cyrilzakka/clinical-trials huggingface dataset:
Modafinil in Cancer Related Fatigue

Cancer related fatigue (CRF) is a highly prevalent and highly significant entity among patients with cancer. 'Cancer related fatigue' is not a simple symptom, but is an entity in itself, in that it is different from routine fatigue. Cancer related fatigue is that fatigue which persists even after rest and has significant effects on quality of life.

The incidence of Cancer Related Fatigue (CRF) increases during radiation therapy (RT), with almost every patient on radiotherapy complaining of at-least some magnitude of fatigue.

Given that fatigue can affect treatment adherence by patients, it is important to initiate measures to either prevent or mitigate Cancer Related Fatigue.

The investigators intend to use modafinil in cancer related fatigue, in view of the fact that it has safety and efficacy in other diseases such as narcolepsy, multiple sclerosis and fibromyalgia. In addition, there have been a few small trials which have hinted towards benefit with the use of modafinil in cancer related fatigue.

The investigators have chosen a dose of 100mg/day in the morning, to be compared with placebo. The study arm and the placebo arm will be stratified with respect to age, sex, disease site, baseline performance status.

Primary outcome would be fatigue, which will be assessed by the use of Brief Fatigue Inventory (BFI). Secondary outcomes include Quality of Life, improvements in performance status, changes in systolic and diastolic blood pressure, and changes in weight.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pathological confirmation of cancer
* Age 18 years to 70 years
* Performance status (Karnofsky scale) not less than 60
* Providing consent

Exclusion Criteria:

* Psychiatric illness
* Hypertension
* Diabetes
* Thyroid disorders
* Epilepsy
* Tuberculosis
The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics

The goal of this clinical trial is to assure the safety of long term therapeutic plasma exchange (TPE) with and without Intravenous Immunoglobulin (IVIG) and its effects on biomarkers and epigenetic biologic clocks in forty individuals. The main question is to assure the safety from long term TPE using changes in clinical and laboratory outcomes and also evaluating changes on additional blood biomarkers and epigenetic clocks during and after TPE treatment. Researchers will compare the TPE treatment group to the Sham treatment group to identify changes due to TPE. Participants will receive six TPE or Sham treatments over one of two treatment schedules and may receive IVIG with treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 50 years of age with or without chronic inflammatory condition

Exclusion Criteria:

* Poor peripheral vascular access
* Diagnosis of active malignancy
* Late-stage Alzheimer's disease Any medical condition which may deteriorate because of plasma exchange procedures. These include, but are not limited to, symptomatic coronary artery disease, congestive heart failure and restrictive pulmonary disease (COPD). The investigators reserve the right to exclude anyone they feel may be harmed in any way by participating in the trial.
* Presence of active infection
* Alcohol or drug dependency
* Psychiatric disorder that will interfere with participation in the study (e.g., schizophrenia, bipolar disorder)
Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution

This study is a post-marketing surveillance in Japan to investigate the safety especially focusing on injection site adverse events and efficacy in patients with Ciprofloxacin iv administration without dilution in the daily practice.It is a local prospective and observational study of patients who have received Ciproxan intravenously for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. A total of 500 patients are to be enrolled and assessed during the period of treatment with Ciproxan.


Eligibility Criteria:
Inclusion Criteria:

* - The mentioned bellow patients caused by the following bacteria which are sensitive to this drug: Indicated microorganisms:Staphylococcus, Enterococcus, Bacillus anthracis, Escherichia coli, Klebsiella , Enterobacter, Pseudomonas aeruginosa, Legionella. Indications: Sepsis, Secondary skin infections (superficial burn, operative wounds, trauma), Pneumonia, Peritonitis, Cholecystitis, Cholangitis, Anthrax
* The patients treated with this drug without dilution due to strict restriction of fluid intake.
* In hospitalized patients who retain consciousness ,and at the same time who are able to report (such as vascular pain) side effects..

Exclusion Criteria:

* Patients who are contraindicated based on the product label.
Retinal, Cerebral and Vascular Precursor Markers of Cerebral Small Vessel Disease.

Cognitive impairment and dementia are primarily due to a combination of vascular brain injury and neurodegenerative lesions. The vascular component is now recognized as a major contributor to the pathophysiology of dementia, with small vessel disease (SVD) being its most frequent substrate. This study aims to collect retinal microvascular markers as well as various parameters related to blood pressure and arterial stiffness, in a young adult population. The main objective is to explore the association between these parameters and structural changes on brain MRI. Results will allow to determine the most relevant biomarkers associated with very early brain imaging markers of SVD.

Small Vessel Disease is most often covert i.e detectable only on brain images without being associated with a clinical stroke. Covert SVD (cSVD) is highly prevalent in older persons from the general population and is a powerful predictor of future cognitive decline and dementia risk. Better detection of covert cSVD, particularly at the earliest stages, would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. Studying the association of retinal and vascular biomarkers with MRI markers of brain structure will enable to facilitate the detection of patients at high risk of developing cSVD and its complications. This study aims to collect ophthalmological (retinal image acquisition - Part 1 of the study) and blood pressure / arterial stiffness (vascular assessment - Part 2 of the study) markers from 400 young adults from the Bordeaux bio-Share study. In Part 1, microvascular retinal biomarkers will be revealed by two complementary advanced technologies: the Swept-source optical coherence tomography angiography (SS-OCT-A) and the Adaptative Optics (AO). In Part 2, participants will benefit from an in-depth vascular assessment.

Eligibility Criteria:
Inclusion Criteria: Young adults from the i-Share cohort will be included in the study:

* having signed the informed consent form of the MRi-Share sub-study,
* having signed the informed consent form for the bio-Share sub-study,
* for whom brain MRI images and for whom the results of the genome-wide genetic association study (GWAS) are of good quality
* having signed freely, an informed and written consent for this study (at the latest on the day of inclusion and before any examination required by the research),
* being affiliated with social security.

Exclusion Criteria: Will not be included in the study:

* participants with severe myopia greater than -6 dioptres
* participants with known allergy to Tropicamide (Mydriaticum®)
Deep Learning Model for the Prediction of Post-LT HCC Recurrence

Identifying patients at high risk for recurrence of hepatocellular carcinoma (HCC) after liver transplantation (LT) represents a challenging issue. The present study aims to develop and validate an accurate post-LT recurrence prediction calculator using the machine learning method.

In 1996, the introduction of the Milan criteria (MC) strongly modified the selection process of hepatocellular cancer (HCC) patients waiting for liver transplantation (LT). Many attempts to widen MC have been proposed. Initially, exclusively morphology-based (nodules number and target lesion diameter) criteria were created. In the last years, extended criteria also based on biological parameters have been added. Among the most adopted biology-based features, the levels of different tumor markers, liver function parameters like the model for end-stage liver disease (MELD), the radiological response after neo-adjuvant therapies, and the length of waiting-time (WT) can be reported.

Unfortunately, all the proposed models showed suboptimal prediction abilities for the risk of post-LT recurrence. Such impairment was derived from the limitations of the standard statistical methods to account for many variables and their non-linear interactions. Therefore, developing a model based on Artificial Intelligence (AI) represents an attractive way to improve prediction ability.

Thus, the investigators hypothesize that an AI model focused on an accurate post-transplant HCC recurrence prediction should improve our ability to pre-operatively identify patients with different classes of risk for HCC recurrence after transplant.

This study aims to develop an AI-derived prediction model combining morphology and biology variables. A Training Set derived from an International Cohort was adopted for doing this. A Test Set derived from the same International Cohort and a Validation Cohort were adopted for the internal and external validation, respectively. A user-friendly web calculator was also developed.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult (≥18 years) patients enlisted and transplanted with the primary diagnosis of HCC during the period 2000-2018.

Exclusion Criteria:

* Patients with HCC diagnosed only at pathological examination (incidental HCC)
* Patients with mixed hepatocellular-cholangiocellular cancer misdiagnosed as HCC
* Patients with cholangiocellular cancer misdiagnosed as HCC
* Patients dying early after LT (≤ one month)
Reconstruction of Nasal Floor for Three-dimensional Repair of Alveolar Cleft

reconstruction of alveolar cleft with autogenous bone after elevation of mucoperiosteal flap and suturing of nasal floor and palatal flap

gingival mucoperiosteal flaps are designed along the cleft margins and elevated medial and lateral mucoperiosteal flaps are generated from the cleft and the gingival sulcus of the teeth. To obtain adequate mobility of the posterior flap, the flap must be extended to the first or the second molar and back-cut up to the buccal sulcus while taking care not to injure the alveolar bone covering the roots of the teeth. These flaps are raised up to and around the piriform aperture, and then are separated from the nasal mucosa the palatal mucoperiosteal flaps along the cleft margins are then elevated from the palate. After complete exposure of all the bony clefts, the nasal lining of the nostril floor is approximated and sutured, and the palatal flaps are then turned back and sutured to make a soft-tissue pocket. Grafting of the defect is accomplished with cortical bone only from the chin the cortical shelf is prepared to be two layers perpendicular to each other the first one is parallel to the nasal floor and second one is continuous with buccal cortex of alveolar ridge then cancellous bone will be packed under these shelves and be compressed into the cleft defect to maximize the number of osteo-competent cells and the osteoid material per unit graft volume. When packing bone particles, it is better to create the maxilla and alveolar ridges and elevate the depressed nostril by appropriately supporting the nasal base and aligning the symmetry. The rest can then be covered with gingival mucoperiosteal flaps through tension-free transposition

Eligibility Criteria:
Inclusion Criteria:

patients had alveolar cleft adequate and healthy soft tissue

-

Exclusion Criteria:

* age less than 9 very wide cleft scared soft tissue
Prevalence of Hypogonadism in Male Cancer Patients

Cancer and its complications are common problems. In most cases, this condition has a profound impact on survival and quality of life (QoL). Fatigue, sexual dysfunction, decreased sexual drive, depression and poor appetite are commonly seen in these patients. However, these symptoms also are seen in men with other conditions including those with low testosterone levels.

The objective of this study is to determine the number of male patients with cancer that have low testosterone levels and to establish the relationship between testosterone levels and the symptoms that these patients experience.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects ≥ 18 years of age with histological diagnosis of cancer for cancer group.
2. Provide written informed consent prior to screening.
3. Histological diagnosis of cancer other than non-melanoma skin cancer for the two cancer groups.

Exclusion Criteria:

1. Concomitant use of GH, Megestrol, Marinol, or any other anabolic agent, appetite stimulant (including corticosteroids other than dexamethasone at the time of IV chemotherapy administrations), tube feedings, or parenteral nutrition during the 3 months prior to entering the study.
2. Participation in a clinical trial with investigational agents within 1 month of enrollment.
3. Prior or current use of other medications that interfere with gonadal axis (androgens, estrogens, anti-androgens, etc).
"Galectin-3 as a Marker of Subclinical Inflammation in FMF"

The goal of this observational study is to learn about the relationship between serum Galectin-3 levels and subclinical inflammation in patients with Familial Mediterranean Fever (FMF). The main questions it aims to answer are:

* Are serum Galectin-3 levels higher in FMF patients compared to healthy controls?
* Is there a positive correlation between serum Galectin-3 levels and Serum Amyloid A (SAA) protein levels in FMF patients?

Participants will:

* Provide blood samples to measure serum Galectin-3 and SAA levels.
* Complete a sociodemographic and clinical data form.
* Fill out the FMF Quality of Life (QoL) scale.

Researchers will compare FMF patients and healthy controls to see if there are significant differences in serum Galectin-3 levels and to determine the correlation between Galectin-3 and SAA protein levels in FMF patients.


Eligibility Criteria:
Inclusion Criteria:

* for the Patient Group:

  1. Aged between 18 and 65 years,
  2. Able to provide written informed consent for the study,
  3. Literate,
  4. Diagnosed with Familial Mediterranean Fever (FMF) according to the Tel Hashomer criteria and not currently experiencing an attack (with at least 15 days since the last attack).

     * Inclusion Criteria for the Healthy Control Group:

  <!-- -->

  1. Aged between 18 and 65 years,
  2. Able to provide written informed consent for the study,
  3. Literate.

Exclusion Criteria:

* Exclusion Criteria for the Patient Group:

  1. Presence of known inflammatory diseases other than FMF,
  2. Presence of known systemic, chronic, severe medical conditions,
  3. Presence of active infection,
  4. Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
  5. Being pregnant or in the lactation period.
* Exclusion Criteria for the Healthy Control Group:

  1. Presence of known systemic, chronic, severe medical conditions,
  2. Presence of inflammatory diseases,
  3. Presence of active infection,
  4. Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
  5. Being pregnant or in the lactation period. -
A Novel Technique for the Removal of Pterygiums

The aim of this study is to introduce a new surgical technique for the removal of pterygiums that entails the use of bipolar electrocautery to secure the graft, rather than sutures.

With this, the objective is to evaluate the benefits of a new technique for pterygium surgery with respect to postoperative patient comfort, surgery time, cost and recurrence rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients with one or more pterygiums over age 18

Exclusion Criteria:

* Patients with glaucoma
Effects of Touch on Brain Connectivity and Metabolic Biomarkers in Preterm Infants

Improving the quality of life of preterm children by 2035 is the top priority of worldwide health organisations, including the WHO. Every year, 15 million preterm infants, particularly those under 32 weeks of age, are at significant risk of neurocognitive impairments with adverse health consequences (disability, developmental delay, disease), exacerbated by the lack of post-hospital care for newborns.

Intervening on the health of the preterm newborn through certain types of "touch" from its first days of life to activate its cutaneous senses permits, in reality, a significant improvement in the clinical state of the infant, hence promoting its growth, development, and social behaviour.

In the neonatal period, during which significant neurological development occurs, tactile interactions and close physical proximity between infants and caregivers have significant short-term effects on the health of premature infants (weight gain, brain and vision development) and medium- to long-term effects on their development and expression of sociability.

The likelihood that a premature newborn may develop attention and autism spectrum disorders, brain, gastrointestinal, and respiratory difficulties, as well as sleep disorders during the preschool years, is so high that clinical and social settings must prioritise care.

Utilizing functional magnetic resonance imaging (fRMI), computerized electroencephalogram (EEG), and metabolomics, the research aims to explore the effects of touch, including physiotherapy and manual therapy (OMT) approaches, on brain activity.

This research intends to examine the impact of touch on premature infants' brain activity (physical biomarker) and metabolic activity (biological biomarker).


Eligibility Criteria:
Inclusion Criteria:

* Preterm birth, between 32.0 and 33.6 weeks gestational age (GA);
* Absence of comorbidities that could affect the stability of vital parameters, and therefore represent a contraindication to the proposed intervention. Comorbities include sepsis, pathologies pertaining to surgery, respiratory or cardiovascular instability, birth from a drug-addicted or HIV-positive mother) or known congenital pathologies;
* Obtaining informed consent for participation in this research project from parents or legal guardians.

Exclusion Criteria:

* Preterm infants born before 32.0 weeks of GA and after 34 weeks and with respiratory and neurological pathologies and any additional comorbities.
* Children whose parents will not read and sign or in case of failure to obtain informed consent will be excluded from the study.
Comparative Effectiveness of Financial Incentives and Nudges to Reduce Cellphone Use While Driving Among UBI Auto Policy Holders

The investigators are proposing an experiment to help a national auto insurance company test behavioral economic strategies to reduce the amount of time policy holders actively use their cell phone while driving. Interventions include financial incentives, social comparison, and nudges, and survey data will also be collected. Data collected from this internal trial will be shared with the Penn research team and analyzed


Eligibility Criteria:
Inclusion Criteria:

* Progressive Snapshot Users with policy activated within recruitment period
* Progressive Snapshot policy holder in one of the following states and regions: MI, PA, TX, FL, TN, OR, GA, NE, OK, OH, MT, MO, NV, CT, WI, MD, KY, MN, NH, NJ, AZ, ME, LA, SC, CO, MS, IN, IA, AL, ND, UT, RI, WV, WY, IL, AR, DE, KS, SD, NM, VT, ID, and the District of Columbia
* Has an email address

Exclusion Criteria:

* Progressive Snapshot Mobile App not updated to enable push notifications
* Customer's residential address is in a state in which phone use while driving is factored into insurance rating
* Customer's Snapshot Mobile App does not collect trip data with all sensors active
* Customer in Snapshot program for \< 30 days or more \> 70 days
Photophlethysmography Evaluation of Pulse Waveform

Aim 1. To explore a novel, non-invasive PPG technology for purposes of monitoring heart rate variability and pulse waveform by harmonic resonance analysis.

Aim 2. To analyze collected data to determine whether it provides useful information about other measures of underlying health.

The proposed study will first investigate whether a novel PPG device will be able to measure the harmonic-analysis indexes of the blood pressure waveform (BPWs) to provide information about arterial pulse transmission (by monitoring arterial pulse waveform, Cn) and cardiovascular regulatory activities (by monitoring coefficients of variation, CVn).

Secondarily, data on Cn and CVn could be useful for detecting the arterial elastic properties induced by external stimulation such as exercise, cold stimulation, mental stress, acupuncture, medications such as antihypertensive drugs, or pathological factors such as metabolic syndrome, and breast cancer. The collected data may thus provide information about underlying health.

Photoplethysmography (PPG) is a non-invasive optical technique for evaluating the pulse and hemodynamic changes in frequency. The device obtains a volumetric measurement of an organ via optical illumination (e.g LED). PPG has been used to determine the PaO2, heart rate, and blood pressure (systolic blood pressure, SBP and diastolic blood pressure, DBP) at fingertip and harmonic proportion at fingertip or from the radial artery waveform at the wrist.

However, to the investigator's knowledge, this is the first preliminary study to determine the effects of physical activity on harmonic proportion evaluating by PPG at fingertip. Ultimately, this data may help to develop a non-invasive, external device that could rapidly detect information about cardiovascular and underlying health.

Eligibility Criteria:
4) Inclusion criteria:

1. Ability to understand consent (no proxy consent) in English or Chinese.
2. Self-Reported ability to undertake a 20 minute cycling activity at 60-70% exercise intensity.
3. Ability and willingness to abstain from use of medications for three days preceding cycling activity, smoking/intense exercise/alcohol for 12 hours preceding cycling activity, and caffeine intake for 4 hours preceding cycling.

5) Exclusion criteria:

1. Inability to finish a 20 min cycling activity in 60-70% exercise intensity.
2. Adverse reaction to adhesive tape.
3. Raynaud's phenomenon
4. Angina or recent myocardial infarction (previous 6 months)