cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia

Statins are medications that lower blood cholesterol by inhibiting cholesterol production in the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report muscle aches/pain while taking statins. In a very small percentage of patients (\<0.01%; less than one in 10,000 people), muscle aches/pains may be accompanied by more serious muscle damage. In these patients, statins must be discontinued. In some reports, patients taking statins have reduced blood levels of coenzyme Q10. Coenzyme Q10 is an essential protein which is present in all human cells needed for normal cell function. Coenzyme Q10 has been tested in patients with heart failure where it has been shown to be safe and effective. Many patients with heart conditions take coenzyme Q10, but the risks and benefits of supplementation with this product is unknown. Coenzyme Q10 is considered a dietary supplement and is not approved by the Food and Drug Administration (FDA) for any medical condition. Coenzyme Q10 has very few, if any, side effects. Upset stomach (gastritis), headache, body ache, and low blood pressure have been reported. The objectives of this project are to test the efficacy and safety of coenzyme Q10 in treating muscle aches/pain in patients already taking statins who develop these symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are taking statins and develop unexplained, persistent myalgia with a normal plasma creatinine kinase level

Exclusion Criteria:

* Women of childbearing potential
* Patients currently taking coenzyme Q10 (or have taken in the previous 30 days)
* Patients receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that effect cholesterol levels or interact with statins
* Patients with a history of alcoholism or malnutrition
* Patients who have had acute coronary syndrome or muscle trauma in the prior 7 days
* Patients with a history of chronic muscle/joint pain, fibromyalgia, or degenerative disk disease.
Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder

The objectives of the current study are

1. to evaluate the efficacy of escitalopram in treatment for post-traumatic stress disorder,
2. to find the structural changes of brain using magnetic resonance imaging and its association with the symptoms reduction, and
3. to look at the differences of brain imaging findings and symptoms changes according to genetic differences of brain-derived neurotrophic factor (a biological molecule facilitating neuronal growth in human).


Eligibility Criteria:
Inclusion Criteria:

* 18-65 year-old male or female
* PTSD diagnosed by SCID-IV

Exclusion Criteria:

* Previous or current treatment history for PTSD
* Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
* Any other axis I psychiatric disorder diagnosed by SCID-IV
* Borderline personality disorder or antisocial personality disorder
* IQ below 80
* Any contraindication to MRI scan
* Any current psychotropic medication
* Unstable medical illness or severe abnormality in laboratory test at screening assessment
* Women who are pregnant, breastfeeding, or planning pregnancy
* Any contraindications to drug used in the study (e.g., allergy, intolerance, etc.)
Metformin Plus Insulin on Non-obese Autoimmune Diabetes

The objective of this study is to evaluate the therapeutic effect of metformin as additional treatment with insulin on non-obese autoimmune diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes according to ADA criterias \<5 years.
* Age≥ 18 years and less than 70 years.
* Non-obese: defined as BMI less than 28 kg/m2
* Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A
* Fasting or postprandial plasma C-peptide more than 100 pmol/L
* Written informed consent from the patient or family representative.

Exclusion Criteria:

* History of any malignancy or other severe diseases
* Female patients who are pregnant or breastfeeding before or during the three-year follow-up
* Poor compliance or refusal to participate.
Efficacy of Ecabet Sodium and Proton Pump Inhibitor Combination Therapy in the Treatment of Iatrogenic Ulcer After Endoscopic Submucosal Dissection

* Endoscopic submucosal dissection (ESD) is widely indicated to treat gastric adenomas and early gastric cancer (EGC).ESD is able to obtain en bloc resection of larger specimens. However, ESD has more frequent complications (delayed bleeding, ulcer healing, ulcer pain, and etc) due to a more complex procedure. To prevent delayed bleeding, to induce rapid ulcer healing, and to control the ulcer pain acid-suppressing agents (PPI, H2RA) are generally administered. although PPIs are widely indicated as first-line drugs for peptic ulcers, PPI drugs are not fully superior to H2RAs or other combination drugs for treatment of iatrogenic ulcer healing and delayed bleeding.
* Ecabet sodium (ES)is a widely used mucoprotective agent for the treatment of gastric ulcers. Recently, one study showed the additional benefits of using ES in combination with the PPI after ESD. however, this study did not show the difference of delayed bleeding and the benefit of ulcer pain control. thus, our study prospectively evaluated the difference of delayed bleeding and the benefit of ulcer pain control after ESD.


Eligibility Criteria:
Inclusion Criteria:

* gastric adenomas or differentiated EGC (any size without ulcers or signs of submucosal invasion; intramucosal differentiated-type EGC \< 3 cm with a scar; and no lymph node involvement or metastasis by CT)

Exclusion Criteria:

* recent use of a PPI, H2RA, bismuth, and antibiotics
* current use of aspirin, non-steroidal anti-inflammatory drugs, or corticosteroids
* Helicobacter pylori infection not evaluated appropriately by endoscopic biopsy and serology
* a history of subtotal gastrectomy; patients who underwent surgery due to ESD complications; known hypersensitivity to PPIs
* chronic co-morbid disease, such as chronic liver and renal disease
Effects of a Multidisciplinary Outpatient Rehabilitation Program in Patients With Ehlers-Danlos Syndrome.

The management of patients with Ehlers-Danlos syndrome (EDS) is still underdeveloped in healthcare institutions in France. Although multidisciplinary management through exercise rehabilitation has demonstrated its benefits in many chronic pathologies, it has not been evaluated for EDS. As a result, to date there is no evidence of its effectiveness in patients with EDS. The objective of this study is therefore to objectively evaluate the effectiveness of such a treatment on the different dimensions of these patients' health.


Eligibility Criteria:
Inclusion Criteria:

* EDS diagnosis.
* Inclusion in the rehabilitation program.

Exclusion Criteria:

* Absolute and relative cardio-vascular contraindications to rehabilitation.
* Other contraindications to exercise.
* Psychological contraindication (Beck questionnaire score ≥ 20)
Evaluating the Relationship Between Environmental Risk Factors in Housing Types and Chronic Respiratory Diseases in Ho Chi Minh City

The research question is "Are the different types of house in Ho Chi Minh city equally contributing to chronic respiratory diseases?".

According to this question, a cross-sectional and explorative study was set up to explore the differences in the environmental characteristics and prevalence of chronic respiratory diseases among common housing types in Ho Chi Minh city. Preliminary work was performed in 100 houses (20 houses per type, included tube houses, rental houses, rural houses, slum and apartment) from November 2013 to June 2015. It included measures by environmental devices, questionnaires and indoor activities diaries.

This study will aim to collect information about the prevalence of chronic respiratory diseases (CRDs) inside those house types to understand more about role of house types in developing CRDs.

The objective is:

1. to evaluate the relationships between the type of house and lung function of inhabitants in each housing type.
2. to evaluate the effects of environmental risk factors in each house type on prevalence of CRDs


Eligibility Criteria:
Inclusion Criteria:

* Everybody

Exclusion Criteria:

* Not able to answer the questionnaire or give informed consent
* Have a contra-indication for lung function test (acute myocardial infarction less that 1 month ago, pain related to spirometry, dementia/confused)
A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy

The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained.
* Has ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1 or 2 at the time of the randomisation.
* Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
* RAS status must have been determined (mutant or wild).
* Has at least one measurable metastatic lesion.
* No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.
* Previous adjuvant (or neoadjuvant for patients with rectal cancer) chemotherapy is allowed only if if it has been completed more than 6 months before start of study treatment.
* Patient is not a candidate for combination chemotherapy with irinotecan or oxaliplatin, or for curative resection of metastatic lesions.
* Is able to take medication orally (i.e., no feeding tube).
* Has adequate organ function.
* Coagulation parameters in normal limit (or in therapeutic limit for patients treated with anticoagulant drugs).
* Women of childbearing potential must have been tested negative in a serum pregnancy test. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control. Women and female partners using hormonal contraceptive must also use a barrier method.

Exclusion Criteria:

* Is a pregnant or lactating female.
* Has certain serious illness or serious medical condition(s) as described in the protocol.
* Has had certain other recent treatment e.g. major surgery, field radiation, received investigational agent, within the specified time frames prior to randomisation.
* Has previously received Trifluridine/tipiracil or history of allergic reactions attributed to compounds of similar composition to Trifluridine/tipiracil or any of its excipients.
* Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
* Has contra-indication to bevacizumab or capecitabine.
Capnographic Monitoring of Propofol-sedation During Colonoscopy

The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Indication for colonoscopy
* Patient wishing sedation during colonoscopy
* ≥ 18 years of age
* Signed informed consent form

Exclusion Criteria:

* Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
* Non-contractually capable persons
* Pregnancy
* Lactation
Impact of Mobile App on Purpose and Well-Being Among College Students

This study will examine the impact of a mobile app (JOOL) focused on promoting purposeful living on student health behaviors, academic performance, self-regulation, well-being, resiliency, and self-efficacy.

Participants will be recruited from a large undergraduate classroom. Participants will be randomly assigned to one of two conditions and asked to complete either online reflections or engage with a mobile app over the course of the semester. Students who elect to not participate will be provided an alternate assignment to complete, to be coordinated by their teaching assistant. Participants will additionally be asked to complete (1) a pre-survey, (2) post-survey, and follow-up survey 14 days after the class concludes. The study will examine changes in health-related behaviors, resiliency, well-being, and self-efficacy reported between the start and conclusion of semester/study.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Enrolled in Consuming Happiness course during the Spring 2017-18 semester.
* Must have access to WiFi, cellular service or computer with internet connection and web browser.

Exclusion Criteria:

* None
Physical Activity Intervention Among College Students

This project was to examine the effects of incorporating modern wearable technology into the credit-based Physical Activity Instructional Program for promoting habitual levels of physical activity among college students.

This project was a cluster randomized trial examining the effects of utilizing a wearable activity tracker in a credit-based Physical Activity Instructional Program on promoting habitual levels of physical activity (PA) in college students.

The project was conducted in a large public university located in the mid-south region of the US. The university offers more than one hundred 1-credit hour PAIPs per academic semester. Considering the pilot nature of the study, the target PAIPs was limited to those meeting the following inclusion criteria: 1) PAIP with a size of 30 students that generally show an approximately equal gender distribution; and 2) PAIP that delivers the principles and practice of individually tailored habitual activity plans. The investigators randomly selected 14 eligible PAIPs and assigned them into intervention (k=7) and control (k=7) groups. The outcome measures of interests were the changes in objectively and subjectively measured physical activity over an academic semester.

Eligibility Criteria:
Inclusion Criteria:

* healthy college students who were enrolled in 1-credit physical activity instruction programs.

Exclusion Criteria:

* did not wish to participate;
* have currently used their own wearable activity tracker;
* indicated any major physical, psychiatric, or cardiovascular-related problems diagnosed by a physician.
Effect of Vitamin D-biofortified Eggs on Wintertime Serum 25-hydroxyvitamin D in Adults: Randomized Controlled Trial

While there have been a considerable number of studies on the impact of additional vitamin D in the diets of hens on the resulting egg vitamin D content, the effect of consumption of such vitamin D-enhanced eggs on vitamin D status of healthy human subjects has not been tested in a RCT.

The aim of this study was to investigate the effect of consumption of vitamin D3 versus 25-hydroxyvitamin D3 biofortified eggs on winter serum 25(OH)D in adults using a 8-wk randomized controlled trial. This research will provide new data on the potential of vitamin D enriched eggs as a food-based strategy for prevention of vitamin D deficiency.

Eligibility Criteria:
Inclusion Criteria:

- consenting white men and women aged 45-70 years

Exclusion Criteria:

* consumption of vitamin D-containing supplements throughout the study. planning to take a winter vacation (during the course of the 8-wk intervention) - to a location at which either the altitude or the latitude would be predicted to result in significant cutaneous vitamin D synthesis from solar radiation
* planning to use tanning facilities of any type.
* a severe medical illness,
* allergy to egg products,
* medically advised to limit egg intake in relation to managing hypercholesterolemia,
* hypercalcaemia,
* known intestinal malabsorption syndrome,
* excessive alcohol use,
* the use of medications known to interfere with vitamin D metabolism
Dexmedetomidine and Esmolol Early Post Operative Cognitive Dysfunction

Dexmedetomidine is a highly selective α2adrenoceptor agonist recently introduced to anesthesia that produces dose dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites) without respiratory depression.

From a pharmacokinetic perspective,dexmedetomidine has a half life of nearly 2 hours, duration of action of nearly 4 hour, and thus, a side effect profile that is shorter in duration than clonidine.

Esmolol is a cardioselective beta₁ receptor blocker with rapid onset, a very short duration of action (elimination half-life is approximately 9 minutes) , and no significant intrinsic sympathomimetic or membrane stabilising activity at therapeutic dosages

The study will be a randomized double blinded study and will be carried by the Department of Anaesthesia at Beni-Suef University Hospital after obtaining approval from local research and ethical committee. Written informed consent will be obtained from each patient before operation. Aiming to assess of the early cognitive dysfunction after controlled hypotensive anesthesia with either dexmedetomidine or esmolol during middle ear surgeries

Eligibility Criteria:
Inclusion Criteria:

Patients aging 20-50 years ASA physical status I-II . Males , females

Exclusion Criteria:

1. hypertensive patient
2. Patients receiving sedatives as midazolam.
3. Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases.
4. Patients with cerebrovascular diseases.
5. Patients with impaired kidney function.
6. Patients with history of chronic liver diseases.
7. Patients with asthma, chronic obstructive lung diseases.
8. Patients with diabetes mellitus, coagulation disorders, pregnancy.
9. Patients with history of allergy to the drugs used in the study or patients with substance abuse .
The Effect Of Kinesiotape Application In Chronic Low Back Pain

This study was conducted to determine the effects of kinesiotaping (KT) and sham KT applied with exercise program on clinical parameters such as pain, sleep, and quality of life in postmenopausal women with chronic low back pain. A randomized controlled experimental design, characteristic of quantitative research, was utilized. The subjects consisted of 60 postmenopausal women. The Visual Analog Scale (VAS), Roland Morris Disability Questionnaire (RMDQ) and Pittsburgh Sleep Quality Index (PSQI) were used as data collection tools.

With rising life expectancy, women are expected to spend a third of their lives in the postmenopausal stage. Consequently, focusing research on postmenopausal women is considered crucial. This study was conducted to determine the effects of kinesiotaping (KT) and sham KT applied with exercise program on clinical parameters such as pain, sleep, and quality of life in postmenopausal women with chronic low back pain. A randomized controlled experimental design, characteristic of quantitative research, was utilized. The subjects consisted of 60 postmenopausal women. The Visual Analog Scale (VAS), Roland Morris Disability Questionnaire (RMDQ) and Pittsburgh Sleep Quality Index (PSQI) were used as data collection tools.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal patients with chronic nonspecific mechanical low back pain for at least three months
* VAS score of at least 3

Exclusion Criteria:

* Patients with a neurologic deficit, history of lumbar surgery, inflammatory low back pain, spinal stenosis, spondylolisthesis, a history of cardiopulmonary disease preventing exercise, severe osteoporosis, or a skin infection in the application area
A Safety, Tolerability and Pharmacokinetic Study of CPP-115

Primary Objective:

• To evaluate the safety and tolerability of ascending single oral doses of CPP-115

Secondary Objective:

• To determine the pharmacokinetic profiles of CPP-115 following administration of a ascending single oral doses


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to give written informed consent and comply with study procedures and requirements.
2. Males, age 18 to 65 years.
3. Body Mass Index between 19 and 32 kg/m2.
4. Normal systolic blood pressure (BP \[90-140 mmHg\]), diastolic BP (50 90 mmHg) and heart rate (HR \[resting HR 40-90 beats per minute (bpm)\]).
5. Willing and able to abstain from drug, alcohol, and tobacco use during study participation.

Exclusion Criteria:

1. Medical history and/or findings on physical examination indicating the presence of clinically significant illness.
2. Clinically significant abnormalities of vital signs or clinical laboratory results (including hematology, chemistry, and urinalysis).
3. Presence or recent history (within 28 days prior to Screening) of active and clinically significant (as judged by the Investigator) gastrointestinal, renal, cardiovascular, hepatic, metabolic, allergic, dermatologic, hematologic, pulmonary, neurological or psychiatric illness or disorder.
4. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
5. Clinically significant ECG abnormalities including QTc ≥ 450 msec.
6. Use of any tobacco-containing or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to Screening.
7. Use of any prescription, illegal, or investigational drug within 28 days prior to Day 1.
8. Use of any over-the-counter (OTC) drug, including vitamins, minerals, dietary/herbal supplements, or grapefruit or grapefruit juice within 14 days prior to Day 1.
9. Use of alcohol, caffeine, or poppy seed-containing foods or beverages within 72 hours prior to Day 1.
10. History of recent (within 6 months) drug or alcohol abuse, as defined in DSM IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition).
11. Positive urine drug screen, urine cotinine test, or alcohol breath test at Screening or check-in to the clinical study unit (CSU). Subjects with results believed to be false positives can be allowed to screen while results are retested at a specialized laboratory.
12. Positive serology for the surface antigen of Hepatitis B (HBsAg), Hepatitis C (anti HCV), or human immunodeficiency virus (HIV) antibody screen.
13. Donation of blood or plasma to a blood bank or for a clinical study (except for study screening) within 28 days prior to Day 1.
14. Receipt of blood products within 2 months prior to Screening.
15. Any condition or other reason that, in the opinion of the Investigator, would render the subject unsuitable for the clinical study.
Pilates in Ankylosing Spondylitis

This study was planned to examine and compare the effectiveness of two different pilates exercise methods (mat pilates vs reformer pilates) in individuals with Ankylosing Spondylitis(AS).


Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 20-65, using stable medication for at least 3 months, being sedentary (Not regularly participating in exercise activities for the past 3 months).

Exclusion Criteria:

* the presence of cardiovascular, pulmonary, orthopedic and neurological problems, another rheumatic disease, being pregnant, inability to participate in at least 75% of the exercises.