cyrilzakka/clinical-trials huggingface dataset:
Sedentary Behavior Interrupted: A Trial of Acute Effects on Biomarkers of Healthy Aging

This protocol "Sedentary Behavior Interrupted: A randomized crossover trial of acute effects on biomarkers of healthy aging in the laboratory (Project 1)" is part of a National Institutes of Aging Program Grant called "Sedentary Time \& Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 1 of the STAR program) is a 3-condition randomized crossover clinical trial of up to 86 postmenopausal women to test whether different interruptions to prolonged sitting improve metabolism.

The specific aims of this protocol include:

Aim 1. To investigate the acute effect of sitting interruption modalities on postprandial glucose and insulin concentrations, compared to prolonged sitting.

Aim 2. To investigate the acute effect of sitting interruption modalities on the physiologic parameters of endothelial function, compared to prolong sitting.

Aim 3. To explore the moderating effect of age.

Eligibility Criteria:
Inclusion Criteria:

* female
* 55 years of age and above
* any ethnicity or race
* screened to sit for 8 or more hours per day, perform less than 60 sit-to-stand transitions per day \& engage in less than 20 minutes of moderate-to-vigorous physical activity (MVPA) per day
* BMI 25 - 45 kg/m2
* ambulatory
* medically stable without any health conditions that would inhibit standing or PA;
* able to give informed consent \& comply with study protocols;
* able to read, communicate, and write fluently in English;
* able to travel to study visits;
* no menstruation for at least one year;
* not participating or not planning to participate in a physical activity or weight loss program or research study.

Exclusion Criteria:

* Mental state that would preclude complete understanding of the protocol or compliance;
* type 1 diabetes;
* type 2 diabetes using insulin or with poor glycemic control (greater than 10% for all participants);
* poorly controlled hypertension (Systolic Blood Pressure ≥165 or Diastolic Blood Pressure ≥100);
* chronic illness that may be associated with weight change (HIV/AIDS, active cancer, or uncontrolled thyroid disease),
* anemia (hemoglobin ≤11g/dL);
* personal or first-degree relative history of venous thrombosis;
* weight instability in past 3 months (no more than 5% up or down);
* regular use of vasodilator medication and high risk of stroke and/or heart attack (i.e., history of multiple hospitalizations (\>2X) in the last 6 months), congestive heart failure, atrial fibrillation, and/or stroke;
* regular use of immunosuppressant or corticosteroid medication;
* blood donation less than 56 days prior to screening visit,
* smoking cigarettes or smoking or ingesting anything, and other use of tobacco products including e-cigarettes.
* diagnosis of orthostatic hypotension
Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome

The purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old at time of presentation
2. First ever episode aneurysmal SAH
3. Confirmed aneurysmal SAH diagnosis: as confirmed by treating Neurosurgeon or Neuro-interventionalist and supported by blood in subarachnoid space (demonstrated on cranial imaging or cerebrospinal fluid positive for xanthochromia) that is the result of a ruptured saccular aneurysm (confirmed by cranial imaging - cranial topography or magnetic resonance imaging angiography or catheter angiogram)
4. Incident hemoglobin ≤100g/L within 14 days following SAH (defined by first day of hospital presentation)

Exclusion Criteria:

1. Physician and or family decision to withdraw/withhold critical care at time of enrolment
2. Active bleeding with hemodynamic instability at time of enrolment
3. Patients with contra-indication or known objection to blood transfusions
4. SAH due to causes other than saccular aneurysm rupture including mycotic, traumatic and dissecting aneurysms, and aneurysms associated with arteriovenous malformations.
DNA Methylation and Arsenic-associated Urothelial Carcinoma

The investigators previously pointed out the significant association between urinary arsenic profiles and urothelial carcinoma (UC) risk through a 12-year follow-up study. Further, the investigators observed the increased UC risk in people with lower plasma folate and higher homocysteine than those with higher plasma folate and lower homocysteine in 2010. S-adenosylmethionine (SAM) is one factor included in one-carbon metabolism pathway and is the main donor of methyl group in cells. The ratio of SAM and its metabolite S-adenosylhomocysteine (SAH) not only reflected the intake level of dietary folate but also demonstrated the extent of global DNA methylation. These factors might play important roles in UC carcinogenesis. The investigators would expect to take three years to explore the interactions among global DNA methylation, one-carbon metabolic pathway factors, urinary arsenic profiles, the polymorphisms and haplotype of Glycine N-methyltransferase (GNMT) and UC. In the first year, the investigators would measure the levels of plasma folate, homocysteine, SAM and SAH and evaluate the associations between these factors and UC risk. In the second year, the investigators would set up the method of immunohistochemistry stain and compare the differences between the global DNA methylation from bladder tissues and blood. In the last year, this investigators would analyze the GNMT gene polymorphism and haplotype variation. At the same time, the investigators would explore the impact of GNMT genetic variation and global DNA methylation on UC risk. Based on the results from our research, the investigators might propose that the decreased ratio of SAM/SAH resulted in UC risk increased. This mechanism might be through the changed levels of urinary arsenic profiles and global DNA methylation.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of urothelial carcinoma
* The voluntary of participating the study

Exclusion Criteria:

* Age smaller than 20 years
* Pregnant women
* Not willing to participate the study because of their personal reasons
Low Level Laser Therapy Versus Pharmacotherapy in in Improving Masticatory Muscle Pain

tempromandibuar disorders are a group of heterogenous pathologies affecting temporomandibular joint,muscles or both.in more than 90%of cases muscles are the origin of pain.TMDs cause pain,movement disability and deficit in quality of life.in more than 90%of cases pain is the major complaint.we run this investigation to find the analgesic effct of low level laser therapy versus pharmacotherapy with naproxen in improving pain.


Eligibility Criteria:
Inclusion Criteria:

* patients with TMD affecting masticatory muscles

Exclusion Criteria:

* systemic disease
* GI problem
* pregnancy
* epidermal cancer
Safety and Efficacy of SRD441 Ointment in Patients With Atopic Dermatitis

Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. The objective of this study is to determine whether SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18 or over
* Subjects with a history of AD
* Written and dated informed consent
* Satisfactory medical assessment with no clinical relevant abnormalities.

Exclusion Criteria:

* Subjects with current or recurrent disease (except AD) that could affect the site of application, the action, absorption or disposition of the investigational product, or clinical or laboratory assessments.
* Subjects who have medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
* Subjects with any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible drug application sites which could impact the application of the test agent or confound the local assessments during this study.
* Subjects with clinically significant renal and liver parameters, as defined as greater than 1.5 x creatinine and 3 x AST ULN (upper limit of normal) respectively.
Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study

To compare the frequency of regurgitation and other digestive outcomes between infants who receive an infant formula based on whole goat milk and an infant formula based on cow milk proteins during the transition period from breastfeeding to formula feeding, using predominantly breastfed infants as a reference group.

The study is a randomized, double-blind, parallel-group trial to study the effect of feeding infants goat milk or cow milk formula in the first 6 months of life on the prevalence of functional gastrointestinal disorders and other health outcomes, including gastrointestinal health and sleep during the transition from breastfeeding to formula-feeding. A predominantly breastfed group is used as a reference group.

Eligibility Criteria:
Inclusion Criteria:

* healthy full-term born infants (≥ 37 weeks + 0 days and \< 41 weeks + 6 days of gestation)
* birth weight ≥ 2.5 kg and ≤ 4.5 kg
* born from a singleton pregnancy
* live in Bangkok or nearby with no plan for geographical migration before 6 months of age
* for experimental and active comparator groups only: parent(s) has expressed the intention to partially (in combination with breastfeeding) or fully formula-feed the infant and ready to enroll in the study before the age of 4 months/120 days
* for no intervention group only: parent(s) has expressed the intention to predominantly breastfeed (according to study definition) and ready to enroll in the study before the age of 4 months/120 days
* infant has been predominantly breastfed for at least 2 weeks before enrollment
* parent(s) has sufficient Thai language skills to understand the study information, the informed consent, and to comply with the study procedure
* parent(s) is willing and deemed able to fulfil the requirements of the study protocol and procedures
* at least one parent is of legal age of consent

Exclusion Criteria:

* infant has any disorder considered to interfere with nutrition, growth or development of the immune system
* participation of the infant in any other interventional trial or participation of the mother in any intervention trial with infant follow-up
* for experimental and active comparator groups only: infant has been formula-fed for more than 1 week before enrolment
* for experimental and active comparator groups only: cow milk allergy or intolerance of the infant
* for experimental and active comparator groups only: enrolled infant who never consumed any study product until the first visit 2 weeks following enrolment
Vital Signs Monitoring of Emergency Responders in Different States

The goal of this observational study is to learn about emergency responder in different states. The main questions it aims to answer are:

* Ten vital signs and behavioral parameters in different states (quiet, after post, after physical training) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide.
* Eight vital signs and behavioral parameters in different environments (altitude, confined space, energized work, job site) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), and partial pressure of end-expiratory CO2 concentration.

Participants will normal operating conditions, the researcher collects vital sign information.

1. General information: name, age, height, weight, place of origin, smoking history, and whether or not they snore.
2. 10 vital signs and behavioral parameters in different states (quiet, after duty, after physical training), including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, partial pressure of transcutaneous carbon dioxide.
3. 8 vital signs and behavioral parameters in different environments (overhead, confined space, energized work, work site), including: respiratory rate, pulse rate, oxygen saturation, body position, thoracic and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), and partial pressure of end-expiratory CO2 concentration.

Eligibility Criteria:
Inclusion Criteria:

* No history of coronary heart disease, hypertension, asthma, upper respiratory tract infection, decompression sickness, or anemia.

Voluntarily participated in this study and signed an informed consent form

Exclusion Criteria:

* Patients with severe heart disease and arrhythmia; patients with vital organ failure; patients with significant generalized edema; patients with dermatologic disease and generalized skin breakdown; and patients with vascular disorders of the limbs.
Salient Aquamantys Spine Trial

The purpose of this study is to compare standard of care hemostasis techniques with and without the use of Aquamantys in reducing peri-operative blood loss.

The primary objective of the study is to assess the effectiveness of Aquamantys in reducing peri-operative blood loss compared with standard electrocautery

Secondary objectives include :

* Rate and volume of transfusions
* Evaluating the reduction in hemoglobin and hematocrit values post- operatively
* LOS costs, and operative time
* Gathering operator feedback on qualitative criteria, including ease of use and surgical visualization between the two treatment groups

Eligibility Criteria:
Inclusion Criteria:

1. Be candidate for three level (or greater) fusion surgery from T1 to S1 utilizing a direct posterior approach
2. Male or female 18 to 70 years of age (inclusive)
3. Must sign the IRB approved Informed Consent Form

Exclusion Criteria:

1. Undergoing spinal fusion for \< 3 lumbar levels, or using an approach other than direct posterior
2. Undergoing an interbody fusion
3. Planned use of hypotensive anaesthesia
4. Pregnant or lactating
5. Morbid obesity, defined as Body Mass Index (BMI) greater than 40
6. Previously diagnosed coagulopathy or bleeding diasthesis
7. Currently, or within the previous 7 days prior to surgery, taking any medications that would produce bleeding diathesis including, but not limited to NSAIDs, aspirin, clopidogrel (Plavix), ticlopidine, or valproic acid
8. History of significant cardiac disorders that would necessitate special fluid management protocols
9. Serious trauma other than that confined to the spine
10. History of acute myocardial infarction and/or acute angina within the past year prior to enrollment
11. PT/INR \>1.3 in the 14 days prior to surgery
12. PTT \> 40 in the 14 days prior to surgery
13. Platelet count \<100K in the 14 days prior to surgery
14. Based on clinical history, physical exam and subject presentation, subject has or is suspected to have a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements
15. Prisoner or transient
16. Enrolled in another drug or device investigational study (currently or within past 30 days)
17. Unable or unwilling to sign the Informed Consent Form or comply with protocol specified procedures
Integrase Resistance Analysis in HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression

Prospective study to evaluate the potential persistent viral effect of raltegravir in 20 treatment experienced HIV patients with incomplete viral suppression


Eligibility Criteria:
Inclusion Criteria:

* Subjects on Raltegravir-containing regimen with confirmed virological failure (VL \>500c/mL for \> 3 months).
* Patients treated with a raltegravir-containing regimen for at least for 24 weeks.
* CD4 cell count \> 50 cell/mm3.
* Adherence \>90%, measured by short -self report questionnaire during the 3 months preceding the study entry.
* No reasonable additional therapeutic options

Exclusion Criteria:

* History or suspicion of alcohol or drug use which in the investigator's opinion would likely compromise subjects' safety and/or study procedures.
* A positive urine drug test for amphetamines, cocaine and opioids at two consecutive screenings (a positive drug test at study screening will be repeated at baseline).
* Life expectancy less than 6 months.
* Subject has any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following 2 exceptions:

  1. Stable cutaneous Kaposi's Sarcoma that is unlikely to require any form of systemic therapy during the study period.
  2. Wasting syndrome due to HIV infection if, in the investigator's opinion, it is not actively progressive.
* Any active clinically significant disease (e.g. TB, cardiac dysfunction) or findings during screening of medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study.
* Pregnant or breast-feeding female.
* Renal impairment: serum creatinine \> 2 x ULN.
* Chronic Hepatitis B or C with ALT or AST \> 3 x ULN.
* Acute Hepatitis A, B or C. Acute Hepatitis A, B or C.
* Any grade 3 or 4 toxicity according to the enhanced ACTG grading severity list, except for grade 3 or 4 asymptomatic triglyceride/cholesterol elevations, isolated grade 3 increased in GGT, grade 3 increases in glucose, asymptomatic grade 3 increases in amylase with no elevation of lipase.
* Currently significant diarrhea, gastric stasis or constipation that in the investigator's opinion could influence drug absorption or bioavailability.
* Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (INR \> 1.3 or albumin \< 30g/l or bilirubin \> 2.5 x ULN).
Study of Efficacy and Safety of INC424 in Regularly Transfused Patients With Thalassemia.

Patients with severe thalassemia (thalassemia major) present with severe anemia that required life-long transfusion therapy, spleen enlargement that led to increased transfusion requirement, and other serious complications as early death, growth retardation, bone deformations and iron overload due to blood transfusions. Splenectomy can significantly reduce transfusion requirement in thalassemia patients, but it is associated with an increased risk of serious complications such as sepsis and thrombosis. Preliminary preclinical and clinical data suggested that JAK2 inhibition, by reducing spleen size, could improve hemoglobin levels, thereby eliminating the need for splenectomy and reducing transfusion requirement and related iron overload.


Eligibility Criteria:
Inclusion Criteria:

* Patients with thalassemia on a regular and stable transfusion regimen (at least 2 RBC units within every 4-week interval for 24 weeks prior to Screening) and anticipated to receive the same transfusion regimen during the study.
* Patients with spleen enlargement at Screening, defined as spleen palpable below the costal margin and spleen volume of ≥ 450 cm3 as confirmed by MRI (or CT scan in applicable patients).
* Patients need to be on iron chelation treatment (deferoxamine or deferasirox) for at least four weeks prior to Screening

Exclusion Criteria:

* Splenectomy prior to or planned during the study
* Active serious bacterial, mycobacterial, fungal, parasitic or viral infection which requires therapy (e.g., pneumonia, tuberculosis, systemic mycosis, herpes zoster)
* Hemoglobin \<65 g/L (\<4.0 mmol/L) at Screening
* Platelet count \<75×109/L, absolute neutrophils count \< 1.5×109/L at Screening.
* Estimated MDRD \< 30 mL/min/1.73 m2 at Screening.
* ALT (SGPT) levels \>5 times ULN at Screening.
* Hepatocellular disease such as hepatitis B (presence of HBs antigen), hepatitis C (presence of HCV RNA), liver cirrhosis.
* HIV positivity
Effect of Task-oriented Training Assisted by Force Feedback Hand Rehabilitation Robot on Finger Function in Stroke Patients With Hemiplegia

Over eighty percent of stroke patients experience finger-grasping dysfunction problems, compromising independence in daily life activities and quality of life. In routine training, task-oriented training is usually used for functional training of the hand, which may improve the finger grasping performance after stroke, whereby augmented therapy may lead to a better treatment outcome. Technology-supported training holds opportunities for increasing training intensity. However, most of the hand rehabilitation robots commonly used in the clinic are based on passive training mode and lacks the sensory feedback function of fingers, which is not conducive to patients completing more accurate grasping movements. The force feedback hand rehabilitation robot can make up for the above defects, but its clinical efficacy in stroke patients are not known to date. The aim of the present study was to investigate the effectiveness and added value of the force feedback hand rehabilitation robot combined with task-oriented training for stroke patients with hemiplegia.


Eligibility Criteria:
Inclusion Criteria:

* First-ever stroke
* Aged 20\~80 years old
* Post-stroke time≤6 months
* Clinically diagnosed with a central paresis of the right arm/hand (Brunnstrom stage of the affected upper limb≥II, Brunnstrom stage of the affected hand II\~V, Active flexion range of motion of the affected finger joint≥10°, MAS of affected upper limb and finger≤1+
* Sitting balance≥Level 2
* No serious depression and no visual impairment
* Cognitive and speech abilities sufficient to understand instructions and to provide informed consent

Exclusion Criteria:

* Severe additional neurological, orthopedic, or rheumatoid impairments before stroke which could interfere with task performance
* Sensory disturbance of fingers
* Severe joint pain caused by various reasons affects the functional activities of fingers
* Complicated with serious heart, lung, liver, kidney or infection
* Attending another study or therapy to improve arm-hand function