cyrilzakka/clinical-trials huggingface dataset:
"Pecos" B-adrenergic and PPAR-G Stimulation Upregulates Lipid Metabolism in Human Subcutaneous Fat

This study compares four treatments to see which one causes the most weight loss, fat loss, loss of abdominal fat and improvement in blood tests like cholesterol. The four treatments are: Placebo, Ephedrine plus caffeine, Pioglitazone, Combined pioglitazone and ephedrine plus caffeine

The sympathetic nervous system, via the intracellular messenger cAMP and MAPK activation, and thiazolidinediones via PPARγ control lipid metabolism have been implicated in body weight regulation. The present study was undertaken to determine whether the simultaneous activation of these two signaling systems might synergize to exert beneficial effects on the expression of key genes involved in lipid metabolism and mitochondrial biogenesis in subcutaneous fat in healthy, non-diabetic subjects. Fifty seven non-diabetic women and men were randomized into four groups: 1) placebo/placebo (PP); 2) ephedrine plus caffeine/placebo (ECP); 3) placebo/pioglitazone (PPio); 4) ephedrine plus caffeine/pioglitazone (ECPio). Adipose tissue samples were obtained after 12 weeks of treatment to determine gene expression by real time RT-PCR.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* not pregnant or nursing
* using adequate contraception
* between 18 and 50 years of age
* BMI between 30 and 35 kg/m2

Exclusion Criteria:

* significant renal, cardiac, liver, lung or neurological disease
* high blood pressure
* diabetes
* prior use of thiazolidinedione
* prior use of beta-blockers alcohol or drug abuse
* history of thrombophlebitis, vascular or blood clotting disorders
* unwilling or unable to abstain from caffeinated beverages and alcohol prior to adipose tissue biopsy and metabolic rates measurements
* increased liver function test at baseline
* have metal objects that would interfere with the measurement of the body composition
* use drugs known to affect lipid metabolism, energy metabolism or body weight
* use herbal supplements containing ephedrine and/or caffeine
* take chronic medication, except hormone replacement or contraception
* are a woman unwilling to use effective contraception during the trial
* have heart disease or history of stroke
* have urinary symptoms from enlarged prostate
* have gained and or lost more than 10 pounds in the last 6 month
* have use a monoamine oxidase inhibitor medication in the last month
* have high or low thyroid function that has not been controlled in the normal range for at least 2 months
Canadian, Multi-Centre Study of Symptom Burden and Clinical Management in Subjects With GERD

This is a cross-sectional study of symptom burden and clinical management. A subset of patients who have attended the Primary Care (PC) office with reflux symptoms during a retrospective period of 4 months (Index Visit) are invited to complete health survey questionnaires and partake in a subject-physician/study nurse interview (Visit 1), in order to assess the type, intensity and frequency of GERD symptoms at both visits and describe the treatment provided. Additionally, the impact of GERD on subjects' life, productivity and willingness to pay for GERD symptom relief will be explored. This design will give a "real-life" clinical practice picture in a representative population of PC doctors and subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Ability to complete PRO instruments (non-applicable to "non-attendees")
* Subject with GERD symptom(s). At least presence of troublesome heartburn and/or regurgitation even if not specifically recorded at the Index Visit.
* At least one visit during the Retrospective Visit Period (-6 to -2 months prior to study start).

In the reasons for the Index Visit section of the medical record mention of acid regurgitation and/or heartburn symptom(s) or GERD diagnosis or GERD complications has to be explicit or a treatment decision (prescription) in a previously diagnosed subject although no mention of symptoms is made.

Exclusion Criteria:

* Prophylactic PPI use to reduce the risk of ulcers in subjects being treated with NSAIDs
* PPI treatment to heal an ulcer induced by NSAID treatment
* PPI treatment for H-pylori eradication
* Participation in any other clinical study in the time window between the Index Visit and Visit 1
Safety and Effectiveness of Style 410 Silicone-Filled Breast Implant Study

Safety and effectiveness of Style 410 Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.


Eligibility Criteria:
Inclusion Criteria:

* Female, age 18 years or older
* Patients seeking primary breast augmentation (i.e., no previous breast implant surgery) indicated for the following: Patient dissatisfaction with size or shape of breast (e.g., mammary hypoplasia), asymmetry, ptosis, aplasia
* Patients seeking breast reconstruction
* Patients seeking breast revision-augmentation
* Patients seeking breast revision-reconstruction
* Adequate tissue available to cover implants
* Patients must be willing to undergo MRI at their 1, 3, 5, 7, and 10-year follow-up visits (serial MRI). The patient must be eligible for MRI (for example, no implanted metal or metal devices and no history of severe claustrophobia that may make her ineligible for MRI).

Exclusion Criteria:

* Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy
* Existing carcinoma of the breast, without mastectomy
* Abscess or infection in the body at the time of enrollment
* Pregnant or nursing
* Have any disease, including uncontrolled diabetes (e.g., Hb AIc \> 8%), that is clinically known to impact wound healing ability
* Show tissue characteristics that are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration
* Have, or under treatment for, any condition that may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems)
* Show psychological characteristics that may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation (e.g., body dysmorphic disorder)
* Are not willing to undergo further surgery for revision, if medically required
Impacts of Different Pressure Pneumoperitoneum on Myocardial and Pulmonary Injuries After Robot-assisted Surgery

This study is aimed to determine whether low- and standard-pressure pneumoperitoneum have different impacts on troponin T（TnT) level as well as pulmonary complications after prolonged robot-assisted surgeries in the Trendelenburg position.

The hypothesis of this study is based on several studies reported that increased postoperative troponin T(TnT) level was significantly associated with 30-day mortality, and some other reports showed that low-pressure pneumoperitoneum had better haemodynamic outcome than that of standard-pressure pneumoperitoneum. Hence, we hypothesize that different pneumoperitoneal pressure may lead to different levels of TnT after prolonged robot-assisted surgeries.

This clinical trial will be conducted in Huadong Hospital Affiliated to Fudan University and Ruijin Hospital Shanghai Jiao Tong University School of Medicine,both are tertiary hospitals in Shanghai, China.

After signing the Informed Consent, subjects who meet the eligibility criteria will be randomly assigned to low- or standard-pressure pneumoperitoneum group.The randomization plans will be implemented using statistical software R, and will be stored in an online database.These subjects will be recruited from January 1st 2016 to December 31st 2017.

TnT is set as the primary endpoint for this trial to evaluate the myocardial injuries, and will be measured for each patient who will undergo in-patient robot-assisted urological surgery within 24 hours postoperatively using the fourth-generation high-sensitivity TnT assay.

The total sample size will be 280.With 140 patients in each of the two treatment groups, the power will be at least 0.70 to detect an increment of TnT level among 80% of subjects.Chest CT scan is used to diagnose the pulmonary complications on the third day postoperatively.

Data will be collected to analysize whether prolonged different intraperitoneal pressure has different impacts on cardiopulmonary injuries.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo Robot-assisted radical prostatectomy or other robot-assisted urological surgeries last longer than 3 hours
* Patients who are classified as American Society of Anesthesiologists（ASA）I and II
* Patient's preoperative troponin T(TnT) level is normal

Exclusion Criteria:

* Patients with preoperative cardiopulmonary dysfunction who can not understand prolonged surgeries in the Trendelenburg position：severe pulmonary dysfunction or New York Heart Association(NYHA) classification is Ⅲ-Ⅳ.
* Body Mass Index\>30.
* Any intraoperative situation as follows：1. Any cause to cancel operation or change robot-assisted surgery to open surgery 2. Intraoperative cardiovascular accidents.
Effects of Mulligan's Mobilization With and Without Clamshell Exercises in Sacroiliac Joint Dysfunction

Sacroiliac joint dysfunction is the changing of joint structure (ligaments, muscles and cartilage) that cause impairments and movement restrictions. It is one of the primary sources of low back pain among female population and often misdiagnosed. Almost 15-30% patients are suffering from sacroiliac joint dysfunction who presented with the complaint of low back pain. The aim of the study is to determine the effect of mulligan's mobilization with and without clamshell exercise on pain, disability and quality of life in patients with sacroiliac joint dysfunction.

A Randomized controlled trial will be conducted at Fatima Memorial Hospital Physiotherapy Clinic \& Boston Physiotherapy and wellness Clinic through consecutive sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A \& group B. Group A will be treated with only mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise. Group B will be treated with mulligan's mobilization with movement and clamshell exercises. Outcome measures will be conducted through pain, disability and quality of life questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Male and female between the ages of 20 to 50 years with positive Leslett's criteria.
* Sacroiliac pain of sub-acute level with the duration of 4 weeks

Exclusion Criteria:

* Spondylosis
* Lumbar canal stenosis
* Spondylolisthesis
* Pervious spinal surgery
* Congenital postural deformities and
* Lumbar disc herniation
* Pelvic bone fractures
Dental Engagement Study Behavior Modification

This is a pilot study to determine whether knowledge gained by an individual of genetic risk for severe periodontitis changes the patient's health behavior as measured by an increased frequency of their preventive dental office visits. In addition to the primary objectives of the study, the overall design and logistics will be used to inform a possible future study.

Data to be analyzed in this study will be gathered through a patient questionnaire, genetic testing and tracking of preventive dental office visits. Eight hundred (800) total participants will be randomly assigned to either the Usual Care or Experimental Groups. Two hundred participants will be assigned to the Usual Care Group and 600 will be assigned to the Experimental Group. It is anticipated that approximately 17% (\~100) of the Experimental Group subjects will refuse to enroll in the study, leaving a final total of approximately 500 subject in this group. Within the Experimental Group, 125 subjects positive for the IL-1 genetic test (PerioPredict® Genetic Risk Test, Interleukin Genetics, Inc., Waltham, MA) will be identified and \~375 will test negative for the IL-1 genetic test.

The Sponsor will enter the subject's dental office registration number into a master spreadsheet and randomly assign every fourth patient to the Usual Care Group and all others will be assigned into the Experimental Group. Information about the study and informed consent will be made available by the dental office for the specific groups, either by directing to a website location with videos and ICFs, or alternatively by by dental office showing informational videos on provided tablet and gathering signed hardcopy ICFs at schedule first visit.

Eligibility Criteria:
Inclusion Criteria:

* All adult (18 years of age or older) patients from multi-site, practice-based research network dental offices who have dental insurance coverage for preventive care twice per year, but have only used the benefit once per year in the past 2-3 years.

Exclusion Criteria:

* Patients who previously have had an IL-1 dental genetic test.
* Patients who have been diagnosed with periodontal disease.
BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients

Adjuvant therapy with dabrafenib plus trametinib in melanoma was approved in 2018 by the EMA (EUropean Medicines Agency).

The purpose of this non-interventional study is to assess the usage of adjuvant dabrafenib and trametinib in clinical practice, where the patient population may differ from study population.

Melanoma is a disease of significant metastatic potential if not detected very early. Oncogenic mutations in BRAF (B-Raf proto-oncogene, serine/threonine kinase) are found in approximately 40% of melanomas and result in constitutive activation of the MAPK (Mitogen-Activated Protein Kinase) pathway.

Treatment with the BRAF inhibitor dabrafenib plus the MEK (Mitogen-activated protein kinase kinase) inhibitor trametinib showed improved overall survival in patients with unresectable or metastatic BRAF V600E/K-mutant melanoma (COMBI-d and COMBI-v studies). In an adjuvant setting treatment with dabrafenib and trametinib significantly reduced the risk of melanoma recurrence in patients with high-risk, stage III BRAF V600-mutant melanoma, with improvements in OS (Overall Survival), DMFS (Distant Metastasis Free Survival), and FFR (Freedom From Relaps) (COMBI-AD study). Based on these results, adjuvant dabrafenib plus trametinib therapy was approved in 2018 by the EMA.

Compared to the metastatic situation, issues of compliance and treatment adherence may be more relevant in adjuvant treatments, as patients are free of disease and potentially cured even without adjuvant treatment. As the routine administration of drugs including dosing, treatment interruptions, and early termination in clinical practice may vary from procedures defined in clinical trials, this study aims to assess the usage of adjuvant dabrafenib and trametinib in the routine clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complete surgical resection of histologically confirmed AJCC (American Joint Committee on Cancer) (8th edition) clinical stage III (IIIA, IIIB, IIIC, IIID) melanoma, for whom a decision for adjuvant treatment with dabrafenib and trametinib has been made before entering the study.
* V600E/K mutation-positive cutaneous melanoma
* Adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) as indicated in the SmPC (Summary of Product Characteristics) and by prescription, that has been started no longer that 4 weeks before inclusion of the patient into the study or which will be initiated directly after inclusion
* Age ≥ 18 years
* Signed written informed consent

Exclusion Criteria:

* Lack of basic demographics and staging information
* Current or planned participation within a clinical trial. The participation in a follow-up phase of a clinical trial without active intervention is allowed.
* Current or planned treatment of another tumor disease except keratoacanthoma, squamous cell or basal cell carcinoma of the skin
CARDIOLITE-413: A Study for Patients Who Had a PCI for an Acute MI

The purpose of this clinical study is to learn if there are any changes in how blood gets to your heart muscle and if your heart size changed after your heart attack.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing primary or rescue PCI for acute MI with ECG evidence of a large territory at risk.

Exclusion Criteria:

* History of prior MI or CABG surgery, persistent LBBB, Atrial Fibrillation, End stage renal disease, Weight \> 350 lbs.
Physiotherapy for Sciatica; Is Earlier Better?

This study aims to evaluate the whether receiving physiotherapy early after onset of the problem is better than waiting a few weeks to see if it gets better before starting physiotherapy. 80 people with sciatica will take part in the study, half of which will receive physiotherapy 2 weeks after seeing their G.P. The other half will receive physiotherapy at the usual time, around 6 weeks after seeing their G.P.

Sciatica is a relatively common problem which is often caused by nerve compression or irritation due to a lower back (Lumbar) disc prolapse. The problem is likely to improve in time as the body heals itself. However, this can take many months or sometime years. Sciatica can be a very painful condition, it may cause pins and needles, numbness or weakness in the legs affected. This, can cause great difficulty for people carrying out normal day to day activities.

Physiotherapy is often used to help people with sciatica but in many places in the United Kingdom it can take many weeks or months to begin therapy.

This study aims to see if having physiotherapy at 2 weeks after the patient has seen their G.P helps them get back to normal day to day function. This will be compared with another group of patients who will have physiotherapy at the 'usual' time of around 6 weeks after they have seen their G.P.The investigators will also be interviewing participants for their views of sciatica and physiotherapy. Each patient will receive a goal orientated physiotherapy management programme with achievement of those goals acting as secondary outcomes. Primary outcomes are feasibility objectives including patient recruitment rates, acceptability of outcome measures and intervention and rates of adverse events.

This is a pilot study which means that the investigators won't be directly comparing the 2 groups, but seeing if doing a full-scale study in the future is going to be feasible.The investigators will do this by measuring several different things, such as whether patients want to take part in the study or not, whether the tests the investigators will perform are the right tests and to see if the patients and physiotherapists find the treatment useful.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18-70 years of age with unilateral LRS defined as pain and or sensory disturbance and or weakness in a dermatomal and or myotomal distribution.

Exclusion Criteria:

* Patients with bilateral LRS.
* Patients with 'red flag' signs and symptoms of potential serious pathology.
* Cancer at the time of the study.
* Proven vascular claudication.
* Cauda Equina Syndrome (CES).
* Spinal fracture within the last 3 months.
* Chronic regional pain syndromes.
* Recent lower limb fracture.
* CVA with physical or psychiatric disability.
* Poor English skills (necessitating the use of an interpreter and invalidating outcomes measures-ODI).
* Other significant co-morbidities preventing regular attendance at physiotherapy clinics.
* Patients with significant mental health problems for which treatment adherence may be difficult or psychologically disabling.
Appropriate Timing of Surgery After Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

This study aimed to compare the outcomes of early versus late surgical resection in patients who underwent curative total mesorectal excision after neoadjuvant chemoradiation. Half of the participants will undergo surgery before 8 weeks, while the other half will undergo surgery after 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Clinic stage II-III cancer ( T3- T4 tm or/and N(+) disease )
2. Patients with histologically confirmed adenocarcinoma of the rectum
3. Tumor distal border located within 15 cm. from anal verge (as measured by rigid rectoscopy)
4. Standardized total mesorectal excision surgery
5. Tumor must be clinically resectable with curative intent (R0 resection must be most likely)
6. Elective operation
7. The patient must consent to be in the study and the informed consent must be signed

Exclusion Criteria:

1. Clinic stage I and IV cancer disease
2. Patients with malignant disease of the rectum other than adenocarcinoma
3. Recurrent rectal cancer
4. Emergency cases (Mechanical bowel obstruction, perforation)
5. Other previous or concurrent malignancies
6. Any contraindication for radiochemotherapy
7. Previous chemotherapy or radiotherapy to the pelvis
8. Tumor has arisen from chronic inflammatory bowel disease or hereditary polyposis disease
9. American Society of Anesthesiologists Score \>3 patients