cyrilzakka/clinical-trials huggingface dataset:
Comparison Study of Cefazolin Versus Cefazolin Plus Azithromycin Prophylaxis in Post-Cesarean Endometritis

Despite the generalized use of preoperative antibiotic prophylaxis, endometritis remains as the most frequent post-cesarean delivery complication. This increased morbidity translates into extended post-partum antibiotic use and prolongation of hospital stay with the subsequent increase in health care expenses. The current regimen recommended by the American College of Obstetricians and Gynecologists for cesarean delivery prophylaxis (1st generation cephalosporins) does not cover for Ureaplasma Urealyticum, a microorganism that has been associated with an increased risk of endometritis in post-cesarean section patients. Azithromycin, an antibiotic that has both aerobic and some anaerobic coverage, uniquely covers Ureaplasma and would be an excellent second antibiotic for cesarean section chemoprophylaxis. Our hypothesis is that the addition of azithromycin to standard chemoprophylaxis with cefazolin can effect a 25% reduction of post-cesarean section endometritis.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients between 37 and 42 weeks gestational weeks.
* Pregnant patients undergoing indicated cesarean section at Truman Medical Center Hospital July 2012 and July 2014.
* Pregnant patient that received prenatal care at Truman Medical Center. Hospital Hill, Samuel Rogers or Swope Parkway health centers at least 1 month prior to the Cesarean delivery.
* Signed informed consent.

Exclusion Criteria:

* Allergy to cephalosporins or azithromycin.
* Refusal to sign consent form.
* Clinical signs of chorioamnionitis: fever 100.4 F or higher, uterine tenderness, maternal or fetal tachycardia.
* Immunocompromised condition: HIV positive with CD4 count below 200, chronic steroid use, pregestational diabetes, cancer, chemotherapy.
* Need for emergent cesarean precluding consent or availability of study medication.
* Need for hysterectomy at cesarean section.
* Use of antibiotic in the 72 hours prior to admission.
Spinal Cord Injury Leg Rehabilitation

The purpose of this study is to determine if individuals with incomplete spinal cord injury (SCI) who remain unable to walk normally 1 year after their SCIs are able to sense and move the affected legs better after 10-13 weeks of treatment with a new robotic therapy device.

The hypothesis is that using the AMES device on the legs of chronic subjects with incomplete SCI will result in improved strength, sensation in the legs, and improved functional gait in the treated limbs.

Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual.

In this study 10 subjects, more than 1 year post injury, will be enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in the rehabilitation of the legs of participants with incomplete SCI.

Eligibility Criteria:
Inclusion Criteria:

* Paraplegia or tetraplegia due to SCI
* At least 1 year post incomplete Spinal Cord Injury
* Can tolerate sitting upright for at least one hour
* Capable of weight-bearing and taking a step with or without an assistive device
* On the ASIA sensory function (light touch), a score of at least 1 at the L4 and L5 level
* Primary ASIA Motor Criterion (PAMC) a total score of 4-12 for hip extensors, knee extensors, ankle dorsiflexors and ankle plantarflexors, with a minimum score of 1 for each of these muscles in the qualifying leg

Exclusion Criteria:

* Fracture of the treated limb resulting in loss of range of motion
* Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study), or other neurological injury or disease
* DVT of the treated extremity
* Peripheral nerve injury of the treated extremity
* Osteo- or rheumatoid-arthritis limiting range of motion
* Contractures equal to or greater than 50% of the normal ROM
* Skin condition not tolerant of device or sitting upright
* Progressive neurodegenerative disorder
* Botox treatment of the treated extremity in the prior 5 month
* Chronic ITB therapy
* Uncontrolled seizure disorder
* Uncontrolled high blood pressure/angina
* Pain in affected limb or exercise intolerance
* Participation in another therapy or activity-based program
* Combined score on ASIA motor function for knee extensors, ankle dorsiflexors and ankle plantarflexors outside the range of 3-9
Permeaderm Versus Homograft for Full-thickness Burns

Frozen Human Cadaver Allograft (FHCA) is, nowadays, the gold standard for temporary coverage of excised full-thickness burns, but is also very expensive and requires additional personnel and major storage spaces in comparison to other products. The purpose of this study is to determine the extent to which PermeaDerm® dressing promotes wound bed maturation when used as a temporary dressing for excised full-thickness burn wounds. Efficacy and safety in promoting wound bed maturation for successive autografting will be determined through direct comparison to FHCA.

In this prospective, randomized, matched design pilot study, we aim to compare the current standard of care FHCA to PermeaDerm®.

30 patients for each study arm (n total = 60) meeting the inclusion criteria will be enrolled to randomly receive FHCA and PermeaDerm® on two adjacent or symmetric body areas.

Prior to randomization of study areas and application of study dressings, baseline assessments of wound size and burn depth will be performed by the experienced physician and documented using photography and when indicated laser Doppler (Moor Laser Speckle®, Moor Instruments, Devon, UK) measurements. Percentage of graft take and wound healing after removal of the temporary wound dressings and secondary autografting (study arm 1) or after excision and direct autografting with wiedely-meshed autograft and temporary wound dressings as overlay (study arm 2) will be assessed.

Secondary outcomes will include complications such as infections, signs of rejection/non-adherence, fluid accumulation/hematoma beneath dressings and mid- and long-term clinical scar maturation, as assessed by the POSAS and objectively with the DermaLab Combo® device (Cortex Technology ApS, Hadsund, Denmark).

Eligibility Criteria:
Inclusion Criteria:

* ≥ 2 % total body surface area (TBSA) full thickness burned.
* Patients with two adjacent or body symmetrical full thickness burned areas (each ≥ 1 TBSA) and comparable in size (TBSA ± 0.5), that require debridement and autografting.

Exclusion Criteria:

* Time from injury to admission \>= 5 days
* Sepsis on admission or clinically suspected infection (as per attending physician)
* Pregnancy or childbearing
* Positive HIV or hepatitis screens
* History of active malignancy
* Patients who do not require surgical debridement and autografting
* Patient with burn injuries originating from other causes (chemical, and frostbite)
Regulated Cannabis Access in Basel

The randomised controlled study on regulated cannabis access in pharmacies in Basel aims to investigate the effects of regulated cannabis access on consumption behaviour and mental and physical health in comparison to the illegal market.

This project consist of two parts: The first part is a randomised controlled study, the second part is an observational study. The randomised controlled study will last six months. Participants will randomly be assigned to one of two groups: Group 1 has immediately access to regulated cannabis in pharmacies; Group 2 has to wait for six months. After six months all participants will have access to regulated cannabis in pharmacies (oberservational study). Every six month participants will be invited to answer online-questionnaires on their cannabis consumption behavior, their mental and physical health. The entire study lasts 2.5 years.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years, residence in Basel-Stadt, consuming cannabis at least monthly during the last 6 months (positive urine sample)

Exclusion Criteria:

* pregnant or breastfeeding, currently suicidal, currently psychotic, current inpatient psychiatric treatment
The Oral Symptom Assessment Scale in Older Patients With Frailty

Oral (or mouth) symptoms are common in older patients who live with frailty. It is known that frailty describes someone's overall resilience and how this relates to the chances of recovery following a health problem. A questionnaire called the Oral Symptom Assessment Scale (or OSAS) was designed to look at mouth symptoms in patients who had an advanced cancer. These symptoms may overlap with patients who have frailty.

This research study is taking place to find out if the OSAS will be a suitable questionnaire that can be used in older patients with frailty.

This study will take place in Our Lady's Hospice \& Care Services, Harold's Cross and St James' Hospital over six months.

Participants will be asked by one of our researchers about the presence or absence of 21 mouth symptoms in the last week. If present, the participant will be asked about how bothersome each symptom is as well as the severity and frequency. Up to three additional mouth symptoms that are not listed in the OSAS can be reported and rated in the same way by the participant. Participants will be asked about the questionnaire itself to provide feedback. This will take approximately 10-15 minutes to complete both.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 65 years old
* Clinical Frailty Score ≥ 5
* No known history of dementia
* The attending clinician should have no concerns about a participant's capacity to consent for this research

Exclusion Criteria:

* Inability to provide informed consent
* Inability to complete the questionnaire
* Abbreviated Mental Test Score -4 (AMT4) \<4
Community Intervention and Demonstration Area Construction

The objective of this intervention study was to understand the visual health status of nearly one million children and adolescents in ten provinces in China, and then to conduct intervention and evaluate the effect of intervention measures with the development of myopia as the outcome indicator. The study will be conducted in the form of a stepped intervention and will answer the following questions.

Current China children and adolescent's vision health, including the different degrees of myopia prevalence, and farsightedness reserve status. To evaluate the implementation and effect of eight appropriate technologies and six interventions developed in this study, to reduce the incidence of myopia among children and adolescents in China, to achieve the purpose of nationwide application.

In the early stage of this study, a baseline survey will be conducted on participants. In the middle stage, participants will be required to adjust the seat height regularly and increase the time for outdoor activities, etc. In the later stage, intervention measures will be evaluated based on the overall research situation to consider national promotion.


Eligibility Criteria:
Inclusion Criteria:

* ● Kindergarten kids.

  * Grade of 1 to 6 in elementary schools.
  * Grade of 1 to 3 in middle schools.
  * Grade of 1 to 3 in high schools.
  * Sign the informed consent.

Exclusion Criteria:

* ●Visual defect or other eye diseases.

  * wearing orthokeratology; refractive surgery history.
  * Not considered suitable for inclusion in the study by the investigator.
CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM

This is an open-label phase 1 study to assess the safety and feasibility of autologous T cells co-expressing two CARs targeting the cryptic EGFR and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with EGFR-amplified glioblastoma, IDH-wildtype that has recurred following prior radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Signed, written informed consent
2. Male or female age ≥ 18 years
3. Patients with glioblastoma, IDH-wildtype (as defined by WHO 2021 Classification of CNS Tumors) that has recurred following prior radiotherapy. For patients with tumors harboring methylation of the MGMT promoter, at least 12 weeks must have elapsed since completion of first-line radiotherapy.
4. Tumor tissue positive for wild-type EGFR amplification by NeoGenomics Laboratories. Archival tumor from patient's initial surgery at time of original diagnosis or recently collected tumor from time of recurrence are acceptable.
5. Surgical tumor resection for disease control/management or tumor biopsy to confirm tumor recurrence is clinically indicated in the opinion of the physician-investigator.
6. Adequate organ function defined as:

   1. Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 30 ml/min and not on dialysis.
   2. ALT/AST ≤ 3 x upper limit of normal range and total bilirubin ≤ 2.0 mg/dl, except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome (≤ 3.0 mg/dl).
   3. Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO/MUGA
   4. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air
7. Karnofsky Performance Status ≥ 60%.
8. Subjects of reproductive potential must agree to use acceptable birth control methods.

Exclusion Criteria:

1. Active hepatitis B or hepatitis C infection.
2. Any other active, uncontrolled infection.
3. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
4. Tumors primarily localized to the brain stem or spinal cord.
5. Severe, active co-morbidity in the opinion of the physician-investigator that would preclude participation in this study.
6. Receipt of bevacizumab within 3 months prior to physician-investigator confirmation of eligibility.
7. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10 mg daily of prednisone. Patients with autoimmune neurological diseases (such as MS or Parkinson's) will be excluded.
8. Patients who are pregnant or nursing (lactating).
9. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
Modified Laryngeal Handshake Technique

In this study, we compare the conventional laryngeal handshake technique and modified laryngeal handshake technique for locating the cricothyroid membrane in terms of accuracy and speed. The conventional laryngeal handshake technique is performed with the non-dominant hand, identifying the hyoid bone and thyroid laminae, stabilizing the larynx between thumb and middle finger, and moving down the neck to palpate the cricothyroid membrane with the index finger.

The modified laryngeal handshake is performed with the non-dominant hand, stabilizing the trachea between thumb and middle finger from the suprasternal notch and moving up the neck to palate the cricoid cartilage and cricothyroid membrane with the index finger.


Eligibility Criteria:
Inclusion Criteria:

* Patients who would be scheduled elective surgery under general anesthesia

Exclusion Criteria:

* Diseases or anatomical abnormalities in the neck or larynx
* History of neck surgery
Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death

Sudden Cardiac Death is a leading cause of mortality and remains a major public health burden worldwide. Cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. The investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. In addition, the study aims to characterize the prevalence of other adrenal pathology i.e. silent adenomas, cortisol-producing adenomas and pheochromocytomas in sudden death. The investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.


Eligibility Criteria:
Inclusion Criteria:

Consecutive patients with out-of-hospital, sudden death

Exclusion Criteria:

1. Estimated time from death to refrigerator more than 24-48 hours and in the refrigerator time more than 7 days (susceptibility to excessive tissue breakdown)
2. Terminal disease
3. Institutionalized patients
SBRT+TACE+Sorafenib Vs Sorafenib in the Treatment of uHCC With PVTT

To evaluate and compare the efficacy and safety of SBRT sequential TACE combined with sorafenib versus sorafenib alone in the treatment of unreactable HCC with PVTT.

HCC Patients classified as BCLC stage C present with PVTT, and the recommended first-line treatment is systemic therapy with sorafenib according to updated Barcelona Clinical Liver cancer (BCLC) treatment algorithms.However, recent data from observational studies suggest that the combination of TACE and SBRT would be as effective as sorafenib.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Child-Pugh score ≤ 7
* Performance status: ECOG score ≤ 2
* HCC diagnosed by biopsy or by the noninvasive criteria of the Chinese Liver Cancer Guideline 2017
* the primary HCC being unresectable (BCLC C stage/ CNLC Ⅲa-b) according to NCCN guideline
* No previous therapy for HCC
* at least one measurable target lesion according to RECIST 1.1
* Adequate hematopoietic function: Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count ≥ 750/mm3; Platelet count ≥ 50,000/mm3
* Serum total bilirubin ≤ 2 x ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 10 x ULN
* Creatinine ≤ 1.5 x ULN
* No plan for pregnancy or breast feeding. Active contraception.
* Willing to give informed consent

Exclusion Criteria:

* Prior history to or exposure of transarterial chemoembolization, external beam radiation to liver, or sorafenib
* Complete obstruction of hepatic outflow
* Uncontrolled ascites of hepatic encephalopathy
* Prior liver transplantation
* Positive for human immunodeficiency virus (HIV)
* Active gastric or duodenal ulcer
* Other uncontrolled comorbidities or malignancy
* Inability to give informed consent
Observational, Non-interventional, Non Comparative Real Life Data Collection of Depo-Eligard® 7.5 mg, 22.5 mg and 45 mg in Male Prostate Cancer Patients

Tremodi is an observational, non-interventional, prospective, open-label, non-comparative study that will collect real life data of a treatment with Depo-Eligard® in 3 different administrations in male prostate cancer patients.

Once the examining physician has decided on the therapeutic approach and if the selection criteria are fulfilled, he will propose the patient to participate in the study. An informed consent form will be collected for all participants in the study.

There are 2 possible study visits that coincide with a routine consultation, namely visit 1 (inclusion visit) and visit 2 (end of study visit). On both visits, Adverse Drug Reactions (adverse event caused by Depo-Eligard®) are collected and the patient will be asked to complete a Quality Of Life questionnaire (EORTC QLQ-C30). At visit 2, the examining physician will give a global evaluation of the treatment with Depo-Eligard® and assesses the treatment benefit of the patient.

Testosterone and Prostate Specific Antigen (PSA) blood values are collected during both visits, if available.


Eligibility Criteria:
Inclusion Criteria:

* Patients having been prescribed Depo-Eligard® 7.5 mg - 22.5 mg - 45 mg in accordance with the terms of the marketing authorization.
Study of the Cerebral Bases of Tool Use and Tool Evolution

Tool use is considered to be the hallmark of complex cognitive adaptations that humans have achieved trough evolution, that provides an adaptive advantage to the human species. Even if nonhuman species do use tools too, human tool use is much more complex and sophisticated. Besides, only humans can make their tools evolve by improving them. If Man has special abilities for tool use, it has to be grounded in a specific neuroanatomical substrate. Humans and nonhumans share a similar prehension system located within the superior parietal lobe and the intraparietal sulcus. However, there is a human specificity : the surpramarginal gyrus within the left inferior parietal lobe is unique to Man, and could play a central role in tool use and tool evolution.

This project aims to study the neural correlates of human tool use with functional Magnetic Resonance Imaging (fMRI), to precise the cognitive mechanisms through which humans are able to use tools. We also wish to study what are the cognitive abilities that allow us to make our tools evolve by improving them, and the neural correlates associated.


Eligibility Criteria:
Inclusion Criteria:

* To be between the ages of 18 and 65 years old
* Having given an informed consent for the study
* Being right-handed
* Being registered with the French Social Security System

Exclusion Criteria:

* No signature on the consent form, including inability to read or write French.
* Neurologic or psychiatric illness, known or revealed durnig the inclusion visit
* Substance intake ( taking psychoactive medications or recreational drugs) on the day of the experiment
* Noise intolerance
* Minor person, pregnant or breastfeeding woman
* Persons under curatorship or deprived of civil rights or deprived of their freedom
* Unable to fill a questionnaire (severe cognitive troubles)
* Subjects must not have metallic or electronic implants in the body : pacemakers or pacemaker wires, open heart surgery, artificial heart valve, brain aneurysm surgery, middle ear implant, hearing aid, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, or artificial limb or joint o foreign metallic objects in the body (bullets, BBs, pellets, schrapnel, or metalwork fragments) or current or past employment as machinists, welders or metal workers, tattoos near the head or neck regions, permanent makeup
* Claustrophobia