cyrilzakka/clinical-trials huggingface dataset:
Comparison of Efficacy Between 100% Platelet-rich Plasma and 100% Serum Eye Drops in Dry Eye Disease

Dry eye disease (DED) is a common eye problem, affecting 5% to 50% of the world population. Although the disease is not fatal, it substantially reduces quality of life and creates a high economic burden as high as over 50 billion from a societal perspective. Several biological tear substitutes (e.g., autologous serum (AS), autologous platelet rich plasma (APRP), and autologous platelet lysate (APL)) could effectively improve dry eyes, especially in patients with moderate to severe DED.. However, evidence on their comparative efficacy is controversial. The objective of the study is to compare the efficacy of 100% APRP with 100% AS eye drops in patients with moderate to severe DED.

The study is a single-center, double-blinded randomized, parallel, non-inferiority trial. Patients will be recruited from out-patient clinic, Department of Ophthalmology, Ramathibodi Hospital, Bangkok and will be randomized to receive either 100% APRP or 100% AS eye drops (1:1 ratio) for 4 weeks. The primary outcomes include ocular surface disease index (OSDI) and ocular surface staining evaluated using the Oxford scale. Secondary outcomes are fluorescein break-up time (FBUT), Schirmer's I test (ST I), meibomian gland parameters and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to less than 75 years.
* Have OSDI scores ≥ 23 or Oxford staining grade ≥ 2.
* Do not have following conditions:

Uncontrolled systemic diseases, active infection, advanced cancer. Pregnant and nursing women. • Have not recently used the following medications/interventions/surgery: Anticoagulants or anti-platelets. Topical undiluted blood products within 3 months. Punctal plug or contact lenses. Ocular surgery within 6 months.

* Do not have active ocular infection/inflammation, abnormal eyelid function or severe meibomian gland dysfunction (MGD stage 4).
* Have no contraindication for blood donations:

Positive human immunodeficiency virus, hepatitis B or C, or syphilis. Anemia (Hb \< 11 g/dL) or platelet concentration \< 150,000/ml.

* Being able to stop current dry eye treatment for 48 hours before staring trial intervention
* Willing to comply with the 4-week study protocol and provide informed consent.

Exclusion Criteria:

• None
En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Aim: To compare the surgical method of En Bloc resection to the conventional transurethral resection of non-muscle invasive bladder cancer (NMIBC) in terms of complete removal of tumour, specimen quality, and pathological certainty.

Background: NMIBC is a common disease with a 5-year recurrence rate reported as high as 64%. The cornerstone in the treatment of NMIBC is transurethral resection (TURB) where the tumour is dissected in pieces, removed from the bladder, and pathologically examined for potential muscle invasion. As the tumour is fragmented before removal, the method violates basic oncological principles and compromises pathological examination. Hence, TURB is possibly part of the mechanism causing recurrences. En Bloc resection (EBR), where the tumour is removed in toto, can potentially overcome the flaws of conventional TURB, but large randomized trials are needed.

Methods: This project will be a multicentre randomised controlled clinical trial comparing EBR to conventional TURB. Patients with suspected NMIBC tumours with largest tumour diameter ≥1cm and ≤6cm will be randomised to either the intervention group, thus undergoing EBR, or the control group, undergoing conventional TURB. The investigators intend to include 220 patients in total, 110 patients in each group. The RCT will be initiated in 2022.

Perspectives: If EBR can be shown to remove bladder tumours with better pathological quality and certainty, this could potentially spare patients from undergoing surgeries in the future, thereby reducing costs for both patients and society.


Eligibility Criteria:
Inclusion Criteria:

* Demographics: all BMI, smokers and non-smokers
* Primary, papillary, non-solid bladder tumour visualised by flexible cystoscopy
* Tumour diameter measured on CT-scan ≥2cm ≤6cm at largest diameter
* Ability to fully comprehend the information provided and comply with protocol
* Signed consent form
* Patients with multiple tumours can be included if it seems feasible to resect them in one procedure

Exclusion Criteria:

* Clinically suspected muscle invasive bladder cancer (invasion in to bladder muscle or extravesical extension visible on CT or solid tumour without papillary elements seen at cystoscopy)
* Tumour located in a bladder diverticulum
* Investigating physician concludes that en bloc resection is not technically possible
* Pregnancy
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation

This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on the Quality of Life in adults submitted to multi-stressor situation. Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for 7-weeks.


Eligibility Criteria:
Inclusion Criteria:

* male and female aged 18-29 years
* attending 7 weeks of firemen training school
* a 19 to 29 kg/m2 body mass index
* found medically healthy (in particular, free of respiratory and GI tract symptoms)
* agreeing to a written informed consent, and who appreciates dairy products and multi-fruit flavour.

Exclusion Criteria:

* Subject who is not reading and writing French, or not understanding informed consent or study protocol
* subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose), or with any known food or respiratory allergy;
* subject presenting a severe evolutive or chronic pathology (Ex: cancer, tuberculosis, Crohn disease, cirrhosis, multiple sclerosis, Type I diabetes...) or any past or actual health condition that may interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease...)
* subject having experienced any infectious disease during the last 7 days
* subject with current diarrhoea or constipation
* subject who is frequently using laxatives or who has been using laxatives during the week prior his participation to the study
* subject who was under artificial nutrition, had gastro-intestinal surgery or any intervention requiring general anaesthesia the last 2 months prior to his participation to the study
* subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation...) or with eating disorders (anorexia, bulimia, alcoholism...)
* subject currently receiving, or who has received during the last months, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, antiseptics,antifungal, corticoids, vaccines, anti-histaminic molecules, non-corticoid anti-inflammatory substances, immunosuppressant treatment...
* subject already enrolled in another clinical study, or currently under an exemption period from a previous study
* female subject who is currently pregnant or breast-feeding, or willing to become pregnant during the 2 coming months after enrolment in the study
* subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject
Static Muscular Stretching for Treatment of PAD

Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in PAD patients. This is a single-blinded study in 40 patients with stable symptomatic PAD. Patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). Patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. Measurements will consist of ankle-brachial index (ABI) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (NIRS)), and 6 minute walk test (6MWT), performed at baseline and after 4 weeks of stretching (or control splint placement). In addition, NIRS will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. Primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. Results from this study will be used to support funding applications for a larger efficacy trial.


Eligibility Criteria:
Inclusion Criteria:

* Age 40+
* A resting ankle-brachial index (ABI) of 0.90 or less in either leg
* Stable disease (PAD) for a minimum of 3-months

Exclusion Criteria:

* Habitual exercise (30 minutes of continuous activity for 3 or more days per week)
* Cardiovascular rehabilitation program during the past 3 months
* Below or above-knee amputation, critical limb ischemia (ulceration or gangrene)
* Leg pain at rest
* Cardiorespiratory disease
* Diabetes
* Major surgery or lower extremity revascularization during the previous 3 months
* Major medical illness treatment during the prior 12 months
* Central neurological disease
* Limited ankle or knee joint range of motion
* Requirement of oxygen with activity or exercise
* More than a class II New York Heart Association level of heart failure
* Wheelchair confinement, or inability to walk
* Cognitive disorder
* Vasculitis problem including Takayasu's arteritis, Buerger's disease, collagen disease or Raynaud's disease
Pilot Deployment of ePNa Into Epic EHR

Intermountain Health has developed a electronic decision support tool to help doctors provide the best care for pneumonia. The purpose of this study is to enhance the existing tool (called ePneumonia (electronic Pneumonia) or ePNa) so that it can be used at other institutions, and to test deployment of the tool at another institution's hospitals.

This study as funded by the AHRQ (Agency for Healthcare Research and Quality) involves making the current ePNa system a "SMART on FHIR" compatible application that will enable the same core software and processes to work across the Cerner and Epic electronic health record platforms. The investigators will then engage with emergency department providers and patients to improve user centered design, considering clinician preferences and feedback for use as well as patient needs for information. Finally, the investigators will evaluate the feasibility and acceptability via a pilot implementation trial of the interoperable ePNa platform at two Vanderbilt affiliated hospitals.

Eligibility Criteria:
Inclusion Criteria:

For the baseline database and assessment of clinical outcomes, all data will be pulled from the Epic Clarity data warehouse.

* 2500 patients that presented to the Vanderbilt and Wilson county EDs who are \>= 18 years old will be identified by ICD-10 codes for pneumonia or acute respiratory failure or sepsis with secondary pneumonia codes for the baseline database.
* An additional 2500 patients that presented to the Vanderbilt and Wilson county EDs who are \>= 18 years old will be identified by having had conventional PA (posteroanterior) and lateral or portable CXRs (chest X-rays), independent of ICD-10 codes.
* During the one year pilot trial, patients seen in the 2 EDs, who are \>= 18 years old will be identified by ICD(International Classification of Diseases)-10 codes for pneumonia or acute respiratory failure or sepsis with secondary pneumonia codes (estimated to comprise 1800 patients).

Exclusion Criteria:

For all above patients:

1. Patients seen with a history of recent trauma.
2. Subsequent episodes of pneumonia from the same patient within the study period.
3. Patients directly admitted to hospice/comfort care.
4. Patients admitted to a non-study hospital for further care.
5. Patients transferred from outside hospitals.

For the groups selected by ICD-10 pneumonia codes, an additional exclusion is:

• Patients without radiographic evidence of pneumonia or with clear radiographic evidence for an alternative diagnosis.
Essure Transvaginal Ultrasound (TVU) Study

The Essure procedure, FDA approved since 2002 and CE Mark approved since 2001, is the first permanent birth control method that can be performed in the comfort of a physician's office without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor performs an Essure Confirmation Test. In the United States, this test is called a hysterosalpingogram and evaluates the location of the inserts and whether the fallopian tubes are blocked. Outside of the United States, a standard x-ray is performed to evaluate the location of the inserts.

The purpose of this study is to evaluate whether a transvaginal ultrasound is an effective method of confirming micro-insert location.

This study has previously been posted by Conceptus, Inc. (USA).

After acquiring Conceptus, Inc., Bayer HealthCare AG (Germany) is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Women who are 21 to 44 years of age
* Women who are between 90-300 pounds (40-136 kilograms)
* Women who are scheduled to undergo an Essure micro-insert placement procedure for permanent birth control
* Women who are willing to accept the risk of pregnancy occurring while relying on the Essure device for prevention of pregnancy
* Women who are believed to have two viable fallopian tubes
* Women who are able and willing to provide written informed consent
* Women who have the mental capacity to understand the Informed Consent, comply with the protocol requirements, and provide reliable feedback regarding device wearing
* Women who can be available for all study visits
* Women who are willing to allow data to be shared with the sponsor and with regulatory bodies
* Women who are not contraindicated for the Essure procedure according to the Essure Instructions for Use (IFU)

Exclusion Criteria:

* Women who have known proximal tubal occlusion in either fallopian tube
* Women who have had a fallopian tube sterilization procedure
* Women who have a unicornuate uterus
* Women who have known endometrial or myometrial pathology that is likely to prevent access to the fallopian tube ostia
* Women who are scheduled to undergo any other intrauterine procedures at the time of Essure placement
* Women who are pregnant or suspected of being pregnant
* Women who have had a delivery or termination of pregnancy within the last six weeks
* Women who have an active or recent upper or lower pelvic infection
* Women who are contraindicated for Essure micro-insert placement according to the Essure Instructions for Use (IFU)
* Women who have a known intolerance to transvaginal imaging
Normobaric Hyperoxia Stabilizing Ischemic Penumbra

To investigate the safety and efficacy of normobaric hyperoxia (NBO) stabilizing penumbra in acute ischemic stroke patients.

All the enrolled patients were randomly assigned to NBO and control group. NBO group will be given 100% oxygen ( (10L/min for 4h) via a storage oxygen face mask and control group will be given oxygen using nasal oxygen(2L/min for 4h) .

Eligibility Criteria:
Inclusion criteria:

* Age≥18岁
* The signs and symptoms are consistent with anterior circulation infarction, and baseline NIHSS score：6-20
* Level of consciousness on admission：0-1
* mRS score before stroke: 0-1
* Patients who did not receive revascularization therapy
* The time from onset (finally normal) to randomization is less than 24h
* Patients who signed informed consent
* CTA or MRA confirmed internal carotid artery occlusion or M1/M2 segment occlusion of middle cerebral artery
* The low-perfusion area with Tmax\>6s was larger than the core infarction, and the mismatch ratio was greater than or equal to 1.8.

Exclusion Criteria:

* Evidence of rapid improvement in neurological function and NIHSS score \<6, or spontaneous recanalization before randomization
* The disease affecting assessment of baseline NIHSS score (dementia, epilepsy, neuromuscular disease, or psychiatric disease)
* Symptoms suggesting subarachnoid hemorrhage (even if CT scan is normal)
* Combined with the history, cerebral embolism due to sepsis or infective endocarditis was suspected
* Active or chronic obstructive pulmonary disease, pulmonary fibrosis, pneumonia, pleural effusion, acute respiratory distress syndrome, irregular breathing
* It is necessary to inhale (\>3L/min) oxygen to maintain peripheral arterial oxygen saturation (SaO2\>95%)
* Anemia or polycythemia vera or other conditions needing emergency oxygen patients
* Patients with upper gastrointestinal bleeding or nausea and vomiting can not complete inhalation oxygen using face mask
* Baseline blood glucose \<2.78mmol/L or \>22.2mmol/L
* Baseline platelet count \<50×109/L
* Hereditary or acquired bleeding tendency, lack of coagulation factor, recent oral anticoagulant INR\>3 or PPT more than 3 times
* Unstable vital signs (heart rate ≤50 beats/min or ≥120 beats/min, oxygen saturation ≤90%, R≥30 beats/min or ≤10 beats/min)
* Hypertension not controlled by medication: systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg
* Acute myocardial infarction suspected
* Pregnancy,
* Life expectancy \<90 days
* Heart, liver and kidney failure
* Magnetic resonance contraindications
* Claustrophobia
* Allergic to contrast media
* Participating in other drug or device research
Longitudinal Assessment of Children With Severe Asthma and Severe Pre-school Wheeze

Cross-sectional study to characterize cohorts of children with asthma and healthy controls in terms of clinical features, physiological measurements and non-invasive measurement of biomarkers and develop phenotype handprints for children with severe asthma


Eligibility Criteria:
Inclusion Criteria:

1. Parent / guardian must be able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to undertaking any study procedures.
2. Assent should be obtained from all children in the study where appropriate.
3. Male or female subject aged between 1 - 17 years inclusive at screening.
4. The parent / guardian, or where appropriate the child must be able to read, comprehend, and write at a sufficient level to complete study related materials.
5. Subjects will be allowed to enrol in other studies while taking part on this study. However, Permission from the Scientific Board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.

Exclusion Criteria:

1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
2. The subject has a history of drug or other allergy, which, in the opinion of the responsable physician, contra-indicates their participation.
3. Subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. If a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses
4. The child has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. Any U-BIOPRED assessments should be deferred until 3 months after the first dose or invasive procedure. Permission from the Scientific Board must be obtained to enroll or allow the continued participation of a child enrolled in another study.
5. Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
6. Prematurity ≤35 weeks gestation
7. The child had changed asthma medication within 4 weeks of the screening assessment(except those using the Symbicort maintenance and reliever therapy (SMART) regime)(assessment should be deferred)
8. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessment (assessment should be deferred).
9. The child has had a severe exacerbation (requiring ER attendance or hospital admission and/or a course of high dose OCS for at least 3 days duration) within 4 weeks of the baseline assessment (assessment should be deferred).
Effect of Preoperative Oral Energy Drinks Compared to Warming Matress on Body Temperature During Combined Spinal-epidural Anesthesia for Elective Cesarean Delivery.

It is not known which is better for intraoperative temperature protection, warming matress or preoperative oral functional drinks in elective cesarean section. We plan to conduct a non inferiority randomized trial to clarify this problem.


Eligibility Criteria:
Inclusion Criteria:

* Women pregnant with a single fetus;
* American Society of Anesthesiologists (ASA) physical status II;
* Willingness to undergo elective cesarean delivery under CSEA;
* An age of 20-40 years;
* A body mass index (BMI) of 19-30 kg·m-2;
* A gestational age of 38-40 weeks.

Exclusion Criteria:

* Contraindications for CSEA;
* A diagnosis of delayed gastric emptying, hyperemesis gravidarum until late pregnancy, or consumption of drugs that affect gastrointestinal motility within 3 days before surgery;
* Preoperative body temperature \>38°C or \<36°C or the use of drugs that affect body temperature;
* Pregnancy combined with diabetes, hypertension, or metabolic disorders (eg, hypothyroidism or hyperthyroidism);
* Ear diseases (eg, otitis media, tympanic membrane perforation, etc) affecting measurement of ear temperature .
* Patients who were simultaneously undergoing other operations (eg, removal of uterine fibroids and ovarian cysts) or had a surgical time \>1.5 hours;
* Patients with blood transfusion or autologous blood transfusion intraoperatively;
* Patients who did not receive the anesthetic specified in the protocol;
* Patients who failed to drink adequate energy drinks as prescribed before surgery.