cyrilzakka/clinical-trials huggingface dataset:
Study of AOC 1044 in Healthy Adult Volunteers and Participants with Duchenne Muscular Dystrophy (DMD) Mutations Amenable to Exon 44 Skipping

AOC 1044-CS1 (EXPLORE44) is a Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of single and multiple ascending doses of AOC 1044 in healthy adult volunteers and participants with DMD mutations amenable to exon 44 skipping.

Part A is a single dose design with multiple cohorts (dose levels) in healthy adult volunteers.

Part B is a multiple-ascending dose design with 3 cohorts (dose levels) in participants with Duchenne.


Eligibility Criteria:
Part A:

Key Inclusion Criteria:

* Aged 18 to 55 years, inclusive, at the time of informed consent
* Body mass index (BMI) of 18.5 to 32.0 kg/m2

Key Exclusion Criteria:

* Clinically significant abnormalities in laboratory results, ECGs, or vitals
* Current or recent use of prescription or nonprescription drugs
* Positive drug/alcohol test at Screening or Day -1
* Elevated blood pressure (BP) \>130/80 mmHg at Screening
* Participation in a clinical study in which an investigational product was received within 1 month of screening or 5 half-lives of the investigational product
* Blood or plasma donation within 16 weeks of planned AOC 1044 administration Note: Other protocol defined Inclusion/Exclusion criteria may apply

Part B:

Key Inclusion Criteria:

* Aged 7 to 27 years, inclusive, at the time of informed consent
* Clinical diagnosis of DMD or clear onset of DMD symptoms at or before the age of 6 years
* Confirmation of DMD gene mutation amenable to exon 44 skipping
* Weight ≥ 23 kg
* Ambulatory or non-ambulatory

  * Ambulatory participants: LVEF ≥50% and FVC≥50%
  * Non-ambulatory participants: LVEF ≥45% and FVC≥40%
* PUL 2.0 entry item A ≥3
* If on corticosteroids, stable dose for 30 days before screening and throughout the study

Key Exclusion Criteria:

* Biceps brachii muscles unsuitable for biopsy
* Serum hemoglobin \< lower limit of normal
* Uncontrolled hypertension or diabetes
* Prior treatment with any cell or gene therapy
* Prior treatment with another exon 44 skipping agent within 6 months prior to informed consent
* Recently treated with an investigational drug
* History of multiple drug allergies
Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability

This is a randomized trial investigating the use of the IMPELLA RECOVER LP 2.5 compared to Intra-aortic balloon pump (IABP) in patients with Acute Myocardial Infarction.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Subject presenting with STEMI undergoing primary PCI
* Patient presents with at least 1 of the following:
* Unstable blood pressure
* Tachycardia and tissue hypoperfusion
* The need for intravenous pressor or inotropic support
* Patient presents with STEMI:
* CK-MB\>2x normal

Exclusion Criteria:

* Unwitnessed cardiac arrest
* Abnormalities of the aorta
* Recent stroke or TIA
* Mural thrombus in the left ventricle
Electrical Stimulation of Accessory Spinal Nerve in Cortical Activation and Autonomic Response in Healthy Subjects

This randomized, crossover sham controlled trial with sham intended to study the effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects.

Participants will be assessed through measure changes in cortical activation, local muscular peripheral perfusion and autonomic responses before and after intervention and intervention-sham, and crossed after a period of wash-out.

The design aims to contribute to assessment of one electroacupuncture's techniques by measuring some of the physiological effects caused by peripheral stimulation.

In recent years, there are growing evidence that many diseases such as chronic pain and psychiatric disorders can be managed with non-pharmacological techniques. The possibility of inducing central neuroplastic responses through transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) has been widely studied, as well as peripheral stimulation techniques such electroacupuncture (EA) and intramuscular stimulation (IMS). However, there are few studies on physiological mechanisms, indications and limitations of each technique.

Thus, this randomized, crossover sham controlled trial, where sham intended to study the effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects.

Participants will be assessed through measure changes in cortical activation, local muscular peripheral perfusion and autonomic responses before and after intervention and intervention-sham, and crossed after a period of wash-out.

The design aims to contribute to assessment of one electroacupuncture's techniques by measuring some of the physiological effects caused by peripheral stimulation.

Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects
* right handed
* basic education

Exclusion Criteria:

* contraindication to infrared technology NIRS
* brain stimulator device
* drug and alcohol abuse
* chronic disease (any);
* chronic pain condition
* tobacco use
* psychiatric disorders
* Beck Depression Inventory higher then score 12
* psychotropic drugs
* use of pain-killers or anti-inflammatories 12h previous experiment
Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions

The aim of this study is to test a surgical technique for the treatment of gingival recessions. The hypothesis of the study is to promote greater root coverage and better healing.


Eligibility Criteria:
Inclusion Criteria:

* Recession defects are Miller's class I or II and do not vary more or equal than 3 mm
* Main complaint aesthetic issues or dentine hypersensitivity
* The patient must be a candidate for bilateral root coverage procedure
* Patient shows sufficient plaque control (FMPS \< 20%)
* The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
* The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent

Exclusion Criteria:

* Smokers
* Systemic diseases
* Pregnants or lactating
* Periodontal disease
* General contraindications for dental and/or surgical treatment are present
* The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years
* The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
Underlying Causes and Related Factors, and Rehabilitation Approaches

This study will be a cross-sectional observational study, followed by a pilot intervention. The aim of the study is to examine the underlying causes of walking-related performance fatigability, together with other related and influencing factors, to make up a clinical profile of patients with MS showing walking-related performance fatigability. In the second part of the study a pilot intervention will be executed to see if the investigators can improve the clinical status of the MS patients with walking-related performance fatigability.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years.
* MS diagnosis according to McDonald Criteria.
* Capable of walking 6 minutes (independent or with unilateral support) without stopping.

Exclusion Criteria:

* Exacerbation or relapse within last 3 months before study
* Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia, stroke, Parkinson).
A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-D4010 in Healthy Subjects

The purpose of the study is to evaluate the effect of food, gender, and age on the single-dose pharmacokinetics (PK) of SUVN-D4010.

The main objective of the study is to evaluate the safety and tolerability of orally administered SUVN-D4010 under single-dose conditions in healthy adult male and female subjects and healthy elderly male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, aged 18 to 45 years, inclusive; healthy female subjects, aged 18 to 45 years, inclusive; healthy elderly male subjects, aged ≥65 years.
* Have a body mass index (BMI) between 18.0 and 30.0kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the (first) administration of the study drug.
* Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
* Plasma or blood product donation within 1 month of the (first) administration of the study drug and any blood donation/blood loss more than 500 mL within the 2 months prior to the (first) administration of the study drug.
* As judged by the Investigator that the subject should not participate in the study if he/she is considered unlikely to comply with study procedures, restrictions, and requirements.
Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis

The main purpose of this study is to describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation and to differentiate cases with anterior scleritis from those with episcleritis and normal controls.

A total of 40 eyes will be included. 20 eyes with scleral inflammation and 20 eyes from healthy subjects as controls. Each patient will undergo complete ophthalmic and medical examination. Laboratory studies will performed whenever indicated. Optical coherence tomography B-scans of the sclera in the perilimbal area will done for all cases.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years any gender
* Patients with clinical signs of scleritis or episcleritis
* Signed informed consent

Exclusion Criteria:

* Infectious keratitis or conjunctivitis
* Patients 18 years or younger
* Inability to open the eye
POCD in Elderly Patients Following Desflurane or Sevoflurane General Anesthesia

The use of desflurane in elderly subjects (\>65 years old) undergoing general anesthesia with endotracheal intubation will result in decreased POCD compared to sevoflurane if the patient's MAP is within 20% of the patient's baseline and the cerebral suppression state index stays within the moderately anesthetized range during general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>65 years old)
* Scheduled for elective surgery requiring general anesthesia at LLUMC HSH
* Airway management expected to include endotracheal intubation
* Expected surgical duration 120 to 240 minutes

Exclusion Criteria:

* Pre-existing significant psychiatric disease or mental status changes
* Clinically significant cardiovascular, respiratory, hepatic, renal,neurological, psychiatric, or metabolic disease
* Patient's weighing \>50% ideal body weight

  * Men: Ideal Body Weight (in kilograms) = 50 + 2.3 kg per inch over 5 feet
  * Women: Ideal Body Weight (in kilograms) = 45.5 + 2.3kg per inch over 5 feet
* Patients who have undergone a general anesthetic within the past 7 days
* Patient refusal
Assessment of Stress Levels in Consumers Using Ovulation Tests in Order to Conceive

Approximately 150 female volunteers wishing to become pregnant will be recruited via web recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All volunteers will complete study questionnaires and provide a urine sample at designated time points though out the menstrual cycle.

A sub-arm to this study, applied the same protocol to women in an infertility treatment setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe male-factor infertility (with \<5 million motile sperm per ejaculate). For this arm, the protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent to participate in the study and agree to comply with study procedures.
* Has menstrual bleeds.
* Seeking to become pregnant.
* Living in UK

Exclusion Criteria:

* Used hormonal contraception within the last 3 months.
* Currently undergoing fertility treatment or investigation.
* Diagnosed as infertile following investigations.
* Drug or alcohol dependency.
* history of depression, anxiety or panic attacks
Post-partum Perineal Pain - Chirocaine®

The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. The pain intensity is measured in immediate postpartum period by using a numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest, defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are also evaluated at each time.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:
* Patients aged 18-45 years
* Single pregnancy.
* Vaginal normal birth in cephalic presentation or assisted vaginal delivery by vacuum extractor.
* Patients having a mediolateral episiotomy or a first-degree perineal tear, epidural analgesia.
* Patients affiliated to a national insurance scheme
* Patients who have given their written consent

Exclusion Criteria:

* Patient not speaking, reading, writing French.
* Multiple pregnancy.
* Breech delivery or instrumental delivery by forceps or spatula.
* Intact perineum.
* No epidural analgesia.
* Patient who represent contraindication to local anesthetics, severe arterial hypotension.
* Previous tear requiring sutures.
Artificial Intelligence (AI) in Cardiotocography (CTG) Interpretation

The project leaders plan to create a clinical decision support (CDS) system by programming a self-learning software to analyze the cardiotocography (CTG) traces in the - already existing - database from the maternity department of the Inselspital Berne. The project leaders will process and analyze all clinical outcomes of the estimated 10000-15000 eligible patient records. CSEM will design, develop, and validate several AI architectures with the intend to create the CDS system. The AI would learn to assist on this task by training machine learning (ML) algorithms. The main purpose of the AI-CDS will be to determine the best fetal extraction moment during labor, based on a self-learning approach, as a "superhuman" support tool for obstetricians in decision making during labor.


Eligibility Criteria:
Inclusion Criteria:

* CTG-registrations of patients with singleton pregnancies during labour from 01.01.2006 to 31.12.2019
* Gestational age ≥ 24+0 weeks
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Documented refusal
* Multiple pregnancies
* CTG-registrations of planned caesarean sections
Comparison of Perioperative Outcomes Between Energy Device During Laparoscopic Gastrectomy

To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat

comparing postoperative CRP level in each group

To find out which instrument can be much better for laparoscopic gastrectomy among Harmonic scalpel, Ligasure Maryland, Thunderbeat

comparing postoperative CRP level in each group

1. post operative 2nd day CRP level
2. post operative 4th day CRP level
3. post operative IL-6, 10 level in 2nd, 4th day

Eligibility Criteria:
Inclusion Criteria:

* pathologically proven adenocarcinoma in stomach
* patients who are expected for R0 resection with distal gastrectomy
* pre-operative clinical stage should be stage I
* patients who is able to be followed up with in postoperative 30 days
* patients whose CRP is normal before surgery

Exclusion Criteria:

* patients who had an abdominal surgery
* patients who received chemotherapy, radiotherapy before surgery
* patients who received ESD before surgery
* Patients who had an ascites on pre-operative CT scan
* liver cirrhosis
* cardiovascular disease (Ejection Fraction\<50%)
* serum creatinine \> 1.4 mg/dL or BUN\>26mg/dL
* PT INR \>1.2 or aPTT\>45sec
* uncontrolled diabetes
* Crohn's disease, ulcerative colitis
* patients who receives anti-coagulants
* patients who need pre-operative steroid booster because of steroid treatment
* pregnancy
* patients who have allergic reaction to iodine
Comparison of 4.0 mg/kg Sugammadex at 1-2 Post Tetanic Counts (PTC) in Renal or Control Patients (19.4.328)(P05769)

The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with normal renal function.

The results of previous trials showed that the safety profile of sugammadex

observed in subjects with impaired renal function are not appreciably different from subjects with normal renal function. Reoccurrence of neuromuscular blockade was not observed, and sugammadex was safe and generally well tolerated in subjects with severe renal impairment. In a previous trial, subjects (n=15) with severe renal impairment received a dose of 2.0 mg.kg-1 of sugammadex. The effects of the other proposed recommended dose for routine reversal, 4.0 mg.kg-1, on efficacy, safety and pharmacokinetics had not been studied thus far in subjects with severe renal impairment. The objectives of this trial were to assess equivalence with respect to the efficacy of sugammadex in subjects with normal renal function or severe renal impairment, to evaluate the safety of sugammadex in these subject groups and to compare the pharmacokinetic profiles.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* ASA class 1-3
* Creatinine clearance (CLcr) \< 30 mL/min and no anticipated clinical

indication for high flux hemodialysis during first 24 hours after

sugammadex administration (for renally impaired group) or CLcr \>= 80

mL/min (for control group)

-Scheduled for a surgical procedure under general anesthesia with propofol

requiring neuromuscular relaxation with the use of rocuronium

* Scheduled for a surgical procedure in supine position
* Written informed consent

Exclusion Criteria:

- Subjects known or suspected to have neuromuscular disorders impairing

neuromuscular blockade and/or significant hepatic dysfunction

* Subjects scheduled for renal transplant surgery
* Subjects known or suspected to have a (family) history of malignant

hyperthermia

-Subjects known or suspected to have an allergy to narcotics, muscle

relaxants or other medication used during general anesthesia

* Subjects receiving fusidic acid, toremifene and/or flucloxacillin
* Subjects who have already participated in a sugammadex trial
* Subjects who have participated in another clinical trial, not pre-approved

by the sponsor, within 30 days of entering into 19.4.328 (P05769)

* Female subjects who are pregnant
* Female subjects who are breast-feeding
Can we Make a VAST Improvement? Promoting Anaesthetists' Non-technical Skills Through the Vital Anaesthesia Simulation Training Course in a Low-resource Setting

Rationale: The World Health Assembly resolution 68.15 identified surgical and anesthesia care as core components of universal health coverage. However, about 5 billion people worldwide lack access to essential surgical and anesthesia services. Of the 313 million procedures undertaken each year only 6% occur in the poorest countries with an estimated 30% of all deaths globally associated with common surgical conditions. Patient safety in low-resource settings is hindered by severe workforce shortages, lack of essential resources, hierarchical culture and few opportunities for professional development.

Non-technical skills (NTS), such as communication, team working, and task coordination, are vital to patient safety. Up to 70-80% of untoward events in health care are associated with errors in NTS8. The Anaesthetists' Non-Technical Skills framework (ANTS) describes behaviour markers for NTS in anesthesia. This framework has been found applicable in low-resource settings.

Simulation-based education is widespread for NTS training in well-resourced countries. Traditionally, high costs have prohibited this modality in low-resource settings. Foundational work in Rwanda and at Dalhousie University has demonstrated that effective training in ANTS can be achieved through simple low-cost simulation. The Vital Anaesthesia Simulation Training (VAST) Course is a three-day simulation-based program designed de-novo to focus on core clinical practices and NTS that promote safe perioperative care in low-resource settings. The course uses low-cost materials in an immersive simulated environment to replicate common cases managed in district hospitals in low-resource settings. Realism is created with simple mannequins, iPads with the SimMon App functioning as monitoring, basic props (e.g., airway equipment, syringes, drapes), photographs of pathology, and briefing cards for scenario role-play.

Purpose: To assess the impact of the VAST Course on ANTS and explore factors that influence long-term retention of ANTS amongst anesthesia providers in a low-resource setting.


Eligibility Criteria:
Inclusion Criteria:

* All anesthesia (anesthesiologists, anesthesia residents and non-physician anesthetists) VAST Course participants during the study period.

Exclusion Criteria:

* VAST Course participants who do not practice anesthesia (surgeons, nurses, midwives etc.)
Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT)

REaCT-RETT will demonstrate the non-inferiority of concurrent compared to sequential endocrine therapy in patients receiving post-operative radiotherapy for early stage breast cancer.

Clinical equipoise exists around the optimal time to start adjuvant endocrine therapy in patients who will receive post-operative radiotherapy for breast cancer. Patients receive either concurrent or sequential endocrine and radiation therapy, where concurrent therapy consists of endocrine therapy started before, with or during radiotherapy, while sequential treatment is defined as endocrine therapy starting after the completion of radiotherapy. A recent survey of Canadian oncologists showed that the main reason for prescribing sequential endocrine therapy was a concern that concurrent endocrine therapy and radiotherapy would worsen the toxicity of endocrine treatment. This is despite the absence of any clinical trial evidence to support this. Indeed, a recent systematic review by our group was unable to confirm or refute whether increased toxicities, related to the timing of endocrine therapy and radiotherapy actually exist in clinical practice. The investigators are therefore proposing a pragmatic randomised trial to assess whether or not concurrent endocrine therapy and radiotherapy worsens endocrine treatment-related symptoms in an era of modern endocrine and radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed early stage, hormone receptor positive breast cancer
* Planned to receive both endocrine therapy and post-operative radiotherapy
* Able to provide verbal consent

Exclusion Criteria:

* Previous endocrine therapy for invasive breast cancer
* Previous radiotherapy for breast cancer in the same breast