cyrilzakka/clinical-trials huggingface dataset:
Effect of Physical Activity Pattern on Cardiometabolic Health

The goal of this study is to understand the interaction between the circadian system and physical activity.

Participants will:

* complete 2 inpatient stays
* perform moderate exercise
* be provided with identical meals
* have frequent blood draws
* provide urine and saliva samples

The endogenous circadian system (i.e., an internal biological rhythm) plays an important role in regulating blood glucose, blood pressure, and energy expenditure. Physical activity improves health and reduces the risk for cardiovascular diseases and type 2 diabetes. The goal of this study is to understand the interaction between the circadian system and physical activity. We aim to test whether such relationship between the circadian system and physical activity can be used to enhance the health benefits of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 yr old
* Body mass index (BMI) 25-34.9 kg/m2
* No acute, chronic or debilitating medical conditions (e.g. metabolic, cardiovascular, respiratory, neurological, cancers, etc.)
* Willing to adhere to the protocol requirements for the duration of the study

Exclusion Criteria:

* Currently smoking/vaping or 5 or more years of smoking/vaping
* Currently pregnant or breastfeeding
* History of drug or alcohol dependency
* History of psychiatric illness or disorder
* Any hospitalization due to COVID-19
* Inability to exercise for any reason
* Any known contraindication to exercise testing based on current ACSM guidelines
Automated Volume Assessment of Acute Stroke

Stroke is a common disease. It is increasingly managed in non-specialized centers.

The volume of the lesion, evaluated on the diffusion weighted imaging, is a prognostic factor of clinical progression and is useful for the treatment decision.

There is therefore a real interest in having a reliable software able to detect the stroke and evaluate the volume of the cerebral infarction. The aim is to provide rapid information to the interventional neuroradiologist and optimize the care of the patient.

The Alberta Stroke Program Early Computed Tomography Score currently used to predict response to treatment divides the territory of the middle cerebral artery. It has a few limitations, it is unreproducible and concerns only the territory of the middle cerebral artery.

Manual volumetry is a long and also not very reproducible technique. The aim of our study is to evaluate the reproducibility and diagnostic performances of the automated segmentation software based on the diffusion weighted imaging sequence, and to compare it to manual and semi-automatic measurements.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for a recent neurological deficit (less than 24 hours), suspected for a stroke.

Non inclusion criteria :

* Pregnant or breastfeeding women
* Patients with absolute contraindications to MRI
Desensitizing Efficacy of Polymeric Nano Calcium Fluoride Containing Varnish

The aim of this study is to evaluate the Desensitizing efficacy of polymeric nano calcium fluoride containing varnish and its implementation into clinical practice.

Increasing the demand to find a desensitizing agent that should be biocompatible, easy to apply, painless, not changing the dental color, fast onset, and maintain a long-term effect gives a highlight to the patented formula of the polymeric nano calcium fluoride which newly introduced into the practice .

OliNano SEAL is an innovative "varnish-like" protector based on a patented silicone polymer with a true nano technology that provides an exceptional adhesion to enamel and dentin without prior etching for approximately 12 months (other available products max. 2-3 months).

It consists of four components Silicone polymer provides excellent adhesion to enamel and dentine, with transparent formula. NANO-fluoroapatite flows into enamel micro cracks \& seals it, penetrating into the dentinal tubules closing them eventually. As for the NANO-calcium fluoride it behaves as a fluoride reservoir, provides gradual and long-term fluoride release. The fourth component Amine fluoride (Olaflur) provides immediate fluoride ion release and accelerates natural remineralization.

Eligibility Criteria:
Inclusion Criteria:

* Patients with good oral hygiene.
* The age range of 18-65 years.
* Patients from both gender.
* Patients suffering from pain due to dentin hypersensitivity.
* hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentine).
* non carious cervical lesions: abrasion,erosion, abfraction, and recession with cervical dentin exposure

Exclusion Criteria:

* Patient with bad oral hygiene.
* Patients with constant use of analgesic, antihistaminic, anticonvulsive, sedative, tranquilizing, or anti-inflammatory medications 72 hours before treatment and pain assessment.
* patients having received any desensitizing treatment during the last 3 months.
* Patients with allergy of any materials will be used in the study . teeth with pulpitis.
* teeth with periodontal disease installed.
* teeth exhibiting mobility (grade 2 or 3).
* carious lesions, fractured teeth, defective restorations or prosthesis.
* Patients with orthodontics appliance.
Microinvasive Pars Plana Vitrectomy Combined ILM Peeling Versus Anti-VEGF Intravitreal Injection for Treatment-naïve Diabetic Macular Edema

Diabetic macular edema (DME) is the main cause of vision loss in patients with diabetes. At present, anti-vascular endothelial growth factor (VEGF) intravitreal injection is the first-line therapy for DME, nevertheless, some patients do not respond well to anti-VEGF agents and often require multiple injections, which increases the psychological and economic burden of patients. Microinvasive pars plana vitrectomy (PPV) has been proven to be safe and effective for refractory DME. However, there are few studies on treatment-naïve DME. The purpose of this study is to explore whether early PPV combined with internal limiting membrane (ILM) peeling can reduce the treatment burden of DME patients, prevent vision loss, and maintain long-term stabilization of diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Patients and their families fully understand the research and sign the informed consent form
* Diagnosed with type 1 or 2 diabetes mellitus
* Hemoglobin A1c (HbA1c) of less than 10% within 3 months
* Clear media for adequate OCT and optical coherence tomography angiography (OCTA) images
* Treatment-naïve DME diagnosed clinically
* Central subfield thickness (CST) of \>300μm and intra- or subretinal fluid seen on (spectral-domain) SD-OCT
* Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA between 24 and 73 letters on the day of randomization
* Treatment within 12 months of DME diagnosis
* No contraindication of vitrectomy or conbercept intravitreal injection

Exclusion Criteria:

* Any previous DME treatment (i.e. anti-VEGF injections, intraocular corticosteroids, macular photocoagulation)
* Macular edema caused by other disease (i.e. neovascular age-related macular degeneration, retinal vein occlusion, uveitis)
* Any previous intraocular surgeries (cataract surgery performed at least 3 months before study entry will not be exclusionary)
* Vision loss caused by other ocular disease (i.e. cataract, proliferative diabetic retinopathy, glaucoma, high myopia)
* A follow-up duration of less than 12 months
* Severe dysfunction of the heart, liver, kidney, lung and other organs
Association of Preoperative Sarcopenia and Intraoperative Hypotension in Patients Undergoing Minimally Invasive Pylorus Preserving Pancreaticoduodenectomy : Prospective Observational Study

The aim of this study is to determine whether preoperative sarcopenia (low muscle strength/muscle mass) is correlated with time weighted average intraoperative hypotension in patients undergoing minimally invasive pylorus preserving pancreaticoduodenectomy.


Eligibility Criteria:
Inclusion Criteria:

1. patients 20 years or older who undergo minimally invasive pylorus preserving pancreaticoduodenectomy

Exclusion Criteria:

1. emergency surgery
2. patients who cannot read consent forms(e.g., illiterate, foreigner, etc.)
3. patients with cognitive dysfunction
4. pregnant, lactating women
5. When hand grip test cannot be performed
6. patients with atrial fibrillation, moderate or severe valvular heart disease, left ventricular ejection fraction less than 35%
AT278 and NovoRapid® in Glucose Clamp Study

A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of type 1 diabetes for at least 12 months
2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
3. HbA1c concentration ≤8.5% at screening
4. Weight within the range 75kg - 100kg (both inclusive)

Exclusion Criteria:

1. Known or suspected hypersensitivity to Investigational Medicinal Products
2. Clinically significant concomitant disease or abnormal lab values
3. Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG
Improving Surgical Patient Knowledge and Safe Use of Opioids

Opioids are commonly prescribed for surgical patients to treat moderate to severe pain after surgery. However, opioids can be associated with serious complications such as respiratory depression and death. Currently, it is not routine practice to educate surgical patients about the risks of opioids and how to safely use opioids after surgery. The investigators have developed an educational pamphlet specifically for surgical patients to educate them about the safe use of opioids. The objective of this pilot study is to determine the usability and readability of an educational pamphlet about the safe use, proper storage and disposal of opioids. The educational pamphlet will be modified based on the feedback from the pilot study and subsequently used for a randomized controlled trial.

Twenty participants presenting to the preoperative clinic will be recruited for the pilot study. After informed consent is obtained, patients will be given an opioid knowledge questionnaire to complete before the education. They will then be given an educational pamphlet to review. After they have reviewed the educational pamphlet, they will complete the same opioid knowledge questionnaire. They will also complete a questionnaire evaluating the patient educational pamphlet. The pamphlet will be modified based on the feedback from the patients in the pilot study.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years adults
2. Proficient in English
3. scheduled for elective surgery

Exclusion Criteria:

1. Patients who are on opioids for chronic pain
2. Patients have taken opioids in the past 30 days
3. Patients who are unable to read and understand English -
Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy

The objective of this proposal is to investigate the effect of non-invasive repetitive cerebellar transcranial magnetic stimulation (rTMS) on motor control in progressive supranuclear (PSP). The central hypothesis is that augmenting cerebellar inhibition via cerebellar rTMS will decrease postural instability in patients with PSP. We will use functional near infrared spectroscopy (fNIRS) to examine changes in motor and premotor cortical activity after cerebellar rTMS.


Eligibility Criteria:
Inclusion Criteria:

* probable or possible PSP by the revised MDS PSP Criteria (Hoglinger 2017)
* age 40-85 at time of screening
* ability to understand and cooperate with simple instructions in English
* ability to read at 6th grade reading level in English
* ability to stand unassisted for at least 30 seconds and to be able walk independently with a walker
* ability to refrain from new physical and speech therapy programs for the duration of the study
* ability to remain on stable doses of any cholinergic, dopaminergic, serotonergic sedative or NMDA receptor antagonists for the duration of the study
* females of child-bearing age must perform a urine pregnancy test and be on reliable birth control during the course of the study

Exclusion Criteria:

* other significant neurological or vestibular disorders
* presence of electrically, magnetically or mechanically activated implants or history of injurious metal exposure in eyes, head, or body
OpSens PRIME CLASS

In this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment. Post-TAVR FFR will be taken as the reference for predicting ischemic lesions, and angiography and physiology - FFR and diastolic pressure ratio (dPR) - will be performed immediately before and after TAVR, in an all-comer multicentric observational study.

This is a post-marketing, prospective, observational, single arm, multi-center, single country study in Subjects who have severe symptomatic aortic stenosis with a formal indication for TAVR, and one or more intermediate coronary lesions in a relevant coronary artery (\>2mm). This study aims to assess if OpSens non-hyperemic dPR (based on a proprietary algorithm) and/or OpSens FFR are suitable methods for the physiological assessment and prediction of ischemic coronary lesions in Subjects with aortic stenosis who are considered for TAVR. This will be done by comparing pre-TAVR measurements of angiography, dPR and FFR and placing them against the post-TAVR FFR, which is considered as the gold standard. Also the post TAVR dPR will be compared with post-TAVR FFR.

A maximum of 137 subjects will be enrolled in 5 to 10 sites in Spain to obtain the required minimum of 137 lesions (see section 11.2 Sample Size Determination) The main hypothesis is that the specificity to predict ischemic lesions in TAVR candidates based on a pre-TAVR dPR ≤ 0.89 is superior compared to the specificity based on angiography alone (both QCA and visual assessment of the stenosis \>50%), taking the post-TAVR FFR value of ≤ 0.80 as a reference for positive lesions.

The pressure guidewire used to measure dPR and FFR during diagnostic angiography is the commercially available (CE-marketed) OptoWire family of pressure guidewires from OpSens Inc.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years old
* Subject has a degenerative aortic stenosis with mean valvular gradient ≥40 mmHg
* Subject has a formal heart-team indication for TAVR
* Subject has one or more stable coronary stenosis lesions 30-90% by visual estimation, in a vessel over 2 mm in diameter, and which is amenable for pressure-wire analysis
* Subject agrees to participate in the study and is able to sign the informed consent form

Exclusion Criteria:

* Subject is unable to provide informed consent
* Subject has asthma or acute bronchospasm
* Subject has unstable angina or myocardial infarction
* Subject meets any contraindication in the applicable OptoWire IFU
* Subject is pregnant
Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia

Evaluate the safety (P-I), pharmacokinetics and anti-tumor effect of immunotherapy of autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR) (TBI-1501) for relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia.

Enroll patients after confirming eligibility. Following enrollment, peripheral blood mononuclear cells and blood plasma will be obtained from each subject by apheresis to start the manufacturing of TBI-1501.

Before TBI-1501 administration, it is necessary to pass the quality tests. Subject will be hospitalized from Day -3 to Day 28, and administered Cyclophosphamide (1,000 mg/m2/day×2 days) on Day -3 and Day -2.

Eligibility Criteria:
Inclusion Criteria:

1. In phase-1 study, patients must be ≥ 18 years of age. In phase-2 study, patients must be ≥ 16 years of age.
2. Patients with relapse or refractory CD19+ acute B-cell lymphoblastic leukemia
3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
4. Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc), as defined below

   * Total bilirubin level ≤1.5xULN (Upper limit of normal)
   * AST(GOT)/ALT(GPT) level ≤5.0xULN
   * Serum creatinine ≤2.0mg/dL
   * SpO2 ≧ 92%
   * LVEF ≥50%
5. Patients must be able to understand and willing to sign a written informed consent document (for patients \<20 years of age their legal guardian must give informed consent).

Exclusion Criteria:

1. White blood cell counts ≧ 50,000/uL
2. Received expected antitumor therapy (chemotherapy or radiation therapy, etc) within 2 weeks.
3. Received HSCT within 12 weeks before enrollment.
4. Under treatment for GVHD.
5. lymphocytes except for blasts ≦ 500/uL
6. Presence of active CNS-3
7. Concurrent use of systemic steroids or immunosuppressive agents (except for replacement therapy and local administration. e.g. inhalation, application and so on).
8. HBs Ag positive ,or either HBc Ab positive or HBs positive with HBV-DNA \> 1.3LogIU/ml
9. Presence of active hepatitis C infection
10. HIV Ab or anti-HTLV-1 Ab positive
11. History of allergy about component of investigational product or animal(cattle and/or mouse)-derived additives
12. Hypersensitivity to antibiotics.
13. Presence of symptomatic cardiac arrhythmias or serious heart disease.
14. Presence of another malignant tumor.
15. Psychiatric disorder, alcohol addiction or drug addiction that affects the ability of informed consent.
16. Active or serious infection.
17. Both men and women who have generative functions, and who cannot agree with using contraceptive devices from the day of the consent to the end of study.
18. Pregnant or lactating women.
19. Any other patients judged by the investigators to be inappropriate for the study.
Pharmacist-Led Intervention to Improve TB Treatment and Outcomes

The goal of this clinical trial is to compare the adherence of co-morbid patients in control and experimental group

The main question\[s\]it aims to answer are:

1. To evaluate the impact of pharmacist-led educational intervention on treatment adherence among patients with PTB using the health belief model theory and MARS-5.
2. To evaluate the impact of pharmacist-led educational intervention on treatment outcomes among patients with PTB.
3. To evaluate the impact of pharmacist-led educational intervention on HRQoL among patients with PTB.

Participants will be interviewed to measure the level of adherence.

If there is a comparison group:

The enrolled patient will be counselled and educated by the pharmacist on the therapy and the benefits of adherence (Control group).

Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence. (Experimental group).

In 2019, tuberculosis (TB) remained the leading cause of death due to a single infectious pathogen. An estimated 10 million people had TB worldwide, with 1.2 million TB fatalities among Human immune deficiency virus (HIV)-negative people and 208, 000 deaths among HIV-positive people. Literature indicated that treatment adherence for coinfections diseases is difficult due to the complexity, low tolerability, and extended duration of current treatment regimens, especially for both drug-susceptible and drug-resistant TB. There is a need for continuing the quest for low-cost, reliable, and acceptable measures of adherence for the treatment of TB and HIV co-infection. A qualitative approach and pharmacist-led intervention are needed to improve the adherence level of medication for TB patients. The study is aimed to investigate the degree of adherence and evaluate its impacts on clinical outcomes in TB and HIV co-infected patients. To determine the uptake and usage of the intervention, the study will include nested qualitative and economic evaluation sub-studies as well as a process evaluation. A longitudinal study design will adopt to carry out the present study, involving TB and HIV co-infected patients in either the pharmacist-led intervention (adherence and medication reminder, follow-up reminders, and counselling) or control arm. To determine the uptake and usage of the intervention, the study will include theoretical and conceptual models and theories. The study will conclude with targeted efforts of Pharmacist led intervention to improve and sustain excellent adherence in the real-world clinical setting which is critical for maximizing the effectiveness of each medication and treatment. These innovative technologies can thereby be harnessed to improve adherence to TB and HIV regimens in Malaysia and worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years or more.
* Newly bacteriologically confirmed TB case.

Exclusion Criteria:

* Pregnancy and any medical condition unrelated to TB
Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)

This study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer.

To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the treatment of resectable metastatic colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about:

   * Primary tumor had been removed of the metachronous liver metastasis patients and no residue from the eyes or microscope.
   * Primary tumor has been removed more than 1 month of the simultaneous liver metastasis patients.
2. Age of≥18 and ≤80
3. ECOG≤2
4. Signed written informed consent

Exclusion Criteria:

1. Peripheral neuropathy(CTC\>1)
2. Had a neurological or mental disorders
3. Active infection
4. Allergy to Platinum-based and other drugs
5. Other acute diseases including infection, heart-disease(CHF, stable or unstable angina)
6. Pregnant or nursing patients