cyrilzakka/clinical-trials huggingface dataset:
Assessment of Pharyngeal Carriage of Microorganisms Responsible for Transmissible Acute Respiratory Infections in HAJJ Pilgrims.

The objective of this project is to study the prevalence of viruses and bacteria responsible for transmissible acute respiratory infections in the respiratory tract of pilgrims returning from the trip. The patients included, will be the consultant pilgrims to the traveler health center, and before leaving for Hajj. Based on the results obtained in previous studies, it is estimated that 200 pilgrims will be included each year, 600 in total (inclusion period of 3 years). Respiratory secretions are then collected by nasal swab and throat (swab) prior to departure for the hajj. In return, patients will be reconvened systematic consultation to record medical events potentially encountered during the trip, and it will again be performed the same nasal swabs and throat. It will then be performed on these samples' return from hajj "molecular detection (PCR and RT-PCR) of 35 viruses and bacteria respiratory tropism: influenza (3), RSV (2), metapneumovirus (1), Coronavirus (4), Parainfluenzavirus (4), enteroviruses (4), rhinovirus (1), adenovirus (6) bocavirus, polyomavirus (2), pneumococcus, Bordetella pertussis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Haemophilus influenzae, Neisseria meningitidis and Coxiella burnetii. Samples "return of hajj" positive should be cultured for the isolation of the strain. For patients positive return, it will be done further research of these 35 viruses and bacteria on samples "start of hajj," the same method described above. In addition to this systematic consultation, and if symptoms return, the pilgrims will be seen in consultation for a diagnosis evaluation and therapeutic management.

This study will shed light on the acquisition of microorganisms respiratory tropism during the stay and on the potential risks associated with the circulation of these pathogens after the trip.


Eligibility Criteria:
Inclusion Criteria:

* All travelers presenting during the study period in the service of international vaccination for mandatory meningococcal ACYW135 vaccination ,
* Affiliated to a social security insurance regime
* Male or Female
* Aged over 18 years
* Having signed informed consent form
* able to understand and answer the study questions

Exclusion Criteria

* Patients aged under 18
* Patient whose protocol compliance seems unlikely to investigator
* Participant in another clinical trial or in exclusion period of a previous clinical trial,
* Unable to understand the nature and objectives of the study,
* Refusing to sign the informed consent form.
Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis
* At least 3 months prior treatment with Methotrexate (MTX)
* At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
* Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

Exclusion Criteria:

* participants who have failed more than 3 DMARDs
* participants previously treated with an approved biologic drug
* History of cancer in the last 5 years
* Severe or recurrent bacterial infection
* Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
* Women of Child Bearing Potential
Tools And Practices To Decrease CVD And Complications In The Diabetic Population Of Mexico

This project will look to improve standards of care for diabetic patients by evaluating a program that supports participants in making healthy lifestyle changes.

The program consists of 13 educational sessions that contain information about the prevention and care of diabetes and cardiovascular disease, physical activity, nutrition, community health and emotional well being.

Researchers propose to address extremely high rates of cardiovascular disease morbidity and mortality in Sonora, Mexico through use of an evidence-based community health worker intervention for adult patients with diabetes who receive care at health centers operated by the Secretaría de Salud, an office of the Mexican government. Researchers will conduct a cluster-randomized trial with a total of 400 patients at 20 health centers to understand whether the 13-week educational intervention, Meta Salud Diabetes, can effectively reduce clinical, behavioral, and psychosocial risk for cardiovascular disease among adults with diabetes. Researchers will also conduct an implementation study that will consist of systematic engagement of local, state and national decision makers to identify barriers, facilitators, and strategies to adopt and integrate community health worker-led cardiovascular disease prevention interventions throughout the 209 health centers in Sonora.

Eligibility Criteria:
Inclusion Criteria:

* adults ≥18 years old
* have been diagnosed with controlled or uncontrolled diabetes

Exclusion Criteria:

* \< than 18 years of age
* not diagnosed with diabetes
Safety and Efficacy of an Antibody to CCR5 in Individuals With HIV Who Are Not Currently on Antiretroviral Therapy

This is a phase 1, randomized, placebo-controlled, dose-escalation study of CCR5mAb004 in HIV-1 seropositive individuals who are not receiving concurrent antiretroviral therapy. Subjects will be randomly assigned to receive a single intravenous (IV) infusion of one of four dose levels of CCR5mAb004 or matching placebo. A minimum of 10 subjects will be randomized to each cohort at a ratio of 4:1 (active:placebo). A minimum of 40 and maximum of 60 subjects will be enrolled. This study will be conducted at up to 10 sites in the United States.

Subjects in each cohort will be followed for 56 days after study agent administration. The safety, tolerability, and immunogenicity of CCR5mAb004 will be evaluated based on physical examination, adverse event (AE) reporting, and clinical laboratory tests. Blood will be collected at specified times for the determination of CCR5mAb004 serum concentrations, HIV-1 RNA levels, and CD4+ and CD8+ cell counts. If CD4+ cell counts are less than 200 during the study period, the subject should be offered standard-of-care per HIV treatment guidelines that may include the initiation of appropriate anti-retroviral therapy (AVR). CCR5mAb004 pharmacokinetic (PK) and pharmacodynamics (PD) will be measured over the 56-day study period. Anti-CCR5mAb004 antibody titers will be assessed prior to dosing on Day 0 and on Day 28 and Day 56.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection confirmed by enzyme immunoassay (EIA) and Western blot.
* Age 18 to 64 years.
* HIV-1 RNA \> 5000 copies/mL.
* CD4+ T cell count \> 250 cells/uL.
* Treatment naïve, or off antiretroviral treatment for at least 30 days prior to screening and 60 days prior to Day 0
* CCR5 tropism confirmed by R5 PhenoSense assays.

Exclusion Criteria:

* CXCR4 tropic or dual tropic virus at screening.
* Laboratory values of Grade 3 or greater according to the Modified Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Tables.
* History of Category C AIDS-defining illness according to the 1993 Centers for Disease Control and Prevention (CDC) AIDS surveillance definition.
* History of any medical disease or condition that makes the subject (in the opinion of the investigator) unsuitable for the study.
* Malignancy within the past 5 years (except for basal carcinomas of the skin and in situ cancers of the cervix).
* Females who are pregnant or breastfeeding, or who plan to become pregnant during the study.
* Subjects whose dosage or number of prescription medications has changed within 30 days prior to screening
* Positive for hepatitis B surface antigen (HBsAg) or antibody to hepatitis C virus (HCV).
* Positive alcohol or drug screen
Healthy Weight at Home: A Pilot Weight Loss Program for Parents of Children With a Disability

The objective of this study is to design, implement, and pilot a lifestyle-based, 12-week, weight loss program for parents of children with a disability. This weight loss program supports weight loss among parents. It is a first step towards a parent-only approach to promote healthier weight among children with a disability.


Eligibility Criteria:
Inclusion Criteria:

Parent

* age ≥18
* English speaking
* completion of screening and baseline data collection
* BMI ≥ 25 and weight \< 300lbs (weight limit due to scale limitations)
* willing to lose weight through physical activity, weight tracking and decreased caloric intake
* willing to make changes at home to facilitate a healthy weight
* willing to complete 12 weekly weight loss video coaching sessions (20 minutes/session)
* willing to use Skype, FaceTime, Zoom, or WebEx for regular intervention contact
* Internet/ cellular plan that is sufficient for weekly program video conferencing
* willing to use the study scale with cellular technology to report weights at baseline, 12 weeks, and 24 weeks.
* willing to use the study scale with cellular technology at least weekly during the study (12 weeks)
* completion of screening and baseline data collection

Child

* age 8-18
* has a disability
* assent is required if the child is capable and willing to have height and weight taken by the parent at baseline, 12 weeks, and 24 weeks.

Exclusion Criteria:

* parent or child: previously diagnosed eating disorder, or treatment for an eating disorder
* parent: currently pregnant or plan to get pregnant in the next 6 months
* parent: planned weight loss surgery or procedure in the next 6 months
Bedtime Potassium Losartan on CKD With Nocturnal Hypertension Patients With Nondipping Blood Pressure Pattern

Nondipping blood pressure (BP) pattern is a potential independent risk factor for chronic kidney disease (CKD). Whether bedtime administration of potassium losartan has benefit for anti-hypertension and the prognosis of CKD patients is not clear. Patients with nondipping BP pattern or dipping BP pattern were enrolled in this study, and the patients with nondipping BP pattern were randomly divided into two groups and treated with bedtime or awakening doses of potassium losartan.

Patients with nondipping BP pattern or dipping BP pattern were enrolled in this study, and the patients with nondipping BP pattern were randomly divided into two groups and treated with bedtime or awakening doses of potassium losartan. Any patients who had any antihypertension medication at bedtime would withdrawal the drugs for 2 weeks before ABPM. Patients with nondipping BP were then randomly divided into two groups and received a bedtime or awakening dose of potassium losartan. Patients with dipping BP were called the dipper group, while the patients with nondipping BP were called the awakening dose group or bedtime dose group, according to the time of drug administration.

Eligibility Criteria:
Inclusion Criteria:

* night BP is SBP≥120mmHg and/or DBP≥70mmHg；
* presence of CKD;
* estimated GFR (eGFR)\<90 mL⁄ min ⁄ 1.73 m2 (using the Modification of Diet in Renal Disease Study equation) but \>30 mL⁄ min ⁄1.73 m2;
* signed informed consent from participating patients.

Exclusion Criteria:

* pregnancy;
* tumor;
* infection;
* renal replacement;
* history of drug or alcohol abuse;
* night- or shift-work employment;
* treatment with steroids or hormonal therapy;
* acute changes in eGFR \>30% in the past 3 months;
* presence of acquired immunodeficiency syndrome;
* CV disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure,and grade III or IV retinopathy);
* intolerance to ambulatory BP monitoring (ABPM);
* inability to communicate and comply with all of the study requirements.
A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis

This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study treatment is 32 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/=18 years of age
* Body weight \< /=130kg
* Active rheumatoid arthritis of at least 6 months duration, diagnosed according to the American College of Rheumatology (ACR) criteria of 1987
* Disease Activity Score (DAS28) of \>3.2
* Inadequate clinical response to a stable dose of traditional Disease-Modifying Anti-Rheumatic Drugs (DMARD)
* Have received permitted DMARDs, one or more; current DMARD therapy must have been at stable dose for at least 4 weeks prior to baseline

Exclusion Criteria:

* Prior treatment with TNF-inhibitors or other biologic DMARD
* Major surgery (including joint surgery) within eight weeks prior to baseline or planned major surgery within the study duration
* Functional class IV (American College of Rheumatology classification)
* Rheumatic autoimmune disease other than rheumatoid arthritis
* History of or current inflammatory joint disease other than rheumatoid arthritis
Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation

The purpose of this study is to determine the feasibility and acceptability of utilizing an adapted form (i.e. IPT-MBD) of a psychosocial intervention, Interpersonal Psychotherapy for Depressed Adolescents, for youth with severe mood dysregulation (SMD) or disruptive mood dysregulation disorder (DMDD).

The investigators hypothesize that retention rates will be \>80%, satisfaction scores will average 6 (high) on a 7 point satisfaction scale, and that youth who receive the IPT intervention will have overall improvement in SMD/DMDD symptoms.

This research is being done to learn more about how to help teenagers with a sad or angry mood, and emotional responses out of proportion to what would be expected in a situation. Together these symptoms are called Severe Mood Dysregulation (SMD), a research diagnosis, or disruptive mood dysregulation disorder (DMDD), a newer clinical diagnosis. Currently, there is no standard treatment for teens that have SMD/DMDD. These teens usually receive medication and some type of talk therapy. This research is being done to compare two types of talk therapy to see which is most effective in helping teens with SMD/DMDD. Investigators will compare treatment as usual (TAU) with Interpersonal Psychotherapy for Youth with Mood and Behavior Dysregulation (IPT-MBD). Investigators do not know if TAU and IPT-MBD work just as well, or if one is better than the other. When this study is over, investigators hope there will be a better idea of how to study treatments for teens with SMD/DMDD.

For those participants who receive IPT-MBD, are prescribed an antipsychotic, and have significant improvement in symptoms, investigators will gradually taper the antipsychotic dose.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, ages 12 to 17 years, who meet criteria for severe mood dysregulation (SMD) as defined by NIMH criteria or for disruptive mood dysregulation disorder (DMDD).
* Subject has an estimated IQ \>70 on the Kaufman Brief Intelligence Test (KBIT-
* Subjects will have continuously resided with a legal guardian who has known the adolescent well for at least one year before study entry and is legally able to sign the consent form.
* Children's Global Assessment Scale (CGAS) ≤ 60
* CGI-S (SMD) ≥ 4
* Participant and guardian must agree to have therapy sessions audiotaped for training purposes.

Exclusion Criteria:

* Subject poses a significant risk for dangerousness to self or others. Risk will be determined by clinical history, clinical diagnostic interview and KSADS-PL interview of parent and patient by clinician.
* Subject suffers from a concomitant medical or psychiatric comorbidity that makes this study protocol inadvisable (either the treatment is contraindicated or the disorder is not the primary focus of treatment).
* Subject meets DSM-IV criteria for current alcohol or substance dependence or current use (defined as the past 4 weeks).
* Primary caretaker does not speak English or is not capable of completing study measures.
* Pregnant females.
Upper Limb Unilateral Strength Training and Mirror Therapy for Chronic Stroke Patients

This is a pilot randomised controlled trial investigating a combination of unilateral strength training (cross-education) and mirror therapy for the rehabilitation of upper limb impairment following a stroke. This study has been conducted as part of a PhD qualification at the Institute of Technology Sligo in Ireland with all assessments being conducted at the institute and all therapy sessions taking place at the participant's home. The study was conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.

The study necessitated patients with chronic stroke to perform a strength training programme with their less-affected upper limb. The mirror and strength training group observed the reflection of the training limb in a mirror, the strength training only group exercised without a mirror entirely. Patients were referred through Hospital Health Professionals. Prior to trial commencement all participants were given comprehensive trial information and provided signed written informed consent. A total of 32 participants were recruited. After a warm-up participants performed 4 sets of 5 maximal isometric elbow extensions with their less-affected upper limb, three days per week, for four weeks. Patients received outcome assessment prior to the beginning of the intervention, directly after it and at three-month follow-up assessment. All assessments were carried out by a blinded Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for upper limb isometric strength, motor function, muscle tone, and self-perceived participation.

Eligibility Criteria:
Inclusion Criteria:

Chronic stroke diagnosed by a physician at least 6 months prior to study begin Discharged from formal rehabilitation services (not receiving outpatient rehabilitation on more than a monthly basis, but may still be in receipt of occupational or language therapy).

Exclusion Criteria:

Impaired cognition (Mini mental state examination (MMSE) \< 21) Cardiovascular, neurological or musculoskeletal impairments of the upper extremity not related to stroke that would prevent strength training.

Visual impairments that would interfere with the ability to participate safely in isometric training and observe mirror images.
Kinetics of cEVs Over the 24-hour Dosing Interval After Low-dose Aspirin Administration

Extracellular vesicles (EVs) are small vesicles deriving from all cell types during cell activation, involved in transcellular communication, and regarded as predictors of vascular damage and of cardiovascular events. The investigators will test the hypothesis that, in patients on chronic low-dose aspirin treatment for cardiovascular prevention, aspirin may affect the release of EVs within the 24 hours interval.


Eligibility Criteria:
Inclusion Criteria:

* patients on low-dose aspirin treatment for cardiovascular prevention for at least 1 month
* arterial hypertension if well controlled with stable drug therapy
* hypercholesterolemia if well controlled with stable drug therapy

Exclusion Criteria:

* cigarette smoking insufficiency
* clinically significant hepatic insufficiency
* clinically significant renal insufficiency
* clinically significant cardiac insufficiency
* clinically significant pulmonary insufficiency
* history of malignant neoplasms (diagnosed and treated within the past 5 years)
* pregnancy or lactation
* history of malabsorption
* regular (daily) alcohol consumption
* regular (i.e., more than 3 days per week) non steroidal anti-inflammatory drug intake
* type 1 diabetes excluded by islet autoantibodies evaluation (anti-glutamic acid decarboxylase, islet cell cytoplasmic, and IA-2 antibodies), family history of type 1 diabetes, age lower than 40 years, lean phenotype, early requirement for insulin therapy
Study To Evaluate The Impact Of Anti-Cyclic Citrullinated Peptide(Anti-CCP) For Management With Enbrel In Patients With Psoriatic Arthritis(PsA)

This study is to evaluate the local data in Iraqi patients with psoriatic arthritis on Enbrel treatment with positive Anti-Cyclic Citrullinated Peptide using data from the Rheumatologist in Baghdad Teaching Hospital registry.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed PsA patients.
* ≥18 years of age
* Have not received previous biological treatment

Exclusion Criteria:

* Previous use of other biological treatments.
* Etanercept use for less than 1 year duration.
Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication

The experimental medical device is a prototype software. The device comes in the form of a smartphone with a touch interface. The smartphone used to support the software is a commercial smartphone marked CE. The study aims at assessing the feasibility of the use of this expert, patient- decision support systems.

The study hypothesis is that the clinical use of the experimental device is feasible.


Eligibility Criteria:
Inclusion criteria:

* Male or Female 18 years or older (no upper age limit)
* Operated within a surgical department of of the Hautepierre University Hospitals of Strasbourg
* Patient understanding and reading French
* Subject neurosensorially able of interacting with a tactile electronical interface
* Subject able to understand research objectives, risks and provide dated and signed informed consent
* Subject covered by a health insurance scheme

Exclusion criteria:

* Patient with neuropsychiatric or sensory disorders that may interfere with their use of the visual interface
* Unable to provide informed information (subject in emergency, difficulty understanding the subject, etc.)
* Pregnant or lactating woman (on declaration)
* Patient under safeguard of justice, under guardianship, under curatorship