cyrilzakka/clinical-trials huggingface dataset:
Safety of Intravenous Thrombolytics in Stroke on Awakening

The primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting standard criteria for treatment with IV tPA for acute stroke.

The hypothesis is that patients that wake up with stroke symptoms may have developed the stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the ED within that time, therefore IV tPA should be safe and effective in this population.


Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal to 18 years, and lower or equal to 80 years.
* Signs and symptoms of acute ischemic stroke.
* Symptoms present upon awakening.
* Arriving to the Emergency Department within 4.5 hours of awakening. Treatment with IV tPA must be initiated prior to 4.5hours from waking up.
* NIHSS \>3
* A non-contrast head CT without hemorrhage and without hypodensity more than 1/3 of the middle cerebral artery (MCA) territory; or MRI demonstrating no hemorrhage, and with a diffusion-weighted imaging (DWI) lesion no greater than 70 mL and FLAIR without a well defined hyperintense lesion that is more than 1/3 of the MCA territory.
* Pre-morbid modified Rankin score of 0 or 1.

Exclusion Criteria:

* Rapidly improving deficit to an NIHSS less than 3.
* Sustained systolic blood pressure greater than 185 mmHg or diastolic blood pressure greater than 110 mmHg despite treatment.
* Glucose less than 50 mg/dL.
* Stroke or head trauma within last 3 months.
* History of intracranial hemorrhage. Symptoms of subarachnoid hemorrhage.
* Major surgery within 14 days.
* Gastrointestinal (GI)/Genito-urinary (GU) hemorrhage within 21 days.
* International normalized ratio (INR) \> 1.7.
* Heparin within 48 hours with an elevated activated partial thromboplastin time (aPTT).
* Platelet count less than 100,000.
* Presumed septic embolus or suspicion of bacterial endocarditis.
* Suspicion of aortic dissection.
* Use of anticoagulants such as dabigatran, rivaroxaban, apixaban, enoxaparin.
* Pregnant or lactating women.
* Known allergy or sensitivity to tPA.
Improving Weight Loss Outcomes for Binge Eating Disorder.

This study aims to develop and evaluate the efficacy of a behavioral weight loss treatment approach for individuals with binge eating disorder to both reduce their binge eating behaviors and lose weight.

In the current study, we propose to (a) compare the efficacy of an acceptance-based behavioral treatment (ABBT) that targets both binge eating and weight loss in patients with binge eating disorder (BED) to a Standard Behavioral Weight Loss Treatment (SBT), (b) evaluate the extent to which ABBT and SBT target shared maintenance factors for binge eating and overeating episodes, and (c) assess whether treatment efficacy is moderated by baseline values of constructs targeted in ABBT. Our study will be the first to evaluate an ABBT for BED designed to 1) address maintenance factors that give rise to both binge eating episodes and overeating episodes without loss of control and 2) increase adherence to BWL prescriptions.

Eligibility Criteria:
Inclusion Criteria:

* Meet the DSM-5 criteria for Binge Eating Disorder
* Have a BMI range of 27-50kg/m2

Exclusion Criteria:

* are unable to fluently speak, write, and read English
* are currently experiencing severe psychopathology that would limit their ability to engage in study (e.g., suicidality, substance use disorder, psychotic disorder)
* are unable to engage in moderate physical activity (i.e., walk 2 blocks without rest)
* have a medical condition (e.g., acute coronary syndrome, type I diabetes) that would pose a risk to the participant during intervention, cause a change in weight, or limit ability to comply with the recommendations of the program
* Pregnant or planning to become pregnant in the next 2 years
* Recently began a course of or changed the dosage of medication that can cause significant change in weight
* Have a history of bariatric surgery
* Have had weight loss of \> 5% in the past 6 months
Primary HPV Self-Collection in Indonesia

The purpose of this study is to implement human papillomavirus (HPV) self-collection in Indonesia.

After participants give informed consent, they will receive a short educational session about cervical cancer and HPV, after which they will be offered the opportunity to undergo primary HR-HPV testing via self-collection. Participants will be contacted within 4 weeks with their results. Those who test positive for high-risk HPV will receive a follow-up appointment, at which time visual assessment with acetic acid and/or colposcopy will be performed. Those with detectable lesions and/or HPV 16/18+ will undergo treatment with thermal ablation. If they are ineligible for thermal ablation, they will undergo cervical biopsy, endocervical curettage, and/or loop electrosurgical excision procedure (LEEP) as indicated. Anyone with suspicion for cancer will undergo biopsies and referral to a gynecologic oncologist.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-69 years old
* Have not had a Pap test within the last 3 years or an HPV test within the last 5 years
* Have never been diagnosed with cervical cancer or high-grade dysplasia
* Have no history of hysterectomy with cervical removal
* Expressed willingness to participate in the study, including conducting HPV self-collection, follow-up treatment, and related surveys
* Speak Indonesian or English

Exclusion Criteria:

* Being pregnant or within 6 weeks postpartum
* Women who have never engaged in sexual activity
* Medical, psychiatric, or other conditions that may interfere with compliance with protocols, security assessments, and/or ability/competence to give informed consent
* Adults who do not have the capacity to give consent may be excluded, as participants must be able to perform activities required by the protocol
Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color.

The objective of this study is to test the effectiveness of radiofrequency microneedling (RFMN) as a treatment for melasma. The Investigator hypothesize that RFMN will be an effective treatment for melasma in skin of color patients.

The target population is skin of color patients with melasma. Patients will receive 3 consecutive RFMN treatments over a period of three months. Baseline melasma severity will be measured by the modified Melasma Area and Severity Index (mMASI) score. Endpoints will be mMASI scores at 1 and 3 months post-procedure. Patient reported outcomes will be measured using the melasma quality of life (MelasQOL) validated patient questionnaire at screening and at both follow up visits. The long-term goal of future studies would be to provide melasma patients, particularly those with skin of color, with improved therapeutic options for the treatment of their melasma, as compared to current treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, at least 18 years of age
* Fitzpatrick skin types IV-VI
* Clinically diagnosed melasma
* No topicals (retinol, vitamin C serum, etc) for 6 weeks before Visit 1 (with exception of sunscreen)

Exclusion Criteria:

* is currently pregnant or planning to conceive during the study period
* is using topical or oral therapy or other treatment for melasma
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults

A randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of HS-20090 120mg（1.7ml）and Xgeva® in healthy adults.

This is a phase I, single center, randomized, double-blind and parallel group clinical trial .

The primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers.

The secondary objectives are to assess the Clinical safety and immunogenicity similarity of single subcutaneously injection of HS-20090 or Xgeva® in healthy volunteers. Meanwhile，observing the pharmacodynamic similarity of HS-20090 to Xgeva® preliminarily.

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
* Healthy males, Aged ≥18 years or ≤50 years old(including the boundary value);
* Agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug is administered;
* Clinical laboratory examination, chest X-ray, abdominal B-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance.

Exclusion Criteria:

* Occurred or suffering from osteomyelitis or ONJ (mandibular necrosis) previously; The dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed;
* Serum calcium levels are outside the normal range of the laboratory.
* Subject has positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result viral hepatitis (including hepatitis B and hepatitis C), or positive HIV antibodies, or positive test for syphilis.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months or 5 half-lives (whichever is longer).
* Prior use of medications within 6 months before and during the study. This includes medications such as, but not limited to: Bisphosphonates Fluoride Calcitonin Strontium Parathyroid hormone or derivatives Supplemental vitamin D (\>1000 IU/day) Glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) Anabolic steroids Calcitriol Diuretics
SMART (School-aged Children Making Healthy Choices And Recognizing sTroke)

A stroke awareness program for school-aged children to learn the signs/symptoms of stroke, teach their parents and make healthy life-style choices.

1. To educate school-aged children, grades 9th through 12th on the F.A.S.T. (Face, Arm, Speech and Time) acronym, additional signs and symptoms of stroke and the need for immediate activation of Emergency Medical Services (EMS) by calling 911.
2. To improve adults' stroke literacy through educating their children in grades 9th through 12th.

Eligibility Criteria:
Inclusion Criteria:

* High-school student

Exclusion Criteria:

* Not a high-school student
Prognostic Value of Measuring DsAz by MRI in Cirrhotic Patients on Prophylactic Treatment With β Blocker (AzyMR)

Portal hypertension (PHT) that leads to esophageal varices is clinically present, at the time of diagnosis, in 60% of cirrhotic patients (Groszmann NEJM 2005). Variceal bleeding is a life-threatening complication. The yearly incidence of the first variceal bleeding in cirrhotic patients is estimated to 4%. This risk increases to 15% when medium or large varices are initially present, (D'amico Baillieres Clin Gastroenterol 1997); Therefore, for patient with medium or large varices a primary prophylaxis treatment with nonselective beta-blockers must be instituted decreasing risk of bleeding approximately by half (d'amico Hepatology 2005).

The method to evaluate the efficacy of beta blockers treatment is the hepatic venous pressure gradient (HVPG). HVPG \< 12 mmHg or a decrease of HVPG of 20% after beta blocker treatment reduce dramatically the risk of bleeding (Feu F. Lancet 1995). But a good response (HVPG \< 12 mmHg or reduction \> 20%) to beta blockers was observed only in almost 30 % of patients. In non responder patients, the variceal bleeding incidence is estimated to 24 % at 2 years.

In this situation, alternative treatments to beta-blockers have been suggested: endoscopic ligation, which was shown to be as effective as beta blockers in primary prevention, and more recently carvedilol (Reiberger, Gut 2012).

So, HVPG monitoring may provide critical information for patients. However, because of its technical requirement and its invasivity, HVPG measurement is not feasible in clinical practice . So, there is a general consensus to continue indefinitely beta blockers treatment without control of hemodynamic efficiency (merkel J. Hepatology 2009).

Previous studies have suggested the interest of azygos blood flow measurements for evaluating hemodynamic changes in the esophageal collateral vessels of patients with portal hypertension (Bosch J. Hepatology 1985 ). More recently Magnetic Resonance Imaging (MRI) has been reported to be an efficient technique to assess azygos blood flow (Gouya Radiology 2011) in cirrhotic patients. Its feasibility is obviously higher than HVPG measurement.

However, in the same way that HVPG, a large-scale implementation in clinical practice of azygos blood flow measurement by MRI requires to specify minimal absolute threshold, or relative post-therapeutic decrease, related with no variceal bleeding.


Eligibility Criteria:
Inclusion Criteria:

Cirrhotic patients requiring β blocker in primary prophylaxis of bleeding esophageal varices

Exclusion Criteria:

* Patients under 18 year's old
* life expectancy of less than one month
* Patient already has a vasoactive treatment
* patient with CHC or portal vein thrombosis
* patient without social security or deprived of freedom
* contraindication to MRI
* contraindication to beta-blockers
* mental state does not allow the signing of an informed consent
WEGENT - Comparison of Methotrexate or Azathioprine as Maintenance Therapy for ANCA-Associated Vasculitides

Remission of ANCA-associated vasculitis can be obtained in approximately 80% of the patients with a combination of corticosteroids and cyclophosphamide. However, relapses are frequent. This point warrants the prescription of a maintenance treatment with a less toxic immunosuppressant for several months to years. The optimal drug in this indication is not determine. We decided therefore to compare the 2 most used drugs in this indication. Induction therapy consists in the combination of corticosteroids and intravenous cyclophosphamide pulses. Corticotherapy consisted first in one daily methylprednisolone pulse, for 1 to 3 days, followed by oral prednisolone at the dose of 1 mg/kg/d for 3 weeks, then progressively tapered and stopped at the 18th month from the diagnosis. Cyclophosphamide is administered every 2 weeks for the first 3 bolus (0.6 g/m2 - D1, 15 and 30), then every 3 weeks (0.7 g/m2). Once remission is achieved, patients receive 3 additional bolus (0.7 g/m2). At that time, patients are randomized for a maintenance treatment with azathioprine (2 mg/kg/d, orally) or oral methotrexate (starting at the dose of 0.3 mg/kg/wk, then progressively increased every weeks by 2.5mg, if necessary, to a maximum and optimal dose of 25 mg/wk) for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years-old with newly diagnosed systemic Wegener's granulomatosis,
* microscopic polyangitis with at least one factor of poor prognosis according to the five factors score (proteinuria \> 1 g/day, renal insufficiency defined as a serum creatininemia \> 140 µmol/L, specific cardiomyopathy, gastrointestinal tract and/or CNS involvement).

Exclusion Criteria:

* MPA patients with no poor prognosis factor;
* localized WG;
* relapse of previously known WG or MPA;
* treatment with corticosteroids for more than 1 month prior to diagnosis and start of immunosuppressant;
* co-existence of another multi-system autoimmune disease;
* malignancy (unless considered in complete remission and with no therapy for at least 3 years);
* contra-indication to corticosteroids or study immunosuppressants; pregnancy or no use of contraception in non-menopaused women;
* infection with human immunodeficiency virus; mental or physical disturbances not permitting to give consent.
The Effects of Probiotic and HMB Supplementation on Immune and Digestive Function in Special Operations Soldiers

The study will determine whether acute ingestion of a probiotic combined with beta-hydroxy-beta-methylbutyrate (HMB) can enhance immune and digestive function in soldiers during 8-weeks of advanced infantry training.

Up to sixty soldiers from an elite infantry unit will perform a parallel design investigation. Soldiers will be randomly assigned to one of four groups. Group 1 will consume the probiotic plus HMB, group 2 will consume HMB only, group 3 will consume only the probiotic, and group 4 will consume only placebo. All four groups will be garrisoned together, eat the same meals, and perform the same activity. All groups will be tested before as well as after an 8-week advanced infantry training program. During each testing session resting blood samples will be obtained to assess cytokine, inflammatory, and muscle damage markers. Additionally, questionnaires will be used to determine digestive health. Anthropometric, performance, and muscle volume measures will also be assessed prior to and immediately following the supplementation and training protocol.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Member of the same unit of the IDF

Exclusion Criteria:

* Current use of dietary supplements
* Current chronic use of medications
Dual Time Point PET in Lymphoma

This study aims to investigate the value of dual time point PET/CT in lymphoma. Since FDG uptake is linked to glucose metabolism, PET imaging is also used to detect suspected sites for infectious and inflammatory disorders. In a clinical setting, it is a challenge to distinguish between FDG uptake in benign and malignant lesions and this gives rise to a considerable quantity of false positive results and decreased positive predictive values. Performing FDG-PET imaging sixty minutes after injection is common practice in the staging and surveillance of lymphoma but this procedure may not be optimal, especially not in settings where benign inflammatory lesions are of clinical concern.

In an attempt to find an alternative method for this discrimination, dual time point FDG-PET was introduced. This technique has shown itself to be a potentially promising method in FDG-PET imaging for distinguishing between malignant and benign lesions using SUV values. The reason for the different FDG uptake patterns between inflammatory and malignant lesions is unclear. Several factors may contribute to this phenomenon on a cellular basis. It has been shown that cancer cells exhibit increased numbers of glucose transporter and low level of glucose-6-phosphatase. Varying levels between different cancer cell types may explain the different FDG uptake curves. Because various cell types exhibit varying rates of FDG uptake we believe that kinetic investigation may prove to be of value in understanding different types of lymphoma and identifying how to perform precise imaging for staging and surveillance.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Planned for curative treatment

Exclusion Criteria:

* Previously treatment with chemotherapy or irradiation
* Primary CNS lymphoma
* Recurrent lymphoma
* Transformation from indolent lymphoma
* Presence of diabetes mellitus, HIV, chronic inflammatory disease or infections
* Pregnancy or lactation
Trial of Arm Sleeve and Forearm Fatigue During Robotic Surgery

The study objective was to investigate whether wearing a forearm compression sleeve during robotic surgery reduces muscle fatigue as measured objectively by a grip strength dynamometer.


Eligibility Criteria:
Inclusion Criteria:

* Robotic surgeon

Exclusion Criteria:

-
Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202

LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18 (NCT02397499) or LIPO-202-CL-19 (NCT02398188). No risks related to treatment are anticipated as subjects will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in this follow-on study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female subjects who completed Study LIPO-202-CL-18 or LIPO-202-CL-19
* Capable of providing written consent
* Willing to comply with the study procedures and schedule

Exclusion Criteria:

* Female subjects who are pregnant or are not using adequate birth control methods
* Plan on starting a weight loss or exercise program during the study
* Plan to enroll in another investigational drug or device study
* Unlikely or unable to adhere to the study visit schedule
Safety and Efficacy of Lumiracoxib Versus Naproxen in Acute Musculoskeletal Pain

This study is designed to develop our understanding of the risk-benefit of using lumiracoxib in patients with acute musculoskeletal pain due to uncomplicated soft tissue injury.


Eligibility Criteria:
Inclusion Criteria

* Patients with acute musculoskeletal pain following an uncomplicated soft tissue injury (within the last 72 hours) which is expected to be self-limiting, requiring short-term treatment with a NSAID.
* Patients' acute musculoskeletal pain at baseline must be ≥ 50 mm on a 0 - 100 mm on a Visual Analogue Scale.
* Patients may have taken analgesic therapy following injury. However, the baseline pain intensity assessment should be taken: (i) 4 hours after the last dose of ≤ 400 mg ibuprofen, ≤ 1000 mg paracetamol, ≤ 600 mg aspirin or ≤ 2 tablets of other over-the-counter analgesic aspirin-based or paracetamol-based combination medications (ii) or 8 hours after the last dose of \> 400 mg ibuprofen or ≤ 50 mg diclofenac

Exclusion Criteria

* Patients whose pain is due to an acute exacerbation of a chronic condition e.g. osteoarthritis, rheumatoid arthritis, systemic lupus erythematosus.
* Patients who have taken non-steroidal anti-inflammatory drugs in the previous 24 hours (other than aspirin, ibuprofen, diclofenac, as described above).

Other protocol-defined inclusion/ exclusion criteria may apply.
Effects of Breakfast on Cognitive Processes in Children

The objective of this study is to test the effects of breakfast on cognitive processing ability in children.

Breakfast consumption has previously been shown to positively affect cognitive and academic performance in children. Specifically, breakfast consumption has been reported to improve memory, attention, problem solving, and logical reasoning compared to the absence of breakfast. This has been found under both short-term laboratory conditions and within a school environment in children from both a low and high socioeconomic background, although some studies have failed to find favorable effects.

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to maintain their habitual diet and physical activity patterns throughout the study period
* Provision of assent by subject
* Subject's guardian provides informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators

Exclusion Criteria:

* Diagnosis of attention deficit disorder, with or without hyperactivity
* A diagnosis of diabetes mellitus
* Acute illness or use of antibiotics within 5 days of visit
* Subject is a non-breakfast eater defined as not regularly eating food prior to 1000 h
* Known sensitivity or allergy to any ingredients of the study product
* Use of any psychotropic medication within 4 weeks
* Subject did not previously participate in an earlier trial with the same study products
* Exposure to investigational agent within 30 days.
* Individual has a condition the Investigator believes would interfere with his or her ability to provide assent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk