cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Effectiveness of Mirogabalin in Chinese Adult Patients With Diabetic Peripheral Neuropathic Pain (DPNP) in Real-world Clinical Practice Setting (ReMIssion Study)

This study will evaluate the safety and effectiveness of mirogabalin in adult patients with diabetic peripheral neuropathic pain (DPNP) in real-world clinical practice setting in China.

Mirogabalin has been approved in China for the treatment of DPNP. Although there is evidence of the safety and efficacy of mirogabalin, there is a lack of real-world evidence on its safety and effectiveness to inform decision-making among a more diverse patient population in real-world clinical practice, such as patients with moderate or severe renal impairment; patients with more complications, comorbidities, and treatments; and patients with different severity of pain.

This study aims to collect safety and effectiveness data to guide physicians in the clinical use of mirogabalin for the treatment of patients with DPNP in the real-world clinical practice setting.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all the following criteria to be eligible for this study.

1. Age ≥ 18 years at the time of informed consent form (ICF) signed.
2. Patients diagnosed with DPNP (defined as patients diagnosed with type 1 or type 2 diabetes and painful distal symmetric polyneuropathy).
3. Patients with a pain scale of visual analog scale (VAS( ≥ 40 mm on the day of ICF signed.
4. Patients who are mirogabalin naïve prior to ICF signed and planned to initiate mirogabalin treatment.
5. Patients who are able to give signed ICF for study participation and willing to provide access to previous and future medical information.

Patients who meet any of the following criteria will be excluded from this study.

1. Patients who have other severe pain unrelated to DPN at baseline, which may confound the assessment of DPNP.
2. Patients who previously received pregabalin ≥ 300 mg/day or gabapentin ≥ 1200 mg/day to treat DPNP and declared lack of effectiveness.
3. Patients who received pregabalin, gabapentin, crisugabalin, or any other DPNP analgesic medications\* within 7 days prior to ICF signed.

   \*Other DPNP analgesic medication includes TCAs (amitriptyline, nortriptyline), SNRIs (duloxetine, venlafaxine), antiepileptics (carbamazepine), opioids (tapentadol, tramadol).
4. Patients with major psychiatric disorders (depression, Alzheimer disease, Parkinson disease, mania, bipolar disorder, psychosis, or schizophrenia, etc.) at baseline.
5. Patients with contraindications for mirogabalin treatment according to China package insert of mirogabalin.
6. Patients with simultaneous participation in any interventional clinical study.
7. Female patients at the status of pregnancy, potential pregnancy, or breast feeding.
8. Patients who have been judged by the investigator to be unsuitable to participate in the study.
A Smartphone-Based Intervention to Improve Colorectal Cancer Screening in African American Men

The goal of this clinical trial is to test a new smartphone-based program designed to help African American men get screened for colorectal cancer (CRC). The main question it aims to answer is:

° Are African American men who complete the smartphone-based program more likely to get screened for colorectal cancer than men who do not?

Participants will:

* Complete a baseline survey asking about their colorectal cancer screening history and their thoughts and beliefs about colorectal cancer and the medical system.
* Be randomized to receive the new smartphone-based program or to receive text messages containing colorectal cancer education materials designed by the Centers for Disease Control (CDC). The new program sends text messages with information about colorectal cancer. Some of these text messages have links to videos that try to help men overcome anything that may stand in the way of getting screened.
* Complete a follow-up survey 6 months after the baseline survey. This survey will ask the same questions as the baseline survey.
* A medical records review will be conducted at 6 months to verify whether participants received a colorectal cancer screening test during the study period.

Researchers will compare participants who receive the new smartphone-based program to participants who receive the CDC information. The goal is to see whether the smartphone-based program increasing screening more than standard educational materials available on the internet.


Eligibility Criteria:
Inclusion Criteria:

* African American/Black
* not compliant with current United States Preventive Services Taskforce colorectal cancer screening recommendations
* owns a mobile phone capable of text messaging and accessing webpages
* able to speak/understand English

Exclusion Criteria:

* personal history of colorectal cancer
Evaluation of the Review of Automated Ventilator Data's Effect on the Incidence of Ventilator Associated Events in a Medical Surgical Intensive Care Unit

This study will be a retrospective, observational analysis study of ventilator patients in the Medical Surgical Intensive Care unit being monitored via automated near real-time ventilator analytical software.

This study will be a retrospective review of data via chart review of all mechanically ventilated patients in an Intensive Care unit meeting our inclusion criteria during the pre-implementation and post-implementation phases of the study. Data will be collected and a detailed analysis of outcomes will be performed. The major parameters that will be measured will focus on the rate of ventilator associated events during each phases of the analysis.

Ventilator associated events will be defined as Ventilator associated Conditions (VACs), Infection related Ventilator Associated Conditions (IVACs) and Probable Ventilator Associated Pneumonias (PVAPs). According to the Center for Disease \& Control a VAC occurs after a patients has ≥ 2 days of stable or decreasing minimum FiO2 or PEEP values and then experiences at least one of the following: increased in the daily minimum FiO2 of ≥ 0.20 over the daily minimum FiO2 in the baseline period, sustained for ≥ 2 calendar days or increase in the daily minimum PEEP values of ≥ 3 cmH2O over the daily minimum PEEP in the baseline period sustained for ≥ 2 calendar days. An IVAC is defined as the occurrence on or after calendar day 3 of mechanical ventilation and within 2 calendar days before or after the onset of worsening oxygenation, the patient meets both of the following criteria: 1) Temperature \> 38C, or white blood cell count ≥ 12,000 cells/mm3 or ≤ 4,000 cells/mm3 and a new antimicrobial agents(s) is started for ≥ 4 calendar days. A PVAP is occurs when a patient meets the criteria for a VAC and IVAC and one of the following criteria are met: 1) Purulent respiratory secretions (from one or more specimen collections). 2) Positive culture (qualitative, semi-quantitative) of sputum, endotracheal aspirate, bronchoalveolar lavage, lung tissue, or protected specimen brushing.

Eligibility Criteria:
Inclusion Criteria:

* includes all mechanically ventilated patients in the Intensive Care Unit above the age of 18 years of age and who were mechanically ventilated for ≥ 3 days.

Exclusion Criteria:

* any patients under the age of 18 or mechanically ventilated for \< 3days.
Investigation of the Transfusion Practices in Surgical Patients in Turkey

The aim of this study is to describe the transfusion practices in patients undergoing major surgery in Turkey. The transfusion rates of red blood cells (RBC), fresh frozen plasma (FFP) and platelets; the transfusion predictors and transfusion related patient outcomes are investigated.

Patient Blood Management (PBM) is an evidence based multidisciplinary approach for the care of patients who may need blood transfusion. The aim of PBM is achieving better patient outcomes by focusing on the patients' own blood as a source.

To date PBM is considered "good transfusion practice" and is being implemented in a growing number of countries. The Turkish Society of Anesthesiologists PBM Task Force is working on this subject since 4 years and decided to conduct a study. Before starting a PBM program, the transfusion practices of clinicians working at diverse surgical fields; differences between current transfusion practices and PBM strategies; the areas for improvement and the obstacles that could prevent change could be identified with this study. Data collection will also serve to identify the current situation as a reference and to control the achievement of the PBM's aim: improving clinical outcomes. These data will be refered as The Turkish National Perioperative Transfusion Study (TULIP TS) data.

The aim of this study is to describe the transfusion practices in patients undergoing major surgery in Turkey.

The study evaluates i. The perioperative transfusion rates of RBCs, FFP and platelets. ii. With which reasons the anesthesiologists decide to transfuse a patient (co morbidities of the patients, physiologic transfusion triggers, hemoglobin trigger, uncontrolled bleeding, on request from surgeon etc.).

iii. The relation of transfusion and the patients co-morbidity index, the P POSSUM score and SORT score; anesthesia methods; monitorisation methods (hemodynamic, coagulation); amount of bleeding; type of surgery; type of hospital.

iv. The relation of transfusion and patient outcomes (unanticipated ICU admission, prolonged ICU stay, acute renal failure, thromboembolic events, ischemic events, pulmonary complications, cardiac advers events, infections, acute respiratory distress, infection, all-cause mortality).

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing major elective surgery

Exclusion Criteria:

Trauma patients, emergency surgery
Evaluation of Effective Lens Position With a Uniplanar Bi-aspheric IOL

The primary goal of this study is to determine the effective lens position (ELP) - or location an intraocular lens (IOL) "sits" in the eye - of the Softec HD IOL. A secondary study goal is to determine if measures of the eye taken prior to surgery can reliably predict postoperative ELP.

The primary objective of this study is to determine the effective lens position (ELP) of the study lens, and to report the stability of ELP post-operatively. Additionally, correlations of ELP to predicted postoperative lens position, capsular bag metrics, preoperative biometry and age will be statistically analyzed for determination of ELP prediction via one, or a combination of preoperative variables.

Eligibility Criteria:
Inclusion Criteria:

* \>=40 years of age, of any race and either gender
* Operable, age related cataract grade 3+ or lower in the study eye
* Able to achieve best corrected visual acuity (BCVA) 20/30 Snellen or better postoperatively in the study eye
* ≤1.0 diopter (D) of corneal astigmatism preoperatively in the study eye
* Able to achieve a dilated pupil \>6.0 millimeter (mm) in the study eye
* Able to adequately visualize the lens equatorial diameter on ultrasound biomicroscopy (UBM) unit (preoperatively)
* Desire implantation of a monofocal lenses targeted at emmetropia in the study eye
* In good general and ocular health
* Able to competently complete testing
* Willing and able to attend study visits
* Willing and able to understand and sign an informed consent

Exclusion Criteria:

* Previous intraocular surgery or laser treatment
* Severe dry eye
* Uncontrolled IOP or glaucoma
* Retinal or macular pathology (i.e. macular degeneration, proliferative diabetic retinopathy, etc.)
* History of retinal detachment
* Microphthalmia
* Chronic severe uveitis
* Corneal decompensation
* Irregular astigmatism
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
* Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
* Pseudoexfoliation syndrome
* Iris atrophy
* Pupil abnormalities (e.g., corectopia)
* Aniseikonia
* Amblyopia
* An acute or chronic disease or illness that may confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
* Pregnant, lactating, or planning to become pregnant during the course of the trial
* Participation in another clinical trial within 30 days of study start
Treatment of Calcific Total Occlusions in Peripheral Artery Disease

Prospective, multi-center, non-randomized, open label, clinical study intended to provide data to demonstrate safety and performance of the SoundBite Crossing System XS Peripheral.

The CaTO-PAD study includes a below-the-knee (BTK) sub-study (CaTO-BTK)

Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for interventional treatment of de-novo lesion(s) of the following native arteries:

   1. CaTO-PAD: infrainguinal
   2. CaTO-BTK: infrapopliteal
2. Have at least one chronic total occlusion (CTO) with no flow observed in the distal lesion except the flow from collateral circulation
3. Presenting with the following:

   1. CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb
   2. CaTO-BTK Sub-Study: - Category 4 or 5 only for CaTO-BTK Sub-Study CaTO-PAD: claudication or CLI (Rutherford Clinical Category 2-5) of the target limb
4. Age of \> 18 years
5. Have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form
6. Target lesion calcification is at least moderate by PARC definition (see Section 15)
7. Target lesion is refractory as demonstrated by a failed attempt with a guidewire

Exclusion Criteria:

1. Any medical condition that would make subject an inappropriate candidate for interventional treatment as determined by the Investigator, including the following:

   1. Glomerular filtration rate \<30 ml/min
   2. Mortality expected within 30 days
2. Already enrolled in an investigational interventional study that would interfere with study endpoints
3. Target lesion is crossed intraluminally with a conventional guidewire
4. Treatment of an inflow lesion prior to target lesion treatment results in no reflow, thrombus formation, abrupt closure, distal embolization, dissection or perforation requiring treatment
5. Women who are pregnant or breastfeeding
Genetic Analysis and Multimodal Retinal Imaging of Asymptomatic Fovea Plana Cases in the General Population

Albinism is a genetic condition, resulting from mutations in at least 19 known genes responsible for the production of melanin in the skin, hair and eyes.

Ophthalmological manifestations are a constant feature of this disease. Albinism is believed to be responsible for 5% of visual impairments worldwide and all albino patients have some degree of fovea plana. In the milder forms, it is a slightly less marked foveolar depression with conservation of the normal diameter of the cones and, therefore, good visual function.

In addition to its known association with various ocular pathologies such as albinism, aniridia, nanophthalmia and retinopathy of prematurity, fovea plana was found in 3% of a population of normal children (without known ocular or systemic pathology) in a study conducted in 2014 to determine a pediatric normative basis for macular volume measured by optical coherence imaging (Stratus OCT).

More recently, a study carried out at the Hospital Foundation Adolphe de Rothschild showed that at least 35% of parents of albino children, who are totally asymptomatic, present with fovea plana in OCT. This frequency is higher than the 3% prevalence of fovea plana in asymptomatic subjects without a family history of albinism, suggesting a modulation of heterozygosity for a known gene for albinism.

The aim of this study is to verify, in patients with fortuitously discovered fovea plana (preoperative OCT for cataract surgery), with conservation of visual function and without known or manifest albinism, whether they are carriers of mutation in one of the genes referenced for albinism. This will also allow us to characterize these foveolar profiles in OCT according to the classification of Thomas et al., as well as in terms of retinal capillary density in OCT-Angiography, in order to know whether it is the same type of fovea plana or if the phenotype differs depending on the genetic damage.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old;
* Diagnosis of fovea plana in one or both eyes, confirmed by two ophthalmologists blinded to each other from OCT-B imaging;

Exclusion Criteria:

* Known Albinism
* Known family history of albinism
* History of eye surgery other than cataract
* Alteration of macular visual function (loss of visual acuity independent of a disorder of the environments, central scotoma, metamorphopsies, etc.)
* Presence of another anomaly in OCT in addition to the fovea plana (epiretinal membrane, damage to the external retina, etc.)
* Syndromic fovea plana
* Pregnant or breastfeeding woman
Effect of Text Message Interventions in Maintaining Gingival Health in Pregnant Women

Gingivitis is a common condition, affecting more than 60% of pregnant women due to hormonal changes and inadequate plaque control. Left untreated, gingivitis can lead to more serious periodontal diseases and systemic inflammation, posing risks to overall health and reducing quality of life. Therefore, the study aims to assess the effectiveness of text messages in maintaining gingival health in pregnant women. The primary objective is to determine whether these reminders, which focus on proper brushing and flossing techniques, can reduce gingivitis and improve overall oral hygiene during pregnancy.

This research follows a two-group, parallel-arm, single-blind randomized control trial (RCT) design. The trial will be conducted at the Department of Gynecology and Obstetrics at the University of Lahore Teaching Hospital. Eligible participants are adult pregnant women showing signs of gingivitis, excluding those with bleeding disorders or moderate to severe pre-existing periodontal disease. Participants are randomly assigned to either a control group or an intervention group using computer-generated randomization.

Both groups will undergo oral health assessments at baseline, using the Plaque Index (PI), Gingival Index (GI), and Bleeding on Probing (BOP) measures to gauge plaque buildup and gingival inflammation. Follow-up assessments will be conducted at 4-6 weeks and 12-16 weeks. The intervention group will receive a weekly text message reminding them to practice proper oral hygiene, such as brushing and flossing. Both groups will also receive in-person demonstrations of oral hygiene techniques to ensure standardized knowledge on effective oral care.


Eligibility Criteria:
Inclusion Criteria:

* Adult pregnant female in 2nd trimester.
* Access to a personal mobile phone.
* Suffering from gingivitis (\&gt; 10% sites with bleeding on probing)

Exclusion Criteria:

* Bleeding disorders.
* Pre-existing moderate to severe periodontal disease.
HPA Axis Study in Adults

A multicenter, open-label study to evaluate the adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

Assessment of safety, efficacy, pharmacokinetics and adrenal suppression potential of Mapracorat 0.1% ointment in adults with atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Male or female subject aged \>= 18 years
* Diagnosis of atopic dermatitis according to Hanifin and Rajka Criteria
* Investigator's Global Assessment (IGA) score of 3 (moderate) to 4 (severe) at baseline
* Normal ACTH response before start of treatment

Exclusion Criteria:

* Pregnancy or lactation
* Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
* Concomitant medical or dermatological disorder(s), which could interfere with the study conduct or the evaluation and interpretation of the study results
* Clinically manifest immunosuppressive disorder or known history of malignant disease
Advanced MRI Applications Development

The goals of this study are to:

1. To improve upon and develop new innovative magnetic resonance imaging techniques that refine image quality and enhance performance. Improvements in these areas will have positive implications for medical diagnosis and treatment.
2. To correlate MRI images with underlying disease pathophysiology in order to ensure that imaging accurately reflects the disease process.


Eligibility Criteria:
Inclusion Criteria:

* Brain Tumor

Exclusion Criteria:

* Unable to undergo MRI
Shelter Cat Adoption in Families of Children With Autism (Feline Friends)

The overall purpose of this study is to investigate the effect of the introduction of a shelter cat into the family of a child with Autism Spectrum Disorder on the social skills and anxiety of the child, and to examine stress in the cat.

Many families in the United States live with cats as companion animals, including families of children with Autism Spectrum Disorder (ASD). One in 68 children are diagnosed with ASD. There is no cure for ASD, and no one treatment works for all children. Symptoms of ASD include a lack of social skills and anxiety. Companion animals have been helpful for children with ASD. However, no one has studied stress of cats living in families of children with ASD. This study will place 64 pre-screened shelter cats in pre-screened homes and monitor the stress of the cats. Cats ages 10 months to four years that have been screened for calm behavior using a temperament, test will be adopted by families in the study. Families will also be screened for pet issues. No cat will be placed in a home with a child who has a history of aggression to animals. The study will also examine the social skills and anxiety of the children with ASD, and bonding of the parents and children with their cats. Five to eight million dogs and cats are relinquished to animal shelters in the United States each year. Thirty-eight percent of cats are given up for behavioral reasons. Studying cat stress and the placement of cats, with calm and non-aggressive characteristics into homes of families of children with ASD may help shed light on the likely success of the relationships between shelter cats and these families.

Eligibility Criteria:
Inclusion Criteria:

* child with diagnosis of Autism Spectrum Disorder
* no cat currently living with the family
* willingness to adopt a shelter cat
* English speaking
* live within 125 miles of Columbia, Missouri

Exclusion Criteria:

* child with Autism Spectrum Disorder having any history of animal aggression
* children with cat allergies