cyrilzakka/clinical-trials huggingface dataset:
Memantine Treatment for Improving Rehabilitation Outcomes and Preventing Depression in Older Adults

This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or cardiopulmonary condition.

Depression is a serious medical illness that is often difficult to diagnose and treat. It occurs in people of all ages, but is often overlooked in older adults. Depression frequently co-occurs with other serious illnesses, and may be mistaken by both patients and health care givers as a normal consequence of the illness. However, these misconceptions toward depression contribute to the underdiagnosis and undertreatment of depressive disorders in older people. In turn, depression may hinder a patient's recovery from an illness. This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or a cardiopulmonary condition.

This double-blind study will last for 12 months. Participants will be randomly assigned to receive either placebo or memantine, which is a drug that is often used to treat Alzheimer's disease. Both memantine and placebo will be administered to participants for 12 weeks. All participants will be followed for an additional 40 weeks. Outcome measurements will include participants' depressive symptoms, motivation, and learned helplessness. In addition, medication side effects, functional outcome, and incidence of major depressive disorder will be measured. All measurements will be taken at Week 12 and Month 12.

Eligibility Criteria:
Inclusion Criteria:

* Admission to a skilled nursing facility for rehabilitation within 3 months of recent disabling medical event (e.g., hip fracture)
* Medically stable (e.g., no active seizures, delirium, unstable pulse/blood pressure)

Exclusion Criteria:

* Aphasia or cognitive impairments sufficiently severe to prevent valid assessment (e.g., a score of less than 22 on the Mini Mental State Examination)
* Current major depressive episode
* History of or current psychosis or mania
* Current substance or alcohol abuse or dependence (within 3 months of study entry)
* Current use of memantine
* Sensitivity or contraindication to memantine
* End-stage kidney, liver, heart, or lung disease
* Recent hemorrhagic stroke
* A FIM score of greater than 70 (on a 91 point scale)
Locomotion and Global Positioning System in Arterial Disease

The maximal walking distance (MWD) performed on treadmill (TT) remains the gold standard in estimating the walking capacity of patients suffering from peripheral arterial disease (PAD) with intermittent claudication, although treadmills are not accessible to most physicians. We hypothesized that global positioning system (GPS) recordings could monitor community-based outdoor walking and provide valid information on walking capacity in PAD patients.

The study has two main objectives, conducted together. Each objective include several phases.

Objective 1: technical validation of GPS measurements in healthy subjects.

phase 1: technical validation of a GPS device to study outdoor walking (completed).

phase 2: comparison and use of various GPS devices (intra- and inter-GPS variability) in the study outdoor walking (on-going).

phase 3: study of several factors that could influence accuracy of GPS measurements as walking speed, environment, sampling frequency and others technical features as the WAAS/EGNOS function (on-going).

Objective 2: Application in PAD patients to study walking capacity under free-living conditions

phase 1: comparison of GPS measurements (maximal walking distance) with the gold standard treadmill measurement of maximal walking distance (completed).

phase 2: analysis of the variability of the walking capacity under free-living conditions from GPS measurements (completed).

phase 3: study of reliability and sensibility (effect of treatment) of GPS measurements (on-going).

phase 4: study of the relationship between laboratory measurements of walking capacity and GPS-derived parameters.

Eligibility Criteria:
Inclusion Criteria:

* Ankle to Brachial Index (ABI) \< 0.95 for PAD patients
* Age \> 18 years old
* Able to walk on treadmill

Exclusion Criteria:

* limb pain of potential non-vascular origin
* myocardial infraction in the last six months
* uncontrolled angina pectoris
DM1, Effects of Carbo-Counting on Glycemic Control

Carbohydrate counting is the most effective meal-planning strategy in type 1 diabetes (T1DM) to optimize insulin therapy. However, it may lead to weight gain and unhealthy eating habits. This study aims to compare glycemic control parameters, anthropometric measurements and dietary lifestyle in T1DM patients who practice CHO-counting, after attending a structured course to learn how to manage this tecnique, vs a control Group, in a follow up period of 2 years.

patients with type 1 DM will be enrolled in the study. patients in the intervention group will attend a 5-lessons training to learn how to manage insulin therapy depending on the amount of carbohydrates in their meals, patients in the control group will be follow according to the the standard care. after the follow up period glycometabolic, anthropometric parameters and dietary lifestyle changes will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes mellitus
* insulin therapy
* HbA1c from 5.5 to 10%

Exclusion Criteria:

* pregnancy
* celiac disease
* hepatic impairment
* chronic renal failure
Frequency of Gastrointestinal and Hepatic Manifestations Among Patients with Multiple Sclerosis, a Clinical Hospital Based Study

The aim of this work is to identify different pattern of Gastrointestinal and Hepatic symptoms and its Frequency among patients with Multiple Sclerosis

Historically, the routine evaluation of symptoms in MS patients focused on skeletal muscle impairments that restricted mobility. Within the last two decades, symptoms such as dysphagia, bladder and bowel dysfunction, among others, have been increasingly recognized and incorporated into patient assessments \[1-3\]. The GI problems felt to be most common in MS patients involve deglutition and defecation and require volitional muscle coordination. This association may link the development of such GI problems to underlying MS disease progression. However, GI symptoms that are not dependent upon skeletal muscle control are common in the general population and may also be present in MS patients. More than two decades ago, Hinds and colleagues described a high prevalence of anorectal dysfunction in a large cohort of MS patients \[4\]. Since then, the diagnostic and clinical approach to MS care has changed dramatically and now emphasizes the early introduction of disease modifying therapies \[5\]. However, despite changes in MS care, anorectal dysfunction and swallowing problems continue to be an important problem for MS patients . Little is known about other GI symptoms in MS patients in this new era of pervasive use of disease modifying therapies. To address this gap in knowledge, the investigators sought to define the prevalence of GI symptoms and syndromes in a large sample of contemporary MS patients

Eligibility Criteria:
Inclusion Criteria:

* 1- both sex 2- All patients diagnosed MS ( in recovery on DMT) according to the 2017-McDonalds criteria.

  3- Pt with MS suffer from git and hepatic symptoms not explained by known cause as Hepatitis virus،metabolic disorders as Wilson . hemochromatosis,etc Drug induced , Alcohol , Git symptoms as dysphagia, vomiting,reflux

  4- An informed consent will be obtained from all the patients, the study will be approved by ethical committee in faculty of Medicine Assiut University

Exclusion Criteria :1-patients already diagnosed with other GIT disorders before diagnosis of MS

2_ Presence of other disorder or on medications that may affect the neurological or GIT disorders.

3_ Patients failed to commit to the follow up visits and regular MRI scans 4_ Patients refused to sign the written informed consent Patients who will meet the inclusion and exclusion criteria will be assessed in the 1st visit by direct interview followed by clinical examination and neuropsychological assessments. Baseline MRI scans will be obtained at the first visit

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Evaluation of Dose-effect of a New Fermented Food in Healthy Adults

The aim of the study is to assess the safety and tolerance of a new fermented food versus a control product in healthy adults during the 4-week consumption period.


Eligibility Criteria:
Inclusion Criteria:

* Subjects after receiving a full description of the study, provide written informed consent to take part in the study.
* Free-living subject, as evaluated during the clinical examination.
* Male/female subjects aged between 18 to 55 years (bounds included).
* Subjects with a body mass index (BMI) between 18.5 ≤ BMI \< 30kg/m².
* Healthy subjects (as determined by a medical examination)

Exclusion Criteria:

* Subjects with any allergy (food, respiratory...).
* Subjects that have had any surgery or intervention requiring general anaesthesia in the last 4 weeks.
* Subjects with a history of chronic metabolic or gastrointestinal disease with the exception of appendectomy.
* Subjects with chronic or iatrogenic immunodeficiency (e.g. Chemotherapy, HIV).
* Subjects presenting a severe evolutive or chronic pathology (e.g. cancer,tuberculosis, Crohn's disease, cirrhosis, multiple sclerosis, Type I diabetes...).
* Subject with eating disorders.
* Subjects with cardiac, respiratory (including asthma) or renal insufficiency, cardiomyopathy, valvulopathy and medical history of rheumatic fever.
* Subjects with special medicated diet (for obesity, anorexia, metabolic pathology...).
* For female subjects: pregnancy, breast-feeding or not willing to use/not using an acceptable method of contraception
* Subject, in the Investigator's opinion, should not be randomised.
Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment

This study will enroll CML patients who have failed a first TKI stopping attempt. After failure and at least a year of TKI treatment, patients will proceed to dasatinib treatment for another 2 years. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL \>0.1% (IS)), TKI treatment will once again be restarted.

The DASTOP2 study aims to retreat patients who relapse in the Euro-SKI study (or who stopped TKI treatment outside trials but according to EURO-SKI procedures), with TKI for at least another 3 years, out of last two years with dasatinib. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL \>0.1% (IS)), TKI treatment will once again be restarted.

Patients exhibiting hematological relapse after first stop attempt will not be offered a second stop within this study. The same applies to patients in whom TKI was restarted prematurely (without loss of MMR).

Eligibility Criteria:
Inclusion Criteria:

1. CML in chronical phase (CP) under TKI treatment after failing a prior attempt to stop treatment within EURO-SKI or outside the study but according to EURO-SKI trial procedures. For the latter group this requires at least 3 years of TKI treatment (first line or second line due to intolerance to first line) before first stop, and MR4 for at least one year before stopping.
2. Treated with TKI for at least one year after having failed a prior attempt to stop TKI. Previous TKI can be any.
3. Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis or later during the disease course.
4. 18 years or older.

Exclusion Criteria:

1. Previous hematological relapse after first stop of TKI.
2. Previous AP/BC at any time in the history of the disease.
3. Restart of TKI without loss of MMR after first stop
4. Current participation in another clinical study.
5. Previous or planned allogeneic stem cell transplantation.
6. Patients with contra-indications to dasatinib therapy due to comorbidities.
7. Subjects with acute hepatitis B virus (HBV) infections.
8. Uncontrolled or significant cardiovascular disease.
9. Pulmonary arterial hypertension.
10. Pleural or pericardial effusions of any grade at study entry are excluded
11. History of significant bleeding disorder unrelated to CML
12. Hypersensitivity to dasatinib and excipients of dasatinib tablets.
The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.

A Randomized, Three Parallel Arms Clinical Trial to evaluate s the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site.

A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site by comparing the percentage of re-epithelization of the palatal donor site at 5, 10, 14 and 21 days using a standardized intraoral palatal photo.

The secondary objective is to compare the post op discomfort between the three groups during the healing period daily for 2 weeks using the Visual Analogue Scale (VAS) and Analgesic consumption.

All subjects from the University of Kentucky College of Dentistry clinics. Subjects that are coming increasing the width of keratinized tissue or for the treatment of gingival recession, and match the inclusion criteria will be told about the research and offered the opportunity to participate.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects between 18-65 years of age.
2. Subjects need FGG or de-epithelialized Connective tissue graft
3. Good oral hygiene (Plaque and bleeding indexes \<20%).
4. Subjects can withstand alginate impression or wear a retainer.
5. No other surgery or need for analgesics at the same site.

Exclusion Criteria:

1. Subjects with any systemic disorders that might compromise wound healing (Uncontrolled diabetes mellitus, rheumatoid arthritis, osteoporosis, chemotherapy/radiotherapy and immunological disorders).
2. Smokers
3. Patients not maintaining oral hygiene (plaque score \>20%)
4. Pregnant or breastfeeding females.
5. Inability to provide informed consent.
6. Grafts thickness more than 2mm will be excluded from the study.
Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC \[2.5/ 5µg and 5/ 5µg\] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC \[250/50µg and 500/50µg\] delivered by the Accuhaler® after 6 weeks of treatment.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease
2. Relatively stable airway obstruction with a post-bronchodilator 30% \</= Forced Expiratory Volume in 1 second (FEV1)\<80% of predicted normal and a post-bronchodilator FEV1/(Forced Vital Capacity)FVC \<70%
3. Male or female patients, 40 years of age or older
4. Smoking history of more than 10 pack years
5. Ability to perform technically acceptable pulmonary function tests and maintain records
6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI)

Exclusion criteria:

1. Significant disease other than COPD
2. COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.
3. Clinically relevant abnormal lab values
4. History of asthma
5. Diagnosis of thyrotoxicosis
6. Diagnosis of paroxysmal tachycardia
7. History of myocardial infarction
8. Unstable or life-threatening cardiac arrhythmia
9. Hospitalization for heart failure within the past year
10. Known active tuberculosis
11. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
12. History of life-threatening pulmonary obstruction
13. History of cystic fibrosis
14. Clinically evident bronchiectasis
15. History of significant alcohol or drug abuse
16. History of thoracotomy with pulmonary resection
17. oral or patch ß-adrenergics
18. Oral corticosteroid medication within 6 weeks prior to Visit 1
19. Regular use daytime oxygen therapy for more than one hour per day
20. Pulmonary rehabilitation program in the six weeks prior to the screening visit
21. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
22. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
23. Pregnant or nursing women
Reducing Wound Infections Using Bioelectric Wound Dressings

The purpose of this study is to compare the outcomes of using Bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation.

The standard of care for enhance recovery after surgery (ERAS) protocol uses chlorhexidine alcohol base prep as the way to clean the skin preoperatively to decrease bacterial flora before sterile prep at the OR.

Under ERAS protocol there is no recommendations on any post-operative dressing. Biolelectric wound dressing has been introduced, used and proof to decrease wound infection in orthopedic extremity clean surgery for years.

The purpose of this study is to compare the outcomes of using Bioelectric wound dressing on the pre-operative wound site and post operatively and compared it outcomes to the standard of care chlorhexidine skin preparation.

Eligibility Criteria:
Inclusion Criteria:

1. Elective diverticular, benign polyp, or colon cancer resection
2. Age 18-90 years old
3. All patients must receive some kind of bowel prep (SU- prep, pills, Go-Lytely, milk of magnesia, etc....)
4. Must be off antibiotics for more than 2 weeks before surgery
5. Surgery must be laparoscopic, hand assisted or Robotic
6. Skin will be closed in layers and subcuticular interrupted fashion
7. Just one dose of preoperative antibiotics (Invanz or equivalent if patient is allergic)
8. Patients will have a primary anastomosis, no colostomy.
9. Patient must be compliant with dressing care
10. Ability to provide informed consent

Exclusion Criteria:

1. Active infections before surgery -example: Intra-abdominal abscess not drained or actively on antibiotics on the day of surgery, skin infections
2. Inability to take intestinal bowel preparation
3. HgbA1c \>8
4. BMI \>40
5. Immunosuppression
6. Need of steroid stress dose pre-op
7. Patient receiving active chemotherapy
8. Need of stoma (end ostomies after resection protective stoma included)
9. Need of blood transfusion during surgery
10. Use of irrigation with antibiotics or IRRISEPTR during surgery
11. Any standard contraindication to anesthesia and/or surgery
12. Pregnancy or lactating women
13. Inability to provide informed consent
14. Inability to follow instructions for dressing care
15. Sensitivity or allergy to silver or zinc
Measuring Blood Flow in the Brain

This study will test a method of measuring brain blood flow called near infrared spectroscopy (NIRS). It will determine whether NIRS gives the same results as the more commonly used technique, functional magnetic resonance imaging (fMRI).

Healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Participants come to the NIH up to six times for experiments using NIRS and fMRI. They do the following tasks while they are undergoing NIRS or fMRI:

* looking at a computer monitor while a checkerboard pattern changes
* wiggling the toes and moving the fingers
* Reading words on a computer screen and pushing one button if they are plants and another if they are animals.

For NIRS, a frame is placed on the head and held it in place with a metal band. The frame holds sensors that contact the scalp.

For fMRI, the subject lies on a table that can slide in and out of an MRI scanner, a metal cylinder surrounded by a strong magnetic field. fMRI uses a strong magnetic field and radio waves to obtain images of the brain while the subject performs tasks. During the procedure, The subject wears earplugs to muffle the sound of loud knocking noises that occur during scanning.

OBJECTIVE: a) to explore the usefulness of Near Infrared Spectroscopy (NIRS) as a means of mapping brain activity, to see whether the results are similar to those of fMRI and b) to see whether spontaneous brain blood flow changes coincide with changes in behavior.

STUDY POPULATION: 50 healthy volunteers.

DESIGN: The study will look for correlations between NIRS and fMRI signal changes in the same subjects. It will also detect relationships between spontaneous blood flow shifts and shifts and changes in cognitive performance. Finally, NIRS will be combined with a frontal lobe activation task to see if blood flow changes can be detected over the hairless skin of the forehead in a simple, standardized manner that might yield a diagnostic test for frontal injury.

OUTCOME MEASURES: Graded changes in blood flow and oxygen, measured with NIRS and fMRI and variations in response time on a word task.

Eligibility Criteria:
* INCLUSION CRITERIA:

Age 18 to 60, inclusive.

EXCLUSION CRITERIA:

* Pregnancy.
* History of hypertension.
* History of any disease of the central nervous system.
* Current use of sedating medication, including antihistamines.
* Subjects with any of the following will be excluded from MRI testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing due to the possible dangerous effects of the MRI magnet upon metal objects in the body.