cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis

The aim of this clinical trial is to determine the effect and security of low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis.

Focal segmental glomerular sclerosis (FSGS) is characterized by heavy proteinuria and nephritic syndrome in clinic. The major pathological change is scarring of the glomerulus that is focal and segmental. The incidence of FSGS is increasing in recent years, but no unified protocol for FSGS treatment has been provided. Corticosteroid is the primary drug for FSGS treatment in clinic. However, corticosteroid treatment has a low response rate as 20% in clinic but some severe side-effects. The side-effects of long-term corticosteroid treatment urged researchers to find more reliable and secure methods for FSGS treatment. The new immunosuppressants shed light on FSGS treatment recently. The usage of immunosuppressants to FSGS treatment is in the preliminary stage and accounts for a few problems. The main problems include the uncertainty of curative effects, the lack of large-scale clinical trial, the side-effects of long-term application, and the high recurrence rate after withdraw. FSGS is immune-induced damage, which includes abnormality of many steps in humoral immunity and cellular immunity. According to it, we designed to inhibit the immune response at multi-targets with Prednisone Combined With MMF and FK506. Thus the dosage of these drugs can be decreased to a secure level for long-term treatment while the side-effects can be controlled well. Prednisone Combined With MMF and FK506 then can be used to FSGS treatment with effectiveness and security.

Eligibility Criteria:
Inclusion Criteria:

* Urinary protein≥1.0g/24h
* Biopsy-proved FSGS
* Age≥16years
* Understanding of the content of this study，signing informed consent form
* Adherence to drug taking and being able to be long-term followed up

Exclusion Criteria:

* Sharp deterioration of renal function
* Refractory hypertension
* Secondary FSGS
* Serious disease of liver，active stage of viral hepatitis，or AST、ALT≥2.5 times of baseline
* Serious myelosuppression
* Being unable to be long-term followed up
Does Adolescent Idıopathic Scoliosis Cause Pelvic Floor Dysfunction?

The aim of this study was to investigate relationship between the type and severity of scoliosis and pelvic floor dysfunctions in individuals with adolescent idiopathic scoliosis.

While a healthy spine has a flat appearance in the axial line in the frontal plane, individuals with scoliosis have lateral flexion to one side and rotation deformity in the horizantal plane. In other words, it is a 3-dimensional problem that causes severe postural disorder in advanced stages, accompanied by lateral flexion of the spine of 10 degrees or more in the frontal plane, axial rotation in the transverse plane and kyphosis-lordosis deformity in the sagittal plane. Especially the "core" region, which is formed by 4 main muscle groups, stabilizes the pelvic organs by balancing intra-abdominal pressure increases and provides spinal stabilization. Studies showing that pelvic floor functions may be affected in normal spinal physiologic curvature changes are available in the literature. However, the relationship between the angle and severity of scoliosis and pelvic floor dysfunctions due to idiopathic scoliosis has not been clearly clarified.

In this context, the study aims to evaluate and compare scoliosis-related parameters (type of scoliosis, cobb angle, axial rotation angle), pelvic floor dynamics and dysfunctions in individuals with idiopathic scoliosis and healthy individuals with the same age group and characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Those with adolescent idiopathic scoliosis diagnosed above 10' degree,
* Under 19 years of age diagnosed with AIS,
* Individuals whose consent was obtained from their families to participate in the study

Exclusion Criteria:

* Those with congenital scoliosis,
* Those with a history of neuromuscular disease,
* Diagnosed with any systemic disease other than AIS,
* Those with a history of malignancy and/or ongoing treatment,
* Those with a history of urogenital diseases and surgical history,
* Individuals with previous spinal surgery
Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy

A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using Doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. The baseline study will be compared with the study one year after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with prostate cancer who underwent laparoscopic radical prostatectomy

Exclusion Criteria:

* Patients who were not interested in their sexual function and refused to perform this study
* Patients who required adjuvant or salvage treatment for their prostate cancer (radiation therapy, chemotherapy or androgen deprivation therapy) during follow-up.
Adavanced Glycated Endproducts and Development of CAD

Blood sample is prospectively taken from consecutive patients underwent coronary angiogram in our center, after getting informed consent from the patients. Serum level of advanced glycation end products (AGEs) was measured and the clinical features of patients (including angiographic results) were entered into our database. Clinical follow-up was performed for all patients, and the relationship between AGEs and paitents' outcome were analyzed. Further intervention will be adjusted according to the results,including clinical and basic research in lab.

Serum levels of HMGB1, HMGB2, ADAM10, etc. will be measured in lab and animal studies will be designed to intervene the adverse interaction between abnormal serum concentration of AGEs, etc. and worse clinical results.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent coronary angiogram for suspected coronary artery disease and potential percutaneous coronary intervention

Exclusion Criteria:

* patients underwent coronary angiogram for other reasons, including pre-surgery examination
* patients with severe co-morbidity, and life expectancy less than one-year
Smartphone Application Smoking Cessation Study

The purpose of the study is to determine if using the smartphone application quitSTART can help people quit smoking and to understand how use of specific smartphone application features when trying to quit smoking is associated with success.

Cigarette smoking is the leading cause of preventable death in the U.S. and causes multiple cancers. Approximately 34 million U.S. adults currently smoke cigarettes, but over half of all smokers attempt to quit smoking each year. However, only about 6% quit successfully, in part, because many smokers make unassisted quit attempts, due to the lack of accessibility of cessation programs. Mobile health (mHealth) smoking cessation programs delivered through smartphone applications ('apps') can potentially reach a large number of smokers in the U.S., as 81% of U.S. adult smokers own a smartphone. The National Cancer Institute hosts Smokefree.gov, a suite of free, publicly available smoking cessation resources. In addition to web based and text-messaging resources, Smokefree.gov launched the quitSTART smartphone app in 2013, which is a publicly available smoking cessation app.

Participants in this study will be asked to complete a pre-cessation assessment, then download, install, and try to quit smoking using the smoking cessation smartphone application, quitSTART. Participants will be asked to use quitSTART for 4 weeks. Participants will also be asked to complete online surveys 2 and 4 weeks after the start of the study. To understand how people are using quitSTART, the investigators will collect quitSTART usage data from all participants (for example, how often someone opens quitSTART during the study period and what specific features someone uses).

Eligibility Criteria:
Inclusion Criteria:

* Cigarette smoker
* Smoked at least 100 cigarettes
* Able to read and speak English
* Owns a smartphone
* 18 years of age or older
* USA resident

Exclusion Criteria:

* Not a cigarette smoker
* has not smoked at least 100 cigarettes
* Not able to read and speak English
* Does not own a smartphone
* Under 18 years of age
* Not a US resident
* Currently pregnant
Suspension Therapy Effects on Mobility and Balance in Down Syndrome

Down syndrome (DS) is one of the most common congenital disorders. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. These factors are responsible for the developmental challenges faced by children with Down syndrome. These individuals also present with balance dysfunctions. Neuromuscular and musculoskeletal impairments due to the chromosomal abnormality lead to developmental delay. These children also exhibit poor balance with greater instability and inefficient compensatory mechanisms including altered center of pressure displacement and trunk stiffening that predisposes them to falls. The aim of this study is to determine the Effects of Suspension Therapy (ST) on mobility and balance of children with Down syndrome. Suspension Therapy using Universal exercise Unit (UEU) is a three dimensional (3D) cage, consists of system of pulleys, suspensions, belts for supporting and elastic cords. Suspension Therapy is based on the concept of unloading the body against gravity and to perform movement of weak part of body.

The current study will be Randomized Controlled Trial. Inclusion criteria for the study will be children with Down syndrome (DS) of mild to moderate mental retardation aged between 3 and 6 years. Patients with any cardiac issue and orthopedic limitation to exercise such as hip, knee, foot or spinal deformities will be excluded from the study. A sample of 26 children with DS will be selected from both genders. Tools used for data collection will be Pediatric Balance scale (PBS), Four square step test (FSST), Timed up and Go test (TUG) and 1Minute Walk Test (1MWT). Participants will be measured before and after treatment to assess changes. Interventions are carried out 5 days in a week for one hour daily. In this study descriptive statistical tools will used to analyze the data. Data will be analyzed through SPSS version 23.00.

Eligibility Criteria:
Inclusion Criteria: • Diagnosed children with Down syndrome with mild (IQ: 69-50) to moderate (IQ: 50-35) mental retardation

* Aged between 3 to 6 years
* Both gender
* Able to follow the instructions
* Able to stand and walk

Exclusion Criteria: • Any Cardiovascular disease

* Visual and Hearing impairment
* Orthopedic limitation to exercise such as hip, knee, foot or spinal deformities
Biomarkers In Hidradenitis Suppurativa Participants Receiving Brodalumab

Phase 0 Study of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa to identify biomarkers of disease activity and clinical response.

Phase 0, Open Label study of Brodalumab in patients with moderate to severe Hidradenitis Suppurativa. Consisting of n=10 patients receiving 210mg subcutaneously every 2 weeks for 24 weeks. Patients will be followed for a period of 36 weeks (12 weeks after last dose of Brodalumab) to assess for safety.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Diagnosis of Hidradenitis Suppurativa by the PI
* Age 18 or older
* Moderate to Severe Hidradenitis Suppurativa as determined by the PI

Exclusion Criteria:

* Inflammatory Bowel Disease
* HIV Positive
* Active Hepatitis B or C Infection
* Pregnant or Breastfeeding
* no concurrent use of any systemic antibiotics/retinoids/imunosuppressants (require washout period of \>5 half lives)
* Any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well being go the participant during any study procedures or the integrity of the data
* High Suicide Risk as determined by the Columbia Suicide Severity Rating Scale
* History of Keloid Scarring
Encouraging Blood Donation in Patients With a Blood Type in Short Supply

As of November 2021, partly due to the COVID-19 pandemic, there has been a months-long national shortage of several types of blood in the U.S. (O-Pos, O-Neg, A-Neg, B-Neg, and AB-Neg), which has extended to a local blood shortage within the Geisinger community. The broad aim of this collaborative healthcare operations quality improvement project is to determine whether a message indicating that a patient's own blood type is in short supply increases the likelihood that they will donate, compared to a message that mentions a blood shortage without referencing the patient's blood type, or no message at all. Scientists in Geisinger's Behavioral Insights Team (BIT), part of Geisinger's Steele Institute for Health Innovation, will collaborate with Miller Keystone, where Geisinger refers patients who wish to donate blood and from whom Geisinger receives blood for clinical purposes. Patients with one of the needed blood types will be randomized to receive 1) a message about a blood shortage that does not specify the blood types in short supply or their own blood type (no-blood-type message), 2) the same message modified slightly to specify the recipient's blood type, and to mention that their blood type is in short supply (blood-type message), or 3) no message (shortage control group). A second no-contact control group of patients without any of the needed blood types will also be observed (no-shortage control group). Both the blood-type and no-blood-type messages are informed by behavioral science, emphasizing supply needs in local hospitals and providing community-relevant examples of why someone might need blood (e.g., farming or industrial accidents). The BIT will compare how many patients in each group choose to donate blood. They hypothesize that: 1) patients who receive either message will be more likely to donate than patients who receive no message; and 2) patients who receive the blood-type message will be more likely to donate than those who receive the no-blood-type message. With respect to the latter hypothesis, informing the recipient that they have one of the needed blood types may increase their perception that they are in a semi-unique position to help someone in need as compared to a more general message that may suffer from a diffusion of responsibility effect.


Eligibility Criteria:
Inclusion Criteria:

* Documented blood type in short supply (for message groups and shortage control group)
* Documented blood type not in short supply (for no-shortage control group)
* Age 18+

Exclusion Criteria:

* Hemoglobin test result \< 12.5 within the 3 months prior to list creation
Evaluation of WATCHMAN Left Atrial Appendage Occlusion Device in Patients With Atrial Fibrillation Versus Rivaroxaban

This is a prospective, multi-center, randomized, pilot study comparing the WATCHMAN left atrial appendage occlusion device with Rivaroxaban therapy in patients with non-valvular atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal, persistent or permanent non-valvular atrial fibrillation
* Eligible for LAAO and long-term rivaroxaban therapy
* Calculated CHA2DS2-VASc score of 2 or greater.

Exclusion Criteria:

* Contraindicated/allergic to aspirin, clopidogrel and novel oral anticoagulants.
* Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment.
* History of atrial septal repair or has an atrial septal defect/patent foramen ovale device.
* History of valvular heart disease.
* Implanted mechanical valve prosthesis.
* New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction less than 30%.
* Patient has left atrial/left atrial appendage thrombus screened by echocardiography
* Platelet\<100\*109/L or hemoglobin\<100g/L
* Expected lifespan less than 1 years
Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL)

This is a single-center, open-label study to evaluate the efficacy of AKCEA-ANGPTL3-LRx for reduction of fasting triglycerides in participants with familial partial lipodystrophy.


Eligibility Criteria:
Key Inclusion Criteria:

* Must give written informed consent to participate in the study.
* Clinical diagnosis of familial partial lipodystrophy plus diagnosis of type 2 diabetes mellitus and hypertriglyceridemia.
* Diagnosis of diabetes mellitus, made at least 6 months prior to the Screening with hemoglobin A1c (HbA1c) ≥ 7% to ≤ 12% at Screening and on anti-diabetic therapy as defined in study protocol.
* Hypertriglyceridemia as defined by fasting triglycerides (TG) levels ≥ 500 milligrams per deciliter (mg/dL) at both Screening and Qualification visits. Participants with the clinical diagnosis of FPL and with fasting TG levels ≥ 200 (≥ 2.26 millimoles per liter \[mmol/L\]) to \< 500 mg/dL (≥ 5.7 mmol/L) who meet the genetic or family history criteria for study inclusion may be further screened and enrolled in the study.
* Presence of hepatosteatosis (fatty liver), as evidenced by a Screening magnetic resonance imaging (MRI) indicating a hepatic fat fraction (HFF) ≥ 6.4%.

Key Exclusion Criteria:

* Diagnosis of generalized lipodystrophy.
* Diagnosis of acquired partial lipodystrophy (APL).
* Acute pancreatitis within 4 weeks of Screening.
* Acute coronary syndrome within 6 months of Screening.
* Major surgery within 3 months of Screening.
* Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study.
MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)

This is a single-dose clinical study to evaluate the safety, tolerability, pharmacokinetics, and anti-retroviral activity of MK-8527 in antiretroviral therapy (ART)-naïve participants living with human immunodeficiency virus type 1 (HIV-1) infection. The primary hypothesis is that, at a dose that is safe and generally well tolerated, MK-8527 will have antiretroviral activity as measured by a reduction from baseline in plasma HIV-1 ribonucleic acid (RNA) of ≥1.0 log10 copies/mL. A total of 4 arms was initially planned but Arm D was never initiated as the primary objectives were achieved following completion of Arms A to C.


Eligibility Criteria:
Inclusion Criteria:

* Is in good health other than HIV-1 infection
* Is documented HIV-1 positive
* Is ART-naïve, which is defined as not having received any marketed antiretroviral agent for treatment of HIV-1 infection (prior use of an ART for PrEP or investigational therapy is permitted if the last dose was ≥30 days prior to study drug administration)
* Is willing to receive no other ART for the monitoring period of this study

Exclusion Criteria:

* Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological (outside of HIV-1 infection), renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study, until the poststudy visit
* Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit
Teduglutide in Short Bowel Syndrome Patients

A retrospective analysis was performed using data of patients suffering from non-malignant SBS-IF. They were treated with teduglutide in a multidisciplinary SBS-IF program at a single university medical center between June 2016 and June 2020.


Eligibility Criteria:
Inclusion Criteria:

* SBS-IF

Exclusion Criteria:

* \< 18 years
* Incompliance
* \< 6 months of treatment
The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds

The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04% when used as an antiseptic agent and to compare these with Ringers' solution in patients with acute traumatic wounds.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute traumatic cut, crush, abrasion, bite or stab wounds Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations
* Wounds that are a minimum of approximately 4 cm2 in size
* Ability to read and understand the German patient information sheet and informed consent form

Exclusion Criteria:

* \< 18 years of age
* Pregnancy
* Immunosuppression
* Wounds caused by a burn
* Wounds that require treatment of hyaline cartilage, the central nervous system, peritoneum, meningae, inner / middle ear or inner eye
* Simultaneous participation in another clinical trial
* Wounds that require immediate surgical or medical treatment as well patients who are critically ill
* Patient with a known allergy to the active agent or any of the excipients
* Wounds that are \>3 cm in depth
* Wounds that have not received medical treatment for ≥6 hours
* Heavily bleeding wounds
* Open fractures, joints or tendons
* Wounds of the face
Cervical Interbody Fusion Device Patient Registry

The registry has been designed as a prospective, observational program for patients undergoing anterior cervical discectomy and fusion (ACDF) procedures treated with TIDAL cervical interbody fusion device. The ultimate goal of the study is to aid in the development of treatment pathways and improved patient care. All patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the device in either an inpatient or outpatient facility.

The registry is design to collect data prospectively on patients undergoing spinal fusion using the TIDAL cervical interbody fusion device. Patients will be enrolled in the registry after reviewing the protocol with their health care provider and signing the informed consent. Data will be collected at recommended time points based on the standards of care of the participating sites. The registry will serve as a database in which retrospective analysis and exploratory analysis of specific research questions will be answered.

Follow up visits will be defined by the treating physicians based on their standard practice. Typical clinical follow up schedules for patients undergoing this type of surgery are pre-operative and 12 months post-operative.

Eligibility Criteria:
Inclusion Criteria:

* Neck and arm pain for a minimum of 6 weeks before surgery that is recalcitrant to nonoperative treatment modalities, such as physical therapy, reduced activities, and anti-inflammatory medications.
* Radiographic evidence of cervical disc disease that is documented on dynamic radiographs and magnetic resonance imaging (MRI).

Exclusion Criteria:

* Medical condition that required medication, such as steroids or nonsteroidal anti-inflammatory medications, that could interfere with fusion.

There are no restrictions on sex or ethnicity.