cyrilzakka/clinical-trials huggingface dataset:
Child Development and Genetic Biomarkers(II): Gene Verification and Data Integration

The aims of the study include (1) identifying genes associated with child development and developmental delay in Taiwan (2) comparing the differences and similarities between genetic biomarkers of development and developmental delay for children in Taiwan and children from other countries (3) employing precision medicine as the method for genetic screening or test and (4) tracking children's biological, psychological and social adjustment, especially for those who have early-onset developmental delay.

The aims of the study include (1) identifying genes associated with child development and developmental delay in Taiwan (2) comparing the differences and similarities between genetic biomarkers of development and developmental delay for children in Taiwan and children from other countries (3) employing precision medicine as the method for genetic screening or test and (4) tracking children's biological, psychological and social adjustment, especially for those who have early-onset developmental delay.

The study will be completed in two phases over three years and will enroll a total of 475 0\~40-year-old participants. In the first phase, we will recruit 380 participants. Including 50 participants with typical development, 300 participants with developmental delay and 30 parents to whom have children with severe DD. Then, their genetic data will be compared with genetic data of Chang Gung Hospital and the National Center for Genome Medicine, expect to preliminary find genes associated with child language development. At the same time, 20-30 children with severe developmental delay or have family history of developmental delay will be selected as a pilot study, using whole-exome sequencing (WES) to find other genes associated with development. If the gene deficiency was found in the children, we will invite his or her parents to do WES. In the second phase, we will establish a gene panel according to the genes identified in the previous stage and recruit 95 children with developmental delay to test the gene panel prospectively. The long-term goal of this study is to establish a pioneer study for children

Eligibility Criteria:
Inclusion Criteria:

* Consent signing
* 0-40 years old
* Typical development or developmental disabilities

Exclusion Criteria:

* Central Nervous disease
* Neuromuscular disease
* Congenital disease
* Sensory disorder such as blindness or hearing impairment
Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression

This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression.

We are using depression symptom measurements and measurements of brain electrical activity (EEG) to determine what factors may influence whether a patient is likely to show a response to antidepressant medication, placebo, or only clinical visits (without the use of pills) during a treatment trial for depression.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of unipolar major depression

Exclusion Criteria:

* Substance abuse
* Psychotic disorder
* History of severe head trauma
Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators

The EVOLVO study is designed to compare the remote defibrillator management to the current standard of care, to assess its ability to treat and triage patients more effectively.

Heart failure patients with implantable defibrillators (ICD) perform frequent clinic visits for routine device monitoring. Moreover, in case of clinical events, such as ICD shocks or alert notifications for changes in cardiac status or safety issues, they often visit the emergency department or the clinic for an unscheduled visit. These planned and unplanned visits create a great burden on healthcare providers. Internet-based remote device interrogation systems, allowing physician's remote access to patients' data, are being proposed for reducing routine and interim visits and for earlier detection and notification of alert conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patient with left ventricular systolic dysfunction, left ventricular ejection fraction ≤35%, as documented at the moment of ICD implant;
* Patient implanted with a wireless-transmission-enabled Medtronic ICD or CRT-D;
* Patient must be able and willing to replace regularly-scheduled in-office routine follow-ups with remote follow-ups;
* Patient must be able to attend all required follow-up visits at the study center.

Exclusion Criteria:

* Patient is less than 18 years of age;
* Patient is unwilling or unable to sign an informed consent;
* Patient life expectancy is less than 12 months;
* Patient is participating in another clinical study that may have an impact on the study endpoints.
IPTp Plus ITNs for Malaria Control in Pregnant Women

We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs.

Pregnant women are at an increased risk for malaria infection and disease. Maternal anaemia, low birth weight and prematurity are the most frequent adverse effects of the infection. The current WHO recommendation consists on the provision of insecticide treated nets (ITN's) and intermittent preventive treatment (IPT). Results from a recentn trial of ITN's have shown a significant reduction in maternal anaemia, parasitaemia and low birth weight prevalence in women sleeping under impregnated nets. However, scarce information exists on the relative efficacy of IPT and ITNs to reduce the deleterious effects of malaria infection during pregnancy when given at the same time. This information is of relevance to guide national malaria control programmes.

This study consists on the administration of two double blind doses of IPT with Sulfadoxine-Pyrimethamine or placebo at predefined intervals, after the beginning of the second trimester. All women receive an ITN.

Eligibility Criteria:
Inclusion Criteria:

* Less than 28 weeks of pregnancy

Exclusion Criteria:

* Previous allergic reactions to sulphonamides
Dose Range Study of CD5789 in Acne Vulgaris

To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participant, 12 to 35 years old with the following characteristics:
* Facial acne severity grade of the following:

  * Stratum 1: IGA score of 3 or 4
  * Stratum 2: IGA score of 4
  * Stratum 3: IGA score of 3 or 4
* A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata:

  * Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a maximum of one nodule on the face.
  * Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.
  * Stratum 3: Participants of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.

    * Note: Participants of Japanese origin will not be included in Stratum 1 or Stratum 2. Japanese origin is defined as all four grandparents were born in Japan.

Exclusion Criteria:

* The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)
* Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant participates in the clinical trial.
* Known or suspected allergies or sensitivities to any components of any of the study drugs.
* Current participation in any other clinical trial of a drug or device OR past participation within the 30 days prior to the Baseline visit.
Safety, Tolerability, and Pharmacokinetics of HRS-3802 Monotherapy in Patients With Malignant Solid Tumors

The study is being conducted to evaluate the safety and tolerability of HRS-3802 monotherapy in patients with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
2. Age ≥18 years, male or female
3. Patients with advanced malignant tumors confirmed pathologically;
4. Failure of adequate standard treatment, or no effective standard treatment;
5. Patients must have at least 1 extracranial measurable target lesion per RECIST v1.1 ;
6. The expected survival period is more than 12 weeks;
7. The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 - 1;
8. Have sufficient bone marrow and organ function (have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days):
9. Female subjects of childbearing age must undergo a serum pregnancy test within 7 days before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraception during the study period and within 1 months after the last administration of the study drug Measures:

Exclusion Criteria:

1. Subjects had cancerous meningitis or untreated central nervous system metastases
2. Subjects had severe cardiovascular and cerebrovascular diseases
3. There is third-space effusion that cannot be controlled by drainage and other methods (such as massive ascites, pleural effusion, pericardial effusion)；
4. Subjects had or currently had idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia , drug pneumonia, or CT during screening showed active pneumonia；
5. Arteriovenous thrombosis occurred within 6 months prior to the first dose
6. Severe infection occurred within 4 weeks prior to initial administration
7. Subjects with refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications: including malabsorption syndrome
8. Known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS)
9. Subjects had active hepatitis；
10. Subjects were scheduled to receive other systemic antitumor therapies during the study period；
11. Known allergies and contraindications to the investigational drug or any of its components；
12. Other factors as judged by the investigator that may lead to the termination of the study, such as other serious diseases, serious laboratory test abnormalities, or family or social factors that could affect the safety of the subject, or the collection of study data and samples.
A Pharmacokinetic Comparison of Three Butyrate Products

This study is a randomized, three-arm, interventional study of N=10 apparently healthy men. This study will quantify plasma butyrate responses to a single dose of three different butyrate products.


Eligibility Criteria:
Inclusion Criteria:

* Provide voluntary signed and dated informed consent.
* Be in good health as determined by medical history and routine blood chemistries.
* Age between the ages of 25 and 45 (inclusive).
* Body Mass Index of 18.5-24.9 (inclusive).
* Body weight of at least 110 pounds.
* Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5-minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility.
* Normal seated, resting heart rate (\<90 per minute).
* Willing to duplicate their previous 24-hour diet, refrain from alcohol, caffeine, and exercise for 24 hours and fast for 10 hours prior to each of the treatments.
* Participant agrees to maintain existing dietary and physical activity patterns throughout the study period.
* Participant is willing and able to comply with the study protocol.

Exclusion Criteria:

* A history of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal disease.
* The participant's alcohol consumption is more than two standard alcoholic drinks per day or more than 10 drinks per week or has a history of drug/alcohol abuse or dependence.
* History of diabetes (any form) or any endocrine disorder.
* Fasting blood sugar of \> 125 mg/dL.
* Current smokers or smoking cessation within the past month (28 days).
* History of hyperparathyroidism or an untreated thyroid disease.
* History of malignancy in the previous five years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
* Any history of gastrointestinal bypass surgery, etc., or any known functional gastrointestinal disorder that may impact nutrient absorption, e.g., short bowel syndrome, atrophic gastritis, IBD, diarrheal illnesses, history of colon resection, gastroparesis, gastric resection, celiac disease, or Inherited Errors of Metabolism (such as PKU).
* Chronic inflammatory condition or disease (e.g., rheumatoid arthritis, Crohn's Disease, ulcerative colitis, lupus, HIV/AIDS, etc.).
* History of using butyrate or tributyrin-containing dietary supplements within the past seven days.
* Known allergy or sensitivity to any ingredient in the test formulations as listed on the product label.
* Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Internet-based Diabetes Education and Case Management

This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.

Background:

Patients with diabetes and elevated hemoglobin A1c (HbA1c) are at risk for diabetes-related complications. Care-management may be helpful in these patients, by providing direct contact between such high-risk patients and the healthcare system. Web-based systems have previously shown promise as a means of neutralizing access barriers such as scheduling and travel to appointments and may be of particular help in improving diabetes care.

Objectives:

We examined the efficacy of two methods of diabetes education and care management: (1) a traditional model that involved telephone contact and face-to-face encounters (2) a web-based model with access to a diabetes care management web site. We compared these interventions to a study group that received no education or care management but was provided with a computer and access to diabetes self-management websites.

Methods:

This study employed a randomized, parallel group design involving patients with diabetes mellitus and an elevated HbA1c ( 8.5%). Participants assigned to web-based care management received a notebook computer, Internet access and interacted with a care manager through a diabetes education and care management website. Participants receiving telephone-based care management interacted with a care manager using telephone and face-to-face contact. Both care management models employed medication algorithms to improve glucose and BP control. These care management groups were compared to a study group that had no care management but received a notebook computer and Internet access with their "home page" containing links to a series of diabetes self-management websites (i.e. computer only group). The primary outcome measures were HbA1c, blood pressure, and scores on the Problem Areas in Diabetes (PAID) questionnaire, each measured over 12-months.

Status:

Complete

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus
* Age 25-79 years
* HbA1c \>=8.5%
* Ability to speak and understand English
* Telephone access
* VA-based primary care provider
* Interest in using a glucose and BP monitor and notebook computer

Exclusion Criteria:

* Visual impairment that affects ability to read
Comparison of iGel and THRIVE on Bronchoscopic Interventions

THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. However, besides the risk of desaturation, the differences on difficulties to approach vocal cords, the responses to spay of local anesthetics including cough or spasm, the CO2 elimination, the hemodynamic changes, and the effects on postoperative recovery are rarely investigated.

THRIVE and iGEL were applied for maintain oxygenation in bronchoscopic interventions which could not performed with an endotracheal tube. Unlike the nasal cannula with THRIVE, the tips of iGel are located in upper esophagi, it may affect the postoperative swallowing, especially for the aged group. However, the bronchoscopic approach may be easier for an established route to vocal cords. With shared airway for ventilation and interventions, CO2 elimination is hardly monitored besides the risk of desaturation.

In this study, THRIVE or iGel was planned to be randomized used for bronchoscopic interventions in an adult group (age 20-65) and an aged group (age over 65). The difficulties to approach vocal cords, the responses to spay of local anesthetics including cough or spasm, the CO2 elimination, the hemodynamic changes, and the effects on postoperative recovery are compared between THRIVE and iGel groups.

Eligibility Criteria:
Inclusion Criteria:

* plan to receive bronchoscopic interventions with total intravenous anesthesia

Exclusion Criteria:

* awake bronchoscopy pregnancy
Effect of Sufentanil on the Rate of Anesthesia

The aim of this study was to compare the effects of Lidocaine/epinephrine with and without Sufentanil on the rate of anesthesia after supplemental intraligamentary injection (PDL) in teeth with irreversible pulpitis.


Eligibility Criteria:
Inclusion Criteria:

* patients in the age group of 18-65 years old
* healthy (ASA I, II)
* patients with first or second mandibular molars who need endodontic treatment
* vital tooth without a history of past endodontic treatment
* patients with clinical evidence of irreversible Pulpits with moderate to severe pain
* patients who signed consent form
* patients numbness at the lateral edge of the lips after inferior alveolar injection (INA) and those with positive respond to maximum output of pulp tester after INA.

Exclusion Criteria:

* pregnant or nursing
* necrotic tooth
* patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs
* Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs in the past 48 hours
* patient with infectious diseases
* patient with moderate to sever periodontal disease
* those without numbness at the lateral edge of the lips after inferior alveolar injection (INA), and those do not respond to maximum output of pulp tester after INA.
Comparison of Two tDCS Protocols for the Treatment of Major Depressive Disorder

Transcranial direct cranial stimulation (tDCS) is a novel technique based on the application of a weak electrical current over the scalp through two electrodes - the anode, which facilitates neuronal depolarization, and the cathode, which leads to neuronal hyper-polarization. Recently, several open-label and sham-controlled clinical trials applied daily tDCS sessions for the treatment of major depressive disorder (MDD). Theoretically, tDCS displays depression improvement through anodal stimulation over the left dorsolateral prefrontal, inducing excitability-enhancing effects over this area, which is hypoactive during the acute depressive episode. The present study is aimed at comparing two different tDCS protocols: (1) active anodic stimulation over left dorsolateral prefrontal cortex with cathode placed over an extra cephalic area; (2) active cathode placed over the right dorsolateral prefrontal cortex with anode placed over an extra cephalic area.

The present research protocol will evaluate clinical effects of two different tDCS protocols: (1) active anodic stimulation over left dorsolateral prefrontal cortex with cathode placed over an extra cephalic area; (2) active cathode placed over the right dorsolateral prefrontal cortex with anode placed over an extra cephalic area. Patients will be clinically evaluated with the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for depression. Symptoms intensity will be rated according to The Hamilton Depression Scale (HAMD -17 items) - main outcome. Patients with scores higher than 16 will be included. Patients with active neurological or severe disorders (such as cancer or auto-imune disorders) will be excluded. The present study is a double-blinded, controlled, randomized trial with 30 patients with depression. The intervention protocol consist in 15 consecutive daily tDCS sessions (skipping the weekend). After meeting eligibility criteria, patients will be randomized (computer generated list) to one of the two intervention groups. We will use a direct current of 2.0 milliamperes (mA) for 30 min. The 35 cm2-rubber electrodes will be wrapped in cotton material, which should be moistened with saline as to reduce impedance. Patients will be clinically assessed at baseline and at end of 6 weeks. Main outcome will be based on HAMD-17 items at a final endpoint of 6-weeks, with secondary outcomes assessing Beck Depression Inventory (21 items) at 6 weeks. Other evaluation scales include Beck Anxiety Inventory, Hamilton Anxiety Scale and Safety and cognitive assessment will be performed with The Montreal Cognitive Assessment, adverse effects scales and clinical evaluation with a trained physician.

Eligibility Criteria:
Inclusion Criteria:

* patients with age between 18-89 years, depression diagnosis according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-iV); HAMD scores higher than 16; accordance to inform consent

Exclusion Criteria:

* active neurologic or severe disorder (such as cancer or auto-imune)
* pregnancy;
* need for hospitalization
Effect of Bifidobacterium Animalis Subsp. Lactis Bi66 Supplementation on Gut Function in Healthy Adults

The goal of this clinical trial is to learn the effect of Bifidobacterium animalis subsp. lactis Bi66 supplementation on gut function in healthy adults. The main questions it aims to answer are:

1. Does Bi66 affect the gut function(bowel movement frequency and stool form)?
2. Does Bi66 affect the gut microbiota and short-chain fatty acids ? Researchers will compare probiotic Bi66 to a placebo (a look-alike substance that contains no Bi66) to see if Bi66 works to affect gut function.

Participants will

1. Take Bi66 or a placebo every day for 8 months
2. Return the used sachets and stool diaries every 7 days and record bowel movement frequency per week and Bristol Stool Scale
3. Have checkups, including questionnaire survey, physical measurement, dietary survey, collection and detection of biological samples at baseline, week 4, week 8


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old;
* Self-reported bowel movement frequency less than 5 times per week;
* Change of weight no more than 3 kg within the last 2 months；
* No consumption of probiotics, prebiotics, synbiotics within the last 2 months

Exclusion Criteria:

* Pregnant or breastfeeding women；
* Smoking；
* BMI \< 18 kg/m2 or ≥28 kg/m2；
* Suffering from gastrointestinal disorders such as gastroenteritis, gastroduodenal ulcer, ulcerative colitis, Crohn's disease, intestinal stress syndrome, functional diarrhea, gastroparesis, etc；
* History of gastrointestinal surgery (except appendectomy or hernia repair)；
* Change in dietary habits within the last 1 month (e.g. ketogenic diet, etc.)；
* History of major surgery within the last 3 months or major surgery planned in the next 1 month;
* Use of antibiotics, acid-suppressing drugs, pro-digestive drugs (gastrointestinal, morpholine, cisapride, etc.), anti-constipation drugs, anti- diarrhea drugs, etc., in the last 1 month;
* Participate in a similar intervention study within the last 1 month