cyrilzakka/clinical-trials huggingface dataset:
Presentations of Hypertrophic Cardiomyopathy on Myocardial Perfusion Imaging

Chest pain and myocardial ischemia are prevailing features in patients with hypertrophic cardiomyopathy (HCM). Recently introduced single-photon emission computed tomography (SPECT) cameras with solid-state cadmium-zinc-telluride (CZT) detectors have been shown to decrease imaging time and improved the imaging quality of gated myocardial perfusion imaging (MPI). The investigators also correlate the MPI parameters with echocardiographic parameters. This study is to examine the spatial distribution of stress perfusion abnormalities and tissue injury in patients with HCM using a CZT SPECT camera.

The investigators will retrospectively evaluate myocardial perfusion patterns and cardiac function with Thallium (Tl)-201 gated dipyridamole MPI in patients with clinical diagnosis of HCM and patent coronary angiography between January 2013 and October 2016. The inclusion criteria included a spade-like configuration on left ventriculogram, or echocardiographic findings suggestive of HCM. The participants will be then divided into the following three groups: apical, concentric and septal forms. Regional perfusion would be analyzed using a 17-segment model from 0-4 degree (0=normal, to 4=absent perfusion); and summed stress score (SSS), summed rest score (SRS) and summed difference score (SDS) were calculated. Gated SPECT would be processed by quantitative gated SPECT (QGS) software (Cedars-Sinai Medical Center, Los Angeles, CA, USA) and ejection fraction phase analysis. Diastolic parameters would be also acquired by Doppler echocardiography, and correlated with MPI parameters.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of HCM and patent coronary angiography between January 2013 and October 2016.

Exclusion Criteria:

* patient with prior myocardial ischemia, conduction abnormality, valvular disease or other cardiomyopathy
Corneal Cross-linking and Refractive Surface Ablation in Patients With Asymmetric Corneas

The purpose of this study is to evaluate safety and efficacy of corneal cross-linking and photorefractive keratectomy for refractive correction in patients with bilateral asymmetric topography.

Corneal cross-linking (CXL) by the photosensitizer, riboflavin (vitamin B2), and ultraviolet A (UVA) light increases corneal rigidity and has been described as an effective method for stabilizing the cornea in patients with progressive keratoconus. The photochemical reaction in this procedure causes the collagen to form additional covalent connections between its fibers, which stabilizes the stromal collagen fibers, improving the collagen's structure and the cornea rigidity. It is a relatively safe procedure with low rates of complications Photorefractive keratectomy (PRK) it is a traditional technique for refractive surgery. In cases of irregular corneas or re-operation normally the favorite ablation profile chosen is the guided surgery, topography guided or wavefront guided, showing better results. This technique is also relatively safe procedure with low rates of complications. One of the most unwanted complications of this surgery and also rare is corneal ectasia.

Combining PRK and CXL is already done in patients with keratoconus and suspected keratoconus.

This combined procedure uses the principle that CXL stiffen the cornea making it possible to reduce corneal thickness with PRK without weakening corneal strength. Literature show better results, in keratoconus, with simultaneous procedures. Guedj et al performed PRK in keratoconus suspects and within 5 years he did not found any corneal ectasia.

Eligibility Criteria:
Inclusion Criteria:

* bilateral asymmetric topography with inferior steepening
* corneal thickness of 440 micra at the thinnest point
* inferior-to-superior index (I-S) between 1.0D and 1.4D
* maximum keratometric steepness \< 47.00D
* stable refraction more than 1 year.

Exclusion Criteria:

* forme fruste keratoconus and keratoconus
* previous eye surgery
* previous eye trauma
* confirmed pregnancy
Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis

This study will evaluate the prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis. No treatment is administered in this study.

We investigated the prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis by information sheets and direct recruitment of patients of potential study participants diagnosed with rheumatoid arthritis. Subjective assessment for dry eye disease was performed using Ocular Surface Disease Index (OSDI) questionnaire. The following objective tests of dry eye disease were employed: tear osmolarity (TO), tear break-up time (TBUT), corneal fluorescein staining score and conjunctival lissamine green staining scores using the National Eye Institute-recommended grading system, and Schirmer without anesthetic. The Dry Eye Severity Grading Scheme highlighted by the Dry Eye WorkShop was adapted to quantify dry eye disease severity level.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis
* 18 years old or older
* Speaks and understands English and/or Spanish

Exclusion Criteria:

* Unable to provide consent
Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa

The remarkable therapeutic anticaries effect of fluoride is well recognized, but in recent years, toxic effects on the oral mucosa have been discussed. So far, many in vivo studies examining the genotoxic and cytotoxic effect of fluoride in human cells (lymphocytes, bone marrow, germ cells) have been carried out, but there are no studies examining the effect of fluoride on cells of the buccal mucosa. In vitro studies have shown that sodium fluoride can be toxic to fibroblasts of the oral mucosa by inhibiting protein synthesis, suppressing mitochondrial function and consequently reducing the amount of intracellular ATP.

The study would include 80 participants, aged between 18 and 75. All subjects would use the same toothpaste without fluoride for the first month, and then they would be randomly divided into four groups, where three groups would receive a toothpaste with fluoride with one of the active substances (sodium fluoride, sodium monofluorophosphate, amine fluoride) for the next 60 days, while the control group would continue to use the toothpaste without fluorine. Swabs of the buccal mucosa would be taken at 0 (before the start of use) and 30, 45 and 60 days after the start of using the tested toothpastes.

The aim of this research would be to examine the cytotoxic and genotoxic effect of toothpastes containing fluoride with different active substances and to compare their effect. As a measure of genotoxicity and cytotoxicity in cells, the micronucleus test will be used.


Eligibility Criteria:
Inclusion Criteria:

* age of 18 and older
* good oral and general health
* non smokers

Exclusion Criteria:

* subjects suffering from infectious diseases or chronic inflammatory diseases
* use of antibiotics, corticosteroids and anti-inflammatory drugs in the last six months
* damage to the mucous membrane of the oral cavity
* subjects who have fixed-prosthetic works and orthodontic braces
Prospective Analysis of the Effect of Widowhood on CVD

To determine the effect of widowhood on cardiovascular disease.

BACKGROUND:

Widowed persons have been found to have higher mortality rates than married persons in both cross-sectional and longitudinal studies. In many of these studies, excess mortality has been attributed to deaths from cardiovascular disease. Despite these consistent findings, the lack of detailed data collected prior to widowhood has hampered our ability to understand the mechanisms to explain this effect. Furthermore, an understanding of the mechanisms underlying this effect might help elucidate the apparent gender differences in mortality following widowhood.

DESIGN NARRATIVE:

The study took advantage of the data collected as part of the Framingham Study to investigate the effect of widowhood on cardiovascular disease. The Framingham dataset has extensive clinical data related to cardiovascular disease, as well as to health behaviors. These longitudinal data provided the opportunity to prospectively characterize the health of widows prior to and following the loss of a spouse in much greater detail than previously possible. The analyses used a prospective design in which those men and women who had a spouse die during the course of the study (N=626) were compared to men and women who remained married (N=2044). These analyses also provided the opportunity to examine reasons for the beneficial effect found of remarriage. The study addressed the following questions: 1. Can the increased risk of mortality from cardiovascular disease often found following widowhood be explained by pre-widowhood health status? 2. Can increased mortality following widowhood be explained by changes in health behaviors related to cardiovascular disease risk. 3. What pre-widowhood risk factors place the widowed at greater risk for cardiovascular disease morbidity and/or mortality following the death of a spouse? 4. Can pre-widowhood risk factors or post-widowhood behavior change account for gender differences in mortality following widowhood?

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Creating Smokefree Living Together for Chinese Household Pairs

This is a trial of household pairs of a Chinese smoker and nonsmoker randomized either to a smoke-free educational intervention or self-help control group. The smokefree educational intervention includes group education about smokefree environments and smoking cessation, follow-up phone calls, and tobacco exposure lab reports. The control group is referred to usual care with local in-language smoking cessation classes or quitline, and is otherwise assessment only. The investigators hypothesize that pairs in the intervention group will have higher rates of tobacco cessation and elimination of smoke exposure, compared to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Self-identified Chinese Americans who primarily speak Chinese
* Self-identified current smoker men and nonsmoker women
* Pair lives in same household

Exclusion Criteria:

* Current smoker women
* Nonsmoker men
The Effectiveness of Aspirin on Preventing Pre-eclampsia

This study will explore the effectiveness of low-dose aspirin on preventing pre-eclampsia in high-risks pregnant women by comparing the incidence of pre-eclampsia and pregnancy outcomes.

Currently，low-dose aspirin is a commonly used drug to prevent pre-eclampsia. Many guidelines recommend starting low-dose aspirin in early pregnancy in high-risks pregnant women. However, the applicable population and use method of aspirin are still controversial in clinical practice. This study will explore the effectiveness and use method of low-dose aspirin by comparing the incidence of pre-eclampsia and pregnancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-55 years
* Gestational age between 12-20 weeks of pregnancy
* High risk of developing pre-eclampsia

  * At least one of the following risk factors: Pre-eclampsia in a previous pregnancy , Multiple pregnancy，Diabetes Mellitus(Type 1 or 2), Chronic Hypertension，Renal disease, Autoimmune disease.
  * At least two of the following risk factors: Primiparity，Pre-pregnancy Body Mass Index ≥28kg/m2, Age ≥35 years, Family members have a history of pre-eclampsia.
* Maternal informed conset obtained

Exclusion Criteria:

* Contraindication to aspirin therapy (including but not limited to allergy and high bleeding risk)
* Patient with known intention to terminate pregnancy
* Fetal abnormalities detected （including but not limited to major fetal malformation and FGR）
* Severe heart, liver, renal disease who can not burden the experiment
* Alcohol and drug abuse
* Being in another drug experiment within 3 months
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Gladiator Cemented Femoral Stems

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Total hip arthroplasty (THA) has been performed since the early 1920s and is generally considered to be one of the most successful orthopaedic surgeries performed. The 8th Annual Report from the National Joint Registry of England and Wales reported 95.3% component survivorship at 7 years for over 300,000 THA implantations. MicroPort Orthopedics, Inc. (MPO) currently markets several THA components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these THA components. The objectives of this study are to evaluate component survivorship and total functional outcome scores of implanted subjects at out to 10 years follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Has undergone primary THA for any of the following:
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis; or
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Exclusion Criteria:

* Subjects implanted with a metal-on-metal articulation
* Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) in the enrolled THA
* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or have pending incarceration
A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects

To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.


Eligibility Criteria:
Inclusion Criteria:

Healthy male subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 19 and 30

Exclusion Criteria:

1. Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent Document (ICD), places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
2. Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
3. Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic

Nathan Tintle, in conjunction with others at Dordt College including Dr. Kristin Van De Griend and undergraduate student research assistants, have agreed to collaborate with Hope College to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. The distribution of the water filters will begin in September 2018 to Child Hope schools in 4 different countries (Dominican Republic, Guatemala, Honduras, and Nicaragua). In order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms including schools, homes, simultaneous home/school and a control group

Nathan Tintle, in conjunction with others at Dordt College including Dr. Kristin Van De Griend and undergraduate student research assistants, have agreed to collaborate with Hope College and Sawyer Products, Inc. to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. The distribution of the water filters will begin in September 2018 to Child Hope schools in 4 different countries (Dominican Republic, Guatemala, Honduras, and Nicaragua). In order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms:

Arm 1: Simultaneous installation of filters in schools and the villages sending children to the school Arm 2: Initial installation of the water filters in a school, with later installation in the corresponding village Arm 3: Instillation of the water filters in villages, with later installation in the corresponding school Arm 4: Control arm. No filter installation initially but, ultimately, installation of filters in both the schools and villages.

Self-reported information on filter usage and health outcomes will be collected through surveys administered to parents (in the households in the villages), teachers (in the schools) and school administrators. Data collection will occur at baseline (when filters are installed), at 2 and 8 weeks post installation. The major goal of this project is to better understand the different health impacts of each different deployment strategy on child and family wellbeing. Better understanding of these filter installation strategies will help guide us as we make filter deployment decisions to provide access to clean drinking water.

Eligibility Criteria:
Inclusion Criteria:

* Lives in selected villages and has children that attend the local school

Exclusion Criteria:

* No children attending the local school
Horizontal Mattress vs. Interrupted Suture in Surgical Techniques of Pancreaticojejunostomy

The aim of this study is to verify that the frequency of pancreatic fistula (ISGPF grade B and C) in horizontal mattress suture are lower than in interrupted suture during pancreaticojejunostomy in pancreatoduodenectomy by randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

Patients from whom we obtained written informed consent of this study

Exclusion Criteria:

* Patients with severe ischemic cardiac disease
* Patients with severe liver damage
* Patients requiring oxygen administration due to interstitial pneumonia or pulmonary fibrosis
* Patients requiring dialysis treatment due to chronic renal failure
* Patients who are considered as inappropriate by attending physician
Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

Congenital and acquired thrombophilia were identified as risk factors for thrombosis in systemic vessels.Thrombophilias have also been recently found to be associated with preeclampsia, intrauterine fetal growth restriction (IUGR), placental abruption, intrauterine fetal death (IUFD) and repeated pregnancy loss.These severe pregnancy complications are thought to result from thrombotic events occurring in the uteroplacental circulation. Accumulating data have established an association between elevated plasma activity of factor VIII and thrombosis although the mechanism is still not defined and elevated factor VIII activity is now regarded as being equivalent to thrombophilia.

We intend to investigatthe association between factor VIII levels and severe pregnancy complications which are considered to result from placental vascular pathology, i.e., preeclampsia, IUGR, placental abruption and IUFD. We hypothezise that the prevalence of elevated factor 8 will be higher among women with pregnancy complications compared to controls.


Eligibility Criteria:
Inclusion Criteria:

* Women who had either normal pregnancy or complicated pregnancy.

Exclusion Criteria:

* Other causes of pregnancy complication such as infections, anomalies and fetal malformations
A Study To Assess The Efficacy and Safety of HH-120 Nasal Spray for the Treatment of Mild COVID-19

This is a randomized, double-blind, placebo-controlled Phase 2 study in participants over the age of 18 years with mild COVID-19. The main purpose of this study is to evaluate the effect on viral load clearance and clinical recovery, and safety of HH-120 nasal spray in participants over the age of 18 years with mild COVID-19 (according to the FDA definition, 2021).


Eligibility Criteria:
Inclusion Criteria:

* Participants who are ≥18 years of age .
* Participants who are diagnosed with mild COVID-19 and with Laboratory confirmed of SARS-CoV-2 infection as determined by PCR or antigen test.
* Participants who agree to use highly effective methods of contraception. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result.
* Participants who are willing and able to provide written informed consent, or with a legal representative who can provide informed consent.

Exclusion Criteria:

* Have suspected or proven serious disease (cardiovascular, renal, liver systems, etc.), active bacterial, fungal, viral, or other infection (except COVID 19) that in the opinion of the Investigator could constitute a risk when taking the study intervention.
* Bronchial asthma or chronic obstructive pulmonary disease （COPD).
* Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or Extracorporeal membrane oxygenation(ECMO).
* Have prior use (unless required as rescue medication) of any of the following treatments: COVID 19 investigational or Emergency Use Authorization (EUA) approved treatment, including but not limited to convalescent plasma, mAbs against SARS CoV 2, intravenous immune globulin (IVIG) (any indication), where prior use is defined as the past 30 days or less than 5 half lives of the investigational product (whichever is longer) from Screening.
* History of anaphylaxis or other significant allergy in the opinion of the PI or known allergy or hypersensitivity to any of the components of the study intervention.