cyrilzakka/clinical-trials huggingface dataset:
The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring

Research is instrumental for improving medical care and the patient experience. Finding new surgical techniques can create better outcomes and minimize recovery time and complications for patients. Some patients undergoing trigger finger surgery with a pre-existing Dupuytren's cord may develop a thickened surgical scar after surgery, which can cause discomfort, difficulty with moving or using, and other complications in the affected finger(s) or hand. The investigator is investigating a surgical technique to minimize these potential complications and scarring after surgery.

Subjects are being asked to take part in this research study because they have been diagnosed with trigger finger and pretendinous Dupuytren's cord and have decided to undergo surgery rather than try medical treatment.

Patients who have surgery for trigger finger with a thickened overlying Dupuytren's cord are at risk for complications including but not limited to scarring, adhesions, stiffness, injury to underlying structures such as blood vessels, tendons and nerves, loss of motion, pain, bowstringing, and recurrent triggering or contracture. They have been shown to have higher risk for these complications including a thickened scar response. The cause for this is not fully understood, but it could be because the pretendinous cord was cut and not removed. By cutting and not removing this pretendinous cord, this may cause extra scarring that may lead to a thicker palmar scar that may become symptomatic. This study will investigate a different surgical method for relieving the tension caused by a pretendinous cord and whether it reduces complications and scarring.

Eligibility Criteria:
Inclusion Criteria:

* Potential candidates for the study will be selected based upon clinical diagnosis of trigger finger with co-existing pretendinous cord. All potential subjects will have either failed non operative treatment or elected surgical treatment.

Exclusion Criteria:

* \<18 years of age
Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine Candidate in Healthy Adults (19-49 Years)

This was a Phase I, randomized, active-controlled, observer-blinded, multi-center study to assess the safety and the immunogenicity of 4 Pneumococcal Conjugate Vaccines (PCV) candidates in parallel with Prevnar 13, in Healthy Adults (19-49 years) in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 19 to 49 years on the day of inclusion ("19 to 49 years" means from the day of the 19th birthday to the day before the 50th birthday)
* Informed Consent Form (ICF) has been signed and dated
* Able to attend all scheduled visits and to comply with all trial procedures
* Body mass index within the range of 18.5 and 29.9 kg/m2

Exclusion Criteria:

* Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccine injection until at least 4 weeks after injection. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
* Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial injection, except for influenza vaccination, which may be received at least 2 weeks before SP0202 or Prevnar 13 injection.
* Previous vaccination against S. pneumoniae with either a pneumococcal conjugate vaccine (PCV) or a Pneumococcal polysaccharide vaccines (PPSV).
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Simulation-based Learning for Neurosurgical Instruments in Perioperative Nurses

Rapid technological advances in the last 20 years have led to the exponential adoption of simulation-based learning in nursing education.

Simulation-based learning is designed to engage, challenge and enrich the learner's knowledge base and skill set. It presents the opportunity to experience a variety of clinical scenarios, both common and uncommon, in a safe environment allowing repeated skills training and facilitating the transfer of classroom-knowledge to real situations.Research demonstrates that simulation can improve student engagement and learning and is being increasingly used as an educational strategy for nursing students. This prospective randomized controlled study that was undertaken with the following goals:

1. to investigate the effectiveness of simulation-based training in a large sample of perioperative nurses, measured as nurses' learning progress in the simulation environment;
2. to determine whether the learning acquired through this training is transferable to recognizing real surgical instruments; and
3. to evaluate whether simulation-based learning is retained at least one week.

Eligibility Criteria:
Inclusion Criteria:

* Perioperative nurse
* Employed at Queen Elizabeth II Health Sciences Center

Exclusion Criteria:

-Unable to provide informed consent
Effect of Pilates Training in Patients With Multiple Sclerosis

Knee flexor and extensor muscle weakness in MS patients causes a decrease in walking distance and is an important determinant of walking capacity. Exercise training has beneficial effects on muscle strength, balance, and walking in MS patients. Although the effects of aerobic and resistant exercise training in MS patients are often emphasized, today the effect of different exercise types is also wondered. Pilates is a core stability-based exercise method that improves endurance, flexibility, movement, posture, and respiratory control. The aim of this study is to examine the effect of Pilates training on sensation, muscle strength, balance, and walking in MS patients.

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) will be included in the study. The balance, gait, position sense, and muscle strength will be evaluated. The study was designed as a prospective, randomized controlled study. The patients will be randomly assigned to two groups, the "Pilates training" group, and the control group. Pilates training will be performed by the Pilates training group 2 times for 8 weeks under supervision in the outpatient clinic. The control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 8 weeks at home. Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the paired sample t-test.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Having a diagnosis of "Multiple Sclerosis"
* Relapse free in the last 3 mounts
* Having an ambulatory status (Expanded Disability Status Scale score ≤ 6 )
* No diagnosis of depression

Exclusion Criteria:

* Any cardiovascular, orthopedic, visual, hearing and perception problems that may affect the results of the research.
A Study of High Dose MHAA4549A in Healthy Volunteers

This Phase 1, randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of two, single intravenous (IV) high doses of MHAA4549A as compared to placebo when administered to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive
* Weight 40 - 100 kg
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and clinical laboratory evaluations
* Willing to use acceptable contraceptive measures as defined by the protocol
* Agreeable to, and deemed able to by the investigator, to comply with the requirements of the study, including the follow-up period
* Willing to abstain from the use of drugs of abuse while enrolled in the study

Exclusion Criteria:

* History or clinically significant manifestations of disorders
* History of acute allergic reaction or drug allergies
* History or presence of an abnormal ECG
* History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
* History of significant drug abuse within 1 year prior to screening
* Current tobacco smokers
* Positive drug screen at screening or at check-in
* Positive pregnancy test result at screening or Day -1 or breast feeding during the study
* Males who have a pregnant female partner
* Donation of plasma within 7 days prior to study drug administration
* Donation or loss of whole blood
* Receipt of blood products within 2 months before initiation of dosing on Day 1
* History of malignancy within 10 years of screening except completely excised basal cell carcinoma or squamous cell carcinoma of the skin
* History of severe systemic bacterial, fungal, or parasitic infections associated with more than two hospitalizations per year or more than two courses of intravenous (IV) antibiotics within 1 year
* Received oral antibiotics within 4 weeks before initiation of dosing on Day 1, or IV antibiotics within 8 weeks before initiation of dosing
* Hospitalization within 4 weeks before initiation of dosing on Day 1
* Use of any over the counter or prescription medications/products within 7 days prior to Day 1 and unwilling to abstain from the use of such drugs up until at least the Day 29 study visit, unless deemed acceptable by the investigator and Sponsor
* Participation in a clinical trial within 4 weeks
* Received any vaccine within 14 days prior to screening
* Positive blood test for chronic viral infections
Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence

Patient-based surveys will be conducted to evaluate the drivers of medication adherence in patients treated with either 5-alpha-reductase inhibitor (5ARI) therapy, alpha-blocker (AB) therapy, or combination therapy for enlarged prostate (EP). Adherence with EP therapy will be evaluated. The researchers believe that the majority of participants will report that they are compliant with therapy. The data source is a cross-sectional patient survey administered at one time point.


Eligibility Criteria:
Inclusion Criteria:

* Males
* Aged 50 years or older
* Residents of the United States
* Receiving a prescription for an enlarged prostate (EP) treatment within 12 months prior to survey initiation

Exclusion Criteria:

* Patients with prostate cancer
* no health/prescription insurance
* patients receiving medication(s) for EP on a PRN basis
AMG 334 20160172 Pediatric Migraine PK Study.

AMG 334 20160172 Pediatric Migraine PK Study.

An Open-label, Randomized, Multiple-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AMG 334 in Children and Adolescents With Migraine

Eligibility Criteria:
Inclusion Criteria:

* Subject's legally acceptable representative has provided informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
* Male and female children and adolescents ≥ 6 and \<18 years of age upon entry into screening
* Diagnosis of migraines, with or without aura, according to the International Classification of Headache Disorders (ICHD 3rd Edition, 2013) for at least 12 months prior to the study screening
* Frequency of migraine of ≥ 4 migraine days per month in each of the 3 months prior to the study screening period

Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study
* History of migraine with brainstem aura or hemiplegic migraine headache
* Medical history or other condition that compromises the ability of the subject or legally acceptable representative to give appropriate informed consent and/or assent
* Malignancy except non-melanoma skin cancers or cervical cancer in situ within the last 5 years.
* Presence of any clinical condition that in opinion of the investigator might increased the risk of subjects participating in the study.
Cone Beam Computed Tomography (CT) (CBCT) With and Without a Customized Vacuum Immobilization Device (CVID)

This study is designed to investigate whether or not the use of a customized vacuum immobilization device (CVID) to immobilize rectal cancer patients undergoing preoperative pelvic radiation therapy improves the positional stability of patients during each radiation treatment. This question is more relevant now in the era of image-guided radiation therapy (IGRT). Using state of the art IGRT technologies such as cone beam CT (CBCT) scanning, assessments of the accuracy of treatment delivery can be made during a course of radiation therapy allowing for patient set-up corrective strategies to be implemented. The use of CBCT scanning may minimize any potential benefit of of a CVID if the patient's pretreatment position can be corrected prior to treatment and our current immobilization strategy results in a stable patient position. While it is seemingly intuitive to assume that the use of CVID results in better patient stability, there is actually little data to support this.

Rectal cancer accounts for 5% of all cancers diagnosed in Canada for both men and women between 1995 and 2004 (Public Health agency of Canada _ Health 2004). Preoperative radiotherapy (RT), with or without chemotherapy, is an accepted treatment for patients with locally advanced rectal carcinoma followed by surgical resection (Bosset and Horiot 2001; Sauer, Fietkau et al. 2003; Birgisson, Talback et al. 2005). The current standard treatment at Princess Margaret Hospital (PMH) is preoperative pelvic radiation therapy to a total dose of 50 Gy/25 fractions/5 weeks. The total radiation dose is reduced to 45 Gy/25 fractions/5 weeks when there is a concern about the volume of small bowel within the treatment volume. Radiation therapy is delivered with 5-fluorouracil (5-FU), 225mg/m2/24h, by protracted venous infusion (PVI) or oral capecitabine, 825 mg/m2 BID for 5 weeks, starting the first day and completing the day of last day of radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Any rectal cancer patient who is to receive a 5 week course of preoperative pelvic radiation therapy with or without concurrent chemotherapy
* Prone treatment position
* Age 18 years or older
* Informed consent

Exclusion Criteria:

* Inability to provide informed consent
* Inability to tolerate treatment in the prone position
* Pregnancy
* Patients with unilateral or bilateral metallic total hip replacements
Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment

Mechanical alignment (MA) in total knee arthroplasty (TKA) is the most commonly used with well-documented long-term results, however 20% of patients express dissatisfaction following primary TKA. Alternative alignment philosophies have been proposed, aiming to improve patient clinical outcomes and satisfaction. However, evaluation is focused mainly on knee alignment, the pathological findings and other adaptational changes in the ankles and hips are usually neglected.

Thia study aim to comparative effect between mechanical and functional alignment in patient undergone bilateral robotic TKA on ankle alignment and functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-80 years
* Symptomatic bilateral knee Osteoarthritis requiring primary TKA
* Willing to undergo bilateral simultaneous TKA
* Able to give informed consent

Exclusion Criteria:

* ligament deficiency requiring constrained prosthesis
* bone loss with augmentation need
* history of fracture around knee or previous osteotomy
* history of ankle fracture
* patient with neuromuscular disorder or movement disorder
* patient is unable to attend the study follow-up program
Influence of Polymorphisms in the ATP6V1 Gene of the V-ATPase on the Development of Incomplete Distal Renal Tubular Acidosis

Purpose

1. To compare the performance of the two currently employed urinary acidifications tests in stone formers, the furosemide/fludrocortisone and ammonium chloride loading test.
2. To study the impact of polymorphisms in the genes ATP6V1B1, ATP6V0A4 and SLC4A1 on urinary acidification in stone formers.


Eligibility Criteria:
Inclusion Criteria:

* One or more episodes of nephrolithiasis

Exclusion Criteria:

* Absence of informed consent
* All conditions affecting renal acidification
* Pregnancy
* Nursing
Effects of mHealth Message on Metabolic Syndrome and Bone Loss of HIV Infected Persons in Taiwan

With improved AIDS treatment leading to extended survival, HIV-infected individuals face a higher metabolic syndrome incidence. This study aims to determine the prevalence of Non-AIDS related Comorbidities (NARC) in HIV-infected individuals. Using purposive and snowball sampling, the cross-sectional survey targets 400 HIV-infected individuals aged 30 and above. Data collection includes demographics, physical activity, nutrition, depression, and physiological measurements. Analyzing the data through statistical tests and structural equation modeling, the study aims to provide precise care recommendations for preventive medicine and healthy aging in this population.

With the success of treatment, the survival period of Acquired immunodeficiency syndrome (AIDS) patients is prolonged. Compared with non-HIV-infected persons of the same age, HIV-infected persons have a relatively higher incidence of metabolic syndrome (MS). The main purpose of this study is to estimate the prevalence of common Non-AIDS related Comorbidities (NARC) among HIV-infected persons This study is a cross-sectional survey, purposive and snowball sampling will be applied. The recruitment information is released through channels such as AIDS case managers, AIDS non-government organizations, and social networks of HIV-infected people all around Taiwan. The expected sample size is 400 HIV-infected persons over the age of 30, after signing a written consent form, a test will be conducted, including the collection of demographic data, questionnaire data collection with physical activity scale, mini-nutrition assessment scale, and depression self-test scale, and measurement of physiological parameters using instruments including a gripper, body composition meter, sphygmomanometer, blood glucose, and lipid monitor, tape measure. The Chi-square test and independent sample T-test are used to compare the differences in the categorical and continuous data of each variable, and the structural equation model is used to conduct path analysis of the research framework. The research results can be used as precise care recommendations for the development of preventive medicine and healthy aging for HIV-infected persons.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected persons over the age of 30

Exclusion Criteria:

-
A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects

This is a single center, non-randomized, open label Phase 1 study to determine the PK and absolute bioavailability of BIIB122 (DNL151) in 2 conditions: following a single, oral dose of BIIB122 (DNL151) and following consecutive days of oral dosing, approximating steady state.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Women of non-childbearing potential and men either with a vasectomy, using contraception, or having sex with a woman of non-childbearing potential
* Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2
* Considered to be in good health
* Nonsmoker

Key Exclusion Criteria:

* History or presence of any condition or prior surgery that, in the opinion of the investigator, poses a significant risk to subject safety and/or achievement of study objectives
Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

The major purpose of this exploratory developmental study will be to develop a patient-centered and feasible protocol for communicating genetic data as it relates to drug efficacy for smoking cessation inpatients receiving medication that is matched to individual genotypes associated with increased efficacy for bupropion or nicotine replacement therapy.

Therefore, our specific aims are to:

Aim 1: Conduct formative research to develop and refine a clinical protocol for a multi-component smoking cessation intervention, grounded in the extended parallel process model, consisting of pharmacogenetic treatment (smoking cessation drug matched to each individual smoker's genotype) and genetic feedback (delivery of patient-centered, personalized genotype information and its predictive value for smoking cessation treatment efficacy): We will adapt, pilot-test, and refine a theoretically-grounded PGx smoking cessation intervention using formative interviews of 20 African-American and European-ancestry smokers.

Aim 2: Conduct a mixed-methods feasibility trial randomizing treatment-seeking smokers to pharmacogenetic (PGx) treatment combined with genetic feedback (GF) vs. PGx treatment without GF for smoking cessation to examine the feasibility of the newly developed protocol in a primary care setting and characterize its psychological and behavioral impact: Smokers (N = 100) will be randomized to GF vs. no GF and all will receive motivational interviewing (standard care/SC) and PGx treatment. We will assess the impact of GF on time to relapse, medication adherence, and a comprehensive assessment battery of process and cognitive, psychological, and behavioral outcomes. Finally, we will synthesize quantitative and qualitative data to revise protocols, generate hypothesizes, and estimate effect sizes for a follow-up R01 submission.

Eligibility Criteria:
Inclusion and exclusion criteria are the same for participants in the formative interviews (Study A) and the feasibility RCT (Study B) except that Study A will include African American and European American smokers and Study B will include European American smokers.

Inclusion criteria:

* Adults (aged 18 or older)
* Currently smoke at least 10 cigarettes per day
* Motivated to quit smoking (\>=5 on a 10-point Likert scale)
* Have a telephone
* Read and speak English.

Exclusion criteria:

* Any medical contraindications for transdermal nicotine replacement therapy (NRT) or sustained-release bupropion hydrochloride (bupropion) use based on the package labels (e.g., for bupropion, risk of seizure)
* DSM-IV Axis I diagnosis (other than nicotine dependence)
* Subjects who meet criteria for current major depression, or who demonstrate evidence of suicidal ideation at screening will be referred to treatment for depression and will be excluded from the study
* Must agree not to seek other treatment for smoking cessation during the study.