cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Efficacy and Safety of Garetosmab in Japanese Adult Patients With Fibrodysplasia Ossificans Progressiva (FOP)

The primary safety objective of the study is to assess the safety and tolerability of garetosmab in Japanese male and female adult patients with FOP.

The primary efficacy objective of the study is to assess the effect of garetosmab on Heterotopic ossification (HO) in Japanese adult patients with FOP, as determined by the number of new heterotopic bone lesions identified by computed tomography (CT).


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of FOP (based on findings of congenital malformation of the great toes, episodic soft tissue swelling, and/or progressive HO)
* Confirmation of FOP diagnosis with documentation of any Type I activin A receptor (ACVR1) mutation
* FOP disease activity, as defined in the protocol, within 1 year of screening visit
* Willing and able to undergo PET and CT imaging procedures and other procedures as defined in this study
* Able to understand and complete study-related questionnaires and diaries (assistance from caregivers is allowed)

Key Exclusion Criteria:

* Patient has significant concomitant illness or history of significant illness such as but not limited to cardiac, renal, rheumatologic, neurologic, psychiatric, endocrine, metabolic, or lymphatic disease, that in the opinion of the study investigator might confound the results of the study or pose additional risk to the patient by their participation in the study
* Previous history or diagnosis of cancer
* Severely impaired renal function defined as estimated glomerular filtration rate \<30 mL/min/1.73 m2 calculated by the Modification of Diet in Renal Disease equation (1 retest is allowed)
* Uncontrolled diabetes defined as hemoglobin A1C (HbA1c) \>9% at screening (1 retest allowed)
* History of severe respiratory compromise, as defined in protocol
* Concurrent participation in another interventional clinical study or a non-interventional study with radiographic measures or invasive procedures
* Pregnant or breastfeeding women

NOTE: Other protocol defined inclusion/exclusion criteria apply.
SPI-directed Analgesia for Lumbar Discectomy

The aim of this randomized trial is to assess the efficacy of analgesia for lumbar discectomy and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.

Patients received either preemptive local tissue infiltration at surgical site using either 0,2% ropivacaine with fentanyl or 0,2% bupivacaine with fenthanyl or preemptive intravenous infusion using metamizole and tramadol.

Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parametres constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia. This study aims at evaluating utility of SPI-directed analgesia in patients undergoing general anaesthesia (GA) where analgesia intraoperatively will be achieved either with regional preemptive wound infiltration using 0,2 % ropivacaine with fentanyl or 0,2 % bupivacaine with fentanyl or intravenous analgesia using continuous infusion of metamizole with tramadol for lumbar discectomy. Intraoperatively, SPI value will be recorded with sampling frequency of 1 minute. When SPI value reaches a level higher than 15 SPI points above basic level, a rescue dose of 1mg/kg body weight of fentanyl will be administered intravenously every 5 minutes until SPI value decreases to basic level calculated previously before operation started.

Additionally, the investigators will compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) values for monitoring the efficacy of analgesia postoperatively. After emergence from GA patients will be questioned in terms of their pain intensity in a scale 0-10. In the case of pain perception above 3, a bolus of 2mg of morphine will be administered intravenously every 10 minutes until pain perception will be lower than 4. SPI values will be recorded every 1 minute and analysed for aute pain (NRS 7-10), average (4-6) and mild pain perception intervals to assess if there exists a correlation between NRS and SPI.

In addition, some patients develop Failed Back Surgery Syndrome (FBSS) following lumbar surgeries so the investigators will aim to analyze if SPI-directed analgesia intra- and post-operatively reduces rate of FBSS. After 5 months after operation patient will be surveyed using melzack protocol to assess the rate of FBSS as well as symptoms of chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate in the study
* written consent to undergo general anaesthesia with local wound infiltration and surgery of discectomy

Exclusion Criteria:

* allergy to local anaesthetics
* necessity of administration of vasoactive drugs influencing SPI monitoring
* pregnancy
Research of Circulating Tumor Cells Released During Cervical Cancer Surgery

Cervical cancer is a rare pathology. Recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during different steps of the surgery.

The primary goal is to evaluate the spread of CTC during surgery on peripheral blood samples.

The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.

20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.

CTC detection could be a pronostic factor for cancer evolution. Cervical cancer is a rare pathology with increased death rate.

Despite recommendations for coelioscopic treatment of \< 4cm cervical cancers, recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during coelioscopic stadification and laparoscopic surgery.

Hypothesis : Mobilization of the tumor during coelioscopy leads to CTC spread. This spread could explain the recurrence of cervical cancer.

This pilot study will evaluate the possibility of CTC detection during surgery. The primary goal is to evaluate the spread of CTC during the different steps of surgery on peripheral blood samples.

The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.

20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.

Eligibility Criteria:
Inclusion Criteria:

* Woman \>18 years old
* Cervical cancer confirmed by histology
* Early stage eligible for immediate surgical treatment (or post-brachytherapy): stages IA1, 1A2, 1B1 and IB2 with or without emboli determined by MRI performed as part of the treatment
* Histology : epidermoid carcinoma and adenocarcinoma
* Valid Social Security
* Wrote consent

Exclusion Criteria:

* Advanced stage (Stage IB3 and more)
* Concomitant cancer
* Pregnant or breastfeeding woman
* Vulnerable person (Article L1121-6 of the Public Health Code)
* Participation to other study with an exclusion period still in progress
* Participation to other study that may have an impact on the prognosis of cervical cancer
Post-Stroke Enhancement of Delirium Outcomes With Reduction in Neuro-checks

There have been limited studies on delirium in patients hospitalized with acute stroke. There have been no studies on the potential impact of overnight neuro-checks and resulting sleep disruption on delirium or other outcomes. Additional research is needed to determine if overnight checks are necessary or even harmful. We aim to find out if stopping overnight neuro checks may prevent delirium and benefit the patient.

This study hopes to challenge the clinical paradigm that all patients with acute stroke need around-the-clock neuro-checks. The practice of conducting an NIHSS every 4 hours on patients with acute stroke has never been validated, particularly in clinically stable patients, but is the standard of care. This practice potentially comes at the cost of inducing delirium due to poor sleep which can result in numerous adverse outcomes.

This study hopes to identify the impact of eliminating overnight neuro-checks and prioritize sleep and rest. We hypothesize that increased emphasis on sleep will reduce the incidence of delirium and thereby improve the deleterious effects of delirium such as prolonged length of stay and increased likelihood of being discharged to a facility.

A quality improvement project was undertaken to at MUSC to begin to understand the impact of eliminating overnight neuro-checks. This project was focused on patients on the Inpatient Stroke Service, admitted to 9 East. Starting in October 2022, the Stroke team would identify patients who were medically and neurologically stable and place an order to discontinue overnight neuro-checks. Incidence of delirium, LOS, NIHSS, and mRS were compared using data from 4 months prior (June-September 2022) and 8 months after initiation of the project. Compared to pre-intervention, there was a reduction in patients who were delirious from 34-24% and a reduction in average length of stay by 1.5 days. This preliminary data suggests a positive impact of the intervention. There was no change in NIHSS at discharge or the mRS at discharge suggesting there was no negative impact on the patient's neurologic function by eliminating overnight neuro-checks.

The data collect from this preliminary study is exciting, however, warrants more a more scientific evaluation. The proposed study will be a randomized control trial that will help answer these questions more definitively.

Eligibility Criteria:
Inclusion Criteria:

* Admitted with acute stroke Age greater or equal to 18 years old Medical and neurologic stability for discontinuation of neuro-checks, determined by the Stroke Service NP and Attending Physician (no uncontrolled fluctuation in vital signs, seizure like activity or worsening neurologic function) Ability to give informed consent, or identifiable surrogate decision maker

Exclusion Criteria:

Surgical hemorrhagic stroke Subarachnoid hemorrhage Medical or neurologic instability Pregnancy Inmates
Study of the Impact of a Pain Diary in Pediatric Patients

The purpose of this study is to show the impact of a pain diary on the communication of pain by pediatric patients. Participants will be given a pain diary after consent and asked to complete the record each time they have pain. A survey about the efficacy of the pain diary will be taken prior to discharge by the nurse, physician, patient and parents. The hypothesis is that the pain diary will improve the communication.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen.

Exclusion Criteria:

* Admitted to the Pediatric Intensive Care Unit
* Surgical patients, defined as patients having surgery since admission other than minor procedures
* Patients anticipated to receive pain medication for less than 24 hours
* Patients unable to verbally communicate their pain
Imipenem in Critically Ill Patients

Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving respiratory and/or cardiac failure support in critically ill patients, including those with life-threatening severe infections. This cardiopulmonary bypass device has been shown to enhance the profound pathophysiological changes in this patient population, resulting in an alteration of the pharmacokinetics (PK) of antimicrobial agents. The aim of this study was to determine the effect of ECMO on the PK of imipenem in critically ill patients supported by this cardiopulmonary bypass device.

Methods The study was conducted in critically ill patients with respiratory and/or cardiac failure and suspected severe nosocomial infections who were supported by ECMO. All patients received a 1-h infusion of 0.5 g of imipenem every 6 h and imipenem PK studies were carried out on the fourth dose of drug administration.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \>18 year
* Patients who diagnosed as severe sepsis
* Admitted into the ICU
* Supported with ECMO

Exclusion Criteria:

* Patients who pregnant
* Patients who have documented hypersensitivity to carbapenem
Project Women's Insomnia Sleep Health Equity Study (WISHES)

The purpose of this study is to achieve health and healthcare equity by implementing an equity-focused, mindfulness-based sleep intervention to reduce stress and sleep deficiency-related cardiometabolic disease burden in Black women.

In phases 1 and 2, the investigator will identify multi-level barriers and facilitators to implementing the online mindfulness-based therapy for insomnia (MBTI) through an equity lens using community-engaged research with key stakeholders. The investigators will then develop and refine equity-focused implementation strategies with the community advisory board, comprised of community-based organization members, African Methodist Episcopal Zion Church networks, clinicians, and community health workers (CHWs). In phase 3, the investigators will use a Hybrid Type 1 effectiveness/implementation design with a pragmatic randomized controlled trial with MBTI and a waitlist control in Black women with insomnia. Specialists will assess and address social needs of Black women, and registered nurses will deliver the online MBTI intervention in the community settings. The focus of this registration is phase 3.

The study will contribute to equity-focused implementation science and policy decisions by providing multi-level implementation determinants, equity-relevant metrics, and contextual factors through community-engaged research and evaluation of the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* self-identified Black women
* English speaking
* meet ICSD3 diagnostic criteria for insomnia disorders, defined as difficulty initiating or maintaining sleep that occurs despite adequate opportunity to sleep with at least one associated daytime impairment symptom (ISI \> 7)
* additional quantitative insomnia criteria based on research recommendations and the new ICSD3: (a) severity of sleep onset latency or wake time after sleep onset of ≥31 min, (b) occurring ≥3 nights a week, and (c) for ≥ 3 months.

Exclusion Criteria:

* Psychosis or unstable/significant depression, anxiety, or substance abuse under active care (more than 1 monthly mental healthcare visit or requiring more than 1 psychotropic medicine daily)
* significant current practice of any form of meditation (\>15min per day)
* obstructive sleep apnea (OSA), restless legs syndrome (RLS), or circadian rhythm related condition (shift worker, use of medication that influence circadian rhythm, e.g., Parkinson's disease)
* active or terminal cancer.
Risk of Fatigue in Adolescent and Young Adult Hodgkin Lymphoma Patients

Fatigue is one of the most prevalent symptoms endorsed by cancer survivors, particularly those treated for breast cancer or Hodgkin lymphoma. Despite the tremendous implications such work has for effective interventions, little is known about the underlying pathophysiology of fatigue, association with medical co-morbidities and factors that may help predict those to be at highest risk.

The proposed research will utilize Vanderbilt-Ingram Cancer Center REACH for Survivorship Program together with the investigators Hematologic Malignancies Program. In adolescent and young adults (AYA), ages 18 - 39 the investigators will address the following:

Primary Aims Aim 1: Assess the prevalence and severity of fatigue and its impact on functional outcomes Aim 2: Determine host, disease and treatment-related risk factors for fatigue

Secondary Aims Aim 1: Evaluate the association between levels of proinflammatory cytokine activity and fatigue Aim 2: Evaluate the association between fatigue and self reported fatigue in AYA Hodgkin lymphoma (HL) survivors.

Hypotheses:

1. Fatigue is more prevalent and severe among AYA HL patients and survivors, compared to general population and will be associated with impaired functional outcome.
2. Risk factors for fatigue include higher disease stage, B symptoms and elevated erythrocyte sedimentation rate at diagnosis, dose density of chemotherapy and higher doses and more expanded fields of radiotherapy.
3. Risk of fatigue is associated with long-term cardiopulmonary and endocrine complications.
4. Levels of specified proinflammatory cytokines are associated with increased fatigue.


Eligibility Criteria:
Inclusion Criteria:

* Currently 18 years of age or older
* Alive without evidence of recurrent disease
* Must be off therapy (not on active treatment for HL or other malignancies)
* Must not be on any form of chemotherapy (oral or intravenous \[IV\])
* Provide informed consent
* Can read and understand English
* Treated with risk-adapted therapy which may include radiotherapy doses \< 30 Gy

Exclusion Criteria:

* Evidence of a subsequent malignancy following lymphoma treatment
The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure

The relationship between the activation of the vasopressin system and central hemodynamics in heart failure (including right and left heart filling pressures and cardiac output) is not clear. The investigators intend to examine the correlation between levels of copeptin and vasopressin and the central hemodynamic system in patients with advanced (class III or IV) heart failure. The investigators also aim to examine the relationship of selected cardiac biomarkers in blood and urine with cardiac filling pressures and cardiac output in patients with decompensated heart failure.

The study population will consist of 30 patients admitted to the Department of Cardiology at Copenhagen University Hospital. Only patients for whom the attending cardiologist has already decided upon right heart catheterization for clinical/treatment reasons will be recruited for the study.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Left ventricular ejection fraction \< 40 %
3. Diagnosed symptomatic heart failure treated with heart failure medications for at least 30 days.
4. Clinical indication for right heart catheterization for clinical/treatment reasons
5. NYHA-class III-IV
6. Relevant heart failure treatment as tolerated by the patient

Exclusion Criteria:

1. Absence of clinical/treatment indication of right heart catheterization
2. Syndrome of Inappropriate Secretion of ADH (SIADH)
3. Recent acute myocardial infarction within the last 30 days
4. Presence of infection or inflammatory disease
5. Malignant disease
6. Pregnancy
7. Subjects unwilling or unable to provide written consent
Clinical Evaluation of the Vedera KXS for the Treatment of Spherical Myopia

The objective of this clinical investigation is to evaluate the safety and efficacy of the Vedera KXS in sighted eyes for the correction of spherical myopia.


Eligibility Criteria:
Inclusion Criteria:

* Must be undergoing surgery for the correction of myopia
* Intended treatment from -0.5 to -6.0 D of spherical myopia
* Must have 0.50 D or less astigmatic component.
* Must have bilateral physiologic myopia
* BSCVA of 20/25 or better in each eye
* Must have had a stable refraction (0.5 D or less change in spheroequivalent) for at least one year, objectively documented (by previous clinical records, eyeglass prescriptions, etc. over one year old)
* Patients who are contact lens wearers must have hard or gas permeable lenses discontinued for two weeks and soft lenses discontinued for three days prior to the preoperative evaluation
* Must be at least 18 years of age
* Corneal topography must be normal, as judged by the investigator
* Must have a minimal corneal thickness of 475 microns
* Must sign a written Informed Consent form acknowledging their awareness of their participation in this study, the alternative treatments available, the risks involved, and the investigative nature of the procedure, and other issues which conform to the standard of care for Informed Consent practices
* Must be willing and capable of returning for scheduled follow-up examinations for 24 months after treatment

Exclusion Criteria:

* Patients who are unable or unwilling to sign the informed consent form.
* Anterior segment pathology
* Residual, recurrent or active ocular disease
* Patients who have undergone previous intraocular or corneal surgery involving the stroma in the eye to be operated.
* History of herpes keratitis
* Patients with diagnosed autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications (i.e., corticosteroids or antimetabolites) likely to affect wound healing.
* Irregular central keratometry/topography readings with irregular topography patterns or keratometry mires, including signs of keratoconus.
* Patients with known sensitivity to study medications.
* Intraocular pressure of \> 23 mm Hg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspect.
* Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.
* Participation in other ophthalmic clinical trials during this clinical investigation.
An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Brazil

The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.

The aim of this study is to generate dengue disease burden data including estimates of incidence rates, prevalence data and the clinical presentation of dengue across different age groups.

The study will be conducted in at least three cities: Rio de Janeiro, Salvador, and Manaus. This study will also prepare potential sites for future clinical trials, by setting up the logistics and training staff on site to enroll a cohort of subjects perform dengue surveillance and other study procedures.

Households will be randomly selected from communities where a registry system is implemented. All individuals in the household will be eligible for participating in the study. This study will be sponsored by GSK and co-funded by GSK and Fiocruz. As study sponsor, GSK will delegate some activities to Fiocruz, according to the provisions in their Cooperative Research and Development Agreement (CRADA).

Eligibility Criteria:
Inclusion Criteria:

* Written, signed or thumb-printed informed consent (and assent when applicable) must be obtained from the subject or subject's parent(s)/legally acceptable representative(s) (LAR(s)). If the subject/subject's parent(s)/LAR(s) are illiterate the consent form will be countersigned by a witness.
* Male or female at least 6 months of age at the time of enrollment.
* Subject and/or subject's parent(s)/LAR(s) who the study staff believes can comply with the requirements of the protocol.
* Subject who plans, at the time of enrollment, to remain at same residence/study area during their study participation period).

Exclusion Criteria:

* Child in care.
* Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement.
* Terminal illness or severe mental incapacity.