cyrilzakka/clinical-trials huggingface dataset:
A Study Based on Medical Records in Spain That Looks at Diarrhoea Control in People With Pulmonary Fibrosis Who Are Taking Nintedanib

This is an observational, non-interventional, and prospective post authorization safety study (PASS) that will describe the real-world proportion of patients that achieve nintedanib-associated diarrhoea control after 12 weeks of follow-up, in hospital settings in Spain. It will include outpatients (i.e., those attending ambulatory visits) with interstitial lung diseases (IPF) and other progressive pulmonary fibrosis (PPF) treated with nintedanib (150 mg bid) and having a first episode of diarrhoea after nintedanib initiation.


Eligibility Criteria:
Inclusion criteria/definition

* Adults (≥18 years old) at diarrhoea initiation.
* Ability to consent and to conduct all procedures of the study, as judged by the study investigator, and agreeing to participate providing informed consent at baseline.
* Diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) (other than IPF), as registered in electronic medical records (EMR) using free text or international statistical classification of diseases and related health problems (ICD) codes (ICD-9 and/or ICD-10), at least 1 day before diarrhoea initiation.
* Being treated with 150 milligram (mg) bid of nintedanib when initiating diarrhoea symptoms, defined as having a nintedanib anatomical therapeutic chemical (ATC) code (L01EX09) or the molecule/commercial name registered in the EMR, for at least 1 day before diarrhoea initiation.
* First pulmonologist consultation (face-to-face) at the time of recruitment due to a first diarrhoea episode as defined by the pulmonologist since nintedanib initiation. Diarrhoea defined as the passage of three or more loose or liquid stools in a 24-hour period (loose or liquid stools defined as stools with a Bristol Stool Form Scale (BSFS) of 6 or 7 points).

Exclusion criteria

1. Patients diagnosed with systemic sclerosis associated interstitial lung disease (SSc-ILD) as registered in EMR using free text or ICD codes (ICD-9 and ICD-10). Referent to any time before or at diarrhoea initiation.
2. Participation in any clinical trial including a drug or device at any time before or at diarrhoea initiation.
3. Participation in any Patient Support Programme (PSP) at diarrhoea initiation.
4. Having history of chronic gastrointestinal disorder (e.g., inflammatory bowel disease or the short gut syndrome), pancreatic dysfunction/insufficiency, or colon cancer; due to the likelihood of faecal incontinence. Referent to any time before or at diarrhoea initiation.
5. Having a performance status (PS) ≥3 points on the Eastern Cooperative Oncology Group scale (ECOG) scale at diarrhoea initiation, due to the likelihood of faecal incontinence.
FOLFOXIRI Plus Panitumumab In Kras and Braf Wild-Type Metastatic Colorectal Cancer

The GONO-FOLFOXIRI regimen demonstrated higher activity and efficacy compared to FOLFIRI in a phase III trial. Panitumumab with oxaliplatin- or irinotecan-based doublets is feasible and associated with improved activity in KRAS codon 12-13 wild-type patients. BRAF and other RAS rare mutations have been suggested as additional potential biomarkers for anti-EGFR agents in metastatic colo-rectal cancer. The present study aims to demonstrate the feasibility and the activity of the first-line combination of the GONO-FOLFOXIRI regimen and Panitumumab in molecularly selected metastatic colo-rectal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma;
* Availability of formalin-fixed paraffin embedded tumor block from primary or metastasis;
* KRAS and BRAF wild-type status of primary colorectal cancer or related metastasis;
* Unresectable and measurable metastatic disease according to RECIST criteria;
* Male or female, aged \>/= 18 years and \</= 75 years;
* ECOG PS \< 2 if aged \< 71 years;
* ECOG PS = 0 if aged 71-75 years;
* Life expectancy of more than 3 months;
* Adequate haematological function: ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 9 g/dL;
* Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases \< 5 x ULN);
* Serum creatinine ≤ 1.5 x ULN;
* Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
* At least 6 weeks from prior radiotherapy and 4 weeks from surgery;
* Written informed consent to experimental treatment and pharmacogenomic analyses;
* Magnesium ≥ lower limit of normal;
* Calcium ≥ lower limit of normal.

Exclusion Criteria:

* Prior palliative chemotherapy;
* Prior treatment with EGFR inhibitors;
* Symptomatic peripheral neuropathy ≥ 2 grade NCIC-CTG criteria;
* Presence or history of CNS metastasis;
* Active uncontrolled infections; active disseminated intravascular coagulation;
* Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix;
* Clinically significant cardiovascular disease, for example cerebrovascular accidents (CVA) (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;
* Fertile women (\< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception;
* Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment;
* History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

The purpose of the study is to evaluate an investigational medication to treat chronic asthma. The research is being conducted at 20 clinical research sites in the US and is open to both men and women ages 18 to 70 years. Participants in the study will have a number of visits to a research site over an 8-month period. All study-related care and medication is provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.


Eligibility Criteria:
Inclusion Criteria:

* At least a 6-month history of asthma
* No use of inhaled, oral or injectable steroids for at least 1 month prior to enrollment

Exclusion Criteria:

* Patients with \> 10 pack years of smoking history or smoking within 12 months of study enrollment
* No significant disease other than asthma
EGFR Molecular Classification In Vivo

The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status.

The goal of investigators were to evaluate the use of 18F-IRS as a novel PET/CT radiotracer to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients. the investigators want to evaluated the use of 18F-IRS in lung cancer imaging in adult NSCLC patients with different EGFR mutational status of primary and metastatic cancers.

Eligibility Criteria:
Inclusion Criteria:

* Advanced NSCLC
* 18 years or older
* A life expectancy of at least 12 weeks
* Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
* Written informed consent

Exclusion Criteria:

* Claustrophobia
* Pregnancy
* Metal implants in the thorax
Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma

This study is to evaluate the efficacy of risk-adapted treatment strategy for stage I/II extranodal NK/T cell lymphoma. The risk stratification is based on the Korean NK prognostic index. Thus, the group I/II will receive concomitant chemoradiation followed by VIDL chemotherapy. The group III/IV will receive high dose-chemotherapy followed by autologous stem cell transplantation after the completion of VIDL chemotherapy.

1. Concomitant chemo-radiotherapy:

   Radiotherapy 36-44 Gy/18-22 fractions

   + weekly cisplatin 30 mg/m2 for 4 weeks
2. Rest period: 3 weeks
3. VIDL combination chemotherapy: (total 2 cycles) VP-16 (etoposide) 100mg/m2 I.V. D1-3 Ifosfamide 1.2g/m2 I.V. D1-3 Dexamethasone 40mg/day D1-3 L-asparaginase 4000IU/m2 IM D8, 10, 12, 14, 16, 18, 20 Repeated every 28 days
4. Peripheral blood stem cell mobilization G-CSF 400ug/m2/day or 10ug/kg/day S.C. or I.V. for 4-6 days followed by stem cell collection (Minimum requirement of CD34+ cells \> 2×106/kg)
5. High-dose chemotherapy with autologous stem cell transplantation Busulfex 3.2mg/kg/day from day -7 to day -5 Etoposide 400mg/m2/day on day -5, -4 Cyclophosphamide 50mg/kg/day on day -3, -2 Followed by stem cell infusion

Eligibility Criteria:
Inclusion Criteria:

* patients were required to have a biopsy-proven diagnosis of nasal ENKTL
* at least 18 years old
* Ann Arbor stage IE or IIE
* measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* life expectancy greater than 12 weeks
* adequate hematologic (hemoglobin \> 9.0 g/dL, absolute neutrophil count \> 1,500/uL and platelets \> 100,000/uL)
* renal (serum creatinine \< 1.5 mg/dL, creatinine clearance \> 50 mL/min)
* hepatic (total bilirubin \< 2 times of upper limit of normal and aspartate transferase \< 3 times of upper limit of normal) function
* Diagnosis of ENKTL is based on the presence of histological features and immunophenotypes compatible with ENKTL (e.g., cytoplasmic CD3+, CD20-, CD56+, positive for cytotoxic molecules, positive for EBV by in situ hybridization).
* Informed consent

Exclusion Criteria:

* prior or concomitant malignant tumors
* any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
* ENKTL with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
* Other subtypes of non-Hodgkin lymphoma (NHL), including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified, were excluded.
Effects of Mind Body Exercises in Pregnant Women

his Study is a randomized controlled trial (RCT) which will be collected through non probability convenient sampling technique and will be carried out for 10 months duration with a sample size of 34 pregnant women which will be collected through non probability convenient sampling technique. the participants will be divided into two groups. Group A will be involved in mind body exercises and group B will be given relaxation exercises

This Study is a randomized controlled trial (RCT) which will be collected through non probability convenient sampling technique and will be carried out for 10 months duration with a sample size of 34 pregnant women which will be collected through non probability convenient sampling technique. Sample will be collected from Gosha shifa and Ishaq Haroon Hospital. Pregnant women in their second trimester (between 14-28 weeks). Age between 20 to 35 years. Able to understand and participate in mind-body exercises sessions will be included. High-risk pregnancies (e.g., gestational diabetes, hypertension). Pre-existing medical conditions that could interfere with participation (e.g., severe musculoskeletal disorders). will be excluded. Tools used in the study are perceived stress scale (PSS) , Hamilton Anxiety Rating Scale (HARS) and Fatigue severity scale-(FSS).Data will be analyzed by busing SPSS 26.0

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in their second trimester (between 14-28 weeks)
* Primi gravid
* Able to understand and participate in mind-body exercises sessions

Exclusion Criteria:

* High-risk pregnancies (e.g., gestational diabetes, hypertension)
* Pre-existing medical conditions that could interfere with participation (e.g., severe musculoskeletal disorders)
* History of psychiatric disorders requiring ongoing treatment
* History of miscarriage
EF5 in Melanoma Patients

The purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the melanoma tumor microenvironment. The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1 and VEGF, which the investigators term the HRHV axis. Patients with in-transit melanoma (AJCC Stage IIIB or IIIC) (1) will be administered the hypoxia marker drug, EF5, 24 hr prior to isolated limb infusion (ILI) or hyperthermic isolated limb perfusion (HILP). Tumor biopsies will be performed just prior to ILI or HILP, at the 30 minute time point during ILI (or 60 minute time point during HILP), AND 24 hours after ILI or HILP. Tissues obtained will be snap frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will also be examined. The association of the markers with the presence of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in melanoma. This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted.


Eligibility Criteria:
3.1. Inclusion criteria

* Histologically confirmed AJCC Stage IIIB/IIIC/IV extremity melanoma who are undergoing ILI or HILP and have tumor available for biopsy (NOTE: patients with only 1 in-transit lesion are NOT eligible)
* Age ≥18
* KPS status ≥ 70
* Bilirubin ≤ 1.5x normal
* Creatinine ≤ 1.8 ( -EF5 is primarily excreted via the kidney)
* WBC \> 3000/mm3 and platelets \> 100,000/mm3

3.2. Exclusion criteria

* Pregnancy or breast feeding. A negative serum pregnancy test is required of any women childbearing potential prior to enrollment. Pregnant women are excluded from this study because EF5 is an agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with EF5, breastfeeding should be discontinued if the mother is given EF5.
* Allergy to IV contrast dye
* History of grade III or IV peripheral neuropathy as defined by the NCI CTC (other 2-nitroimidazole compounds are neurotoxic)
* Previous history of any malignancy treated with radiotherapy and/or chemohormonal therapy
COMPRESSED - A Longitudinal Study of Compressed Work Schedules Within the Health, Care and Welfare Services

The aim of COMPRESSED is to investigate the potential consequences of a compressed work schedule within the municipal health, care and welfare services.

The aim of COMPRESSED is to investigate the potential consequences of a compressed work schedule within the municipal health, care and welfare services.

A compressed work schedule is defined by an increase in numbers of hours per day, and a reduction of number of days per week. Compressed work schedules are advocated as a tool to reduce involuntary part-time contracts, and improve employee recruitment and retention, as well as improve employee health and quality of care.

However, the empirical support of such claims is limited, mixed, and suffers from several methodological shortcomings. There is a clear lack in studies investigating the potential moderating and mediating mechanisms, despite moderating variables such as shift intensity being likely to have an impact. In collaboration with unions and employers, COMPRESSED uses a longitudinal mixed method design, to investigate the short- and long-term consequences of compressed work schedules, as well as potential moderating and mediating variables. Each of the research questions will be addressed with complimentary methods in each of the work packages.

The project COMPRESSED will examine:

In-depth narrative interviews eliciting employees', employers', and patients'/users' own perceptions of consequences, moderators and mechanisms.

A retrospective intervention study using registry data, examining compressed work schedules implemented over the past 5 years.

A two year longitudinal survey looking at long-term effects and 4) a diary study across two weeks, looking at short-term effects.

Eligibility Criteria:
Inclusion Criteria:

* Employed within the municipal health, care and welfare services.

Exclusion Criteria:

-
Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging

The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. The investigators will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment.

The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. We will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment. We will focus on changes in brain structure and function associated with frequent auditory hallucinations, one of the most disabling manifestations of schizophrenia, and with neuroleptic treatment. In order to address these aims, we will study four groups of subjects:

1. patients who have frequent auditory hallucinations,
2. patients who are beginning a regimen of anti-psychotic medication,
3. patients who do not have frequent hallucinations and are not changing medication strategies, and
4. age-matched normal controls. Each group will contain 15 subjects for a total of 60.

Eligibility Criteria:
Inclusion Criteria:

Investigators will study subjects who:

* Are between the ages of 18 and 65.
* Meet diagnostic criteria for any psychiatric disorder with auditory hallucinations (at least one every 20 minutes) including schizophrenia/schizoaffective disorder OR schizophrenia/schizoaffective disorder without auditory hallucinations.
* Have been treated with an antipsychotic drug for hallucinations at least three months or are unmedicated
* Are willing to change their current antipsychotic medication if indicated
* Are able to provide written consent

Normal controls must :

* Be between the ages of 18 and 65
* Not meet the diagnostic criteria for schizophrenia or schizoaffective disorder or other psychiatric disorder involving hallucinations
* Not currently be treated with an antipsychotic drug
* Be able to provide written consent

Exclusion Criteria:

Subjects and normal controls will be excluded from participation if there is:

* Evidence of non-psychiatric, chronic central nervous system (CNS) disease (such as brain injury or neurological disease)
* Contraindication to MRI, including prior claustrophobic reaction and severe movement disorder
* A recent change in menstrual status other than recent changes in oral or implanted contraceptive use (for females)
* A positive pregnancy result (for females)
Pediatric NMOSD Observational Study

This study is being done to develop a database of pediatric patients in order to study the cause, early detection and best treatment for neuromyelitis optica spectrum disorder (NMOSD) in pediatric patients.

This study is being done to collect information on the natural history of NMOSD in pediatric AQP4-IgG seropositive patients. A major restriction in performing drug studies in pediatric patients with NMOSD is limited information on the course of the disease in these patients. Collecting clinical information over the course of a 1 year observational study would inform on the natural history of the disease in these patients. A repository of pediatric patients with rare diseases can increase knowledge on the natural history of the specific disease, assist in identifying appropriate patients fulfilling specified criteria for drug studies and potentially serve as a control group.

Timepoints: Baseline, 3mo, 6mo, 9mo, 12mo (+/- 1 mo for each time point).

Baseline data:

* Demographics \[age/sex/ethnicity\],
* Clinical presentation information including date of initial diagnosis,
* Clinical phenotype
* Immunotherapy used current and past,
* Family history of autoimmune diseases,
* Serological data results
* Radiologic data as available

Self-Report Assessments will be:

* Current impairment, as measured by the expanded disability status scale (EDSS) score self-reported using Ratzker (1997) EDSS Self Report form,
* Quality of life as measured by the EQ-5D and Varni's (1998) PedsQL over the phone/mail/email.

At follow-up visits 3mo, 6mo, 9mo, 12mo (+/- 1 mo for each time point):

* Attacks/relapses
* Any hospitalizations
* Confirm medications and update records if changes

Self-Report Assessments at follow-up will be:

* Current impairment, as measured by the EDSS score self-reported using Ratzker (1997) EDSS Self Report form,
* Quality of life as measured by the EQ-5D and PedsQL over the phone/mail/email.

Eligibility Criteria:
Inclusion Criteria:

* AQP4 positive
* Ability to give informed consent by patient or caregiver

Exclusion Criteria:

- Inability to complete required forms via phone, mail, or email.
Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins

Aortic stenosis (AE) is a disease that has been increasing steadily in recent years in most countries, including Spain.Risk factors for the development of AE include age, hypercholesterolemia, diabetes mellitus and arterial hypertension, the classic risk factors for the development of atherosclerosis. However, lipid-lowering therapy with statins and ezetimibe has not been shown to reduce the risk of long-term progression of AE by unknown mechanisms. All this suggests that subjects with HFhe have a high risk of developing AD, which has not been shown by the high coronary mortality in this population that precedes aortic calcification

The study includes a single clinical visit with collection of clinical data, blood extraction and the performance of a transthoracic echocardiogram. This visit may be made on different days, but always within 30 days of signing the informed consent.

Eligibility Criteria:
Inclusion Criteria:

Cases:

* Age ≥ 65 years at the time of cardiac ultrasound
* Genetically diagnosed HFH or in a first-degree relative
* History of hypercholesterolemia with LDLc levels\> 220 mg / dL without lipid-lowering treatment

Controls:

* Genetically Similar
* Siblings of the normoccholesterolemic case, defined by LDLc \<190 mg / dl without lipid-lowering treatment.
* In the absence of available siblings, first cousins may be included.
* In the presence of several siblings available, the same sex will be included,
* Environmentally similar
* Stable partner of the case with cohabitation\> 25 years \* Each case will have at least one control.

Exclusion Criteria:

- Personal history of cardiac rheumatic disease