cyrilzakka/clinical-trials huggingface dataset:
Study of Physical Health for Women With Posttraumatic Stress or Depression

The purpose of this study is to obtain a better understanding of how stress is related to health risks.

Participants complete up to two study visits of approximately 3-4 hours each. The first study visit involves an interview about life experiences and emotions. If the participant is eligible for the second assessment, the average length of time between visit 1 and visit 2 will be 1-7 days. The second visit included physical measurements such as cholesterol and blood pressure, performing math and speaking tasks, and surveys to help us learn about healthy behaviors and emotions. No further follow-up of participants is conducted beyond the two study visits.

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal
* Must be able to speak and read English fluently

Exclusion Criteria:

* Specific medications and chronic diseases
* History of heart attack (myocardial infarction)
* Pregnant or given birth in last 3 months
* Peri-menopausal or post-menopausal
Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases: An Extension Study

An Extension Study to Evaluate the Safety of ArcBlate MRgHIFU in Patients with Painful Bone Metastases

Pain palliation of bone metastasis through localized denervation by thermal ablation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, who randomized into Sham control group and withdrew from CTP-BM-22-01 Study (i.e. main study) due to lack of efficacy.
2. Completed 14-day evaluation in main study.
3. Will provide completed and signed written informed consents.

Exclusion Criteria:

1. Pregnant women.
2. Subjects who do not meet any of the inclusion criteria in CTP-BM-22-01 Study (i.e. main study) after re-evaluation.
3. Determined by the investigator to be not suitable for the conduct of the study for any other reasons.
Sargramostim for Myeloid Dendritic Cell Deficiency

The study will determine whether administration of sargramostim will improve myeloid dendritic cell deficiency in various study groups, including healthy subjects and patients with chronic kidney disease, including those with kidney transplants.

The overall objective of this project is to study the ability of sargramostim to enhance mDC level and function, including subsequent stimulation of T cell responses, in various human subjects with demonstrated myeloid dendritic cell (mDC) and T cell deficiency.

Single center nonrandomized trial with an interrupted time series design involving measures on blood samples from three separate populations before and after administration of sargramostim.

The objective is to determine the safety and dose response of sargramostim administration in healthy participants and in patients with chronic kidney disease (CKD) and kidney transplants.

Additionally to determine whether reversal of mDC/T cell deficiency by sargramostim results in augmented T cell responses in these three groups.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years \< 80 years
* Absence of acute or chronic medical condition and taking no prescription medications (Project I)
* Stable native or transplant kidney function (Project II/III)

Exclusion Criteria:

* Age \< 18 or \> 80 years
* History of non-adherence to prescribed medications (Projects II and III)
* Active drug or heavy alcohol use (defined as \> 4 drinks/day)
* Pregnancy or breast feeding
* Active infection (bacterial or viral) or clinically significant infections within the past three months (e.g. those requiring hospitalization, or as judged by the PI, except for CMV viremia in Project III)
* Active malignancy (with the exception of excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or adequately treated pre-invasive cervical cancer in situ)
* Unstable cardiovascular status (angina, arrhythmias, congestive heart failure (CHF) etc...)
* History of liver disease (as defined by a diagnosis of uncompensated cirrhosis)
* History of lung disease (including moderate-severe Chronic Obstructive Pulmonary Disease (COPD), interstitial lung disease, or asthma)
* Known hypersensitivity to yeast-derived products
* Hemoglobin \< 10 g/dL and hematocrit \< 30%.
* Abnormal white blood cell count (WBC) count at baseline (\< 3 or \> 12 x 103 cells/mm3, except Project III)
* Treatment with WBC growth factors (G-CSF or GM-CSF) or immunosuppressive medications (tacrolimus, cyclosporine, mycophenolate, azathioprine, corticosteroids, chlorambucil, cyclophosphamide) within 4 weeks of study (erythropoiesis-stimulating agents will be allowed for Project II and immunosuppression for Project III)
* Treatment with lithium within 4 weeks of study
* History of arterial or venous thrombosis
Baricitinib in Symptomatic Patients Infected by COVID-19: an Open-label, Pilot Study.

There is no specific antiviral treatment recommended for COVID-19, and no vaccine is currently available. Baricitinib, an anti-Janus kinase inhibitor (anti-JAK) acting against JAK1 and JAK2. The drug was found capable to reduce or interrupt the passage of the virus into target cells, and to inhibit the JAK1- and JAK2-mediated cytokine release. The drug was licensed for the treatment of rheumatoid arthritis at the daily dose of 4 mg/orally, with excellent results in terms of clinical response and a good safety profile. Since baricitinib does not interact with antivirals due to its prevalent renal elimination, it may be used in combination.The evidence on the advantageous action of baricitinib on viral entry and cytokine outbreak constituted the rationale to perform a trial on patients with mild to moderate COVID-19 infection receiving baricitinib combined with antiviral therapy.

Study design. Interventional, open-label, 2-week, prospective trial of a cohort of patients with mild to moderate COVID-19 infection.

Objectives. Primary. To assess the efficacy of baricitinib combined with antiviral therapy in patients with COVID-19-related mild and moderate disease in terms of reduction of the percentage of subjects requiring ICU admission.

Secondary objectives. To describe the clinical findings in a cohort of symptomatic COVID-19-infected subjects; to investigate the role of CRP, IL-6, and TNFα levels as predictor of progression to ARDS; to assess the type and incidence of adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with mild to moderate COVID-19 infection
* Age \>18 years,
* Clinical diagnosis of COVID19 infection
* Patients should present fever, cough and myalgia and weakness and radiological findings of pneumonia.
* All patients should be willing and able to provide written informed consent prior to performing study procedures.

Exclusion Criteria:

* Age less than 18
* History of thrombophlebitis.
* Patient with latent tuberculosis infection (Quantiferon test).
* Pregnancy and lactation.
Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

Chlorthalidone will result in improved endothelial function compared to hydrochlorothiazide as measured by flow mediated vasodilatation.

This is a randomized, double-blind, crossover study to evaluate chlorthalidone and hydrochlorothiazide and their effects on endothelial function in hypertensive patients. Subjects will receive chlorthalidone 12.5 mg, hydrochlorothiazide 25 mg, and placebo each for 4 weeks with a 1 week washout between study periods. Sequence of study drugs will be randomized. Flow mediated vasodilatation will be measured at baseline and after each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 or older
* Diagnosis of hypertension
* Current blood pressure \> 120/80 mm Hg

Exclusion Criteria:

* Use of a thiazide-type diuretic within the last 1 month
* Known allergy to any study medications
* History of gout or hyperuricemia
* SCr \>/= 1.8 mg/dl or CrCl \< 25 ml/min
* Pregnancy or breastfeeding or planning to become pregnant during study period
* Dementia or cognitive impairment
* Hypokalemia
* Acute coronary syndrome or stroke within 6 months
* Current use of sildenafil, tadalafil, or vardenafil
COVID-19 and Hereditary Metabolic Diseases

No additional risk factors have been identified in patients with Inherited Metabolic Diseases (IMD) for contracting or presenting complications of COVID-19 compared to the general population. Yet, IMD patients have cell/tissue alterations that could constitute a potential direct or indirect target for the virus. We do not know the impact of this infection on patients suffering from MHM, nor the possible effect of specific treatment of MHM on the evolution of COVID-19.

This study will collect French IMD patients having or having had COVID-19 infection. The main objective is to estimate among IMD patients contracting COVID-19 the frequency of disease aggravation or metabolic decompensation.

The secondary objectives will be : a. to evaluate the incidence of COVID-19 diagnosed in a given group of IMD when the number of patients with this IMD is known (Urea Cycle Deficiency, Gaucher Disease). b. to evaluate the impact of IMD on the and severity of COVID-19 infection


Eligibility Criteria:
Inclusion Criteria:

* Child or adult patient with a diagnosis of IMD
* Symptomatic or asymptomatic patient tested positive for COVID-19 (PCR and/or serology)
* Symptomatic patient non tested but with strong clinical suspicion for COVID-19
* Patient affiliated with the health insurance

Exclusion Criteria:

* inability to receive informed information
* Persons deprived of liberty
Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds

Platelets are a component of blood, which contain factors which can enhance wound healing. This study proposes to evaluate the clinical response of laugh lines treated with a concentrated preparation of the subject's own platelets injected into or under the skin by taking serial photographs of the subject's face over a 12 week period. Also, the same preparation will be injected into or under the skin of the arm near the elbows, and serial biopsies will be taken over a 12 week period.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults
* aged 25- 75 years
* with moderate to severe nasolabial folds

Exclusion Criteria:

* pregnant
* allergy to local anesthetics
* history of bleeding disorder
* active infection at the treatment site
* injectable filler in the nasolabial folds within past year
Prognosis Value of Bioimpedance Analysis (BIA) Phase Angle at Admission in Intensive Care Unit (ICU) Patients

Critically ill patients feature a loss of fat-free mass (FFM) up to 440 g/day, which is associated with increased morbidity and prolonged recovery. In several clinical conditions, FFM or phase angle (PhA)derived from BIA have been associated with clinical outcome. However, solid data to support this association in ICU patients are lacking. Only one retrospective study of 51 ICU patients with acute respiratory failure correlated loss of active cell mass with mortality. In a pilot study performed in 55 ICU patients, the investigators observed that five kHz BIA PhA was significantly related to SOFA (r=0.38, P=0.03). The relation between PhA and mortality remains to be determined in ICU patients.

Classic ICU validated severity scores (e.g. Acute Physiology and Chronic Health Evaluation (APACHE), Sequential Organ Failure Assessment (SOFA), Simplified Acute Physiology Score (SAPS)) and recent nutritional scores have been developed to foresee the clinical outcome of ICU patients. Most of these scores are time consuming and suffer some degree of discriminative power (i.e. APACHE II and SAPS II are not validated in cardiovascular surgery patients).

PhA is reflecting intracellular status: altered intracellular water (ICW) to extracellular water (ECW) distribution is suggested by low PhA. PhA measurement does not require anamnestic parameters, body weight, and lab tests. It could easily, accurately and repeatedly measured at bedside. PhA has been correlated with the disease prognosis in HIV infection, hemodialysis, peritoneal dialysis, chronic renal failure and liver cirrhosis patients. These studies suggest that PhA may be useful in determining increased risk of morbidity in the ICU.

Computerized tomography (CT) images targeted on the 3rd lumbar vertebrae (L3) could accurately measure FFM13 and predict survival in cancer patients. Body composition evaluation by CT presents great practical significance due to its routine ICU use in the initial diagnosis or follow-up. The usefulness of measuring FFM with L3-targeted CT has never been evaluated in ICU patients.

Therefore, the investigators aim to conduct an international multicentre prospective observational study in ICU patients to assess the prognosis value of BIA PhA at admission, and to compare the performances of BIA and L3-targeted CT for FFM measurement.


Eligibility Criteria:
Inclusion Criteria:

* equal or more than 18 years
* expected ICU length of stay of more than 48 hours
* no readmission within the 48 hours following ICU discharge
* no Implanted Cardiac Devices
* no pregnancy or lactation
* affiliated to health insurance regimen
* informed consent by patient or next of kin.

Exclusion Criteria:

* age below 18 years
* expected ICU length of stay \<48 hours
* readmission within the 48 hours following ICU discharge
* Implanted Cardiac Devices
* pregnancy or lactation
* non affiliated to health insurance regimen
* no informed consent by patient or next of kin.
Impact of Advance Care Planning on Care for Patients With Advanced Heart Failure

Aims: Advance care planning (ACP) is considered to be one of the most promising interventions to enable patients with life limiting illnesses to receive treatment at the end of life (EOL) according to their own preferences and to promote EOL conversations between patients and their health care providers. Through a 2-arm randomized controlled trial (RCT) of patients with Class III and IV heart failure (New York Heart Association Functional Classification), we propose to assess:

1. Whether patients in the ACP arm have a greater likelihood of receiving EOL care consistent with their preferences as stated in the latter of the last ACP document or the last patient interview, compared to patients in the control arm.
2. Heath care costs during study duration between patients in ACP and control arms.
3. Patient's understanding of own illness and their participation in decision making between the ACP and control arms.
4. Patient's quality of life, anxiety and depression between ACP and control arms.

Methodology: A total of 254 patients with advance heart failure will be randomized to receive intervention (ACP arm; N=127) or usual care (control arm; N=127).

The RCT will be conducted at the National Heart Centre and Singapore General Hospital. Patients in both arms will be followed for one year or till death, whichever is earlier, and interviewed every 4 months during this duration.

Clinical Significance: If benefits of ACP are shown to add value through this trial, then this study will help to promote acceptance of ACP among patients and health care providers across Singapore and elsewhere.


Eligibility Criteria:
Inclusion Criteria:

Patient participant:

* Patients must be 21 years old or older and must be diagnosed with advanced heart failure (New York Heart Association Class III and IV). Patients must be aware of their diagnosis
* Caregiver/Decision-maker participant: Subject must be 21 years old or older Participant must be either

  * appointed substitute decision maker or
  * most likely to be substitute decision maker for patient (if patient were to lose decision-making capacity)

Exclusion Criteria:

* Patient participant: Patients must not have any psychiatric or cognitive disorders
* Caregiver/Decision-maker participant: Cannot be a maid or foreign domestic worker
Social Media Indoor Tanning Study

The purpose of this research is to develop a social media delivered intervention to reduce unprotected sun exposure in young adults with a history of tanning.

We will use social marketing theory and a user-centered design approach to develop a social media intervention that engages young adults with a history of tanning to practice sun safety behaviors. We will incentivize young adults who have a history of tanning to create social media posts that encourage their peers to engage in sun safety. Focus groups of tanners guided the development of the intervention. Investigators will conduct a pilot feasibility trial where participants will be randomized to a condition in which they are incentivized to create sun safety social media messages to be posted on a sun safety social media account or a condition in which they are incentivized to create social media messages about how to use technology to support healthy lifestyle behaviors to be posted on a health technology social media account. The intervention will last 4 weeks. Feasibility outcomes include recruitment, retention, acceptability, participation, social media message engagement (likes, comments, shares), persuasive impact of messages, unprotected sun exposure, sun protection, and tanning behavior. This work will inform a fully powered randomized trial testing the efficacy of this intervention.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-30
* Tanned indoors or outdoors at least once in the past year
* Intends to tan indoors or outdoors this summer
* Daily user of any social media platform

Exclusion Criteria:

* No smartphone
* Does not use a social media platform daily
* Lives in a state with an average temperature \<75 degrees in May
* Inability to provide consent due to mental illness or a cognitive impairment
* Non-English speaking
* Prisoner
Improvement on Diagnosis of Fetal Congenital Heart Disease Based on Multi-center Collaboration in China

The objective of this study is to improve the diagnosis level of fetal congenital heart disease by the multi-center collaboration in China.

Our center has constructed multi-center collaborative network in 2013, so far which contains more than 170 maternal and child health care hospitals throughout the whole of China. This is a multi-center-based study to improve the integral diagnostic level of fetal congenital heart diseases by fetal echocardiography. Sixty pregnant cases (18-45 years) whose fetuses with heart abnormalities will be recruited in a successive manner from every center every year. Cases are gravidas with fetal congenital heart disease diagnosed by echocardiography in 16th-24th of gestational weeks. Every center will upload the echocardiography materials and the diagnostic reports so that another two experienced echocardiography physicians confirm the diagnosis based on these materials in a double-blinded method. In addition, the golden standard of congenital heart disease depends on the autopsy, heart and vascular casting after abortion and operation after birth. The investigators will provide the report about the rate of missed diagnosis and misdiagnosis and the periodical training on fetal echocardiography for every center every half an year. Only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. Study participants will be asked for their informed consent.

Eligibility Criteria:
Inclusion Criteria:

* 1.Gravida with singleton pregnancy with congenital heart disease taking fetal echocardiography in 16th-24nd of gestational weeks.
* 2.Complete pregnancy check in Beijing Anzhen Hospital and the hospitals contained in our multi-center network collaboration, and finally delivery or abortion in these hospitals.
* 3.Willing to cooperate with our study.

Exclusion Criteria:

* 1. Pregnant women with serious pregnancy complications and suffering from mental illness.
* 2.Pregnant women not willing to cooperate
Aspirin Resistance Following Coronary Bypass Surgery

Aspirin was proved to be the drug preventing vein grafts from closure and improving clinical outcome after coronary artery bypass surgery. It appears to be effective when being prescribed as early as first 48 hr. after the operation without increasing the incidence of bleeding complications. the exact effective dose is not known.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Coronary artery bypass surgery
* Patients who signed Informed Consent Form

Exclusion Criteria:

* Concomitant valve surgery or carotid surgery or off-pump surgery
* Need for anticoagulation therapy for any reason
* Another antiplatelet medications at least 7 days prior to surgery
* Contra-indication for aspirin treatment
* Thrombocytopenia / thrombocytopathia
* NSAIDs treatment for chronic medical conditions
* Reluctance to participate in the study
The Effect of Breastfeeding Support Provided Via Video-conferencing

A randomized control trial was made to examine the effects of breastfeeding support given by the video-conferencing method in the early postpartum period on anxiety, breastfeeding self-efficiency, and newborn outcomes.


Eligibility Criteria:
Inclusion Criteria:

Infants;

* Born between 37 and 42 weeks
* Without severe congenital anomalies

Mothers;

* A single live birth
* Were 18 years of age or over
* At least primary school graduate
* Did not have a disease that prevents breastfeeding
* Had internet access at home or on the phone
* Could speak and understand the Turkish language.

Exclusion Criteria:

* Situations that cause separation of mother and baby
* Hospitalization of the baby in intensive care
* Inability to answer 3 calls in a video call
* They were determined as those who could not be reached during the home visit for the first and second follow
Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair

Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair.

Endothelial dysfunction is central to the pathophysiology of vascular ischemia, bacterial sepsis, toxin-induced thrombotic microangiopathy, and antibody-mediated kidney transplant rejection and often manifest with renal failure. With each of these diagnoses circulating components of the complement cascade bind to endothelial cells and induce disease progression through anaphylactic cellular messaging, monocyte homing, and direct cell membrane disruption. In response to injury during embryologic development avascular metanephric blastema initiate endothelial differentiation. Although circulating hematopoietic progenitor cells have shown therapeutic promise they incorporate into renal vasculature at very low density.

Eligibility Criteria:
Inclusion Criteria:

* Only patients who have a clinical indication for kidney biopsy will be considered.
* All subjects will be at least 18 years of age and may be of any gender.
* Patients undergoing a native or kidney transplant biopsy will be considered.

Exclusion Criteria:

* Patients not undergoing a kidney biopsy will be excluded.
A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet

The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree AIT administered once daily in order to define a dose-range that would be suitable for at-home administration.


Eligibility Criteria:
Inclusion Criteria:

* A history of moderate to severe birch pollen allergy
* Use of symptomatic medication for treatment of birch pollen allergy
* Positive skin prick test to birch extract
* Positive specific IgE against Bet v 1

Exclusion Criteria:

* Overlapping perennial allergies
* History of uncontrolled asthma within the last 3 months
* FEV1 \< 70% of predicted value in adults or FEV1 \< 80% of predicted value in adolescents
* Previous or ongoing treatment with immunotherapy