cyrilzakka/clinical-trials huggingface dataset:
OPTI-FREE Family STUDY

The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 3 commercially available contact lens cleaning and disinfecting solutions in a pediatric population. This study will be conducted in Canada and the US.

Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject and parent/legally authorized representative able to understand and sign an IRB approved informed consent/assent form.
* Subject willing to follow and be able to attend all scheduled study visits as required per protocol.
* Successful wear of daily wear, reusable, soft (including hydrogel and silicone hydrogel) contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular disease or condition that would contraindicate contact lens wear.
* Use of systemic or ocular medication that would contraindicate contact lens wear.
* Any known sensitivity to any ingredients in the study products.
* Current or history of pathological dry eye in either eye that would in the opinion of the Investigator preclude contact lens wear.
* Any use of habitual/prescribed topical ocular medication or artificial tear or rewetting drop (habitual) that would require instillation during the study.
* Other protocol-specified exclusion criteria may apply.
Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. The investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during Ramadan compared to placebo.

evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. Investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan compared to placebo.

The study will be conducted at least from April 2019 to at least June 2030.The study is prospective, two parallel groups, randomized controlled and double blind.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Diagnosed GastroDuodenal Ulcer
Evaluation of Fluid Responsiveness With Recruitment Maneuver After Sternotomy in Coronary Artery Bypass Surgery

Assuming that the basic reliability of dynamic indices will increase with the application of functional hemodynamic tests after sternotomy and protective lung ventilation in patients undergoing elective coronary artery bypass surgery, it is useful to predict fluid responsiveness after sternotomy in coronary artery bypass surgery patients ventilated with 6 ml/kg PBW (ideal body weight). We aimed to reveal the sensitivity and specificity of PPV and SVV changes by applying a lung opening maneuver.

In order to evaluate the fluid deficit in patients undergoing coronary artery bypass surgery, researchers will measure stroke volume index, cardiac index and mean arterial pressure while the patients are in the lima position.

Then researchers will perform a lung opening maneuver (30mmHg for 30 seconds) and measure again.

researchers will measure again after the values return to normal. researchers will give patients balanced fluid at 3ml/kg and record their values.

Can researchers predict fluid response with lung opening maneuver?

Eligibility Criteria:
* Inclusion Criteria:
* 1-ASA2-3 patients between the ages of 18-80 who will undergo elective coronary bypass surgery under general anesthesia
* Exclusion Criteria:
* 1. Be younger than 18 years old, be over 80 years old
* 2. Patients with an ASA score greater than 3
* 3. EF\<40%
* 4. Those with contraindications to anesthetic drugs
* 5. Patients with BMI\>30
* 6. Patients who did not want to participate in the study
* 7. Right ventricular dysfunction
* 8. COPD(Chronic obstructive pulmonary disease)
* 9. Bullous lung disease
* 10. Moderate to severe PHT
* 11. Severe kidney or liver disease
* 12. Patients with hemodynamic instability in the perioperative period
* 13. Pregnancy
Transfusion Strategies for Pediatric Liver Transplantation

The patients assigned to the restrictive group will receive transfusion once the hemoglobin concentration falls below 6.0 g per deciliter, with a target hemoglobin range of 7.5 to 8.0 g per deciliter. Patients assigned to the liberal group will receive transfusion once the hemoglobin concentration falls below 8.0 g per deciliter, with a target hemoglobin range of 9.0 to 10.0 g per deciliter.

The primary outcome: Survival rate in six months after randomization.

Secondary outcomes: Incidence of perioperative complications, including sepsis , pulmonary complications, portal vein thrombosis, hepatic artery thrombosis and transfusion-related adverse events. Intraoperative blood loss, intraoperative blood transfusion amount, postoperative blood transfusion amount in 7 days after surgery, postoperative inflammatory reaction, mechanical ventilation time in the intensive care unit, lengths of stay in the intensive care unit and the hospital，and hospitalization expenses.


Eligibility Criteria:
Inclusion Criteria:

* The investigators study included pediatric patients (the moon's age \<36 months) who will receive standard living-donor liver transplantation (LDLT) in Renji Hospital.

Exclusion Criteria:

* The exclusion criteria of the study were a congenital sufferer from heart, lung, kidney, nervous system or blood disease,active Lung infection, a history of liver transplantation, Multivisceral transplantation, refused to participate the study.
Seroprevalence of Anti-bodies Against Clostridium Difficile Toxins and Prevalence of Asymptomatic Carriage of Clostridium Difficile in IBD Patients.

The objective of this study to evaluate the seroprevalence of anti-bodies against C. difficile toxins A and B and the asymptomatic carriage of C. difficile in IBD patients according to the need and type of immunosuppressive therapy. The ultimate goal is to identify, among IBD patients, those with the highest risk of CDI.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Diagnosed of IBD, either Crohn's disease or ulcerative colitis
* Age: \>18 and \<65 years
* Time since diagnoses of IBD ≥ 6 months
* Present with the criteria included in any of the 4 specified groups in the study population

Exclusion Criteria:

* History of documented CDI
* Active CDI at the moment of study inclusion
* Any of the following immunosuppressive conditions: HIV infection, Liver cirrhosis, CKD stage IV, Receiving chemotherapy, Transplant (solid organ or hematological), Concomitant neoplasia, Hypogammaglobinemia.
Lymphadenectomy In Ovarian Neoplasms

To assess the efficacy of systematic pelvic and para-aortic lymphadenectomy in patients with advanced ovarian cancer and intra-abdominal complete debulking.

Secondary: progression-free survival, complications and quality of life; Exploratory: Role of number of resected lymph nodes for primary and secondary objectives


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of invasive epithelial ovarian cancer FIGO stage IIB-IV (IV only if resectable metastasis in pleura, liver, spleen, and/or abdominal wall)
* Macroscopic complete resection
* Age: 18 - 75 years
* Patients who have given their signed and written informed consent
* Good performance status (ECOG 0/1)

Exclusion Criteria:

* Non epithelial ovarian malignancies and borderline tumors
* Intraoperative clinically suspicious lymph nodes (bulky nodes)
* Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.
* Recurrent ovarian cancer
* Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy
* Diseases of the lymph system (including lymph edema of unknown origin)
* Clinical relevant dysfunctions of blood clotting (including medicamentous conditioned reasons, e.g. ASS, if not stopped at least 7 days prior to surgery)
* Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)
* Prior retroperitoneal lymph node dissection (systematic or sampling)
* Pregnancy
* Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
* Any reasons interfering with regular follow-up
Epidural Clonidine for Lumbosacral Radiculopathy

This was a randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. The hypothesis was that clonidine will be as effective as steroid for this condition.

Patients with approximately 3 months of low back pain and leg pain due to intervertebral disc herniation were randomized to transforaminal epidural injections of 2% lidocaine and either clonidine (200 or 400 micrograms) or triamcinolone (40 mg) (corticosteroid). Patients received one to three injections administered at about 2 weeks apart. Patients, investigators, and study coordinators were blinded to the treatment. The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. The hypothesis was that clonidine will be as effective as steroid for this condition.

Eligibility Criteria:
Inclusion Criteria:

* Residents 18 years or older of Olmsted or contiguous counties and identified as having an acute unilateral radicular syndrome of less than 3 months duration (leg pain\>back, discogenic cause, one or more of the following:

  * Positive Straight Leg Raise (SLR) test
  * Myotomal weakness
  * Dermatomal sensory loss) and with concordant
  * Confirmatory findings on recent MRI or CT myelogram

Exclusion Criteria:

* History of recent spinal trauma
* Cauda equina syndrome (This is a serious neurologic condition in which there is acute loss of function of the lumbar plexus, neurologic elements of the spinal canal below the termination of the spinal cord.)
* Progressive neurological deficit
* Motor deficit
* Pathological or infectious etiology
* Involvement in workers' compensation claim
* History of adverse reaction to corticosteroids, local anesthetic or clonidine
* History of one or more corticosteroid injection(s) (equivalent to 40 mg of triamcinolone acetate) in the preceding 4 months
* Pregnant
* Severe medical disease
Hysteroscopic Monopolar and Bipolar Resection

The aim of the study is to evaluate bipolar equipment versus monopolar, and to see if there is any differences between the two types of bipolar equipment espescially regading both safety and effect.

* Trial design: A prospective randomised study with three arms, one arm with monopolar surgery and two different arms with bipolar surgery. Its a one center study.
* Trial population: Pre-or perimenopausal women reffered to our clinic with bleeding disorders and were we plan to do endometrial resection. Patients with a bleeding disorder due to fibroids type 0 and 1 will be included and patients with polyps were endometrial resection is planned at the same time will also be included.
* Preoperative selection: The fibroids will be mapped using transvaginal ultrasound according to the classification ESGE. Type 0 and 1 fibroids will be included. Diameter of the fibroid must not extend 4cm. The endometrium size double layer will be recorded. Uterine size anetrior /posterior diameter, longitudinal diameter (cavity; top fundal to isthmus) will be measured. Were polyps are included these will be measured; length and width. Higham score (PBAC), Se-hgb, Ferritin, FSH and Oestradiol will be documented at all visits. Menstrual pain will be documented due to a VAS-scale.
* Treatment regimen:Randomisation in blocs of 20 between monopolar and two types of bipolar surgery.
* Surgical Technique: The cervical canal will be dilated to Hegar 10 or 11 and a rigid resectoscope Ch. 26 is passed to the uterine cavity. Glycine 1,5% or Saline (Baxter) is infused to irrigate the uterine cavity (Iglesias technique) Automatic pressure cuff maintains an infusion pressure of 100mm Hg and suction 10-15mmHg is applied to the outflow tube in order to achieve a sufficient flow.Fibroids type 0 and 1 are resected in total if possible or flush to the plane of the uterine wall. The tissue chips are removed at intervals by currette and forceps. The operation will be performed by experienced surgeons.
* Primary response variables: Safety is our primary response variable. Fluid absorption and lowering of Se-Sodium will be analysed. These parameters are the only objective parameters which can tell us about safety. Nausea will be reorded on a VAS-scale.

  * Secondary resonse variables: Operating time, tissue removed, easisness of operation, levels of vaginal bleeding measured by the methosd of Hgham(PBAC)before and at follow up.

After 6 month and one year we will look at secondary intervention like repeated resection or hysterectomy.

Eligibility Criteria:
Inclusion Criteria:-Pre-or perimenopausal women with a bleeding disorder with or without fibroids or polyps -

Exclusion Criteria:-Postmenopausal patient. Infertility. Additional condition requiring treatment detected during examination. Malignancy or atypical hyperplasia detected by histological examination.

-
Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients

The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well as to compare the precision of these tools between adult and pediatric patient populations. This retrospective longitudinal analysis will use 2 different databases: a large managed care database and a large fee for service Medicaid database.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with asthma as determined by ICD-9 codes and asthma drug use
* at least 4 years of age
* use of at least 1 controller or at least 5 albuterol prescriptions in 12 months

Exclusion Criteria:

* Subjects with COPD or treatment for COPD
Investigating the Effects of a Museum Intervention on the Psychological and Cardiac Health of Older Adults

In a recent report, the World Organization for Health provided some evidence that artistic and cultural activities can support the health and well-being of the population. Our previous research suggests that the effect of museum visits on well-being and stress might be tied to relaxing proprieties of contact with art objects, especially when the artwork is viewed with an introspective and self-reflexive approach. This study addresses the effect of a well-being museum intervention of six weeks on cerebral activity associated with artwork contemplation during a museum visit and assesses how it affects the psychological and cardiovascular health of older adults with and without atrial fibrillation. The well-being intervention will engage the participant in a series of 6 visits, in groups of 10, oriented on his feelings, impressions, and interpretations of artworks. This well-being museum intervention will be compared to visits typically provided in the museum, in a cross-over single-blinded design.


Eligibility Criteria:
Inclusion Criteria:

* Men/women aged 50 and over,
* Presenting normal or corrected vision and hearing,
* With or without controlled Atrial fibrillation,
* No specific expertise in visual arts (official degree or training relating to the visual arts),
* Occasionally attended museums and exhibitions (≤ 6 times per year).

Exclusion Criteria:

* Score \> 5/15 on the geriatric depression scale,
* Score on the telephone version of the MMSE \< 19,
* Psychiatric or neurological diagnosis,
* Presence of major functional limitations likely to affect the individual's ability to stand and walk independently.
Benefits of an Aerobic and Strength Rehabilitation Program With Post- SARS-CoV-2 Patients Moderate-severe

The SARS-CoV-2 is a pulmonary pathology which is caused by SARS-COV2 and the main signs and symptoms are fever, dyspnea, cough, fatigue, muscular pain and more. Even if SARS-CoV-2 is an acute respiratory pathology we know that can cause some chronic conditions in the general status health of the patients. Besides, it can have an important impact in the physique condition such as a detrimental of the aerobic capacity, lung capacity based on the severity of the patient.

On the other hand, World Health Organization (WHO) has a criteria to classify the severity of SARS-CoV-2;

Saturation de O2 \<94%,

PaO2/FiO2: \<300mm

Frecuencia respiratoria \> 30p/m

abscess Lung \> 50%

septic shock

Multiorganic failure

Based on the high survival but the important number of side effects of this pathology remaining the detrimental of the health and exercise condition. We justify our study based on an aerobic exercise program with a strength part to improve those conditions of the patients.

The investigators develop an aerobic exercise program for two treatment groups which one of them has a strength program as a supplement to verify if the aerobic exercise plus strength improve more than aerobic exercise alone the condition of COVID patients.

The protocol is based on 8 weeks of program with a baseline measurements and a follow ups after the 8º weeks, at 2, 4 and six months after finish the treatment to compare the effectiveness of both treatment and between them.

Eligibility Criteria:
Inclusion Criteria:

* Patients had been got covid in the last 2 years.
* No fractures, or major injuries which could compromised the movements of the patient
* No major pathologies which deteriorate the general health status

Exclusion Criteria:

* Psychiatric (moderate to severe)
* Acute infection
* Fractures (moderate to severe)
* Cognitive detrimental state
Prevalence of Multidrug Resistant Micro-organism Carriage in Patients Undergoing an ERCP in Four Different Countries

The duodenoscopes currently used for Endoscopic Retrograde Cholangio - and Pancreaticography (ERCP) examinations are reusable and are therefore washed and disinfected after each use. Despite this, these endoscopes sometimes remain contaminated with bacteria. Several reports of outbreaks linked to contaminated duodenoscopes have been published worldwide. Recently, the Food and Drug Administration (FDA) advised manufacturers and health care professionals to transition away from fixed endcap duodenoscopes and instead focus more on the use of duodenoscopes with disposable components or fully disposable duodenoscopes. Single-use endoscopes have been developed, but they are not yet widely used, partly because of the extra costs that these endoscopes add to the examination. A possible interim solution, is to only use these disposable endoscopes in patients who carry multi-resistant bacteria in order to prevent the spread of these bacteria. For this, it is important to know how many people who undergo an ERCP carry multi-resistant bacteria. The primary objective of this study is to measure the prevalence of multi-resistant bacteria in patients undergoing ERCP in four different countries: India, the Netherlands, Italy and the United States. In the Netherlands, some secondary outcomes will be investigated with regard to the prevalence of duodenoscope contamination, the risk of bacterial transmission via a contaminated duodenoscope and the presence of multi-resistant bacteria in the duodenum.


Eligibility Criteria:
Inclusion Criteria:

* The subject is planned to undergo an ERCP procedure, either through an outpatient department or an inpatient department
* The subject is capable to understand the information required to give informed consent

Exclusion Criteria:

* In case the inclusion criteria were not met
Application of TMS Coupled With VR for Slowing the Rate of Cognitive Decline in Patients With Alzheimer's Disease

This is a randomized sham control study to evaluate how repetitive Transcranial Magnetic Stimulation (rTMS), interactive cognitive training, or the combination of rTMS and cognitive training reduce the cognitive decline of patients diagnosed with Alzheimer's disease

Participants may be assigned to one of four experimental arms (1-TMS-Stimulation with X-Torp task, 2-TMS-Stimulation with MindMotion Go, 3-TMS-Sham with X-Torp task, 4-TMS-Sham with MindMotion Go.) The study will be conducted in two phases. During Phase 1, participants will be randomized between experimental conditions 1 and 4. Data will be analyzed upon completion of Phase1 and Phase 2 will commence only if there is efficacy in the TMS arm. During Phase2, participants will be randomized to arms 2 and 3.

Eligibility Criteria:
Inclusion Criteria:

Male or Female between 50-85 years of age

* Able and willing to give informed consent
* Probable AD consistent with NIA/AA criteria
* Modified Hachinski Ischemia Scale (MHIS) score of \<= 4
* Geriatric Depression Scale (GDS) score of \<= 6
* Mini Mental State Exam (MMSE) score 18-26. The MMSE adjusted scoring instructions may be followed for screening patients as applicable.

Exclusion Criteria:

* Unstable medical conditions
* Visual impairments
* Mobility limitations
* Cognition-enhancing medication unless on a stable dosage for at least 3 months before the start of the trial.
* History of epilepsy or seizure disorder
* History of psychosis
* Current thoughts of suicidal ideation or self-harm as assessed by the Columbia-Suicide severity rating scale score
* Progressive neurological disorder or focal signs of abnormality on neurological exam as conducted by a neurologist (other than current diagnosis of AD)
* Tinnitus
* Metal implants (excluding dental fillings)
* Possible pregnancy
* Substance use disorder within the past six months
* Have other mental or physical conditions that are inappropriate for study participation at PI's or delegated sub investigator's discretion.
* Intake of one or a combination of the drugs that may due to their significant seizure threshold lowering potential
An Observational Registry to Evaluate the Incidence of and Risk Factors for Vascular Occlusive Events Associated With ICLUSIG®

This is an observational registry to further characterize the safety profile of patients with chronic myeloid leukemia in the chronic phase (CP-CML), accelerated phase (AP-CML), blast phase (BP-CML), or Ph+ALL treated with Iclusig (ponatinib) in routine clinical practice in the US. The registry is focused on analysis of vascular occlusive events.

The registry is being conducted in an effort to better understand rates, risk factors, and outcomes associated with vascular occlusive events in patients treated with Iclusig (ponatinib) in real world settings. This registry study will collect information about patient demographics, leukemia diagnosis, previous anti-cancer treatments, history of cardiovascular disease, risk factors for vascular complications, and concurrent medications (including antiplatelet and/or anticoagulant agents).

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age ≥18 years) who are diagnosed with CP-CML, AP-CML, BP-CML, or Ph+ ALL
2. Patients who are initiating Iclusig therapy for the first time, or for whom Iclusig therapy was initiated within 30 days before registry enrollment.
3. The decision to prescribe Iclusig must have been made prior to enrollment in the registry and based upon approved US indications.
4. Patients who have the ability to understand the requirements of the registry, and provide written informed consent to comply with the registry data collection procedures.

Exclusion Criteria:

1. Patients previously treated with investigational Iclusig.
2. Patients receiving any investigational agent (eg, any drug or biologic agent or medicaldevice that has not received approval in the US) or receiving Iclusig for any indication not currently approved in the US.
3. Concurrent treatment with another TKI.