with metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. age \>= 18 years 2. histologically proven colorectal adenocarcinoma 3. no previous oxaliplatin based chemotherapy is allowed unless disease free survival after the end of chemotherapy \> = 12 months 4. no previous therapy with vegfr or egfr inhibitors 5. no prior systemic therapy for metastatic crc 6. no previous adjuvant therapy with fluoropyrimidines is allowed unless disease free survival after the end of chemotherapy \> 6 months 7. ecog performance status \< = 2 8. adequate hepatic, renal and bone marrow functions: 9. no uncontrolled hypertension 10. signed and dated written informed consent prior to admission to the study exclusion criteria: 1. treatment with any investigational drug within 28 days of trial onset. 2. history of other malignancies in the last 5 years, in particular those that could affect compliance with the protocol or interpretation of results. 3. serious concomitant disease, especially those affecting compliance with trial requirements or which are considered relevant for the evaluation of the efficacy or safety of the trial drug, 4. major injuries and/or surgery or bone fracture within 4 weeks of trial inclusion, or planned surgical procedures during the trial period. 5. significant cardiovascular diseases 6. history of severe haemorrhagic or thromboembolic event in the past 12 months. known inherited predisposition to bleeding or to thrombosis. 7. patient with brain metastases that are symptomatic and/or require therapy. 8. pregnancy or breast-feeding.
askb589 in combination with capox and sintilimab in patients with advanced, and unresectable g/gej cancer.

Conditions: Gastric Cancer

Summary: this was an open-label, phase 1/2 study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of askb589 in combination with capox and sintilimab in first-line treatment of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.

a two-part, dose-escalation and expansion study of askb589 was initiated to determine the mtd, pk, pd, and efficacy in combination with chemotherapy and sintilimab.

Eligibility criteria:
inclusion criteria: 1. histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction currently ineligible for surgery and radical radiotherapy. 2. investigators determined that the present situation of the patient justifies chemotherapy plus immunotherapy as first-line treatment. 3. tumor tissue samples are cldn18.2 positive detected by central laboratory 4. ecog performance status 0-1. 5. the results of the laboratory tests must meet all criteria 6. life expectancy of at least 3 months. exclusion criteria: 1. known active central nervous system metastasis or suspected cancerous meningitis; 2. there are moderate to large amounts of abdominal and pleural fluid. 3. the presence of clinically uncontrollable third interspace fluid； 4. patients with any other malignant tumors within the past 5 years. 5. applicable to anti-her-2 drug therapy； 6. anti-cldn18.2 antibody, anti-pd-1 antibody, or drug therapy at any time in the past； 7. patients have received antitumor therapy during the first 4 weeks before study drug use; 8. pregnant or lactating women; or women of childbearing age who have a positive blood pregnancy test during screening period; or women of childbearing age and their spouses who are unwilling to take effective contraceptive measures during the period of this clinical trial and within 6 months after the end of the clinical trial;