Kornimate/medical-research-clean huggingface dataset:
evolution of psychoactive substances consumption in connection with covid-19 containment

Conditions: Addiction, Substance; COVID-19

Summary: the current containment linked to covid-19 will have consequences for people suffering from addiction and there is a risk of overdoses when the containment ends. so the investigators hypothesize that this health crisis is an opportunity to develop risk reduction and access to care for vulnerable people who lives with an addiction. the main objective of this study is to describe the changes in the psychoactive substances consumption during the containment in people suffering from addiction. the secondary objectives are to describe the evolution at 1 month from the end of the containment of problematic consumption and the level of access to care of these users


Eligibility criteria:
inclusion criteria: * \>18 years * accept study * live with an addiction exclusion criteria: - not being able to answer the questionnaire

Keywords: risk of overdose on de-confinment covid-19 containment will change drugs practices covid-19 containment will changes access to care addiction is a common disease alcohol containment drug use
safety and efficacy of three different loading doses of clopidogrel, in patients with acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty.

this study will enroll stemi patients, who were planned to undergo pci, and will randomize them to three different clopidogrel loading dose regimens at first medical contact: no pre-treatment, 600 mg or 900 mg. platelet activity after administration of clopidogrel will be evaluated by verifynow™ p2y12 point-of-care system. the study is powered to demonstrate significant differences in the primary end point (the rate of timi myocardial perfusion grade=3).

Eligibility criteria:
inclusion criteria: * st-elevation myocardial infarction: * chest pain lasting more than 30 minutes * not responsive to nitrates * st-segment elevation of more than 0.1 mv in two or more leads on the ecg, or new left bundle branch block * with indication to primary pci, presenting within 12 hour from symptoms onset * age \> 18 years * planned pci * informed consent exclusion criteria: * bleeding diathesis * allergy to study drugs * pregnancy * the performance of a rescue pci after thrombolysis * known existence of a disease resulting in a life expectancy of \<6 months * lack of informed consent

Keywords: angiography percutaneous coronary intervention platelet aggregation inhibitors platelet function tests
continuous wireless monitoring of vital signs and automated alerts in participants at home and during hospitalization

Conditions: Surgical Complication; Pulmonary Disease; Hematologic Diseases; Oncology; Cardiac Disease; Infections

Summary: the primary aim of this study is to test and assess the implementation and effectiveness of continuous wireless vital signs monitoring with real-time alerts on: the frequency of patients monitored with adequate data quality as adequate clinical user satisfaction in the initial versus the last part of the trial (primary outcome).

over the last years, the applicants and research team partners have developed the ward (wireless assessment of respiratory and circulatory distress) project, using continuous wireless monitoring of vital signs and artificial intelligence algorithms for data interpretation in high-risk patient admitted to medical and surgical wards. the ward project combines continuous measurements of 10 different physiological modalities with machine learning to develop the ward-clinical support system (ward-css), based on multiple intelligent algorithms, that automatically monitors, interprets, predicts and alert clinical staff. through a mobile device with a purpose-built graphic user interface (gui), the ward-css stimulates human-machine interaction to improve the monitoring of high-risk hospitalized patients. the ward project has hitherto proven an unmet need for continuous monitoring and the potential for automatic detection and prediction of physiological deterioration events. specifically, observational pilot studies of both patients with acute exacerbations of chronic obstructive pulmonary disease (aecopd) and postoperative abdominal cancer surgery patients have shown that episodes of desaturation, tachycardia, tachypnea, and bradypnea are much more frequently detected using continuous vital signs monitoring than with existing early warning score (ews) systems. ongoing investigations will determine the efficacy in two very selected populations of high-risk surgical patients and acutely ill medical patients with severe disease. this study will investigate the ward-systems' implementation, and effectiveness of use and impact in a cohort of patientparticipants admitted

Eligibility criteria:
inclusion criteria: * adult participants (≥18 years) * patients assessed by the clinical staff as having an acute condition with risk for clinical deterioration and being either at home (with no apparent need for hospitalization), and/or in hospital or * patients at either at home before, in-hospital and/or after hospitalization for elective major surgery, defined as surgery lasting more than one hour under general- or regional anaesthesia exclusion criteria: * the participant expected not to cooperate with study procedures. * allergy to plaster or silicone. * having pacemaker or implantable cardioverter defibrillator (icd) device. * inability to give informed consent.
a study of sgt-003 gene therapy in duchenne muscular dystrophy (inspire duchenne)

Conditions: Duchenne Muscular Dystrophy

Summary: this is a multicenter, open-label, non-randomized study to investigate the safety, tolerability, and efficacy of a single intravenous (iv) infusion of sgt-003 in participants with duchenne muscular dystrophy. there will be 5 cohorts in this study. cohort 1 will include participants 4 to \< 7 years of age. cohort 2 will include participants 7 to \< 12 years of age. cohort 3 will include participants 0 to \< 4 years of age. cohort 4 will include participants 12 to \< 18 years of age. cohort 5 will include participants 10 to \< 18 years of age. initiation of participant enrollment in cohorts 4 and 5 will be subject to the accrual of safety and efficacy data from cohorts 1-3. all participants will receive sgt-003 and will be enrolled in the study for 5 total years for long-term follow up.


Eligibility criteria:
inclusion criteria: * cohort 1: 4 to \<7 years of age * cohort 2: 7 to \<12 years of age * cohort 3: 0 to \< 4 years of age * cohort 4: 12 to \< 18 years of age * cohort 5: 10 to \< 18 years of age * participant ambulatory status at the time of screening part a or rescreening, as defined by the ability to complete a 10-meter walk/run test in \< 30 seconds: * cohorts 1, 2, and 4: ambulatory * cohort 3: either ambulatory or non-ambulatory * cohort 5: non-ambulatory, but having been previously ambulatory by history * established clinical diagnosis of dmd and documented dystrophin gene mutation predictive of dmd phenotype confirmed by sponsor genetic testing. in cases where a genotype may be predictive of residual dystrophin production and/or a clear clinical diagnosis of dmd cannot be made (e.g., due to age), evaluation of dystrophin levels in baseline muscle biopsies may be required to determine eligibility under this criterion. * negative for aav antibodies. * steroid regimen: * cohorts 1, 2, 4, and 5: a stable daily oral steroid regimen of at least 0.5 mg/kg/day of prednisone or 0.75 mg/kg/day of deflazacort for ≥12 weeks prior to screening part a or rescreening, allowing for weight-based modifications consistent with clinical practice. * cohort 3: n/a * meet 10-meter walk/run time criteria * meet time to rise from supine criteria * cohort 5: meet performance of upper limb (pul) 2.0 criteria * participant has body weight: ≤ 90 kg exclusion criteria: * treatment with dystrophin modifying drugs within 3 months prior to screening. * current or prior treatment with an approved or investigational gene transfer drug. * exposure to certain approved or investigational drugs within 3 months prior to screening or 5 half-lives since last administration, whichever is longer. * established clinical diagnosis of dmd that is associated with any deletion mutation in exons 1 to 11 or 42 to 45, inclusive, in the dmd gene as documented by a genetic report and confirmed by sponsor genetic testing. other inclusion or exclusion criteria apply.

Keywords: dmd gene therapy
effect of music therapy in mental subhealth (emtms)

Conditions: Depression, Anxiety

Summary: mental health is increasingly at the forefront of concerns, especially since the start of covid-19 pandemic. however, not all individuals under mental subhealth need pharmaceutical treatment. music therapy (mt) can make peoples gradually relax via relaxing and soothing music, and regulate individual psychological emotions through the influence of music on individuals' cerebral cortex, hypothalamus and limbic system, further improve the mood of daily tension and anxiety. this study adopted randomized clinical trials design, with two groups of mt group and waiting group both under mental subhealth. the mt group received music therapy and routine activities, while the waiting group received music therapy after the therapy of mt group. data collections were performed by trained, certified, and qualified personnel. the study aims to provide that mt is an effective intervention way to alleviate the mental subhealth state in the future.

this study is a double-blind randomized controlled trial aiming at assessing the efficacy of mt compared to waiting group in mental subhealth. participants will be assigned randomly (1:1) to mt group and waiting group. all the participants will be treated with 12 sessions (3 sessions per week), 30 minutes each time, and conducted for 4 weeks. the mt group received music therapy between 1st-4th week, and the waiting group received music therapy between 5th-8th week. pre-mt (baseline) and post-mt (4th week), two group performed symptom assessment and voice data collection (poetry readings). the mt is mainly divided into three stages, and each stage has a topic. the topic of each stage as follow: ① physical and mental relaxation stage: learning the whole body and mind relaxation mode from breathing to muscle; ② nature imagination stage: guiding music imagination; ③ internal self-exploration: excavating the positive experience and positive potential of the listener and adopting resource orientation for psychological intervention. the purposes of the present study are to: 1) evaluate the clinical response the mt in mental subhealth. 2) further understand the possible biological mechanism underlying the efficacy of mt by analyzing alterations of acoustic features.

Eligibility criteria:
inclusion criteria: a total of \> 5 on phq-9 or a total of \> 5 on gad-7 exclusion criteria: acute suicidal thoughts, with a severe or potentially confounding psychiatric disorder (e.g. psychosis, substance misuse).

Keywords: music therapy depression, anxiety acoustic features
comparative study evaluating stability of fracture segments after treatment of mandibular angle fracture with 3d strut plate with or without immf.

Conditions: Mandible Fracture

Summary: comparative study evaluating stability of fracture segments in mandibular angle fracture with 3d strut plate with or with out post operative immf.

two group of patient with mandibular angle fracture indicated for open reduction and internal fixation ,first group will be fixed with 3d stut plate with post operative immf. second group will be fixed with 3d strut plate with out post operative immf. eligble patients will be randomised in equal proportions between study group (3d strut plate with out post operative immf) and control group (3d strut plate with post operative immf). a- 3d strut plate without post operative immf: * pre operative computed tomography will be done for patient. * intra operative :all cases will under go general anathesia. * exposure of the fracture segments using vestubular incision. * inter-maxillary fixation will be done. * the fracture segment will be reduced in normal anatomic postion guided with occlusion. * the fracture segment will be fixed in postion using 3d srut plate. * closure of surgical incision. * post operative computed tomograghy will be done for the patient. * patient will be dismissed from operation room without immf. b- 3d strut with post operative immf: * pre operative computed tomography will be done for patient. * intra operative :all cases will under go general anathesia. * exposure of the fracture segments using vestubular incision. * inter-maxillary fixation will be done. * the fracture segment will be reduced in normal anatomic postion guided with occlusion. * the fracture segment will be fixed in postion using 3d srut plate. * closure of surgical incision. * post operative computed tomograghy will be done for the patient. * patient will be dismissed from operation room with immf for 15 days. follow up for both groups : clinical examination will be done at first week post operative and patients will be examined every week for one month. last follow up visit will be after three months post operative.

Eligibility criteria:
inclusion criteria: * patients with mandibular angle fracture with or witout other fracture indicated for open reduction internal fixation in the mandible. * patient over 15 years old age and both sexes were included in this study. * patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome. * patients with good general condition allowing major surgical procedure under general anesthesia. * patients with physical and psychological tolerance. exclusion criteria: * patients with comminuted fractures as it is not indicated for compression osteosynthesis like3d strut plate . * patients with high risk systemic diseases like uncontrolled diabetes mellitus. as uncontrolled diabetes mellitus has a negative impact on normal bone healing. * patients with old and/or mal-union fractures. as they will affect accuracy of reduction of the fractured segments.

Keywords: 3d strut plate mandibular angle fracture
a phase iii clinical trial to study the safety and immunogenicity of pneumovax™ 23 (v110) in participants from the russian population (v110-018)

Conditions: Pneumococcal Disease

Summary: the purpose of this study is to determine if pneumovax™ 23 (v110) is safe and immunogenic in participants from the russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease


Eligibility criteria:
inclusion criteria: * for participants 50 years of age or older: any underlying chronic illness must be in stable condition * for participants 2 to 49 years of age: participant has an increased risk for pneumococcal disease as a result of one of the following: chronic cardiovascular disease, chronic pulmonary disease, diabetes mellitus, alcoholism, chronic liver disease, cerebrospinal fluid leaks, functional or anatomic asplenia, sickle cell anemia, living in a special environment or social setting such as crowded, closed communities * male, or female not of reproductive potential, or female of reproductive potential who agrees to remain abstinent or to use 2 acceptable methods of contraception through 6 weeks after study vaccination exclusion criteria: * received prior vaccination with pneumococcal vaccine * has known or suspected immune dysfunction or conditions associated with immunosuppression, or is receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids * has history of autoimmune disease * received a licensed live virus vaccine within 3 months before or is scheduled within 3 months after study vaccination * received a licensed inactivated vaccine within 28 days before or is scheduled within 28 days after study vaccination * received an investigational drug or other investigational vaccine within 2 months before or is scheduled within 28 days after study vaccination (3 months if a live virus vaccine) * received any blood product or immunoglobulin preparation within 6 months before or 28 days after study vaccination * hospitalized for acute illness within 3 months before study vaccination * is a pregnant woman or nursing mother * history of invasive pneumococcal disease or of other culture-positive pneumococcal disease * history of fever illness within 3 days before study vaccination * received antibiotic therapy for any acute illness within 7 days before study vaccination * hypersensitivity to any components of the vaccine, including phenol
molecular monitoring of cfdna by ddpcr in non-small cell lung cancer treated by immunotherapy.

Conditions: NSCLC; IMMUNOTHERAPY; QUANTIFICATION OF CELL-FREE DNA

Summary: non-small cell lung cancer (nsclc) is a major public health problem. new treatments as immunotherapy can improve prognosis of patients with nclc tumors. nevertheless, no robust biomarker is actually available. the hypothesis of the trial is to realize a longitudinal molecular monitoring of nsclc patients treated by immunotherapy using a quantitative analysis of cell-free dna. the primary purposes is to study the predictive value of quantification of cell-free dna at the first reevaluation time, on the clinical benefit, in nsclc patients treated by immunotherapy (regardless of line, or associated treatments) the secondary purposes in this population of patients is to study the earlier predictive value (before the second treatment by immunotherapy ) of quantification of cell-free dna, and its relationship with refractory disease and pseudo-progressive disease.


Eligibility criteria:
inclusion criteria: * age over 18 * informed of the objectives of the project and signed consent * non small cell lung cancer, stage iiia, iiib or iv * ps (who performance status) \< or =2 * treatment based on immunotherapy (monotherapy or combination) * at least one measurable target * available results of pd-l1 expression exclusion criteria: * concomitant other type of cancer * another cancer in the last 5 years

Keywords: nsclc cell-free dna immunotherapy digital pcr
study of sc10914 in patients with gbrca1/2 mutation advanced ovarian cancer

Conditions: Advanced Ovarian Cancer

Summary: a phase ii, multicenter, open-label, single-arm study to evaluate the efficacy, safety and pharmacokinetics of sc10914 in subjects with gbrca1/2 mutated advanced ovarian cancer in china.

a total of 104 subjects with gbrca1/2 mutated advanced ovarian cancer is planned to be enrolled to observe the efficacy, safety and pk profile of sc10914. the subjects oral administration sc10914 tablets 400mg on an empty stomach, three times a day, for 28 consecutive days as a treatment cycle, until disease progression (pd) or the toxicity was intolerable. pk blood samples are planned to be collected for each enrolled subject on c1d28 visit.

Eligibility criteria:
inclusion criteria: 1. sign informed consent voluntarily; 2. ≥18 years old; 3. histologically confirmed ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer( high-grade carcinoma cancer or endometrioid carcinoma); 4. gbrca1/2 mutation positive; 5. had recived at least 2 prior lines of chemotherapy; 6. platinum sensitive patients; 7. the last line of therapy befor enrollment failed； 8. ecog≤2； 8. had at least one measurable lesion. exclusion criteria: 1. any previous treatment with parp inhibitor; 2. symptomatic brain metastases; 3. large amount of fluid in the third gap； 4. subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： anc\ 1.5×uln alt, ast\>2.5×uln (without liver metastases) or alt, ast\>5×uln (with liver metastases) cr \>1.5×uln
effect of pre-cooling on whole-body heat loss during exercise-heat stress

Conditions: Thermoregulation; Cold Exposure; Heat Stress; Exercise

Summary: endurance exercise performance declines in hot environments as core body temperature increases. to enhance performance, body pre-cooling strategies, such as cold-water immersion have been employed to lower resting core temperature thereby increasing the body's heat storage capacity. in turn, the increase in body core temperature associated with exercise in the heat is blunted, allowing the individual to exercise at higher intensity and or for a longer period of time. however, the mechanisms by which pre-cooling impacts heat exchange during exercise remain unclear. while existing research has focused on the performance benefits of pre-cooling the body, relatively little is known about the impacts of pre-cooling on whole-body heat exchange during an exercise-heat stress. investigators will therefore evaluate whole-body heat exchange (dry ± evaporative heat loss as assessed using a direct air calorimeter) during a prolonged (1-hour) moderate-intensity cycling bout in the heat (wet-bulb globe temperature of 29°c; equivalent to 37.5°c, 35% relative humidity) performed with and without pre-cooling by cool-water (\~17°c) immersion.


Eligibility criteria:
inclusion criteria: * healthy young males (18-30 years) * non-smoking * english or french speaking * ability to provide informed consent exclusion criteria: * presence of chronic diseases (e.g., hypertension, diabetes) * acute illness (e.g., flu, covid-19) * physical restriction limiting physical activity * use of medication judged by the patient or investigators to make participation in this study inadvisable. * sedentary

Keywords: cold stress heat stress heat dissipation physical activity performance athletes workers
laparoscopic cholecystectomy for acute cholecystitis after 72 hours of symptoms

Conditions: Acute Cholecystitis; Cholecystectomy

Summary: the purpose of this study is to compare the clinical outcomes of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.

in acute biliary cholecystitis, there was a dogma that patients should be operated within 72 hours of evolution. however, retrospective studies suggested that laparoscopic cholecystectomy even after 72 hours was safe. moreover, some randomized controlled-trials did not found any differences in term of complications between early and delayed cholecystectomy, however none of these studies did separate patients according to the onset of symptoms. the aim of our present study was to compare the clinical outcomes of immediate versus delayed cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.

Eligibility criteria:
inclusion criteria: * proven echographic cholecystitis exclusion criteria: * pregnancy * immunosuppression * severe sepsis * perforated cholecystitis * peritonitis * cholangitis * acute pancreatitis