cyrilzakka/clinical-trials huggingface dataset:
Predictors of Chronic Kidney Disease Among Type 2 Diabetic Patients in Assiut University Hospitals

Predictors of Chronic Kidney Disease among Type 2 Diabetic Patients in Assiut University Hospitals.

Globally, the total number of people with diabetes is estimated to increase from 415 million (8.8%) in 2015 to 642 million (10.4%) in 2040, with the largest alterations expected to occur in the urban population of low- to middle-income countries (LMICs)1. Of them, type 2 diabetes mellitus (T2DM) accounts for more than 90% of people with diabetes2,3. By 2040, the difference worldwide is projected to broaden, with 477.9 million affected people living in urban areas and 163.9 million in rural areas1. It has been postulated that the burden of diabetes and its complications in the LMICs may be contributed by the economic development and rapid urbanisation via increased caloric intake and the adoption of a sedentary lifestyle2,4,5. More importantly, the most striking demo graphic change to diabetes prevalence in global terms also seems to be related to the growth of the proportion of the elderly population6. Despite rates of diabetes-related complications such as CVDs decreasing significantly in the past two decades, it has not translated nearly as well as kidney complications7. Approximately 10% of deaths in people with T2DM are attributable to kidney failure8. It is well-established that diabetes-related chronic kidney disease (CKD) is the leading cause of end-stage kidney disease (ESKD) in T2DM patients worldwide9,10.

In our study, we aim to identify and classify patients attending diabetic outpatient clinic with both CKD and

Eligibility Criteria:
Inclusion Criteria:

- Patients with T2DM aged 18 years or older. For patients whom eGFR values \< or =60 ml/min/1.73m2.

Patient with type 2 DM and ESRD on regular HD with duration less than 1 year

Exclusion Criteria:

Having kidney transplantation incomplete data on glycemic control. Patients with type 2 DM and ESRD on regular HD with duration more than 1 year. Pregnant woman. Patients with advanced comorbides(cardiac, hepatic,
Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy

This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-IV cancer who are receiving cancer treatment. Cancer treatment can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. Insomnia can increase fatigue and worsen quality of life. This trial may help researchers determine which treatment works better in reducing insomnia, BBT-CI or HEAL.

PRIMARY OBJECTIVE:

I. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index (ISI) at post-intervention.

SECONDARY OBJECTIVE:

I. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at post-intervention.

MECHANISTIC OBJECTIVES:

I. Examine the efficacy of BBT-CI compared to HEAL for regulating circadian rhythms as measured via actigraphy (i.e., Mesor, Acrophase, Amplitude, I\<O dichotomy index).

EXPLORATORY OBJECTIVES:

I. Examine potential moderators of BBT-CI effects on insomnia (ISI). II. Examine potential mediators of BBT-CI effects on insomnia (ISI). III. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index at the 6-month follow-up.

IV. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at the 6-month follow-up.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (BBT-CI): Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.

GROUP II (HEAL): Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.

After completion of study, patients are followed for up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of at least 12 months
* Be currently receiving any cancer treatment (surgery alone is excluded)
* Report sleep disturbance of 3 or greater on the sleep disturbance question: "Rate your sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problems and 10 is having the most severe problems"
* Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
* Be able to speak, understand and read English to participate in the study assessments and interventions

Exclusion Criteria:

* Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled)
* Be engaged in a formal Cognitive Behavioral Therapy for Insomnia program presently or in the past 30 days. Use of psychotropics and sleep medication are allowed
Abdominal Electrical Stimulation for Bowel Dysfunction in SCI

Many people with spinal cord injury (SCI) have bowel problems resulting in constipation and need a long time to empty the bowel. Some people spend an hour or more to empty their bowel. The investigators want test if using a small device to deliver electrical pulses to the belly (abdomen), would improve bowel function. The investigators hope that electrical stimulation will shorten the time needed to evacuate the bowel (defecation), improve stool consistency, and speed up food passing through the bowel. A pilot study found that electrical stimulation of the belly can speed up defecation if stimulation is making the abdominal muscles contract and squeeze the belly, which is what the investigators expected. However, some results suggested that people may benefit from low stimulation levels without making the muscles contract.

Therefore, the investigators will do small study at the University of Alberta on 12 people who lived with SCI for more than 1 year, to find out the best way to apply the electrical stimulation, and to better understand how it works. The participants will use an electrical stimulator at home, to stimulate the skin with 4 sticky pads attached over the abdomen, without causing the muscles to contract. During a 2-month period, they will use the stimulator for 30 minutes before every bowel routine. The investigators will compare how long it takes to empty the bowel, stool consistency, and how long it takes for food to pass through the bowel, with and without using the electrical stimulator.


Eligibility Criteria:
Inclusion Criteria:

1. Traumatic or non-traumatic SCI
2. \>1 year post injury
3. Injury level C2 - S5 (NLI, neurological level of injury)
4. AIS A, B, C, D (American Spinal Injury Association Impairment Scale)
5. Feels defecation takes too long and wants to do something about it
6. Defecation takes \> 30 minutes

Exclusion Criteria:

1. Bladder stimulator
2. Inflammatory bowel disease
3. Pregnancy
4. Unable to give consent
Interferon for the Intervention of Molecular Relapse in t (8; 21) AML After Allo-HSCT

molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT) is still a problem even after donor lymphocyte infusion.

Interferon seemed to augment graft-versus-leukemia (GVL) effect in this part of patients.

the study is to evaluate the safety and efficacy of interferon for the intervention of molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT)


Eligibility Criteria:
Inclusion Criteria:

* high risk t (8; 21) AML
* molecular relapse after allo-SCT

Exclusion Criteria:

* active graft-versus-host disease
* uncontrolled severe infection
* organ function failure
Making it Work Program for Systemic Sclerosis

The purpose of this clinical trial is to see if an online intervention program for people with Systemic Sclerosis (scleroderma) helps keep people in the workforce and increase self-confidence in dealing with challenges at work. The program is called Making it Work Systemic Sclerosis.

Researchers will compare a group who gets the program to a group who will get the program at a later point in time (wait list control group) to see if self-confidence in dealing with work challenge gets better.

People in the Making it Work group will complete questionnaires and attend one 2 hour meetings each week for 5 weeks and meet with an occupational therapist and vocational counselor. People in the wait list control group will complete the questionnaires and participate in the program at a later point in time.


Eligibility Criteria:
Inclusion Criteria:

* Currently employed (full-time, part-time)
* Over 18 and less than or equal to 67 years of age
* Reside and work in the United States
* Self-report diagnosis with systemic sclerosis (scleroderma; systemic sclerosis)
* Report concerns about risk for job loss
* Possess sufficient spoken English to participate in a group
* Have device with audio and visual videoconferencing capabilities
* Be willing to participate in a 2.0 hour virtual meeting once a week for 5 weeks
* Be willing to complete assigned pre-meeting worksheets
* Be willing to meet virtually with both an occupational therapist and vocational counselor after the 5th weekly sessin.

Exclusion Criteria:

* Not working (full-time, part-time, self-employed, contract work)
* Pregnant
* Less than 18 and over 67 years of age
* Do not work in the United States
* Do not report are not concerned about job loss
* Do not have a device with audio and visual videoconferencing capabilities
* Do note communicate sufficiently in English
* Are not able to participate in the program for 5 weeks
* Are not wiling to complete pre-meeting worksheets
* Not willing to meet with both an occupational therapist and vocational counselor.
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients with Advanced Solid Tumors

To assess the safety, tolerability, PK and preliminary efficacy of CD-001 in patients with advanced solid tumors. and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years , regardless of gender.
2. Patients with advanced solid tumors that are histologically or cytological confirmed, lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.
3. ECOG score ≤ 2.
4. At least one measurable lesion as defined by RECIST v1.1.
5. Expected survival ≥ 3 months.

Exclusion Criteria:

1. Patients with known active central nervous system (CNS) and/or leptomeningeal metastases .
2. Patients who have undergone major organ surgery within 4 weeks prior to the first dosing, or who are expected to require major surgery during this study, or who have severe unhealed wounds, trauma, ulcers, etc.
3. Patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant.
4. Patients who have a past or current history of active or chronic autoimmune disease and who have required systemic therapy within the past 2 years or is receiving systemic therapy for an autoimmune or inflammatory disease.
5. Patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing.
6. At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk.
7. Patients with a history of ≥ Grade 3 (CTCAE) immune-related adverse events (irAEs) during prior anti-tumor therapy or permanent drug discontinuation due to irAEs.
8. Patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.
FEES to Determine Neurological Intensive Care Patients' Oral Diet

Dysphagia is associated with high rates of mortality and morbidity. Adjusting the oral diet of ICU-patients based on flexible endoscopic evaluation of swallowing (FEES) findings might reduce pneumonia rate, mortality and need for intubation/tracheotomy.

Dysphagia, a common complication in neurological disorders, leads to high rates of mortality and morbidity. It is prevalent in critically ill patients, especially those who need mechanical ventilation. The investigators therefore investigate the effect of adjusting the oral diet of our intensive care unit (ICU) patients based on flexible endoscopic evaluation of swallowing (FEES) findings, thereby assessing the impact of FEES on a neurological ICU. All patients treated on the investigators neurological ICU will be eligible for this study.

The investigators will correlate findings with baseline data, disability status, pneumonia and duration of hospitalisation, as well as a need for mechanical ventilation or a tracheotomy.

Eligibility Criteria:
Inclusion Criteria:

* Treatment on neurological ICU
* Clinical suspicion of Dysphagia

Exclusion Criteria:

* none
Trial of Erlotinib in Patients With JAK-2 V617F Positive Polycythemia Vera

The primary objective of this study is to determine the overall response rate to erlotinib in patients with polycythemia vera (PV). Response rate will be assessed by improvement in the complete blood count, ultrasound of the spleen, and JAK2 molecular status. It is purposed in this study to explore a possible molecular targeting of the driving mechanism of PV.

This is a phase II open-label study. Patients will be screened for MPN diagnoses and patients with Polycythemia vera proven to have JAK2V617F mutation will be given the option to enroll. Consenting patients will take erlotinib daily for 16 weeks. Blood work and pharmacokinetics will be drawn for serum level monitoring. Doses will be administered according to side effects or held. First assessment will be at day 15 wth subsequent assessments at 28 day intervals. Non-responders will be taken off the study and managed according to standard of care. Patients who do respond will continue taking the therapy for a total of 12 months. Observation will be for a total of 12 months after finishing treatment. In addition to the clinical aspect of this study, there will be correlative studies where molecular response will be checked and its correlation with clinical response.

Eligibility Criteria:
Inclusion Criteria:

* WHO 2008 diagnosis of Polycythemia Vera Hemoglobin \> 18.5 g/dl for men (16.5 g/dl for women) and presence of JAK2V617F mutation and either bone marrow trilineage myeloproliferation or subnormal serum erythropoietin level Patients may be on active treatment (phlebotomy, aspirin) ECOG performance status 0,1,2,or 3 Adequate hepatic function, adequate renal function

Exclusion Criteria:

* Patient with active malignancy Patients with clinically significant cardiac disease within 1 year Opthalmologic or gastrointestinal abnormalities Concurrent cytoreductive therapy is not allowed
Drug-drug Interaction Study of FYU-981 and Oxaprozin

This is an open-label, 2-period add-on study to assess the drug-drug interaction between FYU-981 and oxaprozin. The purpose of this study is to investigate the pharmacokinetics of each period in a single administration of FYU-981 and concomitant administration of FYU-981 with oxaprozin at steady -state in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy subjects
* Body mass index: \>=18.5 and \<25.0

Exclusion Criteria:

* Subject with any disease or any history of disease that might be unsuitable for participation in the clinical study
Functional Lung Avoidance for Individualized Radiotherapy (FLAIR): A Randomized, Double-Blind Clinical Trial

Concurrent chemoradiotherapy is the standard treatment for locally advanced, unresectable non-small cell lung cancer, but carries a risk of radiation pneumonitis of approximately 30%, and is associated with a decline in pulmonary quality of life.

Standard radiation planning aims to optimize dose to the anatomic lung volume, without consideration of the differences in regional lung function. Functional lung avoidance radiotherapy aims to reduce radiotherapy dose to regions of functioning lung, instead depositing dose in areas of lung that are not well-ventilated. Functional lung regions are determined using noble-gas MRI and co-registered to the radiotherapy planning CT scans. Functional lung avoidance radiotherapy has been demonstrated to be feasible, and this trial aims to compare outcomes between standard radiotherapy (with concurrent chemotherapy) vs. functional lung avoidance radiotherapy (with concurrent chemotherapy).

All consenting patients will undergo hyperpolarized noble gas MRI using 3-He for definition of functional lung volumes. Two radiotherapy treatment plans will be generated prior to randomization: one standard plan using anatomical lung avoidance, and one functional lung avoidance plan. After approval of both plans, patients will be randomized, and both patients and physicians will be blinded to treatment allocation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Willing to provide informed consent
* ECOG performance status 0-2
* Histologically confirmed non-small cell lung carcinoma
* Locally advanced Stage IIIA or IIIB lung carcinoma according to AJCC 7th edition
* History of at least 10-pack-years of smoking
* Not undergoing surgical resection
* Assessment by medical oncologist and radiation oncologist, with adequate bone marrow, hepatic and renal function for administration of platinum-based chemotherapy

Exclusion Criteria:

* Contraindications to MRI
* Serious medical comorbidities (such as unstable angina, sepsis) or other contraindications to radiotherapy or chemotherapy
* Prior history of lung cancer within 5 years
* Prior thoracic radiation at any time
* Metastatic disease. Patients who present with oligometastatic disease where all metastases have been ablated (with surgery or radiotherapy) are candidates if they are receiving chemoradiotherapy to the thoracic disease with curative intent.
* Inability to attend full course of radiotherapy or follow-up visits
* Pregnant or lactating women
Brimonidine vs ALTP in Progressing Human Glaucoma

This study is evaluating possible non-intraocular pressure (IOP) related effects of the alpha-1 agonist brimonidine in human subjects affected by a progressive glaucomatous optic neuropathy. Brimonidine was proven as neuroprotective in several pre-clinical animal studies.

Patients with open angle glaucoma and a history of relative stability of the visual field are followed for 18 months. A visual field is measured every 3 months for a total number of n = 6 eligible fields at the end of this phase. Then, those eyes showing progression of the field (i.e. deterioration of th eexisting glaucoma), are randomized to receive either 0.2% brimonidine tartrate eyedrops b.i.d. or 360° argon laser trabeculoplasty in one session. Either treatment will be put "on top" of the pre-existing anti-glaucoma therapy. Then, a further 18-month phase is planned, with a sequnece of field taken at the same pace as the previous phase. Progression is detected (and measured) acording to a trend-analysis (i.e. regression vs time of single points and of clusters of adjacent points).

Eligibility Criteria:
Inclusion Criteria:

* Glaucomatous visual field defect on achromatic perimetry (24/2 Humphrey full threshold,abnormal GHT and CPSD, p\<0.01) considered clinically "unstable"
* IOP \< 20 mmHg on repeated readings with no more than 2 medications,
* Open angle on gonioscopy,
* Glaucomatous optic neuropathy (HRTII, Moorfields regression analysis),
* Clear lens (LOCS2 score \< C1, N0, P0)
* Best corrected visual acuity better than 0.2 LogMAR (ETDRS chart),
* No previous bulbar surgery
* Manifest refraction within - 5 and + 2 diopters
* No comorbidity (AMD and diabetic retinopathy.and negative history for neurological diseases)

Exclusion Criteria:

* Closed angle
* Previous bulbar surgery
* Unstable IOP
* Unreliable visual fields on historic data
Subclavian Artery Plug Embolization (SAPE)

This is an observational, no-profit, ambispective study: a retrospective arm will include the cases treated between August 2009 and March 2018, and a prospective arm, investigating patients treated from March 2018 until December 2018. Target study population size is 150 patients between two groups analyzed.

Endovascular occlusion of the prevertebral subclavian artery was first used in the Vascular Surgery Department at San Raffaele Hospital in August 2009. During the initial experience (2009-2014) this technique was used with low frequency. Since 2015, the volume of cases receiving this treatment, has increased and the investigators expect to reach the study population target, by the end of 2018.

The objective of this study is describe the casuistry of endovascular occlusion of the subclavian artery by means of the Amplatzer Vascular plug in the Vascular Surgery Department at San Raffaele Hospital, and to evaluate the efficacy of such procedure.

Moreover, the investigators will evaluate the patency and success rate of the carotid-subclavian bypasses performed at the same time of the analyzed procedure.


Eligibility Criteria:
Inclusion Criteria:

* adult patients aged ≥ 18 years,
* patients candidates for endovascular treatment of subclavian artery occlusion with Amplatzer Vascular Plug

Exclusion Criteria:

• none
Calcium Metabolism in Mexican American Adolescents

The purpose of this study is to identify calcium metabolism characteristics in Mexican American adolescents. The investigators predict that calcium requirements to maximize bone health in this population will be lower than for white youth but higher than their current intakes.

Previously significant racial and sex differences in calcium retention and kinetics in adolescents has been found. Other minority groups have increased calcium absorption efficiency at low calcium intakes in contrast to white adolescents. Since Hispanics and specifically Mexican Americans will soon comprise an increasing proportion of our population. We propose to identify calcium metabolism characteristics in this group. We predict that calcium requirements to maximize bone health in this population will be lower than for white youth but higher than their current intakes.

Thus the specific aims of this project include:

* to establish calcium requirements
* to establish the relationship between calcium intake and calcium absorption
* to identify the major physiological parameters(kidney, intestine, bone) that contribute to calcium retention in Mexican-American adolescents

During this two-phase metabolic camp participants will consume either a higher calcium diet(1100-2300mg/d) or a lower calcium diet (600-1200mg/d) during the first 3-week phase and switch to the opposite regime during the second 3-week phase, with a 2-week washout period in between. Subjects will collect all excreta during both phases. Calcium absorption, height, weight, and bone density will evaluated throughout the 6-week period of the study.

Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy adolescents of Mexican American descent
* Mexican American boys age 13-15
* Mexican American girls age 12-14

Exclusion Criteria:

* Malabsorptive disorders
* Anemia
* Smoking
* History of medications known to affect calcium metabolism
* Body weight outside 85-120% of ideal body weight for height
* Regular consumption of illegal drugs
* Contraceptive use
* Pregnancy