cyrilzakka/clinical-trials huggingface dataset:
Digestive ENdoscopy afTeR Out-of-hospitAl Cardiac arresT

Post-cardiac arrest ischemia/reperfusion phenomenon led to organs injury and failure. Among the different organs, gastro-intestinal tract injury could contribute to post-cardiac arrest shock.

The ischemic injury of the gastro-intestinal (GI) tractus is suggested by abnormalities in digestive biomarkers and by the frequent endotoxemia after CA. However, direct mucosal damage has not been clearly demonstrated after OHCA. The real incidence of ischemic lesions of GI tract and their potential involvement in the post-CA shock is therefore unknown.

We propose an original clinical research program aimed at rigorously determining the incidence of upper GI lesions after OHCA and analyzing their contribution to the severity of post-CA shock through a prospective, interventional, multicentric study

The screening of the patients will be performed 2 to 4 days after their Intensive Care Unit (ICU) admission. Procedure and exams at the day of inclusion (day 0):

* collection of digestive symptoms
* carrying out the œsophago-gastro-duodenoscopy and establishment of a formal report with the eventual lesions and their ischemic nature.
* in the absence of contra-indication and upon final decision of the gastroscopist, systematic biopsies of fundic, antral and duodenal mucosa; contra-indication of biopsies are the presence of a vascular or haemorrhagic lesion and the coagulation disorders.
* Blood sample for H. pylori serology, and serum freezing. Urinary sample for urine freezing

Procedure and exams from day 1 to hospital discharge:

* Daily collection of digestive symptoms and needs for vasopressor support
* Sepsis-related Organ Failure Assessment (SOFA) score at day 2 \& 5
* Cerebral Performance Category (CPC) score determination at hospital discharge In case of digestive symptoms after day 0 and in accordance with good clinical practice, a second gastroscopy and/or an abdominal Computed Tomography scan(CT-scan) and/or a colonoscopy will be performed at the physician's discretion.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient hospitalized for less than 5 days in a participating Intensive Unit Care following successfully resuscitated out-of-hospital cardiac arrest
* Patient still mechanically ventilated
* Hypothermia period over, corporal temperature \> 36°C.
* Written consent from a next of kin

Exclusion Criteria:

* In-hospital cardiac arrest
* Patients extubated before gastroscopy
* Contra-indication of gastroscopy: suspicion of digestive perforation, severe bleeding diathesis despite coagulation products transfusion, or suspicion of Creutzfeldt-jacob disease
* Patients with cardiac valvular prosthesis or previous endocarditis
* Pregnancy, lactating women In case of severe coagulation disorders (platelet count \< 30 G/L, International Normalized Ratio (INR) \> 2) or heparin treatment or combined platelet inhibition treatment, the inclusion of the patient will be possible but digestive biopsies will not be allowed.
Effectiveness of Short-Foot Exercises in Water and on Land in Pes Planus

Pes planus is caused by the elongation of the intrinsic muscles in the medial arch of the foot, causing the arch to approach the ground or the sole of the foot to touch the ground completely.

For this purpose, in this project, the effectiveness of short foot exercises in water and on land will be compared in young adults with pes planus.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-25
* Having bilateral pes planus
* People with a score of 6 and above on the Foot Posture Index Score
* Individuals with more than 10 millimeters of pronation according to the navicular drop test were included.

Exclusion Criteria:

* Rigid pes planus, hallux valgus, hallux rigidus, epin calcanei
* Lower extremity surgery
* Neurological or orthopedic problems and history of disease
* Regular exercise for the treatment of pes planus in the last three months
Nipple Areola Complex Conservation

96 patients were offered a nipple sparing mastectomy.

96 patients were operated on 109 breasts between Jul 2003 and May 2006 because of breast cancer, recurrence was observed.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer

Exclusion Criteria:

* inflammatory breast cancer
* clinical skin or nipple involvement
Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery

To evaluate the effectiveness and safety of hypothermia risk prediction combined with active warming management to reduce intraoperative hypothermia in elderly patients undergoing elective general anesthesia, improve the quality of anesthesia management, and enhance patients' awareness of the work of anesthesiologists.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60 years, male or female.
2. Elective general anesthesia for surgery.
3. Operative time ≥ 30 min.
4. Preoperative body temperature within the normal range.
5. Normal preoperative bleeding and clotting time.

Exclusion Criteria:

1. Mental illness.
2. High or low basal hypothermia with high or low metabolic disease (patients with central hyperthermia include those with cerebrovascular vascular disease, traumatic brain injury and brain surgery, epilepsy, central hyperthermia due to acute hydrocephalus; thermoregulatory abnormalities including malignant hyperthermia (MHS), neuroleptic malignant syndrome and those with definite evidence of diagnosed hypo- or hyperthyroidism and current abnormal thyroid function).
3. Impaired skin insulation barriers such as large skin burns.
4. Infectious fever.
5. Other causes of body temperature above 38.5 °C three days before surgery.
6. Other persons deemed unsuitable by the investigator to participate in the clinical trial.
7. Refusal to sign the informed consent form.
Galactagogue Use in Lactating Women with Low Milk Supply

This study aims to determine whether a 20-day supplement with either Oat Mama Lactation Supplement, moringa, or shatavari has any impact on milk production through an increase in serum prolactin levels when compared to the placebo group. This data will be used to determine if clinical recommendations can be made for the use of the studied supplements in increasing milk supply.

This study will be a double-blind randomized control trial where eligible participants will be randomized into one of four treatment groups: Oat Mama Lactation Supplement (O), moringa supplement (M), shatavari supplement (S), or control (C). All participants will receive a supplement or placebo for consumption throughout the 20-day trial period, and all participants will receive support from a lactation consultant once per week to receive appropriate guidance for increasing milk supply. 24-hour milk output will be recorded on day 1, 10, and 20 using either pre- and post-feeding weights, 24-hour pump output, or a combination of both. Additionally, blood samples will be taken on day 1, 10, and 20 and serum will be isolated for later analysis of serum prolactin levels.

Eligibility Criteria:
Inclusion Criteria: Participants in the study must:

* Be struggling with diagnosed or perceived low milk supply
* Be willing to consume a randomly assigned galactagogue or placebo supplement
* Be willing to provide a blood sample at each lactation consult (day 1, 10, 20)
* Be willing to provide 24-hour expressed milk volume either using pre- and post-feed weights, total pump output, or a combination of both on day 1, 10, and 20

Exclusion Criteria: Participants will be excluded if:

* They have a history of breast reduction
* They have a history of utilizing in vitro fertilization
* They are not a biological female with mammary glands present for producing milk
* They have consumed galactagogues with the intention of increasing their milk supply during the current lactation cycle
* They are under age 18 or above age 39
Trigger Point Therapy in Cervicogenic Headache

It is a pilot randomized controlled trial comparing real and simulated manual treatment of trigger points (TrPs) in patients with cervicogenic headache (CeH). The purpose of the current randomized clinical pilot trial was to determine the preliminary effects of TrP manual therapy in individuals with CeH with sternocleidomastoid muscle active TrPs as compared to manual contact over the muscle tissues.

CeH pain has been mostly related to joint, disk and ligament pain from the upper cervical spine; however, clinicians should consider that the upper cervical spine also receives afferent inputs from muscles. In fact, the role of referred pain to the head elicited by muscle TrPs has received particular interest in recent years. No study has investigated the effectiveness of TrP manual therapy in patients with CeH exhibiting active TrPs. Investigators hypothesized that patients receiving a real TrP treatment will exhibit a greater reduction in pain, sensitivity, cervical range of motion and neck endurance than those receiving a manual control non-therapeutic intervention.

Eligibility Criteria:
Inclusion Criteria:

* unilateral pain starting in the neck and radiating to the frontal-temporal region
* pain aggravated by neck movement
* restricted cervical range of motion
* joint tenderness in at least one of the joints of the upper cervical spine (C1-C3)
* headache frequency of at least one per week over a period greater than 3 months
* active TrPs in the sternocleidomastoid muscle

Exclusion Criteria:

* other primary headaches (i.e., migraine, tension type-headache)
* bilateral headaches
* had received treatment for neck or head pain in the previous year
* presented any contraindications to manual therapy
* had pending legal action regarding their neck and head pain.
Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain

The study carry out is to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in post-operative pain management.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of inguinal hernia
* Patient undergo operation under daycare basis
* ASA I-II
* Written consent

Exclusion Criteria:

* ASA \> II
* Allergic reaction against gabapentin and/or pregabalin
* History of recurrent hernia repair.
* Patient who has taken analgesia prior to the surgery
* Liver failure
* Renal failure
* Pregnancy
Does Hirschsprung Disease Increase the Risk of Febrile Urinary Tract Infection in Children

Febrile urinary tract infection (FUTIs) are the most common bacterial infections in children under the age of 2 years. They represent 7% of children presenting with fever without a source. In case of recurrent or undertreated FUTIs there is a risk for kidney function with the threat of chronic renal failure \[7\]. They are more often isolated but some FUTIs may reveal an underlying and facilitating condition. Beside the well-known congenital anomalies of the kidneys and urinary tract such as reflux or obstructions, others risk factors for FUTI are reported. Age less than 1 year, uncircumcised males, poor fluid intake, bladder bowel dysfunction (BBD) including dysfunctional voiding pattern and constipation increase the risk of FUTI. The prevalence of BBD in children with FUTIs is far higher than in the general population. Recommendations emphasize on an efficient treatment of BBD in the first-line management of recurring FUTIs and it has been proven to be efficient (ref).

One of the BBD may include Hirschsprung's Disease (HD). HD is the first congenital malformation of the enteric nervous system with a reported prevalence of 1 in 5000 live birth. It's characterized by an aganglionosis and subsequent dysmotility affect by always the anal canal, most commonly there is a rectosigmoid form (74-80%), and less commonly involves a long segment of colon (12-22%) or a total colonic aganglionosis with ileal involvement upto 50 cm proximal to ileocecal junction (4-13%). The treatment is based on the resection of dysfunctional segment of colon with an anastomosis between the normally innervated bowel to the anus, while preserving normal sphincter function. But significant bowel dysfunction may persist postoperatively. 20% of the children present a fecal incontinence, and 14% a constipation in long-term studies. Bladder dysfunction and associated urological anomalies are also reported in these patients. All of that may facilitate the occurrence of febrile urinary tract infections (FUTI) in patients with HD. Unfortunately, few studies focused on this specific population.

The objective of this study was to find out whether children with HD are more prone to develop FUTIs than controls and which patient with HD are more at risk to develop UTIs.


Eligibility Criteria:
Inclusion criteria:

Patients :

- surgical treatment of an HD confirmed on histopathologic exam.

Controls :

- appendicetomy for acute appendicitis without history of HD, ano rectal malformation or any other colic disease

Exclusion criteria:

* patients with HD but not yet operated
* patient with a stoma at the time of the study
* patient with chronic intestinal pseudo obstruction without HD
3D Printed Mask Adapter Designed From Facial 3D Scans for Fit Testing.

Healthcare workers PPE (personal protective equipment) when interacting with patients either infected or, potentially carrying SARS-CoV-2. One of the major routes of transmission is via droplet spread through oral and nasal mucosa therefore respiratory protective equipment (RPE) is an important part of PPE. There are concerns in dentistry that droplet spread can be increased during aerosol-generating procedures (AGP). This poses an increased risk to dentists and allied professionals in a clinical setting.

Fit testing is needed to ensure a mask forms a facial seal around the mouth and nose. Using a respirator mask without fit testing can reduce its effectiveness from between 6-88% with an optimal facial seal being more critical than the filtering performance. Commercial respirator masks are mass-produced for ' standard' faces, and often fail to provide a good fit for users thereby compromising the intended respirator filtering capability.

Given the high level of fit test failures, without the provision of improved fits of masks, patient care will be highly curtailed for frontline staff at risk of SARS-CoV-2. Therefore, a reusable bespoke 3D printed mask adapter used with a soft FFP3 disposable mask provides an economical solution to address the passing of fit testing.

Barts Health NHS Trust staff members who have previously failed the fit test to the first line FFP3 disposable respirator will be invited to enrol in this study.

Barts/QMUL scan App will be used to capture the facial scan of the subjects using a research allocated smartphone. Participants will be asked to be clean-shaven without any facial jewellery which could hinder the scan data. The App automatically generates a customized 3D print file (.stl) which will be sent for 3D printing.

The mask adapter will be fitted over the first-line FFP3 respirator once it is properly worn and checked as per the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who would have previously failed the quantitative fit test on the Trust's first line FFP3 disposable respirator.
* Subjects willing to use a flexible, disposable FFP3 mask.
* Subjects should be a minimum of 18 years old.

Exclusion Criteria:

* Subjects unwilling or unable to give written consent.
* Subjects who cannot remove their facial hair for religious or other reasons.
The CurePSP Genetics Program

This study is an observational, prospective genetic study. It aims to obtain DNA for research and testing from patients with PSP, CBS, MSA, and related neurological conditions and their families.

Up to 1,000 adults who have been clinically diagnosed with PSP, CBS, MSA, or related neurological conditions will be enrolled. The study intervention involves sequencing of participant blood samples using non-CLIA-approved whole genome sequencing at the National Institutes of Health. Pathogenic variants that are deemed possibly related to these conditions will be confirmed using CLIA-approved testing. The study involves minimal risk to participants.

Genetic research is important for basic, translational, and clinical researchers, and are particularly important for rare disease investigations. Understanding a patient's genetic background may also facilitate participant recruitment for targeted genetic therapeutic trials and has the potential to empower participants with PSP, CBS, MSA, or related neurological diseases and clinicians to make more informed decisions about their clinical care plan. Furthermore, genetic research augments the clinical counseling process by offering participants and their families a clearer understanding of disease risk in relatives. Overall, this study may help to refine current diagnostic criteria for PSP, CBS, MSA, and related neurological conditions, inform genetic counseling, fuel future research studies, and provide insights into potential therapeutic paradigms.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (aged 35 or older) with a clinical diagnosis of PSP, CBS, MSA, or a related neurological disease as confirmed by their healthcare provider, or unaffected family members of participants who have reported a family history of relevant neurodegenerative conditions.
2. Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Possible or Probable PSP (32), clinically established or clinically probable MSA (33), Armstrong criteria (2013) for possible or probable CBS (34). Diagnostic certainty will be determined by the treating/referring clinician.
3. Willingness to undergo genetic testing. Participants will have the option to receive relevant genetic test results.
4. Have the capacity to give full informed consent in writing or electronically, or provide consent through a legally authorized representative (LAR)/power of attorney (POA), and have read, understood, and completed the informed consent form.
5. Are able to perform or have a designee who can perform study activities (including completion of either online or orally administered surveys).

Exclusion Criteria:

1. Individuals who have received a blood transfusion within the past 3 months.
2. Individuals who have active hematologic malignancies such as lymphoma or leukemia.
3. Individuals who have had a bone marrow transplant within the past 5 years.
4. Individuals under the age of 35 or age of majority in applicable states at the time of consenting.
Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates

The primary purpose of this study is to test different methods by which kidney transplant centers can educate potential transplant candidates about living donor kidney transplant (LDKT).

The most effective ways to educate kidney transplant candidates about LDKT remain unclear. The goal is to determine, among a diverse cohort of potential kidney transplant candidates, whether a transplant center-based intervention will increase understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT. The investigators hypothesize that kidney transplant candidates' understanding of living kidney donation and LDKT will be increased by interventions implemented at the transplant center on the day of transplant evaluation.

The investigators propose a single-center, 2-arm, cluster-randomized, controlled trial to compare the effects of two educational strategies upon transplant candidates' understanding of living kidney donation and LDKT:

1. Usual transplant education implemented by the transplant center, on the day of the transplant evaluation (standard care); and
2. Intensive initial transplant education implemented on the day of the transplant evaluation.

Intensive initial transplant education will utilize videos of living donors' experiences as well as a session with a trained Transplant Educator, who will focus upon living donation education. One week after the transplant evaluation day and 3 months later, the investigators will assess transplant candidates' knowledge of LDKT (using questionnaires), identify correlates of increased understanding of LDKT, and assess racial/ethnic differences in the understanding of LDKT.


Eligibility Criteria:
Inclusion Criteria:

* Appear for initial kidney transplant evaluation at Saint Barnabas Medical Center
* 18 years of age or older
* Able to provide informed consent
* Able to speak, hear, and understand English

Exclusion Criteria:
Correlation Between EPB Entrapment Test and Ultrasound Wrist Findings in Patients With deQuervain's Disease

The goal of this observational study is to learn about the correlation between EPB entrapment test and ultrasound wrist findings in patients with deQuervain's disease The main questions it aims to answer are:

* if correlation exist between EPB entrapment test and ultrasound wrist findings in patients with deQuervain's disease ?
* if the the correlation aid in deciding management of patients with deQuervain's disease Participants will be subjected to
* EPB entrapment test
* ultrasound examination of wrist


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Radial side wrist pain
* Finkelstein test positive
* Failure of non surgical treatment

Exclusion Criteria:

• Patients who underwent Previous surgical release
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.

This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count \<250 cells/mm3 and an HIV RNA viral load \<400 copies/mL. Eligible patients will be randomized to receive Fuzeon 90mg bid sc in addition to their current antiretroviral therapy, or to continue their current antiretroviral therapy alone. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* documented chronic HIV infection;
* currently receiving a stable antiretroviral regimen;
* CD4 cell count \<250 cells/mm3;
* HIV RNA viral load \<400 copies/mL for \>12 months.

Exclusion Criteria:

* prior exposure to Fuzeon;
* prior non-adherence to antiretroviral treatment regimens;
* active opportunistic infection;
* currently taking, or anticipated to take during the study, any immunomodulator.
Effects of Tracheal Intubation on Ventilation With a Laryngeal Mask During Percutaneous Dilatation Tracheostomy

The length of tracheal intubation may affect the subsequent ventilation with a laryngeal mask during percutaneous tracheostomy.

Percutaneous tracheostomy is routinely performed while patients are being ventilated with a laryngeal mask. The efficacy of ventilation during tracheostomy may be affected by length of previous endotracheal intubation.

This is an observational and monocentric study aimed to evaluate the impact of length of endotracheal intubation on efficacy of lung ventilation with a laryngeal mask. Two groups of patients who have to undergo elective percutaneous tracheostomy after either a short or long endotracheal intubation will be enrolled.

Data on the correlational effects of the endotracheal tube on the integrity of laryngeal structures and on ventilation will be collected.

Statistical analyses will use standard tests to compare the two groups of patients.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years
* mechanical ventilation
* need of percutaneous tracheostomy

Exclusion Criteria:

* previous pathologies of upper airways or of oesophagus
* risk of bleeding
* need of FiO2 \>70% and/or of PEEP \>10 cm H2O
* difficult insertion of laryngeal mask
* impossibility of endoscopic visualization of the laryngeal structures