Kornimate/medical-research-clean huggingface dataset:
acupuncture for relieving perimenopausal symptoms

Conditions: Perimenopause

Summary: the purpose of this study is to determine whether acupuncture is effective for relieving perimenopausal symptoms.

* a randomised controlled trial with superiority design * a total of 220 participants will be included in 3 centers * 2 arms: acupuncture group and climen® group

Eligibility criteria:
inclusion criteria: * participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. at least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days. * reported relative perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc. * age 40-50 years. * not accompanied with conditions that are needed for hormone therapy, e.g., menopause after surgery, active osteoporosis. * willing to participate and signing the inform consent. exclusion criteria: * had a regular menopausal cycle 3 months before this trial. * taking estrogen, selective serotonin reuptake inhibitor(ssri), soy isoflavone, progesterone, vitamin e or black cohosh in the 4 weeks before inclusion. * receiving chemoradiotherapy. * agnogenic vaginal bleeding. * coagulation defeats, or taking anticoagulant drugs, such as warfarin, heparin, etc. * dermal diseases, e.g., eczema, psoriasis. * liver or kidney failure. * uncontrollable hypertension, diabetes, or thyroid diseases. * with diabetic neuropathy, malignant cancer and mental diseases (including depression). * intend to gestation, in gestation period or lactation period. * using sedative or antianxiety drugs. * with smoking or intemperance problems. * using cardiac pacemaker, or joint prosthesis. * low compliance. * benign tumor in breast. * family history of breast cancer.

Keywords: perimenopause hot flash palpitation
position hto multicenter nis

Conditions: Medial Monocompartmental Osteoarthritis of the Knee

Summary: evaluation of the position hto system in patients with unicompartmental medial arthrosis after open wedge high tibial osteotomy


Eligibility criteria:
inclusion: varus deformity between 0 - 20°, isolated medial arthrosis ≥ level 2 (k\&l) or a congenital deformity or chondromalacia ≥ level 2 (icrs), lateral cartilaginous tissue damage ≤ level 1(k\&l), intact lateral meniscus, age ≥ 18 years, range of motion at least 0° - 0° - 130°, patella/ sliding plane without signifikant signs of arthrosis, stable joint or possibility of intraoperative balancing of the tendon tension; exclusion: clinically relevant disorders of bone metabolism, aktive infection, adipositas (bmi ≥ 35), rheumatoid arthritis, osteomyelitis in the tibia, no availibility for follow-up examinations

Keywords: hto, high tibial osteotomy, open wedge, medial arthritis
study of weekly motexafin gadolinium (mgd) for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Leukemia; Lymphoma

Summary: the primary purpose of this study is to evaluate the safety, toxicities, dosage and response rate for an investigational drug, motexafin gadolinium, administered to patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. the secondary purpose of this study is to evaluate the clinical benefit rate, the time it takes for a patient's chronic lymphocytic leukemia or small lymphocytic lymphoma to worsen, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening. additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * cll as defined by the nci 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t\[11;14\] translocation or cyclin d1) or sll as defined by who classification criteria and is refractory or relapsed as defined by one of the following: * refractory disease: progressive disease while on therapy * relapsed disease: progressive disease after at least one treatment course of therapy with disease response or stabilization * ecog performance status score of 0, 1, or 2 * willing and able to provide written informed consent exclusion criteria: * laboratory values of: * platelet count \< 30,000/µl * ast or alt \> 2 x uln (upper limit of normal) * total bilirubin \> 2 x uln * creatinine \> 2 mg/dl * chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (\> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment * major surgery or hospitalization for a serious illness within the last 3 months * greater than three prior regimens (where a regimen is defined as a treatment for cll/sll given initially or after disease progression) * prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer * uncontrolled hypertension

Keywords: chronic lymphocytic leukemia small lymphocytic lymphoma leukemia lymphoma motexafin gadolinium relapsed chronic lymphocytic leukemia relapsed small lymphocytic lymphoma refractory chronic lymphocytic leukemia refractory small lymphocytic lymphoma
study of human central nervous system (cns) stem cells transplantation in pelizaeus-merzbacher disease (pmd) subjects

Conditions: Pelizaeus-Merzbacher Disease

Summary: the purpose of this study is to determine the safety and preliminary effectiveness of human central nervous system stem cells (hucns-sc®) transplantation in patients with connatal pelizaeus-merzbacher disease (pmd).

enrolled subjects will be transplanted with hucns-sc cells into the brain and will receive immunosuppression for nine months. the study observation period is for one year after transplant surgery. thereafter, subjects will be enrolled in a long-term observational follow-up study for four years.

Eligibility criteria:
inclusion criteria: * confirmed clinical diagnosis of connatal pmd * molecular genetic confirmation of mutation in the proteolipid protein 1 (plp1) gene * mri consistent with pmd as interpreted by a qualified neuroradiologist exclusion criteria: * other significant congenital brain abnormality not related to pmd * previous participation in gene transfer or cell transplant trial * presence of neurological signs and symptoms not consistent with pmd * current or prior malignancy * prior organ, tissue or bone marrow transplant

Keywords: pmd stem cells pelizaeus-merzbacher disease human stem cells central nervous system stem cells
study of velcade and thalidomide in patients with myelodysplasia

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to find out what the maximal tolerated dose of velcade can be given with thalidomide in patients with myelodysplasia.

initial studies using velcade in myelodysplasia with early results demonstrating that 35% had a partial response and 25% had stable disease. the combination of velcade and thalidomide has been studied in patients with multiple myeloma, but not in patients with myelodysplasia. the crr in the mm patients was 22%, with a good safety profile. this is a phase 1, prospective, open-label, dose escalation study to evaluate the dlt and mtd of velcade with given in combination with thalidomide in patients with myelodysplasia. treatment will be given as an outpatient. patients will receive 4 days of velcade (days 1, 4, 8, 11) and 21 days of thalidomide 50 mg/day for each 21 day cycle. there will be 3 cohorts of 3-6 patients each, plus 10 additional patients. the tree dose levels ill be 0.7, 1.0 and 1.3 mg/m2. patients may continue to be treated up to 6 cycles. cycles 2-6 will start within 2 weeks of completion of the previous cycle. disease response will be evaluated after cycle 3 and 6.

Eligibility criteria:
inclusion criteria: * myelodysplastic syndrome with a ipss score of 0.5 or greater * may have had prior chemo/radiotherapy for another malignancy or myelodysplasia * ecog performance status of 0-2 * life expectancy greater than 3 months * total bilirubin \</+ 2xuln * alt and ast \</+ 3xuln * calculated creatinine clearance \> 30 ml/min * use of appropriate method of contraception during the study * anc \> 0.5 x 10(9) * platelet count \> 30 x 10(9) * consideration of treatment with 5 azacytidine is encouraged by not required exclusion criteria: * ejection fraction \< 40% * myocardial infarction within 6 months of enrollment of new york heart association class iii or iv heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * women who are pregnant or breast-feeding * major surgery within 4 weeks prior to enrollment * \>/= grade 2 peripheral neuropathy within 14 days prior to enrollment * uncontrolled intercurrent illness * serious medical or psychiatric illness that could potentially interfere with the completion of treatment * hypersensitivity to bortezomib, boron, or mannitol * received an investigational drug within 14 days of enrollment

Keywords: myelodysplastic syndrome myelodysplasia mds velcade thalidomide bortezomib
olive leaf extracts in the control of diabet

Conditions: Diabetes Mellitus, Type 2

Summary: this study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the chu fb monastir and diabetology consultation, jemmal hospital). patients over 18 years of age with: -diabets

this study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the gr2 study) and 2 external consultations (endocrinology of the chu fb monastir and diabetology consultation, jemmal hospital). all the population will benifit of a biological assessment which include: * complete lipid profile, blood sugar, creatinine * hba1c (if the patient is diabetic). * inflammatory assessment: reactive protein c one population will be rendomized:the population with diabetes. in each study population, the patient will be assigned to one of two treatments (atherolive or placebo). the study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. the placebo will be prescribed identically. continuous blood glucose monitoring to measure indices of glycemic variability is performed at baseline. these patients will be equipped with an ipro continuous glycemic monitoring

Eligibility criteria:
inclusion criteria: * patients over 18 years of age with: * diabetes. exclusion criteria: * exclusion criteria: none.

Keywords: diabetes atherolive
time course comparison of contact lens maintenance systems for hydrogel lenses

Conditions: Myopia; Hyperopia

Summary: the principal aim of this project is to determine the time course of development of contact lens and contact lens case contamination during daily wear of silicone hydrogel lenses. the secondary aim of the study is to determine whether the time course of development of contact lens and contact lens case contamination varies between two different contact lens care systems.


Eligibility criteria:
inclusion criteria: * distance contact lens prescription between +8.00 and -10.00d. * cylindrical component of refractive error no greater than 1.25d in either eye. * vision correctable to 6/12 (0.30 logmar) or better in each eye. * healthy normal eyes without anterior segment infection, inflammation or abnormality, or significant slitlamp findings. exclusion criteria: * concurrent ocular medication * eye injury or surgery within twelve weeks immediately prior to enrolment. * current ocular irritation that would preclude contact lens fitting. * evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. * pregnant, lactating or planning a pregnancy.
conventional oral intake vs delayed oral intake with jejunostomy feeding after esophagectomy (jns study)

Conditions: Esophageal Cancer; Surgery; Jejunostomy; Complications; Nutrition Related Cancer

Summary: comparison of nutritional and early surgical outcome between early and delayed oral feeding after esophagectomy for esophageal cancer

esophageal cancer is a highly aggressive malignancy that metastasizes to the lymph nodes and is associated with a poor prognosis. the 5-year overall survival rate is 40.0 % and the 30-day mortality rate is 1.7 %. surgical resection is the most effective treatment for localized esophageal cancer; however, esophagectomy is extremely invasive and is associated with high morbidity and mortality rates. nutrition is one of the most important factors to consider after esophagectomy in order to reduce surgical mortality. the european society for parenteral and enteral nutrition guidelines recommend early tube feeding after major gastrointestinal surgery for cancer. several studies have shown that enteral nutrition is more effective than parenteral nutrition in reducing postoperative complications in postesophagectomy patients. it has been reported that 5 to 7 days are required for anastomosis site healing. therefore, many centers start oral feeding after esophagectomy on postoperative 7 days after anastomosis site evaluation, and enteral feeding via jejunostomy are maintained for nutritional support. however, the optimal timing for oral feeding after esophagectomy is still under debate. in our center, the investigators routinely place jejunostomy tube for sufficient enteral feeding after esophagectomy. before 2014, the investigators started oral feeding 5 to 7 days after esophagectomy and patients were discharged with soft blended diet. after 2014, the investigators changed our postoperative management protocols: 1) the investigators started only liquid diet 5 to 7 days after esophagectomy and maintained this feeding regimen until the first postoperative clinic visit with supplement of enteral feeding by jejunostomy tube. however, no studies have been conducted showing the optimal timing for oral feeding for esophagectomy patients for nutritional support and postoperative care. the investigators hypothesized that delayed oral feeding after esophagectomy with jejunostomy feeding is superior to conventional oral feeding for nutritional support and early clinical outcome.

Eligibility criteria:
inclusion criteria: * patients who planned to undergo esophagectomy with esophageal reconstruction for esophageal cancer for curative purpose * patients who can understand the purpose and protocol of the clinical trial exclusion criteria: * bmi \ 25kg/m2 * patients who needs colon of jejunum for esophageal reconstruction * patients who needed enteral feeding before esophagectomy * preoperative major organ failure (ex. renal failure requiring renal replacement, hepatic failure) * severe metabolic disorder (ex. uncontrolled diabetes mellitus, uncontrolled thyroid disease) * other patients who are not suitable for clinical trial

Keywords: esophagectomy esophageal cancer nutritional support jejunostomy
double-blind, randomized, parallel-group, placebo-controlled study to evaluate efficacy of cms008618 for common cold

Conditions: Common Cold

Summary: this study evaluates the impact of coldzyme® mouth spray on quality of life during common cold. half of the participants will receive coldzyme® mouth spray, half will receive a placebo device.


Eligibility criteria:
inclusion criteria: 1. men and women 2. age 18 to 70 years old 3. increased risk for common cold (at least 3 self-reported occurences of common cold within the last 12 months prior to v1) but generally in good health 4. readiness to comply with trial procedures, including in particular: * use of ip as recommended * filling in diary * keeping habitual life-style, including diet and physical activity level * no use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/anti-rheumatics, anti-phlogistics, anti-tussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) during the study (except for the defined "rescue" treatment) 5. women of child-bearing potential: * have to agree to use appropriate contraception methods * negative pregnancy testing (beta human chorionic gonadotropin test in urine) at v1 participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, exclusion criteria: 1. known allergy or hypersensitivity to the components of the investigational product 2. history and/or presence of clinically significant condition/ disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject, e.g.: * nasal disorder (e.g. polyposis, relevant septal deviation, ulcer etc.) and/or reconstructive surgery * asthma, chronic obstructive lung disease or any other acute/chronic airways disease/disorder (e.g. chronic cough of any origin) * acute psychiatric disorders * any other acute/chronic serious organ or systemic diseases 3. influenza vaccination within the last 3 months prior to v1 and during the study 4. regular use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to v1 5. pregnancy or nursing 6. history of (in the past 12 months prior to v1) or current abuse of drugs, alcohol or medication 7. participation in the present study of a person living in the same household as the subject 8. inability to comply with study requirements according to investigator's judgement 9. participation in another clinical study in the 30 days prior to v1 and during the study
resistive exercise versus hiit on calcium and vitamin d

Conditions: Vitamin D Deficiency; Calcium; Premenopause

Summary: a comparison between resistive exercise and high intensity interval trainig on calcium and vitamin d in premenopausal women.

a total of 57% of women were vitamin d deficient with higher vitamin d deficiency found among premenopausal women (64.7%). concentrations of 25(oh) d, defined as severely deficient (\ 30 ng/ml). both severe vitamin d deficiency and calcium deficiency was significantly more frequent in premenopausal women compared to postmenopausal women. so, it is important to find effective therapeutic approaches to treat vitamin d deficiency among these women

Eligibility criteria:
inclusion criteria: * premenopausal women having reduced calcium level (less than 500mg) intake as recorded by 24 hours' dietary recall method and vitamin d deficiency (12-19 ng/ml). * their ages will range from 40 to 45 years. * their bmi will range from 25-30 kg/m2. * don't receive hormonal replacement therapy. exclusion criteria: * smoking. * history of chronic disease (uncontrolled hypertension, diabetes mellitus) * osteoporosis. * severe musculoskeletal disorders * cardiovascular disease, thyroid dysfunction
the effect of cervical stabilization training in individuals with migraine

Conditions: Migraine

Summary: studies examining stabilization training and cervical muscle endurance generally focused on headache as the main topic and did not focus on migraine. studies examining the effects of vestibular training focused on the effects on vestibular migraine and did not address migraine holistically. although the effects of vestibular rehabilitation and cervical stabilisation training on balance, cervical muscle endurance and joint position error in individuals with migraine have been examined separately, no study has been found in which all these topics were combined. based on these reasons, this study aims to investigate the effects of two trainings on cervical muscle strength, normal range of motion, anterior tilt, joint position error, deep muscle endurance and balance in individuals with migraine.


Eligibility criteria:
inclusion criteria: * being over 18 years old * being diagnosed with migraine by a neurologist according to the international headache society criteria * complaining of headache at least once a week or more in the last year exclusion criteria: * history of other diseases or operations in the cervical region * having any neurological or orthopedic disease * passing a serious head and/or neck trauma * participating in a physiotherapy program for head and neck pain in the last 12 months * having a visual impairment

Keywords: migraine
s100b in the care of non-traumatic headaches in the emergency department

Conditions: Headache

Summary: the main objective of this pilot study is to make a first assessment of the discriminating ability of a dosage of s100b protein for differential diagnosis between primary headaches and secondary headaches. for this, the investigators will compare serum s100b protein between two groups of headache patients presenting at the emergency department: 1 group of primary headache patients and 1 group of secondary headache patients. if the difference between the two groups proves potentially discriminating, the investigators will seek to determine the discriminating ability of the s100b protein by calculating the area under the roc curve. the reference diagnostic will be set at one month across the entire clinical picture and imaging by an expert committee composed of a neurologist, a radiologist and an emergency physician.

the secondary objectives of this study are: a. to seek an association between s100b protein levels and the onset of pain depending on whether it is more or less than 3 hours. b. to assess the association between s100b protein levels and mortality at day 28. c. to evaluate the association between s100b protein levels and hospital care: average length of stay in the emergency department, lumbar puncture, brain imaging, average length of hospital stay. d. to evaluate the prognostic value of determination of s100b protein on the occurrence of a secondary headache at 1 month.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient has nontraumatic headache pain with a visual analog scale \> 3 exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has a contraindication for magnetic resonance imaging * patients suffering from the following diseases: alzheimer's disease, multiple sclerosis, creutzfeldt-jakob disease, melanoma, trisomy 21.