cyrilzakka/clinical-trials huggingface dataset:
Interventional Therapy of Tracheal Stenosis

After respiratory weaning, decannulation is sought. To do this, the tracheal cannula is first unblocked, so that patients no longer breathe in and out through the cannula, but (at least partially) "passing" the cannula by the natural route. In the presence of tracheal stenosis there is increased breathing effort, possibly restlessness and stridor. This constellation of symptoms suggests the suspicion of tracheal stenosis, so in the next step a tracheoscopy is performed to confirm or exclude tracheal stenosis. In case of symptomatic tracheal stenosis and at least 30-50% stenosis of the trachea (clinical symptoms can be expected from a 30-50% stenosis) then appropriate therapy (here: cryotherapy, other techniques only in exceptional cases) is planned. The goal is to be able to remove the tracheal cannula (long term) after successful therapy, so that patients do not have to be permanently provided with a tracheal cannula. There is no definitive/evidence-based standard therapy for the treatment of tracheal stenosis. Cryotherapy is a gentle therapy that has already been applied and described for the treatment of tracheal stenosis (see above). The examination is performed as part of an analgesic dose, as is routine for a bronchoscopy (in-house SOP). After treatment, a follow-up is planned for about 10 days later.


Eligibility Criteria:
Inclusion Criteria:

* Tracheal stenosis after percutaneous tracheotomy.

Exclusion Criteria:

* Pregnant or breast-feeding women of childbearing potential who refuse pregnancy test.
* lack of consent to participate in the study.
* surgical tracheotomy.
* Involvement of the larynx (above the first tracheal brace).
Comparison 1 Plane-1 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block

Ultrasound-guided supraclavicular brachial plexus block (US-SCBPB) has been a generalized regional anesthesia in upper extremity surgery. It is performed just above the clavicle, in which the neural cluster formed by the trunks or divisions of the brachial plexus is situated superolateral to the subclavian artery (SA).

In many approaches, corner pocket approach \[deposit local anesthetic (LA) at the intersection of the SA, neural cluster, and the first rib\] and cluster approach (direct deposit LA into the neural cluster after penetration of the sheath of brachial plexus) has been well known methods. And single or multiple injection techniques has been used with the above approaches.

In clinical practices, the investigators observed that the neural cluster was shown differently every person on the ultrasound image. Some neural cluster is shown as a typical round cluster of grapes lateral to the SA, in which, any approaches of US-SCBPB can be possible and good success rates are anticipated. But in many cases, neural cluster was shown in part lateral or superolateral to the SA like slightly-hated SA on the ultrasound image, and it passes posterior to the SA when the probe follows the path of the neural cluster along the SA. In that case, corner pocket approach is hard to apply due to the position of the neural cluster far away from the first rib, cluster approach increases chance of lopsided spreading of the LA, and multiple injection is also hard to apply due to narrow-shaped neural cluster. Therefore, we hypothesized that double injection in different plane (we call this new approach as a 2 plane-2 injection approach) would achieve an effect of a "tridimensionally administered LA", which is presented like shortening the onset time or increasing rate of all four nerves block compared with the existing cluster approach (the investigators call this as an 1 plane- 1 injection approach in this study).

Eligibility Criteria:
Inclusion Criteria:

* all patients anticipating surgery of the wrist or hand with aged 18 to 80 years and an American Society of Anesthesiologists physical status (ASA) of I or II.

Exclusion Criteria:

* patients with preexisting neuropathy in the operated limb, ASA greater than III, coagulation disorders, known allergy to local anesthetics, local infection at the puncture site, chronic obstructive pulmonary disease or respiratory failure, pregnancy, breast-feeding and prior surgery in the supraclavicular region, BMI ≥ 35 kg/㎡, uncooperative patients and patients' refusal. an ultrasound view of the perfect circular neural cluster.
Haemorrhages and Thromboembolic Venous Disease of the Postpartum

The aim of this study is to evaluate the frequencey and the determinants of postpartum major complications (hemorrhage and thrombosis) up to 3 months after delivery in the maternity hospitals of Finistère (Bretagne - France)

This is an analytical observational prospective multicenter cohort study , conducted on all the maternity hospitals in Finistère (Bretagne - France), with a biological collection.

This protocol allows to study all women at risk of PPH (Postpartum Hemorrhage) and postpartum venous thromboembolic disease, including maternity level 1-3 without case selection. The prospective nature of the study should provide a more detailed analysis of exposures in this particular population of women (risk factors related to the field, childbirth, the postpartum events ...).

The events of interest were PPH and venous thromboembolic disease.

Eligibility Criteria:
Inclusion Criteria:

* Any woman giving birth and supported in one of Gynaecology Obstetrics services of a maternity Finistere.
* Women ≥ 16 at the time of the collection of non-opposition.
* For minor patients: understanding the patient and at least one parent.
* All births ≥ 15 weeks gestation.

Exclusion Criteria:

* Home Birth
* Expressed opposition to participation in this study.
* Childbirth under X.
* Parent (s) uninformed of the pregnancy of their child.
Vitd and Barrier Function in IBD

Increased Intestinal Permeability is detectable in clinically active Crohn's disease, in stable Crohn's disease and is predictive of clinical relapse. Maintenance of the epithelial barrier integrity is therefore essential for intestinal homeostasis. Vitamin D may have a critical role in improving barrier function.


Eligibility Criteria:
Inclusion Criteria:

* All patients must fulfill the clinical criteria for diagnosis of CD as defined by Lennard-Jones et al. (1976)
* All patients must be in clinical remission for at least 1 month at study entry as defined by a Crohn's Disease Activity Index (CDAI) of \<150
* 18-65 years
* Patients on stable drug therapies for at least 1 month pre-enrolment
* Sufficient English language ability to carry out the study requirements

Exclusion Criteria:

* Symptomatic CD at study entry including CDAI \>150
* Pregnancy
* Previous extensive small bowel resection (less than 200 cm of viable small bowel or a loss of 50% or more of the small intestine)
* Presence of an ileostomy or colostomy
* Known hypersensitivity to vitamin D
* Hypercalcaemia (corrected serum calcium \> 2.66 mmol/L)
* Those currently using supplemental vitamin D \>800 IU/D
* Diagnosis of any of the following: active tuberculosis, sarcoidosis, hyperparathyroidism, renal failure, pseudohyperparathyroidism, malignancy, active, lymphoma, short bowel syndrome
* Antibiotic use in the 4 weeks prior to enrolment
* Current use of bisphosphonates
* Renal Impairment, Diabetes Mellitus
* Patients participating in a concurrent RCT
* Alcohol dependency
Adolescent Inpatient Tobacco and ENDS Intervention

The purpose of this study is to develop and evaluate an evidence-based intervention to assist adolescents and young adults with current vaping to quit vaping and smoking.

Use of electronic nicotine delivery system (ENDS), which are noncombustible tobacco products (e.g., e-cigarettes), has increased dramatically among youth and is associated with numerous adverse health outcomes as well as use of alcohol and other illicit substances. National guidelines recommend counseling to address tobacco use at every adolescent clinical visit; however, many at-risk adolescents do not routinely attend primary care. Although evidence supports treatment of tobacco use during an adult hospitalization, no interventions have been developed or tested in the pediatric hospital setting. Based on promising theoretically-based evidence from the primary care and hospital settings, we will design, iteratively refine and assess implementation of a novel tobacco and ENDS use intervention for hospitalized adolescents and young adults (AYAs). We do so by conducting a randomized controlled pilot study (n=144) with 3-month follow up to evaluate preliminary efficacy as well as implementation outcomes (i.e., acceptability, feasibility, fidelity).

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the hospital
* Screens positive for past 30 day e-cigarette use
* Parent/guardian agrees to leave the room

Exclusion Criteria:

* Age is less than 14 years or over 21 years
* Not comfortable speaking/reading English
* Too ill to participate
* Severe psychiatric illness
* Too developmentally delayed/cognitively impaired
Combined Ketorolac Bupivacaine Versus Bupivacaine Alone for TAP Block in Children Undergoing Lower Abdominal Surgeries

Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.

Ketorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.

Group (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).

Group (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg)

This prospective randomized controlled study were carried out in Sohag university hospitals after getting approval from medical research ethics committee and written informed consents from the patients' parents or legal guardians. This study included 90 ASA status I and II children aged 6-12 years undergoing elective lower abdominal surgeries.Preoperative assessment:

* History taking from the parents.
* Complete physical examination.
* Laboratory investigations: Complete Blood Picture and coagulation profile. Preoperative preparation

Before starting, standard monitoring will be as follow:

1. Non-invasive blood pressure (systolic and diastolic).
2. Peripheral Oxygen saturation (SpO2%). After insertion of intravenous line, all children will receive atropine premedication (0.01-0.02 mg/kg). General anesthesia will be induced using propofol 1% (2 mg/kg), atracurium (0.5 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1-2%) with controlled ventilation.At the end of operation, muscle relaxant is reversed using neostigmine and atropine.

Intraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).

Then TAP block were done under ultrasound guidance using either bupivacaine and ketorolac or bupivacaine alone

Eligibility Criteria:
Inclusion Criteria:

* ASA status I and II children Age 6-12 years Elective lower abdominal surgeries.

Exclusion Criteria:

* Parents' or legal guardians' refusal.
* A history of developmental delay or mental retardation.
* ASA III and IV.
* A known allergy to ketorolac or bupivacaine.
* Hemodynamic unstable patient
* Urgent surgeries
Incidental Cancer in Familial Adenomatous Polyposis

Colectomy is life-saving in patients with familial adenomatous polyposis (FAP) because cancer development is inevitable in individuals with this disease. In this study, we aimed to determine the incidence of incidental malignancy in surgical specimens from patients who underwent colectomy for FAP. Prophylactic colectomy should be performed in patients with FAP, as colorectal cancer transformation is inevitable in these individuals. The possibility of incidental cancer identified via histopathological analysis of colectomy specimens should be kept in mind in these patients.

Colectomy is life-saving in patients with familial adenomatous polyposis (FAP) because cancer development is inevitable in individuals with this disease. In this study, we aimed to determine the incidence of incidental malignancy in surgical specimens from patients who underwent colectomy for FAP. The files of patients diagnosed with FAP who underwent surgery in our clinic between 2010 and 2020 were retrospectively reviewed. Definitive surgery was performed in patients with histopathological malignancy identified in colonoscopic biopsies in the preoperative period, while prophylactic surgery was performed in patients without malignancy. The incidence of incidental malignancy in histopathological specimens from patients who underwent prophylactic colectomy was determined. Prophylactic colectomy should be performed in patients with FAP, as colorectal cancer transformation is inevitable in these individuals. The possibility of incidental cancer identified via histopathological analysis of colectomy specimens should be kept in mind in these patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Familial Adenomatous Polyposis

Exclusion Criteria:

* did not receive surgical treatment
* data deficiencies
Implications of Ethics Determinant on Dentistry and Pharmacy Research

The ethical review of dental and pharmacy research protocols has its own challenges facing the institutional ethical committees. Seemingly low risk procedure might pose controversies among committees' members. The aim of this article is to describe some of the ethical concerns, particular to dental and pharmacy research that an ethics committee could face while reviewing dental research.

The investigators have read all protocols submitted to the MIU IRB and reviewed all meetings' minutes to outline the ethical concerns that warranted discussions in the meetings, and how the committee came to a resolution for those concerns.

Eligibility Criteria:
Inclusion Criteria:

* all protocols submitted to IRB

Exclusion Criteria:

-
The GREEN Project Lunch Box Study

The central hypothesis of The GREEN Project Lunch Box Study is that a school-based communication campaign that combines healthy eating and eco-friendly messages will improve the quality of foods that children bring from home to school more than a healthy eating campaign alone and compared to a control/delayed intervention condition at the end of one school year.

The proposed intervention seeks to improve the quality of foods brought to school from home by taking advantage of a natural synergy between healthy eating and eco-friendly behaviors to increase motivation to adopt healthy eating behaviors. The project involves the design, implementation and evaluation of a novel, school based communications campaign to simultaneously improve the nutrition quality and eco-friendliness of foods that elementary school children bring from home to school.

The intervention is a theory-based multi-channel communications campaign based on qualitative research with the target population: children in grades three and four in public schools in Eastern Massachusetts and their caregivers. Schools were randomized to one of three conditions: (1) a campaign that includes healthy eating and eco-friendly messages; (2) a campaign that includes healthy eating messages only; and (3) a delayed healthy eating eco-friendly campaign after serving as a control group. Foods brought from home and the packaging associated with those foods will be assessed at baseline and at the end of the school year using a photographic technique.

The primary outcome of interest is change in the number of servings of fruits and vegetables. Secondary outcomes will include changes in the quantity of sugar-sweetened beverages; changes in processed, energy-dense foods; and changes in sugar sweetened beverages brought from home. We will also be able to assess changes in trash associated with foods brought from home.

Eligibility Criteria:
CHILD PARTICIPANTS

Inclusion Criteria:

* 3rd or 4th grade student in participating classroom
* Brings food from home to school at least 3 days per week

Exclusion Criteria:

* Not a 3rd or 4th grade student
* Not enrolled in a participating classroom
* Does not bring food from home to school at least three days per week

PARENT/CARETAKER PARTICIPANTS

Inclusion Criteria:

* Child is a 3rd or 4th grade student in participating classroom
* Child brings food from home to school at least 3 days per week

Exclusion Criteria:

* Child is not a 3rd or 4th grade student
* Child is not enrolled in a participating classroom
* Child does not bring food from home to school at least three days per week
Behavioral Trial Studying Programmed Training to Improve Advocacy Skills for Individuals With Traumatic Brain Injury

The Midwest Advocacy Project (MAP) is a community-based multiple-site randomized practical behavioral trial of advocacy skill training for individuals with traumatic brain injury (TBI), their families, and significant others. The purpose is to evaluate the efficacy of a 4-session advocacy training program to improve behavioral advocacy skills compared to self-directed advocacy training of the same session frequency. Groups will be randomly assigned to either a programmed group or a self-directed group in collaboration with the Brain Injury Associations of Minnesota, Iowa, and Wisconsin each year over the 5 year study period. The primary outcome is pre-post measures of written and verbal advocacy skill measured by the Advocacy Behavior Rating Scale.

It is hypothesized that subjects who receive programmed advocacy training will show greater positive change on pre-post measures of advocacy skill measures than subjects receiving self-directed training.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* moderate-severe TBI as indicated by one of the following:
* post traumatic amnesia (PTA) \> 24 hours
* or loss of consciousness \> 30 minutes
* or neuroimaging evidence of trauma-related intracranial abnormality
* Or the family/significant other of an individual with TBI meeting the above criteria
* 1 or more years post-injury
* Functional English speaker
* Signed consent to participate

Exclusion Criteria:

* Severe cognitive impairment as indicated by one or more of the following:
* Disorientation to person or year
* Unable to complete pre-program interview because of severe communication limitations
* Unable to remember important information given in the course of the pre-program interview, such as, time and place of program, number of sessions, and contact person
* Unable to complete the pre-program interview because of loss of emotional control, such as, extended tearfulness, sustained anger, verbal attack on interviewer
Retrospective Evaluation of the Percentage of Subjects Who Have Reached Their LDL-C Objectives After Treatment With INEGY (Study P05103)(COMPLETED)

The main objective of this study is to determine the percentage of patients who met the low-density lipoprotein cholesterol (LDL-C) objective with INEGY, that were not under statin monotherapy treatment.

The type of patient sampling used was consecutive patient sampling

Eligibility Criteria:
Inclusion Criteria:

* man or woman aged over 18;
* patient suffering from primary hypercholesterolemia;
* patient justifying treatment with INEGY® (2nd intention);
* patient currently treated with INEGY® for at least 4 weeks;
* patient with a lipid profile before treatment with INEGY®, documenting a level of LDL-C exceeding the therapeutic objective under treatment with a statin as monotherapy;
* patient with an evaluation of lipid disorder (EAL) treated with INEGY®, performed within 1 to 3 months of starting treatment.

Exclusion Criteria:

* patient not previously treated with a statin;
* patient previously treated with a combination of hypolipemics;
* patient treated with INEGY® as first intention;
* patient treated with INEGY® for less than 4 weeks;
* patient already included in this study.
Stress and Pain in People Living With HIV

This is a basic human experimental study utilizing 4 groups of individuals with and without HIV and complex morbidities of cannabis use disorder and major depression who will participate in 2 sessions of the Yale Pain Stress Task (YPST) and follow-up phase to assess drug use and mood symptoms.

This study aims to address research gaps using a powerful and novel cross-diagnostic approach with multiple complementary approaches to examine the overarching hypothesis that PLWH+CM exhibit impaired stress-related HPA and HPA-immune function due to alterations in epigenetic mechanisms, and these stress-related HPA-immune and related epigenetic aberrations predict distress, craving and substance use symptoms underlying PLWH complex morbidities. This hypothesis will be tested using a combined human experimental stress challenge approach with prospective longitudinal assessment of daily distress, and substance use symptoms as well as assessment of chronic stress (C-stress), social determinants of health (SDoH), and resilience in experimental cohorts of PLWH with and without CM and those without HIV with and without CM.

Eligibility Criteria:
Inclusion Criteria:

* good health as verified by screening examination
* Able to read English and complete study evaluations and provide informed written and verbal consent. Additional criteria PLWH
* HIV-1 lab test positive
* undetectable viral load
* good ART adherence

Additional criteria by group:

PLWH +CM:

* CB positive urine toxicology
* meet DSM-5 criteria for CUD and MDD as assessed using SCID-I. HC
* HIV-1 test negative
* urine toxicology negative
* no major medical and psychiatric diagnoses based on DSM-V.

PLWH Only:

* HIV-1 test positive
* urine toxicology negative
* no major medical and psychiatric diagnoses based on DSM-V.

CM Only:

* HIV-1 test negative
* urine toxicology positive
* meet DSM-5 criteria for CUD and MDD as assessed using SCID-I

Exclusion Criteria:

* meet primary, current moderate and severe criteria for other SUD including cocaine, alcohol, opiates, sedatives, nicotine
* current use or past history of cocaine or opioid use disorder
* history of any psychotic disorder
* current diagnoses of bipolar disorder and PTSD
* psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania)
* significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology that would interfere with study participation
* medications with known central effects on HPA axis and cytokines/immune function
* women who are pregnant, nursing or those using hormonal birth control that affect HPA axis cortisol responses.
Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases

Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases.

Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases. Investigators accept participants of hypertrophic scar, keloid and warts. For participants who are not candidates for traditional surgery, investigators will consider to accept carefully.

Eligibility Criteria:
Inclusion Criteria:

* Age over 16 years
* Diagnosed by 2 or more professional dermatologists
* Willing to underwent a new treatment modality
* Follow up is easy to conduct

Exclusion Criteria:

* Poor general condition
* Bleeding tendency
* Allergy to drug