cyrilzakka/clinical-trials huggingface dataset:
The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function

This study is designed to investigate the role of lipids/lipoproteins as a potential cause for the harmful changes seen in fibrin clot properties with renal dysfunction and atrial fibrillation

This is a prospective, observational, blinded study that will be conducted in two parts. The first study will assess the relationship between lipids/lipoproteins and fibrin clot properties among anticoagulated atrial fibrillation patients with and without renal dysfunction. The second study will assess the effects of statin therapy on lipids/lipoproteins and fibrin clot properties in anticoagulated atrial fibrillation patients with renal dysfunction. Renal dysfunction is defined as an estimated glomerular filtration rate below 50 ml/min/1.73m2 for the purposes for this trial.

Eligibility Criteria:
6.1 Inclusion criteria

WP1:

* On anticoagulation therapy
* Informed consent obtained

WP2:

* Not receiving statins prior to recruitment
* Diagnosed atrial fibrillation
* On anticoagulation therapy
* Estimated glomerular filtration rate of \<50 ml/min/1.73m2
* Informed consent obtained

6.2 Exclusion criteria

* Age \<18 years
* Severe mitral stenosis or presence of metallic prosthetic valve
* Active or recent malignancy (\<6 months)
* Active immunological disease
* Connective tissue disease
* Chronic liver disease
* Recent or chronic serious infection
* Chronic inflammatory disease
* Known haemophilia or thrombophilia
* Active bleeding
* Untreated hypothyroidism or hyperthyroidism
* Recent surgery (\<3 months)
* Familial lipid disorders
* Concurrent use of steroids
* Dietary supplements known to influence lipids
* Contraindications/inability/unwillingness to commence statin (WP2)
Pharmacokinetics and Drug Interaction Study Between DWC20141 and DWC20142 in Healthy Male Volunteers

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between DWC20141 and DWC20142 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male volunteers aged 19 to 45 years
2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion Criteria:

1. A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
2. A subject who shows the following result in clinical laboratory test

   * AST, ALT \> 1.25 times of the upper limit of normal range
   * PR ≥ 210 msec
   * QRS ≥ 120 msec
   * QT ≥ 500 msec
   * QTcF ≥ 500 msec
3. Subject who has taken other clinical medication from another clinical trial within 3-months period prior to the first administration of the study medication.
Project Self in Improving Cervical Cancer Screening Rates in Hispanic and African American Women

This trial studies if Project Self can improve the rate of cervical cancer screening in Hispanic and African American women living in Houston, Texas. Project Self may help to improve cervical cancer screening rates by providing human papillomavirus (HPV) self-collection kits, education, counseling, and navigation.

PRIMARY OBJECTIVES:

I. To examine the feasibility of conducting an education intervention trial regarding cervical cancer screening among women of Hispanic and African American origin living in public housing units in Houston, Texas.

SECONDARY OBJECTIVES:

I. Document cervical screening associated knowledge, attitudes and practices among Hispanic and African American women living in public housing units in Houston, Texas at pre- and post-health education.

II. Document Pap smear screening rate in last 3 years among participants. III. Document HPV positive rate among participants.

OUTLINE:

Participants complete questionnaires, take part in a health education session, and receive an HPV self-collection kit.

After completion of study, participants are followed up at 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as African American or Hispanic women.
* Valid home address reflective of residence in the participating housing development(s) at least 50% of the time.
* Functioning telephone number.
* Speak and read English or Spanish.

Exclusion Criteria:

* Self-reported hysterectomy.
* Self-reported personal history of cancer/cancer diagnosis.
* Self-reported as pregnant.
* Another household member is enrolled in this protocol.
A Study on Improving Detection and Management of Suicide Risk Among Depressed Patients in Primary Care

improve detection and management of suicide risk among depressed patients in primary care

After intervention of training on the identification and management of depression and suicide risk in primary health care professionals, the ability of detection and management of suicide risk among depressed patients in primary care is expected to be improved compared to baseline evaluation.

Eligibility Criteria:
Inclusion Criteria:

* consecutive outpatient

Exclusion Criteria:

* severe physical conditions
Comparison of Hypotension During Spinal Anaesthesia for C-section

Maternal hypotension during C section has been reported due to aortocaval compression (ACC) by full term uterus in supine position. This study aimed at reporting the effect of left tilt on maternal hemodynamics.

C-section is usually done in either general anesthesia or regional (epidural or spinal) anesthesia. The choice lies with the mother. In spinal anesthesia the anaesthetic agent is injected into the subarachnoid space. Hypotension in supine position that is associated with full term gravid uterus has been explained by compression of inferior venacava (IVF) and aorta. This aortocaval compression (ACC) can also cause hypotension during C- section after spinal block.

The aim of our study was to study the effect of left tilt on systolic (SBP) and diastolic blood pressure (DBP), heart rate and the frequency of phenylephrine used to maintain the blood pressure in normal range.

Eligibility Criteria:
Inclusion Criteria:

* Participants ≥ 18 years, undergoing Elective Caesarean Section for term singleton pregnancy, ASA I/II, were included after their consent for the participation of the study.

Exclusion Criteria:

* Participants with co-morbidities (Hypertension, diabetes mellitus, cardiovascular or cerebrovascular disease and a history of coagulation disorders), any contraindication to spinal anesthesia, with multiple pregnancy, pre-eclampsia, obesity (body mass index \> 30 kg.m2), intrauterine growth were excluded from the study.
A Pilot Study of Transcoronary Myocardial Cooling

Patients with heart attacks caused by blocked coronary arteries are usually treated with a technique called primary angioplasty. Although this treatment is very successful it can result in damage to the heart muscle when the artery is opened due to reperfusion injury. Cooling the entire body has been shown to reduce heart muscle damage during heart attacks in some patients but not in others, however it is uncomfortable due to the shivering, expensive and can result in delays in opening the blocked artery. We are investigating a simpler way to cool the heart muscle directly using cooled fluid passed through the catheter without the shortcomings of entire body cooling. This pilot will address safety and feasibility considerations.

The precise mechanisms involved in ischaemia/reperfusion injury is not fully understood but a number of factors are thought to contribute to cardiac dysfunction14, 15. These include : 1. reperfusion arrhythmias; 2. microvascular obstruction or no-reflow phenomenon; 3. myocardial stunning and 4. cardiomyocyte apoptosis. It is estimated that ischaemia/reperfusion injury occurs in \> 30% of patients and is associated with reduced myocardial salvage and poor prognosis16-18. Ischaemia/reperfusion injury may account for up to 50% of the final infarct size9.

Deep hypothermia (\< 30 °C) has long been used in protecting the heart during coronary artery bypass grafting and heart transplantation. Intermittent antegrade or retrograde infusion of cold cardioplegia appears to reduce myocardial ischaemia and improves outcome19, 20. Deep hypothermia however can cause spontaneous ventricular fibrillation and impaired cardiac function and its application is limited to the unconscious patient.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 80 years presenting with ischaemic chest pain of \<6 hours and STsegment elevation on the ECG of \>0.2 mV in 2 contiguous leads.

Exclusion Criteria:

* Patients with cardiac arrest, previous AMI or CABG, known congestive heart failure, endstage kidney disease or hepatic failure, recent stroke, coagulopathy, pregnancy, or cardiogenic shock.
* Patients who are unable or unwilling to provide assent and informed consent.
Efficiency Study of Siwu Tang to Treat Brain Hypoperfusion Syndrome

Brain hypoperfusion patients may cause vascular dementia results from their hypoperfusion state except that is a risk factor for stroke. The most common clinical symptom of hypoperfusion syndrome is dizziness.Siwu tang is made of Angelica sinensis (Oliv.) Diels (當歸), Rehmannia glutinosa (Gaertn) Libosch (熟地黃), Paeonia lactiflora Pall (白芍), Ligusticum chuanxiong Hort (川芎), and that was used to treat patients with blood deficiency for several centuries. the purpose of the present study was to investigate the complementary effect of siwu tang on brain hypoperfusion syndrome patients

We designed a randomized, double-blinded controlled study, and a total of 80 patients with brain hypoperfusion syndrome should be finished assessment in two years. The 80 patients with hypoperfusion syndrome were divided into as follows:1) control group, receiving siwu tang placebo 3 g bid continuously two weeks except ordinary treatment; 2) treatment group, receiving siwu tang 3 g bid continuously two weeks except ordinary treatment. The patients were assessed before, and 4 weeks (weeks±3 days) and 12 weeks (12 weeks±3 days) after siwu tang treatment, respectively. Primary outcome measure was cerebral blood flow by using single photon emission computed tomography (SPECT); Second outcome measure included severity of dizziness by using visual analogue scale (VAS); cognitive function by using Mini-Mental Status (MMSE), Cognitive Abilities Screening Instrument (CASI), and Clinical Dementia Rating (CDR); quality of life by using barthel index (BI) and Functional Independent Measure (FIM).

We predict that siwu tang can improve cerebral blood flow, and clinical manifestation including dizziness, and cognition function and quality of life in patients with brain hypoperfusion syndrome .

Eligibility Criteria:
Inclusion Criteria:

* age between 18y/o to 80 y/o and had brain hypoperfusion syndrome such as dizziness
* barthel index (BI) \> 60。
* single photon emission computer tomography(SPECT) or MRI exam show hypoperfusion area

Exclusion Criteria:

* Patient had cancer or uremia,liver cirrhosis
The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.

Contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. The implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the initial implantation site, increase costs of treatment etc. The research to find any new hernioplasty without the use of meshes is still going on.

Desarda in 2002 year published his own results over hernia treatment with the use of external oblique aponeurosis. These results were comparable with the effects of Lichtenstein technique.

The initial assessment done in our own department revealed good clinical results after hernia treatment with Desarda's method.

To make appropriate and objective clinical assessment of the Desarda's technique for primary inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.

Generally no statistically significant differences were found between these groups. The only difference was higher rate of seroma after Lichtenstein technique and different pain perception in both groups. To the summary it is clear that Desarda technique is quite attractive and good proposition for operative hernia treatment without mesh. The RCT was done with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* primary inguinal hernia
* male adults
* signed informed consent
* god condition of external oblique aponeurosis (assessed during the operation)

Exclusion Criteria:

* age \< 18
* recurrent hernia
* incarcerated hernia
* diagnosed mental disorder
* manual reduction of hernia on inpatient
* infection at groin area
* wound or scar at the groin
* no consent
Combined Viscocanalostomy, Phacoemulsification, OIogen Implant in Open Angle Glaucoma

This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group) . Follow-up period was 2 years. Nd:YAG laser goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after discontinuation of corticosteroid eye drops at any follow-up visit.

Our hypothesis is that using Ologen® implant as a spacer in the subscleral reservoir in phaco-viscocanalostomy reduces fibrosis and increase the success rate of this operation

Background: To study the efficacy of the biodegradable collagen implant Ologen® as an adjuvant in phaco-viscocanalostomy in patients with coexisting cataract and primary open angle glaucoma.

Methods: This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group). Follow-up period was 2 years. Nd:YAG laser goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21 mmHg after discontinuation of corticosteroid eye drops at any follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* the presence of significant cataract interfering with vision (visual acuity ≤ 0.5) in the presence POAG.
* if cataract was associated with uncontrolled glaucoma, (IOP \> 21 mmHg despite maximally tolerated medical therapy)
* if the IOP was ≤ 21 mmHg with use of at least two antiglaucoma drugs with medication intolerance
* poor patient compliance
* patients could not attend medical supervision
* patients had visual field deterioration.

Exclusion Criteria:

* closed-angle glaucoma
* other types of open angle glaucoma (OAG), e.g. pigmentary glaucoma, inflammatory glaucoma or neovascular glaucoma,
* previous ocular trauma or surgery
* lens subluxation
* any eye diseases affecting the vision, e.g. anterior uveitis
* if there was a large perforation of the Descemet's membrane with iris prolapse during surgery (cases with microperforation, which is defined as small perforation with no associated iris prolapse, occurring during surgery were not excluded) intraoperative complications that might affect the IOP, e.g. vitreous loss.
Can Fasting Ramadan in the Third Trimester in Pregnancy Affects the Fetal Growth.

Prospective comparative cohort study including 159 pregnant women at the third trimester recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during the holy month of Ramadan (from 18th June To 16th July 2015).

The patients recorded their pattern of fasting during Ramadan then grouped into three groups A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C- Totally fasting group

.

Many pregnant muslims women fast during Ramadan Since fasting during Ramadan is one of the five pillars of Islam and is a central part of Muslim culture, many women may fear a loss of connection with their communities or would feel guilty if they did not observe Ramadan. Each year, about 400 million out of 1 billion Muslims do this duty. Such tasks like eating, drinking, and smoking are forbidden from sunrise until sunset. Fasting during pregnancy has been always considered as a debatable condition.

Many women ask their obstetricians if fasting is safe for their baby or not? There have been many studies on metabolic changes and different aspects of human health during and after Ramadan .but there have been few studies on the effect of fasting on pregnancy outcome and there are also some controversies in the findings of different studies.

All mothers within the age range of 20 - 35 years and in the 3rd trimester pregnancy (starting from 28 weeks) which is going to be calculated according to the date of the last menstrual period \& confirmed ultrasonically, normal healthy women with average body mass index (BMI) and Women included have no medical disorder.

Women who fulfilled the eligibility criteria were subjected an ultrasound fetal biometry every 2 weeks till delivery and assess fetal weight after delivery.

Eligibility Criteria:
Inclusion Criteria:

* Age from 20 - 35 years.
* Third trimester pregnancy (starting from 28 weeks) which is going to be calculated according to the date of the last menstrual period \& confirmed by ultrasonography.
* Normal healthy women with average body mass index (BMI). Normal range (18.5 to 25).
* Women included have no medical disorder.

Exclusion Criteria:

* History of systemic disorder.
* Smoking narcotics or alcohol use.
* Have previous history of fetal loss.
* Multiple pregnancies.
Lessons Learned From the Family Gene Toolkit

Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer syndrome. Genetic testing identifies mutation carriers and enables them to manage their cancer risk (i.e. chemoprevention, risk-reducing surgery, or intensive surveillance). However, uptake of genetic testing among at-risk individuals is low, implying that information about the disease and genetic testing is not being communicated effectively among family members. Mutation carriers are distressed about disclosing test results, while their relatives do not understand the implications of a positive test result for their own health. Thus, interventions that support family communication about genetic risk, and address psychological distress of family members could contribute to more effective management of hereditary breast/ovarian cancer.

The project aims to develop a family communication and decision-support intervention to 1) increase family communication about BRCA1/2 mutations; 2) reduce psychological distress associated with these mutations; and 3) increase informed decision-making regarding uptake of BRCA1/2 testing among at-risk family members. Focus groups with mutation carriers and at-risk relatives will inform the refinement of the intervention, as well as timing and mode of delivery. Two group, pre-post test study with a new sample of mutation carriers and family members will be used to test the feasibility, acceptability, and effect of the intervention.


Eligibility Criteria:
Inclusion Criteria for mutation carrier:

1. had genetic testing for BRCA 1 or BRCA 2, and received positive test results;
2. are older than 18 years;
3. speak English;
4. agree to invite in the study one female relative who has ≥10% of carrying a genetic mutation AND did not have genetic testing; and
5. have access to an Internet enabled computer.

Inclusion Criteria for relatives

1. did not have genetic testing for BRCA 1 or BRCA 2;
2. are older than 18 years;
3. speak English; and
4. have access to an Internet enabled computer.

Exclusion Criteria:

* Women who have no female relatives
* Women who are unable to consent
* Women who do not have access to the Internet or the computer
Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy

Percutaneous nephrolithotomy (PNL), in conjunction with intracorporeal lithotripsy, allows for the rapid removal of any kidney stone regardless of size. Currently, the choice of intracorporeal lithotripters includes ultrasonic, pneumatic, and combined ultrasonic/pneumatic energy sources. Recently, a novel dual probe design as been introduced by Cybersonics of Erie, Pennsylvania. This dual probe intracorporeal lithotrite is called the Cyberwand, and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 Hz. As this new design has the potential to revolutionize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.

Percutaneous nephrolithotomy (PNL) is used to remove large and complex stones from the upper urinary tract. Intracorporeal lithotripsy is an integral part of PNL. Commercially available intracorporeal lithotripsy modalities include ultrasonic, pneumatic, and combined ultrasonic and pneumatic models. Each modality has its inherent advantages and disadvantages. Ultrasonic lithotrites are capable of fragmenting stones while concomitantly suctioning out fragments. Unfortunately some stones are hard enough to resist fragmentation from ultrasonic lithotripsy. Pneumatic lithotrites are able to fragment all stones regardless of hardness, but this modality is unable to suction out stone pieces at the same time fragmentation is occurring. The newest lithotrite which combines both ultrasonic and pneumatic components is capable of fragmenting any stone, but also has some inherent limitations. The handpiece of the lithotripsy device is somewhat cumbersome, the suction component can clog, and the device has overheated at the maximal settings (Kuo et al). Current intracorporeal lithotrites, while functional, can certainly be improved.

Recently, a novel dual probe design has been introduced by Cybersonics of Erie, PA. This dual probe intracorporeal lithotrite is called the Cyberwand and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 Hz. As this new design has the potential to revolutionalize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient of Methodist Urology in Indianapolis, IN
* Undergoing percutaneous nephrolithotomy for calculi greater than 2 cm
* Age 18 years or older
* Stone easily visible/measurable on kidney, ureters and bladder (KUB) or computed tomography (CT) scan preoperatively

Exclusion Criteria:

* Radiolucent stones
* Size of largest stone less than 2 cm
* Pregnancy
* Inability to give informed consent
* Multiple percutaneous access anticipated
* Active urinary tract infection
* Recent (within last 3 months) extracorporeal shock wave lithotripsy
Postprandial Effects of Milk and Milk Constituents

The purpose of this study is to determine whether the addition of milk or the milk constituents calcium and protein to a high-fat breakfast affects the postprandial lipid and inflammatory response.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) above 27 kg/m2

Exclusion Criteria:

* Smoking
* Diabetes mellitus
* Cardiovascular diseases
* Familial hypercholesterolemia or lipid lowering medication
* Severe conditions that might interfere with the study outcomes, such as COPD, asthma, rheumatoid arthritis, etc.
* Unstable body weight
* Abuse of alcohol or drugs
* Participation in another biomedical study during the past 30 days
* Having donated blood during the past 30 days