cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Convective Prewarming System in Prevention of Perioperative Hypothermia

Although several measures for prevention of perioperative hypothermia have been introduced the last decades, perioperative hypothermia is still a frequent complication and associated with a negative outcome.

For not long lasting surgery without specific risk for hypothermia the standard procedure for prevention of perioperative hypothermia is insulation. However, the insulation is often not effective enough to prevent intra- and postoperative hypothermia. The implementation of a prewarming is difficult because of variable OR schedules and therefore not often applied.

In the planed prospective, multicenter, randomised-controlled trial will the efficacy of a convective prewarming system on prevention of intra- and perioperative hypothermia (Thermoflect™, TSCI, Amersfoort, NL) be compared to an intraoperative application of forced air warming with or without passive insulation before induction of anesthesia.

The studied prewarming device is easy to use and will be applied on the nursery ward 30-60 minutes before transfer of the patient to the OR.

Perioperative hypothermia is a common complication in general aesthesia. Perioperative hypothermia is associated with medical risks as intraoperative impaired coagulation due to reversible platelet dysfunction, a prolonged bleeding time and increased intraoperative blood loss. In the postoperative course the perioperative hypothermia is especially for patients with cardiopulmonary diseases a relevant problem. Not at least sensual cold and shivering is uncomfortable for the patient.

The study is conducted as a multicenter, prospective, randomised controlled trial. All patients will receive intraoperatively a forced air warming device (Termoflect™/Mistral Air ™). For one intervention group will additionally the insulation with the Thermoflect™ will be applied on nursery ward, the second intervention group will receive additionally a convective air warmer/ reflective blanket (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL) preoperatively on study day on nursery ward.

The aim of the study is to prove the hypothesis that a preoperative insulation with a commercial insulation material (Thermoflect™, TSCI, Amersfoort, NL) leads to a lower incidence of perioperative hypothermia in general anesthesia. The second hypothesis is, that an active prewarming (Thermoflect™ with Mistral Air™, TSCI, Amersfoort, NL) is associated with a more less incidence of periopative hypothermia.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years
* BMI from 20 to 30 kg/m2
* Risk class ASA I to III
* Scheduled time for surgery 30 to 120 minutes
* Scheduled anaesthesia with remifentanil, propofol, rocuronium and sevofluran
* Ability of informed consent

Exclusion Criteria:

* Adipositas permagna
* Risk class ASA IV to V
* Hypo- and Hyperthyroidism
* Febrile infection
* Pregnancy
* Scheduled time for surgery \< 30 or \> 120 minutes
* Known incompatibility for midazolam, remifentanil, propofol oder rocuronium
EMG Analysis in ABI: Motor Imagery and Action

This study focuses on electromyographic analysis of upper limb muscle activation in stroke survivors during Motor Imagery (MI) and Action Observation (AO) rehabilitation techniques. By measuring muscle activity in the wrist and finger flexors and extensors, the research seeks to understand the impact of MI and AO on motor function recovery post-stroke. Conducted at the University of Salamanca, the study involves stroke survivors participating in a series of three experimental sessions. The analysis will correlate electromyographic responses with functional independence, limb functionality, and cognitive factors. The research aims to contribute to the fields of occupational therapy and physiotherapy, offering insights into effective rehabilitation methods for improving quality of life in stroke survivors.

This study investigates muscle activation in the upper limbs of stroke survivors using electromyographic analysis during Motor Imagery (MI) and Action Observation (AO). Stroke, a major cause of disability, often results in motor impairments in the upper limb, impacting daily activities. The research focuses on innovative rehabilitation techniques based on neuroplasticity, such as MI and AO, stimulated by the discovery of mirror neurons.

The primary goal is to record upper limb muscle activation during MI and AO, using surface electromyography to measure activation in wrist and finger flexors and extensors. The study will also explore the relationship between electromyographic responses and factors like daily activity independence, limb functionality, quality of life, mental evocation ability, and cognitive impairment.

Conducted at the University of Salamanca, the study will recruit stroke survivors for a three-session experimental protocol involving control, MI, and AO conditions. Data will be analyzed with SPSS Statistics, ensuring anonymity and ethical compliance. The research aims to enhance understanding of effective neurorehabilitation techniques, contributing to the fields of occupational therapy and physiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age
* Diagnoses of established stroke
* Present limitations or motor response deficiencies in the upper limb
* Maintain cognitive functions with the ability to follow the instructions of the interventions and evaluations (MOCA\>14)

Exclusion Criteria:

* Diagnosed with mental illness before the stroke
* Other systemic conditions on the central nervous system
* Cardiorespiratory system pathologies in severe cases
* Acute period, fever, muscle inflammation or myopathies
* Any type of vascular and organic insufficiency
* Liver disease or skin lesions in the area of application of the electrodes.
Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions

The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen (\[Ga-68\]PSMA) for characterization of prostate abnormalities.

Individuals with clinical suspicion of prostate cancer and without prior prostate biopsy are offered abbreviated bi-parametric prostate MRI. As Standard of Care (SOC), MRIs will be examined and scored for likelihood for malignancy using the PI-RADS version 2.1 criteria. Those with PI-RADS 3, 4 or 5 lesions or those with PI-RADS 1 or 2 lesions with clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) will be included on study. Only those receiving care at University Hospitals Cleveland Medical Center will be included into the study.

This study is to evaluate (\[Ga-68\]PSMA) for characterization of prostate abnormalities. For imaging, an FDA approved imaging technology, digital Positron Emission Tomography (PET/CT) will be used. The study team would like to know if digital PET/CT using \[Ga-68\]PSMA provides accurate information whether or not a participant has prostate cancer and if there is potential spread of the disease within the body. \[Ga-68\]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen (PSA), which is overexpressed in prostate cancer. \[Ga-68\]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA). However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a clinical suspicion of prostate cancer defined by PI-RADS 3, 4 or 5 lesions detected on MRI as well as patients with negative prostate MRI or those with PI-RADS 1 or 2 lesions if they have continued suspicion for prostate cancer. Patients who cannot undergo MRI imaging but have a clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) can also be included.
* Able to tolerate PET/CT scans
* Informed consent must be given and signed

Exclusion Criteria:

* Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
* Known allergy against Ga-68 PSMA
* Prior prostate biopsy within the last 2 weeks
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device

The current available diagnostic methods used for the detection of COVID-19 takes up to 4 hours. In some cases, these diagnostics tests make take up to a couple of days. As it is highly contagious, people who are in close contact with the infected person are at high risk of being infected. COVID-19 is transmitted through respiratory droplets produced when an infected person coughs or sneezes. The desire for rapid detection of COVID-19 has become an immediate necessity. The purpose of Kaligia Biosciences' saliva monitoring device (RBA-2) is to detect the presence of the COVID-19 virus in human saliva. The RBA-2 uses Raman Spectros-copy to detect the coronavirus. Once the sample is scanned successfully, the spectra contains the response of the component present in human saliva and provide results in a matter of minutes, rather than hours or days.

The purpose of this study is to calibrate the performance of RBA-2 using people by comparing the results against a standard diagnostics test. The objective of this study is to collect non-invasive in vivo saliva from confirmed cases of both infected and non-infected COVID-19 patients or site staff at the testing site and compare the test results using the RBA-2 against the standard test results used for diagnosis.

The comparison of the results obtained from the current testing methods will be used to calibrate machine learning algorithms of the RBA-2.

Eligibility Criteria:
Inclusion Criteria:

Participants can be patients or staff members at the testing site.

Potential participants may be enrolled if:

1. They are identified as requiring a standard diagnostic test for COVID-19 or are being treated after testing positive for COVID-19;
2. They are age ≥ 18 years old;
3. They are willing and able to provide verbal informed consent.

Exclusion Criteria:

* Patients receiving active treatment with antivirals, chloroquine or immune modulators.
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea

The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone \& Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* dysmenorrhea associated with endometriosis

Exclusion Criteria:

* severe hepatopathy
* pregnant woman
Cognition and Obstructive Sleep Apnea in Parkinson's Disease, Effect of Positive Airway Pressure Therapy

Cognitive dysfunction (impaired memory, thinking, etc) frequently occurs in Parkinson's disease (PD), often progresses to dementia, and profoundly affects quality of life. Obstructive sleep apnea (OSA) is a common disorder in the general population that is treatable with positive airway pressure (PAP) therapy. It is known to impair cognitive function, but whether treatment improves cognitive function is less clear. When already affected by a degenerative process like PD, the brain might be more vulnerable to the effects of OSA, and more responsive to OSA treatment. To date, OSA has not been recognized as a significant factor in PD. In preliminary work in PD patients, the investigators have found an association between OSA and poor cognition, and cognitive improvement with PAP therapy. The investigators now wish to more rigorously evaluate the effect of OSA treatment on cognitive function in PD in a randomized controlled trial. The investigators primary objective is to assess, in PD patients with OSA and cognitive deficit, the effect of OSA treatment on global cognitive function. The investigators will also assess other non-motor symptoms of PD, quality of life, and specific domains of neurocognitive function. PD patients will be recruited from the McGill Movement Disorders Clinic and other Quebec Parkinson Network Centres. Participants will need to have evidence of cognitive deficit and presence of OSA on screening diagnostic polysomnography (sleep study). Ninety subjects will be randomly assigned to PAP or nasal dilator strips. Detailed neuropsychological testing and other measurements (including quality of life) will be done at baseline, 3 months and 6 months. At the end of the study period, subjects will have polysomnography on their respective treatment to assess efficacy with respect to OSA treatment. This study may demonstrate that a non-pharmacologic intervention has the potential to have a marked beneficial impact on cognitive function and quality of life in a significant proportion of PD patients.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease as perMDS criteria
* Evidence of cognitive dysfunction (clinical impression of mild cognitive impairment and MOCA \<=27)
* Presence of OSA (apnea-hypopnea index RDI ≥ 15/h) on screening diagnostic polysomnography (PSG)
* Stable regimen of anti-PD medication for 1 month prior
* Adequate knowledge of English or French for completion of study assessment.

Exclusion Criteria:

* Oxygen saturation \<75% for \>10% of the diagnostic polysomnography as this should lead to active PAP treatment
* Other major neurological disorder
* Unstable cardiac disease, uncontrolled hypertension, or diabetes
* Active cancer or other disorder with an expected survival \< 6 months
* Active treatment of OSA (prior diagnosis of OSA will constitute an exclusion criterion only if the patient is currently being treated for the OSA)
* Significant vision or hearing impairment that could affect performance on neurocognitive assessment tasks.
* Latex allergy.
Impact of Secondary Lymphedema on Symptoms, Functional Status, and Quality of Life After Treatment in Patients With Head and Neck Cancer

RATIONALE: Collecting information about the impact of lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This phase I trial is studying the effects of secondary lymphedema on symptoms, functional status, and quality of life after treatment in patients with head and neck cancer.

OBJECTIVES:

* To examine the association of secondary lymphedema, symptoms, functional status, and quality of life after treatment in patients with head and neck cancer.
* To examine the possible factors contributing to the development of secondary lymphedema in these patients.

OUTLINE: Participants undergo a physical and external (e.g., submental area) and internal (e.g., larynx, pharynx, and oral cavity) lymphedema examination. Demographics, background, and lymphedema treatment information are also collected. Participants' medical records with head and neck cancer information and treatment are reviewed.

Participants complete surveys on Vanderbilt Head and Neck Symptom (VHNSS), Lymphedema Symptom Intensity and Distress Survey Head and Neck (LSIDS-HN), Functional Assessment Cancer Therapy-Head Neck (FACT-HN), Quality of Life Scale, Hospital Anxiety and Depression Scale (HADS), and Body Image Scale.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with head and neck cancer
* At least 3 months since completion of head and neck cancer treatment
* Participating in the Pain and Symptom Management Program at the Vanderbilt-Ingram Cancer Center
* No current evidence of cancer
* No metastatic disease

PATIENT CHARACTERISTICS:

* No other active cancer
* Able to understand informed consent

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent chemotherapy or radiotherapy
Evaluating Acupuncture Points With Scanning Kelvin Probe

The purpose of this study is to characterize the surface electrical potential of acupuncture points with a Scanning Kelvin Probe.

Acupuncture points are anatomical structures described by traditional Chinese medicine. To this day, however, their scientific and Western anatomical characterizations remain unclear. Past studies have suggested that acupuncture points are distinct electrically (increased electrical conductivity). To evaluate this claim, this study uses a Scanning Kelvin Probe to study the electrical potential of three acupuncture points and their respective adjacent controls in 24 healthy individuals. The Scanning Kelvin Probe is a novel device that measures the electrical potential of skin without actually touching the skin surface.

Eligibility Criteria:
Inclusion Criteria:

* Individuals without chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc).

Exclusion Criteria:

* Individuals with autonomic disorders (sweating irregularities), skin disorders, extensive burns/scars on the hand, tremors, neuromuscular conditions, restless leg syndrome, movement disorders, and implanted cardiac defibrillator/pacemaker
Old School Hip Hop: Parent Follow-Up & Spanish Speakers Inclusion

These are the exploratory aims of the original trial cohort study "Old School Hip Hop RCT (AAAR5473)," which recruited 783 parents.

1. Continued follow-up of these families to learn more about the durability of the program through similar assessments to those used during the pre-specified 3-month initial study timeframe - aiming to understand participant knowledge and personal experiences with family members or friends affected by Alzheimer's Disease (AD).
2. Further examining the degree of comfort with dementia, as measured by a simplified version of the Dementia Attitudes Scale (DAS) focused on observable behaviors in children by their parents - aiming to understand the extent of stigmatization of dementia in communities served by this program, and if the trial impacted evidence of stigma.
3. Enrolling up to 75 parents who primarily spoke Spanish who were originally contacted in the RCT but were not eligible for completion of the original round of surveys given that all study materials were in English. This approach aims to better understand the impact of the program and Alzheimer disease on these families.

Hypothesis 1: For the delayed follow-up with parents, the investigator anticipates that those with high dementia literacy or the largest dementia literacy improvement would sustain knowledge over 15-month period.

Hypothesis 2: Children who received the intervention arm of the trial, who also have regular contact with a close friend or family member with dementia, will demonstrate positive dementia attitudes relative to students in the control arm.

Hypothesis 3: Semi-structured interviews with Spanish speaking families will help program capacity to better serve the population and improve involvement in AD care and research.

The goal of the R01 study is to educate children and thereby parents/guardians on health education content through live educators, music, and videos. The study curriculum focuses on healthy aging vs Dementia/Alzheimer's Disease (AD), nutrition, and overall health. The investigator wishes to learn if children are able to absorb these health topics and share what they learn with their parents/guardians. That part of the program has been completed with students. This non-R01 portion of the study is designed to look at the long-term effect of the program, how it may have affected Spanish speaking families that were not approached during the first portion.

Eligibility Criteria:
Inclusion Criteria:

* Parent that participated in the OSHH Trial
* Parent that expressed interest in participating, but originally excluded from OSHH Trial due to language barrier

Exclusion Criteria:

* Did not have a participating child in OSHH Trial
Long Term Follow up of Chronic HCV Patients Receiving DAAS

Follow up of Chronic hepatitis C Patients with moderate to severe fibrosis and cirrhosis treated with Direct Acting Antivirals after Sustained Virological Response for 4-5 years to detect changes in hepatic fibrosis and liver functions.

Treatment of chronic hepatitis C is evolving rapidly. Three classes of direct-acting antiviral agents, including inhibitors of the HCV NS3/4A protease, NS5B polymerase, and NS5A have been approved for the treatment of patients with chronic hepatitis C, both in combination with pegylated Interferon (Peg-IFN) / ribavirin (RBV) and, recently, in interferon-free combination.

The objective of chronic hepatitis C treatment is to achieve SVR which is defined as the absence of viral replication at 12 or 24 weeks after treatment completion. SVR reduces morbidity and mortality and is equivalent in most cases to cure the HCV infection. Studies have demonstrated that SVR is associated with histological improvement, assessed by liver biopsy, and with the prevention of complications, such as the development of liver cirrhosis and HCC.

Eligibility Criteria:
Inclusion Criteria:

* Chronic HCV patients with moderate to severe hepatic fibrosis (F2: F4) or cirrhosis who received direct-acting antivirals and achieved SVR.

Exclusion Criteria:

* Other liver diseases as Chronic hepatitis B and autoimmune liver disease. HIV co-infection.
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)

This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
* Confirmed PEI by historical Coefficient of fat Absorption \< 70% without supplementation or current or historical fecal elastase \< 50µg/stool (within the last 12 months)
* Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
* Clinically stable condition without evidence of acute respiratory disease or any other acute condition
* Stable body weight and agrees to abstain from sexual activity

Exclusion Criteria:

* Ileus or acute abdomen
* History of fibrosing colonopathy, celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome
* History of distal ileal obstruction syndrome within 6 months of enrollment
* Use of an immunosuppressive drug
* Any type of malignancy involving the digestive tract in the last 5 years
* Known infection with HIV
Prognosis Analysis of Elderly Donor Liver in Liver Transplantation

Based on the follow-up data of elderly donation after cardiac death(DCD) donor liver transplant recipients from the CLTR, a database and official website for national data gathering. patients who met the enrollment criteria were screened for postoperative complications and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

Since the Chinese organ donation system was developed in 2015, donation has been the only source of organs for transplantation in China. Adult patients (age 18 or older) who underwent LT using grafts from deceased donors between January 1st, 2015, and December 31st, 2018, were retrospectively identified using the CLTR, a database and official website for national data gathering. Based on the follow-up data of elderly DCD donor liver transplant recipients from the CLTR, a database and official website for national data gathering. patients who met the enrollment criteria were screened for postoperative complications and survival for statistical analysis to understand the prognosis of patients and analyze the risk factors affecting their prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Recipient age ≥ 18 years and \< 65 years.
2. Donor age ≥ 18 years.

Exclusion Criteria:

1. Recipient age \<18 years or ≥65 years.
2. Donor age \<18 years.
3. Patients who died within 30 days after transplantation.
4. Secondary liver transplantation.
5. Multiple organ transplantation.
6. Patients with incomplete data or failed follow-up.