cyrilzakka/clinical-trials huggingface dataset:
Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)

The objective of this study is to evaluate the efficacy and safety of DHP1401 in patients with mild-moderate Alzheimer's disease treated with donepezil


Eligibility Criteria:
Inclusion Criteria:

1. ≥55 and ≤85 years of age
2. Patient who was diagnosed mild to moderate Alzheimer's disease by National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association(NINCDS-ADRDA) or National Institute on Aging-Alzheimer's Association(NIAAA)
3. Korean Mini-Mental State Examination(K-MMSE) score 15 to 26
4. Patient who maintained on donepezil without dose escalation or reduction for at least during 3 months before screening (visit 1)
5. Clinical Dementia Rating(CDR) score 0.5 to 2.0 at screening (visit 1)
6. Written informed consent voluntarily
7. Patient who has a relative/caregiver who support the information of patient's status
8. Patient who are deemed adequate to participate in the clinical trial by the investigator
9. Infertility or patients and his/her spouse consent with contraception during the study period

Exclusion Criteria:

1. A diagnosis of vascular dementia or dementia by other cause according to the criteria of the NINCDS-ADRDA
2. Structural brain abnormality or impairment
3. Schizophrenia, depressive disorder and bipolar disorder
4. Any neurological disease except Alzheimer' disease (ex. Parkinson's disease, Huntington's disease, brain tumor, normal-pressure hydrocephalus, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, epilepsy, delusion and head injury required hospitalization)
5. History of any cancer within previous 5 years
6. History of stroke within previous 2 years
7. Heart failure required medication or interventional treatment including myocardial infarction, valvular heart disease, arrhythmia within previous 1 year
8. Uncontrollable diabetes
9. Uncontrollable hypertension
10. Abnormal liver or kidney function
11. Patient with significant clinical meaning to affect cognitive function
12. Patient who participated in other clinical trial within previous 3 months or has a plan to participate in other clinical trial during study period
13. History of abuse of a drug or alcohol within previous 2 years
14. Patient who has administrated other acetylcholinesterase inhibitors except donepezil within previous 4 weeks
15. Patient who are deemed inadequate to participate in the clinical trial by the investigator(ex. a illiteracy, etc.)
16. History of hypersensitivity reaction to the main ingredient of the investigational drugs
17. Patient who has administrated other drugs except donepezil for dementia treatment (it is possible to enroll after washout for 28 days)
Impact of Virtual Reality on Pediatric Patients with ESRD on Regular Hemodialysis Through Arteriovenous Fistula.

This case control study will be conducted to study the effectiveness of Virtual Reality technique on pain during arteriovenous cannulation and on reduction of anxiety and depression in Pediatric Patients with ESRD undergoing regular hemodialysis through arteriovenous fistula.

This case control study will be conducted at nephrology and dialysis Unit Pediatric Department Tanta University Hospital (TUH) for a period of 6 months starting from April 2024.This study will be conducted on convenient sample of 60 participants. they will be classified as follow group A (cases) Group B (controls)each group will contain 30 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly at our nephrology Unit at TUH during the period of the study

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with end stage renal disease aged from 8 to 18 years on regular hemodialysis through functioning arteriovenous fistula and are fully oriented with time, persons and place at time of data collection. All participants either cases or controls suffer from anxiety, depression or both.

Exclusion Criteria:

* Children with temporary or permanent catheter for dialysis.
* Children with mental illness, visual and auditory defects.
* Children took any pharmacological pain reliever or antipsychotic drugs.
* Non anxious or depressed Children.
An Evaluation of Kinerase Pro+Therapy Regimen Vs. Kinerase Vs. Control for the Treatment of Skin Aging

The purpose of this study is to compare the efficacy of the Kinerase Pro+Therapy regimen versus a single Kinerase product vs. control for the treatment of the signs of skin aging.


Eligibility Criteria:
Inclusion Criteria:

* Female patients 35-55 years of age with at least moderate signs of facial aging
* Written informed consent
* Likely to complete all study visits and follow study protocol

Exclusion Criteria:

* Any dermatological or medical condition which would make patient participation unsafe or interfere with study outcomes or measurements
* Known hypersensitivity to any study product or their components
* Recent (within 4 weeks of baseline) surgical treatment to face (including IPL and other laser procedures)
* Prior use of anti-aging treatments for 30 days prior to study entry (physician dispensed or prescribed treatments)
* Planned facial procedures during the study (microdermabrasion, facials, etc)

  o Botox and fillers cannot be used during the trial or for 3 months prior to study entry
* Recent (within 60 days) or concurrent participation in another clinical trial
* Concomitant topical or systemic therapy that my interfere with study measurements or outcomes
* Use of any other topical photoaging/antiaging therapies during the study, other than the prescribed study regimens
* Patients who are habitual tanners (outdoors or with tanning beds) who plan on tanning during the study
* Wearing of cosmetics during study visits
Influence of Physical Exercise on Semen Quality

Our study addresses a previously selected population or by physical activity but not for semen quality semen donor candidates donation program within the clinic.

Total physical activity was analyzed according to the universally accepted international physical activity questionnaire (IPAQ) The existence of confounding factors associated She purge age, snuff, weight, BMI, alcohol, drugs, type of sport and associated blood parameters determinations will be made to exercise.

The level of physical activity recommended great unknown and its influence from the therapeutic point of view to improve semen quality.

For it will be held:

* 3 groups of physical activity are established, according to their score in the IPAQ: High, minimum of physical activity between \> 1500 MET week Moderate: minimum of physical activity of between 600- 1500 MET week Low : until \< 600 MET week
* Implementation of a double analysis: Seminal and hormonal
* Standardization of confounding factors associated with the individual

Eligibility Criteria:
Inclusion Criteria:

* Appear as sperm donor
* Age between 18-35 years
* First sperm donation
* Sexual abstinence 3-5 days
* Having signed informed consent

Exclusion Criteria:

-
ICBT for Anxiety and Depressive Symptoms in Brazilian Young Adults

This study aims to investigate the effects of a selfguided internet-based cognitive behavioral therapy (ICBT) program on depressive and anxiety symptoms in young Brazilian adults. Treatment group will be compared to a waiting list control group. Participants will be recruited in Brazil with a nationwide recruitment.

This is a randomized controlled trial carried out to evaluate the effects of an internet-based cognitive behavioral program for depressive and anxiety symptoms in young Brazilians adults. The program consists of 8 weeks of treatment and is carried out through an online platform. During treatment, participants have the support of a therapist who can be reached on demand via the platform\&#39;s text messaging channel. The program was adapted to Brazilian culture from previous work.

Eligibility Criteria:
Inclusion Criteria:

* (1) age between 18 and 24 years old; (2) have a device with Internet access that allows access to the platform; (3) speak and read Brazilian Portuguese.

Exclusion Criteria:

* (1) having a severe psychiatric diagnosis such as bipolar disorder and schizophrenia; (2) having severe suicidal ideation or reported suicidal intent; (3) reporting substance abuse; (4) being in an ongoing psychological and/or psychiatric treatment; (5) changing psychiatric medication less than 3 months before the treatment starts; (6) scoring extremely severe on all three subscales of DASS-21 (28+ for depression, 20+ for anxiety and 34+ for stress.
Efficacy of Chronoterapy in Oral Surgery

Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Recently, it is seen that circadian rhythm may play an important role on drugs metabolism, modulating its effect depending on the moment of administration. The aim of the study is to analyze if dosage modification of a Non Steroideal Anti-Inflammatory (ibuprofen) affects on postoperative pain, swelling and open mouth limitation comparing to the normal dosage.

A randomized crossover split-mouth clinical trial will be performed. After third molar extractions, patients will be prescribed ramdomly in one side wit the normal medication dosage while the contralateral side will be prescribed a modified dosage. Moreover, a blood sample will be obtained to analize the inflammatory profile.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35 years old
* Bilateral retained lower third molar

Exclusion Criteria:

* NSAID allergic
* Contraindication for surgical removal of third molar
Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease

The purpose of this study is to improve the investigators understanding of the relationship between Crohn's disease and blood levels of the drug infliximab (Remicade). The investigators want to determine whether measuring drug levels can be helpful in understanding how patients respond to this treatment.

The efficacy of infliximab to maintain remission in Crohn's disease has been confirmed by randomized, controlled trials, however the utility of serum infliximab and ATI titers is less clearly described in the clinical practice setting to manage dose and interval levels.

The primary objective of this study is to evaluate the clinical responsiveness of active (HBI \>10) Crohn's disease to infliximab as it relates to serum infliximab levels. Though the assay for an infliximab level is commercially available, current dosing practices rely on the assessment of clinical data (laboratory data, symptoms, colonoscopy, etc). In order to understand this relationship, serum infliximab and ATI titers will be collected over the course of 8 (approximately 1 year) infusions. The results of these levels will be retrospectively correlated to the patient's clinical response to treatment.

The secondary objective is to identify predictors of poor response to infliximab by evaluating the efficacy of a dose escalation strategy in patients classified as primary or secondary non-responders.

Understanding the association of serum infliximab levels to disease response may be a useful objective tool to optimize and individualize dosing amount and frequency especially in patients with incomplete or loss of response to therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active (HBI \>10) refractory inflammatory and/or perianal fistulizing Crohn's disease who are prescribed infliximab as standard of care by their gastroenterologist.

Exclusion Criteria:

* Pregnant women.
A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)

The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.

This is an observational study, where the BEAR Implant will be evaluated in a real-world setting. The registry seeks to enroll consecutive uses of the BEAR Implant at participating sites. There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. A retrospective cohort will be available for all subjects treated with a BEAR Implant at each participating site. There is no control group.

Eligibility Criteria:
Inclusion Criteria for Prospective Cohort:

1. Scheduled to undergo ACL surgery with the BEAR Implant
2. Willing and able to provide informed consent
3. Willing and able to complete required follow-up visits and assessments

Inclusion Criteria for Retrospective Cohort:

1. Underwent ACL surgery with the BEAR Implant

Exclusion Criteria:

1. The subject is participating in another ACL trial or any other clinical trial where the study procedure or treatment might confound the study end point
2. Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling
Early Postoperative Pain and 30-day Complications Following Major Abdominal Surgery: an Observational Study

In this retrospective cohort study, we assess the relationship between the intensity of early postoperative pain and the risk of infectious- and non-infectious complications within 30 days after major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Major abdominal surgery under general anesthesia

Exclusion Criteria:

* younger than 18 years of age
* procedures outside the operation room
* procedures solely under regional anesthesia, i.e. no general anesthesia
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot

A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.

The purpose of the Revo-M Study is to characterize differences in performance and patient reported outcomes between the Revo investigational prosthetic foot and a comparative prosthetic foot (Taleo or Proflex XC) when compared to the control foot which is the subject's currently used energy storage and return (ESR) prosthetic foot. The data obtained from this study may also serve to determine the long-term performance of Revo.

Eligibility Criteria:
Inclusion Criteria:

1. Person is 18 years or older.
2. Currently uses an energy storage and return foot.
3. Person has been a unilateral transfemoral (TF), or transtibial (TT) amputee using a prosthesis for at least 1 year.
4. For TF amputees, the person must be wearing an Ottobock Microprocessor-controlled Knee (MPK) with a compatible prosthetic foot
5. Person weighs ≤ 275 lbs (125 kg) size 26-27cm or ≤ 220 lbs (100 kg) size 24-25cm
6. Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL).
7. Prosthetic foot size is 24 to 27 centimeters.
8. Socket Comfort Score of at least 7
9. Ability to read and understand English
10. A person is able and willing to give consent

Exclusion Criteria:

1. Current prosthetic foot is too old or worn out as assessed by the CPO.
2. TT subject with currently fit with a Proflex XC or TF subject currently fit with a Taleo.
3. Patient is pregnant or planning to become pregnant.
4. Person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease).
5. Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking, problems with vestibular system, etc.).
6. Ulceration or skin breakdown of the residual limb.
7. Person currently has residual limb issues that significantly reduce their ability to load the prosthesis.
SNAPS Breast Cancer Patient Study Breast Cancer Patients

Differential immunogenomic signatures from peripheral blood CD14 (phagocytic) and CD2 (non-phagocytic) cells have been associated with multiple cancers and disease states. In particular several large clinical studies at Immunis.AI have demonstrated robust immunogenomic signatures in early-stage prostate cancer. Immunis.AI therefore hypothesizes that a peripheral blood immunogenomic signature will identify patients with various stages of breast cancer from healthy negative controls.

Efficient next generation RNA sequencing platforms have allowed for whole genome expression profiling of individual populations of immune cells as a novel means of searching for patterns of gene expression to aid in the identification of meaningful signals unique to various disease states. Single cell sequencing techniques have provided additional information useful in deconvolution strategies applied to model development on purified populations of immune cells. Recent interest in peripheral leukocyte subset gene expression profiles suggests that diagnostic information for many disorders may be contained therein. Mononuclear phagocytic cells including the various CD14+ subsets have been studied extensively in various disease states including some solid tumors. Previous large clinical studies at Immunis.AI have determined that transcriptomic profiles of CD14+ cell populations subtraction normalized from CD2+ cell populations were associated with aggressive disease phenotypes such as prostate cancer. Tumor heterogeneity, multifocality, and oligoclonality have been a significant barrier to development of meaningful tissue based multigene signatures for predicting cancer biologic behavior. The findings at Immunis.AI strongly suggest that analysis of RNA expression data from the body's immune surveillance cells has the potential to summarize the entire heterogeneous tumor. The investigators believe that the CD14/CD2 log ratio can be understood as a subtraction normalization of gene expression which yields superior signal of early-stage cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 yrs of age.
* Patients diagnosed with stage I-IV breast cancer, who have not begun definitive therapy.
* Patients undergoing screening mammograms for breast cancer.

Exclusion Criteria:

* Patients with a history of a different cancer within the previous 3 years (except non melanoma skin cancer).
* Any prior treatment (surgery, chemo, hormonal, radiation, biologics, etc.) for current cancer.
* Any biopsy which resulted in the entire tumor tissue being removed.
* History of previous breast cancer.
* Patients unable to provide informed consent.
* Patients with an abnormal screening mammogram.
* Patients whose hormone receptor and/or HER2 status are not available.
Impact of the COVID-19 Pandemic on Vaccination

The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health.

Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP.

Two vaccines are recommended for person at risk of infection according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious in patients with chronic diseases (diabetes, cardiac insufficiency..) compared to the general population.

The vaccination coverage rate of at-risk populations is dramatically below the vaccination coverage targets set by the Ministry of Health. Indeed, there are many barriers to vaccination, medical and para-medical barriers, but also individual barriers.

The current COVID-19 pandemic has identified people at risk of severe infection and death risk, particularly those with co-morbidities (diabetes, cardiovascular disease, etc.). Thus, this pandemic may have contributed to change in patients' perceptions regarding both the risk of infection and the potential interest and benefit of vaccination.


Eligibility Criteria:
Inclusion criteria:

* Person at risk of infection according to french 2019 immunization schedule
* Patients aged above 18 years old

Exclusion criteria:

- Patient \< 18 years
Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone

The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future.

We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption.

Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.

The drug Lupron, will temporarily turn off the body's production of testosterone after two weeks. At that point, we will administer testosterone by mouth on six days in the next two weeks to see how much is absorbed and present in the bloodstream after administration. The day Lupron is given, and for 24 days after that, subjects will take the second medication, Dutasteride, which alters testosterone breakdown in the body. Fifteen days after the Lupron shot, subjects will take the first formulation of testosterone by mouth and undergo blood draws to see how much of this testosterone makes it into the blood stream and how long it lasts. The next day(Day 2) subjects will take a larger dose of testosterone and undergo blood draws. On study day 3, subjects will again take the larger dose of testosterone, this time with a meal and undergo blood draws. During the 2nd week of the study, subjects will repeat the testosterone doses, with a 2nd formulation of testosterone. The first two doses of testosterone each week will be taken on an empty stomach, while the third will be taken with breakfast. Please note that six study days: 1,2,3,8,9 and 10 will require repeated blood draws over a 12 hour period.

Eligibility Criteria:
Inclusion Criteria:

* Male 18-50 yrs old
* In good general health based on normal screening evaluation (consisting of medical history, physical exam, normal serum chemistry, hematology, and baseline hormone levels)

Exclusion Criteria:

* Poor general health, with abnormal blood results at screening
* A known history of alcohol or drug abuse
* Participation in a long-term male contraceptive study within three months of screening