cyrilzakka/clinical-trials huggingface dataset:
Effects of Cognitive Remediation Therapy on Schizophrenia Patients Through Functional Magnetic Resonance Imaging

Cognitive Remediation Therapy (CRT) can enhance cognitive performance in patients with schizophrenia improving clinical outcome. However, the neurobiological mechanism underlying cognitive improvement is not well understood. The aim of this study is to investigate functional connectivity patterns before and after the neurocognitive rehabilitation therapy, especially in fronto-temporal circuitry.

A controlled randomized study will be carry out with three different groups: patients receiving cognitive rehabilitation treatment (CRT), patients receiving another psychological intervention of control and a healthy control group. A descriptive study of cases will be also carried out. The functional MRI (fRMI) techniques as well as voxel-based morphometry allow individual analysis of cases.

The independent variable is the cognitive rehabilitation treatment. The CRT will be applied according to the manual of Wykes \& Reeder (2005) Cognitive Remediation Therapy: Theory and Practice, Ed: Routledge. The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors.

The main dependent variable is the functional connectivity cerebral pattern obtained by means of functional magnetic resonance. Other secondary dependent variables are neurocognitive functioning, the symptomatic pattern and the psychosocial functioning obtained from the psychometric evaluation.

All the participants will be evaluated before and after the experimental intervention in neurocognitive areas (Battery will be composed by WAIS-III, RAVLT, Trail Making Test, STROOP color word, WCST, FAS-COWAT), symptomatic area (PANSS) and in social functioning (Social Functioning Scale SFS; Birchwood et al. 1990). The evaluations will be carried out by expert evaluators that will be blind to the experimental distribution. The statistics results analysis will be carry out by means of the statistical package SPSS 15.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV-TR and confirmed by the semi-structured interview (SCID) for the axis 1.
* Presence of cognitive deficit confirmed by the neuropsychological battery.
* Stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment.

Exclusion Criteria:

* Presence of organic-cerebral affectation due to neurological or traumatic conditions
* Abuse of psychotropic substances
* Presence of other psychiatric symptomatology
Tele-rehabilitation in Chronic Respiratory Disease: an Observational Cohort Study

Pulmonary rehabilitation is a program that helps people with lung disease improve their function. It uses exercise, education, and self-management strategies to improve physical ability and quality of life. Because some people are unable to visit West Park Healthcare Centre, we established a remote supervised pulmonary rehabilitation program that patients can access via an electronic device (computer, tablet or smart phone). Regular quality assurance is necessary to ensure that the program is effective. We plan to collect and summarize the program's results. The benefit of doing so is that it allows us to make any changes or improvements that may help patients with chronic respiratory conditions.


Eligibility Criteria:
Inclusion Criteria:

* stable chronic respiratory disease
* qualified candidates for pulmonary rehabilitation,
* current non-smoker;
* primary diagnosis chronic respiratory disease limited by dyspnea (mMRC≥2);
* free of exacerbation at the time of admission, and
* stable co-existing conditions

Exclusion Criteria:

* completed PR within the previous 12 months of the current admission and
* being unable to communicate with the treating team.
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath

A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health

This is a Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Health.

Approximately 110 participants (88 active product and 22 placebo recipients) will be included in the study Participants will be screened up to 42 days before IP administration and will be followed for 12 months after IP administration.

Eligibility Criteria:
Inclusion Criteria

1. Adults in good general health as assessed by medical history, physical examination, and laboratory tests
2. At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of vaccination
3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
4. Willing to undergo HIV testing, risk reduction counselling, and receive HIV test results
5. Use effective method of contraception
6. Understand the study and provide written informed consent

Exclusion Criteria

1. Confirmed HIV-1 or HIV-2 infection
2. Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease
3. Any clinically significant chronic medical condition that, in the opinion of the Investigator, makes the participant unsuitable for participation in the study
4. Pregnant or lactating
5. Bleeding disorder that was diagnosed by a physician
6. Prior receipt of another investigational Lassa vaccine candidate
7. Receipt of blood transfusion or blood-derived products within the previous 3 months
8. Prior exposure to LASV as documented by history
9. History of severe local or systemic reactogenicity to any vaccine
10. Body mass index (BMI) ≥35
11. Mild or greater hearing impairment defined as ≥26dB loss in either ear
Hemodynamic Impact of the Administration of PAracetamol in Patients Hospitalized in the Intensive Resuscitation Medicine Department [PAREA]

Paracetamol is commonly used in case of pain or fever. Few previously clinical studies has highlighted an arterial hypotension linked to intravenous administration of paracetamol. Currently, fewer data are available on the link of intravenous administration of paracetamol and effects on arterial tension. The aim of this study is to describe the frequency of occurrence of significative arterial hypotension within one hour following intravenous or per os administration of paracetamol . Other factors who can be associated to occurence of significative arterial hypotension will be also observe (for example age, weight, pain, vasopressor dosage or sedative...)


Eligibility Criteria:
Inclusion Criteria:

Inclusion:

* 18 years of age or older
* Patient with arterial catheter
* Indication of paracetamol's administration by the patient's attending practitioner.
* No opposition to patient or support person participation in the study if the patient is unable to participate

ExclusionCriteria:

* No Social Security Patient
* Pregnant or nursing patient.
* Patient with a legal protection measure
* Hypersensitivity and/or allergy to paracetamol.
* Contraindication to the use of paracetamol.
* Patient opposition to health data collection.
Jump Rope Training and Shoulder Isokinetics in CrossFit

The goal of this quasi-experimental clinical trial is to evaluate whether weighted jump rope (WJR) training can improve the isokinetic shoulder strength profile in male and female CrossFit practitioners.

The main questions it aims to answer are:

* Does six weeks of WJR training affect internal and external shoulder rotational peak torque relative to body mass?
* Does WJR influence the external/internal shoulder rotation ratio in dominant and non-dominant arms at varying angular velocities? Researchers will compare pre- and post-intervention isokinetic measurements to see if WJR training leads to significant changes in shoulder strength and balance.

Participants will:

* Incorporate WJR sessions three times per week into their usual CrossFit training.
* Undergo isokinetic testing of both shoulders at baseline and post-intervention at 60°/s, 180°/s, and 300°/s.
* Have their training adherence and technique monitored throughout the study.

Model: Single Group

Model Description:

This study followed a single-arm, quasi-experimental pre-post design in which all participants underwent the same intervention: six weeks of weighted jump rope (WJR) training, integrated into their regular CrossFit routines. The intervention's impact on isokinetic shoulder strength variables was assessed by comparing pre- and post-intervention measures within the same group of participants.

Number of Arms

1, Only one group received the intervention-there was no control or comparator group.

Masking Outcomes Assessor.

Masking Description:

Due to the nature of the physical intervention (WJR training), blinding participants and care providers was not feasible. However, outcome assessors conducting the isokinetic tests were blinded to the study's hypotheses and group allocations to reduce measurement bias.

Allocation N/A. Participants were not randomly assigned but instead enrolled in a single group to undergo the same intervention protocol.

Enrollment 18 participants

Eligibility Criteria:
Inclusion Criteria:

* self-reported CrossFit training experience. Accordingly, participants were classified into one of three categories (Torres-Banduc et al., 2021): advanced level (≥36 months of regular training, defined as ≥3 sessions of ≥120 minutes per week); intermediate level (12 to \<36 months); and beginner level (6 to \<12 months).
* no injuries in the three months preceding the study.

Exclusion Criteria:

* musculoskeletal issues impacting muscle strength or the ability to undergo isokinetic shoulder evaluation.
* self-reported use of anabolic steroids or other prohibited substances that might influence the study results.
Simulation of Consecutive Day Shift Work

The purpose of this study is to determine differences in physiological recovery between two consecutive days of simulated fire suppression work. The secondary purpose is to determine differences in heat gain and heat loss between two consecutive days of simulated fire suppression work. Subjects will complete two consecutive days of simulated structural firefighting shift work, 24 hours apart. Before and after each laboratory visit, subjects will continuously wear a Holter monitor and ambulatory blood pressure monitor to quantify parasympathetic tone and recovery from work.


Eligibility Criteria:
Inclusion Criteria:

* 18-39 y old men and women
* Self-reported to be healthy

Exclusion Criteria:

* History of any cardiovascular, neurologic, renal, or metabolic disease
* Current tobacco use or regular use within the last 2 years
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
* History of exertional heat stroke
* Currently pregnant or breastfeeding, or planning to become pregnant during the study
* Inability to follow the rules of the protocols or understand the consent form
* No contraindications for ingestion of the gastrointestinal temperature pill
Montelukast in Chronic Asthma

Treatment of patients insufficiently treated with ICS or ICS + LABA.


Eligibility Criteria:
Inclusion Criteria:

* Patients Insufficiently Treated With ICS Or ICS + LABA.
Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

The objective of this study is to elucidate the potential mechanisms responsible for the increased risk of cardiovascular disease among patients with hypertension and comorbid insomnia.

The investigators propose to utilize a behavioral intervention to manipulate sleep quality in 150 adults with hypertension and comorbid insomnia, who will receive a 6-week Cognitive Behavioral therapy for Insomnia (CBT-I) intervention, which has been shown to markedly improve sleep quality and promote consolidated sleep in approximately 60% of those treated. A lowering of nighttime blood pressure is one of several proposed mechanisms to be examined.

Eligibility Criteria:
Inclusion Criteria:

* Systolic BP ≥ 130 mm Hg based upon two standardized BP screening assessments
* A current diagnosis of insomnia disorder as defined in the International Classification of Sleep Disorders (ICSD-3); or undiagnosed, but suspected, insomnia disorder that is confirmed at their screening lab visit

Exclusion Criteria:

* Uncontrolled hypertension (screening office BP \> 160/100 mm Hg)
* Antihypertensive medication use
* Cardiovascular medications
* Previously diagnosed moderate or severe obstructive sleep apnea
* Severe obesity defined by BMI\>40 kg/m2
* Pacemakers
* Atrial fibrillation
* Acute coronary syndrome or coronary revascularization procedure within 6 months of enrollment
* Congestive heart failure
* Identifiable cause of hypertension (e.g., primary hyperaldosteronism, renal artery stenosis, untreated hyper- or hypothyroidism, chronic kidney disease, Cushing's disease, pheochromocytoma, coarctation of the aorta)
* Severe uncorrected valvular heart disease
* Current pregnancy
* Active diagnosis of psychosis, bipolar disorder
* Diabetes
* Severely impaired hearing or speech
* Participation in another interventional study to address insomnia
* Rotating shift workers
* Prominent suicidal or homicidal ideation (as assessed through a clinical interview)
* Psychiatric Hospitalization within the past 12 months
* Alcohol or drug abuse within 12 months
* Exposure-based PTSD treatment
* Dementia
* Unstable comorbid sleep disorder requiring assessment and/or treatment outside of the study protocol
* Medical or psychiatric conditions judged to be the primary cause of insomnia
* Inability to comply with the assessment procedures or inability to provide informed consent.
Testing the Use of Prompts to Increase Adolescent Immunization Rates

Although most US adolescents visit their primary care doctor, their immunization rates are low. Primary care practices from two networks, one in upstate New York as well as a national network of pediatric clinics were surveyed to ask what they thought was the best strategy to increase immunization rates. Point-of-care prompts (either by an electronic health record message or by a nurse) when an adolescent patient comes in for any type of visit and is due for a vaccine was chosen. This study will determine if these prompts will increase immunization rates after a 12-month intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 11 - 18 who had a visit to their primary care provider during the 12 month intervention period

Exclusion Criteria:

* Adolescent is pregnant during intervention time period
ILX23-7553 in Treating Patients With Solid Tumors That Have Not Responded to Previous Therapy

RATIONALE: ILX23-7553 may help solid tumor cells develop into normal cells.

PURPOSE: Phase I trial to study the effectiveness of ILX23-7553 in treating patients who have solid tumors that have not responded to previous therapy.

OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of ILX23-7553 in patients with refractory solid tumors. II. Determine the principal and dose limiting toxicities of this treatment regimen in terms of duration and reversibility in this patient population. III. Determine the preliminary evidence of antitumor activity with this treatment regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients receive oral ILX23-7553 for 5 days. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ILX23-7553 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 10 patients experience dose limiting toxicity. Patients are followed monthly for at least 2 months.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor refractory to conventional therapy or for which no standard therapy exists Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL (regardless of liver metastases) SGOT/SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Calcium no greater than 9.5 mg/dL No nephrocalcinosis Cardiovascular: No congestive heart failure No angina or ischemia Other: Ability to swallow or nasogastric or gastrostomy tube present Adequate organ and immune system function No known hypersensitivity to ILX23-7553 or analogues HIV negative No active uncontrolled infection No other severe disease or psychiatric disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and recovered No concurrent curative antineoplastic drugs Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent curative radiotherapy Surgery: At least 4 weeks since prior surgery and recovered Other: At least 30 days since prior investigational agents At least 2 weeks since prior vitamin D, calcium supplementation, or cholestyramine No concurrent vitamin D, calcium supplementation, or cholestyramine No concurrent digoxin No concurrent hypercalcemia therapy (i.e., biphosphonates or insulin)
U-LABA/ICS Effects on Exercise Performance, Vilanterol

The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist vilanterol + fluticasone furoate


Eligibility Criteria:
Inclusion Criteria:

* Age 18-39
* Physically active \> 5 h weekly
* Maximal oxygen consumption classified as high or very high

Exclusion Criteria:

* Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
* ECG abnormality
* ACQ score \> 1.5
* Severe bronchial hyperreactivity as determined by mannitol test
* FEV1/FVC ratio \< 0.7 determined with spirometry
* Chronic illness determined to be a potential risk for participant during study
* In chronic treatment with medication that may interfere with study results
* Pregnancy
* Smoker
* Blood donation during the past 3 months
Fomepizole Dosing During Continuous Renal Replacement Therapy (CRRT)

The project is a prospective observation study of patients with suspected or confirmed toxic alcohol poisoning treated with fomepizole and continuous renal replacement therapy (CRRT)


Eligibility Criteria:
Inclusion Criteria:

* Patients (over 18 year) with suspected or confirmed toxic alcohol poisoning treated with fomepizole and CRRT.

Exclusion Criteria:

* Patients who wish to withdraw from the study
The Effect of Educational Intervention on Delivery Type Selection in Pregnant Women at Kermanshah, Iran

In an experimental research, 100 nulliparous pregnant women who had referred to health care centers in Kermanshah were randomly selected and after taking Written Informed Consent letter, assigned into case and control groups. instruction based on TPB was provided just for the case group. Afterwards, post-test was taken by both groups and the results were analyzed.

In an experimental research, 100 nulliparous pregnant women with the gestational age of 28-36 weeks who had referred to health care centers in Kermanshah (western Iran) were randomly selected and after taking Written Informed Consent letter, assigned into case and control groups. The inclusion criteria consisted of nulliparous pregnant women with the gestational age of 28-36 weeks, women under 35 years old, and no contraindications for normal childbirth. Exclusion criteria included the absence of women in continuous training sessions, premature delivery, and maternal unavailability during the completion of the questionnaires.

Three Training sessions each lasted for one hour during twenty days were hold for the case group. The first session was conducted to affect their attitude and provide favourable attitude towards natural delivery. The second session was allocated to presenting feasible methods for reducing pain in order to enhance mothers' perceived behavioral control. In the 3rd session the methods were exercised practically so that they could better employ them whenever needed during the parturition. As a result, the mothers' selection of the sort of delivery was checked out. In order to influence the subjective norm, pregnant women were also asked to transfer their knowledge to their husbands. The control group also received only routine training sessions by the midwives in the health care centers.

In each one-hour training session; 45 minutes was dedicated to listening to lectures, having colloquies, and discussing methods via using teaching aids such as pamphlets, and manuals. The last 15 minutes was allocated to summarizing the issues and answering mothers' questions.

At the end of the training sessions, the post-test was administered for both groups and the data were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* consisted of nulliparous pregnant women with the gestational age of 28-36 weeks, women under 35 years old, informed consent of the mother and her husband, and no contraindications for normal childbirth.

Exclusion Criteria:

* Included the absence of women in continuous training sessions, premature delivery, and maternal unavailability during the completion of the questionnaires.
Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy if the complementary use of Methotrexate could provide better results. We evaluate the success of treatment and the time required for titers of β-hCG to become negative. Methods: A double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients will be divided into two groups: in one patients will be administered a single intramuscular dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day. When the decline of beta-hCG titers was \> 15% in this interval, the patient was followed with weekly dosing of β-hCG until the titers become negative. The criterion of success is when the β-hCG was negative. The treatment failure occurs when surgery was necessary.


Eligibility Criteria:
Inclusion Criteria:

* Hemodynamic stability
* Initial β-hCG \<2000 mIU / mL
* Titers of β-hCG in decline in 48 hours before treatment
* Adnexal mass \<5.0 cm
* Desire for future pregnancy

Exclusion Criteria:

* Alive embryo
* Ectopic pregnancy other than in tubal location
* Pregnancy of unknown location