cyrilzakka/clinical-trials huggingface dataset:
Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

This is a prospective, multicenter, single-arm, open-label study. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX/GX for postoperative adjuvant treatment of pancreatic cancer.

This clinical study is designed as a prospective, multicenter, single arm, open-label study to evaluate the clinical efficacy and safety of combination Nimotuzumab with mFOLFIRINOX/GX as postoperative adjuvant therapy in pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included overall survival (OS) and safety.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18 years or older, gender unlimited;
* 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* 3. Had undergone complete macroscopic resection for pancreatic cancer (R0 or R1 resection) with histological confirmation and with no evidence of distant metastasis as demonstrated by imaging;
* 4. No prior tumor therapy;
* 5. Adequate organ and bone marrow function, defined as follows: White blood cells (WBC) ≥ 3.0×10\^9/L; absolute neutrophil count (ANC)≥1.5×10\^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1×ULN or estimated creatinine clearance ≥ 50 mL/min;
* 6. Left ventricular ejection fraction (LVEF) ≥ 50%;
* 7. Fertile subjects are willing to take contraceptive measures during the study period.
* 8. good compliance and signed informed consent voluntarily

Exclusion Criteria:

* 1. Prior systemic anti-tumor therapy, such as chemotherapy, radiotherapy;
* 2. Participated in other drug clinical trials within 4 weeks;
* 3. History of other malignancies;
* 4. Immunodeficiency, or other immune-related disorders requiring medical intervention;
* 5. Postoperative complications such as bleeding;
* 6. Woman who are pregnant or breastfeeding;
* 7. Drug abuse, or clinical, psychological or social factors that may have an impact on informed consent or the implementation of the study;
* 8.Known allergy to prescription or any component of the prescription used in this study, including nimotuzumab, oxaliplatin, irinotecan, fluorouracil, gemcitabine, and capecitabine.
Epidemiological Study In Tuberculosis-Endemic Urban Area in Senegal

A cross-sectional childhood M. tuberculosis infection survey of age-specific rates (defined by positivity to the test QuantiFERON-TB Gold Plus) will be conducted in Senegal to collect information on the local TB endemic to inform site selection, sample size, and recruitment strategies for a future efficacy trial of vaccine candidate MTBVAC in young children.

MTBVAC is a new TB vaccine candidate based on an attenuated clinical isolate of M. tuberculosis. The clinical development consortium of this EDCTP program is preparing for future years an MTBVAC efficacy trial by setting up a network of three African sites in South Africa, Senegal and Madagascar. Each site has established an operational clinical research infrastructure. As a first step, Senegal site needs to collect crucial epidemiological data on TB in children, to allow a rapid transition to a phase 3 trial in infants.

The primary objective is to estimate the prevalence of TB infection by the QuantiFERON-TB Gold Plus technique in 500 children splined in 1-year, 2-year, 5-year, and 12-year-old age groups living in the study area (Saint Louis, Senegal).

Secondary objectives are:

* To study the socio-demographic characteristics, the vaccination history of each subject and the possible tuberculous contacts he has.
* To map selected populations (from GPS residence data) according to the status (infected or uninfected) of each subject.
* To ensure the orientation of children found positive by the QuantiFERON-TB Gold Plus test for care and follow-up related to the TB diagnosis and treatment at one of the Health Centers (THC) located in the study areas.
* To estimate the number of tuberculosis cases detected in children aged up to 12 years and resident in the study area from THC registries and data from the National Tuberculosis Control Plan (PNB).

Eligibility Criteria:
Inclusion Criteria:

* Children resident in the study area (St Louis City)
* Obtaining written consent from one of the parents / guardians.
* Children meeting one the following age criterion:

  * 1-year old child (12 months -1/+4 months);
  * 2-year-old child (24 months -1/+4 months);
  * 5-year old child (60 months +/-6 months);
  * 12-year old child (12 years old +/-6 months);

Exclusion Criteria:

* Child resident outside the study area.
* Participation refusal by one of the parents / guardians.
* Objection of the child belonging to the 12-year old group.
* Child with a known chronic pathology (severe asthma, epilepsy, type 1 diabetes, severe immunosuppression ...)
* Child considered by the Principal Investigator as medically unfit to participate in the study.
Preemptive Analgesia Combination of Celecoxib and Pregabalin in THA

This is a double-blinded randomized controlled trial aims to evaluate the effect of preemptive analgetic combination of celecoxib and pregabalin to acute pain after total hip arthroplasty. This study will be conducted in Cipto Mangunkusumo Hospital, Jakarta, Indonesia, from October 2022 to April 2023. The subject of this study is adult patient who will be performed total hip arthroplasty.

1. Research design This is a double-blind, randomized clinical trial which aimed to evaluate the effect of preemptive analgesia combined with Celecoxib and Pregabalin on acute post-THA pain.
2. Study location This study will be conducted at the Cipto Mangunkusumo Hospital, Jakarta, Indonesia.
3. Study time This study will be conducted in October 2022 - April 2023
4. Population and sample The target population of this study is adult patients undergoing THA surgery. The randomization technique used in this study is a simple randomization technique. Researchers randomly determine the allocation of samples without looking at subjects' status in the population.
5. Inclusion criteria

   * Patients \>18 years old
   * Patients who come to the RSCM Orthopedic Polyclinic
   * Patients undergoing THA surgery
   * Patients with Primary and Secondary Pelvic Osteoarthritis
   * The patient is taking anti-pain and anti-inflammatory drugs regularly
6. Exclusion criteria

   * Patients with mental disorders
   * Patients with a history of renal impairment
   * Pelvic arthritis patients due to rheumatoid arthritis or infection
   * Patients with diabetes and obesity
   * Allergy to non-steroidal inflammatory drugs
   * Asthma history
   * Coagulation disorders
   * Patients in the study procedure experienced an incident of severe pain that required another analgesic regimen
   * History of hypersensitivity to NSAIDs or sulfonamides

Eligibility Criteria:
Inclusion Criteria:

1. Patients \>18 years old
2. Patients who come to the RSCM Orthopedic Polyclinic
3. Patients undergoing THA operasi surgery
4. Patients with Primary and Secondary Pelvic Osteoarthritis
5. The patient is taking anti-pain and anti-inflammatory drugs regularly

Exclusion Criteria:

1. Patients with mental disorders
2. Patients with a history of renal impairment
3. Pelvic arthritis patients due to rheumatoid arthritis or infection
4. Patients with diabetes and obesity
5. Allergy to non-steroidal inflammatory drugs
6. Asthma history
7. Coagulation disorders
Prediction of Outcomes Following Total Knee Replacement- Pilot

This study seeks to examine multiple risk factors as predictors of pain and function following total knee arthroplasty (TKA). Risk factors will be measured pre-surgically using psychophysical testing procedures, multimodal evaluation of sleep, standardized questionnaires. Additionally, this study will collect pilot data on a brief mindfulness-based cognitive-behavioral treatment that may help to improve long-term TKA outcomes.

The pilot study compared TKA patients that received brief mindfulness-based cognitive behavioral therapy (MBCBT) to the treatment-as-usual (TAU) group from the parent study.

The present study seeks to collect pilot data on a brief mindfulness-based cognitive-behavioral treatment to determine the feasibility of this intervention and its potential benefits. The study includes 6 total contacts, 1 visit before surgery and 3 after surgery, and 2 phone calls. The last visit will be about 6 months after surgery. The study includes evaluation of peoples' pain, physical functioning, medication use, and physiological responses to sensory stimuli such as heat and cold. The research takes place at the Brigham \& Women's Pain Management Center, 850 Boylston St, Chestnut Hill.

Eligibility Criteria:
Inclusion Criteria:

1. Age 45 or older,
2. Meet the American College of Rheumatology criteria for knee OA,
3. Scheduled to undergo total knee arthroplasty,
4. Facility with the English language that is adequate to complete study procedures

Exclusion Criteria:

1. Cognitive impairment preventing completion of study assessment procedures.
2. Myocardial infarction within the past 12 months.
3. Presence of Severe Raynaud's or severe neuropathy,
4. Active vasculitis or severe peripheral vascular disease,
5. Current infection,
6. Use of oral steroids,
7. Recent history of substance abuse or dependence,
8. Known anemia
The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction

Anterior cruciate ligament (ACL) reconstruction surgery is a common procedure performed by orthopedic surgeons. Postoperatively, patients often experience pain, muscle tension, and concerns about their ability to return to sports. These factors influence the recovery and return to sports capabilities of ACL patients. According to research, only 64% of patients are able to recover to their pre-injury level after surgery, and the success rate for returning to competitive sports is only 56%. Psychological factors during the recovery process may explain this disparity. ACL injury is associated with anxiety, pain reaction, and emotional disorders, with fear of re-injury being the most common obstacle to returning to sports, accounting for 19%. A study by Lentz et al. (2015) also found no significant differences in pain assessments between individuals who were afraid of re-injury and those who were able to return to sports at six months and one year after surgery. This suggests that fear of pain may limit activity and increase the risk of unsuccessful return to sports.

Mindfulness intervention is a psychological approach that involves non-judgmental awareness and focus on moment to moment. Mindfulness practice is known to reduce stress in athletes, promote recovery, enhance athletic performance, and improve sleep quality. Good sleep quality contributes to emotional stability and physical recovery. Even short daytime naps can be beneficial for athletes. A review of 37 studies of moderate quality found that daytime napping can improve physical and cognitive performance, psychological state, and nighttime sleep.

Therefore, investigators hypothesize that integrating mindfulness practice into daytime napping may lead to improved spirit upon waking, reduce sleep inertia, and over time, potentially increase the rate of return to sports after ACL reconstruction.


Eligibility Criteria:
Inclusion Criteria:

* Within the first month after ACL reconstruction without mindfulness practice experience

Exclusion Criteria:

* below 18 years old, previous exposure to mindfulness intervention
miRNA and Relevant Biomarkers of BC Patients Undergoing Neoadjuvant Treatment

MicroRNA (miRNA) is a type of endogenous non-coding RNA. They are responsible for post-transcriptional regulation and participate in many vital biological processes. Expression profiling has shown that miRNAs can distinguish between normal breast and tumor tissues. In recent years, circulating miRNAs have become promising biomarkers based on their stability and their non-invasive testing and feasibility in clinical practices.

Current reports showed that serum microRNA expression could be used as an early marker for determining the breast cancer risk. The concentrations of some circulating microRNAs in human breast cancer have been correlated with tumor development and progression. Aberrant miRNA expression may be involved in drug resistance to various chemotherapeutic agents in breast cancer. Therefore, we hope to investigate the value of miRNAs in predicting the effect in breast cancer neoadjuvant treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Early breast cancer patients;
2. Stage II-III disease;
3. sign informed consent form;
4. receive neoadjuvant treatment;
5. Age between 18-75.

Exclusion Criteria:

1. Women during pregnancy;
2. Metastasis patients or stage IV breast cancer patients;
3. Male breast cancer patients;
4. Inflammatory breast cancer patients;
5. Patients with neoadjuvant endocrine treatment.
A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF 01913539] In Subjects With Severely-Impaired And Normal Renal Function

This study is to compare the pharmacokinetics of Dimebon in subjects with severe renal impairment to subjects with normal renal function after oral administration of a single oral 20-mg dose of Dimebon. This study is also to assess the safety and tolerability of a single oral 20-mg dose of Dimebon in subjects with severe renal impairment and subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects between the ages of 18 and 75 years, inclusive
* For severe renal impairment group, subjects with creatinine clearance of less than 30 mL/min, but not yet on dialysis and in good general health commensurate with the population with chronic renal disease; however, subjects with type 1 and 2 diabetes that are reasonably controlled and who do not have a predisposition to severe hypoglycemia can both be included.
* For normal renal function group, healthy subjects with creatinine clearance of greater than 80mL/min and demographically comparable to subjects with impaired renal function

Exclusion Criteria:

* Pregnant or nursing women; women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to the first dose of study medication.
* For normal renal function group, use of prescription or non-prescription drugs, vitamins, or dietary supplements within 7 days of 5 half-lives (whichever is longer) prior to the first dose of study medication.

Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Acetaminophen at doses of ≤ 2 grams/day is permitted.

* For renal impairment group, a known history of clinically significant coronary heart disease, cerebrovascular disease or peripheral vascular disease and/or an event/intervention during the past 6 months. Systemic therapy with CYP3A or CYP2D6 inhibitors within 7 days or 5 halflives (whichever is longer) prior to the first dose of trial medication.
Use of a Radiopaque Localizer Grid and Methylene Blue Staining as an Aid to Reduce Radiation Exposure

Localization of small femur lesions for resection can be challenging and may be associated with the need for significant fluoroscopic imaging and tissue dissection.

This study was performed to evaluate the use of a radiopaque localizer grid along with methylene blue staining for resection of small femur lesions in children, and to determine this technique's effectiveness at reducing radiation exposure and tissue injury.

Eligibility Criteria:
Inclusion Criteria:

* patients with lesions \<20.0 mm

Exclusion Criteria:

* patients with lesions \>20.0 mm
Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury

The aim of this randomized trial was to assess the efficacy of oral midodrine tablets for the management of intradialytic hypotension among critically ill patients with acute kidney injury.

In This open -label study, patients in ICU with acute kidney injury are randomized to either midodrine tablets or placebo. the number of intradialytic episodes and both systolic and diastolic blood pressure between both groups are compared. Mortality and adverse effects are monitored and compared as well.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients
* acute kidney injury
* age above 18 years
* documented hypotension during dialysis

Exclusion Criteria:

* packed red blood cells transfusion
* intravenous inotropes
* alteration of blood pressure medications
Intra-Operative Metrics With CENTURION® and INFINITI® Vision Systems

The purpose of this study is to evaluate intra-operative phacoemulsification machine metrics after phacoemulsification with the CENTURION® vision system configuration compared with the INFINITI® vision system configuration.


Eligibility Criteria:
Inclusion Criteria:

* Eligible to undergo cataract extraction via phacoemulsification with primary ACRYSOF Intraocular Lens (IOL) implantation;
* Free of severe disease(s)/condition(s) listed in the "Warnings" and "Precautions" section of implanted ACRYSOF IOL;
* Willing to undergo second eye surgery within 14 days of first eye surgery;
* Willing and able to understand/sign a written Informed Consent Document;
* Willing and able to return for scheduled follow-up examinations;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Planned multiple procedures at the time of surgery or during the course of the study (eg, LASIK, LRI, etc.);
* Previous intraocular or corneal surgery of any kind;
* Poorly dilating pupil;
* Severe retinal disorders (eg, macular degeneration, proliferative diabetic retinopathy);
* Corneal disease (eg, herpes simplex, herpes zoster, etc) or retinal detachment;
* Severe conditions that per Investigator's clinical judgment would increase the operative risk or confound the result of this investigation;
* Female patients who are pregnant, lactating, or planning to be pregnant during the course of the study;
* Currently participating in another drug or device clinical trial, or participated in another drug or device clinical trial within 30 days of enrollment into this trial;
* Other protocol-defined exclusion criteria may apply.
Electrophysiological Properties of the Pulmonary Veins

The pulmonary veins are the predominant sources of AF induction and maintenance. This study aims to assess the electrophysiological properties of the pulmonary veins and their relation to AF in humans.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* No antiarrhythmic drug treatment
* Indication for an electrophysiological study

Exclusion Criteria:

* Structural heart diseases
The Effect of Virtual Reality Glasses Applied During Emergency Surgical Intervention

This randomized controlled trial evaluates the effect of virtual reality glasses applied during emergency surgical intervention with local anesthesia on patients anxiety. This study hypothesizes that virtual reality glasses reduces anxiety.

The sample of this study consisted of 138 patients in the experimental (n=69) and control groups (n=69). Virtual Reality (VR) application will be applied to the experimental group during the emergency surgical intervention under local anesthesia. Anxiety level will be assessed with the Spielberger State Anxiety Scale and measured by physiological responses of anxiety such as systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR) and peripheral oxygen saturation (SpO2) before and after VR application. In the control group, no application will be made except for standard care only.

Eligibility Criteria:
Inclusion Criteria:

* Emergency surgical intervention with local anesthesia,
* Between the ages of 18-65,
* Conscious, oriented and cooperative,
* Able to read and understand Turkish,
* Agree to participate in the study
* Does not have physical problems that will prevent the application of virtual reality glasses,
* No previous experience with virtual reality glasses,
* Not diagnosed with anxiety,
* Does not use drugs for anxiety,
* Does not use alcohol and/or drugs,
* No mental illness
* Patients who signed the Informed Consent Form/Written Consent Form

Exclusion Criteria:

* No emergency surgical intervention with local anesthesia,
* Those under the age of 18, over the age of 65,
* Unconscious, oriented and uncooperative,
* Can't read and understand Turkish,
* Those who do not agree to participate in the study,
* Having a physical problem that will prevent the application of virtual reality glasses,
* Diagnosed with anxiety,
* Using drugs for anxiety (anxiolytic, antidepressant, antipsychotic, etc.),
* Using alcohol and/or drugs,
* Having a mental disorder,
* Patients who did not sign the Informed Consent Form/Written Consent Form
Prevalence of Secondary Hyperparathyroidism Among Patients With Diabetic Nephropathy

The aim of this study is to evaluate the prevalence of secondary hyperparathyroidism among patients with diabetic nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* \[1\] Age was above 18 years, \[2\] Patient had diabetic nephropathy which was diagnosed based on the presence of urinary albumin/creatinine ratio (uACR) ≥ 30 mg/gm ± 24 hours' urinary protein measurement ≥ 300 mg/day

Exclusion Criteria:

* \[1\] patients were already receiving cinacalcet and/or \[2\] patients had undergone neck surgery for parathyroidectomy.