cyrilzakka/clinical-trials huggingface dataset:
M4C Nutraceutical Intervention Human Health Effects Pilot

This 3 month pilot study will be an unblinded, convenience sampling, nutraceutical intervention trial. Twenty fasted subjects will undergo a baseline health assessment via a questionnaire, baseline clinical chemistries, blood lipids, dexa and impedence testing (to identify bone mineral density and body muscle/fat/water composition), and metabolite/novel biomarker testing through whole capillary blood, saliva, and urine collections. Assessments will be repeated every month (3 times after initial assessment) to cover a 3 month period. All measurements from each visit will be compared with baseline using paired t-tests or Chi square testing depending on variable. Power analyses are not included due to the pilot nature of the study. This pilot study will provide the necessary variability estimates for future trials.

The purpose of this study is to explore potential positive human health effects of a proprietary nutraceutical formulation known as M4C. The impetus for M4C came from Dr. McGraw's attempt to alleviate the chronic inflammation a family member was experiencing through a non-invasive, natural, nutraceutical approach. Anecdotal findings of M4C show an antiinflammatory effect (observed in the presence of inflammatory conditions and after traumatic injury such as a sprain or fall), improved metabolic, gastrointestinal, and mental health, as well as enhanced exercise response and recovery. In this study the investigators will examine whether supplementation with M4C is associated with any changes in lipids, clinical chemistries, body composition, questionnaire covariates, metabolites/novel suspected lipopeptides, hemoglobin A1C, or bone mineral density.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* amputation
* blood clotting disorder
* metal implants or implanted electrical device(s)
* known acute or chronic illness; gastrointestinal, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension
* inability to fast i.e. low blood sugar
* pregnant or may be pregnant during the course of the study
* amino acid metabolizing disorder i.e. phenylketonuria
* severe edema
* did not pass screening criteria as determined by MRI facility
* allergies/intolerance to any nutraceutical ingredients: amino acids, vitamins, minerals, tapioca starch, sunflower lecithin, stevia, limes or fatty acids like docosahexaenoic acid
Community-Based Kiosks for Hearing Screening and Education

The overall goal of the project is to evaluate innovative, cost-effective, community-based automated hearing screening and education methods to motivate individuals with mild-to-moderate hearing loss to enter the hearing healthcare system.


Eligibility Criteria:
Inclusion Criteria: :

* Some subjects will have a complaint of hearing difficulty without a recent hearing evaluation

Exclusion Criteria:

* For all groups: minimum age 18 years. No current hearing aid use
Neuro-Ox 2018: Assessment of Cerebral Oxygenation Under Three Clinically Relevant Conditions

This is a prospective observational study, consisting of 3 substudies carried out during elective neurosurgery under general anaesthesia. Each participant will take part in all 3 substudies. First, the capability of Near Infra Red Spectroscopy (NIRS) to measure the brain oxygenation is examined. A NIRS-electrode is placed on forehead skin, on the skull, and on dura. Secondly, a small dose of Phenylephrine is given, and the brain oxygenation is measured by a Clark-electrode and a NIRS-electrode, to see how Phenylephrine affects these measurements. In the third substudy, the brain oxygenations' (NIRS and Licox) response to an inspired oxygen fraction of 0.30 vs. 0.80 is investigated.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years) patients
* Elective craniotomy

Exclusion Criteria:

* Repeat craniotomy
* Preoperative hypotension (defined as systolic blood pressure below 110 mmHg)
* Preoperative hypoxia (defined as peripheral oxygen saturation (SpO2) \< 90% without oxygen supplementation before surgery)
* No negative pregnancy test for women \<50 years.
Inflammation and Electroconvulsive Therapy

The purpose of this study is to explore whether electroconvulsive therapy (ECT) accidentally leads to a side effect of brain inflammation. Patients with treatment resistant depression who are planning to take ECT will be subsequently approached to participate in the study.

The first scan will take place before the first ECT session. The second scan will occur after a minimum of six ECT sessions (average 2.5 weeks). Secondary measures will include mood symptom severity, neurocognitive measures, peripheral inflammatory markers and TSPO genotype.

The hypothesis is that neuroinflammation will be increased by ECT.

There will be no alterations to standard care of depressed patients due to participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* stable physical health
* diagnosis of non-psychotic, non-catatonic, major depressive disorder, either unipolar or bipolar and a non-response to at least three clinical trials at appropriate dose of antidepressant medication from at least three different pharmacological classes
* at least a 17 on the17-item HDRS despite taking antidepressant treatment prior to ECT
* have not received ECT within the last 12 weeks

Exclusion Criteria:

* currently pregnant
* current substance abuse or dependence
* neurological or unstable medical illness
* use of anti-inflammatory drugs within the past month
* diazepam or other benzodiazepine use within the past month, except for lorazepam and clonazepam
Investigating the Effects of a High GI Versus a Low GI Diet on Hepatic Metabolism and Satiety Levels in Healthy Subjects

The aim of this study is to investigate the effect of a one week high versus low glycaemic index dietary intervention on hepatic glycogen and lipid levels and blood hormone levels in a two way cross overs study and to see if there is any correlation between this and satiety or appetite.

8 Healthy subject will be scanned the start and end of a 7 day high versus low glycaemic in diet with a 4 week washout between arms. During scan days the hepatic glycogen response to a corresponding high versus low glycaemic index test meal will be measured using 13C Magnetic resonance spectroscopy (MRS) to explore any acute changes in metabolic response. Baseline liver lipid levels will be measured using 1H MRS to explore any long term changes in liver lipid levels.

Blood samples will also be obtained throughout the test day to measure for blood glucose, insulin and blood hormone response. Satiety surveys will also be taken throughout the test day and during the diet week.

The main hypothesis is that a one week calorie matched Glycaemic index varied diet will result in an altered response of liver glycogen levels acutely following a meal and also longer term hepatic liver lipid levels. A secondary hypothesis is that there will also be associated changes in blood sugar and hormone levels and that all these changes will have an effect on satiety levels in subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Caucasian
* Self-reported non-athletic but healthy: not carrying out strenuous exercise (no high sweat, out of breath, high heart rate activities and less than 2 hours moderate exercise a week), moderate drinkers (less than 3 units a day), no smokers
* Routinely eating 3 meals a day
* Stable weight
* Age ≥ 18 and ≤ 35
* Body mass index (BMI - weight / squared height ) ≥ 20.0 and ≤ 27.0 kg/m2
* Suitable for MRI scanning (e.g., absence of metal implants, infusion pumps and pacemakers) as assessed by the attached MRI safety questionnaire.
* Suitable for blood samples and cannula insertion (e.g., no aversion to needles)
* Willing to follow both prescribed diet plans
* Not taking any concurrent medication

Exclusion Criteria:

* No diabetics or other metabolic disorders (e.g. insulin resistance, thyroid dysfunction)
* No volunteers with liver disease
* No clotting disorders
* No Participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
* No use of any medically or self-prescribed diet from the moment of pre-study examination till the end of the study
* Taking prescription medication or any other drugs that may influence liver function or glucose and energy metabolism.
* Any allergy or food intolerance
* Unsuitable for MR scanning (i.e. have pacemakers and/or medical implants)
* The subject is an employee of Unilever or the site conducting the study.
The Effects of Vitamin D2 Supplement During Pregnancy

The effects of vitamin D2 supplement during pregnancy on postpartum maternal and fetal vitamin D levels: the randomized controlled trial

Vitamin D structurally similar to steroids. Made from the skin. And metabolism of the liver, kidneys, vitamin D levels in the bloodstream are two types of vitamin D 2 (Ergocalciferol) and vitamin D 3 (Cholecalciferol) Vitamin D regulates calcium and phosphorus levels in the body. Including the accumulation of minerals in the bone. Vitamin D is important in the formation of bones and teeth and the normal growth of children, affects the reabsorption of amino acids in the kidneys, regulates the amount of calcium and phosphorus in the blood Vitamin D deficiency in pregnant affects the mother and baby example high maternal blood pressure during pregnancy, diabetes during pregnancy, increase birth body weight of baby. low calcium seizures Infants, baby have bones and growth disorders. Currently, no vitamin D supplement is used in pregnant women in Thailand who attend antenatal clinics. The researcher has proposed to study the effects of vitamin D supplement during pregnancy on postpartum maternal and fetal vitamin D levels by using vitamin D 20,000IU / week

Eligibility Criteria:
Inclusion Criteria:

* Women who have pregnant and ANC at Rajavithi hospital
* Women who have age at least 18 year
* Women who have Thai nationality
* Women who have pregnant of gestational age under 20week

Exclusion Criteria:

* Women who don't plan of delivered at Rajavithi hospital
* Women who have complication of pregnancy
* Woman who delivered before gestational age 37week
* Women who have abnormal kidney function
* Woman who have been used anticonvulsant drug or others form of vitamin d
* Women who have vitamin d allergy
Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve

The purpose of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus laparoscopic cyst deroofing on ovarian reserve measured by serum levels of anti mullerian hormone and antral follicle count in patients with endometriomas.

One of the major concerns about excision of endometriomas is their negative effect on ovarian reserve because of follicle loss, removal of endometriomas has been associated with poorer performance in IVF procedures, and decreased ovarian volumes have also been reported after surgery.Ovarian reserve is defined as the functional potential of the ovary which reflects the number and quality of the follicles left in the ovary, and is well-correlated with the response to ovarian stimulation using exogenous gonadotrophin. Over the years, various tests and markers of ovarian reserve have been reported; the static tests include serum markers, such as basal FSH, inhibin-B and anti-Mullerian hormone (AMH), and ultrasonographic markers, such as ovarian volume and antral follicle count.This study will include 122 patients aged between 18 and 35 years who have been diagnosed with endometrioma (unilateral or bilateral) and they are candidates for laparoscopic surgery. They will be selected according to inclusion and exclusion criteria.they will be randomized into two study groups, one study group will undergo laparoscopic ovarian cystectomy, the other study group will undergo laparoscopic cyst deroofing.AMH,AFC and ovarian volume will be measured pre-operative and post-operative.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18-35 year
2. Regular menstrual cycles.
3. Endometrioma (unilateral or bilateral) diagnosed by transvaginal ultrasound with diameter ≥ 3 cm.

Exclusion criteria:

1. Any previous ovarian surgery.
2. Evidence of polycystic ovary syndrome according to Rotterdam criteria

   -Two of three of:
   * Oligo- or chronic anovulation.
   * Clinical and/or biochemical signs of hyperandrogenism.
   * Polycystic ovaries.
3. Evidence of premature ovarian failure diagnosed by follicle stimulating hormone level ≥40 IU/L
4. Any endocrinal disease affecting ovarian function e.g. thyroid dysfunction, hyperprolactinemia.
5. Previous hormonal medications e.g. oral contraceptive pills, gonadotropin-releasing hormone analogue within the last 3 months before surgery.
6. Any suspicious findings of ovarian malignant diseases diagnosed by transvaginal ultrasound.
7. Contraindication to surgery.
Impact of Assistive Forces on Activities of Daily Living

This study is a cross-sectional study investigating the impact of assistive forces applied by the body-weight support system "the FLOAT" on the study participants. The study is conducted at the University Hospital Balgrist in Zurich over a period of around 3 years. During this time measurements on approximately 140 able bodied subjects and 60 patients with an incomplete spinal cord injury will take place. The study participants are invited for a single visit of around 140 min duration to the University Hospital Balgrist. During this visit the study participants will repeatedly perform various activities of daily living (free walking, standing up and sitting down, stair climbing and balancing) with and without assistive forces from the body-weight support system. While performing the tasks, the study participants' motions and muscle activities will be measured to evaluate the naturalness of their movements. In addition, the collected data permits us to compare different movement patterns and make conclusions about effective and optimal movement support. Obtaining this knowledge will help us to shape the therapy of these activities to be tailored to the patients and to train these movements with the help of the FLOAT under optimal conditions.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with incomplete spinal cord injury (AIS C-D) or able bodied persons
* informed consent as documented by signature
* bodyweight \< 120 kg

Exclusion Criteria:

* a significant psychiatric or orthopedic diagnose
* any secondary neurological complications that may impact the outcome variables
* dermatological conditions (pressure ulcers, etc.)
* pacemaker or other implanted, electronic devices
* contraindications for FLOAT training
* inability or unwillingness to provide written informed consent or follow study procedures e.g. due to language problems
* psychological disorders, dementia, etc.
* known or suspected non-compliance, drug or alcohol abuse
* enrolment of the investigator, his/her family members, employees and other dependent persons
Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects

This will be a phase I, randomized, double-blind, placebo-controlled, single-dose escalation study. This study will be conducted in three periods: the screening period , the treatment period and the follow-up period.

This study aims to evaluate the pharmacokinetics, target engagement and pharmacodynamic biomarkers of ASC47 in healthy subjects.

The study will consist of 8 cohorts, each with different doses of ASC47.

Eligibility Criteria:
Key inclusion Criteria:

* Subject have provided informed consent before initiation of any study-specific procedures
* Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive).
* Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg.

Key exclusion Criteria:

* Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator.
* Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
* Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia.
* Have a history of febrile illness within 14 days prior to screening.
* Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years.
* Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
* Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product.
Tri-modal Imaging Instrument for Thyroid Cancer

Thyroid cancer affects 6,000 Canadians each year. Nodules on the thyroid are detected using ultrasound imaging and surgery is the most common treatment. However, most nodules are benign, and therefore a biopsy is needed to decide whether surgery is necessary. Ultrasound imaging is very sensitive for localizing nodules, but does not differentiate between cancerous and benign ones. To address this limitation of US imaging, investigators have designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel imaging system that performs complimentary imaging modalities (ultrasound (US), photoacoustic (PA)) that could potentially help diagnose nodules without the need for biopsy and unnecessary surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients with thyroid nodules (cancerous, benign or undetermined)
2. 18 years of age or older
3. Have been consented to their standard-of-care surgery for resection of the thyroid (partial or complete) and lymph nodes (if applicable)
4. Have had pre-surgical US imaging of the thyroid and lymph nodes

Exclusion Criteria:

1. Inability to provide informed consent
2. Pre-operative therapy for current thyroid cancer (including chemotherapy, endocrine therapy and radiotherapy)
3. History of photosensitivity or skin disease (exposure to laser light is involved in PA imaging)
4. Pregnancy
Examination of Operative Approach in pwFSHD (Patient With Facioscapulohumeral Muscular Dystrophy)

Facioscapulohumeral Muscular Dystrophy (FSHD) is one of the most common forms of muscular dystrophy, characterized by pronounced skeletal novelistic weakness and with a broad spectrum of diseases. It is a hereditary disease seen in 3-5/100,000 of society, usually starting with weakness in the facial and shoulder muscles and progressing to the trunk, pelvis and leg muscles, giving symptoms in the twenties. In FSHD, which shows slow progression and can lead to loss of ambulation ability in about 20% of patients, patients may have difficulty performing activities above shoulder level with the influence of the periscapular area.

Skeletal muscle weakness leads to posture and balance disorders, and postural instability is a common problem in patients with FSHD. Weakness of the trunk and lower limb muscles found in more than half of patients causes problems with postural balance and walking. The calf, iliopsoas, and gluteus maximus muscles together form the main determinants of walking speed in healthy people, where kalf muscles are known to contribute the most. Individuals with FSHD have been reported to have decreased speed, step length, and step frequency compared to healthy controls. Impaired upper body control can compromise the maintenance of dynamic stability. In patient with FSHD the effects of muscle tone, motor coordination, loss of joint range of motion and muscle weakness on posture, balance control and gait are observed more clearly.

The aim of the study was to compare the effects of scapular management treatments on balance and gait in FSHD patients.

H0: There is no difference in balance and walking parameters of patients with FSHD who have had scapulothoracic arthrodesis surgery and have not undergone surgery.

H1: There is a difference in balance and walking parameters of patients with FSHD who have had scapulothoracic arthrodesis surgery and have not undergone surgery.

Voluntary patients who have been diagnosed with FSHD will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. One group will include patients who have undergone scapulothoracic arthrodesis surgery, while the other group will include patients who have not undergone surgery. Both groups will undergo some outcome measures to assess their balance and walking.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Score between 0,5 and 3,5 according to CSS (clinical severity rating)
* Score between 3 and 5 according to FAS (functional ambulation scale)
* Being included in the surgical group the patient has undergone unilateral or bilateral scapulothoracic arthrodesis surgery

Exclusion Criteria:

* Presence of lower extremity orthopedic problems/problems that can cause balance and walking problems
* Presence of any other upper limb orthopedic problems/problems and surgery
* Having undergone Spinal fusion surgery
* Presence of additional neurological problems/problems
* Having a level of visual and auditory problems that will prevent communication