Kornimate/medical-research-clean huggingface dataset:
building undergraduate coping & knowledge for stress-resilience

Conditions: Alcohol Use; College Drinking; Anxiety

Summary: nearly 60% of college students use alcohol and 30% binge drink monthly. this is alarming given that heavy alcohol use is linked to serious detrimental outcomes. despite various prevention and intervention strategies, heavy alcohol use has remained relatively stable over the past decade. individual differences in stress response connote risk for alcohol use disorder. anxiety sensitivity (as) and intolerance of uncertainty (iu) are two key cognitive vulnerabilities that can hinder resilience by amplifying stress responses and promoting maladaptive coping strategies, such as alcohol use. effective stress management is a cornerstone of resilience. the intervention for managing psychological responding to overwhelming emotions (improve) targets as and iu, key barriers to resilience, by modifying cognitive processes that amplify stress and negative affect. in this study, undergraduate students who engage in heavy drinking behaviors and experience elevated anxiety symptoms will be randomized to improve or a control health promotion intervention (n=20 per arm). all participants will complete daily ecological momentary assessments (ema) delivered to participants' mobile phones to capture real-world alcohol use before, during, and after the intervention. the investigators will evaluate the feasibility and acceptability of improve (aim 1). the investigators will also include a multimodal battery of self-report and objective lab-based measures of as and iu involving startle eyeblink potentiation and event-related potentials via electromyography (emg) and electroencephalography (eeg). this will allow the investigators to examine whether improve changes iu and as, and to assess if changes in these targets are associated with changes in alcohol use (aim 2).


Eligibility criteria:
inclusion criteria: * report elevated psychological distress (i.e., kessler psychological distress scale scores \>12) * engage in heavy drinking behaviors (i.e., 15 drinks per week for biological males and 8 drinks per week for biological females) * age 18 or older * can read and comprehend english * has access to a smartphone exclusion criteria: * limited mental competency/inability to give informed consent * current comorbid moderate to severe substance use disorder other than nicotine

Keywords: alcohol transdiagnostic anxiety college students
irinotecan discontinuation and reintroduction for advanced colorectal cancer

Conditions: Colorectal Neoplasms; Metastases

Summary: the purpose of this study is to evaluate the feasibility and efficacy of first-line folfiri discontinuation after initial 8 cycles and reintroduction after progression.

for medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with folfiri or folfox. although a strategy of using sequential 5-fu, irinotecan and oxaliplatin has been thought to maximize overall survival in such patients, significant toxicity remains a problem. it has been suggested feasible that chemotherapy can be discontinued after 2-3 months and restart same treatment on progression in patients with chemosensitive colorectal cancer. thus we designed this pilot phase ii study to evaluate the feasibility and efficacy of first-line folfiri discontinuation after initial 8 cycles and reintroduction after progression.

Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of colon and rectum * no prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy * advanced, metastatic or recurrent not amenable to curative local therapy * measurable lesion(s) * ecog performance status 0 to 2 * normal marrow, hepatic and renal function * provision of written informed consent exclusion criteria: * active infection and/or severe comorbidity * known history of anaphylaxis of any origin

Keywords: no prior chemotherapy
preventing cognitive decline with alternative therapies

Conditions: Dementia; Memory Disorders

Summary: preventing dementia is an important goal for our aging population. this proposal is an initial 42 months study of the effect of standardized ginkgo biloba extract (gbe) on preventing or delaying cognitive decline in people age 85 years or older (the oldest old). the study focuses on the oldest old who present a distinct advantage for primary prevention studies because of their particularly high risk for developing mild cognitive impairment (mci), a precursor to dementia. because this is a population that has previously been out of the mainstream for use of alternative medicine, the safety of gbe in this age group will also be tested in this study. the study is randomized, placebo controlled and double blind. approximately 200 elderly cognitively healthy subjects will be enrolled and followed for detection of conversion to mci. this pilot study is viewed as a necessary first step in order to demonstrate that gbe, an alternative or complementary therapy, has a disease modifying effect on the brain, distinct from a symptomatic effect. the study will test the feasibility of the randomized start design, a trial design proposed as a method for discerning brain- or disease- modifying from symptomatic effects. the magnitude of biological effect of the treatments will also be assessed with volumetric quantitative mri, a complementary means of confirming whether there is a brain modifying effect (measured as a decrease in brain volume loss with treatment). peripheral markers of oxidation status will measure possible anti-oxidant effects of gbe.

see brief summary

Eligibility criteria:
inclusion criteria: * can identify a collateral informant who has frequent contact with the subject * no memory complaints compared to others of same age group and has not sought attention for concerns about memory or cognition * normal memory function defined by an education-adjusted score on the logical memory subscale of the wechsler memory scale-revised * mini-mental state examination score \>23 * clinical dementia rating (cdr) of zero
evaluation of the effect of ave0657 in cheynes-stokes breathing syndrome patients

Conditions: Heart Failure; Sleep Apnea Syndromes; Cheyne-Stokes Respiration

Summary: the primary objective of this study is to assess the activity on breathing parameters of 4 escalating doses of ave0657 in comparison to placebo in patients with cheynes-stokes breathing syndrome.


Eligibility criteria:
inclusion criteria: * presence of congestive heart failure (chf) defined as ejection fraction ≤40% by history of echocardiography data and new york heart association (nyha) class ii-iii and of typical cyclic crescendo and decrescendo change in breathing amplitude ahi ≥10 and \<60 and majority of the apneas to be ≥60% central in origin. exclusion criteria: * subject on supplemental oxygen the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: cheyne-stokes breathing
evaluation of heparin bonded vascular graft versus standard graft in prosthetic arteriovenous access for hemodialysis

Conditions: Hemodialysis Fistula Thrombosis

Summary: the majority of bridge graft fistula with polytetrafluoroethylene (ptfe) for hemodialysis access will develop stenosis at the venous anastomosis and eventually will fail. aspirin have been used for many years as a prophylactic drug therapy to prevent thrombosis but good clinical evidence for its benefit is lacking. many drugs have been used to reduce intimal hyperplasia in animal models. until recently there has been little success in clinical trials of anti-inflammatory, antiproliferative, antiplatelet, antithrombotic or calcium channel blocking drugs. recently a major breakthrough was done by gore when introducing the new heparin bonded ptfe graft by covalent attachment. this trial is planed to assess and compare between the gore-tex® propaten vascular graft versus unmodified eptfe grafts the patency and complication.


Eligibility criteria:
inclusion criteria: * all the patients who are scheduled for the creation of a new prosthetic access with informed consent will be enrolled in the trial * investigators will attempt to enroll a male:female ratio of patients representative of their current patient population exclusion criteria: * anticoagulation therapy

Keywords: renal failure, end stage blood vessel grafting hemodialysis surgical arteriovenous shunt
the effect of fast weight efficiency after laparoscopic sleeve gastrectomy on the cobb angle in morbid obese patients

Conditions: Obesity, Morbid; Back Pain; Scoliosis

Summary: obesity has become an increasingly common health problem today. in this context, although many anatomical, physiological and metabolic problems arising from obesity in morbid obese patients are tried to be solved in daily practice, it has been proven that eliminating obesity is sufficient in the treatment of many diseases. when we look at the literature, it is known that morbid obesity causes deformation and excessive wear in most body joints. when morbid obesity disappears, it has been shown that the previously existing neck, waist, back and knee pains regress. the aim of this study is to reveal the cobb angle change in morbidly obese patients who achieved rapid weight loss after obesity surgery; to investigate the effect of weight loss on vertebral anatomy.

90 morbidly obese patients who underwent laparoscopic sleeve gastrectomy were included in the study. cobb angle measurements were made by a radiologist included in the study from the pa chest radiographs of the operated patients in the preoperative period and in the first postoperative year, and they were recorded in a previously prepared database. in addition, in the preoperative period and postoperative first year evaluations of the patients; patient satisfaction questionnaire in terms of low back pain, back pain, neck pain, and the value in% ewl of weight given after surgery were also recorded in the database.

Eligibility criteria:
inclusion criteria: * patients over the age of 18. * patients with a diagnosis of morbid obesity, body mass index\> 40 exclusion criteria: * patients who have undergone previous vertebral surgery due to any disease * patients hospitalized for more than 10 days due to postoperative complications

Keywords: morbid obesity cobb angle laparoscopic sleeve gastrectomy scoliosis
the mots (medication overuse treatment strategy) trial

Conditions: Migraine

Summary: there are two commonly used treatment strategies for treating patients who have chronic migraine with medication overuse. this study will compare the outcomes amongst patients randomized to one of the two treatment strategies.


Eligibility criteria:
inclusion criteria * adults, at least 21 years of age * chronic migraine - diagnosed according to ichd3beta criteria * medication overuse - diagnosed according to ichd3beta criteria * willingness to be randomized to either of the two treatment arms * willingness to maintain a headache diary * plan for follow-up care with the clinician * no changes to migraine prophylactic therapy within the 4 weeks prior to randomization. exclusion criteria * younger than 21 years of age * headache diagnoses other than chronic migraine with medication overuse; episodic tension-type headache on 3 or fewer days per month is allowed * not willing to be randomized to either of the treatment arms * not willing to maintain a daily headache diary * not planning on follow-up care with the clinician * in the opinion of the clinician, randomization to either treatment arm would be considered unsafe (ex: pregnancy, immediate discontinuation * prisoners * diminished decision-making capacity which in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
hdupe 2004: gastro-oesophageal haemorrhage in emergency : gastric préparation to endoscopy

Conditions: Upper Gastrointestinal Bleeding

Summary: gastric lavage is usually used for gastric preparation before endoscopy in patients with upper gastrointestinal bleeding. however, the benefit-risk balance of putting a nasogastric tube in these patients is not clearly defined. this randomized trial is aimed to determine if the use of erythromycin iv before endoscopy could avoid to put a gastric tube for the management of upper gastrointestinal bleeding.

acute upper gastrointestinal haemorrhage is one of the main digestive emergencies involving hospital admission. endoscopic examination plays a key role to determine the cause of the bleeding and to carry out a therapeutic procedure. endoscopic performance depends on the quality of the examination that may be hampered by residual blood in the gastric cavity. gastric lavage is usually performed to clear the stomach. however, several teams consider that it is possible to avoid putting a nasogastric tube because it is ineffective in half of the patients, disagreeable in most of them, can induce side effects and need a long time work for nurses. it could be replaced by the use of erythromycin. there are no official recommendations in that field. recent studies have shown that erythromycin, a macrolide antibiotic with gastro kinetic properties can accelerate gastric emptying by inducing gastric contraction. this motilin receptor agonist could improve the gastric cleaning and the quality of endoscopic examination and decrease its duration. this randomized trial is aimed to determine if the use of erythromycin iv before endoscopy could avoid putting a gastric tube for the management of upper gastrointestinal bleeding. it is a prospective, controlled, randomized, multicentric study with a blind assessment of the main criteria. all patients aged more than 18 years with an acute upper gastrointestinal bleeding, defined by melena or hematemesis, managed by emergency department are enrolled. 270 patients are expected. informed consent including for endoscopic examination and no contraindication for using erythromycin (qt enlargement) is needed. patients are randomized in three groups: erythromycin alone, nasogastric tube with gastric lavage alone or both erythromycin and nasogastric tube. patients are followed-up until first month after bleeding. the main criteria are the visualization of the gastric tract and the other criteria are rebleeding until d 30, transfusion, gastric tube or erythromycin complications.

Eligibility criteria:
inclusion criteria: * hematemesis or melaena * no qt enlargement exclusion criteria: * refusing endoscopy * glasgow \< 15

Keywords: bleeding endoscopy gastric tube erythromycin randomized
rsa of the attune knee system: rct comparing traditional vs enhanced-fixation device designs

Conditions: Knee Osteoarthritis

Summary: the principal objective of this study is to compare migration patterns between the attune and attune s+ ps knee systems using model-based rsa over the first 2 post-operative years. secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, quantify changes in functional and health status of subjects following surgery and compare between study groups, and assess occurrences of complications following surgery.

this is a multi-centre, randomized controlled trial of patients undergoing posterior-stabilized total knee arthroplasty. in this study, the investigators propose to randomize 50 subjects to receive either the standard attune ps tka (n=25) or the enhanced fixation attune s+ ps tka (n=25) and follow them for a period of 2 years post-operatively. the primary outcome of the study will be stability of fixation of the tibial baseplate as measured by model-based rsa. secondary outcomes will be to determine the functionality of patients after surgery using self-reported questionnaires.

Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty * between the ages of 21 and 80 inclusive * patients willing and able to comply with follow-up requirements and self-evaluations * ability to give informed consent exclusion criteria: * active or prior infection * medical condition precluding major surgery
hand function tests in carpal tunnel syndrome: a cross-sectional study

Conditions: Carpal Tunnel Syndrome

Summary: this is a cross-sectional study that aims to establish the test-retest reliability of two standardized tests (jebsen-taylor hand function test and nine-hole peg test) in individuals with carpal tunnel syndrome (cts). the study will involve at least 50 participants with cts who will complete the tests twice, with a 1-week interval between the two assessments. the test-retest reliability will be assessed using intraclass correlation coefficient (icc) and bland-altman plots. the study is expected to provide information on the reliability of these tests in individuals with cts, which can help clinicians more accurately assess hand function and monitor treatment outcomes.


Eligibility criteria:
inclusion criteria: * individuals diagnosed with carpal tunnel syndrome (cts) * 18 years of age to 60 years old * able to provide informed consent to participate in the study exclusion criteria: * history of hand or wrist surgery within the past 6 months * severe hand or wrist pain that would prevent completion of the tests * severe cognitive impairment or language barrier that would prevent understanding of the test instructions * any other medical condition that could affect hand function or interfere with test completion * participation in any other clinical trial or research study involving the hand or wrist within the past 3 months * inability to comply with study procedures or follow-up requirements
safety and tolerance of the biopsies in auto-immune rare diseases

Conditions: Tolerance; Biopsy Site Itching

Summary: biopsies are performed in several autoimmune diseases to diagnose or classify them tolerance and information of the patients have been poorly evlauated our objective is to evaluate tolerance and information of the patients after the biopsies for salivary gland, temporal arteries and neuromuscular.

patinets that benefited of arterial temporal biospy or salivary gland biospy or muscuar biopsy or neuro muscular biospy for his auto -mmune disease will be included and fill standardized questionnaires concerning tolerance, information and side effect at inclusion , day 7 and day 30 after the biopsy data will be analysed to evaluate information, tolerance and risk factor af side effect

Eligibility criteria:
inclusion criteria: * biospy required for the diagnsis or follow up aged of more than 18 non opposition form exclusion criteria: * unable to consent demencia unable to fill the form and questionnaire patient under juridical protection refusing to participate
drug-related problems : focus on age and diabetes

Conditions: Adverse Drug Events

Summary: drug-related problems (drp) are a variety of events or circumstances that can interfere with the expected results of a treatment. they may be due to the drug itself, its association with other treatments, its incompatibility with the patient, its misuse... when these situations result in harm, they are referred to as adverse drug events (ades). drp and particularly ade represent a major public health problem in healthcare institutions because of their impact on morbidity and health costs. drps are largely preventable and actions can be set up to detect and correct them. it is in this context that clinical pharmacy has expanded, with the development of new activities to help secure drug management. in our institution, the investigators have implemented several activities in different care services, including * medication reconciliation, * an ade detection. these activities have interesting and encouraging results in terms of impact on the prevention of drp. however, they can only be carried out on a limited number of patients, depending on the pharmaceutical resources available. the investigators therefore need tools to prioritize our activities on the most at-risk patients. in this study, the investigators seek to identify drp risk factors and develop drp risk scores, with the objective to improve the detection and even prevention of drp. translated with www.deepl.com/translator (free version)


Eligibility criteria:
inclusion criteria: - patients aged above 18 years old, admitted to the emergency department or hospital exclusion criteria: * patients presenting acute psychological disturbance * patients that did not agree to participate

Keywords: drug-related problems clinical pharmacist elderly diabetes
is nirs able to detect ischemia following brain insult

Conditions: Brain Trauma; SAH; ICH

Summary: we hypothesize that newly developped nirs sensor (equanox advance™, 8004ca, nonin medical, usa)is able to detect ischemic events recorded by brain tissue oxygen probe (licox, integra neurosciences, usa) and that values are correlated.


Eligibility criteria:
inclusion criteria: * necessity of monitoring by ptio2 and icp exclusion criteria: * inability to apply nirs sensor

Keywords: ptio2 nirs
a trial to evaluate the safety and antimicrobial efficacy of dbi-002 probiotic in adults with tinea versicolor

Conditions: Tinea Versicolor

Summary: a randomized, double-blinded, aqueous gel-controlled dose escalating trial to study the safety and antimicrobial efficacy of dbi-002 probiotic vs. aqueous gel and vehicle gel vs. aqueous gel in adults with tinea versicolor (dbi-202).


Eligibility criteria:
inclusion criteria: 1. ability to understand, agree to and sign the study informed consent form (icf). if the subject is unable to provide consent him/herself, the subject's legally acceptable representative may provide written consent. 2. male or female subjects of any race 18 - 65 years of age. 3. subjects with a clinical diagnosis of tinea versicolor (tv is a common benign superficial cutaneous fungal infection usually characterized by hypopigmented or hyperpigmented macules and patches on the chest and back). 4. a positive potassium hydroxide (koh) examination consistent with malassezia prior to the treatment period done at the clinical site. 5. agree to not use soap and water on the chest and back for at least 12 hours before the study visits for baseline/day 1, day 5, and day 14, and follow all study instructions for use of soap and water on the chest and back during participation in the study. exclusion criteria: 1. females who are pregnant, planning a pregnancy, or breastfeeding. 2. any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation. 3. any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below). 4. known sensitivity to any of the components of the study medication. 5. use of a prescription or non-prescription topical treatment on the targeted tv anatomical locations within the previous 4 weeks, for example: anti-fungal, antibacterial or anti-microbial products, selenium and anti-inflammatories (e.g., corticosteroids). 6. use of a systemic anti-fungal or antibiotic treatment for tv within the previous 4 weeks, use of medicated shampoos and/or soaps within the previous 4 weeks. 7. treatment of any type of cancer within the last 6 months. 8. history of any significant internal disease which contraindicates use of live microbiome (e.g. leukemia, liver failure, cardiovascular disease). 9. subjects who are known to be allergic to any of the test product(s) or any components in the investigational product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the investigator's brochure (ib). 10. aids or aids related complex by medical history. 11. known or suspected use of immunosuppressive medications and/or has a known or suspected autoimmune disease. 12. any subject not able to meet the study attendance requirements. 13. subjects who have participated in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study.