cyrilzakka/clinical-trials huggingface dataset:
A Study to Examine the Efficacy, Safety and Tolerability, and Pharmacokinetics of Exenatide Once Monthly Suspension

The purpose of Study BCB111 is to collect efficacy, pharmacokinetic, pharmacodynamic, safety, and tolerability data in patients with type 2 diabetes to assess the feasibility of once monthly dosing of the exenatide suspension formulation.


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years old at study start
* Has been diagnosed with type 2 diabetes mellitus
* Has HbA1c of 7.1% to 11.0%, inclusive, at study start
* Has been treated with diet and exercise alone or with a stable regimen of metformin, pioglitazone, or a combination of metformin and pioglitazone, for a minimum of 2 months prior to study start
* Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: hormone replacement therapy (female subjects); antihypertensive agents; thyroid replacement therapy; or antidepressant agents

Exclusion Criteria:

* Clinically significant medical condition that could potentially affect study participation including:
* Acute or chronic pancreatitis
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2
* Active cardiovascular disease within 3 months of study start
* Underlying hepatic or renal disease
* Inflammatory bowel disease, or other severe gastrointestinal diseases (particularly those that may affect gastric emptying, such as gastroparesis, pyloric stenosis, and metabolic surgery)
* Has had \> 2 episodes of major hypoglycemia in the preceding 6 months before study start
* Has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start
* Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:

  * Any exposure to exenatide (BYETTA®, exenatide once weekly, or exenatide suspension), liraglutide (Victoza®), or any GLP-1 receptor agonist
  * Any DPP-IV inhibitor, sulfonylurea (SU), or rosiglitazone (Avandia®) within 3 months prior to study start
  * Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days prior to study start
  * Insulin within 2 weeks prior to study start, or for more than 1 week within 3 months prior to study start
  * Systemic corticosteroids by oral, intravenous, intra-articular, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
  * Prescription or over-the-counter weight loss medications within 3 months prior to study start
Can Methods From Computational Psychology be Used to Phenotype Individuals Most Likely to be Non-adherent to Fitness Goals?

This is a longitudinal study combining objective sensor data, with decision-making games and contextual personality traits to identify patterns in exercise decay. The data generated will be used to build computational models to predict digital personas, and help identify those individuals most likely to abandon exercise goals.

Interested individuals to be recruited on social media and invited to download the study app. The plain language statement and informed consent are embedded in the app. Once e-consent is obtained, individuals will share their Fitbit data and complete the following questionnaires; Type D Personality, Goal Setting, and Self-Efficacy questionnaire and a decision-making game based on the IGT. After a 6 month time period, they will be requested to retake the questionnaires and decision-making game.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals who have a Fitbit

Exclusion Criteria:

* Individuals under the age of 18 years of age.
Myorelaxant Effect of Cannabis Cream Topical Skin Application in Patients With TMD

Evaluation of myorelaxant effect of cannabis cream.compared to placebo cream in topical skin application in patients with TMD

Cannabis sativa has a very wide application in various fields of medicine. In patients with temporomandibular disorder, especially with myofascial pain of masticatory muscles there is a special need to seek an effective pain therapy and muscle relaxing methods. Patients with TMD suffer from chronic pain and depression, cannabis topical skin application therapy seems promising in that field. Patients attending The Department of TMD in Zabrze, Polska were randomly divided into two groups: experimental and placebo. sEMG activity values were compared during 14 days therapy with cream. Positive results were obtained confirming the efficacy of the cannabis cream used in the study, compared to placebo.

Eligibility Criteria:
The inclusion criteria were as follows:

1. Patient agreement to participate into the research study
2. Age ≥22 and ≤ 27
3. Good general health,
4. Temporomandibular disorder-positive RDC/TMD examination for group Ia and Ib
5. Presence of all teeth (with the exception of the third molars)

The exclusion criteria were:

1. Cannabis cream/ placebo cream allergy
2. Hypersensitivity to substances to be used in the study
3. Skin wounds with skin surface discontinuation
4. Addiction to cannabis
5. Patients being treated with analgesic drugs and/or drugs that affect muscle function
6. Fixed or removable dental prosthesis
7. Disease or autoimmune disorder associated with generalized muscular tension
Schema, Emotion, and Behavior Therapy for Children

The study is a randomized controlled trial to examine the efficacy of individual cognitive behavioral therapy (CBT) relative to a standard community treatment, in youngsters with autism spectrum disorder (ASD). The individual CBT program has been tailored over the last five years to the clinical needs of high-functioning youth with ASD.

Autism spectrum disorder (ASD) is among the most common childhood developmental disorders. A key goal in the field is the discovery of methods that reduce core autism symptoms. Core autism symptoms include social-cognitive impairments, pragmatic language deficits, and repetitive and rigid behaviors. The core symptoms tend to be stable and resistant to intervention. Most treatments involve group-based social skills training (SST), with limited effects. No treatment for core autism symptoms in school-aged children with ASD meets American Psychological Association guidelines for possible efficacy. Cognitive behavioral therapy (CBT) offers a novel approach for addressing core autism symptoms in higher functioning school-age youngsters. Initial results suggest that individual CBT may also be promising for reducing core autism symptoms (Wood et al., 2009b; Drahota, Wood et al., 2011). The treatment is based on a contemporary model of memory retrieval competition, employing strategies for enhancing the retention of adaptive conceptual and behavioral responses and the suppression of idiosyncratic beliefs and behaviors in daily social contexts, emphasizing the use of deep semantic processing to enhance memory retrieval. We are proposing a randomized controlled trial to examine the efficacy of individual CBT relative to a standard community treatment in youngsters with ASD.

Eligibility Criteria:
Inclusion Criteria:

* Meets research criteria for a diagnosis of autism, based on child scores on the ADI-R and ADOS tests.
* If taking medication, have maintained a stable dose for 1 month prior to baseline assessment.
* Between the ages of 9-13 years.
* The child's teacher consents to participate in the study to play a modest role in helping implement the intervention and facilitate the school observation assessment.

Exclusion Criteria:

* IQ less than 85.
* The child starts taking new medication(s) or current medication dose changes either (a) less than 1 month prior to the diagnostic evaluation, or (b) during the study period.
* The child is participating in an intensive early intervention program for autism such as applied behavior analysis or floortime.
* For any reason the child or parents appear unable to participate in the treatment program.
Snuff Use, Smoking, Periodontal Health and Premature Death: 30-year Study

Snuff use and smoking associated with poor periodontal health, especially if used together.

Aim: The investigators investigated how snuff use and smoking affect periodontal health parameters and mortality in a Swedish cohort, hypothesizing that snuff use increases the risks.

Material and methods: Study cohort of 1 532 subjects aged 30 to 40 (758 men and 774 women) from Stockholm area was clinically examined and followed up from 1985 to 2015. Associations were analysed between periodontal health parameters, snuff use, smoking and age of death. For analyses, all subjects were classified into four groups: "dual-users" (current and ex-snuffers, current and ex-smokers); "pure snuffers" (current and ex-snuffers); "pure smokers" (non-snuffers, current and ex-smokers) and "non-users" (non-snuffers and non-smokers). Cross-tabulation, chi-square and Fisher's exact tests were used.

Eligibility Criteria:
Inclusion Criteria:

* In 1985-1986 a sample was selected from the registry file of all inhabitants of the Stockholm area, of people born on the 20th of any month from 1945 to 1954.The sample comprised 3200 people. They were informed about the purpose of the study and called for clinical investigation. 1681 (52.5%) individuals, 840 men and 841 women, participated in the study. From the remaining 1519 non-respondents to the initial call, 100 randomly selected subjects, 45 men and 55 women, were reinformed and persuaded and finally agreed to participate in this investigation. They were used as a drop-out control sample.

Exclusion Criteria:

* Other people
Stanford's Outcomes Research in Kids

The investigators intend to investigate whether the rise in childhood obesity is caused by the loss of recurrent and chronic infections in modern, industrialized society, beginning in utero and extending through early childhood. The investigators will also examine whether the antimicrobial triclosan, present in numerous cleaning and hygiene products, decreases the incidence of infection within a household.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to participate in the study:

1. Able to provide written informed consent.
2. Able to communicate effectively in verbal English or Spanish.
3. Willing to provide blood, saliva, urine and stool specimens from herself, and willing to provide blood, saliva, urine and stool specimens from her infant.
4. Willing to provide consent for review of Primary Provider Medical Records regarding, for the mother, medical history and infectious and other conditions during pregnancy, and for the infant, Apgar scores, height and weight measurements at birth and over time, infectious and other disease diagnoses and treatment, and vaccination records.

Exclusion Criteria:

1. More than one fetus.
2. High risk pregnancy.
3. Intent to move from the Bay Area within three years after enrollment.
4. History of diagnosis and/or treatment, and any current diagnosis or treatment, of type 1 diabetes or of major mental illness.
5. History of diagnosis and/or treatment, and any current diagnosis or treatment, of a thyroid disorder or other endocrine condition.
6. History of diagnosis and/or treatment, and any current diagnosis or treatment that has resulted in severe immunosuppression.
7. A household member who has a compromised immune system
8. Other conditions that in the opinion of the PI would make the subject an unacceptable candidate for this study.
Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue recovery after exercise. The investigators measured fatigue recovery parameters , including lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 19-60 years old
* Hemoglobin concentration between 13 and 14 g/dL(men), 12 and 13 g/dL(women)
* Able to give informed consent

Exclusion Criteria:

* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile

Participants in this study will be randomized to receive either oral vitamin D pills OR ultraviolet light treatment. The investigators will compare how these two methods of raising vitamin D levels will affect cholesterol levels.

Potential subjects will be screened for eligibility, including serum 25(OH)D levels \<20ng/ml. Eligible subjects will be randomly assigned to receive either: 1) oral vitamin D3, 50,000 units weekly for 8 weeks or 2) narrow-band UVB radiation, 2 treatments/wk for 8 weeks. Duration of treatment will be based on skin type. After 8 weeks, 25(OH)D levels will be measured monthly. For participants with levels \<35 ng/ml, additional doses of oral vitamin D3 or UV radiation will be administered.

A subset of participants from both groups will participate in a skin biopsy cohort, where skin biopsies are obtained before and after 8 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Vitamin D 25-OH level \< 20 ng/ml

Exclusion Criteria:

1. Serum calcium \> 10.5 mg/dl
2. Serum phosphorus \> 5.5 mg/dl
3. Serum parathyroid hormone (PTH) level \< 12 pg/ml
4. LDL cholesterol \> 190 mg/dl
5. History of recent acute infection (within 1 month)
6. Glomerular filtration rate(GFR) \< 60 mL/min
7. Liver Function tests indicative of liver disease (aspartate aminotransferase (AST) or alanine transferase (ALT) \> 3x ULN)
8. Current use of Vitamin D \> 400 IU/day
9. Current use of any statins, fibrates, niacin, or ezetimibe
10. Current use of any medications affecting sensitivity to UV light
11. Pregnancy (self-reported)
12. Intentional UV exposure (e.g. tanning bed use) in the last 2 weeks or planned use while participating in the study
13. history of malignancy not in remission (\> 6 months)
14. History of malignant melanoma
15. Participation in an investigational drug study within 30 days of the screening visit
16. Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
17. History of any non-melanoma skin cancer
Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma

The only curative option for pancreatic cancer patients is surgery, but the patients within 20% of them are possible for a radical surgery. Accordingly, concurrent chemo-radiation therapy is generally used for palliation of unresectable pancreatic cancer patients. So far, the use of 5-fluorouracil (5-FU) was the traditional method of chemotherapy. However, these days, oral anti-cancer medicine, capecitabine(Xeloda®), was developed and considered as an alternative medicine of 5-fluorouracil (5-FU). Furthermore, according to the recent results of clinical trials, the clinical use of capecitabine(Xeloda®) with radiation therapy was proved to be very effective and safe. Proton therapy is a new radiation therapy which remaining energy is released when they reach the tumor, delivering the most effective dose of radiation and which can minimize the exposure to normal tissues. The purpose of this trial is to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of the pancreas or a serum CA19-9 level higher than normal limits and an pancreas cancer-compatible radiological features in one or more in CT/MRI/PET scans
* Unresectable disease base on institutional standard criteria of unresectability or recurrent disease following radical surgery. There is no evidence of metastatic disease in the major viscera and no peritoneal seeding
* Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation
* All malignant disease must be encompassable within a single irradiation field (15x15cm maximum)
* All patients must have radiographically assessable disease
* No previous irradiation to the planned field
* Age of ≥ 18 years
* Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
* Required Entry Labortory Parameters:

  * WBC count ≥ 2,000/mm3
  * hemoglobin level ≥ 7.5 g/dL
  * platelet count ≥ 100,000/mm3
  * total bilirubin ≤ 2.0 mg/dL (Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decreased ≤ 2.0 mg/dL prior to study entry)
  * creatinine ≤ 3.0 mg/dL
* Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.

Exclusion Criteria:

* There is evidence of metastasis in the major viscera or peritoneal seeding.
* Age of \< 18 years
* Previous history of RT adjacent to planned field
* Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
* Pregnant or breast feeding status
* Previous history uncontrolled other malignancies within 2 years
A Prospective Study of Vasopressor on Cerebral Oxygenation During General Anesthesia

The purpose of this study is to investigate whether norepinephrine(N), phenylephrine(P) or ephedrine(E) have different effect on cerebral oxygenation in abdominal surgery with propofol or sevoflurane.

This study was a single-center, randomized, double-blinded, controlled trial. First, the effects of E, P, or N on cerebral oxygen saturation(rScO2) under general anesthesia in abdominal surgery were studied. Patients with abdominal surgery were evaluated using near-infrared spectroscopy. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured with LiDCO rapidV3 monitoring system. To investigate the individualized therapeutic options \& specific mechanisms of the three vasopressors on rScO2 and CO.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III, age 18-80 years
* Elective abdominal surgery
* Signed informed consent

Exclusion Criteria:

* ASA≥IV
* Preoperative unstable blood hemodynamics
* Allergy to ephedrine, phenylephrine or norepinephrine
* Decrease in MAP \<20%
* Severe cardiovascular disorder
Effect of Action Video Games and Stroboscopic Glasses on Dynamic Visual Acuity.

The study aims to observe the possible improvement of performance in dynamic visual acuity (DVA), in terms of speed and trajectory, comparing training using action video games and strobe glasses. The results will allow us to understand which visual training is more beneficial for improving dynamic visual acuity in athletes.

During the last years there have been several investigations related to the effect of action video games (VA) on the visual system, specifically perceptual and cognitive processes. These investigations indicate that playing VA can be a powerful tool for improving visuo-spatial attention, visuo-motor control, and reaction time. On the other hand, certain studies indicate that the use of stroboscopic glasses can help improve sports performance, and especially dynamic visual acuity , as well as various visual performance skills. The study aims to observe the possible improvement of performance in dynamic visual acuity (DVA), in terms of speed and trajectory, comparing training using action video games and strobe glasses. The results will allow us to understand which visual training is more beneficial for improving dynamic visual acuity in athletes.

Eligibility Criteria:
Inclusion Criteria:

* No strabismus and/or amblyopia.
* Not presenting accommodative difficulties or difficulties in ocular convergence.

Exclusion Criteria:

* Presence of amblyopia and strabismus, accommodative insufficiency, convergence insufficiency
* Be federated in any sport in which they train more than 3 hours a week in the past and previous year (1 year ago) from the day of the experimental measurements.
Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition

Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid responsiveness. However, its usefulness in open-chest conditions has been equivocal. The investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid responsiveness after sternotomy.


Eligibility Criteria:
Inclusion Criteria:

- Adult patients undergoing elective off-pump coronary arterial bypass grafting

Exclusion Criteria:

* Preoperative LV EF \<= 35%
* Moderate or severe valvular heart disease
* Cardiac arrhythmia
* Intracardiac shunt
* Severe renal or liver disease
* Moderate to severe pulmonary hypertension (mean PAP \> 35 mmHg)
* Patients with bullous lung disease or combined pneumothorax
Sleep Apnea in Heart Failure With Preserved Ejection Fraction

This is a prospective interventional study to better understand i) the prevalence of Obstructive Sleep Apnea (OSA) in Heart Failure with preserved Ejection Fraction (HFpEF), ii) its hemodynamic correlates, and iii) the impact of intervention with Continuous Positive Airway Pressure (CPAP) on quality of life.

This is a prospective non-randomized observational study which will recruit patients with gold standard HFpEF defined by exercise catheterization or following HF hospitalization. The prevalence of OSA will be determined in all HFpEF patients at baseline using home sleep apnea testing and all patients will complete the Mayo Sleep Questionnaire. Patients with known OSA at baseline will also be included only for the baseline assessment to accurately estimate prevalence of OSA in gold standard diagnosed HFpEF. The subset of initially recruited patients with HFpEF who have newly diagnosed OSA will be offered and initiated on CPAP therapy to treat their underlying OSA. Repeat evaluation after 3 months of CPAP therapy for end point assessment with remote accelerometry (2 weeks prior to study completion), ESS and KCCQ, which will all be identical to baseline measurements.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of HFpEF by catheterization with resting PCWP\>15 mmHg or exercise PCWP\>25 mmHg or hospitalization with HFpEF
* Ambulatory (not wheelchair/scooter dependent)
* If no known diagnosis of OSA, must not be pacemaker dependent with either atrial pacing or VVI without sinus rhythm
* If no known diagnosis of OSA, must be able to temporarily hold nitrates or alpha channel blockers for home WatchPAT testing (3 hour washout period)

Exclusion Criteria:

* Ejection fraction \<40%
* Obstructive hypertrophic cardiomyopathy
* Constrictive pericarditis or tamponade
* Active myocarditis
* Complex congenital heart disease
* Other valve disease requiring surgical intervention
* Terminal illness (other than HF) with expected survival of less than 1 year
* Inability to comply with planned study procedures
* Pregnancy or breastfeeding mothers