cyrilzakka/clinical-trials huggingface dataset:
Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study

The primary purpose of TAPAS study is to demonstrate the superiority of analgesic effect of trans abdominal plane block (TAP block) performed at the beginning of stoma reversal, compared to standard of care.

The hypothesize is that a TAP block performed at the beginning of surgery of stoma reversal would improve patient's satisfaction (evaluated by Quo-r40 questionnaire), would reduce the incidence of post operative pain, time spent in recovery room, and reduce hospitalisation time

The patient will arrive in the department the day before the surgical intervention (D-1). During this preoperative visit (D-1), the investigator

* will preselect potentially eligible patients
* will offer to participate to this study
* will give the notice form to the patients
* will present the research: objectives, benefits and constraints for the patients

The intervention day (D0):

The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.

The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.

Surgical Intervention (D1):

All patients will receive standard anaesthesia using sufentanyl, propopol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score. Anti microbial prophylaxis is performed according recommendations.

All patients will receive post operative multimodal analgesia using, acetaminophene, ketaminophene (if no contra indication), nefopam, and morphine if NRS (numerating rating scale) \> 3 At the end of the surgery, patients in the experimental group will receive a ultrasound guided trans abdominal plane block with 20 ml of 5 mg/mg of ropivacaine. Patients in the control group will not receive the block

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patients operated of a scheduled stoma reversal surgery
* Patients having given consent in the mannen described in Article L1122-1-1 of the Public Health Code
* Patients affiliated with asocial security regimen or beneficiary of such a regimen

Exclusion Criteria:

* Renal insufficiency (ie glomerular filtration output \< 35 ml/min)
* Patients with chronic inflammatory bowel disease
* Body mass index \> 35 kg/m2
* Chronic pain with opiates
* Patients with cognitive troubles
* Coagulation disorders (platelets count \< 80G/L, PT\< 50%, V factor \< 50%)
* Pregnancy
* Breastfeeding
* Local anesthesics (amide class) allergy
WE BEAT - HEART Club Fontan Wellness Project: a Virtual Resilience Promotion and Frailty Prevention Program

This trial is being conducted to evaluate the effect of a small-group wellness education program combined with a longitudinal, individualized prescription exercise program on the wellness, resiliency, and daily activity levels of pediatric patients with Fontan physiology.

There will be two phases for this project. The first phase is the "WE BEAT Group Wellness Education Program" and participants will be transitioned into the phase two HEART Club following phase one.

The trial will look at feasibility and acceptability of the program. Additional hypothesis include home whether exercise interventions can:

* be delivered without any associated serious cardiac events;
* will result in a decreased proportion of patients who are categorized as frail when compared to the cohort's pre-test baseline.
* will result in increased measured peak oxygen consumption when compared with their pre-intervention baseline.
* will result in increased step counts measured monthly from baseline to end of intervention
* will improve self-reported quality of life from baseline to post-intervention.
* will result in increased patient reported activity level from baseline to post-intervention


Eligibility Criteria:
Inclusion Criteria:

* Males and females with Fontan physiology who are 13 to \<19 years of age at enrollment
* Own a mobile device capable of installing the University of Michigan Patient Portal application
* Fluent in English
* Participant consent or parental/guardian consent and participant assent

Exclusion Criteria:

* Height \< 130 centimeters
* Current intravenous inotropic drugs
* Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment.
* Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
* History of arrhythmia with exercise (excluding isolated supraventricular or ventricular ectopy without symptoms).
* Inability to complete exercise testing at baseline screening.
* Noncardiac medical, developmental, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
* Suicidality or homicidality in the past 6 months.
Temperature Measurement in Post-Anesthesia Care Units

This study will evaluate the accuracy of several thermometers and temperature changes during surgery and immediately after surgery.

Several measurements of temperature will be taken at 30 minute intervals during surgery under general anesthesia and in the post operative care unit. Measurements will be taken as follows:

* esophagus using an internal stethoscope
* urinary bladder using a catheter
* ear canal
* skin of the forehead using adhesive devices(4 thermometers)
* axilla ("armpit") using adhesive devices(2 thermometers)
* mouth
* skin of the upper chest

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age
* American Society of Anesthesiologists (ASA) physical status of 1-3
* laparoscopic surgery of the abdomen or pelvis that is expected to require general endotracheal anesthesia and insertion of a Foley catheter expected to be in place for at least one hour after surgery

Exclusion Criteria:

* under 18 or over 80 years of age
* pre-existing nasogastric tube
* require bispectral index monitoring
* upper esophageal disease
* forehead rash or infection, oral infection or trauma, or ear infection or drainage
A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus

It is thought that Edratide may be able to reduce the symptoms of SLE.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to give written informed consent
2. Between the ages of 18 and 65 years (inclusive)
3. Fulfilled at least 4 ACR classification criteria
4. SLE patients with moderate, active disease
5. Subjects on stable dose of SLE medications for at least 4 weeks before randomization.
6. Women of child-bearing potential must practice a medically acceptable method of contraception..
7. Must understand the requirements of the study and agree to comply with the study protocol.

Exclusion Criteria:

1. Any condition which the investigator feels may interfere with participation in the study.
2. Subjects having a history of chronic infection
3. Subjects with a history of immunodeficiency syndrome or malignancy,
4. Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization,
5. Subjects treated with any cytotoxic agents in the 3 months prior to randomization.
Evaluation of the Risk of NSF Following MultiHance Injection in Patients With Chronic Kidney Disease

The objective of this long-term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1 - patients with moderate chronic kidney disease eGFR 30 to 59 and Cohort 2 - patients with severe chronic kidney disease or kidney failure eGFR \<30).


Eligibility Criteria:
Inclusion Criteria:

COHORT 1

* Is going to receive or has received MULTIHANCE injection during an MRI examination;
* Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the MULTIHANCE injection.
* Provides written informed consent and is willing to comply with protocol requirements.

OR

COHORT 2

* Is going to receive or has received MULTIHANCE injection during an MRI examination;
* Has CKD with eGFR below 30 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the MULTIHANCE injection.
* Provides written informed consent and is willing to comply with protocol requirements.

Exclusion Criteria:

COHORT 1

* Has received a GBCA within the past 12 months prior to inclusion in this study;
* Has unstable kidney function;
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
* Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
* Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.

OR

COHORT 2

* Has received a GBCA within the past 12 months prior to inclusion in this study;
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
* Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
* Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.
Effect of Respiratory Versus Aerobic Training on Respiratory and Immunity Efficiency in Recovered COVID- 19 Patients

This study will be conducted on eighty patients of both sexes with age ranging from 35 to 45years. The will be recovered from COVID-19 infection with chest symptoms. They will be selected from Nasr city police authority hospital. They will be randomly assigned into 3 equal groups.

This study will be conducted on eighty patients of both sexes with age ranging from 35 to 45years. The will be recovered from COVID-19 infection with chest symptoms. They will be selected from Nasr city police authority hospital. They will be randomly assigned into 3 equal groups.

Participants will be assigned into 3 groups equal in number (group A, group B, group C)

Group A (Respiratory Training Group) : It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive respiratory training for 6 weeks.

Group B : (Aerobic Training Group) : It will include 30 patients of both sexes, recovered from COVID-19 infection. In addition to medical drugs, they will receive aerobic training for 6 weeks

Group C : (control group) :It will include 20 patients of both sexes, recovered from COVID-19 infection on medical drugs only will receive no exercise as control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients recovered from COVID -19 infection.
* Patients with body mass index 25 - 35 kg/m2
* Patients previously diagnosed with chest symptoms of COVID- 19 infection.
* Patients' body temperature less than 37.5
* Blood oxygen saturation ≥95%

Exclusion Criteria:

* Smokers
* Patients with Myocardial infarction
* Patients with diabetes.
* Patients with autoimmune disease.
* Patients with positive COVID -19 infection.
* Patients with previous chest diseases
* a heart rate of \>100 bpm
* a blood pressure of \<90/60 mmHg or \>140/90 mmHg
* a blood oxygen saturation of ≤95%
* other diseases that are not suitable for exercise (osteoarthritis knee - stroke patients, etc)
Dry Needling for Cervicogenic Headache

Currently, it is unknown if dry needling when performed to the trigeminal innervation field improves neck pain and or headache for patients with cervicogenic headaches. The aim of this study is to determine if dry needling of the trigeminal innervation field improves pain, pain-pressure thresholds, and neck mobility in patients with cervicogenic headaches, with or without migraine.

Dry needling is a widely used intervention performed by physical therapists for a wide range of musculoskeletal and neurological conditions. Dry needling has been shown to be beneficial for cervicogenic headaches but treatment is typically applied to the neck. It is well-established that cervical pain can upregulate the trigeminal nerve and vice versa in various forms of headaches. Thus, it is plausable that reducing inflammation and irritation of the trigeminal nerve may in fact reduce neck pain and impairments. This study aims to look investigate whether dry needling the trigeminal innervation field will reduce pain and impairments known to exist in patients with cervicogenic headaches compared to a sham comparator. The study is a pilot trial for a larger RCT and will look at immediate effects only.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older
* Symptoms: (1)Unilateral pain starting in the neck and radiating to the frontotemporal region or posterior fossa, (2) pain aggravated by neck movement, (3) restricted cervical range of motion, (4) non-throbbing and non-lancinatingnpain, 5) dysfunction/headache pain in at least one of the joints of the upper cervical spine(C0-C4), and (6) headache frequency of at least 1 per week over a period greater than 3 months.

Exclusion Criteria

* Pain \<2/10
* Contraindications to the interventions
* Whiplash associated disorder within 6 weeks
* Pending litigation for neck pain and/or headache.
EFFECTIVENESS OF ULTRASOUND FOR LOCAL FAT TREATMENT

It's evident that the literature shows good results on the use of aesthetic ultrasound in the treatment of localized fat, however, little has been explored so far, about possible psychological influences of this method and therefore, it is believed that it is pertinent to elaborate studies that include a placebo group, in order to measure the real effects from the exclusive application of ultrasound. Therefore, the objective of this study will be to verify the influence of the application of aesthetic ultrasound in the treatment of localized fat, using for both clinical, biochemical and functional parameters.

There will be included 30 participants, female gender, communities between 18 and 30 years, apparently Saudi, local abdominal fat, located in three groups: control (n = 10), experimental (n = 10) and placebo (n = 10) . Or group control não recebeu nenhum type of intervention. No experimental group, 10 sessões de ultrassom (Skinner brand, São Paulo) will be carried out in the previous region for 20 minutes. No placebo group will be applied ultrassom (Skinner brand, São Paulo), pormem com zerada intensities. Anthropometric avaliação e of dobras cutâneas will be carried out at this time before applying the treatment protocol. As skin folds will be measured by means of adipometers.

Eligibility Criteria:
Inclusion Criteria:

* Additional inclusion criteria included body mass index (BMI) equal to or less than 25.0 kg / m2
* Adipose tissue thickness 2.6 cm or more in the treatment region;
* Preserved elasticity and local tissue integrity;
* In addition, participants had to agree not to change their daily routines during the study.

Exclusion Criteria:

* Pregnancy.
* Breastfeeding;
* History of liposuction;
* Lipolysis by injection therapy;
* Abdominoplasty or surgery in the treatment region;
* Weight reduction medication;
* Recent surgery in the last 12 months;
* Implantable electrical device;
* Neurosurgical deviation;
* Hernia;
* Sensory loss or dysesthesia in the treatment region;
* Cancer;
* Circulation problems;
* Or chronic systemic disease such as diabetes or metabolic syndrome.
Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study

The planned HERMES study is to investigate and compare the effects of Insulin Glulisine, Insulin Aspart and regular human insulin on postprandial nitrotyrosine concentrations and several clinical and laboratory markers of postprandial endothelial cell function, sub-clinical inflammation and cardiovascular risk in patients with type 2 DM. The primary parameter in this study are the postprandial changes in the nitrotyrosine concentrations, a biomarker for oxidative stress. As vascular data on Insulin Glulisine vs. Insulin Aspart are missing, it is not possible to calculate sample size and statistical power. Therefore the goal of the HERMES-Pilot-Study is to generate preliminary data for statistical considerations and estimations on the probability of success of HERMES.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Stable BOT (basal oral therapy) with Insulin Glargine + ≥ 2 OHA (oral hypoglycemic agents except for TZD) for a minimum of three months before entering the study
* HbA1c ≤ 8.5%
* Age between 30 and 75 years inclusively
* Body mass index ≤ 40 kg/m2
* Patient consents that his/her family physician will be informed of trial participation

Exclusion Criteria:

* Type 1 diabetes mellitus
* Unspecific infection or inflammation (hsCRP \>10mg/L in POC test)
* Use of thiazolidinediones within the last 3 months prior to study start
* Retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases
* History of drug or alcohol abuse within the last five years prior to screening
* History of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
* History of severe or multiple allergies
* Treatment with any other investigational drug within 3 months prior to screening
* Progressive fatal disease
* hepatic (ALAT and/or ASAT \> 3 times the normal reference range), renal (creatinine \> 1.3 mg/dl in women and \> 1.6 mg/dl in men), neurological, psychiatric and/or hematological disease as judged by the investigator
* Pregnant or lactating women
* Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
* Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
The Time of Positive Conversion of Interferon-γ Releasing Assay After Tuberculosis Exposure

The aim is to evaluate the time of positive conversion after exposure to smear positive pulmonary tuberculosis (TB) in a platoon of Korean military, a closed communal setting.

In a platoon where TB outbreak occurred, we performed low dose chest CT (LDCT), QuantiFERON-TB gold in tube (QFT) and two-step (0, 4weeks) TST for outbreak investigation. We perform QFT at 0, 2, 4, 8 and 12 weeks after initial investigation for soldiers with negative QFT results, and soldiers with positive QFT and normal LDCT took isoniazid and rifampin for 3 months as treatment of latent TB.

Eligibility Criteria:
Inclusion Criteria:

* All soldiers who assigned to the military platoon where a tuberculosis outbreak occurred

Exclusion Criteria:

* Soldiers who could not complete study or refused the study protocol
Long-Term Follow-up Study of Subjects With Fabry Disease Who Received Lentiviral Gene Therapy in Study AVRO-RD-01-201

This is a multinational, long-term follow-up study to assess the long-term safety and durability of AVR-RD-01 treatment in participants who received a single dose administration of lentiviral gene therapy in Study AVRO-RD-01-201 (treatment study). No investigational product will be administered in this study. Participants will continue periodic safety and efficacy assessments in this long-term follow-up study up to 15 years from AVR-RD-01 gene therapy infusion.

Participants enrolled in the AVRO-RD-01-201 study will be offered participation in the AVRO-RD-01-LTF01 study. The Baseline visit for the AVRO-RD-01-LTF01 study will coincide with the participant's last visit in the AVRO-RD-01-201 study. Participants confirmed eligible for the AVRO-RD-01-LTF01 study will be asked to return for study visits at approximately 6-month intervals for the first 4 years and annually thereafter for 10 years (for a total of 15 years from AVR-RD-01 infusion) during which time continued safety, engraftment, and efficacy of treatment will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have been enrolled and received AVR-RD-01 in the AVRO-RD-01-201 study.

Exclusion Criteria:

1. Subject has any medical, psychological, or other condition that, in the opinion of the Investigator:

   * Might interfere with the subject's participation in the study (including consenting to procedures); and/or
   * Poses any additional risk to the subject; and/or
   * Might confound the results of any study-required assessments.
2. Subject is currently enrolled in an AVROBIO-sponsored AVR-RD-01 treatment study.
Single Level Anterior Cervical Corpectomy Without Posterior Stabilization

evaluate and assess short term outcome of treating degenerative and non-degenerative cervical conditions with single level anterior cervical corpectomy without posterior fusion

Cervical corpectomy is a procedure that removes damaged vertebrae and intervertebral disc that are compressing the spinal cord and spinal nerves. Various graft materials or spacers are used to maintain height and stability followed by anterior plating. It has an important role in the management of various degenerative, traumatic, neoplastic and infectious disorders of cervical spine.

While ACCF effectively decompresses the spinal cord, it is debated whether it can provide enough cervical stability, or an additional posterior fixation (PF) is required. Studies show that in multi-level anterior cervical corpectomy, additional posterior fixation provides extra support to improve cervical stability whether it is performed initially, or later as a supplementary surgery if material failure or instability occurred, On the other hand, in single level corpectomy, it remains controversial as single level ACCF showed sufficient stability in the majority of cases without additional support but pathologies affecting bone quality like infections and neoplasms seemed to be risk factor for construct failure and instability so additional PF was required .

Eligibility Criteria:
Inclusion Criteria:

- All patients with degenerative and non-degenerative cervical conditions (trauma, tumors and infections) treated with "single level anterior cervical corpectomy without posterior fusion

Exclusion Criteria:

* Patients who refuse to participate in the study
* Patients who are not available for 6 months follow up