Kornimate/medical-research-clean huggingface dataset:
effect of photobiomodulation in patients with temporomandibular dysfunction refractory to botulinum toxin treatment.

Conditions: Temporomandibular Joint Disorder

Summary: the objective of this preliminary research was to identify the effect of low-level laser photobiomodulation therapy (lllt-pbmt) in patients with myofascial temporomandibular disorders (tmds), refractory to botulinum toxin (btx) treatment. specifically, the hypothesis of lllt-pbmt as a safe, low-cost, painless, and minimally invasive alternative therapy was proposed to improve complete muscle recovery and significantly reduce muscle paralysis in patients with masticatory muscle disorders previously treated with btx. additionally, different treatment alternatives were investigated, and a protocol was suggested for the application of lllt-pbmt in myofascial tmds and the pain associated with masticatory muscles, also analyzing its complications and negative effects


Eligibility criteria:
inclusion criteria: * female patients diagnosed with tmds. presence of unilateral or bilateral painful symptoms. associated conditions: bruxism, hypertrophy of the masticatory muscles, headaches * previous treatment with btx: minimum of 3 doses (100 iu) applied in masticatory muscles and intracapsular area no favorable results obtained exclusion criteria: * patients without prior treatment of this type. * patients receiving treatment in the pain unit. * patients undergoing invasive treatments: open surgery in the cervicofacial region or tmj arthrocentesis.

Keywords: temporomandibular disorders low- level laser- photobiomodulation therapy tmd myofascial tmd
cryoablation effects on acute and chronic pain after thoracotomy and thoracoscopy

Conditions: Pain, Postoperative; Intrathoracic Procedure

Summary: the researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. the research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.


Eligibility criteria:
inclusion criteria: * patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at michigan medicine * patient is opioid naïve exclusion criteria: * patients who are pregnant * patients with cognitive impairment * patients with psychological disorders * patients with prior thoracic surgery * patients with fibromyalgia * patients with redo ipsilateral thoracic surgery * patients undergoing bilateral thoracotomy
initiative for clinical long-read sequencing

Conditions: Genetic Predisposition

Summary: the study aims to comprehensively introduce long-read genome sequencing (lr-gs) based genetic testing into clinical routine. in order to demonstrate the superiority of untargeted lr-gs over short-read genome sequencing (sr-gs) to establish firm genetic diagnoses, the investigators will rely on a multi-center "translate nationale aktionsbündnis für menschen mit seltenen erkrankungen" (translate national action alliance for people with rare diseases germany, tnamse) cohort of unsolved patients with neurological, neurodevelopmental, and imprinting disorders that is expectedly enriched for complex genomic variation. within the framework of genomde, the investigators will then implement, for the first time, lr-gs in the diagnostic work-up of a prospective cohort of patients with a broad range of clinical indications including rare diseases and cancer predisposition.

the proposed study aims to develop a blueprint for the implementation of lr-gs in clinical diagnostics. hence standard operating procedures (sops) and guidelines for library preparation, bioinformatic analysis, and clinical interpretation will be compiled. furthermore, the investigators intend to develop an open source 'gold standard' bioinformatics pipeline, addressing all relevant types of genomic alterations, thus providing the bioinformatic basis for a streamlined implementation of lr-gs at other sites. in addition to in-depth phenotype information the availability of sr-gs will be instrumental to benchmark the ability to detect different types of genomic variation. additional relevant issues for genetic testing such as variant calling in difficult-to-map genomic regions, detection of genomic methylation patterns, characterization of repeat expansion and duplicated genes, and haplotype-phased genome de novo assembly will be addressed. moreover, based on the strong background in artificial intelligence (ai) driven variant prioritization in the consortium, the investigators aim to implement and/or develop tools that enable an efficient prioritization of disease-causing variants. beyond the usage within the context of the proposed study, generated datasets will be made available according to the findable, accessible, interoperable and reusable (fair) principles for national (german human genome-phenome archive, ghga) and international (european genome-phenome archive, ega, genome-phenome analysis platform, gpap) data repositories. the investigators aim to establish a population scale reference dataset for structural variants (sv), which is absolutely mandatory in the context of rare disease diagnostics.

Eligibility criteria:
inclusion criteria: * unclear molecular cause of the disease (retrospective cohort) * indication for genome diagnostics (prospective cohort; e.g. within the initiative for genomic medicine (genomde) based on §64e sgb v) * suspected genetic cause of the disease exclusion criteria: - missing informed consent of the patient or legal guardian

Keywords: long-read sequencing rare diseases cancer preposition translate-namse german initiative for genomic medicine (genomde)
a study to evaluate the safety and immunogenecity of lbve(multivalent pneumococcal conjugate vaccine) in healthy infants

Conditions: Pneumococcal Infection

Summary: the purpose of this study is to evaluate the safety and immunogenicity of lbve (multivalent pneumococcal conjugate vaccine) in healthy infants.


Eligibility criteria:
inclusion criteria: * healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment. * the parents or lar(legally authorized representative) able to understand and comply with planned study procedures. * signed informed consent by subject's parents or lar(legally authorized representative) exclusion criteria: * previously received any pneumococcal vaccine * receipt of immunoglobulin or blood-derived product before the study * known or suspected immune disorder, or received immunosuppressive therapy * known major congenital malformation or serious chronic disorder * participation in another interventional trial
alk21-004: single-dose opiate challenge of medisorb® naltrexone (vivitrol®) in adults who use opioids

Conditions: Opiate Dependence

Summary: this was a phase 2, multicenter, randomized, double-blind pilot study in opioid-using adults to assess the presence, duration, and degree of opiate blockade as well as the safety and tolerability of medisorb® naltrexone (vivitrol®). subjects were randomized in a 1:1:1 ratio to receive a single gluteal intramuscular (im) injection of medisorb naltrexone 75, 150, or 300 mg.

potential subjects were screened within 21 days prior to dosing of study drug (medisorb naltrexone or placebo) on day 0. screening evaluations included a baseline hydromorphone challenge session in which increasing doses of hydromorphone (0 mg \[placebo\], 3 mg, 4.5 mg, and 6 mg) were administered at hourly intervals to produce a cumulative dose-response curve. throughout the 4-hour challenge period, subject-rated measures (visual analog scale \[vas\] questions) and physiological measures (ie, pupil size) were recorded. as a safety measure, at least 7 days after the baseline hydromorphone challenge, a naloxone challenge was performed followed by a 1-day oral naltrexone tolerability assessment. on day 0, eligible subjects were administered a single dose of study drug. to assess the level of opiate blockade and surmountability attributable to medisorb naltrexone, experimental hydromorphone challenge sessions were conducted postdose at days 7, 14, 21, 28, 42, and 56, with a single placebo hydromorphone challenge administered at a randomly selected visit. pupil size was measured 15 minutes prior to the first hydromorphone dose and at 15, 30, 45, and minutes after each ascending hydromorphone/placebo for hydromorphone dose. blood samples for measurement of naltrexone and 6b-naltrexol were obtained at screening and before hydromorphone/placebo administration on days 7, 14, 21, 28, 42, and 56. subjects were monitored for safety through day 56.

Eligibility criteria:
primary inclusion criteria: * adults who had used opioids: non-medically for at least 1 year; at least once per week for at least some period during their use history; and fewer than 3 times per week on average for the 30 days prior to screening. * provided written informed consent * demonstrated a positive response to hydromorphone challenge during screening * willing to use contraception for study duration if of childbearing potential primary exclusion criteria: * any clinically significant medical condition or laboratory abnormality at screening * participated in a clinical trial within prior 30 days * dependent on opioids * seeking treatment for opioid abuse * psychosis or any major mood or anxiety disorder * pregnancy or lactation

Keywords: opiate dependence
new biomarkers in facioscapulohumeral muscular dystrophy, multispectral optoacoustic tomography.

Conditions: FSHD

Summary: facioscapulohumeral muscular dystrophy (fshd) is one of the most frequent muscular dystrophies in the adulthood. multi-spectral optoacoustic tomography (msot) is an innovative imaging technique able to non-invasively characterize the molecular composition of the muscle tissue. with this pilot study we will explore the performance of msot imaging in fshd patients and correlate the findings with clinical and mri data, with the final aim to identify new disease biomarkers.


Eligibility criteria:
inclusion criteria: * molecular diagnosis of fshd * recent pelvic and lower-limb muscle mri exclusion criteria: * presence of conditions that can alter the signal of the muscles under investigation: eg. tattoos, scars or skin abrasions at the site of probe evaluation, recent trauma, decompensated diabetes, symptomatic radiculopathies, acute or chronic inflammatory diseases * current or presumed pregnancy * inability to give informed consent
a study to evaluate adverse events and change in disease activity in participants between 18 to 75 years of age treated with intravenous (iv) infusion and subcutaneous (sc) injections of abbv-154 for moderately to severely active crohn's disease

Conditions: Crohn's Disease

Summary: crohn's disease (cd) is a long-lasting condition causing inflammation that can affect any part of the gut. cd may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. this study evaluates how safe and effective abbv-154 is in participants treated for moderately to severely active cd. adverse events and change in the disease activity will be assessed. abbv-154 is an investigational drug being evaluated for the treatment of cd. in the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. around 265 participants 18-75 years of age with moderately to severely active cd will be enrolled in the study at approximately 200 sites worldwide. the study is comprised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. in the maintenance period, responders will be randomized to receive subcutaneous placebo or abbv-154 in 2 different doses every other week. participants in the placebo group who are initial responders will receive abbv-154 in the maintenance period. there may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of crohn's disease (cd) for at least 3 months prior to baseline of the induction period. * crohn's disease activity index (cdai) score 220 to 450 at baseline of the induction period. * endoscopic evidence of mucosal inflammation as documented by an simple endoscopic score for crohn's disease (ses-cd) of \>= 6 for ileocolonic or colonic disease or ses-cd of \>= 4 for isolated ileal disease as scored by a central reader. all eligible scores must exclude the presence of narrowing component. * demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, or risankizumab. exclusion criteria: - participants with prior intolerance to adalimumab.

Keywords: crohn's disease abbv-154
seasonal influenza vaccine, quadrivalent versus trivalent in patients with advanced chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of gold stage c and d copd vs. those patients without copd.

primary objectives: to evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of gold stage c and d copd (vs. those patients without copd). to demonstrate immunogenicity by measuring hemagglutination inhibiting antibodies (hi) against the components of viral antigens using seroconversion (≥4 fold increase over baseline titers) and sero-protection (hi titer of ≥40 against the vaccine components). secondary objective: to assess the degree of antibody response of copd patients based on severity of disease as measured by fev1. to assess the impact of inhaled corticosteroids on the adaptive immune response after vaccination.

Eligibility criteria:
inclusion criteria: inclusion criteria for patients with copd will be: 1. signed informed consent prior to initiation of study-mandated vaccination. 2. patients with spirometric data in the preceding 18 months confirming the diagnosis of copd. 3. patients meeting gold classification of stage c or stage d copd. 4. patients 50 years old - 64 years old. inclusion criteria for healthy participants will be: 1. signed informed consent prior to initiation of study-mandated vaccination. 2. no active symptoms of lung disease. 3. fev1/fvc in the normal range \> 70% age predicted value. 4. no history of tobacco use/abuse. 5. no prior history of alpha-1 antitrypsin deficiency. 6. patients 50 years old - 64 years old. exclusion criteria: 1. severe allergy to eggs. 2. severe reaction to past doses of influenza vaccine. 3. guillian-barre syndrome. 4. currently recieving dialysis. 5. current, active, treatment for cancer. 6. history of transplant (allograft). 7. dementia or alzheimer's disease diagnosis. 8. prior diagnosis of hiv or aids. 9. moderate to severe pulmonary hypertension. 10. serum ast/alt \> 3x the upper limit of normal. 11. patients with exacerbations or respiratory infection during the 4 weeks preceding the onset of the study. 12. active pregnancy. 13. systemic immunomodulating medications.
balloon vaginoplasty for treatment of vaginal-aplasia

Conditions: Vaginal Abnormality

Summary: vaginal aplasia is a congenital anomaly characterized by congenital absence of the vagina with an incidence approximately 1:4,500-6,000. it carries an emotional, sexual, and social embarrassing effect on those women, the primary aim of treatment is creation of a neo vagina for restoration of the ability for vaginal intercourse. there are several techniques for neo vaginal construction with variable satisfaction rates. most of these procedures are either invasive and technically demanding or require long duration in a very motivated patient

numerous surgical and nonsurgical procedures with varying degrees of success have been described for correction of the vaginal aplasia, but none have proved to be universally accepted. balloon vaginoplasty was first introduced in 2003 by el saman et al for construction of a naturally lined neo vagina through a laparoscopic. technique hosts the triad of a perfect management modality; namely: simplicity, safety and success. the technique acts via mechanical expansion of the vaginal epithelium and underlying tissues at the pre-existing vaginal dimple being a relatively new modality of management, it went through many refinements to make it much easier and feasible. the cornerstone of refinement always ran around the access to the peritoneal cavity. the latest of which was the fractionated intra umbilical micro ports which have the merits of totally hidden scar at the bottom the umbilicus consequently the best cosmetic outcomes. however, during its insertion process a troublesome partially unmonitored insertion was inevitably observed

Eligibility criteria:
inclusion criteria: * married females with vaginal aplasia scheduled for balloon vaginoplasty. exclusion criteria: * females who refused to consent for participation in the study. * unstable marital relationship.
a study to evaluate preventive treatments for talquetamab-related oral toxicity

Conditions: Relapse Multiple Myeloma; Refractory Multiple Myeloma

Summary: the purpose of this study is to identify preventive treatments that can minimize the occurrence, severity, and duration of talquetamab-related taste changes (dysgeusia), during the prophylaxis (preventive) treatment phase, and to better characterize the signs or symptoms of talquetamab-related taste changes.


Eligibility criteria:
inclusion criteria: * multiple myeloma (mm) according to imwg diagnostic criteria * were triple-class exposed (received prior treatment with a pi, an imid, and anti cd38 mab) * documented evidence of progressive disease based on investigator's determination of response by imwg criteria on or after their last regimen * have an eastern cooperative oncology group-performance status (ecog-ps) of 0 or 1 at screening. participants with ecog-ps 2 or 3 are eligible for the study if the ecog-ps score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and not related to multiple myeloma or associated therapy * be willing and able to adhere to the lifestyle restrictions specified in the protocol exclusion criteria: * contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients * stroke, transient ischemic attack, or seizure within 6 months prior to screening * any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction; major thromboembolytic event (e.g., pulmonary embolism, cerebrovascular accident), clinically significant ventricular arrythmia or heart failure new york heart association functional classification class iii or iv. uncomplicated deep vein thrombosis is not considered exclusionary * major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of talquetamab, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment * a wett score suggesting severe dysgeusia at screening. also unresolved/severe dysgeusia referred by the participant or a finding in the physical examination/oral cavity inspection. some examples include leukoplakia, prior mouth cancers, extensive dental caries, severe periodontitis, active oral infections, candidiasis, parotic gland removal, or radiotherapy with resultant xerostomia
asthma exacerbation study

Conditions: Asthma

Summary: this study will establish the safety as well as demonstrate benefit of the addition of a laba to an ics by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma * reversibility fev1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol * fev1 of fifty to ninety percent of predicted * currently using inhaled corticosteroid therapy * history of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year exclusion criteria: * history of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest * respiratory infection or oral candidiasis * - uncontrolled disease or clinical abnormality * allergies * taking another investigational medication or prohibited medication
effects of tracheal intubation on ventilation with a laryngeal mask during percutaneous dilatation tracheostomy

Conditions: Neurological Diseases, Heart or Respiratory Failure,; Sepsis, Trauma.

Summary: the length of tracheal intubation may affect the subsequent ventilation with a laryngeal mask during percutaneous tracheostomy.

percutaneous tracheostomy is routinely performed while patients are being ventilated with a laryngeal mask. the efficacy of ventilation during tracheostomy may be affected by length of previous endotracheal intubation. this is an observational and monocentric study aimed to evaluate the impact of length of endotracheal intubation on efficacy of lung ventilation with a laryngeal mask. two groups of patients who have to undergo elective percutaneous tracheostomy after either a short or long endotracheal intubation will be enrolled. data on the correlational effects of the endotracheal tube on the integrity of laryngeal structures and on ventilation will be collected. statistical analyses will use standard tests to compare the two groups of patients.

Eligibility criteria:
inclusion criteria: * age 18-80 years * mechanical ventilation * need of percutaneous tracheostomy exclusion criteria: * previous pathologies of upper airways or of oesophagus * risk of bleeding * need of fio2 \>70% and/or of peep \>10 cm h2o * difficult insertion of laryngeal mask * impossibility of endoscopic visualization of the laryngeal structures

Keywords: endotracheal intubation tracheostomy laryngeal mask