Kornimate/medical-research-clean huggingface dataset:
precision acupuncture in the treatment of peripheral neuropathy after taxanes chemotherapy in breast cancer

Conditions: Breast Cancer

Summary: precision acupuncture in the treatment of peripheral neuropathy after taxane chemotherapy in breast cancer

associated peripheral neuropathy in breast cancer patients has a significant impact on their quality of life and treatment compliance. many studies have shown that acupuncture has a certain therapeutic effect on peripheral neuropathy. studies have shown that taxane induced peripheral neuropathy in breast cancer is related to genetic factors. based on snps related to peripheral neuropathy, this study screened snps related to peripheral neuropathy caused by taxane drugs, and established a prognostic model. eligible patients diagnosed with stage i, ii or iiia breast cancer and experiencing peripheral neuropathy for at least 2 weeks were assessed by the functional assessment of cancer therapy/gynaecologic oncology group-neurotoxicity，fact/gog-ntx) and the european organisation of research and treatment of cancer quality of life questionnaire-cipn twenty-item scale(eortc qlq-cipn20). likert level 5 and level 4 scores were used for all items in the above two scales. the investigators will temporarily divide the study into a group, and the investigators will increase the group if necessary. laboratory personnel were blinded to all clinical and outcome data.

Eligibility criteria:
inclusion criteria: 1. the patient was at least 18 years old and had reported grade 1 or higher neuropathic symptoms for more than 2 weeks; 2. patients were screened for eligibility by the investigator prior to enrollment, including verification of baseline neuropathic symptoms. 3. patients had a diagnosis of stage i, ii, or iiia breast cancer; 4. have completed at least 2 weeks of chemotherapy; 5. higher scores indicate more severe symptoms; 6. voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent); 7. eastern cooperative oncology group (ecog ) score of physical condition (0-1); 8. patients with previous local recurrence were eligible; 9. the basic indexes were consistent, and the blood routine and ecg were normal. exclusion criteria: 1. patients with needle phobia; 2. low platelet count (\<50 000); co-morbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels \<10 g/dl and haematocrit \<30; anaemia on active pharmacological treatment or receiving blood transfusion or steroids; 3. having metastatic or recurrent disease, history of preexisting peripheral neuropa- thy prior to chemotherapy, uncontrolled seizure disorder, unstable cardiac disease or myocardial infarction within 6 months prior to study entry; 4. being pregnant or nursing, or having used acupuncture for peripheral neuropathy within 6 months prior to study entry; 5. life expectancy \<6 months; 6. lymphedema of limbs;

Keywords: acupuncture breast cancer peripheral neuropathy taxane chemotherapy
nicotine's potential abuse with menthol

Conditions: Nicotine Dependence

Summary: to examine if switching from menthol to non-menthol cigarettes will change the dose-effect curves for positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate in smokers.

a placebo-controlled study that will recruit male and female menthol nicotine dependent smokers. following screening and evaluation as described above, eligible participants will be enrolled in the study which will last about 4 weeks. eligible, participants will be randomized to menthol or non-menthol smoking condition for 2 weeks (phase 1) and then will be switched to the alternative condition for another 2 weeks (phase 2). the smoking condition will be open label. participants will be provided with free cigarettes in phases 1 and 2. for the menthol condition, participants will be provided their usual brand of menthol cigarettes and for the non-menthol condition, they will be provided a matched-brand non-menthol cigarette (e.g., newport non-menthol gold 100s for those who smoke newport menthol gold 100s). in week 2 of each phase, participants will have a test session. each session will include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5 minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes. once the participants complete the test session, participants will be crossed-over to the alternative treatment. the period between the 2 phases will not be longer than one week.

Eligibility criteria:
inclusion criteria: * 1) female and male smokers, aged 21 to 35 years, who have been smoking tobacco cigarettes for at least a year; * 2) smoke ≥ 5 and less than 20 cigarettes per day; * 3) urine cotinine levels \> 100 ng/ml consistent with nicotine intake of an active smoker * 4) not seeking treatment at the time of the study for nicotine dependence; * 5) in good health as verified by medical history, screening examination, and screening laboratory tests; * 6) for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods. exclusion criteria: * 1) history of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study; * 2) regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics); * 3) current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine; * 4) use of e-cigarettes more than 10 days in the past 30 days; * 5) urine drug screening indicating recent illicit drugs use (with the exception of marijuana).
longitudinal study for treatment with botulinum toxin a injections in naïve and pre-treated patients suffering from cervical dystonia [cd-nis-longterm]

Conditions: Cervical Dystonia

Summary: the objective of this study is to investigate the efficacy of dysport® in the treatment of cervical dystonia (cd) in a non-interventional long-term study in naïve and pre-treated patients.


Eligibility criteria:
inclusion criteria: * suffering from cervical dystonia with rotational torticollis/-caput or laterocollis/-caput as the primary component * naïve to botulinum toxin a or pre-treated with botulinum toxin a on a regular basis for at least 2 years prior to inclusion and last injection with dysport® and last injection between 3 and 6 months prior to inclusion * with the intention to be treated with dysport® exclusion criteria: * the subject has already been included in this study * participation in an interventional trial * suffering from anterocollis or retrocollis as primary component
the effects of diquafosol tetrasodium ophthalmic solution, 2% in subjects with dry eye disease (p08637)

Conditions: Dry Eye Disease

Summary: the purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.


Eligibility criteria:
inclusion criteria: * have best corrected visual acuity in both eyes of at least +0.7 or better * central corneal staining of 3 on the nei scale * if female, are non-pregnant or non-lactating * have a history of dry eye disease in both eyes * have normal lid anatomy exclusion criteria: * unable to withhold the use of contact lenses during the study or 2 weeks prior to the study * have had ocular surface surgery within the past year * are considered legally blind in one eye * have a serious medical condition which could confound study assessments
mobility and activity patterns in hospitalised severe brain injury

Conditions: Brain Injuries

Summary: the purpose of this observational study is to quantify physical activity patterns in patients with severe acquired brain injury admitted for in-hospital rehabilitation.

patients admitted for rehabilitation will be included for two periods of one-week monitorization of physical activity. the investigators will include all patients with moderate to severe brain injury. this is an observational cross-sectional study including patients 18 years or above. patients with conditions such as unstable fractures that restricts mobilisation are excluded. physical activity is measured continuously during rehabilitation at two separate seven-day periods using a body-worn activity tracker. the first period will be initiated in the early phase of rehabilitation (3 days after admission) and the second at the late phase (10 days before discharge). baseline variables considered predictors, confounders or modifiers for physical activity will be collected along with registration of variables during the measurement periods and functional outcome variables at discharge.

Eligibility criteria:
inclusion criteria: * 18 years old exclusion criteria: * planned discharge within two weeks * fractures of lower extremities, pelvis or spine prohibiting weight-bearing * amputation of lower extremities

Keywords: exercise physical activity
pain relief for submucosal resection of nasal septum in adults does ketamine have a pre-emptive effect?

Conditions: Nasal Obstruction

Summary: pain is an unpleasant sensory experience associated with actual or potential tissue damage. acute pain management is an important aspect of perioperative anesthetic care. moreover, it is the most important factor related to patient discomfort after surgery. adequate pain management, ideally resulting in the complete absence of postoperative pain, not only provides comfort to patients, but may also contribute to improved healing and a reduction in the incidence of postoperative complications. inadequate postoperative analgesia has been shown to contribute to adverse outcomes, including, but not limited to, immunosuppression, hyperglycemia, poor rehabilitation, and progression to chronic pain.

patients who are scheduled for submucosal resection of nasal septum with or without turbinectomy will be recruited for the study the patients will be will be assigned to either the treatment group who will be administered ketamine prior to the operation or the control group who will receive a normal saline injection, both in identicle syringes. all patients will be operated on by the same surgoens and by the same method of dissection and hemostasis (2-5 2 ml lidocadrain carpules, monopolar suction-cautery set on 25). patients folow-up will be reported in their medical charts. the post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using vas (visual analogue scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day in the otolaryngology - head and neck department

Eligibility criteria:
inclusion criteria: * patients undergoing submucosal resection of nasal septum with or without turbinectomy. * over 18 years of age. * asa (anesthsiology severity score) score of 1-2. * signed informed consent by patient or caregiver. exclusion criteria: * allergy to ketamine * unable/ unwilling to comply with the protocol requirements * pregnancy or breast feeding * chronic use of analgetics * history of alcohol and/or drug abuse * previous nasal surgry
operant conditioning of spinal reflexes training system--reflex operant down conditioning

Conditions: Spinal Cord Injuries; Neurological Injury; Paralysis; Spasticity, Muscle

Summary: the purpose of this study is to validate the capacity of a reflex training system to change the size of the targeted reflex. for this, the researchers are recruiting 25 individuals with chronic incomplete sci who have spasticity in the leg to participate in the reflex training procedure. the study involves approximately 45 visits with a total study duration of about 6 months.


Eligibility criteria:
inclusion criteria: 1. a clinically stable spinal cord injury (above t11) that occurred at least one year previously 2. the ability to ambulate at least 10 m with or without an assistive device (i.e., walker, crutches, or cane, not parallel bars) within 100 sec (those with 10-meter walking time \>100 sec are excluded because it is unlikely that they are able to participate in and complete our planned locomotion evaluation procedures) 3. clinical signs of spasticity in the plantarflexor muscles at least unilaterally (i.e., hyperreactivity to achilles tendon tap, and increased muscle tone, score \>1 on modified ashworth scale) 4. spastic hyperreflexia reflected in exaggerated h-reflex 5. functionally and medically stable for at least 3 months 6. medical clearance to participate 7. reasonable expectation that current medications (including antispasticity medication such as baclofen, diazepam, and tizanidine) will not change over the conditioning period. each participant's medication and dosage will be monitored and recorded throughout the study. once enrolled, the subject will remain enrolled even if medication changes. (because only neurologically stable subjects will enter this study, medication changes will be unlikely.) exclusion criteria: 1. motoneuron injury; 2. a cardiac condition (history of myocardial infarct, pacemaker use, etc.) 3. an unstable medical condition 4. a pre-existing or confounding neurological condition (e.g., history of multiple sclerosis (ms), traumatic brain injury (tbi), stroke, parkinson's disease) 5. a condition that prevents lower extremity mobility testing or weight bearing (e.g. fracture, severe sprain/strain, botox muscular injection) (orthotic knee hyperextension is not excluded; in severe cases of knee hyperextension, the brace can be worn during the study sessions) 6. a cognitive impairment that precludes giving informed consent (e.g., severe intellectual disability) 7. use of a functional electrical stimulation (fes) foot-drop stimulator or an fes bicycle on a daily basis (fes applied to the arm is acceptable) 8. deep vein thrombosis within the past 6 months 9. depression (due to potential interference of anti-depressant medication with the intervention and possible reduced participation reliability) 10. pregnancy (due to expected changes in weight and posture and potentially unstable medical condition).

Keywords: neuroplasticity spinal reflex
study of ppi-668, bi 207127 and faldaprevir, with and without ribavirin, in the treatment of chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: this study is designed to provide a preliminary assessment of the safety and effectiveness of the combination of ppi-668, bi 207127 and faldaprevir, with or without ribavirin, in the treatment of chronic hepatitis c virus infection.


Eligibility criteria:
inclusion criteria: 1. male or female, 18 to 65 years of age; if females are of childbearing potential, then they must be willing to use two non-hormonal methods of birth control 2. body weight greater than 40 kg and less than 125 kg 3. clinical diagnosis of chronic hepatitis c 4. treatment-naïve for hepatitis c: no previous treatment with interferon, pegylated interferon, ribavirin, telaprevir, boceprevir, or any investigational therapies for hepatitis c 5. no symptoms or signs of intercurrent illness at screen (other than those attributable to hepatitis c) 6. no clinically significant abnormalities in the 12-lead electrocardiogram at screen 7. signed informed consent prior to trial participation. exclusion criteria: 1. seropositive for hiv antibody or hepatitis b surface antigen at screen 2. liver disease due to causes other than chronic hcv infection 3. symptoms or signs of decompensated liver disease, or evidence of cirrhosis 4. any medical condition that may interfere with the absorption, distribution or elimination of study drugs 5. poorly controlled or unstable hypertension at screen. 6. clinically significant, unstable cardiovascular or pulmonary disease, including cardiovascular or pulmonary disease requiring pharmacologic intervention other than anti-hypertensive medications, statins, and/or prophylactic aspirin (or similar anticoagulant). 7. red blood cell disorder, including (but not limited to): thalassemia major or minor, sickle cell anemia. 8. diabetes mellitus treated with insulin or hypoglycemic agents 9. history of asthma requiring hospital admission within the preceding 12 months 10. history of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements, or with the safety or efficacy assessments in this study 11. patients requiring treatment, during this study, with any of the medications on the restricted medications list (provided in the investigator site file), are not eligible for this study due to considerations of possible drug interactions with the study drug regimen.

Keywords: liver diseases virus diseases ribavirin protease inhibitor ns5b polymerase inhibitor ns5a inhibitor
effect of chitin and ascorbic acid on dietary insect iron absorption

Conditions: Iron Deficiency (Without Anemia)

Summary: iron is involved in many vital metabolic processes such as oxygen transport, electron transport in cells, dna synthesis and repair, and muscle metabolism. however, iron deficiency and iron deficiency anemia continue to affect many people, particularly preschool children (\<5 years), adolescents, and pregnant and non-pregnant women of childbearing age. iron deficiency is characterized by a lack of total iron stores in the body, which is mainly caused by insufficient dietary iron intake, physiologically increased iron requirements, poor intestinal iron absorption, or chronic blood loss. animal foods are important sources of highly bioavailable iron in the human diet. meeting human nutritional needs for the rapidly increasing world population while targeting food production within the planetary boundaries will require the identification of sustainable iron sources, such as edible insects. a previous iron absorption study showed that insect iron is absorbed moderately well. the present study will examine if and to which extent chitin, a polysaccharide within the insect biomass, inhibits iron absorption. in addition, the enhancing iron absorption of ascorbic acid on iron absorption from tenebrio molitor larvae will be studied. this knowledge can support to optimize the composition of an insect-based meal to increase its iron absorption. to distinguish iron absorption from insect biomass from other sources, insects are labeled with stable iron isotopes (fe-57, fe-58, fe-54) and iron absorption in the blood is measured.


Eligibility criteria:
inclusion criteria: * female aged between 18-45 years * normal bmi (18.5 - 24.9 kg/m2) * body weight \< 70 kg * low iron status (being in the lower half of the serum ferritin distribution at screening) exclusion criteria: * anaemia (hb \< 12 g/dl) * inflammation (crp \> 5.0 mg/l) * pregnancy or intention to become pregnant during the study or within 30 days after the discontinuation of the study intervention * lactating up to 6 weeks before the study initiation * chronic digestive, renal and/or metabolic diseases * antibiotics in the last 4 weeks prior to the study and during the study * mineral and vitamin supplementation in the last 2 weeks prior to the study and during the course of the study * chronic medication intake (except for oral contraceptives) * blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months * earlier participation in a study using stable isotopes or in any clinical study within the last 30 days * food allergies, especially known hypersensitivity to crustacea, dust mites, sea food, gluten, milk, or eggs * cigarette smoking (\> 1 cigarette per day)

Keywords: edible insects tenebrio molitor iron deficiency iron bioavailability chitin ascorbic acid
consequences of the quarantine relating to the covid-19 epidemic on the mental health of the patients followed in psychiatry

Conditions: SARS-CoV 2; Traumatic Stress Disorder

Summary: quarantine related to the covid-19 pandemic has begun on the 03/17/2020 in france. quarantine has already be linked to pejorative effects on mental health. in this study, we aim to evaluated ptsd symptoms of patients already followed by a psychiatrist during quarantine, one month and 3 months after inclusion. it will be also evaluate various psychiatric symptoms.


Eligibility criteria:
inclusion criteria: * patients already followed in psychiatry before quarantine by one of the psychiatrists subscribed to l'encéphale online. exclusion criteria: * refusal to complete the questionnaire

Keywords: covid-19 quarantine psychiatric traumatic stress disorder
efficacy of letrozole and cc alone in an iui program in cases with surgically treated minimal to mild endometriosis

Conditions: Endometriosis

Summary: to evaluate pregnancy rates with letrozole and cc alone in an iui program for women with recently surgically treated minimal to mild endometriosis.


Eligibility criteria:
inclusion criteria: * patient with minimal-mild endometriosis recently treated by laparoscopy with a waiting period of 6 to 12 months following the procedure * no other infertility factors. * normal serum basal hormone levels as well as documented ovulation exclusion criteria: * moderate or severe endometriosis * dense adnexal and/or ovarian adhesions due to pelvic inflammatory disease or previous pelvic surgery * age more than 36 years, bmi more than 30 kg/m2 * women with a previous pregnancy

Keywords: minimal to mild endometriosis letrozole clomiphene citrate iui
electrical brain stimulation for cognitive impairment in schizophrenia: a tdcs-fmri study

Conditions: Schizophrenia; Cognitive Impairment

Summary: the purpose of this study is to investigate the mechanism of action of transcranial electrical brain stimulation over the dorsolateral prefrontal cortex for cognitive impairment in schizophrenia. to do so the effect of a 3-ma stimulation protocol on neurocognitive functions will be investigated using behavioral performance and fmri.

thirty schizophrenic patients will be recruited after meeting the inclusion criteria and will be randomly assigned to active and sham stimulation groups. a single session of concurrent prefrontal tdcs/fmri will be conducted. participants will undergo baseline task performance before the intervention. one week later, they will undergo the tdcs intervention (active or sham) next to the scanner during which they perform the working memory task varying in cognitive load. they will perform the task 24 h later again. they will be then transferred to mri scanner right after stimulation

Eligibility criteria:
inclusion criteria: * men or women (18-50 yrs old) with a dsm 5 scz diagnosis, * if female, negative urine pregnancy test * significant cognitive impairment (1 sd below the norm on the working memory/executive functioning task performance) * feasibility for tdcs interventions according to safety guidelines * stable medication regime especially the classical neuroleptics and all cns-activating medications, if taken, 4-6 weeks before the experiment * fluency in the native language * right-handed * ability to provide informed consent. exclusion criteria: * pregnancy * alcohol or substance dependence * history of seizure * history of neurological disorder * history of head injury * presence of ferromagnetic objects in the body that are contraindicated for mri of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces). eligibility will be determined by the "mri safety screening questionnaire" and verified, if necessary, by a radiology consultant.

Keywords: schizophrenia cognitive impairment transcranial direct current stimulation fmri