cyrilzakka/clinical-trials huggingface dataset:
Microvascular Partial Toe Transfer

Microvascular partial toe transfer for reconstruction of traumatic amputation of the digits

Microsurgical toe transfer has become a gold standard option for amputated digit reconstruction. It can be used to correct almost any thumb defect. However, for optimal functional and esthetic results, proper initial care, preoperative planning, proper selection of suitable techniques, adjunct or secondary procedures and proper, postoperative rehabilitation are important.

The transfer of a toe to replace an amputated thumb represents one of the first applications of microsurgical techniques, yet to this day remains an epitome of reconstructive surgery, restoring critical function and form to the hand-injured patient. While techniques have greatly evolved to permit the treatment of multiple finger amputations, dystrophic nails and pulps, and traumatized or arthritic joint, the amputated thumb retains its status among the most indubitable indications for toe transfer. Microsurgical techniques have been refined to such a degree that almost any ablative deformity of the thumb could be corrected with some form of toe transfer. The question, therefore, is not if a defect could be reconstructed, but whether the patient is willing to undergo reconstruction. The concepts of "adequate function" and "optimal function" are therefore of central importance when discussing treatment options with a patient. Obviously, these parameters will be different for each patient depending upon his/her vocation, avocations, and desires. For many people, adequate function might be expected with an amputation that retains some length of the proximal phalanx (assuming sufficient soft tissue coverage is present or can be provided). However, for patients who require full length of their thumb, or who desire optimal rather than adequate function, toe transfer should be considered.

At present, the decision to use a particular toe transfer technique is mostly based on the surgeon's preference and training. The current data are inadequate to make any comments with regards to donor site morbidity. Till such data are available, an evidence-based recommendation for the superiority of a specific type of toe-to-thumb transfer cannot be made. We hypothesis that partial toe transfer provides the best aesthetic and functional reconstruction and the least donor site morbidity amongst all other types of transfers.

Eligibility Criteria:
Inclusion Criteria:

* Patient from 18-50 years old
* one or more finger amputations
* Minimum follow-up period of 6 months

Exclusion Criteria:

* patients whose loss was due to congenital anomaly.
* Patients who did not have a minimum follow-up period of six months .
Long-Term Outcome of Pediatric Traumatic Wound Repair: Suture Versus Tissue Adhesive

This project is an observational trial investigating wound cosmetic appearance after repair of traumatic skin lacerations in the head area of pediatric patients with two different approaches to skin closure: sutures versus tissue adhesive. Photographs will be taken at two follow-up visits after repair and later assessed by external blinded plastic surgeon using standard cosmetic assessment scales. The investigators hypothesize that cosmetic wound outcome will be equivalent in these two wound repair treatment options.

Investigation of the long-term outcome of 300 pediatric patients with traumatic skin lacerations in the head area. After primary wound repair with suture or with tissue adhesive, eligible patients will be enrolled on the emergency department (baseline visit). The second follow-up visit will take place 5-10 days after the baseline visit and the third follow-up visit will be completed 6-12 months after trauma. At both follow-up visits, clinical examination and a brief interview will be performed. Photo documentation is completed at both the baseline and the follow-up visit.

Encrypted photo documentation will be evaluated by blinded external plastic surgeons. Primary Outcome is the cosmetic appearance using standard assessment scales, secondary outcomes are the occurrence of complications, cost-effectiveness and patient's satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* 0 till16 years of age
* Any primary wound repair treatment of a laceration caused by trauma and involving the skin of the head area
* Patient or caregiver must be able to understand and sign an informed consent

Exclusion Criteria:

* Pre-existing conditions that affect wound healing adversely
* Patients who demonstrate severe or life-threatening injuries
* Patients / caregivers with communication / logistic barriers that would make them unfit to provide informed consent or to attend the follow-up visits
Whole Brain Radiotherapy (WBRT) Versus Stereotactic Radiosurgery (SRS) for 4 Upto 10 Brain Metastases

Recently stereotactic radiosurgery (SRS) in 5 up to 10 brain metastases showed to have equal survival as in 2 up to 4 brain metastases. Whole brain radiotherapy (WBRT) is currently the gold standard for patients with more than 3 brain metastases, but has significant side effects. In this prospective randomized phase III trial WBRT is compared to SRS for patients with 4 up to 10 BM.

Dutch guideline advices stereotactic radiosurgery (SRS) for patients with 1 up to 3 brain metastases (BM) and whole brain radiotherapy (WBRT) for patients with 4 or more BM. The interim analysis from the QUARTZ study showed that WBRT did not provide benefit in quality of life nor survival over best supportive care. WBRT has significant side effects, such as hair loss, fatigue, and cognitive dysfunction which may impair quality of life. A recently published study showed that SRS in patients with 5 up to 10 BM had a comparable survival to patients treated with 2 up to 4 BM. Many systemic therapies do not have a satisfactory intracranial response, because of the blood-brain barrier. The potential advantages of SRS i.e, limiting radiation doses to the uninvolved brain and a high rate of local tumour control by just a single treatment. Next logic step would be to compare WBRT with SRS alone in patients with 4-10 BM and evaluate whether SRS is superior to WBRT with regard to QOL.

Eligibility Criteria:
Inclusion Criteria:

* Minimal 4 up to a maximum of 10 BM on diagnostic MRI scan
* Max diameter of single GTV 2.5cm
* Max cumulative GTV of 30cm3
* Karnofsky performance status ≥ 70
* Any solid primary tumour. Small cell lung carcinoma, germinoma, and lymphoma are excluded
* Ability to provide written informed consent

Exclusion Criteria:

* Contra-indication for MRI
* Prior treatment for BM (i.e. surgery, SRS or WBRT)
* Concurrent use of systemic therapy
* Maximum cumulative GTV of more than 30cm3 on planning-MRI
* More than 10 BM on planning-MRI
* A brainstem metastasis with a PTV of more than 20 cm3
Helping Families Pilot of a Family Resilience Program for Families Experiencing Homelessness

The goal of this study is to pilot an adapted family resilience program among families with a recent history of homelessness in Los Angeles County and to assess for feasibility and acceptability. The investigators have adapted a family resilience program called Families Overcoming Under Stress (FOCUS), a trauma-informed intervention designed for families experiencing trauma, parental substance use, and homelessness. Our primary hypothesis is that the adapted family resilience program will be feasible and acceptable to families with a recent history of homelessness. Families that are eligible to participate in the study will be assigned to the adapted family resilience intervention. The intervention program consists of around 8-10 modules lasting up to one hour each. The program provides psychoeducation and teaches resilience skills including communication, problem solving, goal setting, and how to deal with stress. Families will be asked to fill out 3 surveys (one at the beginning of the program, one at the end of the program, and at 6 months follow-up). Some families may also be asked to participate in a hour long interview after the completion of the program for feedback on the program.

At this time, all assessments and intervention are being conducted remotely due to the pandemic.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Family has a history of homelessness within the past two years (homelessness defined by the Department of Health and Human Services definition)
* Parent/guardian/caregiver has custody of and cares for a youth between the ages of 8-17
* Both youth and parent/guardian/caregiver are able to take part in an 8 module session intervention

Exclusion Criteria:

* Does not meet inclusion criteria
* Has taken part in a Families OverComing Under Stress (FOCUS) intervention previously
What Needle Diameter Should Physician Use When They Perform Lumbar Puncture ? A Randomized Controlled Trial

This study is intended to help guide the choice of needle diameter when performing a lumbar puncture.

Smaller spinal needles have been shown to decrease rate of adverse events such as post-lumbar puncture headache and hearing loss.

The main drawback to using smaller needles is diminished flow rate; some textbooks recommend using needles no smaller than 22 gauge because of the slow flow rate though others recommend smaller needles, namely 22-24 gauge.

Some authors have described a successful use of spinal needles as small as 25 gauge when performing a lumbar puncture.

The investigators do not believe that the flow-rate difference between 22 and 24 gauge needles is significant enough to justify using the larger needles.

The investigators trial will compare the Whitacre 22 gauge and Whitacre 24 gauge needles for flow rate, and incidence of the known complications of pain during procedure and backache at 8 and 15 days post-procedure.

The investigators will also look at whether smaller needles are associated with less pain during the procedure and less backache the next 2 weeks after the procedure.

The purpose of this randomized, double-blinded clinical trial is to assess whether a 24 gauge spinal needle can provide an acceptable flow rate of cerebrospinal fluid (CSF) when compared to the traditionally used 22 gauge needle.

Smaller needles, according to The Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology are 'associated with reduced frequency of post-lumbar puncture headache (Level A recommendation).'

Given that flow rate of CSF is the limiting factor when choosing a spinal needle gauge, two previous studies have compared various needle sizes for adequacy of flow. These studies, however, have important limitations and have not led to a clear consensus in clinical practice. For instance, one study used a 0,9 % solution of sodium chloride at room temperature, the other used an 'artificial CSF solution' of unknown viscosity and nature.

Patients referred to the neurological day center of the Montreal Neurological Institute/Hospital for lumbar puncture will be recruited to the study. Participants will be randomized to have the puncture with a Whitacre 22 or 24 gauge needle.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (\>= 18 years old) referred at the Neurological Day Center to get a lumbar puncture

Exclusion Criteria:

* Contraindication to get a lumbar puncture
TIME ASPIRIN: Chronotherapy With Aspirin for Reduction of Cardiovascular Disease

This study will be a comparative effectiveness research to determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after awakening and aspirin before bedtime.

Aspirin is the cornerstone of preventive cardiovascular disease (CVD) treatment and bedtime intake of aspirin (chronotherapy) has been shown to reduce morning activity of platelets. It has been shown that platelet reactivity follows a clear circadian rhythm, with a peak of platelet reactivity during the morning (6-12 AM). Importantly, studies have shown in meta-analyses that high platelet activity is predictive of adverse cardiovascular outcomes in patients with stable CVD. Given this knowledge, it is highly likely that the morning peak of platelet reactivity contributes to the morning peak of cardiovascular events and that reduction of morning platelet activity prevents cardiovascular events during morning hours. This may be achieved by intake of aspirin at bedtime instead of on awakening. This study will be a comparative effectiveness research to determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after awakening and aspirin before bedtime.

Eligibility Criteria:
Inclusion Criteria:

* Use of low-dose aspirin (acetylsalicylic acid 80mg \[brand name: acetylsalicylic acid cardio TEVA\]\~)
* Patients using aspirin from an MDD ('Baxter')
* Capacity to give informed consent (IC)

Exclusion Criteria:

* Pregnancy
* Mental or physical disability to fulfil study requirements
* Insufficient knowledge of the Dutch language
* Patients currently participating in another (clinical) trial or study
Exercise Habit and M-PAC

The promotion of physical activity (PA) is paramount to public health, yet interventions in the social cognitive tradition have yielded negligible improvements. Two reasons for these results may be the over reliance on intention as the proximal determinant of behaviour and a lack of consideration of implicit/automatic determinants of PA. The purpose of this study was to apply Multi-Process Action Control (M-PAC), a framework centered on PA intention-translation and the gradual building of habit to examine PA change using a two-arm parallel design, randomized controlled trial.

Background: Two of the most prominent limitations of traditional social cognitive models used to understand moderate-to-vigorous physical activity (MVPA) are the gap between intention and behaviour and the lack of consideration of implicit processes in behavioural enactment. Thus, new models are now being examined that attempt to consider these potential limitations. Multi-Process Action Control (M-PAC) is one such attempt to build a more comprehensive schematic, whereby intention is established via the means of constructs from traditional social cognitive theories (i.e., outcome expectations, perceived capability), but the success of translating this intention to behaviour depends on behavioural-regulation (self-regulatory tactics) (BR), affective judgments (expected pleasure) (AJ) and opportunity (time, access). Over time, M-PAC proposes that habit (stimulus -behaviour bonds) and identity (role-behaviour bonds) develop from performing the behaviour and largely contribute to the maintenance of PA.

Aim: The purpose of this study was to conduct at two-arm parallel design, RCT to determine if the M-PAC experimental group would demonstrate greater change in PA and post-intention constructs across time.

Methods: Participants (n=94) were inactive new gym members and were randomized into a control or M-PAC experimental group. The experimental group attended a workshop and received a booster phone call follow-up at week four. Measures for both groups included accelerometry and M-PAC at baseline and at week eight.

Eligibility Criteria:
Inclusion Criteria:

* New gym member
* age 18-65
* Par-Q pass

Exclusion Criteria:

* age \<18 or 65+
* Par-Q fail
Optimization Management Study of Community Urinary Tract Infections Spectrum

Urinary tract infections are the second most common community-acquired infections. Even if extended spectrum β-lactamase-producing Enterobacteriaceae (ESBLE) cause fewer urinary tract infections, their proportion is increasing. New recommendations were published by ANSM in 2015, with specific recommendations for infections due to ESBL-producing Enterobacteriaceae. In this study, we wanted to evaluate the effectiveness of a recall of the 2015 recommendations in the form of a table attached to the ECBU report, associated with hygiene recommendations.

Methodology: This prospective, multi-center, non-interventional study was conducted in collaboration with the Labazur laboratory over two 2-month periods, one without modification of the laboratory's practices, the other with the addition of documents on the CBEU report. The primary endpoint was the adequacy of prescriptions to ANSM 2015 recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient who were prescribed by a GP a CBEU during the 2 inclusion periods (from 1/10/2016 to 28/02/2017 with a first period from 01/10/2016 to 30/11/2016 and a second period from 02/01/2016 to 28/02/2017)
* CBEU analyzed by Labazur laboratory
* CBEU positive for a spectrum β-lactamase-producing Enterobacteriaceae (ESBLE)

Exclusion Criteria:

* Children
* Refusal of consent
* CBEU prescribed by a specialist
* patient hospitalised for management of the infection
Communication With in Vitro Fertilization (IVF) Patients About Risks

The primary objective of this trial is to determine whether written educational materials plus brief education by telephone will help patients better understand and participate in the decision on how many embryos to transfer to the uterus during treatment of infertility with in vitro fertilization (IVF). The main study hypothesis is that women and men who receive the study's educational intervention will experience favorable changes in knowledge and beliefs about benefits, susceptibility and severity of multiple gestation that impact decisions about the number of embryos to transfer. Secondary objectives are to understand patient beliefs, knowledge and information preferences regarding other possible risks of IVF, to compare perception of IVF-related risks to familiar risks that are included in routine preconception health promotion, and during IVF, and to prepare couples to manage IVF-related obstetrical risks when they make the transition to prenatal care after becoming pregnant.

Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment

The long-term objective of this research is to improve patient understanding of the known and strongly suspected risks from treating infertility with assisted reproductive technologies such as in vitro fertilization (IVF). During IVF, when more embryos are transferred to the uterus, the risk of pregnancy with multiple fetuses increases. In addition, single infants conceived with IVF are at greater risk for low birth weight. This study will promote behaviors that may reduce these risks. One in 3 women who completes a pregnancy conceived with assisted reproductive technologies such as IVF delivers multiples, and these treatments produce over 12,000 multiple birth deliveries annually in the United States. This study will lead to a better understanding of the most effective ways to counsel IVF patients about the embryo transfer decision. This study will also help define how to prepare IVF patients to work most effectively with their prenatal care team to manage IVF-related obstetrical risks.

Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age

Exclusion Criteria:

* Using a gestational carrier in the current cycle of IVF
The Compartmental Biology of HIV in the Male Genital Tract

Male participants taking tenofovir-emtricitabine (TDF/FTC) will provide semen and blood samples which will be analyzed to better understand the pharmacology of antiretroviral therapy in the male genital tract.

8 HIV positive men taking TDF/FTC and 8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis will provide multiple semen and blood samples during a 48-hour inpatient visit. 8 HIV positive men taking TAF (tenofovir alafenamide) will provide multiple semen and blood samples during a 48-hour inpatient visit.

Participants will take part in the study for approximately two months. After the screening visit, there is one 2 day overnight visit for intensive PK/PD (pharmacokinetic/pharmacodynamic) sampling. The investigators will study drug concentrations and intracellular endogenous nucleotide concentrations (dATP and dCTP) in seminal plasma and (where appropriate) seminal cells.

Samples will be analyzed through the use of novel laboratory methods to determine the seminal plasma and seminal cell concentrations of tenofovir and emtricitabine. New technologies will be used to better understand compartmental and intracellular antiretroviral pharmacology of nucleoside/tide reverse transcriptase inhibitors. Pharmacokinetic modeling will be used to estimate the primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Born male between the ages of 18 and 60
* HIV positive taking TDF/FTC (and a third drug) as treatment; or HIV negative men receiving TDF/FTC as pre-exposure prophylaxis; HIV positive men taking tenofovir alafenamide
* if on routine treatment must have been taking medication for at least 3 months and adherence to medication as assessed by blood plasma HIV RNA less than 50 copies per mL.
* documentation of at least 80% adherence to antiretroviral (ART) regimen, through clinician or self-report, with no missed doses in the 3 days prior to the inpatient visit.
* willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that would pose unnecessary risk or interfere with study results.
* unwilling or unable to abstain from sexual activity 72 hours prior to overnight sampling visit
* unlikely to remain on current drug regimen during study period
* anemia that precludes blood donation
* unable to provide semen specimen
* current receipt of other medications that may affect endogenous nucleotide concentrations, such as additional HIV nucleoside reverse transcriptase inhibitors, ribavirin, or adefovir
Correlation of PaCO2 to the Inspired and Expired Oxygen Gradient

The purpose of this study is to evaluate whether a correlation exists between the partial pressure of carbon dioxide existing within arterial blood and the gradient between inhaled and exhaled fractions of oxygen.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65.
* Scheduled for surgical procedure that will last at least 2 hours.
* Arterial cannulation is planned because of either the complexity of the surgery or patient comorbidity.
* At least two arterial blood gas analyses are planned during the surgery.

Exclusion Criteria:

* No arterial cannulation is necessary or planned for the procedure.