cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating FMC-376 in Participants with KRAS G12C Mutated Solid Tumors

The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
* Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematological, renal, and hepatic function
* Agrees not to participate in another interventional study while receiving study drug

Exclusion Criteria:

* Leptomeningeal disease or carcinomatous meningitis
* Clinically significant toxicity resulting from prior cancer therapies
* Known or suspected hypersensitivity to FMC-376 or any components of the study drug
* Condition that would interfere with study drug absorption
* Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data
Transdiagnostic Cognitive Behavioral Treatment for Anxiety

This study is a randomized controlled trial examining the effectiveness of a transdiagnostic cognitive behavioral treatment (CBT) in improving Veterans' community reintegration and quality of life. Veterans with anxiety-based disorders, including posttraumatic stress, panic, social anxiety, and generalized anxiety disorders (with or without co-occurring depression) will be randomized to an intensive CBT (iCBT) treatment delivered over one weekend, standard CBT (sCBT) delivered over 12 weeks or treatment as usual (TAU). The study will also evaluate the potential of the compressed weekend format of iCBT in producing more rapid improvement in outcomes and increasing psychotherapy engagement compared with a standard psychotherapy format. Qualitative interviews will be conducted with Veterans who receive iCBT and their family members to examine how iCBT and environmental factors impacted their process of recovery.

The current project proposes to evaluate a brief but intensive transdiagnostic CBT that simultaneously targets multiple anxiety disorders with or without co-occurring depression. This will be accomplished by evaluating an innovative treatment delivery method that directly addresses barriers associated with standard psychotherapy delivery. The main objectives are to (1) determine if an intensive CBT protocol (iCBT) delivered over one weekend can improve community reintegration, quality of life, and emotional functioning compared with standard CBT (sCBT) and treatment as usual (TAU); (2) examine the rates of psychotherapy engagement in iCBT compared with sCBT; and (3) obtain a deeper understanding, through qualitative interviews with Veterans and their family members, of how iCBT and environmental factors may impact the process of reintegration and quality of life.

The proposed study is a randomized controlled trial with 3 treatment arms. A transdiagnostic group CBT protocol will be compared in a compressed weekend format (iCBT) with a standard group delivery format involving 3 months of weekly sessions (sCBT). A treatment as usual (TAU) condition will be included to compare outcomes. Veterans with one or more anxiety-based disorder(s) (with or without co-occurring depression) will be randomized to one of the three treatment arms. Veterans will be asked to attend a total of four assessments during the study including a baseline evaluation, 1-month, 3-month, and 6-month follow-ups. Qualitative interviews will be conducted with Veterans who completed iCBT and family members.

Eligibility Criteria:
Inclusion Criteria:

* Veterans enrolled to receive VA medical care
* Current diagnosis of at least one anxiety-based disorder
* Moderate-to-poor life enjoyment and satisfaction
* Stable on psychotropic medication 4 weeks prior to participation
* Willing to be randomized to treatment condition

Exclusion Criteria:

* Active symptoms of mania or psychosis at baseline
* Depression with active suicidal ideation/intent
* Moderate-to-severe cognitive impairment
* Active drug/alcohol abuse during initial 3 months of study enrollment
* Undergoing concurrent transdiagnostic CBT for anxiety
Prevalence of Vertebral Fractures in HIV Infected Patients Older Than 50 Years

Prospective cohort study to determine the prevalence of vertebral fractures in HIV infected patients older than 50 years.

To determine the prevalence of asymptomatic vertebral fractures in HIV patients older than 50 years, and the risk of fracture during a follow up of 2 years, according to bone mineral density at inclusion, the level of serum bone biomarkers, and the presence of secondary factors such as hypovitaminosis D or/and secondary hyperparathyroidism.

Eligibility Criteria:
Inclusion Criteria:

* Age above 50 years
* HIV infection

Exclusion Criteria:

* Pregnancy
* Receiving corticosteroids or antiresorptive therapy
Nutrition Throughout the Treatment Course - Expanding Care From Hospital to Home

Patients with cancer have increased risk of malnutrition due to the disease itself and the treatment regimen they undergo. This is particularly relevant for patients with head and neck cancer (HNC), where 74%-95% are malnourished. HNC is a heterogenous group of cancers, including oral cavity, larynx, pharynx and salivary glands. The present project will study the effectiveness and implementation of remote patient monitoring of nutrition and tailored nutrition support throughout the treatment course in patients with head and neck cancer. The implementation will be evaluated in a randomized controlled trial (RCT), and the aim of the project is to reduce the prevalence of malnutrition and increase the quality of life among patients with HNC.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer
* Older than 18 years

Exclusion Criteria:

* Patients admitted with the classification of malignant tumors (TNM) stage 4
* Terminal condition (life expectancy \< 6 months)
* Patients who do not understand the Norwegian language.
Reduction of Intraoperative EEG Burst Suppression

Burst suppression (BS) is a not physiological pattern in the electroencephalogram (EEG). BS during general anesthesia is mainly seen as a sign for too deep hypnosis and may increase the risk of postoperative delirium (POD), a disturbance of consciousness arising within 24 hours after surgery. This monocentric, simple masked randomized study aims primarily to investigate, whether particular anesthesiological interventions reduce the occurrence of intraoperative burst suppression. The investigator initiated trial includes 66 patients (male and female) aged ≥ 60 years in two groups (intervention and control group). Secondary aims will be the correlation of burst suppression and mean arterial pressure, concentration of anesthetics and postoperative delirium.

Intraoperative burst suppression represents a non physiological EEG pattern. According to the literature and scientific knowledge, intraoperative burst suppression patterns might be caused either by hypotension resulting in a reduced cerebral circulation or by an oversedation of anesthetics correlating with a very deep level of hypnosis.

Some publications exist that discuss the occurrence of intraoperative burst suppression especially in elderly people (aged ≥ 60 years) as a predictor of postoperative delirium and postoperative cognitive dysfunction.

None of the studies however was able to prove a causal relationship between burst suppression and postoperative delirium. Contrary it might simply be an epiphenomenon.

Conducting this interventional trail primarily aims to prove whether specific anesthesiological interventions, such as the treatment of intraoperative hypotension in first line and/or the reduction of the concentration of anesthetics in second line, reduce intraoperative burst suppression. Hence it might be possible to investigate a possible casualty between burst suppression and postoperative delirium in a second trial.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Surgical interventions in general anesthesia (volatile or total intravenous anesthesia)
* expected surgery duration ≥ 1h
* American Society of Anesthesiologists (ASA) 1-4
* written informed consent prior to study participation

Exclusion Criteria:

* Neurological or psychiatric disorders
* hearing difficulty
* deafness
* neurosurgical (intra)cranial surgery
* pregnancy
* expected continuous mandatory ventilation after surgery
Post-op Treatment With Hyaluronic Acid Injections

This study will look at patients with post-operative treatment of a meniscal tear or degenerative joint disease (degenerative arthritis). They will be randomized into one of three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are randomized into the injection group will receive a series of three injections (one a week for 3 weeks), then a "booster" injection at 6 months post-op. Several questionnaires will be given after the first set of injections, then again at a one year follow-up.

The hypothesis is that patients receiving hyaluronic acid injections will have better pain and function scores as compared with placebo and no further treatment at all time points.


Eligibility Criteria:
Inclusion Criteria:

* Patients in post-op stage of treatment for meniscal tears or chondropathy/DJD
* Over 40 years of age
* A daily knee pain above 20mm on a 100mm visual analogue scale

Exclusion Criteria:

* Previous recipient of viscosupplementation injections
* Had rheumatoid arthritis or other inflammatory arthritis
* Had intra-articular steroid injections within the previous 2 months
* Invasive knee procedures within the past 6 months
* Contraindications to hyaluronate (an allergy)
* Medications that could interfere with the planned interventions
PAthwAy of Dyspneic patIent in Emergency (PArADIsE)

This is an observational retrospective single-center study (CHRU of Nancy) in patients cared for acute dyspnea by a medical team of the emergencies of the CHRU of Nancy.

The main purpose of the study is to evaluate the outcome of patients cared for acute dyspnea by a medical team of emergencies of CHRU of Nancy.

This observational retrospective single-center study will be conducted using data from medical records, acquired as part of usual care, patients cared for acute dyspnea in the last 5 years (from the date of authorization of data processing). About 4,000 patients will be affected, including more than 800 patients with acute heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Man or women ≥ 18 years
* Patients with acute dyspnea cared by a medical team of the emergencies of CHRU of Nancy.

Exclusion Criteria:

* Cardiorespiratory arrest before the care by a medical team of the emergencies of the CHRU of Nancy.
An Observational Modified Prescription-event Monitoring Study of Asenapine (Sycrest)

This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to further investigate the safety profile of asenapine in clinical practice. The aim of this study is to proactively capture safety and drug utilisation data in the post-marketing phase of license approval of asenapine as prescribed to patients by general practitioners (GPs) in England. This data is obtained through the completion of questionnaires by GPs.


Eligibility Criteria:
Inclusion Criteria:

* Patients prescribed asenapine for any indication by NHS GPs in England.
* Patients for whom a study questionnaire containing useful information has been returned, will be included in the study cohort regardless of the dose or frequency of administration of asenapine, and irrespective of whether any medicines are concurrently administered.

Exclusion Criteria:

* patient no longer registered with the practice
* patient for whom no information is provided on study questionnaire
* patients for whom information provided on study questionnaire relates to another antipsychotic drug
* patients for whom the index date is an improbable date (i.e. before market launch date)
* patients for whom the GP reports that the patient did not take or was never prescribed asenapine
Strategies for Musculoskeletal Symptoms Relieving and Ergonomy in Operating Room

It is well known that surgery requires not only a mental diligence, but also a real physical stress due to the need to assume particular postures for many hours or to repeat specific maneuvers several times. To this peculiar condition of surgical specialities over the years has been added the development of a series of instruments and technologies ranging from the use of loopes, to laparoscopic and robotic surgery. From the studies reported in the literature, between 74% and 87% of surgeons report symptoms related to their work with consequent effects on the quality of life (sleep loss, inability to carry out their recreational activities, etc.). Similarly, a lack of knowledge of the principles of ergonomics to be applied during the performance of one's surgical activity emerged, which could improve musculoskeletal symptoms with a positive effect on the quality of life of surgeons and consequently hoping for an improvement in professional performance.


Eligibility Criteria:
Inclusion Criteria:

* young surgeons

Exclusion Criteria:

* no consent to partecipate
Cognitive-Behavioral Approach and Anger

A randomized controlled study was conducted to investigate the effects of a cognitive-behavioral approach-based psychoeducation program on nursing students' trait anger and anger expression styles.

Anger, which is an emotion experienced by all people, is a natural and normal reaction that can occur depending on the interaction of the person with his/her environment. However, frequent anger can damage physical and mental health and can lead to violence and aggression. Anger is interpreted according to the way it is expressed and a person can express anger in different ways (anger-in, anger-out, anger-control). While anger-in and anger-out are negative behavioral reactions, anger control is an appropriate response. One of the groups that often experiences anger is nursing students. Students studying in the department of nursing are considered as the health workforce of tomorrow and both study in stressful environments and work in stressful environments. Anger is an emotion experienced as a reaction to stress among nursing students. The inability of students who do not have anger management skills to control their anger may negatively affect their approach to patients, relatives and teammates. Since negative expression of anger can have a negative impact on interpersonal relationships with others, it may hinder the development of working alliances between nursing students and patients. Students studying in the department of nursing graduate without adequate training on how to express their anger correctly. Anger coping programs for nursing students should primarily include the assessment of anger expression styles and provide techniques for expressing anger appropriately and coping with anger. This study aimed to investigate the effect of a psychoeducation program based on the cognitive-behavioral approach on nursing students' trait anger and anger expression style. The hypothesis that there was no difference between the intervention and control groups in terms of trait anger, anger-in, anger-out and anger control after the intervention were tested.

Eligibility Criteria:
Inclusion Criteria:

* To agree to participate in the study,
* Not to have participated in the training program on anger expression and management given by mental health professionals before,
* Not to have a psychiatric diagnosis-treatment history,
* Not to have hearing-vision problems,
* To be between the ages of 18-25,
* To have participated in at least four of the sessions,
* To get a high score from the Trait Anger Sub-scale compared to other students

Exclusion Criteria:

* Having previously attended a training program on anger expression and management given by mental health professionals
* Having a problem that prevents filling out the forms to be used in the research
* Having hearing or vision problems
* Being under 18 or over 25
* Having a history of psychiatric diagnosis and treatment
* Having not attended more than four sessions
The Effect of Therapeutic Play on Children's Pain and Fear and Parents and Students' Satisfaction Levels

This study aims to determine the effects of playing with therapeutic toys made by nursing students on children's fear and pain levels towards treatment and the satisfaction levels of student nurses and parents.

There are a limited number of studies in the literature examining the effects of therapeutic play implemented by nursing students. Although there are many studies showing that therapeutic play intervention is an effective intervention for sick children, it is seen that these studies are mostly conducted by researchers or clinical staff, and nursing students who have been in pediatric wards for a long time due to their clinical practices are far from therapeutic play practices. Therapeutic play may be a way for nursing students to initiate communication with children more easily. Therefore, there is a need for large-scale studies including nursing students. Starting from their student years, nursing students using therapeutic play as a means of communication with sick children may make them more willing to use such activities in their professional lives. In addition, determining the satisfaction levels is important for the continuation of such studies in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Having a child aged 3-6
* Having at least two days of inpatient treatment in the hospital (to gain experience with medication administration)
* Being accompanied by a parent
* Having one invasive drug treatment ordered by a doctor - Knowing and speaking Turkish
* Being willing to participate in the study

Exclusion Criteria:

* Those who are in intensive care,
* Those who have undergone surgery,
* Those who do not have a companion with their mother,
* Children with neurological and psychological disorders and parents,
* Children who only receive oral medication (as the level of pain and fear related to treatment will be low)
The Role of Physical Activity for Acute Exacerbations of COPD

The investigators plan to study the association between physical activity, malnutrition and sarcopenia and the occurrence of acute exacerbations of COPD / the evolution of the COPD assessment test (CAT) over 1 year in a telehealthcare cohort of patients with COPD. The investigators hypothesize that malnutrition and/or sarcopenia at baseline and a decline in the fat-free mass index over time is associated with an increased rate of acute exacerbations of COPD and an increased CAT score meaning a higher risk for mortality, morbidity and impairment of quality of life.


Eligibility Criteria:
Inclusion Criteria:

* COPD GOLD stage B or higher
* Written informed consent

Exclusion Criteria:

* Inability to provide written informed consent
* Insufficient knowledge of the trial language
Effect of a Calisthenic Exercises on Premenstrual Symptoms

The aim of this study is to examine the effects of an eight-week calisthenic home exercise program on premenstrual symptoms, pain and sleep quality in young women.

The study was conducted on 30 volunteers who met the inclusion criteria among female students studying at Haliç University Faculty of Health Sciences. The "Premenstrual Syndrome Scale (PMSS)" was used to assess the individuals' premenstrual symptoms; the "Visual Analog Scale (VAS)" was used to assess pain for each of the abdominal, lumbar and general body pain; and the "Pittsburgh Sleep Quality Index (PSQI)" was used to assess sleep quality. Then, the participants were randomly divided into two groups as "Group 1: Control group (n=15)" and "Group 2: - Calisthenic home exercise group (n=15)". Participants in the first group were not subjected to any intervention and were asked not to participate in any exercise program for eight weeks. Participants in the second group were informed about calisthenic home exercise programs face to face and were asked to perform these exercises as home exercises for eight weeks. At the end of the treatment process, participants' PMSS, VAS and PSQI scores were re-evaluated.Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Being a woman between the ages of 18-25
* Studying at Halic University Faculty of Health Sciences
* Voluntarily participating in the study
* Having a normal menstrual cycle
* Not exercising
* Having a score above the mild level on the Premenstrual Syndrome Scale

Exclusion Criteria:

* Having a condition that prevents exercise
* Pregnancy
* Menopause
* Having a gynecological disease (endometriosis, ovarian cyst, pelvic infection, myoma/uterine tumor, etc.)
Biological Significance of the Bloom's Syndrome Protein

Since 1960, persons with the very rare disorder Bloom's syndrome (BS) have been followed clinically, documenting clinical matters as obtained from their doctors. This has been a worldwide search for cases, though a few in the New York City area are seen (personally, by us) perhaps once every 2-3 years. BS is a rare genetically-determined disorder described in NYC in 1954. The clinical courses of the 169 persons diagnosed BS by 1991 are followed in a program referred to as the Bloom's Syndrome Registry. BS is the prototype of the "chromosome-breakage syndromes." BS cells mutate at a greater rate than any other, and the consequence is the greatest known predisposition to cancers of the types that affect the general human population. We are defining the clinical syndrome and at the same time are studying cells from affected families in the experimental laboratory. BS is a model for learning about cancer. Our contact with families lets us know of cancers arising, but blood, and sometimes tiny biopsies of skin, is taken if available so that (a) the chromosomes can be studied and (b) the gene mutations can be defined in molecular terms.

Although an occasional person with BS will be admitted to the hospital for special study (endocrine evaluation mainly)--two in the last 25 years--the Registry does not develop a doctor/patient relationship with affected persons. They have their own doctors. We gather information about the affected persons and publish reports. We also publish reports of experiments carried out in the research laboratory using BS cells. Because we are a central repository for information on BS, families or their physicians find contact with us beneficial, and we provide them with information requested. Sometimes pregnancies at risk occur, and we have on occasion made cytogenic (chromosome) analysis of cultured cells of amniotic fluid (the cultures being initiated elsewhere and sent to us for cytogenetic study).

Although the accessioning of new cases to the Registry was closed in 1991, 4-5 new patients are referred to us each year, and their clinical courses also are being followed. To date, the 169 officially registered and 36 additional cases are under our surveillance.

Eligibility Criteria:
1. families include those ascertained by physician referral and those families already accessioned to The Bloom's Syndrome Registry
2. the family has at least one affected member with BS