cyrilzakka/clinical-trials huggingface dataset:
A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart

The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

Patients will be recruited from either inpatient coronary care or general medical units, or recruited from outpatient cardiology offices.

Masking:

Apixaban: Open label.

VKA: Open label.

Acetylsalicylic acid film coated tablet: Double Blinded.

Placebo matching Acetylsalicylic acid film coated tablet: Double Blinded.

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days
* Planned use of antiplatelet agents for at least 1 to 6 months
* Males and Females ≥ 18 years of age
* Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug

Exclusion Criteria:

* Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
* Severe renal insufficiency (serum creatinine \> 2.5 mg/dL or a calculated creatinine clearance \< 30 mL/min
* Patients with a history of intracranial hemorrhage
* Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
* Patients with known ongoing bleeding and patients with known coagulopathies
* Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin
Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients

The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.

This open-label multicenter, randomized, inter-individual comparative, prospective clinical trial was designed to evaluate the efficacy and safety of MD 3511356 sunscreen in preventing AK and SCC in post transplant immune-suppressed patients compared to standard of care.

The present multicenter trial is intended to contribute to the evidence that daily sun protection will have a prophylactic effect in this high risk population of chronically immune compromised patients.

Eligibility Criteria:
Inclusion Criteria:

* Out-Patients of either sex aged ≥ 40 years
* Life-expectancy of 2 years at minimum
* Solid organ-transplant recipients who received a kidney (including pancreas), liver, lung, or heart transplant
* Patients treated for 5 years with an immunosuppressant medication
* Severe sun damage of the skin
* Multiple actinic keratoses (2-5 lesions) and/or multiple dysplastic naevi
* No present squamous cell carcinoma, basal cell carcinoma or malignant melanoma; but history of cutaneous/cutaneous invasive malignancy with restitutio ad integrum is allowed
* Patients who are able to understand and provide written informed consent to participate in the clinical trial (signed informed consent) according to ICH GCP

Exclusion Criteria:

* Non-Caucasian
* Absence of sun damage i.e. no signs of AK
* Multi-organ transplantation (exception: simultaneous transplantation of kidney and pancreas)
* Evidence of systemic infection, except viral hepatitis, at the time of recruitment
* Known or supposed systemic malignant tumour or systemic chemotherapy within the last 5 years prior to randomisation
* Patients participating in a clinical trial within the last four weeks before trial
* Patients treated with the antitumour/antiangiogenetic immunosuppressant sirolimus, respectively everolimus, or acitretin or any other systemic treatment for AK at the time of randomisation
* Patients treated with a topical drug for the AK at the time of randomisation (exception: excision or Cryotherapy for hyperkeratotic lesions are allowed)
* Change of the immunosuppression-treatment less than 3 months ago or planned
* Present or planned interferon therapy (in liver transplant patients with hepatitis B/C)
* Female patients with childbearing potential with a positive pregnancy test, breast feeding, or female patients with childbearing potential without adequate contraception
Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma

Multiple myeloma remains incurable disease in most patients . Cellular immunotherapy using dendritic cells is emerging as a useful immunotherapeutic modality to treat multiple myeloma. Vax-DC/MM is an potent immunotherapeutic agent generated by dendritic cells loaded with the ultraviolet B-irradiated autologous human myeloma cells. The main purpose of this study is to examine the safety and efficacy of Vax-DC/MM in patients with relapsed or refractory multiple myeloma.

* To create the Vax-DC/MM, myeloma cells will be obtained from the bone marrow of the participants, and leukapheresis will be performed to obtain dendritic cells
* Not everyone who participants in this study will be receiving the same dose of study vaccine. A small group of patients will be enrolled into the study and given a certain dose. If they tolerate it, the next group of patients enrolled will received a higher dose.
* Before the first injection of Vax-DC, low dose cyclophosphamide will be administered to stimulate immune response.
* Participants will be received a certain dose of Vax-DC weekly four times.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory multiple myeloma who received at least one prior therapy including thalidomide, bortezomib, or lenalidomide-containing regimen
* Subjects with measurable disease defined as at least one of the following Serum M-protein ≥ 1.0 g/dL Urine M-protein ≥ 400 mg/24hr
* Eastern Cooperative Oncology Group Performance Status ≤ 2
* Hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L): Prior red blood cell transfusion or recombinant human erythropoietin use is allowed.
* Absolute neutrophil count (ANC) ≥ 1.0 x 109/L
* Aspartate aminotransferase (AST) \< 3 times the upper limit of normal
* Alanine aminotransferase (ALT) \< 3 times the upper limit of normal
* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Smoldering or indolent myeloma
* Uncontrolled or severe cardiovascular disease (cardiac ejection fraction\<0.5, Severe conduction disorder )
* Sepsis or current active infection
* Pregnancy or breastfeeding
* Received other immunotherapy treatment
* Clinically significant autoimmune disease
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
FeNO Hairdressers Pilot

A 5-day cohort diurnal FeNO study of exposed and unexposed to airway irritants during hair treatments and commuting.

The project aims to increase the knowledge of daily variations in FeNO with emphasis on exposure of airway irritants during hairdressing treatments in an occupational setting and commuting. Daily measurements of FeNO before and after workplace exposure in an exposed and an unexposed cohort during a workweek (Monday to Saturday) will indicate patterns of proinflammatory responses in a dose-dependent manner. These may or may not be indicative of an increased risk for airway related disease. Results may be used for further studies of occupational hygiene, airway related disease and identification of endogenous volatile organic compounds during proinflammatory responses.

Eligibility Criteria:
Inclusion Criteria:

* have given informed consent.
* employed as hairdressers or at Oslo University Hospital as healthcare workers.
* scheduled work for at least 3 hours daily for 5 days in the study week.

Exclusion Criteria:

* lung disease.
* active smoker.
Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment

To observe the efficacy of cefuroxime-containing bismuth quadruple regimen in the eradication treatment of Helicobacter pylori, and to evaluate whether it can be used as a remedial treatment for Helicobacter pylori after initial or repeated treatment failure.

Introducing cefuroxime into the remedy treatment of Helicobacter pylori, on the one hand, the investigators will observe whether cefuroxime can replace tetracycline like amoxicillin, on the other hand, the investigators will observe whether it can reduce the rate of adverse effects caused by tetracycline and avoid the allergy of penicillin. If the experiment is successful, it will provide an effective and safe second-line treatment for the majority of patients with failed treatment of Helicobacter pylori.

Eligibility Criteria:
Inclusion Criteria:

* Employees, family members, and patients with positive C13 breath test in our hospital;
* Has received one or more previous Helicobacter pylori eradication therapy (no use of cefuroxime or tetracycline), and the result is still positive by C13 breath test;
* Willing to undergo gastroscopy and HP cultivation and identification;
* Age 18-70, gender unlimited;
* Willing to participate in and cooperate with the study, and willing to sign the informed consent.

Exclusion Criteria:

* Drugs that may affect the study results, such as PPI, H2 blockers, bismuth agents, antibiotics, etc. were taken in the 4 weeks before enrollment;
* Patients with gastrointestinal malignancy tumor;
* Patients with gastrinoma;
* After gastric or esophageal surgery;
* Suffers from serious diseases of the heart, lung, kidney, liver, blood, nervous system, endocrine system or mental system;
* Patients with contraindications or previous allergic reactions to the drugs used in this study;
* Pregnant or breastfeeding women;
* Patients with other medical conditions that may increase the treatment side effects;
* Those who cannot give informed consent;
* Has participated in other drug trials within 3 months;
* Not considered suitable for participants by the investigator.
Prediction of Postpartum Hemorrhage With Uterine Artery Doppler Measurement

The aim of the study is to evaluate the uterine artery doppler just before labour in term low risk pregnancies. And to investigate with this measurement if investigators could foreseen the amount of postpartum hemorrhage looking at decreased in the hematocrit values.


Eligibility Criteria:
Inclusion Criteria:

* singleton term pregnancies

Exclusion Criteria:the pregnant women who have

* polyhydramnios
* Large for gestational age fetuses
* multiple pregnancies
* preterm labour
* chorioamnionitis
* history of atonia or postpartum hemorrhage
Using Virtual Reality to Prevent Pre-operative Anxiety in Ambulatory Surgery Patients

The primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.

As secondary objectives, the study aims

* to evaluate post-operative analgesic according to non-drug pre-operative hypnosis, measured by reduction in analgesic intake, and by evaluate of pain;
* to evaluate factors which permitting discharge rapidly from hospital in case of hypnosis with virtual reality.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years;
* Autonomous patient living at home;
* Affiliated to a social security scheme;
* Informed consent signed by patient;
* Patient will undergo a planned ambulatory surgery for hallux valgus.

Exclusion Criteria:

* Inability to understand STAI-A questionnaire;
* Patient refusal;
* Patient underwent a bilateral surgery;
* Patient judicial decision;
* Covered by french AME health system.
Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.

Obesity is an epidemic in Western society and is the biggest risk factor for insulin resistance and type 2 diabetes. The investigators have recently shown that exposure to hyperbaric oxygen (HBO) leads to an increase insulin sensitivity in males ubjects and that this improvement can be measured in all men, not just those with diabetes. The aim of this study is to investigate the time course of this effect and explore the mechanisms involved. The investigators suspect that insulin sensitivity as measured by hyperinsulinaemic-euglycaemic clamp will be increased within the time-frame of one 2-hour hyperbaric oxygen exposure, and that the improvement will be measurable in females as well as males.


Eligibility Criteria:
Inclusion Criteria:

* Overweight to obese (BMI 25-35 kg/m2)
* Age \>18 years (no specific upper age limit)
* Fit to enter hyperbaric chamber as assessed by hyperbaric physician.

Exclusion Criteria:

* Personal history of Diabetes
* Personal history of major psychiatric disorders
* UIse of prescribed or non-prescribed medications which may affect glucose homeostasis (e.g. steroids),
* Uncontrolled asthma,
* Current fever or upper respiratory infections
* Individuals who regularly perform high intensity exercise (\>2 week),
* Pregnancy, lactation and women who are planning to become pregnant
* Current intake of \>140g alcohol/week,
* Current smokers of cigarettes/cigars/marijuana,
* Current inatke of any illicit substance,
* Claustrophobia
* has donated blood within past 3 months.
Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery

Severe pain after arthroscopic surgery is a common experience for the patients . Different regional anesthetic technique has been applicated for postoperative pain relief . The main goal of regional anesthesia regarding postoperative pain relief is to reduce opioid requirements. The most commonly used approach is Interscalene brachial plexus block (ISB), since it provides effective postoperative analgesia upto 12 hours. Erector spinae plane block (ESPB) has been reported for a variety of indications such as thoracic and abdominal surgery. Recently, a novel description of a T2-3 erector spinae plane (ESP) as an alternative to a BP block for an upper extremity surgical procedure. Following these studies, direct cervical ESP block has been recently performed successfully as both clinical and cadaveric study. The investigators hypothesized that cervical ESP block is as effective as (non-inferior) interscalene brachial plexus block in terms of postoperative analgesia of shoulder surgery. To evaluate the effectiveness of the cervical ESP block, the investigators have designed a randomized study. Primary aim is to evaluate the postoperative opioid consumption. Secondary aim is to evaluate postoperative pain scores by Numeric Rating Scale (0 to 10 point scale).

This study has been designed as a prospective, randomized and single-blind trial. Local ethics committee of Ataturk University has approved the study (B.30.2.ATA.0.01.00/142). After obtaining the patients' written informed consents, we will include a total number of 94 patients (47 patients for each group). The inclusion criteria of the study was considered as age between 18-80, American Society of Anesthesiologists (ASA) status I-III, eligible for regional anesthesia, and unilateral shoulder surgery. The patients who have clotting disorder, contra-indication for regional anesthesia, infection on the injection site, chronic opioid usage, previous same side shoulder surgery, severe Chronic obstructive pulmonary disease (COPD) , diaphragmatic paralysis, BMI 35 or over will be excluded. A computer-generated randomization program will be used to allocate the patient into two groups. Interscalene brachial plexus block group will be named as Group ISB (n=47) and cervical ESP block group will be named as Group cESP (n=47). The assessor of the outcomes will be blinded to the study groups of the patients. Both ISB block and cervical ESP block will be performed under ultrasound guidance in the block room preoperatively.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-80
2. ASA I-III
3. Eligible for regional anesthesia
4. Unilateral shoulder surgery

Exclusion Criteria:

1. The patients who have clotting disorder
2. Contra-endication for regional anesthesia
3. Infection on the injection site
4. Chronic opioid usage
5. Previous same side shoulder surgery
6. Severe COPD
7. Diaphragmatic paralysis
8. BMI 35 or over
Progressive Relaxation Exercises in COPD

Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. PMR were applied once a day for four weeks in the intervention group in addition to the standard treatments. The control group received standard treatment.

Background: This study aimed to determine the effect of progressive relaxation exercises (PMR) on dyspnea and anxiety level in individuals with COPD Methods: The study was conducted in the pretest-posttest randomized-controlled trial and completed with 44 COPD individuals, 22 interventions and 22 controls. PMR were applied once a day for four weeks in the intervention group in addition to the standard treatments. The control group received standard treatment. For data collection Questionnaire Forms, Patient Follow-Up Schedules, Modified Borg Scale (MBS), Modified British Medical Research Council Dyspnea Scale (mMRC), COPD Assessment Test (CAT), and Beck Anxiety Scale were used.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD,
* Must be able to competence to answer the questionnaire questions,
* Must be able to communicate verbally,
* Over 18 years of age,
* To have 2nd or 3rd grade COPD according to the GOLD Guide Staging System,
* To have 2 or more severe dyspnea according to the mMRC Dyspnea Scale,
* No medication changes have been made in the last three months,
* Not having received pulmonary rehabilitation in the last 6 months,

Exclusion Criteria:

* To have severe psychological disorders,
* To have non-COPD pulmonary diseases,
* To have cancer,
* To have renal failure,
* To have thyroid dysfunction,
* To have liver dysfunction
REBOA for Out-of-hospital Cardiac Arrest

Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved.

The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.

The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study.

Data collected:

* from enrolment of the patient until hospital arrival
* every 24 hours
* at discharge or 7 days post enrollment
* at 30 days post enrollment

The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.

Eligibility Criteria:
Inclusion Criteria:

* Witnessed cardiac arrest
* Bystander or professional CPR within 5 minutes
* Refractory cardiac arrest

Exclusion Criteria:

* End Tidal CO2 \<1,3 kPa
* Traumatic cardiac arrest
* Women with known pregnancy
* Patients with known terminal disease
* Patients with known do-not-attempt-CPR order
* Patients with overdose
Autologous vs. Implant-based Breast Reconstruction

Although breast reconstruction is an integral part of breast cancer treatment, there is little high-quality evidence to indicate which method is the most effective. The objective of this study is to compare implant-based and autologous breast reconstruction, in non-radiated patients. The primary outcome is patient reported breast-specific quality of life/satisfaction and the secondary outcomes are complications, factors affecting satisfaction, and cost-effectiveness. Moreover, the study aims to improve the evidence for trial decision-making in breast reconstruction. Randomized controlled trials (RCT) are generally thought to provide the most solid scientific evidence, but there are significant barriers to conducting RCTs in breast reconstruction, making both recruitment and achieving unbiased and generalisable results a challenge. The study design partially randomised patient preference trial (RPPT) might be a way to overcome these challenges. In the present study, patients who consent to randomisation will be randomised to implant-based and autologous breast reconstruction, whereas patients with strong preferences will be able to choose method. The study is designed as a superiority trial based on BREAST-Q and 124 participants will be randomised. In the preference cohort patients will be included until 62 participants have selected the least popular alternative. Follow-up will be 60-months. Embedded qualitative studies and within-trial economic evaluation will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Biological female
* \>18 years of age
* American Society of anesthesiologist classification (ASA) 1-2
* Patient must have had or be scheduled for a mastectomy
* Ability to give informed consent
* Ability to communicate in Swedish

Exclusion Criteria:

* ASA \> 2
* BMI \> 30 kg/m2
* Smoking1 radiotherapy to the breast in question.
* Radiotherapy is expected post-operatively.
* Locally advanced breast cancer
* Metastasised breast cancer
* Comorbidity and/or drugs that affect wound healing.
* Unstable psychiatric co-morbidity
* Abdominal scaring/chest scaring making a DIEP/implant-based reconstruction unsuitable