cyrilzakka/clinical-trials huggingface dataset:
Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit

The goal of this observational study was to learn about the long-term clinical efficacy of conservative treatment in atlantoaxial dislocation patients without neurological deficit. The main question it aims to answer is:

Is surgical intervention always necessary in atlantoaxial dislocation patients without nerve deficit?

Patients who refuse surgical intervention will continue to be treated conservatively. Clinical outcomes will be summarized over five years of follow-up


Eligibility Criteria:
Inclusion Criteria:

* The patients meet the diagnostic criteria for atlantoaxial dislocation, that is, the ADI exceeds the normal range: it is over 3 mm in adults and over 5 mm in children.
* The patients have no clinical manifestations of the nervous system, including occipital neuralgia, manifestations of cranial nerve impairment (such as dysphagia, dysarthria, nystagmus, etc.) and manifestations of spinal cord impairment (such as unsteadiness in holding objects, unsteady gait, decreased limb muscle strength, etc.).
* After fully understanding their own conditions as well as the advantages, disadvantages and risks of both conservative treatment and surgical treatment, the patients can choose the initial treatment method on their own. If they choose conservative treatment, they will be included in the conservative treatment. If they choose surgical treatment, they will be included in the surgical intervention group.

Exclusion Criteria:

* Patients who have undergone surgeries in the cranio-cervical junction previously.
* Patients with infections or tumors in the cranio-cervical junction.
* Patients with fresh fractures in the cranio-cervical junction.
* Patients with clinical manifestations of nerve deficit.
* Patients with severe diseases in other spinal regions such as the thoracic and lumbar spine that affect their clinical symptoms; patients with motor neuron diseases like amyotrophic lateral sclerosis and other severe neurological diseases.
* Patients who have participated in other clinical trials within the recent three months.
* Patients with mental disorders whose cognitive impairments (or those of their legal guardians) prevent them from giving full informed consent.
* Patients who refuse to participate in this study.
MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)

This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient is a candidate for mitral valve repair, with our without concomitant procedures.
* Subject is willing to give informed consent for collection of his/her clinical data.

Exclusion Criteria:

* Severe organic lesions with retracted chordae
* Congenital malformations with lack of valvular tissue
* Severe valvular calcifications
* Evolving bacterial endocarditis
* Known Sensitivity to Nickel or Chromium
Neuronal Correlates of Priming on Goal-directed and Cue-dependent Behavior

The current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.

Food choice and intake is a daily and throughout normal subject. However, for more and more people eating habits and the question of food choice are of increasing interest and in several cases even a problem. The prevalence of obesity has tripled in the last decades and it is even spoken of an obesity epidemic. Life style interventions to lose weight often fail on the long run, also because people fall back into former unhealthy eating habits. Various factors influence our daily food choice, not all of which are apparent to ourselves. Thus, food choice might be goal-directed and therefore conscious and reflective, yet in other circumstances the choice to eat something specific might be based on cue dependent processes which are automatic and thus difficult to control. Since a change in eating-behavior and long-lasting weight loss is most problematic to achieve, the current proposal aims to investigate neuronal correlates of implicit and explicit priming paradigms for changing cue-dependent and goal-directed nutritional behavior.

Eligibility Criteria:
Inclusion Criteria:

* experimental: participants with obesity
* control: participants with normal-weight

Exclusion Criteria:

* currently dieting
* intolerance to provided food
* cognitive impairment
* contraindications for fMRI measurements
Predictive Value of Aortic Stiffness on Recurrence of Atrial Fibrillation After Disconnection of Pulmonary Veins (VARIABLE).

The ablation of atrial fibrillation (FA) by disconnection of pulmonary veins is a burgeoning intervention. It allows a long-term treatment of this arrhythmia with a success rate of about 80%. There are, nevertheless, some recidivism.

Risk factors for recidivism are poorly codified and need further research. Indeed the identification of factors of poor prognosis could lead to not propose this procedure to the patients who present them and at least to inform them of an increased risk of failure.

To date, aortic stiffness has not been studied in the context of assessing the risk factors for FA recurrence after ablation. On a physiopathological level, the aortic stiffness leads to increase left ventricle's post-load. Cardiac remodeling was observed with diastolic dysfunction and increased left atrial size. That may constitute a substrate for FA recurrence.

In the literature, aortic stiffness can be measured in several ways:

1. Measurement of systolo-diastolic variation of the inner diameter of the aorta by scanner or transesophageal Echography (ETO).
2. Measuring of the Pulse Wave Velocity.
3. Measurement of aortic calcifications.

The investigators propose to evaluate the impact of aortic stiffness on the recidivism of FA 6 months after ablation procedure performed in the Croix-Rousse cardiology's department.


Eligibility Criteria:
Inclusion Criteria :

* 18 years old of both sexes,
* Patient carrying a paroxysmal or persistent atrial fibrillation, benefiting from a first procedure of atrial fibrillation's ablation in the in the Croix-Rousse cardiology's department.
* Patient who signed the consent to participate in the study.

Exclusion Criteria :

* Patient carrying a permanent atrial fibrillation
* Patient who're in atrial fibrillation during the ablation
* Atrial fibrillation relapse's history after ablation
* Pregnant and nursing women
* Patients refusal.
Predictors of Post-clamping Neurologic Deficits During Carotid Endarterectomy With Regional Anesthesia

Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established.

The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.

Patients undergoing carotid endarterectomy may suffer from neurologic deficits (ND) during the carotid cross-clamping due to cerebral hypoperfusion. An associated risk of postoperative stroke incidence is also well established.

The aim of this study is to evaluate the predictive factors associated with ND during CEA performed with RA. The perioperative implications of the ND were also evaluated.

All consecutive patients from a tertiary referral center who underwent CEA for carotid artery stenosis (CS) and consecutive patients who presented alterations in the neurologic examination after ICA clamping during CEA are selected. The control patients, submitted to the same procedure but with no neurologic alterations, are consecutively selected.

Eligibility Criteria:
Inclusion Criteria:

* carotid endarterectomy under regional anesthesia
* Postclamping carotid deficit

Exclusion Criteria:

* carotid stenting
High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation

High Power Short Duration Ablation Compared to Moderate Power Long Duration Ablation for Pulmonary Vein Isolation: safety and acute procedural outcome


Eligibility Criteria:
Inclusion Criteria:

* symptomatic, documented, drug-resistent paroxysmal atrial fibrillation
* effective oral anticoagulation

Exclusion Criteria:

* any prior left atrial ablation procedure
* presence of left atrial thrombus
* secondary atrial fibrillation due to electrolyte imbalance or thyroid disease
* any prior oesophageal or gastric surgery
Tall Stature Women Fetal Weight Estimation

To investigate the difference of clinical VS sonographic fetal weight estimation of tall women stature (above 10t percentile)

Women undergoing delivery after week 39 will be estimated of their fetal wight with clinical estimation and then sonographic estimation.

each women will be case control 1:1 for the actual fetal weight of the delivery.

the fetal weight will be blinded for each estimation.

Primary outcome is the actual fetal weight Secondary outcomes will be mode of delivery, fetal complication as APGAR score and fetal hypoxia and maternal complication as perineal laceration

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women above 172 cm height
* above 39 weeks of gestation

Exclusion Criteria:

* contraindication for vaginal delivery
* Intrauterus growth restriction
Buprenorphine to Improve HIV Care Engagement and Outcomes

The purpose of this study is to compare two models of substance abuse treatment in Vietnam, and how they each affect HIV care. In Vietnam, the current model for treating people with HIV who are also dependent on opioids is to refer them to methadone maintenance treatment centers. The new model the protocol will study is treatment of HIV and opioid dependence with buprenorphine/naloxone and counseling in the HIV clinic.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* Current moderate or severe Diagnostic and Statistical Manual (DSM-V) opioid use disorder
* Urine drug screen positive for opioids
* Interested in receiving treatment for opioid dependence
* Age at least 18 years old
* Willing to practice an effective method of birth control, if female

Exclusion Criteria:

* Known hypersensitivity to buprenorphine or naloxone
* aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) \> 5x upper limit
* Currently pregnant or breastfeeding
* Serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection, psychosis) that precludes safe participation in the opinion of study physician
* Methadone maintenance treatment within 30 days of consent
Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)

This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1 chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian patients with genotype 1 chronic hepatitis C. This study is also designed to provide a randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at 24 weeks after therapy completion.


Eligibility Criteria:
Inclusion Criteria:

* Comply with all current Australian Schedule of Pharmaceutical Benefits S100 eligibility criteria.
* Able to give written informed consent and adhere to study visit schedule.
* South East Asian ethnicity (except for Caucasian Gt1/1b in comparator arm) i.e. born in Vietnam, Cambodia, Laos, Thailand, Hong Kong, and China or have both parents born in these countries.
* Genotype 1, 1a, 1b, 6, 6a, 6b, 7, 8, or 9, as classified by INNO-LiPA assay.
* Hemoglobin \>=120 g/L (females), \>=130 g/L (males).
* Platelet count \>=100 x 10\^9/L.
* Neutrophil count \>=1.5 x 10\^9/L.
* Negative pregnancy test for females.
* Thyroid stimulating hormone (TSH) within normal limits.

Exclusion Criteria:

* Participation in any other investigational drug program within 30 days of the Screening Visit.
* Human immunodeficiency virus (HIV) antibody positive or hepatitis B surface antigen (HBsAg) positive.
* Genotype 2, 3, 4, or 5, as classified by INNO-LiPA assay.
* Non South East Asian ethnicity (unless recruited to Caucasian GT1 comparator arm).
* Evidence of liver disease due to other disorders (e.g., hemachromatosis, Wilson's disease).
* Ongoing drug or alcohol abuse which in the opinion of the investigator would jeopardize the patient's ability to comply with study requirements.
* Inability to comply with study requirements for other reasons.
* Decompensated cirrhosis (Ascites, history of encephalopathy or bleeding varices, serum albumin \<35 g/L, prothrombin time (PT) prolonged by greater than 3 sec).
* Present or prior history of severe psychiatric disease requiring hospitalization or medication.
* History of severe seizure disorder.
* History of autoimmune disorders (e.g., rheumatoid arthritis, inflammatory bowel disease, immune thrombocytopenic purpura, systemic lupus erythematosus, or other mixed connective tissue disease, psoriasis, optic neuritis).
* Poorly controlled thyroid disease.
* Creatinine clearance \<50 mL/min.
* Severe cardiovascular disease.
* Hepatocellular cancer.
* Clinically significant ophthalmologic disorders.
* Hemoglobinopathies (e.g., thalassemia, sickle-cell anemia).
* Treatment or recent treatment with immunosuppressive agents (excluding short-term corticosteroid withdrawal), and immunosuppressed transplant recipients scheme.
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years of age.
* Rheumatoid arthritis of ≤ 2 years duration.
* Disease Activity Score 28 (DAS28) \> 3.2.
* Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.
* Rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative \> 1 erosion required at screening).
* Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L at screening.

Exclusion Criteria:

* Previous treatment with tocilizumab.
* Previous treatment with methotrexate or biologic agent.
* Rheumatic autoimmune disease other than rheumatoid arthritis (RA).
* History of or current inflammatory joint disease other than RA.
* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in RA.
Efficacy Study of Kissing Drug-Eluting Balloons in Coronary Bifurcation Lesions

KISSING DEBBIE's aim at assessing angiographic and clinical outcomes of provisional treatment of coronary bifurca6on lesions according to TAP sten6ng with BMS and final kissing DEB


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* De novo major bifurca6on lesion of the left coronary artery (LAD-D; LCX-OM)
* RVD 2.25-4.0 mm

Exclusion Criteria:

* LMCA
* AMI within 48 hours
* Limited compliance with 3-month dual antiplatelet therapy
Zinc Supplement in Regorafenib Treated mCRC Patient

Phase II randomized trial to investigate whether supplementation of zinc decreases the incidence of HFSR that occurs after treatment of tyrosine kinase inhibitor, regorafenib.

This study is aimed to investigate the effect of zinc supplementation on improving regorafenib treatment safety and efficacy in patients with metastatic colorectal cancer (mCRC). The difference in grade 2 or worse hand-foot skin reaction (HFSR) incidence within the first 8 weeks of regorafenib treatment between two arms will be examined as the primary objective.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib
* Ability to understand and willingness to sign written Informed Consent Form (ICF)

Exclusion Criteria:

* Patients participating in an investigational program with interventions outside of routine clinical practice
* Patients with baseline Zinc level above 120 ug/dL
* Patients with known allergy to Zinc supplementation
* Pregnancy
* Patients who are unsuitable for study participation, based on investigator's discretion
Effect of Obesity on Extracellular Matrix Composition

The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.

The main questions to answer,

- is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men

Three groups of young (n=10) and old (n=10) healthy men and obese young (n=10) men are recruited.

After verbal and written information is provided signed consent is obtained.

Subjects arrive at the lab overnight fasted and not having done exercise the prior day and having consumed a normal isocaloric carbohydrate rich diet.

After a voiding and a 15 min rest body composition is determined by DXA. After this blood pressure is measured in the supine position in triplicate separated by 1 min. Following this a venous blood sample is obtained from a cubital vein, and kept on ice until further handling.

Subsequently an adipose tissue biopsy is obtained by the Bergström technique applied with suction from an incision 3-5 cm lateral from the umbilicus. After compression and a 30 min rest, the subject perform an incremental exercise test to determine maximal fat oxidation. In brief pulmonary oxygen uptake and carbon dioxide excretion is measured using a COSMED Quark B2 on-line system during 5 min rest sitting on a cycle ergometer, and then during exercise with 3 min increments starting at 60 Watt and increasing by 35 watts. When the respiratory exchange ratio is above 1 the exercise is stopped. After a 5 min break an incremental test until voluntary exhaustion is performed to determine maximal oxygen uptake. This completes the experiment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men aged \[18,35\] and BMI \[20,25\]
* Obese men aged \[18,35\] and BMI \[30,40\]
* Healthy older men aged \[60,75\] and BMI \[20,25\]

Exclusion Criteria:

* Present or former cardiovascular disease and chronical inflammatory disease
* Consumption of medications and supplements that influence substrate use at rest and/or during exercise
Roles of T Helper 1 Cytokines in Type 1 Diabetes

The mechanism of β cell destruction in Type 1 diabetes is not exactly known, Our hyphotesis is that interferon gamma, interleukin-2 and tumor necrotizan factor alpha have impotant roles in β cell destruction.

T helper (h)1 cells are known to have important roles in the destruction or/and dedifferentiation of β-cells in type 1 diabetes (T1D). Significant increase in IFN-γ-producing Th1 cells in the pancreas and in the serum levels were determined in type 1 diabetic patients at diabetes oneset. This data indicated that this proinflammatory mediator serve as a biomarker of advanced autoimmunity. We aimed to investigate the relationship between Th1 cytokines (IFN-γ, IL-2 and TNF-α) and T1D and the effect of those cytokines on β-cell function.

Eligibility Criteria:
Inclusion Criteria:

* Patients giving consent to participate the study
* Patients with type 1 diabetes according to WHO definiton

Exclusion Criteria:

* Acute and chronic inflammatory diseases,
* significant concomitant diseases which may interfere with glucose metabolism
* cancers,
* hemoglobinopathies,
* recently received antibiotics,
* drugs influencing β-cell function and
* insulin sensitivity or anti-inflammatory drugs
* recent history of trauma
Medical Gas Humidification During Noninvasive Mechanical Ventilation

In this study, the investigators aimed to study the role of medical gas humidification during noninvasive mechanical ventilation.

The medical gases are usually dry and cold thus when they are used during invasive mechanical ventilation they must be conditioned. No data are present on the necessity to condition the medical gases during non invasive mechanical ventilation. In this study the investigators studied the humidity and the temperature of the medical gases with and without any conditioning during non invasive mechanical ventilation in a group of healthy subjects and critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients requiring non invasive mechanical ventilation

Exclusion Criteria:

* Comatose patients
A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel

Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively.

Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively. This study has been withdrawn and no additional data is available.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects of any race, 18 yrs or older
* No clinically significant findings on physical exam
* Signed informed consent

Exclusion Criteria:

* Damaged, denuded or broken skin at the designated site for application of the medicated plaster or gel.
* Know allergies to lidocaine, tetracaine or other local anaesthetics
* Concomitant use of prescription strength analgesics
Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator

This study will look at what happens to the level of protection against hepatitis B (HB) disease if a 'helper' gel is applied to the skin over the injection site of a small dose of hepatitis B vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Previously vaccinated with conventional hepatitis B vaccine series 10 or more years ago
* Generally healthy
* Is and has been free of HB disease and/or is negative to core antibody
* Known to have sero-converted to positive after vaccine series (without extra doses)
* Speaks and understands English adequately
* Available for all 4 visits within the designated timelines (30 days)
* No allergies to HB vaccine or components
* No blood or blood components within previous 6 months
* Not pregnant or breastfeeding