cyrilzakka/clinical-trials huggingface dataset:
Monitoring Intermittent Fasting for Human Optimization Using Wearable Technology: An N-of-1 Study

There is a growing interest in personalized health strategies, including diet, exercise, and fasting regimens, to enhance metabolic fitness. Recent research indicates that intermittent fasting (IF) is useful not only for weight management, but also for energy production and improvement of metabolic well-being.

IF can potentially reduce systemic inflammation and help to prevent chronic diseases. IF research can also help athletes sustain performance during fasting periods. This prospective study aims to investigate the effects of a human optimization program on an individual\&#39;s metabolic health and overall well-being.

This research examines the correlations between continuous glucose monitoring, ketone measurement, exercise routines, heat/cold interventions, diet, supplements and intermittent fasting patterns. The study involves a single participant -the principal investigator- who will adhere to a personalized regimen involving wearable monitoring of metabolic changes, training and intermittent fasting. This research seeks to understand the potential relationships between these factors, contributing to the emerging knowledge on individualized health optimization.


Eligibility Criteria:
Inclusion Criteria:

* The principal investigator is the sole participant in this N-of-1 trial: a healthy individual with no chronic diseases or conditions affecting metabolic health.

Exclusion Criteria:

* The principal investigator is the sole participant in this N-of-1 trial.
A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard chemotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Written (signed) informed consent(s)
* Inoperable and incurable, locally advanced, recurrent or metastatic NSCLC
* Relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients)
* Age \>=18 years
* ECOG performance status of 0 to 3
* Recovered from the toxic effects of prior therapy
* Able to comply with study and follow-up procedures
* Able to take oral medication
* Use of an effective means of contraception (for patients with reproductive potential)
* Granulocyte count \>=1.0 x 10\^9/L
* Platelet count \>=75 x 10\^9/L
* Serum bilirubin \<1.5 x upper limit of normal (ULN)
* SGOT (AST) \<2 x ULN unless elevation is clearly due to liver metastases; then SGOT (AST) must be \<5 x ULN
* Serum creatinine \<=1.5 mg/dL

Exclusion Criteria:

* Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease)
* Prior therapy with any systemic HER1/EGFR small molecule inhibitor, including gefitinib (Iressa), erlotinib (Tarceva), or other investigational agents in this class
* History of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of \>=90%
* Known central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable
* Nursing mothers or pregnant females
Nurse AMIE (Addressing Malignancies in Individuals Everyday)

Nurse AMIE 3.0 is testing the effectiveness of an electronic symptom management system on overall survival in people with stage 3 and 4 cancer who live in rural areas.

After being informed about the details of the study, including risks and potential benefits, participants who give their informed consent will do baseline measurements. After these measures are collected, participants will be randomly assigned to either receive the computer tablet Nurse AMIE program or a supportive care book. Participants will be asked to complete measurements throughout the course of their active participation, which will last for 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patient receiving care for their cancer
2. Age: 18+ years of age
3. Has stage 3 or 4 cancer, or an unstaged cancer that is considered 'advanced' (greater than stage 2) by their treating oncologist
4. Must be within six months of initiation of pharmacologic or radiation treatment, for curative or palliative purposes, from a medical or radiation oncologist
5. Clinician-rated ECOG function of 0-3
6. Lives in a county with RUCC code 4 - 9 and/or zip code with RUCA code 4-10
7. Has access to personal device capable of receiving telephone calls for study facilitator check-ins
8. Fluent in written and spoken English
9. Sufficient vision/hearing to interact with the tablet and study staff
10. Clinician-defined life expectancy of 6 months or more

Exclusion Criteria:

1. Patients with medical or psychiatric conditions documented in the medical record (beyond cancer, its treatments, and its symptoms) that would impair our ability to test study hypotheses (e.g. psychotic disorders, dementia, inability to give informed consent, or follow study instructions).
2. Patients who are participating in any other supportive care or behavioral intervention studies.
3. Non-English speaking patients will be excluded, as they represent less than 2% of the population targeted.
Immunological Profile of Solid Tumors Sample

It has become clear in the recent year that the nature of the immune cells infiltrate within a tumor was essential in the control of the tumor growth. This so-called immune contexture does vary between cancer types and in response to treatments. In this context, this trial is a non-interventional, mono-centric in patients with solid tumors. Samples in paraffin-embedded material block of biopsies or surgical pieces (either primitive tumor or metastases) will be analysed. For each sample, clinically relevant data associated with treated cancer and needed for characterization of tumor microenvironment will be documented.

This trial is, through accessing to well documented selected archival tumor materials, to validate selected biomarker for early phase trial.


Eligibility Criteria:
Inclusion Criteria:

* Sample must have had a valid written informed consent for available archival tumor samples for scientific purposes.
* Sample from patients with histologically documented cancer in target population.

Exclusion Criteria:

* Samples from subject unwilling to give their informed consent;
* Unusable sample or biologically deteriorated.
Double Pet Project : A Comparison Between 11C-Acetate and 11C-acetoacetate Heart and Kidney Uptake

The objective of this study is to make a comparison between 11C-acetate and 11C-Acetoacetate heart and kidney metabolism

Healthy people will have two positron emission tomography scan to perform. One, with a 11C-Acetate Tracer and the other with 11C-Acetoacetate. The results will allow to determine if both tracers are used in a similar way but the organs and see if the investigators can use the already validated analyse method for acetate to make acetoacetate analysis

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 55
* BMI between 18,5 and 28
* Healthy
* Normal value for blood pressure

Exclusion Criteria:

* Taking drugs that could influence metabolism
* Diabetes or prediabetes
* Pregnancy or lactation
* Participation in a intensive sport program
* Being on a ketogenic diet
* Any clinical abnomally in prescreen blood sample
Biobank Cycle Collection

This study will provide daily urine samples from volunteers who are trying to conceive in order to maintain the SPD biobank.

Study volunteers, seeking to conceive will be provided with a CE marked Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception. All volunteers will provide daily early morning urine samples throughout the study period and keep a study diary of menses and pregnancy test results for up to 3 menstrual cycles.

Urine samples will be received in the clinical laboratory and aliquoted and stored at -80˚C until required.

The purpose if this study is to maintain the SPD Biobank with urine samples from cycles in which conception occurred and ones where conception did not occur, together with associated sample information including demographic and clinical data e.g. menses days, volunteer age and reproductive hormone concentrations.

Study volunteers, seeking to conceive will be recruited to the study after providing written informed consent. All volunteers will be provided with a CE marked Clearblue Ovulation product to help them pinpoint their most fertile time and aid conception and be required to collect daily early morning urine samples throughout the study until pregnancy is confirmed or their next menstrual period starts. Volunteers will be required to keep a daily diary of menses, sample collection and pregnancy test results. The study will last for up to 3 consecutive menstrual cycles.

Urine samples will be received in the clinical laboratory and will be tested for the presence of hormones related to pregnancy and fertility, then aliquoted and stored in the SPD Biobank at -80˚C until required for product development or evaluation purposes.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 and over actively trying to conceive
* At least 2 regular consecutive cycles since last pregnancy/miscarriage/ stopping breastfeeding or contraception
* Willing to disclose their pregnancy status and provide urine samples.
* Willing to give informed consent and comply with the study procedures

Exclusion Criteria:

* Trying to conceive for \>6 months (under 35 years) or \> 3 months (35 years and over)
* Has a diagnosis of Polycystic Ovary Syndrome (PCOS)
* Taking medication or has known condition which means they should not get pregnant.
* Currently pregnant or breastfeeding
* Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
* Using or has previously used infertility medications or hormone replacement medications containing LH or hCG \\ (e.g. Pregnyl®)
* Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as IVF or ICSI
* Peri-or post-menopausal, e.g. experiencing symptoms: irregular menstrual periods, hot flushes, night sweats, sleep disturbances and/or moods swings
* Abnormal liver or kidney function
* Taking antibiotics containing tetracycline.
* Participated in this study within the last 6 months
Comparing an Intraoperative vs. a Standard Wavefront Device

Comparison of intraoperative measured wavefront data with pre- and post-operative wavefront data.

Different technologies are in use for measuring wavefront aberrations, such as Hartmann-Shack wavefront aberrometry, Tscherning aberrometry, Laser Raytracing and automatic retinoscopy. While Hartmann-Shack wavefront aberrometry, the most widespread of these techniques, uses a lenslet array to record distortions of light bundles coming from a single source form the retina, Tscherning aberrometry uses a matrix of pinholes. Laser Ray Tracing in contrast measures the aberration of a laser beam at different locations. All three systems compare distorsions of the measured light beams with a perfect optical system to calculate the wavefront errors. Repeatability of wavefront devices was studied in young healthy subjects and different devices have been compared to each other. These results do not represent the typical cataract patient. Several factors, such as tear film instability and pupil size, have an influence on the measurements and these factors may change significantly with age.

Intraoperative measured data could help to get a better information about wavefront aberrations.

Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Age 21 and older
* Able to understand the patient information
* Willing to follow the instructions and attend all follow-up visits
* Willing to sign informed consent prior to surgery

Exclusion Criteria:

* Relevant other ophthalmic diseases that are likely to reduce the refractive outcome, such as pseudoexfoliation syndrome, traumatic cataract, severe corneal scars
* Previous ocular surgeries on the study eye
* Patients who are not able to cooperate, with eccentric fixation or insufficient ability to fixate (tremor, nystagmus)
* Pregnant or lactating women (pregnancy testing will be performed preoperatively on women of reproductive age)
Comparative Results of Six Biomaterials Used in Two-stage Maxillary Sinus

Objectives: The aim of the study was to compare histological and histomorphometric results of six bone substitute materials used as graft in two-stage maxillary sinus augmentation model, after 6-month-healing.

Materials and Methods:

A two-stage sinus augmentation was carried out in six patients using mineralized solvent-dehydrated bone allograft (MCBA), freeze-dried mineralized bone allograft (FDBA), anor-ganic bovine bone (ABB), equine-derived bone (EB); synthetic micromacroporous biphasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hydroxyap-atite (HA-β-TCP 30/70), or bioapatite-collagen (BC).

Eligibility Criteria:
Inclusion Criteria: patients healthy, absence of systemic pathologies (ASA class I), non-smokers, good oral hygiene, not pregnant or lactating, absence of painful symptoms and associated inflammatory or osteolytic pathologies, maxillary partial edentulism involving the premolar/molar areas, residual bone height between the sinus floor and alveolar ridge ranging from 2 to 4 mm, as measured on computerized tomography (CT) scan.

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Exclusion Criteria:

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Dose Range Finding Study of Fedovapagon in Men With Nocturia

The purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency.

Fedovapagon is a selective vasopressin V2 receptor (V2 receptor) agonist that is being developed for the treatment of Nocturia.

The antidiuretic effect of V2 receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and Nocturia.

Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of Nocturnal Voids). It is the most bothersome symptom of benign prostatic hypertrophy (BPH) and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (Nocturnal Polyuria).

The purpose of this Phase IIb study is to determine the efficacy of different doses of fedovapagon in reducing the number of times subjects with Nocturia void during the night together with other parameters including increasing the time between going to bed and waking to first void. By establishing the effective doses of fedovapagon on these clinical endpoints, the data from this study will determine the most appropriate dose(s) of fedovapagon for the treatment of Nocturia to be taken forward into further studies.

Eligibility Criteria:
Inclusion Criteria:

* Males aged 55 or over
* History and/ or symptoms of Nocturia (2 - 5 voids per night)
* Generally well (concomitant illness / conditions well controlled)
* Serum sodium, potassium, chloride and bicarbonate within normal limits
* No clinically significant abnormalities in other laboratory parameters, urinalysis, electrocardiogram (ECG) or physical examination
* Prostate specific antigen (PSA) within the normal range or not considered clinically significant
* Ability to comply with the requirements of the study
* Written informed consent.

Exclusion Criteria:

-
A Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination With Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer

A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer

A Phase I-II Trial of Capecitabine (Xeloda), Oxaliplatin and Irinotecan in Combination with Bevacizumab in 1st Line Treatment of Metastatic Colorectal Cancer

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed Metastatic Colorectal Cancer

Exclusion Criteria:

* Patients with diagnosis other than Metastatic Colorectal Cancer
Afatinib Osimertinib Sequencing NIS

This is a non-interventional, multi-country, multi-centre cohort study based on existing data from medical records of patients with EGFR mutation-positive advanced NSCLC treated with afatinib (Gi(l)otrif®) as the first-line treatment followed by osimertinib in case the T790M resistance mutation was developed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)
* The tumour harbours common EGFR mutations (Del19, L858R) at start of first-line treatment
* Patients who initiated second-line osimertinib treatment for acquired T790M mutation at least 10 months prior to data entry, AND who were treated with afatinib (Gi(l)otrif®) in the first-line
* Patients treated with osimertinib within an EAP/CUP or regular clinical practice
* Age ≥ 18 years
* Signed and dated written informed consent per regulations (Exemption of a written informed consent for NIS based on existing data in countries per local regulations and legal requirements)

Exclusion Criteria:

* Patients who received drug(s) other than osimertinib as the second-line treatment and/or patients who received drug(s) other than afatinib (Gi(l)otrif®) as the first-line treatment
* Patients with active brain metastases at start of treatment (either afatinib/Gi(l)otrif® or osimertinib)
Irbesartan/Hydrochlorothiazide and Irbesartan in the Treatment of Mild to Moderate Hypertension

Study Objectives :

* To demonstrate the reduction in office Blood Pressure following a 8-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference.
* To demonstrate the reduction in office Blood Pressure after 4-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference.
* To compare the response rate (defined as office Systolic Blood Pressure/Diastolic Blood Pressure reduce more than 10mmHg from Week 0) of patients after 4-week and 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan.
* To compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan
* To ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate hypertension with office Diastolic Blood Pressure (DBP) 90-109 mmHg and/or Systolic Blood Pressure (SBP) 140-179 mmHg
* All women of child-bearing potential must have negative urine pregnancy tests within a week prior to initiation of therapy

Exclusion Criteria:

* females who are pregnant or breast feeding
* office DBP ≥ 110 mmHg or office SBP ≥ 180 mmHg
* history of significant cardiovascular diseases which includes:

  * acute myocardial infarction within six months or any ischemic heart disease requiring medication.
  * cerebrovascular disease
* history of significant renal diseases including:

  * serum creatinine \> 3.0 mg/dl.
  * creatinine clearance \< 30 ml/min.
* severe biliary cirrhosis and cholestasis
* refractory hypokalemia, hypercalcemia
* history of autoimmune disease, collagen vascular disease, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
* hepatic disease as indicated by any of the following:

  * SGOT or SGPT \>3 x upper limit of normal.
  * Serum bilirubin \> 2 x upper limit of normal.
* any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objectives.
* any other investigational drug given within 30 days of initiation of therapy, and participation in other clinical studies while enrolled in this protocol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Duplication in CHIT1 Gene and the Risk for Aspergillus Lung Disease in CF Patients

Title: Duplication in Chitotriosidase (CHIT1) Gene and the Risk for Aspergillus Lung Disease in CF Patients.

Aim: To evaluate the link between CHIT1 duplication in CF patients and the predisposition to ABPA or persistent Aspergillus infection.

Patients: 40 CF patients. Design: Observational, single visit. Methods: All patients will be assessed for pulmonary function tests (PFT), sputum cultures, and blood tests for: CHIT1 duplication, immunoglobulin E (IgE) and Eosinophils levels. Part of the patients will be assessed for RAST, skin prick test.

Primary outcome measure is the difference in CHIT1 genotyping between the groups.

Title: Duplication in Chitotriosidase (CHIT1) Gene and the Risk for Aspergillus Lung Disease in CF Patients.

Introduction: Chitinases are the enzymes that digest the chitin polymer. Plants use CHIT1 as an important innate defense mechanism against fungi. CHIT1 is the major chitinase in the human airways.Variation in the coding region, with 24-bp duplication allele results in a reduced CHIT1 activity. Recently, CHIT1 duplication was found in 6/6 patients with severe asthma and fungal sensitization Aspergillus often persists in the respiratory tract of patients with Cystic Fibrosis (CF) and may cause allergic broncho pulmonary aspergillosis (ABPA).

Aim: to evaluate the link between CHIT1 duplication in CF patients and the predisposition to ABPA or persistent Aspergillus infection.

Patients: 40 CF patients divided to three groups .Group 1: patients who have neither ABPA nor Aspergillus infection in the past (the control group).Group 2: patients with persistent Aspergillus infection, without ABPA. Group 3: patients with current or past ABPA.

Design: Observational, single visit. Methods: All patients will be assessed for pulmonary function tests (PFT), sputum cultures, and blood tests for: CHIT1 duplication, IgE and Eosinophils levels.

Patient's characteristics including demographics, CF mutations, pancreatic status and sweat test will be derived from the charts.

Patients with ABPA as well as Aspergillus infection had also radioallergosorbent test (RAST) for molds, as well as skin prick test for Aspergillus and blood Galactomannan.

The primary outcome measure is the difference in CHIT1 genotyping between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Cystic Fibrosis.

Exclusion Criteria:

* Inability to produce sputum, or previous history of lung transplantation.
Head Position on Pediatric Nasotracheal Intubation

The aim of study is to evaluate whether the head position facilitates pediatric nasotracheal intubation when using a video-laryngoscope.


Eligibility Criteria:
Inclusion Criteria:

* Age 2-8 years old
* Amerian Society of Anesthesiologists I or II
* Patients who need nasotracheal intubation for surgery

Exclusion Criteria:

* A recent airway infection within 14 days
* Anatomical deformity in head and neck
* Modified Mallampati score IV
* Bleeding tendency in preoperative laboratory examination