cyrilzakka/clinical-trials huggingface dataset:
Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women

The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.

Pregnant women with high viral load (HBV DNA\>2 × 10\^5 IU/mL ) are recommended to be given Tenofovir Disoproxil Fumarate(TDF) for mother-to-child blocking of Chronic hepatitis B(CHB) by guidelines. Tenofovir alafenamide (TAF) is a new targeted pro-drug of Tenofovir (TFV) and was approved for use in China in December 2018. Compared with TDF, the therapeutic dose of TAF is small. 25mg TAF can obtain the antiviral effect similar to 300mg TDF, thus reducing the concentration of TFV in the blood.

This is a prospective clinical study, aiming to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women when used for prevention of mother-to-child transmission of hepatitis B virus. 50 HBeAg-positive and HBV DNA levels ≥ 2 × 10\^5 IU/mL pregnant women will be enrolled to receive Tenofovir alafenamide (TAF) from week 28-32 of gestation until delivery. According to the mother's wishes, intensive blood samples will be collected to determine the concentration of TAF and TFV in plasma of pregnant women before and after taking TAF, calculate the pharmacokinetic parameters. And the mother's milk is collected every day for 5 days for TAF concentration determination. The primary endpoint was the pharmacokinetic parameters of TAF and TFV, rate of mother-to-child transmission, the congenital malformation rate of infants. The secondary endpoint was the decrease of HBV DNA level at delivery, the clearance and seroconversion rate of HBeAg, postpartum ALT flare, concentration of TAF and TFV in milk,and other adverse events of mothers and infants.

Eligibility Criteria:
Inclusion Criteria:

* Age of 20-40 years; Positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg); HBV DNA level \>200 000 IU/mL during the 24th-32nd week of pregnancy; Willing to take TAF for mother-to-child blockade; Both husband and wife are willingly sign an informed consent.

Exclusion Criteria:

* Co-infected with hepatitis C or HIV, or other chronic diseases; History of spontaneous abortion or congenital malformation; Decompensated cirrhosis and liver cancer; History of kidney injury, CCr \<50ml/min and urine protein test positive (\>300mg/L); Fetal malformations detected by B-ultrasound during pregnancy; ALT \> 2×upper limit of normal (ULN); TBIL ≥ 1×ULN; Albumin (ALB) \< 25 g/L.
Continuous Saphenous Nerve Block for Total Knee Arthroplasty

Our study will compare the use of continuous saphenous nerve block performed at the adductor canal in addition to Local Infiltration Analgesia (LIA) versus a Sham block in addition to LIA for total knee replacement. The investigators hypothesize that the saphenous nerve block performed at the level of the adductor canal in addition to LIA provides better pain relief than the LIA alone without significantly compromising muscle strength and physiotherapy, enabling patients to mobilize early with reduced opioid consumption and les side effects.

The investigators will enroll a total of 40 patients (20 patients will receive continuous saphenous nerve block in addition to LIA and 20 will receive the sham block and LIA). Until discharge, the investigators will record patients' pain scores, opioid consumption, side effects and physical therapy progress.

If our study proves that the continuous saphenous nerve block in addition to LIA can effectively reduce postoperative pain scores to an acceptable level with better physical therapy progress and less opioid consumption, it could be seen as a more attractive alternative to LIA alone or other traditionally used methods of postoperative pain control that compromises muscle strength and physiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Age: 40-75
* Unilateral TKA
* Use of Spinal anesthesia

Exclusion Criteria:

* Allergy to any of the study medications
* Intolerance to morphine
* Contraindication to a spinal anesthetic
* Intraoperative use of any volatile anesthetic
* Chronic opioid use
* ASA Class 4-5
* Rheumatoid arthritis or Diabetes mellitus with neuropathy
* Liver or kidney failure
* BMI above 40
* Severe COPD
Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.

Stress related upper Gastrointestinal (GI) bleedings are important events associated with morbidity and mortality among seriously ill patients. Data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. Esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. This study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by Chinese seriously ill patients.

Eligibility Criteria:
Inclusion Criteria:

1. Critically ill patients
2. Requirement for mechanical ventilation
3. At least one major risk factor for stress ulcer related bleeding

Exclusion Criteria:

1. History of gastric or oesophageal surgery
2. Evidence of active GI bleeding
3. Advanced renal disease
4. Treatment with any Proton Pump Inhibitors
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).

After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).


Eligibility Criteria:
Key eligibility criteria:

* Post-menarchal females, aged 12 years or more
* Diagnosis of BV by Amsel criteria (ie all four of the following signs/symptoms: presence of white to grey homogeneous discharge; positive whiff test indicating an amine (fishy) odor with addition of potassium hydroxide; vaginal pH greater than 4.5; and presence at least 20% clue cells of total epithelial cells
* Nugent score of at least 4
* Otherwise healthy, as determined by medical history, physical examination
* normal Pap smear at or documented within 24 months of screening
Is Microlearning the Alternative in the Age of Hyperconnectivity

This Quasi-Experimental Study evaluated whether microlearning a strategy delivering brief, focused learning units enhances knowledge acquisition and retention among fifth-year medical students studying pediatric spinal deformities compared to a traditional block-format module.

Methods: twenty-four students will be included into two groups. The microlearning group will receive sequential daily learning units over ten days, while the traditional group will engage in a comprehensive two-day self-learning module. Pretest, immediate post-test, and one-month post-intervention assessments will be performed using standardized MCQ and SAQ instruments. Learner engagement, time investment, and content clarity were additionally evaluated via structured surveys.


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled fifth-year medical students Registered for the optional module in Physical Medicine and Rehabilitation Access to a personal computer, tablet, or smartphone with internet connectivity Ability to access the institutional Modular Object-Oriented Dynamic Learning Environment (Moodle) learning management system (LMS) Voluntary oral informed consent Commitment to complete both pre-assessment and post-assessment evaluations Willingness to participate in either learning modality (microlearning or traditional block-format) as determined by randomization

Exclusion Criteria:

Failure to complete the pretest assessment Non-completion of the pre and post-test assessment Withdrawal of consent at any point during the study Development of circumstances that would render continued participation burdensome to the participant
Prognosis Association of Hypocalcemia on Moderate-severe TBI, COHORTE STUDY

Will have bad prognosis the patients with low calcium (less of 24 hrs of te admission in hospital)after moderate - severe TBI that the patients that do not developed this condition?

Through the years the investigators have seen that the patients with low calcium after moderate-severe TBI had bad prognosis including more complications, and more days in hospital. The investigators want to make an association between the patients that developed this condition and the patients that do not developed this condition

Eligibility Criteria:
Inclusion Criteria:

* Man - woman between 16-65 years old with moderate -severe TBI less as 24 hrs,Count with tomographic study

Exclusion Criteria:

* Use of steroids, use of statins, Administration of Tromethamine, calcium antagonists, fibrates, niacin, cyclosporine, macrolides.
* Unclassifiable lesions in brainstem
Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study

This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients age is18 years or greater;
* Patients undergoing a first-time ablation procedure for AF;
* Patients with persistent AF;
* Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 3 years.
* Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication;
* At least one episode of persistent AF must have been documented by ECG, holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation;
* Patients must be able and willing to provide written informed consent to participate in this investigation; and
* Patients must be willing and able to comply with all peri-ablation and follow-up requirements.

Exclusion Criteria:

* Patients with paroxysmal AF;
* Patients with long-standing persistent AF;
* Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
* Patients with AF felt to be secondary to an obvious reversible cause;
* Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor;
* Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view); and
* Patients who are pregnant.
Incidence of Body Dysmorphic Disorder (BDD) in a Population of Patients Undergoing Orthognathic Surgery

Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery

Assessment of the incidence of Body dismorphic disorder in a population candidated to orthognathic surgery by using 3 validated questionnaires

Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for orthognathic surgery
* Age: 18 to 50 years;
* Informed consent

Exclusion Criteria:

* - Patients diagnosed with another psychiatric pathology
* Patients affected by syndromes involving the cervical-facial district
* Patients affected by clefts
* Patients affected by OSAS and candidates for orthognathic surgery for this indication
* Patients affected by connective tissue disorders (e.g. Ehler-Danlos, scleroderma, etc.)
* Patients candidates for orthognathic surgery due to facial trauma
Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers in the age between 19 and 50 years old.
* Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
* After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
* Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.

Exclusion Criteria:

* Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
* Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to investigational product or the same component or other drugs (aspirin, antibiotics, etc.).
* Aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
* Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
* Heavy smoker (\>10 cigarettes/day).
The Effect of Laparoscopic Splenectomy and Azygoportal Disconnection on Liver Reserve Function for Cirrhosis Patients

In this study, the investigators compared the improvement of liver reserve function related indicators in patients with liver cirrhosis after laparoscopic splenectomy and azygoportal disconnection. To determine whether surgical treatment can help enhance postoperative liver reserve function and improve patient prognosis.

The patients were enrolled according to the research criteria, and collected the general basic information of the patients. After the preoperative preparation was perfected, the same surgical team performed laparoscopic splenectomy and azygoportal disconnection, and the same nursing team performed the nursing after the operation. Then, patients received a unified treatment plan after surgery, including medication, other treatments and follow-up. During the treatment, the liver reserve function related indicators of the patients were monitored before surgery, 3, 6, 12 and 24 months after surgery, including TBIL, DBIL, ALB, ALT, INR, PT, Child-Pugh, ascites, prealbumin, ICG-K, ICG-R 15 and ICG-T/2.

Eligibility Criteria:
Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
* Splenomegaly with secondary hypersplenism
* gastroesophageal variceal bleeding
* Informed consent to participate in the study

Exclusion Criteria:

* Hepatocellular carcinoma or any other malignancy,
* Child-Pugh grade C
* Recent peptic ulcer disease
* History of Hemorrhagic stroke
* Pregnancy.
* Uncontrolled Hypertension
* Human immunodeficiency virus (HIV) infection
Cold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide - 2

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To evaluate: cold water immersion modulates the reinforcing effects of nitrous oxide in healthy volunteers.


Eligibility Criteria:
Please contact site for information.
Percutaneous Revascularization in Infarction With Late Presentation and Absence of Viability: Effects on Left Ventricular Remodeling and Contractility

The purpose of this study is to evaluate whether late recanalization in patients with ST elevation myocardial infarction (STEMI) without Viability on Cardiovascular Magnetic Resonance Image (MRI) can reduce the reverse remodeling through the reduction of the End Systolic Volume (ESV) at 6 months.

The purpose of this study is to evaluate whether late recanalization in patients with ST elevation myocardial infarction (STEMI) without Viability on Cardiovascular Magnetic Resonance can reduce the reverse remodeling through the reduction of the End Systolic Volume (ESV) at 6 months and through the improvement in segmental contractility of infarcted related artery at MRI.

Eligibility Criteria:
Inclusion Criteria

1. STEMI not reperfused between 24 hours and 28 days
2. MI-related artery with \> or = 50%
3. Segmental dysfunction in the artery related to infarction.
4. Technical feasibility for PCI recanalization
5. Absence of Myocardial Viability

3.3 Exclusion criteria

1. Age \> 80 years
2. \< 1 year life expectancy
3. Post MI Angina
4. Clinical Instability
5. Electrical Instability
6. Previous Infarction with segment disfunction
7. New York Heart Association (NYHA) class III or IV of heart failure.
8. Previous diagnosis of congestive heart failure or cardiomyopathy
9. Severe heart valve disease
10. Absence of segmental dysfunction in the artery related to infarction
11. Coronary angiography without obstructive lesions
12. Indication of myocardial revascularization surgery
13. Opted for clinical treatment for technical reasons
14. Serum creatinine concentration greater than 2.5 mg/dl
15. Pacemaker or Implantable Cardiodefibrillator (ICD)
16. Brain Clip Carriers
17. Patients with Cochlear Implants
18. Refusal to sign the Informed Consent Form (ICF).
19. Inability to maintain outpatient follow-up for 6 months.
ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of glioblastoma multiforme.

PURPOSE: Phase II trial to study the effectiveness of ZD 1839 in treating patients who have glioblastoma multiforme in first relapse.

OBJECTIVES:

* Determine the activity of ZD 1839 in patients with glioblastoma multiforme in first relapse.
* Determine the pharmacokinetics and toxicity of this drug in these patients.
* Assess the relationship between epidermal growth factor receptor status in these patients and activity of this drug.

OUTLINE: Patients receive oral ZD 1839 once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for at least 6 months.

PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed glioblastoma multiforme in first relapse

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* More than 12 weeks

Hematopoietic:

* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin less than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN

Renal:

* Creatinine less than 1.5 times ULN

Cardiovascular:

* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia

Other:

* No other uncontrolled concurrent illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No prior allergic reactions to compounds of similar chemical or biologic composition to ZD 1839
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Ocular inflammation must be fully treated before study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

* Must be on stable dose of steroids for at least 1 week

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered

Surgery:

* At least 1 week since prior surgery

Other:

* No other concurrent investigational agents
* No other concurrent anticancer therapy
* No concurrent combination antiretroviral therapy for HIV
* No concurrent enzyme-inducing anticonvulsant drugs
A Long-Term Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)

The purpose of this study is to evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients


Eligibility Criteria:
Inclusion Criteria:

* Japanese SCD patients with ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Cognitive Adaptations to Reduce Emotional Stress Associated With Type 1 Diabetes

The purpose of this study is to evaluate a new intervention (CARES: Cognitive Adaptations to Reduce Emotional Stress Associated with Type 1 Diabetes) designed to reduce caregiver depressive symptoms in families of children with T1D. This is a pilot in which all enrolled parents/caregivers will be placed in the intervention group to assess initial pre- to post-treatment impact of the intervention on parent/caregiver depression, distress, and diabetes-related outcomes (e.g., glycemic control).


Eligibility Criteria:
Inclusion Criteria:

* Parent/primary caregiver of a child diagnosed with T1D between 5-12 years old
* Parent/caregiver elevated depression symptoms on the CESD-R (score ≥ 16 at time of screening)
* Child with T1D receiving intensive insulin regimen by multiple dose injections (MDI) or continuous subcutaneous insulin infusion (pump)

Exclusion Criteria:

* Child with T1D currently in foster care or not living with legal guardian
* Child with evidence of type 2 diabetes or monogenic diabetes
* Child with a co-morbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D
* Children who are chronically using medications that may impact glycemic control (i.e., systemic steroids)
* Parents/caregivers who do not speak English (currently there is no way to recruit non-English speaking families because the study questionnaires are only available in English)
Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)

The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female patient minimum 18 years of age
2. No significant (\>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff;
3. Target lesion is 18mm in length (visual estimate);
4. Target lesion is 3.0mm and 3.5mm in diameter (visual estimate);
5. Target lesion stenosis is \>50% and \<100% (visual estimate);

Exclusion Criteria:

1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
2. Ejection fraction 30%;
3. Stent placement of target lesion covers a side branch \>2.0mm in diameter;