cyrilzakka/clinical-trials huggingface dataset:
Biological Dating of Cerebral Ischemia With GST-π/PRDX1 to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis

The FLAG1 study will assess the diagnostic performance of biomarkers Glutathion S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1) to identify cerebral infarction of less than 4,5 hours in a population of patients with neurological deficiency of less than 12 hours.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients with symptoms consistent with stroke and a National Institute of Health Stroke Score ≥3 at the inclusion time
* Time symptom onset ≤ 24 hours at inclusion:

  * For patients with time of symptom onset is \<4.5h at inclusion, the time of symptom onset has to be precisely known, with a margin of error not exceeding 30 minutes (through patient or witness interview)
  * For patients with time of symptom onset is \>4.5h at inclusion, knowledge of precise time of symptom onset is not required. For these patients, to ensure onset-to-inclusion time is between 4.5 and 24 hours at inclusion:
* last time patient presented no deficit must be less than 24 hours,
* symptoms must have been first recognized more than 4.5 hours before blood draw.
* Possibility to perform MRI within the 30 minutes following blood collection
* Person affiliated to or beneficiary of a social security plan

Exclusion Criteria:

* Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the French Public Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of public guardianship) ; Adult person incapable of giving consent and not under legal protection.
* Persons deprived of liberty for judicial or administrative decision.
* Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code.
* Known cancer in progression.
* Known cirrhosis.
* Myocardial Infarctions, stroke, Subarachnoid hemorrhage or intracranial injury within 3 months prior to enrolment.
Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis

B7451037 is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2a study to investigate the mechanism of action of PF-04965842 by correlating efficacy outcomes with changes from baseline in key skin and blood biomarkers in adult participants at least 18 years of age with moderate-to-severe atopic dermatitis. Participants will be screened within 28 days prior to the first dose of study intervention to confirm eligibility. A total of approximately 51 participants will be randomized in a 1:1:1 ratio to receive PF-04965842 200 mg once daily (QD), PF004965842 100 mg QD, or matching placebo QD for 12 weeks. At the end of the 12-week study treatment, qualified participants will have the option to enter the long-term extension study B7451015 (NCT03422822). Participants discontinuing early from this study will undergo a 4-week off-treatment follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic moderate-to-severe atopic dermatitis (AD) for at least 1 year
* Recent history of inadequate response to medicated topical therapy for AD or required systemic therapy to control disease
* Moderate-to-severe AD defined as affected BSA at least 10%, IGA at least 3, EASI at least 16, Peak Pruritus NRS at least 4

Exclusion Criteria:

* A current or past medical history of conditions associated with thrombocytopenia, coagulopathy, or platelet dysfunction
* Currently have active forms of other inflammatory skin diseases, i.e. not AD, or have evidence of skin conditions (e.g. psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that would interfere with evaluation of AD or response to treatment
* Participants who have received prior treatment with any systemic JAK inhibitors
* Require treatment with prohibited concomitant medication(s) or have received a prohibited concomitant medication within specified time frames prior to the first dose of study medication, including topical treatments that could affect AD
* Pregnant or breastfeeding women or sexually-active women of childbearing potential who are unwilling to use contraception
CCRC: Understanding the Effects of Omega-3 Fatty Acids Versus Lignans in Flaxseed on Metabolic and Inflammatory Markers Leading to Diabetes and Cardiovascular Disease

The aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma inflammatory markers, and insulin sensitivity.

We hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease triglyceride, total and LDL-cholesterol and increase HDL-cholesterol).

Flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (SDG). Lignans are estrogens found in plant sources that behave similar to endogenous estrogens and have been associated with cardiovascular benefits due to their antioxidant activity. Therefore, we also hypothesize that flax-lignans will cause a significant decrease in LDL oxidation and in inflammatory markers such as C-reactive protein (CRP), interleukin-6 (IL-6), IL-1B, serum fatty acid binding protein 4 (FABP-4), and serum amyloid attached to high density lipoprotein (HDL-SAA).


Eligibility Criteria:
Inclusion Criteria:

* Men or postmenopausal women in the 40-65 years age range. Body Mass Index in the range of 25-39

Exclusion Criteria:

* Women are are premenopausal
* Smoking
* Diabetes
* Cancer
* Gout
* Untreated thyroid disease
* Kidney Disease
* Liver Disease
* Use of lipid lowering drugs
* Use of insulin sensitizing drugs
* Use of ACE inhibitors or other blood pressure lowering medications
* Use of over the counter or prescription anti-obesity medications
* Weight loss of 10% or more within the last 12 months
A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>=70 years of age
* Non-small cell lung cancer
* Naive to prior chemotherapy or specific immunotherapy
* Presence of at least 1 measurable lesion

Exclusion Criteria:

* Active non-controlled infection or disease
* CNS metastases
* Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)
Influence of Specific Collagen Peptides on Recovery After Exercise Induced Muscle Damage

The present study aims at investigating the potential influence of specific collagen peptides on recovery after exercise induced muscle damage with focus on long-term effects.


Eligibility Criteria:
Inclusion Criteria:

* No subjective symptoms during physical exertion
* Stable weight and dietary behaviour
* Body Mass Index (BMI) between 18.5 and 24.9
* No extensive strength/endurance sports so far (less than 3 h/week)
* No complaints during strenuous physical activity

Exclusion Criteria:

* Circumstances that impair/prevent sporting activity (e.g. chronic heart disease, arrhythmia, heart valve disease, arthritis etc.)
* Intolerance/aversion to animal protein
* Arterial hypertension (high blood pressure) (syst \> 200 mmHg and/or diast \> 105 mmHg) at rest
* Presence of insulin-dependent diabetes mellitus
* Liver and/or kidney disease that precludes a high protein load
* Collagen supplementation or regular intake of other dietary supplements in the last 6 months.
6 Weeks Plyometric Training on Vertical Jump and Agility in Relation to Gender Among Badminton Players

This study exmine the effects of plyometric training on vertical jump and agility in male and female badminton players.The two groups will be subsequently randomly assign into the experimental group and control group.

After approval from the graduate committee permission will be obtained from the higher authorities of the naval anchorage badminton club islamabad. Purpose of this study will be explained to the all participants written informed consent will be obtained.participants will recive 6 weeks intervention with a generic warm up consisting of ten body weight squats,ten forward lunges each side and 3 mintues of dynamic stretching of relevant lower extremity muscles. The agility t-test will be used to measure and seargent vertical jump test will be used to measure vertical jump.

Eligibility Criteria:
Inclusion Criteria:

* Male and female clients
* Players whose age lies between 18 and 25 years.
* Players who played badminton for at least 6 months

Exclusion Criteria:

* Musculoskeletal or neurological disease
* Pathological condition of spine , hip, knee and pelvic
Efficacy and Safety of DA-9401 on Improvement of Sperm Motility

This study was conducted to investigate the effects of daily supplementation of Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) on improvement of sperm motility.

This study was a 12 weeks, multi-center, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Allium cepa L. and Cuscuta chinensis Lam. Extract Mixtures (DA-9401) or a placebo group. sperm motility profiles before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-55 years
* sperm motility 40\~69%

Exclusion Criteria:

* History of alcohol or substance abuse
* Participation in any other clinical trials within past 1 months
* intense constipation
A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Levothyroxine and the Influence of Co-administered Tablets on the Pharmacokinetics of Semaglutide Administered Orally in Healthy Subjects.

This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of levothyroxine and the influence of co-administered tablets on the pharmacokinetics of semaglutide administered orally in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-50 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) 20.0 to 29.9 kg/m\^2 (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Smoker (defined as a subject who is smoking at least 1 cigarette or the equivalent per day)
* Unable or unwilling to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods
* Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening
* History (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* History (as declared by the subject) or presence of clinical or non-clinical thyroid disease, including thyroid palpation abnormalities, levels of T3 or T4 (total and free) or TSH outside reference limits, or presence of thyroid antibodies (Thyroid Stimulating Hormone Receptor Antibody, Thyroperoxidase Antibody or Thyroid Antithyroglobulin Antibodies)
A Prospective Study in Chinese Patients With Lower Extremity Ankle Fracture of Oral Anticoagulants to Prevent Venous Thromboembolism (VTE)

Deep vein Thrombosis (Deep Venous Thrombosis, DVT) and Pulmonary Embolism, Pulmonary Embolism, PE) both collectively known as Venous thromboembolism (VTE) (Venous Thrombus Embolism, VTE), is a common clinical disease, and tremendous harmful. Ankle fractures in patients requiring long-term bed braking, increase the incidence of lower extremity deep vein thrombosis, anticoagulant therapy as an important measures to prevent thrombosis in clinical widely accepted, however, the literature anticoagulation effect incision healing. Whether to strike a balance between the two, to develop a foot fracture in accordance with the Chinese characteristics of anticoagulant solution is we try to solve the problem. The purpose of this study is aimed at the use of oral anticoagulants and physical anticoagulant treatment knee far foot fracture patients randomized controlled studies in China.


Eligibility Criteria:
Inclusion Criteria:

* (1) year full 18 one full year of life (2) one side of ankle fractures, calcaneal fractures, the metatarsal bone fracutures will use the internal fixation treatment 3) participants must be able to normal conversation, and understand the problems in the "subject subjective questionnaire", and could provide feedback using the appropriate language.

Exclusion Criteria:

* 1)Subjects did not provide a voluntary agreement 2) subjects participating in clinical research for pregnant or lactating women 3) has preoperative examination in the diagnosis of venous thromboembolism (VTE) 4) in patients with preoperative oral antiplatelet/anticoagulation drugs for a long time.

  5) surgery time fractures occur over time more than 3 weeks 6) patients exist pilon fractures (AO type 43-43 - B and C) and ankle multiple fractures, 7) pathological fractures (e.g., primary or metastatic tumors) 8) severe soft tissue injuries, open fractures or vascular injury or the combining bone fascia room syndrome; 9) multiple injuries, judge doesn't fit into the study by researchers, and other parts of the three or more than fracture 10) revision surgery (e.g., malunion, bone nonunion or infection) 11) merger of anticoagulant taboo disease, judge doesn't fit into the study by researchers, such as the active bleeding and clotting disorders, severe head trauma or acute spinal cord injury, platelet count \< 20 ╳ 109 / L, etc.; 12) patients with anesthesia and surgery patients with contraindications to 13) on pp shaaban drug allergy 14) patients may be poor compliance, the researchers determined doesn't fit into the daily (such as excessive drinking or smoking, taking drugs) 15) patients in the past three months participated in other clinical trials; 16) in patients with poor compliance, judge not according to the study by the researchers plan to complete the test, such as schizophrenia and dementia
CIPN Decision Aid for the Improvement of Chemotherapy Decision Making in Patients With Breast Cancer

This clinical trial studies how well a chemotherapy-induced peripheral neuropathy (CIPN) decision aid works in improving chemotherapy decision making among patients with breast cancer. CIPN involves numbness or tingling in the hands or feet and is a debilitating side effect of several commonly used classes of cancer drugs. CIPN symptoms are typically minor at first but can progress with continued treatment to severe symptoms that can affect long-term function, falls risk, and quality of life. Symptoms sometimes resolve after treatment but in patients who experienced CIPN, symptoms are still present 1 year post-treatment in about two-thirds of patients and 3 years post-treatment in approximately half of the patients. Previous studies indicate patients lack awareness of long-term CIPN symptoms. A decision aid that provides information about permanent CIPN, that helps patients understand their treatment priorities, and prepares them for a discussion with their medical oncologist may lead to improvements in treatment decision making, satisfaction with decision making, and ultimately increase patient's achievement of their treatment goals.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer
* Currently receiving cycle three of taxane treatment
* Approval of medical oncologist to enroll patient
* Experiencing any CIPN based on enrollment screening question, "In the last 7 days, what was the severity of your numbness or tingling in your hands or feet at its worst? None, Mild, Moderate, Severe, Very Severe. Patient is eligible if their answer is anything except "None"
* Access to a smartphone or similar device that can complete CIPN DecisionAid via Qualtrics while in the waiting room

Exclusion Criteria:

* Inability to read or speak English
Treatment of Intracranial Wide-neck Aneurysms Using Stent-assisted Coil Embolization

This device was designed to assist in the stent-assisted coil embolization of intracranial aneurysms, specifically those that have a wide neck that would not otherwise maintain the coil embolization material within the aneurysm because of the wide opening at the base of the aneurysm. This device was designed to treat aneurysms that are: unruptured, wide-necked, intracranial, saccular aneurysms arising from a parent vessel ≥ 2 mm and ≤ 4.5 mm. Wide-necked was defined as having a neck \> 4mm or dome-to-neck ratio \< 2.

This is a prospective study to investigate the efficacy of using stent-assistance for embolization of intracranial aneurysms with a wide neck (defined as \> or = to 4mm, or with a dome to neck ratio of 2:1 or less). We plan to investigate successful embolization of intracranial aneurysms defined by angiographic occlusion of greater than or equal to 90% at 6 months. Patients will be followed for a minimum period of 2 years from the date of the procedure, with a planned total duration of 4 years of the study, including follow up time. Participants will be initially assessed and if included, will undergo procedure that includes use of the device. Afterwards, they will be scheduled for regular follow up at 2 weeks for clinical assessment, then again at 3 months for clinical assessment and MRA to investigate the stented region, then again at 6 months for clinical assessment and possible cerebral angiogram vs possible MRA, and then again at 1 year post-procedure, and then again at 2 years post-procedure. Patients may then follow up on an annual basis or every 2-3 years, depending on preference and any residual or recurrent aneurysm. A more specific timeline and treatment course is described below.

Patients will receive cerebral angiography for evaluation of their cerebral vasculature and aneurysm configuration to ensure that the parent vessel diameter is adequate and that the aneurysm is 4mm in size with a wide neck. In these cases, if it is determined that the patient will require additional vascular support in order to adequately embolize the aneurysm then the use of stent-assisted coil embolization may be offered to the patient.

Once enrolled, patients will undergo endovascular stent-assisted coil embolization of the aneurysm, and clinical outcomes will then be assessed. Data will be collected for analysis according to the primary and secondary outcome measures in addition to any deviations from the protocol or safety concerns as well

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years old or older) with intracranial aneurysms with a wide neck (defined as \> or = to 4mm, or with a dome to neck ratio of 2:1 or greater).

Exclusion Criteria:

* Small-necked aneurysms,
* Inability to tolerate anti-platelet medication
Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients

The purpose of this study is to determine whether the combination of paclitaxel, capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT) in patients with squamous-cell anal cancer.

This trial aims to investigate the efficacy of chemoradiotherapy with or without paclitaxel in squamous-cell anal cancer. This is a prospective multicenter open-label randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either standard IMRT with capecitabine and mitomycin or IMRT with capecitabine, mitomycin and paclitaxel. A stratification will be performed based on T stage, N stage and clinical center. Doses of capecitabine and mitomycin in experimental group were reduced for better treatment tolerance. The target accrual is 157 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 15% 3-yr disease-free survival (70% vs 85%), α=0,05, power 80% in the experimental arm. An interim analysis is planned after 50% of the patients will reach a 3-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging and followup. Pelvic MRI and histological diagnosis are subject to central review. Conduction of this study and data collection are controlled by a local institutional board.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Histologically verified squamous-cell anal cancer
* Stage I-IIIB (Union for International Cancer Control (UICC) TNM classification v7)
* Eastern Cooperative Oncology Group (ECOG) status 0-2
* HIV (Human Immunodeficiency Virus) negative
* Haemoglobin (HGB) \> 90 g/L
* Platelet Count (PLT) \> 120x10\*9/L
* Serum creatinine \< 150 µmol/L
* Total bilirubin \< 25 µmol/L

Exclusion Criteria:

* inability to obtain informed consent
* distant metastases
* synchronous or metachronous tumors
* previous chemotherapy or radiotherapy
* clinically significant cardiovascular disorders (myocardial infarction \< 6 months before visit, stroke \< \< 6 months before visit, instable angina \< 3 months before visit, arrhythmia, uncontrolled hypertension \> 160/100 mm hg
* clinically significant neurological disorders
* previous neuropathy 2 or higher
* current infection or heavy systemic disease
* pregnancy, breastfeeding
* ulcerative colitis
* individual intolerance to treatment components
* proven dihydropyrimidine dehydrogenase (DPD) deficiency
* participation in other clinical trials
* psychiatric disorders, which render patient unable to follow instructions or understand his/her condition
* technical inability to perform pelvic MRI
* inability of long-term followup of the patient
Removing Background Talker Noise for Cochlear Implant Users

When hearing-impaired listeners are properly aided with a hearing aid (HA) or cochlear implant (CI), they are often able to comfortably maintain a conversation in quiet environments. However, in group environments, such as a large family dinner, restaurant, or other environment where multiple people are talking simultaneously, hearing-impaired listeners have great difficulty participating in conversations and frequently withdraw or avoid the situation. As such, it would be highly beneficial to implement an algorithm into HAs or CIs to remove background talkers ("babble") from the signal to reduce listening effort for the hearing-impaired listener and allow them to converse as if they were in a quiet environment. Although HAs and CIs frequently incorporate noise reduction algorithms, these algorithms are not effective when the background is babble. The problem of removing babble involves segregating speech from speech. Hence, the spectral properties of the signal and noise are extremely similar.

Despite these challenges, we developed an algorithm to remove background babble. In the following study will test the ability of cochlear implant users to understand speech with background babble noise using our noise reduction algorithm or no noise reduction algorithm. We hypothesize that CI users will be able to understand significantly more speech in babble noise when using our algorithm.


Eligibility Criteria:
Inclusion Criteria:

Subjects with CIs 12 years of age and older with no diagnosis of other communicative or cognitive disorders. Subjects must have native or native-like English proficiency.

Exclusion Criteria:

No diagnosed cognitive or communicative disorders (other than hearing loss), presence of acute/chronic otitis media, useable acoustic hearing, and non-English speaking.