Kornimate/medical-research-clean huggingface dataset:
open label immunotherapy trial for ovarian cancer

Conditions: Ovarian Cancer

Summary: this phase ii will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. we will test new tableted preparation, v3-ova, obtained from hydrolyzed, inactivated blood and tumors of patients with cancer of ovaries. study will last 3 months, 20 patients will be recruited, given one pill per day for three months. the primary clinical endpoint is effect on tumor size and burden after 3 months. secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.

ovarian cancer (oc) - a malignant disease affecting the ovarian tissue - is the sixth most diagnosed cancer among women and causes more deaths than any other cancer of the female reproductive system. for treatment of oc, surgical intervention, chemotherapy, as well as radiation methods are used. despite treatment, about 70% of patients have a relapse. many different types of immunotherapy (especially checkpoint inhibitors) of oc being tested, but so far the successes have been insignificant, and serious side effects are frequent and unpredictable. this phase ii will evaluate a new type of ovarian cancer immunotherapy based on a fundamentally new approach that has been successfully tested in a published clinical study of liver cancer. we will test new tableted preparation, v3-ova, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with cancer of ovaries. study will last 3 months, 20 patients will be recruited, given one pill per day for three months. the primary clinical endpoint is effect on tumor size and burden after 3 months. secondary endpoint will be effect on levels of tumor markers on monthly basis compared to baseline.

Eligibility criteria:
inclusion criteria: confirmed diagnosis of ovarian cancer positive for ca125 tumor marker at above normal threshold level - exclusion criteria: metastases to other sites -

Keywords: ovary ovarian immunotherapy cancer
a prospective, multicenter, single arm feasibility study of the safety and performance of gradion™ hip total cartilage replacement (tcr)™ in the treatment of degenerative joint disease of the hip

Conditions: Degenerative Joint Disease of the Hip

Summary: this is a prospective, multicenter, single arm feasibility study of the safety and performance of the gradion™ hip total cartilage replacement (tcr)™ in patients who require cartilage replacement.


Eligibility criteria:
inclusion criteria: * primary hip surgery for noninflammatory degenerative joint disease (nidjd) such as osteo/degenerative arthritis, and is indicated for cartilage replacement * skeletally mature or at least 18 years of age and has normal anatomy * patient signs the informed consent form * failed medical management * there will be size limitations on patients also - available size range is 46mm-54mm. exclusion criteria: * allergic to polyether urethane, sodium polyacrylate, bone cement or any of its components * previous fusion, acute femoral neck fracture and/or above knee amputation * revision of any previous hip procedure * slipped capital femoral epiphysis (scfe) * rheumatoid arthritis * avn
a composite mr neuroimaging marker for alzheimer's disease

Conditions: Alzheimer's Disease; Mild Cognitive Impairment; Frontotemporal Dementia

Summary: the purpose of this study is to use a functional mri (fmri) index to compare the brain activity of healthy volunteers to that of people with mild cognitive impairment (mci) and alzheimer's disease. the ultimate goal is to develop an early diagnostic tool for alzheimer's disease. the study hypotheses are: 1. the fmri index will differentiate between alzheimer's disease, non-alzheimer's dementia, and healthy volunteers; 2. the fmri index will distinguish participants with mci who convert to alzheimer's disease from those who convert to a non-alzheimer's dementia and those who remain stable; 3. mci participants with a lower fmri index at baseline who convert will progress to alzheimer's sooner than those with a higher fmri index, and mci participants with a faster rate of fmri index decline who convert will have an earlier onset of alzheimer's disease.

the onset of alzheimer's disease is insidious and the boundary between normal aging and alzheimer's disease is blurred. in order to prevent and treat alzheimer's disease, the investigators must be able to mark its preclinical stage, before brain damage becomes irreversible. there is a substantial body of research dealing with predictive markers of alzheimer's disease in individuals with mild cognitive impairment (mci). despite these advances, however, researchers have not had enough evidence to recommend specific techniques that mark preclinical alzheimer's disease. this new functional mri (fmri) index may fill this gap. participants will have two visits, one for memory testing and neurological examination, and one for an mri scan. each visit will take approximately 1½ hours. for volunteers who wish to do so, all study procedures may be completed in a single visit. participants with mci will be followed annually. the investigators are currently enrolling healthy volunteers, as well as individuals with mci (memory loss that does not significantly affect normal daily activities), alzheimer's disease, and frontotemporal dementia (includes primary progressive aphasia).

Eligibility criteria:
inclusion criteria: * 60 years of age or older (50 years of age or older for frontotemporal dementia patients) * normal memory, mild cognitive impairment (memory loss that does not significantly affect normal daily activities), or clinical diagnosis of alzheimer's disease or frontotemporal dementia (includes primary progressive aphasia) * right-handed * general good physical health exclusion criteria: * history of stroke or neurological disease (other than alzheimer's disease or frontotemporal dementia) * seizures or head injury with loss of consciousness within the last five years * ferrous (magnetic) or electronic implants (due to the magnet in the mri scanner) * claustrophobia

Keywords: alzheimer's disease mild cognitive impairment frontotemporal dementia fmri functional neuroimaging memory
video-based cognitive behavioral therapy for insomnia in adults cancer patients and survivors

Conditions: Insomnia

Summary: sleep-4-all-1 is a pilot and ecological study corresponding to the developpement phase of a randomized controlled multicentric trial sleep-4-all-2. the main objective of this second study will be the validation of a stepped-care model in the treatment of persistant insomnia in cancer patients. the primary objective of sleep-4-all-1 is to determine the acceptability of a self-screening for insomnia in cancer outpatients at gustave roussy.


Eligibility criteria:
inclusion criteria: 1. adults outpatients at gustave roussy, 2. with a breast, colorectal, pulmonary or urological, 3. localized or metastatic cancer, 4. during or after their treatment, 5. able to readily read and understand french, 6. able to use informatic tools confidently and with internet access at home, 7. who have signed a written informed consent form prior to any study specific procedures, 8. affiliated to a social security system or beneficiary of the same. exclusion criteria: 1. age \> 85 years old, 2. patient receiving a cancer diagnostic during a consultation of announcement 3. with a who index of 3 or 4 4. severe cognitive impairements or psychiatric disorders which are incompatible with the conditions and the conduct of the study (understanding of the objectives, completion of the questionnaires) 5. simultaneous participation in another study of the same type 6. patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
gynecare prosima* pelvic floor repair system for pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to is to evaluate the success of the gynecare prosima\* system in women with symptoms for pelvic organ prolapse (pop) requiring surgical correction of pop. (\*trademark)

the gynecare prosima\* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.

Eligibility criteria:
inclusion criteria: * candidates with symptomatic pelvic organ prolapse of ics pop-q stage ii or iii, suitable for surgical repair. vaginal hysterectomy, perineal repair and/or mid urethral sling procedures for incontinence may be performed concurrently. * age ≥ 18 years. * agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the ethics committee / irb approved informed consent. exclusion criteria: * additional surgical intervention concurrent to the prosima procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation). * previous repair of pelvic organ prolapse involving insertion of mesh. * previous hysterectomy within 6 months of scheduled surgery. * experimental drug or experimental medical device within 3 months prior to the planned procedure. * active genital, urinary or systemic infection at the time of the surgical procedure. surgery may be delayed in such subjects until the infection is cleared. * coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery. * history of chemotherapy or pelvic radiation therapy. * systemic disease known to affect bladder or bowel function (e.g. parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma). * current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia). * nursing or pregnant or intends future pregnancy. * in the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
a study of proquad in healthy 4 to 6 year old children (v221-014)

Conditions: Measles; Mumps; Rubella; Varicella

Summary: the study was conducted to determine if proquad may be used in place of the second dose of m-m-r ii routinely given to children 4 to 6 years old who were previously immunized with m-m-r ii and varivax.


Eligibility criteria:
inclusion criteria: * in good health * received primary dose of m-m-r ii at less than or equal to 12 months of age * received primary dose of varivax at less than or equal to 12 months of age * negative history of varicella, zoster, measles, mumps, and rubella exclusion criteria: * history of receiving more than once dose of m-m-r ii or varivax * any immune impairment or deficiency * exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination * vaccination with an inactive vaccine with in the past 14 days * vaccination with a live vaccine within the past 30 days * receipt of immune globulin, or blood product in the past 5 months
influence of verticalization on bone mineral density and biological parameters of bone remodeling in children with severe cerebral palsy

Conditions: Cerebral Palsy; Osteoporosis; Bone Mineral Density; Bone Remodeling Disorder; Fracture

Summary: low bone mineral density affects 77% of children with severe cerebral palsy (gmfcs iv \& v) with an increased fracture risk of 4%. one strategy supposed to improve bone mineral density is verticalisation with static devices. nowadays there is no time recommendation of verticalisation however high intensity verticalisation has been shown to be effective in improving bone mineral density in childrens with cerebral palsy, but difficult to apply in real life due to lack of qualified therapists, device's complexity, and severe impairment in those children. the investigators aim to compare bone mineral density and bone remodelling factors of verticalized and non verticalized childrens with severe cerebral palsy as achieved in everyday life. the investigators conduced a retrospective study comparing bone mineral density and factors who influence bone remolling in severe cerebral palsy's according to whether they are verticalized or not.


Eligibility criteria:
inclusion criteria: * patients with cerebral palsy gmfcs (gross motor functional classification scale) iv-v * age of patients 3-18 years exclusion criteria: * patients with neuro muscular disease * patient age \ 18 years old * patient with constitutionnal bone disease * patient with growth hormone treatment * patient with surgery \< 6 months * patient with fracture \<3 months * refusal of the legal representative

Keywords: cerebral palsy osteoporosis bone mineral density bone remodelling factors fracture static verticalization device weight bearing exersices
daxibotulinumtoxina injection for treatment of adductor spasmodic dysphonia

Conditions: Adductor Spasmodic Dysphonia; Voice Disorders; Spasmodic Dysphonia

Summary: spasmodic dysphonia (sd) is a neurologic condition causing inappropriate contraction of the laryngeal musculature, leading to abnormal voicing. the three types (adductor, abductor, and mixed) affect varying muscle groups which produce characteristic voice patterns. the vast majority of patients with sd have adductor type, which impacts the lateral cricoarytenoid and thyroarytenoid muscle complex. while many treatment modalities have been investigated, the most effective treatment is botulinum toxin injection to these muscle groups, performed transcervically with or without electromyography (emg) guidance. patients undergoing this treatment typically require re-injection every 3 months. due to its specialized nature, the laryngeal injections are not performed routinely outside of academic medical centers; thus, patients may come from a distance to receive this treatment. both due to the significant impact on voice quality when the injections wear off and the sometimes challenging access to treatment, a longer-acting agent is desired. injectible daxibotuliumtoxina (daxi, revance therapeutics inc., newark, ca) has been shown in large clinical trials to provide safe, effective treatment for glabellar lines and cervical dystonia and may offer a longer-lasting result when compared with onabotulinumtoxina. thus, a study examining the effect of daxi for patients with adductor spasmodic dysphonia is proposed. this study aims to assess the efficacy of daxi for transcervical laryngeal injection in patients with adductor spasmodic dysphonia.


Eligibility criteria:
inclusion criteria: * greater than 18 * diagnosis of adductor spasmodic dysphonia * previous successful treatment with botoxa * stabilized dose for last 3 treatments exclusion criteria: * age less than 18 * exclusively having other neurologic conditions such as: * abductor spasmodic dysphonia * als * multiple sclerosis * parkinson's disease * essential tremor

Keywords: adductor spasmodic dysphonia
adjuvant radiotherapy versus observation after radical cystectomy in high risk urothelial bladder cancer

Conditions: High-Risk Cancer; Urothelial Carcinoma Bladder

Summary: this is a prospective randomized clinical trial in high risk urothelial bladder cancer to compare adjuvant radiotherapy versus observation after radical cyctectomy. this is to clarify the benefit of adjuvant radiotherapy while limiting gastrointestinal toxicities for patients with pathological high-risk bladder cancer through assessing locoregional control (lrc).

this is prospective randomized trial in high risk urothelial bladder cancer that includes 2 arms. the randomization will be done by permuted block method to 2 equal comparable groups. the total number of subjects will be 50 in each arm (total=100 subjects). this study include patients who may receive neoadjuvant chemotherapy \[gemcitabine+cisplatin\]) or not. arm (1) in this study (n=50) will received irradiation of both the bladder tumor bed and pelvic lymph nodes using imrt technique. for arm (2) (n=50) will undergo observation following radical cystectomy.

Eligibility criteria:
inclusion criteria: patient with muscle-invasive urothelial cancer, who received neoadjuvant chemotherapy followed by radical cystectomy and urinary diversion with negative safety margin and belongs to one or more of the categories: * ≥ 18 years old. * pt3 or pt4a tumors. * grade 3 urothelial cancer. * positive infiltration of the dissected pelvic lymph nodes. exclusion criteria: * residual tumors upon cystectomy. * previous pelvic irradiation. * non-urothelial bladder tumors. * who performance status above 2. * any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.

Keywords: adjuvant radiotherapy neoadjuvant chemotherapy radical cystectomy high risk urothelial carcinoma bladder local control disease free survival (dfs)
a pilot study to determine the efficacy of a low carbohydrate diet in treatment of adolescents with metabolic syndrome

Conditions: Elevated Triglycerides; Systolic Hypertension; Insulin Resistance; Abdominal Obesity

Summary: the purpose of this study is to determine the effectiveness of two different non-energy restricted controlled carbohydrate programs with the american diabetes associations' diet on glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic syndrome, a constellation of symptoms associated with the development of type 2 diabetes and cardiovascular disease.

the purpose of this study is to determine the effectiveness of two different non-energy restricted controlled carbohydrate programs with the american diabetes associations' diet on glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic syndrome, a constellation of symptoms associated with the development of type 2 diabetes and cardiovascular disease. we plan to address the following issues: 1. to test the hypothesis that a controlled carbohydrate nutrition plan will be superior to the standard ada diet in controlling blood sugar (as measured by glycosylated hemoglobin \[hba1c\]), decreasing cardiovascular risk factors (serum lipid levels, blood pressure) and decreasing weight in adolescents with metabolic syndrome 2. to evaluate the tolerability of a non-energy restricted very-low carbohydrate diet in these patients as measured by the sf-10 for children, the brief symptom inventory (bsi) and a scaled questionnaire regarding side effects. 3. to compare two different maintenance programs in the group who receive the non- energy restricted very-low carbohydrate diet and compare each group to the group

Eligibility criteria:
inclusion criteria: * adolescents and young adults ages 13-18 with a bmi\>95% for age or over 30 for young adults, with pre-existing metabolic syndrome exclusion criteria: * subjects on any chronic medication other than antihistamines, asthma medications, oral contraceptives or diabetes medications, smoke more than 5 cigarettes/day, suffer from alcoholism or drug abuse or have any significant abnormality not associated with metabolic syndrome on screening labs will be excluded from randomization. * subjects currently taking byetta will be excluded from the study, as a side effect of the drug is weight loss. * subjects with familial hypercholesteremia may be excluded if the investigator considers the history to be severe. the data collected from subjects with a hba1c greater than 12.5 will be analyzed in a separate group, although they will still be randomized to one of the three treatment groups. this is due to the fact that past experience has shown that these individuals run a high risk of being non-compliant with medication use, diet, and exercise plans. results from this group will be reported separately. * subjects who are pregnant or those desiring pregnancy will be excluded, as the safety of this intervention in pregnancy has not been established.

Keywords: ada diet low carbohydrate diet metabolic syndrome
effect of resistance training in adults with complex congenital heart disease

Conditions: Congenital Heart Defect

Summary: adults with complex congenital heart disease have impaired muscle function compared both to health controls and patients with lesions classified as simple. there is only one study assessing the effects of resistance training in patients palliated with fontan procedure. the hypotheses of the present study is that home based resistance training will improve muscle function in adults with different complex congenital hear diseases.

the number of adults with complex congenital heart disease is increasing and today they outnumber the children with corresponding lesions. however, the longterm prognosis is still unknown and continuously changing as new therapeutic options are introduced. patients with complex congenital heart disease have reduced muscle function compared to healthy controls as well as patients with lesions classified as simple. furthermore, men with congenital heart disease are more commonly underweight and less commonly overweight obese compared to the general population. in addition, men with complex lesions are shorter in comparison to controls. this indicates an altered body composition i.e. muscle mass, fat mass and bone density in this population. moreover, impaired muscle metabolism has been reported in patients palliated with fontan procedure. adult patients with complex congenital heart disease will be recruited based on defined inclusion and exclusion criteria. muscle function, muscle strength, muscle metabolism and body composition will be evaluated before randomisation and at follow-up after twelve weeks. the patients will be randomised to twelve weeks of home based resistance training or to a control group. the randomisation ratio will be 1:1 ( intervention:control). the control group will be instructed to continue with their habitual physical activities. the resistance training protocol will be individualised based on the results of the muscle function and muscle strength tests. the aim of this study is to investigate the effects of resistance training on muscle function, muscle strength, body composition and muscle metabolism in adults with complex congenital heart disease.

Eligibility criteria:
inclusion criteria: * complex congenital heart disease ( e.g. tetralogy of fallot, transposition of the great arteries, pulmonary atresia, patients palliated with fontan procedure or total cavo-pulmonary connection). * clinically stable without significant change the last 3 months. * adult (\> 18 years of age). * informed consent. exclusion criteria: * cognitive impairment affecting the ability of independent decision making. * present strategy of regularly executing resistance training \> 2times per week in purpose to increase muscle strength. * other comorbidity affecting physical activity. * other circumstance making participation unsuitable.

Keywords: resistance training adult muscle strength muscle endurance muscle metabolism