cyrilzakka/clinical-trials huggingface dataset:
PK TDF in Thai HIV-infected Children

This study will assess the pharmacokinetics of TDF in Thai HIV-infected children

HIV-infected children who are currently on TDF-base once daily regimen will be enrolled into this study. PK visit will be performed at least 1 month after changing regimen to once daily regimen. Adherence 3 days before PK study will be confirmed using adherence questionnaire. 100% of adherence is needed for PK study. If there is adherence problem on PK visit, PK study will be deferred to at least 3 days. On PK visit, blood drawn will be performed at 0, 2, 4, 6, 8, 10, 12, 24 hr. after taking ARVs for PK study. Blood drawn for safety evaluation will be drawn at any time-point on the PK visit. There is no study drug in this study. All ARVs that patient taking will be according to patient's requirement, and physician judgment. ARVs dosage will follow the Thai national pediatric guideline. CBC, CD4, viral RNA, viral resistance, ALT, cholesterol, and triglyceride results can be from other visits within 4 weeks window period.

Statistical considerations Sample size calculations. There are no pharmacokinetic data in children. In adults, the mean (SD) AUC following administration of a 300mg Viread tablet in fasting state is 2.29 (0.69) microg.hr/mL. In patients taking lopinavir/ritonavir and atazanavir/ritonavir, the mean AUC of TDF is increased by 32% and 24% respectively. Efavirenz does not change the AUC of TDF. If the weight adjusted dose of TDF in children and adolescents achieves the same AUC as in adults and concomitant dosing with a protease inhibitor increases the TDF AUC by 30% but concomitant dosing with Efavirenz does not change the TDF AUC, then 20 treated with Efavirenz and 20 patients treated on a PI based regimen would provide 90% power to detect this difference at the 5% significance level.

Statistical Analysis.

Primary endpoints Pharmacokinetic parameters will be calculated based on individual plasma concentration vs time data, using noncompartmental methods. Data will be summarized overall and by whether the patient is taking a PI or an EFV-based regimen. Formal statistical comparisons of parameters will be made using ANOVA techniques or non-parametric equivalents as appropriate. Effect sizes and 95% confidence intervals will be given for all comparisons.

Eligibility Criteria:
Inclusion Criteria:

* children between the ages of 8-18 years with documented HIV infection
* currently on TDF once daily regimen
* have signed the informed consent

Exclusion Criteria:

* the child or care taker refuse to participate in the study
* severity of adverse events is more than grade 3 thirty days before participating in the study
Tai Chi in Rheumatoid Arthritis (TaiChiRA)

The investigator's hypothesis is that tai chi sessions would increase physical activity of patients with Rheumatoid Arthritis. The main objective is to study the effect of tai chi sessions (16 vs.0) on total physical activity of Rheumatoid Arthritis patients, compared to a control group without tai chi.

Detail protocol:

Selection and inclusion of patients will be done by principal investigator of Rheumatology Department. After verification of inclusion and non-inclusion criteria by principal investigator and signature of consent, patients will be randomized by 1: 1 randomization (centralized randomization by statistician into 2 groups at Month 0). They will participate in sessions in a deferred manner due to two per week for each group:

* Interventional "A" group: 32 sessions (on average 2/week) performed from Month 0 to Month 4 in 15 patients.
* Control "B" group: 16 sessions (on average 2/week) performed from Month 2 to Month 4 in 15 patients.

Patients of "B" group will be not performing sessions with "A" group patients. Sessions lasting about 45 minutes will be proposed from Monday to Friday in a room planned from this activity within the CHU. Exercises will be adapted and personalized according to each one. Evaluations will be carried out for group 1 (interventional) before the first session of tai chi at Month 0, before the session at Month 2 and at the end of the protocol at Month 4. The same evaluations will be carried out for group B (control) at Month 0, before first session of tai chi at Month 2 and at the end of the protocol.

Assessment of pain and stress will be done before and after each session. Final assessment will be done at 4 months after randomization. Fitness assessment and tai chi sessions will be conducted by APA student. Clinical examination of patient, installation and removal of cardio frequency meter will be performed by nurse. Data entry will be done by Clinical Research Associate of the Rheumatology Department. Statistical analysis will be carried out by biostatistician affiliated to the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18 years old with RA (ACR/EULAR criteria) in remission (CDAI ≤2.8) or with low disease activity (CDAI ≤10).
* Patient able to walk without help
* Patient able to complete a questionnaire
* Patient giving informed consent.
* Patient covered by social security

Exclusion Criteria:

* Patient with disorder of higher mental function or psychiatric disorders.
* Patient who has previously contribute to a tai chi program.
* Patient with an absolute contraindication to physical activity.
* Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.
Effect of Priming During Induction and Consolidations in Younger Acute Myeloid Leukemia (AML)

The purpose of this study is:

1. To compare priming with Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) during induction and consolidation courses versus no priming.
2. To compare as consolidation timed sequential chemotherapy versus four courses of high dose cytarabine.

Patients aged 15-50 are enrolled and randomly assigned to receive GM-CSF or no GM-CSF during all remission-induction and consolidation courses of chemotherapy. Induction chemotherapy consists of a timed-sequential chemotherapy including a first sequence of chemotherapy combining daunorubicin, 80 mg/m2 per day, administered IV as a short infusion over 3 days (days 1-3), and cytarabine, 500 mg/m2 per day IV as a continuous infusion over the same period. The second sequence, administered after 4-day free interval, consists of mitoxantrone, 12 mg/m2 per day, administered IV as a short infusion over 2 days (days 8 and 9), and cytarabine, 500 mg/m2/12h, administered as a 3-hour infusion for 3 days (days 8-10). Salvage therapy consists of cytarabine, 3 g/m2/12h on days 1,3,5,7, combined with amsacrine, 100mg/m2 per day on days 1 to 3. GM-CSF (Leucomax, recombinant human GM-CSF from Escherichia Coli, Schering Plough, Kenilworth,N.J., USA) is given at a dose of 5µg/kg per day, intravenously beginning at day 1 of each chemotherapy course and continuing until the last day of chemotherapy of each course.

Patients who achieve CR after induction chemotherapy or salvage therapy are randomly assigned to consolidation courses consisting of either a timed sequential chemotherapy similar to that of the ALFA-9000 trial (P2 arm) or the CALGB postremission chemotherapy (P1 arm), which includes 4 cycles of high-dose cytarabine, followed by 4 additional maintenance courses.

Eligibility Criteria:
Inclusion Criteria:

* A morphologically proven diagnosis of AML according to the WHO classification
* Serum creatinine \< 2N; AST and ALT \< 2.5N; total bilirubin \< 2N (unless related to the underlying disease).
* ECOG performance status 0 to 2.
* Women of child-bearing must use acceptable contraceptive methods, and must have a negative serum or urine pregnancy test within 2 weeks prior the beginning treatment on this trial.
* Must be able and willing to give written informed consent

Exclusion Criteria:

* Patients with M3-AML. Patient with AML following diagnosed myeloproliferation or patient with prior history of MDS known for more than 3 months. Patients with AML secondary to previous treatment with cytotoxic chemotherapy or radiotherapy (therapy-related AML).
* Patient presenting any diagnosis of uncontrolled or metastatic tumor.
* Patients with uncontrolled severe infection,
Desarda Repair Compared to Lichtenstein Repair for the Treatment of Inguinal Hernias

The Lichtenstein technique for hernia repair is safe and simple, but the underlying mesh prosthesis has its setbacks, as it acts as a mechanical barrier5. The mesh does not provide mobile and the physiologically dynamic posterior wall. The most dangerous complication associated with the mesh prosthesis is its migration from the abdominal cavity's primary implantation site. The relatively knew technique developed by Dr. Desarda does not utilize the synthetic mesh rather it uses a strip of external oblique aponeurosis to strengthen the posterior wall. Our study has compared the two methods regarding various aspects.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of age between 20 to 70years
2. A primary inguinal hernia
3. Consented to participate in the research.

Exclusion Criteria:

1. Age below 20,
2. Recurrent and pantaloons hernia
3. Patients who did not give the informed consent
4. Patients who lose the follow-up
Pharmacokinetic Evaluation of Serum Testosterone Concentrations After Administration of Clomiphene Citrate

This is a randomized, open-label trial examining two doses of clomiphene citrate in men with low serum testosterone concentrations (total testosterone (TT) \< 300 ng/dl).

This is a randomized, open-label trial examining two doses of clomiphene citrate in men with low serum testosterone concentrations (total testosterone (TT) \< 300 ng/dl). The investigators will perform a pharmacokinetic analysis of serum hormone concentrations (TT, LH, FSH, estradiol) after medication administration. Researchers hypothesize that testosterone levels will increase in both groups and this may allow to dose clomiphene citrate so that patients do not need to take the medication daily.

Eligibility Criteria:
Inclusion Criteria:

* Male, 21-45 years of age
* Serum testosterone concentration \< 300 ng/dl measured on two separate occasions (separated by at least one week), with collection prior to 10AM

Exclusion Criteria:

* Serum testosterone concentration \> 300 ng/dl
* Abnormal serum prolactin (PRL) concentration (PRL \> 15.2 ng/ml)
* Concurrent or prior use of hormone-modifying medications (clomiphene citrate or other SERM, testosterone replacement therapy or other testosterone-containing products/treatments, gonadotropin therapy, aromatase inhibitors, estrogen-containing products/treatments)
* Documented karyotype abnormality
* Diagnosis of Kallmann syndrome
* Any prior chemotherapy, radiation therapy to the groin/pelvis, or known exposure to gonadotoxic agents
* History of cryptorchidism or prior orchiopexy
* History of testicular cancer or prior orchiectomy
* History of pituitary tumor or resection of pituitary tumor
* History of prostate cancer or severe benign prostatic hypertrophy
* History of epididymitis or epididymo-orchitis, or orchitis (including mumps)
* History of primary hypogonadism
* History of prior urinary tract infection
* History of intravenous drug use
* Any of the following comorbidities: renal insufficiency, heart disease, peptic ulcer disease, cerebrovascular disease, liver disease, psychiatric disorders, chronic pain, bleeding diatheses, anemia, polycythemia, vision problems
* Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
* Documented allergy or hypersensitivity to clomiphene citrate or other SERM
Action Modules on Resilience and Psychological Health

This study aimed to determine whether interventions that use the Specific Thematic Nursing Care Action Modules (STNC-AM) platform improve patients' psychological health over a two-month period.

The STNC-AM platform that investigator present here is an educational program that integrates education and coaching. STNC-AM has six key aspects: stroke prevention, management of emotions, management of fatigue, physical activity, caregiver training, and integrative resources. Each scope contains detailed care guidance. The nurse coaching component was based on the six key aspects detailed above. This online platform can guide nurses' health education for the comprehensive care of stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* remaining hospitalized within 6 months after a stroke attack.
* being able to communicate verbally.
* being willing to participate.

Exclusion Criteria:

* Aphasia
Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery

This study aims to learn more about blood management in children undergoing heart surgery, such as the right amounts, and the best blood products, to administer. It also aims to develop a mathematical model that may help researchers better predict and treat patients who need blood transfusions during heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients under 18 years of age undergoing cardiac surgery with clear prime on cardio-pulmonary bypass (CPB) at Boston Children's Hospital (BCH).

Exclusion Criteria:

* patients with known hemolytic disorders, patients on nitric oxide preoperatively, and patients found to have abnormal coagulation on routine preoperative assessment. Patients receiving heparin, American Society of Anesthesia (ASA) status, apixaban, warfarin, or bivalirudin held appropriately (i.e. for elective surgery) will not be excluded
Fentanyl Sublingual Spray in Opioid Naive Participants

The primary objective of this trial is to determine the pharmacokinetic and pharmacodynamic relationship of multiple dose administration of fentanyl sublingual spray in opioid naive participants. The secondary objective is to determine the safety and tolerability of multiple dose administration of fentanyl sublingual spray in opioid naive subjects.

For all cycles, blood will be drawn according to the following schedule:

The 0 time (pre-dose) blood sample will be collected within 60 minutes prior to first study drug administration.

Cohort l: 0 (pre-dose), 5, 15 and 30 minutes after the first dose and at 1, 2, 4 (prior to second-dose), 4.083, 4.25, 4.5, 5, 6, 8 (prior to third-dose), 8.083, 8.25, 8.5, 9, 10, 12, 16 and 24 hours after the first dose.

Cohort 2: 0 (pre-dose), 5, 15 and 30 minutes after the first dose and at 1, 2 (prior to second-dose), 2.083, 2.25, 2.5, 3, 4 (prior to third-dose), 4.083, 4.25, 4.5, 5, 6, 8, 10, 12, 16 and 24 hours after the first dose.

Cohort 3: 0 (pre-dose), 5, 15, 30 and 45 minutes after the first dose and at 1 (prior to second-dose), 1.083, 1.25, l.5, 1.75, 2 (prior to third-dose), 2.083, 2.25, 2.5, 2.75, 3, 4, 8, 12, 16 and 24 hours after the first dose.

Cohort 4: 0 (pre-dose), 5, 15, 30 (prior to the second-dose), 35, and 45 minutes after the first dose and at I (prior to the third-dose), 1.083, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 4, 8, 12, 16 and 24 hours after the first dose.

Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* History or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) 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
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)

The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female patients
* Presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening
* At Baseline: Disease activity criteria defined by \>= 6 tender joints out of 68 and \>= 6 swollen joints out of 66

WITH at least 1 of the following at screening:

* Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibodies positive OR
* Rheumatoid Factor positive

AND WITH at least 1 of the following at screening:

* High sensitivity C-Reactive Protein (hsCRP) \>= 10 mg/L OR
* Erythrocyte Sedimentation Rate (ESR) \>= 28 millimeter (mm)/1st hour
* Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent
* Patients must be taking MTX or any other DMARD (but not more than 1 DMARD) for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week for MTX or other DMARD at maximum tolerated dose)

Exclusion Criteria:

* Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
* RA patients functional status class IV according to the ACR 1991 revised criteria
* Patients who have ever received biologic immunomodulating agents except for those targeting TNFα
* Previous treatment with any cell-depleting therapies

Other protocol-defined inclusion/exclusion criteria may apply.
A Study to Confirm the Accuracy of Locally Advanced Gastric Cancer Diagnosis

With the introducing of neoadjuvant therapy, it becomes ever more important to evaluate the preoperative TNM (cTNM) stage accurately facilitating preoperative treatment as well as the adjuvant therapy.

At present, the recommendation of neoadjuvant chemotherapy varies among guidelines especially between eastern and western countries. According to the updated Japanese gastric cancer treatment guidelines (ver.5), neoadjuvant chemotherapy is the recommended standard procedure for patients with cT2-4 stages. However, the acknowledgement of preoperative therapy accompanied by the higher risk of overtreatment. As mentioned in JCOG1302-A, the overall precision rate in cT staging is 38.8%. Patients diagnosed with pI stages postoperatively account for 6.5% in cT3-4N+ treatment indicating more likely to avoiding the overtreatment comparing to patients with other cT stages.

Inspired by JCOG1302-A, this multicentre study prospectively collect data in preoperative TNM staging assessment using CT(computed tomography, CT) scan and the postoperative TNM (pTNM) staging according to histopathologically examination. By analyzing the accordance between the cTNM and pTNM, this study aims to evaluate the current accuracy of the cTNM staging in china, verifying the proportion of pI stages less than 5% in cIII stage diagnosis patients, learning the overtreating rate in neoadjuvant chemotherapy in China and furthermore, to discover the scope of beneficiaries for neoadjuvant chemotherapy.

OBJECTIVES:

I. Confirm the inclusion of pathological stage I (pI) among clinical stage III(T3-4aNx) (cIII) diagnosis patients less than 5% II. Figure out the suitable criterion of NAC and avoid overtreatment, by examining the rate of pI rate in different diagnostic criterion groups, including cIII, TxNy(x+y\>4), cN1-3, cT3-4.

III. Evaluate the current state of diagnostic accuracy of preoperative CT staging in china.

OUTLINE:

This is a prospective, multi-centers, cohort study of clinical TNM staging diagnostic accuracy.

Patients are divided into 3 preoperative stage groups according to AJCC 8th edition (cI, cII, cIII) preoperatively. All patients receive the D2 gastrectomy after cTNM diagnosis and the pathological stages is given following surgery.

The concordance of preoperative staging is evaluated in each cohorts as well as the subgroups to obtain the accuracy rate. The pI proportion will calculate in each latent criterion groups to assess the suitable NAC criteria.

PROJECTED ACCRUAL: A total of 968 patients will be accrued for this study within two years.

Eligibility Criteria:
Inclusion Criteria:

* Histological prove of adenocarcinoma of the stomach by endoscopy
* Preoperative imaging data by contrast-enhanced CT and clinical TNM stages were given
* No evidence of stage IV disease
* No previous gastrectomy or preoperative treatment.

Exclusion Criteria:

* Discovery of distant metastasis (stage IV) during surgery
* Number of retrieved lymph node less than 15
The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes

Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye.


Eligibility Criteria:
Inclusion Criteria:

* age 18-30
* being directly affected by the earthquake in Mardin
* providing voluntary consent to participating in the study

Exclusion Criteria:

* involvement in an existing active regular exercise program
* the presence a physical problem capable of preventing exercise
* the presence of severe psychiatric disorders or cognitive and/or perceptual problems
* regular use of sedative or neuropsychiatric drugs
* active alcohol or drug addiction
* missing assessment parameters
* failure to participate in the intervention programs, or not continuing wıth the study