cyrilzakka/clinical-trials huggingface dataset:
Effect of Remifentanil on Postoperative Cognition Function in Patients Undergoing Major Abdominal Surgery

The purpose of this study is to investigate the effects of two different analgesic methods (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status of patients.

The purpose of this study is to investigate the effects of two different analgesic methods (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status of patients. In particular, whether there is a correlation between type of anesthesia and the appearance of postoperative cognitive disorder (POCD), including type of anesthesia and levels of pro and anti inflammatory cytokines and investigate whether there is an association between presence or absence of POCD and cytokines levels

Eligibility Criteria:
Inclusion Criteria:

* Age over 60 years
* Patients undergoing major abdominal surgery, in General Anesthesia
* ASA class status I-III

Exclusion Criteria:

* History of allergy to drugs used in the study
* Mini-Mental State Examination (MMSE) value \< 26
* Expected duration of anesthesia less than 1 hour and more than 4 hours
* Presence of a cognitive disorder severity of overt such as to prevent collaboration of the patient
* Presence of severe electrolyte disturbances or not controlled bool glucose levels
* History of pain or cerebral vascular disease on the basis of significant carotid or cerebral artery stenosis, to be verified by scanning eco-color doppler
* Habitual use of tranquillizers or other drugs affecting the central nervous system
* Difficulties in the management of the airways, such as to make the necessary changes in anesthesia technique
* Severe hypotension or hypertension or other vascular disorders, particularly thrombotic events or bleeding during surgery or in the perioperative period
* Bleeding that requires blood transfusion
* Medication needs higher or lower than that indicated in the protocol to ensure the depth of hypnosis, indicated by values of BIS targets
* Refusal by the patient
Treating Intraoperative Bradycardia in Non-cardiac Surgery Patients With Atropine at Heart Rates Below 60 Versus 30 Beats Per Minute and Norepinephrine Requirements

The RAPID trial is a randomized, single-center trial investigating whether giving atropine at heart rates below 60 beats per minute versus giving atropine only at heart rates below 30 beats per minute reduces the amount of norepinephrine needed to keep MAP above 65 mmHg in non-cardiac surgery patients with intraoperative bradycardia.


Eligibility Criteria:
Inclusion Criteria: Consenting patients ≥50 years scheduled for elective non-cardiac surgery with general anesthesia that is expected to last ≥60 minutes with at least two of the following risk criteria for developing acute kidney injury:

* Age ≥65 years
* American Society of Anesthesiologists physical status III or IV
* Chronic arterial hypertension
* Diabetes mellitus requiring medication
* Intraabdominal surgery
* Preoperative renal insufficiency (serum creatinine ≥1.2 mg/dL)

Exclusion Criteria:

Patients with the following exclusion criteria: contraindication for atropine administration (e.g., myasthenia gravis, high-grade aortic stenosis, high-grade coronary artery disease, glaucoma, paralytic ileus, prostatic hypertrophy); renal replacement therapy within the previous 3 months; chronic kidney disease with an estimated glomerular filtration rate \<20 mL/min/1.73 m2; pregnancy.
Study of Covalently Closed Circular DNA (cccDNA) in Liver Transplant Patients With B Virus Markers

The aim of this study is to validate in the context of liver transplantation, the interest of the cccDNA assay technique developed by the team of Professor Zoulim (INSERM U1052) on liver biopsy and correlate this assay cccDNA in hepatitis B virus (HBV) viral load and serum liver through several groups of patients at transplantation (on graft and native liver explant) and after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patient registered on the national Organ Transplant Waiting List for liver transplantation
* Indication of transplantation :
* Alcoholic related disease without serum anti-hepatitis B core antibody (HBc) (less than 4 weeks) OR - HCV related disease without serum anti-HBc antibody (less than 4 weeks) OR - Patients who sign consent for liver transplantation from hepatitis B core antibody positive donors OR - HBV related disease with positive serum HBs antigen (with or without HBV replication measured by polymerase chain reaction (PCR) within 6 months prior transplantation)
* Signed consent form
* Patient with a social cover
* Patient not covered by any measure of legal protection

Exclusion Criteria:

* Co-infection with HIV, hepatitis delta virus (HDV), HBV (for control arm), HCV (for Test arm) - Positive serology within the4 weeks before inclusion
* Patient covered by any measure of legal protection
* informed consent not signed
The Mechanism of Modified Utral-long Protocol in Improving Endometrial Receptivity in Patients With PCOS and IR

NF-κB pathway activation-induced endometrial insulin resistance was one of the causes of infertility patients with PCOS and insulin resistance whose endometrial receptivity is declined .The investigators' previous findings indicated that the use of modified utral-long protocols ( GnRH-a was used twice in mid-luteal phaes) can improve clinical outcomes by improving endometrial receptivity in patients with PCOS , but the mechanism was not clear. Previous research also found that GnRH-a reduced the activity of NF-κB pathway in endometrial stromal cells and depended the dose and time.Thus, The investigators' subject will try to applicate GnRH-a to explore the influence of NF-κB pathway activity 、the state of insulin resistance and embryo implantation rate ;then we will investgate GnRH-a whether reduce NF-κB pathway activity-induced insulin resistance and ultimately improve endometrial receptivity by using GnRH-a in infertility patients with PCOS and insulin resistance.The investigators' research attempt to provide ideas for seeking inflammatory medication target in assisted reproductive technology in patients with PCOS by exploring the immune mechanism of GnRHa on improving the endometrial receptivity .

The endometrial biopsy was performed in the previous cycle of the protocol. According to the expression of NF-κB in the endometrium random group. The difference of NF - κB expression in patients with different protocol were compared.

Eligibility Criteria:
Inclusion Criteria:

* age\<36years,
* PCOS,
* Insulin resistance (HOMA-IR = fasting insulin (FINS) × fasting blood glucose (FPG) / 22.5, HOMA-IR ≥ 2.69 ）;

Exclusion Criteria:

* uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus and uterine mediastinum),
* intrauterine adhesions,
* endometriosis, adenomyosis,
* Hydrosalpinx,
* uterine fibroids (submucosal fibroids, non-mucosal fibroids \> 4 cm and / or endometrial pressure),
* Hyroid dysfunction and hyperprolactinemia.
Intravenous Paracetamol Compared Dexketoprofen for Postoperative Analgesia After Septoplasty

The investigators conducted a prospective, randomized, double blind study to compare the effectiveness of intravenous paracetamol and dexketoprofen for preventing pain during first 24 hours postoperative period in adult patient undergoing septoplasty.

Postoperative pain scores as measured by Visual Analog Scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60 minutes and 2th, 4th, 6th, 12th and 24th hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* After patient's inform consent was approved, a total of 70 ASA (American Society of Anesthesiology) physical status I and II adult patients age 18 to 65 undergoing septoplasty were planned include the study.

Exclusion Criteria:

* History of clotting disorders or blood dyscrasias,
* Gastrointestinal ulcer or chronic dyspepsia,
* History of allergy to the study drugs,
* Active bleeding or bleeding disorders.
The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients with Type 1 Diabetes

Investigating the effect of oxytocin on pancreatic endocrine functions by determining glucagon secretion during hypoglycemia in participants with type 1 diabetes.

Glucagonotropic effects of oxytocin will be examined in 16 participants with type 1 diabetes, during a hypoglycaemic clamp with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomised, double-blinded design. This will determine the effect of oxytocin on the glucagon response to hypoglycemia. Additional changes in plasma/serum concentrations of insulin, C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP) and glucagon-like peptide 1 (GLP-1) will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index from 19 to 30 kg/m2
* T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c \<69 mmol/mol (\<8.5%)
* T1D duration of 3-30 years
* C-peptide negative (stimulated C-peptide ≤ 100 pmol/l)
* Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months

Exclusion Criteria:

* Anaemia (haemoglobin below normal range)
* Liver disease (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)
* Kidney disease (serum creatinine above normal range)
* Late microvascular complications except mild non-proliferative retinopathy
* Regular tobacco smoking or use of other nicotine-containing products
* Long QTc on electrocardiogram (ECG) at screening (≥0.45 seconds)
* Pituitary gland disease
* Treatment with any glucose-lowering drugs besides insulin
* Any ongoing medication or physical or psychological condition that the investigator feels would interfere with trial participation
Evaluation of the Modified VISTA Technique Using ALB-PRF vs CTG in the Treatment of Multiple Miller Class III Recessions

treatment of miller class III RT2 gingival recession using modified vista technique using connective tissue graft vs albumin PRF

treatment of gingival recession is an important element in the treatment of periodontitis this study covers clinical evaluation of using the modified VISTA technique with using Albumin-PRF VS connective tissue graft in the treatment of miller class III / RT2 for root coverage outcomes

Eligibility Criteria:
Inclusion Criteria:

* 18 years old good oral hygiene

Exclusion Criteria:

* smokers patients with poor oral hygiene
Applied Forces During Neonatal Face Mask Ventilation With Different Face-mask Air Cushion Volumes

Positive pressure ventilation (PPV) is the most important intervention in neonatal resuscitation. During PPV, it is important to hold the face-mask with care, as applying excessive pressure could cause injury to the infant, while insufficient pressure could be a contributor of mask leak and reduced effective ventilation. Application of positive pressure to face structures may trigger a vagally mediated reflex via the trigeminal nerve that innervates the skin of the face leading to apnoea and a decrease in heart rate (TCR, trigeminal-cardiac reflex).

In neonatal manikins, ventilation with a partially or fully inflated face mask does not seem to result in differences in mask leak. The force exerted by providers to improve mask seal might result in pressure lesions and in the elicitation of the trigeminal-cardiac reflex. However, information about the applied forces is unknown.


Eligibility Criteria:
Inclusion Criteria:

* Level III NICU consultants and pediatric residents

Exclusion Criteria:

* None
Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Surgical Wound After Abdominal Surgery

Surgical site infections (SSI) pose a common challenge in the field of surgery. Current evidence and literature do not provide clear consensus whether the use of subcutaneous drainage will help reduce the incidence of SSI in patients who underwent abdominal surgery, especially in wounds that are categorized as contaminated (class 3) or dirty/infected (class 4).

The objective of this clinical study is to compare the rate of surgical site infection in contaminated and dirty/infected surgical wounds among patients whose wounds are inserted with subcutaneous drainage and patients who are not inserted with subcutaneous drainage.

This study is a randomized, controlled and open study, where participants who undergo abdominal surgery will be randomly allocated into two groups: (i) patients whose wounds are inserted with subcutaneous negative pressure drain and (ii) patients whose wounds are not inserted with subcutaneous negative pressure drain.

The participants in this study will know the details about the presence of their drain placement after the operation. If the patient was assigned to the drain group, the drain will be placed for five days or until there are no content observed in the drain. The primary outcome of this study is the occurrence of SSI, which will be tracked up to 30 days post-operation. The patient in both groups will also be evaluated by the surgeons at day 3, 5, 7, 14 and 30 post-operation for signs and complications of SSI. In situation where the patients are discharged prior to the date of evaluation, the patients will be scheduled for evaluation during the follow-up visits.

If SSI is detected in the drain group prior to removal, the drain will be removed and the patient will be treated with wet dressing combined with antibiotics. Complications of SSI will also be noted. Patient's data on demographic, medical history, clinical presentation, details of operation, and other laboratory findings will also be collected to investigate for risk factors for development of SSI between each group.

Eligibility Criteria:
Inclusion Criteria:

* Age equal or over 18 years old
* Admitted to Queen Savang Vadhana Memorial Hospital
* Receive abdominal surgery and were classified as class 3 or 4 wound

Exclusion Criteria:

* Patients who undergo operation for ostomy
* Patients who do not receive appropriate antibiotics
* Patients who undergo operation before full recover of prior operation
* Patients who undergo laparoscopic operation
* Pregnant women
* Patients who had history of prior radiation therapy at abdomen
* Patient with immunocompromised status
* Patient with chronic skin disease
Behavioral Telehealth in Low-resource Primary Care Settings for Anxiety and Depression in Youth

The goal of this clinical trial is to test a brief, behavioral telehealth treatment program (STEP-UP) for depression and anxiety in youths (age 8-16 years old). Youths and families will be recruited through participating community health centers and will be randomly assigned to either: (a) receive STEP-UP care from providers at their health center or (b) be referred to care from local community mental health clinicians. Youth and families will be interviewed before treatment starts, 16 weeks later, and 24 weeks later to assess how youth are feeling. The main question the study aims to answer is whether STEP-UP improves youths functioning in daily life, anxiety symptoms, and depression symptoms. Researchers will compare STEP-UP to referral to community treatment-as-usual mental health services to see if STEP-UP is more effective.


Eligibility Criteria:
Inclusion Criteria:

* Youth is a patient in a participating community health center.
* Youths meet criteria for clinically significant anxiety and / or depression as indexed at baseline assessment by either:

  * research diagnosis of anxiety (Social Anxiety Disorder, Generalized Anxiety Disorder, Separation Anxiety Disorder) and / or depressive disorder (Major Depressive Disorder, Persistent Depressive Disorder).
  * scores in the clinically elevated range on a standardized anxiety and / or depression symptom measure .
* Youth lives with a legal guardian (hereafter referred to as "parent") \>= 50% of the time who consents to study participation.
* Youth speaks English.
* Parent speaks English or Spanish.

Exclusion Criteria:

* Youth requires alternate treatment as indexed by:

  * current clinically significant Post-Traumatic Stress Disorder symptoms (meets diagnostic criteria in research interview and / or scores in the clinically elevated range on a standardized symptom measure) at baseline.
  * current suicidal ideation with plan at baseline and / or suicidal behavior within the last year.
  * current substance dependence at baseline.
  * experience of physical or sexual abuse within the six months prior to baseline.
  * parent /guardian does not identify anxiety and / or depression as a treatment priority at baseline.
* Youth is in an active, alternate psychosocial intervention for anxiety or depression that would be concurrent with study participation.
* Youth is on an unstable regimen of psychotropic medication (i.e., receives medication but has not been at a stable dose for at least 8 weeks, or if medication has been discontinued for less than 4 weeks) at baseline.
* Youth is receiving lithium or and anti-psychotic medication at baseline.
* Youth is placed in a special education program for greater than 50% of the school day and / or youth school placement is below the second-grade level at baseline.
* Youth is placed in foster care at baseline.
A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth

This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).

This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.

Eligibility Criteria:
Inclusion Criteria:

Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.

Exclusion Criteria:

There are no exclusion criteria for this study
Vascularized Free Fibula Flap and Computer-guided Implant Surgery

The rehabilitation of patients affected by defects of the jaws after tumor resection is still very challenging. Resection can lead to significant facial deformity, impaired oral functions such as speech, swallowing, saliva retention, and concomitant psychological problems. Moreover, the loss of teeth and the alveolar and basal jawbone can lead to significant impairment of mastication. The reconstruction of such defects with autogenous bone grafts or revascularized free flaps has become a valuable means for the rehabilitation of these patients. Major benefits of such procedure include an usually low morbidity of the donor site and an extensive length of the bone graft. Moreover, vascularized grafts provide a good bulk of bone in which to place implants and a satisfactory contour. In fact, after reconstruction, local hard and soft tissue conditions often exclude the integration of conventional dentures because of the impairment of dental prosthetic retention by thin cutaneous tissue, the thickness of subcutaneous tissues, the absence of a perilingual and vestibular groove, and the fragility of soft tissues. In Literature it has been well established the high biologic value of vascularized fibula grafts regarding the potential of implant osseointegration, which seemed to be equal to regional mandibular or maxillary bone and eventually capable to provide sufficient stabilization of prosthesis.

It must be kept in mind that the final prosthetic success may be affected by some difficulties in this clinical scenario. These include the limited opening of the scar-contracted oral cavity, the huge amount of soft tissue covering the fibula, with little information about the profile of the underlying harvested bone, the need for limited bony exposure in a field that may well have been irradiated and they all may cause poor prosthetically-guided implant positioning and eventually disappointing results in dental rehabilitation, either functionally or esthetically. It can be postulated that these complications can be overcome, or at least reduced, by adopting the new methods of computed tomography (CT)-assisted implant surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients with free fibula flaps for maxillary and mandibular reconstruction needing full arch or quasi full arch rehabilitation

Exclusion Criteria:

* radiation therapy
* malignant tumor
AVANDIA With Glyburide In African American And Hispanic Patients With Type 2 Diabetes Not Controlled by Glyburide Alone

This study was designed to evaluate the safety and efficacy of AVANDIA (rosiglitazone) (8mg once daily) in African American and Hispanic patients with type 2 diabetes mellitus. As microvascular and macrovascular disease are significant contributors to diabetes morbidity and mortality and previous studies suggest that the thiazolidinedione compounds could have potentially beneficial vascular effects, the effects of rosiglitazone therapy on serum parameters associated with endothelial dysfunction, vascular inflammation and impaired fibrinolysis were examined in this study. Improvement in these parameters suggests that rosiglitazone may provide an additional beneficial vascular effect, apart from its ability to improve glycemic control.


Eligibility Criteria:
Inclusion criteria:

* African American or Hispanic.
* Type 2 diabetes mellitus.
* FPG\>=140mg/dL plus HbA1c\>=7.5% whilst receiving SU monotherapy.

Exclusion criteria:

* Patients who use insulin.
* Clinically significant liver, kidney or heart disease, including high blood pressure.
Drug Interaction Study

The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 to 50 years old with a body mass index (BMI) of 18 to 32 kg/m²
* Prior to enrollment, subjects must have physical and laboratory test findings within the normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ECG) or clinical laboratory determinations
* Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration
* Use of any other drugs, including over-the-counter medications of herbal preparations within 1 week prior to study drug administration