Kornimate/medical-research-clean huggingface dataset:
performance and safety of the polylactic interference screw used in anterior cruciate ligament reconstructions

Conditions: Knee Ligament Injury

Summary: the evaluation of the clinical data has demonstrated the conformity of the polylactic interference screw (pis), with the relevant essential requirements for its use in orthopaedic applications. the polylactic interference screws are intended for tibial and femoral ligament/graft fixation in the case or anterior cruciate ligament (acl) reconstructions. it has been concluded that the risks associated with the use of the device are acceptable when weighted against the benefits to the patients. in order to improve the clinical data on the pis, the manufacturer, biomatlante, decided to assess that the performance and safety of the device are maintained until the reaching of its intended use. in this objective, the goal of this study will be to observe the following parameters: objective ikdc score (clinical evaluation) subjective ikds score (functional evaluation) safety (report of any adverse event) follow-up of the patient's recovery


Eligibility criteria:
inclusion criteria: * acute or chronic anterior cruciate ligament deficiency with complete or partial lesion of the anteromedial bundle requiring primary reconstruction of the anterior cruciate ligament with hamstring tendons * males or females aged from 18 to 60 years * no history of surgery on the affected knee * patients not under guardianship or judicial protection * signature of non opposition form (consent of the patient exclusion criteria: * history of ligament, meniscal surgery or fracture of the affected knee * pregnancy of breastfeeding women

Keywords: knee ligament injury anterior cruciate ligament rupture anterior cruciate ligament reconstruction knee ligament rupture knee ligament reconstruction
human umbilical cord mesenchymal stem cells (huc-mscs) transplantation in women with primary ovarian insufficiency (poi)

Conditions: Primary Ovarian Insufficiency

Summary: there is a high incidence of women suffering from primary ovarian insufficiency (poi). one of the most common treatments for poi is hormone replacement therapy (hrt), but hrt doesn't work well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer, and breast cancer. the ability of mscs to differentiate into oocyte-like cells has been previously documented. herein the purpose of this work is to evaluate the therapeutic potential of cell therapy in women suffering from poi.


Eligibility criteria:
inclusion criteria: 1. diagnosed with primary ovarian insufficiency; 2. women between 20 and 40 years; 3. have fertility requirements, husband has sperm; 4. willing to sign the informed consent form. exclusion criteria: 1. primary amenorrhea; 2. abnormal karyotyping (e.g. turner syndrome, fragile x syndrome); 3. thyroid dysfunction; 4. severe endometriosis; 5. contraindications for pregnancy; 6. prior personal history of ovarian cancer; 7. unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period; 8. history of serious drug allergy or allergic constitution; 9. autoimmune disease, history of severe familial genetic disease; 10. hiv+, hepatitis b, c;
nutritious eating with soul (the new soul study)

Conditions: Cardiovascular Disease Risk Factors; Overweight and Obesity

Summary: this study addresses two challenges seen among african american (aa) participants during previous weight loss and dietary interventions aimed at reducing cardiovascular disease (cvd) risk: poor weight loss results and high attrition rates. investigators will target both of these challenges by using a randomized design to compare a plant-based dietary intervention (vegan diet) vs. an omnivorous (omni) diet and by focusing on culturally-tailored food choices for aa adults living in the south. therefore, the objective of the study is to conduct a culturally-tailored, randomized trial examining how a vegan diet affects cvd risk factors and weight as compared with an omni diet. the study will randomize overweight aa adults (n=130) to follow one of two different diets (vegan or omni) for 24 months. investigators will accomplish objectives and test hypotheses by following two specific primary aims: primary aims: using a randomized design, determine the impact at 12 months of two different, culturally tailored diets (n=65 omni and n=65 vegan) on changes in: 1. risk factors for cvd, including ldl cholesterol and blood pressure; and 2. body weight. secondary aim 3. examine long-term changes in cvd risk factors and body weight at 24 months.


Eligibility criteria:
inclusion criteria: * self-identify as african american * be between the ages of 18-65 years * body mass index between 25- 49.9 kg/m2 * live in the columbia, sc/midlands area * be able to attend all monitoring and weekly class visits * be willing to be randomized to either diet exclusion criteria: * currently following a vegan diet * diagnosed with diabetes that is controlled by medication * currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months) * under the age of 18 years old * over the age of 65 years old * currently participating in a weight loss program * has lost more than 10 pounds in the past 6 months * diagnosed with stroke or heart attack
pembrolizumab plus paclitaxel, cisplatin followed by surgery for locally advanced escc (keystone-001)

Conditions: Esophageal Squamous Cell Carcinoma; Stage III

Summary: the purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin followed by da vinci robot radical surgery for locally advanced esophageal squamous cell carcinoma.

the preoperative chemoradiotherapy with surgery is the standard treatment in nccn guideline. but many patients refused or abandon radiotherapy because of the intolerable adverse effects. we designed a single-arm, open-label, phase ii trial of pembrolizumab plus paclitaxel, cisplatin followed by da vinci robot radical surgery for locally advanced (stage iii) esophageal squamous cell cancer. the purpose of this study is to observe and evaluate the efficacy and safety.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed esophageal squamous cell carcinoma; 2. potentially resectable ct3n1m0，ct1-3n2m0(stage iii)(ajcc 8 tnm classification); 3. have a performance status of 0 or 1 on the ecog performance scale; 4. age 18-70 years old, both men and women; 5. be willing and able to provide written informed consent/assent for the trial; 6. demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation; 7. female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; 8. be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on day 1. subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the sponsor. exclusion criteria: 1. prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer; 2. ineligibility or contraindication for esophagectomy; 3. has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 4. has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); 5. has severe hypersensitivity and adverse events (≥grade 3) to nivolumab and/or any pd-1/pd-l1 inhibitors.
the effects of sports drinks on urinary lithogenicity

Conditions: Urolithiasis

Summary: the effect of sports drinks on the tendency to form kidney stones has not been assessed. patients will drink 1 liter a day of 2 sports drinks and collect urine to determine changes in urine chemistry that may decrease the risk of forming stones.

participants will drink 1 liter of water each day for one week in the control period, then 1 liter of sports drink each day for one week during the experimental period. urine collections will be performed during both periods. diet will be chosen by participants and a food diary will be kept so that participants can replicate diet during the urine collections.

Eligibility criteria:
inclusion criteria: * age 18-80 years old * men and women * able to sign informed consent exclusion criteria: * history of kidney stones * bone disease * parathyroid disease

Keywords: nephrolithiasis citrate oxalate
long-term safety extension with sr57667b in patients with alzheimer's disease

Conditions: Alzheimer Disease

Summary: the primary objective is to assess the long term safety/tolerability of 4 mg/day of sr57667b in comparison to placebo in patients with mild-to-moderate alzheimer's disease (ad). a secondary objective is to describe the long term progression of alzheimer's symptoms in patients treated by 4 mg/day of sr57667b.

multinational, multicenter, randomized, parallel-group, double-blind, phase ii study

Eligibility criteria:
inclusion criteria: * patients who have participated in study efc5286 and completed the study. * patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures specifically for this lts5283 extension. exclusion criteria: * females who are pregnant or breast-feeding. * females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-hcg pregnancy test at the screening visit,and must use an acceptable method of birth control.

Keywords: alzheimer disease nerve growth factors clinical trial
exploratory clinical study to evaluate the optimal dosage of mosapride and probiotics in irritable bowel syndrome without predominant diarrhea

Conditions: Irritable Bowel Syndrome Without Diarrhea

Summary: the purpose of this study is to evaluate the optimal dosage of mosapride (medirac) and probitics in irritable bowel syndrome without predominant diarrhea.


Eligibility criteria:
inclusion criteria: * aged 18-75 years who satisfied romeiii criteria for the diagnosis of ibs * signed informed consent exclusion criteria: * ibs-d * evidence of cathartic colon or history laxative abuse

Keywords: irritable bowel syndrome without predominant diarrhea probiotics(medirac) 10/mosapride 10mg probiotics(medirac) 15/mosapride 10mg probiotics(medirac) 15/mosapride 15mg probiotics(medirac) 30/mosapride 15mg probiotics(medirac) placebo/mosapride placebo
the effect of hybrid simulation on evaluating neonatal jaundice

Conditions: Nursing Education

Summary: this study will be conducted as a single-blind randomized control group intervention trial to determine the effectiveness of the hybrid simulation method using standard patient and low-fidelity baby simulators in the intervention of nursing students for neonatal physiologic jaundice.


Eligibility criteria:
inclusion criteria: * enrolled in the course * had not taken this course before * accepted to participate in the research exclusion criteria: * have any records of absence * taken this course before * graduate of health vocational high school

Keywords: nursing education hyperbillirubinemia simulation
lichen sclerosus - the influence on quality of life

Conditions: Lichen Sclerosus

Summary: a randomised controlled trial of lichen sclerosus in a period of six months measuring quality of life and sexuality among women with lichen sclerosus.

the patients are randomized to an intervention group and a control group. the intervention gets 6-8 visits with clinical sexologist and the control group is having the usual care.

Eligibility criteria:
inclusion criteria: * patients diagnosed with lichen sclerosus * age over 18 years exclusion criteria: * patients who does not understand or speak danish * patients with a psychiatric diagnosis and can not follow the course

Keywords: treatment quality of life sexology women
ultrashort gnrh agonist/antagonist versus gnrh antagonist ivf

Conditions: Infertility

Summary: the purpose of this study is to evaluate the appropriate controlled ovarian hyperstimulation (coh) protocol in good prognosis patients undergoing ivf treatment. the stimulation characteristics of cycles which include ultrashort flare gnrh agonist combined with flexible multidose gnrh antagonist will be compared to the flexible multidose gnrh antagonist protocol. the investigators hypothesized that combining the stimulatory effect of gnrh agonists and immediate suppression of the gnrh antagonist in a unique protocol may be a valuable new coh strategy for ivf patients, resulting in improved art outcome.

the ultrashort flare gnrh agonist combined with flexible multidose gnrh antagonist protocol during coh cycle resulted in a significantly higher clinical pregnancy rate in patients with poor embryo quality, with repeated ivf failures and in poor responders. this protocol combines the effect of the microdose flare on endogenous follicle stimulating hormone (fsh) release with the benefit of an immediate luteinizing hormone suppression of the gnrh antagonist. the basic hypothesis of this approach can also benefit ivf patients with good prognosis without compromising the ability to use gonadotrophin-releasing hormone (gnrh) agonist to effectively trigger ovulation, while completely eliminating any threat of clinically significant ovarian hyperstimulation syndrome (ohss). the purpose of the study is to compare cycles consisting of ultrashort flare gnrh agonist combined with flexible multidose gnrh antagonist with those using the flexible multidose gnrh antagonist protocol 1. to compare the ivf outcome variables and ongoing pregnancy rates.

Eligibility criteria:
inclusion criteria: * up to three previous ivf attempts exclusion criteria: * patients with poor or no response in previous coh for ivf cycles * abnormal ovarian reserve test i.e. anti-mullerian hormone (amh), antral follicle test * risk factor for diminished ovarian reserve

Keywords: gnrh agonist gnrh antagonist ohss
oxygen consumption after acute whole body vibration session

Conditions: Aged; Oxygen Consumption

Summary: noninvasive assessment of vo2 during a single session of whole body vibration and changes in blood flow caused by the acute activity.

a single whole body vibration session into two groups, a young adults groups and elderly group, booth healthy, will be held with concomitant collection of vo2 consumed during the session, by metamax cortex. immediately after the session, it will be checked peripheral blood flow through us surface in color doppler mode.

Eligibility criteria:
inclusion criteria: * healthy young adults (between 20 to 30 years) and healthy elderly (between 60 to 74 years), sedentary according international physical activity questionnaire. exclusion criteria: * presence of thrombosis, labyrinthitis, osteoporosis and individuals who have difficulty adapting to the assessment or training protocol.

Keywords: oxygen consumption aged whole body vibration
an open, non-comparative study of intravenous and oral fluconazole in the treatment of acute cryptococcal meningitis

Conditions: Meningitis, Cryptococcal; HIV Infections

Summary: to evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial treatment for acute cryptococcal meningitis followed by oral therapy in aids and non-aids patients. lack of satisfactory response will allow increase of dose. both newly diagnosed and relapsed patients are eligible.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antivirals such as zidovudine (azt). * prophylaxis for pneumocystis carinii pneumonia (including aerosolized pentamidine). concurrent treatment: allowed: * radiation therapy for mucocutaneous kaposi's sarcoma. written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian. * patient's treatment status must be one of the following: * no prior systemic antifungal therapy for cryptococcosis. * relapse after prior therapy. the success of prior therapy must have been documented by negative csf culture at the end of therapy. following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin b in the 4 weeks before entry into the study. prior medication: allowed: * antivirals such as zidovudine (azt). * prophylaxis for pneumocystis carinii pneumonia (including aerosolized pentamidine). exclusion criteria co-existing condition: patients with the following are excluded: * evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. * a history of allergy to or intolerance of imidazoles or azoles. * moderate or severe liver disease defined by specified lab values. * life expectancy of \< 2 weeks. concurrent medication: excluded: * coumarin-type anticoagulants. * oral hypoglycemics. * barbiturates. * phenytoin. * immunostimulants. * investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine. concurrent treatment: excluded: * lymphocyte replacement. patients with the following are excluded: * evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. * a history of allergy to or intolerance of imidazoles or azoles. * moderate or severe liver disease defined by specified lab values. * life expectancy of \< 2 weeks. prior medication: excluded: * coumarin-type anticoagulants. * oral hypoglycemics. * barbiturates. * phenytoin. * immunostimulants. * investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine. prior treatment: excluded: * lymphocyte replacement.

Keywords: aids-related opportunistic infections meningitis injections, intravenous cryptococcosis fluconazole administration, oral acquired immunodeficiency syndrome
interest of the reborn® doll as a to in the care of residents with alzheimer's disease or a related disorder

Conditions: Dementia Alzheimers

Summary: the primary objective of this study is to evaluate the benefits of the reborn®doll as an ot for the care of residents with alzheimer's disease or related disorders, by assessing the frequency of resident agitation. the secondary objectives are to study the frequency of treatments, evaluate the average time of exposure to the reborn® doll, study the behavior of the residents, study the interest of this therapeutic workshop, thanks to an evaluation grid and finally study the repercussions of this ot on the nursing staff.

dementia affects 50 million people worldwide, and this number is set to continue rising as the population ages. indeed, the world health organization (who) expects this number to reach 82 million by 2030. at present, there is no cure for dementia. in order to limit the need for drug treatments for dementia-related symptoms (agitation, aggression), non-drug treatments can be used to improve residents' lives and soothe them. in the late 1960s, researchers turned their attention to non-medication therapies (snozelen concept, animal mediation, calinotherapy, tovertafel, carpe diem, doll'therapy). this doll is used by caregivers to calm anxiety attacks, aggression or apathy in residents with mnd. the doll helps to calm the elderly by focusing them on an object. several studies have shown that residents are calmed and feel valued by taking care of the doll. this also helps to avoid physical or chemical restraints, as well as the use of drug therapies in cases of agitation. reborn® dolls are an evolution of doll'therappy.

Eligibility criteria:
inclusion criteria: * resident aged 65 and over * moderate to severe cognitive impairment diagnosed using the npi-es scale * behavioral disorders (agitation, aggression, anxiety, apathy) assessed using the npi-es scale * covered by a social security plan * written consent of representative (tutor/ curator/trusted person) exclusion criteria: * resident or representative refusing to participate * resident under judicial protection

Keywords: alzheimer reborn doll agitation behavioural disorders cognitive disorders
role of xaliproden on recovery rate from severe neuropathy in patients who have completed adjuvant chemotherapy with oxaliplatin based regimens

Conditions: Colorectal Neoplasms

Summary: primary objective: to assess the effect of xaliproden hydrochloride (xaliproden) 1 mg per oral daily on the rate of complete resolution of peripheral sensory neuropathy (psn) at 6 months, following randomization, after the completion of oxaliplatin-based adjuvant chemotherapy for colon cancer. secondary objective: * to assess the effect of xaliproden on patient-reported outcomes using the functional assessment of cancer therapy/gynecologic oncology group-neurotoxicity scale (fact/gog ntx-12 subscale). * to assess the effect of xaliproden on the rate of at least partial recovery of grade \> 2 psn at 6 months * to assess the effects of xaliproden on the time to complete recovery from psn * to evaluate the safety profile of xaliproden


Eligibility criteria:
inclusion criteria: * have completed an oxaliplatin-containing chemotherapy regimen post complete surgical removal of primary colon tumor no later than 6 weeks before randomization; * have grade ≥ 1 psn, as defined by the nci-ctcae version 3.0 * have an eastern cooperative oncology group (ecog) performance status ≤2; * blood tests within 14 days prior to randomization: (a) ast (sgot) and alt (sgpt) ≤2 x upper limit of normal (uln); (b) serum creatinine ≤1.5 x uln; (c)hba1c ≤7%; (d) neutrophils ≥1.5x10\^9/l ; (e) platelets ≥50x10\^9/l; (f) serum d-dimer within normal limits exclusion criteria: * pre-existing peripheral neuropathy prior to treatment with oxaliplatin * receiving any further anti-cancer treatment * history of any recent (≤1 year) thrombo-embolic events and current clinical evidence of thrombo-embolism * unstable cardiac disease * history of significant neurological or psychiatric disorders including dementia or seizures, * active uncontrolled infection * active disseminated intravascular coagulation * other serious underlying medical conditions which could impair the ability of the patient to participate in the study; * use of antidepressant/antiepileptic medication (for the treatment of psn), unless commenced before informed consent form signed. the addition of these medications (for the treatment of psn) once the patient has consented is not allowed * concurrent treatment with any other experimental drugs * pregnant or breast-feeding women; * women of childbearing potential must be protected by effective contraceptive methods of birth control. post-menopausal women must have been amenorrheic for at least 12 months to be considered as having non-childbearing potential * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. those conditions should be assessed with the patient before registration in the trial. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.