cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Nursing Intervention on Caregivers

The purpose of this study is to evaluate the effectiveness of a structured nursing intervention (PCE), including two types of intervention defined in the literature (coping strategies promoting social support and empowerment through health education), which has an effect on the perceived quality of life for the caregiver, when compared with conventional intervention or non-support.

Aim: to compare the effectiveness of a standardized care plan (SCP) compared to the usual nursing intervention to improve the quality of life for primary caregivers over 65 years old measured through points change with the EuroQol-5D (EQ-5D) scale.

Secondary objectives:

Evaluate the influence of prognostic variables on quality of life of caregiver. Describe the level of caregiver burden. Describe the socio-demographic profile of the dependent person and caregiver.

Method:

Design: cluster randomized trial. Setting: study in Health Centers Primary Care of Area of Madrid Health Service. Subjects: unit of randomization: primary healthcare centres. Analysis unit: caregivers over 65 years old.

Intervention: The SCP in the treatment group and the usual intervention in the control group.

Sample size adjusted for design effect= 218 (109 in each arm). Main response variable: perceived quality of life (EQ-5D). Secondary response variables: nursing diagnosis, Zarit Caregiver Burden Interview, objective overload level.

Prognostic variables:Dependent person-related: dependence level (Barthel, Lawton-Brody), cognitive dysfunction (Pfeiffer).

Caregiver-related: depression scale (Yesavage), anxiety level (Goldberg), family function (family Apgar). Sociodemographic variables.

Data Analysis: Analysis of main effectiveness by intention to treat, comparing the difference in units on the EQ-5D scale before and post- intervention in both groups at 0, 6, 12 and 18 months. The estimation adjusted, using logistic regression with aleatory effects, those data that can act as confounding factors or change the effect.

Eligibility Criteria:
Inclusion Criteria:

* Not psychological treatment or social support during the study period.
* Be able to follow the trial's demands.
* Experience of caring for at least 6 months in a year.
* Caregivers who consent to take part.

Exclusion Criteria:

* Caregivers of patients hospitalized during the initial data collection.
* Caregivers of institutionalized patients.
* Severe psychiatric conditions including depression and major affective pictures.
* Paid caregivers.
* Experience as a caregiver for less than a month.
Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.


Eligibility Criteria:
Inclusion Criteria:

* Understanding the nature of the study, agreement to its provisions and written informed consent
* Written informed consent of subject´s parents / legal guardians (if subject is under 18 years of age)
* Aged \>= 16 years (from the 16th birthday) to \<= 65 years (to the last day before the 66th birthday)
* Clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial)
* Negative pregnancy test result at the first medical examination (if female and capable of bearing children)
* Agreeing to employ adequate birth control measures for the duration of the study (if female and capable of bearing children)
* Agreeing to keep a subject diary.

Exclusion Criteria:

* History of any previous TBE vaccination
* History of TBE infection
* History of infection with other flaviviruses
* History of vaccination against yellow fever and/or Japanese B-encephalitis
* History of allergic reactions, in particular to one of the components of the vaccine
* Suffering from a disease (e.g. autoimmune disease) or undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions
* Known or suspected problem with drug or alcohol abuse (\> 4 liters wine / week or equivalent level of other alcoholic beverages)
* Donation of blood or plasma within one month of study start
* Having received a blood transfusion or immunoglobulins within one month of study entry
* HIV positivity (an HIV test is not required specifically for the purpose of this study
* Simultaneous participation in another clinical trial including administration of an investigational product
* Participating in any other clinical study within six weeks prior to study start
* Participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)
* Pregnancy or lactation (if female)
* Having received any other vaccination within two weeks prior to study entry
A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients

To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..

Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV seropositivity.
* Disseminated MAC.
* No MAC therapy between time of last positive blood culture draw and study entry (single-agent prophylaxis allowed).
* Life expectancy of at least 2 months.
* Consent of parent or guardian if below legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known hypersensitivity to macrolide antibiotics (erythromycin, azithromycin, or clarithromycin) or ethambutol.
* Inability to take oral medications.
* Condition likely to interfere with drug absorption (e.g., gastrectomy, malabsorption syndromes).

Concurrent Medication:

Excluded:

* Another investigational drug started in the week prior to study entry.

Prior Medication:

Excluded:

* MAC therapy between time of last positive blood culture draw and study entry (although single-agent prophylaxis is allowed).
Dietary Treatments for Cognitive Impairment in Older Adults

This trial seeks to establish the feasibility of implementing a ketogenic, modified Atkins diet (MAD) to older adults with mild cognitive impairment (MCI) or early Alzheimer's disease (AD) living in the community. A secondary aim is to determine whether adherence to the MAD results in better cognitive test scores than adherence to a non-ketogenic control diet. A final aim is to determine the role of apolipoprotein E (ApoE) genotype in participants' response to the MAD. Participants will be randomly assigned to a 12-week trial of either the MAD or a placebo diet based on the National Institute on Aging's recommendations for senior nutrition.

It is well established that Alzheimer's disease (AD) is associated with insulin resistance and, hence, abnormal glucose metabolism. In fact, abnormalities in the brain's uptake of glucose can be observed on PET imaging in advance of clinical symptoms. In patients with established dementia due to AD, the severity of cognitive impairment is strongly correlated with the decrease in glucose uptake. Ketone bodies, the products of fat metabolism, can serve as a "backup" fuel when glucose is unavailable. Ketone body metabolism appears to bypass the metabolic processes that are abnormal in AD and may provide better nourishment for neurons. As a result, ketone body metabolism may slow cognitive decline or even improve cognition in patients with AD.

Participants will be 60 people, age 60 or older, with MCI or mild probable AD and without significant cardiovascular disease. They will be required to obtain the consent of their primary care physicians for their participation. Each patient will have a study partner who is cognitively healthy, lives with the participant, and can help him/her adhere to the diet. A research dietitian will teach participants and partners the new diet and monitor participants' adherence with food logs, in-person assessments, and urine ketone testing. After an initial baseline visit, participants will complete four in-person assessments during which adherence to the diet will be assessed and neurocognitive tests will be administered. It is hypothesized that the MAD will be feasible and well tolerated by seniors with MCI and AD. It is further hypothesized that adherence to the MAD will be associated with a greater increase (or less decline) in cognitive test scores than the placebo diet, particularly for those participants who do not carry an ApoE ε4 allele.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild cognitive impairment or Alzheimer's disease
* availability of cohabitating study partner without cognitive impairment
* consent of primary care physician

Exclusion Criteria:

* history of stroke
* history of coronary artery disease
* history of pancreatitis
* untreated hypothyroidism or B12 deficiency
* history of renal disease or recurrent kidney stones
* history of liver disease
* insulin-dependent diabetes
* body mass index \<18.5
* multiple food allergies
* follow strict diet (e.g., vegetarian, gluten-free)
Application of Virtual Mandibular Position in Temporomandibular Jont Reconstruction With Costochondral Graft in Children Jaw Deformity

Hypothesis：Computer-aided design virtual mandibular position is feasible for costochondral graft growing and occlusion stabilizing in the one-stage treatment of children temporomandibular joint ankylosis (TMJA) or condyle absence with jaw deformity.

Methods: The inclusion criteria is children patients younger than 12 years old with unilateral TMJA or condyle absence. A virtual mandibular position is designed preoperatively according to the CT data of jaw and dentition. 3D printed templates and occlusal splints are used to guide the costochondral graft and mandibular position. During surgery, the affected ramus is reconstructed with costochondral grafting under the virtual mandibular position. After surgery, the occlusal splint is fixed to maxilla at least one month, and then, replaced by orthodontic functional appliance to promote downward growth of the maxilla. Occlusion, facial symmetry, costochondral graft growing would be evaluated and analysed until adulthood.


Eligibility Criteria:
Inclusion Criteria:

* \<12 years old
* Unilateral temporomandibular joint ankylosis or condyle absence；
* Temporomandibular joint reconstructed with costochondral graft；

Exclusion Criteria:

* Bilateral temporomandibular joint ankylosis or condyle absence
* Combined with systematic disease
Testing Effects of Melatonin on Uterine Contractions in Women

The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. The basic physiology work has been conducted in in vitro models of the human myometrium characterizing its responses to melatonin, and in pilot in vivo studies correlating the number of uterine contractions with melatonin concentrations that were manipulated by different types of light exposure. The planned experiments will test a causal link between circulating melatonin levels and uterine contractions in full-term pregnant women by manipulating melatonin levels using exogenous melatonin (i) during the day when endogenous levels of melatonin are very low (Experiment 1), and (ii) during the evening under conditions with lighting that would be expected to suppress the higher evening and nighttime levels of endogenous melatonin (Experiment 2).


Eligibility Criteria:
Inclusion Criteria:

* nulliparity, age between 18 and 35,
* BMI\<36 pre-pregnancy,
* ≥38 weeks of pregnancy with a single fetus at time of study.

Exclusion Criteria:

* color blind;
* prescription drugs affecting sleep, melatonin, and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs);
* a health or pregnancy related condition that might affect melatonin or uterine contractions;
* medical conditions or medications for which melatonin might be contraindicated or there may be a drug interactions (e.g., Central Nervous System depressants/sedatives, Fluvoxamin (Luvox), medications for diabetes, immunosuppressants, anti-coagulants, Nifedipine, Verapamil).

Note: We cannot list all possible exclusionary criteria. Dr. Carolina Bibbo (co-I), our Obstetrics Investigator at Brigham and Women's Hospital (BWH), will make final determination of suitability including any safety concerns for each potential participant.
Head Movement Effect on Different Tracheal Tubes

A breathing tube, which is used to secure the airway and allow ventilation of the lungs during general anaesthesia, is inserted into the windpipe either through the nose or mouth. In children, different formulas exist to determine the appropriate size of the tube according to age, and how far it should be advanced into the airway. Head movement can alter the position of the breathing tube, making it go in or come out too far. Different types of breathing tubes may also differ in their change of position with head movement. The aim of this study is to assess the accuracy of the formulae commonly used in our institution for depth of breathing tube placement, and to measure the degree of tube displacement on head movement with different types of tubes.

An endotracheal tube, which is used to secure the airway and allow ventilation of the lungs during general anesthesia, is inserted into the trachea either through the nose or mouth. In children, different formulae exist to determine the approximate size of the tube according to age, and how far it should be advanced into the airway. Once a tracheal tube is inserted, its position is routinely checked to make sure both lungs are ventilated. To prevent displacement, the tube is taped to the lip, chin or at the nose. However, head movement could cause alteration of the tube position, and risk selective endobronchial intubation or inadvertent extubation. Knowledge of how the different tracheal tubes move with head position can help determine the best tube selection to reduce the risk of accidental tube advancement or removal, in cases where certain head positions are required for surgical access.

The aim of this study is to assess the accuracy of the formulae commonly used in our institution for depth of breathing tube placement, and to measure the degree of tube displacement on head movement with different types of tube. Testing the formulae will enable us to be more aware of how frequently inaccurate tube placement may occur. Knowledge of how the different breathing tubes move with head position can help determine the best tube selection to reduce the risk of the tube going in too far or coming out accidentally, for cases were certain head positions are required for surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing any procedure in the Image Guided Therapy (IGT) department requiring tracheal intubation and chest x-ray

Exclusion Criteria:

* Premature neonates
* Patients with cranio-facial anomalies
* Cervical spine/upper thoracic anomalies
* Laryngomalacia/tracheomalacia
* Chronic hypoxemia (i.e. cardiac conditions with right to left shunts)
* Patients requiring positions other than supine
Overcoming Membrane Transporters to Improve CNS Drug Delivery - Improving Brain Antioxidants After Traumatic Brain Injury

The overall purpose of this research study is to investigate the safety of pharmacological therapies that may potentially improve pediatric outcomes after traumatic brain injury. Traumatic brain injuries are the leading cause of death and disability among children and young adults.

Hypothesis: Combinational therapy with a membrane transporter and antioxidant are safe after TBI and can overcome barriers to the brain and synergistically improve bioavailability and efficacy the antioxidant content of the body and CNS after TBI.

Specific Aim: Define the capacity of the combination of probenecid and NAC to safely and synergistically preserve levels of GSH and reduce oxidative stress in children with severe TBI. We will enroll 20 children age 2 to less than 18 years old (less than 216 months) after severe TBI in a randomized, controlled study of administration of the combinational therapy and test if the administration of these drugs is safe and if antioxidant reserve can be preserved within the serum and CSF.

Probenecid (at the same dose that is used as an adjunct to antibiotic therapy) and NAC (at the same dose that is used for acetaminophen-induced liver disease), or vehicles will be given for 3 days. The primary outcomes of the study will be the safety of drug administration and the CSF and serum levels anti-oxidant reserve (AOR), with the presumption that maintaining anti-oxidant levels within the brain may prove neuroprotective. Other secondary outcomes (CSF and serum probenecid, NAC, GSH and phenytoin concentrations) will also be tested. Adverse events occuring during treatment with these drugs after TBI will be monitored by a local Data Safety Monitoring Board.

Eligibility Criteria:
Inclusion Criteria:

* Children (age 2 - 18 y) with severe TBI (GCS \< or = 8) with an externalized ventricular drain placed for measurement of intracranial pressure

Exclusion Criteria:

1. Brain dead on admission to ICU
2. Pregnancy
3. Contraindications to enteral medications
4. Contraindications to probenecid:

   * status epilepticus
   * blood dyscrasias
   * under 2 years-of-age
   * coadministration of salicylates
   * renal dysfunction or urate kidney stones
   * hypersensitivity to probenecid
5. Contraindications to N-acetylcysteine: hypersensitivity to N-acetylcysteine
6. Family unwilling to consent
Role of Instructions in Nitrous Oxide Effects and Choice - 10

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To evaluate the role of instructions in nitrous oxide subjective effects and choice.


Eligibility Criteria:
Please contact site for information.
Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC).

The primary objectives of this study are to compare the effect of SG to SOC on objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed diagnosis of SCLC.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.
* Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC.

Key Exclusion Criteria:

* Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) \< 30 days (independent of the immunotherapy maintenance).
* Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I.
* Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg/day of prednisone or its equivalent.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.

The disruption of the pancreatic duct seems to be a major cause pseudocyst formation and persistence in patients suffering from acute/chronic pancreatitis. No prospective randomized studies have been conducted on the influence of pancreatic duct stenting for the patients' benefits and recurrence rates. The aim fo this study is therefore to evaluate prospectively in a randomized, controlled fashion in patients wit pancreatic pseudocysts, wether pancreatic duct stenting of a disrupted pancreatic duct is beneficial in terms of quicker clinical recovery and avoidance of recurrence of pancreatic pseudocysts.


Eligibility Criteria:
Inclusion Criteria:

* pancreatic pseudocyst, at least 6 cm in diameter
* symptomatic pancreatic pseudocyst
* increasing size of pancreatic pseudocyst within 6 weeks

Exclusion Criteria:

* Pregnancy
* Age less than 18 years
* Postoperative status preventing access to papilla
* Allergy to contrast preventing from ERP
* Missing informed consent to study
* PTT above 1.5 times of normal, unless substituted
* Platelet count less than 50.000/µl, unless substituted
* Pancreatic ascites or fistula
* Life expectancy less than 2 years
* Percutaneously drained cysts are not part of the study
The Effect of Music on Postoperative Anxiety

In this study, it is planned to compare the effect of listening to the music preferred by the patient and classical music on postoperative anxiety.

Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II. 225 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 will be included in our study. Preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into three groups as preoperative patient preferential music, classical music and not played. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones. The STAI will be repeated at postoperative, the Numeric Rating Scale (NRS) and patient satisfaction will be measured at postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Undergo inguinal hernia surgery under general anesthesia,
* Being the ability to speak, read and write the Turkish language

Exclusion Criteria:

* Poor vision
* Significant hearing loss
* Dementia
* Active opioid use
* Regular use of anxiolytics or discontinuation of them on the day of surgery
* Unwillingness to participate in the study
* Unwillingness to listening to music