cyrilzakka/clinical-trials huggingface dataset:
Prognostic Model of GC/TAC in the Treatment of MN

The goal of this observational study is to explore the factors that can predict the prognosis difference in patients with idiopathic membranous nephropathy (IMN) under the treatment of glucocorticoid + tacrolimus. The main questions it aims to answer are:

* to explore the factors that can predict the prognosis difference in patients with IMN under the treatment of glucocorticoid + tacrolimus
* to establish a clinical prediction model and verify it to provide a reference for the early Participants will receive standard the treatment of glucocorticoid + tacrolimus treatment and will then be divided into remission and non remission groups based on the treatment effect after the standard treatment cycle. Blood, urine, and fecal samples were collected from patients to explore possible factors influencing treatment efficacy.

Researchers will compare \[remission group and non-remission group\] to see if the gut microbiota and its metabolites are factors that influence the efficacy of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years, the patient was diagnosed as idiopathic membranous nephropathy or anti phospholipase A2 receptor (PLA2R) antibody positive by renal puncture biopsy, and the clinical data were complete;
2. According to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines in 2020, it conforms to the medium and high risks in the risk level of progression of renal function loss.
3. In general, they are in good condition, have a good understanding of their own conditions and physical conditions, have self-awareness, and can communicate well with others;
4. Volunteer to participate in the study, understand the significance of this experiment and the indicators to be measured, and sign the informed consent form.

Exclusion Criteria:

1. There are factors causing secondary membranous nephropathy, such as immune diseases (systemic lupus erythematosus), tumors/infections (viral hepatitis), drugs or toxins;
2. At the same time, immunoglobulin A nephropathy (IgAN), interstitial nephritis, acute nephritis and other renal pathological types were combined;
3. The medication was not standardized during the treatment process, accompanied by serious infection, acute renal injury and other complications, and serious cardiovascular, cerebrovascular, digestive and blood system diseases;
4. During follow-up, the patient cannot actively cooperate or accurately understand and express.
Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease

Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease


Eligibility Criteria:
Inclusion Criteria:

* Adults between 19 and 75 years old based on the date of written agreement
* Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid reflux within the last 7 days

Exclusion Criteria:

* Those who have undergone gastric acid suppression or gastric, esophageal surgery
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
* Clinically significant abnormal laboratory values during screening
Ankle Taping and Functional Ankle Instability

Background and purpose:

Ankle inversion sprains are the commonest injuries of the lower extremities. Taping is routinely used after ankle sprain to support the joint and prevent reinjury. The effect of taping on functional performance in participants after ankle sprain has received little attention and generally with inconsistent findings. Besides, the perception of confidence and reassurance that may come with the ankle being taped might lead to the improvement of functional mobility performance. Therefore, the purpose of this study is to investigate the effects of rigid ankle tape and fibular tape on functional performance, self-efficacy and perceived stability, confidence and reassurance during functional tasks in participants with functional ankle instability.

Methods:

This study is a randomized controlled trial. Forty subjects with functional ankle instability will be recruited and randomly assigned into the rigid tape group and the fibular tape group. Participants will perform functional mobility tests with and without the ankle taped. The functional tests are: figure-8 hopping test, lateral hopping test, star excursion balance test (SEBT), single-leg stance and stair decent test. Secondary outcome measures were self-efficacy and perception measure.

Statistics:

Two-way analysis of variance with repeated measures was used to determine the effects of intervention on each dependent variable. Model effects were group, time (pre, post), and their interaction. Post hoc pairwise comparisons between pre and post in each group, and independent t test between groups, were used to document the difference. The statistical significance was set at p less than 0.05.


Eligibility Criteria:
Inclusion Criteria:

1. participants had to have sustained at least two ankle sprain from a sudden inversion trauma, at least one month prior, which resulted in pain and swelling over the lateral ligament and limping, and have at least moderate functional ankle instability
2. a score of \<27 on the Cumberland Ankle Instability Tool (CAIT)
3. anterior drawer test: negative
4. talar tilt test: negative

Exclusion Criteria:

1. if they had sprained their ankle within two weeks of testing
2. had a neurological or vestibular disorder or were unable to understand the nature of the protocol and test instructions.
3. have received intervention for ankle instability
4. PI's research assistant -
A Close Examination of Patient Experiences in Cluster Headache Clinical Research

Historically, participation in clinical studies is highly skewed towards particular demographic groups of people.

This research will invite several participants to gather a wide range of information on clinical trial experiences for cluster headache patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of cluster headache.

The data collected from this study will help improve future outcomes for all cluster headache patients as well as those in under-represented demographic groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with cluster headache
* Patient has access to a home internet connection in order to provide regular updates through the course of the study
* Participant must be 18 years of age or older

Exclusion Criteria:

* Patient has an ECOG score of 4 or higher
* Patient is not able to provide consistent digital updates as per study requirements
* Patient does not complete or agree to terms outlined in the Informed Consent Form
A Study to Assess the Systemic Disposition of ASP1585 After Administration of 14C-labeled Drug

The objective of this study is to assess the systemic disposition of ASP1585 after oral administration of 14C-labeled drug in healthy male subjects.

Subjects will receive study drug for 18 days with a radioactive dose of study drug given on Day 15. Blood, urine and feces will be collected to confirm recovery of radioactivity.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 32 kg/m2, inclusive and minimum body weight 45 kg
* Agrees to sexual abstinence or to use a highly effective form of birth control which includes a barrier method throughout the study
* In good health

Exclusion Criteria:

* History of any clinically significant disease
* History of bowel obstruction, swallowing disorders, gastrointestinal disorders, gastrointestinal surgery, actively bleeding hemorrhoids, or gastric/duodenal ulcers
* Irregular bowel habits (\<1 bowel movement per day)
* Clinically significant illness within 30 days
* Received any drug or medicine (prescription or over-the-counter), including topical medications, complementary and alternative medicines and vitamin and mineral supplements within 14 days prior to the first dose of study drug
* Received any investigational medication during the last 30 days or 5 half-lives, whichever is longer, prior to screening
* Consumes \>10 units of alcohol per week or history of alcoholism or drug/chemical abuse within past 2 years
* Smokes cigarettes or other nicotine-containing products
* Anticipates an inability to abstain from alcohol use for 48 hours prior to first dose of study drug or from grapefruit, Seville oranges, star fruit or products containing these items from 72 hours prior to first dose of study drug until end of study
* Positive drug or alcohol screen at Screening or Day -1
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) value of \>2x upper limit of normal at Screening or Day -1
* Known positive for human immunodeficiency virus (HIV), Hepatitis A, Hepatitis B or Hepatitis C
* Unwilling or unable to swallow large numbers of capsules
* Significant blood loss, donated one unit of blood or more, or received a transfusion of any blood or blood product within 60 days or donated plasma within 7 days prior to Day -1
* Known cumulative radiation exposure \>5 rems for the whole body, active blood forming organs, ocular lens, and gonads, and \>15 rems for other organs
* Has had nuclear medicine procedures, computed tomography scans, or significant x-rays (other than dental) within the past 12 months, has received radiolabeled material within the last 6 months, or has had significant occupational radiation exposure
* Has participated in a radiolabled study within the last 6 months or participated in more than one radiolabeled study within the last 12 months
Active Choice in the EHR to Promote Statin Therapy

Cardiovascular (CV) events are the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing CV events and mortality, but statins are often either not prescribed or under-prescribed for patients that meet evidence-based guidelines. In this study, we will evaluate a health system initiative using active and passive choice prompts in the electronic health record to prompt cardiologists to prescribe evidence-based statin therapy. In partnership with the health system, this will be conducted as a randomized, controlled trial to evaluate its effect.

This study will use a randomized, controlled trial to evaluate a health system initiative. Cardiologists randomly assigned to the control arm will receive no interventions. For cardiologists randomly assigned to the active choice intervention, the electronic health record will be used to prompt cardiologists to initiate or change statin therapy for patients not on evidenced-based guidelines based on the 2013 American College of Cardiology / American Heart Association (ACC/AHA) and the National Lipid Association (NLA) through a "best practice alert" in Epic which appears on the screen and forces a decision before the clinician can move on. For cardiologists randomly assigned to the passive choice intervention, the electronic health record will be used to create a passive alert using the same evidence-based guidelines. The passive alert will not block clinician workflow and instead will be available in the background for the cardiologist to open and then use to make a prescribing decision. The intervention period will be 6 months in duration.

Eligibility Criteria:
Inclusion Criteria:

* Have a cardiologist at the University of Pennsylvania Health System
* Meets 2013 ACC/AHA or NLA guidelines for statin prescription

Exclusion Criteria:

* Allergy to statins
* Severe renal insufficiency defined as glomerular filtration rate (GFR) less than 30 mL/min or on dialysis
* Adverse reaction to statins including a) myopathy, b)rhabdomyolysis, c)hepatitis
* Pregnant
* On a PCSK9 Inhibitor medication
The Effectiveness of Eldecalcitol in the Bisphosphonate Non-respondered-patients With Osteoporosis

In the patients with osteoporosis, bisphosphonates (BPs) are a golden standard treatment. However, the bone turnover markers or the bone mineral density (BMD) are not improved in some osteoporotic patients even though they have taken BPs and alfacalcidol more than several years. In those case, the investigators better off prescribing BPs and Eldecalcitol, instead of BPs and Alfacalcitol.

Alfacalcitol and Eldecalcitol are the similar vitamin D drugs. However, Eldecalcitol is an improved vitamin D drug than Alfacalcitol. Therefore, we investigate the effectiveness of Eldecalcitol in this study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Osteoporosis
* Must be able to swallow tablets

Exclusion Criteria:

* N/A
Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD

It is a prospective, multi-institutional clinical study and targets patients diagnosed with chronic obstructive pulmonary disease. About 120 subjects (35 at Ilsan Paik Hospital, 35 at Severance Hospital, and 50 at Asan Medical Center in Seoul) will be subject to a random allocation of 1:1. The arbitration group implements living rules for responding to fine dust, supports air purifiers, and only general guidance is implemented in the non-property group. Patients are recruited from Asan Medical Center in Seoul (Songpa-gu, Seoul), Severance Hospital ( Seodaemun-gu, Seoul), and Ilsan Paik Medical Center (Goyang, Gyeonggi-do) for 12 months. During outpatient visits, lung function tests and airway resistance tests shall be conducted, and surveys presented in the research plan shall be conducted.

It is a prospective and multi-institutional clinical study targeting patients with chronic obstructive pulmonary disease in general.

A total of 120 COPD patients will be recruited from three institutions: Asan Medical Center, Severance Hospital, and Ilsan Paik Hospital. (60/30/30 expected) A panel of COPD patients is established to conduct prospective studies, and measures to mediate recurrence and deterioration of adult chronic respiratory diseases due to exposure to fine dust are presented. Improvement of the lifestyle of the arbitration forces. Detailed research methods such as air purifier support are presented in the research plan.

In addition, a fine dust measurement researcher visits each household to measure indoor fine dust concentration. The measurement method of fine dust concentration will be using the process test method, IoT-based sensors, and direct-to-read measuring devices to measure Air Korea's air pollution. Detailed visit timing and methods are carried out in the manner specified in the research plan.

We collect sputum at every visit and blood at the last visit.

Eligibility Criteria:
Inclusion Criteria:

* 40 years of age or older
* Waste function test results show FEV1/FVC\<0.7, FEV1 \<80% of forecast

Exclusion Criteria:

* Patients under 18 years of age with changes in medication (such as inhalants).
* Older people over 80 years of age.
* People with no respiratory symptoms with mMRC 0.
* Who doesn't understand a simple explanation for fine dust exposure devices.
* Someone who disagrees with the study.
Knowledge Attitudes Behaviours and Practices Regarding HIV of Sex Workers in the French Antilles

The aim of the study was to determine the knowledge attitudes, behaviours and practices of sex workers regarding HIV in Martinique, guadeloupe and Saint martin.


Eligibility Criteria:
Inclusion Criteria:

* sex worker living in the french antilles

Exclusion Criteria:

* refusal to participate
Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519

The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519.

A randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519 in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 aged and 45 aged in healthy adult male
* Body weight more than 50, Body Mass Index between 18 and 29kg/m²
* Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
* Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent

Exclusion Criteria:

* Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
* Have a acute disease within 28 days before the beginning of study treatment
* Have a disease history that can effect drug absorption, distribution, metabolism, excretion
* Have a clinically significant chronic disease
* Systolic blood pressure\<100mmHg or\>140mmHg, diastolic blood pressure\<60mmHg or\>90mmHg
* Defined by the following 12-lead ECG, QTc\>450msec
* Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
* Subject treated ethical drug within 14 days before the beginning of study treatment
* Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
* Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
* Cannot take standard Meal
* Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing
* Blood transfusion within 30 days
* Taking drugs have received any other investigational drug within 90 days prior to the first dosing
* Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
* Continuously taking caffeine(caffeine\>5 cups/day), drinking alcohol(alcohol\>210g/week), smoking excessive cigarettes(cigarette\>10cigarettes/day)
* Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasons(for example, noncompliance, a disobliging manner)
Use of Vibration During Constraint-induced Movement Therapy

The purpose of this study is to determine whether the hand function will improve more by using low-level vibration during constraint-induced movement therapy (CIMT), compared to CIMT alone without vibration.

The low-level vibration has been shown to increase therapy outcome when used as an adjunct to therapy in adults with hemiparesis. Children who participates in the CIMT camp at MUSC will be recruited to take part in the study. Participating children will wear a watch device on their weaker arm during CIMT. The watch will vibrate only for the children who were assigned to the treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral upper limb motor weakness
* Can use the affected upper limb as a gross assist during play and self-care activities
* Ambulatory for their age with intact balance and protective reactions in the less involved upper limb.

Exclusion Criteria:

* Developmental delays limiting spontaneous use of the affected upper limb
* Other health impairment
Alveolar Ridge Preservation With Different Grafting Strategies

The aim of the present study was to compare the half-packed grafts that are covered with either a collagen or a nonresorbable membrane to the conventional alveolar ridge preservation procedures involving full-packed grafts and collagen membrane. The primary purpose was to evaluate the bone dimensional changes between the groups, and the secondary objective was to assess the potential contributing factors to clinical, radiographic and implant-related outcomes under different alveolar ridge preservation procedures.

Regarding different surgical approaches in alveolar ridge preservation, limited studies directly compare collagen and non-resorbable membrane, and the comparison between half- and full- grafting strategy in clinical and radiographic outcomes was still lacking. The comparable effect of dimensional preservation between groups was shown except for more radiographic bone gain in full-grafting group. Contributing factors, including thin bone thickness , vertical root fracture related sockets, non-molar sites and large BPD might attenuate the effect of ARP. At implant placement, similar results in bone quality and keratinized mucosal width was found in all groups, while thicker vertical mucosal thickness was obtained when using nonresorbable membrane. All surgical modalities in alveolar ridge preservation yield stable peri-implant health 1 year after implant placement.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 20 years old
2. presence of one or more hopeless teeth requiring extraction and subsequent implant placement due to reasons such as crack tooth, vertical root fracture, endodontic failure, unrestorable caries and severe periodontitis
3. the extraction socket should have more than two walls for ARP, which includes type I-II sockets (Palatal/ lingual defects were also included)
4. participants should have a stable periodontal condition or history of periodontitis that is well-controlled with good oral hygiene. The pocket depth of the adjacent tooth around the socket should be less than 3 mm as assessed with a periodontal probe (Hu-Friedy, Chicago, IL, USA).

Exclusion Criteria:

1. heavy smokers consuming more than half pack of cigarettes daily
2. women who were pregnant, lactating, or planning to be pregnant
3. history of psychiatric disorders
4. uncontrolled and complicated medical conditions that might hinder wound healing or bone metabolism, including poorly controlled diabetes, autoimmune disorders, receiving current radiotherapy in the head and neck regions, taking bisphosphonate and other antiresorptive agents.
A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD

The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.


Eligibility Criteria:
Inclusion Criteria:

* Subfoveal CNV secondary to AMD
* At least 1 but not more than 3 prior treatments for AMD

Exclusion Criteria:

* Subfoveal scar or subfoveal atrophy
* Significant media opacities, including cataract, which might interfere with visual acuity
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18 years or above at the time of signing the informed consent
* Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m\^2)

Exclusion Criteria:

* Glycated haemoglobin (HbA1c) ≥ 6.5 % (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening
* History of type 1 or type 2 diabetes mellitus