cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients

Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Recipients of a kidney transplant from a deceased donor or a living donor

Exclusion Criteria:

* Recipient of any transplanted organ other than a kidney;
* Recipients of a bone marrow or stem cell transplant;
* Recipients of a kidney from a cardiac death donor;
* Recipients of a kidney from an ABO incompatible donor;
Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease

The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic coronary syndrome
2. Non-target lesions with stenosis ≥50% by visual assessment
3. Angina symptoms manageable via antianginal medication
4. High attenuation coefficient (≥-70.1 HU) of perivascular adipose tissue (PVAT) around non-target lesions as assessed by coronary CT angiography (CCTA)
5. Patients who are able to complete the follow-up and compliant to the prescribed medication

Exclusion Criteria:

1. Under the age of 18
2. Unable to give informed consent or currently participating in another trial and not yet at its primary endpoint
3. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
4. Concurrent medical condition with a life expectancy of less than 3 years
5. Haemodynamical unstable
6. Known contraindications to medications such as test drug and its components, heparin, or contrast
7. The following criteria are met for any of the laboratory test indicators at the time of screening ①ALT/AST \>3ULN；②TBil ≥2ULN；③WBC\>2ULN；④NEUT\<0.5×109 /L；⑤PLT\<30×109 /L；⑥eGFR \&amp;lt;60 mL/min/1.73 m2（CKD-EPI formula）
8. Suffering from severe systemic diseases, tumors, immune system disorders, infections, malignancy, which in the opinion of the investigator make participation in this study inappropriate
Efficacy of Manual Therapy and Sacroiliac Joint Injection in Sacroiliac Joint Dysfunction

The purpose of this study is to compare the efficacy of manual therapy and sacroiliac joint injections in patients with sacroiliac joint dysfunction


Eligibility Criteria:
Inclusion Criteria:

* Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
* Pain score greater than 3 according to NRS
* Unresponsiveness to conservative treatment (such as exercise, NSAID)
* At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive

Exclusion Criteria:

* Refusing to participate in the study
* Pregnancy
* History of inflammatory disease (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, etc.)
* Infective sacroiliitis
* Malignancy
* Osteoporosis
* Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
* Neurological finding in the lower extremity
* Pain spreading below the knee
* History of spinal surgery
* History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)
Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy

The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN.

Symphogen was the sponsor for planning/conducting and reporting results for this trial.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
* Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation
* Previous treatment with an anti-EGFR monoclonal antibody (mAb) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:

  * Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on the anti-EGFR mAb-based therapy and
  * Documented disease progression (verified by computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\] according to RECIST (1.1) during or within 12 weeks following the last administration of anti-EGFR mAb
* Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies
* Other protocol-defined inclusion criteria could apply

Exclusion Criteria:

* More than 2 lines of prior chemotherapy in the palliative setting
* Expected survival \<12 weeks
* Subjects with known brain metastases
* Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
* Anti-EGFR mAbs within 14 days prior to Visit 2
* Major surgery within 4 weeks prior to Visit 2 and subjects must have recovered from effects of major surgery
* Other protocol-defined exclusion criteria could apply
Age Related Differences in Respiratory Immune Responses in Influenza Virus Infection

The goal of this observational study is to understand immune responses to viral airway infection in adults, including the elderly. The main question(s) to answer is/are:

Why do some individuals acquire only asymptomatic or mild Influenza A virus (IAV) infection while others become severely ill and even succumb to the same disease?

Participants will be asked to donate samples when seeking health care for influenza-like symptoms or if hospitalized for IAV or SARS-CoV-2. Samples asked for are:

* Blood sample by venepuncture
* Blood sample by capillary sampling
* Nasopharyngeal aspirate
* Nasopharyngeal swab
* Endotracheal tube aspirate
* Nasal swab
* Nasal curette
* Breath Explor (sampling of expired air)

Researchers will compare obtained results with the same type of samples from healthy controls.

This observational study will specifically investigate different immunological parameters in blood and at the site of infection in patients with IAV symptoms or confirmed infection to understand parameters related to disease course. Blood and airway samples will be analyzed for immune cell subsets and their functionality, antibodies and other soluble mediators and linked to clinical data. Immune cells will be analyzed using multi-color flow cytometry, RNA sequencing, and in vitro functionality assays. Fluids (plasma, serum, supernatants from airway samples and cell culture supernatants) will be analyzed using ELISA (and or similar methods), proximity extension assay (Olink), etc.

Eligibility Criteria:
Inclusion Criteria Patients:

* Influenza A like symptoms and/or
* Confirmed airway infection

Exclusion Criteria Patients:

* Current malignancies
* Immunosuppressive treatment, not including/except hydrocortisone

Exclusion Criteria Controls:

* Airway infection within the past four weeks
* Ongoing antibiotic treatment
* Immunosuppressive treatment
Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis

Primary objective

* To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery
* To validate the Thai version of disease-specific quality of life tool SNOT-22

Secondary objectives

* To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C with those who receive placebo
* To compare the disease-specific quality of life in patients who receive Mitomicin C with those who receive placebo
* To compare the side effects of Mitomicin C versus placebo


Eligibility Criteria:
Inclusion Criteria:

* All Thai adults (18 years and older) patients undergoing bilateral endoscopic sinus surgery for CRS
* Patients must not have following diseases or conditions

  * Cystic fibrosis based on positive sweat test or DNA test
  * Gross immunodeficiency (congenital or acquired)
  * Congenital mucociliary problem (eg. Primary ciliary dyskinesia)
  * Altered immune function such as patients with systemic vasculitis, systemic lupus erythematosus, end stage renal disease, cirrhosis, currently taking immunosuppressant or granulomatous disease
  * Severe comorbidity with life expectancy of less than 1 year, such as advanced stage malignancy patient, or severe infection
* Patients are willing to participate and provide written informed consent

Exclusion Criteria:

(None)
A Randomized Multicenter Study to Compare Two Types of Transplant in Adult Patients With Hematologic Malignancies

This is an open-label, prospective, observational, multicenter, randomized study to compare the efficacy between unrelated umbilical cord blood transplantation (UCBT) and HLA-haploidentical related hematopoietic stem cell transplantation ,after myeloablative conditioning for adult patients with hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. Age: subjects ≥ 18 and ≤ 55 years old.
2. Patients without suitable matched related donor
3. Diagnosed with acute leukemia or myelodysplastic syndrome in which allogeneic transplantation is considered the most potentially curative therapeutic option.
4. Written consent form signed.

Exclusion Criteria:

* Performance status: Eastern Cooperative Oncology Group(ECOG) score \>2
* Prior allogenic hematopoietic stem cell transplant
* Left-ventricular ejection fraction at rest \< 45%, uncontrolled arrhythmias or symptomatic heart failure.
* Diffusing capacity (DLCO) and/or forced vital capacity (FVC) \< 39% of predicted values or symptomatic pulmonary disease
* Altered liver function tests (total bilirubin \> 2 mg/dL and/or alanine aminotransferase, aspartate aminotransferase , and or active hepatitis or cirrhosis.
* Serum creatinine \> 2 mg/dL or estimated creatinine clearance \< 50 mL/min
* Evidence of uncontrolled bacterial, viral or fungal infection prior to the conditioning regimen
* Serious diseases that prevent patients from receiving chemotherapy treatments.
* Concomitant neoplasms.
* Pregnancy or breast-feeding.
* Any other medical, surgical or psychiatric condition that is considered by the attending and/or medical team as a contraindication for intensive treatment
Pelvic Angioembolization: A Prospective Multi-Institutional Study (Data From All Campuses Will be Used)

The investigator's propose a multicenter prospective observational study to investigate the use of embolization in patients with negative angiogram and to ascertain the optimal level of treatment when the angiogram is positive; non-selective vs. selective embolization.

The investigator's propose a multicenter prospective observational study to investigate the use of embolization in patients with negative angiogram and to ascertain the optimal level of treatment when the angiogram is positive; non-selective vs. selective embolization. The investigator's will divide patients into groups based on positive or negative angiogram. Within each group the investigator's will compare those embolized and level of embolization. All blunt trauma patients undergoing angiography for pelvic fracture associated hemorrhage will be eligible for the study. Demographic, physiologic, operative, and post-operative data will be collected including blood product resuscitation, classification and management of pelvic fracture, associated injuries, angiographic details, complications, outcomes and overall injury burden. The study population will be stratified based on presence of arterial hemorrhage on initial angiogram (positive or negative angiogram) and then further stratified based on performance of embolization. NSE will be defined as embolization of the main internal iliac artery, either unilaterally or bilaterally and SE as any embolization distal to the main internal iliac artery. Bivariable and multivariable analyses will be performed to determine differences in pelvic hemorrhage as measured by transfusion necessity and quantity of products required, complications and to identify independent risk factors for outcome variables. A power analysis was performed based off of thromboembolic complication difference in selective vs. non selective embolization and then again with blood transfusion requirement difference in embolized vs. not embolized for those who have no evidence of arterial bleeding on angiogram (IE the two questions the investigator's are trying to answer).The investigator's plan to complete the data collection and analysis by 1/1/2019.

Eligibility Criteria:
Inclusion Criteria:

* • All blunt trauma patients undergoing angiography for pelvic fracture associated hemorrhage

Exclusion Criteria:

* • Pregnant patients

  * Patients \< 18 years old
  * Patients undergoing angiography greater than 24 hours from arrival
Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life

This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life.

This was a single blind randomised controlled experimental study. The sample size of the study was calculated using the G\*Power 3.1.7 program, considering a 5% margin of error and 95% confidence interval, and was determined to be at least 61. Therefore, the sample was planned to consist of 122 pregnant women, including 61 pregnant women in the intervention group and 61 pregnant women in the control group.

Study Inclusion Criteria Being at least a primary school graduate. Being a primiparous pregnant woman. Being able to provide feedback. Study Exclusion Criteria Being a multiparous pregnant woman. Being a high-risk pregnant woman. Participants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained. The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre. The data were collected between November 2022 and November 2023. The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms. Each pregnant woman was individually enrolled in an education session held in the breastfeeding room. The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women. The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor.

Eligibility Criteria:
Inclusion Criteria:

* Being at least a primary school graduate.
* Being a primiparous pregnant woman.
* Being able to provide feedback.

Exclusion Criteria:

* Being a multiparous pregnant woman.
* Being a high-risk pregnant woman.
AMOUNT OF INTRAORAL OCCLUSAL ADJUSTMENTS IN OCCLUSAL SPLINTS FABRICATED USING FULLY DIGITAL VERSUS COMBINED DIGITAL WORKFLOW IN TMD PATIENTS

Each eligible patient will be randomly into one of two groups:

group A: Occlusal splints fabricated using a fully digital workflow including the use of a jaw tracking device.

group B: Occlusal splints fabricated using a combined digital workflow using a conventional bite technique.

The intervention involves the fabrication of 3D printing of occlusal splint with fully digitalization technique by the aid of Jaw Tracing Device (Zebis JMA, Germany). The acquisition and scanning of the patients are done by using an intra oral scanner (Medit i700, South Korea) and designing them using a designing software (Exocad, USA). This device will be printed with a 3D printer (Anycubic, China) utilizing printable resin material with codes for which the outcome assessor is kept totally unaware.

For the comparator group, upper and lower arches will be scanned intraorally. The bite will be registered at centric by using rubber base bite registration material after patient deprogramming with Lucia jig. Then the bite will be scanned.

The splint will be designed and printed in the same workflow as the intervention group.

The amount of intraoral occlusal adjustments (represented by the 3-dimension volumetric changes) will be measured by Medit link by millimeters before the splint insertion.


Eligibility Criteria:
Inclusion Criteria:

* (1) 18-40 years old

  (2) Complete dentition.

  (3) Normal jaw opening.

  (4) Intact teeth.

  (5) No occlusal disorder; stable jaw relation.

  (6) No ongoing dental therapy, such as orthodontic or prosthodontic treatment.

  (7) TMD patients with more than one of following symptoms or signs: myofascial pain and /or pain in the TMJ, myofascial pain and/or pain in the TMJ on palpation, muscles tenderness, headache or earache.

  (8) Patients who had unsuccessfully undergone splint therapy or other TMD treatments in the past were not excluded.

Exclusion Criteria:

* (1) Patients with an unstable occlusion

  (2) Patients with systemic diseases and comorbidities

  (3) Temporomandibular joint lesions found on clinical palpation or medical imaging examination

  (4) Jaw opening less than 3 fingers

  (5) Patients with occlusal dysfunctions

  (6) Patients with severe or moderate periodontitis

  (7) Unable to undergo examination or treatment due to the presence of a psychological or mental disorder.
Safety, Tolerability and Pharmacokinetics of CSL112 in Healthy Volunteers

The purpose of this study is to assess the safety and tolerability of escalating doses of CSL112 after single intravenous infusions in healthy volunteers and to measure the pharmacokinetics of CSL112 after single intravenous infusions in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females aged 18 years to less than 55 years
* Body weigh 45 kg or greater

Exclusion Criteria:

* Evidence of a clinically significant medical condition, disorder or disease
* Evidence of clinically relevant abnormal laboratory test result
* Evidence of history of alcohol or substance abuse
Functional Trunk Training in Ataxia Patients

The study is to examine the effect of functional trunk training on trunk control and upper extremity functions in patients with autosomal recessive ataxia.

Hereditary ataxias are a group of genetic diseases characterized by slow progressive gait disturbance. In addition, coordination disorders can be seen in extremities, speech and eye movements. Atrophy is common in the cerebellum. Friedreich's ataxia, ataxia telangiectasia, ataxia with vitamin E deficiency, infantile-onset spinocerebellar atrophy and Marinesco-Sjögren syndrome are autosomal recessive hereditary ataxias. The constant main sign of autosomal recessive ataxia is progressive ataxia.

The trunk has an important role on dynamic stabilization for postural reactions and limb movements. A good trunk support enables movements in other parts of the body to occur more regularly. Trunk stabilization is important to support upper and lower extremity movements, to meet the loads, and to protect the spinal cord. The relationship between upper extremity function, daily living activities and trunk functions has been emphasized in many studies but comparative studies about the rehabilitation were very less.

This study is to evaluate the effect o functional trunk training in patients with autosomal recessive ataxia.

Eligibility Criteria:
Inclusion Criteria:

* Without any communication impairment (seeing, hearing, hearing),
* Have not had surgery for the upper and lower extremities in the last 6 months,
* Between the ages of 5 and 18,
* The mental level determined by the pediatrician is sufficient,

Exclusion Criteria:

* Patients who want to leave the study at any stage of the study
* Patients who do not attend regular training
Culturally Appropriate Strategies for Chinese Americans With Diabetes (CASCADe)

The project aimed to evaluate the implementation process and efficacy of a culturally tailored Diabetes Self-Management and Education (DSME) program with mobile health (mHealth) technology integration, entitled Culturally Appropriate Strategies for Chinese Americans with Diabetes (CASCADe), among Chinese American adults with Type 2 diabetes.

The CASCADe program includes 1) a home visit for training of monitoring devices use, WeChat app and acquiring family support, 2) 8 weekly education sessions with a combined format of group class, games, food demonstration, group exercise, video and discussion, 3) WeChat follow-up on education tips, monitoring data summary, and group discussion. The monitoring system used a smartphone to coordinate cloud data transmission from a set of wireless devices to capture daily monitoring data on physical activity, body weight, blood pressure and blood glucose levels. WeChat app was used to facilitate behavioral self-monitoring by providing daily messages related to diabetes education curriculum, weekly summary reports on monitoring data as well as reinforcement messages and group discussion on readings and monitoring results implication. A single group pre-post-test design was adopted to evaluate changes of primary (HbA1c) and secondary (Self-efficacy, quality of life and stress coping) outcomes assessed at pre and post of intervention. Engagement and adherence in education sessions and self-monitoring system, and satisfaction with the content and delivery of intervention were also evaluated at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* have been diagnosed with Type 2 diabetes
* having been managing diabetes with diet, oral hypoglycemic agents or insulin, or both
* confirmed HbA1c level \>=6.5% and \<10%
* 21-75 years old
* residents of San Gabriel Valley
* speak and understand of Mandarin
* willing to use the smartphone-based monitoring devices provided by the project.

Exclusion Criteria:

* unable or unwilling to give informed consent
* plan to move out of the area within the 1-year participation study period
* are or plan to be pregnant or breastfeeding in the next 12 months
* have a condition that inhibits movement (e.g., unable to walk unaided, or cannot walk 1/4 mile without stopping)
* have major physical disability or condition that prevents them from participating in person.