Kornimate/medical-research-clean huggingface dataset:
the effect of d-serine as add-on therapy in recent-onset psychosis

Conditions: Psychotic Disorder

Summary: in psychotic disorders, negative symptoms and cognitive impairment are difficult to treat with antipsychotics, which are mostly effective for positive symptoms. however, it is important that negative symptoms and cognitive impairment are treated as well, as they both play a large part in the acute episode and long-term course of schizophrenia outcome. previous studies have used d-serine as add-on treatment in patients with psy-chotic disorders and high-risk patients, with positive results. so far, no study has investigated the effects in a sample of recent-onset psychosis patients. therefore, this study will include 30 patients (18-50 years old) with recent-onset psychosis. in addition to their regular treatment, patients will receive either d-serine (2 g/d) or placebo for 6 weeks. d-serine is an amino-acid naturally occurring in the brain which is prescription-free available as nutritional supplement. the primary outcome measure is total score on the positive and negative syndrome scale (panss). secondary measure-ments include panss subscales, neurocognitive tests, (f)mri, and eeg


Eligibility criteria:
inclusion criteria: * age 18-50 * recent onset psychosis (\< 5 years of overt psychotic symptoms) * able to read and understand study procedures and participant's information exclusion criteria: * clozapine use * suicidal ideation * psychotic disorders and symptoms associated with general medical conditions or substance abuse * bmi \> 30 * renal impairment (history and creatin levels (\< 80 ug/l for woman and \< 97 ug/l for men)) * hearing impairment * current or past (\< 6 months) enrolment in another clinical trial with the primary outcome to improve symptoms * pregnant or lactating women (pregnancy test)
role of stem cells, platelet rich plasma in treatment of scars

Conditions: Atrophic Scar

Summary: the objectives of this randomized controlled trial aiming to establishing a protocol of post scar revision care and to study the effect of prp and/or adipose derived mesenchymal stem cell injection in improvement of atrophic scar after scar revision.

forty patients with atrophic scar since one to five years including 25 males and 15 females with ages ranging from ten to 35 years with main age of 22.68 will be divided into four groups each included ten patients. one group will be treated with scar revision only (control group or group i), 2nd group will be injected with prp after scar revision, 3rd group will be injected with adscs after scar revision and the 4th group will be injected with a combination of prp and adscs after scar revision. all groups were assisted pre-operative and six months post-operative. complications, scar width, vancouver scar scale (vss), surgeon assessment scar scale and patient assessment scar scale will be considered the outcome measurements.

Eligibility criteria:
inclusion criteria: * patient with atrophic scar. * age group: 5 years up to 35 years. * no previous medications, surgeries or laser therapy. exclusion criteria: * patient with hypertrophic or pigmented scar. * patient with any blood disease. * patients with lipodystrophy.

Keywords: atrophic scar prp adscs
ventilation distribution in copd patients during breathing exercises

Conditions: Chronic Obstructive Pulmonary Disease; Healthy

Summary: eltgol (slow expiration with the opened glottis in the lateral posture) is an airway clearance technique performed in the lateral decubitus position. this technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure. this study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (copd), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during eltgol on ventilation distribution.

electrical impedance tomography will be used to verify the effect of the lateral posture and associated breathing techniques in copd and healthy individuals. the subjects will be placed in a standardised position before the measurements begin. the subjects will be placed in a right lateral recumbency position. the protocol comprises four manoeuvres, each interrupted by a short rest phase. each subject will begin the experiment with the spontaneous ventilation manoeuvre in order to obtain the reference ventilation distribution. this will be followed by four other manoeuvres during which ventilation was measured: 1) using an spirometer to obtain a tidal volume of 1l, 2) performing the eltgol technique independently, 3) performing the eltgol technique assisted by manual pressures applied by a physiotherapist. 4) using a positive expiratory pressure (pep) device.

Eligibility criteria:
inclusion criteria: * healthy subjects: no acute or chronic respiratory disease, normal lung function, non-smoker. * patients with copd: forced expiratory volume at one second (fev1) ≤ 80% predicted value, in stable state. exclusion criteria: * healthy subjects: obesity (bmi \> 35kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease; active implant (cardiac pacemaker or an implantable cardioverter-defibrillator (icd); thoracic skin lesion. * patients with copd: obesity (bmi \> 35kg/m²); severe scoliosis; severe cardiovascular disease; neuromuscular disease; active implant (cardiac pacemaker or an implantable cardioverter-defibrillator (icd); thoracic skin lesion.
comparison between conventional angiocatheter versus new anchoring device (karahoc) used for paracentesis

Conditions: Ascites Hepatic

Summary: comparison of success rate and complication between conventional angiocatheter versus new anchoring device (karahoc) used for paracentesis in cirrhotic patients with ascites.

this study is a multi-center, prospective, interventional study, in which subjects who meet the selection criteria are registered at each institution during the study period from the date of research approval. regardless of the order, paracentesis using karahoc and conventional angiocatheter will be performed once in all patients. the criteria for successful paracentesis is set as 3l or more of ascites drainage. during paracentesis, albumin will be infused in all patients. heart rate and blood pressure will be measured before the procedure and right after the completion of drainage, and 30 minutes later. the incidence of complications will be compared between two methods. in addition, patient and operator satisfaction will be investigated using a visual analogue scale.

Eligibility criteria:
inclusion criteria: * adult over the age of 19 * patients with pathological or clinical diagnosis of liver cirrhosis * patients with grade 2 or higher grade of ascites as a complication due to portal hypertension * patients requiring periodic paracentesis * patients consent to this study exclusion criteria:(if at least one of the following conditions apply) * patients with ascites due to peritoneal metastasis due to malignant tumor * patients with high bleeding risk (pt inr\>3, plt\<30,000/mm3) difficult to perform ascites puncture * patients with hepatic encephalopathy or hepatorenal syndrome(hrs) * patients with severe cardiovascular disease, lung disease, or dic * patients refusing paracentesis * patients who can control ascites using diuretics * pregnancy

Keywords: paracentesis cirrhosis ascites
drug concentration, immunogenicity, and efficacy study in patients with rheumatoid arthritis currently treated with etanercept, adalimumab, or infliximab

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to examine the relationship between anti-drug antibodies, serum drug concentrations, and clinical response for rheumatoid arthritis patients being treated with etanercept, adalimumab or infliximab.

cross-sectional population will be selected through convenience sampling. patients sequentially visiting the rheumatology clinic for routine care who are receiving etanercept, adalimumab, or infliximab for between 6 and 24 months will be evaluated for eligibility and interest in participation. a maximum of 200 patients per treatment will be enrolled.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. diagnosis of ra based on the 1987 american college of rheumatology revised criteria 3. current continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months. exclusion criteria: 1. treatment with biosimilar or investigational etanercept, adalimumab, or infliximab within past 6 months. 2. treatment with any other investigational drugs within past 3 months or five half lives of the drug, whichever is longer. 3. any medical condition that would interfere with rheumatoid arthritis evaluation or other study assessments (eg, fibromyalgia, lupus).

Keywords: rheumatoid arthritis etanercept adalimumab infliximab anti-drug antibody immunogenicity drug concentration
to evaluate safety, tolerability, pharmacokinetics, and food effect of single doses of gsk945237 in healthy subjects

Conditions: Healthy Subjects; Infections, Bacterial

Summary: gsk945237 is the first molecule of a new chemical class that is being developed for treatment of respiratory tract and other infections such as skin and soft tissue. this study drug has been tested in animals but has never been given to humans. this is a two part study. the purpose of the first part is to study the side effects of this drug in humans, and to study how much of the drug gets absorbed in the blood stream the second part of this study will compare absorption of the study drug in the blood stream when given with food and when given under fasting conditions


Eligibility criteria:
inclusion criteria: * healthy male and female adults between 18 and 60 years of age. * body weight proportional to height. * female subjects must be of non-childbearing potential. * qtc less than 450 msec at screening exclusion criteria: * any clinically relevant abnormality identified on the screening history and physical, or on laboratory evaluations or the 12-lead surface electrocardiogram at screening or pre-dose. * a positive pre-study alcohol/urine drug screen. * use of nicotine-containing products. * a positive pre-study hiv antibody, hepatitis b surface antigen (hbsag) or hepatitis c antibody result. * recent participation in another study, use of certain medications, consumption certain fruits, juices, or red wine

Keywords: healthy volunteer
investigation of cardiac function and cardiovascular risk factors in marathon runners- the munich marathon study

Conditions: Modes of Exercise and Myocardial and Endothelial Function; Microcirculation; Subclinical Endorgan Damage; Obesity

Summary: the purpose of this study is to determine the cardiovascular risk involved in the exertional exercise of marathon running. the researchers aim to investigate the beneficial effects of regular well-dosed exercise on health and compare these findings with the effects of the extreme strains of marathon running. subclinical injuries to heart and arteries are being investigated in different groups of runners, including obese participants.

regular exercise leads to an improvement of cardiovascular risc factors in patients with coronary heart disease, atherosclerosis and metabolic disorders. aerobic exercise has anti-inflammatory effects. in contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. this may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction. the researchers aim to define the critical role of inflammatory markers and cardiovascular risk factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners. the study groups are divided into average trained runners (40 km/week), average trained obese runners and highly trained runners (\> 70km/week). training programmes are supervised by professional coaches. individual scientific marathon contests are organized for the assessments. diagnostic tools include measurements of pulse wave velocity and heart rate turbulence, echocardiography and, for the first time, mri-scans pre- and post marathon running. additionally, cardiovascular markers such as endothelial progenitor cells (epcs)and adiponectin are measured. inflammatory markers include c-reactive protein (crp), interleukins and tumor necrosis factor.

Eligibility criteria:
inclusion criteria: * men aged 30-60 years * obese subjects: bmi \> 27 and waist circumference \> 102cm exclusion criteria: * manifested heart disease * insulin dependent diabetes mellitus * multiple drug therapy * gfr \< 60 ml/min. * claustrophobia * metal implants

Keywords: cardiovascular risc factors inflammation aerobic and exertional exercise
evaluation of prognostic monitoring for breast cancer patients with recurrence and metastasis after surgery

Conditions: Breast Cancer

Summary: the relationship between immune inflammation-related protein complexes in blood and recurrence or metastasis of breast cancer with completed standard treatment will be studied.

200 patients with breast cancer and recurrence or metastasis after surgery will be followed up. peripheral venous blood was collected every 3 to 6 months. change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. the relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Eligibility criteria:
inclusion criteria: * female * invasive breast cancer patients confirmed by postoperative pathology after surgery for breast lump * breast cancer-related chemotherapy and radiotherapy completed * breast cancer patients with recurrence and metastasis after surgery exclusion criteria: * male * aged above 60 * breast carcinoma in situ * women in pregnancy or breastfeeding * suffering from other malignant tumors * non-compliant patient
rhgaa in patients with infantile-onset glycogen storage disease-ii (pompe disease)

Conditions: Glycogen Storage Disease Type II; Pompe Disease; Acid Maltase Deficiency Disease; Glycogenosis 2

Summary: glycogen storage disease type ii ("gsd-ii"; also known as pompe disease) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (gaa). normally, gaa is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. in patients with gsd-ii, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. this study is being conducted to evaluate the safety and effectiveness of recombinant human acid alpha-glucosidase (rhgaa) as a potential enzyme replacement therapy for gsd-ii. patients diagnosed with infantile-onset gsd-ii who are greater than 6 months old, but less than or equal to 36 months old will be studied.


Eligibility criteria:
inclusion criteria: * the patient or the patient's legal guardian(s) must provide written informed consent prior to any study-related procedures being performed * the patient must have a clinical diagnosis of infantile gsd-ii as defined by: (a) the patient has/had documented (in a medical record) onset of symptoms compatible with gsd-ii by 12 months of age; (b) the patient has documented gaa deficiency as illustrated by an endogenous gaa activity less than or equal to 2% of the mean of the normal range as assessed in cultured skin fibroblasts; and (c) the patient has a left ventricular mass index greater than 2 standard deviations above the mean for age * the patient is greater than 6 months old and less than or equal to 36 months old at the time of the first dose of rhgaa * the patient and his/her legal guardian(s) must have the ability to comply with the clinical protocol exclusion criteria: * signs and symptoms of cardiac failure and an ejection fraction less than 40% * major congenital abnormality * clinically significant organic disease (with the exception of symptoms relating to gsd-ii), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the trial or potentially decrease survival * use of any investigational product within 30 days prior to study enrollment * received enzyme replacement therapy with gaa from any source

Keywords: glycogen storage disease type ii gsd-ii pompe disease
evaluation of the feasibility and efficacy of computerized anxiety treatment in a group setting

Conditions: Computerized Anxiety Sensitivity Treatment; Health Education Treatment

Summary: * statement of the research study. participants are being invited to volunteer to take part in our research study. it is up to participants whether to choose to take part or not. there will be no penalty or loss of benefits to choosing not to take part or decide later not to take part. * purpose. the reason that the researchers are doing this research is to evaluate the effectiveness and feasibility of administering a computerized anxiety intervention in a setting of five or more individuals. this intervention has already been tested and shown promise with individuals, and researchers want to see if it will function in a group setting as well. * duration. researchers think that taking part in our study will last approximately two hours, with an additional follow-up survey one month later to be completed at home via computer or smartphone. * research activities. participants will first be asked to complete several questionnaires dealing with your thoughts and feelings. once these questionnaires are completed, participants will be assigned to one of two groups, with each group viewing one of two computerized presentations and completing some group exercises afterward. once participants have completed the designated intervention, participants will then be asked to fill out surveys once again, which will complete the study appointment. one month following the appointment, participants will be sent surveys once again and will be asked to complete them at home. risks: the risks or discomforts to participants while taking part in this research include temporary distress or anxiety pr potentially feeling mild discomfort answering questions about your thoughts and feelings. benefits: as a result of taking part in this research, participants may experience improvements in mental health.


Eligibility criteria:
inclusion criteria: * adults aged 18+ and ability to use a computer or smartphone. exclusion criteria: * inability to engage in any interoceptive exercises.
success rate of immediately loaded implants with platform switched design placed in anterior part of mandible and restored with fixed prostheses

Conditions: Edentulism

Summary: change in crestal bone level implants at 5% significance level.


Eligibility criteria:
inclusion criteria: * age 18 to 80 * male or female (female non-pregnant) * sufficient oral hygiene * no inflammation/disorder in the area of implant site * edentulous mandible and sufficient prosthetic and conservative * sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm * provide written informed consent exclusion criteria: * demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas * exhibit angulation requirements of restoration exceeding 15 degrees * systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration * taking medication that would compromise post-operative healing and/or osseointegration * bone disorders such as osteoporosis, hyperparathyroidism, paget's disease, diabetes mellitus * oncology treatment * oral infection * acute gingivitis and/or periodontitis * local bone defects in the area of planned implantation * disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions) * received investigational drug within 30 days * history of illicit drugs or alcohol abuse * history of addiction to medication * allergic to dental materials * nicotine abuse (\> 20 cigarettes/day) * pregnant or nursing * clinical significant or unstable medical or physiological conditions that would compromise participation in study * unable or unwilling to return for follow-up visits for a period of 24 months

Keywords: subjects with edentulous mandible
study of trabodenoson in adults with ocular hypertension or primary open-angle glaucoma

Conditions: Primary Open-Angle Glaucoma (POAG); Ocular Hypertension (OHT)

Summary: phase iii trial involving topical application, in both eyes, of trabodenoson ophthalmic formulation 3.0% or 6.0% once per day or 4.5% twice per day, placebo twice per day, or timolol 0.5% twice per day for 12 weeks in adult subjects with ocular hypertension or primary open-angle glaucoma. all subjects who meet the study's enrollment criteria following screening will undergo washout of all prohibited medications, including their routine glaucoma medications. during the placebo run-in period, placebo is administered twice daily to both eyes in all subjects. during the treatment period, study drug is applied to both eyes for a total of 12 weeks followed by an observation period of approximately 7 days wherein no study eye drops are instilled. the purpose of the study is to assess the efficacy, tolerability, and safety of binocular topical application of trabodenoson ophthalmic formulation 3.0% or 6.0% qd or 4.5% bid for 12 weeks. timolol is being included in the trial in order to have an active control to ensure the integrity of the trial from an efficacy perspective; the primary comparator for all statistical purposes is the placebo arm.


Eligibility criteria:
inclusion criteria: * diagnosis of ocular hypertension (oht) or primary open-angle glaucoma (poag) * mean intraocular pressure (iop) of ≥24 and ≤34 exclusion criteria: * significant visual field loss or any new field loss within the past year * cup-to-disc ratio \>0.8 * central corneal thickness \ 610 µm * a recent (acute) or chronic medical condition that might obfuscate the subject's study data

Keywords: glaucoma primary open-angle glaucoma ocular hypertension adenosine agonist eye drop trabodenoson trabecular meshwork