Kornimate/medical-research-clean huggingface dataset:
evaluation of the hypoallergenicity of an extensively hydrolyzed formula

Conditions: Cow Milk Allergy

Summary: the aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.


Eligibility criteria:
main inclusion criteria: infants: * with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months, * successfully fed an eviction diet for at least 2 weeks main non-inclusion criteria: infants: * fed with an extensively hydrolyzed formula with no improvement of the symptoms, * who refused to drink an extensively hydrolyzed formula anytime prior to inclusion, * fed a vegetable based formula * fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations * who had an anaphylactic reaction in the past
exercise program for knee recovery in football players with acl injuries

Conditions: ACL Injuries

Summary: this study aims to evaluate the effectiveness of a structured exercise program in improving knee function, muscle strength, and range of motion in football players recovering from anterior cruciate ligament (acl) injuries. the study seeks to answer whether a rehabilitation program can restore the performance of the injured leg to levels comparable to the uninjured leg and significantly improve knee functionality over time.

anterior cruciate ligament (acl) injuries are among the most common and challenging injuries faced by athletes, particularly football players. these injuries can significantly impact knee stability, muscle strength, and range of motion, making effective rehabilitation essential for a full recovery and return to sports. this study investigates the impact of a structured exercise program on knee rehabilitation in male football players aged 18-22 years with acl injuries. the goal is to understand whether this program can restore knee function and strength in the injured leg to levels comparable to the uninjured leg. the rehabilitation program is designed to be implemented over 22 weeks, starting with five sessions per week and tapering to three sessions per week in the later stages. the program focuses on progressively strengthening the thigh and leg muscles, improving knee flexibility, and enhancing overall joint function. the study uses a pre- and post-measurement experimental design with a single group of participants. the results will help determine whether structured exercise programs can effectively rehabilitate the knee after acl injuries, enabling football players to regain performance and reduce the risk of future knee problems. the findings will contribute valuable insights for sports medicine professionals, physiotherapists, and trainers in developing evidence-based rehabilitation protocols for athletes.

Eligibility criteria:
inclusion criteria: * confirmed injury to the anterior cruciate ligament (acl). * currently active in playing football. exclusion criteria: * history of previous surgery to the knee. * presence of other musculoskeletal injuries. * diagnosis of chronic health conditions.

Keywords: anterior cruciate ligament (acl) injury knee rehabilitation muscle strength range of motion
transcranial direct current stimulation associated with pilates in low back pain

Conditions: Low Back Pain; Transcranial Direct Current Stimulation

Summary: this is a randomized and blind clinical trial, whose objective is to evaluate the effects of transcranial stimulation by direct current associated with exercises based on the pilates method on the performance of patients with chronic low back pain.

considered a public health problem, low back pain is globally presented as a symptomatology of high prevalence, incidence and recurrence. in addition, it is responsible for a large part of disabilities, reduced functional performance, absences from work and impaired quality of life, which brings biopsychosocial impacts to the affected subjects. treatments that relieve the symptoms of these patients are of great importance to improve the quality of life of these individuals. thus, this study aims to evaluate the effects of transcranial direct current stimulation associated with pilates based exercise on chronic low back pain. this is a randomized clinical trial that will be composed of women between 18 and 65 years of age, with a history of low back pain for more than 12 weeks and a minimum pain intensity equal to 3 cm on the numerical pain scale. the volunteers will be randomized into two distinct groups: stimulation + exercise group (eg - will perform a pilates based exercise protocol combined with transcranial direct current stimulation) and sham stimulation + exercise group (sg - will perform the same exercise program combined with sham stimulation). the interventions, regardless of the group, will be carried out three times a week for four weeks. participants will be submitted to three assessments: the first (t0) will be performed before the treatment protocols; the second (t1) will be performed after the four weeks of intervention; and the third (t2) will be a follow-up one month after the end of the treatment protocol. pain sensation, performance, pressure pain threshold, use will be evaluated. for the statistical analysis, a mixed model anova will be performed for the inter and intragroup comparison, with tukey's post hoc, considering a significance level of 5%.

Eligibility criteria:
inclusion criteria: women with chronic nonspecific low back pain (for more than 12 weeks) and minimum pain intensity of 3 on numerical pain rating scale exclusion criteria: * diagnosis of fracture and spine pathologies, fibromyalgia, spine surgery in the last year; * low cognitive level assessed by the mini mental state examination; * presence of central neurological diseases (such as parkinson's and stroke) or psychiatric (such as depression or schizophrenia); * history of epileptic illness; * seizure history; * brain implants; * pacemaker; * pregnancy

Keywords: transcranial direct current stimulation low back pain exercises chronic pain performance treatment
a phase ii study looking at moderate to severe osteoarthritis knee pain

Conditions: Osteoarthritis

Summary: the purpose of this study is to look at the effects of rn624 on moderate to severe knee pain due to osteoarthritis. this study will look at the safety and pain relieving effects of rn624 compared to placebo over a 4 month period.


Eligibility criteria:
inclusion criteria: male or non-pregnant female aged 40-75 with chronic moderate to severe knee pain due to oa (scoring 50 out of 100 on a visual analog scale on knee pain). subjects must meet one of the following: unwilling to take non-opiate pain medications, or for whom non-opiate pain medications have failed, or are candidates for or seeking invasive interventions such as intraarticular injections, knee arthroplasty, or total knee surgery exclusion criteria: history or symptoms of autoimmune disorders, cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision, allergic reaction to monoclonal antibodies or igg-fusion proteins, hepatitis b, c or hiv, drug abuse, fibromyalgia, clinically significant cardiac disease, diabetes mellitus requiring oral treatment or insulin, clinically significant neurological disease or clinically significant psychiatric disorders

Keywords: osteoarthritis monoclonal antibody
preliminary study of piclozotan in patients with motor complications associated with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with parkinson's disease.


Eligibility criteria:
main inclusion criteria: * idiopathic parkinson's disease for at least 5 years * presence of motor fluctuations and dyskinesia * stable regimen of levodopa/carbidopa for 30 days * at least 25% response/improvement in unified parkinson's disease rating scale (updrs) part iii scores after dosing with regular parkinson's disease (pd) medications * mini-mental state examination (mmse) score of 25 or higher main exclusion criteria: * atypical or secondary parkinsonism. * prior use of neuroleptic agents. * history of intracranial procedures for pd. * active psychosis. * history of drug or alcohol abuse in past 12 months. * cardiac conduction system abnormality. * predisposing medical condition that causes nausea or vomiting or routine use of an anti-emetic.

Keywords: parkinson's disease motor complications dyskinesia motor complications associated with parkinson's
study to evaluate efficacy and safety of inclisiran in adolescents with homozygous familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia - Homozygous

Summary: this was a pivotal phase iii study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (hofh) and elevated low density lipoprotein cholesterol (ldl-c).

this was a two-part (double-blind, inclisiran versus placebo \[year 1\] followed by open-label inclisiran \[year 2\]) multicenter study in adolescents (aged 12 to \ 130 mg/dl; 3.4 mmol/l) on stable, individualized, optimal standard of care (soc) background lipid-lowering therapy (including maximally tolerated statin treatment, at the investigator's discretion) to evaluate the safety, tolerability, and efficacy of inclisiran in this pediatric patient population. following an approximately 4-week screening/run-in period, the study had 2 sequential parts as follows: part 1/year 1: 12 months double-blind, parallel group period, in which participants were randomized in a 2:1 ratio to receive either inclisiran sodium 300 mg subcutaneous (s.c.) or placebo. the primary endpoint was assessed at day 330. part 2/year 2: 12 months single arm, open-label follow-up period, with all participants receiving inclisiran sodium 300 mg s.c.

Eligibility criteria:
inclusion criteria: * homozygous familial hypercholesterolemia (hofh) diagnosed by genetic confirmation * fasting ldl-c \>130 mg/dl (3.4 mmol/l) at screening * on maximally tolerated dose of statin (investigator's discretion) with or without other lipid-lowering therapy; stable for ≥ 30 days before screening * male or female participants \>=12 to \<18 years of age at screening exclusion criteria: * documented evidence of a null (negative) mutation in both ldlr alleles * heterozygous familial hypercholesterolemia (hefh) * active liver disease * secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome * previous treatment with monoclonal antibodies directed towards pcsk9 (within 90 days of screening) * treatment with mipomersen or lomitapide (within 5 months of screening) * recent and/or planned use of other investigational medicinal products or devices

Keywords: homozygous familial hypercholesterolemia (hofh) ldl-cholesterol (ldl-c) adolescents pediatric small interfering ribonucleic acid (sirna)
onset and duration of forearm nerve blockade

Conditions: Carpal Tunnel Syndrome

Summary: this pilot study will evaluate the latency of onset and duration of sensory-motor block in patients undergoing hand surgery. patients will be randomized to receive nerve blocks of the distal forearm or of the distal and proximal forearm. local anesthetic will be injected to anesthetise the median and ulnar nerves in the distal forearm (1-injection site group) or the median and ulnar nerves in the distal and proximal forearm (2-sequential injection sites group) to accomplish anesthesia for surgery on the hand.


Eligibility criteria:
inclusion criteria: * scheduled to undergo daycare surgery for carpal tunnel syndrome under peripheral nerve blocks * american society of anesthesiologists (asa) physical status i, ii or iii * able to demonstrate sensory function in the ulnar and median nerve distribution by exhibiting sensitivity to cold, pinprick and light touch * scheduled to undergo primary hand surgery * able to understand the dutch language, purpose and risks of the study * able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule, and complete all study assessments exclusion criteria: * currently pregnant or nursing * history of hypersensitivity to local anesthetics * contraindication to lidocaine, bupivacaine, paracetamol * medical condition that will make it difficult to assess sensory distributions of the upper extremity peripheral nerves or to communicate with staff * suspected or known recent history (\< 3 months) of drug or alcohol abuse * concurrent physical condition that may require analgesic treatment (such as nsaid or opioid) in the postsurgical period for pain that is not strictly related to carpal tunnel syndrome and which may confound the postsurgical assessments * infection at the planned block site(s) * initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (ssris), selective norepinephrine reuptake inhibitors (snris), gabapentin, pregabalin (lyrica®), or duloxetine (cymbalta®) * body weight \ 44 kg/m2 * uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments * any chronic neuromuscular deficit affecting the ulnar and median nerves or muscles of the surgical extremity * any chronic condition or disease that would compromise neurological * presence of pre-existing coagulation disorders * baseline neurological deficits
citrulline in severe sepsis

Conditions: Severe Sepsis; Acute Lung Injury

Summary: this is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate biochemical, clinical, and safety effects of 2 doses of intravenous l-citrulline compared to placebo in patients with severe sepsis at risk for or with acute lung injury. the hypothesis is that intravenous l-citrulline will decreased the development or progression of acute lung injury in patients with severe sepsis compared to placebo.


Eligibility criteria:
inclusion criteria: * severe sepsis exclusion criteria: * no consent * malignant or other irreversible condition * moribund and not expected to survive 48 hours * end stage liver disease * enrolled in another ind study * pregnant or breast feeding female * age\<13 years old * allergy to citrulline or arginine
influence of stress on non surgical periodontal treatment

Conditions: Chronic Periodontitis

Summary: treatment of periodontal diseases is influenced by several risk factors. psychological stress is considered as one of them. aim of this study is to assess if stress influences results of non surgical periodontal treatment in severe chronic forms of periodontitis.


Eligibility criteria:
inclusion criteria: * severe generalized chronic periodontitis * minimum 15 teeth * attachment loss \> 5mm * 30% of sites affected- 5% of pockets\>5mm * bone loss- bleeding on probing exclusion criteria: * patient at risk of endocarditis * pregnant women * patient under therapy for depression * patient treated for periodontal diseases previously
identification of genes and pathogenesis involved in familial thoracic aortic aneurysm

Conditions: Thoracic Aortic Aneurysm

Summary: the primary objectives of the study are * to assess the contribution of alteration of each known gene on non-syndromic taa. * to map and identify unknown gene involved in the non-syndromic taa.

the secondary objectives of the study are * to study the correlation of phenotype-genotype, in particular, to compare the aortic phenotype of non-syndromic taa patients and taa syndromic patients. * to develop national standardized strategies of genetic diagnosis and of clinical management using genetic data.

Eligibility criteria:
inclusion criteria: for all: * aged \> 18 years. * written informed consent obtained. * people with health insurance. for individual: * people ≥ 45 years, thoracic aortic aneurysm without syndrome, * or people \> 45 years with familial taa. for family: * at least 2 members of family in 2 generations have taa without syndrome and at least 2 patients of taa will undergo blood collection. * all people in family will undergo blood collection, each member should declare at first his (her) status (with or without taa, unknown), the relationship (direct relative family or family in-law), no limit of age. for the children, only those with taa will perform blood collection for the study. exclusion criteria: * thoracic aortic aneurysm with different syndromes (marfan syndrome, ehlers-danlos syndrome, loeys-dietz syndrome, turner syndrome, noonan syndrome). * arterial hypertension.

Keywords: thoracic aortic aneurysm (taa) gene familial taa blood collection
orkambi treatment in 2 to 5 year old children with cf

Conditions: Cystic Fibrosis

Summary: the purpose of this observational research study is to determine the effects of clinically prescribed orkambi treatment on 2 to 5 year old children homozygous for the f508del mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene on sleeping energy expenditure, growth status and gut health and function.

orkambi is a novel fda approved (august, 2018) therapy for use in patients with cystic fibrosis (cf) who are 2 to 5 years of age and homozygous for f508del mutations in the cftr gene. it is a combination of lumacaftor and ivacaftor that addresses both the processing and gating defects of the f508del mutation. this investigator-initiated study is designed to evaluate the nutritional, growth and gi impact of orkambi treatment for this unique younger (2 to 5 years) patient cohort. this proposal extends previous highly informative nutrition and weight gain investigation of ivacaftor treatment in people with cf gating mutations to another cftr modulator treatment (orkambi) in people homozygous for f508del mutations. the primary aims of the study are to evaluate the impact of 24 weeks of orkambi treatment in 2 to 5 year old subjects with cf homozygous for f508del mutations on sleeping or resting energy expenditure, growth status and gut health and function in n=32 children ages 2.0 to 5.9 years of age. protocol evaluations will occur at baseline (pre-treatment) and 12 and 24 weeks after clinically prescribed orkambi treatment has begun. other outcomes of significant clinical interest in young subjects with cf will be explored. all subjects will be evaluated as outpatient at the children's hospital of philadelphia, and will be recruited both regionally and nationally to ensure timely enrollment.

Eligibility criteria:
inclusion criteria: * cystic fibrosis and homozygous for f508del mutations, approved for treatment * age: 2.0 to 5.9 years * in usual state of good health * a clinical decision has been made for subject to begin orkambi treatment * family committed to the 6 to 8 month study protocol with visits to the children's hospital of philadelphia (chop) that will last 2-3 days for the baseline visit (visit 1) prior to orkambi and the 24 week visit (visit 3) after clinically prescribed orkambi treatment has begun, and will last up to 2 days for the 12 week visit (visit 2) after orkambi treatment has begun. exclusion criteria: * on parenteral nutrition * use of any medications that inhibit or induce cytochrome p450 (cyp) 3a * liver function tests elevated above 3x the reference range for age and sex * lung disease considered severe based on clinical impression by home cf center. * other illness affecting growth or nutritional status * other contraindications described for orkambi therapy

Keywords: cf cftr cystic fibrosis
the effect of ondansetron on spinal anesthesia in caesarean section

Conditions: Hypotension

Summary: the purpose of this study is to compare the administration of two different doses of ondansetron to placebo to prevent hypotension and bradycardia following spinal anaesthesia. apart from haemodynamic parameters (blood pressure and heart rate),characters of the spinal blockage (time of onset and regression) will be recorded too.

the day before surgery the procedure will be explained to the patient and the written consent will be obtained. in the operating room, intraoperative monitoring will include electrocardiography (ecg), noninvasive blood pressure, oxygen saturation by pulse oximetry (spo2) and heart rate (hr). two peripheral intravenous catheters wil be placed for fluid replacement and administration of drugs. participants will be randomly assigned to one of the following groups: group a: women will receive 4 milligrams (mg) of ondansetron diluted in 100 milliliters (ml) of normal saline 0.9 percent 10 minutes before spinal anaesthesia group b:women will receive 8 mg of ondansetron diluted in 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia group c:women will receive 100ml of normal saline 0.9 percent 10 minutes before spinal anaesthesia subsequently, after receiving 500ml of colloid solution, spinal anesthesia will be performed at level l3-l4 or l4-l5 in the vertebral space with 1.6ml of 0.75 percent ropivacaine and 15mcg of fentanyl, using a 27-gauge pencil point spinal needle with patients in a left lateral position. after subarachnoid infusion, participants will be placed supine with left uterine displacement and anesthetic and motor blockage will be evaluated every one minute until anesthetic blockage reaches the level of t4 neurotome and the motor block becomes complete (bromage grade 3). this time will be called time to max effect (tmax). hypotension, defined as systolic blood pressure below 100 millimeters of mercury (mmhg), will be treated using 5mg ephedrine if the heart rate is less than 100 beats per minute or with 20mcg of phenylephrine if the heart rate is greater than 100 beats per minute. bradycardia, defined as a fall in heart rate below 60 beats per minute will be treated with atropine (0.6mg). immediately after the delivery of the neonate, all women will receive a solution of oxytocin (20 units) intravenously. half an hour before the end of the procedure they will receive an additional 1g of paracetamol and 75mg of diclofenac.

Eligibility criteria:
inclusion criteria: * physical status according to american society of anesthesiologists (asa) i-ii * singleton pregnant women in full term pregnancy * patients scheduled for cesarean section * height 158cm-170cm exclusion criteria: * patient's own refusal * contraindications to spinal anesthesia (coagulation disorders, inflammation at the puncture site, allergy to local anesthetics) * ondansetron allergy * body mass index\> 33kg / m\^2 * height \ 170cm * hypertensive disorders of pregnancy * cardiovascular disease * receiving selective serotonin reuptake inhibitors (ssri's) or treatment for migraine * placenta previa.

Keywords: ondansetron