cyrilzakka/clinical-trials huggingface dataset:
Study of the Efficacy and Safety of Cholecalciferol Supplementation on the Activity of Rheumatoid Arthritis in Patients With Vitamin D Deficiency

Vitamin D plays a key role in the regulation of calcium metabolism and bone physiology and also presents immunomodulatory effects. In contrast to healthy individuals, macrophages and synoviocytes synovium of patients with rheumatoid arthritis (RA) have receptors for vitamin D. In vitro, 1,25 Vitamin D inhibits T cell proliferation and cytokine synthesis and decreases pro-inflammatory process. There is an inverse relationship, at least in some epidemiological studies, between the circulating levels of 25OH vitamin D and the occurrence and / or activity of RA. The hypothesis of our study is that natural vitamin D supplementation in patients with RA and a vitamin D deficiency (vitamin D \<30 ng / mL) improves functional disability.

This is an interventional, multicenter (13 rheumatology units) randomized, double-blinded study against placebo, lasting 24 weeks. The main objective is to demonstrate that treatment with cholecalciferol improves functional disability (HAQ) in patients with RA not in remission (DAS28 VS\> 2.6 and the investigator does not think to change the treatment in the 3 months after enrolment) and vitamin D deficiency (vitamin D \<30 ng / ml). Secondary objectives will be to examine whether there is a decrease in disease activity (tender joint count, swollen joint count, VAS, EVA activity, ESR, CRP, EULAR criteria, ACR), a decrease in fatigue (FACIT EVA - fatigue), improved quality of life (SF36, EMIR, PASS, MOS) and the impact of RA (RAID).

Eligibility Criteria:
Inclusion Criteria:

- Patients with RA (ACR 1987) not in remission (DAS28\> 2.6) in whom no change in treatment is considered by the investigator for at least 3 months, DMARD stable RA for at least 3 months and lack of infiltration in the last 2 months

- Serum 25-OH vitamin D \<30 ng / ml

Exclusion Criteria:

* Arthritis resulting in class IV functional disability (according to the ACR criteria)
* Hypercalcemia (serum calcium\> 2.6 mmol/L) and/or known hypercalciuria (calcium excretion\> 4 mg / kg / day), history of renal colic, thiazideic therapy.
* Known hypersensitivity to vitamin D
* Patient refused to sign the consent form, pregnant or nursing women, patients minor, major patients under protection of the Act
Programming Cochlear Implant With Artificial Intelligence

This thesis project proposes to investigate the "state of the art" of the programming of the cochlear implant. In the center of audiophonologie Brussels, the classic 'manual programming' has been in use over 20 years and also the new way 'Artificial Intelligence programming'. The investigators want to compare, objectify, and control this new mode of programming.

The study is planned over 4 years, in order to test, randomized, 15 subjects with manual programming and 15 other subjects with Artificial Intelligence programming. To test the performance of Cochlear Implant patients, audiological, language auditory perception and questionnaire tests will be presented.

This research aims to determine the contribution and results of Artificial Intelligence programming.


Eligibility Criteria:
Inclusion Criteria:

* unilateral cochlear implant
* post-lingual hearing loss
* a good command of French.

Exclusion Criteria:

* non deaf
* bilateral cochlear implant
* deaf without cochlear implant
Determinants of the Nutritional Composition of Donor Human Milk

Human milk is the most complete and correct way to feed a newborn, as it provides all the nutrients and bioactive factors essential for adequate growth and neurodevelopment. In special circumstances, such as prematurity or illness, breast milk is not always available, and donor human milk (DHM) is an option. Some studies have reported growth retardation in babies fed DHM, probably due to the less adequate nutritional composition. There are several factors that contribute to changes in its nutritional composition. Among the various factors, the following are worth highlighting: wide variety of donors with different characteristics (e.g. gestational age, lactation phase, diet); inconsistency of the collection method; impact of milk processing, i.e. the pasteurization process.

As the Human Milk Bank of North (BLHN - Banco de Leite Humano do Norte) is the first in the North region of Portugal, and there are few studies developed in this area in Portugal, the present project aims to study the influence of the following factors on the composition of the DHM:

* Pasteurization process;
* Dietary habits of donors;
* Body composition of donors.

Study design and sampling: observational study with a cross-sectional and prospective design. The sample will consist of mothers who donate human milk to the BLHN of the Centro Hospitalar de São João.

Data collection: in order to meet the objectives of the research project, a questionnaire was drawn up for the participants, to be administered on paper, in an interview format, in the context of an outpatient consultation.

The questionnaire lasts around 20 minutes and consists of sociodemographic information (age, household composition, marital status, nationality, educational qualifications, profession); personal history (pathologies, number of pregnancies and births, date of last birth, gender, age, birth weight and length of the newborn, presence of gestational diabetes, hypertension in pregnancy, pre-eclampsia, term or pre-term birth, twin pregnancy); anthropometric data and body composition of the donor; food frequency questionnaire; physical activity; nutritional composition of the donated milk before and after processing (pasteurization).

Eligibility Criteria:
Inclusion Criteria:

* Human milk donors at BLHN
* Informed consent of the participant

Exclusion Criteria:

* None
Mobilization of Endothelial Progenitor Cells and Aspirin

Aspirin at doses used during acute myocardial infarction may inhibit the mobilization of endothelial progenitor cells (EPCs).

Aspirin has been shown to lower the number of EPCs in a time- and concentration-dependent manner. In vitro studies also show that aspirin may reduce the migratory and adhesive capacity of isolated EPCs, inhibit iNOS and tubule formation, which are pre-requisites for angiogenesis. This is relevant when patients are given a loading dose of 325mg at the time of diagnosis of acute myocardial infarction where higher numbers of EPCs have been associated with better outcomes. Furthermore, in the PLATO (Platelet Inhibition and Patient Outcomes) trial, high dose aspirin appeared to counteract the beneficial effect seen when ticagrelor or clopidogrel was used with low doses of aspirin in acute coronary syndromes (ACS).

As aspirin is currently standard of care in the management of ACS, it is difficult to conduct a study of the effect of aspirin versus placebo in that scenario. However, during alcohol septal ablation for hypertrophic obstructive cardiomyopathy, the indication for an antiplatelet agent is not well defined and varies between operators. When a small amount of myocardium is deliberately destroyed in this process, it serves as an ideal model to study the effect of aspirin on the biology of EPCs in vivo. This could provide an explanation to the different effects of high versus low dose aspirin when combined with a second antiplatelet agent in the management of ACS.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been selected to undergo alcohol septal ablation for hypertrophic obstructive cardiomyopathy based on clinical need
2. Age \>18 years, \<80 years

Exclusion Criteria:

1. Patients with known allergy to aspirin
2. Inability or refusal to consent to participate in the study
3. Patients who are on non-steroidal anti-inflammatory drugs and cannot be stopped for the duration of the study
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects

This Phase 2, open label, randomized study will investigate the virologic benefit, clinical efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised adult and pediatric subjects.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed influenza A by rapid antigen testing
* Immunocompromised as defined by recent solid organ or hematopoietic transplant, chronic graft vs. host disease, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose chemotherapeutics, HIV positive
* Clinical diagnosis of influenza
* Onset of illness within 5 days
* Male and female subjects agree to contraception through 24 weeks after last dose

Exclusion Criteria:

* Received more than 1 dose of antiviral agents
* Critically ill
* Creatinine clearance less than 80 mg/mL
* Females who are pregnant and males whose female partners are pregnant
* Received live attenuated virus vaccine within 3 weeks
Southern Methodist Alcohol Research Trial (SMART)

The purpose of this study is to look at the effects of assessment, feedback and motivational interviewing on alcohol consumption among college drinkers.

Excessive alcohol consumption has been a growing problem at many US colleges. In response, colleges and universities have instituted a range of alcohol intervention and prevention programs for students. Motivational Interviewing (MI) is one brief intervention that has been shown to reduce heavy drinking among college students. To date, all college studies of MI have used a format that includes an assessment and feedback delivered in an MI style. Although this format has considerable empirical support, it remains unclear which of the components is necessary to produce behavior change. This study will evaluate the separate and collective effects of MI and feedback among "binge" drinking college students. Additionally, this study will evaluate the effects of the initial drinking assessment, through including a delayed-assessment control group. After an initial screen, 350 students at Southern Methodist University who report at least one heavy (i.e., "binge") episode during the previous two weeks will be randomized to: (1) MI with feedback, (2) MI without feedback, (3) Mailed feedback only, (4) Assessment only, or (5) Delayed assessment only. MI sessions will be delivered by trained and supervised counselors. Participants will be assessed via a secure Internet site at baseline, 3, 6 and 12 months (12 months only for the Delayed-assessment group), with primary outcome measures including self-reported quantity and frequency of drinking, and drinking-related problems. Since college drinking is associated with substantial negative effects for drinkers, as well as for others, the findings of this study may have significant public health implications in terms of reducing costs, and improving services for students who choose to drink.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be enrolled in Southern Methodist University.
* Participants must report one "binge" episode (4 or more drinks in one setting for women, 5 or more drinks in one setting for men) in the past two weeks.
* Participants must be at least 18 years old.

Exclusion Criteria:

* Participants will be excluded if they are not enrolled at Southern Methodist University.
* Participants will be excluded if they do not report at least one "binge" episode in the past two weeks.
* Participants will be excluded if they are less than 18 years old.
Clinical Trial to Evaluate the Efficacy and Security of Deep Brain Stimulation in Alzheimer´s Disease

Approximately one million of Spaniards suffer from AlzhEimer´s Disease (AD) and this figure is expected to triple by 20150. The approved treatments modulate neurotransmission in general and are not specific or anatomically directed. In AD there is a dysfunction in cognitive and memory circuits. It has been shown that the deep brain stimulation (DBS) can specially modulate circuits in such a way that is modulable, and this approach is safe. The safety of this treatment and its biological effects are convincing enough to require further study of possible therapeutic effects of DBS in AD. The objectives are: To evaluate the security of DBS in AD (main objective). To study the influence of DBS in the progress of AD, to compare the effects of DBS on the brain metabolism neural connectivity and hubs using MEG, and to compare the effects between two different groups: fornix and Basal nucleus of Meynert (BNM). To achieve this, a prospective, double-blind comparison study between groups will be conducted, to evaluate the effects of DBS in 6 patients: group I (fornix) and group II ( BNM).


Eligibility Criteria:
Inclusion Criteria:

* Age: Between 50-80 years old
* Diagnosis criteria of Alzheimer disease (Dubois criteria) in the previous 2 years
* Presence of tau, p-tau or Aβ in cerebrospinal fluid or positive amiloid-PET scan
* Clinical dementia rating scale (CDR): 1
* Use of cholinesterase inhibitors and/or memantine during one year at least, and worsening in neuropsychologic tests in spite of the treatment
* Informed consent (patient and caregiver or legal representative)

Exclusion Criteria:

* Brain structural disorders: primary or metastatic tumor, Hydrocephalus, stroke, brain abscess or cerebral malformation
* Vascular dementia (NINCDS-AIREN criteria)
* Neurodegenerative disease other than AD
* Psychiatric disease
* Epilepsy
* Severe or unstable comorbidity (mellitus diabetes, high blood pressure...)
In Home VR Therapy

Virtual reality is a video game in which a person and their real-time movements are represented on a screen in a virtual environment. This study will compare the use of multi-user virtual reality (VR) to single-user VR to determine if either provides superior engagement in upper extremity therapy and greater motivation to perform repetitive training.

Stroke survivors will participate in a longitudinal study in which they will have the opportunity to perform rehabilitative training with multi-user VR and single-user VR modes in their homes. They will use each mode for 2 weeks, completing 4 session per week, each session is 1 hour long. Upper extremity motor control, level of engagement, and active range of motion will be assessed at time points during the intervention period.

Subject evaluations will take place before the intervention, at the midpoint of intervention (between switching from multi-user to single-user modes, or vice versa), and at the end of the intervention.

The investigators hope to address two aims:

Aim 1: To determine if the use in-home multi-user virtual reality treatment results in greater engagement in therapy compared with in-home single user virtual reality treatment.

Aim 2: To determine if in-home virtual reality treatment results in greater practice

The investigators hypothesize that stroke survivors will be more engaged in therapy when training with the multi-user VR system and this will translate into greater practice.


Eligibility Criteria:
Inclusion Criteria:

* Are between the ages of 21 and 80
* Experienced a single stroke at least 6 months prior to enrollment
* Have moderate arm impairment as indicated by a score between 4 and 6 on the Chedoke-McMaster Stroke Assessment, arm subscale
* Live within 20 miles of the Rehabilitation Institute of Chicago (as study personnel will need to travel to their home)

Exclusion Criteria:

* Other neurological, neuromuscular, or orthopedic disease
* Pain in the upper extremity with movements required in the treatment
* Contracture that limits use of the VR system
* Vision problems which would preclude the ability to use the VR system
* Cognitive or language deficits that would prevent them from understanding the tasks
* Concurrent enrollment in another intervention study involving the affected arm or hand
* Botox injection in the arm within the previous 6 months
Hemodynamic Optimalization in Pediatric Patients

Hemodynamic unstability, defined by macrocirculation and/or microcirculation dysfunction or alteration is common in critically ill pediatric patients. The initial treatment of hemodynamically unstable patient is the fluid resuscitation (fluid challenge therapy). However, the stabilization of hemodynamics only with fluid resuscitation can be achieved in less than 50% pediatric patients. In case of persistent hypotension (defined as mean arterial pressure below 65 mmHg, or by the formula - 55 + 1,5 x age in years), or in case of persistent lactate levels and base deficit elevation is the catecholamine therapy method of choice in case of sufficiently restored intravascular volume. In adult patients, the drug of choice (the first line therapy of persistent hypotension) is considered norepinephrine (based on evidence-based data). The norepinephrine is administered intravenously in form of continuous infusion, with the dose adjusted to the target level of mean arterial pressure (MAP). It should be preferably administered through the central venous catheter to minimize the complications associated with the damage of the peripheral vein wall damage in case of administered into the peripheral vein. Due to lack of evidence-based data (EBM) for pediatric population, there is still significant heterogenity of clinical practice and dobutamin, dopamine, norepinephrine and epinephrine are being used for hemodynamically unstable pediatric patient.

After Ethics committee approval, pediatric patients admitted to the Departement of pediatric anesthesiology and intensive care with the need of vasopressor and/or inotrope therapy in the selected study period will be included. The primary aim of the trial is the describe the therapy effect on the vital signs (heart rate, blood pressure), level of lactate and base deficit in 1,3,6,12,24,48 and every other 24th hours. The secondary aim of the trial is the incidence of complications: arrythmias, hypertension, defects of peripheral perfusion, mortality, renal failure, the PELOD-2 and pSOFA score at admission and every next 24 hours. The cumulative overall dose and the cumulative 24 hours dose of vasopressors/inotropes will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients in selected age interval
* admitted to the pediatric intensive care unit
* hemodynamic instability with the need for vasopressor and/or inotrope therapy

Exclusion Criteria:

* patients with no hemodynamic instability
* patients with achieved hemodynamic stability after fluid resuscitation
A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors

This clinical study evaluated the efficacy and safety of T3011 in combination with PD-1/PD-L1 inhibitors in subjects with advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with advanced solid tumors;
2. At least one measurable lesion;
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
4. Expected survival \> 12 weeks;
5. Laboratory inspection meets the requirements;
6. For women of childbearing potential, the serum pregnancy test results must be negative prior to the first dose，and effective contraceptive measures must be taken from signing the informed consent form (ICF) until at least 6 months after the last dose;
7. Male subjects of childbearing potential agree to use effective contraception from signing the ICF until at least 6 months after the last dose; In addition, male subjects must agree not to donate sperm during this period;
8. Understand and voluntarily sign the ICF，willing and able to comply with all experimental requirements.

Exclusion Criteria:

1. Subjects who have received other antitumor therapy within the prescribed time prior to the first dose;
2. Subjects with a history of other malignancies within the prescribed time prior to the start of study treatment.
3. At screening, subjects with a history or evidence of high risk cardiovascular disease;
4. Subjects with persistent or active infection requiring intravenous anti-infective therapy;
5. Subjects with autoimmune diseases or a history of autoimmune diseases;
6. Subjects with known psychiatric disorders that may affect trial compliance;
7. Subjects who have pleural effusion, pericardial effusion, or ascites before starting treatment and require puncture drainage, or who had received puncture drainage within the specified time before starting the study treatment;
8. Subjects requiring systemic treatment with anti-HSV drugs during the study period;
9. Subjects who have received live or attenuated vaccines within the prescribed time prior to the first dose, or who plan to receive such vaccines during the study period; Subjects who have received any tumor vaccine in the past;
10. Subjects who had undergone major surgery within the prescribed time before the first dose，and had not recovered from surgery-related adverse reactions or were still in the postoperative recovery period，or who plan to undergo major surgery during the study period;
11. Subjects with a history of drug use，drug abuse or alcohol abuse within the year prior to signing the ICF;
12. Female subjects who are pregnant or breastfeeding, or planning to conceive or have children during the study period;
13. The investigator considers it inappropriate to participate in this study.
Prevention of High Altitude Pulmonary Edema

A double-blind placebo controlled study

* To compare the effect of tadalafil and dexamethasone versus placebo on Ppa and pulmonary edema formation in subjects susceptible to HAPE.
* To investigate the effect of dexamethasone on alveolar fluid clearance, as assessed by measurement of the nasal potential difference, and prevention of HAPE.
* To investigate the effect of the tadalafil and dexamethasone versus placebo on the dynamic CBF autoregulation properties and on the development of AMS in HAPE susceptible subjects.


Eligibility Criteria:
Inclusion Criteria:

* At least one previous episode of high altitude pulmonary edema

Exclusion Criteria:

* pulmonary arterial hypertension
* congenital heart disease
* any chronic lung disease
Cemented Marathon/Corail Versus Pinnacle/Corail

A randomised, comparative, prospective, single-blinded trial of two hip prosthesis:

1. Marathon cemented all-poly acetabular cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana) and
2. Pinnacle/Marathon uncemented cup(Depuy, Warsaw, Indiana), Corail uncemented femoral stem(Depuy, Warsaw, Indiana), 32mm Alumina Biolox Forte femoral head(Depuy, Warsaw, Indiana)

There will be a further in-group randomisation to a Corail femoral stem with or without a collar, creating a number of 4 study-groups in total.

The aims of the study are:

* To compare polyethylene wear and migration of the moderately cross-linked Marathon polyethylene in a cemented version(Marathon) and in an uncemented cup(Pinnacle/Marathon)
* To evaluate micromigration and periacetabular bone mineral density of the 2 cups using radiostereometry(RSA)
* To evaluate the migration patterns and proximal femoral bone density changes around the Corail stems with and without a collar


Eligibility Criteria:
Inclusion Criteria:

* Age under 70 years with primary or secondary arthritis of the hip, aseptic necrosis of the femoral head, acute hip fracture or sequelae after hip fracture.

Exclusion Criteria:

* Active malignant disease, rheumatoid arthritis or other generalised auto-immune arthritic disease,
* BMI \> 35,
* insulin dependent diabetes mellitus, 0 chronic or recurrent infection,
* liver disease,
* Paget's disease,
* dementia or lack of compliance for other reasons,
* uncompensated cardiac or pulmonary disease(ASA class 3 or 4). Prosthesis in the contralateral hip does not exclude the patient, but only one hip in each patient can be included in the study.