cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm

The goal of this randomized clinical trial is to assess if adjunctive bosentan therapy, in comparison to placebo, can reduce the rate of epicardial vasospasm at follow-up spasm provocation CFT (fuCFT) in patients with previously proven epicardial vasospasm on acetylcholine reactivity testing (at index CFT) and ongoing angina(-like) complaints.

Participants will

* Use either endothelin receptor antagonist or placebo for 10 weeks
* Undergo follow-up acetylcholine spasm provocation test after 10 weeks
* Answer online questionnaires on angina and quality of life


Eligibility Criteria:
Inclusion Criteria:

1. Definitive diagnosis of epicardial vasospasm on maximal acetylcholine dose of 100µg (at iCFT)
2. At least 18 years of age
3. On optimal regular care ( current or previous treatment with at least 2 daily anti-anginal medicines i.e. nitrate and calcium channel blocker
4. Continuing episodes of angina(-like) complaints at least once weekly despite 3.
5. Signed online informed consent for participation in NL-CFT registry (the Netherlands Registry of invasive coronary vasomotor function testing), or willing to co-sign for registry at time of inclusion in EDIT-CAS
6. Written informed consent for EDIT-CAS

Exclusion Criteria:

1. Systolic blood pressure (SBP) \<85 mmHg measured at Visit 1
2. Significant hepatic impairment at time of iCFT lab (ASAT/ALAT \>3x upper limit of normal (ULN)) or history of liver cirrhosis (Child-Pugh 7-15)
3. Severe anemia (Hb\<6.0mmol/L) without identified cause at time of inclusion
4. Patients with limited life expectancy (\<1 year)
5. Participation in another randomized clinical study with an use of an Investigational Medicinal Product (IMP) up to one month prior to enrolment.
6. Pregnancy, active desire to become pregnant or unwilling to take adequate\* contraceptive measures when of child bearing potential for the duration of 6 months (active medication period + 3 months safety).
7. Known heart failure with reduced ejection fraction\<35%
8. Known pulmonary hypertension of any type
9. Potentially dangerous interaction due to the use of another CYP3A4 or CYP2C9 substrate (e.g. ciclosporin A, glibenclamide, fluconazole, rifampicin, tacrolimus/sirolimus, lopinavir/ritonavir)
10. Repeat spasm provocation test deemed unsafe (e.g. allergic reaction at iCFT)

    * Adequate in this case meaning if on hormonal contraceptives, additional measures to be taken (e.g. condom).
Prevention of Catheter-Related Bloodstream Infection in Patients With Haemato-Oncological Disease

We, the researchers at Centre National de Greffe de Moelle Osseuse, have shown in a randomised study (in press), that a low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease.

The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease:

* Group A: heparin impregnated catheters
* Group B: low-dose unfractionated heparin (100 IU/kg/daily)

Studies have shown that catheter-related infection may be due to fibrin deposition associated with catheters. Interventions designed to decrease fibrin deposition and thrombus formation have the potential to reduce catheter-related infections. Seven randomised studies have been performed to assess the safety and efficacy of heparin (either as an infusion or bonded to central venous catheter) on central venous catheter-related bloodstream infections. Although a meta-analysis of 4 studies looking at heparin either as an infusion or bonded to central venous catheter showed a strong trend for a reduction in catheter-related bloodstream infection with the use of heparin, these studies used variable definitions of catheter-related infections.

We have shown in a randomised study (in press), that low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease. The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease:

* Group A: heparin impregnated catheters
* Group B: low-dose unfractionated heparin (100 IU/kg/daily)

Eligibility Criteria:
Inclusion Criteria:

* Age between 4 and 60 years
* Short term non-tunneled percutaneous central venous catheter

Exclusion Criteria:

* Presence of a central venous catheter at admission
* Major blood coagulation disorders (platelet count \< 50 x 10\^9, disseminated intravascular coagulation)
* Absence of catheter-tip culture at the time of catheter removal
Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy

RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective than observation after mastectomy in treating women with stage II breast cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with standard therapy in treating women with stage II breast cancer who have undergone mastectomy.

OBJECTIVES:

* Determine the overall survival of women at intermediate risk for locoregional recurrence of breast cancer treated with ipsilateral chest wall adjuvant radiotherapy after mastectomy.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive standard of care and observation only. After completion of study therapy, patients are followed up twice in the first year, and then annually for up to 10 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed unilateral invasive breast cancer

  * pT1, pN1, M0 disease
  * pT2, pN1, M0 disease
  * pT2, pN0 disease with grade III histology and/or lymphovascular invasion
  * Multifocal breast cancer meeting both of the following criteria:

    * Largest discrete tumor ≥ 2 cm if N0
    * Grade III histology and/or lymphovascular invasion
* No bilateral breast cancer
* Axillary node negative status by axillary clearance, axillary node sampling, or sentinel node biopsy

  * Patients with axillary node positive (1-3 positive nodes, including micrometastases\* \> 0.2 mm and ≤ 2 mm) must have had an axillary node clearance (minimum of 10 nodes removed) performed

    * No more than 3 pathologically involved lymph nodes
  * No internal mammary nodes visible on sentinel node scintigraphy in the absence of negative histology NOTE: \*Isolated tumor cells not counted as micrometastases
* Underwent total mastectomy (with minimum of 1 mm margin clear of invasive cancer and DCIS) and axillary surgery with staging procedure

  * Must have undergone adjuvant systemic chemotherapy if indicated for intermediate-risk breast cancer
  * Patients undergoing immediate breast reconstruction allowed
* No known BRCA1 and BRCA2 carriers
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Not pregnant
* Fit for adjuvant chemotherapy, adjuvant endocrine therapy, and post-operative radiotherapy
* No prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent trastuzumab
* No prior neoadjuvant systemic therapy
Post-marketing Surveillance Study of Adalimumab (Humira®) for Non-infectious Intermediate, Posterior, or Panuveitis Patients

The objective of this study is to evaluate the safety and effectiveness of Humira® (Adalimumab) for the treatment of non-infectious intermediate, posterior, or panuveitis patients under a routine treatment practice.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with Non-infectious intermediate, posterior and pan-uveitis
* Patients voluntarily signed a patient authorization \& informed consent form.
* Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study.
* Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines.

Exclusion Criteria:

* A patient who are contraindications to originator adalimumab (Humira®) as listed on the approved Korean label.
* A patient who is participating on other interventional clinical trials
* Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.
Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.


Eligibility Criteria:
Inclusion Criteria:

* 18-64 years of age at date of first vaccination
* Good health as determined by medical history and physical inspection
* Females of child-bearing potential must have a negative pregnancy test prior to first and second vaccination in the country of origin; females of child-bearing potential must agree not to become pregnant throughout the duration of study
* Subjects must have planned travel to DC, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 7 days (no maximum stay is specified for inclusion).
* Subject must be able to communicate in English

Exclusion Criteria:

* Abnormalities as determined by the Investigator/clinician during physical inspection;
* Participated in research involving investigational product within 30 days before planned date of first vaccination;
* Ever received LT, ETEC, or cholera vaccine;
* History of diarrhea while traveling in a developing country within the last year;
* Women who are pregnant or breastfeeding;
* Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease;
* History of Irritable Bowel Syndrome;
* Seizure disorder within the last year;
* Current use of immunosuppressive therapy (excluding inhaled steroids) or immunodeficiency;
* Known or suspected alcohol abuse or illicit drug use within the last year;
* Medical history of HIV, HBV, or HCV;
* An employee of a study site;
* Known allergies to any component of the vaccine, including adhesives;
* Planned use of antibiotics with known activity against gram negative facultative anaerobes;
* Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar from two weeks prior to randomization through the surveillance phase of the study;
* An employee of Intercell (global) or an immediate family member.
Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Overdenture

Comparing the quality of life and periimplant condition around a single implant retained mandibular overdenture in two groups one will have a ball attachment and the other is having a (CM-LOC) one.

Single implant retained mandibular overdenture is considered an economic and simple treatment modality for edentulous subjects. Resin matrix (CM LOC) is one of the low profile attachments which represent a promising retention values with subsequent improvement in chewing ability and in turns enhance patient quality of life.Oral health impact profile for edentulous patient (OHIP-EDENT) is more specific to edentulous subjects.

Peri-implant soft tissue health (bleeding, inflammation, etc...) is a valuable marker to implant success. The study will record different attachment influenced-tissue response and its relation to implant success and oral health related quality of life (OHRQOL)

Eligibility Criteria:
Inclusion Criteria:

* No contraindications for implantation.
* Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
* Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
* Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm This will be confirmed by the CBCT.
* Patients seeking to install a single symphyseal implant and for whom new dentures will be constructed.
* Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
* Patients, who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, it is found that there are technical problems with regard to denture design and/or occlusion; then new maxillary and mandibular dentures will be fabricated
* All patients should have adapted to their dentures for at least six weeks before being included in the trial.
* Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.

Exclusion Criteria:

* Patients with a systemic or local contra-indication for implant placement.
* Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
* Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
* Incompliant and not cooperative patients.
* Patients smoking more than 10 cigarettes per day.
Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the treatment of patients suffering from ISR after scoring balloon pre-dilatation.

Treatment of patients with ISR remains a challenge. Currently both drug-eluting stents (DES) and drug-coated balloons (DCB) are considered as the strategies of choice in this setting. However, data on the value of BVS in patients with ISR is scarce. BVS are very effective to inhibit neointimal proliferation and they avoid the need of implanting a new permanent metal layer. Accordingly, currently, there is a major interest to elucidate the potential value of BVS in patients with ISR. The use of scoring balloon pre-dilatation has not been studied previously in this setting.

This prospective Spanish multicenter study will assess the clinical and angiographic outcome of patients with ISR treated with BVS with scoring balloon pre-dilatation. BVS will be implanted in selected patients (fulfilling inclusion and exclusion criteria) presenting with either BMS-ISR or DES-ISR. Care will be paid to ensure device optimization. Scoring balloon pre-dilatation is mandatory. Angiographic follow-up will be obtained at 6-9 months. A centralized angiographic corelab will be used to provide QCA measurements. Clinical follow-up will be also obtained at 1 year and then yearly. Clinical events will be adjudicated by an independent Clinical Event Committee.

Eligibility Criteria:
In-stent restenosis with ischemia. Signed Informed Consent IRB approval

INCLUSION CRITERIA:

PATIENT

* Age \> 20 and \< 85 years of age
* Acceptance of late angiographic evaluation
* Angina or objective evidence of ischemia

LESION

* ISR (\>50% diameter stenosis on visual assessment)
* Previous stent location known

EXCLUSION CRITERIA:

PATIENT

* Inclusion in other clinical research protocol
* Allergy to antiplatelet agents
* Women in childbearing age
* Severe associated systemic diseases (including renal or liver failure) or diseases affecting life expectancy
* Recent myocardial infarction
* Time from index stent implantation \< 1 month
* Anticipated difficulties for late angiographic evaluation

LESION

* Stent thrombosis or large thrombus within the stent
* Angiographic failure during initial stent implantation or persistence or large dissection.
* Severe tortuosity or calcification or major difficulties during previous stent implantation
* Vessel diameter \< 2.25 mm (visual assessment)
* Stenosis outside stent stent edge (edge ISR are eligible)
* Very diffuse ISR (\>30 mm in length)
Cardioprotective Effects of GLP-1 and Their Mechanisms

Ischaemic heart disease is the most common cause of death in the UK. Glucagon-like peptide-1 (GLP-1) has been demonstrated to protect the heart when it is deprived of blood supply (ischaemia). The mechanism for this protection is not clear. Similar protection occurs with ischaemic conditioning of the heart, which is dependent on potassium channel opening.

The investigators intend to establish whether GLP-1 mediated protection shares a similar mechanistic pathway. In order to do this the investigators will measures pressure--volume loops generated in the main pumping chamber of the heart at the time of a percutaneous coronary intervention (stenting). Patients will be allocated to GLP-1 alone, GLP-1 with glibenclamide (a potassium channel blocking medication approved for human use), saline control or glibenclamide alone.

The investigators hypothesis is that the effect of GLP-1 will be abrogated by use of glibenclamide.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Able to give informed consent
* Elective percutaneous intervention for a single vessel coronary stenosis
* Normal left ventricular function

Exclusion Criteria:

* Severe Co-morbidity
* Type 2 Diabetes Mellitus
* Nicorandil, Sulphonylureas, DPP4 inhibitors, GLP-1 agonists or Insulin use
* Women of child bearing age
* Myocardial infarction in previous three months
* Previous coronary artery bypass grafts
Use of Whole-Body Periodic Acceleration Therapy To Aches and Pains

The purpose of this study is to test the effectiveness of whole body periodic acceleration for helping with symptoms of aches and pains suffered by many patients.

This is an unblinded cross-over study of whole-body periodic acceleration (WBPA) to ascertain if this treatment modality provides symptomatic relief of pain, stiffness, and abnormal gait and balance in a variety of conditions. The study will compare a specific mechanism of motion, whole-body periodic acceleration (WBPA), that has been shown to increase the release of beneficial mediators from the vascular endothelium into the circulation, to a control condition of slow passive motion that promotes relaxation but does not increase release of beneficial mediators into the circulation. The study tests the efficacy and safety of a commercially available device that consists of a motion platform, called Exer-Rest©, that is capable of producing both types of motion to be tested. In this investigation, 15 subjects will be randomly assigned to either procedure for 10 treatments for 2 weeks followed by a one-week "wash-out" period. Then the opposite treatment will be employed for two weeks.

Eligibility Criteria:
Inclusion Criteria:

Subjects qualifying for this study satisfy the following criteria:

1. Over 18 years of age;
2. Complain of either chronic pain, joint stiffness, and/or dysfunctions of gait and balance;
3. Complaints have been annotated by a competent physician, and the subject has been evaluated for conditions that commonly contribute to the respective symptoms;
4. Capable of completing the appropriate testing and baseline assessments, such as quantitative electroencephalography (qEEG) and questionnaires;
5. Tolerate the motion and duration of treatment of the WBPA.
6. Be available for regular visits to the research site for the duration of the study.

Exclusion Criteria:

WBPA is contraindicated for subjects who are pregnant or who suffer with unexplained leg pain, skin eruptions, or who have unstable spinal injuries or conditions. Subjects who cannot tolerate the motion and duration of treatment are also excluded.
Opioid Approach Bias Modification

To investigate the neurobiological mechanisms underlying opioid approach bias during a pilot RCT of opioid approach bias modification. The investigators are combining novel ultra-high field MRI technology with the promising treatment of modifying cognitive bias away from detrimental prescription drug use will generate novel neural data and potentially yield a new therapeutic tool to reduce problematic opioid use.

The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 6-session (over 2 weeks) clinical trial of opioid approach bias modification (OABM) in 20 male and female veterans with chronic pain at high risk for opioid-related adverse events at the San Francisco Veterans Affairs Health Care System, between ages 18-69. The study consists of screening, 2-week cognitive training, Week-3 post-assessment. Assessment of the neurobiological mechanisms of opioid approach bias will be administered at baseline and Week-3.

Eligibility Criteria:
Inclusion Criteria:

* Male and female veterans eligible for VA services
* Ages 18-69
* Chronic pain (current pain lasting ≥ 90 days)
* Prescribed chronic opioids (≥ 90 days in past year)
* High risk for opioid-related averse outcomes (≥ 20mg morphine equivalent daily dose).

Exclusion Criteria:

* Psychotic, bipolar disorders or other psychiatric disorders judged to be unstable by the PI
* Current or past history of the following: intrinsic cerebral tumors, cerebrovascular accident/disease, brain aneurysm, arteriovenous malformations, surgical implantation of neurostimulators or cardiac pacemakers, demyelinating and neurodegenerative diseases, penetrating traumatic brain injury, and any other MRI contraindications.
* No female participant will be pregnant or actively attempting to conceive to prevent any unnecessary exposure to high magnetic fields or radio frequency energy to the unborn child.
* Concurrent participation in a treatment study
* Moderately Severe/Severe withdrawal from opioids based on a score of 25 or more on the Clinical Opiate Withdrawal Scale (COWS)