cyrilzakka/clinical-trials huggingface dataset:
Composite Probiotics Stabilize Lipid Metabolism in Chronic Hepatitis B Patients:A Clinical Trial

The goal of this is to verify the clinical efficacy of compound probiotics in reducing HBV infection levels and regulating intestinal flora in patients with chronic hepatitis B.

The main question it aims to answer is:

• Conventional antiviral therapy combined with a 3-month probiotic intervention was used to evaluate the clinical efficacy of reducing HBV infection levels (HBeAg, HBsAg, and HBV DNA levels) and regulating gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the hepatitis B clinical diagnostic criteria of the Chronic Hepatitis B Prevention and Treatment Guidelines (2022 edition), excluding patients infected with hepatitis C virus, hepatitis D virus and other hepatitis viruses;
2. Be aware of the content and purpose of this study, and voluntarily sign the treatment study consent.

Exclusion Criteria:

1. Patients infected within 3 months;
2. Received antibiotic treatment within 3 months;
3. Received probiotic and probiotic therapy within 3 months;
4. Complicated with hypertension or diabetes;
5. Obesity or significantly low weight;
6. Obvious atherosclerosis;
7. Chronic kidney disease;
8. Inflammatory bowel disease, irritable bowel syndrome, or a history of gastrointestinal surgery;
9. Malignant tumors;
10. Autoimmune diseases;
11. Mental illnesses such as Parkinson's disease, Alzheimer's disease and stroke;
12. Pregnant or lactating women;
13. Patients with cirrhosis or decompensated liver disease;
14. Subjects cannot participate in the experiment due to their reasons; Those who meet any of the above criteria will not be selected.
Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling

The purpose of the study is to evaluate the efficacy of quetiapine compared to valproate during a 12 month treatment period in subjects with Bipolar Disorder I or II with Rapid Cycling.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, men and women aged ³18 to £65 years with diagnosis of DSM-IV criteria for bipolar I or II disorder, most recent episode manic, hypomanic, mixed or depressive with Rapid Cycling.

Exclusion Criteria:

* Substance or alcohol dependence, female patients who are pregnant, lactating or at risk of pregnancy, diagnosis of schizophrenia or borderline personality disorder or antisocial personality disorder, history of seizure disorder, acute suicidal or external aggressive behaviour, legal incapacity or indication for treatment against the will of the patient by law.
Risk of Post Transfusion Hepatitis C Virus Infection

To determine the risk of transfusion-transmitted hepatitis C virus (HCV) in cardiac surgery patients before and after donor screening for anti-HCV and surrogate markers of non-A, non-B hepatitis (NANBH). Also, to characterize donors who were HCV seronegative and who lacked surrogate markers at the time of donation, but whose recipient seroconverted to HCV.

BACKGROUND:

In the early 1990s, posttransfusion NANBH, mainly caused by HCV, was the most common serious complication of transfusions, occurring in 2-5 percent of transfusion recipients. About 50 percent of those infected developed chronic hepatitis, of whom, 10 to 20 percent developed cirrhosis. Hepatocellular carcinoma had been reported to occur in some. This study provided the first evaluation of the effectiveness of donor screening for anti-HCV by the then recently licensed HCV antibody test and surrogate markers of NANBH. It also provided a precise estimate of the risk of transfusion-transmitted HCV. The results allowed examination of risk factors for HCV infected donors who were seronegative at the time of donation.

DESIGN NARRATIVE:

The study was a nonconcurrent prospective, seroepidemiologic study. To estimate the incidence of HCV infection, six-month postoperative serum samples were tested for antibody to HCV. Preoperative samples corresponding to positive postoperative sera were also tested. The donors of a patient who received blood screened for HCV, i.e., a donation since May, 1990, and seroconverted in the six months since transfusion were located and retested for antibodies to HCV. The donors were administered a questionnaire designed to ascertain risk factors for HCV infection. A sample of donors who were HCV positive at the time of donation were given the same questionnaire. Comparison of these three groups of donors (i.e., seropositives, donors tested negative but implicated in seroconversion, seronegatives) allowed an investigation of factors associated with false negative screening results. Analytical methods included standard methods for contingency tables and both conditional and unconditional logistic regression.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effects of Exercise in Patients With Metastatic Breast Cancer

Currently, the effect of exercise on metastatic breast cancer has not been extensively studied, even though the benefits are evident in the curative setting. The investigators designed the EFFECT study to assess the effects of a 9-month structured and individualised exercise intervention in 350 patients with metastatic breast cancer (stage IV) on cancer-related physical fatigue, Health-Related Quality of Life (HRQoL), and other disease and treatment-related side effects at six months (primary endpoint).

The EFFECT study is a multicentre, randomised controlled trial. The intervention group will participate in a 9-month exercise intervention. The exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. The multimodal exercise program comprises aerobic-, resistance- and balance components. After completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine.

Unsupervised exercises will be supported by an activity tracker (FitBit) and an exercise App specifically designed for the EFFECT trial. Patients randomized to the control group will also receive an activity tracker (like the intervention group). The investigators will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer stage IV
* ECOG (Eastern Cooperative Oncology Group scale) performance status ≤ 2
* Able and willing to perform the exercise program and wear the activity tracker

Exclusion Criteria:

* A potential subject who meets any of the following criteria is not eligible for enrolment into this study:

  * Unstable bone metastases inducing skeletal fragility as determined by the treating clinician
  * Untreated symptomatic known brain metastasis
  * Estimated life expectancy \< 6 months as determined by the treating clinician
  * Serious active infection
  * Too physically active (i.e. \>210 minutes/week of moderate-to-vigorous intentional exercise
  * Severe neurologic or cardiac impairment according ACSM criteria
  * Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise
  * Uncontrolled severe pain
  * Any other contraindications for exercise as determined by the treating physician
  * Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician
  * Pregnancy
Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study

A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.

Approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. The maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.

Acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to understand and provide written informed consent.
* Must have completed the treatment period in the RECAST SLE study.
* Women of childbearing potential must have a negative urine pregnancy test on Day 1.
* Nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose.

Exclusion Criteria:

* Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration.
* Participation in another clinical study with an IP during the RECAST SLE study period.
* Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety.
* Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit 1.
* Clinically significant active infection at Visit 1, in the opinion of the Investigator.
* Pregnant or lactating females.
Evaluation of New MRI Sequences Including 3D-FGAPSIR for the Optimization of Inflammatory Spinal Cord Lesions Research

* verification of inclusion and non-inclusion criteria
* information and collection of consent
* standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.
* 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

* verification of inclusion and non-inclusion criteria
* information and collection of consent
* standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.
* 3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* To benefit from a medullary exploration planned by 3T MRI as part of a first evaluation or a reassessment of inflammatory involvement of the nevrax
* Express consent to participate in the study
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant, parturient or breastfeeding woman
* Absolute or relative contraindication to MRI
Tibial Shaft Nailing Treated With Suprapatellar Nailing

The goal of this project is to determine the incidence of intra-articular knee pathology following tibial shaft fractures as evaluated by intraoperative knee aspiration and physical exam, and to evaluate for chondral injuries following treatment with a suprapatellar tibial nail via MRI.

Suprapatellar tibial nailing is gaining popularity throughout the orthopedic community for tibial shaft fractures, however the secondary effects of this technique on the articular cartilage of the knee is unknown. Additionally, the incidence of intra-articular knee pathology in the face of tibial shaft fractures has not been described in the orthopedic literature. An undiagnosed cruciate/collateral ligament injury can result in post-traumatic arthritis, as well as a delay in justified ligamentous reconstruction of the knee, causing further injury. Long term sequelae of now commonplace suprapatellar nailing on the patellofemoral joint of the knee have been sparsely elucidated in the literature.

The primary objective is to determine the consequences of suprapatellar tibial nailing on cartilage of the patellofemoral joint.

As a secondary objective, this study will seek to determine the incidence of intra-articular knee pathology following tibial shaft fractures in patients presenting to Orlando Regional Medical Center.

Eligibility Criteria:
Inclusion Criteria:

1. skeletally mature
2. open or closed fractures of the tibial shaft

Exclusion Criteria:

1. concomitant tibial plateau or tibial pilon injuries
2. a knee dislocation
3. skeletally immature
4. those who will undergo standard (infra-patellar) tibial nailing
Gastric Emptying and Insulin Response to Test Drink

Surgery is a stress on the body and recovering well after surgery is very important to patients and their doctors. It is therefore important to prepare patient's bodies for the stress of surgery, and one way to do this is to provide proper nutrition. In the past, patients were asked to prepare for surgery by fasting from midnight before surgery. Today, it is known that this practice is not beneficial to patient's recovery. In fact, it has been recognized that drinking a sugary beverage (e.g., juice) before surgery stimulates the production of insulin, which is a hormone that helps make the proteins needed for wound healing after surgery. This is currently practiced at the MUHC. It might also be beneficial, however, to drink a beverage that contains sugar and whey proteins (a protein isolated from milk) before surgery. In fact, whey proteins stimulate insulin and may also have the added benefit of improving muscular strength. In this study, investigators will measure the level of insulin produced after drinking a carbohydrate (i.e., sugar)-whey protein beverage to determine how it compares to the level of insulin produced after drinking the sugary beverage used at the MUHC.

It is hypothesized that the increase in plasma insulin following a mixed carbohydrate whey protein drink is significantly greater than that elicited by a carbohydrate drink.

Eligibility Criteria:
Inclusion Criteria:

- Healthy volunteer

Exclusion Criteria:

* diabetes,
* neurological disorders
* chronic kidney failure
* chronic liver disease
* disorders of gastric motility
* gastro-esophageal reflux
* achalasia
* gastroparesis
* intestinal obstruction
* previous abdominal surgery
* lactose intolerance
* body mass index below 17 or above 29
* allergy to acetaminophen.
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants With Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants

A study to investigate the pharmacokinetics, safety, and tolerability of AZD4144 in participants with severe renal impairment, end-stage kidney disease, and in healthy participants

This is an open-label, single dose, non-randomised, parallel group, Phase I study to assess the pharmacokinetics, safety, and tolerability of AZD4144 in male and female participants with severe renal impairment and end-stage kidney disease (ESKD) compared with healthy control participants.

The study will comprise of:

* A Screening Period of 21 days.
* Cohort 1 and 2: a single Treatment Period with an in-clinic period of 7 days.
* Cohort 3: two Treatment Periods each with an in-clinic period of 7 days, and a washout period of 6 days after the in-clinic treatment period.
* A Follow-up visit 7 days following discharge.

Eligibility Criteria:
Inclusion Criteria:

Healthy Matched Control Participants Only (Cohort 2):

* Stable renal function (for example, no clinically significant change in an estimated glomerular filtration rate (eGFR) within 3 months or longer prior to study the Screening Visit), as determined by the investigator.
* Have an eGFR of ≥ 90 milliliter/minute/1.73m2 (mL/min/1.73m2) as determined via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula without race.

Renally Impaired Participants Only (Cohort 1)

* Participants who have renal impairments.
* Participants with severe renal impairment must have an eGFR ≥ 15 to \< 30 mL/min/1.73m2 not on dialysis.
* Cohort 1 should have at least 3 participants with eGFR ≤ 20 mL/min/1.73m2.

Cohort 3

* Participants with ESKD on IHD must have been on stable IHD for at least 3 months prior to Visit 1.
* All renally impaired participants should be on stable standard of care for at least 4 weeks prior to Visit 1.

All cohorts:

* Body weight of at least 50 kilograms (kg) and body mass index (BMI) within the range ≥ 18 to ≤ 35 kg/m2, inclusive.
* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.

Exclusion Criteria:

* History of QT prolongation associated with other medications that required discontinuation of that medication.
* Congenital long QT syndrome.
* Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
* Concomitant immunosuppressive, steroid treatment.
* Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal including bone fractures, endocrine including adrenal insufficiency, metabolic, malignant, psychiatric, major physical impairment) (Cohort 2).
* Renal transplant participants, participants on dialysis, and those with a history of acute kidney injury (Cohort 1).
* Use of any of the prohibited medications in the 4 weeks prior to Visit 1 (Cohorts 1 and 3).
* Participants with a known hypersensitivity to AZD4144 or any of the excipients of the product.
A Study of Naltrexone SR/ Bupropion SR in Overweight and Obese Subjects Who Are Nicotine-Dependent

The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of nicotine-dependence in overweight and obese subjects.


Eligibility Criteria:
Key Inclusion Criteria:

1. Female and male subjects must be 18 to 65 years of age;
2. Have body mass index (BMI) greater than or equal to 27 and less than or equal to 45kg/m2;
3. Have smoked an average of at least 10 cigarettes/day in the preceding year, with \< 3 month total abstinence period;
4. Self-reported level of motivation to stop smoking ≥ 7, on a scale of 1-to-10;
5. At least moderately concerned about gaining weight after quitting smoking
6. Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;
7. Able to comply with all required study procedures and schedule;
8. Able to speak and read English;
9. Willing and able to give written informed consent.

Key Exclusion Criteria:

1. Obesity of known endocrine origin
2. Serious medical condition
3. History of drug or alcohol abuse or dependence
4. Use of excluded concomitant medications
5. History of surgical or device (e.g. gastric banding) intervention for obesity;
6. History or predisposition to seizures
7. Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
8. Planned surgical procedure that can impact the conduct of the study;
9. Use of investigational drug, device or procedure within 30 days prior to Screening;
10. Participation in any previous clinical trial conducted by Orexigen Therapeutics;
11. Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
Physical Exercise as a Targeted Therapy in Patients With Chronic Rheumatic Muscle Inflammation

The objectives of this study are to test if hypoxia in muscle tissue is an important factor contributing to clinical symptoms in chronic rheumatic muscle inflammation and to evaluate if a 12 week endurance exercise program will improve muscle tissue hypoxia and disability in patients with chronic rheumatic muscle inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic, stable polymyositis or dermatomyositis with diagnosis of definite or probable polymyositis or dermatomyositis (Bohan and Peter 1975)
* Age 18-80 years
* Duration since diagnosis \> 6 months
* Exercising \< once a week,
* Stable disease activity and medication for at least one month.

Ten healthy controls matched for age, gender and physical exercise level will be included.

-

Exclusion Criteria:

* Severe pulmonary fibrosis
* Heart or lung conditions that contraindicate vigorous exercise
* Severe osteoporosis
* Not being able to perform the exercise program.
Cyberbullying Awareness Training for Secondary School Students

The study will be conducted with the randomized controlled experimental method. The purpose of this research is to determine the cyberbullying awareness training given to 7th-grade secondary school students' awareness levels of cyberbullying. Students will be randomly assigned to groups by lottery method. After the randomization students in the intervention group will be given 'Cyberbullying Awareness Training'. The cyberbullying awareness level of all students will be determined with the 'Cyberbullying Awareness Scale' before and 3 months after the training. Students in the control group will not be educated. The cyberbullying awareness level of the students in the control group will be determined with the 'Cyberbullying Awareness Scale' when they are included in the research and 3 months later.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 12 and 14,
* No auditory, visual, or mental problems that would affect communication
* Speaking and understanding Turkish at native level

Exclusion Criteria:

* Being younger than 12 years old and older than 14 years old,
* Having auditory, visual, or mental problems that would affect communication
* Not speaking and understanding Turkish at native level
Efficacy and Safety of SHR-1314 in Patients With Active Ankylosing Spondylitis

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in patients with active ankylosing spondylitis


Eligibility Criteria:
Inclusion Criteria:

- Active Ankylosing Spondylitis, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response, contraindications or intolerance to NSAIDs

Exclusion Criteria:

- pregnancy or lactation, serious infectious, malignancy, previous exposure to any biological agent excluding TNF antagonists
Psychodynamic Internet Treatment Versus Cognitive Behavioral Therapy (CBT) for Generalized Anxiety Disorder

The objective is to test if Internet-delivered cognitive behavior therapy (iCBT) or Internet-delivered psychodynamic therapy (iPDT) performs better for a population with generalized anxiety disorder (GAD), compared to a wait-list control condition.

This was a non-inferiority trial within the context of a parallel group study with unrestricted randomisation in 1:1:1 ratio conducted in Sweden. Outcome assessors were blind to treatment status.

Eligibility Criteria:
Inclusion Criteria:

* fulfill the diagnostic criteria for GAD according to DSM-IV
* have access to the Internet
* have good knowledge of the Swedish language

Exclusion Criteria:

* recent (during last 6 weeks) change in psychiatric medication
* presently in any other psychological treatment
* severe depression
* suicidal ideation
DiGESTnewborn Study

We wish to study the effect of a mothers sugar (glucose) control during pregnancy on her baby's sugar control after birth.


Eligibility Criteria:
Inclusion Criteria:

* mothers and their babies who have been enrolled in DiGest Trial and who have provided informed consent

Exclusion Criteria:

* none