cyrilzakka/clinical-trials huggingface dataset:
A Post Market Clinical Follow-up Study With the aneXys Cup

The purpose of the study is the evaluation of the clinical and radiological short- to long-term safety and performance of the aneXys cup. The data will be used for an ongoing evaluation of the product safety and performance.

Prospective observational multicenter case series providing short-term migration results and long-term post-market clinical data on the safety and performance of the aneXys cup. The study includes patients undergoing primary total hip arthroplasty. In total 100 patients in 3 clinics will be included. In each clinic 10-57 consecutive patients shall be included. In addition, to meet the regulatory requirements, a total of minimum 20 cases with screw fixation shall be included in the study.

Clinical and radiological follow-up (FU) is planned after 6-12 weeks, 6 months, 1, 2, 5, 7 and 10 years. An additional FU at 3 years is planned to apply for an ODEP (Orthopaedic Data Evaluation Panel) rating.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form (signed by participant and investigator)
* Primary implantation
* Suffer from primary or secondary osteoarthritis of the hip, femoral head and neck fractures or necrosis of the femoral head. In all cases a stable anchoring of the implant has to be possible.
* Age at inclusion: between 18 and 75 years old
* Willing to participate in the follow-up examinations
* Complete recovery is expected

Exclusion Criteria:

* Missing informed consent form (signed by participant and investigator)
* Known or suspected non-compliance (e.g. drug or alcohol abuse)
* Enrolment of the investigator, his/her family, employees and other dependent persons
* Patients younger 18 years old
* Revision surgery
* Presence of sepsis or malignant tumours
* ASA (American Society of Anesthesiologists) Classification \>3
* Pregnancy
A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects

This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for subsequent clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. Subject who voluntarily participate and sign the informed consent form;
2. Healthy male/female volunteers aged 18 to 45 years;
3. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 \~ 28.0 kg/m2, inclusive;
4. Able to comply with the lifestyle restrictions.

Exclusion Criteria:

1. Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
2. Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
3. Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;.
4. Subject has a history of self-mutilation; or at risk of suicide;
5. Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial;
6. Subject has abnormal vital signs, laboratory abnormalities, and ECGs;
7. Subject has used any of over-the-counter products within 14 days or prescription medications within 28 days prior to dosing;
8. Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);
9. Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results;
10. Subject has a history of substance abuse or a positive urine drug screen;
11. Subject who has daily smoking of ≥ 5 cigarettes;
12. Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
13. Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
14. Subject who has participated in other clinical trials within 3 months before administration;
15. Subject has used blood products or being blood donor or blood loss;
16. Pregnant, lactating women, or positive pregnancy test;
17. Subject who refusal to contraception, or plan to donate sperm or ovums;
18. Other conditions which would make participation in the study unsuitable.
Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.

The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand however its use was stopped because of its association with sepsis and enterocolitis caused by the excipient of vitamin E. The purpose of this study is to use vitamin E to prevent ROP, without the previously used excipients.

Antioxidant defence mechanisms include cellular and extracellular enzymes. Vitamin E is the main fat-soluble vitamin responsible for the protection of cell membranes against peroxidation, thus, it protects polyunsaturated fatty acids from peroxidation which is a step in the pathogenesis of ROP.

Previous research on the roles of vitamin E, in the prevention of BPD and ROP was halted because of complications involving sepsis and necrotising enterocolitis. These complications were caused by the compositions of vitamin E oral presentations, which contain polyethylene glycol, propylene glycol, ethanol and, polysorbate 80. These substances, which are used as excipients, may generate adverse effects in premature newborns. These preparations were not used in this project to avoid the development of necrotising enterocolitis, and because these formulations are not commercially available in Mexico.

The infants were randomly assigned to one of two groups using a computerized random number generator sequence; this process was handled by the hospital pharmacy staff. The treated group, received vitamin E 12.5 IU orally every 12 hours, from 72 h after birth until 28 days of age, the first blood sample collected from the newborns before the intervention was considered the baseline, and subsequent samples were obtained at 15 and 28 days of age.

Control group: received orally sterile water (placebo)

Eligibility Criteria:
Inclusion Criteria:

* Newborn weight \< 1500 g
* Diagnosed respiratory distress syndrome (RDS)
* Patients who required mechanical ventilation or CPAP

Exclusion Criteria:

* Congenital malformations
* Rh incompatibility
* Non-immune or immune hydrops fetalis
* Intraventricular haemorrhage III/IV grade
Our Anesthesia Experience During MRI Scan

In this study we aim to investigate the relationship between our anesthesia practice and post procedure complications after MRI scanning with sedation. This is a retrospective, single center observational study. All patients undergoing MRI scan during the study period will be included.

In this study we aim to investigate the influence of patient characteristics and anesthesia choice on possible complications in patients undergoing MRI under sedation retrospectively.

After one of the routine sedation protocol used in our department was chosen and applied according to the physical status of the patient and the physicians decision, the datas of the patients will be recruited to the study from the medical records . Patient characteristics (age, gender, weight, height), ASA (American Society of Anethesiology) classification, associated diseases will be recorded . After the procedure was completed all the complications during the 2 hours waiting period in the recovery room will be recorded from the medical records. All the complşcation and recovery times will be recorded from the medical records. Whether the patient received radiocontrast material or not will also be recorded. The patients will be called by phone, and will be questioned for the complications, any epileptic seizure attack, or increase in the number of seizures, any admission to emergency room or any in patient admission to the hospital will be recorded which developed in the first week after the procedure.

Eligibility Criteria:
Inclusion Criteria:All patients undergoing MRI scan wth sedation anesthesia and giving written informed consent.

Exclusion Criteria: patients refusal to be studied.

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Induction and Expansion of T Cell Repertoire Using Growth Hormone and Vaccination in HIV-1 Infected Patients

Concomitant administration of recombinant human growth hormone (rhGH) may boost the expansion of immune reconstitution and broaden specific T cell responses not achievable by vaccination alone. The main objective of that study is to test the validity of this hypothesis with vaccines which are routinely administered to HIV-1 patients(tetanus toxoid and hepatitis A virus vaccines) in order to, if proven of value, use this strategy of HIV vaccination in the near future. This is a pilot, randomized, clinical open label study aimed to investigate thymic functionality and the HIV-specific responses after administration of rhGH in HIV-1 infected patients in highly active antiretroviral therapy (HAART) regimen.

The purpose of a therapeutic vaccine is to control, induce and expand humoral and cellular immune responses capable to control HIV infection. The administration of a conventional vaccine results in the expansion of peripheral clones. Concomitant administration of rhGH may boost this expansion and reconstitute specific T cell responses not achievable by vaccination alone. In this study we want to investigate whether the administration of rhGH expand T cell repertoire and whether there is an increase in the specific cellular responses to HIV-1 and recall antigens and, lately, whether this responses can be further amplified after immunization with tetanus toxoid and hepatitis A vaccines. This Hypothesis will be evaluated by the measurement of thymic volume, the expansion of naïve, memory and effector cell subsets, analysis of thymic emigrants (TRECs) before, during and after rhGH administration and vaccination. Moreover, T cell receptor rearrangement, specific antibodies and cellular responses to antigenic peptides will be determined.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 asymptomatic patients in HAART regimen (\> 6 months)
2. Viral load \< 50 copies/ml
3. Number CD4 cells \> 250 cells/mm3
4. Non responders to vaccination (tetanus toxoid and/or Hepatitis A virus)
5. Well-disposition to rhGh daily administration (6 months of treatment)

Exclusion Criteria:

1. AIDS outbreak
2. Allergy or hyperreactivity to rhGH or vaccines
3. Diabetes Mellitus
4. Renal, hepatic, pancreatic disorders
5. Chronic diseases
6. Dementia
7. Pregnancy
Emollient 'Plus' vs Urea 10% for Mild-Moderate Atopic Dermatitis

The goal of this clinical trial is to evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis The main question it aims to answer is:

" To evaluate the effectiveness and tolerability of an Emollient Aqua Posae + Microesyl compared to urea 10% in patients with mild-moderate atopic dermatitis age 18 years and above". Moisturizer application will be performed twice daily, 3 minutes after bathing, with a standardized dose using the Finger Tip Unit (FTU) method.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥18 years
* AD patients who meet the criteria for AD diagnosis according to the Hanifin-Rajka criteria.
* Patients with mild-moderate AD according to the SCORAD index.
* Patients who have AD lesions on the hands and/or feet.
* Patients with good general condition.
* Patients are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

* Pregnant and lactating patients.
* Patients with a history of allergies to ingredients contained in moisturizers
* Patients who clinically have other skin diseases such as psoriasis, seborrheic dermatitis, contact dermatitis or AD with secondary infections that can affect the SCORAD index parameters, skin hydration, skin pH and side effects on the skin area being assessed.
* Patients receiving topical or systemic immunomodulatory and/or immunosuppressant therapy.
* Patients receiving topical and/or systemic antibiotic therapy
* Patients receiving systemic antihistamine therapy (patients who require antihistamines during the study will be recorded on the observation sheet)
The Electronic Asthma Action Plan System for Implementation in Primary Care

Asthma is a common and potentially fatal chronic disease. An asthma action plan (AAP) is a written plan produced by a physician for a patient with asthma, to provide education and guidelines for self-management of worsening asthma symptoms. Studies have shown that AAPs effectively improve asthma control, but physicians fail to provide AAPs due to lack of time and adequate skills. Physicians also often fail to determine if their patients have good asthma control, and to adjust medications in response to patients' control level. The investigators propose to develop and test a computerized tool that will help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic version of the AAP, all based on patient responses to a questionnaire. The investigators hope that this system will eliminate the barriers that physicians face in determining asthma control, adjusting medications, and delivering an AAP, and will increase the frequency with which physicians are able to achieve these goals in patients with asthma. The objectives of the study are to determine the impact of this system on asthma action plan delivery by primary care physicians, the frequency of checking control level, and the frequency and appropriateness of asthma medication changes (in accordance with control). We will also attempt to determine the impact of the system on hospitalisations, emergency room (ER) visits, unscheduled visits to the doctor, total visits to the doctor, days off work or school, nocturnal asthma symptoms, daytime asthma symptoms, daytime rescue puffer use, and quality of life, and to measure physicians' perceptions of and satisfaction with the system.

This is a 2-year prospective interrupted time series (ITS) study of usual asthma care (baseline period) (year 1) compared to care with the eAAPS in place (intervention period) (year 2). The setting is two academic family health teams (primary health care teams including family physicians, nurses, and allied health members) in Hamilton, Ontario and one community-based family health team in Brampton, Ontario.

Eligibility Criteria:
Inclusion Criteria:

* Eligible physicians will include all primary care physicians at the 4 sites.

Eligible patients will include:

* patients with asthma, as determined by a validated electronic chart record search algorithm for asthma and on an asthma medication \[but not a Chronic Obstructive Pulmonary Disease (COPD) medication\] within 1 year;
* patients \>/= 16 years of age who understand English

Exclusion Criteria:

* Pregnant patients will be excluded given that conventional AAP recommendations may not be appropriate in this population.
* Any patient deemed to have cognitive limitations or a life expectancy of \< 1 year
Workplace Fall Prevention Through Slip Recovery Training

The goal of this clinical trial is to evaluate the feasibility of applying slip recovery training, a novel balance training exercise intervention, to workers who are at increased risk of slip-induced falls. This will be done via field studies with industrial partners. Note that the slip recovery training is not a device or drug. It is a detailed exercise regimen that aims to improve the the ability to recover balance after slipping.

The main specific aims are are:

* To investigate the feasibility of on-site slip recovery training
* To validate field assessments for evaluating slip recovery training efficacy in subsequent research

Participants will complete 3-6 once-weekly sessions of slip recovery training, answer daily text messages indicating any falls they experience while working over the 12 weeks after completing slip recovery training, and a subset of workers will be asked to participate in focus group discussions after the 12 weeks to provide information on the long-term feasibility of slip recovery training. A group of workers at Virginia Tech will also be asked to complete a laboratory session of testing during which they will be exposed to a laboratory-induced slip so that gold-standard measures of slip-induced fall recovery can be used to validate field assessments.

Workers who complete slip recovery training will be compared to another group of workers who complete an alternative balance training that should improve balance but not improve slip recovery that is targeted by slip recovery training.


Eligibility Criteria:
Inclusion Criteria:

* Virginia Tech workers in Dining Services, Facilities and Housekeeping, and construction.
* Veolia field workers in water distribution and water main construction
* age 18-65 years old
* willing to complete 3 or 6 training sessions, lab testing session, and daily falls tracking for 12 weeks

Exclusion Criteria:

* weigh over 250 pounds
* answer 'no' to all questions of the Physical Activity Readiness Questionnaire
The Study of Lithogenesis Processes in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. In order to study the association between NAFLD and nephrolithiasis while minimizing the confounding effect of metabolic syndrome, we investigated the impact of different degrees of NAFLD severity on potential risk factors for stone formation.


Eligibility Criteria:
Inclusion Criteria:

* subject \>= 18 years old
* able to sign the ICF
* Liver biopsy with report compatible with NAFLD

Exclusion Criteria:

* alchol use \> 20g/die
* other causes of liver disease
* active neoplasm
The BMI Project (Body, Mind, Inflammation)

Obesity and chronic inflammation influence the development and progression of many types of cancer. These conditions share several of the same causes, including physical inactivity, poor nutrition, stress, and insufficient sleep. Emerging adulthood (ages 18-25) represents an important developmental period in which to address behaviors and psychological variables that affect both weight status and inflammation. At least 40% of emerging adults have overweight/obesity, and this transition from adolescence to early adulthood is associated with significant increases in fast food consumption, decreases in physical activity, unpredictable sleep schedules, and alarmingly high rates of depression and perceived stress.

Despite this high risk for obesity, very few weight loss interventions are designed specifically for emerging adults. Preliminary findings from weight loss interventions targeting this population have shown some promise, but generally produce modest outcomes with less consistent effects than programs in older adults. Depression and stress have been found to interfere with weight loss among emerging adults, and may be in part responsible for poorer outcomes. This proposal will develop and test an Integrated Lifestyle Intervention (ILI) that comprehensively addresses both psychological distress and traditional weight management targets. This novel approach has not been tested before and has the potential not only to enhance weight loss outcomes in this high risk population, but also to produce reductions in markers of inflammation beyond those achievable by weight loss alone.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 25 years
* Body Mass Index between 25 and 45 kg/m2

Exclusion Criteria:

* Currently pregnant or lactating; pregnancy in the last 6 months or plans to become pregnant in the next 6 months
* Type 1 or type 2 diabetes
* Any uncontrolled medical conditions that could make it unsafe to participate in unsupervised exercise
* Medical conditions associated with chronic inflammation
* Inability to read, understand and speak English
Prevena Vascular Groin Wound Study

The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.

The study randomizes patients (1:1) considered high risk, according to a specific set of risk factors, for wound complications into standard post-op dressings vs. Prevena vacuum dressing. The wounds will then be assessed for wound complications in the 30 days postoperatively. Wound complications include breakdown, infection and lymph leak. Patients not considered high risk will have standard post-op dressings and followed similarly to controls. The investigators will also assess economic impact of negative pressure dressing on length of stay and overall inpatient costs.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing a femoral incision during vascular reconstruction or repair will be considered for study

Exclusion Criteria:

* Emergency procedure
* Unable to give informed consent