cyrilzakka/clinical-trials huggingface dataset:
Intravenous Transplantation of Mesenchymal Stem Cell in Patients With ALS

ALS is a debilitating disease with varied etiology characterized by rapidly progressive weakness, muscle atrophy and fasciculations, muscle spasticity, difficulty speaking (dysarthria), difficulty swallowing (dysphagia), and difficulty breathing (dyspnea). ALS is the most common of the five motor neuron diseases.Riluzole (Rilutek) is the only treatment that has been found to improve survival but only to a modest extent. It lengthens survival by several months, and may have a greater survival benefit for those with a bulbar onset. It also extends the time before a person needs ventilation support.Stem cell transplantation is a new hopeful way to improve the patients conditions and reduce the period of disabilities.

In this study our purpose is to evaluate the safety of intraventricular injection of bone marrow derived mesenchymal stem cell.the patients who are eligible,underwent bone marrow aspiration.after cell separation and preparation,the patients underwent mesenchymal stem cell intraventricular injection by stereotaxis.after injection he will be under observed in ICU to monitor the adverse events(allergic and neurological side effects).patients are followed 1th,3th ,6th and 12 months after injection and each time these parameters are checked:ALS-FRS,EMG-NCV,FVC,side effect check list.

Eligibility Criteria:
Inclusion Criteria:

* - Age:18-65
* both gender
* duration of disease\<2 years
* FVC\>40% ALS-FRS\>26

Exclusion Criteria:

* - neurological and psychiatric concomitant disease
* concomitant systemic disease
* treatment with corticosteroid,Ig,immunosuppressive during 12 months.
Eating Disinhibition and Vagal Tone and the Postprandial Response to Glycaemic Load

Reducing the glycaemic load (GL) of the diet may benefit appetite control but its utility is complicated by psychological influences on eating. Disinhibited behaviour, a risk factor for overconsumption, is characterized by reduced prefrontal cortex activity, which in turn directly modulates vagal tone; a phenomenon inversely associated with blood glucose (BG) and insulin levels. This double blind randomised controlled trial explores the influence of disinhibited eating and vagal tone (heart rate variability) on the postprandial response to GL and hunger.

There is growing recognition that lowering the glycaemic load of the diet might reduce a range of cardiovascular risk factors such as raised plasma triglycerides, HbA1c and C reactive protein and aid in body weight regulation. A proposed mechanism includes higher satiety and prolonged satiation by virtue of improved postprandial metabolic control, although, whether lower GL meals result in greater weight loss or increased satiety is still a matter of debate. One matter complicating the issue is that the desire to consume food may be driven by psychological factors; food reward centres in the brain may override hormonal regulation of food intake. Amongst psychological factors disinhibition has the largest and most consistent body of empirical data that associates it with weight gain although the mechanisms involved are unknown. This study will investigate whether, irrespective of BMI or habitual diet, disinhibited eaters have greater glycaemic excursions following a high glycaemic load drink and whether this predicts subsequent satiation.

Eligibility Criteria:
Inclusion Criteria:

* Young healthy adults who scored either high or low on the Three factor eating questionnaire disinhibition subscale

Exclusion Criteria:

Participants were excluded if they

* had a cardiovascular or metabolic disorder
* gastrointestinal problems
* were pregnant
* had a current diagnosis of a mood or eating disorder
* and/or were taking medications or herbal supplements to manage body weight or control appetite
Physical Therapy vs Remote Exercise for Knee Pain Due to Osteoarthritis (OA)

The purpose of this clinical study is to demonstrate that after six weeks of at home exercise, 3 times per week with SimpleTherapy, participants with clinical indications of knee OA will on average have improved outcomes noninferior than traditionally prescribed physical therapy regimens.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥ 18 years)
* Living in the tristate area - CT/NY/NJ
* Symptomatic OA (National Institute for Health and Care Excellence clinical criteria for OA)
* Chronic knee pain (\>3 months) as a primary pain complaint
* Average pain score ≥ 4 on an 11-point numeric rating scale at baseline
* Access to a device with internet connection
* KL Stages 1-2-3

Exclusion Criteria:

* Prior documented history of cognitive impairment;
* History of total knee arthroplasty;
* History of: Inflammatory arthritis (e.g. rheumatoid arthritis); or any neuropathies affecting the lower limbs, spinal cord injury, spine fractures, advanced heart disease, bleeding issues (i.e. hemophilia), surgery within the last 90 days; fall within 90 days; high risk of fracture;
* History of knee injury, within the last 3 months;
* Currently engaged with other PT or strengthening program;
* Present unstable/uncontrolled cardiovascular condition
* Undergoing active chemotherapy for cancer
Safety and Tolerability of Repeat Courses of IM Alefacept

Previous Biogen studies have provided experience with the tolerability, immunogenicity, and efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage, experience in larger studies, as well as the FDA-approved labeling, is confined to treatment courses of 12 weeks. The purpose of the present study is to offer an extended course of therapy with alefacept.

Twenty statistically matched patients (15 males, 5 females, aged between 28 and 70 years, median 50 years) with moderate to severe psoriasis (PASI: 7-36) were included in this study. They were treated with 15 mg alefacept i.m. weekly. Peripheral blood was taken prior to first alefacept application and then weekly until week five and thereafter every second week, until the end of treatment at week 13. At the same time points severity of disease and thereby possible reduction of symptoms was evaluated applying the PASI. Investigators analysing the samples were blinded to the outcome of the study. The protocol concerning human subjects was approved by the ethics commission of the Charité University Medicine Berlin Campus Mitte, Germany .

Eligibility Criteria:
Inclusion Criteria:

1. Must give written informed consent.
2. Must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to Visit 1.

Exclusion Criteria:

1. Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
2. Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed).
3. Serious local infection (e.g., abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
4. Any subject whose CD4+ lymphocyte count at study entry is less than 404 cells/mm3.
5. Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
6. Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
7. Phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA), within 28 days prior to investigational drug administration.
8. Known HIV+, known viral Hepatitis infection, known tuberculosis infection.
Allocentric Memory in MS and Resting State Functional MRI

The goals of this study are to 1. Investigate the sensitivity of allocentric visual memory when compared to more established measures of cognition in identifying cognitive difficulties among MS subjects when compared to controls. 2. Determine which cognitive test variable will be most strongly associated with self and informant reports of cognition. 3. Determine which MRI metric will be most strongly related to neuropsychological test performance 4. Determine the degree to which allocentric visual memory is related to functional connectivity on fMRI.

This is a cross-sectional, case-control, observational experimental design. The study will enroll subjects with multiple sclerosis (MS) and age/gender matched on a battery of neuropsychological cognitive tests and self-report measures of cognition.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old
* Right handed
* Capacity to provide informed consent and sign consent
* Diagnosis of Relapsing Remitting MS that meets the revised McDonald Criteria (2010) within the last 10 years
* EDSS 0- 5.5

Exclusion Criteria:

* Diagnosis of primary progressive MS
* Contraindications for MRI
* Subjects required to take medications known to either benefit or adversely affect cognition at the time of testing and impact neuroimaging
* Non-MS neurological disorders
* Other medical or psychiatric disorders likely to affect cognitive performance
* Active immunodeficiency, chronic infections, or history or progressive multifocal leukoencephalopathy
* Individuals with severe level of depression on the BDI-II or severe anxiety on the BAI
* MS subjects who are actively experiencing acute exacerbation in symptoms and they must be at least 4 weeks free of steroid medication, are currently taking a chemotherapy agent, or have changed medication in the last two months
* Subjects who fail symptom validity measures during neuropsychological testing will be excluded
Serosurveillance Study of Maternally Derived Anti-GBS Antibody

Globally, neonatal mortality remains unacceptably high, with little change in the death rate in the first 28 days of life since 1990, despite reductions in under-5 mortality of up to 50% over the same period. In 2014, neonatal deaths accounted for 44% of all deaths in children under 5 with neonatal infection accounting for over a third of all deaths. Group B Streptococcus (GBS) is a major cause of septicemia and meningitis in infants globally and a cause of severe adverse neurodevelopmental outcomes in up to 50% of meningitis survivors. It can also lead to sepsis in pregnant women. GBS acquisition occurs through vertical transmission in 15%-50% of infants born to a vaginally/rectally colonized mother. Maternal colonization is a prerequisite for early onset (EO) and a risk factor for late onset (LO) disease.

Our proposal will provide these critical data in Uganda (a country with high neonatal disease burden) in a 12 month pilot study to determine: the burden of GBS disease in a cohort of mother/infant pairs and establish an active surveillance platform for monitoring of early and late onset neonatal infection in term and preterm infants in Uganda and compare this to the burden known for other African countries. This provides essential data on GBS disease outcomes from a high-HIV burden African cohort reflecting the usual standard of care in a low income, highly deprived urban environment. This pilot study will establish minimum disease estimates in the Ugandan cohort to determine the feasibility of a cohort study over three years to determine the level of antibody against GBS in cord blood from pregnancies where women are GBS colonized and non-colonized but whose infants do not develop GBS disease in the first three months of life and compare this to the level in the blood of infants who develop GBS disease. We will compare these results with those from other African countries such as South Africa to enable a robust estimate of potential sero-correlates of protection from natural infection against the most common GBS-disease-causing serotypes.


Eligibility Criteria:
Delivery (Birth) Cohort

Inclusion Criteria:

* consecutive mothers greater than or equal (≥) the age of 18 years delivering at Kawempe Hospital (live or stillbirth) and emancipated minors aged between 14-17 years of age,
* willing to stay in the area for the first three months of life or willing to travel to clinic until their child is 2 years old if their infant has known or presumed GBS infection).

Exclusion Criteria:

* Unable to give written informed consent

Active Surveillance Cohort Matching \& Adjustment Criteria: (these will be applied at the analysis stage): (i) exposure to intrapartum antibiotic prophylaxis: defined as intravenous penicillin, ampicillin, cefazolin, clindamycin or vancomycin, for ≤2 hours before delivery. (ii) blood transfusion in the 30 days before delivery (iii) HIV status (iv) Maternal age (v) Infant gestational age
Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients?

We aimed to address the issue whether statins affect insulin resistance. To this end, we combined the available state-of-the art technology for detailed assessment of both whole-body and tissue specific insulin sensitivity in vivo in humans (euglycemic-hyperinsulinemic clamp, stable isotope \[6,6-2H2\]glucose dilution technique, proton nuclear magnetic resonance spectroscopy - 1H MRS - of liver and skeletal muscle). Outcome measures were determined before and after 8 weeks therapy with 80 mg Simvastatin in hypercholesterolemic patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients with known duration of disease: 3-10 years
* Age: 35-75 years
* BMI\<32 kg/m2
* Hypercholesterolemia: fasting serum low density lipoprotein (LDL)
* Cholesterol concentration \< 4.16 mmol/L (\<160 mg/dl)
* Normotriglyceridemia: fasting plasma triglyceride concentration \< 2.75 mmol/L (250 mg/dl)
* Creatinine levels \< 1.8 mg /dl
* Liver transaminases \< 20% over the upper limit with no active liver disease and CK \< 50% above the upper limit
* Blood pressure less than 160/100 mmHg were accepted as eligible for enrollment

Exclusion Criteria:

* Hypertension, cardiovascular disease or metabolic diseases other than T2DM as determined by medical history, physical examination and routine laboratory tests
* Alcohol consumption (more than 10 drinks/week)
* Poor glycemic control (HbA1c\<9%)
* Patients requiring insulin, patients with type 1 diabetes
* Patients taking any medicine known to interfere with metabolism of statins or with insulin sensitivity as summarized in an exclusionary drug table
* Patients receiving any hypolipidemic medication or diet during the last 2 months before enrollment
Investigating the Impact of the SGLT2 Inhibitor Empagliflozin on Postprandial Hypoglycaemia After Gastric Bypass

Bariatric surgery is an effective anti-obesity treatment providing durable weight loss and profound beneficial effects on glucose metabolism. However, bariatric surgery also comes with an increased risk for a late metabolic complication known as postbariatric hypoglycaemia (PBH). The condition presents with hypoglycaemic episodes 1-3 hours after meals and develops one to several years after bariatric surgery, mainly gastric bypass. PBH affects approximately 30% of patients without preexisting diabetes. For a subset of patients, hypoglycaemia-associated impairment of daily living and social functioning are commonly observed. The underlying mechanisms of PBH are multifactorial. It is considered that inadequately high insulin secretion caused by both accelerated glucose absorption from the gut and increased insulinotropic hormones such as GLP-1 are important pathophysiologic mechanisms. Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor reduces glucose exposure by increasing urinary glucose excretion. In a pilot study, a single dose of 10mg of empagliflozin taken before a mixed meal reduced the risk of PBH by 74%. Both, postprandial glucose and insulin exposure were significantly lower with empagliflozin vs. placebo, which makes Empagliflozin a potential treatment for PBH. In this study, treatment naïve patients will be randomized to receive either oral empagliflozin 25 mg daily in the morning for 20 days, followed by 2-6 weeks wash out and 20 days placebo once daily in the morning, or the reverse sequence. Urine and blood analysis will be performed as detailed in the protocol.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Age 18 years or older
* Gastric bypass surgery ≥1 year ago
* Biochemically confirmed postprandial hypoglycaemia (plasma or sensor glucose \<3.0mmol/l) within the past three months

Exclusion Criteria:

* Diabetes on anti-diabetic treatment (insulin and/or non-insulin agents)
* Genito-urinary infection, if not treated successfully
* Chronic kidney disease (defined as CKD-EPI eGFR \< 60 mL/min per 1.73 m2 body surface area)
* Pregnant and lactating women (urine pregnancy test to be performed for women of childbearing potential \[defined as women who are not surgically sterilized/ hysterectomized, and/ or who are postmenopausal for less than 12 months\]) or women of childbearing potential that refuse to use an effective contraceptive method \[birth control pill or intrauterine device (IUD)\]).
* Inability to understand and follow the protocol
* Known allergy to the study drug
* Participation in another interventional clinical trial overlapping with the current trial
Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia

The purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III guidelines, overall and by country, in the following sub-populations:

* Primary/secondary prevention patients.
* Patients with metabolic syndrome (according to NCEP III definition).

In addition, the purpose is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines/national guidelines, in the survey population and in the following sub-populations:

* Primary/secondary prevention patients.
* Patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* On lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks. ·
* Subject must sign informed consent

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent.
Simvastatin Reduces Adiponectin Levels and Insulin Sensitivity

We hypothesized simvastatin may reduce adiponectin levels and insulin sensitivity in overweight hypercholesterolemic patients.


Eligibility Criteria:
Inclusion Criteria:

* Low-density lipoprotein cholesterol levels more than 100 and body mass index more than 23.0

Exclusion Criteria:

* Patients with overt liver disease
* Chronic renal failure
* Hypothyroidism, myopathy
* Uncontrolled diabetes
* Severe hypertension, stroke
* Acute coronary events
* Coronary revascularization within the preceding 3 months, or
* Alcohol abuse.
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates

This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.

Following a screening period of up to 28 days, subjects will be admitted to the clinical research unit into one of three cohorts. On the morning of Day 1, subjects in cohorts 1, 2, and 3 will receive fasted doses of probe substrate(s) per assigned cohort. On Day 5, Cohort 2 only will receive a second fasted dose of probe substrates. Subjects in cohorts 1, 2, and 3 will receive the final fasted dose of probe substrate(s) on Day 13. Fasted ecopipam administration will begin on Day 5 and will continue through Day 17 at \~2mg/kg for all cohorts. Ecopipam doses will be tapered starting on Day 18 by 25 mg/day increments until subjects are off drug, with final discharge occurring 24 hours after the ecopipam HCl dose has been reduced to 25 mg (Day 21, 23, or 25).

Eligibility Criteria:
Inclusion Criteria:

* Male subjects or female subjects of non-childbearing potential
* ≥18 and \<55 years of age at the time of consent
* BMI \>18.5 and \<30 kg/m2 and a weight of ≥50 kg for males or ≥45 kg for females
* Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug
* Male subjects must be willing not to donate sperm until 90 days following the last study drug administration

Exclusion Criteria:

* Personal or family History of significant medical illness
* Clinically significant abnormalities on screening tests/exams
* History of or significant risk of committing suicide
* Donation of plasma within 7 days prior to dosing
* Donation or significant loss of blood within 30 days prior to the first dosing
* Major surgery within 3 months or minor surgery within 1 month prior to admission
* Use of prohibited prescription, over-the-counter medications or natural health products
* Alcohol-based products 24 hours prior to admission
* Female subjects who are currently pregnant or lactating
* Positive pregnancy test
* Use of tobacco or nicotine products within 3 months prior to Screening
* Significant alcohol consumption
* History of drug abuse within the previous 2 years, or a positive drug screen
* History of allergy to study medications
* Undergoing abrupt discontinuation of alcohol or sedatives
* Not suitable for study in the opinion of the Principal Investigator
Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Enalapril maleate may help protect heart cells from the side effects of chemotherapy. It is not yet known whether giving enalapril maleate before or after doxorubicin hydrochloride is more effective in treating women with breast cancer.

PURPOSE: This randomized clinical trial is studying giving enalapril maleate together with doxorubicin hydrochloride to see how well it works in treating women with breast cancer.

This study is a drug interaction study designed to study the effects of enalapril on doxorubicin metabolism. Women with breast cancer for whom at least two cycles every 14 day doxorubicin is planned will be considered for enrollment. Study participation will be for 2 treatment cycles of doxorubicin or approximately 4 weeks. Patients will receive a 14 day course of daily enalapril in association with one cycle of doxorubicin and receive no study agent during the other cycle allowing patients to act as their own control. The sequence of enalapril dosing will be assigned by randomization at study enrollment. Blood samples for pharmacokinetics will be drawn before and at 7 time points after each of the two doses of doxorubicin. For each patient, serum doxorubicin and doxorubicinol concentrations both on and off of enalapril will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Tissue diagnosis of a breast carcinoma
* The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen
* Have acceptable organ function within 14 days of enrollment defined as:

  * liver function: total bilirubin, AST and ALT within normal institutional limits
  * kidney function: estimated Creatinine Clearance \> 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72)
* At least 18 years old
* Patient must have given written informed consent indicating an understanding of the investigational nature of the study
* Agrees not to consume grapefruit juice while on the study

Exclusion Criteria:

* Known allergy to enalapril
* Taking any known P450 cytochrome inducers or inhibitors
* Taking any herbal supplements while on the study or the week prior to receiving doxorubicin
* Taking an ace-inhibitor or angiotensin receptor blocker
* Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters)