cyrilzakka/clinical-trials huggingface dataset:
Optimal Procedural Sequence in Same-day Bidirectional Endoscopy: A Prospective Randomized Controlled Study

The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However, the optimal sequence of performing a same-day BDE has not been well-established.The primary aims of this study are to compare the sedative doses and patient discomfort between the study groups who received a colonoscopy followed by and EGD (colonoscopy-EGD), or an EGD followed by a colonoscopy (EGD-colonoscopy) during a same-day BDE. The secondary aim is to assess colonoscopy performance, including the cecal intubation time and adenoma detection rate between the two endoscopic sequences.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients, aged 20 to 75 years, who are scheduled for same-day bidirectional endoscopy examination for any indication are invited to participate in the study.

Exclusion Criteria:

* 1. previous gastrectomy or colectomy 2. inadequate bowel preparation, 3. obstructive lesions of the colon 4. severe colitis, gastrointestinal bleeding 5. allergy to fentanyl or midazolam 6. American Society of Anesthesiology (ASA) classification of physical status grade 3 or higher, 7. mental retardation 8. regular use of narcotics 9. pregnancy 10. refusal to provide a written informed consent.
Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients

The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.


Eligibility Criteria:
Inclusion Criteria:

* be 18 to 75 years of age;
* progressive loss of renal function as defined by glomerular filtration rate (GFR) ≤ 45 mL/min/1.73 m²;
* be clinically stable in the opinion of the investigator;
* be serum negative for HBsAg, anti-HBsAg, antibody to hepatitis B core antigen (HBcAg), Hepatitis C virus (HCV), and human immunodeficiency virus (HIV);
* if a woman of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase and for up to 28 days after the last injection;
* is not scheduled to undergo a kidney transplant in the next 12 months;
* be able and willing to provide informed consent.

Exclusion Criteria:

* if female, is pregnant, breastfeeding, or planning a pregnancy;
* has a history of or is considered by the investigator to be at high risk for recent exposure to HBV, HCV, or HIV; for example, current intravenous drug use, has unprotected sex with known HBV/HIV positive partner;
* has known history of autoimmune disease;
* has previously received any HBV vaccine;
* has a history of sensitivity to any component of study vaccines;
* has current illness other than renal disease or has substance or alcohol abuse that in the opinion of the investigator would interfere with compliance or with interpretation of the study results;
* is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin;
* has uncontrolled diabetes or hypertension;
* is unwilling or unable to comply with all the requirements of the protocol;
* has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period;
* has received the following prior to the first injection:
* 3 days: erythropoietin (exclusionary window does not apply for subjects on dialysis)
* 7 days: intravenous iron
* 21 days: any inactivated virus vaccine
* 28 days:
* any live virus vaccine
* systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids
* granulocyte or granulocyte-macrophage colony-simulating factor (G/GM-CSF), any other investigational medicinal agent
* At any time: an injection of deoxyribonucleic acid plasmids or oligonucleotide
Haemodynamic Response to Aortic Surgery

Open elective abdominal aortic surgery is a high risk procedure involving clamping of the aorta. Indications include abdominal aortic aneurysm (AAA) or aortic occlusive disease (AOD) causing lower limb ischaemia.

These patients are often regarded as one entity in postoperative study settings. However, previous studies indicate that risk profiles, inflammatory activity, and haemodynamic capacity may differ between these groups. The first aim of this study was to evaluate postoperative ICU-requirements after open elective abdominal aortic surgery, hypothesising that AAA-patients had longer ICU-stays and needed more mechanical ventilation or acute dialysis than did patients with AOD.

The investigators see a relatively high incidence of postoperative acute kidney injury (AKI) following aortic surgery. Neutrophil Gelatinase Associated Lipocalcin (NGAL) may be useful in the early diagnosis of postopeative AKI. However, NGAL is also known as a marker of inflammatory activation. The ischaemia-reperfusion injury and subsequent inflammatory response to aortic cross clamping may per se induce a rise in NGAL despite intact renal function. Therefore NGAL may not be a reliable marker of AKI after AAS.

The second aim of this study is to describe the changes in NGAL after AAS in patients with and without postoperative dialysis-dependent AKI.


Eligibility Criteria:
Inclusion Criteria:

* CT verified aortic aneurysm or aortic occlusive disease

Exclusion Criteria:

* age\<18 y
* contraindications to the use of oesophagus doppler monitor, eg mycosis, perforation, stenosis.
Dexmedetomidine to Improve Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery

The study is to observe whether dexmedetomidine could reduce agitation during emergence from general anesthesia in patients undergoing retroperitoneal laparoscopic surgery.

Agitation during emergence is frequent after retroperitoneal urologic surgery. Dexmedetomidine is alpha-2 receptor agonist which shows sedative and algesic effect. In this study we will compare the effect of dexmedetomidine given by different protocols on emergence agitation.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for retroperitoneal laparoscopic surgery
* Patients with written informed consent

Exclusion Criteria:

* Patients with difficulty of communication
* Patients with risk of obstructive sleeping apnea syndrome
Buprenorphine Maintenance for Opioid Addicts - 3

The purpose of this study is to evaluate buprenorphine in a medical maintenance model three times a week.


Eligibility Criteria:
Please contact site for information.
Electrical Stimulation for the Relief of Freezing of Gait (FOG) in Parkinson's Patients

Potential for electrical stimulation to ameliorate Freezing of Gait (FOG)

The purpose of this study is to investigate the potential for an electrical stimulation intervention to ameliorate Freezing of Gait (FOG) and related gait disturbances in Parkinson's patients.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of idiopathic Parkinson's Disease (PD) (UK, PD Brain Bank Criteria)
* A Hoehn and Yahr stage of 2 - 4
* Exhibiting Freezing of Gait or another gait abnormality in the ON state.
* An ability to mobilise independently with or without a walker or walking cane for the purpose of research when in the 'ON' state

Exclusion Criteria:

* A serious cognitive impairment (MMSE\<24)
* Pregnant or currently involved in another clinical trial.
* Pacemakers
* On opioid or neuropathic pain medication
FLT-PET / MRI Brain Mets

Brain metastasis (BrM) develops in approximately 40% of cancer patients. Stereotactic radiosurgery (SRS) is a form of radiotherapy that delivers high-dose per fraction to individual lesions that is commonly used to treat BrM.

Radionecrosis (RN) is an adverse event that occurs in approximately 10 - 25% of patients 6 - 24 months after treatment with SRS. Tumour progression may also occur due to local failure of treatment. Radionecrosis and tumour progression share very similar clinical features including vomiting, nausea, and focal neurologic findings.

Radionecrosis and tumour progression also share overlapping imaging characteristics. Due to their similarities, physicians need to perform a surgical resection to diagnose the complication. By using a hybrid FLT-PET/MRI scan, the investigators propose that this combination scan will provide robust data with which to differentiate between radionecrosis and tumour progression without the need for surgery. The investigators plan to conduct a single center feasibility study to investigate the potential in differentiating between SRS and tumour progression in patients, including those who may have previously undergone SRS for BrM, who are suspected to have either RN or tumour progression using hybrid FLT-PET/MRI imaging.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Previously treated with SRS for BrM
3. New intracranial lesion with clinical and radiographic findings suspicious for either RN or tumour progression
4. May be planned surgical resection of the lesion in question. The determination that the lesion is appropriate for and may require surgical resection will be made by the multi-disciplinary brain metastasis team. Surgery is preferred but not required. If a patient is planned for surgery, the date does not need to be established and the patient does not need to have consented in order to be eligible for this study, however the imaging procedure will need to occur prior to the date of surgery.
5. A negative serum pregnancy test within the two-week interval immediately prior to PET-MRI imaging for women of child-bearing age
6. Ability to provide written informed concern to participate in the study

Exclusion Criteria:

1. Previous radiotherapy to the intended treatment volume
2. Active malignancy other than sarcoma
3. Inability to remain supine for at least 60 minutes
4. Pregnancy or breast feeding
5. Age \<18 years
6. Failure to provide written informed consent
7. Contraindication for MRI as per current institutional guidelines
Study of Bevacizumab With Different Manufacturing Process in Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetic similarity of bevacizumab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of bevacizumab with different manufacturing process.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements;
* Age≥18 years and ≤50 years, healthy male subjects;
* Weight ≥ 50kg and ≤ 100kg,BMI≥ 19kg/m2 and \< 28 kg/m2
* Clinical examinations in the screening period are normal or abnormal without clinical significance.
* Agree to take effective contraceptive measures throughout the study period and until at least 6 months after receiving the last dose of study drug

Exclusion Criteria:

1. Any prior VEGF(vascular endothelial growth factor) and VEGFR(Vascular Endothelial Growth Factor Receptor) antibody or protein treatment within one year.
2. Serious, non-healing wound, active ulcer, or untreated bone fracture, or major surgical procedure within 2 months prior to randomization or anticipation of need for major surgery during the course of the study or 2 months after end of the study.
3. Use Rx or OTC drugs or nutritional health products within 5 half-lives or within 2 weeks before the first dose of study drug (According to the longer time).Herbal supplements need to stop at 28 days before the first dose of study drug.
4. Positive hepatitis b surface antigen (HBsAg), hepatitis c virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody or syphilis.
5. Known hypersensitivity to bevacizumab or any excipients, known allergic disease or allergic constitution.
6. History of blood donation within 3 months before the first dose of study drug.
7. Treatment with any other investigational agent or participation in another clinical trial within 3 months prior to screening.
IMPACT: Safety and Feasibility of a Single-stage Procedure for Focal Cartilage Lesions of the Knee.

Articular cartilage defects in the knee have a poor intrinsic healing capacity and may lead to functional disability and osteoarthritis. Cartilage cell therapy using autologous chondrocyte implantation (ACI) has been established as the first advanced treatment therapy medicinal product. Although this technique has achieved good mid-term results, it is a costly and extensive two-stage procedure which is limited by the number of chondrocytes obtained by biopsy and the dedifferentiation resulting from the expansion phase. Therefore, there is a need for improvement. A new cartilage repair technique should aim at decreasing surgical trauma, lowering complexity, improving logistics and cost-effectiveness while retaining or improving clinical outcome. Direct contact between mesenchymal stromal cells (MSCs) and dedifferentiated articular chondrocytes in vitro showed improvement of the chondrogenic phenotype of dedifferentiated articular chondrocytes. In addition, preserving the pericellular matrix of chondrocytes improves cartilage formation. These chondrons (chondrocytes with their pericellular matrix) have shown improved cartilage formation when combined with allogeneic MSCs in extensive preclinical studies. The cells are mixed with fibrin cell carrier and applied to the cartilage lesion within one surgical procedure. This will reduce patient morbidity and improve patient care through immediate transplantation of a potent cell-based cartilage product. This is a phase I/II prospective monocenter study to evaluate the safety and feasibility of the IMPACT for treatment of focal articular cartilage lesions of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 and \<45 years old
* Symptomatic isolated full-thickness articular cartilage lesion on the femoral condyle or trochlea.
* Size 2 - 8 cm2
* Intact anterior cruciate ligament

Exclusion Criteria:

* (History of) osteoarthritis, defined as Kellgren-Lawrence grade \>3 as determined from appropriate X-ray.
* Concomitant inflammatory disease that affects the joint (rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis)
* (History of) Septic arthritis.
* Malalignment requiring an osteotomy.
* (History of) total menisectomy in the target knee joint.
* Any surgery in the knee joint 6 months prior to study inclusion.
* Risk groups for MRI scanning due to the magnetic field like patients with pacemakers, nerve stimulators, metal particles, stents, clips or implants, (possible) pregnancy or breast feeding.
* Patients with severe anxiety for MRI scans and/or needles
A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function

The purpose of study is to evaluate the pharmacokinetics of a single, subcutaneous dose of JNJ-64565111 in adult participants with varying degrees of renal function including participants with end stage renal disease, requiring hemodialysis, compared with participants with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, or if sexually active, be practicing an effective method of birth control before entry and throughout the study
* A woman must have a negative highly sensitive serum (beta human chorionic gonadotropin \[hCG\]) at screening. On Day -1, female non-end-stage renal disease (ESRD) participants should have a negative urine pregnancy test and female ESRD participants requiring hemodialysis (HD) should have a negative serum pregnancy test
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction (from screening through Day 42 postdose)
* Body mass index (weight \[kilogram {kg}\]/height\^2 \[ meter {m}\]\^2) between 18 and 40 kg/m\^2 (inclusive), and body weight not less than 50 kg
* Have normal renal function defined as: predicted estimated glomerular filtration rate greater than or equal to (\>=) 90 milliliter (mL)/minute based on the Chronic Kidney Disease-Epidemiology formula (for participants with normal renal function)

Exclusion Criteria:

* History of, or a reason to believe a participant has a history of, drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day -1 of the treatment period (unless medically prescribed)
* Any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug, with the exception of renal impairment as described in the inclusion criteria, and except for participants who had a cholecystectomy or a hernia repair
* History of clinically significant allergies, especially known hypersensitivity or intolerances
* Known allergy to JNJ-64565111 or its excipients
* Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study or at least 2 months after the completion of the study
Kinetic Chain Approach for Rotator Cuff Tendinopathy

The aim of this research is to determine the effectiveness of the kinetic chain approach on pain, functional disability and kinesiophobia in patient with rotator cuff tendinopathy. Randomized controlled trials done at National institute of rehabilitation and medicine. The sample size was 44. The subjects were divided in two groups, 22 subjects in Group A that received Conventional Treatment and 22 subjects in Group B that received Kinetic chain approach and conventional treatment. Study duration was of 6 months. Sampling technique applied was non probability connivance sampling technique. Patient with age between 40 to 65 years, Clinically diagnosed and Patients who meet the diagnostic criteria ≥ three positives in five shoulder impingement tests: Neer's sign, Hawkins and Kennedy test, Empty Can test, painful arc of abduction, and external rotation (ER) resistance test, Patients in acute (4 weeks) and sub-acute stage (4-6 weeks).Patients with positive scapular assistance test (SAT) and scapular retraction test (SRT). Were included. Tools used in the study are NPRS (Numeric Pain Rating Scale). SPADI (Shoulder Pain and Disability) .Tampa Scale for Kinesiophobia TSK-11. Data was be analyzed through SPSS -25


Eligibility Criteria:
Inclusion Criteria:

* Both male and female.
* Age between 40 to 65 years.
* Clinically diagnosed and Patients who meet the diagnostic criteria ≥ three positives in five shoulder impingement tests: Neer's sign, Hawkins and Kennedy test, Empty Can test, painful arc of abduction, and external rotation (ER) resistance test (14)
* Patients in acute (4 weeks) and sub-acute stage (4-6 weeks).
* Patients with positive scapular assistance test (SAT) and scapular retraction test (SRT).

Exclusion Criteria:

* Patients with Cervical radiculopathy or previous shoulder surgery.

  * Any Participants with a full thickness tear of rotator cuff tendon.
  * History of glenohumeral dislocation, or other traumatic injury to the shoulder
  * Diagnosed patients of rheumatoid arthritis and osteoarthritis.
  * Hemiplegia affecting the shoulder and lower extremity
  * A complex myofascial pain syndrome.
  * History of significant lower extremity problems, including severe joint pain, recent fractures, or major musculoskeletal disorders (e.g. chronic ligament injuries)
Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures

Spinal fracture surgery is a common surgery. Post-operative pain has been reduced by the advent of so-called minimally invasive techniques. The immediate post-operative pain, however, remains relatively high, mainly because of muscle pain following the trauma.

The erector spinae plane block (ESPB) is a loco-regional anesthesia technique first described in 2016.

A retrospective cohort study showed an improvement in post-operative analgesia of percutaneous osteosynthesis spinal surgery through a reduction in 24-hour morphine use.

In order to prove and confirm the effectiveness of this technique, we will conduct a double-blind randomized controlled study.

The objective will be to demonstrate the analgesic effectiveness of the technique by reducing morphine consumption in post-operative. The expected reduction in morphine consumption is set at 30%, based on the clinical experience developed in our practice.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with percutaneous arthrodesis spine surgery for fracture
2. Insured persons
3. Age 18 years
4. Being able to receive informed information
5. Have agreed to participate in writing

Exclusion Criteria:

1. Minor patient
2. Patient refusal
3. Pregnancy
4. Lack of social security coverage
5. Under guardianship or curatorship
6. Inability to express consent
7. History of spinal surgery
8. Unable to use morphine PCA
9. Contraindication to the use of local morphines and/or anesthetics
10. Contraindication to Loco-Regional Anesthesia
11. Long-term opioid patient (Level II and Level III analgesics)
12. Patient with preoperative neuropathic pain (score greater than or equal to 4 on the DN4 questionnaire or taking anti-epileptic or anti-depressant treatments for neuropathic pain)
İs There a Relationship Between Severity of Preeclampsia and Maternal Heavy Metal Levels?

The purpose of this study, to investigate whether severity of preeclampsia is associated with altered levels of heavy metals (Cd, Hg, arsenic and Pb) in maternal blood, fetal blood, and maternal hair.

The unfavorable effects of heavy metals on human health is well known. The main threats to human health from heavy metals are associated with exposure to lead, cadmium, mercury and arsenic. They may be toxic at the levels previously thought to have no adverse effect on human.In utero environmental exposures can have long term consequences to health and development.İn spite of what is known about the neurotoxicity from exposure to heavy metals, the health effects from co-exposure to these chemicals and the biologically effective doses are not known exactly.

Preeclampsia is associated with increased maternal and infant mortality and morbidity. The exact etiology is not clear. Several evidences indicate that various environmental factors and elements may play a role in pre-eclampsia.

significant increase in Pb, cadmium (Cd), copper (Cu) and magnesium (Mg) and decrease in zinc (Zn) in amniotic fluid are associated with preeclampsia. Pb as this metal has well known adverse effects on renal system and blood pressures Effects of Pb on reproductive system have been studied intensively, e.g. other pregnancy outcome and pregnancy hypertension.

However, the relationship between the severity of pre-eclampsia and heavy metal levels have not been investigated.

The purpose of this study, to investigate whether severity of preeclampsia is associated with altered levels of heavy metals (Cd, Hg, arsenic and Pb) in maternal blood, fetal blood, and maternal hair.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of preeclampsia (diagnosed per ACOG criteria)

Exclusion Criteria:

known chronic disease multipl pregnancies