cyrilzakka/clinical-trials huggingface dataset:
Tenofovir Alafenamide With Fine Needle Aspiration Biopsy in Chronic Hepatitis B:

The objective of this study is to identify immunological mechanisms that contribute to normalization of liver inflammation in chronic hepatitis B (CHB) patients starting the antiviral nucleoside analogue, Tenofovir alafenamide (TAF).

Investigator-initiated, phase 4 study in which recruited patients will receive, TAF 25mg once daily, for 48 weeks (Figure 1 and Table 1). The total duration of the study to End of Follow-up (EOF) will be 48 weeks. After Week 48, participants will be offered 2 years of TAF therapy. Sample collection 0, 12, 24 w was chosen to analyze immune responses based on ALT normalization rates. This mono-center study will be conducted at Toronto Centre for Liver Disease, Canada.

Eligibility Criteria:
Inclusion Criteria:

* • Age \>18 years

  * Chronic hepatitis B (HBsAg positive ≥ six months)
  * HBeAg positive or negative
  * ALT \>19 for females and \>30 for males (AASLD criteria)
  * HBV DNA\>4 log IU/mL for HBeAg positive and \>3 log for HBeAg negative patients
  * No oral antiviral treatment or IFN for ≥6 months
  * Adequate contraception. For males, at least one method of contraception should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
  * Written informed consent

Exclusion Criteria:

* • Treatment with any investigational drug within 60 days of entry into this protocol

  * Immune-suppressive treatment within the previous 6 months
  * History of decompensated cirrhosis (defined as direct (conjugated)
  * bilirubin \> 1.2 × ULN,
  * prothrombin time (PT) \> 1.2 × ULN
  * platelets \< 100,000/mm3
  * serum albumin \< 3.5 g/dL
  * prior history of clinical hepatic decompensation (jaundice in the presence of cirrhosis, ascites, gastric bleeding, oesophageal varices or encephalopathy)
  * Liver transplantation
  * Co-infection with hepatitis C virus, hepatitis D virus or HIV
  * Other significant liver disease: alcoholic liver disease, drug-related liver disease, auto-immune hepatitis, hemochromatosis, Wilson's disease or alpha-1 antitrypsin deficiency
  * Estimated glomerular filtration rate \<50 mL/min/1.73m2 or any significant renal disease.
  * Alpha-fetoprotein \> 50 ng/ml
  * Pregnancy, breast-feeding
  * Other significant medical illness that might interfere with this study: significant pulmonary dysfunction in previous 6 months, malignancy other than skin basocellular carcinoma in previous 5 years, immunodeficiency syndromes (e.g. HIV positivity, auto-immune diseases, organ transplants other than cornea and hair transplant)
  * Substance abuse, such as alcohol (≥80 g/day), I.V. drugs and inhaled drugs in past 2 years. Current methadone usage is allowed.
  * Any other condition which in the opinion of the investigator would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the study
A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of SSRIs.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version of SCID-I.
* HAM-D (17-item) ≥ 22 at Screening (Visit 1) and \> 20 at Baseline (Visit 2).
* Minimum CGI-S ≥ 4 at Screening (Visit 1) and at Baseline (Visit 2).

Exclusion Criteria:

* Known failure to satisfactory respond after adequate dose and duration (12 weeks) of treatment with clomipramine and one SSRI, or with two or more SSRIs.
* Subjects with \> 20% HAM-D (17-item) improvement (decrease) from Screening (Visit 1) at Baseline (Visit 2).
* Subjects with uncorrected hypothyroidism or hyperthyroidism.
QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia

To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-75 years of age;
* Histopathological or cytological examination confirmed cancer , chemotherapy cycle of 21 days;
* Participant experienced thrombocytopenia and chemotherapy delay;
* ECOG performance status 0-1;
* The estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles.

Exclusion Criteria:

* Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
* Participant has serious bleeding symptoms;
* History of allergy to the study drug;
* Patients with hepatitis C antibody positive and detection of HCV-RNA exceeding the upper limit, patients with hepatitis B surface antigen positive and detection of HBV-DNA exceeding the upper limit, patients with severe cirrhosis, HIV antibody positive and syphilis antibody positive;
* Pregnant or lactating women;
* Participant has received any experimental therapy within 28 days prior to screening
* Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Long Term Follow-Up of Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania

This protocol is for the long term follow-up study of "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy (ART) in Tanzania", a 3-arm randomized controlled trial led by Professor Sandra McCoy at the University of California Berkeley and Dr. Prosper Njau at the Tanzanian Ministry of Health and Social Welfare. The investigators will determine the long-term effectiveness of short-term incentives for ART adherence and retention in care. The study will also determine whether incentives can also be used to re-engage PLHIV with HIV care after they have fallen out of care.

This study will build on preliminary data from a randomized study conducted in Shinyanga, Tanzania which found that short-term cash and food assistance improved ART adherence and retention in care among food insecure people living with HIV infection (PLHIV) after 6 and 12 months of follow-up. The investigators will now determine the long-term effectiveness of these incentive strategies. In this 2-year study, investigators will first determine 24-month adherence and retention outcomes using medical and pharmacy records for the 781 PLHIV who were alive at the end of the previous study, which concluded after 12 months of follow-up (Aim 1). Then, leveraging an existing program of home based care, investigators will determine the prevalence of undocumented transfers and deaths among the subset of patients found to be lost to follow-up or transferred in clinic records. Investigators will use these data from home visits to adjust estimates of the interventions' effectiveness on retention in HIV care and mortality (Aim 2). Among the PLHIV found to be disengaged from care, investigators will conduct a pilot study of a one-time cash incentive to encourage PLHIV to re-engage with care, with the goal of mitigating the barriers posed by transportation and opportunity costs (Aim 3). At the conclusion of the project, investigators will understand the long-term effectiveness of cash and food incentives for adherence and retention, and whether they can also be used for re-linking PLHIV to care, data highly relevant to 'Treat All' programs in Fast Track countries.

Eligibility Criteria:
Inclusion Criteria:

* Study participant in the prior study "Comparing Food and Cash Assistance for HIV-Positive Men and Women on Antiretroviral Therapy in Tanzania" (NCT01957917)
* Alive and willing to provide written informed consent
* Not currently enrolled in HIV care services

Exclusion Criteria:

- None
A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 Days

The purpose of this study is to determine the safety, tolerability and blood levels of AZD9742 after daily dosing for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 19-30

Exclusion Criteria:

* Positive Fecal Occult Blood Test
* Prescriptions that inhibit liver function
* Received flu/H1N1 vaccine within 2 weeks before first dose
Evaluation of Long-term Buprenorphine Plasma Exposure

The study objective is to characterise the long-term plasma exposure to buprenorphine after stopping SUBLOCADE treatment. There are no interventions planned.

This multicentre investigation will enroll participants from Study RB-US-13-0003 (NCT02510014) or both Studies RB-US-13-0003 and INDV-6000-301 (NCT02896296) and who received at least 2 subcutaneous (SC) injections of SUBLOCADE.

There are two parts to the study:

Part A consists of a single visit during which urine samples are collected to measure free buprenorphine and free norbuprenorphine concentrations; qualitative urine drug samples (UDS) for opioids, including buprenorphine; quantitative UDS for buprenorphine, norbuprenorphine and naloxone; and determination of creatinine concentration. Blood samples are collected for the determination of buprenorphine and norbuprenorphine plasma concentrations.

Results on the quantitative UDS performed in Part A determine enrollment in Part B: participants who provide a quantifiable (i.e., positive) result for buprenorphine and/or norbuprenorphine and a non-quantifiable (i.e., negative) result for naloxone meet continuation criteria to move on to Part B if Part B is still open to enrolment. Part B consists of two visits 30 days apart in which the same tests are run as were done in Part A.

Data indicate that after discontinuing SUBLOCADE patients may have detectable concentrations of buprenorphine in plasma and urine for 12 months or longer. Previous Phase II/III studies did not evaluate the pharmacokinetics (PK) of buprenorphine beyond 2 months after the last injection; this study will characterize the long-term plasma exposure starting at least 12 months after the last injection. The study will also assess relationships between plasma drug concentrations, free drug concentrations in urine and urine drug screen (UDS) results in order to provide refined guidance to patients and physicians with respect to long-term exposure to buprenorphine after stopping SUBLOCADE treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participated in Study RB-US-13-0003 or both Studies RB-US-13-0003 and INDV-6000-301 and received at least 2 subcutaneous (SC) injections of SUBLOCADE
* Within 12 to 36 months post his or her last SUBLOCADE injection at the time of the Screening Visit
* Female individuals of childbearing potential must agree to have a pregnancy test administered prior to enrollment and throughout the study. Pregnancy does not prohibit participation
* Willing to adhere to study procedures and provide written informed consent prior to the start of any study procedures.

Exclusion Criteria:

* Received SUBLOCADE or any other long-acting buprenorphine product at any time after ending their participation in Study RB-US-13-0003 or Study INDV-6000-301
* Taken any buprenorphine (prescribed or illicit) within 3 weeks prior to the Screening visit (study Part A, Visit 1)
Respiratory Muscle Strength in Volleyball Players Suffered From COVID-19

In literature, there is no data evaluating respiratory functions in volleyball players during Covid-19 pandemic. The aim of this study is to evaluate and compared pulmonary functions, respiratory muscle strength, body compositions and performance situations perceptions in female volleyball players with Covid-19 and non-Covid-19.


Eligibility Criteria:
Inclusion Criteria:

* having passed at least 30 days after the Polymerase Chain Reaction (PCR) test turned negative
* willing to participate in the study

Exclusion Criteria:

* having a history of chronic lung disease
* unwilling to participate in the study
Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants

The overall goal of this study is to examine the efficacy of the video-based Diabetes Self-Management Education and Support (DSMES) (hereafter VIDEO), or the video-based DSMES+community health worker (CHW) intervention (hereafter VIDEO+CHW), compared with a wait-list control group (hereafter CONTROL) to improve glycemic control among Chinese immigrants with uncontrolled Type 2 diabetes in NYC.

Participants will be randomized with equal allocation to one of the 3 groups. The VIDEO group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The VIDEO+CHW group will receive the same DSMES videos plus bi-weekly support calls from a CHW for 24 weeks. The CHW will assess participants' social determinants of health (SDOH) barriers to Type 2 diabetes care and link them to available resources in the community. The CONTROL group will continue to receive their usual care and at the end of the study, they will receive DSMES videos.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as a Chinese immigrant;
* be between 18-70 years old;
* have a diagnosis of Type 2 diabetes (T2D) in the medical record;
* have had an appointment with a physician for routine T2D care within the past 12 months;
* have a most recent HbA1c of at least 8%;
* be willing to receive brief videos regarding T2D management; and
* possess a smartphone or, if they do not have one, be willing and able to use a study smartphone.

Exclusion Criteria:

* unable or unwilling to provide informed consent;
* unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment);
* unwilling to accept randomization assignment;
* is pregnant, plans to become pregnant in the next 6 months, or becomes pregnant during the study; or
* is breastfeeding (e.g., they may have potential dietary restrictions).
Uroflow Measurements in Urogynecology Patients Compared to Healthy Female Volunteers

To compare uroflowmetry measurements of patients undergoing urodynamic testing as part of an incontinence work-up in an urogynecology practice to healthy female volunteers.


Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent urodynamics at the urogynecology clinic during the past 12 months
* Voids larger than 50 mls.

Exclusion Criteria:

* History of pelvic organ prolapse, incomplete bladder emptying, and voids less than 50cc.
Internet Gaming Disorder and Psychiatric Disorder

The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) recently identified Internet gaming disorder as a new potential psychiatric disorder which need further research. Several studies showed the important prevalence of psychiatric disorders among patients suffering from internet gaming disorder. Investigators hypothesize that on an other side the prevalence of internet gaming disorder among patients suffering from psychiatric disorders shall be high but it has never been studied yet.

The main goal of this trial is to examine the prevalence of internet gaming disorder using the Internet Gaming Disorder Test-10 (IGDT-10) among inpatient aged from 12 to 17 of 4 psychiatric units of French region Auvergne-Rhône-Alpes.

Secondary goals will be to assess a parental version of the IGDT-10 (IGDT-10-P) and to compare the two versions.

IGDT-10 will be passed during 6 months to every inpatient and IGDT-10-P to their parents within the 21 first days of the hospitalisation.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged from 12 to 17
* Parents of the patient, older than 18 years old
* Patients hospitalized in 4 psychiatric units of French region Auvergne-Rhône-Alpes

Exclusion Criteria:

* Patient and/or theirs parents are not fluent in French
* Intellectual deficit (known intelligence quotient below 70)
* Behaviour disorder making impossible to pass the questionnaire
A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function

The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy participants. The study will last up to 5 weeks, excluding screening.


Eligibility Criteria:
Inclusion Criteria:

Normal Participants:

* Healthy male and female participants as determined by physical examination
* Participants with normal renal function assessed by estimated glomerular filtration rate (eGFR) ≥ 90 milliliter per minute (mL/min).
* Body mass index (BMI) ≥ 19.0 and ≤ 40.0 kilograms per meter squared (kg/m²)
* Male participants who agree to use contraception and female participants of child bearing potential must agree to use contraceptive methods and women not of child bearing potential can participate.

Participants with Renal Impairment:

* Have acceptable blood pressure (BP) and pulse rate, as determined by the investigator
* Participants with type 2 diabetes must have a glycated hemoglobin (HbA1c) ≥ 5.0% and ≤ 11.5%
* Are males or females with severe renal impairment as determined by a stable eGFR \<30 mL/min, not requiring hemodialysis OR
* Are males or females with end-stage renal disease (have received hemodialysis for at least 3 months)

Exclusion Criteria:

* Have known allergies to LY3437943 or related compounds
* Have a current, functioning organ transplant. Nonfunctional renal allografts may be allowed
* Have any abnormality in the 12-lead electrocardiogram (ECG)
* Are women with a positive pregnancy test or women who are lactating
Bioavailability of Omega-3 Fatty Acids from Fish Oil Supplements

This study is investigating whether a new type of fish oil supplement, in the form of soft chews, leads to better absorption of omega-3s in the body compared to traditional fish oil capsules. Omega-3s, found in fish oil, are known to support heart health and reduce inflammation, but they may absorb better in certain forms. In this study, participants will take both types of supplements (soft chews and capsules) at different times to compare how well the omega-3s are absorbed. Researchers will measure the levels of omega-3s in the blood over several hours to determine if the soft chews offer a better option for people seeking the health benefits of omega-3s.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy adults (18 - 50 yrs);
* Body mass index (BMI) ≥18.5 and ≤30 kg/m2;
* Having veins suitable for blood sampling via a catheter (judged by study nurse/ medical doctor);
* Willing to refrain from fish, fish oil, and products with added omega-3 starting from 2 weeks prior to the first postprandial test day and during the study period;
* Willing to keep a stable dietary pattern throughout the study.

Exclusion Criteria:

* Having a disease that may interfere with the outcomes of this study, such as a known metabolic, gastrointestinal, inflammatory or chronic disease (such as anaemia, diabetes, hepatitis, hypercholesterolemia, cardiovascular disease), as judged by the medical investigator.
* Having a history of medical or surgical events that may significantly affect the study outcome, including: inflammatory bowel disease, pancreatitis, ulcers, gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; known or suspected gastrointestinal disorders, colon or GI tract cancer;
* Use of medication that may interfere with the study outcomes, including gastric acid inhibitors, laxatives, and lipid lowering drugs, as judged by the medical supervisor;
* Anaemia (Haemoglobin (Hb) values \<7.5 mmol/L for women and \<8.5 mmol/L for men), as assessed by finger prick blood during screening visit; NL87485.041.24 Ocean's O3
* Allergic for fish;
* Having swallowing problems with capsules;
* Recent blood donation (\<1 month prior to test day 1 of the study) or not willing to stop donation during and 1 month after the study;
* Average alcohol intake \>21 (women) or \>28 (men) glasses of alcoholic beverages per week;
* Reported to follow or having planned a slimming or medically prescribed diet;
* Use of recreational drugs;
* Current smokers, or stopped smoking in the last 3 months before study start;
* Insufficient proficiency in Dutch to understand information brochure and questionnaires
* Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before test day 1 of this study and during the study period;
* Being an employee of the department Food, Health \& Consumer Research Wageningen Food \& Biobased Research.
Randomized Controlled Trials on Laparoscopic No. 14v LNS Dissection

The purpose of this study is to explore the short-term, long-term and oncological outcomes of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer.

A prospective randomized comparison of laparoscopic No. 14v lymph node dissection in advanced lower third gastric cancer will be performed, to evaluate the short-term, long-term and oncological outcomes. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:• Age from 18 to 75 years

* Primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* American Society of Anesthesiology score (ASA) class I, II, or III
* Written informed consent

Exclusion Criteria:• Women during pregnancy or breast-feeding

* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* Enlarged or bulky regional lymph node envelop important vessels
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values