cyrilzakka/clinical-trials huggingface dataset:
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.


Eligibility Criteria:
Inclusion Criteria:

* Available parent or legal guardian capable of participating in informed consent process
* Documented history of heavy prenatal alcohol exposure (self-report, social service records, or adoption records) or presence of facial dysmorphology characteristic of FASD or both
* Evidence of cognitive deficit in at least one neurocognitive domain

Exclusion Criteria:

* History of neurological condition (ex. epilepsy, cerebral palsy, traumatic brain injury)
* History of medical condition known to affect brain function
* History of other neurodevelopmental disorder (ex. autism, down syndrome)
* History of very low birthweight (\<1500 grams)
* History of prenatal exposure to drugs other than alcohol, nicotine, and caffeine
The Comparison of PYY, Ghrelin, GLP1, Glucose Level, Level of Satiety, and Ad Libitum Intake in Obese and Non-Obese Patients After Breakfast With Balanced Macronutrient Composition

Obesity can occur due to an imbalance of energy. This energy balance is greatly influenced by hunger and satiety. Obese person cannot resist hunger, while non obese can control hunger. Gut hormones, such as PYY and ghrelin, are associated with appetite and satiety control. This study's objective is to compare the effect of breakfast with balance composition on gut hormones, glucose and ad libitum intake four hours after breakfast between obese and non obese..

The research methodology was used a clinical trial with 18 obese women and 22 non obese women participants. Subjects were given a balance breakfast (protein 12,4%, carbohydrate 68,2%, fat 22,6%). Gut hormones (PYY, Ghrelin, GLP -1) level , Glucose level and satiety level were measured at 0, 15, 60, 120, and 180 minutes after breakfast. Ad libitum meal was given four hours after breakfast and measured after.


Eligibility Criteria:
Inclusion Criteria:

* BMI 25 - 30 (for obese am)
* BMI 18,5 - 23 (for NON- obese am)
* with stable body weight within the last 6 months (body weight change less than 4 kg)
* normal blood glucose level.

Exclusion Criteria:

* Patients who never had breakfast
* patients in weight loss program
* patients consuming lipid-absorption inhibitor or appetite-suppressing drugs
* patients that have had gastrointestinal tract resection.
rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence

This study will compare the clinical efficacy and safety between rPMS device and pelvic floor exercises for the treatment of urinary incontinence. The subjects will be enrolled and assigned into two study groups - active and control group. Subjects will be required to complete six (6) treatment visits and five follow-up visits - 1, 3, 6, 9 and 12 months after the final treatment.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 25-70 years
* Suffers from specific types of UI - Stress Urinary Incontinence (SUI), Urge Urinary Incontinence (UUI) and/or Mixed Urinary Incontinence (MUI)
* Voluntarily signed informed consent form
* Subjects willing and able to abstain from partaking in any treatment of urinary incontinence other than the study procedure
* Subjects currently undergoing any treatment for stress, urge and/or mixed urinary incontinence, have to undergo a two-week wash-out period before start of the study

Exclusion Criteria:

* Use of Botox® in the bladder or pelvic muscles in the last year
* Use of Interstim® or similar device for the treatment of UI
* Suffers from other types of urinary incontinence other than SUI, UUI, MUI
* Pelvic organ prolapse grade 2 and higher
* Pronounced lesions of the pudendus nerve during clinical neurophysiological examination
* Currently lactating
* Cardiac pacemakers
* Implanted defibrillators and/or neurostimulators
* Electronic implants
* Metal implants, including copper IUD
* Drug pumps
* Hemorrhagic conditions
* Anticoagulation therapy
* Fever
* Pregnancy
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over areas of the skin which lack normal sensation
* Any disorders that the Investigator deems would interfere with study endpoints or subject safety
Prospective Comprehensive Molecular Profiling In Neuroendocrine Tumors

Prospective study to obtain fresh tumor biopsies and three blood samples from patients with a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs) for molecular profiling.

In this prospective study the aim is to obtain fresh tumor biopsies and three blood samples from patients with a confirmed histological or cytological diagnosis of well-differentiated neuroendocrine tumors (NETs) or well-differentiated pancreatic neuroendocrine tumors (PanNETs). Eligible population includes: NETs and PanNETs patients who have undergone or are undergoing treatment with targeted therapies and have shown prolonged clinical benefit, and NETs and PanNETs patients who have been treated with these agents and just recently progressed. RNA and DNA from fresh tumor biopsies and from mononuclear blood cells will be subjected to transcriptome sequencing and DNA sequencing analyses to evaluate possible genes of interest and related targetable pathways. Moreover, archived tumor samples will be requested from all patients to perform additional genomic testing. Remaining RNA and DNA will be banked for additional exploratory analyses (e.g. further genomic testing, or DNA copy number analysis, or epigenetic evaluations).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Histological or cytological proof of NETs or PanNETs.
* At least one biopsiable lesion deemed medically accessible and safe to biopsy.
* Current/recent treatment with targeted therapies with confirmed clinical benefit; confirmed progression disease to targeted therapies at the time of study enrollment.
* Fulfills local institution's laboratory parameters for tumor biopsy.
* Willingness and ability of patient to provide signed voluntary informed consent.

Exclusion Criteria:

* Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
* Any contraindication to undergoing a biopsy or blood collection procedure.
"Cancersensor": Circadian Rhythms

Observational, non randomized study aimed at measuring the circadian rhythms in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer and in 30 age and sex-matched healthy subjects.


Eligibility Criteria:
Inclusion Criteria for patients:

* Histologically-confirmed metastatic colorectal cancer;
* 0 to 3 prior chemotherapy lines;
* Signed informed consent;
* Good understanding of the protocol and of the follow-up;
* Estimated life expectancy exceeding 3 months;
* At least one measurable metastatic lesion (RECIST criteria);
* Performance Status (WHO) of 0 to 2;
* Good haematological, hepatic and renal functions.

Inclusion criteria for healthy subject

* Age ≥ 18 ans
* Signed informed consent;
* Good understanding of the protocol and of the follow-up;
* Good haematological, hepatic and renal functions.
* Test HIV and B and C hepatitis negative test
* No chronic or acute diseases

Exclusion Criteria for patients:

* Poor performance status (\>2);
* Poor haematological, hepatic or renal functions;
* Uncontrolled chronic disease;
* Serious unhealed wound, ulcer or fracture within the previous month;
* Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
* Pregnancy or breast-feeding during the previous month;
* Transmeridian trip of more than 4 time zones within the prior 2 weeks;
* Person with legal restriction to participate into clinical research, according to the current law in France.

Exclusion criteria for healthy subject:

* Poor haematological, hepatic or renal functions;
* Uncontrolled chronic disease;
* Serious unhealed wound, ulcer or fracture within the previous month;
* Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
* Pregnancy or breast-feeding during the previous month;
* Transmeridian trip of more than 4 time zones within the prior 2 weeks;
* Person with legal restriction to participate into clinical research, according to the current law in France.
The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses

The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.

The purpose of this bilateral cross-over study is to evaluate the clinical performance of senofilcon A lens with the stenfilcon A lens. In particular, the study will focus on ocular physiology, lens fit, lens surface, visual acuity, and subjective response.

Eligibility Criteria:
Inclusion criteria

Subjects will only be eligible for the study if:

* They are of legal age (18) and capacity to volunteer.
* They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They agree not to participate in other clinical research for the duration of this study.
* They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
* They have a spectacle cylindrical correction of -0.75D or less in each eye.
* At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
* They currently use soft contact lenses or have done so in the previous six months.
* They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).

Exclusion criteria

Subjects will not be eligible to take part in the study if:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They have had cataract surgery.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
* They are pregnant or lactating.
* They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
* They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
* They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
* They currently wear either MyDay (daily) or the Acuvue Oasys (2 weekly) lens.
Low Dose Radiation Therapy for Glioblastoma Multiforme

To evaluate the safety and effectiveness of low dose rate radiation therapy plus temozolomide. This will be in patients with High Grade Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) who have previously been treated with surgery followed by radiation surgical resection followed by adjuvant radiation therapy plus temozolomide.

In vitro and in vivo studies have suggested that low dose fractionated radiation therapy (LDFRT) may be used to potentiate full dose chemotherapy, decreasing the development of resistance found with standard doses of radiation and chemotherapy. This is a nonrandomized, open label, single institution phase II trial with a safety run-in to evaluate the safety and efficacy of LDFRT plus temozolomide in patients with High Grade Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) previously treated with surgical resection followed by adjuvant radiation therapy plus temozolomide. The primary objective of the phase II study is to estimate response rate in patients treated with twice daily fractions of low dose radiation plus temozolomide chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have recurrent GBM (Glioblastoma Multiforme)or Anaplastic Astrocytoma.
* The diagnosis of GBM or Anaplastic Astrocytoma.
* Patients must have been previously treated with surgical resection (any extent okay) and adjuvant radiation therapy plus temozolomide.
* Patients must be at least 12 months from completion of radiation therapy
* At least 2 months from completion of temozolomide (to be consistent with the the "rechallenge" group from Perry et al. JCO 2010).
* Age \>18 years
* ECOG performance status \<2 (Karnofsky \>60%, see appendix A).
* There must be measurable disease on MRI.
* Patients must have normal organ and marrow function as defined below:
* Women must not be pregnant
* Ability to understand and the willingness to sign a written informed consent document
* Temozolomide re-treatment is planned by the treating neuro-oncologist.
* The most recent brain tumor pathology obtained for the patient must be glioblastoma.

Exclusion Criteria:

* Must be able to receive an MRI
* Patients may not be receiving any other investigational cancer treatment agents at the time of enrollment.
* Patients may not have previously failed treatment with salvage temozolomide.
* Patients may not have previously failed treatment with a VEGF inhibitor.
* Patients may not have previously been treated with \>1 course of radiotherapy.
* Patients may not have previously been treated with radiosurgery to the brain.
* Uncontrolled intercurrent illness
* Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use and acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. Male subjects must also agree to use effective contraception for the same period as above.
Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06817024 in healthy volunteers, in participants with chronic rhinosinusitis, with nasal polyps and in participants with moderate-to-severe Atopic Dermatitis

The purpose of the study for Part 1 is to evaluate the safety and tolerability of PF-06817024 in healthy subjects.

The purpose of the study for Part 2 is to evaluate the safety and tolerability of PF-06817024 in patients with chronic rhinosinusitis with nasal polyps.

The purpose of the study for Part 3 is to evaluate the safety and tolerability of PF-06817024 in patients with moderate-to-severe Atopic Dermatitis

Eligibility Criteria:
Inclusion Criteria

* Healthy male subjects, healthy female subjects of non-childbearing potential, 18-55 years of age (Part 1)
* Male subjects, female subjects of non-childbearing potential, female subjects of childbearing potential with documented bilateral tubal ligation (tubes tied) or bilateral salpingectomy (tubes removed), 18-65 years of age, and 2 of the following symptoms: nasal congestion/obstruction, nasal discharge, face pain/pressure,or reduction/loss of smell (Part 2)
* Male or female subjects between the ages of 18 and 75 years, inclusive with moderate-to-severe Atopic Dermatitis, agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps, or other ultraviolet light sources during the study (Part 3)

Exclusion Criteria:

* Clinically significant diseases (cardiac, psychiatric, autoimmune, renal, etc.), positive urine drug test, fever within 7 days of dosing, active infections within 28 days of dosing (Part 1 and 2 and 3)
* History of allergic reaction to topical lidocaine, nasal surgery within 6 months (Part 2)
* Exposure to live or attenuated vaccines, have skin conditions other than Atopic Dermatitis, use of JAK inhibitors and biologics (Part 3)
Multicenter Diagnostic Clinical Performance Study For Automated Detection of Diabetic Retinopathy

This study is a retrospective study to assess the efficacy and accuracy of the EyeCheckup software in screening for diabetic retinopathy in healthcare settings.

This is a clinical diagnostic performance study for EyeCheckup with data obtained consecutively at multiple geographically different sites within the US population. These sites include all healthcare settings with a trained ophthalmic camera operator using non-mydriatic cameras that are compatible with EyeCheckup. Moreover, primary endpoints are devised that will be used to validate EyeCheckup to diagnose DR in the primary care and eye care settings. During this color fundus images representing either 4 wide field or 7 standard fields of view will be graded by a qualified professional for diabetic retinopathy according to ETDRS on DRSS scale. The human grading output will be compared with diagnosis generated for diabetic retinopathy by AI software. A comparison of both these grades will be used to determine sensitivity and specificity for the EyeCheckup software for screening for diabetic retinopathy.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of either diabetes type 1 or diabetes type 2
* 22 years of age or older
* Patients Fundus images must include at least 1 macula centered and 1 optic disc nerve centered image
* All the subjects must be sequentially photographed meaning no omissions of data between a certain time frame by the sites providing images to ensure consecutive selection
* No history of any other retinal vascular disease, glaucoma, or another disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed)

Subject with image taken by color fundus photography that meets the following requirements:

* The resolution of image is 1024×1024 pixels or higher
* The ability to provide a 7 standard or 4 wide field of view
* Must obtained from either Topcon NW400 or Cannon Model CR-2 AF or CR-2 Plus AF or Optomed Aurora Cameras along with the following data: their age, ethnicity and gender, patient ocular history as evaluated of verified by the clinical sites where data is obtained

Exclusion Criteria:

* No diagnosis of either diabetes type 1 or diabetes type 2
* The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the certified ophthalmologist who is grading the images.
Establishing a Non-invasive Method to Measure Your Heart's Performance

The purpose of the study is to evaluate a new way to examine cardiac function, using software developed at Caltech. The experimental device is software loaded on an iPhone. The iPhone is used to capture a pulse (waveform) by simply placing the iPhone lightly over the neck where the carotid pulse can be felt. In this study the information collected from the iPhone app is compared to cardiac function data obtained from the current gold standard for measuring cardiac function, cardiac magnetic resonance imaging (MRI). Subjects referred from cardiologists will also generally have echocardiography information available for comparison with the iPhone app. For the study, subjects will have completely non-invasive studies done in one setting: The iPhone app to capture the waveforms (over carotid and radial (wrist) arteries), tonometry (another non-invasive method using a modified stethoscope), standard pulse oximetry, followed by a 30 minute MRI examination of the heart. A second complete study will be done about 6 months after the first. The complete study session takes about 1.5 hours.

Investigators at Caltech have developed an iPhone-based application that allows them to capture an arterial waveform using the iPhone camera held over the skin. Then based on the captured waveform and previous laboratory experiments and models, the investigators are able to calculate ejection fraction, the percentage of blood that goes out of the heart into the circulation with each beat. Previous studies suggested that the iPhone app measurements of ejection fraction were similar to those obtained with traditional cardiac echocardiography. In the current study the iPhone app measures are being compared to ejection fraction obtained using cardiac MRI. The iPhone also measures other physical properties of the heart and aorta that the investigators call "intrinsic frequencies". Using healthy subjects they have established the normal pattern/range of intrinsic frequencies, and in this study, a more diverse population of subjects (some with heart disease) will be studied, to determine how intrinsic frequency measures compare to traditional clinical measures of cardiac function.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 18-90, outpatients

Exclusion Criteria:

* Inability to lie flat for 30 minutes with periodic breath holding
* Metal implants or other standard contraindications to MRI
* Acute cardiac decompensation (active chest pain, shortness of breath)
* Hypotension (SBP\<90 mm Hg)
* Claustrophobia
* Patient too large to fit in closed MRI
The Effectiveness of Lifestyle Redesign Training in Elderly With Cognitive Decline

Taiwan is already an aging society due to the rapid increase of the aging population. To cope with this situation, it is necessary to make preparations for the care of the elderly. World Health Organization (WHO) proposed aging health strategy in recent years, and the community participation is the most important for the elderly. The courses provided by the community empowering are important to promote the healthy life of the elderly. However, at this stage, there are relatively few courses related to cognitive functions, life-style activities and aging education. It is needed to add more courses related to multi-domain.

Taiwan is already an aging society due to the rapid increase of the aging population. To cope with this situation, it is necessary to make preparations for the care of the elderly. World Health Organization (WHO) proposed aging health strategy in recent years, and the community participation is the most important for the elderly. The courses provided by the community empowering are important to promote the healthy life of the elderly. However, at this stage, there are relatively few courses related to cognitive functions, life-style activities and aging education. It is needed to add more courses related to multi-domain.

Investigators anticipate recruiting a total of 50 participants with cognitive decline. The participants will receive a total of 12 training sessions, and each session will contain 120 minutes of training. The programs contain sequential cognitive and exercise training, health lectures, and groups of daily living participation. Investigators plan to assess the participants before and after the intervention programs. Investigators expect that elders receiving training will improve on outcome measures. The results of the study will provide evidence of interventions for elderly with cognitive decline.

Eligibility Criteria:
Inclusion Criteria:

* able to follow instruction (MMSE\>= 20)
* self- or informant-reported memory or cognitive complaint.

Exclusion Criteria:

* recent myocardial infarction,heart failure,recent heart surgery,
* severe asthma, concomitant with other neurological disorders, or joint deformity that might prevents them performing exercise or cognitive training.