cyrilzakka/clinical-trials huggingface dataset:
Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist

Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist injection. Subjects will be screened within 48 hours of previously scheduled MRI, those meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have moderate (eGFR 30-59 ml/min/1.73 m\^2) renal impairment and be scheduled for a contrast enhanced MRI with Magnevist Injection at the recommended dose of 0.1 mmol/kg.

Exclusion Criteria:

* Gadolinium Based Contrast Agent (other then Magnevist) enhanced MRI within 12 months prior to administration of Magnevist
* History of NSF
* Clinically unstable or age \<2 yrs
Prior Statin Use and Risk of CHF, ALO and Malignant Arrhythmia in Indonesian Post-Acute Coronary Syndrome Patients

This study aims to evaluate the effect of statin for primary prevention, towards lowering the incidence of heart failure, acute lung edema, malignant arrhythmia and death in ACS patients.

Adult patients (≥ 18 years of age) with acute coronary syndrome which are diagnosed under ICD-10 coding of I24.9 without a prior history of heart failure, acute lung edema and arrhythmia were included in this study. The inclusion criteria are patients with primary diagnosis of I24.9 and with a complete record of prior medical and treatment history, electrocardiographic findings, cardiac marker results and outcomes. Participants were grouped into 2 groups - statin and non-statin based on prior history of statin use prior to ACS. Diagnosis of ACS was made based on clinical, electrocardiographic and cardiac marker findings found in the medical record.

Data such as age, sex, ethnic, education, prior medical and treatment history, electrocardiographic and cardiac enzyme results as well as outcomes were collected from the patients' medical records. Outcomes of interest were defined as either concomitant heart failure, acute lung edema, malignant arrhythmia, mortality or combinations of them as diagnosed in the medical records. Heart failure is defined based on echocardiographic findings from the medical records. Acute Lung Edema is defined based on medical records or reported clinical findings of lung edema - rhonchi reported in 1/3 of the lungs with oxygen saturation \<90%. Whereas malignant arrhythmia is defined as the presence of ventricular tachycardia (VT) or ventricular fibrillation (VF).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Acute Coronary Syndrome
* Presence of detail on statin prescription history

Exclusion Criteria:

* History of heart failure, acute lung edema and arrhythmia
* Unavailability of electrocardiographic findings, cardiac marker results
* Incomplete records of prior medical and treatment history
Inulin and Protein Fermentation in Hemodialysis Patients

An important group of protein-bound uremic retention solutes originate from protein fermentation in the colon. P-cresol is a putrefaction metabolite of tyrosine. Indole is generated by fermentation of tryptophan. After absorption, the majority of p-cresol and indole are further metabolised and conjugated to form p-cresylsulphate and indoxyl sulphate. There is clear evidence, both in vitro and in vivo, that accumulation of these conjugated fermentation metabolites in kidney disease is correlated with clinical (cardiovascular) endpoints.

Bacterial protein fermentation can be influenced by altering the colonic microenvironment, influencing the ratio of available carbohydrates to nitrogen, by shortening the colonic transit time or a combination of these. From a theoretical point of view, functional foods, i.e. pro-, pre- and synbiotics, fulfil these criteria.

Prebiotics have been defined as non-digestible food ingredients that beneficially affect the host by selectively stimulating growth, and/or activity, of one or a restricted number of bacteria in the colon. Dietary fibre may suppress the generation of bacterial protein fermentation either by altering the colonic microenvironment or by shortening the colonic transit time. Animal and clinical studies evaluating the effect of dietary fibre supplements on the generation of bacterial fermentation metabolites have provided conflicting results. These discrepancies may be related to specific properties of the dietary fibre investigated. Dietary fibre may impair protein assimilation and the fermentability may vary to a substantial extent.

Inulin and oligofructose have attracted much attention recently as nonabsorbable carbohydrates with prebiotic properties. When inulin and oligofructose were added to a controlled diet, significant increases were noted in colonic bifidobacterial populations, and it has been proposed that these changes promote both colonic and systemic health through modification of the intestinal microflora. Inulin and oligofructose are rapidly and completely fermented by the colonic microflora with the production of acetate and other short-chain fatty acids. In healthy individuals, supplementation with a mixture of inulin and oligofructose was shown to lower p-cresol generation. Although data in healthy volunteers are promising, no data are available in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients on maintenance dialysis treatment.
* 18 years of age or older
* Written informed consent

Exclusion Criteria:

* Use of pre-/pro-/syn- or antibiotics in preceding 4 weeks.
Response of Alkylresorcinols to Different Cereals

Cereal grains contain a wide variety of different phytochemicals which may play different roles in physiology. Their response in plasma and urine after a meal is poorly defined for most cereals. This study will investigate the plasma response and urinary excretion of cereal compounds after eating 6 different types of cereal preparation, with a focus on alkylresorcinols.

This was a cross-over, randomized, double blind study with 6 arms (flours of different composition). Thirteen subjects completed the trial, where 100 g of each flour, mixed with 300 mL milk, was fed to all subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Normal-overweight (BMI 19-28 kg/m2)
* Non-smokers

Exclusion Criteria:

* Regular consumers of wholegrain cereals
* Allergy to cereal or milk products
Carbetocin Versus Syntometrine for Prevention of Postpartum Hemorrhage After Cesarean Section

to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

A double blind randomized study conducted on 450 pregnant subjected randomly either to single 100 μg IV dose of carbetocin (150 women) or combination of 5 IU oxytocin and 0.2 mg ergometrine (300 women) after fetal extraction and before placental removal.

Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic

Eligibility Criteria:
Inclusion Criteria:

* All participants are at 37 - 40 weeks of gestational age
* Noncomplicated pregnancy.

Exclusion Criteria:

* Participants with placenta previa
* Patients with coagulopathy
* preeclamptic women
* known sensitivity to oxytocin or methergine were excluded
Clinical Effectiveness of First Trimester Pre-eclampsia Screening Program.

To evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

The incidence of pre-eclampsia is about 2-8%, it is a leading cause of maternal and perinatal mortality and morbidity. Both ACOG (American Congress of Obstetricians and Gynecologists) and NICE (National Institute for Health and Clinical Excellence) guideline advocate the use of traditional screening method, which uses demographic characters and medical history to identify high risk women. This method detects only 35-40% of pre-eclampsia women. Study has shown that combination of maternal factors and biomarkers (uterine artery pulsatility index, placenta growth factor, PlGF; pregnancy associated plasma protein-A, PAPP-A) improves the detection rate.

In Taiwan, the prevalence of pre-eclampsia is about 1.21%. The incidence of pre-eclampsia is correlated with maternal age, with a relative risk of 5.13-fold in women aged 40 and above. Marrying late predisposes these women at high risk of developing pre-eclampsia. Our institution will be implementing first-trimester screening program starting from April 2019, this study aims to evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

Eligibility Criteria:
Inclusion Criteria:

- Women who are 20 years of age or older with singleton pregnancy between 11 to 13 + 6 weeks and received first trimester pre-eclampsia screening test in this institution.

Exclusion Criteria:

* Women who are not regularly inspected or not receiving prenatal care in this institution.
* Women who received first trimester pre-eclampsia screening test at other institution
A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration

The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-552 in healthy, male volunteers following administration of a single oral dose.


Eligibility Criteria:
Inclusion Criteria:

- Male volunteers in general good health at Screening.

Exclusion Criteria:

- Considering fathering a child or donating sperm during the study and for 100 days after study drug administration.
Full-Leg vs Below-Knee Elastic Stockings for Prevention of the Post-Thrombotic Syndrome

Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated compression (30-40 mm Hg at the ankle) elastic stocking for prevention of the post-thrombotic syndrome (PTS). All patients are followed up to three years to assess the development of the PTS, defined according to a validated clinical score (the Villalta scale). The rate of PTS is compared between the two study groups. In addition, there is an assessment of patients' compliance and tolerability of the two different devices.


Eligibility Criteria:
Inclusion Criteria:

* First episode of proximal deep vein thrombosis, as shown by compression ultrasound

Exclusion Criteria:

* Previous ipsilateral deep vein thrombosis
* Preexisting chronic venous insufficiency
* Bilateral deep vein thrombosis
* Life expectancy lower than 1 year
* Severe arteriopathy of the lower limbs
* Known allergy to elastic stockings
* Lack of written informed consensus
Implementation of a Pharmacist-Based, Post-Chemotherapy Follow-up Clinic

The purpose of this study is to determine the impact of pharmacists on reducing chemotherapy-related side effects by providing education before and after patients receive intravenous chemotherapy at one of Cedars-Sinai outpatient infusion centers.

Participants will be interviewed via telephone within 7 business days after receiving intravenous chemotherapy from the outpatient cancer center infusion clinic.

The study involves participation at a single timepoint only.

Participants who consented to participate and are considered eligible will be interviewed by a pharmacist via phone at approximately 7 business days after receiving intravenous chemotherapy infusion. Phone call will be made between the hours of 9am - 6pm on Monday - Saturday. Calls are anticipated to last between 15 to 20 minutes. Participants will be asked if they have experienced any adverse events since the infusion, whether or not they have had any barriers taking supportive care medications, and if the patient understands how to manage potential adverse events. If applicable, participants will be provided further education on optimizing adverse events, guided on proper medication administration times, and will be provided with non-pharmacological clinical pearls to minimize chemotherapy-related side effects and optimize supportive care management.

If unable to reach the participant or caregiver after three attempts, the participant will be considered ineligible. Participants can decline participation at any time during the phone call.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Diagnosed with cancer and is receiving treatment with intravenous chemotherapy
* Treatment initiated at Cedars-Sinai Cancer Samuel Oschin Cancer Center (SOCC) or Cedars-Sinai Cancer Beverly Hills (CSCBH)
* English-speaking or lives with English-speaking person
* Access to a working phone

Exclusion Criteria:

* Received follow-up calls through other specialty pharmacy program
* History of infusion related reactions
* Declined participation on follow-up interview
* Age less than 18 years old
* Non-English speaking
* Electronic health record flagged for research opt out
3D Endoanal Ultrasound and Anal Fistula

The study aims to evaluate the use of 3D endoanal ultrasound in preoperative management of anal fistula disease.


Eligibility Criteria:
Inclusion Criteria:

* anal fistula
* no previous fistula procedures

Exclusion Criteria:

* previous fistula procedures
* ano/rectovaginal fistula
* inflammatory bowel disease
* more than one internal openings
Evaluation of the Effect of TMS on Primary Dysmenorrhea

Based on the pain threshold and visual simulation score, primary dysmenorrhea patients will be divided into treatment effective group or non-effective group.According to the functional magnetic resonance imaging, the investigators investigate whether there is characteristic or secondary brain features before and after rTMS intervention.

Long term primary dysmenorrhea may induce a series of disorders involving psychology, lower quality of life, or even developing chronic organic lesion or chronic pain. Effective symptom improvement is urgently needed. During the Non-pharmaceutical interventions, repetitive transcranial magnetic stimulation (rTMS) is received preliminary approval because of its noninvasive and safe analgesic effect. In this randomized single blind longitudinal study, the investigators investigate the analgesic effect of rTMS in long term moderate-to-severe primary dysmenorrhea women. Based on the pain threshold and visual simulation score, primary dysmenorrhea patients will be divided into treatment effective group or non-effective group. According to the functional magnetic resonance imaging, the investigators investigate whether there is characteristic or secondary brain features before and after rTMS intervention. By combining pre and post performances of the degree of dysmenorrhea, behavioral data and sensitive hematological indicators, the investigators intend to build an association model between brain and pain development curve. Using correlation and multiple regression analysis method, the investigators intend to find sensitive neuroimaging biomarkers in predicting the analgesic effect of rTMS. The current study is not only contributing to improve the central nervous systematic mechanism of rTMS in chronic pelvic pain, but also significant for clinical effective treatment based on neuroimaging predictive markers.

Eligibility Criteria:
Inclusion Criteria:

* consistent with the diagnostic criteria for primary dysmenorrhea according to the American College of Obstetricians and Gynecologists;
* regular menstrual cycles (27-32 days);
* the average intensity of dysmenorrhoeic pain in the past 6 months should be rated ≥4 on a visual analogue scale (VAS) (0 = no pain, 10 = the worst imaginable pain).

Exclusion Criteria:

* organic pelvic disease;
* using oral contraceptives, hormonal supplements, Chinese traditional medicine or any central-acting medication (e.g., opioids, anti-epileptics) within 6 months before the study;
* comorbid chronic pain states;
* alcohol, nicotine or drug addiction;
* neurologic disease or psychiatric disorder;
* history of childbirth;
* a positive pregnancy test or immediate plans for pregnancy;
* any MRI contraindications. In addition, no analgesics were consumed 24 hours prior to the experiment.
Risk Factors of Psychiatric Disorders and Sexual Dysfunction in Infertile Men

To investigate the prevalence of psychological symptoms and sexual dysfunction, and to estimate their possible interactions in infertile men.

Although psychological disorders such as anxiety and depression are known to be associated with sexual dysfunction, and their interactions have been reported by many studies, particularly the prevalence of these two aspects and the relationship between them in infertile men in China have not been well investigated.

The investigators' aim is to evaluate the prevalence of psychological symptoms and sexual dysfunction and interactions between them systematically by using validated questionnaires and scales.

Eligibility Criteria:
Inclusion Criteria:

* men who seek treatment for infertility (infertility is defined as the inability to conceive after 1 year of unprotected intercourse)
* age ≥ 18 years
* in a heterosexual, stable relationship for at least 1 year
* able to read and speak Chinese

Exclusion Criteria:

* inability to read and understand the questionnaire because of language difficulties
* already evaluated during an earlier survey
* men on medication that could have affected their ejaculatory and erectile function and/or psychological status
Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk

The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are:

* to evaluate if Bremelanotide (BMT) is secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC.
* to measure the concentration and characterize the pharmacokinetics of BMT secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC.

This open-label, pharmacokinetic (PK) study will be performed in 10 healthy lactating female subjects between 10 days and 6 months post-partum (inclusive). The maximum duration of subject participation in the study will be approximately 29 days, consisting of 3-week Screening period, a 1 day treatment period, and up to a 7 day follow-up period.


Eligibility Criteria:
Inclusion Criteria (Main Criteria):

* Female subjects ≥18 to 55 years of age (inclusive) and premenopausal
* Lactating, between 10 days and 6 months postpartum (inclusive).
* Exclusively breastfeeds their infant prior to participation in the study
* Is willing to pump and store breastmilk for feeding her infant for a minimum of 48 hours in advance of study initiation and discontinue breastfeeding their infant for the duration of their study participation (beginning from time of dosing with BMT) and a minimum of 24 hours following the Safety Follow-Up visit (i.e., a minimum of 48 hours following dosing with BMT).
* Ensure at the time of screening that the breastfed infant can feed from a bottle during maternal participation in the study
* The subject is not pregnant, and does not intend to become pregnant before, during, or within 1 complete menstrual cycle or 2 months after administration of study drug
* Subjects of childbearing potential who are sexually active with a nonsterilized male partner must have stable, continuous use of an acceptable method of contraception throughout the duration of the study, and for at least 60 days after the dose of study drug

Exclusion Criteria (Main Criteria):

* Breastfeeding is not well established in the mother-infant pair (e.g., poor latching of the infant or low milk supply).
* Any condition that interferes with the successful collection of milk from one or both breasts including but not limited to lactation mastitis (typically presents as a tender, hot, swollen area of the breast that may or may not involve an infection), milk blister that may present as a blocked nipple pore, breast abscess, etc.
* Has used any investigational compound and/or an experimental medical device within 28 days before Screening.
* Has taken BMT within 24 hours of participation in the study
Improving Patient Education for Lymphoma and Leukemia Inpatients

The purpose of this study is to evaluate the impact of a structured, DVD educational intervention about what to expect during inpatient treatment of a newly diagnosed cancer. The focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their family members. Outcome variables will be the patient and family member's satisfaction with inpatient teaching and anxiety about inpatient treatment.

The purpose of this study is to evaluate the impact of a structured, DVD educational intervention about what to expect during inpatient treatment of a newly diagnosed cancer. The focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their family members. Outcome variables will be the patient and family member's satisfaction with inpatient teaching and anxiety about inpatient treatment.

The experimental group will watch a DVD educational presentation of information about unit routines and activities; leukemia/lymphoma; treatment modalities and procedures; treatment of side effects; and patient and family members activities of importance to prevent infection and promote well-being during cancer treatment.

Participants in the control group will receive usual educational teaching by their assigned nursing staff.

Eligibility Criteria:
Inclusion Criteria:

For participants admitted for suspect diagnosis of leukemia or lymphoma:

* Admission to the hematology/leukemia unit (6E) at Emory University Hospital with a suspected or actual new diagnosis of leukemia or lymphoma within the past 24 hours
* English-speaking
* Completed education to at least the 6th grade level
* No significant auditory or visual deficits with corrective devices
* No central nervous system involvement of disease
* Physiologically stable
* Not at end of life
* No alterations in mental status
* Agrees to family member (family member; significant other; friend) participation in study and to selecting the individual who could participate

For Family Members:

* Willing to view DVD and read education booklet
* Selected by patient to participate
* English speaking
* No significant auditory or visual deficits with corrective devices
* No alterations in mental status
* Completed education to at least the 6th grade level

Exclusion Criteria:

* At end of life
* Altered mental status
* Significant auditory or visual deficits with corrective devices
Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis

This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign \& symptom score and positive microscopy

Exclusion Criteria:

* Allergy to the allylamine class of antimycotics or excipients in the formulation.
* Chronic, hyperkeratotic plantar (moccasin) tinea pedis
* Other fungal disease or intertrigo
* Other abnormal findings on the affected foot
* Systemic antifungal or antimicrobial treatment within the last 3 months
* Topical treatment for skin lesions on feet within the last 3 months
* Diabetes mellitus and peripheral artery occlusive disease