cyrilzakka/clinical-trials huggingface dataset:
Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia

This study aims to define the contribution of cancer and chemotherapy to muscle and systemic alterations that drive the onset of cachexia in rectal cancer patients and validate in human cancer cachexia (CC) the alterations in mitochondrial function and neuromuscular junction (NMJ) observed in the experimental models, thus providing the rationale for potential anti-cachexia strategies based on exercise and or exercise mimetics.

This is a multicenter observational prospective cohort study in rectal cancer patients after neoadjuvant therapy (ycTNM) stage II, III, and IV (AJCC 8th edit), clinically stratified in the pre-cachectic or cachectic stage according to Fearon K et al. definition. That will be subject to curative or palliative surgery through any surgical approach. And a control subgroup of patients who will undergo any abdominal surgery type through any approach type for no neoplastic or inflammatory disease.

The study will take place in four Italian centers of colorectal surgery.

Will be run a preoperatory physical performance, and will be recorded the physical activity by wearing a SmartWatch.

The quantity of muscle will be estimated by the cross-sectional area (CSA) or the skeletal muscle area (SMA) from the magnetic resonance imaging (MRI) or computed tomography CT, respectively, and the Skeletal muscle index (SMI). The muscular quality will be studied by the mean skeletal muscle radiation attenuation (SMRA) and MRI proton density fat fraction (PDFF). All these parameters will be calculated by a radiologist from the preoperative MRI or CT imaging study.

The study includes the analysis of preoperatory inflammatory and nutritional biomarkers. And a muscular biopsy harvested by the surgeon from the rectum or oblique abdominal during rectal resection-palliative surgery. The sample will undergo morphological and structural studies using histology, immunohistochemical, immunofluorescence, biochemical, and molecular analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed histopathological diagnosis of rectal adenocarcinoma ycTNM stage II, III, or IV (AJCC 8th).
* Patients treated with neoadjuvant therapy.
* Patients that will be subject to curative intent or palliative surgery through any approach (open, laparoscopic, or robotic).
* Ability to sign the informed consent.

Exclusion Criteria:

* Rectal cancer stage I or any stage without neoadjuvant therapy.
* Age \< 18 and \>75 years
* Long steroid treatment for any cause.
* Emergency setting.
* Co-existent inflammatory bowel disease.
* Inflammatory comorbidities (liver failure, diabetes, metabolic acidosis, acute and chronic renal failure, sepsis, AIDS, acute and chronic hepatitis, autoimmune disorders, and chronic obstructive pulmonary disease).
* Healthy volunteers.
* Other (simultaneous) neoplastic disease
Evaluation of Different Doses of Letrozole in Ectopic Pregnancy

The utilization of letrozole at a daily dose of 10 mg for medical treatment of ectopic pregnancy considerably has a high success rate without imposing any serious side effects compared to daily 5mg letrozole.

Letrozole, an aromatase inhibitor, has recently been introduced as favorable medical treatment for ectopic pregnancy. We aimed at evaluating the effects of different doses of letrozole for induction of abortion Sixty patients with undisturbed ectopic pregnancy were classified into three equal groups. Group I: The control group that contained women who were undergoing laparoscopic salpingectomy, Group II: Patients who received letrozole (5 mg d-1) for 10 d, and Group III: Patients who received letrozole (10 mg d-1) for 10 d. After that, the human chorionic gonadotropin (β-hCG) levels were determined for the first day and after 11 d of treating. letrozole (10 mg d-1) markedly reduced the receptors of estrogen and progesterone, and subsequent vascular endothelial growth factor signals, resulting in marked apoptosis in the placenta tissue. The utilization of letrozole at a dose of 10 mg d-1 for inducement of abortion typically results in a substantial high-successful rate without any severe side effects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed ectopic pregnancy was by
* Absence of an intrauterine gestational sac on vaginal ultrasound Coupled with
* β-hCG titers beyond the discrimination zone of at least 2,000 milli-International units (mIU/m).

Exclusion Criteria:

* Patients had contraindications for letrozole
* Patients with any systemic disease ( diabetes, hypertension, ....)
* Patients with b-hCG levels \>3,000 mIU/mL
* Patients with hemoglobin level \<10 g/dL,
* Patients with platelets count \<150,000/mL,
* Patients with elevated liver enzymes,
* Patients with elevated blood urea, or serum creatinine
* The presence of a fetal heartbeat in a gestational sac detected outside the uterine cavity
Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Off-pump Coronary Artery Bypass Graft

High mobility group 1 (HMGB1) protein is both a nuclear factor and a secreted protein, and has recently been identified as a cytokine mediator of systemic inflammation. HMGB1 is released by inflammatory cells actively, or increased during cell death passively and mediates inflammatory response. It has been reported to have association with the prognosis after acute coronary syndrome, ischemia-reperfusion injury of myocardium, atherosclerosis and heart failure. This study aimed to investigate the relationship of serum levels of HMGB1 and post operative prognosis of patients who had undergone off-pump coronary artery bypass graft.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20
2. Patients undergoing off-pump coronary artery bypass graft

Exclusion Criteria:

1. Age \< 20
2. Patients undergoing off-pump coronary artery bypass graft with other simultaneous surgery
3. Patients participating other study
Application of 3D Printing Guide Plate in Spinal Minimally Invasive and Interventional Surgeries

Application of 3D printing guide plate in spinal minimally invasive and interventional surgeries

This study applies 3D-printed customized guide plate in assisting the accurate puncture in endoscopic spinal surgery, radiofrequency ablation of the medial branch of the dorsal ramus or sensory ganglion or joint, disc coblation nucleoplasty, etc. in patients with low back pain, lumbosacral radicular pain, joint pain, perineal pain and pelvic pain. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.

This study involved lumbar disc herniation (LDH), lumbar spinal stenosis (LCS), radiculopathy, facet joint disorder syndrome, ischemic pain of the lower extremity, cancer pain, etc.. Spinal minimally invasive and interventional surgeries are effective treatments for these disease. Needle Puncture is the key technology in spinal minimally invasive and interventional surgeries.

In the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. If the position of the needles is not satisfactory, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem could be well solved by applying the 3D printing guide plate.

The key processes for the 3D printing guide plate procedure: the model of the spine or bone is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. The final position of needle is confirmed by C-arm fluoroscopy or CT.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old,
2. Pain lasting ≥12 weeks,
3. The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
4. Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
5. Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features,
6. Agree with spinal minimally invasive and interventional surgery treatments, including endoscopic spinal surgery, radiofrequency treatment of the medial branch of the dorsal ramus or nerve root or sensory ganglion or joint, disc coblation nucleoplasty, etc.

Exclusion Criteria:

1. Patient refusal to participate in the study,
2. Pregnant or nursing
3. Allergies to local anesthetics, contrast dyes or steroids
4. Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
5. Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
6. Steroid injection within the previous 12 weeks,
7. Systemic infection,
8. Injection site infection,
9. Unstable medical or psychiatric condition
Is ESWT Better in Plantar Fasciitis Treatment?

It was aimed to compare the pain and functional results of ESWT, kinesiotherapy and corticosteroid injection in patients with treatment-resistant plantar fasciitis.

The groups were randomized in patients with chronic plantar fasciitis who did not benefit from conservative treatment. A questionnaire study was conducted at the first visit, sixth week, third month, and sixth month. Visual analog scale (VAS) and The American Orthopedic Foot and Ankle Society (AOFAS) score were applied as a questionnaire at each control visit of the patients.

Eligibility Criteria:
Inclusion Criteria:

* previously diagnosed with PF,
* did not benefit from conservative treatment for at least six months,
* did not use anticoagulants,
* did not have bleeding disorders,
* did not have a psychiatric disease

Exclusion Criteria:

* previous ESWT or CI treatment
* obesity,
* seronegative spondyloarthropathy,
* tarsal tunnel syndrome,
* peripheral neuropathy,
* foot-ankle deformity (pes cavus, pes planus, etc.),
* history of mass around foot and ankle,
* previous foot or ankle surgery
* degenerative arthritis around this region
AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV

The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is in treating HIV-1 infected people who have failed treatment with lamivudine.

Lamivudine or emtricitabine are commonly used in combination with other drugs for first-line treatment of HIV infection. Although effective initially, many people later on develop resistance to some or all of the drugs (including lamivudine) leading to virological failure. Resistance is associated with characteristic mutations, which for lamivudine is the M184V mutation. A change to new, active drugs must take place when patients fail their current regime, to regain control of the virus. Although there are other types of drugs available for second line treatment, there is currently no fully active, well tolerated cytidine analogue that can replace lamivudine in a second-line regimen when patients fail first line treatment. This study will measure the efficacy and safety of AVX754 (a novel cytidine analogue with activity against HIV resistant to other nucleosides) as part of a new regimen to treat patients who have failed treatment containing lamivudine, compared to the best alternative new regimen which continues to include lamivudine.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* M184V mutation in reverse transcriptase
* Currently taking lamivudine
* Viral load \>2000 copies/ml

Exclusion Criteria:

* Hepatitis B surface antigen positive
* Pregnant or breastfeeding females
* Hepatitis C RNA positive and requiring treatment
A Study Evaluating the Use of an Indoor Air Quality Monitor to Promote a Smoke-free Home

The purpose of this study is to evaluate how using an indoor air quality monitor can promote a smoke-free home for cancer patients who are enrolled in MSK's Tobacco Treatment Program.


Eligibility Criteria:
Inclusion Criteria:

* Adult (aged \>18 years) MSK patients as per the EHR
* Has been referred and enrolled in the MSK TTP and completed the initial counseling session as per the TTP clinical database
* Reports current (within the past 30 days) tobacco use (i.e., cigarettes and/or any other tobacco products) as per the TTP Intake form
* Must be English-speaking in the EHR
* Must be reachable by phone as per self-report
* Must have Wi-Fi available at home as per self-report

Exclusion Criteria:

* Patient reports that no smoking is allowed, by them or anyone else, in the home as per the TTP intake form and/or per self-report
Impact Evaluation of Training Civil Servants on Violence Against Women in Medellín, Colombia

The purpose of this study is to determine whether the training of civil servants leads to a reduction in the violence suffered by women, as well as in their psychological wellbeing and attitudes towards violence.

The Secretary of Women of Medellin, through the ICONTEC, intends to conduct training to officials of the 22 family commissioners in Medellin. The objective of these trainings is to standardize procedures in order that women do not feel re-victimized and can forward complaints. Since the training will be done in phases in 2014 and there is willingness of relevant stakeholders to generate a random order on which commissioners the training is first performed, it can be done a cluster randomized trial.

We will require all 22 commissioners to be randomly assigned into two groups, one treatment and one control. To implement it is intended to:

* Conduct a baseline survey amongst women who used the services of the commissionaires between June and Septmber 2013, completed the process of care and signed informed consent.
* Training of a randomly chosen set of 11 commissioners will take place between June and September 2014.
* Conduct an endline survey amongst women who used the services of any of the 22 commissionaires between June and September 2014, completed the process of care and signed informed consent.

Women will be contacted through the commissioners. Women who have completed the process of care will be ask whether they want to participate in the study. If they agree, their contact details will transfer to the investigators for the survey to be conducted. This process would be conducted twice for baseline information before beginning the training, and for endline, once half of the first 11 commissioners have been trained.

Eligibility Criteria:
Inclusion Criteria:

* Women who initiate and finalize the process with the comissaries of family
Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose

Assessing the effects of a nutraceutical supplement (Berbevis™) in adults with impaired fasting glucose (100-126 mg/dL) and BMI between 25 and 35. Ninety participants will be assigned to three parallel groups receiving Berbevis™ at increasing daily doses (500 mg, 750 mg, and 1000 mg) for 2 months.


Eligibility Criteria:
Inclusion Criteria:

* fasting blood glucose between 100 and 126 mg/dl
* BMI between 25 and 35 kg/m\^2

Exclusion Criteria:

* Fasting blood glucose below 100 mg/dl
* BMI \< 25 or \> 35 kg/m\^2
Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)

A prospective study of the use of two novel MRI techniques (oxygen-enhanced and fourier decomposition MRI) in the initial diagnosis and follow-up of patients with Pulmonary Hypertension. The investigators believe these techniques may present a novel set of imaging biomarkers that may be used for risk stratification, prediction of treatment response and longitudinal disease monitoring. The reserach MRI is in addition to standard of care and will not affect treatment decisions.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Pulmonary Hypertension.
* Age 18 and over.

Exclusion Criteria:

* Standard contra-indications to MRI (as per NHS MRI safety questionnaire).
* Not medically fit for transfer to MRI.
* Patient judged inappropriate for involvement in study by clinical team e.g. secondary to emotional burden of recent diagnosis.
Mobility of Vulnerable Elders (MOVE): Translating Knowledge to Health Care Aides in Long-term Care Facilities

Almost 90 percent of residents living in long-term care facilities have some type of mobility limitation, which worsens quickly once they move into a long-term care facility. This means that they cannot easily walk or move around in their day-to-day lives and this can have serious consequences for their general health and well-being. Researchers have shown that exercise can help the mobility of even the oldest of adults but elderly residents in long-term care facilities still commonly sit or lie in bed for long periods of time, in many cases for most of their waking hours. The purpose of this research is to study the effect of a simple physical activity on the mobility and quality of life of residents in long-term care facilities. Researchers will introduce a sit-to-stand activity to health care aides which will become part of their daily routine with residents. The basic sit-to-stand movement is already a part of the daily activities that health care aides do with residents. Specifically, health care aides will ask residents to repeat the sit-to-stand activity at mealtimes, when using the toilet, and on other occasions of daily activity. An important part of this research is to find out how well the activity preserves the ability of residents to stay mobile and also to examine how this will improve their quality of life in the home. The MOVE study will demonstrate whether it is possible to delay the loss of mobility in long-term care residents by incorporating the sit-to-stand activity into the regular practice of health care aides.


Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of Alzheimer disease, vascular dementia, or mixed dementia
* are able to transfer independently or with the assistance of one person

Exclusion Criteria:

* have a diagnosis of fronto-temporal or Lewy-body dementia
* require the assistance of more than one person to transfer, or a transfer lift
Neovascularization Induced by Mechanical Barrier disrUption and Systemic Erythropoietin in Patients With Cerebral Perfusion Deficits

Neovascularization Induced by Mechanical Barrier disrUption and Systemic erythropoietin in patients with cerebral perfusion deficits (NIMBUS trial)


Eligibility Criteria:
Inclusion Criteria:

* age 20\~85
* Acute period (ischemic stroke confirmation on DWI or TIA within 14 days after symptom onset)
* Below 20 point of initial NIHSS score within 14 days after stroke onset and enrolment.
* Confirmation of atherosclerotic or steno-occlusive stroke mechanism (proximal cerebral arteries) on CTA or MRA .
* At least hemodynamically, perfusion status of a candidate is stage II or III (decrease of regional Cerebral blood flow on CBF map), moyamoya disease
* If female then not of childbearing potential
* Informed consent

Exclusion Criteria:

* Primary intracerebral haemorrhage (ICH), or parenchymal haemorrhagic transformation of infarction (type PHI or PHII as defined in ECASS), subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), cerebral aneurysm, or cerebral neoplasm
* Treated with a thrombolytic \<24 hours (if \>24 hours and excluded ICH then eligible)
* Score \>=1 on the NIHSS item 1a
* Pre-stroke mRS score \<2
* Uncontrolled hypertension(irregularity systollic BP \> 150mmHg
* Previous treatment with erythropoietin
* At screening: Hemoglobin \>14 g/dl, prolonged PT or PTT, serum Cr \>2.0 ,mg/dl, BUN \>40, thrombocytopenia or neutropenia as defined by the lower limit of normal for the platelet count or white blood cell count, respectively (absolute neutrophil count of \> 1800/mm3 required for participation), or \> 2 times of normal on liver function tests (SGOT, SGPT, total bilirubin)
Calcium Metabolism in Asian Adolescents

Maximizing calcium retention by the skeleton within the genetic potential is a key strategy to prevent osteoporosis. It has been shown that calcium retention varies between blacks and whites and between gender within race. This study is designed to study the relationship between calcium intakes and calcium retention in Asian adolescent girls and boys. It is hypothesized that calcium intakes which maximize calcium retention will be lower in Asians than for whites studies under the same conditions. In addition it is thought that the differences between races in the physiological mechanisms involved in calcium metabolism will result in a lower calcium intake required to observe a plateau in calcium retention. This is turn could be translated into lower calcium requirements in Asians relative to Caucasians for achieving optimal peak bone mass.

Adolescent Asian boys and girls will consume a controlled diet for two three-week periods. The basal diet will contain 600 mg/d calcium and will be supplemented with beverages fortified with calcium citrate malate to achieve a range of intakes from 600-2100 mg Ca/d. Each participant will be studied on one of four combinations of a lower and a higher calcium intake within that range in a cross-over design.

Eligibility Criteria:
Inclusion Criteria:

* healthy teens of Asian descent

Exclusion Criteria:

* malabsorptive disorders
* anemia
* smoking, illegal drugs
* oral contraceptives
* pregnancy
* drugs that influence calcium metabolism
* body weight for height greater than 85 percentile
Transient Receptor Potential Channels

Neurovascular signaling in the skin associated with stimulation of the transient receptor potential (TRP) channels. These channels are stimulated by both temperature and naturally occurring bioactive agents found in mint, chili peppers, garlic, etc. The aim of the study is to examine how topically applied TRP channel agonists including menthol, capsaicin and camphor impact neurovascular responses in the skin.


Eligibility Criteria:
Inclusion Criteria:

* 18-85 years old.
* Women will not be pregnant and/or breastfeeding.

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Nicotine use (e.g., smoking, chewing tobacco etc.), quantified as more than 100 cigarettes or cigars in a lifetime)
* Known skin allergies or current rash, skin disease, disorders of pigmentation
* Diabetes
* Body mass index \>35kg\*m-2
* Using calcium channel blockers
* Raynaud's syndrome
* Allergy or hypersensitivity to menthol, camphor, capsaicin or adhesive
* Regular use (defined as greater than once a week) of topical analgesics that contain menthol, camphor or capsaicin