cyrilzakka/clinical-trials huggingface dataset:
Postoperative Morphine Consumption After Caesarean Section- TAP Block vs Intracutaneous Infiltration

The purpose of this study is to investigate whether a regional-block (TAP block) in Caesarean section will give a measurable benefit in form of reducing Morphine consumption as compared to local infiltration of the wound with local anesthetic.

Caesarean section is one of the most common surgical procedures in the world and postoperative pain afflicts both mother and the newborn- especially the first 48 hours after birth.

Pain management at the investigators hospital is multimodal (balanced analgesia). Peroperatively the wound is infiltrated with local anaesthetic performed by the obstetrician at the end of the procedure. Postoperatively the patient gets routinely a combination of Paracetamol and NSAID's orally and Morphine intravenously as required. The side-effects of Morphine (nausea, vomiting, itching and sedation) do interfere, dose dependent, with the interaction between mother and child, breastfeeding and postpartum experience.

Previous studies have compared transversus abdominis plane block (TAP block) with reduction of morphine consumption in C-section (up to 50%! (1,2). So far no one has compared TAP-block with local infiltration in C-section patients.

Ultrasound guided TAP-block is done by an anaesthesiologist at the end of the operation, and it is viewed as a safe and easy procedure to perform. The investigators assumption is that the TAP-block reduces the morphine consumption with 50% as compared to local infiltration. Due to maximal dosage of Bupivacaine, it is not possible to give both types of anaesthesia at the same time.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women that are scheduled for elective C-section

Exclusion Criteria:

* relevant drug allergy
* history of drug abuse
Assessment of an Endotracheal Tube Securement Device

Endotracheal intubation is the translaryngeal placement of a tube into the trachea via the nose or mouth. Endotracheal tubes must be securely fixed to prevent movement, which may result in accidental slippage of the tube into a mainstream bronchus or into the pharynx. Hollister Incorporated is assessing the functionality and performance of an endotracheal tube securement device.

This was a multiple site assessment of the Anchor Fast with enhanced tube protection. Subjects already intubated who required a change of tube-securing device or subjects requiring intubation for greater than 24 hours who meet the inclusion and exclusion criteria were eligible to enroll into the study.The study was open to adult subjects without an existing neck injury who required oral tracheal intubation for greater than 24 hours. Subjects were required to have intact skin on the application site and to be free of facial hair, damaged skin or conditions on the application site (e.g. sunburn, scars, moles or other disfigurations), and significant skin diseases on the application site (e.g. psoriasis, eczema, atopic dermatitis, active cancer) which may have contraindicated participation.

Eligibility Criteria:
Inclusion Criteria:

* Is 18 years of age or older; male or female and requiring oral tracheal intubation.
* Has intact skin on application site.
* Willingly signs or their authorized representative willingly signs the Informed Consent.
* Is qualified to participate in the opinion of the Investigator.

Exclusion Criteria:

* Has an existing neck injury.
* Has protruding upper teeth, without teeth or is unable to wear upper dentures.
* Has facial hair.
* Has clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer.
* Has damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site.
* Has a known or stated allergy to adhesive bandages, or any of the product types being tested.
* Uses of topical drugs on the application site.
* Uses lotions, creams or oils on the application site.
* Currently is participating in any clinical testing which may affect performance of this device.
* Has been previously intubated with skin irritation or pressure sores surrounding the mouth.
Multiomic Analysis of Traumatic Brain Injury and Hypertension Intracranial Hemorrhage Lesion Tissue

The goal of this experimental observation study is to figure out differently expressed biomarkers in lesion tissues in traumatic brain injury or hypertension intracranial hemorrhage patients. The main questions it aims to answer is:

* Which RNA, protein and metabolites are differently expressed in lesion tissues?
* What molecular mechanism is participated in TBI or ICH? Participants will be treated by emergency operation, and their lesion tissues will be collected during the operation.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 and \<65
2. Within 12 hours after brain injury
3. GCS ≥3 and ≤8
4. Closed brain injury with frontotemporal contusion or basal ganglia intracranial hemorrhage
5. Need emergency intracranial hematoma evacuating operation
6. Patient's agents are informed and consent the research

Exclusion Criteria:

1. With TBI, stroke, ICH or intracranial tumor history
2. Death within 24 hours
3. Immunosuppression state
4. Severe organ dysfunction
5. Complicated infective disease
6. Pregnant
Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98

RATIONALE: Studying samples of fingernails in the laboratory from patients with breast cancer may help in evaluating bone health in postmenopausal women undergoing hormone therapy for breast cancer.

PURPOSE: This laboratory study is examining fingernails as a way of evaluating bone health in postmenopausal women with breast cancer undergoing hormone therapy on clinical trial IBCSG-1-98.

OBJECTIVES:

Primary

* Compare the effects of tamoxifen vs letrozole on the chemical properties of fingernails by Raman spectroscopy in postmenopausal women with breast cancer undergoing adjuvant hormonal therapy on protocol IBCSG-1-98.
* Determine the efficacy of nail structure for evaluating bone fragility.

Secondary

* Compare fingernail assessments in patients who have had a bone fracture vs those who have not.
* Determine the natural variation in chemical (Raman spectroscopy) properties of 2 fingernails sourced at 1 appointment from the same donor.
* Evaluate the effect of further drug treatment (after 6 months) on the chemical properties of fingernails.

OUTLINE: This is a single-blind, multicenter, pilot study. Patients are stratified according to treatment on protocol IBCSG-1-98 (tamoxifen vs letrozole) and bone fracture (yes vs no).

Fingernail clippings are collected at baseline and 6 months later. Fingernail clippings are examined by Raman spectroscopy.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Enrolled on protocol IBCSG-1-98

  * Currently receiving (i.e., have not yet completed) 5 years of treatment with tamoxifen or letrozole and expected to receive ≥ 6 months of additional treatment on protocol IBCSG-1-98
* No recurrent breast cancer or second primary cancer
* No known bone disease (including osteomalacia or osteogenesis imperfecta)
* Hormone receptor status

  * Estrogen and/or progesterone receptor positive tumor

PATIENT CHARACTERISTICS:

* Female
* Postmenopausal
* No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases
* No malabsorption syndrome or clinically relevant vitamin D deficiency

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 1 year since prior and no concurrent anticonvulsants
* More than 6 months since prior and no concurrent corticosteroids at doses \> the equivalent of 5 mg/day of prednisone for \> 2 weeks total
* No prior or concurrent sodium fluoride at daily doses ≥ 5 mg/day for \> 1 month
* More than 12 months since prior and no concurrent anabolic steroids
* More than 6 months since any prior drug for the prevention of osteoporosis (excluding calcium or cholecalciferol \[vitamin D\])
* Concurrent warfarin allowed provided duration of treatment is no more than 4 weeks
The Validation and Development of Termination-of-Resuscitation (TOR) Rules in OHCA Patients in Asia Countries

Objectives/Hypotheses

1. Prehospital termination-of-resuscitation (TOR) rules were developed in North American and European sites. Whether they remained valid in different geographic, ethnic, and cultural background areas is still under debate.
2. Differences in characteristics of out-of-hospital cardiac arrests (OHCAs) and configurations of emergency medical service (EMS) between the Western and Asian countries, including relatively lower rate of presenting shockable rhythm (i.e. ventricular fibrillation / ventricular tachycardia; VF/VT), lower rates of bystander CPR, less advanced life support (ALS) implementation, and less public access defibrillators, might create potential threats to the prediction accuracy of TOR rules.
3. We aim to conduct a study to validate the performance of ever published TOR rules in Asian OHCA population, including non-traumatic, traumatic, and pediatric OHCA patients. Furthermore, assess the possible variables that may impact the performance of TOR rules.
4. We also aim to develop new TOR rules based on PAROS registry for Asia population, focusing on non-traumatic, traumatic, and pediatric OHCA patients, respectively.


Eligibility Criteria:
Inclusion Criteria:

* out of hospital cardiac arrest (OHCA) patients

Exclusion Criteria:

* age \<18 years
* non-EMS transport to the emergency department
* obvious signs of death (e.g. decapitation, rigor mortis, lividity, and decapitation) or having do-not-resuscitate (DNR) orders
* missing data despite meeting the inclusion criteria.
Acute Uncomplicated Diverticulitis and Conservative Treatment: Accuracy of Inflammatory Indexes for Failure Prediction: Observational Prospective Cohort Study. (AUDRIP Trial)

This is an observational multicenter study that will analyse the accuracy of inflammatory indexes as neutrophil-lymphocyte ratio and platelet-lymphocyte ratio, to predict the failure of conservative treatment of patients diagnosed of acute uncomplicated diverticulitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18, diagnosed of acute uncomplicated diverticulitis.
* Diagnosis made by CT or ultrasound

Exclusion Criteria:

* Patients younger than 18.
* Patients diagnosed of acute complicated diverticulitis
Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase

The purpose of this study is to evaluate the efficacy of a video shown using an iPad, compared to a standard treatment, to reduce preoperative anxiety in children who have to undergo to elective surgery procedure


Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 11
* No cerebral impairment or cognitive impairment
* Child and his/her family native speaker of Italian
* admission to the hospital at list one day before the sugery procedure
* presence of written consent of the parents to the study

Exclusion Criteria:

* age lower than 6 or upper than 11
* presence of cerebral impairment or cognitive impairment
* Child and his/her family are not native speaker of Italian
* absence of written consent of the parents to the study
COVID 19-Caregivers IGg Seroconversion

According to recent publications, the percentage of caregivers infected with COVID 19 is evaluated between 10 and 30% . This great variability is due, on the one hand to the intensity of the influx of covid plus patients and, on the other hand, to the disparity in the preparation of caregivers in the face of this emergency. Indeed, we can understand that the strict application of hygiene rules can be faulted in the face of the volume of patients, the lack of protective equipment and the lack of specific training for caregivers in this area. As a result, within healthcare teams, there are many questions that generate anxiety: will I be able to provide care properly while protecting myself from the risk of contamination? This anxiety is also present and sometimes manifests itself aggressively in the entourage or in the vicinity of caregivers, due to lack of scientific data adapted to the local ecology of the crisis.

Thus, the aim of this study is to show that the risk for caregivers of being contaminated by COVID in an area dedicated to COVID positive patients is no higher than being a caregiver in a non-COVID area that he either in the adult or pediatric sector.


Eligibility Criteria:
Inclusion Criteria:

* caregivers staff assigned to a non-intensive care COVID service
* or caregivers staff assigned to a non-COVID adult service
* or caregivers staff assigned to a non-COVID pediatric service
* Age \> = 18 years old
* With health insurance
* Express consent

Exclusion Criteria:

* Protected persons
* Refusal to participate
Collaborative Urological Prosthetics Investigation Directive Research Group

The purpose of this study is to determine if an additional 6 days of oral antibiotics decreases the risk of penile prosthesis infection after implantation.

Erectile dysfunction is a common problem and the incidence increases with age. Penile prosthesis placement for medication refractory erectile dysfunction is well established with high success rates. However, infection remains a dreaded complication with significant patient morbidity requiring device explant. Device innovations such as antibiotic coating and adaptations in technique have led to device infection rate reduction to \~1-3% in the hands of high volume implanters in modern series. The study team will perform a non-inferiority trial of post-operative antibiotic prophylaxis for IPP procedures with InhibiZonetm coated AMS 700 devices to confirm the hypothesis that a prolonged postoperative antibiotic regimen does not influence infection-related outcomes in de-novo IPP placement. The study team will determine potential risk factors for prosthetic infections and which patients would benefit from an extended post-operative oral antibiotic course of 6 days along with other objectives.

Eligibility Criteria:
Inclusion Criteria:

1. Males aged 35 to 90 yo with no racial or ethnic restrictions and a diagnosis of erectile dysfunction.
2. Males clinically indicated for de-novo InhibiZonetm coated AMS 700 devices IPP placement procedure per local clinical guidelines who have elected to pursue penile prosthesis as an ED treatment.

Exclusion Criteria:

1. Patients with indwelling foreign body in the urinary tract \> 24 hours prior to the procedure (i.e. foley catheter). Patients using clean intermittent catheterization will not be excluded.
2. Prior history of or current symptomatic urethral stricture.
3. History of cystitis caused by Tuberculosis.
4. Active Cytoxan/cyclophosphamide therapy or immunosuppressive systemic chemotherapy.
5. Prior augmentation cystoplasty or cystectomy.
6. Systemic neuromuscular disease known to affect the lower urinary tract such as Spinal Cord Injury, Multiple Sclerosis or other condition leading to neurogenic bladder.
7. Antibiotic use within the past 1 week or need for antibiotic management immediately prior to the study.
8. Cases where patients have had a prior penile prosthesis.
9. Any protected population (i.e. Prisoners)
A Trial of Observed Long-acting, Anti-HIV Treatment With a Monoclonal CCR5 Antibody (PRO 140) as an Adjunct to a New, Optimized, Oral Antiretroviral Regimen in HIV-infected Injection Drug Users With Viral Rebound and Documented Poor Adherence

PRO 140 2102 is a phase 2b, national, multicenter, randomized, double-blind, placebo-controlled study in order to evaluate the safety and efficacy of PRO 140 (anti-CCR5 monoclonal antibody) administered subcutaneously as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen.


Eligibility Criteria:
Key Inclusion Criteria:

1. Only R5 virus
2. HIV-1 RNA \> 1,000 copies/mL but \< 100,000 copies/mL
3. CD4+ lymphocyte counts \> 100 cells/μL
4. Non-prescription recreational drug use within the previous 6 months

Key Exclusion Criteria:

1. Females who are pregnant (positive blood test), lactating, or breastfeeding, or who plan to become pregnant during the study
2. Prior use of any CCR5 entry inhibitors
3. History of any acquired immune deficiency syndrome (AIDS)-defining illness
A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis.

A Trial to Investigate the Pharmacokinetics (PK) Effects and Safety Profile of K-808 (Pemafibrate) in Primary Biliary Cholangitis (PBC) Subjects with and without Cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a PBC diagnosis as demonstrated by the presence of ≥2 of the following three diagnostic criteria (Lindor et al, 2019; Hirschfield et al, 2017):

  1. History of ALP above ULN for at least 6 months
  2. History of positive antimitochondrial antibody (AMA) titer or positive PBC-specific antinuclear antibody (ANA) titers
  3. Historical liver biopsy consistent with PBC
* Has PBC with cirrhosis Child-Pugh grade A (well-compensated disease; score 5 to 6) at Screening. Group 2 (PBC w/ CIRR CP-A) only
* Male or female participant is ≥18 years of age at consent.
* Able to understand and comply with study requirements and procedures and provide written informed consent.
* Meet all other inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

* Female subject of childbearing potential who is known to be pregnant, has a positive pregnancy test (serum test, or urine test that is confirmed by a positive serum pregnancy test), or is lactating and breastfeeding, or planning to become pregnant or breastfeed during the study.
* Subject has had ongoing conditions that may affect drug absorption such as gastroparesis, intestinal obstruction, severe gastritis, severe gastric reflux syndrome, conditions causing frequent vomiting and/or diarrhea.
* Subject who has participated in another investigational drug, biologic, or medical device study within five half-lives of the agent (or within 8 weeks when half-life is unknown) prior to the first dose of study drug, or prior participation in an investigational antibody drug study within 6 months prior to the first dose of study drug. Participation in noninterventional studies (eg, observational studies, registries) is allowed.
* Meet any other exclusion criteria outlined in the clinical study protocol.
Family-Clinician Collaboration to Improve Neglect and Rehabilitation Outcome After Stroke

Spatial neglect may occur in patients who have had a stroke. People with spatial neglect often pay much more attention to one side of the body while ignoring the other side, even though they have no difficulty seeing. The purpose of this study is to evaluate the impact on stroke recovery, including spatial neglect, of the Family-Clinician Collaboration program, where a family member of a stroke survivor actively interacts with clinical staff members providing inpatient rehabilitation services to the stroke survivor.

Spatial neglect (SN) frequently occurs in patients who have had a stroke. The problems caused by SN result in patients failing to attend to the space contralateral to the side of the stroke. This failure to attend to half of the patient's field may result in problems with perception, memory, action planning and navigation. These deficits hurt both the patients and their caregivers, and make it difficult for them to resume daily activities as they were before the stroke. More than half of the patients who had SN at admission still had it when discharged from an inpatient rehabilitation facility.

This study examines a new behavioral treatment, where the clinician and the caregiver work together to provide better treatment. The family members will engage in frequent meetings with clinicians, set goals, learn about SN and coping strategies and have the patient to perform easy, safe treatment exercises. The study will compare this Family-Clinician Collaboration with the inpatient treatment control. This study will compare the groups in measures of spatial neglect and independence in the patients and measures of caretaker burden and mental health in family members. Participants will also report on their overall opinions of the new treatment condition.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral right brain stroke
* Functionally independent before stroke
* Presence of spatial neglect (moderate to severe, will be confirmed during the screening session)
* Ability to follow instructions and understand verbal or written English
* Currently living with a family member who will be enrolled into the study as well

Exclusion Criteria:

* History of progressive neurological disorder
* History of a significant psychiatric disorder
* Living outside of 50-mile radius of Kessler Foundation (West Orange, NJ)
Local and Peripheral Immune Responsive Landscape Induced by Local Cryoablation in Patients With Lung Adenocarcinoma

The goal of this observational study is to learn about local and peripheral immune and metabolic changes in patients with lung adenocarcinoma undergoing cryoablation. The main question it aims to answer are:

* local and peripheral immune changes in patients with lung adenocarcinoma undergoing cryoablation.
* local and peripheral metabolic changes in patients with lung adenocarcinoma undergoing cryoablation.

Peripheral blood, biopsy tissues of patients will be collected at the baseline and after cryoablation. Single-cell sequencing, single-cell immune bank, metabolomics and spatial metabolomics will be used to explore the local and peripheral immune changes and metabolites changes in patients with lung adenocarcinoma before and after cryoablation.


Eligibility Criteria:
Inclusion Criteria:

1. Primary or metastatic lung cancer with definite pathological diagnosis.
2. Patients are not suitable for thoracotomy due to serious lung or systemic disease.
3. Peripheral lung cancer involves pleura and chest wall, which cannot be completely removed by surgical resection.
4. There are indications for surgical resection, but the patient refuses surgery.
5. Single tumor, maximum diameter ≤5cm; Or the number of tumors ≤3, the maximum diameter ≤3cm.
6. ECOG-PS score≤2.
7. Patients with an expected survival of more than three months.
8. Patients have not participated in other clinical validation within 3 months.
9. Subjects voluntarily sign informed consent.

Exclusion Criteria:

1. Serious heart and brain disease or other mental illness.
2. Severe pulmonary fibrosis, especially drug-induced pulmonary fibrosis.
3. Patients with previous severe pulmonary dysfunction, pulmonary ventilation disorder, and multiple pulmonary bulla.
4. A history of immunodeficiency, including a positive HIV test (enzyme-linked immunoassay and Western spot assay).
5. Patients treated with chemotherapy, radiotherapy, interventional therapy, ablative therapy or surgery within 30 days before surgical treatment.
6. There is a serious bleeding tendency, platelets less than 50×109 /L and coagulation function is seriously disturbed.
7. Coagulation index (PT, TT, APTT) \> 2.5 times the upper limit of normal.
8. Ablation of ipsilateral malignant pleural effusion is not well controlled.
9. Poor general condition, multiple organ failure, cachexia, severe anemia and nutritional metabolism disorders.
10. Patients with extensive extrapulmonary metastasis are not suitable for ablative therapy.
11. People who regularly use sedatives, sleeping pills, tranquilizers or other addictive drugs.
12. Pregnant or breastfeeding women.
13. Patients who cannot evaluate the efficacy.
14. Other conditions determined by the investigators to be unsuitable for inclusion, such as inability to tolerate cryoablation surgery, difficulty in follow-up, and other serious diseases.