cyrilzakka/clinical-trials huggingface dataset:
Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment

Globally, approximately 55 million people suffer from dementia, and 60-70% of cases are due to Alzheimer's disease (AD). Increasing scientific evidence highlights that the pathological changes underlying AD and other forms of dementia begin long before the onset of symptoms. Mild cognitive impairment (MCI) is a clinical condition that in people over 65 shows a prevalence ranging from 3% to 22%. The characteristics of MCI are the presence of a subjective memory disorder and a reduced ability to learn new information with normal general cognitive functioning, normal ability to perform daily activities and the absence of other conditions, such as depression, that could justify the memory disorder. Currently, the diagnosis of MCI is based exclusively on clinical evaluation, including neuropsychological tests.

Currently, there are no therapies available to prevent and/or treat dementia and the options for intervention are represented by treatments such as physical exercise and cognitive treatment. These practices refer to the concept of cognitive reserve. Computerized cognitive training (CCT) is characterized by being a personalized intervention, allows multi-domain training and increases the cognitive processes of patients with MCI. The National Low Vision Center has been using a software called nLIFE EyeFitness for several years, certified as a Class I Medical device. It allows you to carry out individualized rehabilitation exercises at home, using your own PC or tablet, with monitoring by the Center's operators. The exercises currently present stimulate attention, short-term visual memory, reaction time, executive function, working memory and, therefore, also appear suitable for stimulating subjects with MCI.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 60 years with a diagnosis of aMCI
* Signing of informed consent

Exclusion Criteria:

* Age \<60 years
* History of dementia
* Diabetes mellitus
* Uncontrolled hypertension
* Diagnosis of major depression
* Glaucoma
* Age-related macular degeneration
* Media opacity and vitreoretinal pathologies that may preclude a correct evaluation
* • Failure to obtain informed consent
Management of Intraoperative Fluids in Ambulatory Surgery

This is a single-center prospective randomized control trial (RCT) to determine whether the continuous monitoring of the plethysmographic variability index (PVI) during low-risk surgeries, can be used to optimize the intraoperative fluid administration. Low-risk patients that attend our day surgery unit, and who will be operated under general anesthesia, will be randomized to either a liberal fluid group, a restrictive fluid group or a dynamic monitoring group (PVI-directed). The amount of fluid infused together with the time to discharge, will be assessed in each participant during the postoperative period along with additional secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* participants attending the unit for a day surgery procedure
* participants whose surgeries will be performed under general anesthesia
* aged between 18-65 years
* no abnormal findings on chest x-ray or electrocardiogram on preoperative evaluation
* patients undergoing procedures which do not require opening of the abdominal or thoracic cavities

Exclusion Criteria:

* ASA score III or higher
* patients undergoing surgeries which require additional pain management procedures (e.g. selective nerve blockade, epidural anesthesia, etc.)
* known pregnant women
* known kidney disease (or serum creatinine \>1.8 mg/dl)
* known liver disease (or AST/ALT \>60 U/l)
* known chronic heart failure (determined by a LVEF \<55%)
* participants who develop hypotension intraoperatively and do not respond to 4 fluid challenges (1000 ml), requiring aggressive fluid resuscitation OR vasopressors
* estimated blood loss during surgery \>250 ml
* development of an adverse reaction to any of the drugs administered during surgery (requiring additional medical management)
Person-centred Interactive Self-management Support in Primary Healthcare for People With Type 2 Diabetes

The aim of this study is to develop and evaluate a person-centred digital intervention in primary healthcare for people with T2D, in addition to their usual diabetes care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes within the last five years
* 18 years of age or older
* Ability to read and communicate in Swedish
* Own a smart phone

Exclusion Criteria:

* 81 years and over at inclusion
* Life-threatening physical illness (e.g. cancer)
* Documented cognitive impairment
* Those not responsible for their own self care
* Those not residing in their own home environment (e.g. those in nursing homes, in-patient hospital wards)
Diagnostic Performance of Urinary Gluten Immunogenic Peptides in Monitoring the Adherence to Gluten-free Diet.

The purpose of the GRRES study is to assess the clinical usefulness of urinary gluten immunogenic peptides test as a marker of gluten-free diet adherence using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies.

A strict and permanent gluten free diet (GFD) is the only effective treatment resulting in full clinical, serological and histological remission, avoiding long-term complications in celiac disease (CD) patients. Gluten immunogenic peptides (GIP) are fragments of gluten proteins resistant to gastrointestinal digestion and detectable in urine after intestinal digestion, providing direct evidence of recent gluten ingestion. A significant variability in the amount of excreted urinary GIP has been reported in individuals administered with similar doses of gluten and, so far, inadequate information is available about the amount of excreted GIP in subjects ingesting traces or low amount of gluten. This is an important issue, as even a strict GFD could be contaminated by traces of gluten, e.g. in wheat starch and processed food. The aim of this study is to assess the clinical usefulness of urinary GIP as a marker of GFD adherence using a rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies. This is a prospective, randomized, triple-blind, placebo-controlled, clinical trial. In this study, healthy volunteers following a normal diet will be requested to be on strict GFD for 5 days. On day 4th, participants will be requested to collect a baseline urine sample and in case of a negative GIP test result they will be assigned to ingest a specific dose of purified gluten incorporated in a capsule (0 mg, 10 mg, 50 mg, 100 mg, 500 mg and 1000 mg, according to randomization). Participants will be requested to collect urine samples in a container and take a 5 mL aliquote for the GIP test at the 9th and 24th hour from the time of the administration of the dose. During the collection, volunteers will also be requested to record the volume of the excreted urine and to store the collected urine at 4°C. Urine tubes will be stored at -20°C until the quantitative evaluation of GIP. GIP test will be performed using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies iVYCHECK GIP Urine™ test (Biomedal, Spain) according to the manufacturer's instructions.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* 20-40 years old
* written informed consent

Exclusion Criteria:

* type 1 diabetes
* chronic or acute inflammatory diseases of the gastrointestinal tract (CD, non-celiac gluten sensitivity, Crohn's disease, ulcerative colitis, food allergy, acute gastroenteritis ≤ 4 weeks prior to the study start)
* pregnancy or lactation
* chronic intake of medications and supplements
* refusal/withdrawal of written informed consent.
Conventional Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

The objective of the investigators study is to assess conventional repetitive transcranial magnetic stimulation (rTMS) in patients with chronic severe tinnitus. A randomized, double-blind, sham-controlled procedure, with four increasing levels of magnetic "pseudo-dose" has been designed, in order to characterize the effectiveness of rTMS while controlling its safety and tolerability. By combining various rTMS protocols with a twelve-month follow-up, and using an effect modeling, the study aims at: (i) specify the effective values of rTMS parameters, with an adequate tolerance; (ii) determine the expected benefit and the persistence of effect; (iii) assess the practical feasibility of this kind of therapeutic management.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18 and 75 years old;
* Adequate medical condition (ASA P1 or P2 in Physical Status Classification System);
* Disabling tinnitus (STSS \> 8/16 or THQ \> 50%), with the following characteristics: continuous, subjective, non-pulsatile; unilateral (or bilateral with unilateral predominance), chronic (duration for at least one year), refractory for usual treatments taken for at least six months;
* Naive regarding TMS;
* Able to provide informed consent.

Exclusion Criteria:

* Objective tinnitus or tinnitus with treatable cause;
* Presence of intracranial or intraocular ferromagnetic materiel or particles (with the exception of dental fillings and MRI-compatible stapedectomy prosthesis);
* Cardiac pacemaker or other electronic implants (including cochlear implant);
* Serious heart disease or other unstable major medical condition;
* Personal history of central nervous system disorder, head injury, stroke or seizures (including childhood febrile seizures);
* Familial history of epilepsy;
* Concomitant medication with antidepressants and antipsychotics;
* Possibility of pregnancy;
* Known claustrophobia;
* Others known contraindications to rTMS or brain MRI;
* Refusal to be informed about the results of anatomical MRI
A Phase IIa Study With Escalating Dose of MS1819-SD

This is a Phase IIa study sponsored by AzurRx SAS and Syneos Health is a local representative sponsor and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (EPI) caused by chronic pacreatitis (CP) and/or distal pancreatectomy. The new medication is called MS1819 Spray Dried (MS1819-SD) which is a lipase produced by the LIP2 gene of Yarrowia lipolytica using recombinant DNA technology.

The primary purpose of this study is to investigate the safety of escalating doses of study drug MS1819-SD in people with chronic pancreatitis. This enzyme has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common with CP patients. The deficiency in this enzyme can be responsible of greasy diarrhea, fecal urge and weight loss.

The design of the study is open-label, meaning that all eligible participants will receive the study drug MS1819-SD. The MS1819-SD dose will increase throughout the study during dose escalation visits in each treatment period; study includes a total of four treatment periods.

The total duration of the MS1819-SD treatment phase is of 48-60 days, The total duration of patient participation in the study is of 74-93 days.

Approximately twelve patients will be enrolled in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent form,
2. Age \>18 years,
3. Male or female,
4. Body weight within the range \[50-100 Kg\] for males or \[40-90 Kg\] for females,
5. Distal pancreatectomy for any disorder (e.g. acute pancreatitis or its complications, CP or its complications, pancreatic endocrine or exocrine cancer, or others) and/or CP of any etiology (e.g. alcohol, genetics, hypercalcemia, or others) of grade 2 or higher (Cambridge classification),
6. Faecal pancreatic elastase-1 \<100 μg/g of stools at screening or within one month of the screening visit,
7. CFA measurement ≤ 75% at washout
8. Female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception during the study.
9. Being considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator.

Exclusion Criteria:

1. Cystic fibrosis,
2. Total or partial gastrectomy,
3. Cephalic or total duodenopancreatectomy,
4. Documented fibrosing colonopathy,
5. Any small bowel disease possibly responsible for malabsorption, including small intestinal bacterial overgrowth, celiac disease, small bowel resection ≥1 meter length, etc.,
6. Acute pancreatitis or exacerbation of CP ≤3 months,
7. Pancreatectomy for exocrine or endocrine cancer ≤1 year,
8. Metastatic or locally recurrent exocrine pancreatic cancer,
9. Known hypersensitivity or other severe reaction to any ingredient of the investigational medicinal product,
10. Bilirubin \>3 times ULN (upper limit normal),
Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency

The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at screening visit)
* Treatment with regular FXIII replacement therapy initiated at least 6 months prior to screening and one of the following : a documented history of at least one 1 treatment-requiring bleeding episode prior to initiation of regular replacement therapy or a documented family history of FXIII congenital deficiency (only for subjects on regular replacement therapy prior to screening)
* Documented history of at least two 2 bleeding episodes requiring treatment with FXIII containing blood products within the last 12 months prior to screening (only for subjects receiving on-demand treatment prior to screening)

Exclusion Criteria:

* Known neutralizing antibodies (inhibitors) towards FXIII
* Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
* Documented history of at least 2 treatment-requiring bleeding episodes per year during previous regular replacement therapy with FXIII containing blood products (fresh frozen plasma (FFP), plasma-derived FXIII (pd FXIII) and cryoprecipitate)
* Known or suspected allergy to trial product(s) or related products
* Planned major surgery during the trial period. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject
* Renal insufficiency defined as current dialysis therapy
* Any history of confirmed venous or arterial thrombo-embolic events
Pepsinogens as the Early Marker of H. Pylori Eradication

Helicobacter pylori (H. pylori) eradication increases the serum pepsinogen (PG) I/PG II ratio and the percentage change in PG I/PG II ratios was found to be a useful marker of H. pylori eradication (e.g., the PG method). We studied whether the PG method could be an early diagnostic marker of H. pylori eradication even in patients persistently treated with a proton pump inhibitor. Sixty-two H. pylori-positive patients underwent H. pylori-eradication therapy, followed by treatment with a PPI to cure ulcers. Serum levels of PG I and PG II were measured before, at the end of, and at 4 weeks after the eradication therapy. At more than one month after the end of treatments, 13C-urea breath test (UBT) was performed. The cut-off values of percentage changes in PG I/PG II ratios for the diagnosis of eradication of H. pylori were set in proportion to PG I/PG II ratios before eradication in accordance with our previous report. Using the results of UBT as the standard, the percentage change in serum PG I/PG II ratios is useful as an early diagnostic marker for judgment of H. pylori eradication irrespective of PPI treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with H. pylori infection

Exclusion Criteria:

* Patients without H. pylori infection
Young Patients With Early Breast Cancer

The prognosis of young patients with breast cancer is relatively poor. Chemotherapy damages ovarian function. Endocrine treatment for up to 10 years delays the childbearing time of patients. Treatment regimens in young breast cancer patients are still controversial in the following: 1. Exemption from chemotherapy based on gene prediction results; 2. Removing drugs that damage ovarian function from chemotherapy regimens; 3. Giving ovarian protection drugs during chemotherapy for patients with hormone receptor (HR)+; 4. The right time to get pregnant. In view of the above problems, the treatment scheme recommended in the guidelines cannot meet the personalized needs of young breast cancer patients. The project plans to establish a prognosis model for young patients with breast cancer, and provide the patients hierarchical and refined management, which is significant for prolonging survival time, improving quality of life, and protecting fertility. This project plans to observe the relationship between the characteristics of immune genes, pathological staging, molecular typing, treatment plans and prognosis in the cohort of young breast cancer patients, and establish a young breast cancer prognosis model and verify it. The project is expected to establish a prognosis model and provide a hierarchical and personalized precision treatment plan for young breast cancer patients, so as to prolong the survival time, improve the fertility rate, and improve the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* patients with breast cancer received operation in Peking Union Medical College Hospital
* age ≤40 year old and ≥20 years old
* treatment regimen was made in Peking Union Medical College Hospital

Exclusion Criteria:

* patients without pathological information
* patients with metastasis
* patients with history of other malignant tumor (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous cell skin carcinoma)
* patients with palliative resection of breast
Effects of Physical and Cognitive Training in Neuroplasticity, Health and Cognition. Movement Project

The MoveMent project applies non-pharmacological strategies - physical exercise and cognitive training - that have been shown to be effective in promoting active and healthy aging. The objective is to study the molecular and neural mechanisms of these strategies to stimulate brain plasticity and improve brain health and cognitive functioning.

It is a randomized controlled study with three intervention groups - physical, cognitive and combined - and a control group. The intervention is carried out over 3 months, with a frequency of 5 weekly sessions of 45 minutes each. Cognitive training is applied through a computerized program, physical training consists of a walking aerobic program, and combined training arises from the addition of the two previous ones.

140 participants will undergo an exhaustive pre- and post-intervention evaluation that includes neuropsychological, neuroimaging, genetic and biochemical analysis before and after the intervention as well as physical and health status assessment.

The present project aims to examine the independent and combined effects of exercise and cognitive stimulation in functional and structural brain plasticity, cognitive performance, emotional state and quality of life, and will determine the demographic and clinical factors that can modulate neuroplasticity. It will allow us to study the neurophysiological mechanisms by which the different types of intervention have an effect on the structure and functioning of the brain and cognition within an omics framework.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 70
* Underactive or sedentary (\<2 hours a week of physical activity).
* Adequate visual, auditory and fine motor skills.
* Able to speak and understand Catalan or Spanish language.
* Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki.

Exclusion Criteria:

* Mini mental State examination \< 24 and Montreal Cognitive Assessment- Short (MoCA -S) \< 6.
* Diagnosis of mild cognitive impairment, dementia or other serious neurological, psychiatric, or systemic illness.
* Presence of another illness that render them unable to engage in physical activity (signs or symptoms of chronic heart disease, chronic obstructive pulmonary disease, orthopedic problems).
* History of drug abuse or alcoholism.
* Psychotropic consumption
* Contraindication to magnetic resonance imaging
Effects of Topical Hyaluronic Acid Gel on Postoperative Pain and Wound Healing

This clinical study aims to investigate the impact of a topical hyaluronic acid (HA) gel on postoperative pain and wound healing at palatal donor sites in patients undergoing mucogingival procedures involving a de-epithelialized gingival graft (DGG) from the palate. The study design is a Phase III, randomized, double-blind, parallel-group, clinical trial, conducted in a single center, with 30 subjects aged 18-70 years.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, between 18-70 years of age
* Informed Consent Form signed and availability for the duration of the study
* Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study
* Clinical indication for mucogingival surgery that requires a de-epithelialized gingival graft (DGG) from the palate
* Willingness to provide information related to their medical history
* Minimum of 10 uncrowned permanent natural teeth (excluding third molars)
* Normal salivary flow

Exclusion Criteria:

* Oral pathology, chronic disease, or a history of allergy to testing products
* Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study
* Subject participating in any other clinical study
* Subject pregnant or breastfeeding
* Subject allergic to oral care products, personal care consumer products, or their ingredients
* Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study
* A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc
* Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)