cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia

The study is designed to be a randomized, open, multi-center, phase IIa/IIb seamless adaptive trial.

Phase IIa: The study consists of a screening period, a core treatment period, an open label extension period, and a safety follow-up period Phase IIb: At present, a preliminary exploratory study (i.e., phase IIa study) will be conducted first. The design of the phase IIb study (including the selection of populations) will be clarified after a relatively clear understanding of the therapeutic effect, value, risks and benefits of the BTK inhibitor for ITP is obtained.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences, and potential risks of the trial, understood the study procedures, and voluntarily signed a written ICF before the study.
2. Males or females aged from 18 to 80 years (including the marginal values).
3. With a body weight of ≥ 35 kg at screening.
4. Diagnostic criteria:the diagnosis of persistent (3-12 months) or chronic (≥ 12 months) ITP is met
5. Patients who have failed at least 1 prior first-line standard therapy for ITP, or who have failed to tolerate a standard therapy.
6. Women of childbearing potential must take a complementary barrier method of contraception in combination with a highly effective method of contraception at screening, throughout the trial, and within 90 days after the last dose of the investigational drug.
7. The mean of two platelet counts is less than 30 × 109/L and no platelet count is greater than 35 × 109/L during the screening visit and/or before the first dose.

Exclusion Criteria:

1. Severe hemorrhage occurred within 4 weeks prior to screening.
2. Subjects suffer from severe ITP at screening
3. Subjects have other diseases which mention in protocol
4. Subjects develop intracranial hemorrhage within 6 months prior to screening.
5. Active and uncontrollable infection
6. Subjects have a history of coagulopathy other than ITP
7. Subjects with a history of malignancies.
8. History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
9. Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients.
10. Subjects with a Medication history and surgical history which mention in protocol
11. Subjects do not meet the criterion of the laboratory test in protocol

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Neuropsychomotor Functions in Children With Autism Spectrum Disorder

The aim of the study is to describe the feasibility of the passation of the assessment battery of psychomotor functions tests (NP-MOT) in children aged 4 to 11 years with a diagnosis of autism spectrum disorder: number and type of evaluable events, number and type of tests with a deficit compared to the standard results.

After informed consent obtention, the children will be submitted to the different tests of the battery to evaluate the psychomotor functions. The results will be compared with other data collected from the routine practise : socio-demographic data, medical and developmental antecedents,psychological tests (KABC II, Rey test, London Tower test, ...), psychomotor evaluation (MABC, evaluation of manual praxis, visual abilities, Frostig test), understanding data (N-EEL test), neuropediatric examination, clinical assessment (ADI-R, CARS).

The use of this battery allows this fine discriminative assessment of the psychomotor functions involved in the movement. Exploring each function will allow to take into account qualitative and quantitative aspects of the movement in every aspects, and this is not applied in the routine care until now. Calibration for each event can explore each function independently of each other, and will provide information to determine any specific developmental characteristics improve care.

Eligibility Criteria:
Inclusion Criteria:

* informed consent from the parents or the legal representative
* age 4 to 11
* autism spectrum disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition- text revised

Exclusion Criteria:

* bad understanding of the french language
* motor disability from lesion or accidental origin, proved genetic or neurologic disease
* deafness, blindness
* parents with administrative or judiciary protection, and without health insurance
A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery

The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating internal camera (Vivasight DL) with a standard double lumen tube.

Single lung ventilation is frequently carried out to facilitate surgery on the lungs and pleura. In most instances this is achieved by insertion of a double-lumen endotracheal tube and then selectively ventilating one lung or both. Precise positioning of these tubes is essential for optimal performance. It has become the standard of care to perform bronchoscopy to confirm tube position.

A new double lumen endotracheal tube (Vivasight DL) has recently been developed. It has all the features of a standard double lumen endotracheal tube but also incorporates an internal camera which, when connected to an external screen, allows continuous confirmation of tube position.

This is randomized, single blinded controlled trial. The participants will be allocated to two study groups (Vivasight DL or standard DLT), in which the primary airway management device will be respectively Vivasight DL double lumen tube or a standard double lumen endotracheal tube.

Clinical Research Ethics Committee approval has been obtained. Suitable participants will be recruited after written informed consent.

Standard anesthetic preassessment and anesthesia will be provided.

Consenting patients passing the inclusion and exclusion criteria will be randomly allocated to either of the 2 study groups.

Protocol for attempts at placement and tube position confirmation will be followed.

The investigators will monitor a number of parameters, including time and ease of tube insertion, ability to verify tube position with the primary imaging modality for each group, need to perform tube position adjustment maneuvers, need to use fiberoptic bronchoscope during the case, quality of lung collapse, problems with ventilation and other.

The primary hypothesis is that the new Vivasight DL tube system will provide a comparable optical view to the fiberoptic scope view obtained via standard double lumen endotracheal tube in order to confirm optimal position.

Eligibility Criteria:
Inclusion Criteria:

* 16 - 85 yr old patients capable of informed consent
* ASA (American Society of Anesthesiologists physical status) 1-3
* non-emergency surgery of expected duration \< 6 hours
* one-lung ventilation required

Exclusion Criteria:

* BMI \> 35
* expected difficult airway
* Mallampati score \>2
* increased risk of aspiration
* upper airway or upper GI problems
* live pregnancy
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)

This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 25 years
* Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
* BCVA using ETDRS of 20/32 to 20/400

Exclusion Criteria:

* Any history of previous vitrectomy
* Any prior treatment with verteporfin photodynamic therapy in the study eye.
* Previous cataract surgery within the preceding 2 months of Day 0
* Active intraocular inflammation in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease)
* Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
* Prior anti-vascular endothelial growth factor (VEGF) (Macugen, Avastin, Lucentis) in the study eye prior within 30 days prior to enrollment in this study
* Known allergy to any component of the study drug
* Blood pressure \>180/110 (systolic above 180 or diastolic above 110) If blood pressure if brought below 180/110 by anti-hypertensive treatment, the patient can become eligible.
* Major surgery within 28 days prior to randomization or major surgery planned within the next 12 months. Major surgery is defined as a surgical procedure that is more extensive than needle biopsy/aspiration placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
* Myocardial infraction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
* Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization.
* History of recurrent significant infections or bacterial infections
* Pregnancy (positive pregnancy test) or lactation
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception, surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicide gel, an intra uterine device (IUD), or contraceptive hormone implant or patch
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial.
Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes

Purpose: To describe an extensive scleral excision technique to treat or prevent uveal effusion in nanophthalmic eyes.

Design: Prospective interventional case series.

Methods:

* Setting: Institutional.
* Patient Population: Consecutive patients with nanophthalmos were operated on by one surgeon.
* Intervention Procedure: A single, 90% thickness scleral window extending from immediately behind the extraocular muscle insertions to the vortex veins was performed for 3 and 1/4 quadrants as a circumferential strip.
* Main Outcome Measure: Resolution or prevention of uveal effusion.

Surgical Technique All surgeries were performed under general anesthesia by one surgeon (AMM). Because the majority of the patients were young with narrow palpebral fissures and very deep set globes in small orbits, special surgical techniques were required. Lateral canthotomy was performed on all patients except for the first. Limbal 360o conjunctival peritomy was followed by securing of each rectus muscles with a modified muscle hook and 2-0 silk suture. Scleral dissection was performed from immediately behind to the muscle insertions posterior to the vortex veins. A 90% depth scleral window was excised over 3 and ¼ quadrants, excluding 3/4 of the superior temporal quadrant to avoid damaging the superior oblique muscle.

Eligibility Criteria:
Inclusion Criteria: nanophthalmos -

Exclusion Criteria: None

-
An Open Label Extension Study in Participants With Rheumatoid Arthritis

To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
* Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)

Exclusion Criteria:

* Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any safety event, \[including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment\] that in the opinion of the investigator poses an unacceptable risk to participation in the study.
* Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.
* Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.
Relationship Between Liver Cancer and Sarcopenia

By tracking the short-term and long-term results of patients after hepatectomy, the difference of short-term results between patients with sarcopenia and patients without sarcopenia was analyzed, and the correlation between sarcopenia and short-term and long-term results of patients after hepatectomy was explored, so as to improve people's awareness of sarcopenia and pay attention to its prevention and treatment.

All implementation details are based on the newest EWGSOP definition. The investigators consecutively admitted patients the questionnaire and evaluated the assessment of muscle strength (grip strength test and chair stand test), muscle quantity (L3 plane total skeletal muscle area) and physical performance (gait test) following the F-A-C-S approach, to confirm patients with sarcopenia accurately. And by tracking the short-term and long-term outcomes of patients after hepatectomy, the differences were analyzed and the relationship between sarcopenia and liver cancer was explored.

Eligibility Criteria:
Inclusion Criteria:

* Patients with preoperative clinical diagnosis of liver cancer
* No cancer other than liver cancer has been diagnosed
* Age ≥18 years

Exclusion Criteria:

* Patients who could not complete the standard tests and questionnaires
* Patients who did not accept liver resection after evaluation of treatment plan
* Patients who had other concomitant preoperative causes of muscle weakness (injury, fracture, stroke, etc.)
* Patients who missing CT data or CT scan did not reach the level of the third lumbar vertebra (L3)
Naproxen for the Prevention of HO After Complex Elbow Trauma

Complex elbow fractures can lead to formation of new bone (called Heterotopic ossification). This new bone is unwanted and it can restrict motion. This research study is being done to learn more about the effect of the drug naproxen, on unwanted formation of new bone around the elbow as it heals after a fracture. Naproxen belongs to a class of drugs called NSAIDs which stands for non-steroidal anti-inflammatory drugs.

Several research studies suggest that NSAIDs such as Naproxen can prevent the unwanted formation of new bone around the hip. The effect of NSAIDS on the formation of bone around the elbow has not been studied as well as it has been studied for their effect on the hip.

The drug, Naproxen is approved by the US food and drug administration (FDA) for sale but ot specifically for the treatment of heterotopic ossification.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18 years or greater
2. Operative treatment of one of the following injuries

   * An elbow dislocation with or without associated fractures
   * An olecranon fracture-dislocation, but not simple olecranon fractures
   * A distal humerus fracture

Exclusion Criteria:

1. An existing diagnosis of one of the following conditions

   * Injury to the central nervous system, thorax, or abdomen precluding the immediate use of non-steroidal anti-inflammatory medications
   * Fracture of any long bone since non-steroidal anti-inflammatory medications may increase the risk of nonunion
   * History of gastritis, peptic ulcer disease, or upper gastrointestinal bleeding
   * Impaired renal function (creatinine \> 2.0), hypovolemia, heart failure, high blood pressure ( \> 160/90), fluid retention, asthma, liver dysfunction (bilirubin \> 2.0), or a coagulation disorder
   * Allergy to non-steroidal anti-inflammatory medications
   * Asthma, nasal polyps, urticaria, and hypotension associated with the use of NSAIDs
   * Considerable dehydration
2. Pregnant or breast-feeding women
3. Concomitant use of one of the following drugs:

   * Aspirin
   * Other naproxen products (ec-naprosyn, anaprox, anaprox ds, naprosyn suspension, aleve)
   * Methotrexate
   * Diuretics (thiazides / furosemide)
   * ACE-inhibitors (captopril, enalapril, ramipril etc.)
   * Beta-blockers (propanolol etc.)
   * Probenecid (for gout or hyperuricemia)
   * H2-blockers, sucralfate and intensive antacid therapy
   * Lithium
   * Anticoagulants / Warfarin (coumadin, waran, jantoven etc.)
   * Sulfonamides
   * Anticonvulsant medication (peganone, mesantoin, cerebyx, dilantin, etc.)
Diabetes Self-Management Education with Sleep Hygiene

This study will test whether adding sleep hygiene education and support to diabetes self-management education and support (DSMES) in diverse patients (African American, Hispanic, Pacific Islander, and Caucasian) with type 2 diabetes myelitis (T2DM) from rural UAMS Regional Programs clinics is more effective than DSMES alone. The specific aims for this study are:

* Aim 1A (Primary): Determine if this model improves blood glucose levels as measured by the HbA1c test in diverse adults with T2DM.
* Aim 1B: Determine the preliminary effectiveness of DSMES+SHES on sleep duration and sleep quality, blood pressure, fasting lipids, body mass index (BMI), self-management behavior, self-efficacy, diabetes-related distress, and diabetes-related quality of life in diverse adults with T2DM.
* Aim 2A: Determine the feasibility and acceptability of DSMES+ SHES when implemented with diverse adults with T2DM.
* Aim 2B: Determine the feasibility and acceptability of DSMES+ SHES implementation in Regional Programs clinics.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosed with type 2 diabetes
* Speak English

Exclusion Criteria:

* Received DSME in the past three years
* Have a condition that makes it unlikely they will be able to follow the protocol
Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women

Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subject requesting contraception and willing to use the IVR
* Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
* History of regular cyclic menstrual periods
* Subject is willing and able to attend the scheduled study visits and comply with study procedures

Exclusion Criteria:

* Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
* Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator
* Undiagnosed abnormal genital bleeding
* Wish for pregnancy during the study
* Major surgery scheduled during the study period
The Association Between Psoriasis and Intestinal Bacterial Population

At least 20 psoriasis patients will be compared to at least 20 participants without psoriasis Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal bacterial populations will be compared in order to examine whether there are differences between the groups.

Intestinal bacterial population has a significant influence on health and sickness conditions. It affects the development and the function of the immune system (Th2, Th1 or Th17) by bacterial protein expression and by the composition of the bacterial population.

Psoriasis is an immune related dermal disease. The trigger for this disease is currently unknown but, it is possible that intestinal bacteria are a factor in its development.

Study design:

Participants will be divided into 3 groups:

* Psoriasis patients treated with topical medications
* Psoriasis patients treated with IV or sub-cutaneous medications (e.g biological medications)
* Healthy participants (control group) Bacterial genomic DNA will be extracted from stool samples of participants. The intestinal bacterial populations will be compared in order to examine whether there are differences between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Dermal psoriasis patients diagnosed by a dermatologist.

Exclusion Criteria:

* Treatment with antibiotics or probiotics within the prior 3 months.
* incapable of signing an inform concent.
Transversus Abdominus Plane Catheters for Open Inguinal Hernia Repair

This study is designed to evaluate pain control of continuous transversus abdominis plane (TAP) blocks placed for open inguinal hernia repair. The investigators hypothesize that there will be improved pain control when compared with sham blocks.

This study is a randomized, controlled trial designed to determine whether continuous transversus abdominis plane (TAP) block versus sham block has a substantial impact on pain following open inguinal hernia repair. Our primary outcome is to determine whether there will be a difference in opioid consumption within the first two days following surgery. Secondary outcomes will include: pain scores and activity assessment score.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral open inguinal hernia repair
* ASA physical status I-III
* \>18 years old
* Consent to participate in the study

Exclusion Criteria:

* Refusal to participate in the study
* \<18 years old
* Chronic opioid use
* Localized infection
* Pregnancy or lactating
* Pre-existing coagulopathy or active anticoagulant use
* Allergy to ultrasound gel or local anesthetics