Kornimate/medical-research-clean huggingface dataset:
randomized phase iii trial of surgery alone or surgery plus preoperative gemcitabine-cisplatin in early stages nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: preoperative chemotherapy is considered to play a role in early stage non small cell lung cancer (nsclc) .the use of preoperative cisplatin/gemcitabine chemotherapy has proven feasible and without excessive morbidity or mortality in the phase ii setting. the aim of the present phase iii study is to determine whether 3 cycles of preoperative chemotherapy with cisplatin/gemcitabine improves progression free survival of nsclc patients versus surgery alone. postoperative chemotherapy will not be utilized in this phase iii trial.


Eligibility criteria:
main inclusion criteria: * must have pathologic documentation of non-small cell lung cancer, ib, ii, iiia. * ecog performance status of 0 - 1 * bidimensionally measurable disease or evaluable disease * adequate organ function main exclusion criteria: * have greater than grade 1 neuropathy - motor/sensory * significant history of cardiac disease * pleural effusion
prevalence of geophagy and knowledge about its health effects among native sub-saharan africa, caribbean and south america healthy adults living in france

Conditions: Geophagia

Summary: since geophagy is widespread among women from sub-saharan africa, south america and the caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in france.

since geophagy is widespread among women from sub-saharan africa, south america and the caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in france. a cross-sectional study was performed in the consultation for travel medicine and international vaccination in reims university hospital, france. all adult travellers who were natives of sub saharan africa, south america and the caribbean or born in france of parents from these countries were eligible to complete a confidential questionnaire about geophagy, which was defined as eating soil or clay. descriptive analysis was performed.

Eligibility criteria:
inclusion criteria : all adult travellers who were natives of sub saharan africa, south america and the caribbean or born in france of parents from these countries

Keywords: geophagia
self-regulation strategies to improve exercise behavior among schizophrenic patients

Conditions: Schizophrenia; Schizo-affective Disorder

Summary: patients who suffer from diseases of the schizophrenia spectrum are frequently burdened by weight gain. sport programs have been shown to improve somatic and psychological health. however, the motivation to participate in sports therapy is usually impaired due to illness-related factors such as anhedonia and negative symptoms. previous attempts to increase participation in sports therapy have used psycho-educational and behavioral attempts that require a lot of resources. in this study the investigators will use a brief method developed in experimental social psychology to build up implementation intentions. this method has been shown to improve psychological test performance in schizophrenia patients but has never been used in a clinical context. in two psychiatric hospitals, in-patients with schizophrenia who have been examined by a medical doctor, for whom any medical concerns for sports therapy participation have been excluded and who declared their motivation to participate in an existing standard sports exercise program will be recruited for the study. after information on the study and signing of an informed consent patients will be randomly assigned to two treatment conditions. in the control condition, the main therapist will individually deliver a 10-minute psycho-education on the helpfulness of sports to improve the health; this will be repeated in a shorter form in the regular individual treatment sessions over the following weeks. the intervention condition will use a structured procedure of the same duration to build up implementation intentions to participate in the sports therapy. the implementation intentions will briefly be repeated and updated in the following session. primary outcome variables will be percentage of attended sport therapy sessions, persistence and compliance. secondary outcome variables will be body mass index. as confounding variables the investigators will assess amount of anti-psychotic medication in chlorpromazine equivalents, negative and depressive symptoms, usual sport activities and cognitive impairments. the investigators expect that building up implementation intentions will increase participation, persistence and compliance of the patients in the sports and exercise therapy program compared to the patients who just have received psycho-education.


Eligibility criteria:
inclusion criteria: * schizophrenia or schizo-affective disorder exclusion criteria: * manic episode * florid positive psychotic symptoms * catatonic symptoms * medical concerns for possible damage to patients health by participation in sports therapy * patient is aggressive * patient is suicidal * epilepsia

Keywords: schizophrenia exercise sport weight control fitness
impact of preemptive intravenous ibuprofen on intraoperative analgesia in third molar teeth

Conditions: Preemptive Intravenous Ibuprofen; Intraoperative Analgesia

Summary: this study was planned to evaluate the analgesic efficacy of preemptive intravenous (iv) ibuprofen on pain occurring during and after the mandibular third molar surgeon


Eligibility criteria:
inclusion criteria: * patients who are to be elected third molar tooth extraction * patients between the ages of 20-35 * patients who are symptomatic * third molar tooth angular or horizontal settled patients exclusion criteria: * patients who refuse to participate in the study * patients under 20 years old, over 35 years old * patients who are allergic to known non-steroidal anti-inflammatory drugs * pregnant patients * patients with severe liver failure, * patients with severe renal insufficiency

Keywords: preemptive intravenous ibuprofen intraoperative analgesia third molar tooth surgery
serum and tissue cefazolin concentrations in patients undergoing cesarean delivery

Conditions: Cesarean Delivery; Wound Infection; Obesity

Summary: patients undergoing cesarean delivery (c-section) with a body mass index of 35 or greater (this bmi number is in the obese range) will be given either 2 grams or 4 grams of an antibiotic before surgery. the antibiotic is intended to prevent infection from the surgery.it is unknown what the best dose for large women is for the usual medicine used for this purpose (an antibiotic medicine called cefazolin).samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. a sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. blood tests will be done at the start and end of surgery to test the antibiotic level. a blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. the umbilical cord blood sample will be tested for the antibiotic level.these tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in large women undergoing c-sections.


Eligibility criteria:
inclusion criteria: 1. age 18 years or above 2. body mass index (bmi) of 35 or greater at the time of the first obstetric clinic visit 3. undergoing cesarean delivery exclusion criteria: 1. bmi less than 35. 2. not undergoing cesarean delivery. 3. age less than 18 years. 4. pre-existing infection. 5. allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin. 6. cesarean delivery being performed under emergent circumstances.

Keywords: cesarean delivery wound infection obesity prophylactic antibiotics
ssr240600c treatment in women with overactive bladder

Conditions: Overactive Bladder

Summary: the primary objective of this study is to evaluate the efficacy of ssr240600c in women with overactive bladder compared to placebo using tolterodine as a study calibrator.


Eligibility criteria:
inclusion criteria: * diagnosis of overactive bladder exclusion criteria: * stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history * urinary incontinence due to cause other than detrusor overactivity (eg, overflow incontinence) * current urinary tract infection (uti) or frequent utis * urinary retention or other evidence of poor detrusor function * pain during voiding or bladder pain without voiding * history of radiation cystitis or history of pelvic irradiation * history of interstitial cystitis or bladder related pain syndrome the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: urge urinary incontinence
inflammatory responses to acute and chronic opioid exposure in humans

Conditions: Inflammation

Summary: we aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.

we are interested in learning how the immune system and the inflammation process is effected by acute and chronic opioid exposure. preliminary evidence in animal models show that acute opioid exposure leads to decreased inflammatory responses, while chronic opioid exposure causes increased inflammatory responses, as measured by local cytokine release at the site of injury. translating these findings to humans will lead to important new mechanistic knowledge that may ultimately improve our ability to treat pain.

Eligibility criteria:
inclusion criteria: * 18-60 years old * healthy volunteer * not allergic to remifentanil exclusion criteria: * patients younger than 18 or older than 70 * patients unwilling or unable to follow study instructions * patients who don't speak english * patients who are taking prescription opioid medications (e.g. vicodin, percocet) or are unwilling to refrain from taking anti-inflammatory medications such as advil or naproxen during 2 weeks prior to and during the 1 month study

Keywords: inflammation, opioids, immune system
microrna profile and erenumab treatment

Conditions: Migraine

Summary: erenumab, a monoclonal antibody acting on the calcitonin gene-related peptide (cgrp) receptor, is an effective and safe migraine-specific preventive drug. the use of migraine-specific preventive drugs paves the way for a novel method to study migraine pathogenesis. migraine is a complex disorder with several genetic and epigenetic influence, including that of microrna. several micrornas, including those of inflammation and of endothelial function, have high expression levels in subjects with migraine; however, the findings of the available studies are insufficient to provide epigenetic biomarkers for migraine. besides, little evidence is available on the role of migraine preventive treatments in the expression of microrna. the study aims at evaluating the expression profiles of micrornas before and after erenumab treatment prescribed according to clinical indication. the study will include women with episodic or chronic migraine treated with erenumab 140 mg monthly according to the summary of product characteristics and local reimbursement criteria. the study will compare the expression profile of micrornas in women with episodic and chronic migraine; besides, it will investigate differences in migraine-associated microrna expression according to age, migraine characteristics, pain intensity, response to erenumab, migraine-related impact and disability.


Eligibility criteria:
inclusion criteria: * women aged 25 to 50 years * chronic or episodic migraine with or without aura diagnosed according to the international classification of headache disorders - 3rd edition * receiving a first prescription of erenumab for migraine prevention according to the summary of product characteristics and local reimbursement criteria * at least 1 year from migraine onset * provided informed consent exclusion criteria: * headache other than migraine * prior exposure to erenumab or other monoclonal antibodies targeting cgrp or its receptor * use of any migraine preventive treatment in the last 60 days or 5 half-lives or 4 months if ever treated with botulinum toxin a * pregnant or nursing * body mass index \ 30 kg/m2 * heavy smoking (more than 20 cigarettes per day) * myocardial infarction, stroke, transient ischemic attack, unstable angina, or coronary artery bypass surgery or other revascularization procedures within 12 months prior to first visit * illicit drug abuse * major psychiatric disorders * infective or inflammatory diseases * any chronic medication prescribed for indications different from migraine within 60 days before study initiation

Keywords: cgrp monoclonal antibodies microrna epigenetic migraine prevention
effect of lutein, zeaxanthin, and meso-zeaxanthin supplementation on skin carotenoid concentration: a six-month, placebo-controlled crossover study

Conditions: Macular Degenerative Disease

Summary: to compare skin carotenoid scores over 12 weeks of individuals randomized to placebo or macuhealth and comparing that to a 12 week crossover evaluation.


Eligibility criteria:
inclusion criteria: * adult patients 18-50 years old of any sex and any race. * willing to comply with the protocol instructions. * has read (or has had read to), understood, and signed an informed consent. exclusion criteria: * current smoker * pregnant, plan to become pregnant or breastfeeding * history of any non-controlled disease states including diabetes, cancer, heart diseases etc (we need to confirm this with previous protocols) bmi greater than 30 * currently taking macuhealth or similar supplements or previous use

Keywords: carotenoids macular degeneration macuhealth
operative treatment of extraarticular colles' fractures of the distal radius (otec)

Conditions: Colles' Fracture; Radius Fractures

Summary: this is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. the patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or kirschner wires. the aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (rct). the primary outcome criterion is the functional status measured by the disability of the arm, shoulder and hand (dash) questionnaire. secondary outcome criteria are pain, range of motion (rom), grip strength, and radiological parameters. since this is a pilot study it is intended to generate a study hypothesis for the main rct.


Eligibility criteria:
inclusion criteria: * isolated, extraarticular, unstable colles' fracture of the metaphysis of the distal radius (ao type a3) * age 65 years or older * patient agreed with and signed the "informed consent" form exclusion criteria: * fractures older than 7 days (more than 1 week between injury and treatment) * other injuries of the hand * other relevant injuries of the upper extremities * open fracture * patients with one hand missing * clinical or radiological signs of any rheumatoid disease, osteoarthritis, or polyarthritis * previous skeletal injury or severe soft tissue injury of the arm * history of drug or alcohol abuse * patients unlikely to cooperate or attend all scheduled visits * patients who have participated in any other device or drug clinical trial within the previous month * patients with legal incompetence

Keywords: distal radius fracture extraarticular colles fracture
study of urc102 to assess the safety and efficacy in gout patients

Conditions: Gout; Hyperuricemia

Summary: the purpose of this study is to assess safety, pharmacokinetics/pharmacodynamics and urate lowering effect of urc102 in gout patients.


Eligibility criteria:
inclusion criteria: * diagnosed with gout exclusion criteria: * participated in other clinical study within 12 weeks prior to enrollment, and received an investigational product (including placebo)
efficacy and safety study of abt-384 in subjects with mild-to-moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to test if the investigational medication, abt-384, is a safe and effective treatment for adults with mild-to-moderate alzheimer's disease.

this is a phase 2 study designed to evaluate the safety and efficacy of abt-384 in approximately 260 adults with mild-to-moderate alzheimer's disease (ad). subjects will be randomized to one of four treatment groups (abt-384, donepezil, or placebo) for a 12-week treatment period.

Eligibility criteria:
inclusion criteria: 1. the subject and caregiver must voluntarily sign and date and informed consent. if the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject. 2. subject is male or female between the ages of 55 and 90 years of age, inclusive, at day-1. 3. subject meets the nincds/adrda criteria for probable ad. 4. subject has a mini-mental status examination (mmse) score of 10 to 24, inclusive, at screening visit 1. 5. subject has a cornell scale for depression in dementia (csdd) score ≤ 10 at screening visit 1. 6. with the exception of a diagnosis of mild-to-moderate ad and the presence of stable medical conditions, the subject is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and 12-lead ecg. 7. if female, subject must be postmenopausal for at least 2 years or surgically sterile. 8. if male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control. 9. subject has an identified reliable, caregiver (e.g., family member, social worker, nurse), who will provide support and ensure compliance with the study medication and procedures. 10. subject and caregiver are fluent in the language used for administration of the rating scales or cognitive tests and have sufficient visual, hearing and graphomotor skills to complete procedures. exclusion criteria: 1. subject has a known hypersensitivity or intolerance to donepezil that led to discontinuation or a known reported history of donepezil treatment failure. 2. subject is currently taking or has taken a medication for the treatment of ad or dementia within 60 days of screening visit 1, or is participating in cognitive therapy for the treatment of ad or dementia. 3. subject has a history of a drug or alcohol disorder (abuse/dependence), based on either dsm-iv-tr or icd-10 criteria, excluding nicotine, within 2 years prior to screening visit 1. 4. in the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject. 5. the subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication. 6. for any reason the investigator considers the subject to be an unsuitable candidate to receive abt-384 or donepezil.
efficacy of lu 31-130 in patients with schizophrenia

Conditions: Schizophrenia

Summary: the main purpose with the study is to evaluate the efficacy and safety of lu 31-130 in patients suffering from schizophrenia compared to placebo.

schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. however, none of the available drugs is ideal, in particular because of their complex safety profile and the limited effectiveness against certain symptoms of the disease. thus, only one dimension of the morbidity, that is, the positive symptoms, can be expected to respond to treatment whereas negative symptoms and cognitive deficits are, at best, only marginally targeted. given this, there is no doubt that the current antipsychotic drugs leave much room for improvement and call for new, more effective pharmacotherapies in the treatment of schizophrenia. in the current study, patients suffering from schizophrenia and experiencing clinically significant symptoms of the disease will be included. in the current study, eligible patients will be randomised in a 2:1 ratio to blinded treatment with either lu 31-130 (3, 5, 7, 10 or 14 mg/day) or placebo for 8 weeks. the study includes 5 parts with increasing doses of lu 31-130 (part a \[3 mg/day\], b \[5 mg/day\], c \[7 mg/day\], d \[10 mg/day\], and e \[14 mg/day\]). a decision to initiate part b \[5 mg/day of lu 31-130\], c \[7 mg/day of lu 31-130\] or d \[10 mg/day of lu 31-130\] will be based on safety and tolerability of the previous study part. dependent on the safety, tolerability and pk data from part d the study may proceed with part e. the efficacy and the safety of lu 31-130 will be evaluated in comparison to the pooled placebo group from all 5 study parts.

Eligibility criteria:
inclusion criteria: * the patient has a primary diagnosis of schizophrenia * the patient experiences clinically significant symptoms * the patient did not experience an acute exacerbation requiring hospitalisation within the last 6 months * the patient's medication has been stable for at least 4 weeks prior screening * the subject has normal serum values of parameters associated with liver function

Keywords: schizophrenia antipsychotic lu 31-130
glycine vs placebo for the schizophrenia prodrome

Conditions: Schizophrenia Prodrome

Summary: glycine is a natural amino acid neurotransmitter that acts as a co-agonist at nmda receptors in brain. we hypothesize that symptoms of the schizophrenia prodrome will improve with glycine to a greater degree than with placebo.

a pilot clinical trial comparing glycine to placebo in patients with the schizophrenia prodrome.

Eligibility criteria:
inclusion criteria: * meet sips criteria for schizophrenia prodrome exclusion criteria: * history of psychosis

Keywords: schizophrenia prodrome