cyrilzakka/clinical-trials huggingface dataset:
Subclinical Atherosclerosis in HIV-infected Patients

We will obtain data using multi-slice CT technology to detect subclinical coronary disease in the HIV population. Determination of subclinical cardiovascular disease using noninvasive technology and elucidation of the associated risk factors will help to guide targeted therapy to prevent cardiovascular events in this patient population.

We will investigate the prevalence of coronary plaque lesions and coronary artery calcifications in men and women with HIV disease as determined by 64-row multidetector computed tomography (MDCT) and MDCT coronary angiography in comparison to age-matched control subjects without HIV infection. We hypothesize that evidence of coronary artery calcification and coronary plaque lesions as seen by MDCT will be present in individuals with HIV more than non-HIV control subjects of the same age. We also hypothesize the degree of atherosclerosis will be increased in HIV patients compared to control subjects.

We will evaluate the metabolic and inflammatory factors associated with coronary artery disease in HIV-infected individuals. We hypothesize that traditional cardiac risk factors as well as metabolic and inflammatory changes associated with HIV and its treatment such as dyslipidemia, increased secretion of inflammatory markers, decreased adiponectin, increased insulin resistance and increased visceral fat may be associated with coronary artery disease in HIV-infected individuals.


Eligibility Criteria:
Inclusion criteria for HIV infected subjects arm:

1. Men and women age 18-60
2. BMI 20-35
3. Previously documented HIV disease for 5 years or longer either on stable highly active anti-retroviral therapy (HAART) or not on HAART.
4. No changes in antiretroviral regimen within the prior 3 months.

Inclusion criteria for non-HIV infected control subjects arm:

1. Healthy men and women age 18-60
2. BMI 20-35

Exclusion criteria for both arms:

1. Previously diagnosed coronary artery disease, cerebrovascular disease, or peripheral vascular disease.
2. Use of glucocorticoids, growth hormone, testosterone, or other anabolic agents within past 6 months
3. Renal disease or creatinine \>1.5 mg/dL
4. Anti-inflammatory medications
5. Opportunistic infection within past 6 months in HIV infected individuals and current acute infectious illness in both HIV-infected subjects and normal controls.
6. Nitrates or others medications that can alter endothelial function
7. Contraindication to beta-blocker use
8. Body weight greater than 300 lbs due to DEXA scanner table limitations
9. Patients with previous allergic reactions to iodine-containing contrast media or to iodine will be excluded from participation
10. Active illicit drug use
11. Pregnancy or breastfeeding
12. Estrogen or progestin use
Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting nearly 0.4% of the general population. It is a real public health issue. International guidelines recommend strict control (remission or low disease activity) of the disease, to avoid joint destruction in order to reduce the functional impact of the disease in the long term and to improve the quality of life of the patients.

This care is based on a close follow-up requiring regular visits with the specialist which represents an additional cost (transport, visits). In this context, tele-medicine is often proposed as a complementary approach in the management of these chronic patients.

Thus, the investigators propose to study the interest of a connected device by comparing a group of patients using this Smartphone application, coupled with a hand dynamometer during the 6 months following initiation of a new DMARD.


Eligibility Criteria:
Inclusion Criteria:

* • Patients between 18 and 75 years old with rheumatoid arthritis according to 2010 ACR (American College of Rheumatology) / EULAR Classification Criteria

  * Patients that need a treatment initiation for rheumatoid arthritis
  * Patients with DAS 28 \> 3.2 (Disease Activity Score )
  * Patients who agreed to participate in this study and provide the informed consent

Exclusion Criteria:

* • Insufficient level of understanding to perform the measurement and self-report questionnaires

  * Patients without an internet connection
  * Difficulties in using a dynamometer due to a dominant-hand surgery done during the previous 12 months, carpal tunnel symptoms, or ulnar nerve compression, or cervicobrachial neuralgia, known presence of motor dysfunction of the upper extremity, or neurological disease
  * Pregnancy
Ketamine-ketorolac Versus Fentanyl- Ketorolac I.M in Children During Bone Marrow Biopsy

investigators aim to compare between anaesthetic regimens that included dual-agent (fentanyl and ketorolac) or (ketamine and ketorolac) analgesic therapy

regarding patient registry; a prior G power analysis was done. Based on the assumption that the pain score in intramuscular ketamine group will be similar to similar to those in previously published data; forty children would be required per group to detect a difference of 30% in CHEOPS pain scores with a power of 90% (α =0.05, β =0.1)

- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences), program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain and emergence behaviour scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status II

Exclusion Criteria:

* Any known allergy to the studied drugs.
* congenital heart disease
* Any cardiac problems.
* Use of psychotropic medication
* mental retardation
* any organ dysfunction
Sensing Ventricular Arrhythmias by His Bundle Leads

The purpose of this trial is to determine if implantable cardiac device leads implanted in the His bundle are capable of detecting ventricular arrhythmias.

During routine testing of implanted leads, the His bundle lead will be connected to a separate device with all therapies disabled. Testing will be done to see if the His bundle lead can detect ventricular arrhythmias.

Eligibility Criteria:
Inclusion Criteria:

* Individuals undergoing routine defibrillation threshold testing of a right ventricular implantable cardioverter defibrillator lead who also have previously placed His bundle lead or who are undergoing placement of a His bundle lead.

Exclusion Criteria:

* Individuals with contraindications to defibrillation threshold testing
Rotigotine Effect on Nocturnal Hypokinesia Compares to Placebo Control: A Quantitative Assessment by Wearable Sensors

Parkinson's disease (PD) is the neurodegenerative disease which is caused by Lewy bodies deposition in central and peripheral nervous system. The mains symptoms include both motor and non motor symptoms such as bradykinesia, rigidity, rest tremor, postural instability, autonomic dysfunction or neuropsychiatric symptoms. Moreover, the PD symptoms not only occur in the daytime, but also in the nighttime. The nighttime symptoms or nocturnal symptoms can make the patients disabling as well as the daytime symptoms. The bradykinesia that occurs in the nighttime is called nocturnal hypokinesia which also make many serious consequences such as bedsore, falling or aspiration or death.

In this study, the investigators aim to study the effects of rotigotine transdermal patch compare to placebo on mainly the aspect of nocturnal hypokinesia.

The investigators recruited PD patients who had history of nocturnal hypokinesia and randomized by running number (blind) into 2 groups including active and placebo group. Baseline demographic, disease characteristics, nocturnal questionnaires and wearable nocturnal sensors data were collected before drug titration. In active group, participants received the rotigotine transdermal patch titration from 2 mg/day to maximum dosage which participants had no side effect or 16 mg/ day every week. In placebo group, participants would get the placebo patch titration as the active group. After participants got maintenance dosage, participants would get the physical examination, nocturnal questionnaires and wearable nocturnal sensors as before study.

Eligibility Criteria:
Inclusion Criteria:

* Patients: PD patients (age ≥ 18 years) who have history of nocturnal hypokinesia
* Patients not taking levodopa were eligible for study
* Patients who taking immediate- released levodopa,they had been on a stable dose for 28 days prior to baseline assessment and during the study
* Patients did not use control-released L-dopa at bedtime

Exclusion Criteria:

* History of narcolepsy, excessive daytime sleepiness, sudden onset of sleep
* History of hallucination, dementia and psychosis
* Evidence of ICDs
* Clinical relevant to cardiovascular disorders (including prolonged QTc ≥ 500 ms, recent MI)
* History of seizure or stroke in the past 1 year
* Patients had participated in other clinical trial in the past 28 days
Phase I Clinical Trial of 68Ga-NOTA-SNA002

The clinical trial was a single-center, dose-increasing, open trial.In this clinical trial, 68Ga-NOTA-SNA002 was injected intravenously to observe its safety tolerance, radiation absorption dose, distribution characteristics, etc. in patients with solid tumors.

The study consisted of four phases: screening period , baseline period , trial period and safety follow-up period .

Screening period 2 weeks before the start of the trial, all eligible subjects were selected to participate in the clinical trial. The informed consent signed by the subjects is required before performing all the examinations in this clinical trial.

Baseline period The admission criteria were checked again, and the subjects were enrolled on the same day after the check.

Trial period Including drug administration, blood collection, image collection and pathological tissue collection.

Safe follow-up period All adverse events and drug combinations are processed and recorded during this period.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old (including boundary values);
2. Those who have behavioral capacity, voluntarily participate in this clinical study, and sign an informed consent form (ICF);
3. Physical condition (ECOG) score 0-2 points;
4. Basal heart rate 60\~100 beats/min (including the boundary value, which refers to the seated heart rate of the patient in a calm state);
5. Blood pressure measurements \< High blood pressure level 1 (includes a history of high blood pressure, systolic blood pressure treated with exercise or medication; 140 and diastolic blood pressure\< 90mmHg); Specialty situation
6. Patients with confirmed solid tumors (including but not limited to non-small cell lung cancer, breast cancer, head and neck squamous cell carcinoma, malignant melanoma) with or without metastatic tumors;
7. Patients whose imaging findings indicate that at least one target lesion is measurable and can be biopsied (CT, MRI, or 18F-FDG PET-CT results are acceptable);
8. Pathological findings were obtained within the previous 1 year.

Exclusion Criteria:

1. Patients who are unable to perform visits or undergo relevant examinations, operations or biopsies in accordance with the clinical trial protocol;
2. Poor nutritional status, screening BMI\< 18.5, can not tolerate the test;
3. People with known or suspected evidence of active autoimmune disease (e.g., vitiligo, diabetes, residual hypothyroidism due to autoimmune disease requiring hormone replacement therapy only, autoimmunological disease such as psoriasis that does not require systemic treatment), Or diseases that are not expected to recur in the absence of external triggers are allowed to be included in the study);
4. Patients who take large doses of hormones, such as hydrocortisone or 5mg prednisone in the morning and hydrocortisone or 2.5mg prednisone in the evening;
5. Patients with serious diseases or other malignant tumors (except those who have been cured one year ago or do not require additional treatment);
6. People with known severe allergy to 68Ga-NOTA-SNA002, similar drugs or excipients.
Effect of Tahneek on Hypoglycemia in Newborn Infants

Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. Neonatal hypoglycemia is common in the first few days after birth. Up to 15 % of normal newborn babies will have low blood glucose concentrations. It has been demonstrated that treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing the hypoglycemia, and also reduced the rate of NICU admission. investigators study is using dates to asses its effect on hypoglycemia in infants at risk.

Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. It is a noble practice in Islam, with which the newborn is greeted upon entering into life, usually before milk feeds. It is done by rubbing a softened date on the palate of the new-born just after the birth. The tahneek also exercises the muscles of the mouth and helps with the circulation of blood in the mouth - this may help the baby to be able to suck and take mother's milk. Neonatal hypoglycemia is common in the first few days after birth. Up to 15 % but the incidence in babies with risk factors is much greater upto 50 % in infants of diabetic mothers, large and small babies and 66 % in preterm babies. Neonatal hypoglycemia is associated with brain damage, death and developmental delay in later life. Treatment of neonatal hypoglycemia with oral dextrose gel was more effective than feeding alone in reversing hypoglycemia, and thus reducing the rate of NICU admission for hypoglycemia. investigators study is using dates to asses its effect on hypoglycemia in infant at risk.

Eligibility Criteria:
Inclusion Criteria:

* Babies at risk of hypoglycemia less than 1 hour old admitted to the normal nursery.
* Infants of diabetic mothers (any type of diabetes)
* Late Preterms (34 - 37 weeks' gestation)
* Low birth weight (\< 2.5 kg ) or Small for gestational age
* Large for gestational age (\> 4 kg or \> 90th centile on Fenton's growth chart)

Exclusion Criteria:

* Major congenital abnormality including severe cleft lip and palate.
* Babies requiring NICU admission immediately after birth
* Babies less than 34 weeks of age.
* Babies whose parents refused to consent
Transfusion for Major Haemorrhage in Trauma - Characteristics and Outcomes

Background: Trauma is the leading cause of death in young adults worldwide and the most common causes of mortality are haemorrhage and brain injury. About 40% of trauma related deaths are due to massive haemorrhage and approximately 30% of trauma patients have an associated trauma induced coagulopathy. In order to improve outcome, the optimal care for the bleeding patient need to be further understood.

Aim: The overall aim of this project is to evaluate characteristics and outcomes in patients receiving blood transfusion in the early phase after major trauma at a Level 1 trauma center in Sweden.

The specific aims are:

i) To describe outcome, characteristics and effects on the coagulation system in patients receiving early blood transfusion compared to those not receiving transfusion in the early phase.

ii) To describe outcome, characteristics and effects on the coagulation system in patients receiving prehospital blood transfusion compared to patients where transfusion is initiated in the trauma unit.

iii) To describe the effect from concurrent treatment with procoagulant drugs and intravenous fluids on outcome, characteristics and effects on the coagulation system in patients receiving blood transfusion after major trauma.

Method: This is an observational study of trauma patients admitted to the Trauma Unit at the Karolinska University Hospital Solna, Stockholm, Sweden. Data from patients receiving blood transfusion (erythrocytes, plasma or whole blood) in the early phase of the resuscitation will be collected. All patients receiving transfusion within two hours from arrival will be included. Data on trauma details, injuries, physiological parameters, coagulations tests and treatment will be collected prospectively and from existing registries. The control group will consist of patients not receiving transfusion during the first two hours of care.


Eligibility Criteria:
Inclusion Criteria:

* All trauma patients admitted to the trauma unit at the Karolinska University Hospital Solna.

Exclusion Criteria:

* Patients with injuries från hanging, drowning, burns or smoke inhalation.
Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke

Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.

This is a randomized sham-controlled trial reported following the 2010 CONSORT guidelines. The subjects were randomly allocated into 1 of 4 groups in a double-blinded parallel study design. Each patient received 10 sessions (5 consecutive days for 2 weeks) of real or sham stimulation at 2 mA intensity and current density equivalent to 0.05 A/m2.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute stroke
* Able to walk 10m independently
* High risk of falling

Exclusion Criteria:

* Severe functional limitations
* Cognitive impairment
Observe Alternating Hemiplegia of Childhood (OBSERV-AHC) Study

Alternating Hemiplegia of Childhood (AHC) is a rare and serious disease that is in need of effective, and hopefully even curative, therapies. Afflicted patients suffer from severe paralyzing crises, often excruciatingly painful muscle spasms, severe often life threatening epileptic seizures, and frequently severe developmental and psychiatric/psychological disabilities. Based on the repeated input from family organizations and from professionals, as expressed at the London 2016 ATP1A3 in Disease meeting, there are urgent clinical research needs for AHC that are essential to better understand the disease, evaluate its treatment options and plan for future controlled clinical trials.

The goal of the study is to evaluate different parameters involved in the evolution of the AHC. The investigating team's hypothesis is that the evolution is variable so it aims to evaluate the factors which could contribute to the progression of the disease.


Eligibility Criteria:
Inclusion Criteria:

- Patients who fit the Aicardi Alternating Hemiplegia of Childhood clinical criteria of any age. The Aicardi Criteria are six :

* Paroxysmal hemiplegia episodes.
* Bilateral hemiplegia or quadriplegia episodes.
* Other paroxysmal manifestations, such as abnormal eye movements, nystagmus, strabismus, ataxia, dystonia, choreoathetosis, tonic spells, or autonomic disturbances.
* Evidence of permanent neurological dysfunction, which can manifest as cognitive impairment, developmental delay, and/or persistent motor deficits such as spastic diplegia/quadriplegia, hypotonia, ataxia, choreoathetosis, or dystonia.
* Sleep relieves symptoms, although attacks may resume soon after awakening.
* First signs of dysfunction occur prior to the age of 18 months.

Exclusion Criteria:

* Patients who do not have a mutation of the ATP1A3 gene and having only some of the above criteria
* Patients and / or their parents / legal guardian having provided their opposition to the study.
* Incapacity of patient / parent or other referent adult to participate in the prospective phase of observation of different paroxysmal events of the disease and in the scoring of the Vineland II adaptive behavior scales.
* Diagnosis of another disease, which could explain the presence of symptoms mentioned in the criteria of Aicardi.
EUS Glue vs Endoscopic Variceal Band Ligation for Prevention of Rebleeding in Patients With HCC and EV Bleeding: a Retrospective Comparative Study

SP by EUS-CYA improves clinical outcomes (eg, EV rebleeding) in patients with HCC and prior EV bleeding when compared with SP by EGD-VBL

Variceal bleeding is a life-threatening complication in patients with portal hypertension and cirrhosis. Rebleeding is common in patients who survive the acute variceal bleeding episode without secondary prophylaxis (SP). Hepatocellular carcinoma (HCC) and portal vein thrombosis (PVT) are associated with recurrent variceal bleeding and worse clinical outcomes. Rebleeding rates of esophageal varices (EV) and gastric varices (GV) remain substantial in HCC patients despite conventional endoscopic treatments.

Lack of SP was associated with a higher rate of rebleeding and mortality in a multicenter study of HCC patients with prior EV bleeding. SP of variceal rebleeding in suitable HCC patients has been suggested in the latest practice guideline of the American Association for the Study of Liver Diseases, but the optimal endoscopic approach for SP in HCC patients has not been well defined. Whether conventional strategies such as variceal band ligation (VBL) or cyanoacrylate (CYA) injection for EV can achieve durable variceal control in HCC patients remains unclear since HCC patients were often excluded from clinical trials. This remains a pertinent issue as recent advances in the treatment of advanced HCC with tyrosine kinase inhibitors (TKI) and immunotherapy means that some patients may achieve reasonable survival and benefit from further variceal management.

Recently, endoscopic ultrasound (EUS) guided variceal interventions by CYA, coiling, or a combination of both have gained clinical attention due to its high clinical success. When compared with conventional endoscopic variceal treatments, EUS guided variceal interventions allow real-time confirmation of intra-variceal delivery of therapy and flow obliteration after treatment. A recent study from our group reported that SP by EUS-CYA reduced rebleeding rate and improved variceal bleeding-free survival in patients with inoperable HCC and variceal bleeding when compared with no SP. However, there has been no dedicated study comparing the clinical outcomes of SP by EUS guided CYA (EUS-CYA) or conventional VBL by esophagogastroduodenoscopy (EGD) in patients with HCC and EV bleeding. Therefore, we propose this retrospective study to compare the clinical outcomes after EUS-CYA or EGD-VBL for SP of EV rebleeding in this often difficult-to-treat patient group with HCC.

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive HCC patients with history of EV bleeding who underwent EUS guided cyanoacrylate injection or variceal band ligation by EGD for secondary prophylaxis to prevent EV rebleeding
2. Age \> 18 years

Exclusion Criteria:

1. HCC patients with non-variceal upper GI bleeding
2. HCC patients with history of EV bleeding who did not undergo further endoscopy for secondary prophylaxis for EV rebleeding