cyrilzakka/clinical-trials huggingface dataset:
Primary Prevention of Major Depression Based on the Level and Profile of Risk of Primary Care Attenders: Cluster, Controlled, Randomised Trial

The main objective is to measure the effectiveness of a new intervention for primary prevention of major depression based on the level and profile of risk of primary care attendees. Among the secondary objectives is to evaluate the cost-effectiveness and cost-utility of the intervention versus usual care. METHODS: This is a cluster, randomised controlled trial of a community intervention with cluster at the level of practice. It will be undertaken in primary medical care in 7 Spanish cities and 5 autonomous communities.The aim is to evaluate a new intervention for primary prevention of major depression based on patients' level and profile of risk. Family doctors in the intervention practices will provide the intervention for patients at risk. Patients at risk who are recruited in control practices will receive usual primary care. The main outcome is the accumulated incidence of major depression (measured by CIDI) during the follow-up. The investigators will assess main outcomes and other covariables at baseline, 6, 12, and 18 months. A random sample of 3,381 primary care attendees (1,690 for each arm), aged 18-75 and without major depression will be recruited in 70 health centres (140 family doctors) in 7 cities. The investigators shall undertake a logistic regression multilevel model with 4 levels (time, patient, doctor and health centre). The investigators shall also undertake multivariate gamma and quantile regression to assess respectively the cost-effectiveness and cost-utility of the new intervention versus usual care, estimating their standard errors by bootstrap.


Eligibility Criteria:
Inclusion Criteria:

* Patients among those attending to primary care centers.

Exclusion Criteria:

* Age under 18 or over 75 years.
* Unable to understand or speak Spanish.
* Represented patients (that is, someone else comes to visit on behalf of the patient).
* Cognitive impairment.
* Psychosis.
* Terminal illness.
* Planning to be outside of the the city during 4 or more months during the next 18 months.
Bioenergetics in Surgical Patients

To identify patients who may be predisposed for developing MOF (multiple organ failure)by the sampling of blood.

The rationale for doing this study is the recognition that mitochondrial DNA Damage Associated Molecular Patterns (mtDAMPs) accumulate in the circulation after severe injury. Furthermore our own studies in severely injured patients identify that the mtDAMPS are increased 3-28 fold in those patients who eventually develop multiple organ dysfunction syndrome (MODS) compared to those severely traumatized patients who did not develop MODS. The relative risk of death from MODS after severe trauma was increased 8-20 times in those patients with elevated mt DAMP levels.

This study is then being done to correlate mitochondrial damp levels in surgical trauma to assess the time course and the levels of mtDAMPs with the type of surgical procedure. We believe that this information will help us to determine the time course of events and the triggers for development of multiple organ dysfunction seen after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients @ USAMC undergoing surgical operations expected to have microcirculatory changes, i.e., CABG, open heart, aortic or other revascularizing operations, general surgical operations such as colon resections, bowel resections or any other surgical procedures in which the subject could be expected to or might develop multiple system organ failure.

Exclusion Criteria:

N/A
The Effects of Ketamine on Respiratory Stimulation and Transpulmonary Pressures

Impairment of airway patency is a common cause of extubation failure and opioids and hypnotics can adversely affect airway patency. Ketamine, a noncompetitive antagonist of N-methyl-D-aspartate (NMDA), unlike other anesthetics activates respiratory effort and promotes bronchodilation. At subanesthetic plasma concentration, ketamine reduces both opioid and propofol requirements.

The purpose of this pharmaco-physiological interaction trial is to evaluate the effects of ketamine on breathing and electroencephalography in mechanically ventilated patients.

Maintaining the patency of the upper airway in sedated and anesthetized patients is challenging especially when patients are ready to be weaned from mechanical ventilation. Spontaneous breathing trial (SBT) is used to expedite the weaning process, which oftentimes requires the reduction and/or discontinuation of sedatives and analgesics. In some surgical patients, reducing these medications can lead to pain associated agitation and inability to conduct SBTs, which may prolong the need for mechanical ventilation. Using medications with narcotic sparing effects and that do not cause respiratory depression may allow for the reduction or discontinuation of agents that depress respiratory drive and subsequently facilitate extubation.

Ketamine has been used for many years in critically ill patients for sedation and analgesia. This noncompetitive antagonist of N-methyl-D-aspartate (NMDA) is used as an anesthetic and analgesic and has been shown to reduce opioid consumption and to prevent the development of opioid tolerance. Unlike other anesthetics, ketamine activates respiratory effort and promotes bronchodilation. At subanesthetic plasma concentration, ketamine reduces both opioid and propofol requirements.

The goal of this pharmaco-physiological interaction trial is to evaluate the effects of ketamine at a subanesthetic dose on breathing and electroencephalography. The investigators hypothesize that ketamine drip at a subanesthetic infusion rate (low dose ketamine 5 - 10 mcg/kg/min) is associated with respiratory stimulating effects and does not markedly increase transpulmonary pressure in mechanically ventilated patients.

The primary outcome is respiratory function, assessed through peak inspiratory flow, tidal volume,respiratory rate, duty cycle, and minute ventilation measured 15 minutes prior to initiation of ketamine infusion (to serve as baseline), at 60 minutes of ketamine infusion at 5mcg/kg/min, at another 60 minutes of infusion at 10mcg/kg/min, at which point the infusion is stopped for 3 hours for a final set of measurements.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years admitted to ICU requiring mechanical ventilation
* Suitable for spontaneous breathing trial
* Candidate to received low dose ketamine by the primary critical care team

Exclusion Criteria:

* Esophageal injury
* Allergic to ketamine
* Known neurodegenerative disorders
* Major neurologic disorders (elevated ICP)
Musical Intervention on Stress Effects in Critically Ill Patients

Aim: To evaluate the effects of a musical intervention on serum cortisol, prolactin, interleukin-6 levels and physiological parameters in sedated patients undergoing invasive mechanical ventilation.

Design, Setting and Study Subjects: A randomized clinical trial will be conducted in the ICU of a spanish tertiary hospital. The study subjects will be adults, intubated, subjected to invasive mechanical ventilation, arterial catheter undergoing invasive mechanical ventilation, carrying an arterial catheter, with an adequate level of sedation and who do not present pain during the intervention.

Variables: The main variable will be total serum cortisol, prolactin, interleukin-6 levels. Secondary variables: secondary variables will be those used to measure physiological parameters to assess the patient's hemodynamic status of the patient in relation to the intervention.

Data collection: There will be 2 groups: intervention and control. The sample will be randomized as patients are admitted. First, they will be receiving the corresponding daily care. The first group of patients will receive the corresponding daily care. The patients in the intervention group will start the music therapy session through headphones, the patients in the control group will remain relaxed without any interruption during this time. All the variables will be collected before starting the study, during the study and at the end of the study.

Data analysis: A descriptive analysis of each variable will be performed. Subsequently, a bivariate analysis, previously checking the normality and homoscedasticity of the data.and homoscedasticity of the data. If statistically significant, post-hoc tests will be performed using Dunn's test.Dunn's test. Statistical significance will be accepted when p ≤ 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Admitted to the ICU for a minimum of 24 hours
* Intubated patients undergoing invasive mechanical ventilation
* Arterial catheter carriers / central venous catheter
* Sedation level: BIS: 40 - 60
* No pain at the time of and during the procedure, which will be measured by a score of 0 on ESCID scale
* Not having previously undergone any other musical intervention.

Exclusion Criteria:

* Severe neurological disease or injury (CNS pathologies such as encephalitis, diffuse axonal injury, etc.)
* Severe psychiatric illness
* Suspected or confirmed drug or alcohol overdose/intoxication/abstinence
* Hearing impairment
* Skull lesions that preclude the use of headphones
* Patients with limitation of therapeutic effort or death expected within 24 hours
* Brain death diagnosis
* Failure to obtain informed consent from the legal representative within 72 hours of presentation
* Refusal of the responsible physician.
Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency As Open Label Extension

This is an open-label extension study for patients previously enrolled in the AB2 Bio Ltd. ongoing Phase III clinical trial NLRC4/XIAP.2016.001 (IND N° 127953). This OLE study will evaluate the long-term safety and tolerability of Tadekinig alfa in patients suffering from pediatric monogenic autoinflammatory diseases harboring deleterious mutations of NLRC4 and XIAP.

Pediatric auto-inflammatory conditions related to spontaneous activating mutations of the NLRC4 and with recurrent MAS-like flares with constitutive IL-18 hypersecretion, may require long-term blockade of the IL-18 pathway.

Patients with X-linked inhibitor of apoptosis (XIAP) deficiency and suffering from Hemophagocytic-Lymphohistiocytosis (HLH), a MAS-like syndrome, also show high levels of serum IL-18 and may benefit from IL-18 blockade treatment until a curative hematopoietic stem cell transplantation can be performed The safety of IL-18 blockade during long-term periods is of major interest for the treatment of these patients

Eligibility Criteria:
Inclusion Criteria: (both criteria must be met)

1. Patients have participated in AB2 Bio ltd. Phase III clinical trial NLRC4/XIAP.2016.001 (IND N° 127953) by one of the following mechanisms : a) Patients that have completed the first 18-week RCT phase of the preceding clinical trial but were not eligible for the RW phase due to flare symptoms. Or b) Patients that completed the first 18-week RCT phase and completed the RW phase of the preceding clinical trial. Or c) Patients who have exited either the RCT or RW phase of the preceding clinical trial due to treatment failure requiring rescue immunosuppression. Such patients must wait a minimum of 4 weeks after treatment discontinuation from the preceding clinical trial before enrolling in this OLE. If patients do not consent to enroll in the OLE after their early termination in the main study, they will be asked to continue with the planned visits of the main study
2. Women of childbearing potential with negative urine pregnancy test (UPT) at all visits

Exclusion Criteria:

1. Patients may not enter the OLE if they voluntarily withdrew from RCT or RW study or if the time period between participation exceeds 3 months
2. Evidence or history of malignancy
3. Evidence of invasive or life-threatening infection
4. History of tuberculosis
5. Life-threatening bleeding within 2 weeks of screening
6. Vaccination with a live vaccine within the previous 3 months
7. Evidence of severe organ compromise including but not limited to: (see details in the protocol)
8. Pregnant or breastfeeding females
9. Inability to follow highly effective birth control recommendations during the study and until 1 month after the end of the treatment.
10. Inability to provide informed consent, and also assent if applicable
11. Life expectancy less than 4 weeks
12. Concomitant use of other immunosuppression except NSAIDs, glucocorticoids, cyclosporine, tacrolimus, IL-1 inhibitors (Anakinra, Canakinumab, or Rilonacept)
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)

This is a Phase 1/2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of DNL593 in two parts followed by an optional open-label extension (OLE) period.

Part A will evaluate the safety, tolerability, PK, and PD of single doses of DNL593 in healthy male and healthy female participants of nonchildbearing potential. Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of DNL593 in participants with frontotemporal dementia (FTD) over 25 weeks. Part B will be followed by Part C, an optional 18-month OLE period available for all participants who complete Part B.


Eligibility Criteria:
Key Inclusion Criteria:

Part A:

* Women of non-childbearing potential (surgically sterilized or post menopausal) or men, aged ≥18 to ≤ 55 years
* BMI of ≥ 18 to ≤ 32 kg/m²
* When engaging in sex with a woman of child bearing potential, two forms of birth control are required

Part B:

* Women of non-childbearing potential (surgically sterilized or post menopausal) or men, aged ≥18 to ≤ 80 years. Women who are of childbearing potential but on highly effective, low user dependent contraceptive methods will be allowed.
* BMI of ≥ 18 to ≤ 32 kg/m²
* Have a Clinical Dementia Rating® plus National Alzheimer's Coordinating Center frontotemporal lobar degeneration global score ≥ 0.5
* Have confirmed granulin (GRN) mutation via genetic testing or historical records available for review by investigator
* When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception

Part C:

* All participants who completed Part B of this trial are eligible for an 18-month OLE if the participant has no unresolved clinically significant TEAEs, where continued dosing may represent a risk to participant safety.

Key Exclusion Criteria:

* Have any history of clinically significant neurologic, psychiatric, endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
* Have a history of malignancy, except fully resected basal cell carcinoma or other malignancies at low risk of recurrence
* Have a clinically significant history of stroke, cognitive impairment due to causes other than FTD, seizure within 5 years of screening, or head trauma with loss of consciousness within 2 years of screening
* Have a positive serum pregnancy test or are currently lactating or breastfeeding
Intervention for Victimized Youth

IVY (Intervention for Victimized Youth). Just as ivy plants are strong and can flourish in difficult environments, the goal of IVY will be for targets of peer victimization to thrive academically and socially despite challenging circumstances.

The project involves the development of a virtual intervention program for targets of peer victimization. Intervention for Victimized Youth (IVY) will improve upon many limitations of existing interventions described above since it is the first intervention program to specifically address the needs of targets of peer victimization from a trauma perspective. Moreover, it addresses key limitations of CBITS and increases the flexibility of the intervention by using a virtual delivery model. Just as ivy plants are strong and can flourish in difficult environments, the goal of IVY is for victimized youth to thrive academically and socially despite challenging circumstances. IVY uses a cognitive behavioral therapy (CBT) approach to address current distress due to peer victimization and teach strategies for handling any future peer victimization. Common elements of effective CBT-based trauma treatments are psychoeducation, emotion regulation skills, imaginal or in vivo exposure, cognitive processing, and/or problem solving. Several methods are used within sessions to teach the content, including psychoeducation, didactic teaching, modeling, role playing, and guided self-reflection.

The proposed 8-week intervention. The focus of the first 4 sessions will be on teaching skills to help students overcome emotional difficulties associated with being victimized. Weekly topics include: 1) Introduction \& Psychoeducation, 2) Emotional Regulation Skill Building and Practice, 3) Identifying \& Coping with Difficult Thoughts and Emotions, and 4) Connecting Thoughts, Emotions, and Behaviors. The last 4 sessions are specific to peer victimization issues with a focus on avoiding re-victimization since victimized youth often are victimized repeatedly and report that they defend other victims. Weekly topics include: 5) Options for Protecting Yourself, 6) Social Problem-Solving Skills, 7) Adaptive Thinking, and 8) Future Planning \& Celebration. Participants will be taught several options for intervening. A decision-making process for evaluating social situations will be taught. Based on the outcome of that decision-making process, participants will be taught options for responding with the goal of avoiding re-victimized.

Eligibility Criteria:
Inclusion Criteria:

* current middle school student in US (defined as grades 6, 7, or 8)
* experience at least one instance of peer victimization in past month
* Have elevated or extremely elevated social-emotional distress score, as measured by the BESS (Behavior and Emotional Screening System)

Exclusion Criteria:

* not current middle school student
* not experience victimization in past month
* no elevated score on BESS
Factors Associated With Postoperative Pain in Patients Undergoing TAPP Hernia Repair for Inguinal Hernia

The most common symptom after an inguinal hernia is postoperative pain. According to the severity of the pain, the quality of life of the patient is also affected. There are many factors associated with postoperative pain. In this study, the results related to the factors affecting postoperative pain were investigated.

The most common symptom after an inguinal hernia is postoperative pain. According to the severity of the pain, the quality of life of the patient is also affected. There are many factors associated with postoperative pain. In the literature, there are factors whose relationship could not be determined clearly in the guidelines prepared for this. A meta-analysis showed that TAPP was associated with less chronic pain than open hernia repair. In another study, it was reported that hernia size and type were unrelated to pain. In the same study, the relationship between preoperative pain and postoperative pain was examined. Etele et al. reported that mesh fixation may increase pain. It is thought that the determination of these multiple predictive factors will both guide postoperative pain management and strengthen patient communication. As a result of the research, it is planned to obtain results related to the factors affecting the postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing TAPP for inguinal hernia for the first time

Exclusion Criteria:

* Patients under 18 years of age
* Patients undergoing open hernia repair
* Patients converted from laparoscopic to open
* Patients who are pregnant or likely to become pregnant
* Patients who cannot comply with the treatment or give their own consent for treatment due to their mental state
A Study for Patients Who Completed VITALITY-ALS (CY 4031)

The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).

Enrolled participants will begin dosing of tirasemtiv 125 mg twice daily (250 mg/day) for a period of 4 weeks and will titrate to their tolerated dose, the maximum dose being 250 mg twice daily (500 mg/day). This study will also compare the clinical course of patients who completed treatment with tirasemtiv in CY 4031 with those who completed treatment with placebo in CY 4031 during continued treatment of both groups with tirasemtiv during CY 4033, compare the clinical course of patients who completed treatment with tirasemtiv in CY 4031 during that study with their clinical course during continued treatment with tirasemtiv during CY 4033, and compare the clinical course of patients who completed treatment with placebo in CY 4031 during that study with their clinical course during treatment with tirasemtiv during CY 4033.

Eligibility Criteria:
Inclusion Criteria:

* Able to comprehend and willing to sign an Informed Consent Form (ICF). If verbal consent is given, a Legal Designee of the patient must sign the ICF form
* Completed participation on study drug and the Follow-Up Visit in the CY 4031 study
* Male patients, who have not had a vasectomy AND confirmed zero sperm count, must agree for the duration of their participation in the study to either:

  * Use a condom during sexual intercourse with female partners who are of childbearing potential AND to have female partners use a highly effective means of contraception OR
  * Abstain from sexual intercourse during participation in the study
* Female patients who are not post-menopausal (≥ 1 year) or sterilized, must:

  * Not be breastfeeding
  * Have a negative pregnancy test
  * Have no intention to become pregnant during participation in the study AND
  * Practice sexual abstinence, defined as refraining from intercourse during the duration of the study OR if male partners are not vasectomized with a confirmed zero sperm count, require use of a condom AND use of a highly effective contraceptive measure

Exclusion Criteria:

* Has a diaphragm pacing system (DPS) at study entry or anticipate DPS placement during the course of the study
* Has taken an investigational study drug (other than tirasemtiv) prior to dosing, within 30 days or five half-lives of the prior agent, whichever is greater
* Use of tizanidine and theophylline-containing medications during study participation
* Participation or planning to participate in any form of stem cell therapy for the treatment of ALS or another investigational drug
A Prospective Study of Surgical Treatment Strategies for Chordoma

Chordoma is a rare but locally invasive cancer that arises from the embryonic notochord. Total resection is challenging in mobile spine because of the complex anatomy and bone invasion.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 70 ys,
* With a diagnosis of chordoma confirmed by pathology,
* Undergone surgical treatment in our hospital,
* Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent.

Exclusion Criteria:

* Suffer from other tumors,
* Suffer from cardiovascular disease, cerebrovascular disease, or immune system disease.
Quality of Life (QOL) Registry for Patients With AL Amyloidosis

This is an online registry to document the psychometric properties of SF-36v2 among patients with AL Amyloidosis, to document patients' burden of disease, to better understand the patient's experience and to follow quality of life issues using a variety of QOL measures.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have AL Amyloidosis

Exclusion Criteria: