cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Adult Stem Cells to Treat Patients With Severe Leg Artery Disease

Peripheral artery disease (PAD) due to leg artery blockages can result in painful leg muscles, skin ulcers and infection due to poor blood flow. In severe forms, the only treatment may be amputation. Adult stem cells injected into affected legs may cause new blood vessel formation and improve blood flow. The purpose of this study is to determine the feasibility and safety of injecting adult stem cells into the leg muscles of patients with severe PAD, in an attempt to improve blood flow.

Lower extremity peripheral artery disease (PAD) is a common, debilitating and potentially life-threatening illness. Obstructive PAD can progress to limb-threatening ischemia with rest pain, ulcers, and gangrene requiring amputation unless blood flow to the ischemic limb can be restored. Surgical revascularization options are often limited by arteries that are too small to bypass. Patient co-morbidities also make surgical options risky. Percutaneous revascularization techniques are similarly limited by small distal artery caliber, technical difficulty and high restenosis rates. Amputation may be the only treatment option for non-healing ulcers or gangrene. Direct intramuscular injection of adult stem cells may result in improved lower extremity perfusion, symptomatic improvement and limb salvage in patients with critical limb ischemia not optimal for conventional revascularization. This study aims to demonstrate the safety and feasibility of this therapeutic approach.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory critical limb ischemia (Rutherford Score 4/5)
* Not optimal for surgical or catheter-based revascularization
* Obstructive atherosclerosis of at least 1 major artery in both limbs
* Ankle-Brachial Index \<0.6 or Absolute Ankle pressure \<60mmHg or toe pressure \<40mmHg or pulse volume recording that is flat or barely pulsatile

Exclusion Criteria:

* Gangrene(Rutherford 6) or pre-existing major tissue loss
* Unstable Angina, MI, stroke, CHF (class III or IV) within 6 months of study treatment
Impact of Nutritional Counselling in Children With Autism

Autism Spectrum Disorder (ASD) is a complex group of behavioral disorders characterized by defects in social interaction and communication associated with restricted and repetitive behaviors and activities. The prevalence in pediatric age is continuously increasing in Western countries (58-67 / 10,000). The Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) describes a worldwide population prevalence of approximately 1%. According to the latest data from the National Observatory for the monitoring of ASD, in Italy 1 child out of 77 (age 7-9 years) has the disease with a higher prevalence in males: males are affected 4.4 times more than females . The clinical manifestations of ASD are the result of complex interactions between genetic, epigenetic, environmental and microbiological factors. Alterations in nutritional status, eating habits and adverse reactions to food appear to be more frequent in children with ASD. It is estimated that 46-89% of children with ASD have feeding problems which can include unusual eating patterns, rituals and food selectivity. These types of eating behaviors can lead to severe alterations in nutritional status. Furthermore, the data present in the literature concerning the eating habits of children with ASD suggest a high consumption of "junk food" and foods rich in calories together with a refusal of fruit, vegetables or proteins. These data suggest that the dietary and behavioral problems frequently present in these children could favor a condition of obesity. Finally, a high percentage of children with ASD undergo elimination diets, characterized by exclusions of foods relevant to the diet of a child such as milk and gluten to alleviate the symptoms of the disease. Such elimination diets are only rarely supervised by a nutritionist with further consequences on nutritional status.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of autism spectrum disorders

Exclusion Criteria:

* Age at enrollment \<24 or\> 48 months.
* Concomitant presence of other chronic diseases
* epilepsy,
* neurological syndromes,
* immunodeficiencies,
* diabetes,
* congenital heart disease,
* autoimmune diseases,
* inborn errors of metabolism,
* tuberculosis,
* cystic fibrosis,
* chronic respiratory tract diseases,
* inflammatory bowel disease,
* celiac disease,
* eosinophilic pathologies of the gastrointestinal tract,
* functional gastrointestinal disorders,
* obesity,
* tumors,
* malnutrition • Major malformations or previous surgery of the gastrointestinal / urinary / respiratory tract.
Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis

The primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with PROM later than the 37+0 weeks of gestation. The secondary aim is to compare the rates of infection between immediate and delayed induction in women submitted to antibiotic prophylaxis.

In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to group A (immediate induction with antibiotic prophylaxis), group B (immediate induction without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).

Eligibility Criteria:
Inclusion Criteria:

* term (≥ 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes for less than 12 hours and a negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks.

Exclusion Criteria:

* active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis, contraindication to expectant management or to vaginal delivery
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men

Aromatase inhibition versus estradiol during 1 week


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained.
* Male subjects
* Age 18 - 40
* weight \< 120 kg

Exclusion Criteria:

* Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
* Treatment with insulin, corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine).
* Impaired renal function defined as serum-creatine \> 1.5 mg/dL
* Impaired liver function, defined as ALAT \> 2.5 times upper limit of normal
* Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the investigator
* Cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial
* Palpable prostate nodule or induration, PSA \> 3 ng/mL, prostatism, untreated sleep apnee syndrome, erythrocytosis (hematocrit \> 50%) or hyperviscosity.
* Known or suspected abuse of alcohol or narcotics
* Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
Eye Screening in German Secondary Diabetes Care Centers

In patients with confirmed diagnosis of diabetes, an eye examination and a comprehensive survey are conducted after recruitment in secondary diabetes care centers. All patients undergo a comprehensive eye examination including wide-angle fundus photograph and ocular cohaerence tomography. A questionnaire assesses the characteristics (history: diabetes duration, type of treatment), knowledge and personal attitudes of the persons affected. The relevant lab findings were collected from the electronic files.

Main focus of the study is the concordance to the national screening recommendations (last eye exam, presence of retinopathy).


Eligibility Criteria:
Inclusion Criteria:

- diabetes

Exclusion Criteria:

* mental handicap
* in the case of blindness absence of a caregiver
MRI Compared to PET/CT for Staging and Treatment Response in Lymphoma

The lymph nodes or masses,positron emission tomography/computed tomography (PET/CT) standardized uptake values(SUV) results, whole body magnetic resonance imaging(MRI) intravoxel incoherent motion(IVIM) sequence D, D\*, f values and MRI volumes of lymphoma patients were compared before and after the chemotherapy in this project prospectively to provide data for evaluating the dependency and differences of PET/CT and whole body MRI in lymphoma staging and therapeutic evaluation. Long-term therapeutic effect indexes obtained in follow-up visits of patients such as Overall Survival(OS), Progression Free Survival (PFS) etc. were used to evaluate the diagnostic sensitivity and differences of MRI and PET/CT. The research could provide a new method of nonionizing radiation iconography for physicians to give appropriate treatments and predict prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Lymphoma subtypes were diagnosed on the basis of tissue samples obtained by biopsy or surgery according to the criteria outlined in the current World Health Organization (WHO) classification of hematologic and lymphoid malignancies, by a reference pathologist.
* Patients who gave written informed consent were referred for DWI-MRI and 18F-FDG-PET/CT.
* Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging).

Exclusion Criteria:

* Pregnancy, general contraindications to MRI, and therapeutic interventions between DWI-MRI and 18F-FDG-PET/CT were used.
Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome

Chronic postoperative pain is an entity that is usually neglected by anesthetists, but several studies show that the choice of anesthetic technique may interfere with this prevalence. Esmolol is a selective beta-blocker of ultra fast duration that has been studied as a perioperative venous adjuvant with antihyperalgesic and opioid sparing action. The investigators ventured the possibility of this anti-hyperalgesic effect attenuating the chronic pain syndrome post-mastectomy.


Eligibility Criteria:
Inclusion Criteria:

- Patients previously submitted to the study Analgesic Effect of Intraoperative Esmolol in Mastectomies: a randomized placebo controlled trial

Exclusion Criteria:

* Patient aged less than 18 years and over 65 years;
* Patients who refuse to participate in the study;
* Patients with pulmonary disease;
* Patients with cardiac, renal or hepatic disease;
* Use of psychoactive drug;
* Patients with sinus bradycardia;
* Pregnant women;
* Patients with allergy to dipyrone, morphine;
* Patients with chronic pain prior to the surgical procedure;
* Patients with neurological disorders;
* Patients undergoing surgical resurfacing
Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV

The goal of this phase II, open-label, randomized, controlled clinical trial is to evaluate the impact of Gammora®, a 16-mer HIV integrase-derived peptide associated with a boosted darunavir antiretroviral regimen compared Gammora® arm) to a boosted darunavir antiretroviral regimen only (control arm) in the estimated HIV reservoir among antiretroviral naïve people living with HIV. The main questions it aims to answer are:

1. Will the proviral (total) HIV-1 DNA decrease rapidly in the Gammora® arm compared to the control arm?
2. Will the apoptosis markers evaluated in the CD4+ T cell by flow cytometry increase in the Gammora® arm compared to the control arm? Forty antiretroviral naïve viremic people with HIV with CD4+ T cell counts \>350 cells/mL will be randomized to receive 20 mg of Gammora® in 2mL SC solution plus Tenofovir/3TC and Darunavir 800mg+Ritonavir 100mg (Gammora® arm) or antiretroviral only (control arm). In the Gammora® arm, participants had a 2-week Gammora® monotherapy lead-in period with Gammora® given daily before antiretroviral treatment is started, followed by 12 weeks of antiretroviral therapy plus Gammora® given every other day. The first two weeks of the trial (lead-in period for the Gammora® arm) were labeled w-2 and w-1 for both groups, and blood samples were collected for both groups. w0 denotes the week ART was started in both arms.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed HIV infection;
2. Antiretroviral naive;
3. HIV Viral load \> 1.000;
4. CD4+ T cell counts \>350 cells/mm3;
5. Body weight \> 50 Kg;
6. Signed informed consent form.

Exclusion Criteria:

1. BMI \< 18.5 kg/m2 at screening;
2. Coinfection with HBV (HBsAg +) or HCV;
3. Any significant acute illness within one week before the first visit.
4. Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within four weeks before screening;
5. Active malignancy or malignancy in follow-up.
6. Changes in safety tests: neutrophil count \< 1,000 u/L; Hb \< 9.0 gm/dl; platelet count \< 75,000 u/L; creatinine \> 1.5 mg/dl, direct bilirubin \> 85 μmol/L, AST or ALT \> 2.5 X UNL;
7. Potential allergy or hypersensitivity to the components of the Gammora® formulation.
8. Participation in another clinical trial within 12 months before screening.
9. Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the investigator's discretion.
A Clinical Study of Hyperthyroidism in Children

This study intends to conduct a retrospective and prospective study on children with hyperthyroidism, and it is a non-intervention study to collect information on diagnosis and treatment and long-term follow-up of children with hyperthyroidism. To investigate the clinical characteristics, treatment effect, side effects and remission of hyperthyroidism in children, to analyze the predictive factors for the effect of antithyroid drug treatment, remission and recurrence after drug withdrawal, and to explore the risk factors related to the occurrence of antithyroid drug-related adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≤14 years old
2. Initial diagnosis of hyperthyroidism

Exclusion Criteria:

1. Hyperthyroidism had been treated with medication in other hospitals,
2. History of autoimmune hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation,
3. Patients with incomplete clinical data
HBOT Global Functioning After Stroke

Stroke is one of the leading causes of disability and death in North America and Europe. Up to 30% of stroke survivors never recuperate completely and suffer from loss of function and poor quality of life. To improve recovery after stroke, innovative interventions should be a priority.

Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than 1 absolute atmosphere (ATA). There is a growing body of evidence that HBOT can enhance ability of brain to changes its structure (neuroplasticity) in order to recover. Exercise program during HBOT can augment the effect. Although, recent randomized controlled trials in patients with chronic brain injury showed promising results, there are no studies demonstrating combine effect HBOT and exercise rehabilitation program on stroke recovery.

The proposed study investigates feasibility, safety and efficacy of using a combination of HBOT and exercise program to improve arm function recovery in chronic stroke patients. In this pilot randomized control trial, investigators will compare the combination of HBOT and the focused rehabilitation exercise program versus exercise program alone on recovery of arm function in patients with chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* history of ischemic or hemorrhagic stroke 6-48 months confirmed by CT
* arm hemiparesis/hemiplegia
* Chedoke-McMaster Stroke Assessment Scale 3-6
* ability to follow verbal commands

Exclusion Criteria:

* women with positive pregnancy test or plans to become pregnant during the study period
* severe cognitive dysfunction (The Mini Mental State Examination \<24 )
* claustrophobia
* seizure disorder
* active asthma
* severe chronic obstructive pulmonary disease
* history of spontaneous pneumothorax
* history of severe congestive heart failure with left ventricular ejection fraction \< 30%; unstable angina
* myocardial infarction (within the last 3 months)
* chronic sinusitis
* chronic acute otitis media or major ear drum trauma
* current treatment with bleomycin, cisplatin, doxorubicin and disulfiram
* participation in another investigative drug or device trial currently or within the last 30 days
SmartConsent: A Computerized Informed Consent for Patients

SUMMARY:

The purpose of this study is to learn how to better educate patients about oral health procedures and treatments through an improved informed consent process. We will gather information from patients and health care providers, and design and test a computerized consent system called SmartConsent.

HYPOTHESIS:

1. Subjects who use SmartConsent will have increased knowledge (cognitive achievement) about oral health disease and treatment than patients who view the standard consent
2. Subjects who use SmartConsent will have less decisional conflict in their decision regarding an oral health procedure than those who view the standard consent form
3. Subjects who use SmartConsent will have greater visit satisfactions scores than those who view the standard consent form

Communicating personalized information to patients about the risks, benefits and other critical information about dental disease and treatment is often difficult for providers. In this proposal we seek to develop a novel informed consent system that can accurately translate and communicate information to patients in a standardized and effective manner based on their diagnosis and prescribed treatment. We aim to integrate SmartConsent into the institutional electronic patient record (EPR). This research is translational as it seeks to determine how providers can better communicate information to patients so they can make appropriate decisions about dental treatments and options.

The advent of electronic health records allows an informed consent document to be automatically personalized based on a patient's demographic profile, literacy level, language preference, and prior medical history. A computerized consent also allows the presentation of information in a format beyond text such as through the use of multimedia. Further, in a computer-based consent, we can quickly test a patient's knowledge about a diagnosis and procedure to ensure that key information has been delivered. In this proposal we seek to discover if a computer-based informed consent is more effective in educating patients about common oral health disease and treatment (e.g., reason for extracting a tooth, causes of periodontal disease, risks associated with dental implants). We also seek to determine its feasibility in a real clinical practice by measuring time taken and impact on workflow compared to the traditional consent process.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* English-speaking
* Diagnosis of pulpal disease

Exclusion Criteria:

* Treatment required referral outside of clinic
A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)

To compare the safety and IOP-lowering efficacy of TRAVATAN and XALCOM in subjects with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Patients of any race and either sex with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension.
Distances From Cricoid Cartilage to the Targets of Stellate Ganglion Block

Stellate ganglion block targets are C6 transverse process or C7 transverse process in anterior paratracheal approach which is most popular method. Cricoid cartilage is known that it is located at C6 level in supine neutral position of the neck. But stellate ganglion block is performed in supine extended position of the neck. So cricoid cartilage will move up to cephalad direction and pain doctors should find C6 or C7 transverse process at lower neck area than cricoid cartilage.


Eligibility Criteria:
Inclusion Criteria:

* adults above age of 20 reserved for musculoskeletal ultrasonography

Exclusion Criteria:

1. past history of neck surgery
2. the limitation of neck motion due to rheumatoid arthritis, et al.
3. severe neck pain
4. inability to communicate or read or write
Micardis® / MicardisPlus® Program for Therapy Optimization With Telmisartan in Cardiovascular Diseases (PROTEKT)

Study to evaluate efficacy and tolerability of Micardis®/MicardisPlus® under usual daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the clientele of cardiologists, nephrologists, and diabetologists


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years

Exclusion Criteria:

* Age \< 18 years
Management of Drug Hypersensitivity in Children

The aim of this study is (1) to assess the incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic; (2) to evaluate the diagnostic values of the different allergy tests available; (3) to investigate the pathophysiology of drug allergies, particularly by investigating the role of viruses, and by performing HLA typing and a gene expression profile both in the acute phase of the reaction and 2 months later.


Eligibility Criteria:
Inclusion Criteria:

* Participation will be proposed to any children (0 to 16 years) receiving one or several drug(s) and developing one of the following clinical manifestations: urticaria, maculopapular rash, bullous eruption, flush, anaphylaxis, serum sickness-like disease, SJS, TEN, DRESS or fever linked to drug intake.

Exclusion Criteria:

* Patients will be excluded if the symptoms occur more than 72 hours after any treatment was stopped or if the symptoms are clearly linked to another cause (measles, rubeola, roseola, varicella, fifth disease, Gianotti-Crosti syndrome, scarlet fever, Gibert's pityriasis or food allergy).
Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients

The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.

To investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis. Patients with liver cirrhosis were randomly separated into two groups. Umbilical cord MSCs were infused to patients using interventional method via hepatic artery for One group. After the catheter placed at proper hepatic artery was confirmed by angiography, umbilical cord MSCs were infused slowly for 15-20minutes. The control group accepted conserved therapy.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18\~70 years.
* Liver cirrhosis
* written consent

Exclusion Criteria:

* The end-stage of liver cirrhosis.
* Severe problems in other vital organs(e.g.the heart,renal or lungs).
* Hepatocellular carcinoma or other malignancies
* Pregnancy
* sepsis
* Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
* Cardiac, renal or respiratory failure
* Active thrombosis of the portal or hepatic veins