cyrilzakka/clinical-trials huggingface dataset:
Study to Document the Phenomenon of Vitamin D Deficiency and Its Added Value in Patients with Low-energy Osteoporotic Hip Fracture, in Daily Practice in Greece.

Vitamin D, through its action on calcium metabolism, is essential for bone physiology. Vitamin D deficiency can affect muscle function and increase the risk of falls in the elderly, while severe deficiency is common in patients with fragility fractures. Vitamin D and calcium supplementation, in addition to anti-osteoporosis treatment after surgery or conservative treatment, can ensure optimal recovery and survival, especially in patients with a hip fracture.

The goal of vitamin D supplementation is to bring the serum 25-(OH)-D concentration above 30 ng/ml.

Clinical pathways have been developed to support orthopedic surgeons in improving the medical management of patients after orthopedic/surgical fracture management. Pathways include advising primary care physicians and orthopedic surgeons on diagnostic and therapeutic approaches, promoting their appropriate use without compromising quality of care, and educating patients on non-pharmacological management of their disease (physical therapy, lifestyle habits life and nutrition).

This is an observational cohort study that will record data on the use of vitamin D in daily practice in patients with low-energy fractures.

The aim of this study is to measure vitamin D levels in the patient and provide these patients according to daily practice with appropriate supplementation for a period of one year, observing if there is a good functional outcome and a reduction in the risks of new fractures.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old
* Patients with a low energy fracture
* Vitamin D levels \< 30 ng/ml
* Patients with available medical history before and after initiation of study treatment
* Patients providing informed consent for this study

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients receiving different osteoporosis treatment
* Patients with known hypersensitivity to vitamin D
* Patients participating in another similar study at the same time with other drugs
* Patients with vitamin D contraindications according to the medical instructions for use
* Patients with a fracture due to a traffic accident
Depression in the Elderly and Cerebral Amyloid Plaques: Characterization by [18F] AV-45 Affectives Symptoms and Amyloïd Plaques (ASAP)

The primary objective of the study is to compare the brain amyloid load in fully, partially and non remitting depressed elderly patients at 8 weeks of antidepressant therapy, by using PET with \[F18\]AV45.

The main aim of this study is to assess the brain amyloid load in treated depressed elderly subjects using PET with \[F18\]AV45. The investigators hypothesize that the brain amyloid load will be higher in non or partially remitting depressed subjects treated with antidepressants than in fully remitting ones. An additional two years follow-up will allow comparing the brain amyloid load at baseline between those who will have evolved towards MCI or MA and those who will not, including ApoE genotype, the cognitive performances at baseline, the hippocampus volume as assessed by MRI, the type and profile of mood disorder (number of past episodes, age at first episode, vascular risk factor profile, response profile to antidepressants), as covariates.

Eligibility Criteria:
Inclusion Criteria

* Adult 55 years or older
* Native language : french
* Study period \> 7 years
* Major depression defined on the DSM-IV criteria assessed by MINI and HDRS score of 10 or over
* Affiliation to the national health insurance system
* Signed informed consent

Exclusion Criteria

* History of alcoholism or drug addiction
* MMSE less than or equal to 17
* Major depression with psychotic features
* Depressive episode resistant, patient who received two different antidepressants well conducted without significant therapeutic response
* Any current or past episode of mania, schizophrenia or any other psychotic disorder
* Any past history of stroke or Parkinson's disease
* Any current significant unstable illness
* Any past diagnosis of Alzheimer's disease
* Any current treatment by AcethylCholinesterae inhibitor, memantine or antidepressant therapy.
* Contraindications to MRI in patients with:

  1. Metallic foreign body eye.
  2. Any implanted electronic medical irremovably (pacemaker, neurostimulator, cochlear implants ...)
  3. Metal heart valve,
  4. Vascular clips formerly located on cranial aneurysm.
* Contraindications to antidepressants
* History of progressive disease that can affect the central nervous system such as uncontrolled diabetes, blood pressure greater than or equal to 180/100; chronic lung disease with hypoxia, head trauma with loss of consciousness greater than or equal to 15 minutes; brain surgery, encephalitis, recently treated cancer (\<1 year), altered cerebral metabolism including subjects with stroke sequelae extended. Patients with lacunar stroke without thalamic or striatal may be included.
Classic Yin and Yang Tonic Formula for Osteopenia

The purpose of this study is to evaluate the efficacy and safety of the classic yin and yang tonic formula for osteopenia and to research the mechanism of efficacy.

Osteoporosis is a growing problem worldwide, with the greatest burden resulting from fractures. Nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (BMD) only moderately lower than young normal individuals) Since life long drug therapy is an expensive option with uncertain consequences and side effect, natural herbal therapy offers an attractive alternative. The classic Yin and Yang Tonic Formula (eg.Zuogui Pill, Yougui Pill) have been used for osteoporosis or osteopenia in traditional Chinese medicine(TCM) for a long time. For this reason, Chinese guidelines for the treatment of osteopenia include natural herbal therapy, however, there is currently no randomize placebo controlled trial to verify the efficacy for treating low BMD. This trial is randomized, double blind, placebo controlled design. Results of this study will provide evidence regarding the value of the classic Yin and Yang tonic formula as an intervention for increase BMD and decreasing fracture risk in osteopenia. Furthermore, the mechanisms of action can be identified by this study.

Eligibility Criteria:
Inclusion Criteria:

* BMD T-scores of the hip (femoral neck or trochanter)and/or spine between -1.0 and -2.5;
* pattern differentiation is kidney deficiency in TCM.
* informed consent.

Exclusion Criteria:

* Osteoporotic (T-score\< -2.5) at any site or a fracture in the past 2 years not caused by motor vehicle accident;
* prior or current use of medication that increase risks of fracture (e.g. steroids, anti-convulsants, anticoagulants,lithium);
* prior or current use of medications that modify bone metabolism (e.g. bisphosphonates, selective estrogen receptor modulators such as Raloxifene);
* use of calcium supplements above levels suggested within the recommendations of standard care (i.e., above 1200-1500 mg);
* current or prior year use of estrogen or calcitonin;
* Malignancies other than skin cancer;
* conditions that cause secondary osteoporosis (e.g. Cushing's syndrome, Marfan's syndrome);
* lactation and gestational period;
* physical or mental disabilities that will preclude informed consent or active study participation;
* supersensitivity body constitution.
* osteoporotic fracture of having operating indication.
Cognitive Embodiment Activation by tDCS

The main objective of the proposed research is to extend our understanding of how gesture and language interact, focusing on the role of cognitive embodiment in this interaction, and to explore the neural systems that support links between language and actions systems.


Eligibility Criteria:
Inclusion Criteria:

* Right handedness
* unobtrusive neuropsychological screening

Exclusion Criteria:

* History of severe alcoholism or use of drugs.
* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
* Contraindication for MRT (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).
Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation

The aim of this study is to develop an intervention that will produce a sustained improvement in physical activity and chronic stress as a means to slow the menopause-related accumulation of visceral adipose tissue in mid-life women.


Eligibility Criteria:
Inclusion Criteria:

* Resident of the Beverly or Morgan Park neighborhood of Chicago or contiguous neighborhoods
* Female
* African American or Caucasian
* Age 42 years or older
* Intact uterus, at least one functioning ovary, at least one menstrual period in the last 12 months prior to screening.
* Sufficient motivation level to make lifestyle changes, as determined by WISHFIT staff.

Exclusion Criteria:

* Hysterectomy
* Physical activity \> 90 min per week
* Metabolic conditions or use of medications that affect weight of visceral adipose tissue (diabetes, acquired immune deficiency syndrome, weight \> 300 lbs)
* Presence or history of major psychiatric comorbidity (i.e. dementia, schizophrenia, bipolar disorder, alcohol/drug addiction) in the last 6 months
* History of inpatient mental health treatment
* Currently prescribed antipsychotic medication
* History of hallucinations or bizarre thoughts
* Current pregnancy
* Has been told by a physician that it is unsafe to engage in physical activity
* An illness expected to limit functional status or life expectancy, including: heart failure, recent heart attack, liver cirrhosis, kidney failure, oncologic conditions, history or heart surgery, angioplasty or artery stenting.
Vitamin C Efficacy in Reducing Post Operative Pain

Opioids are the corner stone in the treatment of post operative pain. Because of the several side effects of opiods, non-steroidal anti-inflammatory drugs are usually added postoperatively to decrease the total requirements of opioids. However, non steroidal anti-inflammatory drugs have side effects of their own. Vitamin C, with virtually no side effects when used on short-term basis, has been shown to have promising analgesic effects in chronic pain and acute pain relief following orthopedic surgeries.

The investigators propose to assess the role of a prophylactic single dose (2g) of vitamin C in reducing the intensity of pain and the consumption of opioids in patients undergoing laparoscopic cholecystectomy at AUB-MC.

All eligible patients undergoing laparoscopic cholecystectomy at AUB-MC will be included in the study. Patients will be randomized into two groups to receive either single dose oral vitamin C (2g) (Study Group) or identically looking placebo capsules (Control Group). Both the patients and the investigation team will be blinded to the type of intervention. Intraoperative anesthesia management will be similar for both groups. Postoperative pain control will be achieved with patient controlled analgesia via a patient controlled morphine pump in both groups. At several time intervals and up to 24 hours postoperatively, the pain scores, morphine consumptions, nausea/vomiting scores, sedation scales, itching scales, and patient satisfaction scales will be obtained for all patients. Also, the peak vitamin C concentration will be determined for each patient.

Patients demographics will be obtained and compared between both groups. The differences in pain scores, morphine consumptions, nausea/vomiting scores, and sedation, itching, and patient satisfaction scales will be compared between the two groups with the Student-t test, the analysis of variance, the Fisher exact test, and the Kruskal-Wallis test. The peak vitamin C plasma concentration will be correlated with the pain scores in each group using regression analysis.

This study will provide relevant information on whether a single dose (2g) of vitamin C can reduce morphine requirements and non steroidal anti-inflammatory drugs need and thus eliminating their side effects in patients undergoing laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both gender
* Between 18-75 years old
* ASA class I, II, or III
* Scheduled to undergo laparoscopic cholecystectomy

Exclusion Criteria:

* Intake of anti-inflammatory drug in the past 24 hr
* Allergy to morphine
* History of chemical dependence
* Chronic pain state
* Inability to use PCA pumps
* History of obstructive sleep apnea
* History of severe asthma
* History of COPD
* History of gastroesophageal reflux disease
STAR and Deferred Stenting Study

STAR is a minimal-risk pragmatic clinical trial of patients admitted for a CTO-PCI procedure. The overall objective of the STAR Study is to address the current gaps in knowledge regarding use of STAR during CTO-PCI, as a prospective, multi-center study of 150 participants with randomization of timing of staged PCI. Five sites will be selected to participate in STAR from a national network of highly experienced CTO-PCI centers across the United States.

To date, there have been no studies that prospectively and systemically evaluated the efficacy and safety of STAR with deferred stenting and described the frequency of its use in the hybrid approach. The aim of this study is to address these current gaps in knowledge, including the frequency of use of STAR by experienced operators, the safety of its use, optimal timing of staged stenting and health status change associated with this procedure. This prospective study will enroll 150 patients undergoing elective PCI of native CTO utilizing the STAR technique and will subsequently randomize patients in a 1:1 fashion to early (5-7 weeks) and later (12-14 weeks) timing of subsequent stenting.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled for a PCI procedure for at least one chronic total occlusion with TIMI antegrade flow of zero.
2. Subject is ≥ 18 years of age at the time of consent
3. The operator attempted STAR technique defined as knuckle guidewire across or into the CTO segment during the CTO PCI and is planned for a staged procedure.
4. English speaking due to follow up.

Exclusion Criteria:

1. The CTO segment is in a graft.
2. Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
3. Unable to participate in telephone follow-up

   1. Too hard of hearing to do follow-up by telephone or deaf.
   2. Incarcerated prisoner.
   3. History of dementia.
   4. Subjects without a way for contact by telephone for follow-up.
4. Previously enrolled in STAR.
5. Patient not a candidate for baseline and final angiography (CKD with eGFR\<30).
6. The knuckled guidewire did not cross into the CTO segment during STAR attempt.
7. A stent was placed into the STAR segment during the Index Procedure.
8. Refused participation in the study.
9. Patient enrolled in another study.
PLA for HCC and Esophageal ca Serum

The primary goal of this study is to quantify the biomarkers of pre-radiation therapy(RT), during-RT, and post-RT serum samples from hepatocellular carcinoma (HCC) and esophageal cancer patients undergoing definitive or neoadjuvant RT, and to correlate them with tumor response, patterns of failure, survival outcome, and RT-related lung or liver toxicity. The secondary goal of this study is to set up the PLA platform in our institute for future biomarker test.

There have been many biomarkers, such as angiogenesis factors and cytokines, related to cancer progression or microenvironment interaction. However, the commonly used enzyme-linked immunosorbent assay (ELISA) requires the certain volume of each sample for specific antigen or antibody. It may not be practically efficient to test a broad spectrum of biomarkers with limited volumes of serum from cancer patients. Proximity ligation assay (PLA), an established concept and platform requiring very little sample volume to quantitatively detect a variety of biomarkers, is being developed with multiplex versions of improved sensitivity and dynamic range by the Stanford group. From the three completed trials ("In vivo/vitro radiation-induced liver disease in HBV carrier（9261700196）", "Bystander effect study of radiation-induced viral hepatitis B reactivation（9261700196）", and "Pre- and post-chemoradiation blood RNA-microarray analysis to predict response and outcome of locally advanced esophageal squamous cell carcinoma（200805061R）") and one ongoing trial ("A phase I dose escalation trial of conformal hypofractionated radiation therapy for patients with hepatitis B virus-related Child A cirrhosis and hepatocellular carcinoma（200906051R）"), we have collected the pre-treatment and post-treatment serum samples of patients with hepatocellular carcinoma undergoing definitive radiotherapy and patients with esophageal cancer undergoing neoadjuvant chemoradiotherapy. Altered patterns of failure for post-radiotherapy hepatocellular carcinoma, especially intrahepatic and extrahepatic metastasis, and treatment response for post-chemoradiotherapy esophageal cancer upon esophagectomy, demands the effective biomarkers for the early prediction and appropriate management. The limited sample volumes form the obstacle of testing adequate number of biomarkers by ELISA. In this study we plan to collaborate with the Stanford group, to send and process these samples (100 μL each) to measure the dynamic changes of up to 56 or more biomarkers. We try to find the potential biomarkers correlating with treatment responses and patterns of failure for the future clinical practice, and wish to set up this viable PLA platform in our institute through this collaboration.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of locally advanced esophageal cancer or Hepatocellular Carcinoma, RT is indicated
* Informed consent signed

Exclusion Criteria:

* not completed RT
Abdominal Binding in Chronic Obstructive Pulmonary Disease

Conventional approaches to relieve dyspnea (respiratory discomfort) in chronic obstructive pulmonary disease (COPD) have focused on improving respiratory motor drive (e.g., hyperoxia) and/or dynamic respiratory mechanics (e.g., bronchodilators). Although these approaches yield meaningful symptom improvements there remains many COPD patients incapacitated by dyspnea. Accumulating evidence suggests that abdominal binding (AB) is a potentially novel method of improving respiratory muscle function and, by extension, dyspnea and exercise tolerance in COPD. Thus, the purpose of this randomized, cross-over study is to test the hypothesis that AB improves exertional dyspnea and exercise tolerance in symptomatic patients with COPD by improving dynamic respiratory muscle function. To this end, the investigators will examine the effects of AB on detailed assessments of baseline pulmonary function (spirometry, plethysmography), dyspnea (sensory intensity \& affective responses), neural respiratory drive (diaphragm EMG), contractile respiratory muscle function (esophageal, gastric \& transdiaphragmatic pressures), ventilation, breathing pattern and cardiometabolic function during symptom-limited constant load cycle exercise (75% Wmax) in 20 patients with GOLD stage II/III COPD.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Aged ≥40 years
* Ambulatory
* Cigarette smoking history ≥15 pack years
* No change in medication dosage or frequency of administration, with no exacerbations or hospitalization in the preceding 6 weeks.
* Post-bronchodilator Forced Expiratory Volume in 1 second between 30-80% predicted
* Post-bronchodilator Forced Expiratory Volume in 1 second/forced vital capacity ratio of \<70%

Exclusion Criteria:

* Presence of active cardiopulmonary disease other than COPD
* Use of domiciliary oxygen
* Exercise-induced arterial blood oxyhemoglobin desaturation to \<80% on room air.
* Body Mass Index \<18.5 or ≥35 kg/m2.
* Allergy to latex
* Allergy to lidocaine or its "caine" derivates.
Esmolol vs. Labetalol in Endoscopic Sinus Surgery

The purpose of this study is to compare esmolol and labetalol bleeding and intra-operative visibility scores in functional endoscopic sinus surgery.

BACKGROUND: Improved intraoperative visibility during functional endoscopic sinus surgery (FESS) decreases the risk of serious orbital or skull base injuries. Beta blockers are among several methods used to reduce mean arterial pressure (MAP), heart rate (HR) and mucosal bleeding. Labetalol (mixed alpha-1-beta blocker) reduces HR and MAP; however, its alpha-1 blockade may mitigate topical epinephrine decongestant effects. Esmolol (selective beta-1 blocker) does not have direct antagonistic effects on topical epinephrine. This study compares the hemodynamic parameters (rate of blood loss, MAP control, HR) and intraoperative visibility during FESS between esmolol and labetalol.

Eligibility Criteria:
Inclusion Criteria:

* History of CRS with or without nasal polyps
* Undergoing FESS for CRS
* American Society of Anesthesiologists (ASA) physical status 1 (healthy) or 2 (patient with mild systemic disease).

Exclusion Criteria:

* Pregnancy
* Asthma
* COPD
* Bradycardia
* Heart failure
* End stage renal disease
* Cerebrovascular accident
* Diabetes mellitus
* Preoperative use of NSAIDs, aspirin, or beta-blockers
* Body mass index (BMI) greater than 40 kg/m2.
Design and Testing of a Web-Based Tool for the Improvement of End-of-Life Planning in Patients With Advanced Cancer

This clinical trial examines a web-based tool, in partnership with Peacefully, Inc, designed to improve end-of-life planning among patients with advanced cancers. This program helps users prepare comprehensively for end-of-life (e.g., medical wishes, legal estate planning, financial planning and transfer of accounts, legacy building, and emotional support). It is expected that this web-based end-of-life planning program may reduce distress and improve end-of-life preparation among advanced cancer patients.

OUTLINE:

Patients are randomized to 1 of 2 groups and their engagement in end-of-life planning is assessed at baseline and four weeks post-randomization.

Group I (intervention): Patients receive Peacefully's web-based tool to help with end-of-life planning on day 7.

Group II (control): Patients receive standard of care.

After completion of study, patients are followed up at 4, 12, and 24 weeks post-randomization.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer and/or disease progression following at least first line chemotherapy
* Access to a computer or mobile device
* The ability to provide informed consent

Exclusion Criteria:

* Not fluent in English
* Severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of \< 6)
* Too ill or weak to complete the interviews (as judged by the interviewer)