cyrilzakka/clinical-trials huggingface dataset:
Automated Fastener Device Versus Manually Tied Knot in MiAVR

The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT).

Four hundred and forty patients were operated for AVR by RAMT. Of these patients, 221 underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158.

The aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in the AT group compared with the MT group. Clinical outcomes were similar in the two groups, whether in the analysis of non-matched or matched groups. There was no difference in 30 day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in patients undergoing AVR by right anterior minithoracotomy.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* Elective patient
* Isolated aortic valve replacement with stented prosthesis
* Minimally-invasive approach (right anterior minithoracotomy)

Exclusion Criteria:

* Associated procedure
* Aortic valve replacement with sutureless or rapid valve deployment prosthesis
* Active endocarditis
* Prior cardiac surgery
Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up

Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data

Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee

Eligibility Criteria:
Inclusion Criteria:

1. Only subjects that were enrolled and met the inclusion criteria for the Cingal 16-02 trial and signed the informed consent are eligible for Cingal 17-02 trial.
2. Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.

Exclusion Criteria:

Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.
Transdiagnostic Internet Intervention to Improve Mental Health Among University Students: Pilot Study

This study comprises the pilot phase of a randomized controlled trial (NCT05085756) that will investigate the feasibility of a transdiagnostic CBT-based treatment for symptoms of depression and anxiety offered to Swedish university students. It will offer treatment to participants who have previously responded to a universal online mental health screen conducted in university setting (WHO-WMH-ICS survey).

The pilot study initially has a prospective single-group design where 30 college students with elevated depressive and/or anxiety symptoms are enrolled in 8 weeks of therapist-guided CBT treatment via the Internet. All participants included will receive treatment. Mid-treatment, participants that are judged to be at risk of treatment failure will be randomized (1:1 ratio) to either continued treatment with no change, or to receive added therapist-support intended to enhance outcome.

Pilot study outcomes include various aspects of feasibility: participant uptake, self-reported credibility and expectancy, adherence to treatment protocol and assessments, treatment satisfaction, potential adverse events, causes for premature termination of treatment, and procedures for providing additional therapist support to a subsample of participants after mid-treatment. Within-group effects for primary depression and anxiety measures will be quantified. A range of secondary measures are piloted for the subsequent randomized controlled trial. The assessment points for this study: Baseline; 8 points during treatment; post-treatment; 6-month follow-up; 12-month follow-up; 24 month follow up.

Note. This study is retrospectively registered; this registration was completed prior to any outcome data-analyses.


Eligibility Criteria:
Inclusion Criteria:

* College/university student at institution of higher education in Sweden
* Score 5-19 on the PHQ-9, and/or
* Score ≥5 on the GAD-7
* Completed baseline assessment

Exclusion Criteria:

* Pharmacotherapy for mental health issue during the past 3 weeks)
* Concurrent psychological treatment during the past 3 weeks
* Mild levels of mental ill-health (under cut-off for primary outcome measures)
* Severe levels of mental ill-health
* Suicidal ideation or plans
Magnesium Food Frequency Questionnaire

The study aims to develop a quick tool to assess magnesium intakes.

The study aims to develop a quick tool to assess magnesium intakes. Participants will be asked to record a complete dietary intake for 14 consecutive days, the magnesium food frequency questionnaire along with a calcium food frequency questionnaire, and a brief participant data form. Data from the 14 day consecutive food diary will be correlated with the food frequency questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* 20-75 years of age
* Fluent in spoken and written English

Exclusion Criteria:

* Unable to report continuous food diary for 14 days
* Medical conditions/medications/supplements affecting metabolism and/or magnesium or calcium status
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment

The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.

The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 34 and 56.
* Women presenting for their baseline screening mammography examination

Exclusion Criteria:

* Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE).
* Women who may be or are pregnant by self report
* Women older than 55 years of age or younger than 35.
* Women with known fatty breast tissue
* Males and children
* Women who are unable to understand or execute written informed consent
Physical Therapy in Addition to Standard Care Following C-Section

The purpose of this study is to determine whether a physical therapy program which includes scar management, core retraining, and lumbar and pelvic joint mobilization will significantly impact the postpartum recovery following Cesarean section during the immediate postpartum period and during the first 1.5 years following childbirth.

All patients who enroll in the study will receive standard treatment following a C-section delivery. Subjects will be randomized into one of two groups; one group will receive physical therapy in addition to standard post C-section treatment, and the other group will receive standard post C-section treatment with no additional physical therapy. Both groups will complete questionnaires regarding their pain and recovery from C-section delivery to determine if there is a difference in recovery between the group receiving physical therapy and the group not receiving physical therapy.

Cesarean section (C-section) represents the most commonly performed inpatient surgical procedure, with recent prevalence estimates of 1.3 million annually (approximately 22% of first births) in the United States. Currently, postoperative recovery support is typically characterized by verbal and written instructions regarding lifting and pelvic rest as well as slow return to activity and exercise.

There are multiple known complications during and after the postpartum period following Cesarean section deliveries. Some of the most common are back pain (up to 53% prevalence reported), bowel and bladder issues (20-30% prevalence reported), and scar tissue/adhesions. Multiple studies have indicated a higher incidence of low back and pelvic girdle pain in patients following Cesarean section compared to an unassisted vaginal delivery (estimates range from 2-5 times increase).

The purpose of this study is to determine whether a physical therapy program which includes scar management, core retraining, and lumbar and pelvic joint mobilization will significantly impact the postpartum recovery following Cesarean section during the immediate postpartum period and during the first 1.5 years following childbirth.

Eligibility Criteria:
Inclusion Criteria:

* Caesarean section delivery, English speaking

Exclusion Criteria:

* Heart problems, postpartum eclampsia, any medical issue which contraindicates exercise, active untreated infection, chronic narcotic use
Identification of Genes Predisposing to Atherosclerosis

To find genes important in the susceptibility to coronary heart disease.

BACKGROUND:

Coronary heart disease (CHD) is a complex disorder constituting a major health problem in Western societies. The study assesses the unknown genetic background of CHD by investigating the most common familial dyslipidemia predisposing to CHD, familial combined hyperlipidemia (FCHL). The population prevalence of FCHL is estimated to be 1-2 percent and the disorder affects 10-20 percent of families with premature CHD. In FCHL, serum cholesterol, triglycerides, or both are elevated. Both environmental and genetic factors are suggested to affect the complex FCHL phenotype. Since the molecular basis of FCHL is unknown, a significant number of genetically predisposed individuals remain unidentified and exposed to premature CHD. The study uses samples from the genetically isolated population of Finland.

DESIGN NARRATIVE:

The investigators will use the unique study samples from the genetically isolated population of Finland and apply molecular genetic tools to first restrict the genetic locus they have identified and then to characterize the causative gene underlying the FCHL disorder on chromosome 1q21. Specifically, they first aim to further restrict the region by dissecting the different component traits. They will genotype an extended study sample consisting of all available family members of 61 FCHL families with dense sets of microsatellite markers and single nucleotide polymorphisms to fully utilize the refined quantitative phenotype information in fine mapping. Second, they aim to build a transcript map over the critical region on 1q21-q23 and to identify the causative FCHL gene among the regional candidate genes. This region on 1q21-q23 is orthologous to a region on mouse chromosome 3, where a locus (Hyplip 1) for combined hyperlipidemia has been identified. They have analyzed the human homolog of the Hyplip 1 gene but disappointingly, the human Hyplip 1 gene was found 10 Mb from the peak linkage markers and no evidence emerged for Hyplip 1 as a causative gene for FCHL. Their targets to identify the FCHL gene are currently the genes showing strongest association near the linkage peak. The FCHL gene will then be functionally characterized to prove the biological dysfunction. Characterizing one gene for FCHL would improve their understanding of molecular mechanisms of cardiovascular disease, and potentially lead to more accurate diagnosis, treatment and prevention.

Eligibility Criteria:
No eligibility criteria
Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

In this single-center, longitudinal observational study, we will comprehensively examine clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand how different heart failure types may develop and progress over time. We will evaluate distinct sub-groups of heart failure (also known as heart failure phenotypes) and cardiomyopathies including amyloidosis with an ultimate goal of bringing the right medications and therapy to the right patients to optimize benefit and minimized side effects, an effort to improve precision medicine in heart failure.

Patients 18-years and older with and without heart failure (across all left ventricular ejection fraction) and cardiomyopathies including amyloidosis will be enrolled in this single center, longitudinal observational Registry.

Baseline and one-year follow up blood samples including DNA as well as clinical characteristics, events leading up to heart failure diagnosis, etiology of heart failure, the presence and duration of other medical problems, laboratory, echocardiographic data and images, and therapy information will be obtained.

Clinical outcomes of interest include major adverse cardiovascular events (a combination of all-cause death and heart failure hospitalizations), individual endpoints of all-cause death, cardiovascular death, all-cause hospitalization, cardiovascular hospitalization, heart failure hospitalization, right-sided heart failure, and kidney injury.

Results from the Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) trial will comprehensively examine longitudinal clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand pathophysiology of heart failure and phenotypes in heart failure with an ultimate goal of improving precision medicine in heart failure.

Eligibility Criteria:
Inclusion criteria for patients with HF:

* 18 years and older
* History of clinical symptoms consistent with HF and at least one of the following supporting evidence of HF:

  * NT-proBNP \> 125 pg/mL
  * BNP \> 35 pg/mL
  * Capillary wedge pressure ≥ 15 mmHg on right heart catheterization or CI \<2.8 L/min/m2
  * LVEDP ≥ 15 mmHg
  * Radiographic evidence of pulmonary edema
  * Improvement in symptoms with diuretic initiation of increase
  * CPET evidence of cardiac etiology of symptoms

HFpEF: LVEF ≥ 50% HFrEF: LVEF \<50%

Exclusion criteria (for all patients, including both those with HFpEF and HFrEF):

- End stage renal disease on dialysis
Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma

This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have a life expectancy of at least 12 weeks
* Patients with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
* Patients who have an ECOG PS of 0, or 1
* Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria

Exclusion Criteria:

* Primary ocular or mucosal melanoma
* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\] \& T1 \[Tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 3 years prior to study entry
* History of cardiac disease
* Known history of human immunodeficiency virus (HIV) infection
Short-term Effects of Active Post-training Slider Neural Mobilization

Jiu Jitsu is a martial art that consists of various techniques that aim to place the opponent in submission. It is essentially a ground fight that requires large movement variety, among which flexibility is a substantial physical aptitude, required to perform specific positions of attack or defence, especially flexibility of the thoracolumbar spine and hamstrings. The literature reports that abnormal posterior lower limb neurodynamics may influence hamstring extensibility and muscle length, and lead to changes in perception of stretch and pain. The objective of the present study is to evaluate the effect of NM, using sliding techniques of the sciatic nerve, immediately after Jiu Jitsu training, on HM flexibility of Jiu Jitsu practitioners. The hypothesis is that NM sliders applied immediately after training would be as effective as an isolated intervention, as demonstrated in soccer players.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults of regular practitioners of Jiu Jitsu;
* Aged between 18 and 59 years;
* Both sexes.

Exclusion Criteria:

* Straight Leg Raise (SLR) test \> 75º;
* Hamstrings injury in the previous three months;
* History of any neurological disorder (such as sensory deficits and irradiated pain) or orthopaedics (such as soft tissue or bone injuries) that affected a lower extremity;
* Positive neural tension test (uni or bilateral);
* Fracture in a lower extremity with surgical treatment history in the previous12 months and with conservative treatment in the previous 6 months;
* Herniated lumbar disc diagnosis.
Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort

The anatomic ACL reconstruction aims at functional restoration of the ACL to its native dimensions, collagen orientation and insertion sites. Even if the anatomic foot prints are correctly chosen for the tibial and femoral tunnels does the position of interference screw in the tibial tunnel alter the ACL orientation? The study hypothesized that the position of interference screw in the tibial tunnel would alter the graft orientation in anatomic ACL reconstruction. The purpose of this study was to compare graft orientation and inclination angle with posterolateral and anteromedial interference screw position in tibial tunnel in aperture fixation techniques.


Eligibility Criteria:
Inclusion Criteria:

* magnetic resonance imaging (MRI) of patients with ACL reconstruction was compared to MRI in which ACL was intact.
* patients with isolated ACL injury who underwent ACL reconstruction surgery using quadripled hamstrings graft and operated by a single senior surgeon
* Both pre-operative and post-operative MRI should be available for assessment
* No history of trauma in the post-operative or rehabilitation period

Exclusion Criteria:

* Concomitant bony or other ligament injury to the same knee
* history of previous surgery to the same knee
* Revision ACL reconstruction surgery
* surgery done at other center or by other doctors at our institute
* Pre-operative and/or post-operative MRI not available
Prenatal Education Video Study

A randomized, controlled trial will be conducted during which pregnant women will be randomized to receive the intervention - viewing a prenatal education video about how to breastfeed an infant - or the sham intervention - viewing a prenatal education video about maternal nutrition and physical activity during pregnancy. Participants will be interviewed via telephone at one, three, and six months post-partum to determine how they feed their infants at each of these time frames.

Research assistants will screen potential candidates at the University of Virginia Health System and Virginia Commonwealth University Primary Care Center and approach potential participants during a standard clinic visit. The charts of the day's patients will be screened prior to approaching women to invite them to enroll in the study.

Following administration of the enrollment questionnaire, the patient will be randomized to the intervention or sham intervention arm of the study. The research assistant will open the study packet with the corresponding study identification number containing the intervention assignment. The research assistant will then load the assigned video into the DVD player and ask the patient to view the video. The participants will be blinded to which video is the true intervention.

Following delivery, research assistants will abstract the medical records of the woman and infant. Data regarding complications for both the mother and baby will be recorded and the length of stay for mother and baby as well as information about the way in which the baby was fed during the hospital stay.

Participants will be administered a one-month follow-up questionnaire by telephone. Follow-up questionnaires will be administered by research staff that did not enroll the participant such that the research assistant administering the telephone questionnaire will be blinded to the patient's assigned intervention group. The three-month questionnaire will be administered by telephone in the same fashion as the one-month. The six-month questionnaire will be administered by telephone. This questionnaire will conclude the study. A current address will be obtained at this time, and a children's book will be mailed to the participant thanking her for completing the study. For subjects lost to follow-up, we will contact the baby's pediatrician to retrieve the information on the questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Receiving prenatal care at the Primary Care Center, University Physicians for Women at Northridge, the University of Virginia Teen Health Center
* WIC-eligible 185% Federal poverty Enrolled in Medicaid, TANF, food stamps
* Pregnant, 24 - 41 weeks gestation
* Singleton gestation
* Access to a telephone
* Plan to deliver at UVa
* Primary language is English or Spanish

Exclusion Criteria:

* Multiple gestation
* Known contraindication to breastfeeding Illicit drug use HIV + Recipient of chemotherapy
* Primary language other than English or Spanish
Pharmacokinetics of Misoprostol With Titrated Oral Administration

The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol.

The primary outcomes measures of the study are the area under the curve of serum concentration of misoprostol acid against time up to 240, 360 and 480 minutes.

Eligibility Criteria:
Inclusion Criteria:

* 20-40 Y/O healthy and non-pregnant woman

Exclusion Criteria:

* heart, liver or kidney disease, anaphylaxis to misoprostol