cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Deficiency in Patients With Hypertension

This study will evaluate the effects of Vitamin D replacement and the effects of an approved medication for hypertension, aliskiren (Tekturna), in patients with high blood pressure who have low levels of vitamin D in their blood. The study will compare the effects of vitamin D or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.

This study will assess whether aliskiren will lower clinic blood pressure and 24-hour blood pressure in patients with hypertension and vitamin D deficiency. Additionally, this study will further explore the potential additional effects of adding vitamin D to aliskiren in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Men or women over 21 years of age with a history of Stage 1 or 2 hypertension (defined as a seated diastolic BP ≥ 90 mmHg and \< 110 mmHg in the untreated state).
* Patients under treatment for hypertension must be willing and able to discontinue any previous antihypertensive medications for the duration of the study.
* 25-hydroxyvitamin D levels \< 30 ng/ml and \> 12 ng/ml.
* Women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial, must have a negative serum pregnancy test at screening, and must have a negative urine pregnancy test within 7 days before initiating aliskiren therapy.

Exclusion Criteria:

* Vitamin D levels \< 12 ng/ml
* Known hypersensitivity or allergy to aliskiren
* Clinic blood pressure \> 180/110 mmHg
* Known forms of secondary hypertension
* Chronic atrial fibrillation
* Uncontrolled or unstable cardiovascular diseases
* Shift or night workers
* Mid-arm circumference \> 42 cm in diameter
* Current or recent (\<1 year) alcohol or drug abuse
* Pregnant or lactating women
A Phase 1 Dose Escalation Study of AV-203, an ERBB3 Inhibitory Antibody, in Subjects With Advanced Solid Tumors

This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated in an expansion cohort at the RP2D for safety and anti-tumor activity.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Histologically and/or cytologically confirmed primary diagnosis
* Metastatic or advanced solid tumor, that has recurred or progressed following standard therapies, or for which no standard therapy exists
* Must have available tumor tissue or be willing to undergo biopsy prior to enrollment
* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
* Blood Chemistry and Hematology results within defined limits

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent
* Current central nervous system (CNS) or leptomeningeal metastases, or history of CNS or leptomeningeal metastases.
* Significant conduction disturbance, history of a severe arrhythmia, or history of a familial arrhythmia
* Significant cardiovascular disease
* Significant thromboembolic or vascular disorders within prior 3 months
* Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results
* Known history of positive results for hepatitis C, hepatitis B, or human immunodeficiency virus.
* For female subjects, pregnancy or lactation.
Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa

Study to look at the effectiveness, tolerability and safety of two doses of Study Medication in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.


Eligibility Criteria:
Inclusion Criteria:

Men and women with Parkinson's disease (PD) whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without other known or suspected cause of parkinsonism.

Subjects must be age 35 years or older.

Subjects not taking or requiring anti-parkinsonian medications, except for anticholinergics.

Exclusion Criteria:

Subjects with unstable systemic medical problems or clinically significant malignancy, with particular attention to clinically significant or unstable vascular disease
Post-Operative Treatment With Ketorolac After Abdominal Myomectomy

The purpose of this study is to determine if ketorolac, given after abdominal myomectomy, will decrease the frequency of post-oerative fevers as well as improve post-operative pain management.


Eligibility Criteria:
Inclusion Criteria:

* Ant patient undregoing abdominal myomectomy

Exclusion Criteria:

* Patients with contraindication to NSAIDs including history of peptic ulcer disease, renal disease, bleeding diathesis, or hypersensitivity to NSAIDS
Cost-effectiveness of FDG-PET

Evaluation of cost-effectiveness of FDG-PET for the public health system in Brazil.

To provide detailed information about cost and effectiveness of FDG-PET in multiple oncological diseases, such as Lymphoma, lung cancer and esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Cancer

Exclusion Criteria:

* Other malignancy
* Uncontrolled Diabetes
* Pregnancy
Reiki Therapy to Improve Key Symptoms in Integrative Oncology Clinic (REIKI)

The purpose of this research is to investigate the delivery of Reiki to integrative oncology patients and assess its potential for improving cancer-related symptoms in this population.

Reiki is a biofield therapy originating in Japan, in which a trained practitioner places their hands on or above the body of a receiver or themselves to generate a relaxation and healing response. Systematic reviews and meta-analyses report Reiki to be effective for improving psychological and physical health symptoms. With respect to adults with cancer, Reiki has been shown to improve participants' relaxation, pain, fatigue, sleep, anxiety, stress, and wellbeing/quality of life compared to care as usual. However, one study showed no improvement in comfort and wellbeing in those receiving Reiki compared to sham Reiki control, but those receiving Reiki reported improvements above usual care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 89.
* Neoplasm diagnosis (i.e., ICD-10 C00 - D49) confirmed in electronic health record (EHR)/Caisis
* Receiving care at a UH Connor Whole Health Integrative Oncology Clinic.
* Reporting at least three ESAS symptoms ≥4/10 at baseline screening including fatigue and ≥2 other symptoms on the 9-item questionnaire.
* Able to speak and understand English.
* Has an email address, and access to a computer with internet and/or a mobile device with a functioning data plan

Exclusion Criteria:

* Significant cognitive impairment that has not been corrected.
* Significant visual impairment that has not been corrected.
* Unable to provide informed consent.
* Active psychosis.
* Pregnancy.
* Metastatic disease.
* Reiki therapy within 3 months of study enrollment
* Active immunotherapy, chemotherapy, or radiation treatment, or completed within 3 months before study start. Aromatase inhibitors and tamoxifen are exceptions.
Endoscopic Ultrasound-Guided Gastroenterostomy Nationwide: Prospective Registry.

This is project of help and support for the introduction of the GASTROENTEROANASTOMOSIS technique guided by ENDOSCOPIC -ULTRASOUND (EUS-GE) in centers in Catalonia, facilitating a teacher training.

The main objective is facilitate a safe introduction of the technique, limiting technical failures, and if necessary, support in rescue techniques.

The goal of this interventional study is to assess the impact of a teaching and on live-support model in the introduction of the gastroenteroanastomosis technique, evaluating its effects in safety and the learning curve.

regarding the results in safety and learning curve of for the introduction \[type of study: observational study or clinical trial\] is to \[learn about, test, compare etc.\] in \[describe participant population/health conditions\]. The main question\[s\] it aims to answer are:

* \[question 1\]
* \[question 2\] Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more
* Gastric outlet obstruction (GOO) caused by passable /unpassable stenosis in the antrum-duodenal region, to malignant or non-malignant conditions
* Patient capable of understanding and signing informed consent form
* Patient understanding the type of study and complying with the follow-up of complementary tests during the study's duration

Exclusion Criteria:

* Massive ascites.
* Complete stenosis
* Failure to sign informed consent form
* Patients with intellectual handicap who are unable to understand the nature and possible consequences of the study, unless there is a competent legal representative
* Patients unable to adhere to subsequent follow-up requirements
* Severe coagulation disorder: INR \> 1.5 not correctible with administration of plasma and/or platelets \< 50,000/mm3
Driving Pressure Guided VT in ARDS Patients

A prospective physiologic study, in participants with COVID-19 related or non-COVID-19 related acute respiratory distress syndrome (ARDS) requiring mechanical ventilation less than 48 hours. The investigators assessed the effect of different tidal volume guided by different levels of driving pressure on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (EIT) in supine and/or prone position.

Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the participant's chest at the fifth or sixth intercostal space and connected it to an EIT monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany).

Data were collected in the enrolled day (Day 1),Day 3 and Day 7 including demographic and anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen in inspired air (FiO2).

Volume control mode without spontaneous breathing, PEEP will be set according to best respiratory compliance method, and tidal volume (VT) will be set to reach three levels of driving pressure (High 14-15cmH2O, moderate 10-11 cmH2O, and low 7-8 cmH2O). Each level of VT was maintained 10 minutes in supine and/or prone position. In the last minutes of each phase，the participants received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 10% NaCl solution was injected via the central venous catheter. Clinical data and outcome will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. aged ≥ 18 years old
2. admitted to intensive care unit with a moderate to severe ARDS
3. invasive mechanical ventilation

Exclusion Criteria:

1. contraindications for prone position ventilation
2. Past chronic respiratory diseases (long-term family oxygen therapy for chronic respiratory diseases such as pulmonary fibrosis or COPD)
3. New York Heart Association class above II
4. gave written or witnessed verbal informed consent.
5. Contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)
6. Impending ECMO (on the basis of clinical judgment, including clinical and physiological parameters).
The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome

The purpose of this study is to prospectively examine the impact of various lifestyle habits in both men and women on the outcome of in vitro fertilization. There are 25 infertility centers in the United States which use the electronic medical record collection entity eIVF, made by Practice Highway, to collect medical and demographic information on the patients who are undergoing treatment at these centers. Information on every aspect of each cycle is also electronically collected daily during each cycle. Demographic and lifestyle information will be collected on all patients prior to cycle start and lifestyle habit information will be collected each time a patient logs onto the patient portal, which averages every few days.


Eligibility Criteria:
Inclusion Criteria:

Eligible patients include, any patient whose:

* infertility clinic uses eIVF
* is scheduled to undergo an IVF cycle
* has access to the internet on a daily basis
* can read and understand English
* logs onto the patient portal on eIVF
The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)

Randomized, double blind, double dummy, positive drug parallel comparison, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with influenza (acute upper respiratory infection).

Treatment group: Fuganlin Oral Liquid 10mL. Control group: Xiaoer Jiebiao oral liquid 100mL. Treatment for one week. Patients who were recovered within one week can withdrawal at any time.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as acute upper respiratory infection.
2. Patients with Traditional Chinese Medicine syndrome of qi deficiency and wind-heat.
3. Patients aged 1 to 12 years.
4. With course of disease in 48 hours or less.
5. Signed informed consent by a Parent or legal guardians.

Exclusion Criteria:

1. Patients diagnosed as tonsillitis, bronchitis, bronchiolitis, pneumonia;
2. Patients have a history of hyperpyretic convulsion;
3. Severe malnutrition, rickets patients and merge the heart, brain, liver, kidney and hematopoietic system and other serious primary diseases;
4. The increased of serum creatinine (Cr), blood urea nitrogen (BUN), alanine aminotransferase (ALT), and urinary protein, urine RBC above "+", which can not use the test illness or possibly combined disease conditions to explain;
5. Patients with allergic physique (Allergic to above two kinds of substance), allergic to the composition of the preparation or control drug;
6. According to the doctors' determination,likely to loss to follow up.
Routine Health Care of Patients With FSHD

On the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve the physical performance of patients with FSHD.The result of this clinical trial showed that antioxidants supplementation may improve skeletal muscle function of patients with FSHD and suggest that an antioxidant strategy adapted may be a relevant therapeutic approach for these patients. Since then, patients with FSHD who attend consultation at Montpellier hospital are systematically supplemented with antioxidants according their own blood tests.

This study will assess course of patients with FSHD in accordance with usual care performed within the Department of clinical physiology at the University hospital of Montpellier. This prospective longitudinal study include an initial assessment. Then the follow up of patients will be monitored at 12 months and annually. The eventual objective will be to develop a FSHD disease cohort in care at the Montpellier hospital. A statistical analysis will be performed at 3-years follow-up

Eligibility Criteria:
Inclusion Criteria:

* Molecular and clinical diagnosis for FSHD
* patients, men and women aged \> 7 years,

Exclusion Criteria:

* pregnant women
* Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
* Major protected by law (guardianship, curatorship or under judicial protection)
Lipid-lowering Therapy Individualization

This clinical study will explore individual factors influencing statin pharmacokinetics in a cohort of 150 patients treated with atorvastatin.

Atorvastatin is widely prescribed for the treatment of hypercholesterolemia to prevent the risk of cardiovascular diseases, a leading death cause in industrialized countries. There exists considerable inter-individual variability in response to statins, reflected by differences in lipid-lowering effect or risk of presenting adverse drug reaction; mainly myotoxicity. A plethora of different factors (demographic, genetic, physiopathologic, environmental...) have been tested to explain this variability but it lacks of pharmacokinetic (PK) data and/or replications of observations are rare and results remain inconclusive, probably because of non-adapted designs and no-clear driven-hypothesis but also due to a lack of scientific rationale and deep mechanistic understanding. This clinical study will explore individual factors influencing statin PK in a cohort of 150 patients treated with atorvastatin. The collection of meticulous clinical PK data and a rigorous statistical analysis will allow quantifying the effect of each identified parameter on statin PK and eventually, defining a population-based PK model taking into account the combined effect of all covariates in a quantitative approach. This innovative prospectively designed clinical study will ultimately allow predicting atorvastatin PK fluctuations and anticipating any inadequate dosing in clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Treatment with atorvastatin (any dose)

Exclusion Criteria:

* Unable to provide informed consent
Low Grade Chondrosarcoma Versus Enchondroma

The purpose of this project is to verify possible clinical and radiological findings with regard to distinguishing enchondroma from low grade chondrosarcoma of the long bones. In addition, this study presents the outcome of patients with enchondroma and low grade chondrosarcoma of the long bones who were treated with curettage (intralesional surgery).

The investigators retrospectively review the records of 65 patients with enchondroma and 37 patients with low grade chondrosarcoma of the limbs treated by curettage between 1988 and 2014 in a single Institution.

Eligibility Criteria:
Inclusion Criteria:

* chondroma or low grade chondrosarcoma of long bones

Exclusion Criteria:

* chondroma or low grade chondrosarcoma of spine and pelvis
The Effects of Ketone Ester Supplementation During a 5 Week Live High, Train Low Altitude Training Camp

This study aims to investigate the effects of post-exercise and pre-sleep exogenous ketosis via oral ketone ester supplementation during a 5 week simulated altitude training camp.

Altitude training camps, where you train at sea level but live at altitude, have become a popular way for athletes to prepare for upcoming races or events. The main aim of such training camps is to benefit from the adaptations following prolonged hypoxic exposure (increased EPO concentrations leading to an increase in oxygen carrying capacity in the blood). Recently, ketone bodies have been shown to cause similar adaptations. Therefore, this study aims to investigate whether the combination of exogenous ketosis and an altitude training camp is more beneficial compared to an altitude training camp on its own.

Participants will follow a 5 week simulated altitude training camp where they spend 75 hours per week at altitude (2000-3000 meters), while taking ketone or placebo supplements after every training sessions and before going to sleep. During these 5 weeks, they will adhere to a prescribed training plan, consisting of 5 to 7 training sessions per week. Before, after and 1 week after the training camp, their exercise performance, EPO concentrations, hemoglobin mass and VO2max will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Physically fit and regularly involved in physical activity (2-5h per week)
* Good health status confirmed by a medical screening
* Non-smoking

Exclusion Criteria:

* Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise
* Any kind of injury/pathology that is a contra-indication for exposure to hypoxia
* Ongoing pregnancy or breastfeeding
* intake of any medication or nutritional supplement that is proven to affect exercise performance during the last month prior to the start of the study
* Involvement in elite athletic training at a semi-professional or professional level
* Exposure to altitudes higher than 1500 m during the 3 months prior to the start of the study
* Blood ferritin levels below 30 ng/mL
* Current participation in another research trial
* Any other argument to believe that the subject is unlikely to succesfully complete the full study protocol
Changes in Physician Performance Through Continuous Professional Development

The purpose of this study is to determine whether having physicians evaluate their management of certain diseases as part of board recertification results in improved patient care.

In the year 2000, the American Board of Internal Medicine introduced continuous professional development as part of its board recertification process. The purpose of these changes were to achieve the following goals:

* To improve the quality of patient care;
* To affirm the high standards expected of a self-regulating, accountable profession;
* To foster continuing scholarship and self-improvement;
* To offer diplomats a portfolio of credentials attesting to competence; and
* To add value to the health care system.

The most notable change in the new recertification process was the addition of practice improvement modules (PIMs). These modules require physicians to review how well they manage a particular chronic disease within their practice and to develop an improvement plan for their practice. In April 2005, it became a requirement that all internists complete a PIM as part of board recertification.

Currently, it not known whether having physicians evaluate their management of certain diseases as part of board recertification will achieve its intended goal of improving patient care. Therefore, the purpose of this trial is to assess whether practice improvement modules result in improved clinical performance.

The PIM selected for this study will focus on asthma. As PIMs seek to improve the quality of care within a practice, the unit of randomization in this study will be clinics (i.e., practices) within the Henry Ford Health System. We will enroll practicing, board-certified internists within the Henry Ford Medical Group (\~40 internists or 20 per arm). Clinics (\~16 or 8 per arm) will then be randomized to either complete the PIM or not complete the PIM. Participating internists at a site randomized to complete the PIM will be encouraged to work together to complete the asthma PIM. Participating internists at control sites will continue usual care and will not be asked to complete an asthma PIM.

Comparisons: We will assess differences in asthma care by prospectively surveying patients seen by physicians in the intervention group and control group following the intervention period. These analyses will be adjusted by the baseline characteristics of asthma patients seen by participating physicians.

Eligibility Criteria:
Inclusion Criteria:

* Previously board-certified in internal medicine
* Practicing general internist within the Henry Ford Medical Group

Exclusion Criteria:

* None