cyrilzakka/clinical-trials huggingface dataset:
A Study of AST-008 in Healthy Subjects

AST-008 will be dosed subcutaneously to healthy volunteers in a combined SAD/MAD study to evaluate its safety, tolerability, pharmacokinetics and pharmacodynamics.


Eligibility Criteria:
Main Inclusion Criteria:

1. Healthy male or female subjects aged ≥18 and ≤40 years of age at the time of first dosing.
2. Subjects must have a body mass index (BMI) between 18.0-25.0 kg/m² inclusive.
3. Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation (haematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with the subject's participation in or ability to complete the study as assessed by the Investigator.
4. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
5. An understanding, ability, and willingness to fully comply with study procedures and restrictions.

Main Exclusion Criteria:

1. Current or recurrent disease (e.g., cardiovascular, haematological, neurological, endocrine, renal, liver, GI or other conditions) that could affect the action, absorption, or disposition of AST-008, or could affect clinical assessments or clinical laboratory evaluations.
2. Any history of cancer.
3. Any history (including significant and confirmed family history) of autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, autoimmune hepatitis, or thrombocytopenia.
4. Has had an acute illness within two weeks prior to screening.
5. Current or relevant history of physical or psychiatric illness that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
6. Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study may influence the result of the study, or the subject's ability to participate in the study.
7. Female subjects who are pregnant or breastfeeding.
8. Subjects with abnormal findings of inguinal, axillary, or cervical lymph nodes at screening or Day -1.
9. A positive human immunodeficiency virus (HIV) antibody screen, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody screen.
10. Titres above reference ranges (according to local laboratory) for autoimmune antibodies: rheumatoid factor (RF), anti-nuclear antibodies (ANA), anti-neutrophil cytoplasmic antibodies (ANCA).
A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine

This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patients with essential hypertension

Exclusion Criteria:

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of myocardial infarction.
* Other protocol-defined inclusion exclusion criteria also apply.
Cognitive Training for Nicotine Dependence

This randomized clinical trial tested the effects of a computerized (web-based) cognitive training intervention on smoking cessation.

All participants received 8 weeks of standard nicotine patch therapy, smoking cessation counseling, and were randomized to 1 of 2 different training programs: cognitive training vs. control training.


Eligibility Criteria:
Inclusion:

1. Healthy male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months
2. Plan to live in the area for at least the next 8 months
3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form
4. Able to communicate fluently in English (speaking, writing, and reading)
5. Have uninterrupted access to a home computer with sound capabilities, keyboard, mouse, and active Internet connection
6. Provide a Carbon Monoxide (CO) breath test reading greater than or equal to 8 parts per million (ppm) at Intake Visit
Incorporation of Patient Reported Outcomes Data in the Care of US Veterans With Rheumatoid Arthritis

The overall goal of this proposal is to address barriers to the use of patient reported outcome (PRO) data in the Dept. of Veterans Affairs (VA) health care system.

This is a randomized, controlled, single-blinded study that compares outcome data in patients for whom PRO data either is or is not made available to the treating physician. The question addressed by this proposal is whether patient reported outcome (PRO) data change patient's outcomes. The hypothesis is that the availability of these data in the form of the patient-completed Multidimensional Health Assessment Questionnaire/routine assessment of patient index data (MDHAQ/RAPID3) questionnaire will change patient-centric outcomes such as patient reported well-being, patient satisfaction and medication compliance.

Eligibility Criteria:
Inclusion Criteria:

* US veteran
* Within North Florida/South Georgia (NF/SG) Veterans Integrated Service Network

Exclusion Criteria:

* Outside of service network
* Non-veteran
Pain Blocking During Drug Administration or Blood Collection With Needles

There is a gating mechanism in the dorsal horn of the spinal cord that acts to facilitate or inhibit transmission of pain signals to the brain. The gate can be closed by mechanical stimuli such as touch and vibration.

The researcher develope a device that can use to reduce pain during drug administration or blood collection with needles.

Eligibility Criteria:
Inclusion Criteria:

* Receiving an injection with a needle
* Able to score the pain on a scale of 0-10 using the universal pain assessment tool, preferably 7 years of age or older

Exclusion Criteria:

* Current pregnancy
* Inability to understand and carry out instruction
Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury

This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

The safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge. Nasogastric tube feeding has been the mainstream choice in China but with the risk of complications. Intermittent Oro-esophageal Tube Feeding is an established modality of enteral nutrition support that can be used with routine treatment. This study reports the clinical outcomes of Intermittent Oro-esophageal Tube Feeding vs. nasogastric tube feeding, in patients receiving routine treatment. This was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury, confirmed through MRI
* score of Glasgow Coma Scale (GCS) \<8;
* presence of no contraindication for enteral nutrition;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
* informed consent form was obtained from the patient\&#39;s family members.

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
* complicated with other intracranial lesions, such as stroke;
* with severe consciousness disorders caused by other diseases.
Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus Patients

Extra virgin olive oil (EVOO) is known for its cardiovascular effects and its effect on glucose lowering. However, the effects of EVOO on the blood glucose of Type 2 Diabetes Mellitus Filipino patients has not been studied. The investigators aimed to determine whether a significant difference exists in meals containing EVOO versus meals without EVOO among Type 2 Diabetes Mellitus patients.

Thirteen patients were included in this randomized controlled cross-over trial. They were randomized to receive a meal with or without EVOO followed by a one week wash out period, where they were given the other intervention. The primary outcome is the trans-meal blood glucose, which is calculated as the percent change in 2-hour postprandial blood glucose.

During their first visit, the participants were oriented on the conduct of the study. They were advised to be compliant with their medications throughout the duration of the trial.

On their second visit, participants were asked to do a six to eight-hour overnight fast, and their fasting blood sugar was drawn. Serum samples were analyzed through the hexokinase method. The participants were then randomly allocated (first allocation) by the dietician through a coin toss to receive a standard breakfast without EVOO or a meal admixed with one tablespoon of EVOO. The standard meals were labeled with serial numbers, and both the participants and the investigator were blinded to the intervention. The meals were consumed steadily in 15 to 20 minutes, after which, the food containers were collected to ensure its full consumption. Breakfast was chosen in order to avoid a second meal bias. The participants were asked to sit in the waiting area of the laboratory until the 2-hour postprandial blood sugar was due to be drawn.

After a one-week washout period, the participants were asked to come back for a cross over to the other treatment arm (second allocation). The participants were given the same test meal to ensure that that the glycemic index of the food remained constant.

Eligibility Criteria:
Inclusion Criteria:

1. patients aged 30-65 years old
2. diagnosed with Type 2 Diabetes Mellitus
3. body mass index under the overweight or obese class I category (by Asia Pacific guidelines)

Exclusion Criteria:

1. pregnant patients
2. patients with history of frequent hypoglycemic episodes
3. those at high risk of developing ketoacidosis and hyperglycemic hyperosmolar syndrome
4. those with identified acute stress during the study (illness, fever, trauma leading to hospitalization)
5. current intake of steroids
6. olive oil allergy or intolerance
7. digestive disorders
The Effect of Oral Carnitine Supplementation on MRS-derived Mitochondrial Function

This is a longitudinal study supported by Pfizer and is a collaboration between DMPI (Duke Molecular Physiology Institute) and DIAL (Duke Image Acquisition Laboratory) to measure the effects of acute exercise on carnitine and acylcarnitine levels in the muscle and on insulin sensitivity in the plasma. This pilot study seeks to explain why moderate intensity exercise provides more improvements in glucose control for pre-diabetic patients than vigorous intensity. The investigators hypothesize that moderate intensity exercise might be beneficial for elderly individuals who are overweight or obese, specifically by: 1. Reducing damaging excess protein acetylation (measured in muscle biopsy), 2. Improving the acylcarnitine/carnitine ratio (measured by MRS), 3. Improving overall mitochondrial function as reflected in reduced phosphocreatine recovery time (measured by MRS) and 4. Increasing insulin sensitivity as measured by a 4-hour oral glucose tolerance test. Investigators intend to use the results of this study to show feasibility in measuring mitochondrial function at Duke for a larger federal grant submission. Investigators hypothesize that carnitine insufficiency might contribute to mitochondrial dysfunction and obesity-related impairments in glucose tolerance and insulin action.


Eligibility Criteria:
Inclusion Criteria:

* Age: 60-80 years
* Moderately Overweight: BMI - 25.0 - 35.4
* Sedentary - exercise ≤ 1 day/week
* Fasting plasma glucose: \> 100 - \< 126 mg/dL
* Readings from two separate days

Exclusion Criteria:

* Orthopedic limitations, musculoskeletal disease and/or injury
* Allergic to xylocaine
* Inability to give blood continuously through an intravenous catheter
* Have a confounding medical condition that is progressive and unstable such as HIV, Hepatitis C, active cancer, and/or taking medications for those conditions that are likely to confound the assessment of pre-diabetes
* Prior surgical operation within the past 6 months
* Prior injury to the eye involving metallic objects or fragments
* Prior injury involving a metallic object or foreign body (eg. BB, bullet, shrapnel, etc.)
* Tattoos from the waist down to the feet
* Any of the following implants or devices

  * Aneurysm clip
  * Cardiac pacemaker
  * Implanted cardioverter defibrillator (ICD)
  * Electronic implant or device
  * Magnetically activated implant or device
  * Neurostimulation system
  * Spinal cord stimulator
  * Internal electrodes or wires
  * Bone growth/bone fusion stimulator
  * Cochlear, otologic or other ear implant
  * Insulin or other infusion pump
  * Implanted drug infusion device
  * Eye implants
  * Vascular access port and/or catheter
  * Wire mesh implant or stent
  * Other implant
* Claustrophobia
* Prior knee replacement surgery
* Pregnant or intending to become pregnant during the study
PRF+1% MF for Class II Mandibular Furcation Defects

The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.

Background: For improving efﬁcacy and outcomes of regenerative therapy for furcation defects, various materials has been investigated in addition to access therapy. Platelet-rich fibrin (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious member of biguanide group are known to enhance periodontal regeneration. The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.

Methods: This randomized trial was conducted on 75 patients with mandibular class II furcation defects. Defects were surgically treated with either access therapy alone (Group 1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of bone defect fill was done at baseline and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP);
* No history of antibiotic or periodontal therapy in the preceding 6 months.

Exclusion Criteria:

Aggressive periodontitis patients

* Systemic conditions known to affect the periodontal status;
* Medications known to affect the outcomes of periodontal therapy;
* Hematological disorders and insufficient platelet count (\<100,000/mm3);
* Pregnancy/lactation;
* Smoking and tobacco use in any form
* Immunocompromised individuals;
* Those having unacceptable oral hygiene (plaque index \[PI\] \>1.5).
* Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.
Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea

The purpose of this trial is to investigate the mechanisms leading to weight gain during CPAP treatment for obstructive sleep apnea (OSA).

Obesity and obstructive sleep apnea share a bidirectional relationship. While obesity is a major risk factor for OSA, OSA may contribute to weight gain. Recent evidence suggests that OSA treatment is associated with weight gain. The mechanisms involved in weight gain after OSA treatment are not known. The purpose of this study is to determine the mechanisms of weight gain during CPAP treatment for severe OSA leads. The investigators hypothesis is that CPAP leads to a decrease in energy expenditure and prevents the elimination of extracellular fluid that is accumulated during the day. In order to test this hypothesis, 20 patients with severe OSA aged between 50 and 80 years old, under regular treatment with CPAP, will be invited to participate. Using a cross-over design, the investigators will perform bioelectric impedance 5 times over 24 hours in order to assess the circadian effect of fluid accumulation in two different conditions: during CPAP treatment and 7 days after CPAP withdrawal. A full polysomnography will be performed during CPAP withdrawal to confirm severe OSA and during CPAP treatment to confirm adequate control of respiratory events. In addition, basal metabolic rate, hematocrit, serum BNP, urinary sodium, creatinine and osmolality will be determined in the morning during the CPAP and CPAP withdrawal periods.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of severe OSA (AHI\>30 events/h)
* 50 and 80 years old
* regular treatment with CPAP with an average daily use of \>4hours

Exclusion Criteria:

* congestive heart failure
* renal insufficiency
* hepatic failure
* urinary incontinency
* diuretic therapy
Microfracture Technique for Talar Articular Cartilage Lesions With or Without Lateral Ligament Repairment

To study the clinical efficacy of microfracture combined with lateral ligament repairment for cartilage lesions of talus through the comparison between microfracture with and without lateral ligament repairment.


Eligibility Criteria:
Inclusion Criteria:

Full - thickness cartilage injury

Exclusion Criteria:

Age: \> 40 years old or \< 18 years old; BMI \> 30; lesion \> 4 cm2
Out-of Pocket Payments in Patients With Lymphedema

Primary lymphedema is a chronic condition posing a high burden on patients. Clinical guidelines emphasize the role of compression therapy by prescription medical devices. Even in a mandatory publicly funded health insurance system, out-of-pocket payments (OOPP) may exist due to the price and reimbursement setting processes. OOPP may threaten the equity of care and drive patients to forgo care. The investigators aim was to analyze the distributive effects of OOPP for primary lymphedema patients in France.

A prospective, multicenter study will be conducted in France in 2015 on patients with primary lymphedema. Household ability to pay will be specified by net income and OOPP will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). Both mandatory and voluntary health insurance reimbursements will be considered. The investigators will combine concentration curves and concentration indices to assess the distributive effects.


Eligibility Criteria:
Inclusion criteria:

* Patient aged over six years, with primary lymphedema, regardless of the severity of the disease;
* Patient treated in one of the centres participating in the study;
* Patient (and her legal representative for minors) who gave her written consent \[or did not refuse to participate, according to local Law\];
* Patient with Internet access and an active email address.

Exclusion criteria:

* Patients with concomitant chronic venous insufficiency;
* Patient not covered by any health care insurance scheme;
* People protected under the law.
rTMS and Multi-Modality Aphasia Therapy for Post-Stroke Aphasia

Many stroke survivors experience aphasia, a loss or impairment of language affecting the production or understanding of speech. One common type of aphasia is known as non-fluent aphasia. Patients with non-fluent aphasia have difficulty formulating grammatical sentences, often producing short word fragments despite having a good understanding of what others are trying to communicate to them. Speech language pathologists (SLPs) play a central role rehabilitating persons with aphasia and administer therapy in an attempt to improve communication skills. Despite standard therapy, approximately 50% of individuals who experience aphasia acutely continue to have language deficits more than 6 months post-stroke.

In most people, Broca's area is dominant in the left side of the brain. Following a left-sided stroke, the right-sided homologue of Broca's area (the pars triangularis), may adopt language function. Unfortunately, reorganizing language to the right side of the brain seems to be less effective than restoring function to the left hemisphere. Repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, can be used to suppress activity of specific regions in the right side of the brain to promote recovery of function in the perilesional area. Despite preliminary success in existing studies using rTMS in post-stroke aphasia, there is much work to be done to better understand the mechanisms underlying recovery. Responses to rTMS have been positive, yet heterogenous, which may be related to timing of treatments following stroke.


Eligibility Criteria:
Inclusion Criteria:

* Isolated left middle cerebral artery (MCA) stroke more than 6 months ago (chronic)
* Stroke type: Ischemic or hemorrhagic
* Non-fluent aphasia as determined by the Western Aphasia Battery (Fluency \< 5)
* Right-hand dominant prior to stroke
* English is first or primary language
* Ability to follow 3-step commands

Exclusion Criteria:

* Prior stroke to the right frontal lobe
* Current diagnosis of moderate to severe depression
* Diagnosis of any other psychiatric condition
* History of other neurologic disorders (e.g., epilepsy, brain tumor)
* Contraindication to MRI or TMS (metal in the head or any implanted electrical device)
* Has received intensive speech therapy within the past 6 months (\>8 hours per week)
* Enrolled in another interventional study