cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of TAF in Pregnant Women With Chronic Hepatitis B Infection

The effectiveness of mother-to-child block of CHB in pregnant women in the middle and later stages of pregnancy has been recognized by the guidelines. TAF, as a newly marketed antiviral drug, has not been conclusively concluded in terms of its efficacy and postpartum safety in preventing mother-to-child transmission in pregnant women.Our purpose is to explore the TAF for CHB the curative effect of pregnant and postnatal security.

After diagnosis at the infection clinic of the Third Affiliated Hospital of Sun Yat-sen University, the eligible patients were enrolled into the group.Each person will sign the informed consent prior to enrollment.

Eligibility Criteria:
Inclusion Criteria:

* 25 pregnant women with HBeAg (+), HBV DNA ≥ 2\*10\^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B were pregnant women at 24-28 weeks of pregnancy.
* 25 non-pregnant women with HBeAg (+), HBV DNA ≥ 2\*10\^6IU/mL who met the diagnostic criteria in the guidelines for the prevention and treatment of chronic hepatitis B.
* The enrolled patients were all newly admitted patients without treatment, and if they did not meet the standard after completing the relevant examination, they would be removed.

Exclusion Criteria:

* Coinfection with HAV, HCV, HDV, HEV or HIV;
* A history of antiviral therapy or concurrent treatment with immunoregulatory drugs, antitumor drugs, cytotoxic drugs or immunosuppressive steroids;
* Three-dimensional ultrasonography showed fetal malformation;
* The spouse is infected with HBV;
* History of decompensated liver disease (e.g., decompensated liver disease with coagulation disorders, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites and esophageal varicose bleeding), history of liver cancer or other chronic liver disease (e.g., autoimmune hepatitis) or clinical symptoms;
* History of immune diseases;
* A history of serious cardiovascular disease;
* Other reasons the researchers considered it inappropriate to participate in the trial.
The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics

The purpose of this study is to investigate the relationship between the change of intestinal bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort after colonoscopy. And the investigators will also analyze the effects of probiotics on the degree of change, recovery, and symptom development in intestinal flora.

The investigators divided two groups. (total number = 100 subjects)

1. with probiotics group - 50 subjects

   * Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
2. without probiotics group - 50 subjects

   * Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* adults between the age of 30 and 70

Exclusion Criteria:

* subjects with cancer or IBD (inflammatory bowel disease)
* subjects with history of abdominal surgery
* subjects who take medication related to gastrointestinal motility within 3 months
* subjects who take antibiotics within 3 months
Study on the Mechanism of Neurodevelopment Dysplasia of Fetal Brain Caused by ASNS Gene Mutation

The investigators propose to analyze a brain sample and/or peripheral blood by single cell RNA seq from aborted embryos with ASNS mutation.

Congenital microcephaly could cause by gene mutation. Asparagine synthetase deficiency, which is caused by ASNS mutation, is a rare autosomal recessive neurometabolic disorder. It is characterized by severe developmental delay, congenital microcephaly, seizures. The investigators found a family with ASNS mutaion. The investigators propose to analyze a brain sample and/or peripheral blood by single cell RNA seq from aborted embryos with ASNS mutation.

Eligibility Criteria:
Inclusion Criteria:

* Mutation Group: Having ASNS gene mutation by DNA exon sequencing.
* Control Group: No ASNS gene mutation by DNA exon sequencing.

Exclusion Criteria:

* Mutation Group: N/A.
* Control Group: Having other gene mutation which also effect neurodevelopment.
The Role of Augmented Fixation Techniques in Fragility Fracture Pelvis (FFP)

Assessment of the role of augmented fixation of fragility fracture pelvis in improving functional outcome as a primary outcome and improving union and decreasing mortality and complications as secondary outcomes at 6 months and one year follow up.

During the process of aging, the quality of bones deteriorates making bones more vulnerable for fractures after minor trauma or from normal daily activities. This poor bone quality together with comorbidities increase healing problems and complications and make fixation more difficult. Moreover, immobilization due to fractures has serious complications especially in the elderly. For all theses, fragility fracture-which is defined by WHO as a fracture that is caused by an injury that would be insufficient to fracture normal bones and is the result of reduced compressive and or torsional strength of bone - these fractures have unique criteria making them a special category with its own concerns. One of these fractures is fragility fracture pelvis (FFP) which is expected to triple between 2005 and 2030. This type of fracture has its huge effect on morbidity and mortality of this vulnerable group of people. Due to its special criteria , a new classification system was developed to classify it known as Rommens classification system. This was followed by many literatures focused on this fracture, its morbidity and mortality, role of surgery, minimal invasive techniques and different augmentation fixation techniques, but they did not reach to a clear algorithm for management and did not clearly identify the role of augmented fixation techniques on different outcomes of this fracture . Fixation augmentation techniques which are defined as surgical techniques aimed at increasing implant stability and used in poor bone quality like in geriatric population. the investigators hypothesis is augmented fixation will improve the functional outcomes of fragility fracture pelvis. These techniques may include percutaneous transsarcal screws fixation, tension band plating, INFIX technique, triangular fixation and cement augmentation techniques.

the investigators will try to answer this question which is "what is the effect of augmented fixation techniques on functional outcomes of fragility fracture pelvis? ''.

Eligibility Criteria:
Inclusion Criteria:

1. Patients above age of sixty years.
2. Fragility fracture pelvis
3. injury severity score below 17.
4. Controlled comorbidities

Exclusion Criteria:

1. Malignancy in bony pelvis.
2. Chronic kidney disease on regular dialysis,
3. Skin lesion at admission like Morel-Lavallée lesion.
Etco2 Levels on the End-tidal Concentration of Sevoflurane

he assessment of adequate levels of anaesthesia traditionally relies not only on a patient's movement but also on the hemodynamic response (or both) to a surgical stimulus

Currently a derivative of MAC namely, end tidal partial pressure (FET) displayed on the work station as concentration , maybe an alternative useful measure of the anaesthetic effect of an inhaled anaesthetic agent

. Many pharmacological factors have been associated with alterations in MAC and Mac derivatives such as nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, and anesthetics.

However, few studies have focused on physiological factors, such as hypercarbia or hypocarbia. A correlation has been found between Paco2 and Etco2 in ventilated patients with healthy lungs. Some authors have suggested that Etco2 could be considered appropriate for estimating Paco2 even in critical patients. Knowledge of the effects of Paco2 on end tidal concentration of sevoflurane among patients undergoing laparoscopic cholecystectomy may help anaesthesiologists titrate sevoflurane carefully and precisely during different mechanical ventilation settings to avoid dose-dependent hypotension, impaired cardiac contractility, and hypothermia caused by excessive anaesthetic depth of sevoflurane.

Eligibility Criteria:
Inclusion Criteria:

* American Society of anaesthesiologist ASA physical status I, II
* admitted for laparoscopic cholecystectomy

Exclusion Criteria:

* Refusal of patients.

  * Patients with renal or liver dysfunction.
  * Patients with chronic pain other than cholelithiasis.
  * Cardiac disorders as uncontrolled hypertension, arrhythmia, Ischaemic heart disease, valvular heart disease and pulmonary hypertension.
  * Patient with haematological disorder as Sickle cell disease.
  * Chest patient as asthma, COPD.
  * Combined surgery .
  * History of allergy to any of the study drugs.
  * Patients with communication problems, cognitive dysfunction, or psychological disorders.
  * Patients who received analgesics or sedatives 24 h before a scheduled surgery.
  * Alcohol or drug abuse.
Comparative Bioavailability of Dronabinol Oral Solution in Healthy Volunteers

The primary objective of this study is to evaluate the comparative bioavailability of a test product of dronabinol oral solution administered under fed conditions to the reference listed drug (RLD) administered to participants under fed and fasted conditions.

The secondary objective is to compare the onset of detectable dronabinol concentrations between dronabinol oral solution and the RLD.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification
* Fully comprehends and signs the informed consent form, understands all study procedures, and can communicate satisfactorily with the Investigator and study coordinator

Exclusion Criteria:

* History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters
* Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results
Clinical Trial to Assess the Effects of Low-fat Dairy on Systolic Blood Pressure

The purpose of this study is to determine if increased consumption of low-fat dairy can reduce blood pressure and improve endothelial function in men and women with pre or stage-1 hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a female or male, 20-69 years of age, inclusive.
* Subject has a BMI of 18.5 to 39.9 kg/m2, inclusive.
* Subject has resting blood pressure measurements meeting the criteria for pre-hypertension (SBP = 120 to 139 mm Hg and/or DBP = 80 to 89 mm Hg) or stage 1 hypertension (SBP = 140 to 159 mm Hg or DBP = 90 to 99 mm Hg)
* Subject reports history of consuming, on average, ≤2 servings/d of dairy foods as part of their normal diet
* Subject is willing to consume ≤1 serving/d of dairy foods (other than the study products provided) during each treatment phase.
* Subject is willing to maintain a stable body weight and habitual diet and physical activity patterns throughout the trial, with the exception of specific study instructions related to study product intake, alcohol intake, and physical activity.

Exclusion Criteria:

* Subject has known coronary heart disease (CHD) or a CHD risk equivalent
* Subject has a history of any major trauma or major surgical event
* Subject has digital deformities that would prevent EndoPAT measurements.
* Subject has used medications known to alter body weight
* Subject has used medications or dietary supplements that, in the opinion of the Investigator, have strong potential to influence blood pressure or endothelial function
* Subject has extreme dietary habits (e.g., Atkins diet, very high protein/low carbohydrate).
Family Talk Intervention in the Context of Specialised Palliative Home Care

This intervention study aims to evaluate a psychosocial family based intervention in clinical practice, the Family Talk Intervention (FTI), for families with dependent children affected by life-threatening/life-limiting illness, when a parent is ill.

The study has an effectiveness implementation hybrid design where both the effects of FTI and the implementation process in clinical practice are examined.

When a family with dependent children is affected by severe illness this affects the entire family. Still, there is little research evaluating support to such families. This intervention study aims to evaluate a psychosocial family based intervention in clinical practice, the Family Talk Intervention (FTI), for families with dependent children affected by life-threatening/life-limiting illness, when a parent is ill.

The study has an effectiveness implementation hybrid design where both the effects of FTI and the implementation process in clinical practice are examined. FTI will be carried out as a cluster randomized trial at 12 clinics in specialized palliative homecare (6 units=intervention, 6 units=control).

All social workers at these clinics will receive education and training in FTI in 2021. From 2022, FTI will be offered to families cared for at these care contexts.

FTI is manual-based and consists of 6 meetings with the families (together and individually) and is led by the FTI-educated social workers. The aim of FTI are to support the family in talking about illness-related subjects (e.g. prognosis, stress), support parenting, and support the family in identifying their strengths and how to best use them.

FTI will be evaluated through surveys and interviews with families before FTI/baseline and after completed intervention (3 and 6 months after baseline). Further, social workers will be invited to compete questionnaires and take part in focus groups about their experiences of FTI.

The research group has conducted pilot-studies on FTI in these contexts with positive results. The present study allows us to take a further step in the evaluation of FTI- evaluate FTI under real conditions.

Eligibility Criteria:
Inclusion Criteria:

* Families affected by a life-threatening or life-limiting illness and have dependent children, ill or health aged 0-19 years and
* Enrolled in specialized palliative home care
* At least two family members have accepted to participate

Exclusion Criteria:

-
Real Life Evaluation of Rheumatoid Arthritis Patients in Israel Treated With HUMIRA

In Israel, data is lacking regarding the long-term effectiveness of Adalimumab in outpatient real life setting. Moreover, the association between long-term effectiveness of Adalimumab and patients' functional status as well as cultural aspects of sick leaves and visits to physician's clinics has not been demonstrated in this population. This study will collect the required data in real life settings.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is eligible to Adalimumab treatment according to the Israeli National Health Basket and for whom a decision of initiating Adalimumab has already been taken. Patients that are naïve to Adalimumab therapy, that have been prescribed adalimumab in accordance to physician's clinical decision and according to local guidelines, up to 30 days prior to screening.
2. Patient has performed tuberculosis (TB) screening and treatment according to national guidelines for TB screening prior to anti Tumor Necrosis Factor (anti-TNF) treatment.
3. Patient has been diagnosed with Rheumatoid Arthritis (RA) and has disease duration \< 3 years.
4. Patient has moderately to severely active RA defined by Disease Activity Score (DAS) (moderately (3.2 ≤ DAS ≤ 5.1) severely (DAS ≥5.1))
5. Patient is able to sign written informed consent.
6. Patient is treated with Methotrexate (MTX) alone or in combination with other Disease Modifying Antirheumatic Drugs (DMARDs)
7. Patient might have been treated with another anti-TNF inhibitor agent if discontinued due to secondary loss of efficacy or side effects.

Exclusion Criteria:

1. Patient with known hypersensitivity to Adalimumab, or any of its components.
2. Patients suffering from serious infection, latent TB or other conditions prohibiting the use of Adalimumab.
3. Patient had previous non-response to an anti-TNF agent.
4. Patients currently treated with other biologic therapy.
The Effect of Peppermint Flavored Mouthwash Applied to Patients

Treatment of obesity consists of diet/lifestyle modification and bariatric surgery consisting of several procedures. One of the most common complications in the early period after bariatric surgery is nausea and vomiting due to the reduction of gastric capacity. According to the guidelines of the American Society of Metabolic and Bariatric Surgery (ASMBS), acid-base disorders, electrolyte abnormalities (especially calcium, potassium, magnesium, sodium and phosphorus deficiency), insufficiency of fat-soluble vitamins (ADEK), folic acid, iron, thiamine after bariatric surgery. and B12 deficiency etc. On the other hand, anxiety after bariatric surgery is also an important problem.

It is possible to reduce nausea and vomiting by stimulating the vagal nerve. Gargling, laughing, singing loudly, etc. The movements stimulate the vagus nerve by activating the muscles behind the larynx, and the vagus nerve prevents nausea and vomiting by simulating the gastrointestinal tract. With the activation of the diaphragm; The vagus nerve is stimulated, the parasympathetic nervous system is activated and cortisol production decreases, reducing stress and anxiety. The peppermint plant, which is widely used in our country, is also used as a relief in cases such as nausea, stomachache, and colds. It is expected that the nurse, who is a member of the multidisciplinary team, will be able to properly define the surgical risks and comorbidities associated with the clinical status of obesity in patients who have undergone bariatric surgery and to apply the necessary interventions.


Eligibility Criteria:
Inclusion Criteria:

1. Be between the ages of 18-65
2. Having had bariatric surgery
3. Absence of communication barriers
4. Volunteering to participate in research
5. Mental well-being

Exclusion Criteria:

1. Presence of major depression or psychosis
2. Having a communication barrier
3. Being transferred to another unit
4. Leaving work voluntarily
Effects of Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects

The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of two types of juice. This double-blind crossover study requires participants to arrive to the lab 12 hours fasted, consume 12 oz of juice and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over the next 3 hours. Subjects will be asked to complete additional questionnaires at 12 and 24 hours post consumption, from home. Subjects will also be asked to keep a food record for 24 hours prior to their scheduled visit times to assure compliance.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65 Body mass index between 18-29 kg/m2 Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures

Exclusion Criteria:

* • Use of enemas, laxatives, proton pump inhibitors, or antibiotics within the past 3 months

  * Smoker
  * Not a regular breakfast or eater
  * Self-reported history of a past or current gastrointestinal disease
  * High fiber eater (≥3 servings of high fiber foods per day)
  * Concurrent or recent (within 30 days) participation in an intervention trial
  * Recent weight fluctuations
  * Allergies to any of the test products
Effect of Diltiazem on Coronary Artery Ectasia

Coronary artery ectasia (CAE) has been defined as localized or diffuse dilatation of epicardial coronary arteries more than 1.5 fold of adjacent normal segments. Isolated CAE constitutes minor portion of the total CAE cases, with an incidence of 0.1% to 0.79% in which coronary artery stenosis or severe valvular heart diseases are not present. CAE represents not only an anatomical variant but also a clinical constellation of coronary artery disease (CAD) like association with myocardial ischemia and acute coronary syndromes. Patients with CAE without significant coronary narrowing may still present with angina pectoris, positive stress tests, or acute coronary syndromes. Impaired epicardial and microvascular perfusion were demonstrated in ectatic coronary arteries.

Myocardial blush grading (MBG) technique has been utilized in various conditions such as acute myocardial infarction, coronary artery ectasia, syndrome X and idiopathic dilated cardiomyopathy to evaluate myocardial perfusion.

There is still no consensus for management of CAE. Previously improvement of coronary flow has been demonstrated by mibefradil in patients with slow coronary flow. A new trial is needed to explore the effect of calcium channel blockers (CCB) in isolated CAE. Diltiazem improves myocardial perfusion by blocking calcium channels in coronary arteries. This agent has been widely used in coronary catheter labs to prevent and treat no-reflow.

The current study with prospective design was therefore set up to assess whether epicardial flow and tissue level perfusion would be improved by diltiazem in myocardial regions subtended by the ectatic coronary arteries among patients with isolated CAE.


Eligibility Criteria:
Inclusion Criteria: Patients with isolated coronary artery ectasia at least 1 major epicardial coronary artery

Exclusion Criteria:

Patients with known allergy to diltiazem acute coronary syndrome left ventricular systolic dysfunction significant valvular heart disease heart failure systolic blood pressure \<90 mmHg heart rate \<60 atrioventricular block (grade \> I) severe liver or kidney failure significant coronary artery stenosis and patients on treatment with calcium channel blockers were excluded
Evaluation of the Possible Vertical Transmission of SARS-CoV-2 Through Study of Amniotic Fluid and Chorionic Villi of Affected Pregnant Women for the COVID-19

Longitudinal prospective study in pregnant women withpositive serology or PCR for SARS-CoV-2 and indicationinvasive technique (amniocentesis or chorionic biopsy) that has the objective to evaluate the possible vertical transmission of SARS-CoV-2in the amniotic fluid or chorionic villi of pregnant women affected by coronavirus in the different periods of gestation.

Patients will be recruited at the time theypresent an indication to perform a techniqueinvasive (amniocentesis or chorion biopsy). Eitherscreening for first or second trimester aneuploidies ofhigh risk, due to the presence of fetal malformation, due toearly intrauterine growth retardation (ICR) or due tosuspected chorioamnionitis.

The study population will be pregnant women diagnosed with SARS-CoV-2 infection(by PCR on nasopharyngeal aspirate or serology)that have an indication to perform an invasive technique(chorionic biopsy or amniocentesis) along thegestation.The sample size will depend on the duration of theSARS-CoV-2 pandemic.Initially we propose a study period of 18 months in which we would have an approximate total of 225 pregnant women with indication of invasive technique.It is planned to conduct a PCR study for SARS-CoV-2 in amniotic fluid or chorionic villi to those pregnant women diagnosed with SARS-CoV-2 infection(approximately 5% of the total pregnant womenwith indication of invasive technique (11-12 pregnant women)).This determination is made as part of theroutine clinical practice in the context of the study ofscreening for perinatal infections.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women diagnosed with SARS-CoV-2 (by PCR in aspiratenasopharyngeal or serologies)
* Patients indicated for an invasive technique(chorionic biopsy or amniocentesis

Exclusion Criteria:

* Patients who do not meet the inclusion criteria