cyrilzakka/clinical-trials huggingface dataset:
Evaluation the Safety and Efficacy of Cilostazol in Treatment of Patients With Fatty Liver Disease

The aim of the current study is to evaluate the safety and efficay of cilostazol in treatment of patients with fatty liver disease. Several previous reports have shown that cilostazol ameliorates lipid imbalances in NAFLD. Cilostazol appeared to exert beneficial effects against NAFLD


Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 60 years of age, both men and women,
* Clinical diagnosis of NAFLD, confirmed by imaging exams,
* Patients who present levels above the reference values of ALT, AST and ferritin.

Exclusion Criteria:

* Women in the menacing period, with the exception of those who have performed definitive sterilization, such as hysterectomy or tubal ligation.
* Patients with established prior diagnosis of chronic noncommunicable disease (congestive heart failure, decompensated or severe lung disease, neoplasms, renal disease, advanced liver disease - Child Pugh C classification)
* Patients with schistosomiasis;
* Hemochromatosis
* Wilson's disease
* Viral or autoimmune hepatitis
* HIV virus carriers
* Woman who is breastfeeding
* Users of illicit drugs
* Patients with an intake of more than 20 g / day of alcohol and / or past alcoholism with abstention less than 6 months;
* Patients with ingestion of medications such as steroids, estrogens, amiodarone, warfarin, anti-convulsants, antipsychotics, tamoxifen or other chemotherapeutic agents in the last 6 months
* Patients with clinically manifest infections or inflammation, surgery, trauma or hospitalization in the last 30 days
* Chronic non-hepatic degenerative diseases (sclerosis, Parkinson's disease or -Alzheimer's disease)
* Patients who do not participate in all stages of the research.
A Feasibility Study to Determine Whether the Botanical Garden Become a Region of Forest Therapy for Cancer Survivors

The forest healing system is an important topic of alternative therapy in recent years. To investigates forest therapy's effectiveness in alleviating negative emotions among post-cancer patients. It compares therapy outcomes at Taipei Botanical Garden and Fushan Botanical Garden. Utilizing a pretest-posttest experimental design, a two-hour guided forest healing activity serves as the intervention method. Data collection involves instrumental tests and saliva samples.

Introduction:

Cancer's global impact persists, ranking among the top three causes of death in Taiwan. Despite improved survival rates after cancer surgery, negative emotions among patients remain a challenge. Post-cancer depression adversely affects treatment outcomes and overall quality of life. Forest therapy, a natural healing approach, has gained attention for its potential to reduce stress, mitigate negative emotions, and enhance well-being.

Objectives:

This study investigates forest therapy's effectiveness in alleviating negative emotions among post-cancer patients. It compares therapy outcomes at Taipei Botanical Garden and Fushan Botanical Garden. Additionally, the study explores the lasting emotional benefits of forest therapy.

Methods:

Utilizing a pretest-posttest experimental design, this study is conducted at the Botanical Garden in Fushan, Taipei. Participants are cancer patients who are six months post-treatment. A two-hour guided forest healing activity serves as the intervention method. Data collection involves instrumental tests and saliva samples. A comparable location adjacent to Taipei Botanical Garden, excluding urban areas, is selected for comparison activities. Portable heart rhythm monitors track data, and saliva samples are analyzed for salivary α-amylase enzyme kinetics and cortisol concentrations. The study employs questionnaires including the Profile of Mood States 2nd Edition-Adult short (POMS2-A short), Beck Depression Inventory-Second edition (BDI-II), Beck Anxiety Inventory (BAI), and the abbreviated Taiwan version of the World Health Organization Quality of Life-Brief (WHOQOL-BREF).

Eligibility Criteria:
Inclusion Criteria:

* Over 20 year-old
* Cancer patients finished cancer treatments more than 6 months (regardless hormone therapy)
* Voluntary attendance

Exclusion Criteria:

* People who unable to walk for at least 120 minutes
* People who still smoking, chewing betel nut or drinking alcohol (over five standard cups in any situation)
* People who addicted to medicine
* People who attend another clinical trial at the same time or in the follow-up period of an interventional trial
* Pregnant women or breast feeding
* Other conditions that participants unable to cooperate with
Examination of Microcirculation of the Caput Humeri After Proximal Humerus Fracture

This study examines the microcirculation of the caput humeri after proximal humeral fracturation using O2C light probes.

During the operation the blood circulation is measured at four points (tuberculum majus, tuberculum minus, neck and head of the humerus) directly on the bone. The O2C light probes are a none-invasive technique of measuring blood flow, velocity and oxygen concentration. The data is analysed in respect to the fracture type according to the classification of Neer.

Valuable additional information for the correct treatment and prognosis of humeral fractures is expected.


Eligibility Criteria:
Inclusion Criteria:

* traumatic fractures of the proximal humerus
* surgical treatment
* over eighteen years of age

Exclusion Criteria:

* pathological fractures
* conservative treatment
* soft tissue damage
* delay of surgery more than three days
* immunological defects
* multiple trauma
Long Term Safety Follow up of Haematopoietic Stem Cell Gene Therapy for the Wiskott Aldrich Syndrome

An open follow up study of patients enrolled in the Phase 1/2 clinical trial of haematopoietic stem cell gene therapy for the Wiskott-Aldrich Syndrome and treated with autologous CD34+ cells transduced with the w1.6_hWASP_WPRE (VSVg) lentiviral vector.


Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in the initial phase I/II WAS conducted in France and United Kingdom (GTG002.07 and GTG003.08).
* Parents, guardians or patient signed informed consent, guardians or patient signed informed consent

Exclusion Criteria:

• Parents, guardians, patients unwilling to return for the follow up study period.
Duragen® Secure Post Marketing Clinical Follow-up (PMCF)

The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or identified in the animal studies, bench studies or clinical evaluation report.


Eligibility Criteria:
Inclusion Criteria:

* Patient who have undergone a neurosurgical procedure where DuraGen® Secure has been implanted

Exclusion Criteria:

* Patient who does not agree to allow collection of his/her medical data
A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to evaluate if the anti-tumor activity of JNJ-809 combined with apalutamide is improved compared with apalutamide alone for subjects with metastatic castration-resistant prostate cancer (mCRPC).


Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate
* Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans
* Surgically or medically castrated, with testosterone levels of less than (\<)50 nanogram per deciliter (ng/dL)
* Castration-resistant prostate cancer documented by time to prostate-specific antigen (PSA) increase during continuous treatment with androgen deprivation therapy (ADT) OR radiographic progression of soft tissues OR radiographic progression of bone according to PCWG3

Exclusion Criteria:

* Predominately small cell or neuroendocrine carcinoma of the prostate
* Known brain metastases (even if treated) or untreated epidural spread
* Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting, or up to 6 cycles of docetaxel for metastatic hormone-sensitive prostate cancer
* Treatment with medications known to lower the seizure threshold or any investigational agent that were not discontinued or substituted greater than or equal to (\>=)28 days prior to randomization
An Open-label Study of GSK1120212 Compared With Docetaxel in Stage IV KRAS-mutant Non-small Cell Lung Cancer

This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old with histologically- or cytologically-confirmed diagnosis of adenocarcinoma Stage IV NSCLC with a positive mutational status for the KRAS, NRAS, BRAF, or MEK1 gene.
* Documented tumor progression after receiving at least one, but not more than one, prior approved platinum-containing chemotherapy regimen for advanced stage/metastatic NSCLC.
* Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Performance status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
* Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
* Life expectancy of at least three months in the opinion of the investigator.
* Women of childbearing potential must have a negative serum pregnancy test within 14 days of randomization to study treatment and agree to use effective contraception. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the time of randomization to study medication until at least four weeks after the last dose of study treatment.
* Adequate baseline organ function.

Exclusion Criteria:

* History of another malignancy.
* Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
* Treatment with a BRAF or MEK inhibitor or docetaxel as monotherapy or as part of a combination regimen.
* Anti-cancer therapy (including chemotherapy and radiation therapy) within the last three weeks.
* History or current evidence / risk of retinal vein occlusion or central serous retinopathy.
* Any current or history of tumor manifestation in the Central Nervous System.
* History or evidence of cardiovascular risk, including QTcB \>=480 msec, uncontrolled arrhythmias, acute coronary syndrome, coronary angioplasty, or stenting within 6 months prior to randomization, \>=Class II congestive heart failure, treatment refractory hypertension, intra-cardiac defibrillators or permanent pacemakers or cardiac metastases.
* Known Human Immunodeficiency Virus, Hepatitis B Virus (HBV), or Hepatitis C Virus (HBC) infection (with the exception of chronic or cleared HBV and HCV infection).
Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy

This study will compare the effect of two topical non-steroidal antiinflammatory agents to control pain after photorefractive keratectomy (PRK) eye surgery.


Eligibility Criteria:
Inclusion Criteria:

* male or female at least 18 years of age,
* no other ocular studies with 15 days prior to dosing,
* BCVA 20/200 or better,
* return for study visits and follow instructions from investigator and staff,
* self administer test article

Exclusion Criteria:

* Ocular inflammation,
* hypersensitivity to bromfenac or nepafenac,
* any corneal pathology,
* have had radial keratotomy,
* corneal transplant or corneal refractive surgery in the last two years
Optisure Lead Post Approval Study

The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.


Eligibility Criteria:
Inclusion Criteria:

Eligible patients will meet all of the following:

1. Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.
3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

1. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study.
2. Have a life expectancy of less than 5 years due to any condition.
Study of CS-3150 in Patients With Primary Aldosteronism

To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 20 years or older at informed consent
* Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing
* Patients satisfying following blood pressure;

  * sitting systolic blood pressure (SBP) ≥ 140 mmHg and \<180 mmHg
  * sitting diastolic blood pressure (DBP) ≥ 90 mmHg and \<110 mmHg

Exclusion Criteria:

* Secondary hypertension except primary aldosteronism or hypertensive emergency
* Patients diagnosed diabetic nephropathy
* Patients with type 1 diabetes
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
* Serum potassium level \< 3.0 or ≥ 5.1 milliequivalent (mEq)/L
Oral Self Care Protocol and Oral Mucositis

Objective: This study was conducted in order to examine the effect of oral self-care protocol based on Orem's Self-Care Deficiency Theory on oral mucositis and self-care agency.

Method: This study was conducted as a randomized controlled trial between August 2021 and July 2022, patients with hematological malignancies receiving high-dose chemotherapy at the Izmir Ege University Faculty of Medicine Hospital and Izmir Training and Research Hospital. The sample of the study consisted of a total of 60 patients, including 30 application groups and 30 control groups, who met the inclusion criteria using the computer-based stratified randomization method. The study data were collected using "Patient Information Questionnaire," "WHO-Oral Mucositis Toxicity Scale," "Oral Assessment Guide," "Self-Care Agency Scale," "Data Collection Form Prepared According to Orem's Self-Care Deficiency Nursing Theory," "Oral Care Chart," and "Oral Cavity Photography." The oral self-care protocol, which includes training and oral care practices, was applied to the application group for 21 days from the beginning of chemotherapy treatment. The control group was not subjected to any oral care attempts by the researcher and received standard nursing care in the clinic. The data were evaluated by descriptive statistics, the Chi-square test, the Mann-Whitney U test, the Mc Ne-mar test, the Kappa compliance test, and the t test in dependent and independent groups. Keywords: chemotherapy; hematological malignancy; oral mucositis; oral self-care protocol; Orem's theory; self-care agency; nursing


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate,
* Have the ability to read and write,
* Volunteer for oral cavity photography,
* Possess a platelet value above 20,000/mm3, and
* Have intact oral mucous membrane integrity.

Exclusion Criteria:

* Who received combined radiotherapy and chemotherapy treatments
* Had incomplete questionnaire responses.
Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD

Double-masked, uncontrolled, multi-center, study in which participants will be randomized to one of 3 doses of topical ocular PAN 90806 administered once daily for 12 weeks.

Patients with newly diagnosed, active, pathologic CNV associated with neovascular AMD will be screened for inclusion into the study after providing written informed consent. Participants who are eligible for the study will be centrally randomized at Day 1 to one of three doses of PAN-90806 Eye Drops. Participants will be instructed to apply one drop of PAN-90806 to the ocular surface of the identified study eye once daily for twelve (12) weeks.

Participants will return for follow-up visits at Week 2, Week 4, Week 8, Week 12, 1 week after stopping PAN-90806 treatment and 1 month after stopping PAN-90806 treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis in the study eye of active, pathologic, newly diagnosed and previously untreated, subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD
* Aged 50 years or older
* Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye

Exclusion Criteria:

* Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye
* Prior use within the last 3 months or a high possibility of requiring treatment with anti-VEGF therapy in the fellow eye during the study
* Significant retinal serous pigment epithelial detachment (PED), atrophy, or fibrosis/scar involving the fovea
* History of or current clinical evidence in the study eye of aphakia, diabetic macular edema, any ocular inflammation or infections, pathological myopia, retinal detachment, advanced glaucoma, and/or significant media opacity, including cataract
* History or evidence of the following surgeries in the study eye: penetrating keratoplasty or vitrectomy; corneal transplant; corneal or intraocular surgery within 3 months of Screening
* Uncontrolled hypertension despite use of antihypertensive medications
* Participation in any investigational drug or device study, systemic or ocular, within past 3 months
* Women who are pregnant or nursing
* Women of child-bearing potential who are not using a highly effective form of birth control
* Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation
Early Postnatal Management of Gestational Brain Sonographic Malformations.

Gestational sonographic follow up may find some brain malformations. The trial is about to characterize these findings and correlate with the immediate postnatal findings.

Gestational sonographic follow up may find some brain malformations (such as ventricular enlargement, agenesis of corpus callosum, etc.).The trial is about to characterize these findings and correlate with the immediate postnatal findings.

Eligibility Criteria:
Inclusion Criteria:

* All term newborn infants who underwent a neurologic consultation or brain ultrasound.

Exclusion Criteria:

* Prematurity
Airways Dysfunction Following WTC Dust Exposure

In the weeks following the terrorist attacks of September 11, 2001, many patients presented to their physicians with complaints related to exposure to the debris. These included nose and throat complaints (drip, congestion, sore throat), increased GE reflux (heartburn, regurgitation, retrosternal chest burning) and respiratory symptoms (worsening cough, wheezing, shortness of breath, chest tightness, sleep disturbance). In addition, there was a disproportionate rate of self-reported worsening asthma symptoms in patients living in Lower New York 5-9 weeks after the attack; those with exposure to the dust cloud fared worse. The functional abnormalities of firefighters with exposures to dust at the WTC site has been recently described. However, the effects of WTC dust exposure on pulmonary function in residents and workers near the WTC site remain unclear. This study will retrospectively review the charts of all patients referred to the pulmonary function laboratory for evaluation of symptoms following exposure to WTC dust. The main objectives for this study will be to characterize the functional abnormalities in these subjects.


Eligibility Criteria:
Inclusion Criteria:

* age 18-80
* referral for pulmonary function evaluation of respiratory symptoms following exposure to WTC dust

Exclusion Criteria:

* inability to perform testing
Developmental Trajectories in ASD Until Adulthood: A 15 Years Follow-up Study

Epidemiological studies have shown that a wide range of outcome trajectories exist in ASD, but little is known about their determinant in a long-term perspective. The EpiTED cohort was set-up in order to understand the heterogeneity of developmental trajectories among children with a diagnosis of PDD and the role of clinical, biological and environmental factors in their adaptive outcome. It is one of the rare cohorts involving a long term prospective follow-up based on a large set of variables, and precise phenotypes of the entire autism spectrum.

Purpose: Epidemiological studies have shown that a wide range of outcome trajectories exist in ASD, but little is known about their determinant in a long-term perspective. The EpiTED cohort was set-up in order to understand the heterogeneity of developmental trajectories among children with a diagnosis of PDD and the role of clinical, biological and environmental factors in their adaptive outcome. It is one of the rare cohorts involving a long term prospective follow-up based on a large set of variables, and precise phenotypes of the entire autism spectrum.

Participants: This longitudinal study for which recruitment began between 1997 and 1999, has initially involved 281 preschool aged children recruited from 5 French areas. They were seen at 8 (Time 2), 15 (Time 3) and 20 years of age (Time 4), with an average follow-up length of 15 years. At each follow-up, socio-demographical, clinical, developmental and interventional were collected. At Time 4 (fourth visit), DNA was collected to do a genetic study Findings to date: The main results show that there were two developmental trajectories from childhood to adolescence among the cohort leading to very distinct level of adaptive functioning. Prognosis factors in childhood were the intellectual level, the presence or absence of language, the autism degree and the absence or presence of epilepsy. During adolescence there was a negative impact on the quality of life of the parents of the presence of aberrant behavior and low level functioning, The children included in the cohort were followed during 15 years and were assessed four times (at 5, 8, 15 and 20 years on average, see flow chart in figure 1. From 2000 to 2002, 219 of the original group were reassessed (time 2, T2). At time 3 (T3), between 2007 and 2009, they were 152 to be re-assessed and 106 between 2012 and 2015 (time 4, T4).

Eligibility Criteria:
Inclusion Criteria:

* Patients previously include in the troop constituted in 1997 /1999 as part of PHRC 96/97 and having been followed during 10 years.
* Patients are 18
* Patients with diagnosis of infantile autism or atypical autism according to the criteria of the CIM 10 at the time of their initial inclusion.

Exclusion Criteria:

* Refusal of participation
* Women pregnant breastfeeding
* persons deprived of freedom by court order