cyrilzakka/clinical-trials huggingface dataset:
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients

A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of PBC as demonstrated by the presence of at least 2 of the following 3 diagnostic criteria:

  * History of alkaline phosphatase (ALP) elevated above upper limit of normal (ULN) for at least 6 months
  * Positive antimitochondrial antibodies (AMA) titer or if AMA negative or in low titer (\<1:80) PBC specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components (PDC-E2, 2-oxo-glutaric acid dehydrogenase complex))
  * Previous liver biopsy findings consistent with PBC
* At least 1 of the following markers of disease severity:

  * ALP ≥ 1.67 × ULN
  * Total bilirubin \> ULN but \< 1.5 × ULN
* In addition, patients must meet the following biochemical criteria at enrollment:

  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 × ULN
  * Total bilirubin ≤ 1.5 × ULN
  * INR ≤ ULN
* Taking UDCA for at least 12 months, or for at least 6 months and has reached maximal response to UDCA with a plateau in alkaline phosphatase, with no changes in dose for ≥ 3 months prior to Day 1.
* Patients must weigh at least 40 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2

Exclusion Criteria:

* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception for 30 days before randomization, during dosing and for 30 days following the end of treatment.
* Presence of other concomitant liver diseases.

  * Cirrhosis with complications, including history or presence of:
  * Variceal bleed
  * Uncontrolled ascites
  * Encephalopathy
  * Spontaneous bacterial peritonitis
* Significant hepatic impairment as defined by Child-Pugh classification of B or C, history of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥15.
* History of conditions that may cause increases in ALP (e.g., Paget's disease).
* Use of investigational drugs, or immunosuppressive drugs at the time of enrollment, or within 5 half-lives, or 30 days of randomization, whichever is longer; or longer if required by local regulations. Use of high dose oral steroids to treat co-morbid conditions (e.g., airways disease) will be allowed but must be properly documented as such in concomitant medications.
* Currently taking obeticholic acid or have taken obeticholic acid within 30 days of randomization
* Previous participation in CLJN452X2201 and received study medication within three months of randomization (or longer if required by local regulations).
Postoperative Pain Management in Rhinoplasty

The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. To assess the degree of pain, the participants will score the intensity of their pain on a visual analog scale(VAS)of 0-100points (0- no pain and 100- most severe pain), preoperatively and postoperatively (to be documented before each dose) for the duration of the prescribed medications .

Additionally, the study will also seek to track:

1. The total number of pills each patients consume from the prescribed 5 day regimen.
2. Any associated side effects.
3. Additional pain medications prescribed in case of inadequate pain control, postoperatively.

From this study, the investigators hope to learn the following:

1. Is adequate postoperative pain management after nasal surgery achieved with opioid or non-opioid drugs?
2. If opioid drugs are required for adequate pain control postoperatively, is it possible to reduce the number of days the drugs are prescribed for?
3. What are the common side effect profiles of the included drugs?

In light of the current opioid epidemic in the country, it is important the the physicians explore the utility of drugs other than opioids for adequate postoperative pain management. Also, reducing the dosage and/or number of prescribed opioid drugs lessens the propensity for misuse of physician prescribed opioid medications.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Able to speak and understand english.
* Undergoing rhinoplasty for cosmetic purposes
* Undergoing rhinoplasty for treatment of nasal obstruction

Exclusion Criteria:

* Less than 18 years of age
* Cannot speak and understand english
* Patients who have undergone nasal surgery in the past
* Patients not undergoing nasal surgery
* Women will be excluded if they are either pregnant or lactating as this population does not undergo nasal surgery at our center.
* Patients with any known allergies to the class of pain medications used in the study.

Please note: Any person interested in this clinical trial should contact the Facial Plastic and Reconstructive Surgery clinic at (650) 736 - 3223 to schedule a consultation with Dr. Sam P. Most to assess their eligibility for the trial. Please note, enrolling in the clinical trial will not entitle the participant to a waiver of charges associated with undergoing nasal surgery.
Specialty Medical Homes to Improve Outcomes for Patients With IBD and Behavioral Health Conditions

A comparative effectiveness study using an individual-level randomized design along with a pragmatic, mixed-methods approach to compare two strategies (e.g. in-person supported care, technology-supported care) all of which include evidence-based components for delivering IBD and BH care. Quantitative (e.g. self-report, electronic health record, process) and qualitative (e.g., interviews) data will be collected across multiple time points during the study period.

The investigators propose to conduct a comparative effectiveness research (CER) study of two evidence-based, patient-centered approaches implemented within an existing Specialty Medical Home (SMH) model: TEAM, an in-person, multidisciplinary team-based approach delivered at point of care and TECH, a technology-based (digital therapeutics, and telehealth) approach delivered at the patient's convenience with the guidance of health coaches. Both are designed to support care for adult patients with complex, chronic health conditions and behavioral health (BH) disorders, and will be tested in three of the nation's largest and most established SMHs for inflammatory bowel disease (IBD). IBD serves as an exemplary chronic disease model where untreated BH issues have been associated with poor medical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Inflammatory Bowel Disease Diagnosis of Crohn's or Ulcerative Colitis. Behavioral health symptoms mild to severe, defined as a score of \>= 6 on the Personal Health Questionnaire 4 (PHQ4)

Exclusion Criteria:

* Lack of smart phone, and/or are unable to speak, read or understand English at the minimum-required level.
Safety, Efficacy, and Survival Outcomes of Neoadjuvant/Induction Immunotherapy in Surgical and Radiotherapeutic Management of Non-Small Cell Lung Cancer

This multicenter retrospective real-world study aims to evaluate the safety, efficacy and survival outcomes of neoadjuvant/induction immunotherapy in patients with non-small cell lung cancer (NSCLC). The study covers diverse treatment pathways, including surgery, definitive radiotherapy, and non-surgical strategies. It addresses gaps in existing trials by establishing a comprehensive cohort spanning neoadjuvant/induction therapy, perioperative management, and follow-up, providing real-world evidence to support treatment decisions in both operable and inoperable cases.

Lung cancer is the leading cause of cancer-related deaths in both China and the world. In recent years, neoadjuvant immunotherapy has achieved breakthrough advancements in the treatment of non-small cell lung cancer (NSCLC). Evidence from multiple Phase III randomized controlled trials (RCTs), such as CheckMate 816, KEYNOTE-671, and AEGEAN, has demonstrated clear benefits of this therapy in improving survival. However, these studies exhibited several limitations: first, stringent selection criteria resulting in limited heterogeneity among participants challenge the generalizability of their conclusions; Second, some studies and clinical observations have preliminarily suggested that neoadjuvant immunotherapy may increase technical surgical difficulty; however, large-sample, real-world data on its perioperative safety remain limited; third, clinical practice involves numerous borderline resectable and unresectable cases, leading to highly complex treatment decisions (such as timing of surgical intervention after conversion therapy, radiotherapy strategies, etc.), with none of the existing guidelines reach clear consensus.

This study employs a multicenter real-world design, establishing a retrospective cohort covering from neoadjuvant/induction therapy period to the surveillance period. It evaluates the safety, efficacy, and survival outcomes of neoadjuvant/induction immunotherapy across diverse treatment strategies including both surgery and radiotherapy, providing real-world evidence to inform clinical decision-making.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed non-small cell lung cancer (NSCLC), regardless of the presence of EGFR or ALK sensitive driver gene mutations;
2. Clinical staging of IA-IIIC according to the AJCC 8th Edition before neoadjuvant treatment;
3. Received at least one cycle of neoadjuvant immunotherapy (with or without chemotherapy);
4. Assessed as resectable or potentially resectable by surgical experts prior to treatment.

Exclusion Criteria:

1. Confirmed M1 disease;
2. History of previous lung malignancy or other metastatic malignant tumors;
3. Participation in other randomized controlled trials involving neoadjuvant treatment;
4. Significant missing clinical data.
Double Versus Single Pledget Nasal Anesthesia for Transnasal Endoscopy

Unsedated ultrathin transnasal esophago-gastro-duodenoscopy (UT-EGD), in comparison with conventional peroral EGD (P-EGD) has been shown to be more tolerable, safer, cost-effective and time-efficient. The investigators and in other studies have showed that nasal pledgetting (or commonly termed nasal packing) is better than nasal spray in terms of patient tolerance and visual capacity. Although pledgetting method to a selected meatus can achieve better decongestion effect, epistaxis and nasal pain in some patients are still frustrating to endoscopists.

The investigator has proposed a novel meatus scoring scale to evaluate nasal insertability by anterior rhinoscopy using a transnasal endoscope. The investigator also suggest endoscopic-guided gauze pledgetting can provide precise nasal anesthesia, thereby reducing trauma/bleeding in the nasal cavity and increasing patient tolerance during transnasal endoscopy. Endoscopic guidance to deliver a gauze strip can confirm delivering it to at least the posterior end of a turbinate. We hypothesize that by using endoscopic-guided method, gauze pledgetting to both the inferior nasal meatus (INM) and middle nasal meatus (MNM) simultaneously is more tolerable than only gauze pledgetting to a single meatus.

Nasal anesthesia is the rate-limiting step for a well tolerable unsedated transnasal esophago-gastro-duodenoscopy (UT-EGD) procedure. The investigator has proposed that a simple Endoscopic-Guided Gauze Pledgetting method (EGGP) is more tolerable than the "blind" cotton-tippled applicator method to deliver a gauze strip for anesthetizing the nasal cavity. The initial idea of EGGP is to anesthetize only one single selected meatus. To compare patient tolerance, safety and adverse events between double pledget (DPNA, i.e. INM and MNM) versus single pledget (SPNA, i.e. INM or MNM) methods of nasal anesthesia, the investigator is going to conduct a prospective randomized-controlled trial. The rationale for using double pledget is threefold: (1) the middle meatus is bounded by the INT and MNT; (2) the inserting and exserting meatuses may be different; (3) erective spongy tissue is mainly distributed in the inferior and middle turbinates and the nasal septum. Therefore, the primary objective of this study is to evaluate whether DPNA is more tolerable and safer than DPNA before UT-EGD.

Eligibility Criteria:
Inclusion Criteria:

All outpatients with epigastric discomfort (non-ulcer dyspepsia), aged 18-65 years are eligibility for this study.

Exclusion Criteria:

* Patients who can not answer questionnaires, who have prior nasal trauma or surgery, recent or present upper gastrointestinal bleeding and coagulopathy are excluded from this study.
* Patients who are allergic to lidocaine and who have uncontrolled hypertension or coronary artery disease are not recruited.
Pilot Trial on Immunosuppression Modulation to Increase SARS-CoV-2 Vaccine Response in Kidney Transplant Recipients

Mycophenolate has been identified as risk factor for non-response to SARS-CoV-2 vaccination in kidney transplant recipients. Safety and efficacy of temporarily stopping of mycophenolate (or azathioprine) to increase vaccine response has not been established.

This is a non-randomized, controlled pilot study including up to 40 kidney transplant recipients not responding to at least three previous SARS-CoV-2 vaccine doses. Mycophenolate or azathioprine will be stopped for two weeks peri-vaccination starting one week before vaccination until one week after vaccination. Allocation to mycophenoalte or azathioprine discontinuation arm will be based on an overall risk assessment by the transplant physician and patient preference. Patients not stopping mycophenolate or azathioprine will serve as control group.


Eligibility Criteria:
Inclusion Criteria:

* Patient has received a kidney transplantation
* \> 18 years of age
* No SARS-CoV-2 spike protein antibodies four weeks after at least three previous vaccine doses
* Maintenance immunosuppression with mycophenolate or azathioprine

Exclusion Criteria:

* acute illness with fever
* Prior documented infection with SARS-CoV-2
* triple anticoagulation therapy
* Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
* Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study
* Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures
* Subject is pregnant or breast feeding
* SARS-CoV-2 spike protein antibodies four weeks after the 3rd last vaccination \> 0.8 BAU/mL
Peri Implant Soft Tissue Healing in Single Implant Restoration Using Two Different Techniques

The aim of the present study was to propose the employment of Bio-Oss® and Bio-Gide® at implant site in order to evaluate if the increased bucco-lingual bone thickness could enhance the stability of peri implant soft tissue, when compared to the grafting technique ( bilaminar technique), performed in association with implant placement .

With respect to the soft tissue management many surgical approaches have been described in order to increase soft tissue volume and keratinized tissue height at implant site: roll flaps, connective tissue graft , epithelial connective tissue graft. In recent years, soft tissue substitutes , such as acellular dermal matrix or collagen matrix have been proposed to increase the dimensions of peri implant soft tissues; however, further studies have demonstrated that the allograft materials were less effective and less predictable than autogenous soft tissue grafts, in terms of increasing attached keratinized tissue , due to the considerable shrinkage and inconsistent quality of the attached tissue gained ; consequently soft tissue graft from the palate are currently considered the gold standard for augmenting peri implant soft. Some clinical studies proposed the association of contour augmentation by guided bone regeneration (GBR) with implant placement. The aim of these procedures is to restore the missing volume and to establish a facial bone wall of sufficient height and thickness to serve as a support for peri implant soft tissues; in these terms, GBR could be considered important to increase the stability of peri implant soft tissue , preventing the marginal soft tissue shrinkage and the following exposition of implant . This could be a valid approach to stabilize coronal peri implant soft tissue and at the same time less traumatic than grafting procedures.

Eligibility Criteria:
Inclusion Criteria:

* one missing tooth in the anterior maxilla
* facial keratinized mucosa thickness of at least 2mm

Exclusion Criteria:

* heavy smokers
* systemic diseases
Developing a Daily-use Fall Risk Assessment Device in Clinical Setting

Study Objectives Objective 1: Compare the fall risk assessment results between balance sensors, traditional tests, and clinical diagnoses.

Objective 2: Improve the feasibility of using sensors to assess fall risk among older patients in the hospital.

The investigators select Hong Kong as the region for the experiment. Specifically, the community clinics and daytime hospitals are the actual onsite locations for experimenting. The specific venues of these locations need an electrical power supply and a flat ground for conducting the device test. Patients will be recruited for the development and testing of a device for fall risk assessment, study participants will be involved in balancing assessments, and questionnaire surveys, their medical records will be accessed. And during these tests and questionnaire surveys, the investigators will take photos, videos, and or audio recordings.


Eligibility Criteria:
Inclusion Criteria:

1. Older adults aged 60 years and above;
2. Understand Cantonese or Mandarin or English;
3. Clinical patients in the clinics.

Exclusion Criteria:

1. Unable to give written informed consent (e.g., illiterate or with cognitive impairment);
2. Inability to stand for 30 seconds without any assistance.
Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray.
2. Subject's pain score is 8-13 points (Lequesne's index).
3. Ages between 50-70 years.
4. Signed informed consent from the subject.
5. Female subjects should be post-menopausal women

Exclusion Criteria:

1. Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV.
2. Subject not suitable for liposuction surgery.
3. Subject with hypersensitivity/allergy to anesthetic.
4. Subject's creatinine values higher than 1.6mg/dl.
5. Subject with body mass index, BMI over 30.
6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
7. Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
8. Subject enrolled in any other cell therapy studies within the past 30 days.
9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.
Efficacy and Safety Study of GB-0998 for Treatment of Steroid-resistant Polymyositis and Dermatomyositis (PM/DM)

This randomized, double-blind, placebo-controlled trial will carry out to assess the efficacy of GB-0998 in the treatment of the steroid-resistant polymyositis and dermatomyositis based on the changes in manual muscle strength (MMT) scores as primary endpoint, and in addition, to assess the safety of GB-0998.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been defined as "definite" based on the criteria of Bohan and Peter for polymyositis and dermatomyositis.
* Patients who are defined as steroid-resistant ones based on the changes of scores on manual muscle testing (MMT) and serum levels of creatine kinase (CK) during observation period before administration of drug.

Exclusion Criteria:

* Patients with malignant tumors.
* Patients with acute interstitial pneumonia, including acute exacerbation of chronic.
* Patients with severe muscular atrophy for a long period.
* Patients with severe infectious disease.
* Patients who have the anamnesis of shock or hypersensitivity to this drug.
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who have the anamnesis of cerebral infarction or ischemic heart disease, or who having symptom of these diseases.
* Patients who have been diagnosed as IgA deficiency in their past history.
* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant.
* Patients who were administered immunoglobulin dosage within 6 weeks before consent.
The Effect of Different Sound Stimulation on The Residual Inhibition of Tinnitus

The purpose of this study is to compare the effect of different sound stimulation on the residual inhibition of tinnitus. In this study, tinnitus patients will be assigned to a cross-over intervention of tinnitus frequency-centered narrowband noise stimulation and low frequency burst sound stimulation.

Residual inhibition (RI) is a common phenomenon of short-term suppression of tinnitus, which refers to the suppression or reduction of tinnitus even after the end of the masking sound. RI is instructive in selecting tinnitus patients suitable for sound therapy. However, the effect of different sound stimulation on the RI of tinnitus remains unclear.

In this study, we hypothesized that low frequency burst sound stimulation is superior to tinnitus frequency-centered narrowband noise stimulation for tinnitus relief, as measured by subjective tinnitus loudness changes. Meanwhile, the neurophysiological mechanisms were further explored by EEG and fNIRS.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged between 18 and 70 years old.
2. Subjective tinnitus.
3. Unilateral tinnitus or bilateral tinnitus of the same pitch.
4. Can communicate in Mandarin or with the help of an agent.
5. 50 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
6. Subjects or their legal representatives can understand the purpose of the study, voluntarily participate and can cooperate in completing the experiment according to the instructions, and sign the informed consent form.

Exclusion Criteria:

1. Vascular pulsatile tinnitus or objective tinnitus.
2. Bilateral tinnitus with different tones.
3. Patients with significant health problems that interfere with or prevent participation in the experiment or cooperation with follow-up visits.
4. Patients with severe auditory hypersensitivity and psychiatric disorders such as severe anxiety and depression;
5. Currently participating in other research programs that may affect tinnitus.
6. Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial.