cyrilzakka/clinical-trials huggingface dataset:
Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)

This healthy volunteers study will evaluate 210 subjects who will receive a single sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European Union). This study will involve sampling and pharmacokinetics evaluation of drug levels following administration of PF-06410293 and the licensed adalimumab products.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female (non-childbearing potential). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.

Exclusion Criteria:

* Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary gastrointestinal, cardiovascular, hepatic psychiatric, neurologic, autoimmune, or allergic disease.
Mind Your Heart Study

This study investigated the feasibility and acceptability of a phone-delivered mindfulness intervention to improve medication adherence among outpatients with heart failure.

This project seeked to study the role of mindfulness training (MT) in the promotion of medication adherence among patients with chronic heart failure (HF). A prospective pre/post design study was conducted among 50 stable outpatients with HF and sub-optimal self-reported medication adherence. MT sessions (one 30-min session/week over 8 weeks) were phone-delivered by qualified mindfulness instructors. Assessments were conducted at baseline, 3 months (end of the intervention) and 6 months since baseline. The primary outcomes were feasibility and acceptability. We hypothesized we would meet recruitment goals (n=50) within the study timeline, with \< 20% drop out rates by the end of the study and that \> 80% of participants would report high (=grade 5) enjoyment ratings on a self-report intervention enjoyment scale (range:1 to 5). Secondary outcomes were self-reported and objectively assessed medication adherence and functional capacity (a clinical marker of medication adherence. We hypothesized we would observe significant pre-post intervention improvements in medication adherence and functional capacity. Additional outcomes included possible mediators of intervention effect, i.e., cognitive function, mood, sleep quality, and interoceptive awareness.

Eligibility Criteria:
Inclusion Criteria:

* Age \> = 18
* Fluency in English language
* A confirmed diagnosis of heart failure
* Sub-optimal adherence to medications
* Access to a telephone
* Ability to understand and speak English

Exclusion Criteria:

* Unwillingness/inability to provide informed consent
* New York Heart Association (NYHA) class IV heart failure or clinically unstable
* Severe hearing impairment not allowing phone delivery
* Severe depressive symptoms
* Acute psychosis
* Severe cognitive impairment
* Recent hospitalization (\< 6 weeks)
* Current (at least once a month) mind/body practice
A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma

The study is designed to define the immunologic and clinical activity of Tremelimumab in patients with advanced mesothelioma.

No effective standard treatment can improve significantly the prognosis of malignant mesothelioma (MM) patients. However, there is evidence that MM patients may benefit from immunotherapeutic agents.

Clinical studies examining CTLA-4 blockade are providing convincing evidences on the immunobiological effects and on the clinical activity of this new class of immunomodulating therapeutic agents, likely due to their ability to stimulate patients'immune system to more effectively attack tumor cells by blocking a negative regulatory signal.

Tremelimumab is a fully human anti-CTLA-4 monoclonal antibody (mAb), developed as an IgG2 isotype to minimize complement activation and reduce the risk of cytokine storm. As a single agent, Tremelimumab can induce durable tumor regression in 7-10% of patients with advanced melanoma. Tremelimumab has been tested in several clinical trials as single-agent or in combination with other agents in different solid tumors.

The evidences above unveil a strong immunologic potential of treatment with Tremelimumab also in MM patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed malignant mesothelioma (MM)
* Have received only one prior systemic chemotherapy platinum-based regimen for advanced MM
* Disease not amenable to curative surgery
* No known brain metastasis
* Age 18 and over
* Performance status 0-2
* Life expectancy \> 12 weeks
* Adequate hematologic, hepatic and renal function
* Not pregnant or nursing
* Patient must be willing and able to provide written informed consent, and the trial have to be approved by the institutional review board at each institution

Exclusion Criteria:

* Symptomatic chronic inflammatory or autoimmune disease
* Active hepatitis B or C
* Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or not compensated chronic heart disease in NYHA class II or more
* History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent
* Uncontrolled active infections
* Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational agents
* History of other malignancies except for adequately treated basal cell carcinoma or squamous cell skin cancer or carcinoma of cervix, unless the patient has been disease-free for at least 5 years
Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)

This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe chronic spontaneous urticaria (CSU).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed CSU diagnosis for at least 3 months with an inadequate response to H1-antihistamines.
* Subjects who are taking H1-antihistamines must be on a stable regimen 4 weeks prior to Day 1 and while on study.
* Urticaria Activity Score (UAS7) equal to or greater than 16 at Day 1. UAS entries must be completed for a minimum of 4 out of the 7 days prior to Day 1.

Exclusion Criteria:

* Any clinically significant abnormality in laboratory evaluations, physical examinations, vital signs, or ECG at Screening, according to the Investigator's discretion.
* Use of certain medications.
* History of diseases with urticaria or angioedema symptoms, other than CSU and symptomatic dermographism.
* Significant medical history other than CSU, or any other condition which might interfere with the evaluation of CSU.
Postoperative Bleeding Prevention in Massive Bone Tumour Resection

Massive bone tumour resection is often associated with important postoperative bleeding. This may determine systemic (anaemia), as well as local complications (wound healing, seroma, haematoma).

The objective of this study is to determine whether the use of topical tranexamic acid or topical Evicel® will reduce the perioperative bleeding comparing it with usual haemostasis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Musculoskeletal tumor (primary or metastatic, benign or malignant) located in extremities, shoulder girdle or pelvis.
* Massive or bloc tumour resection.
* Patient's consent to participate

Exclusion Criteria:

* Known allergy to ATX
* Allergy or known hypersensitivity to bovine proteins (aprotinin)
* Liposarcomas low grade
* History of thromboembolic disease or prothrombotic conditions:

  * cerebral vascular accident
  * ischemic heart disease
  * deep and / or superficial vein thrombosis
  * pulmonary embolism
  * peripheral arterial vasculopathy
  * thrombogenic arrhythmias (eg: ACxFA)
  * patients with cardiovascular stents
  * prothrombotic alterations in coagulation
* Treatment with contraceptive drugs
Study of the Safety and Tolerability of Oral Capsule Form of PCI-24781 in Advanced Cancer Patients

To determine the highest dose of study drug that can be taken without causing serious side effects in patients with advanced cancer. The study will look at safety of the study drug and whether the treatment schedule is tolerated by patients.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* Histologically confirmed, measurable solid tumor, non-Hodgkin's lymphoma, Hodgkin's disease, chronic lymphocytic leukemia, or multiple myeloma that has relapsed after standard therapy or for which no standard therapy exists
* Ability to swallow oral capsules without difficulty
* Estimated life expectancy \> 12 weeks
* ECOG performance status ≤ 2
* Creatinine ≤ 1.5 × institutional upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 × institutional ULN (unless elevated from documented Gilbert's syndrome)
* AST and ALT ≤ 2.5 × institutional ULN (≤ 5 × institutional ULN in the presence of liver metastases)
* Platelet count ≥ 100,000/µL
* ANC ≥ 1500/µL
* Hgb ≥ 9.0 g/dL
* Patients with previously treated, stable, asymptomatic brain metastases who are not on corticosteroids are eligible
* Willing and able to sign a written informed consent-

Exclusion Criteria:

* Patients who have had immunotherapy, chemotherapy, or radiotherapy within 4 weeks (within 6 weeks for nitrosoureas or mitomycin C) prior to first day of drug dosing
* Patients who have undergone major surgery within 4 weeks prior to first day of drug dosing
* Patients who have received another investigational drug within 4 weeks
* Evidence of leptomeningeal metastasis
* Patients unable to swallow oral medications or with pre-existing gastrointestinal disorders that might interfere with proper absorption of the oral drugs (eg, WDHA syndrome, carcinoid syndromes, diarrhea due to infections, malabsorption syndromes secondary to surgery or chemotherapy)
* Uncontrolled illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
* Patients with risk factors for, or who are receiving medications known to prolong QTc interval and that may be associated with Torsades de Pointes
* QTc prolongation (defined as a QTc interval ≥ 450 msecs) or other significant ECG abnormalities including 2nd degree AV block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).
* History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within the past 6 months.
* Patients with known HIV infection
* Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)
DAART vs PTA/SUPERA STENTING FOR POPLITEAL ARTERY LESIONS

The purpose of this study was to compare the results of directional atherectomy with antirestenotic therapy (DAART technique) and angioplasty/Supera stenting for the treatment of popliteal atherectomy lesions.

Atherectomy offers a way to improve the chances to avoid stent placement, although it did not show superiority in terms of vessel patency or limb salvage compared with POBA. Nevertheless, atherectomy can modify the plaque morphology and the mechanical properties of the baseline disease, which allows better drug penetration and diffusion into the vessel wall.

Moreover, the combination of directional atherectomy devices and drug coated balloons (directional atherectomy with antirestenotic therapy, DAART), theoretically might further improve the clinical outcomes of drug coated angioplasty. The "leave nothing behind" strategies have gained support among interventionalist. Many studies claim that atherectomy improves results when combined with adjunctive DCB.

The Supera stent, when compared with other self-expanding nitinol stents, has proven to deforms less with knee flexion and exhibits less strain. It mimics the natura structure and movement of the anatomy and optimizes luminal gain maintaining a round open lumen in challenging anatomies, as the popliteal artery. Mechanical scaffolding is often required owing to elastic recoil and flow-limiting dissections in complex popliteal lesions.

The purpose to this study was to retrospectively evaluate the efficacy of both techniques for endovascular treatment of atherosclerotic lesions of the popliteal artery.

Eligibility Criteria:
Inclusion Criteria:

* patients with lifestyle limiting intermittent claudication ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at least a 12-months of follow-up

Exclusion Criteria:

* Exclusion criteria were patients who could not receive antiplatelet or anticoagulation therapies. Other exclusion criteria were patients with aneurysm of the ipsilateral superficial femoral artery or popliteal artery, acute thrombus, unsalvageable limb, very limited life-expectancy or with doubts in their willingness or capability to allow follow-up examinations.
Fundamental Asynchronous Stimulus Timing Sound Coding Study

The Fundamental Asynchronous Stimulus Timing (FAST) is a novel cochlear implant sound coding strategy. Potential benefits include improved battery life, in addition to improved localization for bilateral patients.

The Fundamental Asynchronous Stimulus Timing (FAST) strategy offers excellent potential as a low power alternative coding strategy to the current default strategy in Nucleus® cochlear implants, Advanced Combination Encoder (ACE). Additionally, FAST offers potential bilateral benefits - localization and listening in spatially separated noise - because it has been shown in acute, controlled studies to provide more access to interaural timing difference (ITD) cues (Smith, 2010).Previous research with experienced cochlear-implant recipients has shown issues with conversion from ACE to FAST. The FAST strategy typically sounds very different in quality, and acclimatization can be lengthy. This extended adaptation time makes it difficult to show conclusively that FAST is non-inferior to ACE for speech understanding. A potential barrier to evaluating performance with FAST in current cochlear-implant recipients is the extensive amount of prior experience that many recipients have using ACE. Hence, there is a distinct need to evaluate FAST in newly implanted recipients.

Eligibility Criteria:
Inclusion Criteria

* Medical and audiological candidate for a unilateral CI24RE, CI512 or CI532 series implant
* Post-linguistically deafened
* Native speaker of American English
* Eighteen years of age or older

Exclusion Criteria

* Previous or existing cochlear-implant recipient
* Pre-linguistically deafened (onset of hearing loss at less than two years of age)
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
* Diagnosis of retro-cochlear pathology
* Diagnosis of auditory neuropathy
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
* Unwillingness or inability to comply with all investigational requirements
* Additional cognitive handicaps that would delay rate of improvement with the cochlear implant
A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma

This study is a multicentre, randomised, parallel-controlled, open-label, 3 phase clinical trial. The subjects were untreated, unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma with low PD-L1 expression. Patients were randomly assigned to receive chemoradiation or chemotherapy in combination with Tislelizumab at a ratio of 1: 1. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We hypothesized that in advanced esophageal squamous cell carcinoma patients with low PD-L1 expression, chemoradiation versus chemotherapy in combination with Tislelizumab will significantly improve PFS.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histologically confirmed squamous cell carcinoma of esophagus (per AJCC 8th edition).
2. Subjects must have unresectable advanced, recurrent or metastatic ESCC.
3. Subjects must not be amenable to curative approaches such as definitive chemoradiation and/or surgery.
4. PD-L1 expression (CPS) is less than 10.
5. No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease.
6. ECOG Performance Status of 0 or 1.
7. Subjects must have at least one measurable lesion by CT or MRI per RECIST 1.1 criteria; radiographic tumor assessment must be performed within 28 days prior to randomization.
8. Subjects must have adequate organ and bone marrow function.

Exclusion Criteria:

1. Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment.
2. Active known or suspected autoimmune disease.
3. Any serious or uncontrolled medical disorder or active infection.
4. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
5. Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus.
6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures

The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery

Atrial fibrillation (AF) is the single most common post-operative complication after on-pump cardiac surgery, ranging from roughly 25% in CABG procedures, up to 65% in valve replacement procedures. The presence of AF in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates. VitC is an electron donor for a number of enzymatic systems, reducing potentially harmful free radicals. In post-procedural AF, there is increased peroxynitrite concentration, which is a target for vitamin C. A randomized, double blind study will be conducted in order to establish the efficiency of vitamin C as prophylaxis for postoperative AF.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing on-pump cardiac surgery

Exclusion Criteria:

* Off-pump cardiac surgery procedure
* AF before the procedure
* Recent infection and/or infectious endocarditis
* Presence of neoplasia
* Chronic renal failure with creatinine\>2.3 mg/dl
* Hepatic failure
* Autoimmune disease and/or disease that brings about a systematic inflammatory response
* Thyroid disease
* Systematic use of supplements that contain vitC or carnitine
* The use of NSAIDs other than aspirin for a time period up to one month before the procedure
A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)

The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).

LY3471851 is a potential first-in-class therapeutic that may address an underlying immune system imbalance in people with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of inhibitory immune cells known as regulatory T cells. By activating these cells, LY3471851 may act to bring the immune system back into balance.

Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of SLE at least 24 weeks prior to screening.
* Have documentation of having met at least 4 of 11 Revised Criteria for Classification of Systemic Lupus Erythematosus according to the 1997 Update of the 1982 American College of Rheumatology (ACR) criteria for classification of SLE prior to randomization.
* Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA), and/or a positive anti-Smith (anti-Sm) as assessed by a central laboratory during screening.
* Have a total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 during screening.
* Have a clinical SLEDAI-2K score ≥4 at randomization.
* Have active arthritis and/or active rash.

Exclusion Criteria:

* Have severe active lupus nephritis.
* Have active central nervous system (CNS) lupus.
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
Effects of Eccentric Hamstring Training in Prevention of Hamstring Injuries in Sprinters

The goal of this clinical trail is to determine the effects of eccentric hamstring training, in prevention of hamstring injuries in sports involving sprinting among club level athletes.

The main question it aims to answer is :

- Will eccentric exercises have an effect in the recovery of hamstring injuries and injury prevention in sprint performance sports among club-level athletes.

Participants will be divided into two groups. Control group will perform conventional training program and interventional group will perform eccentric exercises.

The most frequent time-loss injuries in sports are hamstring injuries, which are particularly common in modalities that involve rapid accelerations and decelerations like high-speed running. The hamstring muscle group is more susceptible to stresses because of the way it is anatomically arranged.These injuries are more common in sprinters than in other athletes.Ballistic motions like sprinting are typical in most contact and non-contact sports. The most frequent type of activity during sprinting is the running stride. The muscles aggressively extend and contract throughout each stride, forcing the linked segments to accelerate and slow down.In most club-level sports like football, cricket, sprinters and rugby sprinting is a crucial component of the sports and defines the performance of the athletes. If the athlete is a good sprinter he will perform more efficiently in sports. As sprinting is a high-intensity activity and is beneficial for athlete's general health but there are many injuries involved among these athletes. The injury can be disastrous for the athlete, resulting in extended recovery time and the possibility of persistent damage. Injuries in professional athletes are disproportionately often hamstring-related.The most common form of hamstring injury is hamstring strain which can be caused due these reasons. Hamstring injuries can be divided into three types; Grade 1 which is a hamstring pull or strain, Grade 2 partial muscle tear and Grade 3 complete muscle tear. The hamstring muscle is very important as it is involved in generating forward motion. The cause of hamstring injury can be due to multiple activities but the most common is when athletes are sprinting at maximal speeds.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 28 years.
* Rugby players
* Male
* Athletes who have suffered a hamstring injury in the past 6 months.

Exclusion Criteria:

* Those athletes who have undergone any surgery in the lower extremity and athletes with any other lower limb pathology are excluded.