cyrilzakka/clinical-trials huggingface dataset:
Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery

This study was undertaken to compare the two techniques (exteriorized vs in situ) of uterine repair with respect to patient comfort, hemodynamic changes, surgical time and blood loss, in patients undergoing elective CD under a strictly standardized spinal anesthetic. We hypothesized that in situ uterine repair would be more comfortable for the patients.

Uterine repair during Cesarean delivery can be done either by exteriorizing the uterus and replacing it into the abdominal cavity after the completion of a double layer closure, or by suturing it in situ. Exteriorization of the uterus has been shown to decrease blood loss during Cesarean delivery when compared to in situ repair. However, at the same time, it is thought to be uncomfortable for the patient with respect to intraoperative nausea, vomiting and pain. Intraoperative nausea and vomiting in patients who receive regional anaesthesia for Cesarean section is a complex multifactorial problem arising from anesthetic and non-anesthetic causes. Additionally, it can influence hemodynamic stability.

The study was a prospective, randomized and single blinded study. It compared the effects of exteriorization of the uterus and in-situ repair during Cesarean delivery with respect to patient's comfort, hemodynamic changes, uterine contractility and blood loss in patients under spinal anesthesia. All low risk patients undergoing elective C-delivery under spinal anesthesia were considered for this study.

Spinal anesthesia was performed in the sitting position with 10-12 mg of 0.75% hyperbaric bupivacaine, mixed with 100 mcg of preservative free morphine and 10 mcg of fentanyl. Any drop in blood pressure was treated with 100 mg of phenylephrine titrated to maintain systolic blood pressure within 10% of the baseline values throughout the procedure. Oxytocin was used judiciously, in aliquots of 0.5 IU. Obstetricians were asked to allow assisted spontaneous delivery of placenta rather than manual extraction. During surgery, patient's complaints of nausea, vomiting, pain or any discomfort were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women scheduled for elective cesarean delivery

Exclusion Criteria:

* ASA III or IV patients
* Patient with conditions that predispose to uterine atony and post partum hemorrhage
Nervous System Symptoms Associated With COVID 19

This study aim to prospectively evaluate the neuropsychiatric symptoms of patients infected with the SARS-CoV-2 virus by a standardized neuropsychiatric examination : the global CASE scale (Clinical Assessment Scale in Autoimmune Encephalitis), and the prevalence of disturbances of consciousness, focal neurological deficit, cognitive impairment, headache, anosmia, sleep disturbances, impaired autonomic nervous system and peritraumatic stress.


Eligibility Criteria:
Inclusion Criteria:

* Being hospitalized at the Toulouse University Hospital for a COVID-19 infection proven by a probable PCR or COVID-type examination on the chest scan
* Have given oral consent for the collection of clinical neurological data
* Be in a clinical state compatible with a 30-minute neurological examination
* Be French-speaking
* Be affiliated to a Social Security scheme

Exclusion Criteria:

* Refusal of the neurological examination
* History of neurological pathology at a severe stage
* Pregnant or breastfeeding woman
* Persons with tutors or curators
Efficacy of the Application of Xylocaine Impregnated Compress in Reducing Per-procedural Pain During Ultrasound-guided Infiltration of Trigger Finger

The purpose of this study is to assess the efficacy of Xylocaine impregnated compress in reducing per-procedural pain during ultrasound-guided infiltration of Trigger Finger

Trigger finger ultrasound-guided infiltrations are frequent and painful invasive procedures.

However, there is no current recommendation for per-procedural pain management, and in the majority of cases, infiltration is performed without prior skin anesthesia.

Xylocaine patches are of controversial efficacy in pain acute management. In current practice, they are not prescribed in advance and they are not well adapted to the topography of the finger.

On the other hand, a recent study showed the interest of administering lidocaine 2% by J-tip, a needle-free injection technique not available in France, before infiltration of Trigger Finger.

The investigators hypothesize that an impregnated compress in Xylocaine 20 mg/ml injectable solution, applied 15 minutes before the procedure, would reduce per-procedural pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Trigger Finger (clinically defined by painful difficulty or protrusion when extending the finger) with an ultrasound-guided infiltration of cortisone derivatives indication.
* Written consent
* Affiliation to a Social Security system
* Prior medical examination

Exclusion Criteria:

* Neurological conditions affecting the hand other than carpal tunnel syndrome
* Intra-articular infiltration of the hand or the wrist ≤ 2 months
* Allergy to Xylocaine
* Contraindication to Xylocaine or cortisone derivatives
* Cognitive or behavioral disorders that make assessment impossible
* Persons referred to in articles L 1121-5; 6; 8; 9 of the Public Health Code (protected adults, under guardianship or curatorship, etc)
* Pregnancy and breastfeeding; absence of contraceptive method for women of childbearing age
* Participant unable to speak, read and write French
Sirolimus as Primary Therapy for the Treatment of Chronic Graft Versus Host Disease

Evaluate the clinical activity of sirolimus in combination with cyclosporine and corticosteroids as first line therapy for the treatment of chronic Graft Versus Host Disease.

An Open Label Study of Sirolimus as Primary Therapy for the Treatment of Chronic GVHD Following Allogeneic Bone Marrow Transplant

Eligibility Criteria:
Inclusion Criteria:- active chronic GvHD

* ANC \> 1000/mm\^3
* therapeutic cyclosporine Exclusion Criteria:- uncontrolled systemic infection
* elevated serum creatinine
Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial

Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. In the present study, we will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list.

Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. Internet-based CBT can be described as online bibliotherapy with therapist support via a secure messaging system. In this study psychologists will deliver the treatment. We will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorder and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list. We expect that participants who receive ICBT will make superior improvements compared to the control condition on measures of stress, burnout, depressive symptoms, general anxiety and general functioning.

Eligibility Criteria:
Inclusion Criteria:

To be included in the study participants must be between 18 and 65 years of age and suffer from primary stress-related disorders by meeting diagnostic criteria for adjustment disorder or burnout syndrome. Participants must have access to a computer and to the Internet, as well as being able to write and write in Swedish.

Exclusion Criteria:

Exclusion criteria include (a) meeting the criteria for another axis-1 diagnosis that is assessed to be the primary area of difficulty, (b) suffering from substance abuse/dependence in the past 6 months, (c) suffering from current or past psychosis or bipolar disorder, (d) moderate to high suicide risk, (e) initiated or changed pharmachological treatment for depression or anxiety in the past month and (f) other on-going psychological treatment for stress-related difficulties, and (g) not having received CBT for stress-related ill-health in the past year.
Total Body PET-CT Imaging of Prostate Cancer Using Illuccix

Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Male ≥ 18 years of age
3. Patients meeting clinical need for Illuccix PET scan:

   1. Patients with suspected metastasis who are candidates for initial definitive therapy
   2. Patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
4. Patient is physically able to lay flat for the PET-CT procedure

Exclusion Criteria:

1. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
Promoting Repeat Blood Donation Through Social Media Among First-time Donors in a Peruvian Blood Bank

Blood donations are an important need worldwide. In Peru, only 10% of donations are voluntary, of which only a quarter are repeat donors. Repeat donations are crucial to maintaining a safe and adequate blood supply.

Social media presents a unique opportunity to promote blood donation, because of its increasing use and its prior successes in promoting positive health-related behaviors .

The present study aims to develop and evaluate a social media intervention - Facebook and WhatsApp - to improve communication and promote repeat blood donations in voluntary first-time donors attending donation campaigns organized by the Hospital Nacional Cayetano Heredia (HCH).

Main Objective:

To evaluate the effect of social media in the promotion of repeat blood donation among first-time blood donors in a Peruvian blood bank.

Study design:

A randomized control trial will be conducted over a 6-month period, and will compare the rate of repeat blood donation who amongst first-time donors who received promotional messages through social media and those who did not.

Population:

Voluntary first-time blood donors who attend blood donation campaigns organized by the blood bank of the Hospital Nacional Cayetano Heredia (HCH), Lima - Peru.

Sample:

A sample of 105 participants per group was calculated, with a significance of 95% and a power of 80%, to show a difference of 20% in recurrence rate of blood donation between the two groups.

Group assignment:

Participant selection will occur at blood donation campaigns organized by the HCH blood bank. If inclusion and exclusion criteria are met, donors will be invited to participate in the study. After accepting and signing the informed consent form, donors will be randomly assigned to one of two groups using complete block randomization until a total of 212 participants are recruited: 106 in the intervention group and 106 in the control group. All participants will receive an introductory message through social media confirming their participation in the study.

Ethical considerations:

Written informed consent will be requested from participants. Data confidentiality will be maintained. Personal identifiers will be stored in a separate database, which will be password protected and accessible only to the research team.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary first-time Blood Donor
* Eligible to donate blood again
* Facebook or WhatsApp user

Exclusion Criteria:

* Denial to participate in the study
* Refusal to be contacted by social media
PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion \& exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft
* EF \<35%

Exclusion Criteria:

* ST Myocardial Infarction
* Cardiac Arrest
* Cardiogenic Shock
* Thrombus Left Ventricle
Developing a Health Literacy Intervention for Immigrant Kidney Transplant Recipients

The goal of this complex interventions study is to improve health literacy (HL), medication adherence and patient education outcomes in immigrant kidney transplant recipients (KTRs). Furthermore, we aim to strengthen HL sensitivity and cultural competence in nurses providing patient education. The main questions we aims to answer are:

1. What are immigrant KTRs HL strengths and needs, medication adherence and outcomes after patient education in three important transitions following kidney transplantation: the first postoperative phase (3-7 days post-transplantation), preparing for transfer to local hospital (6-8 weeks post-transplantation), and adapting to the home context (3-6 months post-transplantation).
2. What experiences, competence and competence needs does the nurses that engage in patient education to immigrant KTRs post-transplant have?
3. Will a tailored intervention increase HL, medication adherence, and outcomes after patient education in immigrant KTXs and organizational HL and cultural competence in nurses?

Qualitative methods will be used to develop and optimize the intervention.

* Patients will be invited to three individual interviews in the three postoperative phases.
* Nurses in three wards (surgery, medical and outpatient ward) are asked to participants in focus group interviews.
* The interviews will be used to define needs and build the intervention. Ideas to the intervention will be discussed in workshops with nurses, the project group and user participants.
* Parts of the intervention will be tested in the clinic followed by 'think aloud interviews' where both the nurse and the patient are asked to speak freely about their experiences using the intervention.
* The intervention will be evaluated by repeating the interviews with patient and focus group interviews with nurses.
* The intervention will be feasibility tested.


Eligibility Criteria:
Inclusion Criteria:

* Immigrant kidney transplant recipients in Norway. Immigrant defined as a person that has immigrated to Norway and that has two parents and two grandparents born in another country than Norway.

Exclusion Criteria:

* Patients from high-income countries, as defined by the Global Burden of Disease (GBD) framework. The GBD study is the largest and most comprehensive effort to quantify health loss across places and over time (https://www.healthdata.org/research-analysis/gbd). High income countries are western Europe, North America, Australia, New Zealand, Japan, Brunei, Republic of Korea, and Singapore (https://ghdx.healthdata.org/countries). National and international studies report that people with background from low-income countries have lower sociodemographic scores and lower health literacy levels. Therefore, the study will focus on these patients. The majority of immigrant kidney transplant recipients in Norway are from low-income countries.
Effect of Magnesium Sulphate Added to Mepivacaine Hydrochloride on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis in Mandibular Molars: A Randomized Clinical Trial.

the study is conducted to assess the effect of adding magnesium sulphate to mepivacaine HCl compared to mepivacaine HCl alone on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis in mandibular molars


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-55 years old.
2. Systemically healthy patient (ASA I or II).
3. Mandibular molar teeth with:

   * Preoperative sharp pain.
   * No widening in the periodontal ligament (PDL).
   * Vital response of pulp tissue to cold pulp tester (ethyl chloride spray)1.
   * Fully formed roots.
4. Positive patient's acceptance for participation in the study.

Exclusion Criteria:

1. Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment.
2. Pregnant or nursing females.
3. Patients having significant systemic disorder (ASA III or IV).
4. Drug abusers and subjects who were on antidepressant medication.
5. Re-treatment cases.
6. Patients with a contraindication for the use of magnesium sulphate or those known to be allergic to any of the study medications.
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition in Patients With ST-Segment Elevation Myocardial Infarction (MI)

In patients with ST-segment elevation acute myocardial infarction (STEMI) increased LDL-cholesterol reduction (rosuvastatin 40 mg) will provide incremental plaque stabilization (changes in plaque composition) and plaque regression over 12 months beyond the benefit of moderate LDL-cholesterol reduction (rosuvastatin 5 mg) (assessed by IVUS and VH).


Eligibility Criteria:
Inclusion Criteria:

* ST segment elevation acute myocardial infarction
* 20% \< angiographic diameter stenosis \< 50% on a not previously revascularized native coronary artery
* Statin naïve

Exclusion Criteria:

* Pharmacologic lipid lowering treatment before index hospitalization
* Atrial fibrillation, not well rate-controlled
* Ventricle frequency variation with more than a factor 2 over 1 minute
* Unconscious patients
* Total cholesterol \> 7.0 mmol/l
* History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins) including rosuvastatin
* Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have a positive serum pregnancy test (a serum-human chorionic gonadotrophin \[Beta-HCG\] analysis)
* History of malignancy (unless a documented disease free period exceeding 5-years is present) with the exception of basal cell or squamous cell carcinoma of the skin, or in the case of a study designed to investigate antineoplastic properties of rosuvastatin. Women with a history of cervical dysplasia would be permitted to enter the study provided they had 3 consecutive clear Papanicolaou (Pap) smears
* Uncontrolled hypothyroidism (TSH \> 1.5xULN)
* Abnormal LFT's
* History of alcohol or drug abuse within the last 5 years (this may affect compliance)
* Current active liver disease (ALT/SGPT \>2xULN or severe hepatic impairment (to protect patient safety as directed on the labels of currently approved statins)
* Unexplained creatine kinase (CK \> 3xULN) (To protect patient safety) (will be increased at baseline because of acute ST segment elevation myocardial infarction a few days before enrolment)
* Serum creatinine \>176mmol/L (2.0mg/dL) (unless the protocol specifically aims to investigate a chronic renal disease population)
* Participation in another investigational drug study less than 4 weeks before enrolment in the study, or according to subjects local ethics committee requirements where a larger period is stipulated (to avoid potential misinterpretation of overlapping adverse events)
* Treatments with cyclosporine
* Treatment with gemfibrozil
Adult Safety Study of 2009/2010 Seasonal Influenza Vaccine

The purpose of the study is to verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to World Health Organization (WHO)/European Union (EU) recommendation for the 2009/2010 season.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 to 59 years of age, inclusive, at the time of screening
* Subject has given written informed consent prior to study entry
* Subject is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
* Subject agrees to keep a daily record of symptoms for the duration of the study
* If female of childbearing potential, subject presents with a negative urine pregnancy test immediately prior to vaccination on Study Day 1 and agrees to employ adequate birth control measures for the duration of the study
* Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Subject has a history of severe allergic reaction or anaphylaxis
* Subject has an oral temperature of \>= 37.5°C on the day of vaccination in this study Subject has a dermatologic condition or tattoos, which may interfere with injection site reaction rating
* Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
* Subject has been vaccinated with seasonal influenza vaccine for the 2009/2010 season
* Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
* Subject has any inherited or acquired immunodeficiency
* Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\> 800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
* Subject has a functional or surgical asplenia
* Subject has a known or suspected problem with alcohol or drug abuse
* Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.
* If female, subject is pregnant or lactating at the time of study enrollment
* Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study