Kornimate/medical-research-clean huggingface dataset:
an open, non-comparative, multicenter investigation to evaluate the safety and performance of exufiber ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds

Conditions: Pressure Ulcer; Diabetic Foot Ulcer; Venous Leg Ulcer

Summary: an open, non-comparative, multicenter investigation to evaluate the safety and performance of exufiber ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds

the overall objective of this post market clinical follow-up (pmcf) investigation is to confirm performance and safety of the exufiber ag+ dressing in medium to high exuding chronic wounds, with mepilex border flex as the secondary dressing, when used in accordance with the instructions for use.

Eligibility criteria:
inclusion criteria: 1. signed informed consent form 2. patient aged ≥18 years old 3. patient with moderate to high exuding chronic wound (pu (stage ii-iv), vlu or dfu) 4. patient with target wound that is a shallow to deep wound or cavity 5. patient with target wound that is ≥ 4 weeks in age 6. patient with target wound that is ≥ 8 cm2 exclusion criteria: 1. patient is contraindicated for the dressing according to product labeling 2. known allergy/hypersensitivity to any of the components of the investigation products 3. pregnancy/lactating female 4. patient with spreading soft tissue infection/cellulitis in the wound (as judged by the investigator) 5. patient with known immunodeficiency 6. patient taking systemic antibiotics 7. patient with the target wound located on an infected limb and/or interfered by minimal blood flow in the opinion of the investigator. 8. patient with the target wound with an unexplored enteric fistula 9. patient requiring treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide 10. patient who, in the opinion of the investigator, is not expected to comply with the investigation due to physical and/or mental conditions 11. patient who was previously enrolled in this investigation 12. patient participating in other investigations that would preclude the subject from participating in this investigation as judged by the investigator 13. patient involved in the planning and conduct of the clinical investigation (applies to all mölnlycke staff, investigational site staff, and third party vendor)
elnd005 long-term follow-up study in subjects with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of elnd005 beyond the 18 months of treatment in original randomized and blinded clinical trail elnd005-ad201.


Eligibility criteria:
inclusion criteria: * this study is open only to subjects who have completed the week 78 visit in study elnd005-ad201 while taking their assigned dose of study drug medication. exclusion criteria: * subject has no new medical contraindications to continued participation in the study.
caudal analgesia & anticoagulated patient

Conditions: Lumbar Pain Syndrome; Anticoagulants and Bleeding Disorders

Summary: caudal analgesia is an effective intervention for lumbosacral pain. some chronic pain patients take anticoagulants for vasculopathy treatment. anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. caudal analgesia may be safe and effective in anticoagulated chronic pain patients. quantitative analysis of prospective clinical data. evaluation of caudal analgesia efficacy and safety in anticoagulated chronic pain patients. analysis of outcome, and complications.

caudal analgesia is an effective interventional therapy for chronic lumbosacral pain. some chronic pain patients take anticoagulants for vasculopathy treatment. anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. anticoagulation may be discontinued briefly, to allow caudal injection. interruption of anticoagulation may be difficult and dangerous for some high-risk patients. caudal analgesia may be safe and effective in anticoagulated chronic pain patients. quantitative analysis of prospective clinical data. an evaluation of caudal analgesia safety in anticoagulated chronic pain patients. an analysis of treatment outcome, and complications.

Eligibility criteria:
inclusion criteria: * adult chronic pain patients who undergo caudal analgesia exclusion criteria: * chronic pain patients who refuse caudal analgesia

Keywords: caudal analgesia
safety and efficacy of hydrochlorothiazide in the treatment of hypernatremia in critically ill patients

Conditions: Hypernatremia; Critical Illness

Summary: hydra is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia


Eligibility criteria:
inclusion criteria: * hospitalized for intensive care, * over 18 years of age, * two serum sodium measurements above 145 meq / l (with no pre-determined interval between them), * mean arterial pressure greater than 65mmhg exclusion criteria: * absence of consent to participate in the study * cardiac index below 2.5l / min / m2 or signs of ineffective circulation (capillary filling time greater than 2 seconds, cold or sticky skin) or arterial lactate\> 4mmol / l. * use of vasopressors at doses greater than 0.1 mcg / kg / min of noradrenaline or with initiation or increase of dose within less than one hour before inclusion in the study. * unavailable enteral route. * use of hydrochlorothiazide in the last 7 days of icu admission. * history of allergy or intolerance to hydrochlorothiazide or other thiazides. * nephrogenic diabetes insipidus. * renal impairment kdigo 3 * indication of renal replacement therapy. * acute neurological insult. * heart failure american heart association classification (aha), class d. * liver cirrhosis child-pugh c. * pregnant women * exclusive palliative care * dying, with expected survival less than 48 hours

Keywords: hypernatremia critical care
olorinab in irritable bowel syndrome with predominant constipation (ibs-c) and irritable bowel syndrome with predominant diarrhea (ibs-d)

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to determine whether olorinab is a safe and effective treatment for abdominal pain in participants with irritable bowel syndrome (ibs).


Eligibility criteria:
main study inclusion criteria: * diagnosis of irritable bowel syndrome (ibs) with predominant constipation (ibs-c) or predominant diarrhea (ibs-d) according to rome iv criteria at visit 1 (screening) * per the rome iv diagnostic algorithm for ibs, participants 50 years of age and over are to have had one of the following with a result that rules out causes of abdominal pain other than ibs: 1. colonoscopy (within 10 years of visit 1 \[screening\]) 2. flexible sigmoidoscopy and double contrast barium enema (within 5 years of visit 1 \[screening\]) 3. computed tomography colonography (within 5 years of visit 1 \[screening\]) main study exclusion criteria: * diagnosis of ibs with mixed bowel habits (ibs-m) or unsubtyped ibs (ibs-u) * clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to visit 1 (screening) that may confound efficacy assessments in the clinical judgment of the investigator (or designee) * any colonic or major abdominal surgery (eg, bariatric surgery \[including gastric banding\], stomach surgery, small/large bowel surgery, or abdominal large vessel surgery). history of cholecystectomy is exclusionary for participants with ibs-d. for participants with ibs-c, a history of cholecystectomy more than 6 months prior to visit 1 (screening) is allowed. procedures such as appendectomy, hysterectomy, caesarean section, or polypectomy are allowed as long as they have occurred at least 3 months prior to visit 1 (screening). long-term extension inclusion criteria: •all participants must have completed the main study (including both visit 8 \[week 12\] and visit 9 \[week 14\]) long-term extension exclusion criteria: * participant meets any exclusion criteria from the main study at the time of assessing eligibility for the lte, unless approved by the sponsor in advance. * participant had less than 75% overall compliance with ediary entries during the main study. * participant deviated from the prescribed dosage regimen during the main study (ie, overall study treatment compliance less than 85% or more than 115%), unless approved by the sponsor in advance.

Keywords: abdominal pain olorinab apd371 irritable bowel syndrome (ibs) ibs-c (ibs with predominant constipation) ibs-d (ibs with predominant diarrhea)
initial clinical and cbct outcomes of enamel matrix derivative-based regenerative therapy in vertical bone defects

Conditions: Vertical Alveolar Bone Loss

Summary: study of the effectiveness of the application of regenerative therapy with autogenous, platelet-rich plasma in vertical defects investigation of the effectiveness of the application of regenerative therapy with enamel matrix derivatives in vertical bone defects study of the effectiveness of the application of guided tissue regeneration in vertical bone defects with barrier membrane and barrier membrane and autogenous platelet-rich plasma


Eligibility criteria:
inclusion criteria: * good oral hygiene * written informed consent * age * no systemic diseases exclusion criteria: * smokers * horizontal bone loss * untreated periodontium disease
prevention of pressure ulcer on the sacrum

Conditions: Pressure Ulcer Risk

Summary: the aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (msp) in addition to standard preventive care reduces the rate of pressure ulcer (pu) and their severity in population at risk admitted in acute care hospital.


Eligibility criteria:
inclusion criteria: * patients at risk to develop pressure ulcer (braden scale \<17) * without sacrum pressure ulcer * patients or legal guardians who give their consent to take part in the study exclusion criteria: * patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products

Keywords: patients at risk polyurethane foam pressure ulcer
effect of exergame program structured via analytic hierarchy process on trunk control and upper extremity functionality

Conditions: Cerebral Palsy

Summary: the aim of the study is to investigate effects of structured exergame program on upper extremity functions and trunk control in children with cerebral palsy (sp). a 3 phase randomized controlled trial has planned to conduct. in the first phase, baseline assessments will be completed for all participants who are eligible to participate. after the baseline assessments, randomisation will be completed for exergame and activity based exercise groups. during this phase suitable video games for exergame program will be selected. analytical hierarchy process (ahp) will be used to collect expert opinion for most effective video games for upper extremity functionality, postural control, gmfcs i-ii-iii levels. second phase of the study will be started afterwards. upon completing second assessments, interventions for both groups will be conducted. third assessments will be completed after interventions and outcomes will be analyzed for primary results. the third phase of the study planned as follow-up period. all participant will continue their routine ndt trainings and follow-up assessments will be completed after 3 moths of the second assessments. final results will be analysed for all participants.


Eligibility criteria:
inclusion criteria: * diagnosed with spastic cerebral palsy * gross motor level should be in between i-iii according to gross motor function classification system (gmfcs) * manual ability levels should be in between i-iv according to manual abilities classification system (macs) * no botulinum toxin injections 6 months prior to study exclusion criteria: * surgery history related to the musculoskeletal system (upper and lower extremities) * having communication problems * having secondary cognitive-behavioral problems addition to cerebral palsy (intellectual disability)
thalidomide to patients with previously untreated multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to test the effect of thalidomide in patients with multiple myeloma. the patients receive either thalidomide or a placebo tablet (neither patient nor doctor know which of these are given) in addition to the ordinary chemotherapeutic drug against multiple myeloma. we will find out for how long time the patients will stay free of the disease and for how long time they will live, and can evaluate whether thalidomide is a beneficial drug against this disease.

thalidomide has recently emerged as an effective treatment for patients with myeloma refractory to conventional chemotherapy. so far only limited experience is available on thalidomide for newly diagnosed myeloma. therefore the nordic myeloma study group decided to perform a trial comparing traditional melphalan-prednisone therapy with melphalan-prednisone + thalidomide/placebo. the study design is a multicentre double-blind randomised placebo-controlled trial. mainly patients \>65 years of age will be included since patients \<65 years will be treated with high dose chemotherapy with autologous stem cell support. the primary end-point is overall survival. secondary end-points are quality of life, response rate, time to response, response duration and toxicity.

Eligibility criteria:
inclusion criteria: * patients with multiple myeloma in need of treatment exclusion criteria: * previous treatment against multiple myeloma * need of high dose chemotherapy with autologous stem cell support * women in fertile age * psychiatric disease or mental reduction leading to lack of cooperation * lack of consent * life expectancy below 3 months * active cancer of other etiology

Keywords: multiple myeloma phase 3, randomised, double blind study thalidomide
anti-obesity effect of koji-extracted beverage fermented with pediococcus pentosaceus lp28

Conditions: Overweight

Summary: this study is designed to evaluate the effect of koji-extracted beverage fermented with pediococcus pentosaceus lp28 on bmi and body fat in overweight subjects.


Eligibility criteria:
inclusion criteria: * bmi 25-30 kg/m2 exclusion criteria: * taking drugs or functional food that may affect body weight or body fat * pregnant or nursing a child * participation in any clinical trial within 90 days of the commencement of the trial * renal or hepatic dysfunction * heart disease * history of severe disease and/or major surgery
alpha-1 foundation dna and tissue bank

Conditions: Alpha 1 Antitrypsin Deficiency

Summary: this is a long-term follow-up banking protocol that collects medical information and tissue (blood, liver and lung) samples for future research; use of data and samples for research purposes is overseen by the tissue bank advisory committee; the purpose of the bank is to further research on alpha-1 antitrypsin deficiency.

subject participation includes completion of informed consent, medical questionnaire, and email authorization. subjects may provide a blood sample for alpha-1 antitrypsin genotype, phenotype and level. lung and liver tissue may also be provided if available. subjects may be contacted no more often than annually for updated information. this project has a certificate of confidentiality from nih.

Eligibility criteria:
inclusion criteria: * all interested individuals may enroll exclusion criteria: * there are no exclusion criteria

Keywords: tissue banking, research
a study to investigate the safety and tolerability of scr-6920 capsule in patients with advanced malignant tumors

Conditions: Solid Tumor; Non Hodgkin Lymphoma

Summary: a phase 1, open label, multi center, dose escalation and expansion study will assess the safety, tolerability, pk, and preliminary efficacy of scr-6920 capsule in participants with advanced malignant tumors. the purpose of the study is to identify the maximum tolerated dose (mtd) and/or the recommended phase 2 dose (rp2d), and to confirm the tolerability and preliminary efficacy of scr-6920 in participants with advanced solid tumors and relapsed/refractory non-hodgkin lymphoma(nhl).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed locally advanced or metastatic solid tumors or histopathologically confirmed nhl * relapsed/refractory solid tumor or relapsed/refractory nhl who have progressed during or after standard therapy or for which treatment is not tolerated, not suitable, not available. * at least one evaluable or measurable lesion (as defined in the protocol). * ecog performance status 0 or 1. * life expectancy ≥12 weeks. * adequate organ function (as defined in the protocol). * reproductive criteria (as defined in the protocol). exclusion criteria: * any clinically significant gastrointestinal (gi) abnormalities that may alter absorption. * major surgery, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry. radiation therapy within 2 weeks prior to study entry. * adverse reactions from previous anti-tumor therapy have not yet recovered to ≤ grade 1(excluding hair loss, peripheral neurotoxicity caused by chemotherapy have recovered to ≤ grade 2 ). * autologous hematopoietic stem cell transplantation was performed within 9 months prior to the first dose. * history of a second malignancy within 2 years (as defined in the protocol). * active uncontrolled or symptomatic lung disease (as defined in the protocol). * intracranial hypertension or active uncontrolled or symptomatic cns metastases. * known or suspected hypersensitivity to study medications. * known active uncontrolled or symptomatic cns metastases. * the investigator determined that the patient should not participate in the study. * known mental illness or substance abuse that may disrupt therapy. * clinically significant cardiac abnormalities (as defined in the protocol). * gestating or lactating women. * pleural effusion, pericardial effusion or ascites that need diuretics or draining within 2 weeks prior to first dose. * the patient is currently using a drug known to be a strong inhibitor or inducer of cyp3a4.
enhancing post-stroke dysphagia rehabilitation

Conditions: Dysphagia After Stroke

Summary: the goal of this clinical trial is to investigate the effects of a combined swallowing intervention (neuromuscular electrical stimulation (nmes) + neuromuscular taping (nmt) + swallowing exercises) on swallowing function and quality of life in post-stroke dysphagia patients. the main questions it aims to answer are: • does the combination of swallowing exercises, nmes \& nmt have a greater improvement in dysphagia rehabilitation when compared to either nmes or nmt alone? researchers will compare the effects of intervention between the three groups (nmes and swallowing exercises, nmt and swallowing exercises, and nmes with nmt and swallowing exercises). participants will: * receive a combined dysphagia rehabilitation comprised of swallowing exercises, neuromuscular electrical stimulation, and/or neuromuscular taping. * visit the clinic once every 5 days a week for 10 therapy sessions. * undergo baseline and post-intervention evaluation procedures.

this proposed study will be conducted using a prospective, three-group, randomized controlled trial. the participants for this study will be recruited from the post-acute and rehabilitation units who are diagnosed with post-stroke dysphagia at hamad medical corporation hospitals in the state of qatar.

Eligibility criteria:
inclusion criteria: * patients aged 18 - 75 years old, * diagnosed with swallowing disorders between one day and six months post-stroke, * able to attend 10 therapy sessions, * have never received any swallowing treatment before participating in this study. exclusion criteria: * post-stroke patients with severe cognitive impairment, * patients who have swallowing disorders due to other etiologies, * patients who need traditional swallowing therapy other than expiratory muscle strength training (emst) and chin tuck against resistance (ctar). - skin disorders in the submental area and anterior neck, * medical conditions that may affect participation, * a defibrillator and use precision electrical biomedical devices (e.g. pacemaker, etc.).

Keywords: post-stroke dysphagia combined rehabilitation neuromuscular electrical stimulation kinesiology taping neuromuscular taping chin tuck against resistance expiratory muscle strength training
multisensory training in pd

Conditions: Parkinson Disease

Summary: people with parkinson's disease (pd) were characterized by many motor symptoms, including rigidity, postural instability, bradykinesia, and resting tremor. these motor symptoms might cause gait dysfunction. gait dysfunction represented a common sign of pd, including reduced gait velocity, reduced stride length, reduced arm swing, and increased gait variability. poor postural control in people with pd might result to increase gait variability and then increase fall risk. previous studies reported that proprioceptive-vestibular multisensory training improved postural stability in people with pd. however, no literature investigated the effects of proprioceptive-vestibular multisensory training on gait variability. therefore, the purpose of this study is to examine the effect of proprioceptive-vestibular multisensory training on gait variability in people with pd.


Eligibility criteria:
inclusion criteria: * idiopathic pd * hoehn and yahr stage i to iii * age 60\~80 y/o * mini-mental state examination (mmse) ≥24 * ability to ambulate independently (with or without walking aid) exclusion criteria: * affecting the peripheral vestibular system * medical condition that substantially influenced their gait and balance performance * people had joined any rehabilitation past 1 month

Keywords: multisensory training gait variability