cyrilzakka/clinical-trials huggingface dataset:
Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda

BCG vaccination may have non-specific effects (NSE) i.e., additional benefits on childhood morbidity and mortality that are separate the vaccine's effect on the incidence of disseminated tuberculosis. Though the available literature is mostly from observational study designs, and is fraught with controversy, BCG vaccination at birth, in a high risk population of HIV exposed children, may protect infants against serious infections other than TB. Yet, other studies indicate that giving BCG later in infancy, when the immune system is more mature, may offer even greater protection. The appropriate timing of BCG vaccination could therefore be up for revision. This study will therefore compare BCG vaccination at birth with BCG vaccination at 14 weeks of age in HIV exposed (HE) babies.

Methods: This is an individually randomized clinical trial in 4,500 HIV exposed infants. The intervention is an intra-dermal administration of 0.05 ml of BCG vaccine within 24 hours of birth while the comparator will be an intra-dermal administration of 0.05ml of BCG vaccine at 14 weeks of age.

The main study outcomes include:

1. Severe illness in the first 14 weeks of life,
2. Innate and adaptive immune responses to mycobacterial, non-mycobacterial antigens and TLR-agonists
3. Severe illness in the first 14-52 weeks and 0-52 weeks of life.

The study will be carried in two health centers and one district hospital in Uganda.

Implications: A well-timed BCG vaccination could have important additional benefits in HE infants. This trial could inform the development of programmatically appropriate timing of BCG vaccination for HE infants.


Eligibility Criteria:
Inclusion Criteria:

A baby born at a participating study clinic will be included if s/he:

1. has a mother with a positive HIV test (ELISA or rapid test)
2. is receiving peri-exposure prophylaxis as part of the standard/national guidelines in Uganda
3. has a mother that is of legal age for participation in clinical research studies in Uganda or is an emancipated minor
4. has a mother/caregiver that resides within the study area, is not intending to move out of the area in the next 4 months and is likely to be traceable for up to 12 months
5. has a mother/caregiver that gives informed consent to random assignment to either of the two trial arms
6. has a mother that has received antiretroviral therapy (ART) for at least 4 weeks

Exclusion Criteria:

A new-born child will be excluded if she/he has:

1. an identified serious congenital malformation(s)
2. severe illness requiring hospitalization
3. a birth weight \< 2.0 kg
4. a mother participating in another clinical trial on the day of enrolment or a mother who will participate in another clinical trial within the next month.
5. a mother or other household member with symptoms and signs of tuberculosis on the day of enrolment
6. a severely ill mother with (a) condition(s) requiring hospitalization
7. a baby with an Apgar score at 5 minutes \<7
8. a twin or triplet
Cognitive-Motivational Behavior Therapy for Pathological Gamblers

In the proposed two-arm randomized controlled trial, 200 patients meeting DSM-IV criteria for PG will be randomized to 12 sessions of Cognitive-Motivational Behavior Therapy (CMBT) or to Cognitive Behavior Therapy (CBT).

CMBT has been developed by our team over the last five years, and has shown very promising results in a small, NIMH-funded randomized pilot trial (R21 MH 064568). We will assess patients biweekly during the active treatment phase and follow them for 12 months after the end of treatment to obtain data on long-term treatment outcome. We hypothesize that CMBT will show higher efficacy and retention than CBT in the treatment phase, and that gains will be maintained at a higher rate during follow-up.

A second major purpose of the proposed study is to elucidate the presumed mechanisms of change by examining potential mediators (readiness to change, irrational beliefs about gambling, coping skills, therapeutic alliance) and moderators (psychiatric comorbidity with Axis I and II disorders, family history of PG, impulsivity, and baseline motivation to change) of treatment response. A better understanding of how the proposed interventions work will help advance the science and treatment of PG and will be helpful in the future refinement and adaptation of CMBT. Identifying patient subgroups for which the intervention is particularly effective is essential for rational treatment selection. Thus, the immediate goal of the project is to compare CBMT versus CBT for the treatment of PG. A long-term goal of the proposed research is to establish effective treatment procedures that reduce the considerable individual and social costs of PG.

Eligibility Criteria:
Inclusion Criteria:

* pathological gambling
* be able to read, understand and sign an informed consent form prior to any procedure and must be willing to comply with all study procedures and timelines

Exclusion Criteria:

* to meet DSM-IV criteria for comorbid substance use disorders in the last six months
* current comorbid psychiatric conditions which require treatment and are not clearly secondary to pathological gambling
* psychotropic medication
Supplemental Selenium and Vitamin E and Pulmonary Function

To test whether supplementation with selenium and/or vitamin E affects pulmonary function.

BACKGROUND:

There is compelling evidence from observational epidemiologic studies that intakes of nutrients with antioxidant properties are associated with reduced risks of chronic obstructive disease (COPD) and increased lung function. This study is ancillary to the multisite Selenium and Vitamin E Cancer Prevention Trial (SELECT), a 4-arm placebo-controlled, double-blinded randomized trial in 35,000 men testing whether daily supplementation with vitamin E (400mg alpha-tocopherol), selenium (200 micrograms selenomethionine) or both vitamin E and selenium can prevent prostate cancer.

DESIGN NARRATIVE:

This study is ancillary to the multisite Selenium and Vitamin E Cancer Prevention Trial (SELECT), a 4-arm placebo-controlled, double-blinded randomized trial in 35,000 men testing whether daily supplementation with vitamin E (400mg alpha-tocopherol), selenium (200 micrograms selenomethionine) or both vitamin E and selenium can prevent prostate cancer. A total of 3,000 SELECT participants will be enrolled for this respiratory ancillary study, and data collection will be extended to include pulmonary function, respiratory disease, and respiratory symptoms. Biological measures of nutrient exposure (serum vitamin E and selenium) and plasma lipids (total and high-density lipoprotein cholesterol) will be collected on all participants and oxidant burden (urinary F2-isoprostane) on a sub sample of heavy smokers and men with COPD. The primary outcome will be change over about 36 months in forced expiratory volume in the first second (FEV1). FEV1 is a valid and reliable measure of respiratory function that strongly predicts COPD and mortality. Extensive data on diet and dietary supplement use are being collected by the SELECT parent study. All specific aims examine pre-specified contrasts between the 4 arms of the SELECT randomized trial. The underlying hypothesis is that supplements will reduce the age related decline in FEV1 and thus at the 3-year follow-up FEV1, which will be tested in longitudinal and cross-sectional models. A secondary aim considers whether the effect of supplementation is greater among smokers (high burden of exogenous oxidants) who, by purposive selection of the study sites, will comprise about 25% of the sample.

Eligibility Criteria:
Eligibility criteria:

* age ≥ 55 y (≥ 50 y in African-Americans)
* serum prostate-specific antigen ≤ 4ng/mL
* no clinical evidence of prostate cancer

Exclusion criteria:

* Off both SELECT supplements
Fat Reduction in the Submandibular/Submental Area

The purpose of this study is to further evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.


Eligibility Criteria:
Inclusion Criteria

* Male or female subjects \> 22 years of age and \< 65 years of age.
* Submental and submandibular skin fold thickness \> 1cm (measured by caliper).
* No weight change exceeding 5% of body weight in the preceding month.
* Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
* Subject has signed a written informed consent form.

Exclusion Criteria

* Skin laxity in the neck or chin area for which reduction in submental and submandibular fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
* Prominent platysmal bands at rest which may interfere with assessment of submental fat
* Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
* Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
* Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area (below the mandible) within the past 6 months.
* Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the mandible) within the past 6 months.
* History of facial nerve paresis or paralysis (such as Bell's palsy).
* History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
* History of prior neck surgery, or prior surgery in the area of intended treatment.
* Current dental infection.
* Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
* Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* Currently taking or has taken diet pills or weight control supplements within the past month.
* Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
* Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
* Pregnant or intending to become pregnant in the next 6 months.
* Lactating or has been lactating in the past 6 months.
* Unable or unwilling to comply with the study requirements.
* Currently enrolled in a clinical study of an unapproved investigational drug or device.
* Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
APP-based Multifaceted Management After PCI

High rates of recurrent cardiovascular events and readmission after percutaneous coronary intervention (PCI) are important issues. Guidelines emphasize rehabilitation and secondary prevention. But many patients are lack of effective management after PCI.This study is aimed to examine the effect of mobile application (APP)-based multifaceted management on the improvement of long-term care after PCI.

This is a cluster-randomized controlled trial to evaluate the effect of APP-based multifaceted management strategy on improvement of long-term care for medication adherence,risk factor control, and reduction of adverse events, readmission rate and mortality after PCI.It includes knowledge education, medication reminder,advice provision, support to change lifestyle behaviors. The program is interactive between care provider and patients. A total of 20 wards will be randomly assigned to intervention or usual care.Anticipated 1100 patients after PCI will be participated in the trial. All the participants will be followed up until 12 months.

Eligibility Criteria:
Inclusion Criteria:

* patients who have received percutaneous coronary intervention and are discharged alive in the study centers;
* patients who are able to use APP;
* patients who provide informed consent.

Exclusion Criteria:

* patients who are not able to use APP;
* dementia;
* mental disturbed;
* patients who are not willing to receive management and follow up.
Thalamic Deep Brain Stimulation for Tourette Syndrome

The purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* Diagnosis of Tourette Syndrome by DSM-IV
* Tic frequency at least one per minute at screening
* prior failure of at least two dopamine receptor or presynaptic blockers
* negative impact on quality of life

Exclusion Criteria:

* significant structural brain lesion (on imaging studies)
* significant dementia
* severe head trauma preceding onset of tics
* use of dopamine receptor blockers prior to recognition of tics
* prior implanted electrical device
* electroconvulsive therapy (ECT) within 24 months
* suicide attempt within 12 months
* significant sociopathic personality
* current or planned pregnancy
Multicenter Evaluation of Near Vision and Outdoor Time in Kids Study

Currently, optical and pharmacological interventions have been developed to prevent the progression of childhood myopia. However, no myopia control strategy has been shown to have complete efficacy in controlling myopia progression in children. One possible reason is that risk factors contributing to the development of myopia were not controlled in previous clinical studies including time outdoors and near vision behaviour. This study aims to quantify time spent outdoors and near vision behavior in myopic children and its impact on myopia control efficacy. The outcomes of this study will guide clinicians on risk management and improve responses to existing treatments for progressive myopia.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 6 to below 14 years old
2. Spherical equivalent myopic refractive error greater than -0.50 D
3. Best corrected logMAR visual acuity of 0.1 or better in each eye for 6- to 14-year-old children, and 0.2 logMAR or better than in each eye for 4 and 5-year-old children (adjusted for age-related expectations)
4. Good ocular and general health that would not preclude them from myopia control
5. Competent enough in English to fully understand the participant information and consent form
6. Willing to undergo treatment to slow myopia progression for one year

Exclusion Criteria:

1. Strabismus at distance or near, or amblyopia
2. Systemic or ocular conditions that may affect contact lens use (e.g. severe allergy) or refractive development (e.g. ptosis)
3. Previous history of ocular surgery, trauma or chronic ocular disease that may affect their vision
4. Ocular or systemic medication use which may interfere or interact with myopia treatment or ocular development
5. Child, parents or guardians not willing to comply with treatment and/or follow-up schedule and planning to migrate or move during the one-year study duration
Diagnostic Imaging of Bone Metastases in Prostate Cancer Patients

An improved diagnosis of bone metastases in prostate cancer patients can have a significant impact on treatment strategy and probably survival as well.

The primary purpose of the project is to determine the diagnostic accuracy of bone SPECT-CT, choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and Whole-body MRI in the diagnosis of bone metastases in prostate cancer patients.

The project is a prospective diagnostic test accuracy study. The project takes place at Herlev Hospital and is a collaboration between the Department of Radiology and the Department of Clinical Physiology and Nuclear Medicine.

The investigators want to include 300 prostate cancer patients referred to our standard diagnostic imaging (NaF-PET-CT scan) by the clinicians.

In addition to the standard diagnostic imaging (NaF-PET-CT-scan), two project will be performed on all participants. The project has three arms with the following scanning combinations:

A) Whole-body MRI + SPECT-CT B) Whole-body MRI + Cholin-PET-CT C) Whole-body MRI + PSMA-PET-CT The recruitment of project participants takes place on the day when the patients are undergoing a NaF-PET-CT scan in the course of regular clinical practice at our institution.

All readers are experienced radiologists or specialists in nuclear medicine. Patient identification on each scan will be anonymized and the reader will not have access to clinical and biochemical information or previous imaging studies.

Eligibility Criteria:
Inclusion Criteria:

A subject will be eligible for project participation if he meets all of the following criteria:

* Is either 1) a newly diagnosed prostate cancer patient in clinical suspicion of bone metastases or 2) a previously diagnosed prostate cancer patient in clinical suspicion of progression in the form of bone metastases. The subject must have been referred to the standard diagnostic imaging (18F-NaF-PET-CT) at our institution for bone metastases.
* The prostate cancer diagnosis must be biopsy-proven
* The subject is willing and able to comply with the protocol as judged by the investigator

Exclusion Criteria:

A subject will be excluded from the protocol if he meets one or more of the following criteria:

* Has prior malignancy, except for adequately treated basal cell or squamous cell skin cancer
* Has pacemaker or implanted devices (eg. cardiac valves, neurostimulator or insulin pump) that cannot be removed, metal clips/metal prostheses from surgery that are not MRI compatible or metallic foreign bodies in the eye (MRI exclusion criteria)
* Has any condition that places the subject at an unacceptable risk if he undergoes a diagnostic CT-scan (e.g. history of severe allergic reaction to the contrast agent).
* Has severe obesity (\>195 kg is the weight limit for the scanner table)
* Has severe claustrophobia
The Added-value of PSMA PET in Detecting Clinically Significant Prostate Cancer Lesions in Patients Undergoing MRI-targeted Biopsy. (PANDORA)

Prostate Specific Membrane Antigen (PSMA) positron emission tomography/computed tomography (PET/CT), an imaging modality focusing on a protein overexpressed by prostate cancer cells, has revolutionised the staging of both newly diagnosed and biochemically recurrent prostate cancer with better performance when compared to conventional imaging. Indeed, several studies have shown that PSMA PET/CT outperformed choline PET/CT with better detection rate of metastatic disease, particularly in the setting of disease recurrence after therapy even at (very) low PSA level. Moreover, the proPSMA trial reported that PSMA PET/CT had 27% greater accuracy than that of CT and bone scanning when staging patients with high-risk localised prostate cancer. More recently, availability of integrated PET/MRI scanners offers the opportunity for higher accuracy imaging and promising diagnostic studies. It also offers enhanced spatial integration that resulting in better contouring and targeting of prostate lesions.

In the light of current issues, the next question is whether PSMA PET imaging could add to the detection of prostate cancer. Several retrospective case-report studies reported promising results regarding the improved diagnostic accuracy of prostatic PSMA PET/CT . Recently, in the PRIMARY trial, 291 men received successively MRI, PSMA PET/CT and systematic ± MRI-targeted biopsies. Despite similar PPV between imaging methods, the main advantage of PSMA was in men with equivocal MRI. Indeed, they found that 90% of csPCa was identified by PSMA PET/CT in this subgroup and paved the way for further investigation. This finding was confirmed in the most recent systematic review and meta-analysis.

The aim of this prospective study is to evaluate the added-value of PSMA PET in detecting prostate cancer in patients who are candidates for biopsy with equivocal MRI.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the following criteria for inclusion in the study:

* Men ≥ 18 years of age
* Multiparametric MRI within the previous 6 months
* At least one lesion PI-RADS 3
* Able to provide written informed consent

Exclusion Criteria:

Eligible subjects must not meet any of the exclusion criteria listed below:

* Previous prostate cancer diagnostic on MRI-targeted biopsy
* At least one lesion PI-RADS 4-5
* Negative MRI (PI-RADS 1-2)
* Previous treatment for prostate cancer 11
* Contraindication to PSMA PET and/or MRI and/or prostate biopsy
* Low quality of MRI defined by a PI-QUAL score of 1 or 2
* Any medical condition that may interfere with the study procedures.
Proximal Femoral Nail Antirotation (PFNA) Versus PFNA Augmentation

The purpose of this study is to evaluate whether patients with trochanteric fractures being treated with a Proximal Femoral Nail Antirotation (PFNA) and augmentation can better be mobilized than patients without augmentation.

To avoid the pain-causing relative movement between implant and bone, surgical techniques and devices allowing augmentation of the femoral head have recently been developed. Biomechanical studies showed that augmentation leads to a better axial stability and pull-out strength. In clinical practice, this might facilitate early mobilization and full weight-bearing with less pain. The purpose of this study is therefore to evaluate whether patients with trochanteric fractures being treated with a PFNA and augmentation can better be mobilized than patients without augmentation. In particular, it will be measured whether patients with a PFNA Augmentation can walk faster than the non-augmented patients, measured with the Timed up and Go test.

Eligibility Criteria:
Inclusion Criteria:

* Age 75 years and older
* Closed unstable trochanteric fracture: AO 31 - A2 and A3
* Low energy trauma (e.g.fall from standing height)
* Definitive fracture fixation within 72 hrs. after admission
* Indication for PFNA fixation (with or without augmentation)
* Ability to walk independently (walking aids are allowed) prior to injury
* Signed written informed consent and agreement to attend the planned FUs
* Able to understand and read country national language at an elementary level

Exclusion Criteria:

* Pathologic fracture
* Polytrauma
* Any additional fracture
* Open fracture
* Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
* Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years
* ASA class V and VI
* Any implant at the same hip
* Hemiplegia
* Patients with legal guardian
* Patients who have participated in any other device or drug related clinical trial that could influence the results of the present study within the previous month
* Fractures and injuries opening into the articulation and vascular structure
* Infection
* Patients with clotting disorders
* Patients with severe cardiac and / or pulmonary insufficiency
* Patients with known hypersensitivity or allergy to any of the components of Traumacem V+ cement (Polymethyl methacrylate / acrylate, zirconium dioxide, hydroxyapatite,benzoyl peroxide, methyl methacrylate,hydroquinone, N,N-dimethyl-p-toluidine)
* Perforation of the femoral head into the joint with the guide wire used for the PFNA blade
* Risk of potential leakage into the joint identified by using contrast fluid (PFNA Augmentation group only)
* Intraoperative decision to use implants other than PFNA