cyrilzakka/clinical-trials huggingface dataset:
Wellness Through Mobile Health

This pilot project will evaluate the potential of an affordable smartphone app to improve users' mental well-being.

The goal of this pilot study is to evaluate whether a smartphone wellness application has the potential to improve anxiety and depression symptoms in people who otherwise would not have access to behavioral health care. In this pilot study, participants will include patients who present to an orthopedic specialist for chronic musculoskeletal pain and who also endorse elevated anxiety and/or depression symptoms. Patients who otherwise do not have access to adequate behavioral health resources will be eligible to enroll in the study. Through the study, participants will have two months of full access to a commercially available smartphone wellness application which offers resources such as cognitive behavioral therapy via an artificial chatbot, mindfulness and deep breathing training, and text-based access to a human well-being coach. Participants' baseline and 2-month follow-up anxiety and depression symptoms will be compared. Qualitative feedback regarding the user experience with the smartphone application will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Presentation to an orthopedic specialist at the Washington University Living Well Center for a musculoskeletal condition
* Score of 55 or higher on Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and/or Anxiety measures
* Advised to consider behavioral health treatment as a component of comprehensive care for a musculoskeletal condition
* Cannot or does not wish to pursue in-person behavioral health treatment (e.g., with the center psychologist)

Exclusion Criteria:

* No access to an electronic device (such as a smartphone) to download and use the wellness app and to electronically complete follow-up self-reported health measures
* In active mental health crisis (e.g., suicidal/homicidal thoughts, psychosis) which would require an escalated level of care
* Initiating care with a behavioral health specialist
Prospective Study of Antenatal Diagnostic Criteria for Digestive Complications of Gastroschisis

Gastroschisis is a rare congenital malformation consisting in a right para-umbilical defect of the abdominal wall leading to an evisceration of the abdominal content. About 25% of the cases are associated with intestinal malformation, leading to an increase in peri-natal morbidity and mortality. No prospective study has been able to definitely describe predictive factors for complicated gastroschisis on prenatal ultrasound examinations.

The aim of the current study is to prospectively look for US prenatal features predictive of complicated gastroschisis, on a national multicentric cohort.

Patients will be included during the 22 weeks of amenorrhea (WA) ultrasound examination, and pre- and postnatal clinical data will be recorded up to the 6th months of the child.

Data will then be analysed and compared in the groups of simple or complicated gastroschisis, in order to define pre-natal prognostic factors, to correlate them with specific prognosis, and to might better determine specific strategies for better care of these patients.


Eligibility Criteria:
Inclusion Criteria:

Every volunteer pregnant woman, in whom an antenatal ultrasound diagnosis of gastroschisis has been carried, before the end of 22 weeks of amenorrhea.

Exclusion Criteria:

Lack of informed consent or refusal of the person to participate in study
Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

This is a trial to demonstrate the safety and effectiveness of the Mitroflow Aortic Heart Valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Bioprosthetic heart valves offer several advantages over mechanical valves, the most important being freedom from the need for anticoagulation and a low rate of thromboembolic events. Pericardial bioprosthetic valves are known to have hemodynamic performance superior to porcine valves, and the excellent hemodynamic performance of pericardial valves is particularly relevant in patients with a small aortic root. However, long-term durability continues to be the main concern with use of pericardial valves. Although the first generation pericardial valves were withdrawn from the market due to poor durability, further research has indicated that structural failure of early pericardial valves was due to tissue preparation techniques and design failure rather than the pericardial tissue.The unique desing of the Mitroflow Aortic Heart Valve may provide superior hemodynamic performance over other tissue valves.

Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female 18 years old or older
* The subject or subject's legal representative is willing to sign the informed consent
* A bioprosthesis is the most suitable alternative for replacement of a dysfunctional or diseased native aortic valve or prosthesis accord gin to the current medical practice for valve selection at the center
* The subject is able to return for all follow-up evaluations for the duration of the study (i.e. geographically stable

Exclusion Criteria:

* The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position
* The patient requires a double or triple valve replacement
* The patient had a Mitroflow Heart valve during the clinical study but who then had the valve explanted
* The patient has active endocarditis
* The subject is or will be participating in a concomitant research study of an investigational product
* The subject is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
* The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient the patient is pregnant or lactating
Impacts of Nitrogen Deposition in the Natural Environment on Pollen Allergy in Belgium

The investigators want to study the effect of environmental nitrogen enrichment on the allergy burden in pollen-sensitized subjects.

The investigators want to study allergen-specific IgE reactivity from a cross-sectional sample of pollen-allergic patients (and negative controls) against environmental and experimental pollen samples. Following aspects will be compared:

* To study the basophil degranulation with different amounts of pollen on fresh patient-derived basophils, to determine the concentration of pollen needed to degranulate 5% (EC5), and 50% (EC50) of basophils.
* To study he overall intensity (quantitative), as well as IgE-mediated hyper- or hyporecognition of different fragments in the pollen samples (qualitative) in a subset of patients.
* To associate allergic rhinoconjunctivitis and food-pollen syndrome related symptoms with reactivity to different pollen samples.

Eligibility Criteria:
Inclusion Criteria:

* Positive skin prick test for grass and/or birch pollen

Exclusion Criteria:

* Desensitization therapy during the last two years
Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells

The purpose of this study is to investigate the potential use of Wharton's Jelly Mesenchymal stem cells (WJ-MSCs) for treatment of patient diagnosed with Corona Virus SARS-CoV-2 infection, and showing symptoms of COVID-19.

COVID-19 is a condition caused by infection with Coronoa Virus (SARS-CoV-2). This virus has a high transmission rate and is spreading at very high rates. causing a worldwide pandemic. Patients diagnosed with COVID-19 and confirmed positive with the virus, will be given three IV doses of WJ-MSCs consisting of 1X10e6/kg. The three doses will be 3 days apart form each other.

Patients will be followed up for a period of three weeks to assess the severity of the condition and measure the viral titers.

Eligibility Criteria:
Inclusion Criteria:

COVID-19 positive according to diagnosis and clinical management of COVID-19 criteria.

Exclusion Criteria:

* Participants in other clinical trials
* patients with malignant tumors
* pregnant and lactating women
* co-infection with other infectious viruses or bacteria
* History of several allergies
* Patients with history of pulmonary embolism
* any liver or kidney diseases
* HIV positive patients
* Considered by researchers to be not suitable to participate in this clinical trial
* Chronic heart failure with ejection fraction less than 30%.
Doxorubicin, Paclitaxel, and Carboplatin in Treating Patients With Primary Stage III, Stage IV, or Recurrent Endometrial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin, paclitaxel, and carboplatin in treating patients who have primary stage III, stage IV, or recurrent endometrial cancer.

OBJECTIVES:

* Determine the response rate and duration of response in patients with primary stage III or IV or recurrent endometrial cancer treated with sequential doxorubicin, paclitaxel, and carboplatin.

OUTLINE: Patients receive sequential chemotherapy comprised of doxorubicin IV once every 2 weeks for 3 courses, followed by paclitaxel IV over 1 hour once weekly for 9 courses, and then carboplatin IV once every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven primary stage III or IV or recurrent endometrial cancer
* Bidimensionally measurable disease by x-ray, CT scan, MRI scan, or physical exam

  * Sole site may be within a previously irradiated area if documented disease progression since prior radiotherapy

PATIENT CHARACTERISTICS:

Age:

* Adult

Performance status:

* Karnofsky 70-100%

Life expectancy:

* At least 12 weeks

Hematopoietic:

* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin, SGOT, and alkaline phosphatase no greater than 1.5 times normal

Renal:

* Creatinine no greater than 1.8 mg/dL

Cardiovascular:

* Left ventricular ejection fraction at least 50%

Other:

* No active uncontrolled infection
* No greater than grade II neuropathy
* No other active malignancy
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior doxorubicin
* Greater than 6 months since prior paclitaxel, carboplatin, or other platinum compounds

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered

Surgery:

* Not specified
Health Effects of Grain Foods in Adults

This study will assess the effects of eating whole grain foods versus refined grain foods with different amounts of added sugar. It is hypothesized that a diet including grain products will have beneficial effects on taste hedonics, appetite, food/energy intake, body weight, blood pressure, acute and chronic glycemia and acute and chronic lipemia compared to customary diets controlling for added sugars, saturated fats and sodium.

This 16-week, randomized, controlled, parallel-arm, clinical trial will assess the effects of consuming four different categories of grain foods on taste hedonics, appetite, food/energy intake, body weight, and blood pressure as well as acute and longer-term glycemia and lipemia. It will also examine the effects of foods varying in grain/carbohydrate composition on the microbiome and microbiota functionality. One hundred and twenty adults will be recruited and randomly assigned to one of four intervention groups. These groups will be defined by the diets they are prescribed. All will be prescribed diets containing approximately 50%; 35% and 15% energy from carbohydrate, fat and protein, respectively. Grain foods will comprise 50% of the carbohydrate component (i.e., 25% of total energy). The grain foods will be assigned to one of four categories based on whole grain content and concentrations of added sugars. The grain foods meeting these criteria will have the following composition:

Group 1 - High Whole Grain, Low Sugar 6 servings of whole grain and \<13% energy from added sugars.

Group 2 - Low Whole Grain, Low Sugar 3 servings of whole grain and \<13% energy from added sugars.

Group 3 - High Whole Grain, High Sugar 6 servings of whole grain and \>13% energy from added sugars.

Group 4 - Low Whole Grain, High Sugar 3 servings of whole grain and \>13% energy from added sugars.

Detailed Study Design

The study measures and timing are outlined in the following table:

Screening Week 1 Baseline Week 2 Week 5 Week 8 Week 11 Week 14 Fasting Blood X X X XX MTT X X X Weight X X X X X X Body Composition X X CGM X X X Intake X Hedonics (palatability) X X X Appetite X X X Activity X X X Blood Pressure X X X X X X Microbiota X X X X X Compliance X X X X X MTT = Meal Tolerance Test; DXA= Dual-energy X-ray Absorptiometry; CGM=Continuous glucose monitoring

Eligibility Criteria:
Inclusion Criteria:

* male and female; 21 to 60 years old; Hemoglobin A1c concentration between 5.7 and 6.4%
* Prefer no use of medications, but if on medication, must have been on a stable dose for 3 months and plan to remain at the same dose for the duration of the trial.
* low customary intake of whole grain foods (less than 2 servings per day) and high energy from added sugar (greater than 10% energy).

Exclusion Criteria:

* Grain or dairy sensitivities or allergies or celiac disease; sensitivity or allergy to other foods that would result in refusal to eat a class of foods.
* smoker
* intended weight loss or gain during the study period; intended change of activity level during the study period
* use of blood thinners
* prior gastrointestinal surgery.
Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19

The purpose of this study is to assess the efficacy and safety of the administration of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients who are sick enough to warrant hospitalization, but not yet admitted to the ICU (prior to the onset of overwhelming disease including a systemic inflammatory response, sepsis, and/or ARDS).

This study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients.

After confirmation of COVID-19, patients that meet the eligibility requirement and provide informed consent will be randomized in a 2:1 ratio to anti-SARS-CoV-2 convalescent plasma (1 unit of approximately 250 ml) or placebo (1 unit albumin 5%, approximately 250 ml). We will evaluate the ability of anti-SARS-CoV-2 convalescent plasma vs. placebo control to decrease disease progression (measured by the WHO Ordinal Scale for Clinical Improvement) during the 28 days following administration to hospitalized, non-ICU patients. If patient is discharged from the hospital prior to Day 28, Day 28 assessment will be by phone.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age
* Hospitalized with COVID-19-related acute respiratory symptoms
* Initial COVID-19 severity status on the WHO Ordinal Scale for Clinical Improvement = 3 ("Hospitalized, no oxygen therapy) or 4 ("Hospitalized, on oxygen by mask or nasal prongs")
* Laboratory-confirmed COVID-19
* First signs of infection occurring no more than 14 days prior to enrollment

Exclusion Criteria:

* Receipt of pooled immunoglobulin in the past 30 days
* Contraindication to transfusion or history of prior reactions to transfusion blood products
* Admission to intensive care unit at any point during hospital course prior to enrollment
Primary Lymphedema and Mutation CELSR1 (Cadherin EGF LAG Seven-pass G-type Receptor 1)

The investigators will describe the expression of mutation CELSR1 with codon stop and amino acids substitution mechanism in primary lymphedema, in both clinical examination and imaging exploration

According to the literature, it seems that the mutation of the CELSR1 gene is associated with primary lymphedema.

Thus, the investigators have identified families with CELSR1 mutation with codon stop or animo acid substitution mechanisms among patients followed up in vascular medicine department, at Montpellier University hospital for primary lymphedema of lower limbs.

Among the mutation carriers, the investigators have collected the clinical examinations and imaging exploration results, realized systematically during the follow up of all the patient with primary lymphedema (venous Doppler, MRI of the lymphatic system, lymphoscintigraphy of the lower limbs, abdominal ultrasound), in order to search for a morphological and functional pattern associated with the mutation.

Eligibility Criteria:
Inclusion criteria:

* Patient followed up in vascular medicine departement at Montpellier University Hospital for primary lymphedema of lower limbs, who carries the CELSR1 mutation with codon stop or amino acids substitution mechanism.
* Relatives to the index case who carry the mutation for the segregation study.

Exclusion criteria:

* Patients who carry another mutation than CELSR1 responsible for primary lymphedema
* Syndromic form of primary lymphedema
* Patient not followed up at Montpellier University Hospital.
Clinical Study on Implicit Learning, Comorbidity and Stress Vulnerability in Chronic Functional Pain

The project investigates on the role of pain avoidance, comorbidity and stress response for the development of chronic somatic and visceral pain. We, the researchers at University Hospital Mannheim, assume that implicit operant learning of pain sensitization is a central mechanism of the process of pain becoming chronic, which is augmented by fear and by avoidance behaviour. Somatic and psychological comorbidity as well as stress factors are further promoting factors in chronic pain development.

Study 1: Implicit operant learning of sensitization and habituation in an experimental heat pain model will be investigated and compared in healthy controls, chronic pain patients with fibromyalgia, with and w/o visceral pain.

Study 2: Functional imaging of implicit operant learning of sensitization and habituation in an experimental heat pain model (same subgroups as in study 1).

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia according to American College of Rheumatology (ACR) criteria
* Visceral hypersensitivity according to ROME criteria
* Chronic pain according to International Association for the Study of Pain (IASP) criteria

Exclusion Criteria:

* Abnormal quantitative sensory testing
* Psychiatric or neurological anamnesis, except fear and depression
* Acute major depression
* Substance abuse
PRP vs HA Intra-articular Injections in TMDs

This clinical trial aims to compare the multidirectional mandibular mobility following the treatment of TMJ disorders with same-protocol intra-articular injections of PRP and HA. It is questioned whether there is direct clinical evidence of the superiority of PRP or HA in the injection treatment of TMJ disorders.

This study was designed as a two-arm equal-allocation clinical trial with a non-concurrent active treatment control. The study group consisted of consecutive patients receiving PRP injections into the TMJ cavities. The control group consisted of the same number of patients who received HA according to the same protocol. Controls were recruited consecutively, men and women separately, to maintain a consistent male-to-female ratio. The main condition for recruitment was the diagnosis of TMJ pain by a specialist in orthodontics or dental prosthetics and, on this basis, a referral for injection treatment. TMJ pain was diagnosed under the ICOP 2020 guidelines. The treatment was performed at the Maxillofacial Surgery Clinic in Kielce, Poland. The study group received PRP from peripheral venous blood of the elbow bend centrifuged at 160 revolutions per minute for 5 minutes with iFuge D06 (Neuation Technologies Pvt. Ltd, Gujarat, India). The control group received 2% hyaluronic acid Synocrom Forte (Croma-Pharma GmbH, Leobendorf, Austria). In both groups, 0.4 mL of the solution was injected per joint.

Eligibility Criteria:
Inclusion Criteria:

* ICOP 2020 diagnosis of TMJ pain;
* informed consent to participate in the study;
* the possibility of discontinuing the current treatment of the temporomandibular joints;
* generally accepted indications for injection therapy.

Exclusion Criteria:

* active cancer;
* hematopoietic system disease or bleeding diathesis;
* temporomandibular joint prosthesis;
* temporomandibular joint ankylosis;
* skin disease of the preauricular area of the affected side.
Food for Thought: Food Insecurity Screening in the Emergency Department

This study compares food insecurity disclosure rates in face-to-face interviews versus electronic formats, and explores caregiver preferences regarding screening modality and location, in a large, urban pediatric emergency department. Half of the participants were screened for food insecurity verbally, face-to-face by a research assistant, and half of the participants were screened electronically by a tablet.

Children are disproportionately affected by the rise in poverty rates in the United States, and economic hardships can compromise their development, negatively affect their overall health, and adversely affect their abilities to succeed in school and in life. Food insecurity (FI)-the limited or uncertain availability of nutritionally adequate or safe foods- while strongly associated with poverty, is an independent predictor of poor health outcomes for children.

The Emergency Department (ED) of academic medical centers often serves as a point of care entry for impoverished and high-risk families. Although there is a growing interest in the healthcare system's ability to address Social Determinants of Health (SDH), little is known about food insecurity in the pediatric ED. Additionally, there are limited data on how to implement FI screening into practice in a way that maximizes elicitation of social need, while assuring patient and family comfort.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Adult caregiver accompanying pediatric patient in the Children's Hospital of Philadelphia (CHOP) emergency department

Exclusion Criteria:

* Patient (child) in critical condition
* Patient (child) \>18 years of age
* Previously enrolled in study
Acute Neuroendocrine Response to Intravenous Infusion of Diclofenac Sodium

The effects of acute administration of non-steroidal anti-inflammatory drugs (NSAIDs) on the neuroendocrine regulation of hydro-electrolytic metabolism are not precisely known to date.

Although the mechanism by which NSAIDs favor the antidiuretic action of vasopressin (AVP) in the kidney has been partially elucidated, their influence on the mechanisms responsible for regulating its secretion are less known. The interactions between NSAIDs and natriuretic peptides are also not entirely certain.

The present pharmacological research study therefore aims to investigate, in a cohort of healthy subjects, the acute effects of intravenous infusion of diclofenac sodium on the neuroendocrine regulation systems of water and salt balance (i.e. the antidiuretic axis and the system of natriuretic peptides).


Eligibility Criteria:
Inclusion Criteria:

- Any adult healthy subject (with age 20-50 years old) not meeting any of the exclusion criteria listed below

Exclusion Criteria:

* BMI \< 18.5 kg/m2 or \> 25 kg/m2
* Any active pharmacological treatment
* Pregnancy or breastfeeding
* History of polyuria/polydipsia syndrome
* History of dysionia
* History of peptic disease
* History of gastrointestinal bleeding
* History of kidney disease
* History of heart disease
* History of asthma
* Known allergy to NSAIDs
* Any current acute medical condition