cyrilzakka/clinical-trials huggingface dataset:
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children

The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.

Partial epilepsy, the commonest form of epilepsy, is a difficult condition to treat with many patients continuing to have symptoms despite trying several medications. Lack of efficacy and adverse effects are commonly associated with current anti-epileptic drugs.

This study will examine the efficacy in addition to safety and tolerability of a new anti-epileptic drug, Eslicarbazepine acetate (BIA 2-093), as an adjunctive therapy for refractory partial seizures in children.

The primary analysis variables are:

* The responder rate (the proportion of patients with at least a 50% reduction in standardised seizure frequency)
* The relative reduction in standardised seizure frequency

Eligibility Criteria:
Inclusion Criteria:

* girls of child-bearing potential have to follow reliable and medically acceptable contraceptive method throughout the study
* diagnosis of epilepsy for at least 6 months prior to enrolment
* at least 4 partial-onset seizures in the last month prior to enrolment despite stable therapy with adequate dosage of 1 or 2 AEDs
* at least 4 partial-onset seizures during each 4-week interval of the 8-week baseline period
* previous treatment with three or more AEDs, in their maximum tolerated doses, for at least one month, without seizure control
* current treatment with 1 or 2 AEDs (any except oxcarbazepine); if present, vagus nerve stimulation is considered an AED
* stable dose regimen of AEDs during the 8-week baseline period
* cooperation and willingness to complete all aspects of the study, including hospitalisation if required
* written informed consent to participate in the study in accordance with local legislation

Exclusion Criteria:

* primarily generalised seizures
* baseline seizure frequency substantially different from usual seizure frequency
* known progressive neurological disorders
* history of status epilepticus within the 3 months prior to enrolment
* seizures of non-epileptic origin
* Lennon-Gastaut
* West syndrome
* Major psychiatric disorders
* Previous treatment any study with Eslicarbazepine acetate
Effect of Consumption of Post-harvest UV-B Treated Mushrooms on Vitamin D Status of Healthy Adults

This study will investigate whether mushrooms treated with ultraviolet (UV) light to increase their vitamin D2 content are actually a good source of vitamin D when consumed daily with a meal (lunch). The mushrooms will be provided cooked along with a meal which will be a standard, pre-packaged frozen meal. We also hope to learn if the resulting improvement in vitamin D status affects the immune system by decreasing it's level of activation, which may be abnormally elevated in vitamin D deficiency.

Volunteers will be asked to consume a standard meal (lunch) containing one serving of mushrooms daily for six weeks (7 days per week). With the meal, they will also need to take one capsule. The capsule will be either a placebo or will contain vitamin D. The purpose of the vitamin D in the capsule is to determine if the vitamin D from the mushrooms is absorbed as well as vitamin D from a capsule. The total dose of vitamin D that volunteers will receive each day from mushrooms and capsule together will always be the same and will be one of three doses: (1) little or no vitamin D (placebo); (2) 400 IU, which is near the current recommended intake and (3) 1,000 IU, which is up to five-fold higher than the current recommended intake, depending on your age. Both levels of vitamin D are safe. In addition to consuming the meals and taking the capsules, up to 20 mL (4 teaspoons) of blood will be drawn at three times during the study just before the mushroom-containing lunch is provided: (1) at the beginning of the study before the first meal; (3) after three weeks; (3) at the end of the study. The purpose of the blood draw is to measure vitamin D in your blood and to measure the level of activation of your immune system by measuring markers of immune activation.

Eligibility Criteria:
Inclusion Criteria:

* willing to consume a lunch meal 7 days per week for 6 weeks containing mushrooms
* willing to stop eating other sources of mushrooms
* willing to discontinue taking vitamin D and other dietary supplements
* estimated low vitamin D status based on dietary questionnaire, skin reflectance, and sun behavior

Exclusion Criteria:

* women who are pregnant or breastfeeding
* volunteers with anemia
* volunteers with evidence of underlying disease affecting vitamin D metabolism
* volunteers taking medications altering vitamin D metabolism
Accurate Diagnosis of the Invasion Depth in ESCC by a Deep Neural Network Analysis of NBI Endoscopy Data

The goal of this observational study is to accurate diagnose the stage of esophageal squamous cell carcinoma in order to help physicians to decide the appropriate clinical treatment. The main question it aims to answer is:

• To get early accurate diagnosis of the invasion depth of esophageal squamous cell carcinoma by narrow-band imaging endoscopy data.

Participants' clinical informations from routine examinations and treatments will be collected, there will be no harm to participants.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, regardless of gender;
2. Performing esophageal ESD surgery due to esophageal mucosal lesions;
3. Pathological evaluation of ESD specimens.

Exclusion Criteria:

Pathological examination after ESD surgery ruled out esophageal squamous cell carcinoma.
of Caregiver Family Members for the Disabled in Bukhara

The responsibilities of caring for a disabled family member may cause caregivers to develop risky behaviors for caregiver's health. Therefore, we aimed to examine the relationship between caregiver burdens and healthy lifestyle behaviors of family members caring for a disabled child.

In the study, family members living in Bukhara, Uzbekistan, and caring for a disabled person under the age of 24 were evaluated. Caregiver burden was evaluated with the Caregiver Burden Scale and healthy lifestyle behaviors were evaluated with the Healthy Lifestyle Behaviors Scale II. The fact that there is no earlier study on caregivers of disabled people in Uzbekistan and no research in the literature examining the relationship between caregiving burden and healthy lifestyle behaviors in individuals with disabled children, make this study unique.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Having a disabled child to take care of
* Being literate

Exclusion Criteria:

* The age of the disabled person being cared for is over 24 years old.
Post-marketing Study Focused on Evaluating I+Med's DayDrop for Improving Signs and Symptoms of Mild/Moderate Dry Eye

Clinical post-marketing quasi-experimental before-and-after trial to determine the effectiveness of DayDrop treatment in subjects seeking relief from symptoms of dryness and eye irritation based on OSDI questionnaire scores completed by patients.The study will involve 20 patients diagnosed with mild/moderate dry eye disease who meet the inclusion/exclusion criteria. The duration of the study will be 2 weeks, including 3 visits.

Clinical post-marketing quasi-experimental before-and-after trial to determine the effectiveness of DayDrop treatment in subjects seeking relief from the signs of dryness and eye irritation, comparing the scores obtained at the end of the follow-up period with those established before the start of treatment (baseline condition), as measured by the patients according to the OSDI questionnaire.

The study will involve 20 patients diagnosed with mild/moderate dry eye disease who meet the inclusion/exclusion criteria of the protocol. The study duration will be 2 weeks, including 3 visits: baseline, visit 1 (after one week of treatment), and visit 2 (at 2 weeks from the start of treatment).

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes over 18 years of age.
* Patients presenting symptoms of dryness and ocular irritation with an OSDI score ≥13 and ≤22.
* Ability to self-administer the drops.
* Ability to understand the Patient Information Sheet and sign the Informed Consent.
* Willingness and sufficient ability, as judged by the investigator, to respond to the questionnaires included in the study.

Exclusion Criteria:

* Pregnant women or those in the breastfeeding period.
* Known allergy or hypersensitivity to hyaluronic acid or any other ingredient in the product being studied.
* Patients who have undergone previous ocular surgery or experienced ocular trauma in the year prior to the start of the study.
* Severe dry eye diagnosis.
* Presence of inflammatory ocular surface pathology or anterior segment disease, or diagnosed with glaucoma.
* Use of parasympathomimetic or antipsychotic medications.
* Previous cataract surgery.
* Systemic corticosteroid treatment or topical treatment with any ophthalmic medication, except artificial tears, in the week before the start of the study.
* Sjögren's syndrome.
* Stevens-Johnson syndrome.
* History of allergic conjunctivitis.
A Novel Oral Natural Extract for the Treatment of Senile Purpura

A randomized, double-blind, placebo controlled study to assess the safety and effectiveness of a novel oral natural extract to improve the appearance of the skin of patients with senile purpura.


Eligibility Criteria:
Inclusion Criteria:

* Patients with evidence of purpura on physical exam

Exclusion Criteria:

* Preexisting condition that would not allow the patients to take oral calcium supplement
Aerobic Exercise for Cognitive Functioning in Patients With Substance Use Disorder

Impaired cognitive function is common among patients with substance use disorder (SUD). This is particularly related to executive functions (EF), which includes abilities like decision-making, consequence analysis and impulse/self-control. EF is recognized as an important determinant of treatment outcome as it is associated with dropout rate, attendance to therapy sessions and absence of relapse following treatment termination. Exercise seem to improve cognitive/executive functions, particularly in individuals with cognitive impairments. Aerobic exercise also affects signaling substances and growth factors known to inhibit neural degeneration, and improves cerebral insulin sensitivity and blood flow, contributing to improved brain function. There is a lack of knowledge regarding how to improve EF in SUD patients, and whether such improvements can benefit other parts of the treatment, such as psychotherapy. Aerobic exercise is a well-recognized and cost-effective intervention for cardiovascular and metabolic health, with promising effects on cognitive/executive functions. A randomized controlled trial will be carried out to investigate the effects of aerobic exercise on EF, molecular markers of neuroplasticity and brain function, and treatment outcome in SUD patients. The investigators expect to achieve new knowledge regarding cognitive impairment among SUD patients and to what extent aerobic exercise can improve cognitive abilities and treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed substance use disorder (SUD) by ICD-10
* Being in residential inpatient treatment for SUD at Lade Addiction Treatment Center

Exclusion Criteria:

* Recent participation in regular aerobic high-intensity interval training (HIIT)
* Admissions shorter than 12 weeks
* Pregnant
* History of brain injury (except concussions)
* Any acute or chronic somatic or psychiatric condition (e.g. heart disease or psychosis) or a medication that would limit the ability to participate in the exercise training and testing procedures, or any of the other assessments.
Cannabidiol for Prevention of Chemotherapy-induced Peripheral Neuropathy

This protocol describes a phase II trial investigating the efficacy of CBD in paclitaxel- and oxaliplatin-induced peripheral neuropathy. The trial uses multiple assessments such as validated PRO-questionnaires and multifrequency vibrometry.

Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to omission or even discontinuation of antineoplastic drugs, possibly affecting efficacy of cancer treatment. There is a lack of knowledge about the natural course of CIPN and to this date, there are no available methods for the early detection of CIPN. With no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* A diagnosis of cancer.
* Fulfill criteria for starting chemotherapy.
* Scheduled to undergo at least 6 courses of paclitaxel or 4 courses of oxaliplatin based chemotherapy.
* If not postmenopausal (defined as no menses for 12 months without an alternative medical cause), women will have use effective anti-contraception (using definitions in the CTFG\*-Recommendations related to contraception and pregnancy testing in clinical trials) and submit to a monthly pregnancy test (blood test).

Exclusion Criteria:

* Unable to complete PRO-measurements.
* Previously received taxanes or platinum-based chemotherapy.
* If using any antiepileptic or antidepressant medicine (ATC: N03A or N06A). Treatment must be stable (no changes in dosing in last 30 days) prior to inclusion. However, any treatment with Clobazam (N05BA09) is not allowed due to major interaction with cannabidiol.
* Use of cannabinoids. If in use, treatment must be stopped 4 days prior to inclusion.
* Hypersensitivity reactions towards Ascorbylpalmitat or Triglycerides (medium-chain)
* Baseline transaminase level must not be above 3 times the Upper Limit of Normal (ULN) at study beginning.
* Women who are breastfeeding.
* Concomitant treatment with strong inducers of CYP3A4 and/or strong inducers of CYP2C19.

CTFG: The Heads of Medicines Agencies commissioned Clinical Trials Facilitation Group under the European Union's clinical trials directive 2001/20.
Intestinal Flora and Metabonomics of Appendicitis

The goal of this observational study is to learn about the key bacterial flora and metabolites associated with appendicitis in children. The main questions it aims to answer are:

* To screen out the key biomarkers of pediatric appendicitis.
* What are the microbial differences in different parts of pediatric appendicitis patients.

Participants will detect feces using 16s ribosomal RiboNucleicAcid (16S rRNA) gene sequencing technology and differences of the fecal metabolites between healthy children and appendicitis children were analyzed using untargeted metabolomics based on Liquid chromatography-tandem mass spectrometry(LC-M S/MS) platform.Through the analysis of intestinal bacterial flora and metabolomics association and the differential analysis of intestinal bacterial flora in different parts of the case group, the key bacterial flora and metabolites were excavated.

Participants will detect feces using 16s ribosomal RiboNucleicAcid (16S rRNA) gene sequencing technology and differences of the fecal metabolites between healthy children and appendicitis children were analyzed using untargeted metabolomics based on Liquid chromatography-tandem mass spectrometry(LC-M S/MS) platform.

Differences in the intestinal flora of different parts of the case group: the intestinal flora of the case group in feces and rectum were detected by 16s ribosomal RiboNucleicAcid (16S rRNA) gene sequencing technology, and the intestinal flora of different parts were analyzed and compared.

Through the analysis of intestinal bacterial flora and metabolomics association and the differential analysis of intestinal bacterial flora in different parts of the case group, the key bacterial flora and metabolites were excavated.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-14 years who were initially diagnosed with appendicitis and underwent laparoscopic appendectomy
* Children aged 1-14 years with non-digestive tract disease and no history of digestive tract disease

Exclusion Criteria:

* A family history of intestinal disease
* Allergic to antibiotic therapy drugs
* Patients with long-term drug use causing microbial structure changes or intestinal flora disorders
* Patients with other congenital diseases such as Meckel's diverticulum, intestinal rotation and other malrotation
* With other systemic diseases, such as obvious upper respiratory tract infection or myocarditis
* Children with other digestive system diseases after auxiliary examination or surgical diagnosis
Montelukast for Postinfectious Cough

Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute has a 3\~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway inflammation and decrease airway high activity by suppressing the biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO can be used as a biomarker to optimized treatment regimen of sub-acute cough.

Patients in electrical treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in placebo treatment arm were given placebo tablets(main excipient lactose monohydrate,p.o., 10mg, q.d.).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients.

Eligibility Criteria:
Inclusion Criteria:

* Cough is the main or only clinical symptom and was persistent for 3-8 weeks
* Chest X-ray reveals no noticeable pathological changes

  * 18 year old, regardless of gender and ethical background
* Not taking angiotensin-converting enzyme inhibitor
* Patients must join the programme voluntarily and are able to attend examination and follow-up sessions

Exclusion Criteria:

* Patients diagnosed with allergic rhinitis, chronic nasosinusitis or bacterial respiratory tract infections
* Patients diagnosed with severe reportorial disease of other severe systemic disease
* Patients who are allergic to any drugs to be tested
* Patients who are non-cooperative during examination sessions or other steps of the trial
* Patients who are not able to or refuse to sign consent
Effect of Rebound Exercise in Individuals With Type 2 Diabetes

The purpose of this study was to investigate the effect of rebound exercise (mini trampoline jumping) on metabolic outcomes and quality of life in patients with Type 2 Diabetes.

The exercise involved jumping on the mini trampoline with feet slightly apart. Participants stood on the mid portion of the trampoline bed and made repeated up-and-down bouncy movements. Each foot strike equals one step or bounce. With each landing, the mat of the trampoline underwent deformation and the springs released the energy stored in them such that the participant was made to bounce off the mat. Exercise was administered for between 10 - 15 minutes after which a 5-minute period of rest was allowed. A heart rate monitor was used to guide the intensity of the exercise in the moderate range. Each participant accumulated between 20 and 30 minutes of rebound exercise (bouncing on a mini trampoline) per session, administered three times per week for 12 weeks. All data were captured at baseline and at the end of the 12-week intervention period.

Eligibility Criteria:
Inclusion Criteria:

* 30- to 60-year-old male and female individuals;
* A diagnosis of type 2 diabetes ≤ 5 years;
* Attendance at the Diabetes Outpatient Clinics of Aminu Kano Teaching Hospital and Murtala Muhammad Specialist Hospital in Kano, Northwestern Nigeria;
* Self-ambulatory;
* An inactive lifestyle over the last year.

Exclusion Criteria:

* A diagnosis of type 2 diabetes for more than 5 years;
* Hypertension (systolic and diastolic blood pressure more than 140 and 90 mmHg, respectively) or treatment for hypertension;
* Use of insulin therapy
* Lower limb weakness and/or deformities with loss of protective sensation in the feet;
* Back, shoulder or knee problems and/or joint instability;
* History of coronary artery disease, retinopathy and nephropathy;
* Myocardial infarction, cardiac or abdominal surgery within the previous 6 months;
* History of fractures of the spine, hip, knee and/or ankle joints.
Measurement of D-Dimer Levels in Patients With Confirmed Deep Vein Thrombosis

Measurement of D-Di (D-Dimer) levels using the in-vitro diagnostic reagent STA® - Liatest® D-Di and STA® - Liatest® D-Di PLUS in plasma samples from patients diagnosed with Deep Vein Thrombosis (DVT) Data from this study may be used in conjunction with data from the prospective study entitled "STA® - Liatest® D-Di - Exclusion of Venous Thromboembolism (VTE)", NCT01221805, the DiET study,


Eligibility Criteria:
Inclusion Criteria:

* The study population tested will be recruited from ambulatory outpatients (presenting at the emergency unit or outpatient clinic) suspected of having DVT.
* Patient is \< 80 years old.
* Patient presenting at least one of these symptoms indicative of proximal DVT: leg pain, tenderness (discomfort through palpation), leg swelling and /or edema,
* Patient has confirmed proximal DVT by imaging
* Low or moderate Wells score
* Patient provides written informed consent to participate in the sample collection

Exclusion Criteria:

* Patient presenting with a condition that may be associated with increased D-dimer levels, even in the absence of VTE, such as:

  1. Fibrinolytic therapy within the previous seven (7) days,
  2. Bone fracture or surgery (with general anesthesia longer than thirty (30) minutes) within the previous one (1) month,
  3. Deep hematoma diagnosed by imaging techniques within the previous one (1) month,
  4. Disseminated malignancies and active cancer (active cancer defined as: cancer for which therapeutic or palliative treatment is either ongoing at the time of enrolment or has stopped less than six (6) months before enrolment),
  5. Sepsis, severe infections, pneumonia within the previous 1 month,
  6. Known liver cirrhosis,
  7. Pregnancy or post-partum within the previous 1 month,
  8. Atherosclerotic vascular disease thrombosis within the previous 1month (e.g. myocardial infarction, stroke, coronary syndrome, peripheral artery disease stage III or IV),
  9. Sickle cell disease,
* Patients presenting with a suspect thrombotic event related to catheter implantation
* Ongoing therapeutic anticoagulants (curative and preventive treatment) starting twenty four (24) hours or more before the blood drawing for D-dimer testing