cyrilzakka/clinical-trials huggingface dataset:
Testing a Promising Treatment for Youth Substance Abuse in a Community Setting

This study aims to address a serious public health problem (i.e., substance abusing adolescents) by testing the effectiveness of a promising substance abuse treatment implemented in a community-based treatment setting (CM-FAM, a family-based contingency management intervention) in comparison to usual treatment services.

The overriding purpose of the randomized trial is to examine the effectiveness of a promising and efficient outpatient treatment of adolescent substance abuse delivered in a community-based treatment setting. Although several evidence-based treatments of adolescent substance abuse are emerging, none have experienced widespread adoption in community settings. Thus, as noted by the Institute of Medicine (1998) more than a decade ago and reiterated more recently, a considerable science-service gap exists in regards to treatment of substance abuse in adolescents and adults.

For the proposed study, 204 adolescents meeting diagnostic criteria for substance abuse or dependence will be randomized to either the Contingency Management-Family Engagement (CM-FAM) or Treatment as Usual (TAU) conditions. A multimethod, multirespondent approach will be used to track clinical outcomes at 3, 6, 9, 12, and 18 months post recruitment. Clinical level outcomes pertain to youth substance use, criminal behavior, mental health functioning, and key mediators of serious antisocial behavior in adolescents (e.g., self-control, parental supervision, association with deviant peers). In addition, the incremental cost of CM-FAM will be determined for use in cost effectiveness analyses.

Aim 1: Over an 18-month post-recruitment follow-up, determine the relative effectiveness of CM-FAM vs. TAU in reducing adolescent participants' substance use, criminal activity (including incarceration), and mental health symptoms; and evaluate the cost effectiveness of CM-FAM in achieving these outcomes.

Aim 2: Examine possible moderators and mediators of intervention effectiveness. Moderator variables will include youth demographic and clinical (e.g., co-occurring disorders) characteristics. Mediator variables will include measures of self-control, parenting, and association with deviant peers - constructs targeted by CM-FAM.

Eligibility Criteria:
Inclusion Criteria:

* Age of 12-17 years
* Meeting criteria for substance use or abuse.
Diagnostic Usefulness of Fluorine-18-α-Methyltyrosine PET in Combination With 18F-FDG in Sarcoidosis Patient

L-\[3-18F\]-α-methyltyrosine (FMT) is amino-acid tracer for positron emission tomography (PET), and is used for tumor detection because malignant tumor cells accumulate 18F-FMT based on the increased expression of amino-acid transporter. This study was conducted to investigate a usefulness of 18F-FMT PET in combination with 18F-FDG PET for the diagnosis of sarcoidosis in patients with suspected malignancy.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were required to have histologically proven noncaseating epithelioid cell granuloma and at least one disease that the possibility of coexistent malignancy could not be excluded as follows; 1) extrapulmonary lesions mimicking malignant diseases including systemic lymphadenopathy, hepatosplenic involvement, or other lesions, 2) multiple nodular lesions mimicking pulmonary metastasis, 3) the occurrence of BHL in cancer patient.

Exclusion Criteria:

* The patients that PET imaging using 18F-FDG and 18F-FMT was performed before establishment of the final diagnosis of sarcoidosis, patients undergoing treatment for sarcoidosis before the PET study, and patient having diabetes mellitus.
A Musculoskeletal Ultrasound Program to Improve Disease Modifying Anti-Rheumatic Drugs Adherence in Rheumatoid Arthritis

Non-adherence to medications can lead to sub-optimal treatment in rheumatoid arthritis (RA) patients. In order to improve disease modifying anti-rheumatic drugs (DMARDs) adherence, the investigators are conducting a randomized controlled trial to test out an intervention to improve medications adherence among low adherers. This intervention involves the use of a musculoskeletal ultrasound program which allows RA patients to visualize their joint inflammation and damage real time while treatment adherence is simultaneously reinforced. In doing so, the investigators hope to improve patients' understanding of their joint disease and motivate the participants to adhere to their medications.

This is a single center randomized controlled clinical trial conducted in the Singapore General Hospital. Eligible RA subjects meeting the inclusion and exclusion criteria will be screened using a medication adherence measure questionnaire. Thereafter 132 patients who are low adherers on the questionnaire will then be recruited and randomized (in a 1:1 ratio) to either (a) intervention arm (with musculoskeletal US program) or (b) control arm (without musculoskeletal US program), and followed up over a period of about 6 month.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients from 21 to 75 years old
* Underlying rheumatoid arthritis diagnosed using the 1987 or 2010 RA criteria
* On at least one of the following DMARDs (Methotrexate, Sulfasalazine, Hydroxychloroquine and/or Leflunomide)

Exclusion Criteria:

* Pregnancy
The Safety and Tolerability of Alprostadil Liposome for Injection in Healthy Adult Volunteers

Conducted in Chinese healthy adult volunteers,the study aims to observe the safety, tolerability and pharmacokinetic of single-dose administration of different doses of Alprostadil Liposome for Injection as well as to confirm the safety dose range.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers are at least 18 years of age and no older than 40.
* BMI are at least 19.0kg/m2,and no more than 24.0kg/m2.(The male weight is greater than or equal to 50kg.The female weight is greater than or equal to 50kg.)Subjects who are overweight or underweight will not be inclusion.
* Subjects with normal medical history,vital signs,physical examination and clinical examination (routine blood,routine urine,blood chemistry,coagulation function and ECG,X-ray,intraocular pressure and so on).
* A negative hepatitis B surface antigen,hepatitis C,HIV or syphilis test result.
* Subjects with the ability to communicate with investigators.Besides,subjects must be willing to remain at the study center as required per protocal to complete all visit assessments.

Exclusion Criteria:

* Subjects have brain dysfunction,mental development disorders or speech disorders that unable to communicate with investigators.
* Subjects with a history of psychiatric disease or drug dependence.
* Subjects with a medical history about cardiac,liver,renal,digestive system or neurological.
* Subjects with the family history of diabetes,the history of pancreatitis,cholelithiasis or asthma.
* Subjects significantly abuse alcohol or tobacco.
* Drink in 24 hours before post-dosing of study drug.
* Subjects who had taken medications within 2 weeks.
* Subjects who had suffer from exsanguine or donated blood over 400ml within 3 months will be excluded.
* Subjects who participate in other clinical trials within 3 months will be excluded.
* History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes.
* Subjects with a history of fainting.
* Subjects who had infected for unknown reason.
* Subjects with interstitial pneumonia.
* Subjects with glaucoma or intraocular pressure with hyperthyroidism.
* Women who are pregnant or lactating.
Effect of Pyridoxamine Supplementation on Vascular Function and Insulin Sensitivity

A growing body of evidence demonstrates that increased adipose mass, especially visceral adipose tissue, contributes directly towards an increase in systemic inflammation, (micro-)vascular dysfunction and the burden of cardiovascular disease (CVD), insulin resistance and type 2 diabetes. Advanced glycation/lipoxidation endproducts (AGEs/ALEs) are a heterogeneous family of unavoidable by-products, which are formed by reactive metabolic intermediates derived from glucose and lipid oxidation. In addition to the overwhelming amount of data demonstrating the role of AGEs/ALEs in the development of (micro-)vascular dysfunction and disease, accumulation of AGEs/ALEs in the expanding adipose tissue contributes to the dysregulation of adipokines and the development of insulin resistance.

The investigators want to examine, in a double-blind randomized placebo controlled parallel study, the physiological effect of a dietary intervention with pyridoxamine in abdominally obese persons.

A sub-study is implemented next to the clinical trial. The objective of the sub-study is to measure the metabolization and kinetics of pyridoxamine in plasma and urine with UPLC-MS/MS. The sub-study comprises of 5 additional healthy volunteers, with pyridoxamine as an oral supplement.


Eligibility Criteria:
Inclusion Criteria:

* Abdominal obesity: Waist circumference for men should be above 102 cm and for women above 88 cm.
* Caucasian (because of skin fluorescence and capillary microscopy measurements)
* Aged 18-75 years

Exclusion Criteria:

* Diabetes (i.e. using anti-diabetic medication, fasting glucose \>7.0 mmol/L, HbA1c \>6.5%).
* Active or history of cardiovascular disease (e.g. stroke, coronary artery disease, peripheral vascular disease, congestive heart failure, cardiac shunts, cardiac surgery, pulmonary hypertension, cardiac arrhythmias, family history of cardiac arrhythmias or sudden cardiac death)
* Hyperlipidemia (defined as serum total cholesterol \> 8 mmol/L or TG \> 4 mmol/L)
* Smoking (\>10 cigarettes per day)
* High alcohol usage (\>4 U/day) or drug abuse
* Use of medication known to influence glucose metabolism, vascular function (e.g. glucocorticosteroids, NSAID's)
* Higher grade hypertension (\> 179 mmHg SBP and/or \> 109 mmHg DBP) in order not to expose subjects to unnecessary risks)
* Known allergic reaction to ultrasound contrast-agent
* Pulmonary or inflammatory disease
* Kidney failure or electrolyte disorders
* Use of dietary supplements or an investigational product within the previous month
* Unstable body weight (no drastic changes in life style before or during the intervention are allowed, this means no weight gain or loss \>3 kg in the last two months)
* Pregnancy or lactation
* No change in use of oral anticonceptiva or IUD (12 weeks prior of during the intervention)
* Unwillingness to give up being a blood donor (or having donated blood) from 8 weeks prior to the start of the study and during the study
* Insufficient knowledge of the Dutch language
Pacing the Atrium to Confirm or Exclude Pacemaker Indication in TAVI

The current observational registry aims to evaluate in patients undergoing TAVI implantation:

1. the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure,
2. baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation,
3. peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.

The persistent growth in transcatheter aortic valve implantation (TAVI) calls for optimized early discharge programs to handle the increasing patient load. While access site bleeding and stroke rate have decreased with improved technologies and operators' experience, acquired conduction abnormalities necessitating prolonged rhythm-monitoring and permanent pacemaker (PPM) implantation have remained largely unchanged, and even up to 39.9% for some TAVI platforms. Prompt identification of patients necessitating PPM implantation leads to optimal patient care and use of resources. Conversely, prompt identification of patients with low -to no- risk for PPM post TAVI shortens their hospitalization and facilitates early and safe discharge.

Several baseline characteristics such as age, preexistent right bundle branch block (RBBB) and the use of self-expanding valves are associated with post-TAVI PPM implantation, but more practical and clinically more relevant parameters are needed with high negative and positive predictive values that could support clinical decision-making.

En passant rapid atrial pacing (RAP) immediately following TAVI has recently been reported to be a valuable tool in PPM risk stratification. The absence of Wenckebach phenomena post implantation at RAP up to 120/' has a negative predictive value for PPM of 98.7%.2 First use of RAP in routine practice at AZ Sint Jan Brugge can confirm these first results (unpublished data). This technique improves our clinical assessment and identification of low-risk patients for PPM suitable for safe early discharge, as well as high-risk patients requiring further rhythm monitoring and eventual PPM implantation.

The current observational registry aims to evaluate in patients undergoing TAVI implantation:

1. the positive and negative predictive value for PPM post TAVI of Wenckebach phenomenona (WB) during RAP during the TAVI procedure,
2. baseline and procedural characteristics of TAVI-implantation associated with new conduction abnormalities and need for PPM implantation,
3. peri-procedural safety, in-hospital and 1-month outcomes after TAVI implantation.

Eligibility Criteria:
Inclusion Criteria:

* All patients in sinus rhythm with TAVI

Exclusion Criteria:

* Patients in atrial fibrillation at the time of the implantation
* Patients with pre-existent pacemaker
Dry Needling Versus Conservative Treatment in the Rectus Femoris Muscle Approach.

In recent years, dry needling techniques have become widespread in the field of musculoskeletal pain treatment. Specifically, the management of myofascial trigger points has been the focus of these techniques.

One of the objectives has been to improve the flexibility of those muscles that, due to the presence of myofascial trigger points, had a decrease in this parameter.

This study aims to determine whether the application of a dry needling technique is more effective than analytical stretching of the muscle.

Hypothesis of the study Deep dry needling of latent trigger points of the rectus femoris produces greater effects on flexibility, strength and pain than superficial dry needling or stretching.

- Overall objective: To compare the differences that occur in flexibility, strength and pain threshold to pressure after the application of deep dry needling, superficial dry needling and stretching on latent trigger points of the rectus femoris.

- Specific objectives To determine the changes produced by deep dry needling on flexibility, strength and pain threshold to pressure.

To determine the changes produced by superficial dry needling on flexibility, strength and pain threshold to pressure.

To determine the changes in flexibility, strength and pain threshold to pressure produced by conventional assisted stretching.

To check if the changes remain after 7 days of the application of the techniques.

To assess the inter-rater reliability of the Goniometer APP in the study sample.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women between 18 and 65 years old.
2. To have at least 70º of knee flexion.
3. Be aware of and accept the study criteria (informed consent).
4. Healthy subjects, without previous hip or knee pathology or involved musculature.

Exclusion Criteria:

1. To have pain.
2. Having pain in the quadriceps or hip at the time of the study.
3. Currently following physiotherapy or analgesic treatment.
4. Belenophobia (fear of needles).
5. Recent surgery or trauma in the area.
6. Pregnancy.
Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Primary objective:

• To assess the response rate to induction therapy with docetaxel/CDDP.

Secondary objectives:

To assess

* Resectability after induction therapy
* Time to progression
* Overall survival
* Safety profile
* Quality of Life


Eligibility Criteria:
Inclusion Criteria:

1. Histology and staging of the disease

   * Histologically or cytologically confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC
   * Resectable or unresectable NSCLC stage II (T1-2 N1, T3 N0) or stage IIIa (T1-2 N2 or T3 N1-2) or stage IIIb (T1-3 N3 or T4 N0-3)
   * Measurable disease (bidimensionally or unidimensionally according to WHO criteria)
2. General conditions

   * Karnofsky Status \> 70, if age \> 70 years → PS \> 70
   * Adequate hematological function (Hb \> 10 g/dl, ANC \> 2.0 x 109/L, platelets \> 100 x 109/L)
   * Adequate renal and hepatic functions: total bilirubin \< 1 x upper normal limit (UNL), serum creatinine \< 1 x UNL, in case of limit value the creatinine clearance should be \> 60 ml/min, ASAT and ALAT \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL.

Exclusion Criteria:

1. Diagnosis

   * Evidence of brain metastases or other distant metastasis equivalent to stage IV disease
   * History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years
   * Other serious concomitant illness or medical condition:

     * Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia
     * History of significant neurologic or psychiatric disorders, including dementia or seizure
     * Active infection requiring i.v. Antibiotics
     * Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy
   * Hepatic function abnormality: ASAT and/or ALAT \> 1.5 x UNL associated with alkaline phosphatase \> 2.5 x UNL
   * Current peripheral neuropathy WHO grade \> 2
2. Prior or concurrent therapy

   * Prior chemotherapy or immunotherapy for NSCLC, including neoadjuvant or adjuvant treatment
   * Prior surgery or radiotherapy for NSCLC
   * Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy
3. General conditions

   * Pregnant or lactating patients
   * Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparison Between Medial Pivot Versus Symmetric Insert Total Knee Arthroplasty

The functional outcome and longevity of total knee arthroplasty (TKA) is still a concern. Despite various developments in TKA designs, including fixed or mobile bearing, cruciate retaining or posterior stabilized, multi or single radius, it remains unclear which design is superior for achieving a physiological kinematic.

In normal healthy knees the medial and lateral tibial condyles are different: the medial is almost flat while the lateral is somewhat convex. Thus, the movement during flexion is asymmetric: during the flexion, the medial condyle is stable throughout the range of motion while the lateral condyle slides anteroposteriorly with respect to femur). Therefore, the native knee requires a specific degree of rollback of the lateral compartment coupled with a medial pivot, which leads to an external axial rotation of the femur. This rollback is thought to be even more pronounced with increasing knee flexion angles to enable deep flexion without excessive shear forces acting at the patella or overloading the extensor mechanism.

In addition, stability throughout flexion is a crucial element to normal knee function. Most TKA designs removal of the ACL, and the PCL in posterior-stabilized design, but the TKA do not fully restore the function of those ligaments.

Based on this philosophy, the medial pivot TKA was designed to provide better function, patient satisfaction and increased survival.

The objective of this study is to analyze whether the medial pivot design provides better outcome and prosthesis survival than conventional total knee arthroplasty.

Candidates for the study will be consecutive patients eligible for total knee arthroplasty (TKA) at our center. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.

At that time, each patient will be randomized into one of two groups by an independent staff using computer generated randomization and allocation concealment. The two patient groups will include:

1. Study group: patients treated with a medial pivot TKA.
2. Control group: patients treated with a conventional TKA. Patients will be preoperatively assessed and postoperatively at regular intervals (6mo, 12 mo, and then annually) by orthopaedic surgeons not involved in the surgeries or cares.

Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis of the knee
* 50 years and older
* Participants must be able to give informed consent

Exclusion Criteria:

* Inflammatory arthritis
* Traumatic etiology
* Neurologic disease
* Neoplastic disease
* Morbid obesity
* Severe collateral ligament instability (\> 10° varus/valgus)
* Severe knee misalignment (greater than 10° of varus or valgus)
* Flexion contracture greater than 15º
* Prior surgery on the affected knee (except meniscus)
* Knee arthroplasty in the contralateral knee
Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery

The purpose is to determine if an intracameral solution of 0.2% tropicamide and 2% phenylephrine can dilate the pupil for cataract surgery as well as pre-operative topical 1% tropicamide and 5% phenylephrine. We will be looking at two separate groups of patients, those with and those without pseudoexfoliation syndrome.

We will be looking at how each method affects the size of the pupil at the beginning and at the end of cataract surgery. In addittion, we will look at what effect the two different methods have on blood pressure and heart rate in the pre-operative, peri-operative and post-operative periods.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give consent
* Greater than 18 years of age
* Planned clear cornea cataract extraction and placement of foldable posterior chamber intraocular lens
* No secondary procedure planned (i.e. trabeculectomy, keratectomy, corneal transplant, vitreo-retinal procedure etc.)
* Systemic condition capable of undergoing topical anesthesia
* No previous intraocular surgery
* Pseudoexfoliation syndrome (PXF) for group 1
* No Pseudoexfoliation syndrome for group 2

Exclusion Criteria:

* Not fulfilling inclusion criteria
* Any iris pathology including but not limited to posterior synechia, iridocorneal endothelial syndrome, corectopia, traumatic mydriasis, Horner's syndrome, Adie's pupil, cyclodialysis, iridodialysis
* Previous or concurrent use of Flomax® or similar alpha-antagonist medication
* Corneal pathology affecting pupil magnification or measurement (keratoconus, peripheral thinning, sclerocornea, scarring)
* Uncontrolled Hypertension (greater than 170/90 on pre-operative assessment on day of surgery as measured by automated DATEX monitor)