cyrilzakka/clinical-trials huggingface dataset:
Terlipressin in Septic Shock in Cirrhosis

Septic shock is a frequent and severe complication in cirrhosis. Current mortality rate ranges between 50 and 80% of cases. Refractory shock, hepatorenal failure and variceal bleeding are the main causes of death of these patients. Terlipressin administration could prevent these complications and improve survival in this setting.

Aim: To evaluate the effects of terlipressin administration on hospital survival in cirrhotic patients with severe sepsis or septic shock.

Methods: Prospective, open labelled, controlled trial evaluating 72 cirrhotic patients with severe sepsis or septic shock who will be randomized to receive terlipressin plus alpha-adrenergic drugs or only alpha-adrenergic drugs at shock diagnosis. Patients will be submitted to continuous systemic hemodynamic monitoring (S. Ganz catheter or Vigileo). Changes in vasoactive systems and cytokines levels will be also evaluated.

Prospective, open labelled, RCT evaluating 72 cirrhotic patients with severe sepsis or septic shock (36 per arm) who were randomized to receive terlipressin plus alpha-adrenergic drugs or alpha-adrenergic drugs in the first 24h after septic shock diagnosis. Impact of terlipressin administration on shock reversal, changes in vasoactive systems, inflammatory response, incidence of variceal bleeding and type-1 HRS and ICU and hospital mortality was investigated

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years;
2. Diagnosis of cirrhosis based on histology or on clinical, laboratory and ultrasonographical data;
3. Diagnosis of septic shock based on the presence of data compatible with systemic inflammatory response syndrome, a mean arterial pressure below 60 mmHg during more than 1 hour despite adequate fluid resuscitation, and need for circulatory support with vasopressor drugs.

Exclusion Criteria:

1. More than 24 hours of evolution of the shock;
2. Cardiac index \< 2,5 l/min;
3. History of HIV infection or clinically relevant pulmonary, renal or cardiac disease except for atrial fibrillation;
4. Pregnancy;
5. Advanced hepatocellular carcinoma (Milan criteria);
6. Previous history of transplantation;
7. Uncontrolled gastrointestinal bleeding.
Overcoming Analgesic Tolerance to TENS

The purpose of this study is to determine if changing the frequency or intensity of transcutaneous electrical nerve stimulation (TENS) can reduce the development of tolerance to TENS treatment.

Healthy adults will come daily for 5 consecutive days to the testing room. Pressure pain thresholds (PPT) will be the outcome measure and will be used to measure the subject's pain threshold to deep mechanical pressure. Subjects will push a button to stop the PPT test when they first begin to feel a sensation of pain. The PPT test will be done before TENS application. The TENS unit will be applied based on random assignment to 1 of 5 treatment types and subjects will not be told which group they are assigned to. Those groups are: 1) placebo TENS, 2) high frequency TENS, 3) alternating frequency TENS, 4) modulated frequency TENS, or 5) high frequency TENS with increased intensity daily. The TENS unit will be applied for 30 minutes. After 20 minutes the PPT test will be completed a second time. This procedure will occur on all 5 consecutive days of testing. Data will be measured and recorded by an assessor blind to subject group. Blinding will be assessed at the end of testing on day 5.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 Years of Age (YOA)
* no current pain condition

Exclusion Criteria:

* Pregnancy
* Cardiac pacemaker
* Currently experiencing pain
* Abnormal sensation in dominant forearm
* History of seizures
* Prior TENS use
Organ Preservation Media Investigation

Kidney transplantation remains limited by four problems: 1) a too high rate of delayed graft function, 2) early loss of kidneys from chronic rejection, 3) donor kidney shortages, and 4) the need for immunomodulating treatments. Improved cold storage methods can significantly impact on the first 3 of these 4 major problems. The device to be tested is a modification of the existing Viaspan organ preservation solution. The modification of this solution combines four compounds: Bovine neutrophil peptide-1 (BNP-1), Substance P (SP), Insulin-like growth factor-1 (IGF-1), and Nerve Growth Factor (NGF). This solution will be added to Viaspan for preservation of donor kidneys. Preclinical data indicates that trophic factor deprivation during cold storage is a significant and previously unrecognized mechanism of injury in cold stored kidneys. The aim of this study is improved graft function, decreasing early graft loss due to rejection, and decreasing the donor organ shortage.


Eligibility Criteria:
Inclusion Criteria:

* first renal transplant, PRA's \<20%

Exclusion Criteria:

* PRA's greater than 20%
* Subjects who are receiving a non-primary renal transplant
* Subjects under the age of 18
* Pregnant or nursing women
A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)

This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML.

This is a multicenter, open-label evaluation of feasibility, safety and immunotherapy in patients with AML in complete clinical remission. Patients will undergo leukapheresis prior to or shortly after completing consolidation chemotherapy. Dendritic cells will be transfected with the messenger RNA encoding human telomerase reverse transcriptase (hTERT) and a portion of the lysosome-associated membrane protein LAMP-1 (LAMP), matured, aliquoted, and cryopreserved. The final autologous vaccine product is referred to as GRNVAC1. Patients will be vaccinated with weekly for 6 weeks,will "rest" for 4 weeks, then will receive 6 boost injections, each administered every other week for 12 weeks. Patients will be followed every 4 weeks until Week 54, then every 3 months for 1 year, then every 6 months up to approximately 5 years from the first vaccination or until relapse/progression.

Eligibility Criteria:
Inclusion Criteria:

* AML in first complete remission (CR1) or in second complete remission (CR2) with CR1 \>/= 6 months
* Has completed at least one cycle of consolidation chemotherapy within past 6 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hepatic/renal function

Exclusion Criteria:

* CR1 and good risk cytogenetic features \[t(15;17), t(8;21), inv(16) or t(16:16)\]
* Central nervous system or leptomeningeal disease
* Allogeneic stem cell transplant planned or expected
* Documented allergy to penicillin or beta-lactam antibiotics
* Active or ongoing autoimmune disease
* Clinically significant pulmonary or cardiovascular disease
Vibraimage Technology for Detecting Depression in Psychiatric Outpatients

Vibraimage technology captures high-frame-rate images of head-neck movements, converting them into vibraimages that display muscle vibration amplitude and frequency. Using algorithms and calculations, it derives an emotional index from these images. This non-contact, objective method analyzes psychological indicators through micro-movement detection. An algorithm has been developed to detect depression by calculating 12 emotional and 2 psychophysiological parameters. This diagnostic accuracy study aims to validate the technology's ability to diagnose depression in psychiatric outpatients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 70 years.
* No difficulties in reading or writing Chinese; fluent in Mandarin.
* Currently not taking psychotropic medications or on a stable dose for at least 6 weeks.
* Provided informed consent to participate in the study.

Exclusion Criteria:

* Schizophrenia.
* Bipolar disorder.
* History of organic brain disease or significant head trauma.
* Presence of severe systemic medical conditions.
* Suicidal ideation or a score ≥3 on Item 3 ("Suicide") of the 17-item Hamilton Depression Rating Scale (HAMD-17).
* Substance dependence or abuse.
* Intellectual disability or dementia.
* Inability to complete video capture or cooperate due to uncontrollable factors (e.g., hyperactivity, Parkinson's disease, or other conditions that prevent remaining still)
Comparison of Efficacy Between Combination of Amitriptyline-propranolol and Pizotifen for Migraine Prophylaxis.

The goal of this clinical trial is to compare efficacy and observe common adverse effects of a combination of amitriptyline-propranolol and pizotifen as prophylactic treatments for migraine. The main question it aims to answer is:

• Does pizotifen more effective than the combination of amitriptyline-propranolol in migraine prophylaxis?

Participants will be asked to :

* Maintain the provided headache diary accordingly
* Take supplied drugs as described during clinical visits
* Contact principle investigator if there is any issues regarding drug use and/or their adverse effects


Eligibility Criteria:
Inclusion Criteria:

1. Patient of migraine (with typical aura or without aura) according to ICHD-3 (International Classification of Headache Disorder, 3rd edition) criteria.
2. Age at entry: 18 to 50 years (to minimize the risks related to adverse effects of study drugs such as drowsiness, weight gain, A-V conduction block, postural hypotension)
3. Patients not on any prophylactic medications.
4. Patients willing to take part in the study.
5. Patients being able to fill a headache diary successfully \& reliably.

Exclusion Criteria:

1. Age \<18 years or \>50 years
2. Patients having headache other than migraine, complicated migraine, ophthalmoplegic migraine, catamenial migraine, basilar migraine.
3. Patients on prophylactic medication.
4. Co-morbidities such as heart failure, hepatic or renal impairment, diabetes, bronchial asthma, malignancy, intracranial vascular aneurysm, pregnancy \& breastfeeding etc.
5. Patients having known hypersensitivity to amitriptyline, propranolol or pizotifen
The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury

An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.

Patients admitted to Aberdeen ICU with severe traumatic brain injury will have a BIS electrode placed and observed for 24 hours. The study team will be blinded to the result, so not to influence treatment.

All clinical care is at the discretion of the clinical team.

Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18)
* Diagnosis of traumatic brain injury
* Expected to survive
* Expected to require greater than 24 hours of sedation and mechanical ventilation

Exclusion Criteria:

* Brain injury thought to be unsurvivable by ICU clinical team
* Frontal decompressive craniectomy
* Use of ketamine infusion at recruitment or planned use within 24 hours
* Fractured frontal bone or severe overlying soft tissue injury
* Simple extradural haemorrhage with no other obvious intracranial injury
* Pregnant patient
Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm

The purpose of this study is to evaluate the Efficacy and Safety of NABOTA in treatment of essential blepharospasm


Eligibility Criteria:
Inclusion Criteria:

* Male of female of at least 18 years old
* Grade 2\~4 in Scott's scale
Cognitive Processing Therapy (CPT) Memory Support (MS) Study

The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT), an empirically supported and widely disseminated treatment for PTSD. MS was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. A pilot randomized controlled trial (n=52) comparing CPT with Memory Support (CPT+MS) to CPT-alone will be conducted. Study participants will be adults diagnosed with PTSD.

The primary aim of the trial will be to determine if CPT+MS will lead to greater memory and learning of therapy content relative to CPT-alone, and to establish the acceptability and feasibility of integrating MS into CPT. Secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in PTSD symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. Exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of MS. Results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving PTSD treatment outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of PTSD as determined by the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* For potential participants on psychiatric medication, dose must be stable for the past four weeks.
* Veteran status

Exclusion Criteria:

* Current DSM-5 diagnoses of unstable bipolar disorder, past or present psychosis, or organic mental disorder
* Active suicidal or homicidal ideation with plan or intent
* Current moderate or severe substance use disorder, as defined by DSM-5 \[i.e., at least 4 diagnostic symptoms of Substance use disorder (SUD) present\]
* Prior receipt of CPT or concurrent therapy for PTSD
* Significant cognitive impairment as indicated by a score \<10th percentile on the Montreal Cognitive Assessment
* History of moderate or severe traumatic brain injury (TBI) based on the Ohio State University TBI Identification Method and Veterans Administration/ Department of Defense (VA/DOD) guidelines
* High verbal memory ability, as indicated by a score \>1 standard deviation (SD) above the population mean on the California Verbal Learning Test® Third Edition (CVLT-3) immediate recall task
Preoperative Hemogram Parameters and BRAF Molecular Test Detected by Bethesda 3 Cytology.

The main hypothesis of this study is that preoperative hemogram parameters can be used as biomarkers for malignancy in patients with thyroid nodule Bethesda 3 cytology.

The secondary hypothesis is that BRAF molecular testing has a high predictive value in predicting malignancy in patients with thyroid nodule Bethesda 3 cytology.

Primary outcome: Preoperative hemogram parameters. Secondary outcome: BRAF positivity.

The main hypothesis of this study is that preoperative hemogram parameters can be used as biomarkers for malignancy in patients with thyroid nodule Bethesda 3 cytology.

The secondary hypothesis is that BRAF molecular testing has a high predictive value in predicting malignancy in patients with thyroid nodule Bethesda 3 cytology.

Primary outcome: Preoperative hemogram parameters. Secondary outcome: BRAF positivity. This study aims to reduce unnecessary thyroidectomies, thyroidectomy complications and treatment costs due to Bethesda 3 cytology.

The age and gender of all patients to be included in the study will be recorded. Mean Platelet Volume (MPV), Neutrophil/lymphocyte Ratio (NLR), Platelet/Lymphocyte Ratio (PLR) and Lymphocyte/Monocyte Ratio (LMR) will be recorded in preoperative hemograms. Nodule sizes detected by preoperative Bethesda III cytology will be recorded. The sizes of nodules with preoperative AUS cytology after thyroidectomy, determined as a result of pathological examination, will be recorded. Patients with malignant cytology will be divided into papillary thyroid carcinoma (PTC), Follicular Thyroid Carcinoma (FTC), and tumor sizes will be recorded. Among the patients included in the study, BRAF molecular testing will be performed on the preoperative cytology of 25 patients whose thyroidectomy materials were reported to be malignant.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 18 -75
2. Patients who were diagnosed with Bethesda III as a result of preoperative FNAC and decided to undergo thyroidectomy

Exclusion Criteria:

1. Patients over 18 years old and under 75 years old
2. Patients with malignancy detected in another focus with preoperative Bethesda III FNAC
3. Detection of malignancy in another focus other than the nodule with Bethesda III cytological result after thyroidectomy
4. Failure to obtain preoperative hemogram results Patients who do not agree to participate in scientific studies for BRAF testing
French National Registry of Rare Peritoneal Surface Malignancies

Despite advances in the management of and changes in clinical practice, little is known about the epidemiology, patterns of care and outcomes of rare peritoneal surface malignancies patients in France.

In order to better understand the characteristics of rare peritoneal surface malignancies and to evaluate treatment strategies, the RENAPE registry aims at the collection of data from patients presenting with a rare peritoneal surface malignancy in France. Data will be entered prospectively in a specifically designed and secured web database.

All RENAPE's centres and physicians are invited to register patients with a rare peritoneal surface malignancy diagnosis and to participate to the registry. Data will be evaluated within regular time frames, focusing on types of rare peritoneal surface malignancies, treatment modalities and patient outcomes (e.g. survival, recurrence), thereby contributing to the better understanding of these rare cancers.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible if they have a histologically proven rare peritoneal surface malignancy.

Exclusion Criteria:

* Histological diagnostic of peritoneal surface malignancy not confirmed
* Expected clinical follow up data not available
Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

This phase II trial studies the side effects and best dose of propranolol when administered concurrently with SOC neoadjuvant CRT in patients with esophageal carcinoma, with a safety lead-in and dose expansion cohort. Patients who are already on β-blockers will receive standard of care CRT and will be considered separately as a single arm prospective cohort

PRIMARY OBJECTIVE:

I. To determine the safety and efficacy of propranolol hydrochloride (propranolol) in combination with standard neoadjuvant/definitive chemoradiation therapy (CRT) for esophageal cancer.

SECONDARY OBJECTIVE:

I. To estimate overall survival (OS) and pathologic response rate in patients that undergo surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing definitive or neoadjuvant CRT for histologically confirmed esophageal adenocarcinoma
* Have an ECOG performance status of 0-1
* Have the ability to swallow and retain oral medication. If a patient is not able to swallow, they are still eligible for study provided they have an enteric feeding placed which will permit administration of crushed tablets or liquid formula propranolol prior to first radiation treatment
* Participants of child-bearing potential must have a negative pregnancy test at study entry And then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. - Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

Exclusion Criteria:

* Contraindications to the use of beta-blockers, e.g.; uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association (NYHA) Grade III or IV), hypotension ( systolic blood pressure \<100 mmHg), severe asthma or COPD, uncontrolled type I or type II diabetes mellitus (HbA1C \>8.5 or fasting plasma glucose \> 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements, cardiac arrhythmia (atrial fibrillation/flutter), severe bradycardia (heart rate of \<50 beats per minute or 1st/ 2nd /3rd degree heart block)
* Pregnant or nursing female participants,
* Unwilling or unable to follow protocol requirements
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug
Pilot Trial Investigating Every Other Day Dosing of Oral Iron in Premature Infants (IQONic)

Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates

Iron is an important component of hemoglobin, and an essential part of erythropoiesis. It is also a necessary micronutrient for rapidly proliferating and differentiating cells and tissues especially in the brain. Iron deficiency in infancy has been associated with anemia and impaired neurodevelopmental outcomes that extend into childhood. Premature infants are at highest risk for iron deficiency because they are deprived of the iron accretion that occurs in the third trimester of pregnancy, are born with lower iron stores compared to their term counterparts, and have increased utilization and depletion of iron stores with their rapid growth rate.

In older populations, EOD iron supplementation is as effective as daily iron supplementation in the treatment of iron deficiency anemia, with studies revealing significantly fewer gastrointestinal side effects in those who are on EOD iron. Adults regulate their iron status through a feedback pathway involving hepcidin whereby iron-sufficient individuals will have upregulated hepcidin, which leads to decreased iron absorption and availability. Recent studies have revealed that pediatric patients and premature neonates regulate iron absorption through hepcidin in a similar fashion. Though the regulation of iron status through hepcidin has been studied in extremely premature neonates, the clinical effect of EOD dosing of iron has not yet been examined in this population.

This is a non-inferiority, blinded, randomized control trial designed to investigate if EOD iron is comparable to daily iron dosing in achieving iron replete status by reticulocyte hemoglobin measurements in premature infants.

Eligibility Criteria:
Inclusion Criteria:

* Children (Minor \< 18 years of age)
* Neonates
* Hospitalized
* Premature infants who are on full enteral feeds and are started on oral iron
* Premature infants who completed 26 0/7 to 32 6/7 weeks' gestation at birth

Exclusion Criteria:

• Infants with known congenital anomalies or chromosomal abnormalities (such as Trisomy 18 or Trisomy 21), conditions that affect iron metabolism (such as thalassemia or hemochromatosis), bleeding disorders or coagulopathy, and received iron parenterally prior to randomization