cyrilzakka/clinical-trials huggingface dataset:
Fractures in the Elderly Population of El Salvador at Hospital Zacamil: Exploring Knowledge, Causes, Risk Factors, and Outcomes

As the population's life expectancy increases, fractures among the elderly in El Salvador are also increasing. There is currently limited data specific to the incidence and cause of fractures in the elderly within developing countries, such as El Salvador. The problem of inadequate knowledge pertaining to bone health and osteoporosis among the elderly is contributing to this aging population's health issues. The purpose of this study is to investigate the incidence, prevalence, and risk factors effecting elderly patients admitted for fractures at the Hospital Zacamil in San Salvador, El Salvador. The study will also assess the current knowledge in two distinct populations on bone health and osteoporosis. The first population will be the patients over the age of 45 that present to Hospital Zacamil with acute fractures and are consulted by the department of orthopedics. The second population will consist of students at the Evangelical University over the age of 18 in non-medial track studies. All individuals will have to accept the invitation to participate in the study. In addition, educational materials will be developed on the prevention of fractures for medical professionals and for the elderly in El Salvador. The study objectives will determine incidence and prevalence of elderly fractures of patients over the age of 45 at Hospital Zacamil. Secondly, the study will look at demographic information, prevalent causes of fractures, treatment of the fractures, morbidity and mortality, and any complications that may arise in the fracture patients prior to their discharge from the hospital. Thirdly, the study will seek out the current level of knowledge on bone health, osteoporosis, and fracture prevention in the young, educated Salvadorians and patients over the age of 45 at Hospital Zacamil. Fourthly, the study will address the benefits of the information gained by use of educational materials with the patients and doctors of El Salvador.

Hypothesis One:

Fractures of the elderly at Hospital Zacamil are significantly associated with occurring at the hip, wrist, and vertebra in comparison to other fracture locations.


Eligibility Criteria:
Inclusion Criteria:

* For the student population they must be over the age of 18 and a student in non-medical track studies.
* For the patient population they must be over the age of 45 and present to Hospital Zacamil with an acute fracture.

Exclusion Criteria:

* Not accepting the invitation to participate.
Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis

People who have Sickle Cell Anemia (HbSS) produce red blood cells with shorter lifespans. These red blood cells breakdown faster, and this is called hemolysis. When red blood cells breakdown, a tiny amount of Carbon Monoxide (CO) is released into the blood and is eliminated in exhaled breath. This research study will use a device called CoSense™, which will measure Carbon Monoxide (CO) levels in breath. The purpose of the study is to see how well the device measures the CO levels that an individual breathes out.

Subjects diagnosed with homozygous sickle cell anemia (Hb SS) have red blood cells with a decreased lifespan, which leads to an increase in the rate of heme turnover. Carbon monoxide (CO) is a by-product of heme oxidation and is excreted in exhaled breath. The concentration of CO in end-tidal breath can be measured and used to indicate the rate of heme oxidation, bilirubin production and the presence of hemolysis. The objective of this study is to characterize the performance of CoSense™ in children with or without sickle cell anemia. This is a single-center, open-label, non-randomized, proof of concept study to characterize the ability of CoSense™ to assess ETCO levels in subjects with a diagnosis of sickle cell anemia (Hb SS). Up to 40 children (5-14 years old), of which 20 participants will have a diagnosis of Hb SS, will be enrolled. Each participant will have two breath samples collected non-invasively, one immediately after the other. It takes approximately 120 seconds to collect the each breath sample. This study and investigational device are a non-significant risk to the patient. The nasal cannula is made of a biocompatibility-tested polyvinyl chloride (PVC) material with a soft open-end, and will be gently placed adjacent to one of the nostrils and partially inserted by approximately 5 mm. The objective of this study will be assessed through reproducibility of ETCO measurements and comparison of ETCO levels between children diagnosed with Hb SS and healthy children. The study would help in the development of a portable CO measurement device which has potential health applications in monitoring diseases with altered bilirubin metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Parental / legal guardian consent
* Subject assent for participants ages 7 and above
* Male and female children ages 5 - 14 years old
* For Hb SS subjects, hemoglobin ≤ 10 g/dL (based on a laboratory tests performed over the last 6 months and confirmed within 4 weeks prior to breath collection, as part of the subject's clinical care)

Exclusion Criteria:

* For healthy subjects, known to have the sickle cell trait
* Had a red blood cell transfusion within 12 weeks prior to enrollment
* Currently a primary smoker or was a primary smoker within 4 weeks prior to enrollment
* Exposed to second hand smoke within 24 hours prior to breath sample collections
* Have an upper respiratory infection within 2 weeks of ETCO measurements
Promoting Cancer Symptom Management in Older Adults

The purpose of the project is to estimate the effect size of a technology based intervention for older adults with cancer for nausea and vomiting. Participants will be randomized to either an intervention or a wait control group. Outcomes such as symptom severity, quality of life and resource use will be examined.

The goal of this study is to increase the self-management behaviors for chemotherapy induced nausea and vomiting (CINV) and reduce treatment-related negative outcomes in older adults with cancer. CINV is a common reason for unplanned emergency department and/or hospital admissions in older adults with cancer. Early reinforcement of standard education and reframing preconceived beliefs about the potential serious consequences of CINV and the symptoms ability to be successfully managed will increase effective self-management behaviors and improve patient outcomes

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 65 and older
* newly diagnosed with any cancer
* treatment with any chemotherapeutic agent with a moderate to severe emetic potential (on a 3- or 4- week cycle)
* proficient in English
* have a telephone.

Exclusion Criteria:

* Patients with previous diagnosis and treatment for cancer
* advanced or end stage disease with a palliative intent
* visually or hearing impaired.
Effects of Physical-Cognitive Training With Different Task Models in Parkinson's Disease With Mild Cognitive Impairment

The present study will characterize exercise model effects (integrated model vs. consecutive model) of physical-cognitive exercise on dual-task walking control in Parkinson's disease with mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of idiopathic Parkinson's disease
* have decreased cognitive functions but do not interfere with functional independence
* Montreal Cognitive Assessment (MoCA): 21-25
* able to walk independently without walking devices for at least 10 meters and with the ability to turn 180°

Exclusion Criteria:

* a diagnosis of dementia
* other diseases that may influence cognitive functions or walking performance
* a history of brain surgery
* modification of the medication during the exercise intervention
Combined Effects of Virtual Reality and Motor Imagery Techniques With Routine Physical Therapy in Post Stroke Patients

Stroke a devastating neurological condition, causing severe neurological challenges such as balance issues, motor function and cognitive deficits among survivors and can cause disability and death. The use of Virtual Reality and Motor Imagery in rehabilitation of neurologic disorders is on the rise. In stroke patients, VR and MI combination has not been studied. This study aims to investigate the combined effects of Virtual Reality and Motor Imagery Techniques with Routine Physical Therapy in patients with post stroke patients.

This randomized control trial will be conducted at Safi Hospital Faisalabad in 7 months after the approval of synopsis, involving a sample size of 75 participants selected through convenience sampling based on the inclusion criteria. Participants will be randomly assigned to three groups using lottery method, in which Group A, will receive Virtual Reality and Motor Imagery training in conjunction with routine physical therapy three days a week for 12 weeks. Group B will receive VR and routine physical therapy, supplemented by 10-15 minutes of cycling and walking and Group C will receive routine physical therapy with MI techniques, along with 10-15 minutes of cycling and walking.

Fugal-Meyer Scale will be used to motor function, Berg Balance Scale for balance and Barthel Index will be used to assess activities of daily living. Assessment will be carried out at baseline, 6th week, 8th week and at 12th week and at 16th week after the discontinuation of treatment. The data will be entered and analyzed by using SPSS 26

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of stroke of any etiology
2. Age between 40 to 65 years
3. Both genders
4. At least 6 months post-stroke onset
5. Able to follow and understand visual and verbal commands.
6. Hemiparetic
7. No prior experience with VR-based rehabilitation.
8. Able to walk with the use of walking aids or assistive devices.
9. Mini-Mental State Examination (MMSE) score equal to or greater than 24

Exclusion Criteria:

1. Presence of aphasia, apraxia, and hemineglect
2. Serious cardiovascular disease (heart failure, arrhythmias, angina pectoris or myocardial infarction)
3. Cerebellar lesion
4. Multiple brain accidents
5. Muscular disorder effect upper and lower extremities
6. History of seizures or epilepsy.
7. Patients whose injury occurred fewer than 6 months previously, considering the expected time for spontaneous recovery;
8. Patients with associated disorders such as epilepsy, and sensory and perceptual deficits such as hemineglect and Pusher syndrome;
9. Patients with osteo degenerative disorders that would prevent participation in the games or that could influence the body balance; and individuals who had cognitive and communication disorders, affecting understanding, that could compromise performance in the games
10. Inability to commit to the study schedule or attend the required therapy sessions
Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy

To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women
* Patients who is planned to undergo laparoscopic ovarian cystectomy
* American Society of Anesthesiologists Physical Status classification (ASA PS) 1-2
* Patients with adequate bone marrow, renal and hepatic function:

WBC \> 3,000 cells/mcl Platelets \>100,000/mcl Creatinine \<2.0 mg/dL Bilirubin \<1.5 x normal and SGOT or SGPT \<3 x normal

* Patient must be suitable candidates for surgery
* Patients who have signed an approved Informed Consent

Exclusion Criteria:

* Patients with a history of pelvic or abdominal radiotherapy;
* Patients who are pregnant or nursing
* Patients who is receiving or requires hormone replacement therapy after surgery
* Patients who is undergoing hysterectomy at this time
* Patients who is undergoing unilateral or bilateral oophorectomy
* Previous history of ovarian cystectomy or oophorectomy
* Patients with contraindications to surgery
* Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
* Patient compliance and geographic proximity that do not allow adequate follow-up.
* Hormone therapy within 3 months before surgery
Antithrombin III and Post-liver Transplantation Acute Kidney Injury

The reno-protective effect of Antithrombin III (ATIII) has been well-studied in various animal studies; however, little is known about the effect of ATIII on kidney function in patients undergoing liver transplantation (LT). This study aimed to determine the association between preoperative ATIII level and postoperative acute kidney injury (AKI) after LT (post-LT AKI).


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent either living- or deceased-donor LT (LDLT, DDLT) from January 2010 to January 2018

Exclusion Criteria:

* patients who underwent re-transplantation
* patients who were previously diagnosed with end-stage renal disease or Chronic kidney disease
* patients who were being treated with continuous renal replacement therapy
* preoperative or postoperative Antithrombin III levels were not available
Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
* Central subfield thickness \> 300 μm
* BCVA of ≥ 24 and ≤ 68 letters
* Males and non-pregnant females 18 years and over

Exclusion Criteria:

* Macular edema secondary to any condition other than RVO
* Presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye
* Cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss
* Glaucoma or ocular hypertension (IOP \> 21 mmHg or concurrent therapy at screening with IOP-lowering agents)
* Any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye
* Any change in systemic steroid therapy within 3 months of screening
* History of vitrectomy in the study eye
Pre-Surgical Grading System of Asherman Syndrome

Utilising a novel pre-surgical grading system to class cases of asherman syndrome into 3 groups based on expected difficulty of surgery and potential prognostic outcomes.

Using the grading system, patients are classified into Mild, Moderate and Severe Asherman Syndrome. With the mild disease having the best prognostic value and a 1 step procedure, Moderate cases having a mediocre prognosis and usually multi-step procedure and Severe cases having a poor prognosis and counseled to other options. This observational study looks at the surgical outcomes following hysteroscopy for cases graded according to the new system to identify the accuracy of the classification in predicting the surgical success and prognostic value.

Eligibility Criteria:
Inclusion Criteria:

* Asherman Syndrome
* intra-uterine synechiae

Exclusion Criteria:

* patients with a fundectomy or uterine reduction surgery.
Immunostimulatory CpG SD-101 + RT in Recurrent/Progressive Lymphoma After Allogeneic Hematopoietic Cell Transplantation (HCT)

For patients with lymphoma that recurs after chemotherapy, bone marrow transplantation using cells from a healthy donor represents potentially curative treatment. In these individuals, cure is possible because transplantation of healthy donor immune cells can fight the lymphoma in the patient. The goal of this work is to test a strategy that activates the healthy donor immune cells so that they more effectively fight lymphoma and can result in an increased cure rate for these patients. Our group has previously studied CpG, an immune activating medication, in patients with lymphoma and demonstrated modest anti-tumor responses. We now have a more potent form of CpG which we intend to test to see if it will better activate the donor immune cells and result in shrinkage of tumor throughout the entire body, not just at the injected site.

Patients will receive low dose radiation to all bulky or symptomatic lymph nodes on days -2 and -1. SD-101 will be administered intratumorally to the single largest palpable node within 24 hours after completion of radiation, on day 0. Two additional intratumoral SD-101 injections will be performed on days 7 (+/- 2 days) and 14 (+/- 2 days). This is a dose ranging study using a 3+3 design with a definition of maximum tolerated dose (MTD) which our group has found acceptable in the past. The first cohort of patients will receive a SD-101 dose of 0.3 mg per injection. The dose will be escalated to 1 mg and 3 mg based on dose limiting toxicity (DLT).

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-confirmed relapsed, refractory, or progressive NHL or HL (Refer to Section 3.2.1 for excluded subtypes)
* At least 3 sites of disease

  1. One for diagnosis (lymph node or bone marrow biopsy)
  2. One palpable for treatment
  3. One measurable radiographically
* \> 60 days after RIC allogeneic transplant for lymphoma
* 18 years of age or older
* Mixed (5-95%) or complete (\>95%) chimerism
* Eastern Oncology Cooperative Group (ECOG) performance status ≤ 2
* ANC \>1000/mm3, platelets \>50,000/mm3
* Total bilirubin ≤ 2.5 mg/dL, AST and ALT \< 3 times upper limit of normal
* Serum creatinine ≤ 3 mg/dL
* No chemotherapy, RT, DLI or biologic therapy for lymphoma at least 4 weeks prior to scheduled treatment
* Minimal immunosuppression (defined as monotherapy with ≤ 10 mg prednisone daily, ≤ 200 mg cyclosporine daily, or ≤ 2 mg tacrolimus daily) at least 2 weeks prior to scheduled treatment

Exclusion Criteria:

* HIV associated lymphoma
* Acute GVHD at time of enrollment (history of treated and resolved GVHD is permitted)
* Active infection within 14 days prior to scheduled treatment
* Active Cytomegalovirus (CMV) disease at the time of enrollment
* Pre-existing autoimmune or antibody mediated disease (including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, and autoimmune thrombocytopenia)
* Pregnant
Empagliflozin Reversal of Arterial StiffnEss in Aging

Randomized placebo-controlled clinical trial in a cohort of males (n=40) and females (n=40), 60-80 years of age, with the hypothesis that SGLT2 inhibition with empagliflozin (10mg/day for 12 weeks) reduces aging-related arterial stiffening.

The investigators will employ a double-blinded randomized placebo control trial to determine the effects of 12 weeks of sodium glucose co-transporter 2 (SGLT2) inhibition with empagliflozin (10 mg daily), or matching placebo. Empagliflozin has been shown to decrease cardiovascular events and arterial stiffness in different populations. Placebo will be included for comparison purposes as empagliflozin is not a standard therapy for aging-associated arterial stiffness.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide consent
* 60 to 80 years of age at randomization (women must be postmenopausal defined as more than 1 year without menses)
* Stable anti-hypertensive medication regimen (if in use) for at least 90 days
* Evidence of arterial stiffening (defined as carotid-femoral PWV \>/= 8 m/s) at the time of screening visit.

Exclusion Criteria:

* Diabetes
* BMI\>/= 45kg/m2
* Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
* Estimated glomerular filtration rate GFR \< 29 mL/min
* Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
* Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
* Use of hormone replacement therapy
* Body weight change ≥10% within the last 6 months
* Uncontrolled hypertension during screening visit (\>180/110 mmHg)
* Symptomatic hypotension and/or a SBP \<100 mmHg
* History of ketoacidosis
* High fall risk per assessment of study physician and/or safety officer at the time of screening (results must be abnormal for both fall risk assessments and orthostatic blood pressure measurements)
* Anticipated need of prolonged fasting
* History of recurrent UTIs or mycotic genital infections
* Following a low-carbohydrate diet (\<20 grams/day)
* Participation in regular exercise \> 3 days/week per week at a moderate or vigorous intensity
* Known sensitivity to nitrate medications
Inhibition of α-synuclein Cell-cell Transmission by NMDAR Blocker, Memantine

Lewy Body Dementia (LBD), is the second most common form of dementia after Alzheimer's Disease. Dementia is defined as a serious loss in cognitive ability due to damages or disease in the brain beyond what is normal aging. With Lewy Body Dementia, protein deposits, or Lewy Bodies, accumulate in nerve cells throughout the brain, affecting motor control, memory and thinking. LBD can also form with the progression of Parkinson's disease (PD). PD is a degenerative nervous system disorder that affects movement ability. Using more sensitive MRI imaging techniques the investigators are attempting to see if disease progression can be monitored more closely. At the same time, the study medication Memantine will be compared to a placebo to determine if it can be used to slow the progression of PD. The purpose of this study is to assess if disease progression can be better monitored through brain imaging and if Memantine will help slow disease progression.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with idiopathic PD for at least 2 or more years
2. 45 to 85 years of age
3. Have been on stable doses of anti-Parkinson medication
4. Able to give informed consent
5. Able to undergo brain MRI
6. Unilateral symptoms
7. A score of 26 or greater on the Montreal Cognitive Assessment (MOCA), a measure of a patients short-term memory recall, the ability to determine visual-spatial relationships of objects, attention, concentration, working memory, language and orientation to time and place
8. Use of one method of medically approved contraceptive

Exclusion Criteria:

1. History of any surgical intervention for treating PD (i.e. deep brain stimulation)
2. Extreme physical disability
3. History or current diagnosis of unstable psychiatric condition
4. Presence of dementia or any other condition that prevents the ability of the participant to provide fully informed consent
5. Other brain disease
6. Treatment with Memantine 30 days prior to baseline
7. Females who are pregnant or nursing
8. Presence of interacting medications with Memantine or co-morbid medical conditions that may be exacerbated by this agent
9. Moderately significant drug interactions with Dextromethorphan, Amantadine, Sodium Bicarbonate, and Acetazolamide
10. Previous Allergic reaction to Memantine
11. Any genetic form of PD