Kornimate/medical-research-clean huggingface dataset:
non-interventional study (nis) of nivolumab with or without ipilimumab in participants with advanced kidney cancer

Conditions: Renal Cell Carcinoma; Renal Cell Cancer; Adenocarcinoma Of Kidney; Adenocarcinoma, Renal Cell; Kidney Cancer; Cancer of the Kidney

Summary: this is a french, nationwide, prospective, observational, multi-center study in participants diagnosed with advanced renal cell carcinoma, who start a new systemic therapy with nivolumab with or without ipilimumab for the first time and within the market authorization approval.


Eligibility criteria:
inclusion criteria: -adult participants with the diagnosis of advanced renal cell cancer (rcc) (histologically or cytologically) whose physician has already decided to initiate a treatment with nivolumab with or without ipilimumab for the first time for the treatment of rcc, according to the label approved in france note: nivolumab with ipilimumab is indicated for the first-line treatment of adult participants with intermediate/poor-risk advanced rcc exclusion criteria: * primary diagnosis of a cancer other than advanced rcc within the past five years, ie, a cancer other than rcc that requires systemic or other treatment * previously treated with anti-pd1, anti-programmed death-ligand 1 (anti-pdl1) or anti-ctla4 therapy * currently included in an interventional clinical trial for advanced or rcc. participants who have completed participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival (os) can be enrolled * pregnant women and participants under guardianship
the effect of supplementation with curcuminoids for the improvement of musculoskeletal conditions in sedentary adults

Conditions: Sedentariness and Well-being

Summary: the aim of this study is to evaluate the effect of a supplementation with curcuminoids, called cal lx, prior to physical exercise, on the improvement of musculoskeletal conditions in sedentary people, which would lead to more physical exercise regularly.


Eligibility criteria:
inclusion criteria: * to be over 25 years old * to have not exercised systematically during the last 3 months, or do not do physical exercise daily for more than 25 minutes per day for a maximum of 3 days per week * sitting for at least 4 hours continuously * type 2 diabetes patients. exclusion criteria: * to have a history or diagnoses of cardiopulmonary, osteoarticular, type 1 diabetes or autoimmune disorders * pregnancy * smokers.

Keywords: curcuminoid sedentarism recovery inflammation antioxidants
assessment of physical activity during therapy with regorafenib for metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the purpose of this trial is to quantitatively assess the average amount of physical activity that patients are capable to perform while receiving regorafenib for the treatment of metastatic colorectal cancer. the assessment of this reference value, measured by ce (conformité européene)-certified pedometer and international physical activity questionnaire, will allow an estimation on the feasible amount of physical activity for patients in this therapeutic setting. this study is available for patients who are included in the global non-interventional study correlate (safety and efficacy of regorafenib in metastatic colorectal cancer patients; nct01843400) in austria.


Eligibility criteria:
inclusion criteria: * patients diagnosed with mcrc who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib. * patients enrolled in nis correlate in austria * signed patient informed consent for local os exclusion criteria: * subjects unwilling to complete all questionnaires involved in the local os * subjects unwilling to wear the pedometer
amino acid therapy for hot flashes in postmenopausal women

Conditions: Hot Flashes

Summary: the purpose of this study is to determine the safety, tolerability, and effectiveness of the amino acid l-isoleucine in the treatment of hot flashes in postmenopausal women.

hot flashes affect approximately 75% of postmenopausal women. although hormone replacement therapy (hrt) is highly effective in reducing hot flashes, long-term hrt is associated with increased rates of breast cancer and heart disease. safe, effective, and well-tolerated hot flash therapies are needed. the amino acids l-methionine and l-isoleucine have produced reductions in hot flash frequency. however, long-term l-methionine therapy may increase cardiovascular risks. this study will evaluate the short-term effects of l-isoleucine therapy. data from this study will be used to conduct long-term studies in the future. participants in this study will be randomly assigned to receive one of two different l-isoleucine doses for 2 weeks. clinic visits will be made at baseline, week 1, and week 10. participants will record the frequency and severity of their hot flashes in a diary.

Eligibility criteria:
inclusion criteria: * postmenopausal * experience over 5 hot flashes per day exclusion criteria: * hormone replacement therapy (hrt) in the past 2 months

Keywords: postmenopause
effectiveness of the care coordination, assessment, and responsive engagement program for transition-aged adolescents (t-care) with asd

Conditions: Autism Spectrum Disorder

Summary: an analysis of data for adolescents and young adults diagnosed with autism spectrum disorders (asds) who are evaluated as part of the care coordination, assessment, and responsive engagement for transition-aged adolescents (t-care) program which replaced the former autism life care model (alcm), which was a clinical program implemented between fall 2014 and april 2016. the individuals enrolled in the program will be administered a standardized assessment battery during each visit with the care coordinator or study coordinator. the proposed study will analyze data gathered during each of the assessment periods in order to check the efficacy and viability of the protocol.

current collaboration between individuals, families, and providers through in-person meetings are extremely infrequent, costly, and occur most often when providers are intimately involved as part of a multidisciplinary team in a single setting such as at a school. often, little information is transmitted between providers and/or school personnel in determining treatment goals and interventions. furthermore, the transmission of information is often provider to provider or school personnel to provider, which excludes direct patient-input and lessens transparency in decision making. in an effort to improve current care and therefore improve successful adult transitions for adolescents with asd, t-care is designed to mimic multidisciplinary team meetings. these meetings are incredibly impactful as they include direct individual and family involvement through facilitated information-sharing, while also maintaining patient-centered care across multiple providers and complex systems of care.

Eligibility criteria:
inclusion criteria: 1. between 14 and 19 years of age upon entry into t-care 2. a primary diagnosis of asperger's syndrome or autism, as indicated by the social responsiveness scale, second edition (srs-2; constantino \& gruber, 2012) 3. english as primary language spoken 4. ability to self-report (i.e. understand and answer assessment questions written at a third grade comprehension level) (self-report questions to be asked by study coordinator) exclusion criteria: 1. a significant language delay 2. significant psychosis as indicated through a semi-structured interview (mini-international neuropsychiatric interview)
side effects and adherence associated with doxycycline use following medical abortion

Conditions: Abortion

Summary: the effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. the experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. this study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.

medical abortion (ma) consists of administering medication, typically a combination of mifepristone and misoprostol, to induce an abortion without any invasive procedures. early first trimester ma is effective1, highly acceptable to women, and safe. the risk of infection following medical abortion is small, at less than 1%. in rare circumstances, pelvic infection with clostridia bacteria following medical abortion has resulted in death. since 2000, when mifepristone was registered in the united states, 8 such deaths have been recorded in the us. following the publication of case reports of four clostridium-associated deaths after medical abortion in 2005, the reproductive health community reacted swiftly. medical abortion protocols were altered in an effort to curb these drastic and rapidly fatal infections. antibiotic treatment, typically a seven-day course of doxycycline, has become widespread in the united states. the effectiveness of antibiotic treatment at reducing post-abortion infection is unclear. the experiences of women prescribed routine antibiotics after medical abortion is missing from the existing evidence. this study seeks to add to the literature evidence of the side effects associated with antibiotic treatment that women experience and their adherence to prescribed regimens.

Eligibility criteria:
inclusion criteria: * women who are having ma at the study clinic and are willing to complete a self-administered, computer-based questionnaire 7-14 days after taking mifepristone * women who can read english or spanish * in the doxycycline arm: women who have been prescribed doxycycline exclusion criteria: * women who were treated with antibiotics for a medical condition unrelated to their medical abortion between the initial visit and follow-up appointment * women who have previously enrolled in this study

Keywords: medical abortion doxycycline antibiotics adherence nausea
evaluation of potential biomarkers for obstructive sleep apnea and the effect of positive pressure treatment

Conditions: Obstructive Sleep Apnea

Summary: potential biomarkers for obstructive sleep apnea (osa), and full genomic screening will be evaluated and correlated to the degree of osa and to effect of cpap-treatment measured by polygraphy.

this project includes two parts: * genomic screening * biomarkers

Eligibility criteria:
osa-patients with moderate and severe osa (n=15+15) 1. adult, 18-75 years of age 2. moderate (ahi 15-30) or severe (ahi \>30) osa that are currently untreated and planned for cpap-treatment 3. otherwise healthy except for well controlled hypertension since 3 month, max bp 140/90 4. non-smokers 5. not pregnant 6. no medications with antioxidants 7. bmi of \<40 controls (ahi\<5) two groups of controls 1. matched controls the same age, sex and bmi ± 3 and eventual hypertension. these controls should also fulfill criteria 4-6 above. 2. healthy controls with normal bmi (19-25) these controls should also fulfill criteria 1., 4-6 above. exclusion criteria: * if they no not fulfil the inclusion criteria

Keywords: biomarkers genomics
exploratory study of qbkpn ssi in non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability, compliance and mechanism of action of study drug (qbkpn ssi) in subjects with two or more second primary pre-invasive or invasive adenocarcinoma following surgical section of stage 1 nsclc.

please refer to summary above.

Eligibility criteria:
inclusion criteria: * male or female who is at or above the age of consent * histologically confirmed original diagnosis of lung cancer * life expectancy greater than 12 months * ecog performance status 0, 1, or 2 at screening * female subjects who agree to practice two effective methods of contraception from the time of signing the informed consent form through one month after the last dose of study drug * male subjects who agree to practice effective barrier contraception during the entire study drug period and through one month after the last dose of study drug exclusion criteria: * extra-thoracic lung cancer progression * any active malignancies * any uncontrolled or major organ dysfunction * any past or current radiation or systemic therapies for the treatment of lung cancer * known hiv infection or other immunosuppressive disorder * concurrently participating in another study with an investigational immunotherapy or have received investigational immunotherapy within 3 months prior to screening
safety and efficacy of evt 101 in treatment-resistant depression

Conditions: Depression

Summary: this study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. after confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either evt 101 once daily or placebo for 28 consecutive days.


Eligibility criteria:
inclusion criteria: * major depressive disorder * current episode of major depression that has not benefited from at least 1 but no more than 3 adequate treatment regimens * has as score of \>/= 18 on the ham-d-17 exclusion criteria: * pregnant or breast-feeding women * evidence of age-related cognitive decline or mild dementia * at imminent risk of committing suicide * has with the exception of major depression, a serious medical or neurological illness, including seizure disorder, stroke, dementia, or parkinson disease * has an established diagnosis of bipolar disorder, hypomania, schizoaffective disorder, major depression with psychotic features or schizophrenia * has had a substance or alcohol abuse or dependence disorder (except nicotine and caffeine) in the 1 year before screening

Keywords: treatment-resistant depression
hernia repair using the totally extraperitoneal (tep) laparoscopic approach without curare and without orotracheal intubation.

Conditions: Hernia, Inguinal

Summary: laparoscopic treatment of inguinal hernia with the totally extraperitoneal approach (tep) is indicated for simple and bilateral inguinal hernias. it consists of placing a large prosthesis in the posterior position by direct access to the extra-peritoneal space. this prosthesis is interposed between the defective wall and the peritoneum. unlike the transperitoneal laparoscopic method, the strictly extraperitoneal approach reduces complications related to contact with the intestinal loops and preserves the peritoneal layer intact. tep approach is traditionally performed under general anesthesia with curare and orotracheal intubation. in the study, we would like to assess this intervention without curare and without standard orotracheal intubation but with a laryngeal mask airway to permit ventilation.

laparoscopic tep hernia repair is traditionally performed under general anesthesia with curare and orotracheal intubation. indeed, according to the french sfar recommendations (2018) regarding to curarization and decurarization in anesthesia, it is recommended to administer a curare to facilitate intubation of the trachea. moreover, the sfar in these same recommendations specifies that it is probably not recommended to systematically administer curare to facilitate the fitting of a supraglottic airway device (otherwise called a laryngeal mask airway). the idea of this study is to perform this intervention without curare and without standard orotracheal intubation but with a laryngeal mask airway to permit ventilation. this ventilation technique has already been commonly used by the site for several years. the recent global shortage of curares has led them to increasingly resort to this method during this phase of the global pandemic. in addition, limiting the patients exposure to curares avoids possible anaphylactic reactions. according to the sfar, the incidence of anaphylactic reactions to curares varies by country. it was estimated at 184.0 \[139.3 - 229.7\] in france, 250.9 \[189.8 - 312.9\] for women and 105.5 \[79.7 - 132.0\] for men. the main hypothesis of the study is that the repair of inguinal hernia using the totally extraperitoneal laparoscopic approach (tep) is feasible without curares and without orotracheal intubation.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 or over 2. bmi below 30 3. non-recurrent unilateral hernia 4. operating time estimated at less than 60 minutes at the surgeon's discretion 5. patients eligible to an ambulatory surgical setting at the discretion of the surgeon and the anesthetist 6. patient informed of the study and agreed to take part. exclusion criteria: 1. patient under legal protection measures 2. impossibility of using a laryngeal mask airway 3. pregnant or breastfeeding woman
ultrasonography assessment of septic arthritis on native joint

Conditions: Septic Arthritis

Summary: the aim of this trial is to study the interest of ultrasonography among patients with septic arthritis. currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration. accurate assessment of disease activity and joint damage in septic arthritis is important for monitoring treatment efficiency and for prediction of the outcome of the disease. nowadays, magnetic resonance imaging (mri) provides better resolution than radiography or tomography for the detection of joint effusion and for differentiation between bone and soft tissue infectious. the sensibility is reported to be nearly 100% with a specificity of more than 75%. however, mri is expensive and not rapidly accessible. therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can be used to assess the presence and extent of inflammation, destruction, and tissue response. the objective is to describe, using ultrasonography, the abnormalities joint structure influenced the septic arthritis evolution and prognosis. the investigators hope, at the end of this study, to evaluate ultrasonography interest in septic arthritis and to establish ultrasonography prognosis factors to predict treatment efficiency and functional outcome.


Eligibility criteria:
inclusion criteria: * major patients hospitalized in rheumatology, infectiology, orthopedy department (hospital of nantes, of la roche sur yon and of saint-nazaire) with a septic arthritis of shoulder, or elbow, or wrist , or hip, or knee, or ankle on native joint, with positive microbiologic culture joint fluid or positive hemoculture; the diagnosis was based on positive histology or imagery with an inflammatory joint fluid if the microbiologic cultures (hemoculture or joint effusion) were negative. exclusion criteria: * presence of material on the targeted joint * age \< 18 years old * patients under guardianship * pregnancy

Keywords: septic arthritis ultrasonography prognosis parameters
online exercise intervention for psychosis patients receiving residential care

Conditions: Psychosis

Summary: the main objective of this randomised controlled trial (rct) is to investigate the immediate and long-term effectiveness of 8-week online exercise intervention for people with psychosis receiving residential care.

the effect will also be evaluated after 6-month and 12-month, anticipate seeing the maintenance of physical activity throughout a year of time. the secondary objective of this rct is to investigate if the exercise intervention will be effective in improving the clinical symptoms, cognitive functioning and social functioning of the subjects, and to see if the improvement can be maintained (or improve) over a longer period of time (i.e., 6-month and 12-month).

Eligibility criteria:
inclusion criteria: * based on the fifth version of the diagnostic and statistical manual of mental disorders diagnosis to have schizophrenia and related psychotic disorders * have the ability to understand chinese * able to give informed consent exclusion criteria: * severe physical illness (myocardial infarction, hypertension, fracture, spinal problems in which exercise may be contraindicated), and seizure disorders. * comorbid substance dependence * unstable psychotic symptoms * any history of brain trauma or organic brain disease * known history of intellectual disability or special school attendance * other mental conditions that requires other treatment priorities, e.g., suicidal risk. * other medical conditions that severely limits participation, comprehension, or adherence to the treatment or assessment e.g., epilepsy, dementia, terminal medical illness.
investigation of masseter and temporalis muscles sections in individuals with temporomandibular disorders

Conditions: Temporomandibular Joint Disorders

Summary: the aim of the study is to examine masseter and temporal muscle sections with ultrasonography in this individuals depending on the origin of temporomandibular disorders.

multidirectional evaluations are needed to examine the symptoms of temporomandibular disorders (tmd). physical examination, questionnaires towards symptoms, and imaging techniques provide objective data on pathology. the chewing muscles should also be evaluated in this way and the approaches to be followed in subsequent processes should be determined. it is known that muscle sections are changed in tmd, which develops due to muscle disorders. however, regardless of the origin of tmd chewing muscles are affected depending on the condition.

Eligibility criteria:
inclusion criteria: * having a temporomandibular disorder, * individuals who suited temporomandibular disorders/ research diagnostic criteria classification exclusion criteria: * pregnant, * canser, * trauma, * neurologic disorder, * infection, * trigeminal or postherpatic neuralgia

Keywords: temporomandibular joint disorders ultrasonography cross sectional