cyrilzakka/clinical-trials huggingface dataset:
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria

This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.

This study is an open label Phase 1 study evaluating the safety, pharmacokinetics, and pharmacodynamics of a single dose of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria who remain symptomatic despite treatment with antihistamines. Twenty patients with Cold Contact Urticaria, ten patients with Symptomatic Dermographism, and ten patients with Cholinergic Urticaria will be enrolled in four separate cohorts for a total of 40 patients.

Prospective patients will be screened with tests in clinic as well as daily at home diaries for 2 weeks prior to enrollment. CDX-0159 will be administered intravenously on Day 1. Post-treatment, patients will be followed for 12 weeks with an optional longer term follow up period.

Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria which does not respond to antihistamines

   * Diagnosis for ≥ 3 months; symptoms of both hive (wheal) and itch/burning/painful sensation despite concurrent use of anti-histamines
   * During screening, in clinic, for Cold Contact Urticaria, patients must have a positive cold stimulation test, for Symptomatic Dermographism, patients must have a positive FricTest®, and for Cholinergic Urticaria, patients must have a positive pulse-controlled ergometry (PCE) provocation test
   * On stable dose of antihistamines
2. Other than a diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria, no other conditions which would introduce additional risk factors or would interfere with the study procedures, as determined by the investigator, based on a medical evaluation
3. Female and male patients must use highly effective contraception from the time of the screening visit and for at least 150 days after receipt of study treatment
4. Willing and able to comply with all study requirements and procedures including completion of a daily medication diary and questionnaires

Key Exclusion Criteria:

1. A clearly defined diagnosis of hives or angioedema other than chronic urticaria.
2. Receipt of prior biologic therapy (e.g.: omalizumab, dupilumab, ligelizumab) within past 3 months
3. Treatment with immunosuppressives (e.g. systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus and mycophenolate mofetil, hydroxychloroquine or others) within 4 weeks or 5 half lives
4. Active COVID-19 infection
5. HIV, hepatitis B or hepatitis C infection

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
A Randomized Open Label Study of KLH-2109 in Patients With Endometriosis(1)

The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with endometriosis

Exclusion Criteria:

* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Randomized Anticoagulation Trial in Opcab (RATIO)

The RATIO Study is a multicenter, nationwide, randomized, controlled, single blinded, unfunded trial of n. 900 patients undergoing multivessel OPCAB (≥2 grafts). This study is designed to test in patients undergoing off-pump coronary artery bypass surgery the hypothesis that full (high dose, 300 U/kg) and half (low dose,150 U/kg) heparinization are not different in terms of thrombotic complications and major perioperative bleeding events (null hypothesis).

Off-pump coronary artery bypass grafting (OPCAB) is an established alternative to on-pump coronary artery bypass grafting (CABG). OPCAB determines a pro-coagulant state potentially deleterious on grafts patency, that is not counterbalanced by the adverse effects of cardiopulmonary bypass on coagulation occurring in CABG, and that lasts as long as one month. Therefore in OPCAB systemic heparinization is necessary to prevent thrombotic complications during transitory occlusion of coronary arteries and grafts. An internationally accepted standard intra-operative anticoagulation protocol for OPCAB has not yet been defined, and heparinization in OPCAB is a highly variable practice. The intraoperative anticoagulation regimen adopted in patients undergoing OPCAB may influence major postoperative outcomes, such as bleeding, transfusion requirements, inflammatory response, myocardial ischemia and grafts patency, but it has never been the object of large-scale randomized controlled trial (RCT). The 2 most widespread intraoperative anticoagulation protocols in OPCAB are represented by full (300 U/kg) or half (150 U/kg) heparinization, with target ACT ranging from 200 sec to \>480 sec.

Patients enrolled in the study will be randomized to receive full or half heparinization in a 1:1 ratio using a randomization schedule blocked by site. Randomization will take place in the operatory room by the anesthesiologist, and will be blinded to the surgeon.

Eligibility Criteria:
Inclusion Criteria:

Consecutive patients electively undergoing multivessel OPCAB

Exclusion Criteria:

Acute coronary syndrome, on-going double anti-platelets treatment (the second antiplatelet drug should be suspended 5 days before surgery), on-going intravenous heparin or sub-cutaneous low molecular weight heparin, known coagulopathy, documented liver disease, chronic renal failure (creatinine ≥ 2 mg/dl) or previous renal transplantation surgery, previous cardiac surgery.
Pilot Study of the Predictive Value of TREM1 Expression and Activation in Inflammation and Radio-induced Mammary Fibrosis

Breast cancer is the most common cancer in the world. Half of patients with such cancer are treated with radiation therapy. Some patients will develop cutaneous or subcutaneous fibrosis, more or less bothersome. Several studies have shown a correlation between an inflammatory reaction and a protein, called TREM-1. But to date, no link has been proven between TREM-1 and inflammation / fibrosis in the phenomena of fibrosis induced by radiotherapy in patients with breast cancer. Our study aims to understand the involvement of this TREM-1 protein in the development of fibrosis or radio-epidermis in patients with breast cancer.


Eligibility Criteria:
Group A

1. Patients over 18 years old,
2. Breast cancer (adenocarcinoma in situ or invasive)
3. Non-metastatic disease
4. Radiotherapy after conservative surgery with irradiation of the breast alone and complement on the operating bed (optional) completed two to six months ago
5. Absence of postoperative complications
6. Early radio-induced epidermis grade ≥2 (CTCAE v4.0) persistent at inclusion
7. Chest circumference \<120 cm and Cup \<E,
8. Absence of breast reconstructive surgery,
9. Signature of informed consent,
10. Affiliation to a social security scheme for French patients.

Group B

1. Patients over 18 years old,
2. Breast cancer (adenocarcinoma in situ or invasive)
3. Non-metastatic disease
4. Radiotherapy after conservative surgery with irradiation of the breast alone and complement on the operating bed (optional), completed two to six months ago
5. Absence of postoperative complications
6. Early grade 0-1 radiation-induced epidermis (CTCAE v4.0) at inclusion
7. Chest circumference \<120 cm and Cup \<E,
8. Absence of breast reconstructive surgery,
9. Signature of informed consent,
10. Affiliation to a social security scheme for French patients.

Groups C, D

Patients included in the SPLICIRAD study who have formulated their agreement for the use of supernumerary samples at the time of inclusion:

* 10 patients with late pathologic radio-induced fibrosis (more than 6 months after the end of radiotherapy), grade CTCAE v4.0 ≥ 3 vs.
* 10 patients without late pathological radio-induced fibrosis of grade CTCAE v4.0 ≤ 1 (follow-up after RT ≥4 years)

Group E Patients over 18 who have given their consent to the Blood Establishment for the use of their samples for research purposes.

Non-inclusion criteria for groups A, B, C, D:

1. Systemic inflammatory disease associated with individual radiosensitivity
2. Dermatological pathology in the breast
3. Radiotherapy having delivered an overdose\> 107% of the prescribed dose in at least 10% of the PTV
4. Diabetes
5. Active smoking
6. Chronic systemic anti-inflammatory therapy, immunotherapy, immunosuppressants, anti-TNF
How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose

This study is to find out if starting at low dose Avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of Avonex treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of clinically-definite relapsing-remitting multiple sclerosis

Exclusion Criteria:

* Any Product Information-specified contraindications to interferon-beta therapy, or other medical factors which, in the opinion of the investigator, make the subject unsuitable for interferon-beta therapy
* Use of AVONEX, but not other interferon therapies, in the 3 months prior to randomisation into the study
* A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomisation.
* History of seizure in the 3 months prior to randomisation
* History of suicidal ideation or severe depression within the 3 months prior to randomisation.
* Other inclusion and exclusion criteria may apply per study protocol
Dexmedetomidine vs Midazolam for Intraoperative Sedation

This randomized, open clinical trial sought to compare the use of Midazolam and Dexmedetomidine during surgery in patients under regional anesthesia.

The primary objective was to determine the superiority of either drug during the intraoperative period regarding: 1- Depth of sedation and 2- incidence of complications.

Secondary objectives included the determination of superiority regarding the postoperative period.

For that, patients were randomized into two groups and sedated with either Midazolam or Dexmedetomidine.

This study was a randomized, open clinical trial.

Patients undergoing surgery under regional (neuraxial or brachial plexus block) anesthesia were randomly assigned into one of two groups.

Patients in one of the groups (called MDZ) were initially sedated with a 0.05mg/Kg bolus dose of Midazolam.

The ones in the other group (called DEX) were initially sedated with a loading dose of 1 µg/Kg of Dexmedetomidine over 10 minutes, followed by continuous infusion at 0.2 to 0.8 µg/Kg/h.

In order to achieve a Richmond Agitation-Sedation Scale (RASS) score between -3 and -1, the following breakthrough doses were used as necessary:

MDZ: 0.02 mg/Kg bolus dose of Midazolam plus 0.5µg/Kg bolus dose of Fentanyl DEX: 0.5µg/Kg bolus dose of Fentanyl

Depth of sedation and incidence of complications were recorded during surgery, in the Post Anesthesia Care Unit (PACU) and in the Ward for two days following surgery,

Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgery under regional anesthesia

Exclusion Criteria:

* The presence of any Bradyarrhythmia;
* New York Heart Association (NYHA) Functional Classes III and IV Heart Failure and/or Left Ventricle Ejection Fraction under 30%;
* Respiratory Failure, Glasgow Coma Scale score 8 or under, and Liver Failure - due to the increased risk of sedation in patients with these conditions (d) refusal to participate in the study or withdrawal of consent at any moment.
Improving Cardiovascular Risk Prediction Using Hand Held Carotid Ultrasonography Study

1) Research questions:

1a. Can non-sonographer health care professionals in a community medical office practice setting be trained to detect and evaluate subclinical atherosclerosis?

1b. Can carotid ultrasound performed in community office practices improve physician use of evidence-based, risk-reducing interventions and patient motivation to adhere to therapeutic recommendations?

Health care providers from five medical practices will complete a 2-day training program that teaches instrumentation, scanning, measurement, quality assurance, and interpretation. They also will learn about CV risk assessment, intervention, and how to use an ultrasound-based CV risk stratification and treatment algorithm. After certification, each site will recruit 70 patients from their practice (total N=350). Subjects will complete their routine office visit and a pre-test survey designed to assess motivation and intention to change. The physician's initial plan of action based on usual care will be recorded. Next, the subject will have a standardized CV risk carotid ultrasound. The physician will revise his/her treatment plan based on the scan results and an ultrasound-based risk assessment algorithm that includes CV risk factors and ultrasound data. Evidence-based treatment recommendations for lifestyle changes and risk factor targets will be provided. The physician's scan-based plan of action will be recorded. The subject will be informed of the results and repeat the survey. All images, interpretations, and recommendations will be reviewed by the UW AIRP.

Eligibility Criteria:
Inclusion Criteria:

* Informed written consent from the subject prior to testing.
* Age ≥40 years old with at least 1 of the following risk factors for coronary artery disease.
* cigarette smoking
* diabetes mellitus
* hypertension (systolic blood pressure ≥140 mm Hg or taking antihypertensive medication)
* hyperlipidemia (low-density lipoprotein cholesterol ≥130 mg/dl or high-density lipoprotein cholesterol less than 40 mg/dl)
* family history of CV disease in a male first-degree relative \<55 or a female first-degree relative \<65 years old

Exclusion Criteria:

* Age \>70 years
* Use of cholesterol-lowering medications in the past year
* Known active liver disease (AST or ALT \>2x upper limit of normal in home lab)
* Known active thyroid disease (TSH outside normal limits in home lab)
* Uncontrolled hypertension (blood pressure \>180/100 mmHg)
* Chronic kidney disease (on dialysis or known creatinine \>2.5 mg/dL)
* History of coronary artery disease (previous myocardial infarction, coronary revascularization procedure, angina pectoris with documented ischemia)
* History of cerebrovascular disease (previous stroke, transient ischemic attack, or carotid revascularization procedure)
* History of peripheral arterial disease (claudication with abnormal ankle-brachial indices or previous revascularization procedure)
Intraoral Administration of Botox in Patients with Dentoalveolar Neuropathic Pain

Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have an effect on afferent (sensory) neurons independent of its action on muscle tone and secretory glands at the periphery.In human studies, the use of BoNT-A has proven to reduce the severity and intensity of attacks in chronic tension type headaches and chronic neck pain. The PREEMPT study concluded that BoNT-A could be used as a preventive therapy in chronic migraine patients and FDA approval was obtained. According to the International Association for the Study of Pain (IASP), BoNT-A is recommended for the management of peripheral neuropathic pain with subcutaneous administration of 50-200 units (50-200U) to onabotulinum toxin A to the painful neuropathic area every 3 months as a third line of treatment. To our knowledge, there are no clinical trials published investigating the effect of intraoral administration of BoNT-A in continuous dentoalveolar neuropathic pain. The aim of this pilot study is to investigate the potential therapeutic effect of intraoral administration of BoNT-A in patients suffering from continuous neuropathic pain.

HYPOTHESIS:

There will be statistically significant differences in reported pain intensity after the intraoral administration of BOTOX® in patients suffering from chronic continuous dentoalveolar neuropathic pain.

A single subject experiment will be conducted with 10 patients where 50 U of BonT-A will be injected into the painful dentoalveolar area. Eligible subjects will complete a pain diary indicating their pain intensity by means of a visual analog scale during one month to establish a baseline. After the first injection, subjects will continue to monitor the VAS daily for 3 months and the infiltration will be repeated a second time following the same protocol. Patient's response will be monitored with the daily pain diary.


Eligibility Criteria:
Inclusion Criteria:

* History of continuous dentoalveolar pain with clinically evident positive (hyperalgesia, allodynia) and/or negative (hypoaesthesia, hypoalgesia) signs of trigeminal nerve dysfunction and where other possible pain sources have been ruled out.
* Intractable pain to conventional oral and/or topical pharmacotherapy for neuropathic pain according to the recommendations published by NeuPSIG (Neuropathic Pain Special Interest Group) including anticonvulsants, SNRIs (serotonin and norepinephrine reuptake inhibitors) and/or tricyclic antidepressants.
* Subject consent to participate in the study.

Exclusion Criteria:

* hypersensitive to any onabotulinum toxin preparation or any component in the formulation.
* systemic nerve or muscle disorders
* bleeding disorders
* dysphagia
* breathing problems
* pregnancy or breastfeeding
* previous treatment with botulinum toxin in the last 4 months.
A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions

The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years and consentable;
* Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia;
* Angiographically-proven coronary artery disease;
* De novo lesion in a native coronary artery;
* Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation;
* Calcification of the target lesion as determined by angiography (grade 3);
* Unsuccessful lesion preparation (\<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty
* Written informed consent.

Exclusion Criteria:

* Myocardial infarction (within 1 week);
* Limited long-term prognosis due to other conditions;
* Target lesion is in a coronary artery bypass graft;
* Target lesion is an in-stent restenosis;
* Target lesion is aorto-ostial;
* Target vessel thrombus.
A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia

At the end of anesthesia it's important to avoid residual neuromuscular block to ensure adequate respiratory function preventing postoperative pulmonary complications. This trial compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine) after thoracic anesthesia. The trial main objective is to demonstrate that sugammadex is faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is to verify if there is a difference between sugammadex and neostigmine as regards adverse events after extubation and in the postoperative period (until the 30th day after surgery).

Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value during an accelerometric train-of-four stimulation.

Patients undergoing thoracic surgery will receive rocuronium as neuromuscular blocking agent. Anesthesia and neuromuscular blockade will be managed freely until the end of surgery. Then patients will be randomized to receive intravenous sugammadex or neostigmine/atropine as follows:

Sugammadex group:

* If Post tetanic count (PTC)=1-15: sugammadex 4 mg/kg
* If at least 1 twitch at the Train-of-four stimulation: sugammadex 2 mg/kg

Neostigmine group:

* If PTC=1-15: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
* If at least 1 twitch at the Train-of-four (TOF) stimulation: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg

Eligibility Criteria:
Inclusion Criteria:

* Subjects scheduled for pulmonary resection, lobectomy, pneumonectomy, bullectomy, pleurodesis
* Age 18-70 years
* American Society of Anesthesiologists (ASA) class 1, 2, 3
* Body mass Index (BMI) = 18-30 kg/m2

Exclusion Criteria:

* Subjects scheduled for esophagectomy, thoracectomy, vascular resection
* Chronic Obstructive Pulmonary Disease (COPD) Gold class III e IV, respiratory infection, asthma
* Preoperative Forced Expiratory Volume in 1 second (FEV1) \< 60% of predicted, Forced Expiratory Volume in 1 second/Forced Vital Capacity ratio (FEV1/FVC) \<70%
* Preoperative Diffusion Lung capacity for carbon monoxide/Alveolar Volume ratio (DLCO/VA) \< 60% of predicted
* Preoperative oxygen saturation (SpO2) \<92% or Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (PaO2/FiO2) ratio \<300
* Cardiovascular disease with Metabolic Equivalent of Tasks (METS) score less than 4
* Neuromuscular disorder
* Kidney failure defined as Estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1,73 m2
* Pregnant women
Eicosapentaenoic Acid (EPA)and Docosahexaenoic Acid Study

The goal of the study is to test the efficacy of an EPA-enriched oil made by DuPont versus a DHA-enriched oil, a standard fish oil preparation, and olive oil placebo in a double-blind, randomized, placebo-controlled trial. This study will compare the efficacy of 1800 mg/day of EPA versus 1800 mg/day of DHA versus a fish oil product containing 1800 mg of EPA and 1200 mg of DHA/day as compared to olive oil placebo at 6 grams/day over a 6 week period in a parallel arm design study of 120 healthy adults studied in both the fasting and post-prandial state. Safety will be monitored by assessing for adverse reactions, measuring vital signs and a variety of lab tests including a complete metabolic profile and complete blood count. Efficacy will be assessed by measuring changes in fatty acid profile and or fatty acid ratios,as well as by measuring plasma lipids, lipoproteins, and markers of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or surgically sterile females between ages 21-70.
* Body Mass Index of 20-35.
* Plasma Lipoprotein Associated Phospholipase A2 (LpPLA2) values \> 200 ng/ml.

Exclusion Criteria:

* Competitive exerciser.
* Current smoker.
* Those already taking dietary supplements (EPA, DHA, flax seed oil, fish oil, cod liver oil, weight control products, or high doses of vitamin C (\>500 mg/day) or vitamin E (\>400 mg/day).
* Those consuming more than 3 oily fish species/week.
* Those consuming \>2 drinks containing alcohol/day.
* Those taking medications which could affect serum lipids or body weight, or taking coumadin or more than 325 mg/day of aspirin which could effect bleeding time or the coagulation profile.
* History of a bleeding disorder.
* History of significant cardiac, renal, hepatic, gastro-intestinal, pulmonary, neoplastic, biliary or endocrine disorders including uncontrolled diabetes, thyroid disease, or hypertension.
* Plasma LpPLA2 values \< 200 ng/ml.