cyrilzakka/clinical-trials huggingface dataset:
Focused Research On Neurofeedback Therapy In Eradicating Depression (FRONTIER)

This is an exploratory study to test the efficacy of a novel EEG neurofeedback method in depressed patients. The investigators will measure the change in depressive symptoms before and after the intervention of the novel EEG neurofeedback method using the Depression Rating Scale (primary endpoint). In addition, The investigators will measure the changes in brain activity before and after the intervention using fMRI, and compare the changes in depressive symptoms over the treatment period (secondary endpoint).


Eligibility Criteria:
Inclusion Criteria:

* 1. Adults (at least 18 years old at the time consent is obtained)
* 2. Major depressive episode as defined by the diagnostic criteria of the DSM 5
* 3. One of the following

  1. Hamilton Depression Rating Score (HDRS 17) of 19 or higher
  2. Montgomery Asberg Depression Rating Scale score of 20 or higher
  3. Any other patient deemed appropriate by the PI (subprincipal investigator)
* 4. With respect to taking antidepressants, any of the following

  1. not taking antidepressants
  2. If taking antidepressants, willingness to continue them for the duration of the program.
* 5. If receiving psychotherapy, agree to continue the same psychotherapy for the duration of study participation
* 6. Have treated by a psychiatrist
* 7. Written informed consent
* 8. No planned change in employment status after the study begins

Exclusion Criteria:

* 1. High risk of suicide, such as suicidal ideation or suicide attempts
* 2. History of hospitalization for depression or suicidal behavior
* 3. Comorbid addictions (drugs, alcohol) or history of addictions
* 4. Organic brain disease (e.g., moderate or severe intracranial organic lesions or neurodegenerative disease)
* 5. History of seizures or epilepsy
* 6. Has a serious or unstable physical disease
* 7. Difficulty or inappropriateness/contraindication to MRI imaging
* 8. Pregnant women or unwilling to practice contraception during the study
* 9. Participating in another clinical trial at the same time, or have participated in a clinical trial within the past 90 days, or are scheduled to participate in another clinical trial during the study period, and the principal (sub)investigator determines that participation in another clinical trial may interfere with the results of this study
* 10. Other cases in which the principal investigator (or subinvestigator) determines that it is difficult to conduct this study safely.
Peroneal Nerve Dysfunction in Epiphyseal Transfer

Assessment of peroneal nerve dysfunction after proximal fibular epiphyseal resection and evaluation of clinical outcome and EMG changes.

In children the preserved epiphysis of the proximal fibula ensure the exceptional ability to recover both joint function and longitudinal limb growth at the same time. Traumatic bone defect, congenital malformations, malignant bone lesions and infection are all current indications for VFET. The shape and size of the proximal fibular epiphysis aid in the gradual remodeling of the articular surface, allowing for better reconstruction and eventual rehabilitation over time.

Harvesting the proximal epiphysis of the fibula, along with its intact blood supply, is technically demanding, and the success of VFET is a primarily dependent on restoring adequate vascularity to the growth plate and diaphysis.

Anterior tibial artery is the primary and most consistent contributor to the proximal fibular epiphysis and proximal two thirds of diaphysis, it has intimate connection to the motor (deep) branch of peroneal nerve. The success of anterior tibial artery based VFET based on preserving the anterior tibial Vascular bundle, so it may be necessary to sacrifice some branches of peroneal nerve to tibialis anterior muscle. This is a significant flaw in the approach that could result in permanent peroneal nerve palsy.

Eligibility Criteria:
Inclusion Criteria:

* all patients candidate for epiphyseal transfer are included ( patients with traumatic bone defect, congenital malformations, malignant bone lesions and infection )

Exclusion Criteria:

* patients in which there's no injury of nerve supply of tibialis anterior has occurred intraoperative
Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery

This study aims to evaluate the efficacy and safety of applying pulse electrical stimulation around eye in dry eye disease patients who are scheduled for LASEK surgery.

Duration of study period (per participant): Screening period (0-14 days), Intervention period (12 weeks), F/U period (2 weeks) Patient needs to visit site at least 9 times (Screening, baseline, V1, V2, V3, Tele-visit, V4, V5, F/U Tele-visit). Baseline visit will be done on the day of surgery. Visit 1, 2, 3, Tele-visit, 4, 5, F/U Tele-visit is 1 day, 3 days, 1 weeks, 2 weeks, 4 weeks, 12 weeks and 16weeks after baseline visit.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 19 to 60 years of age, at the time of screening
* Those who are scheduled to get LASEK surgery
* According to the guidelines for diagnosing dry eye syndrome of Korean Corneal Disease Study Group, those who fall under Grade II or higher
* Those with an OSDI score of 13 or higher
* A person who has no pregnancy plan during the clinical trial period and has agreed to an effective contraceptive plan for Women of child bearing potential (WOCBP) by a doctor
* A person who voluntarily agreed to participate in this clinical trial

Exclusion Criteria:

Patients who meet any of the exclusion criteria are excluded from this clinical trial.

* A person with an uncontrollable systemic chronic disease (diabetes mellitus)
* Those who are allergic to drugs such as Fluorescein Solution or ophthalmic anesthetics
* In a case where there is a history of receiving ophthalmic surgery known to affect the tear layer within the last 6 months (e.g., Cataract, Pterygium surgery)
* A person who takes systemic drugs (e.g., tetracycline derivatives, antihistamine, isotretinoin)
* A person who has eyelid diseases or structural abnormalities
* A person with acute eye infection or inflammation of the eyeball not related to Meibomian gland dysfunction
* A person with abnormalities in the eyelids or eyelashes
* A person with an eye condition or ophthalmic disease that is considered unsuitable for surgery (e.g., detachment of the retina, cataract)
* Pregnant or lactating women
* Those who can't understand or read the consent form of this clinical trial (e.g., illiterate or foreigners)
* Any other cases that PI considers hard to participate in this clinical trial (e.g., heart-related problems, seizure, epilepsy. Patients transplanted metal or electronic device in head \& neck. Patient suffering from unknown pain. Patients who are warned not to use our clinical trial device or is prohibited from using it (e.g., pacemaker user).)
Myotonic Dystrophy Family Registry

The Myotonic Dystrophy Family Registry (MDFR) is an online, patient-entered database that collects information on myotonic dystrophy (DM) to aid researchers in developing new, effective treatments and help identify participants for research studies and clinical trials.

The Myotonic Dystrophy Family Registry (MDFR) is an online, patient-entered database that collects information on myotonic dystrophy (DM) such as disease symptoms and demographic information to aid researchers in developing new, effective treatments and help identify participants for research studies and clinical trials.

The Registry supports trials and studies, making it easier for researchers to explore data and identify possible trial and study participants. It is the first DM registry that gives community members the opportunity to explore anonymous Registry data, to see what the DM community looks like and what others with DM experience. It also provides information on the community of people living with DM, giving researchers and other medical professionals the opportunity to improve how they treat those affected with DM and learn more about how and why certain treatments work and don't work.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with congenital, juvenile-onset or adult onset DM1 or DM2 (confirmed by clinical exam or genetic test)

Exclusion Criteria:

* Not diagnosed with DM, unaffected family members
Can Ultrasound Replace Amniocentesis for Confirming Fetal Lung Maturation Among Premature Fetuses?

The purpose of this study is to measure prenatally with ultrasound the intratracheal flow volume displaced during breathing cycle in premature fetuses and to check whether a relationship exists between the inspired fluid and fetal lung maturation.


Eligibility Criteria:
Inclusion Criteria:

* Women delivering between 27 to 37 weeks.
* Women undergoing amniocentesis for determining fetal lung maturity between 27 to 37 weeks.

Exclusion Criteria:

* Major fetal malformation.
* Oligohydramnios or rupture of membranes diagnosed before 24 weeks of gestation.
Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress Levels in University Undergraduate Students.

The objective of this trial is to evaluate the efficacy of a heart rate variability biofeedback training protocol, compared to a guided meditation program and a control group, in reducing stress and anxiety levels among university undergraduate students.


Eligibility Criteria:
Inclusion Criteria:

1. Second- and third-year students of the Physiotherapy Degree at various universities in the province of Seville.
2. Enrolled in all courses for the academic year.
3. Enrolled in the courses for the first or second time.

Exclusion Criteria:

1. Having a job in addition to academic responsibilities.
2. Having a dependent family member under their care.
3. Diagnosed with any mental health issues.
4. Diagnosed with severe metabolic, cardiovascular, or respiratory conditions, or cancer.
5. Simultaneously pursuing another degree or a dual degree program.
Comparison of DNA Ploidy and Conventional Cytology

150 patients who had suspected pancreatic malignancy were planed to be enrolled in this study. Equal cytological samples of each patient undergoing EUS-FNA were examined by digital image analysis and conventional cytology respectively. The investigators aim to compare the efficacy of DIA and conventional cytology in diagnosing pancreatic cancer. Further more, the investigators also collected the blood sample of each enrolled patient for advanced study.

The conventional cytology was interpreted independently by two cytopathologists, both of whom are blinded to the DIA results. The conventional cytologic diagnosis were classified as no abnormal cells, atypical cells, suspicious malignant cells and malignant cells. The specimens were examined by two experienced cytopathologists. Any disagreement on specimens would refer to a third cytopathologist to provide a final consensus. The former two diagnosis were determined to be positive, and the latter two to be negative.

DIA is a form of cytologic analysis that quantifies cellular constituents by using spectro photometric principles and a sister technique to flow cytometry. Computer analysis of the pixels produces a digital image of the nucleus and other cellular constituents. Quantification of DNA content, chromatin distribution, and nuclear morphology can be determined and suggest features of malignancy. ThinPrep specimens were prepared as previously described.Per specimen, the DNA content of at least 500 cells was selected for quantification using an image analyzer (Landing Medical High-tech, Wuhan, Hubei, China) and the mean integrated optical density lymphocytes served as an internal standard control. All other histograms suggesting the presence of (1) any cells with DNA\>5c; (2) diploidy cells with a very high proliferation rate where 10% or more of the total cells were found in the proliferation fraction; and (3) a population of aneuploidy stem cells, were called positive for malignancy. Images of cells reporting a DNA amount greater than 5c were examined microscopically by a cytotechnologist to exclude any artifacts such as dust, air bubbles, overlapping cells, etc. from the \>5c cell galleries.

All the final diagnosis are to be confirmed by histopathology or a long term follow up.

Eligibility Criteria:
Inclusion Criteria:

1. who had known or suspected pancreatic malignancy and
2. in whom the endosonographer deemed the target lesion safe and feasible to allow the necessary study passes.

Exclusion Criteria:

1. not willing to sign informed consent,
2. cells obtained from FNA for DNA ploidy test less than 200, and/or
3. patients do not cooperate with follow-up.
Preoperative Melatonin to Decrease Analgesia Usage After Third Molar Surgery

The purpose of the study is to assess if melatonin given for three nights before wisdom tooth surgery decreases post-operative pain and pain medication consumption. Patients will receive either melatonin or a placebo for three nights prior to surgery and we will measure pre-operative anxiety, preoperative sleep quality, post op pain medication consumption, post op pain scores, and blood values.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction under IV sedation
* Ages 18-35
* ASA Class I or II
* English or Spanish speaking patients
* Capacity to sign informed consent

Exclusion Criteria:

* Allergies to melatonin, opioids, or other OTC pain medications
* Anyone currently taking melatonin for any reason
* Cases under local anesthesia
* ASA class III or higher
* Sleep disorder (insomnia/narcolepsy)
* Current or past history of substance abuse
* Chronic pain
* Language/communication barrier
* Psychiatric disease/ Mental impairment
* Current or past use of psychotropic drugs
* Pregnancy
* Renal or hepatic impairment
* BMI \>35
Adaptation of the One-session CBT Protocol for Prevention of Mental Illness for Brazilian Portuguese

1. Recruitment of medicine students of federal university.
2. Psychiatric interview (MINI) and sclaes application.
3. Protocol of CBT
4. Scales and MINI will be applied at the times of 7, 30 and 90 days after the end of the therapy.
5. Statistical analysis


Eligibility Criteria:
Inclusion Criteria:

* be medical student
* be over 18 years of age
* agree to the Term of Free and Informed Consent.

Exclusion Criteria:

* Students with psychotic illness, severe depression, manic episode or acute psychiatric risk.
Serious Game for Fibromyalgia Patients

Aim: To check the applicability of LitEmotion© in people with Fibromyalgia.

Design: randomized clinical trial, with pre, post and follow-up evaluation. Researchers and outcome evaluator blinded.

Method: The experimental group will play during three weeks to LitEmotion© videogame. The control group will not play.

The study will be a longitudinal-transversal research work with two groups. Findings will us prove the correlation between a right management of emotions and the perception of pain, daily life activities and quality of sleeping.

Sample will be selected by following strict rules; people with no requirements will be dismissed.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia diagnosed
* Referred pain during the last month

Exclusion Criteria:

-
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors

A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies

This study has 5 parts. Part 1 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 to estimate the maximum tolerated dose (MTD) and determine the dose recommended for Part 2. Part 2 of the study will further evaluate SBT6050 in select HER2 expressing or amplified advanced malignancies.

Part 3 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 in combination with pembrolizumab to estimate the MTD and determine the dose recommended for Part 4. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab in select HER2 expressing or amplified advanced malignancies.

Part 5 of the study will evaluate the safety, tolerability, and activity of SBT6050 in combination with cemiplimab in select HER2 expressing or amplified advanced malignancies.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) or amplified solid tumor
* Subjects must have received prior therapies known to confer clinical benefit (unless ineligible or refused to receive)
* Measurable disease per RECIST 1.1
* Tumor lesion amenable for biopsy or able to provide tissue from biopsy within last 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, hepatic, and cardiac function

Exclusion Criteria:

* History of allergic reactions to certain components of SBT6050 or similar drugs
* Untreated brain metastases
* Active autoimmune disease or a documented history of autoimmune disease or syndrome
* Human immunodeficiency virus infection, active hepatitis B infection or hepatitis C infection
* Additional protocol defined inclusion/exclusion criteria may apply.
A Single-Dose Study of LY3471851 in Healthy Participants

The main purpose of this study is to estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it when administered under the skin in healthy participants. The study will also evaluate the safety and tolerability of LY3471851. The study is expected to last up to 87 days for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males or females, as determined by medical history and physical examination.
* Body weight greater than 55 kilograms (kg) and body mass index (BMI) within the range of 19 to 30 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Have evidence of clinically significant active infection, including fever 100.5ºF (38ºC) or above, within 28 days of dosing or Day 1 (before dosing)
* Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. Examples include but are not limited to infections requiring intravenous antibiotics, hospitalization, or prolonged treatment
* Are immunocompromised per investigator judgment.
Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia

Homozygous familial hypercholesterolemia (HoFH) is characterized by a six- to eight-fold raise in plasma LDL-cholesterol (LDL-C) concentrations and atherosclerotic coronary artery disease usually occur before the age of 20 if untreated. Lipid apheresis (LA) has been proved to be a reliable method to decrease LDL-C concentrations and therefore decrease cardiovascular disease risk in HoFH. The objective of this crossover study was to compare efficacy of LA performed with heparin-induced extracorporeal LDL precipitation to dextran sulfate adsorption on the reduction of lipids, inflammatory markers, adhesion molecules and LDL particles size in a cohort of HoFH subjects.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65 years
* Subjects with homozygous familial hypercholesterolemia:
* Carrier of a mutation in the LDL receptor gene

Exclusion Criteria:

* Subjects with a previous history of cardiovascular disease
* Subjects with Type 2 diabetes
* Were pregnant or nursing;
* Subjects with a history of cancer
* Subjects with acute liver disease, hepatic dysfunction, or persistent elevations of serum transaminases
* Subjects with a secondary hyperlipidemia due to any cause
* History of alcohol or drug abuse within the past 2 years
* hormonal treatment
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
Study In Healthy Subjects To Evaluate The Changes In The Protein sAPP-Alpha In Cerebrospinal Fluid Following A Single Oral Dose Of PF-04995274

The primary purpose of the study is to evaluate the effect of PF-04995274 on cerebrospinal fluid levels of soluble Amyloid precursor protein fragments and Amyloid beta fragments following single oral dose in healthy volunteers. Safety and tolerability of PF-04995274 single dose administration in healthy volunteers will also be assessed as part of the objectives.

The purpose of the study is to evaluate the effect of PF-04995274 on CSF levels of s-APP and Abeta fragments following single oral dose in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Pregnant or nursing women; women of childbearing potential.