Kornimate/medical-research-clean huggingface dataset:
this study tests the safety of inhaled bay1237592, how the drug is tolerated and how it effects patients with high blood pressure in the arteries of the lungs in the two different disease groups pulmonary arterial hypertension (pah) and chronic thromboembolic pulmonary hypertension (cteph)

Conditions: Hypertension, Pulmonary

Summary: in this trial the effects of the inhaled drug bay1237592 will be studied in patients with high blood pressure in the pulmonary blood vessels due to pulmonary arterial hypertension (pah) and due to chronic thromboembolic pulmonary hypertension (cteph). pulmonary hypertension is characterized by the elevation of pressure in the pulmonary arteries (pap) and of the pulmonary vascular resistance (pvr) leading to increased workload of the right chamber of the heart to eject blood against this elevated resistance. the goal of this study is to measure the safety and tolerability of the drug as well as the reduction of the pvr at different doses in part a patients without specific treatment for ph (untreated patients) will be tested. in part b also patients stably pre-treated with specific ph drugs will be studied in combination with the new inhaled drug


Eligibility criteria:
main inclusion criteria: * patients with pah or cteph undergoing medically indicated routine invasive diagnostics * men and women aged 18 to 80 years part a: - untreated patients: therapy-naïve patients (defined as off treatment with pde-5 inhibitors, endothelin receptor antagonists, prostanoids, or other sgc stimulators/activators) with pah or cteph or patients pre-treated with these medications who have to undergo a drug specific wash-out period at the discretion of the investigator for least 24 h prior to day -1 if medically safe part b: * untreated patients with pah or cteph: -- group 1 (total will be summed up with corresponding dosage group from part a) * pre-treated patients with pah or cteph: * group 2: pre-treated patients with any kind of monotherapy\* for pah/cteph * group 3: pre-treated patients with any kind of double combination therapy\* for pah/cteph \* patients receiving inhaled iloprost, and patients who are known responders to ino are excluded main exclusion criteria: - medical history indicating a different cause for ph than pah or cteph according to the guidelines of the european society of cardiology (esc) and the european respiratory society (ers), such as significant left heart disease, valvular disease, or structural heart defects, as assessed by the investigator, significant pulmonary disease or clinical suspicion of pulmonary venoocclusive disease

Keywords: pah cteph pulmonary arterial hypertension chronic thromboembolic pulmonary hypertension
use of a mesh to prevent parastomal hernia

Conditions: Parastomal Hernia

Summary: randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. the aim of the study was to reduce parastomal hernia (ph) occurrence by implanting a lightweight mesh in the sublay position. patients were followed up a) clinically and b) radiologically by means of abdominal ct. in the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). the implantation of the mesh reduces the appearance of ph, is well tolerated, and does not increase morbidity


Eligibility criteria:
inclusion criteria: * patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum, * aged over 18, * charlson comorbidity index below 7 * elective surgery * radical surgery exclusion criteria: * loop colostomies, * emergency surgery, * body mass index above 35 kg/sq.m., * palliative surgery, * hepatic cirrhosis, * severe copd (requiring home oxygen treatment), * corticoid treatment

Keywords: parastomal hernias tolerance of lightweight meshes paracolostomy hernias peristomal hernias
efficacy and safety (including 24-hour holter monitoring) of tiotropium inhalation capsules in patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this study is to evaluate the effect of inhaled tiotropium bromide on trough fev1 and to assess the cardiac effects through 12-lead and holter ecg monitoring in patients with copd.


Eligibility criteria:
inclusion criteria: * history of copd, fev1 less than or equal to 65%, fev1/fvc less than or equal 70% * smoking history greater than or equal to 10 pack years * not history of clinical diagnosis of asthma and/or atopy * a history of thoracotomy with pulmonary resection * patients requiring the use of supplemental oxygen therapy for \>12 hours per day * chronic use of systemic corticosteroids in an unstable daily dose * patients with a recent history of myocardial infarction * a known hypersensitivity to anticholinergic drugs
minimally invasive reduction and fixation of thoracolumbar fractures

Conditions: Thoracic Fracture; Lumbar Fracture

Summary: spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. depending on the type of injury there are various methods available to stabilize the spine. the proposed study should clarify whether the combined reduction and fixation with a minimally invasive approach can actually be done with the same precision as in a conventional approach. the primary endpoint of this investigation is the monosegmental anterior wedge angle (awa), and its maintenance over the first 6 postoperative weeks. it is the aim of the study to gather key radiological, clinical and subjective patient outcome parameters for its patient population that will allow to compare the results to a historical group of patients. the study design is non-interventional, prospective, open,and multicentric.


Eligibility criteria:
inclusion criteria: * minimum age of the patients of 18 years * indication for operative treatment of fractures of the thoracic or lumbar spine * singular a3.1-3 fractures according to the ao classification system * declaration of consent in participation in this study and willingness to the treatment according to the study protocol * physical and mental ability to meet the clinical and radiological follow-up plan exclusion criteria: * additional severe trauma, that makes survey of the patient difficult or impossible influence the results of the fracture treatment significantly * additional trauma or fractures of the spine * other serious conditions complicating participation in the study * systemic or local infections * pregnancy or planned pregnancy * neurological deficits * severe blood coagulation disorders diagnosed preoperatively * intake of preoperatively anticoagulants * osteoporosis * bone metabolism disorders * laminectomy necessary during surgery results in exclusion of the patient either

Keywords: thoracolumbar fracture fixation fixateur interne minimal invasive percutaneous
taps2 transfusion antenatally in pregnant women with scd

Conditions: Sickle Cell Disease; Pregnancy, High Risk; Blood Transfusion Complication

Summary: sickle cell disease (scd) is a serious inherited blood disorder affecting red blood cells. when oxygen levels drop the red cells become abnormally shaped and unable to move through the blood vessels easily. blood and oxygen do not reach body organs, resulting in episodes of severe pain and other complications. pregnant women with scd have an increased risk of both sickle and pregnancy complications, including raised blood pressure. their babies may grow more slowly in the womb, are more likely to be born early and need special care, and have a higher risk of dying. the only treatments currently available for women with scd are hydroxycarbamide (which cannot be used during pregnancy) and blood transfusion. currently, blood transfusion is only used during pregnancy to treat emergency complications. it has been suggested that giving blood transfusions throughout pregnancy could improve outcomes for both mother and babies. in serial prophylactic exchange blood transfusion (spebt), sickle blood is mechanically removed and simultaneously replaced with donor red cells. a trial is needed to assess spebt given every 6-10 weeks, starting before 18 weeks of pregnancy, compared to standard care. this trial will evaluate outcomes for women (e.g. hospital admission, frequency of crisis) and their infants (e.g. early delivery, birthweight). however, the feasibility of such a study needs to be assessed before embarking on a large multicentre trial. this study is therefore a feasibility study in which we will randomly allocate participants to have either spebt or standard care. the study will be carried out in multiple maternity units in england and last two years. the willingness of eligible women to join the study will be assessed, along with how many participants remain part of the study until the end and if participants find the intervention acceptable.


Eligibility criteria:
inclusion criteria: * pregnant women with sickle cell disease (all genotypes) * gestation 18+0 weeks or below * willing and able to give informed consent * singleton pregnancy exclusion criteria: * on long term transfusion programme prior to pregnancy for amelioration of scd * prior hyperhaemolysis * red cell phenotype or antibodies present prevent likely provision of adequate red cell units to support elective ebt programme * unable to receive blood transfusion for social, religious or clinical reasons * current diagnosis of major medical or psychiatric comorbidity which in the randomising clinicians opinion renders them unable to enter trial

Keywords: pregnancy exchange transfusion perinatal complications
pulsewatch: smartwatch monitoring for atrial fibrillation after stroke

Conditions: Stroke; Atrial Fibrillation

Summary: the goal of this research study is to develop a smartphone application capable of monitoring paroxysmal atrial fibrillation (paf) in people who have survived a stroke or transient ischemic attack (tia) or people who are at risk for a stroke and are age 50 and older. the study team plans to develop a highly effective and easy to use cardiovascular surveillance system to monitor patients for paf on a nearly continuous basis. people involved in the development of this system include patients, their caregivers, health care providers, and computer programmers.


Eligibility criteria:
inclusion criteria: * history of transient ischemic attack (tia) or stroke or at risk for stroke based on a cha2ds2-vasc score equal to or greater to a score of 3, presenting at the umass memorial medical center (ummmc) inpatient service or ambulatory clinic (neurology clinics and cardiovascular clinics included) * age: greater to or equal to 50 years of age * able to sign informed consent * willing to participant in a focus groups and/or hack-a-thon for aim 1 participants only * willing and capable of using pulsewatch (smartwatch and smartphone app) daily for up to 44-days and returning to ummmc for up to two study visits for aims 2 and 3 participants only exclusion criteria: * major contraindication to anti-coagulation treatment * plans to move our of the area over the 44-day follow up period * serious physical illness (e.g., unable to interact with a smart device, or communicate verbally or via written text) that would interfere with study participation * known allergies or hypersensitivities to medical grade hydrocolloid adhesives or hydrogel * patient with life threatening arrhythmia's who require in-patient monitoring for immediate analysis * patient with implantable pacemaker as paced beats interfere with ecg readings * lacking capacity to sign informed consent * unable to read and write in english * plans to move from the area during the study period * unwilling to complete all study procedures * major contraindication to anti-coagulation treatment (i.e., major hemorrhagic stroke) * individuals who are not yet adults * pregnant women * prisoners

Keywords: cardiac arrhythmias
analysis of biological progression and regression of hellp syndrome in time

Conditions: HELLP Syndrome; Preeclampsia

Summary: prospective observational study about progression and regression of biological parameters of hellp syndrome

data collection included a comprehensive review of pathological histories, identification of complications based on clinical presentation, daily monitoring of biological parameters, documentation of transfusion events, recording of corticosteroid administration according to gestational age, and detailed reporting of extraction and analgesia techniques.

Eligibility criteria:
inclusion criteria: * pregnant women who are admitted to the maternal icu for a biological hellp syndrome exclusion criteria: * patients whose biological presentation was attributable to other conditions, such as microangiopathies or leukemia. * patients who benefited from plasma exchange therapy

Keywords: preeclampsia hellp syndrome thrombocytopenia maternal mortality
effect of stabilization exercises in individuals with non-specific chronic neck pain.

Conditions: Neck Pain

Summary: in this study, the effects of an 8-week telerehabilitation-based stabilization training in persons with chronic non-specific neck pain will be investigated.

the aim of the study is to investigate the effects of different telerehabilitation-based stabilization exercises on gait, balance, pain, functionality and depression in individuals with non-specific neck pain. the population of the study will consist of 40 individuals with chronic neck pain, who are followed up with the diagnosis of chronic non-specific neck pain in the department of neurosurgery of dokuz eylul university faculty of medicine. the socio-demographic characteristics of the participants will be recorded through mutual interviews, 'bts g-walk' device for walking, 'biodex balance' device for balance, neck disability index for disability assessment, visual analog scale (vas) for pain severity, the beck depression inventory will be used for depression. all participants will walk to the length of a 10 m walkway and back to the start point with the bts g-walk (bts bioengineering s.p.a., garbagnatemilanese, italy), a wearable sensor device to assess spatiotemporal gait parameters. individuals will walk first in a normal walking pattern and then in a fast walking pattern. biodex stability system will be used for balance measurement. the exercises will be taught to the participants face-to-face once in the first session, within the framework of social distance and hygiene rules, and then they will have exercise sessions by mutual videoconference method via the zoom program for 8 weeks. patients will be randomly divided into two groups. cervical stabilization and scapular stabilization training will be given to the first group, and cervical stabilization and core stabilization training will be given to the second group. the effects of these two different telerehabilitation-based exercise methods will be compared.

Eligibility criteria:
inclusion criteria: * having non-specific neck pain for at least 3 months * having a neck disability index (bdi) score of 10 and above, exclusion criteria: * receiving physiotherapy for neck pain in the last 6 months * having speech and comprehension problems, * those who have undergone neck surgery * those with sensory loss * those diagnosed with orthopedic, neurological or vestibular disease * those with a history of trauma ( wiplash) * cases diagnosed with cancer, osteoporosis or treated will not be included in the study.

Keywords: chronic non-spesific neck pain telerehabilitation gait balance
safety, pharmacodynamics, and efficacy of migalastat in pediatric subjects (aged >12 years) with fabry disease

Conditions: Fabry Disease

Summary: this is a long-term, open-label study to evaluate the safety, pharmacodynamics, and efficacy of migalastat in subjects \> 12 years of age with fabry disease and amenable gla variants


Eligibility criteria:
inclusion criteria: * male or female subjects diagnosed with fabry disease \> 12 years of age who completed study at1001-020 * subject's parent or legally-authorized representative is willing and able to provide written informed consent and authorization for use and disclosure of personal health information or research-related health information, and subject provides assent, if applicable * if of reproductive potential, both male and female subjects agreed to use a medically accepted method of contraception throughout the duration of the study and for up to 30 days after their last dose of migalastat exclusion criteria: * subject's last available estimated glomerular filtration rate (egfr) in the previous study was \< 60 ml/min/1.73 m2 * subject had advanced kidney disease requiring dialysis or kidney transplantation * subject received any investigational/experimental drug, biologic, or device within 30 days before baseline, with the exception of migalastat * subject anticipated starting gene therapy during the study period * subject had any intercurrent illness or condition at visit 1 that may have precluded the subject from fulfilling the protocol requirements or suggested to the investigator that the potential subject may have an unacceptable risk by participating in this study * subject had a history of allergy or sensitivity to migalastat (including excipients) or other iminosugars (eg, miglustat, miglitol) * subject required treatment with replagal® (agalsidase alfa) or fabrazyme® (agalsidase beta) * subject required treatment with glyset® (miglitol) or zavesca® (miglustat) * female subject was pregnant or breast-feeding, or was planning to become pregnant during the study period * in the opinion of the investigator, the subject and/or parent or legally-authorized representative was unlikely or unable to comply with the study requirements

Keywords: lysosomal disease migalastat
hpv self-test to increase cervical cancer screening in asian women

Conditions: Cervical Cancer

Summary: the study was to pilot test the feability of using hpv self-sampling testing to increase cervical cancer screening among under-served asian women through engaging community-based organizations in the greater philadelphia and new york city area, addressing a significant global cancer burden, the preventable infection-related cervical cancer.


Eligibility criteria:
inclusion criteria: 1. gender: female 2. age: 30-55 3. no current diagnosis of cervical cancer, and 4. have not participated in cervical cancer screening within the past 3 years. exclusion criteria: -
comparison of chitosan, ankaferd and tranexamic acid in dental extraction in liver pre-transplant children

Conditions: Liver Cirrhosis

Summary: the aim of the present study is: to assess the hemostatic effect of chitosan-based dressing, ankaferd and tranexamic acid after extraction in children with end stage liver diseases where the: • primary objective: is to evaluate which of the previous materials will be the most effective as a hemostatic agent


Eligibility criteria:
inclusion criteria: 1. patients with end stage liver disease that need dental extraction before liver transplant 2. patients aged between 4 and 9 years old 3. patients having international normalized ratio (inr) values ≤ 4 (i.e. 1-4) exclusion criteria: 1. patients with allergy to sea food because chitosan- based dressing is manufactured from freeze-dried chitosan, derived from shrimp shell. 2. patients having genetic bleeding disorders 3. patients with renal diseases
immunogenicity and safety study of serum-free avonex

Conditions: Multiple Sclerosis

Summary: to evaluate the immunogenicity of a serum-free pre-formulated solution of avonex when given to interferon beta naive patients with relapsing/remitting multiple sclerosis.


Eligibility criteria:
inclusion criteria: * must have a diagnosis of relapsing/remitting ms as defined by mcdonald, et al15; criteria numbers 1-4. * must have an expanded disability status scale (edss) score between 0 and 5.5, inclusive. * must be able to understand and comply with the protocol. exclusion criteria: * has experienced a relapse within 2 months prior to day 1. relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 48 hours, and accompanied by new objective neurological findings upon examination by the investigator. * history of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that would preclude therapy with interferon beta. * abnormal screening or baseline blood tests determined to be clinically significant by the investigator * history of a seizure within 3 months prior to day 1. * history of suicidal ideation within 3 months prior to day 1 or an episode of severe depression within 3 months prior to day 1. * known allergy to natural rubber latex. other inclusion and exclusion criteria apply as per protocol

Keywords: multiple sclerosis interferon beta-1a avonex
optimal duration of anticoagulation therapy for low-risk pulmonary embolism patients with cancer

Conditions: Venous Thrombosis; Neoplasms; Anticoagulants

Summary: the primary purpose of this study is to determine the optimal duration of anticoagulation therapy (6 months versus 18 months) with direct oral anticoagulant (doac) for cancer-associated low-risk pulmonary embolism patients. the major secondary purpose of this study is to investigate whether home treatment of cancer-associated low-risk pulmonary embolism patients with rivaroxaban is feasible, effective, and safe through an observational management study.

venous thromboembolism (vte), including pulmonary embolism (pe) and deep vein thrombosis (dvt), is a major health problem in the world. there have been many clinical studies evaluating vte, although data on low-risk pe, including incidental pe and asymptomatic pe has been quite limited. however, low-risk pe was reported to account for a large proportion of all the diagnoses of pe detected on computed tomography in daily clinical practice, and optimal management strategies for these patients are becoming clinically more relevant. the current american college of chest physicians (accp) guidelines weakly suggest the same approach for low-risk pe patients with cancer as other pe patients with cancer. however, whether anticoagulation therapy should be continued indefinitely remains uncertain and the duration of treatment in these patients might vary widely in daily clinical practice. recently, some observational studies reported that low-risk patients with cancer have a high risk of vte recurrence, suggesting the benefit of prolonged anticoagulation therapy. in this open-label, superiority trial, the investigators randomly assign low-risk pe patients with active cancer to receive either rivaroxaban for 6 months (short doac group) or rivaroxaban for 18 months (long doac group).

Eligibility criteria:
inclusion criteria: * patients with active cancer (solid and hematologic malignancies) presenting with objectively newly confirmed pulmonary embolism who are scheduled to be treated by anticoagulation therapy. * patients with an simplified pulmonary embolism severity index (pesi) score of 1 or less exclusion criteria: * contraindicated patients for rivaroxaban (clinically significant liver disease, bacterial endocarditis, active bleeding, inadequate contraceptive measures if of childbearing potential, concomitant use of strong cytochrome p-450 3a4 inhibitors or inducers or p-glycoprotein inhibitors or inducers) * expected life expectancy \<6 months * patients who do not provide written informed consent * patients who judged to be inappropriate for enrolment by the physician (including patients at a high risk of gastrointestinal or genitourinary bleeding)

Keywords: venous thrombosis neoplasms anticoagulants