Kornimate/medical-research-clean huggingface dataset:
pulsed dye laser treatment of onychomycosis

Conditions: Onychomycosis

Summary: the purpose of this research is to investigate the use of the candela v-beam pulsed dye laser for the treatment of onychomycosis, or nail fungus. hypothesis: complete nail clearance will occur in approximately half of patients after 3 laser treatments.

10 patients will participate nationally. the investigators hope to enroll all 10 patients at jefferson. involvement in the study will last about 8-12 weeks for the subject. the entire study will take about 12 months to complete.

Eligibility criteria:
inclusion criteria: * ages 18-65 years old * diagnosis of onychomycosis based on positive fungal culture for dermatophyte and positive pas from toenail clipping exclusion criteria: * hiv/immunosuppression * candidal toenail infection * prior po antifungal therapy within last 6 months * personal history of psoriasis, lichen planus, or significant photosensitivity disorder * any serious generalized medical condition

Keywords: onychomycosis nail fungus
evaluation of bilateral alveolar cleft grafting with micro plate stabilization versus conventional grafting technique

Conditions: Alveolar Cleft

Summary: the aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.

in conventional cleft grafting technique, there is always risk for grafted bone resorption and recurrence of fistula formation. so alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments will work more efficient and prevent the fore mentioned risk of graft resorption and recurrence of fistula. in conventional cleft grafting techniques, most of the cases reported in literature raised a debate regarding the final gained amount of bone, with subsequent recurrence of oronasal fistula. in this study, alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments and the conventional grafting technique will be compared to evaluate which technique will offer better reconstruction of the alveolar ridge with maintained bone width and height.

Eligibility criteria:
inclusion criteria: * patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old). * repaired cleft lip. * patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene. * both genders males and females will be included. exclusion criteria: * general contraindications to surgical intervention of the area. * patients with unilateral maxillary alveolar cleft. * patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft * subjected to irradiation in the head and neck area less than 1 year before surgery. * untreated periodontitis. * poor oral hygiene. * uncontrolled diabetes. * immunosuppressed or immunocompromised. * active infection or severe inflammation in the area intended for graft placement * unable to open mouth sufficiently to accommodate the surgical tooling. * patients participating in other studies, if the present protocol could not be properly followed. * unable to attend a 9-month follow-up.

Keywords: alveolar cleft iliac crest grafting microplate bone resorption oronasal fistula
repetitive thoughts in fibromyalgia: impact of rumination on the emotional and cognitive dimensions of fibromyalgia

Conditions: Fibromyalgia

Summary: dysfunctional chronic diffuse pain syndrome, concerning 2% of the french population, fibromyalgia (fm) is classified either as a psychological disease or as a somatic disease. this dichotomous reasoning does not lead to a better understanding and does not allow the use or development of new psychological tools of care. the issue of the proximity between fm and depression highlighted by some authors and the presence of anxious comorbidities may arise at a different level, that of the transdiagnostic approach. rumination is one of these transdiagnostic processes that are the subject of recent studies and one of the dimensions of which (abstract analytical rumination) is at work in depression and a number of psychopathologies. the investigator therefore wishes to explore the process of rumination and its abstract analytical dimension in fm and to explore its link with the depressive and anxious manifestations frequently associated with this disorder.


Eligibility criteria:
inclusion criteria: * fm criteria of the american college of rheumatology acr 1990. * major patients * free and informed consent signed * stable treatment for at least one month * native french speaker * patient covered by health insurance. exclusion criteria: * patient deprived of liberty or protected major (under guardianship or curatorship)

Keywords: rumination
assessment of pupil light responses in patients with parkinson disease

Conditions: Parkinson Disease

Summary: parkinson diseases (pd) is the second most common degenerative disease of the central nervous system. the development of early diagnostic biomarkers may help identify at-risk individuals and allow precocious interventions at the onset of disease and more precise monitoring of therapies that may slow disease progression. proof of concept studies indicated significant differences in pupil light response between pd patients and healthy controls. the feasibility of using pupillometry for assesment of pd will be examined.


Eligibility criteria:
inclusion criteria: * general inclusion criteria 1. age 30-75 years old 2. signed written informed consent 3. gender: both (male and female) 4. pupillary reflex to light. 5. clear ocular media patients' inclusion criteria: patients with clinical presentations of the neurodegenerative forms of parkinsonism (bradykinesia, extrapyramidal rigidity, tremor, postural instability and gait disturbance) including: idiopathic parkinson disease (pd), lewy body disease (lbd), progressive supranuclear palsy (psp), multiple system atrophy (msa), corticobasal degeneration (cbd) and secondary parkinsonisms. control group- inclusion criteria 1. normal eye examination 2. best-corrected visual acuity (bcva) of 20/20 3. normal color vision test (farnsworth/lanthon d-15 test) 4. no present ocular disease 5. no past ocular disease or surgery within last 6 months 6. no use of any topical or systemic medications that could adversely influence efferent pupil movements 7. normal 24-2 humphrey visual field and * short duration (≤10 minutes) * minimal fixation losses, false positive errors and false negative errors (less than 30% for each one of reliability indices) exclusion criteria: 1. diagnosis of dementia. 2. cognitive decline that may impair obtaining informed consent. 3. tremor or dyskinesia that could interfere with ophthalmic evaluation 4. history of past (last 3 months) or present ocular disease or ocular surgery 5. use of any topical or systemic medications that could adversely influence pupillary reflex 6. psychiatric illness, active psychosis. 7. previous neurosurgical interventions, including stereotactic neurosurgical procedures. 8. past or current strokes or brain injury and other brain disorders (except pd/parkinsonism for patient group) 9. anti-dopaminergic drugs. 10. intolerance to gonioscopy, slit lamp examination, goldmann applanation tomometry or other schedule study procedure. 11. visual media opacity including cloudy corneas. 12. any condition preventing accurate measurement or examination of the pupil.
phase ⅱ study of neoadjuvant chemotherapy followed by concurrent chemoradiation for stage ⅲ nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the primary objective of this study is to determine the tolerance and overall survival in patients with stage ⅲ npc treated with neoadjuvant chemotherapy and concurrent chemoradiation. secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage ⅲ treated with this regimen.

concurrent chemoradiation is the standard treatment for locally advanced npc. the survival benefit gained from adding neoadjuvant chemotherapy to concurrent chemoradiation has never been defined. in the present trail, we hope to assess the tolerance and survival benefits of neoadjuvant chemotherapy followed by concurrent chemoradiation in patients with stage ⅲ npc.

Eligibility criteria:
inclusion criteria: * histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx. * stage ⅲ disease * kps \>70 * age between 18-70 * patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (agc) of \> 2000 cells/mm3, platelet count of \> 100,000 cells/mm3 (pre treatment without intervention). bilirubin \ 50ml/min. * no prior radiation treatment to the head and neck or any prior chemotherapy * patients with no prior malignancy (not include basal cell carcinoma of skin) exclusion criteria: * evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. * prior radiotherapy to the head and neck region for any reason. * initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. * patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin. * pregnant women

Keywords: phase 2 clinical trial npc neoadjuvant chemotherapy concurrent chemoradiation
pharmacokinetic study of fludarabine in pediatric hematopoietic stem cell transplantation

Conditions: Acute Leukemia; Chronic Leukemia; Severe Aplastic Anemia

Summary: the purpose of this study is to analysis of the pharmacokinetics of fludarabine for hematopoietic stem cell transplantation in pediatric patients.

fludarabine is a commonly used chemotherapeutic agent for hematopoietic stem cell transplantation in children. however, no pharmacokinetic study has thus far been conducted in pediatric patients. fludarabine can cause adverse reactions which include neurotoxicity, damage to lungs. pharmacokinetic study is critical to predict the safety of fludarabine in pediatric patients. through an individualized pharmacokinetic study (which entails numerous samplings) of fludarabine in pediatric patients, this study aims to develop a sampling-minimized analysis method and study the population pharmacokinetics. through a pharmacokinetic analysis, we aim to evaluate whether pediatric patients show similar population pharmacokinetics of adults, for whom fludarabine is authorized, and evaluate the safety (toxicity) and efficacy (event free survival).

Eligibility criteria:
inclusion criteria: 1. conditioning regimen including fludarabine 2. age: \< 19 years old 3. functional class: ecog 0-2 4. no loss of function of major organs. criteria may be individualized. * heart: shortening fraction \> 30%, ejection fraction \> 45%. * liver: total bilirubin \< 2 ⅹ upper limit of normal; alt \< 3 ⅹ upper limit of normal. * kidney: creatinine \ 60 ml/min/1.73m2. 5. no active viral or fungal infection 6. appropriate hematopoietic stem cell donor 7. informed consent from patients' parents exclusion criteria: 1. pregnant or breast feeding 2. disease progression due to clinical test 3. psychiatric disease may interfere with clinical test 4. whether attending physician consider the patient inappropriate for study enrollment

Keywords: hematopoietic stem cell transplantation with fludarabine based conditioning
doxazosin effects on abpm in hypertensive patients with diabetic nephropathy

Conditions: Diabetes Mellitus; Essential Hypertension; Renal Failure

Summary: few studies have reported the effect of alpha1-adrenergic antagonists on 24-h blood pressure and regulation of sympathetic nervous activity in hypertensive patients with diabetic nephropathy. using ambulatory blood pressure monitoring devices equipped with spectral analysis of heart rate variability, we assess the effects of doxazosin on blood pressure in diabetic nephropathy patients and compare the results with those in patients with essential hypertension, patients with diabetes mellitus and patients with chronic nephropathy.

the study is an open-labeled parallel prospective trial comparing the effects of doxazosin (2-8 mg/day) on 24-h blood pressure and autonomic nervous activity. hypertensive patients with non-insulin-dependent diabetic nephropathy, patients with essential hypertension, patients with diabetes mellitus and patients with chronic nephropathy undergo ambulatory blood pressure monitoring before and after treatment with doxazosin. simultaneously, spectral analysis is performed to calculate the high frequency components as a marker of parasympathetic nervous activity, and the low frequency components/high frequency components ratios as an index of the sympathovagal balance.

Eligibility criteria:
inclusion criteria: * hypertensive patients with diabetes mellitus * hypertensive patients * hypertensive patients with renal disease exclusion criteria: * cardiac, hematologic or hepatic disease * renal insufficiency (serum creatinine values\> 2 mg/l) * hormone-induced hypertension * cerebral infarction or hemorrhage * other major diseases

Keywords: ambulatory blood pressure monitoring doxazosin alpha1-adrenergic antagonists sympathetic nervous activity diabetic nephropathy essential hypertension power spectral analysis morning surge
a study of ly2181308 in patients with advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive ly2181308.


Eligibility criteria:
inclusion criteria: * diagnosed with hepatocellular cancer * discontinued all previous therapies * at least 18 years of age exclusion criteria: * have other treatment options that are potentially curative or effective--such as surgical resection, liver transplant or percutaneous ablation, and/or transcatheter arterial embolization. * transplanted liver * hiv positive * more than 2 previous systemic chemotherapy treatments
sevoflurane- safety in long-term sedation procedures

Conditions: Poisoning by Inhaled Anaesthetic; Fluoride Poisoning; Recovery From Sedation; Renal Function; Hepatic Function

Summary: patients needing intensive care often require sedative drugs to reduce anxiety and agitation during ventilator care and invasive therapeutic and diagnostic procedures. at present there is no optimal sedative agent for these patients. the most commonly used sedative agents in intensive care units are midazolam and propofol. both drugs have side effects of clinical importance. at present, a viable alternative to intravenous sedation is inhalatory sedation. sevoflurane, as other inhaled anesthetic agents, is sedative in low doses. a new simplified method of administration of isoflurane or sevoflurane has been developed. the anesthetic conserving device is a modified heat-moisture exchanger (hme) that permits direct infusion of sevoflurane to the airway, where it is vaporized in an evaporator rod in the device. however, the use of sevoflurane is limited to anesthesia and sedation lasting no more than 12 hours, since the possible renal problems posed by inorganic fluoride in prolonged operations remain the subject of controversy. the primary aim (and primary hypothesis) of the current trial is to determine whether sevoflurane can be administered as a sedative drug for more than 48 hours without clinically relevant physiopathological effects on kidney and liver function. other end-points of the trial are to evaluate the quality of sedation of sevoflurane, in terms of sedation control, the rapidity and predictability of awakening, and the incidence of delirium in critical care patients.


Eligibility criteria:
inclusion criteria: * signing of the informed consent document (patient or relatives). * patient age 18 years or older. * expected minimum duration of sedation: 48 hours. exclusion criteria: * chronic renal failure treated with replacement therapy (hemodialysis or peritoneal dialysis). * acute kidney injury in stage 3 of akin classification * grade c hepatic child-pugh classification * established acute respiratory distress syndrome (ards). * central nervous system pathology with cognitive disorders that not allow performing the test of the study: severe dementia, alzheimer's disease, depression, schizophrenia, acute stroke. * head trauma with glasgow \<12. * patient treated with antiepileptic drugs that must be maintained during the study period * patients requiring the use of neuromuscular blocking agents during the infusion of study drug, except for the insertion of the endotracheal tube. * epidural or spinal analgesia * allergy or known hypersensitivity to any of the study drugs * patients with known or suspected genetic susceptibility to malignant hyperthermia * previous participation in this trial * participation in another clinical trial within 4 weeks prior to selection. * pregnant women

Keywords: inhalatory sedation sevoflurane anaconda nephrotoxicity hepatotoxicity midazolam propofol
autologous cell therapy for treatment of fecal incontinence

Conditions: Fecal Incontinence

Summary: the aim of this clinical study is to investigate the safety and feasibility of autologous muscle derived cells (amdc, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.

this study is designed to test the safety and feasibility of iltamiocel (autologous muscle derived cells, amdc) as a treatment for fecal incontinence in men and women. iltamiocel therapy seeks to allow remodeling of the external anal sphincter in patients with fecal incontinence from either defined structural defects or a generalized weakening of the external anal sphincter.

Eligibility criteria:
inclusion criteria: * primary symptoms of fecal incontinence, as confirmed by patient medical history and physical examination * wexner (cleveland clinic incontinence severity (ccis)) score ≥ 9 * etiology of fecal incontinence is related, at least in part, to external anal sphincter dysfunction * failed conservative treatment exclusion criteria: * gracilis sling repair or insertion of an artificial sphincter * inflammatory bowel disease * significant rectocele or rectal prolapse * history of radiation treatment to the anal sphincter or adjacent structures * less than 18 years of age * pregnant, breastfeeding, or plans to become pregnant during the course of the study * neuromuscular disorder * history of neoplasia within 5 years prior to enrollment, except for basal cell carcinoma, or is receiving or planning to receive anti-cancer medications * known bleeding diathesis or uncorrected coagulopathy * medical condition that would preclude treatment due to contraindications and/or warnings of concomitant medications or listed in the experimental product labeling * compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy * participating in another investigational drug or device study * unable or unwilling to provide informed consent * unable or unwilling to commit to the follow-up procedures

Keywords: cell therapy autologous cell transplantation muscle-derived cell anal incontinence rectal diseases intestinal diseases gastrointestinal diseases urinary incontinence
a study to evaluate sage-217 in adult participants with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: this is a phase 3, open-label, 1-year study of the safety, tolerability, and need for re-treatment with sage-217 in adult participants with mdd.

this study was previously posted by sage therapeutics. in july 2024, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: 1. participant has a diagnosis of mdd as diagnosed by the structured clinical interview for diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) clinical trial version (scid-5-ct), with symptoms that have been present for at least a 4-week period. 2. participant is in good physical health and has no clinically significant findings, as determined by the investigator, on physical examination, 12-lead electrocardiogram (ecg), or clinical laboratory tests. 3. participant has a montgomery-åsberg depression rating scale (madrs) total score of ≥28 and a ham-d total score of ≥20 at screening and day 1 (prior to dosing). exclusion criteria: 1. participant has attempted suicide associated with the current episode of mdd. 2. participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder. 3. participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode.
breathing protocol in breath-hold divers

Conditions: Exercise Training; Apnea; Breathholding; Breathing Exercises

Summary: the aim of this randomized controlled trial study was to assess the effects of an 4-week exercise program on the recovery capacity after a voluntary maximal apnea. participants will be randomly allocated to perform an experimental breathing protocol (nr-hb), or an usual training using their usual breathing (ub) protocol.

it is a multi-center study. 2 different spanish freedivers centres are included in the study (madrid and zaragoza). divers were randomly assigned to receive an experimental training (nr-hb) or to be included in the control group (ub). the trial included two study visits. each exercise training program will be applied sessions per week during 4 weeks. participants received baseline assessments at the beginning of any intervention, and post-intervention assessments at the end of the fourth week.

Eligibility criteria:
inclusion criteria: * absence of pain or illness * no changes in cognitive ability * over 18 years old. * member of the spanish federation of underwater activities. * positive medical examination that allows the diver to practice voluntary apnea. exclusion criteria: * people with systemic diseases, tumors, infections, pacemakers, history of epilepsy, hydrophobia, pregnancy women, pharmacological treatment. * to be participating in other physical activities during the experimental research
the effect of ablation therapy on barrett's esophagus

Conditions: Barrett's Esophagus; Early Esophageal Adenocarcinoma

Summary: to assess the effect of ablative therapy (photodynamic therapy or radiofrequency ablation ) on barrett's esophagus

to assess the effect of ablation therapy on barrett's esophagus. proposal ablation therapy is an fda approved treatment to decrease cancer risk in barrett's esophagus mucosa. this is being performed in our barrett's esophagus unit on a regular basis. however, the longterm outcomes of this therapy is not established and there are patients who have been treated who later re-develop barrett's mucosa. this study will allow us store tissue samples that can later be used to assess the effect of ablative therapy on barrett's esophagus.

Eligibility criteria:
inclusion criteria: * patients who have had or qualify for ablation therapy for treatment of their barrett's esophagus with high grade dysplasia or early esophageal adenocarcinoma * ability to provide informed consent exclusion criteria: * eastern cooperative oncology group performance status 3 or 4 * inability to tolerate endoscopic procedures * pregnancy: females of child-bearing age will be screened with pregnancy test.

Keywords: photodynamic therapy barrett's esophagus early esophageal adenocarcinoma