Kornimate/medical-research-clean huggingface dataset:
safety of cat-pad in cat allergic subjects

Conditions: Cat Allergy

Summary: cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma. cat-pad is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of cat allergy. this study will investigate the safety of cat-pad administered as increasing single doses.

this study is designed as a two centre, randomised, placebo-controlled, escalating single dose study in up to 88 cat allergic subjects. cohorts of 8 subjects will be enrolled. each cohort will undergo screening 14-28 days before treatment and a baseline challenge for epsr and lpsr to cat allergen injected into the arm 7 days before treatment. on the treatment day, subjects will be injected either intradermally (into the skin) or subcutaneously (under the skin) with a single dose of cat-pad or placebo and safety observations made for 8 h. after 21 days, subjects will again have cat allergen injected into the arm and the epsr and lpsr will be recorded. the dose of cat-pad will be increased in successive cohorts, provided that the previous dose tested was well tolerated.

Eligibility criteria:
inclusion criteria: * a reliable history of rhinoconjunctivitis (sneezing, rhinorrhoea, nasal blockage, itchy/red/sore/watering eyes) or controlled asthma (gina (2006) classification 1) on exposure to cats for at least 1 year. * late-phase allergic skin reaction (lpsr) to 0.010 hep units leti cat allergen eight hours after intradermal injection of greater than 25mm diameter response on single arm. exclusion criteria: * subjects with asthma falling under gina(2006) classification 2 (partly controlled) and 3 (uncontrolled). * a history of anaphylaxis to cat allergen. * subjects with a cat specific ige \>100 ku/l. * subjects with an fev1 \<80% of normal. * subjects with an acute phase skin response to cat allergen with a weal diameter \> 30mm. * subjects who suffer from hay fever, and cannot complete the clinical study outside the pollen season. * allergen immunotherapy during the last 5 years or cat dander immunotherapy ever. * use of the following therapies for the periods specified prior to the screening visit will make the subject ineligible for the study: corticosteroids: (depot: 90 days; systemic: 30 days; dermatological, intranasal, inhalational: 15 days); cromones (14 days); antihistamines other than loratadine (nasal and long-acting oral: 10 days; short-acting oral, ocular: 7 days); leukotriene inhibitors (10 days); anticholinergics (7 days); alpha-adrenergic agonists (7 days); tricyclic antidepressants (14 days). if it becomes a medical necessity for a subject to use one of these contraindicated medications during the study this will become an individual stopping criteria. * subjects for whom administration of adrenaline is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). * subjects being treated with beta-blockers

Keywords: cat allergy immunotherapy cat-pad
intermittent theta burst stimulation for maintenance therapy in depression

Conditions: Depression

Summary: this is a randomized, multi-center, open-label study in which patients with depression who responded to an open-label treatment with intermittent theta burst stimulation (itbs) will receive this procedure as maintenance therapy. the patients will be randomized to two study arms. the arms differ in the frequency of stimulation (standard itbs (5 treatments every working day for one week) vs. accelerated itbs (5 treatments in one day)). for purposes of effect size estimation an interim analysis will be done after half of the patients.


Eligibility criteria:
inclusion criteria: * adult women and men aged 18 to 70 years with an icd-10 diagnosis of a depressive episode of depressive disorder (f32), recurrent depressive disorder (f33), or bipolar disorder (f31) * moderate or severe current episode prior to initial open itbs treatment (hamd-21 \>16 points) * response to itbs treatment (either reduction in hamd score by 50% or score at the end of treatment \<11 points) * no concomitant psychotic symptoms. * no other relevant psychiatric disorder as assessed by the study physician * residence in germany and german speaking that allows understanding of the information provided * patient is capable of giving consent exclusion criteria: * fulfillment of the general contraindications for tms (electrical implants or metallic objects in the body such as pacemakers or insulin pumps). * severe neurological diseases (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, malformations of the brain, severe head injury in the history) * current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates * acute suicidality * pregnancy * current participation in another study
laser induced bioengineered remodeling of thermally injured skin trial

Conditions: Hypertrophic Scars

Summary: this study will evaluate the efficacy of pulsed dye laser (pdl) and carbon dioxide (co2) laser in conjunction with usual care (med) for the treatment of hypertrophic burn scars and will determine the optimal sequence and timing of lasers and usual care.

the investigator will compare usual care (med), which will be offered to all patients, to two types of laser treatment (pdl and co2), which the investigators hypothesize to be beneficial. the timing and sequence of therapy will be randomized, but all patients will receive some form of laser treatment. if the investigators simply stopped at the end of aim 1, the investigators would complete a traditional randomized control trial (rct), with some patients potentially receiving laser treatment. however, the investigators are interested in determining whether the sequence of laser treatments is beneficial; therefore, the investigators will be employing a sequential multiple assignment randomized trial (smart) design. because of the nature of the study and smart design, the investigators will offer all patients some form of laser therapy.

Eligibility criteria:
inclusion criteria: * have a burn injury which will be at least 6 months old at the time of first treatment, * have one or more symptomatic burn scars (with at least one or more symptoms such as erythema, pruritus, surface irregularity, or tightness not caused by a contracture that would be better served with surgical treatment), * desire laser treatment, * be at least 6 months of age at the time of treatment, * agree to have no aesthetic treatments for their burn scars, such as peels or fillers, until they have completed the study (two-year period), * agree to be randomized into one of the study's treatment conditions, * agree to return for all treatment and follow-up visits for the two-year study period, * agree to refrain from participating in any other treatment-oriented clinical trial for the duration of this study, and * be able and willing to follow the protocol requirements. exclusion criteria: * be women who are pregnant or planning to become pregnant during the study, * have had any previous laser treatment of their burn scars, * have open wounds that are not re-epithelialized in the areas of proposed study treatment, * be taking systemic steroids or immunosuppression medication, * have a connective tissue disorder, * be receiving or planning to receive chemotherapy or radiation during the study, * be medically unable to tolerate anesthesia, or * have other conditions that in the opinion of the investigators or clinicians may affect participant safety or compromise study objectives.
an international phase 2 study of su011248 in patients with advanced / metastatic gastric cancer failing chemotherapy

Conditions: Stomach Neoplasms

Summary: the study consisted of two parts. in part 1 the study enrolled 38 patients (step 1 simon 2 step design) after which step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. sunitinib (su011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. all patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. after discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival.


Eligibility criteria:
inclusion criteria: * gastric or gastroesophageal junction adenocarcinoma cyto/histologically documented * disease progression/ recurrence after treatment with one prior single agent or combination chemotherapy regimen for advanced / metastatic disease (last dose at least 4 wks before study entry). patients may have also received prior adjuvant therapy if recurrence occurred \> 6 months after adjuvant therapy completion * evidence of measurable disease by radiographic technique * adequate organ function. exclusion criteria: * clinically relevant ascites (i.e. requiring paracentesis) * severe weight loss * nci ctcae grade 3 hemorrhage \<4 weeks of starting study treatment * diagnosis of second malignancy within last 3 years * history of or known brain metastases, spinal cord compression, or carcinomatous meningitis * known hiv * serious acute or chronic illness * current treatment on another clinical trial * pregnant or breastfeeding
short and intensive treatment of children and adolescents with obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: obsessive-compulsive disorders are very damaging illnesses; they can already appear in childhood and adolescence and become extremely chronic. with an average prevalence from 1-3%, they are among the most common psychiatric disorders in children and adolescents. 40% of diagnosed children and young adults display persistent and increasingly chronic symptoms and o-c disorders are highly complex syndromes with broadly varying manifestations. they arise from obsessive thoughts (ideas/thoughts or impulses, often senseless or tortured, that impose themselves or intrude) and obsessive behavior (ritualized patterns that must be frequently repeated).


Eligibility criteria:
inclusion criteria: * obsessive-compulsive disorder diagnosis * male and female patients from 8-18 years * good german language speaking skills * iq of at least 75 * at least four days' participation in the treatment/therapy week * written agreement after clear explanation exclusion criteria: - no complete participation in the intensive week treatment/therapy
severity of scorpion sting in relation to hematological parameters

Conditions: Scorpion Stings

Summary: the aim of this study is to investigate the relationship between severity of envenomation and hematological parameter by detectig initial mean platelet volume (mpv), neutrophil/lymphocyte ratio (nlr) and platelet/lymphocyte ratio (plr) in pediatric patients presenting with a scorpion sting.

scorpion stings are common emergency events in many parts of the world. it is common in tropical and subtropical regions. in our locality, upper egypt, scorpions still represent and a life hazard, especially to children .the clinical manifestations of scorpionism are due to complex interactions between sympathetic and parasympathetic stimulation.this leads to increased release of neurotransmitters and mediators, resulting in a cascade of pathological events, involving the nervous system, the cardiovascular and the respiratory system, eventually leading to death.scorpionism results in hormonal and biochemical changes with significant release of catecholamines, increased angiotensin ii and inhibition of insulin secretion .the symptoms and signs of envenomation are usually more severe in children, especially younger ones. local pain represent 66 to 90 percent of stings which is practically immediate, of varying intensity ranging from mild to very intense. it is characterized by tingling, burning, or stinging. regardless of the severity of envenoming, pain and paresthesia may persist at the site or at the affected limb for several days .systemic effects become apparent in 10 to 33 percent of patients.after envenomation, symptoms may begin immediately and typically progress to maximum severity within 5 hours. the clinical effects of stings are characterized, cardiovascular, neurological and gastrointestinal effects .cardiovascular effects are atrial tachycardia, ventricular extrasystoles, t-wave inversion, st-t wave changes, bundle-branch block. catecholamine-induced myocarditis and myocardial ischemia results in pulmonary edema and cardiogenic shock.cardiovascular effects are atrial tachycardia, ventricular extrasystoles, t-wave inversion, st-t wave changes, bundle-branch block. catecholamine-induced myocarditis and myocardial ischemia results in pulmonary edema and cardiogenic shock..gastrointestinal effects: are vomiting, abdominal pain and diarrhea. also acute pancreatitis has been reported.cardiovascular toxic effects and acute pulmonary edema are the most important complications of scorpion stings and the most frequent cause of death in the first 24 hours after the sting .gastrointestinal effects: are vomiting, abdominal pain and diarrhea. also acute pancreatitis has been reported.cardiovascular toxic effects and acute pulmonary edema are the most important complications of scorpion stings and the most frequent cause of death in the first 24 hours after the sting .

Eligibility criteria:
inclusion criteria: * a) patients presented with scorpion sting exclusion criteria: * all other envenomation or intoxications
a study of lorigerlimab with docetaxel or docetaxel alone in participants with metastatic castration-resistant prostate cancer

Conditions: Androgen-Independent Prostatic Cancer; Androgen-Independent Prostatic Neoplasms; Prostate Cancer Recurrent; Androgen-Insensitive Prostatic Cance; Androgen-Resistant Prostatic Cancer; Hormone Refractory Prostatic Cancer; Immunotherapy; Immune Checkpoint Inhibitor; Inhibitory Checkpoint Molecule

Summary: the purpose of this study is to determine whether the amount of time before disease progression can be prolonged in participants with metastatic castration-resistant prostate cancer (mcrpc) who receive lorigerlimab in addition to the standard of care (soc) of docetaxel and prednisone. about 150 participants with mcrpc will be enrolled. participants will be randomized in a 2:1 ratio to receive lorigerlimab with docetaxel and prednisone (experimental arm) or docetaxel and prednisone alone (standard-of-care arm). lorigerlimab+docetaxel or docetaxel will be administered intravenously (iv) in clinic on day 1 of each 3-week cycle. prednisone will be administered orally twice daily. lorigerlimab will be administered for up to 35 cycles. docetaxel and prednisone will be administered up to 10 cycles until treatment discontinuation criteria are met. participants will undergo regular testing for signs of disease progression using computed tomography (ct) scans, magnetic resonance imaging (mri) and prostate-specific antigen (psa) blood tests. participants will be asked to complete questionnaires about their health and well-being. routine examinations and blood tests will be performed and evaluated by the study doctor. participants who have disease progression standard-of-care arm have the option of continuing on the study to receive lorigerlimab monotherapy.


Eligibility criteria:
inclusion criteria: * metastatic castration-resistant adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features. * participants must have ≥ 1 metastatic (measurable or non-measurable per pcwg3) lesion. * participant has prostate cancer progression at study entry based on pcwg3 criteria. * participant shows evidence of disease progression after receiving at least 1 prior androgen receptor axis-targeted therapy (arat) regimen (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide). * patients with known history of documented breast cancer gene (brca) mutation (germline or somatic) must have received an approved poly adp ribose polymerase (parp) inhibitor regimen. * participants must have adequate performance status, life expectancy and laboratory values. exclusion criteria: * any condition preventing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures. * received prior chemotherapy for mcrpc or checkpoint inhibitors for prostate cancer. * current active or chronic infections. * any clinically significant heart, lung, or gastrointestinal disorders. * allergy to any of the study treatments or components of the study treatments.
pharmacokinetic interaction between maraviroc and fosamprenavir/ritonavir in healthy subjects

Conditions: Healthy

Summary: this is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2. * total body weight \>50 kg (110 lbs). exclusion criteria: * history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening. * positive result for hiv, hepatitis b or hepatitis c virus. * treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. * known hypersensitivity or history of allergy to sulfonamides.

Keywords: maraviroc fosamprenavir drug interaction pharmacokinetics hiv aids ccr5 protease inhibitor
addition of enoxaparin to neoadjuvant chemoradiation of esophageal cancer

Conditions: Esophageal Neoplasms

Summary: this is a randomized, single blind, multi-center, phase two clinical trial. inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. sample size is 100 people (50 people in each group). in the intervention group, patients are going to inject an enoxaparin (40 mg) daily concurrent by chemo-radiation. therefore patients with esophageal cancer are going to assign randomly to control group (only chemo-radiotherapy) and intervention group (chemo-radiotherapy+enoxaparin) using 1:1 allocation. four to 6 weeks after treatment, all patients undergo upper gi endoscopy and then esophagectomy. endoscopic and pathological findings (after esophagectomy) are considered as clinical and pathological response, respectively.

this is a randomized, single blind, multi-center, phase two clinical trial. inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. one hundred patients are going to assign randomly by blocked randomized allocation (1:1) to receive radiotherapy (median treatment dose will be 50.40 gy in 25 to 32 fractions) with weekly concurrent chemotherapy (paclitaxel \[50 mg/m2\] plus carboplatin \[area under the carve=2\]) with or without enoxaparin (40 mg daily). during radiotherapy and before each course of chemotherapy, all patients are going to visit by physician and complete blood count will be checked. all patients are going to undergo gastrointestinal endoscopy and then esophagectomy, 4-6 months after completion of chemo-radiotherapy.

Eligibility criteria:
inclusion criteria: * definitive diagnoses of esophageal squamous cell carcinoma by pathological evaluation * non-metastatic esophageal cancer * patient who are candidate for chemo-radiation treatment * normal complete blood count * normal kidney function test * normal liver function test * normal fasting blood sugar exclusion criteria: * previous history of chest wall radiotherapy * previous history of chemotherapy * past medical history of hypertension, diabetes mellitus, renal failure and liver failure * pathological report of adenocarcinoma or small cell carcinoma, neoplasm of other organs * discontent for the study * inability to do daily radiotherapy * unwillingness to esophagectomy

Keywords: neoadjuvant chemoradiation pathologic response low molecular weight heparin
european and north indian cohort of kawasaki disease

Conditions: Kawasaki Disease

Summary: kawasaki disease (kd) is currently the leading cause of acquired heart diseases in children in developed countries. cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (caas) may lead to ischemic heart disease and even sudden death. the current standard of care for kd has consistently reduced caas frequency from 25-30% to about 5%. unfortunately, 10-20% of kd patients results resistant to standard treatment leading to a major risk of cardiac complications. thus, scoring systems have been constructed in order to identify patients likely to be resistant to ivig and who may benefit from more aggressive initial therapy. different scoring scales developed by kobayashi, egami et sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting ivig unresponsiveness in japanese populations. however, their predictive value was not confirmed by subsequent studies in different ethnic populations. recently, the french kawanet group have proposed a ivig unresponsiveness score that provided good sensitivity and acceptable specificity in a non-asian kd population even if it was not subsequent validated by an external study. in our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for kobayashi and sensitivity 77% and specificity 60% for kawanet), will be considered a success.


Eligibility criteria:
inclusion criteria: * patients aged less than 18 years at diagnosis * diagnosis of kd according to the aha criteria exclusion criteria: * patients who do not meet the criteria for kd * patients for which an alternative infectious diagnosis was not investigated and/or excluded.