Kornimate/medical-research-clean huggingface dataset:
a multi-center clinical trial in individuals with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: the overall objective of this project is to investigate the effectiveness of daily acute intermittent hypoxia therapy (daih), coupled with massed practice training, to improve upper-extremity function in individuals with chronic incomplete cervical sci.

specific aim 1: evaluate the effectiveness of a combined intervention utilizing daih and massed practice upper extremity training on arm and hand function in individuals with incomplete tetraplegia. specific aim 2: evaluate the effectiveness of a combined intervention utilizing daih therapy and robotic rehabilitation device-administered upper-extremity training on arm and hand function in persons with incomplete tetraplegia.

Eligibility criteria:
inclusion: 1. history of a non-progressive spinal cord injury, at or below c2, and at or above t1. 2. between the ages of 18 - 75 years. 3. time since injury must be at least 6 months if the injury was traumatic in nature. if the spinal cord injury is non-traumatic, participants must meet at least the initial 6-month criteria in addition to either no regression in symptoms for at least two years, per self-report or per medical monitor discretion. 4. demonstrate voluntary motor activation in hand muscles, with a score of at least a 2 on at least one of the prehension ability grasp patterns of the grassp assessment (cylindrical grasp, lateral key pinch, and tip to tip pinch), on at least one upper extremity. 5. ability to understand and the willingness to sign an informed consent. 6. at least a 10% change in isometric elbow strength above baseline, after a single bout of acute intermittent hypoxia (aih), during screening. exclusion: 1. diagnosed with any of the following medical conditions: congestive heart failure, cardiac arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial infraction, or known carotid/intracerebral artery stenosis. 2. women who are currently pregnant/nursing or planning on becoming pregnant. 3. individuals with a tracheostomy or who utilize mechanical ventilation. 4. individuals who are currently enrolled in another interventional research study or in therapy related to upper extremity function. 5. participants will be excluded if they have had a botulinum toxin injection to upper extremity musculature within the last 3 months. participants will need to refrain from upper extremity botulinum toxin injections for the duration of the study. if participants wean off antispasticity medications to successfully complete the responsiveness to aih screening session, they will need to refrain from the medications for the duration of the study. 6. documented sleep apnea. 7. orthopedic injuries or surgeries that would impact an individual's ability to use the upper extremity. 8. traumatic brain injury or other neurological conditions that would impact the study. 9. blood hemoglobin levels less than 10g/dl.
perfusion assessment in laparoscopic left anterior resection

Conditions: Rectal Cancer; Colon Cancer; Crohn's Disease; Polyp; Procidentia; Diverticulitis

Summary: the purpose of this study is to demonstrate that nir fluorescence angiography using the pinpoint endoscopic fluorescence imaging system ("pinpoint system" or "pinpoint") can assess viability of colon tissue during laparoscopic left colectomy. this information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.

colectomy is a surgical procedure in which a part or all of the colon is removed. it is used to treat a variety of diseases including colon cancer, diverticulitis, inflammatory bowel disease (including ulcerative colitis or crohn's disease) and infarcted bowel. this study is the second phase of a three phase process to demonstrate the clinical utility of perfusion assessment by nir fluorescence angiography in colectomy. the initial phase (phase i) consisted of a number of small investigative studies that have now been completed. upon successful completion of this study, it is anticipated that a prospective, multi center, randomized trial will be conducted (phase iii). information learned from this present study will help guide the design of the randomized trial e.g. specific patient populations that may best benefit from this imaging modality and how randomization should be conducted (e.g. imaged cohort vs. non imaged, or all subjects imaged but then randomized to no image assessment in one arm of the study).

Eligibility criteria:
inclusion criteria: * subject is scheduled for laparoscopic left colectomy in the lower region (planned anastomosis located 5 - 15 cm from anal verge) * a negative pregnancy test for women of childbearing potential prior to surgery exclusion criteria: * subject has a previous history of adverse reaction or known allergy to icg, iodine or iodine dyes * subject has any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure * subject is a pregnant or lactating female

Keywords: laparoscopic low anterior colon resection laparoscopic left colectomy colectomy rectal cancer colon cancer crohn's disease polyp procidentia diverticulitis
evaluation of surgical treatment of terrible triade injury of the elbow joint

Conditions: Treatment of Terrible Triade Injury of the Elbow Joint

Summary: ) terrible triad injury of the elbow is a complex injury that is classically defined as elbow dislocation along with fractures of the coronoid process of the ulna and the radial head. the injury is usually associated with typical soft-tissue disruptions (with common involvement of the lateral collateral ligament complex, elbow joint capsule, as well as the common extensor and flexor-pronator tendons)(2). complications of terrible triad injuries include redislocation, residual instability, elbow stiffness, heterotopic ossification, fracture malunion or nonunion, elbow arthrosis, olecranon bursitis, ulnar or radial nerve palsy (due to the surgical approach or placement of hardware), and hardware related complications(2) . management of trrible triade is conservative or surgical treatment ,in this study we will use surgical treatment and make evaluation of it.

the elbow is the second most commonly dislocated joint in adults and up to 20% of dislocations are associated with a fracture. (1) terrible triad injury of the elbow is a complex injury that is classically defined as elbow dislocation along with fractures of the coronoid process of the ulna and the radial head. the injury is usually associated with typical soft-tissue disruptions (with common involvement of the lateral collateral ligament complex, elbow joint capsule, as well as the common extensor and flexor-pronator tendons) complications of terrible triad injuries include redislocation, residual instability, elbow stiffness, heterotopic ossification, fracture malunion or nonunion, elbow arthrosis, olecranon bursitis, ulnar or radial nerve palsy (due to the surgical approach or placement of hardware), and hardware related complications. management of trrible triade is conservative or surgical treatment ,in this study we will use surgical treatment and make evaluation of it. surgical treatment involves radial head repair or replacement ,medial and lateral collateral ligament repair and coronoid fracture fixation. aim of research isfunctional assessment of surgical treatment of terrible triade injury of the elbow according to mayo elbow performance score, according to the system of mayo, scores of 90-100 are classified as excellent, 75-89 as good, 60-74 as fair, and 0-59 as poor

Eligibility criteria:
inclusion criteria: * 1.skeletally mature patients (over 17 years old) including both sexes. 2.acute fractures within 3 weeks of injury. 3.isolated \& closed fractures . 4.polytrauma trauma patients with no other injuries in the same limb. exclusion criteria: * 1. pathological fracture of proximal radius and ulna. 2. deteriorateed general health. 3. previous history of dysfunction with the affected elbow.
a pilot study on whey protein supplementation in non alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease; Obesity

Summary: an increase in dietary protein intake has been shown to blunt the increase in intrahepatic fat induced by high fat feeding in healthy individuals. the purpose of this study is to determine if a protein supplementation decreases intrahepatic fat in obese patients with non-alcoholic fatty liver disease.

12 obese patients will be be treated with a dietary whey protein supplementation over 4 weeks. their intrahepatic fat content, glucose tolerance, and body weight will be evaluated before and after 4 weeks of supplementation.

Eligibility criteria:
inclusion criteria: * bmi higher than 35 kg/m2 * age 18-50 years * sex male or female * asat/alat \> 1.8 exclusion criteria: * treatment with hypolemic or antidiabetic agents * blood glucose \> 7 mmol/l * alcohol intake \> 20g/day * creatinin \> 120 umol/l) * contra-indications to magnetic resonnance imaging

Keywords: intrahepatic fat obesity body fat impaired glucose tolerance
bis-guided sedation in critically ill patients under deep sedation

Conditions: Delirium; Sedative Overdose

Summary: the goal of this clinical trial is to investigate the effectiveness of sedation guided by the bispectral index (bis) in reducing the incidence of delirium and the doses of sedative drugs used in critical patients who require deep sedation. the main questions this study aims to answer are: * does sedation guided by bis lead to higher delirium and coma-free days compared to clinical monitoring? * does sedation guided by bis result in reduced doses of sedative drugs compared to clinical monitoring? participants in this study will be randomly assigned to one of two groups: clinical monitoring group: participants in this group will receive sedation based on clinical scales. these participants will also be fitted with a bis sensor, but the sensor will be covered. sedation guided by bis group: participants in this group will receive sedation guided by the bispectral index. the study will be conducted as a prospective, controlled, blind intervention trial with random distribution and intention to treat. the primary outcomes to be evaluated include: * delirium and coma-free days after the end of deep sedation using the confusion assessment method for the icu (cam-icu) scale. * total dose of sedative drugs administered. * bis values researchers will compare the two groups to determine if sedation guided by bis is associated with a higher number of delirium and coma-free days, reduced sedative drug doses, and higher values of bis compared to clinical monitoring.

a phase 4, randomized (1:1), controlled, double-blind, unicenter clinical trial aims to assess the effectiveness of sedation guided by the bispectral index (bis) compared to sedation guided by clinical scales in critically ill patients under deep sedation. the primary objective is to investigate whether bis-guided sedation can reduce the incidence of delirium and decrease the doses of sedative drugs administered.

Eligibility criteria:
inclusion criteria: * patients older than 18 years. * under mechanical ventilation in the intensive care unit * indication of deep sedation (rass objective -4, -5) * admission to the icu or indication of deep sedation up to 8 hours prior to randomization. exclusion criteria: * patients with end-of-life care. * family refusal to participate in the study. * impossibility to place the bis sensor (burns, extensive lesions on the forehead, prone position, etc.). * patients with intracranial hypertension or convulsive status, in whom sedation has the objective of suppressing electroencephalographic waves. * patients who, following a decrease in sedation, have a coma, vegetative state or a state of minimal consciousness.

Keywords: deep sedation bispectral index critical care patients delirium sedatives
depression and bipolar disorder

Conditions: Bipolar Disorder

Summary: this study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. study drug and all study-related visits are provided at no cost to the patient. the patient agrees to meet with study research staff for roughly 11 clinic visits.


Eligibility criteria:
inclusion * patients must provide written and informed consent. * diagnosis of bipolar ii disorder and currently depressed for minimum of the last 8 weeks. exclusion * patients must not be suicidal. * patients must not have a history of non-response to antidepressant treatment. * patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry. * patients must not have had epilepsy or hypothyroidism.

Keywords: bipolar disorder
proof of concept : immunogenicity and safety of hepb injection in the dermis using vax-id

Conditions: Hepatitis B

Summary: a proof of concept (poc) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis b in the past (at least 5 years ago) to assess the safety and immunogenicity of intradermal vaccination with hepatitis b surface vaccine antigen using a newly developed intradermal injection device vax-id, compared to intramuscular and intradermal (mantoux technique) injection.


Eligibility criteria:
inclusion criteria: * healthy adults, checked anamnestically (based on medical history) at entry of the study * 18-35 years * vaccination status: fully vaccinated against hepatitis b at least 5 years ago, with proof of vaccine response (to avoid non-response among the subjects). subjects has to ask for a document of this proof at the service occupational medicine of the university of antwerp. * capable of understanding, reading and writing dutch exclusion criteria: * other vaccination(s) 4 weeks before study onset * pregnancy and lactation (women will be questioned during anamnesis) * plan to have other vaccination during the study period

Keywords: immunogenicity safety proof of concept
patient reported experience measures following a first remote orthodontic consultation : a randomized controlled trial

Conditions: Odontologic Disorders

Summary: the objective of this present randomized controlled trial was to investigate patient's and practitioner's reported outcomes measures (proms) following a first standard face-to-face consultation versus a first orthodontic teleconsultation (video-assisted remote orthodontic consultation).


Eligibility criteria:
inclusion criteria : - patients requesting a first orthodontic consultation. exclusion criteria : - children not accompanied by their legal guardian (under 18 years old).

Keywords: remote-assisted teleconsultation
high flow nasal cannula for stabilization of extremely premature infants

Conditions: Premature Infant; Ventilation Therapy; High Flow Nasal Canula

Summary: a prospective observational study evaluates the safety and efficacy of using high-flow nasal cannula to stabilize extremely preterm infants immediately after birth. following placental transfusion, high flow nasal cannula at 6-8 l/min is administered along with intermittent tactile stimulation. criteria for switching to other interventions like continuous positive airway pressure or positive pressure ventilation are set for cases of persistent bradycardia or low saturation of oxygen (spo2).


Eligibility criteria:
inclusion criteria: * preterm infants born between 25+0 and 27+6 gestational weeks * weight above 500 grams exclusion criteria: * previable rupture of membranes, * congenital malformations previable * acute intrauterine hypoxia.
evaluation of the utility of minocycline as an anti-inflammatory agent in the treatment of asthma

Conditions: Asthma

Summary: trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease.

this is a double-blind, placebo-controlled crossover study of adult asthmatics given minocycline 150 mg po bid or placebo as add-on therapy for eight weeks each. each eight week arm is separated by a four week wash-out. spirometry is performed at the baseline and end of each arm. daily symptoms scores, peak flow rates, and oral steroid requirements are recorded. a standardized asthma quality of life symptoms assessment is made every four weeks (aqlq, juniper).

Eligibility criteria:
inclusion criteria: * adult asthmatics * history of or current use of oral steroids to control symptoms exclusion criteria: * pregnant women

Keywords: minocycline asthma oral corticosteroids
acute-phase response & periodontal treatment in obese patients

Conditions: Periodontal Diseases; Obesity

Summary: the aim of this study is to compare quadrant scaling and root planing (q-srp) versus full-mouth treatment (fm-srp) in terms of acute-phase responses following no surgical periodontal treatment in obese patients affected by periodontitis.

periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), will be performed by a single periodontist on obese patients with periodontitis. the aim of this study is to compare quadrant scaling and root planing (q-srp) versus full-mouth treatment (fm-srp) in terms of acute-phase responses following non surgical periodontal treatment. treatment will be provided using both hand and ultrasonic instrumentation with ﬁne tips. fm-srp patients will received treatment within 24 h. q-srp patients will received four quadrants sessions of periodontal treatment with an interval of 1 week between sessions. vital, endothelial function and blood inflammatory parameters will be evaluated at baseline, 24 hours after the first treatment and after 3 months. periodontal parameters will be evaluated at baseline and after 3 months.

Eligibility criteria:
inclusion criteria: * patients affected by periodontal disease * 20% of periodontal pockets of the entire dentition * 20% bleeding on probing of the entire dentition * documented radiographic bone loss * diagnosis of obesity as measured through body mass index (bmi) superior than 30 exclusion criteria: * age younger than 18 years and older than 80 years * pregnant or lactating females * need of antibiotic coverage for periodontal treatment * treatment with statin and/or acetylsalicylic acid * bmi \> 35
daratumumab, bortezomib, cyclophosphamide, and dexamethasone therapy for patients with midd

Conditions: Monoclonal Gammopathy of Renal Significance

Summary: this is an open-label, multicenter, phase 2 study in subjects with newly diagnosed monoclonal immunoglobulin deposition disease treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.

the current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed monoclonal immunoglobulin deposition disease. approximately 25 subjects will receive primary therapy with daratumumab-cybord. the primary endpoint is overall complete hematologic response (chr) rate at 6 months.

Eligibility criteria:
inclusion criteria: 1. diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment 2. ecog 0,1,2 3. neu≥ 1.0\*10\^9/l, hgb ≥70g/l, plt ≥ 50\*10\^9/l. 4. total bilirubin (tbil) ≤3×upper limit of normal (uln); aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤3.0×uln; 5. informed consent explained to, understood by and signed by the patient. exclusion criteria: 1. prior therapy for midd, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid) 2. fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma. 3. presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; 4. severe or persistent infection that cannot be effectively controlled; 5. presence of severe autoimmune diseases or immunodeficiency disease; 6. patients with active hepatitis b or hepatitis c (\[hbvdna+\] or \[hcvrna+\]); 7. patients with hiv infection or syphilis infection; 8. any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Keywords: daratumumab bortezomib monoclonal immunoglobulin deposition disease
evaluation of the effectiveness, safety, and cost of a smart hospital system for patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study aims to analyze the effectiveness/safety/cost of the smart homespital system that provides a service that allows patients with chronic obstructive pulmonary disease to easily access and use biosignals generated using biosignal collection medical equipment at home.


Eligibility criteria:
inclusion criteria: patients diagnosed with copd who meet the following pulmonary function test results: 1. pre fev1 \< 80% \*\*or\*\* 2. pre fvc \< 80% \*\*or\*\* 3. dlco \< 60% exclusion criteria: 1. patients who do not agree to participate in the study. 2. patients who fail to use the medical device equipment. 3. patients where tracking during the study period is expected to be impossible. 4. patients who have difficulty communicating verbally. 5. patients who are bedridden or unable to exercise at all due to severe cardiorespiratory dysfunction. 6. patients receiving hospital-centered rehabilitation treatment during the study period.

Keywords: copd