cyrilzakka/clinical-trials huggingface dataset:
Outpatient Versus Inpatient Surgery for Ankle Fractures

This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.

This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.

Primary outcome: The primary objective of this study is to compare the 12-weeks patient reported Foot and Ankle Outcome Score (FOAS).

Secondary outcomes: Multiple other analysis are planned, but being secondary, they are hypothesis generating. They will include, but are not limited to, cross-over, unscheduled contacts, adverse events, pain, general health, time to return to work and socio-economic consequences between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Ankle fracture indicating surgical treatment.
* Fracture stable in lower leg cast.
* Patient 18 years or older.
* Patient is able to ambulate with walking aid, and perform ADL at home.

Exclusion Criteria:

* Impaired physical, mental or social capacity incapable of participating in study.
* Incapable of reading or understanding Danish.
* Patient does not wich to participate.
* Concurrent major fracture to lower extremity (ipsi- and/or contralateral)
* Patholocigal fracture
* ASA score 3 or higher.
* Pregnancy.
* Open fracture.
* Infectious disease requiring isolation.
Evaluation of a New Daily Disposable Multifocal Contact Lens Design

The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with normal eyes who are not using any ocular medication.
* Must sign the Informed Consent document.
* Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).
* Manifest cylinder less than or equal to 0.75D.
* Best corrected distance VA greater than or equal to 20/25 in each eye.
* Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.
* Presbyopic with a spectacle addition (ADD) \>0.50D and \<2.75D.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular disease, inflammation, or abnormality that contraindicates CL wear.
* Any use of systemic or ocular medications for which CL wear could be contraindicated.
* History of herpetic keratitis.
* History of refractive surgery or irregular cornea.
* A clinically significant dry eye that precludes CL wear.
* Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.
* Monocular (only 1 eye with functional vision).
* History of intolerance or hypersensitivity to any component of the test articles.
* Other protocol-defined exclusion criteria may apply.
Study of the Effect of the Time of Diagnosis (Antenatal vs. Postnatal) on the Post-traumatic Reactions of Parents of Children Undergoing Oesophageal Atresia Surgery "

This is an observational, national multicentre (34 centres involved), cross-sectional study in psychology whose objective is to describe and compare the levels of post-traumatic reactions of mothers to the announcement of their child's EA diagnosis.

An ancillary study will be carried out among the fathers present who agree to participate in the study.


Eligibility Criteria:
Inclusion Criteria:

* Be the mother and/or a father of a living child aged 12 to 24 months who has undergone neonatal surgery following the diagnosis of type 1 or type 3 EA;
* Not to have objected to participating in the study (information and non-objection form signed by the investigator);
* To be socially insured.

Exclusion Criteria:

* Woman or man whose child with AO has a chromosomal abnormality;
* Woman or man whose child with AO has a polymalformative syndrome;
* Female or male minor ;
* Pregnant woman;
* Woman or man who does not speak French;
* Woman or man unable to consent, or benefiting from a legal protection regime (guardianship or curatorship);
* Woman or man deprived of liberty.
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury

The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients between the age of 16 and 70 years, inclusive
2. Weight from 45 to 135 kg, inclusive
3. Sustained a closed head trauma no more than 8 hours before start of study drug infusion
4. TBI diagnosed by history and clinical examination
5. Post-resuscitation Glasgow Coma Scale (GCS) score between 3 to 8, inclusive
6. At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive)
7. Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
8. Indication for ICP monitoring

Exclusion Criteria:

1. Life expectancy of less than 24 hours as determined by the Investigator
2. Prolonged and/or uncorrectable hypoxia (Pa02\< 60 mmHg) or hypotension (systolic blood pressure \< 90 mmHg) at the time of randomization
3. Any spinal cord injury
4. Pregnancy
5. Penetrating head injury
6. Bilaterally fixed dilated pupils at the time of randomization
7. Coma suspected to be primarily due to other causes (e.g. alcohol)
8. Pure epidural hematoma
9. Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome
10. Severe cardiac or hemodynamic instability prior to randomization
11. Known treatment with another investigational drug therapy or procedure within 30 days of injury
12. A history of allergic reaction to progesterone and related drugs or any of the components of the infusion
13. Any disease, in the opinion of the Investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
14. Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol through the final visit (6 months post-injury)
Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures

The primary purpose of this study is to compare the time, risk and cost savings of 2 patient groups who receive FDA approved left ventricular pacing leads.

The purpose of this study is to: a) examine the usefulness of placing an epicardial LV lead at the time of open chest surgery in patients who are likely to benefit from a CRT system following their surgery; b) compare differences between patients who receive LV leads using the transvenous approach and those patients who receive LV leads using the epicardial approach; and c) assess the cost effectiveness of placing the LV lead via the transvenous versus the epicardial approaches.

Eligibility Criteria:
Inclusion Criteria:

1. Left ventricular ejection fraction \< or = 35%
2. QRS duration greater than or = to 120ms
3. NYHA Functional Class 3 or 4
4. Age \> or = to 18 years

Exclusion Criteria:

1. No previous pacemaker or ICD implant
2. No permanent atrial fibrillation
PCV13 + Hepatitis a Vaccine for Adults

The present study explores whether a simultaneously given hepatitis A vaccine (Epaxal) will have an impact on the immune response to PCV13 (pneumococcal conjugate vaccine; Prevenar13) vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. The results of volunteers receiving PCV13 and Epaxal will be compared to that in a control groups of adults receiving either hepatitis A or PCV13 vaccines only.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥50
2. General good health as established by medical history and physical examination
3. Written informed consent
4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
5. Available for all visits scheduled in this study.
6. No previous Pnc vaccination
7. No previous hepatitis A vaccine
8. No other vaccines administered 30 days prior to or during the study

Exclusion Criteria:

1. Previous pneumococcal or hepatitis A vaccination
2. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
3. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of vaccine; patients using oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
5. Pregnancy or lactation
6. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of ≥38 °C).
7. Alcohol or drug abuse
8. Suspected non-compliance
9. Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period
10. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
11. Employee at the investigational site, relative or spouse of the investigator
12. Any other criteria which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the subject's well-being, or the outcome of the study
Physical Activity in the Format of Self-defence Training for Depressive Symptoms

Inadequate mental health care capacity is a long-standing issue in Hong Kong (Yang \& Mak, 2020). For example, a recent study predicts an additional 12% service need for specialist psychiatric care (Ni et al., 2020). It would be helpful to develop interventions that would ease the high demand of the health care system. Physical activity has been shown to reduce depressive symptoms in a number of studies (Bellón et al., 2021; Josefsson et al., 2014; Kvam et al., 2018; Schuch et al., 2016). Its flexibility and low-cost nature make physical activity a good intervention option for depressed individuals to do it anytime and anywhere.

This study aims to investigate the effect of physical activity intervention in the format of self-defence training on depressive symptoms. Around 40 eligible participants with at least moderate level of depressive symptoms will be randomly assigned to the physical activity (PA) group and waitlist (WL) control group. The PA group will receive a 6-week home-based self-defence training programme consisting of 120 min video training (including daily practice time) per week. Self-report questionnaires will be collected at baseline, immediate post-intervention, and 4-week follow up assessments. The primary outcome measure will be the Patient Health Questionnaire-9 to evaluate depression severity. Secondary outcomes will include psychological health symptoms, sleep quality, lifestyle, and quality of life. This research will provide new perspectives on the application of physical activity in the form of self-defence training as an intervention for depressive individuals.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* Hong Kong Residents
* Patient Health Questionnaire (PHQ-9) score ≥ 10; and
* Willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

* Patients with any cardiovascular diseases
* Receiving psychological treatment or medication for psychiatric disorders
* Participated in self defence training in the past 6 months
Bone Marrow Stem Cell Infusion Following a Heart Attack

The goal of this study is to determine the safety of giving a patient's own bone marrow-derived stem cells delivered with a catheter (tube) into the coronary arteries (blood vessels of the heart). Stem cells are simple cells produced by the bone marrow that can develop into many types of cells. It is possible that these cells will decrease the size of damage caused to the heart from a heart attack and increase the pumping efficiency of the heart; which can be decreased due to a heart attack. The stem cells will be taken from bone marrow and then given back into the heart vessels.

This protocol will test the hypothesis that an intracoronary infusion of autologous, unfractionated, bone marrow mononuclear cells will attenuate infarct size and improve left-ventricular function in 60 patients following an acute anterior myocardial infarction who have undergone successful revascularization with PTCA/stenting.

Eligibility Criteria:
Inclusion Criteria:

* Patients age at least 21 years of age
* Patients with an acute anterior myocardial infarction limited to the proximal or mid-LAD with an artery diameter of at least 2.5 mm.
* Ability to undergo cell therapy procedure within 2 to 7 days following acute MI and PTCA/stenting.
* Ejection fraction following reperfusion with PTCA/stenting is between 30% and 50% as assessed by left-ventriculography or echocardiography.
* Consent to protocol and agree to comply with all follow-up visits and studies.

Exclusion Criteria:

* History of sustained ventricular arrhythmias not related to their acute myocardial infarction who do not have an ICD.
* Require coronary artery bypass surgery or percutaneous revascularization due to the presence of residual coronary stenosis \> 70% luminal obstruction in the non-infarct related vessel.
* History of malignancy within the past 5 years excluding non-melanoma skin cancer or cervical cancer in-situ.
* History of anemia (Hb \< 9.0 mg/dl).
* History of thrombocytosis.
* PT or PTT greater than the upper limits of normal.
* Life expectancy less than one year.
* Patients on chronic dialysis.
* History of untreated alcohol or drug abuse.
* Currently enrolled in another Investigational drug or device trial.
* History of stroke or TIA within the past 6 months.
* History of severe valvular heart disease (aortic valve area \< 1.0 cm2 or \> 3+ mitral regurgitation.
* Pregnancy
* Subjects who are HIV, hepatitis B or C positive.
* Patients with active inflammatory or autoimmune disease on chronic immunosuppressive therapy.
* Contraindications to cardiac MRI
Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors

The purpose of this study is to see if it is safe and effective to add a new protease inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse transcriptase inhibitors (NRTIs).

In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients 13 to 18 years of age are enrolled first, followed by children \< 13 when the appropriate pediatric dose has been determined. Patients who are unable to swallow capsules will be accrued when a liquid formulation becomes available.

Eligibility Criteria:
Inclusion Criteria

Your child may be eligible for this study if he/she:

* Is 6 months - 18 years of age.
* Is HIV-positive.
* Has a viral load (level of HIV in the body) greater than 10,000 copies/ml.
* Is able to take medications by mouth.
* Has consent of parent or legal guardian if under 18.
* Has a negative pregnancy test within 7 days of study entry.
* Agrees to practice abstinence or use effective methods of birth control for 1 month before and throughout the study.

Exclusion Criteria

Your child will not be eligible for this study if he/she:

* Has a serious illness, including any life-threatening infection or other chronic serious medical condition.
* Has an opportunistic (AIDS-related) infection or a serious bacterial infection.
* Is allergic to NRTIs.
* Is breast-feeding.
* Is unlikely to complete the study.
* Has received certain medications.
* Has received radiation therapy within the past 4 months, or will need to receive it during the study.
Association Between Preoperative Hyperglycemia and Postoperative Delirium in Geriatric Hip Fracture Patients

This retrospective study aims to collect electronic medical record data from Dandong central hospital spanning from January 2013 to November 2023. The collected data does not contain any personally identifiable information or breach privacy. Additionally, this study design does not involve active intervention measures or patient recruitment. The research aims to investigate the correlation between preoperative blood glucose levels in elderly hip fracture patients and postoperative delirium.

A retrospective observational study is planned to explore specific phenomena or associations using electronic medical record data. The collected data does not contain any personally identifiable information or compromise privacy. Additionally, this study design does not involve active intervention measures or patient recruitment. The study data is sourced from the electronic medical record system of hospitalized patients and has received approval from the hospital's research center, with ongoing supervision by the hospital's ethics committee. The study aims to investigate the correlation between preoperative blood glucose levels in hip fracture patients and postoperative complications.

The retrospective study aims to collect electronic medical record data spanning from January 2013 to November 2023. The data collection process is consistently monitored and verified by the hospital's ethics committee. Throughout the study, adherence to the ethical principles outlined in the 1964 Helsinki Declaration is ensured, and institutional review board (IRB) approval has been obtained for all aspects of the research.

The study aims to provide valuable evidence-based medicine for clinical practitioners by examining the relationship between preoperative persistent hyperglycemia in elderly hip fracture patients and postoperative delirium. Furthermore, it seeks to offer clinical insights for early identification and intervention management of high-risk postoperative delirium patients (POD).

Eligibility Criteria:
Inclusion Criteria:

1) Patients who have undergone surgical treatment for hip fractures.

Exclusion Criteria:

1. Multiple or pathological hip fractures.
2. Emergent surgery.
3. Age below 60 years.
4. Incomplete electronic medical records or preoperative blood glucose levels were assessed fewer than two times.
5. Presence of neurological and psychiatric disorders, except dementia.
Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia

The study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving film) in treatment of anosmia in patients post infested with Covid-19. The study implication based in two methods evaluations

1. Threshold test
2. identification test.

This study was designed to improve smell disorders after corona infection that is very anxious for all patients.

Inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and accept sharing and follow up.

The application of dosage form by ENT specialist at otorhinolaryngology clinic at Minia University hospital. Dose was 100iu of insulin 3 times weekly for 4 weeks. The new dosage form with insulin was compared with a placebo to ensure statistical improvement.

The tests were performed in each visit. Primary outcome was the improvement of smell sensors in those patients

Eligibility Criteria:
Inclusion Criteria:

* anosmia post covid-19 infection

Exclusion Criteria:

* nasal polyps or fractions or syrgery in nose from 6 months or less
Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)

This study evaluates in a group of people with DM 1 the influence in parameters of oxidative stress of the treatments with the different current analogs of insulin

To evaluate by a randomized study in a group of people with DM 1 the influence in parameters of oxidative stress of the treatments with the different current analogs of

Insulin by analyzing:

1. - The circulating levels of oxidative stress markers: A) Anti oxidation: Total antioxidant capacity (CAT), B) Oxidation: 8-iso-prostaglandin F2 alpha (8-iso-PGF2α), acid reactive substances Thiobarbituric (TBARS) and LDL-oxidized.
2. - The relationship between glycemic control variables (HbA1c and mean glycemia) and variability (Standard deviation (SD), coefficient of variation (CV), and MAGE (mean amplitude of Glycemic excursions) and oxidative stress parameters analyzed.

Goal 2:

Study the activation of cellular pathways associated with processes and oxidation states, by means of a Array of expression of up to 50 genes encoding oxidative stress response genes as CPT1a (Carnitine Palmitoyl Transferase 1a, mitochondrial oxidizing b limiting enzyme), TAS (Fatty acyl synthetase), acetyl-coA carboxylase, Acadm (medium chain acyl dehydrogenase), Acadl (long chain acyl dehydrogenase), Acadvl (long chain acyl coA dehydrogenase), SOD1, Hmox1 and Glutamine-Cysteine ligase (Gclc).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 years and 65 years (inclusive).
* DM1 of more than two years of evolution with habitual follow-up in the Diabetes Unit of the University Regional Hospital of Malaga.
* HbA1c ≤ 10%
* Intensive treatment with basal MDI - Bowl for more than 12 months prior to the start of study.
* Gives informed consent.

Exclusion Criteria:

* Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
* Pregnancy or pregnancy planning.
* Diabetes mellitus type 2.
* Hyperuricemia (uric acid ≥7 mg / dl at the time of inclusion or current treatment With allopurinol).
* Absence of collaboration (informed consent).