cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A

The purpose of this prospective study is to determine the efficacy and safety of Rituximab plus Bortezomib in patients with newly diagnosed acquired hemophilia A.

This is a prospective, single-arm, open-label clinical trial to evaluate the efficacy and safety the regimen of Bortezomib with rituximab as first-line treatment to eradicate anti-factor VIII antibodies in newly diagnosed acquired hemophilia A.

All of enrolled patients in this study will be injected Bortezomib plus rituximab. This study will be performed for about 2 years and approximately 22 patients will be enrolled in our insititution.

After obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed.

Patients who meet the inclusion/exclusion criteria will be received the regimens: Bortezomib (1.3mg/m2 d1,4,8,11) with rituximab (375mg/m2 for one dose). The information of adverse events will be collected. In case that the evaluation of treatment response might be performed in regular clinical practice, those data will also be collected as well.

Eligibility Criteria:
Inclusion Criteria:

1. Must be ≥ 18 years;
2. Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted;
3. Diagnosis of acquired hemophilia A；
4. acute bleeding episodes(≥once).

Exclusion Criteria:

1. Uncontrolled systemic infection;
2. Allergy to rituximab;
3. Positive for Lupus anticoagulant;
4. Life expectancy \< 3 months;
5. Pregnant and breastfeeding women;
6. Neuropathy\>Grade 1;
7. Positive for Hepatitis B surface antigen or hepatitis C antibody or human immunodeficiency virus（HIV）antibody;
8. Patients with poor compliance；
9. Patient who is considered by the investigator not suitable for clinical study.
A Study of S6G5T-3 in the Treatment of Acne Vulgaris

To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

In this Phase 3, multi-center, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 9 years of age with facial acne vulgaris will be eligible for enrollment for daily treatment with S6G5T-3 or its vehicle S6G5T-8, for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study.
2. Male and female 9 years of age and older.
3. Have 2 or fewer cysts or nodules.

Exclusion Criteria:

1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter (mm) in diameter).
2. Acne conglobata, acne fulminans, and secondary acne (for example, chloracne, drug-induced acne).
3. History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma).
4. Underlying disease that requires the use of interfering topical or systemic therapy.
5. Other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea.
Sticky Bone and Repeated Injectable PRF (iPRF) Application in Management of Periodontal Intrabony Defects

One of the main objectives of periodontal therapy is the regeneration of the tooth's supporting periodontal tissue to its original levels. The healing after non-surgical and conventional surgical methods is histologically characterized by a long junctional epithelium along the root surfaces. Therefore, reconstructive techniques are required. Although complete periodontal regeneration is unpredictable with any regenerative therapy currently used, so the objective of our trial is to get complete periodontal regeneration by using Sticky Bone and Repeated Injectable PRF (iPRF) in Management of Periodontal Intrabony Defects.


Eligibility Criteria:
Inclusion Criteria:

* No systemic diseases which could influence the outcome of therapy.
* Good compliance with plaque control instructions following initial therapy.
* Teeth involved were all vital with no mobility.
* Each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement
* Selected intrabony defects (IBD) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of ≥ 3 mm, the width of ≥ 3 mm at its most coronal part, with no cratering that involve both mesial and distal surfaces of adjacent teeth.
* Selected probing depth (PD) ≥ 6 mm and clinical attachment loss (CAL) ≥ 4 mm at the site of intraosseous defects four weeks following initial cause-related therapy.
* Availability for the follow-up and maintenance program; 8) absence of periodontal treatment during the previous year.

Exclusion Criteria:

• Pregnant females.
Effects of Core Stability Exercises and Cognitive Tasks on Chronic Non-specific Back Pain

This randomized control trial study aims to compare the effect of core stability exercises and cognitive tasks with general exercises and cognitive tasks on pain, disability, and postural control strategies of chronic non-specific low back pain patients. The main questions are:

1. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in reducing the pain of chronic non-specific low back pain patients?
2. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in reducing the disability of chronic non-specific low back pain patients?
3. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in improving postural stability parameters of chronic non-specific low back pain patients?
4. Are core stability exercises and cognitive tasks more effective than general exercises and cognitive tasks in improving stabilogram diffusion analysis parameters of chronic non-specific low back pain patients? This study is designed to apply two exercise protocols on two groups of 17 people with non-specific back pain. Group A will receive core stability exercises along with cognitive tasks, and group B will receive general exercises along with cognitive tasks.

Patients will be aged between 18-50 years. All patients meeting the inclusion criteria will receive 16 training sessions (thrice a week). The primary outcome measure will be pain and disability. Secondary outcome measures will be postural control strategies (including postural control stability and stabilogram diffusion analysis), quality of life, fear of movement, and fear-avoidance beliefs that will be assessed before and after training sessions and at 3-month follow-up; only primary outcomes will be evaluated in each group.

Eligibility Criteria:
Inclusion Criteria:

* Orthopedist-confirmed diagnosis of chronic nonspecific low back pain that has lasted at least three months since its onset.
* Pain score of 3 or more on a visual analog scale.
* Pain during quiet standing.
* Cognitive level above 24 based on mini-mental state examination (MMSE).

Exclusion Criteria:

* Radicular pain and any neurological signs.
* Uncorrected vision impairment.
* Hearing problems.
* Vestibular dysfunctions.
* Cognitive deficit.
* Previous spinal surgery.
* Severe deformity or injury to the lower extremities.
Effect of IMO on Intestinal Microbiota Translocation in Cirrhosis

The goal of this intervention clinical trial is to learn about the protection of isomaltooligosaccharides (IMO) on intestinal bacterial translocation in patients with liver cirrhosis. The main question is to answer the changes of LPS after adminstration of IMO.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18-75.
* Cirrhotic patients.
* Decompensation event: ascites.
* LPS\>0.45EU/ml.

Exclusion Criteria:

* Pregnant or breast-feeding.
* Active bacterial or fungal infection.
* Other decompensations: Hepatic encephalopathy, gastroesophageal varices and hemorrhage.
* Diagnosis of EASL-ACLF.
* Diarrhea.
* Malignancy.
* Anticipated short survival time.
* Adverse reactions or allergies to oral carbohydrate preparations.
* Substance abuse or addiction.
* Severe extrahepatic diseases (e.g. patients with CKD-5 stage, severe cardiopulmonary dysfunction, and psychiatric disorders).
* Be immunosuppressed or immunodeficient states and the use of immunoglobulins or other immune-boosting conditions.
* Be unsuitable for participating in this trial.
* Participated in any drug trial within the past month
* History of antibacterial or fungal use within 1 week prior to screening
Observational Triveneto Study on the Use of Adjuvant Hormonal Therapies in the Treatment of Hormone-responsive Breast Cancer

There are different types of hormonal therapy medicines for the treatment of hormone-receptor-positive breast cancer. The purpose of this study is to determine the evolution of two types of hormonal treatment (the drug called "tamoxifen" and a group of medicines called "aromatase inhibitors") during two time periods of 12 months each, in years 2006 and 2008, in the northeast Italian regions. The study will include post-menopausal women who have initiated hormonal therapy medicines in 2006. The study will also verify the rate of implementation of the updated national and international recommendations for the use of adjuvant hormonal therapy in the hormone-receptor-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy between January 2006 and December 2006 or between January 2008 and December 2008
* Documented evidence of the way adjuvant hormonal treatment was initiated.

Exclusion Criteria:

* Pre- or peri-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy
* Patients already enrolled in clinical studies aimed at investigating hormone therapies
Effect of Pharmaceutical Consultations Just Before Rheumatology Consultations on Improving Knowledge and Skills for Patients With Inflammatory Arthritis With Subcutaneous Biologic DMARDs

There is a lack of knowledge among patients concerning their treatment with bDMARDs. To increase knowledge and safety skills, patient education is essential.

The aim of this study is to assess the impact of a pharmacist's educational interview on on knowledge and safety skills to bDMARDs in patients with inflammatory arthritis.

This is an observational, controlled, open-label and monocentric study. 60 patients are planned to be included.

Knowledge are assessed three time by self-administered questionnaire:

at baseline before the pharmacist's educational interview at three months apart at six months apart

One primary end-point is defined:

the changes from baseline to M3 and M6 in the patients' knowledge score about subcutaneous bDMARD management (self-administered questionnaire, Biosecure)

As secondary end-points, the changes from baseline to M3 and M6 in patients' adherence, patients' satisfaction regarding the pharmacists' intervention and the effect of the interview on rate of patients treated by biosimilar are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to understand and communicate in French and comply with the requirements of the study and must give his agreement (non-opposition) before any study assessment is performed.
* Patient at least 18 years of age
* Patient with inflammatory arthritis (rheumatoid arthritis or ankylosing spondylitis or other)
* Admission in medical consultation in the rheumatology department
* Patient treated with subcutaneous biologic DMARDs (Tocilizumab, Adalimumab, Etanercept, Golimumab, Certolizumab, Abatacept, Sarilumab, Ustekinumab, Ixekizumab, Anakinra)

Exclusion Criteria:

* Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from completing the study per protocol
Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.

The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.

This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated
* Have clear intraocular media
* Have potential Best Corrected Visual Acuity of 20/40 or better
* Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse

Exclusion Criteria:

* Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period
* Are monocular
* Have current ocular infection
* Are taking systemic steroids or other anti-metabolites
* Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study

Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
How Spinopelvic Movements Affect Hip Function After Total Hip Arthroplasty

Our study aims to evaluate the effect of spinopelvic movement on hip functions in individuals who have undergone total hip arthroplasty (THA). This study will contribute to the literature by helping identify and prevent issues experienced by THA patients, ranging from hip pain to limited mobility and even hip dislocation.

Total hip arthroplasty (THA) is a widely accepted surgical procedure that effectively alleviates pain, enhances mobility, and improves physical function in patients with hip osteoarthritis. However, improper placement of implants during surgery can lead to complications such as abnormal edge loading, early wear of polyethylene components, ceramic insert fractures, or hip dislocations, often requiring early revision surgeries. While Lewinnek's "safe zone" (30°-50° inclination and 5°-25° anteversion for the acetabular component) has traditionally been used as a guideline, recent studies have reported significant dislocation rates even within these parameters, highlighting spinopelvic movement abnormalities as a critical factor. Normal spinopelvic-hip mechanics allow for adaptive changes in the pelvis and acetabulum during positional transitions, thereby preventing anterior or posterior impingement in the hip joint. However, patients with restricted lumbosacral mobility are at a greater risk of impingement-related symptoms. To address these challenges, advanced metrics such as sacral slope difference (ΔSS), pelvic-femoral angle (PFA), and combined sagittal index (CSI) have been introduced to better define functional safe zones and assess risks of hip impingement and dislocation. While the relationship between CSI and hip dislocations is established, its impact on hip function remains unclear. This study aims to evaluate the effect of spinopelvic movement on hip function in individuals who have undergone THA. By identifying and preventing complications such as hip pain, mobility restrictions, and dislocations, the research seeks to provide meaningful contributions to the literature and improve patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 and older.
* At least 12 months post-surgery.

Exclusion Criteria:

* Patients with modular neck implants, metal-metal, or ceramic bearing surfaces.
* Patients with hip infection or advanced osteoarthritis in the contralateral hip.
* Patients with leg length discrepancy.
* Patients with neurological, orthopedic, or systemic diseases affecting gait or balance.
* Patients with a body mass index (BMI) greater than 40 kg/m².
A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Colorectal Cancer

This single arm study will assess the resection rate of liver metastasis, time to disease progression, and safety of neoadjuvant treatment with Avastin in combination with oxaliplatin and capecitabine (XELOX) in patients with metastatic colorectal cancer with unresectable liver metastasis. Patients will receive Avastin 5mg/kg iv on day 1 of every 2 week cycle, oxaliplatin 85mg/m2 iv on day 1 of every 2 week cycle, and capecitabine 1000mg/m2 on days 1-5 and 8-12 of every 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \<=75 years of age;
* chemotherapy-naive for stage IV colorectal cancer with unresectable liver metastasis;
* \>=1 measurable lesion;
* ECOG status 0-2.

Exclusion Criteria:

* prior exposure to Avastin;
* clinical or radiological evidence of CNS metastases;
* uncontrolled hypertension, or clinically significant cardiovascular disease;
* ongoing treatment with aspirin (\>325mg/day) or other medications known to predispose to gastrointestinal ulceration.
A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.

The study consists of Screening Phase(4 weeks before administration of study drug),Active Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study periods,safety assessments(example\[e.g\] recording of adverse events,Vital signs,Tuberculosis evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be performed per the study procedures.The primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of plaque-type psoriasis (with or without \[Psoriatic Arthritis\]PsA) for at least 6 months before the first administration of study drug
* A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0 and agree to urine pregnancy testing before receiving injections
* Agree not to receive a live virus or live bacterial vaccination during the study, or within 3 months after the last administration of study drug
* Agree not to receive a Bacille Calmette-Guérin (BCG) vaccination during the study, or within 12 months after the last administration of study drug
* Agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during study

Exclusion Criteria:

* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has previously received guselkumab or secukinumab
* Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
* Has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance; or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
* Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers

To determine the mass balance of PD 0200390


Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* unhealthy, or concomitant meds
Interventions for Sanctioned Ohio University Students

The purpose of this study is to determine whether (a) a brief alcohol intervention, (b) a brief bystander and social norms intervention, or (c) a brief alcohol and a brief bystander and social norms intervention are effective at reducing alcohol use and sexual-related behaviors among college men mandated to receive an alcohol intervention by their university.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 or older; must be an ohio university student; must be male; must be sanctioned to receive an alcohol intervention by Ohio University

Exclusion Criteria:

* Under the age of 18; not attending the main Ohio University campus (Athens)
Usability and Practicality of Mystic Pets in Hospital Setting: a Feasibility Study

This mixed-methods study seeks to evaluate the feasibility of Mystic Pets software and hardware within the pediatric population. This study will take place at Lucile Packard Children's Hospital (Stanford University, Palo Alto, CA).

Hospitalized children often experience anxiety related to medical procedures, unfamiliar environments, and limited control over their situations. Existing distraction techniques, such as traditional videos and gaming, often rely heavily on visual interfaces, which can be limiting in clinical contexts. Current immersive technology software and hardware for procedural distraction rely on partial to complete immersion in a computer-generated environment to the real world. While immersive technology can reduce anxiety with distraction, some patients experience increased distress due to loss of visual connection with their surroundings and/or caregivers. Using a head-mounted device and hand-gesture inputs, Mystic Pets maintains visual contact with a person's surroundings while gameplay is advanced through audio input and hand-gestures.

This research will significantly contribute to the growing field of digital therapeutics by providing early-stage data on a novel, immersive technology tailored to pediatric clinical care. If proven feasible, Mystic Pets could expand the toolkit available for procedural distraction, enhance patient comfort, and reduce the reliance on pharmacological interventions for anxiety management.

The study also aims to establish preliminary engagement and usability benchmarks to guide future development and deployment of similar technologies in hospital environments.

Eligibility Criteria:
Inclusion Criteria:

* Between 4-18 years
* English speaking participants

Exclusion Criteria:

* Legal guardian not present to obtain consent
* child with hearing impairment
* child with a significant neurological condition, or major developmental disability
* child with facial abnormalities or injuries prohibiting use of headsets