cyrilzakka/clinical-trials huggingface dataset:
Effects of Contact Lens Care Regimens on the Corneal Epithelium

The purpose of this study is to compare the performance of two different contact lens care solutions, specifically their affects on the front surface of the eye.


Eligibility Criteria:
Inclusion Criteria:

1. Is at least 18 years old and has full legal capacity to volunteer.
2. Has read, understood and signed an Information Consent Letter.
3. Is willing and able to follow instructions and maintain the appointment schedule.
4. Is correctable to a visual acuity of 6/6 or better (each eye), with their habitual visual correction.
5. Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D).
6. Has clear corneas and no active ocular disease.
7. Has had an ocular examination in the last 2 years.
8. Has not worn contact lenses before, or has worn contact lenses only for a trial period, with no trials occurring within the last six months.

   An ineligible contact lens wearer is one who:
9. Responds positively to points 1 to 7 above.
10. Has a distance contact lens prescription between -0.50D and -9.00 D.
11. Has astigmatism less than or equal to -1.00D cyl.
12. Currently wears silicone hydrogel contact lenses successfully.
13. Agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants.

Exclusion Criteria:

1. Has undergone corneal refractive surgery.
2. Is aphakic.
3. Has any active ocular disease.
4. Has any systemic disease affecting ocular health.
5. Is using any systemic or topical medications that may affect ocular health.
6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
7. Is pregnant or lactating.
8. Is participating in any other type of clinical or research study.

   An ineligible contact lens wearer is one who:
9. Responds positively to any of points 1 to 8 above for exclusion criteria.
10. Has known sensitivity to the contact lens care solutions used in the study.
11. Has ocular or systemic allergies that could adversely affect contact lens wear.
12. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
13. Has pinguecula/pterygium that in the investigator's judgement makes contact lens wear inadvisable.
da Vinci SP Robotic Gastrectomy

Laparoscopic surgery revolutionized the surgical treatment of gastric cancer saving large incsion and associated pain. Robotic surgical system was introduced to enhance the minimally invasive surgery using articulating robotic arm. The da vinci SP system, which enables single-port surgery, can allow surgeon to provide radical gastrectomy with minimal scar and associated pain.

This study is a phase 1/2, single-arm surgical clinical trial. The primary endpoint is the safety of da vinci robotic gastrectomy. The secondary endpoint is operative time, bleeding, bowel recovery, and hospital stay. In the clinic, informed consent is received from patient who is scheduled to undergo radical gastrectomy. After the general anesthesia, low midline transverse incision is made at suprapubic area. After inserting SP port into the peritoneal cavity, additional port is inserted via right flank that would be used for assistant's energy device and suction devices. Radical subtotal gastrectomy is perfromed using cardiere-forceps, monopolar scissors, and maryland forceps. Reconstruction after gastrectomy is decided according to surgeon's preference. three days after gastrectomy, if the diet build up is complete and the patients has no evidence of complication, the patient is discharged from the hospital. Four weeks after gastrectomy, the patient will be followed up at the clinic. Major complication event within 30days after gastrectomy will be analyzed as primary endpoint as well as other secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed adenocarcinoma of stomach scheduled to undergo radical gastrectomy
* Between 20-80
* ASA score (American society of anesthesiology) class: I - III
* Signed to informed consent after through explanation about the study

Exclusion Criteria:

* distant metastasis
* EMR/ESD canddiate
* complicated gastric cancer (obstruction or perforation)
* Active other primary tumor
* Vulerable subject (illiterate, pregnant)
Promoting Mother-baby Bonding Through Sustainable Breastfeeding Practices

This research aimed to identify sustainable breastfeeding practices and green mothers' initiatives to develop a strong mother-child bond.

This research aimed to identify sustainable breastfeeding practices and green mothers' initiatives to develop a strong mother-child bond.

The sample size was calculated using G\*Power 3.1. 9.7 software (Faul et al., 2007), the effect size was determined to be Cohen's d=0.9780770. Statistical power analysis was performed according to A Priori: Calculate required sample size (Means: Difference between two independent means (two groups)), 95% power (1-β) and α=0.05, and given these parameters it was concluded that a sample size of at least 58 participants was required for the study in question. In the event of data loss, a 20% increase in the sample size was expected as a result of statistical advice. Accordingly, it was planned to conduct the study with a total of n=70 people, n=35 in the intervention group and n=35 in the control group.

It was carried out with the participation of two groups. The green mother education group received 4 training sessions of 60 minutes each. The control group received routine hospital care but no other intervention during this period.

Data for the study were collected by the researcher using face-to-face interviews, a personal information form with demographic questions, and the measurement tools used in the study. The training was completed after 4 weeks. After the training, the measurement tools were used for the woman's postpartum period.

The participants were given an explanation of the green motherhood education and told how, for how long, and where the training would take place. The face-to-face green motherhood education programme was completed by the participants in a specific way for each session (nutrition, breastfeeding, environmental awareness and bonding). The training was delivered using a poster.

Green motherhood education was delivered in this way in 4 sessions. The measurement tools were given to the participants again on the 1st day, 1st month, 3rd month and 6th month after birth.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 24 weeks gestation
* Must be between 18 and 35 years of age.
* Women must provide informed consent to participate in the study, indicating their willingness to participate in the educational intervention and assessments.
* Attend educational sessions
* Pregnant primiparous

Exclusion Criteria:

* Women with significant medical conditions that may affect breastfeeding or nutrition (e.g. serious mental illness, chronic disease) will be excluded.
* Multiple pregnancies
* Previous GREEN MOTHER training
* Substance abuse
* Women considered to be at high risk of non-compliance with the study protocol (e.g. those with unstable living conditions).
A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer

To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. ECOG performance status 0 or 1
2. Histologically confirmed advanced esophageal carcinoma
3. At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
4. Able and willing to provide a written informed consent

Exclusion Criteria:

1. The tumor obviously invades adjacent organs of esophageal lesions
2. BMI≤18.5 kg/m2 or weight loss ≥10% within 2 months prior to screening
3. Subjects with unresolved adverse effects of prior therapy at the time of enrolment
4. Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
Hereditary Colorectal and Associated Tumor Registry Study

After informed consent, participants will be asked to complete a medical/family history questionnaire and provide a blood sample. Participants will also be asked for their permission for study investigators to access medical records and/or recontact them for updates to their medical and family histories. Data and biospecimens will be stored for potential future research projects.


Eligibility Criteria:
Inclusion Criteria:

* Identified gene mutation
* Personal history of colorectal cancer diagnosed ≤ 50
* Personal history of cancer with tumor studies suggestive of Lynch syndrome
* Personal history of multiple primary tumors associated with a hereditary cancer syndrome (colorectal, uterus, stomach, ovary, small bowel, hepatobiliary tract, transitional cell carcinoma of the renal pelvis/ureter, brain)
* Personal history of one of the above cancers and a family history of one or more of the above cancers
* Personal or family history of diffuse gastric cancer
* From a known genetic predisposition family
* Personal history of \> 10 colon adenomas (cumulative over a lifetime)
* Personal history of any number of hamartomatous polyps
* Personal history of multiple large (\> 1cm) serrated polyps to right of sigmoid

Exclusion critera:

* Individuals under the age of 8
* Individuals who cannot travel to Pittsburgh for in-person enrollment
* Individuals who cannot provide informed consent
Diagnosis of MGRS in Patients With Paraproteinemias: Clinical, Anatomopathological and Pathophysiological Study

This is the first prospective study which evaluate patients with small B-cell clones to diagnose monoclonal gammopathy of renal significance (MGRS) and characterize it clinically, anatomopathologically and pathophysiologically taking int account a geriatric approach.


Eligibility Criteria:
Inclusion Criteria:

* Paraproteinemias

Exclusion Criteria:

* Multiple Myeloma
* Waldenstrom Macroglobulinemia
* Chronic Lymphocytic Leukemia
* Malignant Lymphoma
* Monoclonal gammopathy of unknown significance (MGUS) secondary to Infections
* MGUS secondary to Autoimmune Diseases
* Uncompleted hematological evaluation
* Renal tumor except for cysts Bosniak type I/II
* Other malignant neoplasia
* Unresolved obstructive uropathy
* Patients with only one kidney except for renal transplant
* Co-morbidities which would limit the ability to receive aggressive therapeutic intervention
* Fragile old people
* Pregnancy
* Prison
* Impatient in psychiatric institutions.
A Triple-targeted Cell Preparation Targeting CD19/CD20/CD22 in Patients With Relapsed/Refractory B-cell Acute Lymphocytic Leukemia

A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LCAR-AIO, a triple-targeted cell preparation targeting CD19/CD20/CD22, in patients with relapsed/refractory B-cell acute lymphocytic leukemia

This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of LCAR-AIO in patients ≥ 18 years of age with relapsed or refractory B-cell acute lymphocytic leukemia. Patients who meet the eligibility criteria will receive a single dose of LCAR-AIO infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent;
2. Age 18-75 years;
3. ECOG score: 0-1;
4. Detect the expression of at least one of CD19/CD20/CD22 in leukemic cells by Flow cytometry in peripheral blood or bone marrow
5. Leukemia cells in the bone marrow \>5%
6. Pathologically confirmed relapsed/refractory ALL must meet one of the following conditions:

   1. Naive patients who failed to achieve CR1 after standard chemotherapy;
   2. relapse within 12 months after CR1, or relapse after 12 months but fail to achieve CR2
   3. twice or more bone marrow relapse
   4. Philadelphia chromosomal positive (Ph+) and unable to tolerate TKI therapy, failed TKI therapy more than 2 lines, or had contraindications for TKI therapy
7. Clinical laboratory values meet screening visit criteria
8. Expected survival ≥ 3 months;

Exclusion Criteria:

1.Prior antitumor therapy with insufficient washout period; 2.CNS infiltration; Except for patients with prior CNS infiltration who are currently in remission; 3.Have received two or more targets (CD19/CD20/CD22) CAR-T cell therapy (including but not limited to sequential infusion) at any previous time, or have received CAR-T cell therapy from Camel family origin; 4.With acute or chronic graft-versus-host disease; 5.Isolated extramedullary relapse, but hepatic, spleen, or lymph node-isolated extramedullary relapse is acceptable; 6.HBsAg, HBV DNA, HCV-Ab, HCV RNA or HIV-Ab positive; 7.Pregnant or lactating women;

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Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease

WVE-HDSNP1-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120101 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362307 (SNP1). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP1-001.


Eligibility Criteria:
Key Inclusion Criteria:

* 1. Patient successfully completed the Phase 1b/2a study with WVE-120101, WVE-HDSNP1-001.

Key Exclusion Criteria:

* 1. Received an investigational drug other than WVE-120101, including an investigational oligonucleotide, within the past 1 year or 5 half-lives of the drug, whichever is longer.
* 2. Inability to undergo brain MRI (with or without sedation).
* 3. Clinically significant medical finding on the physical examination other than HD that, in the judgment of the Investigator, will make the patient unsuitable for participation in and/or completion of the study procedures.
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.

The purpose of this study is to determine the agreement rate between the CODMAN Valve Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in order to support an alternative to X-ray confirmation with respect to the valve adjustment process.

Patients with Hydrocephalus, managed with an implanted Codman HakimTM Programmable Valve (CHPV), occasionally visit their physician to have their valve adjusted to a different setting to manage their condition. After the adjustment, an x-ray of the skull is taken to confirm the valve setting.

The Codman VPV System is designed to facilitate and confirm the adjustment of a CHPV. After signing the informed consent, Subjects will be enrolled in the study and have their CHPV adjusted using the Codman VPV System. After the adjustment, an x-ray of the skull will be taken to verify the valve setting. No further follow up visit is needed after the adjustment.

This study is expected to enroll about 300 Subjects from up to 20 sites in the United States.

Eligibility Criteria:
Inclusion Criteria:

* A CODMAN Hakim Programmable Valve (CHPV) has been implanted for the management of the Subject's Hydrocephalus.
* The Subject has given written informed consent prior to enrolling in the study.
* The Subject requires adjustment of the CODMAN Hakim Programmable Valve (CHPV) for the management of Hydrocephalus·
* The Subject's implanted CHPV will be adjusted using the Implanted Valve Mode.

Exclusion Criteria:

* The Subject's valve is located in the deep lumbar position.
* The Subject has an open and/or recent wound site in the region of the implanted valve.
* The Subject has a history of Ultrasound gel allergies.
* The Subject is a prisoner.
* The subject has been previously enrolled in this protocol.
Reduce Medication Errors by Translating AESOP Model Into CPOE Systems

Medication errors are common, life-threatening, costly but preventable. Information technology and automated systems are highly efficient for preventing medication errors and therefore widely employed in hospital settings. In this study, investigators would perform a cluster randomized controlled trial of a clinical reminding system that uses DNN and Probabilistic models to detect and notify physicians of inappropriate prescriptions, giving them the opportunity to correct these gaps and increase prescriptions completeness. This study aim is to assess whether or not this system would improve prescription notation for a broad array of patient conditions.

This paper focuses on "Big data" in the knowledge base, using "Data minig" study of DM (Disease-Medication) and MM (Medication-Medication) of relevance to develop associated decision resources system-"the intelligent safety system" (Advanced Electronic Safety of Prescriptions,AESOP Model), and test the system in the clinical environment in hospital can assist physicians when open orders reduce medication errors, the system is named "AESOP Model".

Eligibility Criteria:
Inclusion Criteria:

* Physicians who are working at the outpatient clinics in hospitals.
* Physicians who sign the consent form

Exclusion Criteria:

* Physicians who are unable to participate in this trial for the whole process
* Physicians who do not sign the consent form
Early Childhood Obesity Programming by Intrauterine Growth Restriction

The molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Here, the investigators address major questions about early childhood obesity programming by studying CD3+ T-cells from intrauterine growth restricted (IUGR) newborns who have an increased risk for obesity and other metabolic disorders in adult life.

Epidemiological studies of multiple cohorts suggest an increased risk for obesity, cardiovascular disease-related death and type 2 diabetes in low birth weight infants. However, the molecular mechanisms underlying developmental programming of childhood obesity remain poorly understood. Alterations in DNA methylation during fetal life have been proposed to be one of the mechanisms that regulate this phenotype. Here, the investigators address major questions about early childhood obesity programming by studying purified subpopulations of CD3+ T-cells from intrauterine growth restricted (IUGR) newborns who have an increased risk for obesity and other metabolic disorders in adult life. The investigators will correlate altered CD3+ T-cell DNA methylation profiles in cord and peripheral blood samples and functional changes in CD3+ T-cells with adiposity in childhood.

Eligibility Criteria:
Inclusion Criteria:

* Healthy singleton term IUGR and AGA infants whose mothers are followed by the Obstetric Department of Montefiore Medical Center and who deliver at the Weiler Division of Montefiore Medical Center.

Exclusion Criteria:

* Multiple gestation, maternal depression, maternal renal disease, infants in extremis, Apgar score \<7 at 5 min and umbilical artery pH ≤7.25, chromosomal/ congenital abnormalities, congenital infections and inborn errors of metabolism. We will also exclude infants born to mothers with a history of maternal smoking in the 2nd and 3rd trimester of pregnancy and maternal gestational diabetes/T2D.
Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging.

The accuracy of histologic prediction for the colorectal polyps with the use of narrow band imaging is evaluated between the test group with magnifying colonoscopy and the control group without magnifying colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with colorectal polyps which are in need of EMR

Exclusion Criteria:

* pregnancy, IBD, colorectal cancer, etc.
Study Evaluating ERB-041 With Methotrexate in Rheumatoid Arthritis

The primary objective of this study is to compare the efficacy and safety of 3 dose levels of oral ERB-041 administered daily for 12 weeks versus placebo in subjects with active rheumatoid arthritis who have had a suboptimal response to therapy with stable doses of methotrexate (MTX).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of active rheumatoid arthritis for at least 6 months and on a stable dose of methotrexate for at least 12 weeks
* Rheumatoid arthritis onset after 16 years of age

Exclusion Criteria:

* Any significant health problem other than rheumatoid arthritis
* History of male or female reproductive system cancer
* Clinically significant laboratory abnormalities
Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients

Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and sodium balance or renal replacement therapy is lacking. The predecessor of this study was the HYPNIC trial which found that increased sodium load en decreased sodium excretion preceded hypernatremia development, but was lacking information on the first 48 hours, fluid balances were manually collected before a new data collection system was introduced and was suffering from substantial amounts of missing data and small population for trend analysis.

This study aims to provide better insight in the development and recovery of hypernatremia while paying attention to the limitations from the HYPNIC trial.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to Intensive Care Unit
* Age 18 years or older

Exclusion Criteria:

* Age 17 years or younger