Kornimate/medical-research-clean huggingface dataset:
safety study of use of autologous bone marrow derived stem cell in treatment of age related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: the purpose of this phase i/ii study is to investigate the safety and preliminary efficacy of unilateral intravitreally transplantation of adult bone marrow stem cells in subjects with geographic atrophy secondary to age-related macular degeneration.

this study is an open-label investigation of the safety and preliminary efficacy of unilateral intravitreal injection of autologous bone marrow stem cells in subjects with geographic atrophy secondary to age-related macular degeneration (amd). subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals. human central nervous system -stem cells will be transplanted by a vitreoretinal surgeon. the transplantation will be conducted in the eye with the inferior best-corrected visual acuity (bcva) (i.e., the study eye). only the study eye will undergo transplantation. the adult bone marrow stem cells will be administered into the vitreous cavity through a standard surgical approach. moxifloxacin 300 mg(once per day ) will be administered orally to all subjects for a period of five days ( 2 days pre and post operatively) . subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection .

Eligibility criteria:
inclusion criteria: * diagnosis of age-related macular degeneration with geographic atrophy (ga) * only patients with a specific degree and extent of ga will be eligible * subjects with best-corrected visual acuity (bcva) of less than or equal to 20/400 in the study eye * no prior or current choroidal neovascularization in either eye * able to provide written informed consent prior to any study related procedures * agree to comply in good faith with all conditions of the study and to attend all required study visits exclusion criteria: * prior vitreal or retinal surgery in the previous 6 months * glaucoma * atrophic macular disease of any other cause * diabetic retinopathy or diabetic macular edema in either eye * previous organ, tissue or bone marrow transplantation * autoimmune disease * allergy to moxifloxacin * current or prior malignancy (or is on chemotherapy)

Keywords: adult bone marrow stem cells amd
effectiveness and tolerability of eqwilate in real-life conditions

Conditions: VWD - Von Willebrand's Disease

Summary: modalities of use, effectiveness and tolerability of eqwilate® a balanced combination of vwf and fviii in von willebrand patients in real-life conditions: the one-to-one study


Eligibility criteria:
inclusion criteria: the study will involve patients (≥ 6 years of age) from the participating centres treated with eqwilate® (either on-demand, as perioperative prophylaxis, or as prophylaxis) during the time inclusion period will be opened. patients will be of any vwd type, previously treated or untreated. exclusion criteria: * n/a
3d mre-based evaluation of meningioma mechanical properties and histological features

Conditions: Meningioma

Summary: this prospective single-center study aims to evaluate the feasibility and clinical utility of three-dimensional magnetic resonance elastography (3d mre) in assessing tumor stiffness and adhesion in patients with meningioma undergoing surgical resection. by correlating preoperative mre-derived stiffness and adhesion maps with intraoperative findings and histopathological features, the study seeks to determine whether mre can serve as a noninvasive imaging biomarker for surgical planning, risk stratification, and prediction of tumor behavior.

meningiomas are the most common primary intracranial tumors and are often surgically resectable. however, the intraoperative texture and adhesion of the tumor to surrounding structures vary widely and directly impact the surgical approach, difficulty, and outcomes. current preoperative imaging lacks the ability to quantitatively assess biomechanical properties such as stiffness and adhesion, which are critical for neurosurgical planning. this prospective clinical trial investigates the application of 3d magnetic resonance elastography (mre) in characterizing the biomechanical properties of meningiomas. specifically, it aims to quantify tumor stiffness and adhesion using mre-derived shear modulus maps and correlate these measurements with intraoperative surgeon-assessed stiffness/adhesion scores and postoperative histopathology. the study will also assess the diagnostic performance of mre in predicting challenging resections, high tumor adhesion, and histological subtypes. approximately 300 patients with radiologically confirmed meningioma scheduled for elective resection will be enrolled. participants will undergo standard mri and additional 3d mre scanning. intraoperative findings including tumor stiffness, adhesion, blood supply, and resection difficulty will be systematically recorded. postoperative pathological analysis will include tumor grade and histological subtype. statistical analyses will evaluate correlations, diagnostic accuracy, and potential prognostic value. findings from this study may support the use of 3d mre as a valuable noninvasive tool in preoperative assessment of meningiomas, helping optimize surgical strategies, reduce complications, and inform treatment decisions.

Eligibility criteria:
inclusion criteria: * all patients undergoing meningeoma resection surgery are eligible for inclusion in the study cohort. exclusion criteria: * patients with metallic implants or foreign bodies in their bodies (pacemakers, artificial metallic heart valves, metal joints, metal implants, and those who can not remove dentures, insulin pumps, or contraceptive rings) * pregnant women in the first trimester (within three months) * patients with severe claustrophobia or anxiety * patients with severe fever * patients who can not tolerate mre * patients with vascular malformations and aneurysms. * patients who do not sign an informed consent

Keywords: magnetic resonance elastography meningioma stiffness adhesion neurosurgery
sitagliptin and pioglitazone mechanism of action study in type 2 diabetes mellitus (0431-061)

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: a clinical study to determine the safety, efficacy and mechanism of action of sitagliptin alone and in combination with pioglitazone, in patients with type 2 diabetes mellitus who have inadequate glycemic (blood sugar) control.


Eligibility criteria:
inclusion criteria: * patient has type 2 diabetes mellitus * male * female that is highly unlikely to become pregnant * patient is not on an antihyperglycemic agent (aha) (hemoglobin a1c \[a1c\] 7-10%) or on oral single aha or low-dose combination therapy (a1c 6.5-9.0%) exclusion criteria: * patient has a history of type 1 diabetes mellitus or a history of ketoacidosis * patient has required insulin therapy within the past 12 weeks * patient is on or has been taking a peroxisome proliferator-activated receptor-gamma (ppar -gamma) agent (i.e. thiazolidinediones \[tzds\]) within the prior 12 weeks of the screening visit.

Keywords: type 2 diabetes mellitus (t2dm)
cerebral regional oxygenation with manual versus autoflow ventilation

Conditions: Oxygen Deficiency

Summary: anesthesia induction is associated with hemodynamic imbalances that can affect the blood flow to major organs. moreover it can result in deoxygenation as well. during standard anesthesia induction the patient is manually ventilated with a circle-valve-mask system until the effect of muscle relaxant shows of. near-infrared spectroscopy (nirs) is a modification of a well-known peripheral pulse oxymetry that is used in the detection of the regional oxygen saturation (rso2) in organs, including brain, liver, muscle, and intestines. in this study we will compare the regional oxygenation status of the patients during anesthesia induction in which either standard manual ventilation or mechanical ventilator-assisted ventilation was performed. autoflow(r) mode of draeger-perseus mechanical ventilator will be used for the ventilator-assisted ventilation.


Eligibility criteria:
inclusion criteria: * american society of anaesthesiologists (asa) physical status i-ii exclusion criteria: * asa iii or above * congenital or traumatic brain injury * allergy to nirs probe material * cardiac or vascular disease, including heart failure or hypertension * difficult mask ventilation and difficult intubation * thoracic surgery * head and neck surgery * emergency surgery * obesity
phase 3 clinical trial of periodontal tissue regeneration using fibroblast growth factor-2(trafermin)

Conditions: Periodontitis; Alveolar Bone Loss; Periodontal Attachment Loss

Summary: this study aims to verify the effectiveness of trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.


Eligibility criteria:
inclusion criteria: * probing pocket depth 4mm or deeper * vertical intrabony defect 3 mm or deeper from radiographs at baseline * mobility of tooth 2 degree or less exclusion criteria: * using an investigational drug within the past 24 months * coexisting malignant tumour or history of the same * coexisting diabetes (hba1c 6.5% or more) * taking bisphosphonates * coexisting gingival overgrowth or history of the same
orthopaedic implant removal

Conditions: Implant Complication; Complication, Postoperative; Implant Site Infection

Summary: the necessity of orthopedic implant removal is under intense discussion and even if it is performed as an elective procedure, the risk of complications is present. aim of the study is to identify parameters responsible for an increased risk of early post-operative complications after elective aseptic orthopedic implant removal.


Eligibility criteria:
inclusion criteria: elective aseptic orthopaedic implant removal exclusion criteria: arthroplasty present infection
injectable collagen scaffold™ combined with huc-mscs for the improvement of erectile function in men with diabetes

Conditions: Erectile Dysfunction; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: the intent of this clinical study is to answer the questions: 1) is the proposed treatment feasible; 2) is treatment effective in improving the disease pathology of patients with diagnosed diabetic erectile dysfunction.


Eligibility criteria:
inclusion criteria: 1. type 1 or 2 diabetes,blood glucose controlled well, no effective with oral pde-5i 2. have a consistent partner who is willing to engage in sexual activity more than twice per month during the study 3. males, age 20-65 years 4. iief-5 score is under 16 5. penile arterial insufficiency or venous leakage (doppler): peak systolic velocity（psv） \ 25 cm/sec, end-diastolic velocity（edv）\> 5cm/sec, resistance index（ri）\<0.75 6. hba1c is between 6.5%-10% 7. physical examination with no abnormalities 8. willing to consent to participate in the study follow-up 9. willing to limit alcohol intake eliminate use of recreational drugs for sexual encounters. exclusion criteria: 1. severe cardiovascular disease (angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure; history of malignancy 2. positive for human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv) syphilis test 3. testosterone level is less than 200ng/dl 4. serum ast/alt \>3\*upper limit of normal or creatinine \>1.5\*upper limit of normal 5. hba1c exhibit greater than 10% 6. in the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery 7. patients partner is trying to conceive during the trial period 8. exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study 9. unwilling and/or not able to give written informed consent
observational study on the patient's ability to use a digital platform in heart failure

Conditions: Heart Failure

Summary: heart failure has a global prevalence of 1 to 3% in the adult population with an incidence of 1 to 20 cases per 1,000 people. furthermore, hf is often associated with a number of comorbidities (anaemia, arrhythmias, depression, hyperuricemia, coronary heart disease etc.), which greatly deteriorates the patient's quality of life. despite the development of specific drugs, hf has a very high mortality rate, and it is the first cause of unscheduled income. an increase of 50% of these incomes is expected in the next 25 years. in this context, the use of digital tools/platforms that allow remote monitoring of patients and that facilitate telemedicine have shown potential to improve treatment adherence and facilitate continued therapeutic education, improving clinical results with savings in time and associated costs. this study focuses on studying the ability of heart failure patients with reduced ejection fraction (ef≤40%) to use a digital platform through an application installed on the patient's smartphone.

this is an observational, prospective, single-center study. the protocol and informed consent document have been reviewed and approved by the ethical committee and the study will be performed in accordance with the declaration of helsinki

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * informed consent is obtained from the patient * patients diagnosed with heart failure with reduced ejection fraction (ef≤40%) * patients who extensively use a smartphone. exclusion criteria: * patients who will not be able to commit to carrying out the follow-ups or do not have adequate technological skills. * patients with inability to give adequately the informed consent.

Keywords: heart failure caaring dtx real-world data digital health remote patient monitoring
the effect of chiropractor-informed triage on low back pain patient outcomes and trajectories

Conditions: Low Back Pain; Triage

Summary: almost everyone will have low back pain (lbp) at some point in their lives. lbp is a complex multifactorial condition for which diagnosis and clinical management remains a challenge. factors such as wait times, delays in diagnosis or proper referral can result in canadian patients having difficulty getting the care that they need. the overall objective of this project is to explore how chiropractors, who specialize in the diagnosis and clinical management of spinal conditions, can transform healthcare trajectories and improve the health of patients with lbp by integrating medical specialist team.to do so, patients with low back pain seeking medical care within the public health system will be first seen by chiropractors. chiropractors will play a key role in identifying the type of low back pain and subsequently offering guidance to medical specialists with regard to the best treatment and management options that are currently recommended. participating patients will be followed over a year while extensive health-related data will be collected and compared to non-triage patients with lbp.


Eligibility criteria:
inclusion criteria: * being ≥ 18 years of age * being scheduled in the outpatient clinics with a primary complaint of lbp (either acute, chronic or recurring episodes), consistent with lbp definition (pain between the lower rib margins and the buttock creases, with or without associated symptoms in the lower limb(s)). * being able to comprehend and express oneself in french exclusion criteria: * patients involved in litigation related to their lbp condition (i.e., worker's compensation, public automobile insurance plan or other litigations)

Keywords: low back pain triage care pathways chiropractor pain disability health resources
artificial intelligence in diagnosing dysphagia patients

Conditions: Respiration Disorders; Swallowing Disorder; Phonation Disorder; Stroke; Aspiration Pneumonia; Aspiration; Liquids

Summary: in this prospective study we extracted acoustic parameters using praat from patient's attempt to phonate during the clinical evaluation using a digital smart device. from these parameters we attempted (1) to define which of the praat acoustic features best help to discriminate patients with dysphagia (2) to develop algorithms using sophisticated ml techniques that best classify those i) with dysphagia and those ii ) at high risk of respiratory complications due to poor cough force.

this study was prospective study, and patients who visited the department of rehabilitation medicine in a single university-affiliated tertiary hospital with dysphagic symptoms from september 2019 to march 2021 were included.voice recording was performed at the enrollment with blinded assessment, where the participants first visited the rehabilitation department with chief complaints of dysphagia. the cough sounds were recorded with an ipad (apple, cupertino, ca, usa) through an embedded microphone. from the acoustic files we extracted fourteen voice parameters that include the average value and standard deviation of the fundamental frequency (f0), harmonic-to-noise ratio (hnr), the jitter that refers to frequency instability, and the shimmer that represents the amplitude instability of the sound signal. machine learning algorithms and sophisticated deep neural network analysis will be performed.

Eligibility criteria:
inclusion criteria: - inclusion criteria 1. suspected swallowing disorder who were referred for swallowing assessment 2. dysphagia attributable to brain lesion including stroke exclusion criteria: 1. participants who were unable to perform phonation 2. participants who had no vfss or standardized swallowing assessment results 3. participants with no spirometric measurements
clinical outcome after close rectal ileo pouch anal anastomosis for colitis ulcerosa(cu)

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to investigate a new technique: close rectal dissection (crd) as restorative surgery for ulcerative colitis patients: the close rectal ileo pouch anal anastomosis (cr-ipaa). clinical outcome and quality of life will be compared to the conventional ileo pouch anal anastomosis (c-ipaa) and the ileo neo rectal anastomosis (inra).

ulcerative colitis (uc) is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. the surgery rate after 10 years is 30%. after (sub)total colectomy with end ileostoma patients have a choice for restorative surgery. the conventional ileo pouch anal anastomosis (c-ipaa) is the gold standard of reconstructive surgery. this is al well established technique, but still carries a significant morbidity-rate. the recent studied ileo neo rectal anastomosis (inra) has shown to reduce reservoir-related complications with a similar functional outcome, but is a very laborious technique. therefore, we want to investigate an alternative technique: the close rectal ileo pouch anal anastomosis (cr-ipaa). the cr-ipaa is conducted in the nonanatomic perimuscular plane, resulting in a reduction of reservoir-related complications. after the close rectal dissection an ileo-anal pouch anastomosis will be constructed in a similar way. the close rectal dissection (crd) is very laborious and has therefore never been developed extensively. but recent technical development of electrothermal bipolar vessel sealer (ebvs ) and ultrasound dissection have enhanced the crd technique enormously. this brought along new interest in the crd and justifies the research of its application.

Eligibility criteria:
inclusion criteria: * uc patients with the crd procedure with written informed consent. * age, sex and disease specific matched control group op uc-ipaa patients with written informed consent. exclusion criteria: * pregnancy * malignancy * psychiatric disease or inability to assess follow-up
compare the agility exercise and resistance exercise on physical function and stability in osteoporotic women

Conditions: Postmenopausal Osteoporosis; Agility Exercise; Physical Function; Balance Stability; Fall Prevention

Summary: osteoporosis weakens bones with age, increasing fracture risk. exercise improves physical function and reduces falls, crucial for preventing osteoporotic fractures, especially with balance, resistance, and multi-component training. agility exercise, integrating various aspects like aerobic, strength, balance, and cognitive tasks, is promising for fall prevention in older adults, though its effectiveness in osteoporosis is not extensively studied. this study compares agility and resistance exercise impacts on physical function and balance stability in postmenopausal osteoporosis. fifty-one women (average age: 68±6.3y, bmi: 22.3±2.7 kg/m2) were divided into agility exercise (ag), resistance exercise (rg), and control groups (cg) through purposive sampling. ag and rg received added intervention training once a week for 2 hours over 12 weeks. main outcomes included physical function and balance stability measured through various tests.

main activities of agility training group (ag): use rope ladders and cones to perform multiple tasks of direction changes, acceleration and deceleration of footsteps, hand and foot coordination and spatial orientation training. main activities of resistance training group (ag): resistance training for upper and lower limb muscles and core muscles, including squats, use of elastic bands, and simple bars.

Eligibility criteria:
inclusion criteria: * women with osteoporosis( diagnosed with dxa, t-score≦-2.5 in l-spine or hip) * postmenopausal, more than 50 years old, exclusion criteria: * unable to attend the training sessions due to physical problems * had joined previous exercise program

Keywords: postmenopausal osteoporosis agility exercise physical function multi-component exercise fall prevention
efficacy & safety of inhaled insulin in type 1 diabetes

Conditions: Diabetes, Type I

Summary: to determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 diabetes for at least 1 year * nonsmokers for prior 6 months * bmi less than or equal to 35kg/m2 * hba1c \> or = 7% and \< or = 11% * serum creatinine \< or = 1.8 mg/dl in female subjects and \< or = 2.0 mg/dl in male subjects * fev1 \> or = 70% of predicted, dlco \> or = 70% , tlc \> or = 80% predicted * maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day * urine cotinine \< or = 100 ng/ml exclusion criteria: * history of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings * evidence of severe complications of diabetes * aminotransferase and/or alanine aminotransferase \> than 3 times the upper limit of normal
cataract surgery in indian patients with or without lensx® laser

Conditions: Cataracts

Summary: the purpose of this study is to record and analyze the profile and outcome of cataract patients receiving phacoemulsification (phaco) and artificial intraocular lens (iol) implantation with or without femtosecond laser-assisted cataract surgery (flacs) in indian tertiary medical centers.

legitimate patients will receive standard of care (soc) phacoemulsification treatment for cataract and iol implantation, with or without using lensx® technology, with followup for 1 month using soc postsurgical treatment.

Eligibility criteria:
inclusion criteria: * agree to undergo phacoemulsification cataract surgery in at least 1 eye; * understand and sign an informed consent form; * other protocol-specified inclusion criteria may apply. exclusion criteria: * refuse to sign the informed consent form or have incomplete medical records; * contraindications for phacoemulsification treatment per investigator discretion or listed in lensx® operator's manual; * contraindications for anterior capsulotomy, phacofragmentation of the lens using the flacs; * other protocol-specified exclusion criteria may apply.