cyrilzakka/clinical-trials huggingface dataset:
Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial.

The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.

The secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures.

Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial.

This study's primary objective is to compare the amounts of postoperative bleeding during postoperative 24 hours through chest tube drainage using two different tranexamic acid (TXA) administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery.

The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, thromboembolic complications, and postoperative seizures.

Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.

Eligibility Criteria:
Inclusion Criteria:

* patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
* patients who provide written informed consent

Exclusion Criteria:

* pregnancy
* refusal of allogenic blood transfusion
* taking thrombin
* history of thromboembolic and familial hypercoagulability disease
* recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
* hypersensitive to TXA
* histroy of convulsion or epilepsy
* taking hemodialysis
* history of Heparin-induced thrombocytopenia
Doravirine and Weight Gain in Antiretroviral Naive

The purpose of this study is determine whether different antiretroviral therapy (ART) changes the effects on body fat and predict the weight change in Black and Hispanic females.

Study is three-arm, open-label, randomized, interventional trial, in which all patients who are successfully enrolled will be randomized 1:1:1 to initiate ART therapy with Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate vs. Doravirine + Emtricitabine/Tenofovir Alefenamide, Bictegravir/Emtricitabine/Tenofovir Alafenamide. All patients will be followed or a total o 48 weeks.

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Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* No prior exposure to antiretroviral therapy for \>7 days prior to study entry;
* Plasma HIV1 RNA concentration \>/=5000 copies/mL;
* CD4 T cell count \>/=200 cells/µL.
* For persons capable of becoming pregnant, negative serum or urine pregnancy test within 45 days prior to entry
* Ability and willingness of participant or legal guardian/representative to provide informed consent

Exclusion Criteria:

* Evidence of resistance to DOR, TDF, 3TC/FTC or BIC.
* Creatinine clearance \<60 mL/min
* Use of weight loss agents or plans to initiate weight loss program (diet or exercise-based)
* Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation
Phytosterol Supplementation and Lipoprotein Subfractions

The goal of this clinical trial was to evaluate the effects of phytosterol supplementation to the diet on lipids, LDL and HDL subfractions, and on the quality of LDL in apparently healthy subjects.

The main questions it aims to answer are:

* do phytosterols reduce LDL-cholesterol and modify LDL and HDL subfractions?
* do phytosterols modify the quality of LDL?

Participants were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks, followed by a 7-day washout period, where treatments were switched for another 12-weeks.

Military police from the ROTA (Rondas Ostensivas Tobias de Aguiar, N=60), with hypercholesterolemia in primary prevention were recruited. Of those, 27 did not meet entry criteria, 10 were excluded for not following the protocol. Twenty-three individuals were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks (w), followed by a 7-day washout period, where treatments were switched for another 12-w.

Study was prospective, randomized, open label, cross-over, with parallel arms and blinded endpoints.

Anthropometry, food consumption and laboratory parameters were evaluated every 12-w.

HDL and LDL subfractions were analyzed by the electrophoresis system in polyacrylamide gel (Lipoprint System®).

Plasma LDL was separated by ultracentrifugation and the quality of the LDL analyzed by nonlinear optical response (Z-scan and UV-vis spectroscopy techniques).

Eligibility Criteria:
Inclusion Criteria:

* participants of both sexes, aged \>18 and \<65 years, literate, in primary prevention of cardiovascular disease, with LDL-c ≥130mg/dL and \<190 mg/dL and triglycerides \<400 mg/dL.

Exclusion Criteria:

* secondary causes of dyslipidemia, renal (creatinine \> 2mg/dL), hepatic (AST or ALT \> 1.5 ULN), or metabolic (HbA1c \>8.0%) dysfunction, with BMI \<18.5 or \>40 Kg/m2, recent surgery, disabsortive syndrome, malignancies, under lipid-lowering therapy, unable or unwilling to participate, or with less than 80% adherence to phytosterols
Quadricipital Electrical Stimulation in COPD Patients Rehabilitation

Quadricipital electrical stimulation added to respiratory rehabilitation in COPD patients.

Quadricipital electrical stimulation (ES) in chronic obstructive pulmonary disease (COPD) patients has been demonstrated to improve both dyspnea and physical status. The aim of our study is to demonstrate that ES added to respiratory rehabilitation program induces a greater improvement on exercise tolerance in such patients.

Design : 160 patients with severe COPD will be randomly assigned to 2 groups : either rehabilitation program (group 1), either ES and rehabilitation program (group 2). In both groups, rehabilitation program comprises endurance training, 18 - 24 sessions (6 - 8 weeks), health education, global muscular strengthening. In group 2, bilateral quadricipital electrical stimulation 30 min sessions is added 5 days / week.

Subjects : COPD patients with FEV1 \< 60% pred, FEV1/VC \< 70%, and TLC \> 80%, with dyspnea, in stable conditions, and 18 \> BMI \< 35 kg/m² .

Intervention : 6 min walking distance, incremental exercise test data (aerobic capacity, work rate, ventilatory threshold), physical activity with activity monitor, health related quality of life will be determined before and after training.

Abbreviations : FEV1 = forced expiratory volume in 1 sec; VC = vital capacity; TLC = total lung capacity; BMI = body mass index.


Eligibility Criteria:
Inclusion Criteria:

* Subjects : COPD patients with FEV1 \< 60% pred, FEV1/VC \< 70%, and TLC \> 80%, with dyspnea, in stable conditions, and 18 \> BMI \< 35 kg/m²

Exclusion Criteria:

* BMI 18 \< or \> 35 kg/m²
* Pregnant women
* peripheral neuropathy
* cardio respiratory incremental test contra-indication
* evolutive cancer
* cardiac or cerebral pace maker, implanted cardio defibrillator
* no informed consent given
Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation

The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing ablation for atrial fibrillation at St. Olavs Hospital
* Implanted Reveal
Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.


Eligibility Criteria:
Inclusion Criteria

- Documented S. aureus bacteremia

Exclusion Criteria

- Patients who had received or would have received more than 72 hours of potentially effective systemic antistaphylococcal therapy within 7 days prior to randomization. The following agents were considered potentially effective antistaphylococcal therapy: antistaphylococcal penicillins (including nafcillin, oxacillin, or cloxacillin), cephalosporins, fluoroquinolones, glycopeptides (including vancomycin and teicoplanin) and linezolid
Clinical and Sonoelasographic Evaluation of the Elasticity of the Uterine Cervix in Pregnant Patients at Term

In this study the investigators aim to compare the cervical dilation time in pregnant patients at term who had clinical evaluation of the cervical consistency with patients who had also quantitative measurement of the cervical elasticity in .

Softening of the uterine cervix in pregnant patients at term is usually evaluated clinically by subjective vaginal manual examination (Bishop's score).One of the variables of the score is cervical consistency which is considered important factor.The cervical consistency is described as soft,medium or stiff.However, the digital assessment of consistency is subjective and less reproducible.The Bishop's score also gives information about expected duration of labor after induction. The consistency of the uterine cervix can also be evaluated objectively sonoelastographically by measuring the cervical elasticity.This is illustrated by a color map, where low stiffness (soft tissue) is indicated in red, middle stiffness is in green and high stiffness (hard tissue) is in blue.In this study we aim to compare the cervical dilation time between the clinical evaluation of the cervical consistency and the quantitative measurement of the cervical elasticity in pregnant patients at term.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients at term

Exclusion Criteria:

* Various pregnancy complications
Impact of Live Streaming Exercise on Liver Health in MASLD Pregnant Women

Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) is a clinical and pathological syndrome characterized primarily by excessive intracellular fat accumulation in the liver, excluding alcohol-related and other specific causes. Recent research has identified an association between MASLD and an increased risk of pregnancy-related complications and adverse pregnancy outcomes, including gestational diabetes, preeclampsia, preterm birth, and large-for-gestational-age infants. MASLD in pregnant women poses multiple risks to maternal and infant health. Regular physical exercise during pregnancy has been shown to effectively reduce the incidence of pregnancy complications and adverse outcomes, while also alleviating hepatic steatosis and fibrosis. This study is a randomized controlled trial aimed at exploring the feasibility and effectiveness of online exercise interventions for pregnant women with MASLD, as well as conducting a cost-effectiveness analysis and investigating the underlying physiological mechanisms based on the liver-gut axis. The findings are intended to provide scientific evidence and practical recommendations for managing pregnancy health and intervening in MASLD during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy;
2. Gestational age ≤10-13+6 weeks at enrollment;
3. Age between 20 and 45 years;
4. Patients diagnosed with MASLD;
5. Signed informed consent.

Exclusion Criteria:

1. Cervical length ≤ 25 mm;
2. History of threatened abortion;
3. Exercise contraindications or doctor advice not to exercise during pregnancy;
4. Current or previous use of drugs that affect body weight (such as hormones);
5. Patients with chronic hepatitis virus or other chronic liver diseases, excluding MASLD;
6. Non-natural conception or infertility treatment;
7. Any previous medication for hypertension, diabetes, heart disease, kidney disease, systemic lupus erythematosus, thyroid disease or mental illness;
8. Participating in other pregnancy intervention research projects.
fMRI Connectivity in Fracture Hip Patients

The long-term goal of this study is to evaluate cognitive function preoperatively and develop techniques of intervention in the perioperative period which would optimize brain function and functional recovery following surgery.

In this protocol, subjects who are anticipated to be operated for hip fracture will be studied after surgery. Brief cognitive exam will be done followed by fMRI of connectivity and diffusion tensor imaging (DTI). Connectivity (neuronal changes) and DTI (Anisotropy and mean diffusivity) data will be compared with age matched controls and correlated with subjective measures of cognition.

Eligibility Criteria:
Inclusion Criteria:

* Patients 65 years and older
* Patients who have fracture hip and are anticipated to have surgery

Exclusion Criteria:

* Patients who have contraindications for MRI like pacemaker, automatic implanted cardiac defibrillator (AICD), implanted infusion pumps etc.
* Patients who are claustrophobic
* Patients with severe cognitive impairment (who may not be able to cooperate during the cognitive exam and fMRI)
Propranolol for Treatment of Cocaine Addiction - 2

The purpose of this study is to evaluate the safety and efficacy of propanolol in the early treatment of cocaine dependence.


Eligibility Criteria:
Please contact site for information.
Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

The investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.

The purpose of the project is to determine the effects of using different prosthetic socket designs with the same suspension and components on the biomechanical asymmetry, residual limb movement within the socket (socket pistoning) and comfort/satisfaction of 20 Veterans with a transtibial amputation and 20 Veterans with a transfemoral amputation, 10 males and 10 females per group.

Eligibility Criteria:
Inclusion Criteria:

* The investigators will enroll up to 40 Veterans

  * 20 with unilateral transtibial amputation
  * 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old
* All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation
* Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator

Exclusion Criteria:

* Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)
Experiment to Assess Preferences for Novel Hormonal Therapy and Androgen-deprivation Therapy in Prostate Cancer Patients

The purpose of this study is to quantify the preferences for novel hormonal therapy (NHT) +/- androgen-deprivation therapy (ADT) vs ADT monotherapy among patients with non-metastatic hormone-sensitive prostate cancer (PC) in the United States (US), Germany, Spain, France, Italy, the United Kingdom (UK), South Korea, Australia, and Brazil, using a discrete choice experiment (DCE).

The study will collect data from eligible patients (six total) and physicians (six total) from one-on-one qualitative interviews and eligible patients from online surveys. Approximately 330 patients with PC will be recruited to complete the online DCE survey.

Eligibility Criteria:
Inclusion Criteria:

Physician inclusion criteria

* The physician is a certified urologist or oncologist. The final selection will be adjusted to local practice.
* The physician has cared for at least ten nmHSPC patients in the past year.
* The physician has experience prescribing NHT and ADT. Patient inclusion criteria
* The patient has nmHSPC after radiotheraphy (RT) and/or radical prostatectomy (RP), defined as an adult patient with nmPC who had RT and/or RP.

Exclusion Criteria:

Physician exclusion criteria

* None Patient exclusion criteria
* The patient is castration resistant.
* The patient has metastatic PC.
Effect of Antioxidant Intake on Resistin Levels In Patients With Gum Disease and Diabetes

To evaluate the effectiveness of non surgical periodontal therapy in addition to antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease

A total of 40 patients with diabetes and chronic periodontitis attending the department of periodontics will be recruited in the study. 40 subjects will be randomly divided into two groups(control group and test group with 20 subjects in each group). Clinical parameters such as gingival index, periodontal index, random blood sugar levels(RBS) and glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and 2ml of blood sample will be collected by venepuncture ( baseline and after 3 months) and stored in Ethylenediaminetetraacetic acid containing vials to identify the levels of resistin in the patients by Enzyme linked immunosorbent assay. Group A will receive Alpha lipoic acid at baseline for a period of 3 months. Both the groups will receive scaling and rootplaning at baseline.

Eligibility Criteria:
Inclusion Criteria: Diabetic patients with Chronic periodontitis.

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Exclusion Criteria: Smokers, Pregnant \& lactating women, Prior periodontal therapy within 3 months.
Microbiotic Analysis in Digestive Endocrine Tumors

Incidence of digestive neuroendocrine tumors are increasing. Analysis of individual microbiota is a way to explore new neoplastic mechanisms, tumor identification and therapeutic orientations. This prospective pilot study aims to describe fecal bacterial phylogeny of patients with digestive neuroendocrine tumor.

Bacterial genomic signature will be recorded at initiation of Lanreotide treatment in naive patient with digestive neuroendocrine tumor (pancreas or small intestine), metastatic or locally advanced, as well as after one year follow up.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* naive patient with digestive neuroendocrine tumor (pancreas (cytology or histology per endoscopy or on surgical specimen) or small intestine), secreting or not, initiating a extended release Lanreotide treatment
* registered with a social security scheme

Exclusion Criteria:

* medical contraindication to somatostatine analogs use
* history of extended release somatostatine analogs treatment
* antibiotic use or colonoscopic purge in the last 3 weeks preceding fecal sample
* pregnant or breastfeeding women
* person requiring tutorship, guardianship, or person legally protected
ُEfficacy of Insulin Versus Hyalase Hydro-dissection of Median Nerve in Rheumatoid Arthritis Patients

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy in Rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection using insulin versus hyalase versus saline, ultrasounic guided as an effective treatment

Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy in Rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection of median nerve inside CT twice injections with interval 2 weeks using insulin and 10 cc saline versus hyalase and 10 cc saline versus 10 cc saline, ultrasounic guided as an effective treatment of CT

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis in remission

Exclusion Criteria:

* active Rheumatoid arthritis
Investigating the Performance of a New Adhesive Strip

This study investigates the performance of a new adhesive


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than one year
4. Have intact skin on the area used in the evaluation
5. Has a stoma with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.

5.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265)
Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).

Clomiphene citrate (CC) is the major pharmaceutical treatment of anovulation in polycystic ovary syndrome, used for over 40 years. Despite the vast experience using this drug, the pregnancy rates associated with its use are low and recent large studies from Australia regarding birth defects suggest that CC may be associated with birth defects. Alternatives to CC are limited. Another selective estrogen receptor modulator, Raloxifene (RAL) does not have the long half life exhibited by CC, and has recently been shown to be equivalent to CC in terms of ability to induce ovulation in PCOS women. In addition, prior studies have demonstrated potential benefits on markers of uterine receptivity in a cell line model by blocking estrogen activity. Beyond this, there are no studies to examine whether Raloxifene is an effective oral agent for the treatment of women desiring pregnancy, but the investigators' hypothesis is that Raloxifene will work as well as CC but be better at establishment and maintenance of pregnancy than CC

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 to 36
2. BMI \> 19 \& \< 40
3. PCOS diagnosis as evidenced by:

Oligo- and/or anovulation (\< 6 cycles per year) and one of the following:

* Clinical and/or biochemical signs of hyperandrogenism
* Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumors, Cushing's syndrome)

Exclusion Criteria:

1. Use of ovulation induction agents within the past 6 months
2. Positive pregnancy test before taking study medications
3. History or current thromboembolic disorder
4. Coronary artery disease such as heart attack or stroke
5. Tobacco use or history within the past 6 months
6. History of pelvic inflammatory disease and tubal factor infertility
7. Congenital adrenal hyperplasia
8. Diabetes Mellitus

   * Any subject on Metformin must "wash out" for 30 days prior to screening
9. History of endometriosis
10. Known male factor infertility