cyrilzakka/clinical-trials huggingface dataset:
Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.


Eligibility Criteria:
Key Inclusion Criteria:

* Provided informed consent.
* Completed 11 weeks of treatment in Study NBI-921352-FOS2021.
* Stable treatment with at least 1 but not more than 4 antiseizure medicines.

Key Exclusion Criteria:

* Have developed any other disorder for which the treatment takes priority over the treatment of focal onset seizure or is likely to interfere with study treatment or impair treatment compliance.
The Quality of Recovery After General Anesthesia With Desflurane and Sevoflurane in Endoscopic Ureteral Lithotripsy

The good quality of recovery after general anesthesia is one of goals for short procedures and ambulatory surgeries. The study's objective was to compare the quality of recovery after general anesthesia with desflurane and sevoflurane with laryngeal mask airway for endoscopic ureteral lithotripsy.

This is a randomized controlled trial. There were 60 cases of endoscopic ureteral lithotripsy under general anesthesia with laryngeal mask airway were enrolled. All cases were randomly divided into two group (desflurane or sevoflurane). Each group had 30 cases. Primary outcome was time to awakening. Secondary outcomes were time to wash-out of volatile anesthetics, time to extubation, irritation after awakening, and modified Aldrete score.

Statistical analysis was performed by using Kaplan-Meieir curve and log-rank test for time to adequate depth of anesthesia and time to awakening; t-test for time to wash-out of volatile anesthetics; chi-square test for depth of anesthesia by PRST score, irritation after awakening and Aldrete score; Fisher test for adverse effects of volatile anesthetics.

The research was approved by Gia Dinh People Hospital ethics committee

Eligibility Criteria:
Inclusion Criteria:

* All eligible subjects who underwent endoscopic ureteral lithotripsy under general anesthesia
* ASA I and II

Exclusion Criteria:

* Contraindication to laryngeal mask airway.
* Indication for conversion to tracheal intubation during surgery.
* History of malignant hyperthermia.
* Pregnancy.
* Obese (BMI \>25 kg/m2).
* Substances abuse.
Effect of Alternate Day Fasting Over Standard Medical Management Alone to Reverse Non-alcoholic Steatohepatitis.

The aims of this study are as follows: To compare the role of alternate-day fasting over standard medical management alone to reverse NASH.

Emerging evidence suggests the role of alternate-day fasting (ADF) in patients with obesity and fatty liver. It helps to lose weight and improvement in liver fat content. ADF regimen protocol includes fast day(restricted calorie intake and time-specific feeding) and feast day(ad libitum feed over 24 hours). Lowering the weight and improvement of the fatty liver. NASH is a prevalent cause of liver disease. Literature is evident that ADF improves fatty liver and metabolic components, and NASH improves with weight loss. Still, data about the role of ADF in the management of NASH is lacking. Hence, this study focuses on the role of ADF in NASH.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years. BMI 25-40kg/m3, and CAP more than 290
* Stable weight in the last 3 months prior to enrolling in the study(\<5kg weight variation)
* Imaging showed steatotic liver disease, liver stiffness \<14kPa measured by fibroscan
* Histologically proven NASH/MASH, fibrosis up to F3
* Subjects willing to participate in the study

Exclusion Criter

* Liver stiffness \>14kPa measured by fibroscan or Fibrosis \>F3
* Diabetes with HbA1c\>8.5%
* Patients with another co-existing active liver disease e.g. hepatitis B or C, alcoholic liver disease
* Patients with cirrhosis, hepatocellular carcinoma(HCC), or other malignancy
* Chronic kidney disease, cardiovascular disorders, uncontrolled hypertension
* Chronic infections, chronic inflammatory diseases
* Patients on weight loss medications e.g semaglutide
* Pregnant or lactating women and those planning a pregnancy A patient who is not willing to participate in the study or failed to provide the consent
Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 19 years
* Signed informed consent form
* At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL

Exclusion Criteria:

* Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe
* Liver transaminases \> 2 x upper limit of normal
Early Changes of Diabetes Parameters After Obesity Therapy

The aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients.

Previous studies have shown, that laparoscopic Roux-en-Y gastric bypass (LRYGB), and also laparoscopic sleeve gastrectomy (LSG) leed to a significant improvement of glucose metabolism and in many cases to a complete remission of diabetes type II in obese patients. It is still unclear which mechanisms underlie these changes. Since the positive effects of bariatric surgery have been investigated within few days after surgical intervention, before significant weight loss has been achieved, the caloric restriction has been discussed as a possible mechanism.

The aim of the study is to investigate, if bariatric surgery or the related caloric restriction causes the significant improvement of glucose metabolism, which has been found in bariatric patients. Therefore, the investigator will examine obese patients with diabetes type II or impaired glucose metabolism regarding possible metabolic changes within few days after bariatric surgery (LSG or LRYGB) or caloric restriction only.

Group I: Patients undergoing LSG; Group II: Patients undergoing LRYGB; Group III (Control group): Patients undergoing caloric restriction;

Dietetic, anthropometric, metabolic and hormonal parameters will be measured. Primary outcome marker is the insulin sensitivity according to Matsuda (MISI).

The project is a prospective, controlled study. Study examinations will be performed before intervention, and one, two, three, four and five days after (start of) intervention, as well after one month.

Eligibility Criteria:
Inclusion Criteria:

* BMI (Body Mass Index) ≥ 35 kg/m2
* Clinical diagnosis of type II diabetes or impaired glucose metabolism (Prediabetes: HbA1c \> 5,7%, fasting glucose in capillary blood \> 110 mg/dl - diagnosed by blood glucose test at the first study examination)
* Regarding the patients of the surgical groups: Indication to surgical therapy of obesity (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass). The indication to surgery is independent of the study. The surgeon decides about that in the clinical routine according to the German S3 guideline.
* Written consent to participate int he study

Exclusion Criteria:

* Medication use which affects glucose metabolism, except for diabetes medication (for example: glucocorticoids)
* Insulin need \>1,0 IU/kg/d
* Experimental diabetes medication within the last three months
* Pregnancy
* Gastrointestinal diseases
* Uncontrolled hypo- or hyperthyroidism
* Status after bariatric or other gastrointestinal surgery
The Effects of Pulmonary Hypertension Web-Based Health Care Program on Symptom Management, Social Support, Activity Tolerance, and Quality of Life in Patients With Pulmonary Hypertension.

Pulmonary arterial hypertension (PAH) is a chronic disease characterized by an elevation in pulmonary artery pressures and pulmonary vascular resistance. The condition most often is rarely detected, and patients frequently suffer symptoms for several years before being appropriately diagnosed. Patients with PH suffer from several symptoms, such as exertional dyspnea, fatigue, weakness, chest pain, fainting...et al. Pulmonary hypertension is an incurable and progressive disease with complex symptoms and treatments. Patients must learn to deal with their unpredictable future and manage the complex treatments associated with severe adverse effects and need significant changes in lifestyle.

Therefore, it is important to assist patients to develop the ability of symptom management.


Eligibility Criteria:
Inclusion Criteria:

1. At least 20 years old, diagnosed by clinical specialists as patients with pulmonary hypertension (Group1 and Group 4)
2. Clear consciousness, able to communicate in Mandarin and Taiwanese, with normal hearing
3. Those who have internet or mobile internet at home
4. Adults without mental illness
5. No alcohol or drug abusers.

Exclusion Criteria:

1. critical disease
Dietary Antioxidants, Redox Tone and Health Promotion: an Orthomolecular Study of Interactions

Aging is associated with increased risk of various diseases, and much attention is given to the use of natural products (like herbs) and 'functional food', such as teas, for healthy aging.

The body is continuously exposed to potentially damaging agents (known as free radicals). The imbalance between the amount of free radicals and that of antioxidants in the body is known as oxidative stress. It is known that Type 2 DM is a state of increased oxidative stress, which is thought to lead to many long term complications of Type 2 DM, such as heart disease, vision problems and kidney failure. Antioxidant therapy, including increased consumption of antioxidant rich foods and beverages such as green tea, has been suggested as possibly beneficial in lowering the risk of these complications.

The purpose of this study is to examine the effects of regular intake of green tea on indices of oxidative stress and antioxidant defense within cells, plasma and urine so as to investigate if regular intake of green tea can be recommended for health promotion.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM subjects
* Genotyped for polymorphism in the heme-oxygenase gene promoter region to be homozygous for long (\> 26) or short (\< 24) GT repeats

Exclusion Criteria:

* smokers
* have suffered DM related complication
* already taking antioxidant or herbal supplements
Modafinil in Treating Fatigue in Patients With Cancer

RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with cancer.

PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.

OBJECTIVES:

Primary

* Determine the safety of modafinil in cancer patients.
* Determine the efficacy of this drug, in terms of improving fatigue, in these patients.

Secondary

* Determine the efficacy of this drug, in terms of improving mood, cognitive ability, functional status, and quality of life, in these patients.

OUTLINE: This is a nonrandomized, pilot study.

Patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive additional modafinil at the discretion of the physician.

Fatigue, mood, cognition, functional status, and quality of life are assessed at baseline and in weeks 2 and 4.

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study within 9 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Brief Fatigue Inventory score ≥ 4

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 1-3

Life expectancy

* At least 2 months

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Cardiovascular

* No history of left ventricular hypertrophy
* No history of ischemic ECG changes
* No history of chest pain
* No history of arrhythmia
* No history of other clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use

Other

* Not pregnant or nursing
* Negative pregnancy test
* Thyroid stimulating hormone normal
* No known hypersensitivity to modafinil
* No history of psychotic disorder and/or active psychosis
* No history of any chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Concurrent thalidomide allowed

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* Concurrent narcotics, phenothiazines, or benzodiazepines allowed
* No other concurrent investigational therapy
PECS II Block and Single Port Robot-assisted Transaxillary Thyroidectomy

The da Vinci robotic system was developed to improve both operative maneuverability (through multi-articulated instruments) and the surgical view (via a three-dimensional camera). Although the system has many advantages, skin incision, wide flap dissection, and pneumatic/mechanical retraction remain essential, but cause postoperative pain and slower recovery. Previous studies found that pectoralis fascial blocks were easy to establish; local anesthetics are injected between two adjacent myofascial layers under ultrasound guidance, providing the surgeon with a clear image. Analgesic efficacy has been validated during robotic thyroidectomy in our institution. The pain outcomes were comparable between the groups, but there were fewer complications in the PECS II group. The investigators investigated whether this block can reduce postoperative pain during wide flap dissection for single-port robot-assisted transaxillary thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 19 to 60 years who are scheduled to undergo single-port robot thyroidectomy (lobectomy or total thyroidectomy)
* Patients with cancer stages T1 or T2 (less than 4 cm without invasion of surrounding tissue) when thyroid cancer is suspected in the preoperative examination
* Patients with nodules with a maximum length of less than 4 cm based on ultrasonography if thyroid cancer is not suspected in the preoperative examination
* Patients with a BMI greater than or equal to 18.5 and less than 30.0.

Exclusion Criteria:

* Patients requiring lateral cervical lymph node dissection
* pregnant women
* Uncontrolled diabetes
* Chronic kidney failure
* Patients with previous neck surgery
* Patients with Graves' disease
* People with chronic alcoholism
* Patients with vocal cord paralysis before surgery
* Severe obese patients with a body mass index \>35 kg/m2
* Patients participating in another clinical trial within 30 days
* Patients who expect that it will be difficult for medical staff to fill out the questionnaire on their own
* Patients whose medical staff determines that participation in the study is difficult due to other underlying diseases
Vapocoolant (Pain Ease) Use for Venipuncture

To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in decreasing the pain of venipuncture ("blood draw")

This is a prospective, randomized, blinded, comparator study. This study design is considered standard for establishing safety and efficacy data. Active treatment vapocoolant spray (Pain Ease Medium Stream) spray) will be used. There will be a placebo (sterile water) in this study. The population selected for this study, adults (excluding the very old, \> 80 years old) represents a patient population that may benefit from vapocoolant spray. This is a patient population that according to the treating health care provider already requires venipuncture for "blood draw" but not intravenous cannulation. Because venipuncture is a painful procedure, vapocoolant may confer benefit for the relief of pain.

Eligibility Criteria:
Inclusion Criteria:

* Patient needing venipuncture ("blood draw') but not intravenous cannulation
* Adult 18 years and older up to and and including 80 years old
* Stable patient
* Mentally competent patient able to understand the consent form

Exclusion Criteria:

* Patients with any allergies to the spray components (e.g. 1,1,1,3,3 pentafluoropropane or 1,1,1,2, tetrafluoroethane )
* Critically ill or unstable (e.g. sepsis or shock)
* Extremes of age: geriatric (\> 80 years) or pediatric ( \< 18 years old)
* Pregnant
* Venipuncture site located in area of compromised blood supply. Examples include : patients with peripheral vascular disease, gangrene, Raynaud's disease, Buerger's disease.
* Venipuncture site located in area of insensitive skin; patients with a peripheral neuropathy including diabetic neuropathy.
* Patient intolerant of cold or with hypersensitivity to the cold.
* Patient unable or unwilling to give consent.
* Prior experience with vapocoolant spray
* Currently in another research trial
Good Use of Normal Human ImmunoGlobulins (NHIg): Feasibility of Integrating the Criteria of Hierarchy During of NHIg Dispensations

Supply of Normal Human Immunoglobulins (NHIg) has been in steady tension for almost 15 years in the world. The scarcity of raw material, manufacturing time by industries, and increase consumptions are some of the causes. These phenomena has been accentuated for two years in the context of pandemic.

Faced these difficulties, the french National Medication Security Agency (ANSM) , in collaboration with health professionals and patients associations concerned, established a hierarchy of indications of NHIg to prioritize NHIg for patients without therapeutic alternative (2013 and 2019). Its use is sometimes complex, particularly in the indications where the use of NHIg must combine clinico-biological criteria and/or previous treatment lines.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with NHIg for one of the following 3 indications between 01/10/2021 and 31/12/2021: TIP, CDIP and SID.
* Patients 18 years of age and older

Exclusion Criteria:

* Patient Objection
* Patients treated with NHIg- for another indication
Effects of Nutritional Supplementation in Malnourished Patients in Stable COPD

Insufficient energy intake and systematic inflammation lead to malnutrition in patients with chronic obstructive pulmonary disease (COPD). Nutritional supplementation improves the patients'nutritional status by increasing energy intake and providing anti-inflammatory elements，which can relieve the patients' symptoms and delay the disease progression.

Malnutrition is very common in patients with COPD. The main reasons include short intake of energy and systematic inflammation. In our randomized and controlled clinical trial, patients will be divided into two groups: the experimental group and the control group. Patients in the experimental group will be provided nutritional supplements in addition to usual diet every day for three months and patients in the controlled group with usual diet. According to the changes of patients' body composition, anthropometrics, inflammatory markers, lung function, respiratory muscle function, exercise capacity, degree of dyspnea and health related quality of life(HRQL) after intervention，the nutritional status and inflammation status are assessed, which contributes to the prediction of prognosis. The nutritional supplements is a kind of oral liquid composed of proteins, omega-3 fatty acids, carbohydrate, vitamins, which provides about 260 kcal energy per 200ml. The patients from the interventional group need drink the nutritional supplements according to the estimated energy intake and a record should be made everyday. The patients will be followed up regularly by the researcher.

Eligibility Criteria:
Inclusion Criteria:

Patients from Zhujiang Hospital affiliated from Southern Medical University

Patients aged between 40 and 90 years old

Patients gendered into male or female

Patients with pulmonary function test of FEV1/FVC\<70% and FEV1\<80% predicted

Patients presenting one or more of the following situations of malnutrition or nutritional risk: BMI \<21 kg/m2 (or\<23 kg/m2 in patients ≥ 65); unintentional weight loss \>10% in the past 6 months; unintentional weight loss \>5% in last month; FFMI \<15 kg/m2 (women) or \<16 kg/m2 (men)

Patients able to answer question

Patient able to eat and drink

Patients who signed informed consent

Exclusion Criteria:

Patients with signs of an airway infection

Patients with malignant disorders

Patients with recent surgery

Patients with gastrointestinal ,cardiovascular diseases,neurological diseases or endocrine disease

Patients with bullae lung

patients treated with oral steroids or immunosuppressors

Patients requiring other nutritional supplements or parenteral nutrition

Patients suffering from acute exacerbation over the previous 4 weeks

Patients with lack of motivation or poor compliance
Pushing Spatiotemporal Limits for 4D Flow MRI and Dynamic MRA in the Brain at Ultra-High Field

This study aims at investigating the blood hemodynamics with high spatiotemporal resolution in patients with brain aneurysms and AVMs as well as in healthy controls. Parameters such as peak blood velocity, wall shear stress and other derived parameters will be obtained from 4D flow MRI data acquired at ultra-high field strength (7 Tesla).

The hemodynamic factors responsible for hemorrhagic stroke, resulting in wide variations in the clinical management of underlying vascular lesions, especially when they are found in asymptomatic individuals or individuals with symptoms not related to the disease. Therefore, there is an urgent need for the development of reliable biomarkers based on hemodynamic parameters, which can then enable improvements in risk assessment in patients presenting with these lesions. This need can be met by non-invasive Magnetic Resonance Imaging (MRI) techniques that provide information on high resolution vascular anatomy, visualization of cerebral hemodynamics and quantitative information about blood velocity. However, such techniques as presently employed at 1.5 or 3 Tesla are limited by spatial resolution and prolonged data acquisition times.

The primary goal of this proposal is to overcome these current limitations by exploiting Ultra-High Fields (UHF, i.e. ≥ 7 Tesla (7T)) to attain significantly higher spatial resolution, faster acquisitions and increased lesion conspicuity utilizing

* Qualitative exploration of intracranial blood hemodynamics,
* Quantitative imaging of the spatiotemporally resolved blood velocity vector,
* Derivation of hemodynamic parameters.

Eligibility Criteria:
Inclusion Criteria:

* Subjects / Patients between 18 and 75

Exclusion Criteria:

* Any kind of ferromagnetic implants.
* MR-unsafe non-ferromagnetic implants.
* Cardiac pacemakers.
* A history of shrapnel or shot gun injury.
* A body mass index \> 40.
* Severe claustrophobia.
* Tattoos in the head/neck area or permanent makeup.
Characterization of Enterococci

Study on Characterization of Enterococci because nowadays it become an important cause of nosocomial infections .detection of the most common two species of Enterococci and most common virulence factors \& its genes with determination of antibiotics sensitivity test for the isolated strains


Eligibility Criteria:
Inclusion Criteria:

* any patients in ICU has manifestations of urinary tract infections, surgical wound infections, intra-abdominal infections, intrapelvic infections, bacteraemia and infective endocarditis

Exclusion Criteria:

* patients receiving antibiotics in previous 48 hours