Kornimate/medical-research-clean huggingface dataset:
detection of local field potentials in the ventral tegmental area of the midbrain in chronic cluster headache patients

Conditions: Cluster Headache; Trigeminal Autonomic Cephalgia

Summary: the physiopathology of trigeminal-autonomic cephalalgia, and more particularly of cluster headache (ch) is still partially unknown. three main structures are involved: the trigeminovascular system, the cephalic afferents of the autonomic nervous system, and centrally the hypothalamus. there are many clinical arguments in favor of the involvement of the hypothalamus in ch. in addition, several radiological studies have confirmed the involvement of the posterior hypothalamic region in cluster attacks. thus, a positron emission tomography study showed hyperactivity of the posteroinferior nucleus of the ipsilateral hypothalamus. voxel based mri studies have shown a bilateral increase in the volume of the inferoposterior part of the homolateral hypothalamus. the involvement of the posterior hypothalamic region or more precisely the ventral tegmental area of the midbrain therefore seems acquired, although its real role as a generator or modulator of pain remains to be precised. deep brain stimulation (dbs) is used in the management of chronic drug-resistant ch with an overall efficacy in 2/3 of patients. nevertheless, its mechanism of action remains poorly understood, thus limiting the selection of patients and the optimization of care. the lack of clear neurophysiological criteria to identify the neuronal population to be targeted is a major source of uncertainty in the positioning of dbs electrodes and parameters adjustment. in order to improve the understanding and at the same time the results of this technique, obtaining in vivo electrophysiological data seems mandatory. local fields potentials (lfp) have been recordered by in vivo by dbs in other diseases (parkinson's disease, tremor...) and their analysis has brought new insigights in the characterization and understanding of these pathology. new generations of neurostimulator (percept medtronic) enables continuous recording of lfp in implanted patients. the goal of our study is the recording of lfp at the time of ch attacks via the brainsensetm system. this system included in the stimulator allows in vivo collection of lfp in the absence and presence of stimulation. the pathophysiological data recordered will then be correlated with the clinical benefit of the dbs ( nulber of attacks, duration, pain intensity...). as it is a feasibility study, only 5 patients will be included.


Eligibility criteria:
inclusion criteria: * adult patients (age : 18-70 years-old) suffering from refractory chronic cluster headache * patients eligible for a deep brain stimulation in the ventral tegmental area of the mesencephalon * patients implanted with a deep brain stimulation system percepttm medtronic® exclusion criteria: * secondary cluster headache * patients implanted with another device of deep brain stimulation

Keywords: hypothalamus local fields potentials
ceramic on ceramic (coc) 36mm pas ide rollover subjects; ceramic acetabular bearing with ceramic femoral head in total hip replacement

Conditions: Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis; Post-Traumatic Osteoarthritis of Hip

Summary: this study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to 10-years) information regarding the performance and safety of the commercially available 36mm ceramax® ceramic on ceramic (coc) total hip system from a cohort of study subjects that were previously enrolled in the ide study. (coc = 36mm ceramic acetabular bearing insert component that articulates with a ceramic femoral head in the coc total hip replacement system)

up to five (5) sites will participate. these sites participated in the ide study and will continue subject follow-up. subjects from the original ide study (coc 36mm investigational subjects only) will be seen for a clinic visit at the time of consent (first visit at approximately 5 to 7 years post-op or 1825- 2919 days), and at minimum 8 years (2920-3649 days) , and minimum 10 years (3650-4015 days). harris hip evaluation, radiographic evaluation, subject hip-outcomes, and adverse event information will be collected at each visit. if a subject is not willing or able to return for a clinical and radiographic follow-up for either the minimum 8 year evaluation or the minimum 10 year evaluation, then a telephone interview may be utilized for the purpose of determining device survivorship.

Eligibility criteria:
inclusion criteria: * subjects who were previously enrolled in the coc 36 ide study; * individuals who are willing and able to provide informed patient consent for participation in the study; * individuals who are willing and able to return for follow-up as specified by the study protocol; and * individuals who are willing and able to complete the subject hip outcomes questionnaire as specified by the study protocol. exclusion criteria: * in the opinion of the investigator, the individual does not qualify if there are any concerns with the ability to follow the protocol specified evaluations. * any component of the primary total hip was previously revised.

Keywords: total hip replacement total hip arthroplasty hip joint replacement hip prosthesis replacement
impact of continuous venovenous haemofiltration on organ failure during the early phase of severe sepsis

Conditions: Bacteremia; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Shock, Septic; Sepsis

Summary: the impact of continuous veno-venous haemofiltration (cvvh) on sepsis-induced multiple organ failure severity is controversial. we thus sought to assess the effect of early application of haemofiltration on the degree of organ dysfunction and plasma cytokine levels in patients with severe sepsis or septic shock.

prospective, randomized, open, multicentre study was performed between 1997 and 1999 in 16 french intensive care units. patients were enrolled within 24 hours of development of the first organ failure related to a new septic insult. they were randomized to group 1 (hf), who received haemofiltration for a 96 hr period, or group 2 (c) who were managed conventionally. the primary end-point was the number, severity and duration of organ failures at 14 days, as evaluated by the sofa score, on an intention-to-treat analysis. strict guidelines were provided to perform continuous haemofiltration under the same conditions and objectives in all centres.

Eligibility criteria:
inclusion criteria: * clinically identified focus of infection associated with at least 2 sirs criteria and one or more sepsis-induced organ failures within the 24 hours prior to inclusion, plus a saps ii score between 35-63 exclusion criteria: * patients were excluded if pregnant, younger than 18 years, in a moribund state, in chronic renal failure, or receiving immunosuppressive therapy.

Keywords: sepsis syndrom severe sepsis septic shock hemofiltration multiple organ failure
real-world clinical outcomes of patients with early-stage lung cancer after the surgery

Conditions: Lung Cancer

Summary: the goal of this observational study is to evaluate the efficacy and long-term clinical outcomes of early-stage lung cancer patients who have received surgery using the real-world data. the main questions it aims to answer are: * what is the best surgical strategy for patients with early-stage lung cancer? * what are the risk factors for early-stage lung cancer? participants will receive surgery and the study will analyze the real-world data.

this observational study aims to comprehensively evaluate the effectiveness and long-term clinical outcomes of surgical interventions in early-stage lung cancer patients, utilizing real-world data. central to this investigation are two key questions: * what is the optimal surgical approach for managing early-stage lung cancer? * what are the primary risk factors associated with the development of early-stage lung cancer? participants will undergo surgical procedures, and through rigorous analysis of real-world data, this study endeavors to provide nuanced insights into these fundamental queries, fostering advancements in clinical decision-making and patient management strategies.

Eligibility criteria:
inclusion criteria: 1. aged between 18 and 85; 2. did not receive neoadjuvant therapy before surgery; 3. no history of radiation therapy; 4. eastern cooperative oncology group (ecog) score is 0-1; 5. have complete clinically relevant information including imaging data; 6. all patients underwent relevant preoperative examinations; 7. stage i lung cancer (international association for the study of lung cancer/the union for international cancer control staging eighth edition); exclusion criteria: 1. have previously received chemotherapy, radiotherapy and other anti-tumor therapy; 2. data loss and error in medical records due to human/objective reasons.
dysport in hallux abducto valgus (hav) phase iia

Conditions: Hallux Abducto Valgus

Summary: the purpose of this study is to investigate the efficacy and safety of treatment with multiple doses of dysport in adults suffering from clinically significant pain associated with hav who have not undergone surgery for their condition.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hav * painful hav in the study foot at baseline exclusion criteria: * flat or square metatarsal head, metatarsus primus elevates, or severe cavus/planus in the study foot * other podiatric or orthopedic condition which would interfere with the evaluation of pain and/or function * medical history or clinical evidence of any vascular disease and/or diabetic condition
patients' assessment of satisfaction for stroke prevention in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to describe the treatment perception from patients with non-valvular atrial fibrillation (nvaf) receiving pradaxa® or vka for stroke prevention by using the self-estimation questionnaire of pact-q during a 6-month study period.


Eligibility criteria:
inclusion criteria: cohort a (patients switched from vka to pradaxa) * written informed consent prior to participation. * female or male patients ≥ 20 years of age with a diagnosis of non-valvular atrial fibrillation (nvaf). * at least 3 months of continuous vka treatment for stroke prevention prior to baseline assessment. * patients switched to pradaxa prior to baseline assessment according to the physician's discretion and the summary of product characteristics (smpcs)/reimbursement criteria. or cohort b (patients newly initiated pradaxa or vka) * written informed consent prior to participation. * female or male patients ≥ 20 years of age, newly diagnosed with nvaf, and no previous treatment for stroke prevention (no use of any oac within 1 year prior to enrolment). * patients initiated stroke prevention treatment with pradaxa or vka according to the physician's discretion and the smpcs/reimbursement criteria. exclusion criteria: * contraindication to the use of pradaxa® or vka as described in the smpcs. * patients receiving pradaxa® or vka for any other condition than stroke prevention in nvaf. * current participation in any clinical trial of a drug or device. * current participation in an af-related registry, e.g. the gloria af program.
impact of left atrial function on postoperative atrial fibrillation

Conditions: Atrial Fibrillation

Summary: we aimed to demonstrate the impact of left atrial functions which were evaluated by three different echocardiographic modalities , on postoperative atrial fibrillation.

postoperative atrial fibrillation after coronary artery bypass greft operation (cabg) is major complication with a prevalence of 10-50%. although the men mechanism is not known, in recent studies, age and left atrial function have been demonstrated as the most responsible factors. velocity vector imaging (vvi) is a new modality which may give accurate and detailed information on both left atrial segmental and global function. in this study, our aim was to assess preoperative left atrial function by using three different echocardiographic modalities, vvi, tissue doppler imaging and conventional echocardiography and evaluate the relation between the left atrial functions and the development of post-operative atrial fibrillation after cabg.

Eligibility criteria:
inclusion criteria: * 1coronary artery disease evidenced by coronary angiography * 2patients with a decision of undergoing elective coronary artery bypass greft operation * 3sinus rhythm in electrocardiography exclusion criteria: * 1rheumatic valve disease * 2having prosthetic valve * 3cabg accompanied by other cardiac interventions (such as valvular surgery, asd closure...etc) * 4left ventricular l ejection fraction \<40% * 5mild to moderate mitral stenosis or regurgitation * 6having atrial fibrillation or a history of atrial fibrillation attach during the last two weeks. * 7congenital heart disease * 8chronic liver disease * 9chronic renal disease * 10malignancy

Keywords: atrial fibrillation, left atrium, velocity vector imaging
occlusal reduction effect on postendodontic pain

Conditions: Symptomatic Irreversible Pulpitis

Summary: the aim of this study, thus, was to assess the effect of occlusal reduction on postendodontic pain after the first (post-instrumentation) and the second (post-obturation) visit in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion treated in two visits.

the purpose of this randomized clinical trial was to evaluate the effect of occlusal reduction on post-instrumentation and post-obturation pain in mandibular posterior teeth with symptomatic irreversible pulpitis and sensitivity to percussion treated in two visits. three hundred and eight patients were included in this study. inclusion criteria were posterior mandibular teeth having symptomatic irreversible pulpitis with sensitivity to percussion. patients were randomized into two equal groups. in the intervention group, occlusal reduction was done, while, in the control group, the occlusal surfaces were left intact. conventional endodontic treatment was performed in two visits using a rotary nickel-titanium system followed by the lateral-condensation obturation technique. post-instrumentation pain was assessed after 6, 12, 24 and 48 hours following the first visit, and post-obturation pain after 6 and 12 hours following the second visit. each patient received a pain diary to record their pain levels and rescue medication intake.

Eligibility criteria:
inclusion criteria: * healthy adults 18-65 years old. * the diagnosis of symptomatic irreversible pulpitis with sensitivity to percussion. * posterior mandibular teeth. exclusion criteria: * pregnant women. * patients who reported bruxism or clenching. * patients who took analgesics during the last 12 hours before treatment start. * teeth with no occlusal contact. * unrestorable teeth.
evaluation of the efficacy of prolotherapy treatment in patients with plantar fasciitis: a randomized double-blind study

Conditions: Plantar Fascitis

Summary: plantar fasciitis is the most common cause of heel pain and it is diagnosed by clinically. resting, stretching exercises, weight loss, nonsteroidal anti-inflammatory drugs and physical therapy methods are used in the treatment. steroid injection can be applied in patients who do not respond to these treatments. but steroid injection is not a pathology-based treatment, and also can cause serious side effects, such as fat pad atrophy and plantar fascia rupture. at this stage, in patients who do not respond to conservative treatments, new methods such as dextrose prolotherapy and platelet rich plasma may be used instead of steroid injection. in the literature, there is insufficient study showing effect of prolotherapy in patients with plantar fasciitis. because these studies enrolled small number of patients and lacked controlled design. the investigators design a randomized, double-blind, controlled trial to assess the effect after prolotherapy injection in patients with plantar fasciitis. the participants evaluated with clinically and sonographically. the aim of this study is to compare the pain, function and thickness of proximal plantar fascia in prolotherapy or control group.

after obtaining written informed consent, patients of clinically and sonographically diagnosed with plantar fasciitis were randomized into intervention and control group. participants in intervention group received two-session prolotherapy injection and control group received two-session 9cc salin + 1 cc 2% lidocaine injection in 3 weeks interval. stretching and range of motion exercises were prescribed after treatment. the primary outcome is visual analog scale (vas) and secondary outcomes include foot function index , ultrasonographic measurement of proximal plantar fascia. the evaluation was performed pretreatment as well as on the 1st and 3th month the treatment.

Eligibility criteria:
inclusion criteria: * age between 18-65 year-old. * heel pain for at least 3 months * plantar fasciitis which diagnosed clinically and confirmed using ultrasonography (plantar fascia thickness \> 4mm) exclusion criteria: * history of chronic pain syndromes * patients undergoing steroid injections for the treatment of plantar fasciitis in the last 6 months * rheumatic diseases
the effect of rectus sheath block on the postoperative analgesia in the patients undergoing robotic single port cholecystectomy

Conditions: Gallbladder Diseases

Summary: the primary purpose of this study is to investigate the effect of rectus sheath block on abdominal pain score after robotic single port cholecystectomy. the secondary purpose of this study is to investigate the effect of rectus sheath block on fentanyl consumption during stay of recovery room after surgery.


Eligibility criteria:
inclusion criteria: * robotic single port cholecystectomy for gallbladder disease exclusion criteria: * allergy to ropivacaine, infection, history of abdominal surgery, body mass index more than 30
fevarin® effectiveness in treatment of depression in patients with neurological disorder

Conditions: Depression

Summary: prospective, multicenter, non-comparative, observational program to describe prevalence of depressive symptoms in a variety of neurological disorders and effects of fevarin® on the severity of anxiety and depression, sleep state, and cognitive function.


Eligibility criteria:
inclusion criteria: * outpatients with neurological disorders and mild or moderate symptoms of depression with hospital anxiety depression scale (hads) depression scale score of 8 and higher. fevarin® prescribed not earlier than 7 days before visit 1. exclusion criteria: * labeled contraindications to fevarin®, psychotic symptoms and/or suicidal ideation, schizophrenia, bipolar disorder, schizoaffective disorder, severe dementia, alcohol or drug abuse, acute neurological disorders.

Keywords: depression, depressive symptoms, major depressive disorder, fevarine, fluvoxamine, cognitive function, neurological disorders, sleep state
implementation of a system-level tobacco treatment intervention

Conditions: Smoking Cessation; Lung Cancer

Summary: the proposed study plans to adapt and study the implementation and effectiveness of integrating clinical and community effort against secondhand smoke exposure (cease) into the thoracic oncology setting using mixed methods.

in particular the study aims to see if participants are asked about their smoking status and what services are offered if someone indicates being a former or current smoker. findings from this study will help improve a standard of care at this clinic and allow us to understand what type of tobacco treatment services are preferred by patients. * adaption of cease will entail exit interviews with patients and individual interviews with clinical staff to identify and address facilitators and barriers to the implementation process. * effectiveness of cease will be measured through questionnaires \& biochemical verification of smoking status using a pre-test/post-test study design before (usual care)and after implementation (cease)

Eligibility criteria:
inclusion criteria: * age ≥ 18 * have an actual or potential diagnosis of thoracic malignancy * able to read and write in english. * current or recent former smoker (defined as having smoked within past 6 months) * must have an active telephone number. exclusion criteria: * former smoker greater than 6 months. * have any of the below conditions needing immediate medical intervention * hypercalcemia causing lethargy and confusion, * acute respiratory distress * dehydration * hypotension

Keywords: smoking habits
study of the safety of fg-3019 in incipient nephropathy due to type 1 or type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the phase 1b study is a multi-center trial designed to test the safety, tolerability, biologic activity of escalating doses of fg-3019 in up to 20 patients with type 1 or type 2 diabetes and microalbuminuria (early-stage kidney disease). patients will receive either 3 or 10 mg/kg of fg-3019 administered every two weeks as an infusion for a total of four doses. the ability of fg-3019 to reduce the excretion of protein in the urine is being measured as a secondary endpoint.


Eligibility criteria:
inclusion criteria: * written informed consent * body mass index not exceeding 32.0 kg/m2 * if female, subject must meet one of the following criteria: a) surgically sterile (hysterectomy or bilateral tubal ligation) or b) at least two years postmenopausal or c) using a dual method of contraception and have a negative serum pregnancy test if of childbearing potential * diagnosis of type 1 or type 2 diabetes according to the american diabetes association * fasting plasma glucose of ≥ 126 mg/dl or current treatment with oral hypoglycemic agents or insulin * microalbuminuria defined as albumin to creatinine ratio in a spot collection (first void) of 30 - 300 mg/gram confirmed by two samples two to three days apart * serum creatinine of no more than 1.5 mg/dl for men and no more than 1.1 mg/dl for women exclusion criteria: * female subjects who are pregnant or lactating * non-diabetic renal disease * history of allergic or anaphylactic reaction to human, humanized, chimeric, or murine monoclonal antibodies * coronary artery bypass graft surgery, myocardial infarction, cerebrovascular accident, percutaneous transluminal angioplasty, transient ischemic attack, history of unstable angina, known heart failure, uncontrolled cardiac arrhythmia, or uncontrolled hypertension within six months prior to day 0 * bilirubin, aspartate aminotransferase (ast), or alanine aminotransferase (alt) \> 1.5 times the upper limit of normal * history of cancer of any type in the past 5 years, except non- melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer. * clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study * trauma or surgical procedures (including dental) within six months prior to day 0 * planned elective surgery during the study and for 3 months following the end of the study * participation in studies of investigational drugs within 6 weeks prior to first dose

Keywords: incipient nephropathy type 1 or type 2 diabetes