cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis

This is an open-label, sequential cohorts, flexible dose study to evaluate the tolerability, safety and pharmacokinetics of iloperidone in elderly patients with Parkinson's disease psychosis (PDP).


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide consent and willing to complete all aspects of the study.
* Male or female patients greater or equal to 65 years of age.
* Clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year
* Psychotic symptoms for at least one month and actively experiencing psychotic symptoms each week during the month prior to screening

Exclusion Criteria:

* History of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
* Current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study
A Long-term Observational Study Cohort in Patients With Advanced Prostate Cancer

The purpose of the protocol is to assess the rate of castration resistance, disease progression and overall survival over a 3-year period post-androgen deprivation therapy (ADT) induction in a study cohort of patients with advanced disease.


Eligibility Criteria:
Inclusion Criteria:

* Have participated and received study treatment in the Triptocare study
* Be aware of the investigational nature of this observational study cohort and must give written (personally signed and dated) informed consent

Exclusion Criteria:

* Absence of written informed consent from the patient
Theophylline for Depression Study

Depression is very common and poses a huge disease burden. About 20% of the US population suffers from depression at least once in their lifetime. Inflammations that are hidden inside our body as a result of aging, obesity, chronic diseases, or certain treatments (e.g., interferon for hepatitis C) appear to cause depressive symptoms and even clinical depression. Individuals with such inflammations are more likely to suffer from depression and are less likely to respond to currently available antidepressant medications. This study will test theophylline, a medication currently used for asthma treatment, as a new way to mitigate depressive symptoms in response to such inflammations. This study begins with a 90-minute screening session to determine whether participants are eligible to join the main study. Those who meet the eligibility criteria will then join the main study, which will consist of taking theophylline or methylcellulose (i.e., oral placebo) for 2 weeks at home and an 8-hour session at the UCLA Medical Center. Approximately 20 healthy adults will be recruited for participation in the study. During the course of the study, participants will take theophylline or methylcellulose for 2 weeks at home and then will be injected either lipopolysaccharide (LPS) or saline (i.e., intravenous placebo) at the UCLA Medical Center. LPS is a bacterial substance that can initiate chemical reactions that are similar to those seen in individuals with mild sickness symptoms, such as a slight increase in body temperature, muscle aches, or tiredness. It is a safe way of investigating the body's response to inflammation and how these changes may alter cognitive, emotional, or neural function. It has been given thousands of times to healthy volunteers - both younger and older adults - without any serious side effects.


Eligibility Criteria:
Inclusion Criteria:

* in good general health (as evaluated during the phone and in-person screening sessions)
* aged 18-65 years
* if female, using adequate birth control

Exclusion Criteria:

* history of hypersensitivity to xanthine derivatives (a contraindication to theophylline treatment)
* pregnant or planning to become pregnant in the next 6 months
* current breastfeeding
* chronic diseases such as cardiovascular disease, hepatic impairment, peptic ulcer disease, and seizure disorders
* current use of prescription medications such as steroids, non-steroid anti-inflammatory drugs, immune modifying drugs, opioid analgesics, and psychotropics
* Axis I psychiatric disorders including current major depressive disorder
* current depressive symptoms assessed by the Patient Health Questionnaire (PHQ-9 ≥ 5)
* heavy smoking (1 pack or more per day)
* excessive caffeine use (\>600 mg/day)
* Body-mass index \> 35 due to the effects of obesity on cytokine activity
* evidence of recreational drug use from urine test
* evidence of pregnancy from urine test
* evidence of clinically significant rhythm abnormality on a resting electrocardiogram (ECG)
* clinically significant abnormalities on screening laboratory tests
Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue

Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue.


Eligibility Criteria:
Inclusion Criteria

* Head and neck cancer with planned radiation therapy
* Age \> 18 years

Exclusion Criteria:

* Surgical treatment of head and neck cancer
* Salivary gland disease
* Severe claustrophobia
* Pregnancy or lactation (fertile women must use safe contraceptives)
* Uncontrolled hypertension (\> 220/110)
* Epilepsy
* Lack of ability to equalize inner ear pressure
* Pneumothorax
* Thoracic surgery within one month before HBO treatment
* Abuse of alcohol, drugs or narcotics
* Exposed titanium surfaces or defect titanium in the oral cavity
* Previous HBO treatment
Hemostasis Alterations in Neurosurgical Patients

Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.

Brain parenchyma express tissue factor and other coagulation factors in high concentrations. In addition, neuro critical patients (NCP) may present platelet dysfunction, hyperfibrinolysis, hypo coagulation and / or hyper coagulation status, early after the injury. It is not known whether these alterations of hemostasis are due to a specific brain response to aggression, or they are included into a systemic response. This prospective, observational study is aimed to investigate the coagulation disorders specifically associated with cerebral aggression.

This is a prospective, cohort study including (calculated sample size) a study group of patients undergoing elective surgery (glial tumors) and other one undergoing colo rectal surgery. Alterations of the hemostasis will be evaluated by clotting tests, thromboelastometry and tests for platelet function. Samples will be drawn before and after surgical procedures. Multiple statistical comparisons intra and inter groups will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective surgeries: glioma or colon cancer resections.

Exclusion Criteria:

* Severe bleeding leading to patient's' death.
* Incomplete tumor resection.
* Peri operative complications leading to severe bleeding or prolonged ICU or hospital stay.
* Peri operative blood components transfusion.
* Peri operative transfusion of concentrate coagulation factors.
* Intake of anti coagulant and / or antiaggregant drugs 7 days before surgery.
* History of coagulopathy.
* Inform consent denied for patients or relatives.
Clinical Transcriptomics in Systemic Vasculitis (CUTIS)

Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.

This study employs a multi-center approach to evaluate cutaneous vasculitis across several forms of idiopathic vasculitis. Patients with cutaneous manifestations of vasculitis will be evaluated by teams of primary vasculitis care providers and Dermatologists in order to facilitate optimal selection of patients and sampling of lesions.

A punch skin biopsy at a site of active vasculitis will be the source of material for histopathologic and transcriptomic evaluation. The histopathology of cutaneous vasculitis will be characterized using a standardized approach.

Eligibility Criteria:
Inclusion Criteria:

* Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura, nodules, ulcers, or urticarial) believed to be related to active vasculitis
* Have a suspected or confirmed diagnosis of:

  * Cryoglobulinemic vasculitis (CV)
  * Drug-induced vasculitis
  * Eosinophilic granulomatosis with polyangiitis (EGPA)
  * IgA vasculitis
  * Isolated cutaneous vasculitis
  * Granulomatosis with polyangiitis (GPA)
  * Microscopic polyangiitis (MPA)
  * Polyarteritis nodosa (PAN)
  * Urticarial vasculitis
* Be willing and able to provide written informed consent (or assent for those under

Exclusion Criteria:

* You are less than five years old
* Considered not to be a candidate for a biopsy or have a higher risk of developing an infection, bleeding, etc., from the biopsy, or a doctor believes that the risks for you participating in this study do not outweigh the potential benefit of learning information from your biopsy
* You have a neutrophil count (type of white blood cell) less than 1500/mm3, platelet count less than 50,000/mm3, or a hemoglobin less than 7 g/dL
* You have an uncontrolled disease that could prevent you from completing the study procedures
* You have an active infection at or near the potential biopsy site, have poor circulation, or have bony prominence or other structure that would increase your risk of complications if you participated in this study
* You are pregnant or nursing
* You are not able to provide informed consent
Endocrine Glucose & Lipids Metabolism and Brain Aging: a Longitudinal Study

With aging, brain aging leads to a general decline in cognitive ability, and the prevalence of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD) increases. The prevalence of abnormal glucose and lipid metabolism also increased with age. The imbalance of glucose and lipid metabolism is closely related to brain aging related conditions and diseases, and the relationship between glucose and lipid metabolism and brain aging has not been fully elucidated.

Phase 1: Baseline investigation (community-based survey) Aims: To investigate whether glucose and lipids are the risk factors for brain aging-related conditions, such as mild cognitive impairment.

Subjects and Methods: A community-based survey will be carried out in 10000 natural population aged \>=50 years selected from 10-12 communities stratified according to geographic regions (Ciyao, Huafeng, Dongzhuang, Heshan, Geshi, Jiangji, Gangcheng, Fushan, Dongshu, Sidian, Baxianqiao, and Xiangyin, etc) in Ningyang County, Taian City, Shandong Province. A comprehensive examination including questionnaire (including the MMSE and ADL evaluation for the participants), anthropometric measurements, biochemical analysis will be performed in each study participant. In particular, the investigators randomly selected 1000-2000 participants performing MRI of the brain to evaluate the brain aging related conditions.

Phase 2: Cohort follow-up Aims : To examine glucose and lipids metabolism levels and their changes that modify the risk of brain aging-related conditions.

Subjects and Methods: To recruit and follow all 10000 participants for at least 3-5 years. In particular, all 1000-2000 participants with the baseline MRI examination will perform the MRI examination again for the follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 50 years old;
2. Gender: males and females;
3. Provide written informed consent;
4. Satisfactory compliance.

Exclusion Criteria:

1. Pregnant or lactating women
2. No history of addiction or neurological, psychiatric, or systemic diseases known to affect cognitive function, including head trauma, subdural hematoma, current depression, and epilepsy
3. Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Multiple Sclerosis

The aim of the study is to investigate reliability, validity, and responsiveness of the timed 360° turn test in patients with Multiple Sclerosis.

At baseline, the timed 360° turn test, Berg Balance Scale, Timed Up and Go test, Functional Reach Test, Four Square Step Test, and One-legged Stance Test is applied to the Multiple Sclerosis group. The timed 360° turn test is repeated after seven days from the first application in patients with Multiple Sclerosis. Healthy controls are going to perform only the timed 360° turn test.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years,
* neurologist-diagnosed Multiple Sclerosis,
* Expanded Disability Status Scale (EDSS) score \< 7,
* able to walk 20 m with or without aids,
* no MS exacerbation within the last 2 months,
* use of stable medication in the last 2 months.

Exclusion Criteria:

* other neurologic disorder,
* Pregnancy,
* orhopedic problems affecting gait and stance,
* visual, auditory, orientational problems that could affect study results,
* Cardiovascular, pulmonary, and humoral disease.
Preliminary Survey in Preparation for the Implementation of ERAS at Dr Soetomo Hospital

This study aims to analyze the readiness of the team that will support the ERAS application at Regional General Academic Hospital Dr Soetomo.

This is an observational analytic study with a cross-sectional design using a questionnaire. Patient baseline data were taken from the examination at the anesthesiology outpatient clinic. The patient's level of understanding was assessed by two investigators and rated on a scale of 1 to 5. Primary data and assessment of understanding of doctors and medical personnel were filled in independently by research subjects on online forms and rated on a scale of 1 to 5.

Eligibility Criteria:
Inclusion Criteria:

* Patients with elective cesarean, urology, and simple orthopaedic surgery plans
* Patient with PS ASA 1-2

Exclusion Criteria:

* Patients with communication disorders / mental disorders
* Patients with outpatient surgery plans
Collective Accuryn Physiologic Signals and Signatures

The CAPSS Study is a retrospective and prospective, multi-center, single-arm post-market data collection study with an FDA cleared device. Physiologic data measurements will be collected from enrolled subjects using electronic health records and data streams via the Accuryn Monitoring System. Analysis of these data has the potential to be able to acutely guide resuscitation and monitor trends for emerging critical conditions.

The primary objective of the CAPSS Study is to track and analyze changes in physiologic data streams to identify clinical signatures that may enable earlier diagnosis of, and effective intervention in, critical conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Received Accuryn Monitoring System during hospital stay.
2. Diagnosed with or developed one or more of the targeted conditions while connected to the Accuryn Monitoring System.

Exclusion Criteria:

1. In the opinion of the investigator, the patient is unsuitable for the study.
Stereotactic Radiation Therapy in Treating Patients With Brain Metastases

RATIONALE: Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of stereotactic radiation therapy in treating patients who have brain metastases.

OBJECTIVES: I. Determine the efficacy of stereotactic radiosurgery without whole brain radiotherapy in elderly patients or patients with poor performance status who have brain metastases. II. Determine the neurologic function in these patients after receiving this treatment regimen. III. Determine the quality of life in these patients with this treatment regimen.

OUTLINE: Patients undergo stereotactic head frame placement, followed by stereotactic radiosurgery using Gamma Knife, on day 1. Quality of life is assessed one week prior to and one week after treatment, and then at 2, 4, 6, 8, 10, and 12 months. Patients are followed at one week, at 2, 4, 6, 8, 10, and 12 months, every 4 months for one year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: Approximately 52 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Patients with 1-4 sites of brain metastases Confirmed by MRI with gadolinium texaphyrin scan within two weeks of study If solitary metastases, diameter must be 40 mm or less If multiple metastases, one site may be greater than 30 mm, while all others must be less than 30 mm No metastases in the brainstem or within 5 mm of optic nerves or chiasm Prior surgical resection of metastases allowed if radiographically visible residual disease No prior cranial radiotherapy Patients must be over 65 years of age OR Over 18 years of age with Karnofsky performance status 40-60% All primary histologies allowed except the following: Lymphomas Leukemia Multiple myeloma Small cell lung cancer Germ cell tumors Extracranial disease allowed

PATIENT CHARACTERISTICS: Age: See Disease Characteristics Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 8 g/dL Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 50,000/mm3 Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior or concurrent radiotherapy to noncranial sites allowed Surgery: See Disease Characteristics
Dietary Acid Load and Oral Health Quality in Adolescents

This study investigates the link between dietary acid load and oral health-related quality of life in 374 high school students (226 females, 148 males). Participants completed a demographic questionnaire, the OHIP-14 scale, and provided 24-hour dietary recalls. Dietary acid load was assessed using PRAL and NEAP calculations. Data analysis was performed with SPSS 24 to explore the impact of diet composition on adolescents' oral health.

Introduction: Oral health plays a crucial role in the psychological and physical development of children and adolescents. The composition of the diet consumed significantly affects oral health.

Objective: This study aimed to examine the relationship between dietary acid load and oral health-related quality of life in adolescents.

Method: A total of 374 high school students (226 females, 148 males) participated in the study. Adolescents completed a demographic questionnaire and the Oral Health Impact Profile-14 (OHIP-14) scale, and 24-hour retrospective food consumption records were collected. Dietary acid load was assessed by calculating potential renal acid load (PRAL) and net endogenous acid production (NEAP) based on macronutrient and micronutrient intake from food records. Data analysis was conducted using the SPSS 24 software package.

Eligibility Criteria:
Inclusion Criteria:

* 14-18 ages

Exclusion Criteria:

* those with diagnosed eating disorders
* those with diagnosed psychiatric
* those with diagnosed cancer
What Makes People Better at Describing Photographs?

This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to provide verbal descriptions of photographs. Participants will perform a brief mental exercise, then see three photographs with instructions to describe each thoroughly. Participants will also complete several other surveys and measures. Collected data will give researchers a better understanding of how different variables relate to speech production.

This study is being conducted to learn more about how various personal and situational characteristics are related to the the ability to provide verbal descriptions of photographs. Adult participants ages 18-30 and 65-80 will participate in videoconference calls during which they perform a brief mental exercise, then see three photographs with instructions to describe each thoroughly. Descriptions are to be 30 to 60 seconds in length and are audio recorded for later scoring. Participants will also complete several other surveys and measures, including some about anxiety, mindfulness, vocabulary, and demographics. Participation will take approximately 40 to 60 minutes. Collected data will be de-identified, and the aggregate data will give researchers a better understanding of how individuals' personality and cognitive traits and the mental exercise performed before the study relate to peoples' speech production performance.

Eligibility Criteria:
Inclusion Criteria:

* fluent speakers of English
* ages 18-30 or ages 65-80

Exclusion Criteria:

* non-fluent speakers of English
* people who are not ages 18-30 or ages 65-80
Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies

The goal of this study is to determine if the use of calcium phosphate paste in mandibular lengthening surgery causes more complications as surgical site infections and hardware removal.

An evaluation will be made to determine if the benefits of the use of the paste (3D-stability, prevention of early relapse and unaesthetic indentation) outweighs the disadvantages.

The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies. Correction of distocclusion can be achieved through lengthening of the mandible, and a balanced facial appearance can be obtained by increasing chin projection.

Calcium phosphate paste is used in mandibular lengthening surgery to avoid an unaesthetic notching at the lower border(1)(2) and to help stabilize the segments when osteosynthesis slippage is feared for. A recently performed retrospective study showed an increase of infectious complications when calcium phosphate paste was used for this indications. Several precautions were identified that could be undertaken to decrease the infectious complications. The study concluded that a prospective study was required in which these precautions were implemented to determine whether infectious complications can be reduced.

The aim of this study is to investigate whether the hardened paste still increases the incidence of site infections after implementation of several precautions and the use of a standardized antibiotic prophylactic protocol.

Eligibility Criteria:
Inclusion Criteria:

* All patients with dysgnatic deformities requiring mandibular lengthening surgery
* Gender: M/F
* Age: \>15y-75y

Exclusion Criteria:

* Previous orthognathic surgery
* Congenital facial malformations
* Unilateral SSO
* Immunodeficiency
* Simultaneous removal of lower third molars
* Incomplete postoperative follow-up