cyrilzakka/clinical-trials huggingface dataset:
SMART Embedded Intervention for Military Postsurgical Engagement Readiness

The overarching objective of this proposal is to conduct a multi-site Sequential Multiple Assignment Randomized Trial (SMART) across multiple Military Health System (MHS) sites to optimize the sequencing and integration of two intervention strategies in total knee arthoplasty (TKA) patients: a single-session mindfulness-based intervention (MBI) and an intensive 8-week MBI-Mindfulness-Oriented Recovery Enhancement (MORE) designed to simultaneously reduce prolonged pain and chronic opioid use by enhancing self-regulation. Aim 1: Evaluate the extent to which a brief preoperative MBI improves TKA patients' postoperative musculoskeletal health and reduces chronic opioid use. Aim 2: Evaluate the extent to which an intensive MBI (MORE) improves musculoskeletal health and reduces chronic opioid use among patients non-responsive to preoperative intervention. Aim 3: (A) Determine patient baseline characteristics that moderate MBI treatment responses. (B) Quantify the degree to which the impact of Phase 1 and 2 MBIs on musculoskeletal health and opioid dose are mediated by changes in mechanistic autonomic marker of self-regulation: heart-rate variability (HRV).


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo unilateral total TKA at one of the study sites
* TRICARE beneficiary
* Facility with the English language that is adequate to complete study procedures.

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures,
* Formal mindfulness training (e.g., MBSR, MBCT)
* Severe, active suicidality
* Contralateral TKA in the past 3 months or planned contralateral TKA during the study
* Current cancer diagnoses.
A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age. For patients aged \<20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative
* Histologically or cytologically documented non-squamous NSCLC with completely resectable (Stage II - IIIB N2) disease (according to Version 8 of the IASLC Cancer Staging Manual \[IASLC Staging Manual in Thoracic Oncology 2016\]).
* Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialised in oncologic procedures).
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 at enrolment, with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
* A tumour which harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations (eg., T790M, G719X, Exon20 insertions, S7681 and L861Q).

Exclusion Criteria:

* Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
* History of another primary malignancy (including any known or suspected synchronous primary lung cancer), except for the following: Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease; Adequately treated carcinoma in situ without evidence of disease; Any synchronous Stage IA primary lung cancer that is ≤2 cm and planned to be resected during surgery for the Stage II to IIIB N2 lung tumour.
* Patients who have pre-operative radiotherapy treatment as part of their care plan
* Mixed small cell and NSCLC histology
* Stages I, IIIB N3, IIIC, IVA, and IVB NSCLC
* T4 tumours infiltrating the great vessels, the carina, the trachea, the oesophagus, the heart, and/or the vertebral body; and/or any bulky N2 disease.
* Patients who are candidates to undergo only segmentectomies or wedge resections
* Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
* Prior treatment with EGFR-TKI therapy
* Current use of (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP) 3A4 (at least 3 weeks prior)
The Effect of Age on the Median Effective Dose (ED50) of Intranasal Dexmedetomidine for Rescue Sedation Following Failed Sedation With Oral Chloral Hydrate During Magnetic Resonance Imaging

Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children. We performed a up-down sequential allocation study to determine the ED50 for rescue sedation following sedation failures in children and to investigate age-related differences in the rescue sedation with dexmedetomidine.

About 150 children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) were stratified into four age groups as follows: 1-6 month, 7 -12 month, 13 -24 month, and 25-36 month. The intranasal dexmedetomidine dose was determined by the success or failure of rescue sedation achieved by the previous patients, according to Dixon's up-down sequential allocation method. Successful sedation was defined as a MOAA/S(modified Observer Assessment of Alertness and Sedation) of between 0 and 3. The EC50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression. Patients' sedation status, sedation induction time, time to Wake up, blood pressure, heart rate, and oxygen saturation were recorded.

Eligibility Criteria:
Inclusion Criteria:

* 150 children of ASA physical status I or II, aged between 1 and 36 months, failed chloral hydrate sedation during MRI scanning,

Exclusion Criteria:

* known allergy or hypersensitive reaction to drugs of this study, Weight greater than 20 kg or less than 4.5 kg, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia and congenital heart disease.
Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine

The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.

This study was a 60-month prospective, multicenter, observational study of adalimumab in adult participants with CD who resided in Germany. Visits were scheduled every 3 months for the first year and every 6 months thereafter. Participants continued in the study for a maximum of 60 months or until discontinuation from adalimumab therapy.

Eligibility Criteria:
Inclusion Criteria:

- Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.

Exclusion Criteria:

- Hypersensitivity against the drug or one of the other ingredients.
Effects of Isoflavone Combined With Astaxanthin on Skin Aging

Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the intrinsic aging process, and accounts for the majority of age-associated changes in skin appearance. Reactive oxygen species (ROS) play a key role in UV-induced skin damage and diminish skin matrix protein levels, leading skin aging. Strategies utilizing endogenous skin antioxidants as well as plant-derived or synthetic compounds have been examined.

Astaxanthin mainly from marine algae and crustaceans is a kind of carotenoids which were well-known photo-protective agents with strong antioxidant activity. Several studies have revealed that supplementation of astaxanthin effectively protect skin against UV damage through free radicals.

In addition, matrix metalloproteinase-1 induced by UV irradiation is an important step toward skin aging. Recently, many studies pointed out that phytoestrogens exhibit agonistic and antagonistic estrogen activities, suppressing activity of MMP-1 in skin. Isoflavone is a kind of phytoestrogen from soybean and mainly act on skin and bones, inhibiting MMP-1 effectively.

The present study is designed to take isoflavone combined with astaxanthin to maximize their anti-aging ability and objectively measure the effects of the mixture on facial wrinkles, hydration, and elasticity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy females aged ≥ 45 years
* Facial wrinkle grade 2 to 4

Exclusion Criteria:

* received medical or cosmetic treatment that interferes with the general aging process at least 3 months before the study
* received any hormone replacement therapy at least 3 months before the study
* reported taking functional foods more than 1 month during last 3 months before the study
* history of acute or chronic disease such as severe liver or kidney disease
* history of allergies against any component of trial foods
* any visible skin disease that might be confused with a skin reaction to the test procedure
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or nivolumab).

All subjects will be treated until disease progression, unacceptable toxicity, or subject withdrawal of consent for a maximum of 24 months of treatment.

The total duration of study participation for each subject will be approximately 26 months.

Eligibility Criteria:
Key Inclusion Criteria:

* At least 18 years of age.
* Histologically confirmed unresectable or metastatic melanoma.
* Subject has no prior systemic treatment for advanced disease.
* Subject must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
* Tumor tissue from site of unresectable or metastatic melanoma must be available for biomarker analyses in order to be randomized.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Key Exclusion Criteria:

* Subject has had any prior systemic anti-cancer therapy for the treatment of advanced melanoma.
* Known hypersensitivity to monoclonal antibodies or to any of the excipients of the study drug.
* Subject has active central nervous system (CNS) metastases not previously treated.
* Ocular melanoma.
* Subject has active or known immune-mediated disorders.
* Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.
* Subject has medical conditions requiring systemic immunosuppression with either corticosteroids or other immunosuppressive medications within 14 days of the first dose of investigational product.

Other protocol-defined inclusion/exclusion criteria apply.
Fast Reversal of Warfarin and Early Surgery in Patients With Trochanteric Hip Fracture A Case-control Study

A retrospective case-control study. To evaluate if early surgery within 24hours of troch or subtrochanteric hip fractures using intramedullary nailing is safe in patients on warfarin treatment after fast reversal of the warfarin effect


Eligibility Criteria:
Exclusion Criteria:

* Pathological fracture
* Late presentation to the hospital
* Other injuries
Phase 1 Study of TG01 and Erlotinib in Non-small Cell Lung Cancer (NCSLC) Patients

This is a multicenter, open-label, phase 1, dose escalation study. The purpose is to determine the highest dose of TG01 that can be safely given to patients with Non-Small Cell Lung Cancer in combination with erlotinib.


Eligibility Criteria:
Inclusion Criteria (include but are not limited to):

* Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral effusion) or IV NSCLC.
* Measurable or evaluable disease as defined by RECIST
* Must have failed at least one prior chemotherapy regimen or have refused chemotherapy.
* ECOG perfromance status of 0,1, or 2.

Exclusion Criteria (include but are not limited to):

* Radiation therapy (excluding CNS therapy) \< 2 weeks, chemotherapy, non-cytotoxic investigational agents or high dose corticosteroids within 3 weeks of intitating therpy or patients who have not recovered from adverse effects due to agents administered more than 3 weeks earlier.
* Evidence of New York Heart Associatation Class III or greater cardiac disease.
* History of myocardial infarction, stroke, or cardiovascular intervention within the last 12 months.
* Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin.
* Systemic central nervous system metastases. The patient must be stable after radiotherapy for \>/= to 2 weeks and off corticosteroids for \>/= to 1 week.
* Pregnant or nursing women.
* Patients who are primarily refactory to erlotinib.
Tele-Rehabilitation Study for People With a History of Stroke

Stroke results in long-term disability for many people, and particularly for survivors of stroke who have cognitive impairments. However, a decreasing proportion of stroke patients are able to access or receive publicly funded rehabilitation. The investigators have shown in previous studies that in-person delivery of the Cognitive Orientation to daily Occupational Performance (CO-OP) rehabilitation approach to promoting attainment of everyday life goals has resulted in improvements in functional independence and executive function. In a small pilot study of tele-CO-OP with people with chronic traumatic brain injury (TBI) (n=3), the investigators found the delivery method was feasible and that participants were satisfied with the treatment and demonstrated clinically significant improvements on personally meaningful activities. The investigators will investigate the feasibility, preliminary efficacy, and cost-effectiveness of delivering CO-OP in an online format to reduce disability post-stroke. The study design is a single-blind (assessor), randomized wait-list control trial with a one-month retention follow-up. All therapy and testing sessions will be delivered online. We hypothesize that participants will demonstrate improvement in everyday activities and community participation.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling adults at least three months post-stroke
* Fluent in written and spoken English
* Impairment of executive cognitive functions
* Ability to self-identify specific areas of difficulty in their everyday life that they would like to improve
* Access to a computer or tablet with a high-speed internet connection

Exclusion Criteria:

* Presence of dementia
* Severe concurrent depression
* Severe aphasia
* Concurrent substance abuse
a Neo-adjuvant Chemotherapy Immunotherapy in Resectable ESCC Study

Research Purpose 1: To evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 2: To analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 3: To understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced ESCC in the

Research Purpose 1: To evaluate the therapeutic efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 2: To analyze the influencing factors of the therapeutic effect of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced esophageal squamous cell carcinoma (ESCC) in the real-world setting.

Research Purpose 3: To understand the treatment patterns of neoadjuvant immunotherapy combined with chemotherapy in the treatment of resectable locally advanced ESCC in the

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years (including 18 years old); ECOG 0 or 1; Patients with esophageal squamous cell carcinoma judged to be resectable (including initially non-resectable) by the researcher Received esophageal radical surgery and neoadjuvant immune chemotherapy before surgery Clinical staging belongs to: T1b-4NanyM0;

Exclusion Criteria:

Patients without complete medical information; Received other anti-tumor treatment before surgery; Received radiotherapy treatment; Judged by the researcher, have other conditions unsuitable for participating in this clinical study.

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A Trial of HRS4800 Tables in Healthy Male Subjects

This is a single-site study to evaluate the safety, tolerability and pharmacokinetics (PK) of single dose administration of HRS4800, and the effect of food on the PK of HRS4800 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand the purposes and risks of the trial and comply with all study procedures before entering the trial, and provide signed informed consent.
* Male aged between 18 years and 55 years at screening, inclusive.
* Total body weight ≥50 kg at screening, and body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
* Agree to practice true abstinence; be surgically sterilised (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom if sexually active with a female partner of childbearing potential for at least 3 months after dosing.
* No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry, coagulation function), and ECG, as determined by the investigator. Male aged between 18 years and 55 years at screening, inclusive.

Exclusion Criteria:

* History of severe digestive system disease or having a digestive disease currently within a month of screening or before first dosing, and may affect drug absorption or have safety risks.
* Severe infections, injuries or surgeries within 3 months of screening or before first dosing, or plan to undergo any surgeries during the trial.
* Use of any medicine affecting liver metabolism within 1 month of screening (see Appendix 1); use of any prescription medications within 14 days or 5 half-lives prior to dosing, use of any over-the-counter medicine or herbal products within 7 days prior to dosing; intention to use any other medicine during the trial.
* Whole blood donation or loss of more than 200 mL of blood within 1 month prior to dosing; or blood donation or loss of more than 400 mL of blood within 3 months prior to dosing; or plasma donation within 14 days prior to dosing; or received blood within 8 weeks prior to dosing.
* History of allergy to the study drug or any component of it.
* History of regular alcohol consumption in the past 1 month exceeding an average weekly intake of 21 standard drinks: 1 drink=5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor).
* Subject has used more than 5 tobacco or nicotine-containing products per day in the 6 months prior to dosing and is unable to refrain from use of such products from at least 48 hours prior to check-in through to the final study visit.
* Treatment with an investigational drug within 30 days (or 5 half-lives, whichever is longer) of dosing.
* History of drug abuse within 2 years prior to screening.
* Other conditions or laboratory abnormality that may increase the risk associated with study participation or IP administration or interfere with the interpretation of study results and, at the discretion of the investigator, makes the subject inappropriate for entry into this study.
Evaluation of the Effects of Chinese Medical Treatment on Leucopenia After Chemotherapy in Breast Cancer Patients

This is a two-year double blind, placebo-controlled, and randomized clinical trial, which is aimed to evaluate the effects of Chinese medical treatment on leucopenia after chemotherapy in breast cancer patients.

The study will be conducted in the Department of Breast Surgery in China Medical University Hospital, Taichung. One hundred newly diagnosed breast cancer patient (age ≧18, Stage I, II, IIIa) will be included. After the diagnosis, the patients will undergo operation. Then, each patient will receive one of the following protocol of chemotherapy according to her pathology report and overall evaluation: "FEC\*6", "FEC\*4+Taxotere\*4", and "FEC\*3+Taxotere\*3".

Every participator will start to take the powder of Chinese herb-LCH1 after her receiving first time of chemotherapy until she receives the next cycle.(While receiving "FEC", it will be 3 weeks. While receiving "Taxotere", it will be 4 weeks).

Just before receiving the next cycle of chemotherapy, the blood of the participator will be sampled to check her CBC, GOT/GPT, BUN/Cr and tumor maker.

The investigators also adopt the body constitution questionnaire (BCQ) to evaluate the Chinese medical constitutional status, the EORTC QLQ-C30, EORTC QLQ-BR23, and Karnofsky score to evaluate the quality of life, and to evaluate the adverse effects of the adjuvant chemotherapy with the NCI-CTCAE Version 3.0.

Each participator will take the powder of Chinese herb-LCH1 from her first chemotherapy till 3 weeks after the last cycle of chemotherapy. Over all, it will take about 18 weeks (FEC\*6) to 28 weeks (FEC\*4+Taxotere\*4) to complete the treatment.

This study will also investigate the influence of the chemotherapy on the Chinese medical constitutional status, and in order to provide the basis for the complementary treatment for the breast cancer by adjusting and balancing the constitutional status of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed breast cancer patient (age ≧18, Stage I, II, IIIa)
* Receive chemotherapy after operation

Exclusion Criteria:

* Before receiving operation and chemotherapy, the patient already have other chronic diseases.
* Already have hematological malignancy and other lethal disease.
* Pregnant.
* Have severe psychological diseases.
Sore Throat Prevention Following Intubation

The aim of this interventional study is to find out the incidence of sore throat among intubated patients in Jordan university hospital and to find out which is preventive and effective method to decrease sore throat;is it xylocaine gel on endotracheal cuff as lubricant versus dexamethasone 8 mg intravenously or both.

Three groups were divided into: first group received xylocaine gel as endotracheal cuff lubricant,second group received dexamethasone 8 mg intravenously and third group received both( xylocaine and dexamethasone).

The investigator compared between the three groups regarding sore throat in intubated patients and followed them up to 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3.
* Elective VS Emergency.
* Cuffed endo-tracheal tubes.
* Different types of surgery.

Exclusion Criteria:

* Pregnant ladies.
* ICU patients.
* \<15 years of age
* Laryngeal mask airway