cyrilzakka/clinical-trials huggingface dataset:
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.

Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components.

Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years.

Eligibility Criteria:
Inclusion:

1. EuroSCORE of ≥ 15 %
2. Severe senile degenerative aortic valve stenosis
3. Symptomatic aortic valve stenosis
4. Informed consent
5. Compliance

Exclusion:

1. Logistic Euroscore \> 40 %
2. Evidence of an acute myocardial infarction
3. Congenital unicuspid or congenital bicuspid valve/ non-calcified
4. Mixed aortic valve disease
Efficacy of High Flow Therapy in COPD At Home

Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand during sleep. The central hypothesis of this proposal is that lowering ventilatory demand using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.


Eligibility Criteria:
Inclusion Criteria:

* 1. Consenting adults over the age of 18 with COPD

Exclusion Criteria:

* 1. Apnea Hypopnea Index\>15 events/hr 2. Use of Non-invasive positive pressure ventilation (CPAP + Bilevel) 3. Severe bilateral nasal obstruction (apparent mouth breathing at rest) 4. Documented clinical cardiovascular disease, as defined below:

  1. myocardial infarction in past 3 months
  2. revascularization procedure in past 3 months
  3. implanted cardiac pacemaker or ICD
  4. unstable arrhythmias
  5. congestive heart failure with ejection fraction \< 40%
  6. uncontrolled hypertension (BP \> 190/110) 5. History of end stage renal disease (on dialysis) 6. History of end stage liver disease, such as:

  <!-- -->

  1. Jaundice
  2. ascites
  3. history of recurrent gastrointestinal bleeding
  4. transjugular intrahepatic portosystemic shunt (TIPS) ; 7. Transportation industry worker (commercial truck or bus drivers, airline pilots) 8. Known pregnancy (by self report) 9. Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin. 10. Do you take medications for any of the following reasons:

  <!-- -->

  1. Pain control (besides NSAIDs)
  2. Sleep medication
  3. Benzodiazepines
  4. Methadone
A Study to Evaluate the Superiority, Efficacy and Tolerability of Combination Pantovigar With 2% Minoxidil vs 2% Minoxidil in Women With Female Pattern Hair Loss

Pantovigar - a high effective product designed primarily for the treatment of diffuse hair loss in women as well as for the treatment of damaged hair, in the combined therapy can be successfully applied in other types of alopecia.

The purpose of this study is to evaluate efficacy and tolerability of combination therapy Pantovigar plus 2% minoxidil vs 2% minoxidil. To collect tolerability data for combined treatment Pantovigar plus 2% Minoxidil course therapy.


Eligibility Criteria:
Inclusion Criteria:

* Female patient complaint of hair loss and/or hair density reduction for more than 3 months.
* More than 15 % of telogen frontoparietal hair as shown in the phototrichogram.

Exclusion Criteria:

* Symptomatic diffuse alopecia (screening for iron and thyroid function, thyroid stimulating hormon, triiodothyrine, ferritin , total iron-binding capacity)
* Active or history of systemic autoimmune disease, e.g. lupus erythematodes etc.
* Hyperandrogenic alopecia (polycystic ovary syndrome, adrenogenital syndrome, tumors with androgenic activity) (testosterone, prolactin hormone, androstenedione, dehydroepiandrosterone)
* Initiation or termination of hormone therapy within 6 months prior to entering study
* Hormone therapy with androgenic action, e.g. norethisterone etc.
* Pregnancy or lactation within 6 months prior to entering study
* Alopecia areata
* Scarring alopecia
* Treatment with hair promoting agent within 3 months prior to entering study
* Known hair loss after drug intake
* Concomitant use of the drugs causing a hair loss (e.g. aromatase inhibitors, thyreostatics, cytostatics, etc,)
A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

To assess the safety of S5G4T-1 when applied once daily for up to 40 weeks in participants with papulopustular rosacea who completed either Study SGT-54-01 (NCT03448939) or Study SGT-54-02 (NCT03564119).

This is a long-term safety study for participants who completed either study SGT-54-01 or SGT-54-02. Participants will be admitted into the study only after a written informed consent has been obtained and not missing more than 1 visit of Visits 3, 4 or 5 in these studies. Eligible participants for enrollment will apply the study product, S5G4T-1, daily for up to an additional 40 weeks for a total of up to 52 weeks for some participants.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for the extension study.
2. Participants must complete 12 weeks or within the Week 12 window time (± 4 days) of the double-blind treatment period of Study SGT-54-01 or Study SGT-54-02 and missed not more than 1 visit of Visits 3, 4 or 5 in Study SGT-54-01 or Study SGT-54-02.

Exclusion Criteria:

-
The Effects of Anaesthetic Agents on Postoperative Delirium

The purpose of this study is to prove the correlation between the post-operative delirium (POD) and anesthetic agents. The investigators hypothesized that intravenous anaesthetics would show the lower incidence of POD, compared with inhalation anaesthetics in off-pump CABG.

The medical records of the patients undergoing off-pump coronary artery bypass grafting (CABG) in Konkuk University Medical Centre from Jan 2010 to Aug 2014 were retrospectively reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing off-pump coronary artery bypass grafting

Exclusion Criteria:

* Other concurrent surgery
* Conversion from off-pump coronary artery bypass grafting to on-pump coronary artery bypass grafting
Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease

We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Using computers more than three hours per day
* Having dry eye symptoms based on results on the OSDI Scores of 15 or greater on the OSDI will be considered to have the disorder
* An abnormal confocal image of 5 or greater.

Exclusion Criteria:

* All corneal disorders except for tear disorders.
Single-Cell Sequence Technology Used to Reveal Heterogeneity of Secondary Hyperparathyroidism

This project intends to select cases that meet the research requirements, take secondary hyperparathyroidism, primary hyperparathyroidism and normal human parathyroid tissue, a total of three groups, 4 cases in each group, through the method of single-cell transcription and sequencing, construct a map of human parathyroid function types, reveal the gene structure and gene expression status of cells, and visualize the expression characteristics, intercellular heterogeneity, and heterogeneity of cell subsets of secondary hyperparathyroid cells in a hierarchical manner, draw a single-cell map, and compare the differences between groups. To explore the pathogenesis of secondary hyperparathyroidism.

Secondary hyperparathyroidism, parathyroid tissue of primary hyperparathyroidism and normal parathyroid tissue obtained by accident were collected, frozen and preserved, frozen tissue thawed, single-cell suspension was prepared and each cell was specifically labeled by the Mozhuo Genomics system, after oil breaking, polymerase chain reaction amplification, reverse transcription to obtain complementary DNA, and a library of complementary DNA that passed quality inspection was constructed to obtain high-quality data of parathyroid cells. Cell Ranger, R Seurat package, and t-SNE dimensionality reduction diagram were used to reduce the dimensionality, cluster, and visualize the data.

In order to construct a single-cell atlas of parathyroid glands, investigators performed cluster analysis of similar cells according to the gene expression profile, and then visualized the data by t-SNE. According to the results of cell clustering, the specific and highly expressed genes in each cell cluster were identified. Cell populations were identified according to the expression of landmark genes, and the differences in cell types and proportions between groups were compared.


Eligibility Criteria:
Inclusion Criteria:

* Study participants with a diagnosis of secondary hyperparathyroidism who underwent surgical treatment
* Study participants with a diagnosis of primary hyperparathyroidism who underwent surgical treatment
* Study participants who have obtained informed consent

Exclusion Criteria:

* Other non-secondary hyperparathyroidism conditions such as primary hyperparathyroidism were excluded at the time of inclusion of study participants with essential hyperparathyroidism.
* Other non-primary hyperparathyroid conditions such as secondary hyperparathyroidism were excluded at the time of inclusion of study participants with essential hyperparathyroidism.
* Refusal of informed consent.
Barrier Function and Production of Inflammatory Cytokines in the Rectal Mucosa in Patients With Septic Shock

Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of different inflammatory and infectious markers.

The investigators hypothesize, therefore, that there is a significant difference in the concentrations of inflammatory and infectious markers in the rectal mucosa between patients with septic shock and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Septic shock

Exclusion Criteria:

* Age \< 18 years
* No next of kin
* Pathology of the descending or sigmoid colon or rectum
* Pregnancy
* 1st degree relatives with inflammatory bowel disease
* Severe coagulopathy
The Prevalence of Oral HPV Infection and Oral Lesions in People Living With HIV

The study will evaluate 300 people living with HIV that attend the Vivent Clinic for HIV care. We will characterize our population and include age, race/ethnicity, sex at birth, tobacco use, alcohol use, other comorbidities, HPV vaccination status, other HPV disease, and lab values such as CD4 count and HIV viral load. We will compare results between participants who are HPV positive and negative. We will also evaluate the relationship between HPV oral infections and lesions and the variables above to better understand possible predictors of HPV infections and lesions.

Vivent Health is a non-profit medical home model dedicated to the primary care of People Living with HIV (PLWH) and also provides pre-exposure prophylaxis (PrEP), Hepatitis C, and sexually transmitted infection (STI) treatment. The organization has clinics in Wisconsin (multiple cities), Denver, St. Louis, Austin and Kansas City. All insurances except Kaiser are honored and non-insured people are able to be seen. The Denver medical clinic is a designated medical home that provides adult primary medical and specialty care to approximately 1000 + PLWH. In additional to medical care, this clinic has an onsite pharmacy, case management, HIV and Hepatitis C prevention department, syringe access program, legal department, housing specialists, food bank, a mental health program and dental services. Vivent Health in Denver cares for a diverse population with approximately 11% African-American, 13% Latino, and a recently increasing percentage of women around 13%. This clinic has a strong Electronic Health Record System (EHR- Epic) which provides ample opportunity to recruit a robust study population to investigate the following co-morbidities which might increase the risk of oral HPV infection and related lesions. Given the lack of recommended routine screening for oral HPV in the absence of established masses or lesions, there is a wealth of opportunities to investigate risk factors associated with the presence and prevalence of oral HPV which, in turn, can potentially be used to inform screening and treatment protocols. This proposal is designed to evaluate the prevalence of oral HPV infections and associated oral lesions and associated demographics in HIV treatment clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Documented HIV test on any FDA-approved HIV test
2. Ability and willingness of participant to provide informed consent
3. Capable of performing an oral swish and spit sample collection
4. Willingness to have an oral exam by Denver Vivent Health Dentist
5. Has had at least two visits at the Vivent Health Denver clinic
6. Study participant allows demographics and medical history/laboratory results in electronic medical records to be confidentially evaluated.

Exclusion Criteria:

1. Any medical or mental health diagnosis that the study team concludes would prohibits participation of the protocol
2. CD4 count \< 200 cells/ml
3. History of Oral/tongue cancer
An RCT Evaluation of a Diabetes Dashboard Team Model in Primary Care

To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard.

To compare a usual diabetes care condition (UDC) to a comprehensive diabetes care intervention condition (IC) involving a "diabetes dashboard" clinical decision support tool used by the diabetes team in primary care. The investigators used a parallel-groups randomized design. The diabetes team (i.e., diabetes nurses, diabetes dietitians, and providers) delivered a 5-visit, 6-month intervention to n=199 poorly-controlled (HbA1c \>7.5%) Latino T2D patients (mean age=55 years, 60% female) seen at 2 urban community health centers. This intervention was compared to an established, in-house diabetes team care program (n=200) for its impact on blood glucose control and key psychosocial outcomes (diabetes distress, depression, social distress).

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older,
* self-identified Hispanic ethnicity,
* diagnosis of T2D,
* HbA1c \>7.5%, and
* provider approval given for patient participation

Exclusion Criteria:

* inability to consent,
* pregnant or planning to become pregnant in the next year,
* taking glucocorticoid therapy, or
* having serious psychiatric or medical complications (e.g., late stage diabetes complications, seizures, dementia, psychiatric hospitalization) that would prevent participation in study activities.
Prospective Study of the Variation in the Angle of Anteflexion of the Uterus Before and After Micturition in Nulliparous Women With Uterine Anteversion.

A monocentric, prospective, comparative, and descriptive clinical study examining the uterine anteflexion angle before and after bladder emptying in nulliparous women with uterine anteversion. The study aims to assess how bladder fullness affects the anteflexion angle, which may impact the ease of intrauterine device (IUD) insertion. The primary objective is to determine the variation in the angle of anteflexion of the uterus before and after micturition in nulliparous women with uterine anteversion. Ultrasound measurements will be taken before and after bladder emptying. A secondary objective is to determine the prevalence of uterine anteversion in nulliparous women.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 and over;
* Nulliparous ;
* Feeling the need to urinate;
* Affiliated to a Social Security scheme.

Exclusion Criteria:

* Pregnant women;
* Desire of pregnancy with conception in progress;
* Primary amenorrhea ;
* Menopause ;
* Previous surgical termination of pregnancy;
* Previous medical abortion;
* Previous hysterectomy ;
* Previous conization;
* Absence of uterus;
* Irrepressible need to urinate;
* Inability or refusal to participate in the study.
To Examine Smoking Behavior of Prisoners - 1

The purpose of this study is to understand the smoking behavior of female incarcerated smokers and to determine how smokers differ from non-smokers on measures of substance abuse, personality, criminal history, and mental illness


Eligibility Criteria:
Inclusion Criteria:

* all smokers, non-smokers, and ex-smokers

Exclusion Criteria:

* inability to understand English and inability to be able to provide informed consent due to mental impairment
Effects of Grape Juice With Breakfast on Glycemia and Cognitive Function in Healthy Adults

Assess the impact of 100% grape juice with a meal on postprandial glycemic response and subsequent appetite, food intake and cognitive function.

Investigators earlier studies and published literature suggest that the phenolic content and strong flavor intensity of 100% Concord grape juice hold potential beneficial effects on blood sugar levels. Investigators aim to better understand the consumption of 100% grape juice with a meal modifies appetite and glycemia acutely and over the day using a 24 hour glucose monitor.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25.0-34.9 kg/m2
* Willingness to eat all test foods
* Low consumer of tea and coffee, willingness to refrain from both during the 48 hours prior to test days and on the test day
* Fasting blood glucose below 6.1mmol/l via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA)

Exclusion Criteria:

* Taking medications known to affect glycemia, lipid metabolism or appetite
* Body weight fluctuation of \>5kg in the past 3 months
* Taking vitamin or other supplements
* Smokers
* Acute or Chronic disease
Decisional Process in Male Fertility Preservation

The survey analyses how to improve the decision-making process for fertility preservation in the pediatric population based on

1. patient and parent feelings about fertility preservation counselling
2. influence of the emotional state of patients and parents on fertility preservation acceptance
3. support of medical staff and family The study revealed that attention to the fertility preservation pathways was important for the satisfaction of patient's and parent's expectations

Questionnaire survey via regular mail to an eligible population (boys and adolescents aged 0 to 18 years diagnosed with cancer at the Cliniques universitaires Saint Luc) between January 2005 and May 2013.

Three different questionnaires, for children (\<12 years and 12-18 years) and parents respectively, established based on information from focus groups and subsequently reviewed by the institutional ethics board before being sent.

Eligibility Criteria:
Inclusion Criteria:

* prepubertal boys and adolescents diagnosed with cancer in a university hospital setting between january 2005 and may 2013

Exclusion Criteria:

* none
Fluoroscopy Activation Interval in SWL

Shock wave lithotripsy (SWL) is a noninvasive method widely used as the first step in treating stone disease. This study aimed to reduce radiation exposure to patients and practitioners during SWL sessions by extending the intervals of fluoroscopy controls. The main questions it aims to answer are:

* Will radiation exposure be reduced?
* Will the stone-free status be affected? The researchers will compare the fluoroscopic control intervals of 250 shocks and 500 shocks.

Participants will:

* Take to a maximum of 3 sessions.
* Check once a week
* Group 1 was fluoroscopically monitored every 250 shocks, and Group 2 was fluoroscopically monitored every 500 shocks

SWL works on the principle of focusing on the calculus using ultrasonography or fluoroscopy, transmitting high-energy shock waves from the lithotripter to the calculus and fragmenting it. Fluoroscopic focusing is a commonly used imaging technique that raises concerns about ionizing radiation exposure for patients, technologists, and physicians. Intermittent fluoroscopic monitoring during SWL is widely employed to adjust for patient movement, respiratory movement, and stone displacement within the kidney. However, there is no consensus on the optimal frequency of fluoroscopic monitoring in the literature. This study aims to seek to determine whether increasing the duration between fluoroscopic checks affects the success rate of SWL in achieving stone-free status while reducing radiation exposure to patients.

Eligibility Criteria:
Inclusion Criteria:

* radiopaque renal pelvic stones smaller than 2 centimeters.

Exclusion Criteria:

* anatomical anomalies, coagulation disorders, non-opaque calculi, active urinary infection and distal obstruction
Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls

The aim of this study was to determine whether the prevalence of Human PapillomaVirus (HPV) was increased in patients with Barrett esophagus compared with controls in a prospective study. Secondary objective was to identify, if present, the type of Human PapillomaVirus (HPV) associated in Barrett esophagus.

Barrett's esophagus (BE) is defined by the replacement of normal stratified squamous epithelium in the distal third of esophagus by specialized intestinal metaplasia. It is related to gastro-esophageal reflux disease. Diagnosis is suspected during endoscopy and confirmed on biopsy. The classification of CM from Prague is validated to describe BE during endoscopy. The main complication of the BE is adenocarcinoma, according to metaplasia-dysplasia-cancer sequence. The incidence of esophageal adenocarcinoma is variable, ranging from 0.4 to 3 %. BE is found in 100% esophageal adenocarcinoma and in 42% junction adenocarcinoma. Among the unknown risk factors involved in the onset of dysplasia, viruses can't be excluded.

It is well established that Human Papillomavirus (HPV) is strongly associated with squamous cell dysplasia of female uterine cervix and its progression to cervical carcinoma. HPV is also implicated in others invasive carcinomas including uterine cervix, vulvar, vaginal, anal, penile, head and neck squamous cell carcinoma. Several studies showed that HPV could be associated in head and neck cancers and that tumor HPV status in patients with oropharyngeal squamous cell carcinomas was an independent prognostic factor for survival. The association between HPV and esophageal squamous cell carcinomas is still controversed with epidemiological studies reporting prevalence of mucosal HPV DNA ranging from 0 to 70%. Studies that have investigated HPV and adenocarcinoma of esophagus or Barrett's esophagus (BE) are scarce and data are not clear. A recent prospective study showed that HPV was strongly associated with Barrett'dysplasia and esophageal adenocarcinoma.

The aim of this study was to determine whether the prevalence of HPV was increased in patients with BE compared with controls in a prospective study. Secondary objective was to identify, if present, the type of HPV associated in BE.

Eligibility Criteria:
Inclusion Criteria:

* written consent obtained before gastroscopy,
* patients aged more than 18 years,
* normal coagulation parameters Inclusion criteria for group A "control" and B "BE" were as follows, respectively: patients undergoing gastroscopy for non esophageal reason and presented no clinical, endoscopic or histopathological evidence of GERD or complication and patients undergoing gastroscopy for BE surveillance or suspected BE during gastroscopy.

Exclusion Criteria:

* written consent not obtained before gastroscopy,
* inability to give informed consent,
* pregnant or nursing women,
* major person protected by french law,
* person who is not affiliated to a social security regime,
* patient who is in a exclusion period for another clinical study,
* curative anticoagulation treatment,
* hemostatic disturbances.