cyrilzakka/clinical-trials huggingface dataset:
Efficacy, Tolerability, and Safety Study of DFN-15

Efficacy, Tolerability, and Safety of DFN-15 in episodic migraine with or without aura, being conducted at multiple centers in the United States.


Eligibility Criteria:
Inclusion Criteria:

1. A history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks.
2. Patients who have migraine with or without aura with onset before age 50 years
3. Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.
4. Subjects who are willing and able to:

   1. Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
   2. Record each instance of the use of study drug and rescue medication in real-time using a subject eDiary for the duration of the study;
   3. Comply with all other study procedures and scheduling requirements.

Exclusion Criteria:

1. Minors, even if they are in the specified study age range
2. Medication overuse:

   1. Opioids greater than or equal to 10 days during the 90 days prior to screening
   2. Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during the 90 days prior to screening (applies only if includes opioid and/or barbiturate)
   3. Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
   4. Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening
3. Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).
4. Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.
5. Patients who have received treatment with an investigational drug or device within 30 days of randomization, or participated in a central nervous system clinical trial within 2 months prior to randomization
6. Patients with positive screening test for human immunodeficiency virus \[HIV\], positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus \[HCV\] antibody
7. Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the clinical research study site.
Effects of Virtual Discrete Trial Training on Children With Autism Spectrum Disorder

Autism spectrum disorder (ASD) is a neurodevelopmental disorder categorized by deficits in social communication and the occurrence of restricted interests and repetitive behaviors. The cautionary needs of children with ASD are significant, it affects parents and siblings as well and requires substantial social support. If adequate intervention is not provided to children with ASD on time, then they may face many difficulties for example in academic work. They face social isolation and may develop additional challenging behaviors. Applied behavior analysis (ABA) is one of the most commonly used supported treatments for autism spectrum disorder. Discrete Trial Training (DTT) is one of the most structured Applied Behavior Analysis (ABA) types. DTT is the best standardized therapy for ASD. The ABA explores human interactions with their environment over time and develops interventional strategies to diminish the decline in the troublesomeness of social behavior among individuals with ASD. DTT through video training Program will be an effective in improving the communication skills of children with ASD. The video training program offers excellent accessibility and is inexpensive because it can be administered remotely and at home as well. It also reduces the resource barrios.

A randomized controlled study was conducted on children aged between 3-10 years diagnosed with ASD at PSRD hospital having Different severity levels. DTT was provided through a video training program using digital technology with informed consent from their caregivers/parents. The sample size was 10. Both groups contain 5 participants. The treatment group will be trained on DTT through the video training program. Sessions were conducted thrice a week for 45 minutes. The duration of the experiment was 12 weeks. The control group did not intervene with the video training program during the experiment. Pre \& Post language assessment was done through British Picture Vocabulary Scale.


Eligibility Criteria:
Inclusion Criteria:

* Age range between 3-10 years.
* Clinically diagnosed children from Psychologists were taken for study who had 2-3 words in vocabulary or no vocabulary at all.
* Each group received 3 weekly sessions for 45 minutes for 12 weeks.
* Video training was given through animated videos.

Exclusion Criteria:

* Children with any comorbidities e.g. Intellectual Disability, Cerebral Palsy, Attention Deficit Hyperactive Disorder, Down's Syndrome and Hearing Impaired children will exclude from this study.
* Children diagnosed with severe autism.
Multicenter Registry Study Of Cerebral Venous Thrombosis In China (RETAIN-CH)

This study will investigate the epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of cerebral venous thrombosis in China.

The epidemiology, risk factors, diagnosis and treatment of Cerebral Venous Thrombosis (CVT) in China are still unclear. A retrospective hospital-based study will be conducted at fifty different hospitals across 31 provinces in China. This study will use ICD-10 to search patients diagnosed with CVT between January 1, 2018 and June 15, 2022 across 31 provinces and municipalities of 104 hospitals in China. Risk factors, clinical and radiological findings, treatment and short-term outcomes will be recorded from the hospital record system. Finally, a prospective follow-up will be conducted for all of the patients enrolled above. By combining data collected from retrospective hospital records with the new follow-up, it will be possible to better understand the epidemiology, risk factors, diagnosis, treatment and the long-term prognosis of CVT in China.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral venous sinus thrombosis, deep cerebral vein thrombosis and cortical vein thrombosis diagnosed by digital subtraction angiography (DSA), magnetic resonance venography (MRV), computed tomography venography (CTV) or high-resolution magnetic resonance imaging (HR-MRI).

Exclusion Criteria:

* None of the patient, trustee or immediate family members signed the informed consent.
Intervention Study on Molibdenum Biofortification Vegetables ( Nutri-Mo-Food )

The aim of the project is to study of the influence of Lettuce crop enriched with Molibdenum on hematological parameter. Secondary outcome to find out Molibdenum presence in urine in order to evaluate vegetables, like little crop, as Molibdenum biocarrier.

everal human pathologies are caused by deficiencies of some mineral elements. These deficiencies can be overcome through careful dietary diversification and mineral supplementation. An alternative or even complementary way is represented by the intake of bio-fortified foods. In the field of mineral deficiency increasing the bioavailable mineral concentration in vegetables intended for human consumption; can be a useful tool to prevent many harmful pathologies. Therefore, in this scenario, it appears very important to identify the right dosages and the most effective methods of administration to bio-fortify vegetables with a strong nutritional-health connotation.

The present project aim to investigate the benefits of fortified food intake in a cohort of healthy individuals. Specifically, we have fed healthy individuals with lettuce enriched with Molibdenum and collected plasma and urine samples after 7-10 days. Each subject was subjected to two venous blood samples taken at the beginning of the observation and at the end. The samples thus obtained will be transported in certified containers for the safe transport of biological samples, and, subsequently, processed by the experimenters at the laboratories of the Molecular Biology section of the University of Palermo. Serum and plasma will be obtained from each blood sample. All information thus obtained will be recorded in a database in which each person will be identified with a numerical code, in order to comply with current privacy regulations. Body weight, Barefoot standing height, Body mass index, Body composition will be measured in the different groups of study. Samples will be analyzed and compared for glucose, albumin, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, uric acid, creatinine, AST, ALT, γ-GT, ALP, bilirubin, Ferritin, free Iron, transferrin, total proteins, Magnesium, Calcium, insulin, osteocalcin, hematocrit, hs-CRP, Bone metabolism (Osteocalcin, parathyroid hormone, CTX, Calcitonin), Vitamin D Calcium, Phosphate, Potassium, gastric hormones ( GIP, GLP1, GLP2, ghrelin, glucagon, PYY, CCK) oxidative stress markers (LDL-ox, AGE, urinary 8-iso-prostaglandin F (PGF)2alpha) and inflammatory markers(IL-1, TNF, IL-6, IL-10)

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* age: 18-65 years
* healthy status
* no drug therapy or integration therapy

Exclusion Criteria:

* Inflammatory chronic disease
* use of medication or suffering from any condition
* pregnancy
* breastfeeding
* current smokers
Evaluation of a XIENCE V® Endoprothesis Used for Coronary Angioplasty, for LPPR (List of Reimbursable Products and Services) Indications in Patients Monitored for 2 Years in France

The objective of this study is to prepare elements of response to the Haute Autorité de Santé (High Health Authority) of France, which is expecting data relating to the routine use of XIENCE V® endoprothesis within the 5 years following its marketing.


Eligibility Criteria:
Inclusion Criteria:

All patients enrolled in the study must :

* be at least 18;
* be covered by Social Security
* agree to be enrolled in the study (sign the informed consent after reading the information letter).

In addition, the Xience V endoprothesis implantation must be performed following the LPPR indications here under :

Treatment of coronary heart disease attributable to de novo lesions (reference vessel with a 2.5 to 3.5 mm) of native coronary arteries, solely in the following groups of patients :

* patients with diabetes ;
* lesions of small vessels (diameter \< 3 mm);
* long lesions (longer than 15 mm) ;
* stenosis of proximal anterior intraventricular septum .

The use of the Xience V stent is limited to one per patient, except :

* in case of acute occlusive dissection where three stents, maximum, may be covered ;
* for the pluritroncular diabetic patient, in case a bypass is contra-indicated : a stent per artery, with a limit of three per patient, may be covered.

Exclusion Criteria:

* Pregnant women
* Patients with:

  * a non cardiac vital prognosis endangered during the year following the implantation ;
  * less than 72 hours myocardial infarction ;
  * lower left ventricular ejection fraction \< 30 % ;
  * an allergy to the platelets antiaggregant treatment, to heparin, chrome cobalt alloy, or to the angiography contrast medium ;
  * a stenosis of the unprotected common trunk;
  * a lesion with calcifications that cannot be pre-dilated;
  * a thrombus that can be detected by angiography on the lesion to be treated ;
  * an intra-stent re-stenosis.

Are also excluded :

* patients having had an angioplasty with implantation of an endoprothesis on the same vessel;
* patients having had an angioplasty with implantation of an endoprothesis during the 6 previous months ;
* Patients unable to keep a treatment associating aspirin and thiénopyridines for at least 6 months;
* Patients residing abroad or who cannot be monitored according to the modalities of the study ;
* Patients unable to give on their own free will their informed consent ; On the other hand, in absence of clinical validation, the other sub-groups of at risk patients (notably bifurcation lesions and pluritroncular lesions) cannot be considered , taken alone, as indications for the use of Xience V.
Hypomethylating Agent and Venetoclax After Allo-HSCT in Patients With High-risk Myeloid Malignancies.

The main objective of the study is to evaluate the efficacy and safety of maintenance therapy with hypomethylating agent and Venetoclax to improve leukemia free survival for high-risk myeloid malignancies after allogeneic hematopoietic stem cell transplantation .

This is a prospective single-arm study. Patients with high-risk AML or MDS aged between 18-70 years old will enroll in the study. They will be given hypomethylating agents (azacytidine 32mg/m2 or decitabine 5mg/m2) for 5 days and venetoclax 400mg/d for 7 days after allogeneic hematopoietic stem cell transplantation. The maintenance therapy will start from 60th days posttransplant, repeated every 28 days until up to 1-year posttransplant. The 1-year leukemia-free survival rate，1-year cumulative recurrence rate, and 1-year overall survival will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with AML or MDS and have received allogeneic hematopoietic cell transplantation;
* Patients with AML must have one of the following high-risk factors: Cytogenetics and molecular features consistent with adverse risk group by European LeukemiaNet classification for AML； require more than 2 courses of induction chemotherapy to reach complete remission； Extramedullary myeloid malignancy；≥CR2； Presence of measurable residual disease at the time of HSCT. \*
* Patients with MDS must have one of the following high-risk factors: IPSS-R scores are high-risk or very high-risk； Presence of TP53 mutation； Presence of measurable residual disease at the time of HSCT. \*
* CBC: ANC ≥ 1.0 × 10e9/L, Hb ≥ 80g/L, and PLT ≥ 50 × 10e9/L；
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

  * Presence of measurable residual disease at the time of HSCT is defined as the following: Blast percentage in bone marrow detected by flow cytometry ≥0.01%； Presence of fusion gene or mutated gene by qPCR.

Exclusion Criteria:

* Concurrent use of targeted drugs ;
* Resistant to Venetoclax before transplantation;
* Allergic to decitabine , Azacitidine or venetoclax;
* Active grade II or higher acute GVHD ;
* Active moderate or severe chronic GVHD ;
* Diseases recurrence (abnormal myeloid cells detected by flow cytometry \>0.01%, presence of WT1 or other genes, or extramedullary malignancy ), percentage of donor cells in bone marrow \<90% or graft rejection:
* CBC: ANC \< 1.0 × 10e9/L, or PLT \< 50 × 10e9/L；
* Severe organ dysfunction: Elevated Aspartate transaminase (AST) /alanine transaminase (ALT), or direct bilirubin \>3 times upper limit of normal; Creatinine clearance (Ccr)\<50mL/min or serum creatinine \>1.5 times upper limit of normal, whether hemodialysis treatment is performed;
* Active uncontrolled systemic fungal, bacterial, or viral infection
* Pregnant or lactating women;
* Other severe complications and not suitable judged by researchers.
Distraction and Nitrous Oxide for Venous Puncture

This study will compare the efficiency of the iPad distraction or the administration of Nitrous Oxide on the anxiety decrease when a peripheral venous catheter is needed in children between 3 and 9 years old.

The study is aiming at demonstrating the efficacy of active distraction by an iPad on the anxiety consequent to venipuncture and insertion of a peripheral vein catheter. The comparator is nitrous oxide in a 50% mixture with oxygen that is routinely used for sedation during procedural pain. However, nitrous oxide has secondary effects particularly on the inhibition of Vitamin B12.

The primary outcome is anxiety scores. Secondary outcomes are pain scores and satisfaction of parents and health providers.

All children will have EMLA cream (mixture prilocaine and lidocaine) applied one hour prior to venous punction. Anxiety, pain and satisfaction scores will be recorded at baseline and then within an hour following the venipuncture and insertion of the peripheral vein catheter.

Eligibility Criteria:
Inclusion Criteria:

* Venous track needed
* French mother tongue
* Age between 3 and 9 years old

Exclusion Criteria:

* Children with cognitive disorder (autism, metabolic disorders,
* Children with cerebral-motor disability
* Children who don't speak french
* Children with ADHD treatment
* Children with epilepsy
* Children who present contraindication to the use of Nitrous oxide
Soap on a Rope Trial

The soap on a rope behavioral trial is a school-randomized trial to determine if a disruptive cue (the soap on a rope hall pass) can influence hand washing behavior for students in Namwala District, Zambia.


Eligibility Criteria:
Inclusion Criteria:

* Students in study schools who use the latrine on the day of observation

Exclusion Criteria:

-
Effect of Plasma Ceramides on Peripheral Vascular Function

The goal of this clinical trial is to determine the effect of elevated plasma ceramides on peripheral vascular function. Subjects will consume a high fat meal consisting of long chain fatty acids (to increase plasma ceramides) or medium chain fatty acids (control). Subjects' vascular function will be assessed with laser Doppler flowmetry to measure their artery function and with the CytoCam device to assess their peripheral microvascular endothelial function.


Eligibility Criteria:
Inclusion Criteria:

1. Health adults aged 18-40 years
2. English-speaking only
3. Not pregnant

Exclusion Criteria:

1. Healthy individuals under 18 years or over 40 years of age
2. Non-English speaking
3. Pregnant individuals
4. Heart rate \<60 or \>100
5. Systolic blood pressure \<100 or \>160
6. Subjects with visible open sores or wounds in mouth
7. Lactose intolerant or allergy to dairy products
8. Diabetes Mellitus
9. Coronary Artery Disease
10. High blood pressure
11. High cholesterol
12. Heart failure
13. Current tobacco use
14. Chemotherapy within the last 6 months
Peripheral Nerve Blocks in Elderly Patients With Hip Fracture

As the population ages, the frequency of surgery is increasing proportionally, bringing with it the challenge of managing older patients with frequent comorbid diseases and an increased risk of complications. Poor postoperative quality of recovery may result in patient and family suffering, a prolonged hospital stay, and a greater demand on health care resources.The purpose of this study was to evaluate the ultrasound guided percutaneous femoral nerve+lateral cutaneous nerve versus lumbar plexus+sacral plexus nerve block composite laryngeal mask anesthesia in elderly hip fracture surgery, the application of assessing their impact on the postoperative recovery quality.

In this study, patients who were more than 65 years old with hip fracture were randomized to peripheral nerve blocks 1(PNBs1)- femoral nerve+lateral cutaneous nerve-with laryngeal mask anesthesia, or peripheral nerve blocks 2(PNBs2) - lumbar plexus and sciatic - with laryngeal mask anesthesia. Blocks were performed using ultrasound and 0.5% ropivacaine. All patients received postoperative multimodal analgesia. Postoperative recovery was assessed at 15 minutes, 40 minutes,- 1 day, 3 days, and 7 days after surgery, with the Postoperative Quality of Recovery Scale, in physiological, nociceptive, emotive, modified activities of daily living, modified cognitive, and overall patient perspective domains.

Eligibility Criteria:
Inclusion Criteria:

1. ASA grade I \~ III level;
2. The BMI \<30;
3. The Mini - getting the state examination MMSE \> 23;
4. The operation type:open reduction and internal fixation or bipolar head replace.

Exclusion Criteria:

1. Serious systemic diseases such as respiratory dysfunction, cardiac insufficiency, and renal insufficiency;
2. Has a history of cognitive function disorder or mental illness;
3. Has a history of cerebral infarction and leave sequela;
4. The blood coagulation dysfunction;
5. The hearing or visual impairment;
6. Unable to complete assessment;
7. Operation time more than 90 minutes;
8. The bleeding is greater than 1000 ml.
Hepatic Encephalopathy Prevention With Polydextrose After TIPS: Pilot Study (POEME)

TIPS is a standard for the treatment of portal hypertension related complications. However, it remains at risk of HE after TIPS (around 40% the first year). Dysbiosis plays a key role in pathophysiology of HE.

Polydextrose (PDX) is consider as a prebiotic. Preliminary studies showed that PDX:

1. modified gut microbiota, enhancing "good bacteria"
2. improved gut permeability and immunity in 2 experimental models: infarction and colitis.

The aim of this study is to assess PDX efficacy to prevent HE during the first 6 months after TIPS in cirrhotic patients.

TIPS is a standard for the treatment of portal hypertension related complications. However, it remains at risk of HE after TIPS (around 40% the first year). Dysbiosis plays a key role in pathophysiology of HE.

Polydextrose (PDX) is consider as a prebiotic. Preliminary studies showed that PDX:

1. modified gut microbiota, enhancing "good bacteria"
2. improved gut permeability and immunity in 2 experimental models: infarction and colitis.

Patients will receive PDX 15 days prior to and 6 months after TIPS. We will assess the cumulative incidence of HE 6 months after TIPS. Patients will be followed-up for 12 months after TIPS.

Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age
* Affected (c) cirrhosis in which the establishment of a TIPS is scheduled within the month for: the treatment of ascites or a refractory hydrothorax or the prevention of the recurrence of a related digestive hemorrhage portal hypertension
* Having signed the consent to participate in the study
* Women of childbearing age on effective contraception
* Affiliated to a social security scheme

Exclusion Criteria:

* Contraindication for TIPS
* Digestive short circuit, chronic inflammatory bowel diseases
* Indications of TIPS in emergency or as part of the preparation for a surgical procedure,
* Liver transplant,
* Patient for whom the follow-up is considered impossible due to non-compliance with care or because the vital prognosis is estimated less than 6 months because of an incurable chronic pathology,
* Pregnant or lactating women,
* Those unable to receive enlightened information,
* Those participating in another interventional research including an exclusion period
* Persons placed under safeguard of justice, tutelage or curators.
Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19

Prospective Observational Swiss Cohort Study to Investigate Long-term Pulmonary and Extrapulmonary Effects of COVID-19.

COVID-19 is a coronavirus induced viral pneumonia leading to Acute Respiratory Distress Syndrome. Previous coronavirus infections (SARS and MERS) led to pulmonary fibrosis in up to 30%. Prospective evaluation of lung abnormalities and pulmonary fibrosis after COVID-19 infection is crucial as novel treatments against lung fibrosis of different etiologies are available. No data on pulmonary longterm effects in COVID-19 survivors are currently available. The nation-wide Swiss COVID-19 lung group establishes a meticulously characterized prospective cohort study on pulmonary long-term sequela of patients living in Switzerland.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* All adult patients with COVID-19 over 18 years.

Exclusion Criteria:

* Severe mental or physical disability precluding informed consent or compliance with the protocol for prospective data collection.
* Pregnancy.