cyrilzakka/clinical-trials huggingface dataset:
A Randomized Study to Evaluate FK962 in Subjects With Mild to Moderate Alzheimer's Disease

The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.


Eligibility Criteria:
Inclusion Criteria:

* Subject satisfies the criteria for the clinical diagnosis of probable AD
* Subject has a score =\< 4 on the Modified Hachinski Ischemia Scale at the screening visit

Exclusion Criteria:

* Subject has history or evidence of significant neurologic disease other than AD
* Subject has a history of stroke
* Subject has been treated for schizophrenia or recurrent mood disorder within the previous three years
* Subject has a hematologic or solid malignancy diagnosed within five years prior to study entry
* Subject has medically unstable COPD or asthma
* Subject has end stage CHF (NYHA Class III or IV) or unstable angina
* Subject has evidence of significant renal insufficiency
* Subject has insulin-dependent diabetes mellitus or HbA1C\>8.5% at screening
Evaluation of the Efficacy of Different Nebulization Techniques

COPD is the 3rd most common cause of death in the world, and the most common places of admission in our country with exacerbation of COPD are emergency services. β-2 agonists and/or short-acting anticholinergic drugs use is recommended in patients with COPD Salbutamol is known to cause significant improvement in dyspnea, quality of life and FEV1 in patients with COPD. Various techniques are used to administer drugs, one of which is the nebulization technique and is frequently used in emergency departments. There are limited clinical studies comparing different nebulization techniques, and the aim of this study is to compare the efficacy of Vibrating MESH nebulizer versus Jet nebulizers in a COPD exacerbation patient.

Patients who applied to the Emergency Department of Sultan Abdulhamid Han Training and Research Hospital with the complaint of shortness of breath and were diagnosed with COPD exacerbation according to the Gold Guidelines and to be treated with nebulization will be included in the study. Patients who agreed to participate in the study will be divided into two groups and assigned sequentially according to the simple randomization schedule.

Medication will be applied to one group with Jet nebulizers (Philips Respironics) and to the other group with Vibrating MESH nebulizer (Aerogen Ultra). Vital signs, IPI, spirometric measurements (FEV 1, FVC, FEV1 / FVC, FEF 50, FEF 2575), and dyspnea VAS score will be recorded at admission and re-measured after 1hour of treatment . In addition, single dose nebulization time will be measured and patient satisfaction will be measured with a 5-linkert scale. Demographic data will be recorded. The measurements will be recorded in the patient file and the groups will be coded so that the researcher evaluating the data will be blinded to the groups. The patient could not be blinded because of the different shape of devices.


Eligibility Criteria:
Inclusion Criteria:

* Acute exacerbation of COPD according to GOLD guidline,
* Being over 18 years old,
* Being able to read and to understand the spoken language and give consent.

Exclusion Criteria:

* Patients who need NIMW or intubation.
* Covid 19 or suspected patients
* cognitive disorders
Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.

The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB)
* Must be an outpatient who, following an acute exacerbation of schizophrenia, has been discharged from an inpatient psychiatric hospital within 60 days of screening
* Have a current diagnosis of schizophrenia
* Have available a designated individual who is likely to have knowledge of the subject's health status and who agrees to let the study site personnel know of changes in the patient's circumstances
* Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control

Exclusion Criteria:

* Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone
* Actively abusing intravenous drugs
* Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
* have an unstable medical illness
* Women who are pregnant or breast-feeding, or planning to become pregnant
* Have received injectable antipsychotic treatment within 2 injection cycles prior to screening
* Received treatment with clozapine within 3 months of screening
* Attempted suicide within 6 months before screening or are at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at time of screening
* homeless at time of stuyd consent
Use of Acupuncture In Children With Autistic Spectrum Disorder

This is a study of the efficacy of acupuncture in children with autism.

Autism Spectrum Disorder (ASD) or autism is a neurodevelopmental disorder with unknown etiology. ASD consisted of 3 core features: 1) disorder of language or communication; 2) disorder of social interaction; and 3) obsessive and stereotypic behavior.

Acupuncture had been practiced in China for over two millennia. In Traditional Chinese Acupuncture, nearly 400 acupoints on the body surface are interrelated to various functions. The approach in TCM, in sharp contrast to western medical concept, was a "holistic" approach with a philosophical background of balancing the "Yin-and-Yang". The main objective of TCM was to improve health of body and mind by deblocking the flow of "Qi" in the body. The pathophysiological basis of TCM aimed to improve "energy" or "body-flow" or "Qi" \["de-qui" in Chinese\]. The effect of acupuncture was had been proven in animal and human studies to be due to direct neural stimulation, changes in neurotransmitters such as endorphin, immunological markers or endocrinological signals. Thus, acupuncture is especially effective in chronic disorders, especially neurological ones.

As there is no TCM concept of mental retardation or autism, we propose that ASD is part of the spectrum of the TCM concept of the "Four Delayed Syndrome" in children with "delay in motor skills, speech, hair and teeth eruption" according to TCM concept. Thus, we approach ASD according to TCM concept as part of the lower intelligence due to imbalance of "Heart meridian and Kidney meridian" (i.e. yin-yang imbalance) resulting in communication problem and "Liver meridian" (yin-yang imbalance) leading to behavioral problems.

Our objective is to use a different approach in looking at ASD and to assess the efficacy of TCM model in improving the functional status of these children. Specific acupoints corresponding to various organs and meridians were used for ASD. The organ and meridian concept in TCM model has been as a fundamental basis to improve the behavior, cognition and communicative ability in children with ASD.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of ASD or autism was made according to the criteria of the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and Autism Diagnostic Interview-Revised (ADI-R).
* The diagnosis of autism was made if it satisfied a score greater than 30 in the Childhood Autism Rating Scale (CARS).

Exclusion Criteria:

* Children with associated neurological disorders such as Tuberous Sclerosis, Fragile X Syndrome and epilepsy.
Bone Marrow Sparing Image-Guided Radiation Therapy (RT) Incorporating Novel Use of GCSF and FDG-PET Imaging

This is a research study using Granulocyte Colony Stimulating Factor (GCSF) as a bone marrow stimulating agent for imaging to guide radiation treatment planning. G-CSF is a type of growth factor. Growth factors are proteins made in the body. G-CSF is a type of growth factor that makes the bone marrow produce white blood cells to reduce the risk of infection after some types of cancer treatment. GCSF is being given to stimulate the bone marrow to identify the active (blood cell producing regions) to better spare during pelvic radiation treatment planning.

This is a phase 1/2 study. The phase 1 is a dose finding portion of the study and phase 2 will enroll additional patients at the dose found in phase I. Patients in phase I and phase 2 will have the same treatment and follow-up.

Participants will undergo standard of care diagnostic imaging, complete blood count (CBC) with differential and chemistry labs initially. While receiving the GCSF, participants will have a CBC with differential checked a day after each dose and one day prior to first day of radiation. The treatment planning FDG PET/CT will be performed shortly after the GCSF. During chemoradiation, participants will have weekly CBC with differential checked and other labs as standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Gynecologic cancer patients receiving pelvic radiation and chemotherapy, specifically: 1) Stage I-IIIC1 cervix cancer, 2) stage I-III primary vaginal cancer, 3) stage IIIA-IIIC1 endometrial cancer patients status post hysterectomy and lymph node assessment, and 4) recurrent endometrial cancer patients with pelvic confined disease No required para-aortic or extended field radiation
* Age \> 18 years
* ECOG performance status 0-2
* Adequate kidney function (serum Cr \<1.5 or creatinine clearance \>50 mg/dl)
* Adequate bone marrow function (white blood cells \> 3.0 X 10\^9/L, platelets \>100 x 10\^9/L)
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Treatment for other cancer in the past 2 years
* Previous pelvic radiation
* Medical condition that prevents receiving chemotherapy
Leveraging the Emergency Department to Engage African American Women in HIV Pre-Exposure Prophylaxis

African American (AA) women are more vulnerable to HIV infection than other women. Truvada, when used as pre-exposure prophylaxis (PrEP), is one of the most effective approaches for HIV prevention; however, PrEP use among AA women remains low and has not responded to traditional interventions. This study proposes for the first time an innovative computer-based motivational intervention, increasing PrEP uptake (iPrEP), which couples motivational messages woven into a traditional survey to raise awareness of risky sex and substance use behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Current HIV negative status (based on ED' HIV test outcome)
* Condomless sex in the last 3 months
* Substance use in the last 3 months
* HIV testing during ED visit (usual care)
* Has a non-emergent health condition
* Has a working mobile device with them

Exclusion Criteria:

* Ineligible for PrEP (see eligibility criteria to the right)
* Assigned male at birth
* An HIV positive status
* Currently taking medication that are known contraindications for PrEP (brand name: Truvada)
* Currently on PrEP
Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist

The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.

The purpose of this cross-over study is to evaluate the clinical performance of the ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus on lens wearing comfort.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between 18 and 40 years of age (inclusive)
* Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
* Has had a self-reported visual exam in the last two years
* Is an adapted soft CL (Contact Lens) wearer
* Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so
* Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
* Has less than 0.75D (Diopters) spectacle cylinder in each eye.
* Is correctable to a visual acuity of 20/25 or better in both eyes
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Is willing to comply with the wear schedule (at least 40 hrs per week)
* Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has never worn contact lenses before.
* Currently wears rigid gas permeable contact lenses.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has a CL prescription outside the range of - 1.00 to -6.00D
* Has a spectacle cylinder greater than -0.50D of cylinder in either eye.
* Has best corrected spectacle distance vision worse then 20/25 in either eye.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars.
* Is aphakic.
* Is presbyopic.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
Sleep Quality, Stress Level and Heart Rate Variability of University Students

Purpose: This study aims to determine the impact of mindfulness-based stress reduction programs on sleep quality, stress level and heart rate variability of university students Design: The study was planned as an experimental study with a randomized control group, using pre-test, post-test and follow-up test.

Hypotheses:

H1: The sleep quality level scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to the students in the control group. H2: Students in the intervention group participating in the mindfulness-based stress reduction initiative will decrease their stress level level scores compared to the students in the control group. H3: The heart rate variability of the students in the intervention group participating in the mindfulness-based stress reduction initiative will be higher than the students in the control group.

H4: The sleep quality level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase compared to their pretest scores. H5: The stress level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores. H6: The heart rate variability level posttest and follow-up scores of the students in the intervention group participating in the mindfulness-based stress reduction initiative will increase according to their pretest scores.


Eligibility Criteria:
Inclusion Criteria:

* Being a student of the relevant faculty,
* No barriers to accessing technology for participation in the online program,
* No visual or hearing impairment

Exclusion Criteria:

* Not being a student of the relevant faculty,
* Having barriers to accessing technology for participation in the online program,
* Having visual or hearing impairment
Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence

Background of the study:

Fecal incontinence is a complex problem. The social consequences of this problem result in a lower quality of life. The exact prevalence of FI is unknown, literature reports vary from 13-19%. There are variable treatment options depending on the patient and the etiology of the FI. Dietary manipulation, pharmacological intervention, pelvic floor physiotherapy, as well as surgical interventions are currently used to treat FI.

A promising current treatment is Percutaneous Tibial Nerve Stimulation (PTNS). The nerves in the spine that control bowel function also have branches which go to the ankle. Stimulating these nerves in the ankle has shown to be an effective treatment for FI in the short-term. The treatment has been shown to be safe and well tolerated by subjects with almost no morbidity in prior urology trials.

Objective of the study:

The objective of this study is to show that the results of PTNS are based on the treatment of electrical stimulation and not on a placebo effect with a sham treatment.

Study design:

This study is a multicenter, single-blinded, randomized, placebo-controlled trial.

Primary study parameters/outcome of the study:

The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from baseline after 9 weeks of treatment.

Secondary study parameters/outcome of the study (if applicable):

Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI Score)

Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive Health Status Instrument (DHSI), and Fecal Incontinence Quality of life)

Subject's and Physician's Global Impression


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Must be at least 18 years of age
* Fecal incontinence with solid or liquid stool causing disruption of the subject's lifestyle
* Psychological stability as determined by treating physician
* Willingness to commit to a rigid follow-up schedule and comply with the investigational plan
* Failed conservative therapy (i.e. dietary and behavioural modification, biofeedback techniques and exercises for pelvic floor muscle retraining)
* During treatment the patient exhibits an adequate motor and/or sensory response (flexion of toe and/or twinkling sensation)
* Is able to read and write

Exclusion Criteria:

* Major internal and/or external sphincter defect (defined as \>33% of the anal circumference)
* Fecal impaction
* Pacemaker, implanted defibrillator
* Pregnancy or intention to become pregnant
* Neurogenic or congenital disorders resulting in FI
* Inability to travel to the clinic twice a week
A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study

This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study

This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study (A Phase 1/2a, First-in-Human, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Therapeutic Activity of Single Ascending Doses of KLS-2031 Administered by Transforaminal Epidural Injection in Patients with Neuropathic Pain from Lumbosacral Radiculopathy). Following the end of the Open-label Safety Extension Period of the KS-GIG-001-01 Study (Visit 14), patients will enter the Long-term Follow-up Period. These patients will continue to be monitored for AEs (including AEs of special interest) and serious AEs (SAEs) via phone call every 6 months and outpatient visits every 52 weeks (annually), over 3 years.

Eligibility Criteria:
Inclusion Criteria :

To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:

1. Patients that have completed the KS-GIG-001-01 Study and were in the Active Treatment group
2. Patients having signed the consent forms for both the KS-GIG-001-01 Study and this Long Term, 3-Year Follow-up Study

Exclusion Criteria :

To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below:

1. Enrollment in another AAV or other gene therapy trial
Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19

Patients with Coronavirus Disease (COVID-19) experience distressing and challenging to manage respiratory symptoms. Interventions such as Oxygen (O2) therapy, oral opiates, and traditional nebulizers like ipratropium bromide and salbutamol, are variably effective, and therapeutic responses in individual patients are difficult to predict. The purpose of this study is to investigate the efficacy of nebulized fentanyl citrate on dyspnea, cough, and throat pain in patients with COVID-19, as well as evaluate the safety with any potential adverse events.

In COVID-19, about 59% of patients will exhibit cough, 35% generalized body ache and sore throat and 31% will have dyspnea. Nebulized Lidocaine, magnesium, and opioids are alternative methods for the management of respiratory symptoms in various patients. Fentanyl nebulization was found to be effective in decreasing dyspnea in chronic obstructive pulmonary disease (COPD) patients by decreasing the rate of spontaneous respiratory rate, modulating cortical activity, and diminishing the brain stem chemoreceptor response to hypoxia and hypercarbia. The investigators hypothesize that nebulized fentanyl is superior to nebulized saline in suppressing cough, respiratory drive, improving breathlessness or dyspnea with the additional advantage of throat pain relief with minimal adverse effects in patients with COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 65 years
* Confirmed diagnosis (COVID-19) - positive PCR
* Tachypnoea (Respiratory rate\> 30/min)
* Ability to provide informed consent and perform all study procedures

Exclusion Criteria:

* History of allergy or adverse reaction to fentanyl or other opioids
* Pregnancy
* Active neuromuscular or musculoskeletal disease.
* Active malignancy
* Morbid obesity (Body mass index \>40)
* Use of opioids in the previous 4 weeks.
* Inability to provide informed consent and perform all study procedures.
Type 1 Diabetic Post Prandial Glycemia Evaluation Using an Algorithm

The aim of this study is to demonstrate the efficacy of an algorithm to anticipate the post prandial glycemic profile in type I diabetic patient.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* ≥ 18 years old
* Hb1Ac\<12%

Exclusion Criteria:

* Patient without continuous glucose monitoring system
* Disease other than diabetes (bulimia, anorexia...)
* Dialysis patient
* Known history of drug or alcohol abuse
* Patient under judicial protection
* Person deprived of liberty
* Pregnant, parturient or breastfeeding woman
* Patient in psychiatric care
* Patient admitted to a health or social institution for purposes other than research
* Any reasons that might interfere with the evaluation of the study objectives