cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors

Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at the time of pre-operative exam
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* Demonstration of refractive stability
* Anticipated post-operative stromal bed thickness of at least 250 microns
* Willing and capable of returning for follow-up examinations for the duration of the study

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
* Concurrent use of topical or systemic medications that may impair healing
* History of any medical conditions that could affect wound healing
* History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
* Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
* Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
CT Coronary Angiography and Computational Fluid Dynamics

Angiographically obtained fractional flow reserve(FFR) could provide functional and clinical information about stenotic lesion, but the invasiveness and measuring difficulty of FFR make it unfamiliar to perform. CT coronary angiography is non-invasive tool to evaluate lesion severity and lately developing computational fluid dynamics could provide functional information. The investigators build a patient specific model of computational fluid dynamics by CT coronary angiography and evaluate the functional significance by measuring fractional flow reserve via CT coronary angiography and computational fluid dynamics, and investigate its long-term prognostic implications.


Eligibility Criteria:
Inclusion Criteria:

* Significant stenosis at CT angiography
* Normal ejection fraction on echocardiography
* Informed consented patient

Exclusion Criteria:

* total occlusion and collateral flow to target vessel
* AV conduction abnormality
* Left ventricular hypertrophy
* significant valvular heart or primary myocardial disease
TeleRehabilitation in Hypertension

The purpose of this RCT which will be performed in 60 healthy adults is I. To assess the training effects of 8 weeks of isometric handgrip exercise on BP; and to test whether it yields at least similar effects on BP compared to current exercise recommendations.

II. To assess whether isometric handgrip training yields larger BP reductions beyond the supervised training period at 6 months of follow-up.

III. To determine whether changes in BP following acute exercise and chronic training can be explained by changes in important physiological mechanisms known to mediate or to be associated with BP?


Eligibility Criteria:
Inclusion Criteria:

* not physically active (\< 3 hours of moderate to high levels of PA/week) low cardiovascular risk according to current guidelines (Mancia et al J Hypertens 2013) will be recruited through advertisements. The latter is defined as:
* \>115 mmHg \< systolic BP \< 139 mmHg and/or 75 mmHg\< diastolic BP\<90mmHg in the presence of 0 to a maximum of three other cardiovascular risk factors, excluding diabetes Or
* 139 mmHg \< systolic BP \< 160 mmHg and/or 90 mmHg\<DBP\< 100 mmHg in the absence of other cardiovascular risk factors

Exclusion Criteria:

* current smoker
* pregnancy
* presence of other cardiovascular disease, pulmonary disease or metabolic disease
* inability to perform a standard exercise program due to mental/physical disability.
* use of antihypertensive drugs
A Walking Intervention Through Text Messaging

The purpose of this study is to develop and evaluate adaptive goal setting and feedback interventions (Adaptive Interventions) to promote physical activity behaviors and compare it to static physical activity interventions (Static Interventions) using two levels of goal setting (Adaptive Goals vs. Static Goals) and two levels of reinforcement procedures (Praise/Rewards and No Praise/Rewards) in a 2 x 2 factorial randomized controlled trial. All four groups will receive the intervention via a semi-automated text message system developed by the investigators study team.

The primary aim of this study will be to:

1. Evaluate whether the adaptive interventions result in greater change in physical activity (pedometer-measured steps/day) compared to the static Intervention groups. HYPOTHESES: Participants in the adaptive interventions will increase their steps/day more than participants in the Static Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the other 3 groups.

   The secondary aims of this study will be to:
2. Evaluate the effectiveness of the adaptive and static goal interventions in improving anthropometric, cardiovascular fitness, and cardiometabolic risk factors. HYPOTHESES: Participants in the adaptive interventions will show greater improvements in fitness, lean and fat body mass, and serum biomarkers than participants in the Static Intervention groups. The Adaptive Goals and Reinforcement Group will outperform the other 3 groups.
3. to assess participants' satisfaction with the overall program.


Eligibility Criteria:
Inclusion Criteria:

* women and men of all races/ethnicities living in Maricopa County, Arizona.

Exclusion Criteria:

* be between 18 and 60 years old
* currently not exceeding physical activity recommendations determined by the International Physical Activity Questionnaire (IPAQ short form).
* not have a medical condition based on the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) that requires supervised physical activity
* not taking medication(s) that would prohibit a moderate intensity physical activity program
* have a body mass index between 25 and 55 kg/m2
* not be currently pregnant or planning to become pregnant in the next 4 months
* not be planning to leave Maricopa County for 10 days or more in the next 4 months
* not planning to move from Maricopa County in the next 4 months
* not currently in another physical activity, diet, or weight loss program (e.g. weight watchers)
* have access to Microsoft Windows (XP, Vista, 7, 8) or Mac (10.5+) operating systems on computer with a USB port on a daily basis
* have daily access to email and the internet
* have a mobile phone with text messaging capabilities and be willing to send and receive up to 3-5 text messages per day.
MANS-NRIZ Trial for COVID-19 Treatment : Extension Study

This search will focus on patients with COVID 19 infection this study is a prospective cohort study based on the analysis of response in comparative panel between two arm Nitazoxanide, Ribavirin and Ivermectin plus Zinc arm and other arm without any intervention as regards the safety and efficacy and cost effective result. Two years duration of the project would be enough to cover the stages of the work as shown below in the time plan. Initial stage of collecting materials and patients' clinical data, each patient will undergoes strict follow up period to reveal the clinical, laboratory and radiological response. The procedures are to be approved by the institutional ethical committee.

This search will focus on patients with COVID 19 infection this study is a prospective cohort study based on the analysis of response in comparative panel between two arm Nitazoxanide, Ribavirin and Ivermectin plus Zinc arm and other arm without any intervention as regards the safety and efficacy and cost effective result. Two years duration of the project would be enough to cover the stages of the work as shown below in the time plan. Initial stage of collecting materials and patients' clinical data, each patient will undergoes strict follow up period to reveal the clinical, laboratory and radiological response. The procedures are to be approved by the institutional ethical committee.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years

  * Laboratory-confirmed SARS-CoV- 2 infection
  * Hospitalized patients
* need reservoir mask for oxygen support
* need HFNC for oxygen support

Exclusion Criteria:

* Mechanical ventilations for oxygen support
* Inability to take oral medications
* Pregnancy or breastfeeding
Low Cylinder Toric

Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Cataracts
* Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)

Exclusion Criteria:

* Preoperative ocular pathology
* Planned monovision
Personality and Cancer Care Study

This randomized clinical trial will test whether giving an individualized personality feedback report to adults with a history of cancer can improve their self-awareness, confidence in managing their illness, and mood.

This will be a randomized clinical trial examining whether a personality feedback intervention can improve three outcomes in an online sample of adults with cancer: 1) self-awareness, 2) self-efficacy for managing aspects of their illness, and 3) mood. The study will occur in a single 30-minute online session conducted in Qualtrics, with a pre-post randomized design. Participants will respond to a baseline survey including a measurement of the Five-Factor Personality Model and measures of the 3 outcomes of interest, followed by random assignment to either an intervention group or control group. Both groups will read a brief description of the Five-Factor Model of Personality. Those randomized to the intervention group will also receive an individualized feedback report containing their personality results on each of the five personality factors and recommendations for cancer self-management based on these results. After reading the personality information, participants will respond to the outcome measures again in a post-intervention survey. Control participants will receive their individualized personality feedback reports after the study is complete.

Eligibility Criteria:
Inclusion Criteria:

* consent to participate
* at least 18 years old (self-reported)
* have a current or past cancer diagnosis (self-reported)

Exclusion Criteria:

* under 18 years old (self-reported)
* indicate that they have no known history of cancer (self-reported)
* unable to read or understand English
Efficacy of a Milk-based Nutrient-rich Bar on Nutritional Status and Cognitive Performance of School Children in Vietnam

The objective of the study is to evaluate the impact of the milk-based nutrient-rich bar, specifically the effect of its fortification with zinc, iodine, vitamins A and D and calcium on nutritional status of school children, focusing on vitamin A and, zinc, iodine, calcium and iron status, and on their cognitive performances.

Design: double-masked randomized control trial Place: three schools in South Vietnam, Can Tho district, South Vietnam Subjects: School children aged 6 to 10 years old, from first grade to third grade of 3 primary schools.

Duration of intervention: 6 months (consumption of Goody or "control bar")

Study groups: 2 groups:

Group 1: children will receive micronutrient enriched milk bar. Group 2: children will receive the same milk-based food except for the micronutrient fortification.

Eligibility Criteria:
Inclusion Criteria:

* pupil in one of the 2 selected schools, in grade 1 - 3
* weight for height \> -3 z-scores
* hemoglobin concentration \> 70 g/L

Exclusion Criteria:

* weight for height \< -3 z-scores
* hemoglobin concentration \<= 70 g/L
Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics

In this study the participants can be recruited via scheduled consultation and external institutions (associations, senior club..). Neuropsychological assessment will be realize to determine presence or absence of neurodegenerative disease.

Study test is ecological MAI. This test are assigned in two groups (with or without neurocognitive disorders).

In this study the participants can be recruited via scheduled consultation and external institutions (associations, senior club..). Neuropsychological assessment will be realize to determine presence or absence of neurodegenerative disease.

Study test is ecological MAI. Participation will be 30 minutes for patients see in case of routine care and 2h30 for those accompanying the patients and participants recruited in external institutions.

Participants are assigned in two groups. Group 1 : with neurocognitive disorders Group 2 : without neurocognitive disorders

Benefits :

For participants without neurodegenerative disorder, study enables to take control early if anomaly will be detected.

The study permit to have cognitive assessment.

Risk : It's possible that participants feel tired. No constraints for participants seen during scheduled consultation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 70 ans
* Person have good locomotion, move independently
* Personne agree to participate

Groupe 1 : 17≤MMSE≤24 (GRECO) Diagnosis of neurodegenerative diseases (major neurocognitive disorders: Alzheimer, mixed dementia, lobar frontotemporal degeneration, vascular dementia).

Groupe 2 : MMSE ≥ à 25 (GRECO) Without neurodegenerative disease

Exclusion Criteria:

* Person with legal protective measures
* Person deprived of liberty
* Mental retardation or MMSE≤ 16
* Understanding verbal disorders
* Visual major disturbances
* Person with disease causing increased fatigue
* Person with psychiatric pathology excepted anxiety disorder or depression with mild episodes.
* Person not covered by French national health insurance
Predicting Outcomes of Breast-Conserving Surgery in Breast Cancer Patients Using the Modified 5-Item Frailty Index

Background: Breast cancer is the most common malignancy among women worldwide, with breast-conserving surgery (BCS) being a key treatment. The modified 5-item frailty index (mFI-5), a well-validated tool for assessing frailty, has shown predictive utility in other surgical contexts but remains under-explored in BCS.

Methods: Using the American College of Surgeons National Surgical Quality Improvement Program database (2008-2021), the investigators identified adult female breast cancer patients who underwent BCS. Frailty was assessed using the mFI-5, scored from 0 to 5, with higher scores indicating greater frailty. Multivariable logistic regression was employed to evaluate associations between mFI-5 scores and postoperative outcomes.

Main question: Can the mFI-5 predict adverse postoperative outcomes in breast-conserving surgery patients?


Eligibility Criteria:
Inclusion Criteria

* Data from 14 annual datasets (2008-2021).
* Female breast cancer patients identified using diagnostic codes:
* ICD-9-CM 174: "Malignant neoplasm of female breast."
* ICD-9-CM 233.0: "Carcinoma in situ of breast."
* ICD-10-CM C50: "Malignant neoplasm of breast."
* ICD-10-CM D05: "Carcinoma in situ of breast."
* Focused on patients diagnosed with breast cancer.
* Further refinement:
* Only patients undergoing breast-conserving surgery (BCS).
* Identified by CPT code 19301: "Partial mastectomy without axillary lymphadenectomy."

Exclusion Criteria

* Missing essential anthropometric data (height and/or weight).
* Implausible BMI values (\<7 kg/m² or \>250 kg/m², assumed data entry errors).
* Miscoded or vague ICD or CPT entries.
* Concurrent invasive procedures other than BCS.
* Procedures performed by specialties other than general or plastic surgery.
* Male and non-binary patients or those with gender identity disorders (to focus on biologically female cohort).
* Non-elective (emergency) surgical cases.
* Patients with ASA physical status scores \>4.
* Patients receiving anesthesia types other than general anesthesia.
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection

The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water for injection (SWFI) and compare with those of rAHF-PFM reconstituted in 5 mL of SWFI.


Eligibility Criteria:
Inclusion Criteria:

* The subject or subject's legally authorized representative has provided written informed consent
* The subject has severe hemophilia A as defined by a baseline FVIII activity \<= 1% of normal; tested at screening
* The adolescent/adult subject has a documented history of at least 150 exposure days to FVIII concentrates (either plasma-derived or recombinant), and the pediatric subject has at least 50 exposure days
* The subject is \>= 12 to \<= 65 years of age for the complete pharmacokinetic assessment and \>= 2 to \< 12 years for the incremental recovery assessment The subject has a Karnofsky performance score \> 60
* The subject is human immunodeficiency virus negative (HIV-) or HIV+ with stable CD4 count \>= 200 cells/mm³ (CD4 count determined at screening, if necessary)

Exclusion Criteria:

* The subject has a known hypersensitivity to mouse or hamster proteins or to FVIII concentrates
* The subject has a history of FVIII inhibitors with titer \>= 0. 5 BU (Bethesda Assay) or \>= 0.4 BU (Nijmegen modification of the Bethesda Assay) any time prior to screening
* The subject has a detectable FVIII inhibitor at screening, \>= 0.4 BU (Nijmegen modification of the Bethesda Assay), in the central laboratory
* The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) \> 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices
* The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (e.g. qualitative platelet defect or Von Willebrand Disease)
* The subject has received another investigational product within 30 days of enrollment
* The subject's clinical condition may require major or moderate surgery (estimated blood loss \> 500 mL) during the period of participation in the study
* Subjects with clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
* The subject is a female of childbearing potential with a positive pregnancy test at screening
VNP40101M in Treating Patients With Richter Syndrome or Refractory or Relapsed Chronic Lymphocytic Leukemia or Other Lymphoproliferative Disorders

RATIONALE: Drugs used in chemotherapy, such as VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders.

OBJECTIVES:

* Determine the maximum tolerated dose (MTD) of VNP40101M in patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disease. (phase I)
* Determine the toxic effects of this drug in these patients. (phase I)
* Determine the efficacy, as determined by overall response rate, of this drug at the MTD determined in phase I in these patients. (phase II)

OUTLINE: This is a phase I dose-escalation study followed by a phase II study.

* Phase I: Patients receive VNP40101M IV over 30 minutes on day 1. Courses repeat every 3-6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

* Phase II: Patients receive VNP40101M at the MTD determined in phase I.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following hematologic malignancies:

  * Fludarabine refractory or relapsed chronic lymphocytic leukemia (CLL)

    * CLL in transformation allowed
  * Richter syndrome
  * Other refractory lymphoproliferative diseases

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Creatinine ≤ 2.0 mg/dL

  * Renal dysfunction due to organ infiltration by disease allowed
* AST and ALT ≤ 3 times upper limit of normal (ULN) (unless due to organ infiltration by disease)
* Bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection
* No symptomatic coronary artery disease
* No arrhythmia not controlled by medication
* No uncontrolled, symptomatic congestive heart failure
* No myocardial infarction within the past 3 months
* No other uncontrolled illness
* No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

* At least 2 weeks since prior cytotoxic therapy except in patients with rapidly progressing disease
* No other concurrent standard or investigational treatment for this cancer
* No other concurrent cytotoxic investigational drugs
* No concurrent disulfiram
Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)

The proposed research project is aimed at further characterization of sleep problems and evaluation of their impact in children and adults with TSC, excluding epilepsy as contributing factor. Questionnaire-based studies have shown that sleep problems occur in up to half of the children and a third of adults with tuberous sclerosis complex (TSC). However, there is only limited information on the nature of sleep problems and their impact on patients with TSC and their families.

Questionnaire-based studies have shown that sleep problems occur in up to half of the children and a third of adults with tuberous sclerosis complex (TSC). However, there is only limited information on the nature of sleep problems and their impact on patients with TSC and their families. It is known from a questionnaire-based study in children with TSC that they often wake early or wake frequently during the night, and that they can be more tired during the day. In some children, sleep-problems seem to be related to the presence of seizures during the night. This has been confirmed in a study on 10 children with TSC and epilepsy by a combination of polysomnography (sleep study) and electroencephalography (EEG). A questionnaire-based study in adults also revealed the association with epilepsy features, and showed influence of mental health complaints on sleep.

Sleep structure and quality will be assessed through formal sleep studies (polysomnography and actigraphy). The influence of abnormal brain activity on sleep will be mapped by simultaneous recording of brain activity by means of EEG. The impact of sleep disorders will be determined through interviews with individuals with TSC and their relatives. The investigators will also use questionnaires and diaries to supplement their findings.

Importance: It is expected that the results of this study will 1) improve our understanding of sleep problems in TSC, 2) provide additional information on the influence of TSC on sleep, 3) give a more in-depth view on the impact of sleep problems on the lives of individuals with TSC and their families, 4) increase awareness about sleep problems in TSC, and 5) contribute to a better management of sleep problems by patients and families.

Eligibility Criteria:
Inclusion Criteria:

Children and adults with definite TSC based on the 2012 Consensus Conference Diagnostic

Exclusion Criteria:

* daily alcohol intake
* pregnancy
* caffeine abuse (\>4 cups/day)
* shift work
* drug abuse
* anti-depressive therapy
* medications as benzodiazepine, melatonin, phenobarbital and antihistamines
* the presence of clinical or electrographic seizures.