Kornimate/medical-research-clean huggingface dataset:
non-operative versus operative treatment for high-energy midshaft clavicle fractures

Conditions: High Energy Midshaft Clavicle Fractures

Summary: clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. there is no evidence to date that either option in superior. for this reason, we propose to conduct a prospective, randomized clinical trial of surgical versus non-surgical treatment of displaced high-energy clavicle fractures. this study will use both objective clinical and patient-based outcome measures. the purpose of this study is to see if there is a difference between clinical outcomes (healing rate, time to healing, time to return to work, constant score, complications), functional outcomes (dash score), and health related quality of life (sf-36) in nonoperative care and two types of surgical care for displaced fractures of the clavicular shaft in adults. included patients will be randomized into one of three groups: nonoperative care (group n); surgical care using plates and screws (group p); and surgical care using intramedullary pin put inside of the clavicle to stabilize it (group i).


Eligibility criteria:
inclusion criteria: * ages of 18 and 85 * a midshaft clavicle fracture * fracture displaced the width of the clavicle or shortened at least 1.5 cm * less than 21 days since the injury exclusion criteria: * injury involving the lateral ligaments * fracture involve the sternoclavicular joint * pathologic fracture * open fracture * fracture with neurovascular compromise * displaced fracture with impending skin compromise * medical comorbidities that preclude surgery * associated injuries to ipsilateral shoulder girdle * severe cognitive disability or injury that may inhibit study form completion
combined use of multiple biomarkers with stress testing to detect coronary artery disease

Conditions: Coronary Artery Disease

Summary: main aim of the combat-cad-study is to clarify, if the combination of stress testing with biomarkers improves the diagnostic accuracy. hypothesis of our study is that diagnosis of cad can be improved by adding biomarkers to solely stress testing for the workup of patients with suspected cad or progress of already known cad.

the combat-cad study is an observational study with the aim to improve the diagnostic accuracy by a combination of stress testing with sensitive and specific biomarkers in detecting coronary artery disease or its progress. the main subjects are all patients with cad or suspicion of cad sent to the university heart center hamburg. in these patients, ecg, laboratory examination, symptoms or transthoracic echocardiography in rest could not rule out cad or progress of known cad. the hypothesis of the study is that detection of cad can be improved by adding biomarkers to stress testing for the diagnostic workup of patients with suspected cad or progress of already known cad.

Eligibility criteria:
inclusion criteria: 1. every patient referred to coronary angiography, or diagnostic work-up with suspicion of cad or progress of cad (in case of cabg patients or already treated with pci) exclusion criteria: 1. insufficient knowledge of the german language (able to understand and write the german language) 2. physical or psychological incapability to take part in the investigation 3. persons with no sufficient language ability in german to understand the provided study information material.
paradigm shift in the treatment of patients with acs

Conditions: Acute Coronary Syndrome

Summary: this protocol describes a pilot study intended to test the hypothesis that patients with acute coronary syndrome (acs) caused by plaque erosion can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (pci).


Eligibility criteria:
inclusion criteria: * men or non-pregnant women \>18 years of age and \< 75 years of age * patients undergo cardiac catheterization for acs. patients with stemi, nstemi, and uap will be included. stemi will be defined as continuous chest pain for \>30 minutes, arrival at the hospital within 12 hours from chest pain onset, st-segment elevation \>0.1 mv in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ecg), and elevated cardiac markers (troponin t/i or creatine kinase-mb). nstemi will be defined as a progressive crescendo pattern of angina or angina at rest, in the absence of st-segment elevation on the 12-lead ecg, with elevated cardiac markers. uap will be defined as new onset angina, progressive crescendo pattern of angina, or angina at rest. * culprit lesion located in a native coronary artery * timi flow grade 3 and diameter stenosis \< 70% on angiogram * definite erosion defined by oct * patients able to provide written informed consent exclusion criteria: left ventricular ejection fraction \< 30%. * life expectancy \< 1 year. * contraindication to the contrast media. * creatinine level \> 2.0 mg/dl or end-stage kidney disease. * serious liver dysfunction. * patients with hemodynamic or electrical instability (including shock). * any contraindication against the use of ticagrelor. * investigator considers the patient is not suitable.
efficacy and safety of concurrent chemoradiotherapy with oral vinorelbine in patients with non-small cell lung cancer

Conditions: Vinorelbine

Summary: to evaluate the efficacy and safety of concurrent chemoradiotherapy with oral vinorelbine, and immune maintenance therapy in patients with unresectable stage iii non-small cell lung cancer after neoadjuvant chemo-immunotherapy, with a view to providing an effective treatment regimen for these patients.

patients with unresectable stage iii non-small cell lung cancer after neoadjuvant chemo-immunotherapy are enrolled to receive concurrent chemoradiotherapy with oral vinorelbine, and immune-maintenance therapy. the primary endpoint is objective response rate, and secondary endpoints include disease control rate, progression-free survival, compliance and safety.

Eligibility criteria:
inclusion criteria: 1. age ≥40 years old. 2. patients must have histologically or cytologically confirmed non-small cell lung cancer. 3. ecog ps was 0 or 1. 4. adequate organ and bone marrow function is present. absolute neutrophil counts, platelet counts, and hemoglobin criteria must not be met after blood transfusion or growth factor support within 14 days prior to randomization. exclusion criteria: 1. history of allogeneic organ transplantation. 2. active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease \[colitis or crohn's disease\], diverticulitis \[other than diverticulitis\], systemic lupus erythematosus, sarcoidosis syndrome, wegener syndrome \[granulomatous vasculitis, graves' disease, rheumatoid arthritis, pituitaritis, uveitis\]). 3. there is uncontrolled serious underlying diseases, including active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled arrhythmia, active interstitial lung disease, and severe chronic gastrointestinal disease. 4. history of another primary malignancy. 5. history of active primary immunodeficiency. 6. histological findings showed mixed small cell lung cancer and non-small cell lung cancer. 7. for any unmitigated toxicity during pre-study chemoradiotherapy. patients who develop irreversible toxicity and are reasonably expected not to worsen after study treatment (such as hearing loss) may enter the study after consultation with the study physician. 8. patients who developed ≥ grade 3 pneumonia during study chemoradiotherapy. 9. received any other concurrent chemotherapy, immunotherapy, biotherapy, or hormonal therapy for cancer other than the therapy evaluated in this study.
allogeneic wharton jelly mesenchymal stromal cell (wjmsc) for treatment of autism

Conditions: Autism

Summary: autism spectrum disorders (asds) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.

autism spectrum disorders (asds) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. asds comprise heterogeneous and complex neuro-developmental pathologies with well-defined inflammatory conditions and immune system dysfunction. due to neurobiological changes underlying asd development, cell-based therapies have been proposed and applied to asds. indeed, stem cells show specific immunologic properties, which make them promising candidates for asd treatment.

Eligibility criteria:
inclusion criteria: * 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (asd exclusion criteria: * age \> 14 years. * patient weighing \< 10 kg. * history of severe allergy * history of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke. * seizure within the last year before enrollment, or the need for seizure medications either at present or in the past. * evidence or history of severe, moderate, or uncontrolled systemic disease. * inability to follow the prescribed dosing and follow-up schedule. * use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (adhd) must be discontinued 7 days before the initial randomized study period. * subjects taking a selective serotonin reuptake inhibitor (ssri) must be on a stable dose for a minimum of 30 days before entering the study. * history of premature birth \<35 weeks' gestation. * prior history of stroke in utero or other in utero insult.

Keywords: autism wjmsc
photobiomodulation therapy on pain and range of motion following flexor tendon repair

Conditions: Photobiomodulation Therapy; Low Level Laser Therapy; Flexor Tendon Rupture; Flexor Tendon Repair

Summary: the purpose of the study was to evaluate the therapeutic effect of low-level laser in improving pain and rom following flexor tendon repair surgery.

flexor tendon injury is a common issue requiring early postoperative mobilization. prolonged immobilization can lead to complications such as muscle atrophy, joint stiffness, osteoarthritis, infection, pain, joint cartilage ulceration, joint contracture, and tendon rupture. low level laser therapy has been shown to accelerate inflammation, promote fibroblast proliferation, regulate procollagen messenger ribonucleic acid synthesis, accelerate bone repair and remodeling, encourage wound revascularization, and accelerate tissue repair. this study aims to evaluate the effectiveness of low level laser therapy in pain management and improving range of motion after flexor tendon repair.

Eligibility criteria:
inclusion criteria: * forty-four patients of both genders with age ranged between 20 to 50 years will participate in this study. * all patients with zone ii and iii flexor tendon injuries, will be suffered from pain following flexor tendon repair surgery. * all patients with zone ii and iii flexor tendon injuries, will be suffered from limitation of range of motion deficiency following flexor tendon repair surgery * all patients enrolled to the study will have their informed consent. exclusion criteria: * a wound in the affected area * rheumatoid arthritis. * epilepsy or any psychological disorders * myelopathy or radiculopathy * exposed hand tendons. * concomitant finger fractures, joint injuries, replantation or revascularizations, extensor tendon injury or crush injuries. * impairment of cognitive, perceptual or psychological function that would impede ability to follow verbal instruction. * multiple injuries to one flexor tendon, simultaneous injuries to bone and extensor tendons, skin loss, noncompliant patients or patients under 10 years, and gross contaminations of wounds. * patients with tendon repair associated with a skin graft, nerve injury, arterial injury, systemic disease (e.g. diabetes mellitus), wound infection,
safety and feasibility of the tandem snare device

Conditions: Polyps

Summary: the device is intended to endoscopically transect polyps in the gastrointestinal tract (sessile or pedunculated) using electrocautery. during the same maneuver the polyp is captured, retrieved and submitted for pathological analysis. the tandem snare is an intervention tool inserted through the colonoscope for the resection and removal of polyps sized 6 to 25 mm. the tandem snare utilizes a technology that has the potential to hold the polyp, lift it up, resect and remove it without losing it. this is a feasibility study aiming to demonstrate the safety of the tandem snare used for 6-25mm polyps' polypectomy in screening, diagnostic or surveillance colonoscopy.

the colonoscopy procedure is considered the "gold standard" for detecting, diagnosing and treating abnormalities in the colon. detection and removal of colon polyps is the most significant benefit colonoscopy provides toward the reduction of colorectal cancer mortality and morbidity. the tandem snare is an intervention tool inserted through the colonoscope for the resection and removal of polyps sized 6 to 25 mm. the tandem snare utilizes a technology that has the potential to hold the polyp, lift it up, resect and remove it without losing it. the technology may eliminate the repeated bites with the intervention tool or the need to use additional intervention tools such as the net. it may improve visual perception for resecting the polyp without losing it while removing from the colon. consequently it may increase the potential for complete polypectomy and reduce intervention time and repetitions, polyp lost, risks and cost. this is a feasibility study aiming to demonstrate the safety of the tandem snare used for 6-25mm polyps' polypectomy in screening, diagnostic or surveillance colonoscopy.

Eligibility criteria:
inclusion criteria: 1. adults \> 18 years 2. subjects have been scheduled for colonoscopy 3. subject has signed the informed consent exclusion criteria: 1. suspected or known active inflammatory bowel disease (ibd) 2. coagulopathy or thrombocytopenia. 3. taking dual anti platelet therapy or anti coagulants. 4. bowel preparation is deemed poor by colonoscopist. 5. subjects with known or detected (during colonoscopy) moderate/severe diverticular disease. 6. history of familial polyposis (fap). 7. history of prior surgery to colon and/or rectum. 8. asa ≥ iv. 9. pregnancy (as stated by patient). 10. subjects with altered mental status/inability to provide informed consent. 11. patients who have participated in another interventional clinical study in the last month. 12. subject under a condition which in the investigators opinion may put the subject at significant risk, confound study results, or interfere significantly.
development of a telephone-based continuation treatment for patients with chronic depression.

Conditions: Chronic Depressive Disorder

Summary: there is a high risk for relapse in people suffering from depression. studies indicate that the continuation of an acute psychotherapeutic treatment can reduce the likelihood of relapse. therefore, this pilot study is aimed to investigate the feasibility of a continuation psychotherapy over 6 months, to support people suffering from chronic forms of depression in their daily life. the investigated continuation therapy itself includes about one telephone call per month (therapist - patient), focussing on the integration of strategies into the patient's daily routine. the patients receive either 30 minutes or 50 minutes phone calls. on the one hand, these phone calls are supported by a workbook for patients containing psychoeducative elements, strategies and exercises. on the other hand, the therapist's work is based on a manual containing several modules and strategies. both tools (workbook, manual) are understood as a framework, using the appropriate sections according to the patient's needs. as a result, the patients receive a continuation treatment which is appropriate and adapted to their individual situation. the main purpose of this pilot study is to evaluate the feasibility of a telephone based psychotherapeutic continuation treatment with a small sample of 20 patients suffering from chronic depression. in case of promising results the effectiveness of this kind of treatment is going to be investigated within a comparative trial (including face-to-face intervention, no intervention).


Eligibility criteria:
inclusion criteria: * written informed consent * diagnosis of chronic (300.4) or recurrent (296.31-3) depression (according to the diagnostic and statistical manual of mental disorders, fifth edition) * currently in partial or full remission * previous psychotherapy (acute treatment; some kind of cognitive-behavioral therapy) * adequate knowledge of german language * in case of taking antidepressants: long-term and stable dosage (with unchanged taking since 3 months at least) exclusion criteria: * acute suicidality * psychotic symptoms * severe cognitive impairments * in case of taking antidepressants: anticipated stopping medication within treatment period (6 months)

Keywords: depression, chronic, psychotherapy, telephone, feasibility
carotegrast methyl in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: carotegrast methyl, an oral α4-integrin inhibitor, was recently approved in japan for the treatment of active ulcerative colitis (uc). however, real-world data regarding its efficacy and safety remain scarce. this study aimed to assess the clinical effectiveness and safety profile of carotegrast methyl in patients with active uc.


Eligibility criteria:
inclusion criteria: * patients diagnosed with uc based on endoscopic and histological findings * patients with clinically and endoscopically moderate uc who were eligible for outpatient treatment (however, patients in clinical remission or with mild clinical activity but endoscopically moderate uc were also considered eligible as an exception) * patients who exhibited an inadequate response to or intolerance of 5-asa formulations (including topical agents) or budesonide formulations (including topical agents) * patients who provided informed consent for endoscopic examinations at the start of treatment and during the treatment period * patients who agreed to blood sampling and fecal biomarker tests exclusion criteria: * patients with severe disease on endoscopy (presumed ineffective due to the drug's characteristics) * patients currently using biologics, jak inhibitors, thiopurines, or calcineurin inhibitors (tacrolimus or cyclosporine) * patients with a history of malignancy * patients with severe hepatic dysfunction * pregnant women or those planning pregnancy * patients with acute severe conditions, such as toxic megacolon, sepsis, peritonitis, or infectious colitis
gabapentin for the treatment of tinnitus

Conditions: Tinnitus

Summary: the specific aim of the gabapentin for the relief of idiopathic subjective tinnitus trial is to assess the therapeutic benefit of gabapentin (neurontin®) for subjective idiopathic troublesome tinnitus. we employed a double-blind placebo-controlled randomized clinical trial design to assess the efficacy of gabapentin. adults, between the ages of 18 and 70 with idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater and score of 38 or greater on the tinnitus handicap inventory were enrolled.


Eligibility criteria:
inclusion criteria: * adults, between the ages of 18 and 70 * idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus (icd-9 --388.31) of 6 month's duration or greater * tinnitus handicap score of 38 or greater on the tinnitus handicap inventory. exclusion criteria: * the symptoms of tinnitus can be affected by the concomitant use of tricyclic antidepressants, carbamazepine, phenytoin, valproate sodium, or benzodiazepines. patients who have used these drugs within 30 days of screening will not be enrolled. * impaired renal function as determined from serum creatinine levels, using the following formulas35: adult male ccr = (140 -age) x weight in kilograms/(72 x serum creatinine in milligrams per deciliter); and adult female ccr = \[(140 - age) x weight in kilograms/(72 x serum creatinine in milligrams per deciliter)\] x 0.85,whereccr indicates creatinine clearance. * patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone * patients with any serious or unstable medical or psychiatric condition. * patients whose ability to give informed consent is in question.
botox® drug use investigation (spasmodic dysphonia)

Conditions: Dysphonia

Summary: this study is a drug use investigation program of botox. the objective of this investigation is to collect and assess information on the safety and efficacy of botox injections in subjects with a diagnosis of spasmodic dysphonia in daily clinical practice. all subjects treated with botox for spasmodic dysphonia after obtaining approval for the indication of botox for spasmodic dysphonia will be included in this study. approximately 400 subjects will be included in the study. the observation period per subject will be up to 12 months from the date of the first administration of botox. the total study duration will be will be approximately 3 years from the date of approval for the indication of botox for spasmodic dysphonia. botox is a registered trademark of allergan, inc.


Eligibility criteria:
inclusion criteria: * all subjects treated with botox for spasmodic dysphonia after obtaining approval for the indication of botox for spasmodic dysphonia are included in this study. exclusion criteria: * not applicable

Keywords: spasmodic dysphonia vhi-10 scores botox drug use investigation
pilot trial of valproate as adjunctive treatment for toxoplasma gondii infection in early course schizophrenia

Conditions: Toxoplasmosis; Schizophrenia

Summary: this is an exploratory study in egypt that will combine a treatment trial among early course schizophrenia (ecsz) patients with key analyses suggested by rodent studies. specifically, the study will test the provocative results from animal studies indicating an impact of toxoplasma gondii (tox) exposure on novelty seeking. the study will also test whether exposure to tox is associated with other cognitive and behavioral changes, as well as changes in overall social function. we will also explore the relative efficacy of sodium valproate (depakote, dep) in improving clinical and overall social function among tox exposed and unexposed patients. hypotheses 1. at baseline, tox exposure is associated with increased novelty seeking, clinical severity, and impaired cognitive and overall social function in patients with sz. 2. adjunctive dep treatment improves clinical symptoms, cognitive and social function in sz, particularly among tox exposed sz patients. 3. exploratory hypothesis: adjunctive dep reduces serological indices of tox infection (vip and th levels).


Eligibility criteria:
inclusion criteria: * written informed consent * adult men or women (ages 18-50 years) * schizophrenia / schizoaffective disorder (dsm iv) * duration of illness \< 5 years (since onset of psychosis) * on a stable dose of an antipsychotic for at least a month * scores 4 or more on at least one item of the positive and negative syndrome scale. exclusion criteria: * substance abuse in the past month/dependence past 6 months * history of / or current medical/neurological illnesses e.g. mental retardation (dsm-iv) or epilepsy; * medical conditions that are judged by the consulting internist and research staff to be unstable * pregnant or breast-feeding women * known allergy or serious adverse event to dep, received chlorpromazine, trimethoprim or dep for up to 6 months prior to study entry.

Keywords: schizophrenia toxoplasmosis