cyrilzakka/clinical-trials huggingface dataset:
DESVELA. Personal Skills as Determinants of Morbidity, Lifestyles, Quality of Life, Use of Services and Mortality.

Quantitative study: The main objective is to analyze whether personal skills related to behaviours are independently associated with the incidence of morbidity. Study with quantitative and qualitative methodology. Multicenter project (10 teams) for the creation of a cohort of 3083 people aged 35 to 74 years of 9 Autonomous Communities (AACC). The personal variables that will be evaluated are: self-efficacy, activation, health literacy, resilience, locus of control and personality traits. Socio-demographic covariates, social capital and community health assets will be recorded. As a secondary objective, it will be analyzed whether personal skills are independently associated with lower all cause mortality, better adoption of healthy lifestyles, higher quality of life and less utilization of health services in follow-up. A physical examination, a blood analytical and a cognitive evaluation will be carried out. The incidence of morbidity will be analyzed with a Cox model for each of the six independent variables (objective 1); and mortality from all causes and from the other dependent variables (objective 2). The models will be adjusted by the indicated covariables. The possible heterogeneity between (AACC) will be estimated by introducing random effects into the model.

Qualitative study: To deepen in the opinions and experiences of the population on the relationship between personal skills with their perception of health, their lifestyles and their quality of life. The research will be carried out from a phenomenological perspective. The number of discussion groups needed to reach the saturation of speeches will be made. There will be an analysis of thematic content that will be triangulated between members of the research team. The meanings will be interpreted and an explanatory framework will be created with the contributions of each type of informant.


Eligibility Criteria:
Inclusion Criteria:

- Population ascribed to Primary Health Centres in Spain.

Exclusion Criteria:

* Illness at terminal phase.
* Institutionalization.
* Intellectual disability.
* Dementia.
* Idiomatic difficulties
Home Airway Clearance in CF Patients

Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree.

By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, post-care, and rehabilitation units, etc...). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves.

The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with Cystic fibrosis
* Stabilization of the disease, defined by an at least 4 weeks period since the end of an exacerbation, stabilization will be let to investigator's judgment.
* Age \>12
* Requiring at least 1 bronchial clearing session each week (regardless of the technique)
* Patient (or patient's legal representative if applicable), capable to read and understand the procedure, and capable to express consent for the study protocol.

Exclusion Criteria:

* Severe pneumothorax or hemoptysis (more than 30ml per 24 hours) within 6 weeks before the inclusion day.
* Patient placed on a transplant waiting list
* Any contraindication to an instrumental bronchial clearance technique
* Patients already own and use SIMEOX at home
* Unavailable patient or patient wishing to move to a different region within three months after inclusion.
* Patient currently participating or having participated to another interventional clinical research within a month prior inclusion date, that may impact the study, this impact is left to the investigator's judgment.
* Persons referred by the French Public Health Code to Articles L1121-5 to L1121-8 (includes all protected persons: pregnant women (confirmed by measurement of the serum human chorionic gonadotropin level for any woman wishing to enter the protocol and under childbearing age \< 60), parturient woman, breastfeeding mother, everyone deprived of his liberty by judicial or administrative decision, everyone subject to a legal protection measure.
* Initiation of treatment with a CFTR modulator within the last 3 months
Open Label, Zonegran (Zonisamide) In Partial Onset Seizures

To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18-75.
2. Able and willing to give written informed consent in accordance with the ICH GCP Guidelines.
3. Female subjects of childbearing potential must not be pregnant (as confirmed by negative serum βHCG at screening and negative urine pregnancy test at baseline/during the study), must not be lactating and must use a medically acceptable form of contraception during the study and for at least 1 month after discontinuation of study drug. Medically acceptable contraception as defined here is the oral contraceptive pill, surgical sterilization or hormonal intrauterine device in place for at least 3 months. Women who are less than 2 years post-menopausal are considered to be of childbearing potential.
4. Focal epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the ILAE criteria.
5. Patients with a minimum of 4 partial seizures in the 8 weeks preceding the baseline visit as adequately recorded using a seizure diary card.
6. Patients should be receiving at least 1 but no more than 2 other AEDs as concomitant medication, and the dosage should be stable for at least 8 weeks before the baseline visit.

Exclusion Criteria:

1. History of status epilepticus within the last 5 years.
2. Patients with known significantly impaired renal function and/or severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed. Note Investigators should consult included SmPC as a guide.
3. Patients suffering from clinically significant psychiatric illness, psychological or behavioral problems which could interfere with study participation.
4. Patients with a history (within the last 12 months) of alcohol or drug abuse or dependency.
5. Patient suffering from any CNS progressive disease that may confound study interpretation, any active CNS infection, demyelinating disease or degenerative neurological disease.
6. Patients with a significant drug sensitivity or significant allergic reaction to any drug including sulfonamides.
7. Subjects considered by the Investigator to be an unsuitable candidate for receiving Zonegran or considered unlikely to comply with the protocol.
8. Any patient contraindicated for Zonegran treatment as per attached SmPC.
9. Any patient who is pregnant and/or lactating.
Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult Subjects

Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-810 in healthy adult subjects.

This is a single ascending dose study of ARCT-810 in which approximately 30 subjects are planned to be enrolled. The length of each study participant is approximately 8 weeks from screening to last study visit.

Study participants will be allocated to one of the five different study groups (also called cohorts), to test different doses of ARCT-810. There will be 6 participants in each group. Within each cohort, subjects will be randomized 2:1 to receive ARCT-810 or placebo as an IV infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy males or females aged 18 to 65 at the time of informed consent.
2. Body weight ≤ 100Kg and body mass index \<35 kg/m2
3. Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) and alcohol for at least 72 hours prior to study visits and willing to refrain from taking protein supplements for the duration of the study.
4. Willing and able to comply with protocol-defined procedures and complete all study visits
5. Males must be surgically sterile or, if engaged in sexual relations with a female of child-bearing potential, the subject must be using an acceptable contraceptive method from the time of signing the informed consent form until at least 30 days after the last dose of Study Drug. Females: must be non-pregnant and non-lactating and either: i. surgically sterile or ii. post-menopausal

Exclusion Criteria:

1. Clinically significant abnormalities in medical history
2. Screening laboratory results as follows:

   * ALT, AST, GGT, total bilirubin or alkaline phosphatase, \> ULN.
   * Random blood glucose and/or HbA1c \> ULN
   * Hemoglobin \< LLN
   * Platelet count \< 100x109/L
   * Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m2 calculated by Modification to Diet in Renal Disease \[MDRD\] study equation.
   * Urine protein:creatinine ratio (UPCR) \> 50 mg/mmol
3. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 7 days prior to Study Day 1
4. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
5. Uncontrolled hypertension (BP \> 160/100 mm Hg)
6. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer
7. Recent (within 1 year) history of, or current drug or alcohol abuse
8. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study
Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer

A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of pancreatic adenocarcinoma
* Distant metastatic or unresctable locally advanced diseases
* CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
* At least one lesion measurable by RECIST v1.1 criteria
* Life expectancy\> 3 months
* No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
* No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
* Pain must be monitored before inclusion
* 18 years \< age \< 70
* Performance status: 0-1
* ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
* ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
* Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable),
* creatinine \< 120 μmol/L, or MDRD creatinine clearance \> 60 mL/min
* Patient information and signature of informed consent

Exclusion Criteria:

* Concurrent other effective treatment (including radiotherapy)
* Resectable patients
* Allergy history to other drugs in the same class patients with pregnancy or lactation
* Known severe internal medical diseases
* Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
* Immunocompromised patients, such as HIV positive
* Uncontrollable mental illness
* Other conditions the researchers considered ineligible for the study
Fasting Mimicking Diet and Autophagy

This study aims to evaluates autophagy in circulating white blood cells from generally healthy human volunteers exposed to fasting mimicking diet (FMD), a 5-day dietary regimen.

Fasting-mimicking diet (FMD) was developed to mimic the endocrine and metabolic effects that water-only fasting, while providing a modest calories and essential nutrients. The health benefits of FMD are caused by several molecular mechanisms, including the reduction of body weight, ectopic fat storage, insulin levels, endogenous glucose production and IGF-1. Autophagy is a catabolic membrane-trafficking phenomenon observed in yeast and mammalian cells. Nutrient deprivation induces autophagy. Autophagy has been proposed to be a fundamental cellular process being linked to aging and the progression of age-related diseases. The objective of this study is to evaluate the effects of consuming two FMD formulations on the autophagy process in the cell.

Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to provide written informed consent;
* Ability and willingness to perform the study tests and adhere to study protocol (to the best of the participant's knowledge);
* BMI 20-35 kg/m2 (inclusive) at screening;

Exclusion Criteria:

* Diabetes treatment other than diet or metformin monotherapy;
* History of gastric bypass;
* Subjects with recent weight loss (\>5%), use of weight loss medication, participated in a weight loss program in the past 3 months;
* Type 1 diabetes (based on medical history provided at screening);
* Use of immune suppression drugs;
* Contraindication for study foods (special food needs and allergy);
* Women who are pregnant;
* Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men).
* Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation\* (\*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial);
A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia

The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).

Patients are randomized to receive thioctic acid alone, deprenyl alone, thioctic acid/deprenyl, or placebo alone for 10 weeks, after which all patients may receive active drug on an open-label basis. Patients must have seven clinic visits.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretrovirals provided dose has been stable for at least 6 weeks prior to study entry.

Patients must have:

* HIV seropositivity.
* Mild to moderate cognitive impairment (problems with short term memory, concentration, and feeling slowed down).
* No active opportunistic CNS infection.
* Ability to give informed consent.

Prior Medication:

Allowed:

* Prior antiretrovirals provided dose has been stable for at least the past 6 weeks.
* Prior thioctic acid or deprenyl.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Severe premorbid psychiatric illness including schizophrenia and major depression that would interfere with study compliance.
* CNS neoplasms.
* Any other clinically significant condition or laboratory abnormality that would preclude participation on study.
* Current participation in other drug studies.

Concurrent Medication:

Excluded:

* Chemotherapy for malignancy.

Patients with the following prior conditions are excluded:

* History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease.
* Prior participation in this study.
* History of adverse reaction/allergy to thioctic acid or deprenyl.

Prior Medication:

Excluded:

* Other investigational drugs within 30 days prior to study entry.
Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers

Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. Therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment.

Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. Therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment.

In order to o determine the efficacy of melatonin in healing pressure ulcer it has been designed a multicentre, single-blind, randomized clinical trial comparing melatonin cream as an experimental pressure ulcer treatment versus control group with standard treatment based on moist environment wound healing with a time frame of 8 weeks. In order to assess the healing rate, changes in Resvech 2.0 scale scores will be measured, as well as the ulcer surface reduction. To avoid variability in measuring ulcer surface, it will be done by using software HELCOS after taking a photograph of the wound weekly. An intention-to-treat analysis will be carried out. The t-test or Mann-Whitney will be used to check difference of means in the reduction of the area of the ulcer and variation in the Resvech 2.0 scale. Survival curves will be used to check possible differences in the follow-up time until epithelization.

Eligibility Criteria:
Inclusion Criteria:

* Present at least one category II, III or IV pressure ulcer according to National Group for the Study and Assessment of Pressure Ulcers (GNEAUPP) classification.
* Ulcer area between 1 and 100 cm2.
* People over 18 years of age who have freely given their informed consent in writing of their own volition or it has been given on their behalf by a legal guardian

Exclusion Criteria:

* Ulcer of category I, non-classifiable or affecting internal tissues, but with no break in the skin
* People currently undergoing chemotherapy treatment or who have done so in the previous 6 months
* People with a presumed life expectancy of less than 6 months or in palliative care.
Clinical Application of 68Ga-DOTA-NT-20.3 in the Early Diagnosis of Pancreatic Ductal Adenocarcinoma

The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-DOTA-NT-20.3 in patient with pancreatic ductal adenocarcinoma (PDAC).

This study is design to prospectively investigate the safety and efficacy of 68Ga-DOTA-NT-20.3 in the early diagnosis of pancreatic ductal adenocarcinoma (PDAC). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-DOTA-NT-20.3 in patient with PDAC. Neurotensin receptor 1 (NTR-1) is the high affinity receptor of Neurotensin (NT), which was found abnormal expression in the early stages of PDAC malignant cell transformation. 68Ga-DOTA-NT-20.3 as a new NTR-1 targeted probe was prepared and showed good uptake on PDAC cell line and animal studies. The study intends to recruit 6 PDAC volunteers to participate in the experiment. Patients were evaluated with 18F-fluorodeoxyglucose (18F-FDG). And then all patients underwent a single-injection with 68Ga-DOTA-NT-20.3, dual-modality imaging protocol consisting of a PET/CT and subsequent PET/MR scan. The follow-up period was followed up to assess safety and effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* patient with pathohistologically proven localized or metastatic PDAC;
* patient aged 18 or older, male or female, who can provide written informed consent for this study;
* patient with complete clinical data.

Exclusion Criteria:

* patient age \< 18 years;
* patient with other active cancer;
* patient with PDAC under the treatment blocking NT receptors;
* pregnant or lactating women;
* patient who cannot stay on PET/CT camera for app. 90 minutes;
* patient who cannot stand MRI;
* patient simultaneously participating in another clinical trial;
* patient with HIV, HCV, HVB infection or other serious chronic infection
* patient with serious mental, neurological, cardiovascular, respiratory and other system diseases;
* patient with liver and kidney function (GFR less than 50 ml/min) disease;
* patient with severe severe refractory mental disorder.
Effect of Speech Therapy in Combination With Non-invasive Brain Stimulation on Speech of Patients With Parkinson's Disease

Up to 90% of patients with Parkinson's disease (PD) have hypokinetic dysarthria (HD) in the early phase of the illness. HD is characterized by a harsh breathy voice quality, reduced variability of pitch and loudness and imprecise articulation. This project investigates the novel combination of speech therapy and home-based non-invasive brain stimulation (tDCS) treatment in order to increase overall positive effects on HD in PD. Using a novel multimodal analysis approach based on functional magnetic resonance and acoustic signal processing, we will be able to monitor changes in different domains of speech, as well as associated changes in brain plasticity.

Study will investigate the long-term effects of repeated (20) sessions of home-based tDCS as an add-on to well-established remote LSVT (i.e. the gold standard procedure for HD treatment) as compared to LSVT alone (coupled with sham stimulation) in patients with PD in their "on" dopaminergic condition without dyskinesias.

A two parallel-group, double-blinded, randomized, sham-stimulation-controlled design will be used. Forty PD patients will be randomized into two parallel groups by independent researcher by a computer-generated random number list, 20 subjects in each arm. Participants in the real tDCS group and the sham tDCS group will undergo a baseline assessment (V0), a follow-up assessment after four weeks of combined tDCS and LSVT treatments (V1) and another follow-up assessment 8 weeks after the baseline assessment (V2). Each visit will consist of EEG, speech tasks recording and speech evaluation by a speech therapist; MR scanning will be done at V0 and V1. Both groups will undergo the same speech therapy (LSVT) via telepractice as the gold standard treatment for HD, in combination with real or sham tDCS.

Eligibility Criteria:
Inclusion Criteria:

* patients with clinically established PD (Postuma et al. 2016)

Exclusion Criteria:

* psychiatric disorders, including major depression, hallucinations
* any MRI-incompatible metal in the body
* epilepsy
* lack of cooperation
* presence of dementia