cyrilzakka/clinical-trials huggingface dataset:
Managed Ventricular Pacing ("MVP") Trial

The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). The study will compare how much time either ICD wire is used by the ICD and the status of congestive heart failure.

Recent research supports the hypothesis that reducing the amount of pacing in the lower right chamber of the heart may prevent the progression of congestive heart failure (CHF) in some implantable cardioverter defibrillator (ICD) patients. CHF refers to symptoms (shortness of breath, fatigue, fluid overload) caused by decreased pumping action of the heart muscle. The ICD can be set to use one wire (top or bottom of the heart) or two wires (top and bottom). Both settings allow the heart to beat more naturally using its own electrical signals. Two device settings will be compared. Managed ventricular pacing (MVP) will allow the ICD to use both wires only as necessary. This setting allows the ICD to send electrical signals to the top and bottom chambers of the heart if needed. The other setting, ventricular pacing (VVI) will allow the ICD to operate the bottom chamber of the heart if it is needed.

Eligibility Criteria:
Inclusion Criteria:

* Conventional indication for ICD therapy according to current evidence-based guidelines and in accordance with the corresponding United States Centers for Medicare and Medicaid Services National Coverage Determination for the use of ICDs.
* Prior myocardial infarction ("MI") and an left ventricular ejection fraction ("LVEF") of less than 30%
* Ischemic Dilated Cardiomyopathy (IDCM), New York Heart Association ("NYHA") Class II or II heart failure, and LVEF less than or equal to 35%
* Non-Ischemic Dilated Cardiomyopathy (NIDCM) greater than 3 months, NYHA Class II or II heart failure, and LVEF less than or equal to 35%
* First ICD implant
* Successful implant with a study device with approved labeling

Exclusion Criteria:

* Failure to meet any of the inclusion criteria
* Class I pacing indication
* Chronic atrial fibrillation ("AF") without any documented sinus mechanism for at least 6 months
* Inability or unwillingness to give informed consent
* Life expectancy less than 12 months or a heart transplant anticipated within 6 months
* Inability to successfully comply with study participation and follow up requirements
* Patient involved in another clinical trial that may confound the results of the study
Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients

The purpose of this study is to evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium during general sevoflurane anesthesia in a pediatric population receiving pressure equalization tubes in one or more ear.

Emergence delirium has been described as a dissociated state of consciousness in which the child is irritable, uncompromising, uncooperative, incoherent, inconsolably crying, moaning, kicking or thrashing. The children can run the gambit from restlessness and incoherence to combative and psychotic. The incidence of emergence agitation or delirium is 80% after a procedure with sevoflurane-induced anesthesia.

Dexmedetomidine has been shown to have sedative and analgesic effects. In the pediatric population, it has been shown to provide sedation for radiographic procedures. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intranasally might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing myringotomy and tube placement.

Eligibility Criteria:
Inclusion Criteria:

* ASA class 1 or 2 (healthy patient or acute illness)
* Parental willingness to participate
* Candidate for pressure-equalization tubes (PET) as determined by the ENT department

Exclusion Criteria:

* ASA class 3 or 4 (chronic illness or life-threatening illness)
* Parental refusal to participate
* Significant liver disease by history
* Allergy to dexmedetomidine or midazolam
* Nasal deformity
* Fever in the three days prior to surgery
* Nausea or vomiting
* History of hypertension
* History of cardiac dysfunction/disorder
* Diabetes mellitus
Hidradenitis - an Analysis of Genetic Traits and Linkages in Families

The aim of this study is to find a genetic link or family trait connecting persons with Hidradenitis Suppurativa (HS) to each other. As a result, discover the cause and perhaps treatment for Hidradenitis Suppurativa (HS).

Hidradenitis suppurativa (HS) is a chronic, debilitating skin disease characterized by multiple abscesses located predominantly in areas such as armpit, genital, pelvic, and perineum. It is considered an orphan disease of unknown origin and no existing treatment with a population prevalence estimated between 1-4%. It develops in otherwise healthy patients after puberty and affects patients life-long. HS often requires multiple surgical procedures to drain large abscesses, or hospitalization to treat infected wounds, can lead to feelings of personal embarrassment and social stigmatization.

Anecdotal evidence from affected families shows that HS often "runs in families" and may be inherited in a Mendelian fashion; however, no adequately powered study has been undertaken to investigate this hypothesis. This project aims to characterize the inheritance pattern of HS in families, and identify the genetic cause of this disease in those families with evidence for monogenic inheritance.

Data collection includes blood sample analysis (DNA), medical history, and information pertaining to any known family history of HS, from which a familial pedigree can be generated. This 'family-based' genetic study design will include both affected and unaffected family members, ideally spanning several generations. Therefore, study patients will be asked to refer their immediate and extended (affected and unaffected) family members to this research study.

Eligibility Criteria:
Inclusion Criteria:

* Participants (affected) with Hidradenitis Suppurativa and related symptoms
* Family (unaffected) of participants with Hidradenitis Suppurativa

Exclusion Criteria:

* Children under 7-years of age
Characterisation of Gut Microbiota, Bispectral Index Data and Plasma Kynurenine in Patients Undergoing Thyroid Surgery

The study is a case-controlled observational trial. Forty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data. Firstly, this study aims to characterise the lung microbiota in patients treated with thyroid surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

The study is a case-controlled observational trial. Forty patients will be divided into 2 groups (good or poor sleepers) depending on their first postoperative night Bispectral index data. Firstly, this study aims to characterise the lung microbiota in patients treated with thyroid surgery. Secondly, it aims to evaluate microbiota and its influence on plasma kynurenine.

Eligibility Criteria:
Inclusion Criteria:

* ethnic Chinese;
* age, 18 to 65 years old;
* American Society of Anaesthesiologists (ASA) physical status I or II

Exclusion Criteria:

* Cognitive difficulties
* Affiliated with the Social Security System
* Partial or complete gastrectomy
* Previous esophageal surgery
* Inability to conform to the study's requirements
* Deprivation of a right to decide by an administrative or juridical entity
* Ongoing participation or participation in another study \<1 month ago
Finite Element Study of Biomechanical Changes After Unilateral Hemilamina and Facet Joint Resection of Cervical Spine

Finite element method was used to simulate unilateral hemilaminectomy of cervical spine and facet joint resection of different degrees, and the range of motion and the stress changes of ligament, intervertebral disc and endplate were calculated immediately after operation

The finite element method was used to simulate unilateral hemilaminectomy of cervical spine and different degrees of facet joint resection, and the range of motion and the stress changes of ligaments, intervertebral discs and endplates were calculated immediately after the operation.

Finite element method was used to simulate unilateral hemilaminectomy of cervical spine and facet joint resection of different degrees, and the range of motion and the stress changes of ligament, intervertebral disc and endplate were calculated immediately after operation.

Study Design:

This study is a retrospective and general observational study.In this study, a young patient who was hospitalized in the Neurosurgery Department of the Third Hospital of Beijing University of Medicine and had undergone CT examination of cervical vertebra was selected. The patient had no cervical bony deformity, no cervical degeneration, and no history of trauma.

CT imaging data were collected, and a three-dimensional finite element model of C2-T1 segment of human cervical spine was established by finite element software. On the basis of this model, two and three levels of unilateral hemilamina and different degrees of facet joint resection were simulated.The lower end of the T1 vertebral body was fixed as the boundary condition, and three loading modes were adopted, namely, 2.0nm pure torque was applied to the upper surface of the C2 vertebral body along the sagittal plane, coronal plane and axial plane, respectively.The range of motion between vertebral segments was calculated and compared in different lamina surgical models. The tension of ligaments, the pressure of endplates and the pressure of intervertebral discs were obtained by finite element post-processing

Eligibility Criteria:
Inclusion Criteria:

A young patient hospitalized in the Department of Neurosurgery of the Third Hospital of Beijing University of Medicine underwent CT examination of cervical vertebrae.

Exclusion Criteria:

Cervical bony deformity Cervical degeneration History of trauma
Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is a rare and aggressive type of lymphoma, with only about 3,000 cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being done to better understand how to treat MCL.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated advanced stage mantle cell lymphoma (Clinical stage 2 with abdominal involvement, stage 3 and stage 4).
* Histologic diagnosis confirmed by MSKCC pathologist as mantle cell lymphoma with Cyclin D1, or D2 and/or, D3 staining performed. Presence of measurable disease as determined by FDG-PET, CT, endoscopy, colonoscopy, or bone marrow biopsy.
* Ages 18-70.
* Transplant eligibility as confirmed by the Disease Management Team.
* KPS ≥ 70%.

Adequate organ function:

* WBC ANC ≥ 1000 cells/mcL and platelet count ≥ 100,000 cells/mcL unless felt to be secondary to underlying mantle cell lymphoma at which any count is permissible.
* Adequate renal function as determined by Cr \< or = to 1.5 mg/dL or 24 hr creatinine clearance ≥ 50 ml/hr
* Adequate hepatic function as determined by total bilirubin \< or = to 1.5x ULN (unless known Gilbert syndrome) and AST \< or = to 5.0x ULN.
* Cardiac ejection fraction greater than or equal to 50% as determined by echocardiogram or MUGA.
* For patients ≥ age 60, a stress echocardiogram will be required, with same requirements as above.
* DLCO greater than or equal to 50% as determined by pulmonary function tests performed prior to initiation of treatment.
* Patients with positive Hepatitis B serologies will be treated per institutional guidelines.

Exclusion Criteria:

* Prior treatment for mantle cell lymphoma, including more than 7 days of steroids, immunotherapy, radioimmunotherapy, or chemotherapy. This does not include patients who have initiated R-CHOP at an outside institution within 2 weeks of enrollment.
* Patients using \> or = to 10mg/day of steroids for any chronic medical condition
* Pregnant or breast-feeding. Note: Pre-menopausal patients must have a negative, serum HCG within 14 days of enrollment,.
* HIV positive or Hepatitis C antibody positive.
Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.

This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.

The study comprised of a screening period up to 28 days, one Baseline evaluation on Day -1, a single dose administration of 200 mg of iptacopan followed by PK sampling to 240 hr, and an End-of-Study (EOS) visit (Day 11). All participants had a post study safety follow-up call conducted approximately 30 days after last administration of study drug.

Eligibility Criteria:
Inclusion Criteria:

Participants eligible for inclusion in this study met the following key criteria:

* Written informed consent was obtained before performing any assessment.
* Male participants and female participants of non-childbearing potential 18 to 75 years of age (inclusive).
* Participants were to weigh at least 55 kg to participate in the study and were to have a body mass index (BMI) within the range of 18 to 35 kg/m2 for healthy participants.

For hepatic impairment participants without overt ascites, the BMI was to be within the range of 18 to 40 kg/m2. For hepatic impairment participants with overt ascites, the BMI was to be within the range of 18 to 45 kg/m2.

* Ability to communicate well with the Investigator, to understand and comply with the requirements of the study.
* Participant was willing to remain in the clinical research unit as required by the protocol

Exclusion Criteria:

Participants meeting any of the following criteria were excluded from this study:

* Use of other investigational drugs within the last 30 days or 5 half-lives prior to dosing, whichever was longer.
* History of hypersensitivity to the investigational compound/compound class or its excipients being used in this study.
* Pregnant or nursing (lactating) women. Pregnancy was defined as the state of a female after conception and until termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
* Known history of, or current clinically significant arrhythmias, history of prolonged QT correction formula (QTcF) interval or QTcF \> 450 msec (males) or QTcF \> 460 msec (females) at screening in healthy participants and history of prolonged QTcF interval or QTcF \> 470 msec (males) or QTcF \> 480 msec (females) at screening in participants with hepatic impairment.
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients

PH-HFpEF patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.

This study will enroll PH-HFpEF patients that have completed a controlled levosimendan study. These patients will receive weekly open-label doses of levosimendan and be periodically evaluated for safety and effectiveness in extended use.

Eligibility Criteria:
Inclusion Criteria:

1. Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
2. Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc.
3. May, in the opinion of the Investigator, benefit from continued levosimendan treatment.
4. Female patients of childbearing potential must agree to use a highly effective method of contraception.
5. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

1. Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
2. Pregnant or breastfeeding women.
3. Local access to commercially available levosimendan
4. Inability to comply with planned study procedures
5. Patients with scheduled lung or heart transplant or cardiac surgery
6. Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration)
7. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
8. Liver dysfunction with Child Pugh Class B or C (see Attachment 2)
9. Evidence of systemic bacterial, systemic fungal, or viral infection refractory to treatment
10. Weight \>150kg
11. Systolic blood pressure (SBP) cannot be managed to ensure SBP \>100 mmHg at initiation of study drug
12. Heart rate \>100 bpm with study drug, persistent for at least 10 minutes at screening.
13. Hemoglobin \< 80 g/L
14. Serum potassium \< 3.0 mmol/L or \> 5.5 mmol/L at baseline that is unresponsive to management
Comparison of Dietary Protein Intake Patterns and Inadequate Protein Intake in Older Adults Among Countries

The researchers will compare protein intake patterns per day and per meal among older adults from different countries. The analysis will also compare the proportion of inadequate protein intake per day (different cut points), per meal (breakfast, lunch, dinner), and the number of meals per day that reach an adequate protein content.

There will be a literature review in search of other studies reporting protein intake patterns in older adults. These studies must report total, and per-meal protein intake, evaluated through 24-h dietary recalls, food diaries or food frequency questionnaires. Afterwards, the researchers will contact the authors for data requests and analyze the data; these data will also include some demographic variables (e.g. sex, age, height, weight). Once the data are obtained, the patterns of protein intake will be compared among countries with an ANOVA test. As it is very likely that variances and/or sample sizes will be unequal, a Welch's correction and a Dunnett test for post hoc analyses will be performed. This analysis is going to be performed for the whole sample and by sex. Similarly, the proportion of older adults that do not reach the recommended amounts of protein in a daily (0.8, 1.0, 1.2 g/kg/day) and per meal basis (30 g, 0.4 g/kg) will be calculated. These proportions will be compared among countries with a chi-squared test and employing a z-test for proportions (with Bonferroni adjustment) to identify pairwise differences.

Eligibility Criteria:
Inclusion Criteria:

* Community dwelling

Exclusion Criteria:

* Incomplete data registries
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole

This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.


Eligibility Criteria:
Inclusion Criteria:

* full thickness macular hole
* \>16 years old

Exclusion Criteria:

* any history of previous intraocular surgery (including cataract surgery)
* history of ocular trauma
* history of visual loss greater than 1 year
Spinal Pain and Autonomic Responses to Chiropractic Care

This randomized, single-blinded study will investigate the effects of Spinal Manipulative Therapy on Heart Rate Variability and Pain Sensitivity in a population of patients with recurrent and persistent neck pain. Alongside, the study will also develop a clinical test for Conditioned Pain Modulation and investigate its predictive properties.

Previously, Spinal Manipulative Therapy (SMT) was thought to mechanically affect the restoration of muscular and joint function, by normalising muscle tension and joint mobility. However, recent research has suggested that SMT may be influencing the incoming/ascending pain signals and/or the excitability of the central pain regulating mechanisms. People with chronic neck/shoulder pain have been found to have a disturbance of the Autonomic Nervous System (ANS). Little is known about the changes in the ANS and its relation to changes in pain in a series of treatments conducted in a clinical setting.

This multicentre randomized controlled clinical trial will be carried out in multimodal primary care clinics where both physiotherapists and chiropractors are consulted for musculoskeletal issues are selected to minimize selection bias from the patient's pre-desired treatment modality.

The subjects will be recruited among patients seeking care for persistent or recurrent Neck pain (NP), either self-selected or through referrals from general practitioners in the local areal. The aim is to study the effect of SMT and stretching exercises compared to stretching exercises alone, two well-known interventions for NP, during a two-week treatment regimen.

The primary outcome is the activity of the autonomic nervous system (Heart Rate Variability (HRV), but also Conditioned Pain Modulation (CPM) will be measured. HRV and CPM will be measured at baseline, prior to the third treatment and after the fourth treatment.

The subjective pain experience will be investigated by using two different instruments accessing pain intensity and the affective quality of pain, asked at the assessments during the two weeks of treatment and 2 months after the period of intervention ends.

Highly structured data collection procedures should provide reliable data to answer these questions. The study utilizes normal clinical procedures, which should aid the transferability of the results.

Eligibility Criteria:
Inclusion Criteria:

* minimum 18 years,
* able to read and understand Swedish,
* persistent or recurrent Neck Pain (duration of current episode more than 6 months and at least one previous episode of NP),
* no chiropractic treatment during the previous 3 months.

Exclusion Criteria:

* conditions or medications that will affect the Heart Rate Variability measurements (cardiovascular disease, diabetes, pregnancy, obesity, currently using pain-reducing medication, steroids or antidepressants),
* all contraindications to manual treatment, (anything that could seriously aggravate the pain (such as inflammatory conditions) or signal cerebrovascular injuries (previous drop attacks or a recent episode of new headache or dizziness).
Analysis of Passive Leg Raise Test on Blood Pressure in Critically Ill Patients.

Positioning intensive care patients in Trendelenburg position to identify fluid responsiveness assessed by PiCCO device.

It is a prospective observational study. Patients admitted to Intensive Care Unit of University Clinical Centre of Gdańsk, receiving advanced hemodynamic monitoring with PiCCO method will be enrolled. After blood pressure measurement, PiCCO will be calibrated with transpulmonary thermodilution with 10 - 20 ml of cold saline. Readings will be noted. The patient will be positioned in Trendelenburg position with it's head 15 degrees down. The increase of blood pressure after positioning in relation to the values obtained before the trial will be correlated to the parameters that asses patent's volaemia. After 5 minutes patient will be back to supine position and hemodynamic parameters will be recorded for another 5 minute.

Eligibility Criteria:
Inclusion Criteria:

* hemodynamic instability
* mechanical ventilation

Exclusion Criteria:

* increased intracranial pressure
* increased intraabdominal pressure
* lower limbs sequential compression system
* agitation
* patients exposed to pain stimulus before the test
* aortic aneurysm
* left to right cardiac shunt
* severe valvular insufficiency