cyrilzakka/clinical-trials huggingface dataset:
Mitochondria and Muscle Health in Elderly

The aim of this study is to characterize the relation between skeletal muscle mitochondrial metabolism and muscle health in elderly, physically compromised humans. To study this relation, a cross-sectional study will be performed in well-defined, distinct subject groups. Thus, to obtain insight in the relation between mitochondrial health and muscle function, not only subjects that differ in mitochondrial function (based on physical activity) will be compared but also subjects with high- versus low muscle function will be selected.

Aging is associated with a decline of mitochondrial and skeletal muscle volume, -quality and -function. If a causal link exists between the loss of mitochondrial function and muscle health is unknown, however, both appear with advancing age and are associated with the loss of functional capacity, which increases comorbidities and annual healthcare costs. The aim is to test the hypothesis that a compromised muscle function in sedentary elderly is related to an impaired mitochondrial health. A detailed characterization of mitochondrial metabolism and muscle function is performed in well-defined, (physically compromised) elderly humans, in a cross-sectional design. To obtain insight in the relation between mitochondrial health and muscle function, not only elderly subjects that differ in mitochondrial function (based on physical activity) will be compared but also elderly subjects with high versus low muscle physical function will be selected. Healthy, young (20-30 years,) individuals with normal physical activity levels will be included as absolute controls.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Subject should be in sufficient health to participate in the experimentations, to be judged by the responsible MD based on the subject's medical history
* Caucasian origin (see study groups)

Exclusion Criteria:

* Any contraindications for MRI scan:

Aneurysm clips Implanted neural stimulator Implanted cardiac pacemaker of defibrillator Cochlear implant Iron- containing corpora aliena in the eye or brain Artificial (heart) valves which is contraindicated for MRS Claustrophobia

* Diagnosed with diabetes mellitus
* Poor health as judged by the responsible medical doctor
* Heart problems: In case of an abnormal ECG in rest, this will be discussed with both the participant and the responsible medical doctor
Zynamite® in Cognition and Mood in University Students

This study examines the effects of a single dose of ZynS on cognitive function (memory, concentration, attention, and mental agility) in college students and will test the efficacy of this treatment on mood (anger, fatigue, vigor, agreeableness, tension, and depression).


Eligibility Criteria:
Inclusion Criteria:

* Be an active undergraduate or graduate student
* Be between 18 and 25 years of age
* Be healthy and free of any relevant medical condition or disease.

Exclusion Criteria:

* Suffer from chronic diseases such as asthma, type 1 diabetes, thyroid diseases (such as hypothyroidism or hyperthyroidism), autoimmune disorders (such as Crohn's disease) and psychiatric conditions such as anxiety disorders, major depression, eating disorders (anorexia, bulimia), attention deficit hyperactivity disorder (ADHD), among others; ii) Pregnancy or breastfeeding.
* Known intolerance, hypersensitivity or allergies to any of the ingredients of the products under investigation;
* Intestinal absorption problems, as well as learning difficulties, dyslexia, eye problems or color blindness;
* Intake of psychoactive substances or medications that may influence the results of the study, such as consuming \>500 mg of caffeine per day (\>6 cups of 150 ml filtered coffee) and/or alcohol;
* Having comprehension or communication difficulties that prevent full understanding of the informed consent or effective participation in the study, such as autism spectrum disorders, aphasia, or intellectual disability.
Visualization in Shoulder Arthroscopy With and Without Epinephrine

Adequate visualization during shoulder arthroscopy is of great importance for the procedure to be efficiently and effectively performed. The use of dilute epinephrine in irrigation fluid has been historically utilized to help with visualization. Given the potential safety issues documented in the literature related to epinephrine use, as well as the significant improvements in technique and instrumentation over the last decade, the need for this additive should be reexamined. The objective of the current study was to compare surgeon determined visualization in shoulder arthroscopy using irrigation fluid with and without epinephrine.


Eligibility Criteria:
Inclusion Criteria:

All patients requiring shoulder arthroscopy

Exclusion Criteria:

none
The Combination of ATRA and Danazol as Second-line Treatment in Adult Immune Thrombocytopenia

Randomized, open-label, multicentre study to compare the efficacy and safety of ATRA plus danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.

Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of corticosteroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. All-trans retinoic acid (ATRA) has an immunomodulatory effect on haematopoiesis, making it a possible treatment option.

A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to ATRA+danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study, in order to compare the efficacy and safety of ATRA plus danazol with danazol monotherapy in patients with corticosteroid-resistant/relapsed ITP.

Eligibility Criteria:
Inclusion Criteria:

* Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
* Platelet count of less than 30×109/L at enrolment
* Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation.
* 18 years older.

Exclusion Criteria:

* Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
* congestive heart failure
* severe arrhythmia
* nursing or pregnant women
* aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
* creatinine or serum bilirubin levels each 1•5 times or more than the normal range
* active or previous malignancy
* Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.
A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers

Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the current supplier.


Eligibility Criteria:
Inclusion Criteria:

* BMI 19-27 kg/m2
* smokes \>10 cigarettes per day for preceeding 6 months

Exclusion Criteria:

* inability to stop smoking during study
Efficacy and Safety Study of Dexmedetomidine as an Additive to Local Anesthetics in Shoulder Surgery

The purpose of this study is to test the efficacy and safety of dexmedetomidine added to ropivacaine in patients undergoing shoulder surgery.

Peripheral nerve blocks are used throughout the world in lieu of general anesthesia and, more commonly, to provide analgesia and opioid sparing in the postoperative course. Long acting local anesthetics, such as ropivacaine, can provide analgesia for 11.5 ± 5 hours. This leads to many patients reporting their first pain in the evening and nighttime hours when access to healthcare providers and support is most limited. A number of additives to local anesthetics have been studied in humans with limited success. Recent work by a group in Michigan found a dose dependent increase in the duration of analgesia to a thermal stimulus when dexmedetomidine was added to ropivacaine for sciatic nerve blocks in rat.

The goal of the study is to investigate the safety and efficacy of dexmedetomidine added to ropivacaine for interscalene brachial plexus nerve block for shoulder surgery in humans. Provided the initial safety can be established, the trial will continue to evaluate secondary goals including the duration of analgesia, onset of sensory and motor blockade, and opioid-induced side effects. Tertiary outcomes will include subject satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III adult subjects
* Age 18-75
* Elective shoulder surgery
* Plan for interscalene brachial plexus block combined with general anesthesia
* Interscalene block
* Willingness to be contacted postoperatively for brief (5-10min) phone call questionnaires
* Written informed consent

Exclusion Criteria:

* Age \< 18
* Age \> 75
* Inability to understand protocol due to language barrier; difficulty with German language
* Chronic pain requiring daily opioids \> 15 mg oral morphine equivalents (equals oral usage of \> 10 mg oxycodone/daily; \> 5 mg methadone/day; \> 4 mg hydromorphone/day)
* Moderate (NRS pain score \> 5) daily average pain
* Daily use of gabapentin, pregabalin, tricyclic antidepressant, serotonin- norepinephrine reuptake inhibitor, tramadol
* Hypersensitivity to amide local anesthetics
* History of hypersensitivity or allergic reaction to clonidine or dexmedetomidine
* Uncontrolled anxiety
* Schizophrenia or bipolar disorder
* Preexisting nerve damage (sensory or motor) in the extremity to be blocked
* Peripheral neuropathy
* Significant cardiovascular disease (second (Mobitz II type) or third degree heart block, congestive heart failure, chronic heart failure NYHA III-IV, symptomatic coronary artery disease CSS III-IV)
* BMI \> 35
* Uncontrolled diabetes (blood sugar \> 250 recorded in last 30 days or HbA1c \> 7.5%)
* Chronic clonidine therapy (clonidine patch - Catapres or clonidine tablets)
* Hepatic Impairment (CHILD B or higher)
* Renal Impairment (creatinin \> 2.0 mg/dl)
* Ongoing drug or alcohol abuse
* Pregnancy
* Prisoners
Relation Between Macular and RNFL Thickness Measurement and Quality Grading in OCT

The investigators will enroll and scan normal eyes of healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the participants will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.

Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.

The investigators will enroll and scan 200 normal eyes of 100 healthy individuals using the Spectralis OCT. Each scan is graded on a scale of 0-40, with 0 representing the lowest quality and 40 the best possible one. Each of the subjects will be scanned numerous times using this noninvasive imaging tool, while trying to get as many scans as possible of different quality. The differences in the parameters between the scans will then be recoded.

Collected data will include age, sex, subjects' refractive status, visual acuity, full slit lamp exam and the participants' OCT characteristics and measurements.

Eligibility Criteria:
Inclusion Criteria: At least 20/30 visual acuity (BCVA), refractive error less than ±6 diopters (D) spherical equivalent or 3 D of astigmatism, and normal-appearing optic nerve head and retina on dilated fundus examination.

Exclusion Criteria:

* Any history or evidence of eye disease or surgery.
* Intraocular pressure (IOP) more than 22 mm Hg.
A Comparison of the Drug Telbivudine (LdT) and Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis.

This trial is being done to see if the investigational drug, LdT (Telbivudine), is safe and effective in the treatment of hepatitis B infection. In addition to this, we will be looking at the comparison of the effects (good and bad) of LdT and lamivudine.

This study is a randomized, double-blinded trial looking at the drug Telbivudine (LdT) and comparing it to the drug lamivudine in patients with chronic hepatitis B and evidence of Cirrhosis.

Interested participants will first be seen for a screening visit, to determine eligibility for the study. Participants will have a medical history taken along with a physical exam and a blood draw. Prior to receiving the study drug, participants may be required to have a liver biopsy. If one was done in the past 5 years, it may be possible to use the results of the previous biopsy. If participants are unable to have a liver biopsy due to medical reasons, an ultrasound, CT, or MRI scan may be done instead. If an imaging study has been done in the past two years, it may be possible to use the results from this test.

All eligible participants will be put into one of two groups by chance (as in the flip of a coin). One group will receive 600 mg of LdT (3 tablets) plus a lamivudine placebo capsule (1 sugar pill) daily. While the other group will be receiving 100 mg of lamivudine (1 capsule) plus 3 LdT tablets (3 sugar pills) daily. Participants will take the study drug daily for a total of 104 weeks (2 years).

Participants will return for clinic visits at weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 52, 60, 68, 76, 84, 92, 100, and 104. Participant's vital signs (temperature, pulse, weight) and blood samples will be collected at each visit.

If after one year of being on the drug, there is no hepatitis b found in your blood, you may be stopped from the study drug. Participants will continue to be required to return to the clinic for study visits so information can be continued to be collected and for your condition to be monitored. If future blood tests show that the hepatitis B virus returned, participants will be told to restart their study drug.

At the end of the 104 weeks or if the treatment was stopped early for any reason except a liver transplant, or if additional treatment was not chosen for hepatitis B, participants will be asked to return to the clinic once every four weeks for 4 months. For each return visit to the clinic, vital signs and blood samples will be collected and recorded. A physical exam will be at the last follow-up visit.

If the study was stopped due to a liver transplant, participants will be asked to return for clinic visits at 4 and 16 weeks after surgery. At these visits, no procedures will be done, but a review of the participant's medical record.

Participants will be involved for 2 years and 4 months.

Eligibility Criteria:
Patients with chronic hepatitis b with evidence of cirrhosis, who are at least 18 to 70 years old, may be eligible to participate in this study.
Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index

This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in children under general anesthesia, before skin incision.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery under general anesthesia
* Written informed consent

Exclusion Criteria:

* Chronic pain
* Preoperative analgesic drug
* Neurologic disease
* Ophtalmic disease
Acute Effect of MMT Peel Powder on Glycemic Response, Satiety, and Food Intake in Adults at Risk for Type 2 Diabetes

Open-label, randomised, placebo-controlled, crossover study with two intervention arms. The study was conducted in 30 respondents and the primary objective is to show an improved glycemic response after Melon Manis Terengganu (MMT) peel powder consumption in people at risk of type 2 diabetes.

The main aim of the study is to investigate the acute effect of MMT peel powder on glycemic response in people at risk of type 2 diabetes. Besides, the acute effect of MMT peel powder on perceived satiety and energy intake were explored.

Eligibility Criteria:
Inclusion Criteria:

* Modified Finnish Type 2 Diabetes Risk Assessment Tool (FINDRISC) score ≥ 4
* Capillary fasting blood glucose (FBG) \< 7.0 mmol/L
* Malaysian
* Live, work or study in Kuala Nerus, Terengganu
* Both gender
* Age 18 to 59 years old
* Non-smoker
* Those taking supplement agree to undergo washout period of one week

Exclusion Criteria:

* Had clinical history of type 2 diabetes mellitus (T2DM)
* Capillary FBG ≥ 7.0 mmol/L
* Take oral antidiabetic agents
* Participate in other weight management programme or interventional research
* On a prescribed medical diet
* GI illnesses or conditions
* Allergy or sensitivity to study products
* Pregnant, currently breastfeeding, or planning to become pregnant
* On dietary restrictions
* Smoker
Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms

Hypothesis:

Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.

The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.

Hypothesis:

Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.

We therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.

This study is a multicentre prospective pharmacogenetic observational study, conducted on locally advanced and inoperable upper aerodigestive tract cancers.

Eligibility Criteria:
Inclusion Criteria:

* Patient with recurrent or metastatic squamous cell carcinomas of the upper aero-digestive tract
* Patient with loco-regional extension not readily treatable
* 18 years
* Follow up in participant center
* Patient information and consent for study participation
* Patient presented in multidisciplinary meeting (RCP) in Aquitaine and for whom a treatment containing cetuximab has been proposed
* Belong to a social security system

Exclusion Criteria:

* Pregnancy
* Patient with psychological, social, family or geographical reason, who could not be treated or monitored regularly by study criteria,
* Patients deprived of liberty or under guardianship or who could not give consent for study participation
* Inclusion in another study
Tumor Landscape Pathological Diagnosis by Large Tissue Sections

The aim of this study is to establish large tissue sections for 10 kinds of tumors. in order to observe the tumor landscape on microscope. The tumors including esophageal carcinoma,gastric carcinoma,hepatocellular carcinoma etc.200 cases of each tumor will be compared by traditional sample method and landscape sample method to testify the clinical value and significance of tumor landscape pathological diagnosis .


Eligibility Criteria:
Inclusion Criteria:

1. Older than 15-year-old
2. Did not receive preoperative preoperative chemotherapy or radiotherapy

Exclusion Criteria:

patients undergoing preoperative chemotherapy or radiotherapy
Health Benefits of Expressive Writing Among Chinese Breast Cancer Survivors

This study is a randomized controlled trial (RCT) with the aim of determining the cultural sensitivity, feasibility, and effectiveness of an expressive writing intervention for Chinese breast cancer survivors.

The study examines the potential health benefits (i.e., physical health, psychological health, and quality of life) of this expressive writing intervention for Chinese-speaking breast cancer survivors. The study also explores the mechanism through which expressive writing confers health benefits and investigates who will benefit most from the expressive writing intervention. Chinese-speaking breast cancer survivors who have completed primary treatment will be randomly assigned to a control writing condition, a self-regulation condition, or a enhanced self-regulation writing condition. Health outcomes are assessed at baseline, and 1, 3, and 6 months follow-ups. Mixed qualitative-quantitative mixed methods are used to explore the effect of the intervention on health outcomes and explore the mechanisms that explain the benefits of this intervention.

Eligibility Criteria:
Inclusion Criteria:

1) having a breast cancer diagnosis; 2) completing breast cancer surgery within five years; and 3) being comfortable writing and speaking Chinese (i.e. Mandarin or Cantonese)
Osteopathic Manipulative Treatment Versus Therapeutic Exercises in Subjects With Chronic Non-specific Low Back Pain

This study evaluates the effectiveness of treatment osteopathic manipulation in the treatment of subjects with chronic nonspecific low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with constant or intermittent low back pain with intensity greater than 30 mm visual analog scale (VAS) for at least three months duration, with a diagnosis of chronic low back pain

Exclusion Criteria:

* Subjects who have spine fractures,
* Dislocations
* Ligament ruptures
* Muscle ruptures
* Skin lacerations
* Sacroiliitis
* Vertebral osteomyelitis
* Infection
* Disc herniations with radicular symptoms
* Rheumatic disorders
* Cauda equina syndrome
* Tumors
* Referred pain visceral
* Red flags
* Lower limb discrepancy greater than 2 cm
* Several conditions requiring participants to be absent for more than two weeks of activities in the experiment
* Positioning itself as not volunteer the same.