cyrilzakka/clinical-trials huggingface dataset:
An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis

EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis.

This study aims to prospectively observe the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis and will recruit about 30 patients in China.

Furmonertinib (AST2818) is a brain penetrant third generation EGFR TKI. In preclinical studies, the concentration of furmonertinib and its main active metabolite in the brain was higher than that in the plasma, indicating that furmonertinib had the potential to treat CNS metastases. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily in patients with EGFR T790M mutated NSCLC, the median CNS PFS was 11.6 months and 19.3 months in the 80 mg and 160 mg orally once daily group, and the CNS ORR was 65% and 85% in the 80 mg and 160 mg group.

This study will enroll the EGFR-sensitive mutation positive NSCLC patients with brain metastasis who are treated by furmonertinib, and the efficacy and safety data will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years of age;
2. Histologically or cytologically confirmed metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC);
3. Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.( EGFR L858R or Del 19 with/without T790M )
4. Imaging (MR/CT) confirmed untreated brain metastases before Furmonertinib initiation;
5. Organ function is compatible with oral Furmonertinib therapy (investigator determination based on real-world practice);
6. Life expectancy ≥12 weeks before Fumonertinib initiation;
7. ECOG PS of 0 to 2;
8. Sign the informed consent form.

Exclusion Criteria:

1. Any Third-Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) before Furmonertinib initiation;
2. Known hypersensitivity to Furmonertinib or its excipient components;
3. Simultaneous systemic chemotherapy or WBI;
4. The time from the treatment with any other investigational product or its analogue before Furmonertinib initiation does not exceed 5 half-lives of the drug or 14 days, whichever is longer;
5. Any evidence of severe or uncontrolled systemic diseases;
6. Presence of any disease that may strongly interfere with oral drug absorption; presence of any factor that contributes to QTc prolongation or increased risk of arrhythmia; presence of interstitial pneumonitis.
Combination of Nitrous Oxide 70% With Fentanyl Intranasal for Procedural Analgosedation in Children

This study analyzes the analgesic efficacy and adverse events of nitrous oxide 70% combined with basic analgetics compared to nitrous oxide 70% with fentanyl intranasal for analgosedation for short and painful procedures in children.

Nitrous oxide 70% (N20 70%) combined with 30% oxygen meets many criteria of an ideal pain medication for procedural analgosedation in children. At the emergency department of the Children's Hospital of Zurich, Switzerland, N20 70% is regularly used for short and painful orthopaedic procedures, mostly for reduction of dislocated forearm or finger fractures. The analgesic efficacy of N20 70% still remains controversial. Therefore, all children who are eligible for N20 70% receive additionally either fentanyl or placebo intranasal and then their behavior, level of sedation and adverse events are measured during the painful procedure. The hypothesis is that a combination of N20 70% and fentanyl intranasal is not significant better than N20 70% combined with basic analgetics.

Eligibility Criteria:
Inclusion Criteria:

* indication for nitrous oxide 70% application
* boys/girls aged 2-16 years
* informed consent

Exclusion Criteria:

* due to language barrier no sufficient communication possible to explain the study
* incompatibility to Fentanyl Sintetica
* incompatibility to morphinomimetics
Outcomes Of Laparoscopic Sleeve Gastrectomy In Patients With Hypothyroidism And Depression

Sleeve gastrectomy (SG) continues to be one of the most popular bariatric procedures all over the world. It has been established that obesity is a predisposing factor for several comorbidities, including life-threatening conditions. Many studies have discussed the impact of sleeve gastrectomy on TSH level. But, since most obese patients have some sort of depression, we will try to study the impact of sleeve gastrectomy, depression and hypothyroidism on each other.


Eligibility Criteria:
Inclusion Criteria:

* obese patients with depression and hypothyroidism controlled by medical treatment candidate for sleeve gastrectomy

Exclusion Criteria:

* patients less than 18 or above 60
* other psychiatric or medical disorders.
* patients not fit for surgery
* un controlled patients
Tailored Worksite Weight Control Programs

Given the prevalence of overweight and obesity, worksite-based health promotion programs have been recommended due to their potential reach and social support impact. Within worksite contexts, many strategies to prevent and treat obesity have focused on educational programs delivered in person or to small groups that target knowledge acquisition and strategies targeted at individuals to improve their dietary and activity practices. These programs have been criticized because they typically reach a small percentage of workers-and seldom those that could benefit most, are of short duration, and have typically small effects that are not sustained. They have also typically been conducted in large worksites that have the greatest resources. The lack of success of these programs may be due to: 1) inadequate intervention intensity, 2) implementation challenges, and 3) a lack of theoretical models as the bases for intervention development. To overcome the limitations of previous research we will conduct a 2 group randomized controlled trial to determine the reach and effectiveness of an extensive intervention that: (a) is based upon sound theory, (b) is delivered primarily through scalable interactive technologies, and (c) leverages the existing organizational and environmental context of the workplace.

This study will test the utility of a social ecological theory, individually-targeted internet-based intervention with monetary incentives to reduce the weight of overweight and obese employees (INCENT) when compared to a low-intensity, internet-based weight loss program without incentives (Livin My Weigh). Participants in INCENT will receive daily e-mail support that facilitates goal setting, regular assessments of body weight, and incentives based on percent of original body weight lost at the end of each quarter over the 12-month program. The e-mail supports will target improving perceptions of self-efficacy and outcome expectations related to weight loss or maintaining a healthy weight. In addition e-mail support will facilitate participant problem solving and identification of resources for healthful eating and physical activity at home, in their neighborhoods, and at their worksite. Participants in Livin My Weigh (LMW)will receive evidence-based physical activity and nutrition information to facilitate weight loss through quarterly newsletters and quarterly educational sessions.

Eligibility Criteria:
Inclusion Criteria:

* Employed full time at an eligible worksite
* Access to the internet
* BMI \> 25

Exclusion Criteria:

* BMI \< 25
* no internet access
Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with active acromegaly due to a pituitary adenoma
* Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study

Exclusion Criteria:

* Patients with compression of the optic chiasm causing any visual field defect
* Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
* Patients who have received radiotherapy in the 2 years prior to the start of the trial
* Patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment
* Patients with gallstone disease
* Patients with chronic liver disease
* Known hypersensitivity to Sandostatin or Sandostatin LAR
* Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control and highly effective method for birth control
* History of immunocompromise, including a positive HIV test result
* Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit
* Patients who have participated in any clinical investigation with an investigational drug within 4 weeks prior to dosing
A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
* Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
* Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
* Men must agree to use a reliable method of birth control or remain abstinent during the study
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
* Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)

Exclusion Criteria:

* Current or prior use of biologic agents for treatment of Ps or PsA
* Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDS)
* Current use of more than one cDMARDs
* Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
* Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
* Serious disorder or illness other than psoriatic arthritis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
SWOG-8947 Collecting and Storing Blood Samples From Patients With Previously Untreated Non-Hodgkin Lymphoma

RATIONALE: Collecting and storing samples of blood from patients with cancer to test in the laboratory may help the study of cancer in the future.

PURPOSE: This research study is collecting and storing blood samples from patients with previously untreated non-Hodgkin lymphoma.

OBJECTIVES:

* To establish a central lymphoma serum repository that will serve as a resource to provide specimens for current and future scientific studies.
* To utilize the Southwest Oncology Group clinical database to perform clinicopathologic correlations with the results of those studies.

OUTLINE: Serum is collected and stored for future correlative studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-Hodgkin lymphoma

  * Previously untreated disease
  * Patients must meet the eligibility criteria and be registered to a currently active Southwest Oncology Group-coordinated treatment protocol for previously untreated non-Hodgkin lymphoma

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Thoracic Bio-reactance Measurement of Cardiac Output in Pulmonary Hypertension

Pulmonary Hypertension (PH) is a rare disease characterized by an increase in pulmonary vascular resistance, leading to a progressive decline in cardiac output (CO).Since cardiac output is correlated with the prognosis of the disease, the conduct of a right heart catheterization (thermodilution measurement, reference technique) during the annual follow-up visit of patients in competences centres is recommended. In practice, it is not systematically performed because of it is invasive, with potential risk for the patient, and there is limited logistical capacity for its implementation. The estimation of cardiac output is thus often based on cardiac ultrasound but its measurement is potentially biased.

Starling ™ SV is a non-invasive cardiac output monitor based on thoracic bio-reactance measurement. Several clinical studies have shown that cardiac output measured by bio-reactance is strongly correlated with the measurement obtained by catheterization in different indications. Rich et al. (2013) assessed bio-reactance specifically in 50 patients with Pulmonary Hypertension compared with thermodilution. The results showed that the measurement of cardiac output by bio-reactance was feasible in these patients, had a better accuracy than by catheterization, and was reliable for detecting changes in cardiac output after a vasodilatation test.

The Starling ™ SV monitor could thus have a place in the follow-up of patients who are being treated for Pulmonary Hypertension. Since it is a rapid, non-invasive examination, it could be performed on an outpatient basis, especially as a first-line test to check the stability of the CO, thus avoiding the systematic use of right heart catheterization, which would then be reserved only to patients for whom the measurement by bio-reactance would show a decrease of cardiac output compared to the previous value. Before being able to propose this use in current practice, it is necessary to carry out a pilot study which will make it possible to explore the interest of bio-reactance in this situation.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18
* Presenting pulmonary hypertension (PH) followed by the Competence Center of the Hospices Civils de Lyon
* Follow-up for pulmonary hypertension groups 1, 4 or 5
* Of which the cardiac index is ≥ 2,5 L/min/m²
* Expressing its non-opposition to the participation of this study
* Benefiting from a social security scheme or similar

Exclusion Criteria:

* Adult patient protected by Law
* Patient for whom a thermodilution measurement of cardiac output (CO) is unreliable: right-left shunt; or uncorrected congenital heart disease; or variability\> 10% of the 3 measurements of CO obtained by thermodilution
* pulmonary hypertension groups 2 or 3
* Hemodynamic aggravation since the previous visit: increased pressure or decreased cardiac index
Strengthening Families Living With HIV in Kenya

This study seeks to use a group-based microfinance/internal lending model to develop social capital among people with HIV in Kenya. This will create a context to deliver validated curriculum targeting intimate partner violence, positive parenting, agriculture, small business entrepreneurship, group-interpersonal therapy, and other determinants of well-being and ART adherence among people with HIV. The primary outcomes are viral suppression, ART adherence, and common mental disorders.

It is anticipated that involvement in an internal savings and lending program will create social capital among people with HIV and their guardians (in case of adolescents w HIV). This social capital accrual will be leveraged to support and disseminate social skills (i.e. positive parenting, conflict resolution), economic skills (i.e. entrepreneurship, farming), and health skills (i.e. ART adherence, retention in care to produce viral suppression). The overall outcome is improved social, health, and economic well-being.

Eligibility Criteria:
Inclusion Criteria:

Criteria for inclusion of subjects include:

* testing positive for HIV, confirmed by the Ministry of Health clinics
* being at or older than 13 years of age
* initiating care at a qualified Ministry of Health clinic in the catchment area, or intending to initiate care at such a clinic (see below for definition)
* Any gender, age (13+ years), and comorbid disease states
* Provide informed consent if adult, emancipated minor or mature minor
* Provide assent if minor with guardian, who must provide informed consent

Qualified clinical locations include

* those with accessible and usable public land to convene weekly meetings,
* no current program targeting families with HIV known to the Ministry of Health

Exclusion Criteria:

* Refusal to participate
* Current participation in a similar program
* Residing in a location with a similar program targeting patients with HIV
* Not covered by inclusion criteria.
Analysis of Parameters Indicating the Intensity of Suicidal Behavior in Psychiatric Patients

The aim of this study was to analyse the level of cognitive functioning of patients with history of suicidal behaviour suffering from depression and schizophrenia, and to evaluate their oxidative stress parameters and selected biochemical parameters on the basis of bloodwork.

The study was conducted among 120 patients hospitalized in the Department of Psychiatry of the UMB (Medical University of Białystok). Every participant gave their own voluntary and informed written consent. Blood parameters tests were performed in the Diagnostic Laboratory of the University's Clinical Hospital and in the Department of Hygiene, Epidemiology and Ergonomics of the Medical University of Białystok. In the first stage of the study, an M.I.N.I. 7.0.2 interview was conducted with each patient to verify the intensification of suicidal behaviour. Based on the scores, the patients were classified into one of eight groups: no suicidal behaviour group (G0K, G0M); group experiencing suicidal thoughts without a tendency of implementation (G1K, G1M); group experiencing suicidal thoughts with a tendency of implementation (G2K, G2M); group after a suicide attempt (G3K, G3M).The second stage of the study consisted of biochemical blood tests, where concentrations of vitamin D3, B12, folic acid, sodium, potassium, calcium, magnesium, chlorine, total cholesterol, LDL and HDL fractions, TG and metabolites of the oxidative stress pathway were determined. The following concentrations were determined: dityrosine (AUF/mg protein), TOS (nmol H2O2 Equiv/mg protein), TAC (umol/mg protein), OSI (TOS/TAC ratio), FRAP (μmol/mg protein), GPx (mU/mg protein), SOD (mU/mg protein) CAT (nmol H2O2/min/mg protein), AOPP (nmol/mg protein), NO (nmol/mg protein), GSH (μg/mg protein). The third stage of the study consisted of the participants completing a CogState computerized test to verify their cognitive functioning. The following cognitive functions were assessed: psychomotor drive (DET), metastability of attention (IDN), verbal memory, retrieval of learned material (ISLR) and verbal learning and memory (ISL), visual learning and memory (OCL), processing speed (GMCT), visual memory including deferred retrieval (GMR), executive functions (SETS and GML), working memory (ONB, TWOB).

Eligibility Criteria:
Inclusion Criteria:

* patients of clinical psychiatry
* patients diagnosed with schizophrenia and depression
* age: 20-50 years
* gender: women and men

Exclusion Criteria:

* exclusion criteria were any present major medical illness (somatic or neurological disease)
* use of psychoactive substances
* decreased level of cognitive functioning
* people who do not use a computer
Screening of Subclinical Hypothyroidism in Pregnant Women

this study may help the physicians to evaluate the practice of universal screening of sub-clinical hypothyroidism and thyroid-stimulating hormone level. Detection of sub-clinical hypothyroidism early in pregnancy through thyroid-stimulating hormone sampling in the first trimester will allow achieving proper management and better maternal and neonatal outcome of these patients.

This is a cross-sectional study will be carried out on women attending Obstetrics Outpatient Clinic in Sohag University Hospitals between April and 1st December 2023 for the booking antenatal care visit and to be invited to enroll in the study. The attending physician will explain the nature of the study to the cases, the blood samples will be collected and to be assessed for the routine antenatal screening complete blood count, random blood sugar, hepatitis B virus and HIV, the same blood sample will be used to asses TSH level.

Eligibility Criteria:
Inclusion Criteria:

* Age group 18 years to 45 years.
* first trimester pregnant women.

Exclusion Criteria:

* Women with known thyroid disorders or previous thyroidectomy.
* Pregnant women with hyperemesis gravidarum.
* Molar pregnancy.
Safety and Tolerability of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease

The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6).

Secondary objectives are:

* To determine the biological activity of NV1FGF on collateral artery development.
* To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.

Screening period of 30 days before dosing. Patients receive a single administration or repeated (2) administrations (with a 2-week interval) of NV1FGF. Patients are then followed for a period of 6 months

Eligibility Criteria:
Inclusion criteria:

* Severe PAOD defined as Rutherford's Grade II, category 4 or Grade III, category 5 and 6
* Pain at rest for at least 2 weeks duration and/or trophic lesions for at least the previous 14 days with no signs of healing (no reduction in ulcer size or depth)
* Objective evidence of peripheral vascular disease (resting Ankle Brachial Index \< 0.4 and/or resting Toe Brachial Index \< 0.3 and/or metatarsal Peripheral Vascular Resistance flat or barely pulsatile in the diseased limb on 2 consecutive examinations performed at least 2 weeks apart)
* Angiographic demonstration of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries
* Poor candidate for surgical intervention or revascularization procedures (no tibial artery incontinuity as defined from mid-leg distance from the foot and no autologous tissue available)

Exclusion criteria :

* Previous or current history of malignant disease. Patients who had successful tumor resection more than 10 years prior to inclusion into the study and had no recurrence and patients who had curatively resected basal/squamous cancer of the skin were allowed for inclusion
* Abnormal chest X-ray with suspected malignant tumor presence
* Positive stool hemoccult (expect if due to hemorrhoids)
* Positive Prostate Specific Antigen for men with suspected malignant tumor presence
* Abnormal mammography for women with suspected malignant tumor presence
* Papanicolaou smear (for women) of Class IV or Class V characterization
* Proliferative retinopathy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.