cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Safety & Effectiveness of Vascular Sealant System

To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.

Vascular surgery encompasses a wide range of surgical procedures. In these procedures reduction of blood loss and creation of suture line is of utmost importance to the surgeon. Bleeding at the suture line may require transfusion, as well as prolonged operative and anesthesia time. Suture hole bleeding is common following using synthetic and biological grafts for vascular repair. Several topical hemostatic ans sealing agents have been developed to control suture line bleeding. This new vascular sealant possess high bonding properties, minimal tissue reaction, is biodegradable and absorbed by the body quickly. The primary focus of this study is to compare the safety and effectiveness of the vascular sealant with standard of care methods used today, specifically gelfoam/thrombin and sponge like material.

Eligibility Criteria:
Inclusion Criteria:

Subject was \> 18 years of age. Scheduled for elective vascular surgery that entails placement of a PTFE vascular graft including extra-anatomic, infrainguinal bypass, and primary and secondary arteriovenous access procedures. Subject was willing and able to comply with all aspects of the treatment and evaluation schedule. Informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site

Exclusion Criteria:

Subject had a known local or systemic infection. Subjects with known coagulopathies including hemophilia, factor deficiencies, platelet count \< 80,000 u/mL, heparin induced thrombocytopenia or uncorrected INR \> 1.5. Subject was participating in a clinical trial that requires treatment with another investigational device or drug. Subject was lactating or pregnant, or does not agree to use contraception for the duration of the study. Subject had a known hypersensitivity to any components of bovine thrombin preparations and/or material of bovine origin. The investigator determined that the subject should not be included in the study for reason(s) not already specified
Effect of Cueing on Gluteus Maximus Recruitment

Do specific verbal and tactile cues and instructions help people who perform bridging exercises to improve hip muscle strength to optimize recruitment of the gluteus maximus muscle?


Eligibility Criteria:
Inclusion Criteria:

* female
* 18-40 years of age
* normal muscle strength in lower extremities

Exclusion Criteria:

* evidence of patellofemoral pain syndrome
* evidence of femoracetabular impingement
* evidence of mechanical low back pain causing radicular (lower extremity) symptoms
* history of previous hip or knee ligament injury
* history of lower extremity trauma
* history of lower extremity surgery
* history of neurological conditions that impair motor function
* current lower extremity pain that limits functional activities
HENOX: Enoxaparine in Hemodialysis

Primary objective:

To assess clinical efficacy of single bolus anticoagulation with Enoxaparin in chronic hemodialysis

Secondary objective:

To assess safety and tolerability by the number of spontaneously reported adverse events by patients


Eligibility Criteria:
Inclusion Criteria:

* End stage renal failure requiring maintenance hemodialysis at least twice a week
* Has arterio-venous fistula or arterio-venous graft in upper extremities which can apply to blood flow \> or = 250ml/min as a vascular access for hemodialysis.
* Stable hemodialysis prescription at least 1 month before enrollment
* UFH (Unfractionated Heparin) was prescribed as an anticoagulant in the previous hemodialysis prescription
* No sign of active infection .
* Absence of recent cardiovascular complication such as myocardial infarction, DVT (Deep Venous Thrombosis), arterial occlusion, pulmonary embolism, cerebrovascular disease in previous 3 months.

Exclusion Criteria:

* Women who are breastfeeding, pregnant or of childbearing age and not using medically acceptable effective contraception
* Patients with any evidence of an active bleeding disorder
* Contraindication to anticoagulation:

  * Prior history of cerebral hemorrhage at any time
  * Coagulopathy (acquired or inherited)
  * Recent surgery
  * Major surgery such as neurosurgery within the past 3 months
  * Minor surgery such as intraocular surgery within 1 month.
  * Uncontrolled predialytic arterial hypertension (systolic BP \> 200 mmHg or diastolic BP \> 110 mmHg) at 2 successive readings
  * Impaired hemostasis i.e., known or suspected coagulopathy (acquired or inherited): baseline platelet count \<100,000/mm3 in patients without baseline diagnosis of active cancer and undergoing chemotherapy treatment (for patients with diagnosis of cancer and undergoing chemotherapy, baseline platelet count \>70,000/mm3); aPTT (activated Partial Thromboplastin Time) 1.5X the laboratory upper limit of normal; or international normalized ratio (INR) \>1.5
* Indication for thrombolytic therapy such as ischemic heart disease, ischemic stroke.
* Need for a curative treatment of anticoagulant therapy(DVT ,pulmonary embolism, ischemic heart disease)
* Patients treated with oral anticoagulant therapy within 72 hours prior to inclusion
* Patients who have had spinal or epidural analgesia or lumbar puncture within the preceding 24 hours
* Abnormal liver enzyme and total bilirubin within 2 weeks (SGPT, SGOT, total bilirubin above 2 times of Upper normal limit)
* Known hypersensitivity to heparin or LMWH (Low Molecular Weight Heparin), or pork derived products
* History of documented episode of heparin or LMWH induced thrombocytopenia and/or thrombosis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Improvement of Functional Dyspepsia After Drinking Alkaline Ionized Water From Alkaline Ionizer

The goal of this clinical trial is to evaluate the effect of drinking electrolyzed alkaline reduced water (EARW) compared to drinking purified water (PW) on functional dyspepsia (FD) patients.

The main question\[s\] it aims to answer are:

* Drinking EARW (EARW group) will alleviate gastrointestinal (GI) symptoms and FD symptoms compared to drinking PW (PW group).
* Drinking EARW will make higher the FD-related Quality of Life (FD-QOL) compared to drinking PW.

Patients will drink EARW 10mL/kg/day body weight for 6 weeks according to the instruction of researcher using the experimental device installed at each patient's house. After 6 week, EARW and PW groups will be compared to evaluate effect of GI symptom and FD-related QOL.

This study was designed as a randomized, parallel, double-blind controlled clinical trial. Enrolled patients with FD will be allocated randomly into two groups: EARW group and PW group. For 6 weeks, the patients will drink EARW and PW (10mL/kg/day body weight) in empty stomach condition. For the primary outcome measure, the gastrointestinal symptom rating scale (GSRS) will be used, and for the secondary outcome measure functional dyspepsia-related quality of life (FD-QoL), and Korean version of the Nepean Dyspepsia Index (NDI-K) will be used at baseline and at 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms onset should start at least 6 months before diagnosis based on one or more of the following symptoms Rome IV criteria (Unpleasant postprandial fullness, early satiety, epigastric pain, epigastric burning sensation)
* No evidence of structural disease in gastroscopy within the last 3 months
* Aged 19-70 years
* Who meets Rome IV criteria for functional dyspepsia
* Who have 4 or more symptoms based on the gastrointestinal symptom rating scale
* Patients who voluntarily agree to participate in this study and sign a written consent

Exclusion Criteria:

* Subjects who have a history of serious malignancy including gastrointestinal malignancy, cerebrovascular disease, and heart disease within the past 6 months were excluded

  * Subjects who have uncontrolled diabetes and hypertension despite appropriate management
  * Subjects who have a history of peptic ulcer or reflux esophagitis within the past 6 months were excluded
  * Subject who have history of gastrointestinal surgery were excluded
  * Women who are pregnant or breastfeeding
  * Subjects who are taking drugs that may affect the gastrointestinal tract (minimum of 2 weeks washout period is necessary before participating in the trial (Medications include H2 receptor blockers, anticholinergics, prostaglandins, proton pump inhibitors, gastromucosal protection agents, corticosteroids, non-steroidal anti-inflammatory drugs, aspirin, mucosal protective agents, etc.)
  * Subjects who are under drugs for therapeutic purposes such as functional food that promotes gastric health
  * Subjects who consumed more than 14 times alcohol per week in case of man and 7 times per week in case of female in the past 1 month
Patient Education in Preventing Nausea and Vomiting in Cancer Patients Receiving Chemotherapy

RATIONALE: Patient education may improve the effectiveness of ondansetron in preventing nausea and vomiting in patients receiving chemotherapy.

PURPOSE: This randomized clinical trial is studying how well patient education works in preventing nausea and vomiting in cancer patients receiving chemotherapy.

OBJECTIVES: I. Determine whether an educational intervention to enhance the effectiveness of ondansetron can prevent acute postchemotherapy nausea and emesis in cancer patients. II. Assess any potential effectiveness of the intervention on delayed postchemotherapy nausea and emesis in these patients. III. Examine the effect of the intervention on patient expectations.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified by center and chemotherapy agent (cisplatin vs carboplatin vs doxorubicin). Patients are randomized to one of two treatment arms. Arm I: Patients receive standard educational materials. Arm II: Patients receive specific intervention material in addition to standard educational materials. Patients then complete a patient information questionnaire. Patients receive ondansetron orally or IV over 10-15 minutes in addition to the first 2 courses of chemotherapy. Patients complete a nausea and emesis questionnaire after each of their first 2 chemotherapy treatments.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Chemotherapy naive with diagnosis of any cancer scheduled to receive chemotherapy containing cisplatin, carboplatin, or doxorubicin

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Insulin Therapy in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

The purpose of this study is to determine the effect of preventing hyperglycaemia in patients admitted to hospital with acute exacerbations of chronic pulmonary disease.

Hyperglycaemia is associated with increased morbidity and mortality in patients admitted to hospital with acute critical illness, myocardial infarction and stroke. Moreover patients with hyperglycaemia have a significantly longer hospital stay, higher rates of ICU admission, increased in-hospital mortality and are more likely to require transfer to a nursing home. Recently, interventional studies have linked reversal of hyperglycaemia to better clinical outcomes especially in acute myocardial infarction, cardiac surgery and in critically ill patients.

In England and Wales, it is estimated that the number of people with COPD is approaching 1.5 million. The morbidity and economic costs associated with the condition are extremely high with approximately 10% of all acute medical admissions caused by exacerbations of the underlying condition. As a corollary about 15% of patients with COPD need admission to hospital each year.

Acute hyperglycaemia is common among patients admitted with acute exacerbations of COPD. The reasons for this are likely to be multi-factorial including an association between COPD and increased risk of developing diabetes at least in women, the elderly nature of the two populations and the use of glucocorticoids which markedly increases the risk of hyperglycaemia. Admission hyperglycaemia (\>11 mmol/l) also appears to predict increased morbidity for patients with COPD admitted to intensive care.

The trial will be a randomised trial of comparison of usual treatment vs intensive insulin treatment for patients with COPD who may or may not have diabetes. Patients will take part in the trial for the first 5 days during their hospital stay.

Eligibility Criteria:
Inclusion criteria

* Patients who are NOT diabetic, admitted with COPD who are likely to be prescribed corticosteroids as part of usual care with an admission glucose level (before steroids) between 6.1 and 11.1 mmol/l.

Exclusion criteria:

* Patients with diabetes mellitus
* Patients who are nil by mouth.
* Patients with severe co-morbid disease with an anticipated life expectancy of \< 6 months.
* Patients who are unable to provide informed consent.
* Age \<18 years.
The Incidence of Aphasia, Dysarthria and Dysphagia Following Stroke

The objective of the study is to estimate the incidence and recovery of aphasia, dysarthria and dysphagia in an acute setting (first week) with the NIHSS sub-item scores for language and speech and a dysphagia screening.

Furthermore, we will evaluate the severity of aphasia, dysarthria and dysphagia in an acute setting (first few days) with standardized measurements (ScreeLing, BNT, NSVO-Z, perceptual assessment, MASA/FOIS).

To evaluate the effect of early IVT/EVT in patients with ischemic stroke on functional outcomes for language and speech via the NIHSS scale.

Study population:

Patients who are admitted to the acute Stroke Unit of the University Hospital Ghent will be recruited.

Study course:

The study has a prospective, observational design, with each participant receiving regular standard of care as follows: patients will undergo a clinical examination by a staff neurologists or the present attending in the emergency room. Tailored medical treatment will be given to each patient considering the type of stroke etc. as is standard of care (e.g. thrombolysis and/or thrombectomy for patients with ischemic stroke). Patients that are stable enough are transferred to the Stroke Unit where the neurologist or attending of the unit will reassess all stroke patients. NIHSS scores will be reported at least at day 2 +/- 1. A dysphagia screening is performed by the Stroke Unit nurses when the patient arrives at the Stroke Unit. The scores of the sub-items language and speech of the NIHSS and the dysphagia screening combined with a general screening by a speech language pathologist will be used to confirm or discard aphasia, dysphagia and dysarthria (incidence). When aphasia, dysarthria and/or dysphagia is confirmed, standardized tests will be performed. For this study, data of the following tests will be included for analysis: ScreeLing and/or BNT (aphasia), NSVO-Z and a perceptual assessment (dysarthria), MASA and/or the FOIS (dysphagia). At day 7 +/- 1, NIHSS scores will be reassessed (recovery in time). The diagnostic assessments and the NIHSS sub-items speech/language will be used to investigate the severity and recovery of the symptoms in time. Reports of the neurological clinical examination at follow-up will be retrospectively investigated if possible for additional information about recovery in time.

The total duration of data collection will be approximately 1 week and if possible three months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Acute stroke patients admitted at the Acute Stroke Unit at the university hospital (Ghent)

Exclusion Criteria:

* Previous aphasia, dysarthria, dysphagia
Early Versus Delayed Pneumococcal Vaccination in HIV

The purpose of this study is to determine whether people who are HIV-positive respond better to a vaccine for pneumonia-related disease when they are immunized immediately, or when immunization is delayed until the immune system has improved to a certain level. The study will also compare the effectiveness of polysaccharide and heptavalent vaccines.

A multicentre, randomized controlled trial using a two factorial design. Eighty patients will be randomly assigned to receive either Pneumovax (or Pneumo23 according to standard use at site) or heptavalent pneumococcal conjugate vaccine (Prevnar) prior to reconstitution of the immune system or will have immunization delayed until their CD4 count is greater than 200 cells/mm3 after the introduction of antiretroviral therapy. Randomization will be stratified by study centre. Variable block sizes will be used to try to prevent study personnel from guessing the next allocation. Random allocation lists will be generated by computer.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive
* Between 18 and 65 years of age
* Have a CD4 cell count below 200 cells/mm3
* Willing to begin/change antiretroviral therapy
* Willing and able to provide informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Have had previous pneumococcal vaccination
* Have had occurrence of pneumococcal infection (brain, blood or lung infections) in past 5 years
* Have hypersensitivity to components of either vaccine
* Have acute feverish illness at the time of vaccination
* Have had splenectomy (removal of the spleen)
* Have received treatment with IVIG within the last 6 months
Clinical and Histological Evaluation of Healos® for Alveolar Ridge Augmentation

The purpose of this study is to document and evaluate how a bone graft material (Healos®) can help rebuild bone width. Dental implants can only be placed when enough bone is found and this bone graft may help to rebuild bone width for dental implant placement. The ultimate goal of this study is to evaluate how this graft material can help bone healing.


Eligibility Criteria:
Inclusion Criteria:

* age 21 and older
* 2-4 ADJACENT maxillary front teeth missing
* require ridge augmentation and dental implant
* nonsmoker for at least 6 months
* willing to follow oral hygiene instruction and other study instruction
* able to read, understand and sign informed consent

Exclusion Criteria:

* Residual upper jaw bone equal to or narrower than 3mm.
* Insufficient gum tissue to obtain wound closure after surgery.
* Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth; or other kidney, liver, heart, thyroid, blood, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
* A history of head \& neck radiation treatment due to certain medical conditions.
* Taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, bisphosphonates, medications affecting bone turnover, antibiotics for \>7 days or any investigational drug
* Pregnancy or become pregnant during the length of the study
* Wearing removable partial dentures that may put pressure over the area where the bone graft will be placed.
A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects

This study is to evaluate the effect of multiple doses of rifampin on the single-dose PK of BMS 986141 with parameters like Cmax, AUC(INF), AUC(0-T), AUC(0-144h)


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
3. Subjects with body mass index of 18 to 32 kg/m2, inclusive.
4. Women participants must have documented proof that they are not of childbearing potential.
5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of Rifampin (1 day) plus 90 days for a total of 91 days post-treatment completion.

Exclusion Criteria:

1. Acute or chronic medical illness, subjects with bleeding diathesis, gastroesophageal reflux disease, gastrointestinal ulcer, hepatic disease,coagulation disorder,dyspepsia and being reliant on contact lenses for vision for the duration of study treatment and for 2 days after discontinuation of study treatment (eyeglasses are allowed).
2. History of nausea, diarrhoea, recent surgery, use of tobacco or nicotine containing products, drug or alcohol use, periodontal disease, hemorrhoids with rectal bleeding and recent blood donation.
3. Prior exposure to BMS-986141 or prothrombin complex, any investigational product or placebo within 4 weeks of study treatment start, any prescription or over the counter drugs except those cleared by BMS clinical monitor.
4. History of hypersensitivity to BMS 986141, rifampin, any rifamycins or related compounds, or any component of the formulations
5. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
Maternal Cardiovascular Adaption to Pregnancy in IVF Patients Following Frozen Embryo Transfer (FET)

Aim of the study is to explore the effect of a lacking corpus luteum on maternal cardiovascular and metabolic adaption to pregnancy by the use of magnetic resonance imaging (MRI).

The use of programmed frozen embryo transfer cycle (FET) in IVF women is associated with an increased risk of obstetric complications (pregnancy-induced hypertension, preeclampsia, postpartum hemorrhage and placenta accreta) compared to FET in natural cycle.

The lack of corpus luteum in programmed cycles and the subsequent absence of circulating vasoactive substances may lead to an impaired cardio-vascular adaption to pregnancy and thereby an increased risk of pregnancy-induced hypertension and preeclampsia.

The cardiovascular and metabolic adaption to pregnancy is evaluated throughout pregnancy by use of Magnetic Resonance Imaging (MRI) as well as non-invasive measurements by use of elastography and seismocardiography.

Patients are screened for preeclampsia throughout pregnancy with measurements of blood pressure, urine samples as well as blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Autologous embryo transfer in programmed FET-cycle or modified-natural FET-cycle or
* Planned donor egg transfer in programmed FET-cycle or modified-natural FET-cycle
* Age \< 40 years
* BMI \< 35
* Primary diagnosis being unexplained infertility, male infertility or tubal factor
* Singleton blastocyst transfer

Exclusion Criteria:

* PCOS
* Essential hypertension
* Diabetes Mellitus (type 1 or 2)
* Known cardiac disease
* Antiphospholipid syndrome, Lupus erythematosus, rheumatoid disease
* Preelampsia, gestational hypertension, gestational diabetes or severe intrauterine growth restriction (IUGR) in any previous pregnancy
* Smoking
* Multiple pregnancy
* Severe claustrophobia or any other contraindications to MRI