cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Cilostazol in Patients of Vascular Cognitive Impairment-no Dementia (VCIND)

Patients of vascular cognitive impairment-no dementia (VCIND) in one group is prescribed cilostazol,in the other group is prescribed aspirin. Evaluate both of them in cognitive function, MRI and other sides at given time. The investigators hypothesize that cilostazol is more efficient and safer than aspirin in patients with VCIND.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 50-80, both gender；
2. Small vessel disease and associated cognitive impairment, diagnosed as VCIND；
3. Non-specific subjective symptoms (dizziness, somnolence, numbness in limbs) are acceptable.
4. Normal hepatic and renal function.
5. With good compliance.

Exclusion Criteria:

1. Aged above 80 or less than 50.
2. Dementia.
3. Cerebral infarction(\>2cm).
4. Major vascular lesion. (stenosis\>50%).
5. Cardiac cerebral infarction.
6. Intracerebral Hemorrhage.
7. Clinical manifestations cannot attribute to small vessel disease.
8. Major depression or dysfunction in speech, visual ability, hearing or aphasia that would interfere with the cognitive assessment.
9. Severe systematic organic impairment(cardiac, hepatic, renal dysfunction).
10. Thrombocytopenic Purpura.
11. History of hemorrhage in digestive system or surgery in past 3 months.
12. Previously on cilostazol treatment for more than 3 month.
13. Allergic to aspirin or cilostazol.
14. Enrolled in other clinical trials in past 3 months.
15. Lack of informed consent or compliance.
16. Contraindications for MRI scan.
GSK159802 In Healthy Male Subjects And Asthmatics

GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which is being developed for once daily treatment of asthma and COPD as part of a combination product with a once daily inhaled corticosteroid and also as a standalone product for the treatment of COPD. Stimulation of the beta-2-agonist in the lung mainly relaxes bronchial smooth muscle cells which results in bronchodilation. Unwanted systemic side effects related with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are limited by local administration and also tend to show tachyphylaxis.

The LABAs that are currently available (e.g., salmeterol, formoterol) require twice-daily administration, given their duration of action. Therefore, there is significant opportunity for a once-daily inhaled medication to improve patient compliance and overall disease management by providing sustained, 24-hour bronchodilation.


Eligibility Criteria:
Inclusion criteria:

* Body mass index within the range 18.5-29.9 (kg/m2)
* Current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \< 10 pack years.

Additional criteria for Cohorts 2 and 3 only (Asthmatic Patients):

* Subjects with a documented history of mild to moderate asthma, with the exclusion of other significant pulmonary disease
* Subjects with clinically stable asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 greater than 60% and less than 90% predicted.

During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of \> or equal to 12.0% over baseline and an absolute change of \> or equal to 300 mL within 30 minutes following 400 mcg salbutamol.

Exclusion criteria:

* Any clinically relevant abnormality
* Subjects who have a screening haemoglobin values \< 11 g/dL
* The subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 112 days or a clinical study with any other drug during the previous 84 days
* Subjects with known hypersensitivity to salmeterol or salbutamol or any ingredients in their preparations.
Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly

MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety of MYCAPSSA™ treatment in patients with acromegaly.

The study consisted of 2 periods, a Core Treatment Period of up to 7 months and an optional Extension Treatment Period of up to 6 months, for a total study duration of up to 13 months. The Core Treatment Period consisted of 2 phases, a Dose Escalation Phase of at least 2 months to identify the therapeutic dose for each study participant and a Fixed Dose Phase of 2 to 5 months during which the therapeutic dose was maintained.

Participants were eligible to enter the Fixed Dose Phase of the Core Treatment Period if they were clinically and biochemically controlled. The same criteria were used to allow entry into the voluntary 6-month Extension Treatment Period.

The Core Treatment Period of the study was completed if the participant had at least 2 months of treatment in the Fixed Dose Phase and a total treatment duration of at least 7 months. Participants who elected to continue into the Extension Treatment Period maintained their therapeutic dose during this period. At the end of the study (after the last dose of MYCAPSSA in either the Core Treatment Period or the Extension Treatment Period), there was a 2-week follow-up period for safety assessments.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects, aged 18 to 75 years old, inclusive.
* Subjects with acromegaly defined as documented evidence of growth hormone-secreting pituitary tumor that is abnormally responsive to glucose, or documented elevated insulin-like growth factor-1 (IGF-1), who are currently receiving a stable dose of a somatostatin analog for at least the previous 3 months.
* A serum IGF-1 level \< 1.3 x the upper limit of normal (ULN) and a serum growth hormone (GH) level \< 2.5 ng/mL.
* Subjects able and willing to comply with the requirements of the protocol.
* Subjects able to swallow capsules.
* Subjects able to understand and sign written informed consent to participate in the study.

Exclusion Criteria:

* Receiving regular injections of a somatostatin analog less frequently than once a month, ie, longer than every 4 weeks.
* Symptomatic cholelithiasis.
* Received pituitary radiotherapy within ten years prior to screening.
* Undergone pituitary surgery within the prior 6 months.
* Any condition that may jeopardize study participation.
* Clinically significant gastrointestinal (GI), renal, or hepatic disease as determined by the Investigator.
* Conditions (eg, bariatric surgery) significantly affecting gastric acidity or emptying.
* Current use (within 1 month) of proton pump inhibitors (PPIs) and current chronic use of H2-antagonists.
* Female patients who are pregnant or lactating.
* Current or recent (\< 3 months) therapy with pegvisomant.
* Current or recent (\< 2 months) therapy with cabergoline.
BLITZ Atrial Fibrillation

Management strategies for AF have made many advances over the last decade but there is still a great heterogeneity in the management of AF and it remains unclear how often clinicians adhere to current guidelines.

A survey of an updated AF management would enable a timely assessment of implementation of current International guidelines, allow monitoring of early management of AF when a patients is admitted in a Emergency Room (ER) and Cardiology Unit.

Multicentre, observational study. 200 Italian Hospitals fully representing the Italian cardiology reality in terms of geographical distribution and level of hospital technology.

Data collection in ER: Data on AF and Atrial Flutter episodes in ER will be collected retrospectively by checking the records of ER without collection of any data that can allow to identify the patients. These data will be collected under the responsibility of the Cardiology Departments consecutively for 4 weeks.

Data collected in Cardiology: these data will be collected under the responsibility of the Cardiology Departments for 12 weeks consecutively.

Eligibility Criteria:
Inclusion Criteria:

* All patients with AF, admitted to cardiology wards for an urgent or planned hospitalization.
* All patients admitted in a Day Hospital regimen for treatment of AF The diagnosis of AF must be confirmed by ECG.
* Signed Patient Inform Consent.

Exclusion Criteria:

* The qualifying episode of AF was not documented with an ECG.
* Age \<18 years.
* Patients with AF as a complication of an acute coronary syndrome (within 1 week from symptoms onset).
* Patients with AF associated with cardiothoracic surgery (within 1 week from surgery).
* Concomitant participation in other studies that can modify the diagnostic and/or therapeutic treatments.
* Patients already enrolled in BLITZ-AF
Investigating a Wrist-sensor Oximeter to Screen for Sleep Apnoea.

The primary study objective is to investigate sensitivity and specificity of a wrist sensor pulse oximeter (the Oxitone Medical Oxitone 1000M device) to screen for obstructive sleep apnoea. This study will involve thirty participants attending a sleep centre suspected of suffering from obstructive sleep apnoea (case finding screening). The secondary objective is to assess patient convenience with the screening procedure.

This is an observational study to assess the sensitivity and specificity of a wrist sensor pulse oximeter (Oxitone Medical Oxitone 1000M) to identify obstructive sleep apnoea cases in patients referred to the London Sleep Centre (case finding screening, or case only study). The wrist sensor pulse oximeter streams data (pulse rate, heart rate variability (HRV), blood oxygen saturation levels (SPO2), actigraphy data and skin temperature data) to a software application using bluetooth connectivity to be stored in a securely encrypted database cloud for analysis. The investigators at the sleep centre will be masked when analysing the data from the wrist sensor pulse oximeter when deciding on diagnosis of obstructive sleep apnoea. Data from the wrist sensor oximeter device will be statistically compared with the data from a conventional PPG fingertip oximeter and Peripheral Arterial Tonometry device currently in use. The study outcome will be whether the wrist sensor pulse oximeter device could be used in patients to screen reliably for obstructive sleep apnoea. The study also will include patient feedback on convenience of the screening procedure. The study will not affect routine patient medical management and care for patients assessed at the sleep centre.

Eligibility Criteria:
Inclusion Criteria:

* Thirty consecutive patients referred to the sleep Centre for screening for sleep apnoea that consented to involvement in the study.

Exclusion Criteria:

* Patients who are unable to give written informed consent.
* anaemia or dysfunctional hemoglobin
* upper limb complaints affecting the ability to wear the watch like wrist sensor device such as tenderness, deformity or swelling, skin complaints such as ulceration, swelling or skin breaks
* impairment in circulation in the left upper limb (active Raynauds or other vascular impairment)
* neurological conditions such as tremor or convulsions
* Medical conditions likely to affect the blood oxygen such as chronic obstructive pulmonary disease (COPD) and chronic asthma
* Neurological conditions likely to affect breathing such as stroke
* Conditions likely to affect autonomic nervous system such as diabetes mellitus
Visual Telerehabilitation in AMD Patients

Following the degeneration of the macula and the loss of central vision, the patients naturally relocate the fixation point for high visual acuity peripherally, in an eccentric and healthy part of the retina (PRL), to compensate for visual impairments. However, in many cases, the PRL lands on a sub-optimal retinal area and becomes useless. Modern low-vision rehabilitation procedures for AMD patients include biofeedback training (BFT) to relocate the PRL to a healthy retinal patch and acquire better fixation skills. This study seeks to combine BFT with home-based immersive virtual-reality audiovisual stimulation and measure feasibility and potential effectiveness on oculomotor control and visual perception.


Eligibility Criteria:
Inclusion Criteria:

* Dry-AMD.
* BCVA \> 20/160.
* Ability to follow the visual and auditory stimuli and training instructions.
* Auditory test positive at 50Hz 25-60dBHL.
* Home Wi-Fi access.

Exclusion Criteria:

* Wet AMD.
* Both eyes with media opacity that impairs microperimetry testing.
* Inability to perform during testing and training.
* Psychoactive drugs consumption.
* 3 consecutive VRISE scores \< 25 at inclusion.
* History of vertigo or dizziness
* Prior vision rehabilitation interventions.
Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer

This study will test an investigational vaccine, called DRibbles, for the treatment of non-small cell lung cancer (NSCLC). We hypothesize that vaccination with the DRibble vaccine will cause an immune responses against proteins contained in the DRibble vaccine and the protein antigens targeted by this strong immune response will include common antigens shared by both the vaccine and the patient's tumor.

This is an open-label, randomized study in which the first 33 patients will be assigned to receive the either:

* DRibbles vaccine and HPV vaccine
* DRibbles vaccine, HPV vaccine, and imiquimod
* DRibbles vaccine, HPV vaccine, and GM-CSF After 11 patients have been assigned to each group, the study arm with the greatest number of vaccine-induced strong antibody responses will then continue with enrollment of 15 further patients. The primary objective is to determine the best strategy to induce strong (\>15 fold) tumor-specific or tumor-associated antibody responses in patients with stage III A and B NSCLC. The goal is to select one regimen to advance to additional clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Stage IIIA or IIIB histologically proven non-small cell lung cancer
* Completion of definitive therapy
* Enrollment from 28 days to 12 weeks from completion of definitive therapy
* Toxicities from definitive therapy resolved to less than grade 1
* ECOG performance status 0-1
* Negative pregnancy test in women of childbearing potential
* Agree to avoid pregnancy or fathering a child while on study treatment
* Ability to give informed consent and comply with protocol
* Anticipated survival minimum of 6 months
* Prior therapy with investigational agents must be completed at least 3 weeks prior to study enrollment
* Normal organ and marrow function as defined by specific lab tests
* Archived tumor tissue available

Exclusion Criteria:

* Active autoimmune disease except for vitilogo or hypothyroidism
* Active other malignancy
* Known HIV+ and/or Hepatitis B or C positive
* Medical or psychiatric conditions that would preclude safe participation
* Ongoing chemotherapy
A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests

The Mannheim Multicomponent Stress Test (MMST) is a validated laboratory stress test that combines cognitive, emotional, acoustic and motivational stress components. However the utility of the MMST as a viable alternative to the more commonly used Trier social stress test (TSST) to elicit HPA reactivity remains unclear as meaningful increases in saliva cortisol (\> 2.5 nmol/l) have been shown to occur in \<50% of participants yet the TSST typically elicits meaningful increases in saliva cortisol in \>70% of participants; likely as a consequence of the greater social evaluative component in the TSST.

Using a randomised between groups design, this study aims to compare psychobiological responses to the MMST and TSST.


Eligibility Criteria:
Inclusion Criteria:

Participants who...

* have read and signed the study informed consent
* are healthy, recreationally active men and women aged 18-35 years
* are willing to provide saliva samples throughout through the duration of the study
* are using monophasic birth control (women only)

Exclusion Criteria:

Participants who...

* have a recent history or are a current smoker
* are currently taking prescription/Over-the-counter medication (excluding females taking oral combined contraception
* consume ≥ 91 units of alcohol per month
* have a clinically diagnosed history of cardiovascular and/or metabolic disease including diabetes and abnormal blood pressure
* are pregnant
* have a recent or ongoing viral or bacterial illness in past 4 weeks
* have a clinically diagnosed psychiatric disorder
* have a clinically diagnosed sleeping disorder
* have a clinically diagnosed gambling addiction
* BMI ≥ 30 kg/m2 - calculated in the online health screening questionnaire
* Endurance trained or engage in ≥3.5 hours of physical activity a week
A Dose-finding Study of JMKX003142 in Treatment of Renal Edema

To Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of JMKX003142 Administered Randomly, Open-label, Active-controlled Study in Chinese Renal Edema Patients.

JMKX003142 is an arginine vasopressin（AVP）-V2R antagonist which shows a remarkable diuretic effect in healthy volunteers.In this phase 2 study ，we will observe the safety 、efficacy and pharmacokinetic（PK） characteristics about different dose levels of JMKX003142 tablets in renal edema patients. This phase 2 study is designed as a randomly, open-label, active-controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who can fully understand the purpose and process of the study and voluntarily sign the informed consent form（ICF）;
* Age ≥ 18 years old during screening;
* Diagnosed as renal edema during screening;
* Estimated glomerular filtration rate（eGFR） ≥ 15 mL/min/1.73m2 during screening.

Exclusion Criteria:

* Patients who are receiving the renal replacement therapy during screening or patients who require renal replacement therapy in the short term evaluated by the researchers;
* Patients who are suspected with hypovolemia;
* Patients with the following diseases or symptoms: acute thrombosis, diarrhea, and difficulty urinating;
* Patients who are unable to sense thirst or who have difficulty with fluid intake;
* Patients who have received arginine vasopressin-V2R blockers within 30 days prior to the screening examination;
* The following laboratory indicators are abnormal: glutamic pyruvic transaminase ≥ 1.5 ×upper limit of normal, glutamic oxaloacetic transaminase ≥ 1.5 × upper limit of normal, serum sodium\> upper limit of normal, D-dimer ≥ 2 × upper limit of normal;
* Patients who received diuretics or treatments with diuretic effects from Day-2 to randomization;
* During screening, systolic blood pressure \<90mmHg/diastolic blood pressure\<60mmHg, systolic blood pressure\>160mmHg/diastolic blood pressure \>100mmHg;
* Patients who have a history of allergies to ≥ 3 substances, or are currently in an allergic state;
* Female patients who are breast-feeding or who have a positive pregnancy test result prior to receiving investigational product (IMP);
* Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice birth control or remain abstinent during the trial and for 30 days after the final IMP administration.
Study on Hyperlipidemia Combined With Carotid Atherosclerosis With ShenJu Granules

This study focuses on PWV as the main outcome, aiming to evaluate the efficacy and safety of ShenJu in treating patients with hyperlipidemia combined with carotid atherosclerosis, and provide a basis for traditional Chinese medicine treatment of hyperlipidemia combined with carotid atherosclerosis.

Hyperlipidemia is very harmful and easy to cause atherosclerosis. Atherosclerosis is the main factor of carotid atherosclerosis. Carotid atherosclerosis and plaque are usually the characteristic manifestations of atherosclerosis. Carotid arteriosclerosis is closely related to stroke, and carotid arteriosclerosis, rupture and detachment of carotid plaques, carotid stenosis and occlusion can all lead to the occurrence of cerebrovascular events. Early detection and evaluation of hyperlipidemia with carotid atherosclerosis by various means can effectively reduce the risk of cardiovascular and cerebrovascular diseases. In order to better serve the vast number of patients, Professor Wang Lei has developed ShenJu granules based on traditional Chinese medicine prescriptions and years of clinical experience. Compared to decoction, ShenJu granules have a higher concentration, are more convenient to carry, and are easy to absorb. They have received unanimous praise from patients in clinical applications.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has informed consent and signed the informed consent form
2. Age between 18-65 years old
3. Meet the diagnostic criteria for hyperlipidemia and accompanied by carotid arteriosclerosis
4. Meet the diagnostic criteria of TCM wet certificate: refer to the scoring standard of TCM Wet Disease Scale

Exclusion Criteria:

1. Severe liver, kidney and cardiac insufficiency
2. Any other serious disease or condition such as: malignant tumor, uncontrolled severe hypertension, diabetic ketoacidosis (acute complication/vascular abnormality), arrhythmia, coagulation abnormalities
3. Have participated in another clinical study within 30 days prior to enrollment or have received a history of randomized ketoacidosis in this study
4. Pregnant women, women preparing to become pregnant and lactating women
5. Patients who are allergic to relevant Chinese medicine ingredients
6. Patients who have had a stent inserted
7. Patients who the investigator determines are not suitable to participate in this study
Outcomes Following Total Knee Arthroplasty

The purpose of this investigation is to determine both patient-reported and performance-based outcomes, specifically muscle function and kinematic/kinetic outcomes, between four different surgical total knee prostheses in individuals following TKA. Change scores will be determined based on patient-reported outcomes, kinematic/kinetic data, knee extension strength/power, static/dynamic balance control, mobility measures and functional performance testing during functional tasks (i.e. walking, ascending/descending stairs, sit-to-stand). After evaluating the pattern of change in lower-extremity function, the investigators will be better prepared to address residual functional impairments and prognostic factors linked to maximal recovery over two years.


Eligibility Criteria:
Inclusion Criteria:

* adults \> 40 years of age that are scheduled for primary TKA
* if they have had a previous TKA, it needs to have been performed on the opposite leg at least 3 months prior to the current TKA
* willing to return for follow-up visits and should be willing and able to be transported from the UOC to the Skeletal Muscle Exercise Research Facility (SMERF), in the Department of Physical Therapy study site for scheduled research follow-up appointments

Exclusion Criteria:

* adult with previous additional orthopaedic, neurological, visual or surgical conditions that may affect gait or balance
Anesthetic Efficacy of Intrauterine Lidocaine for Removal of a "Lost" Intrauterine Device

Objective: To evaluate the efficacy of intrauterine lidocaine instillation in reducing patient discomfort during the removal of a "lost" intrauterine device (IUD).

Methods: This double-blinded, randomized, placebo-controlled trial included 68 women who underwent removal procedure for a "lost" IUD. Thirty-four women were allocated to the lidocaine group and 34 to the saline group. The main outcome measure was the intensity of pain during, immediately after, and 20 minutes after the procedure, assessed by a visual analog scale. Statistical analysis was performed using Friedman's test with Bonferroni correction, Student's t test, and 2.


Eligibility Criteria:
Inclusion Criteria:

patients undergoing a minor gynecologic procedure for removal of a "lost" IUD.

Exclusion Criteria:

women with a history of cervical stenosis, known allergy to lidocaine, pregnancy, acute cervicitis