cyrilzakka/clinical-trials huggingface dataset:
The Safety, Efficacy, and Tolerability of Microbial Ecosystem Therapeutic-2 in People With Major Depression and/or Generalized Anxiety Disorder

This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety and other symptoms of depression, such as sleep and anhedonia.

This study will measure the effects of MET-2 on symptoms of depression and anxiety using pre- and post-treatment scores for overall depression and anxiety and other symptoms of depression, such as sleep and anhedonia.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent.
2. Not pregnant
3. Willing to participate in follow up as part of the study
4. Diagnosis of MDD and/or GAD by MINI
5. Current depressive episode with a MADRS score of ≥15 or Current GAD episode with GAD-7 score of ≥8.
6. Able to understand and comply with the requirements of the study
7. Able to provide stool and blood samples.

Exclusion Criteria:

1. History of chronic diarrhea
2. Need for regular use of agents that affect GI motility (narcotics such as codeine or morphine, agents such as loperamide or metoclopramide)
3. Colostomy
4. Elective surgery that will require preoperative antibiotics planned within 6 months of enrolment
5. Pregnant, breastfeeding, or planning to get pregnant in the next 6 months
6. Any condition for which, in the opinion of the investigator, the participant should be excluded from the study.
7. Current use of any antidepressant/antianxiety drug (eligible to participate after a 4-week washout period)
8. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
9. History of alcohol or substance dependence in the past 6 months
10. Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
11. Use of any type of laxative in the last 2 weeks.
12. Consumption of products fortified in probiotics
13. High suicidal risk, as measured by MADRS item 10 score more than 3 (or 4)
14. Current psychotic symptoms
15. Bipolar Depression
16. History of epilepsy or uncontrolled seizures
17. Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. acquired immune deficiency syndrome \[AIDS\], lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants)
18. Unstable medical conditions or serious diseases/conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
19. The use of natural health products (Natural health products \[NHPs\]; e.g. St. John's Wort, passion flower, etc.) that affect depression
20. History of Electroconvulsive therapy (ECT)
Palliative Expeditiously Adaptive Quad Shot Radiation Therapy (PEAQ-RT)

The investigators propose evaluating the feasibility of using the novel cone beam computed tomography (CBCT)-guided Ethos system to deliver expedited, adaptive Quad shot radiation for the purpose of palliative radiation of patients with advanced head and neck cancers or patients with a history of any malignancy experiencing current head and neck lesions. Quad shot radiation was selected as the palliative regimen of choice given its low toxicity profile, well published efficacy in palliation, frequent usage in the US for palliation of head and neck cancers, and safety in the setting of re-irradiation. The use of the Ethos platform to perform online adaptive radiation planning and delivery remains novel and untested. The Ethos system would be used to consolidate CT simulation, replanning, and treatment for Quad shot patients receiving treatment with the benefit of reduced patient travel and a reduction in the unwanted delay between Quad shot cycles. The goal of this pilot study will be to evaluate the feasibility of the Ethos system to eliminate the need for a CT simulation for cycles 2 and 3 of Quad shot radiation.


Eligibility Criteria:
Inclusion Criteria:

* History of a head and neck malignancy or history of any malignancy experiencing current head and neck lesions suitable for radiation. Past history of radiotherapy is allowed for inclusion and brain metastases are allowed for inclusion.
* Deemed medically fit for Quad shot radiation by treating physician
* At least 18 years of age.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

-Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol PI, documentation of this exception is sufficient in lieu of pregnancy test.
Steroid-reducing Effects of Crisaborole

Atopic dermatitis, or eczema, is a chronic skin condition affecting many children. Crisaborole is a non-steroid topical medication which is FDA approved for children aged 2 and older for eczema. This research study seeks to investigate whether crisaborole reduces topical steroid use in children with atopic dermatitis.

Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children. Twice daily topical corticosteroid (TCS) use over several weeks is recommended for active inflammatory disease. Side effects of TCS range from cutaneous atrophy to hypothalamic-pituitary-adrenal axis suppression. Steroid phobia and misunderstanding often lead to poor compliance and inadequate disease control. Topical calcineurin inhibitors (TCIs) are currently recommended as steroid-reducing agents, especially on sensitive areas such as the face and skin folds. However, TCis are associated with burning reactions and come with black box warnings.

Crisaborole (Eucrisa), the newest topical prescription option for AD, is a phosphodiesterase-4 inhibitor with demonstrated efficacy in patients aged 2 and older with mild to moderate AD. Given the good tolerability and favorable safety profile, crisaborole makes for an alternative topical option to its predecessors. However, corresponding data are lacking. It would be of great interest to patients, patients' families and providers if crisaborole can be shown to reduce the amount of TCS necessary for control of AD. The investigators therefore propose a proof-of-concept study to investigate whether crisaborole can serve as an effective steroid-reducing agent.

Eligibility Criteria:
Inclusion criteria:

* Children aged 2 or older (\<18).
* Diagnosed with atopic dermatitis.
* At baseline, AD is mild to moderate (score of 2 \[mild\] to 3 \[moderate\]) on the Investigator's Global Assessment scale (IGA; scores range 0-4, higher indicates greater severity).

Exclusion criteria:

* Known allergy to a constituent of the studied products (crisaborole, vehicle, Aquaphor, topical steroids \[hydrocortisone 2.5% ointment and triamcinolone acetonide 0.1% ointment\]).
* At baseline, AD is severe (score of 4 \[severe\] on the IGA scale).
* Medical problems which interfere with completion of protocols in this study.
* Pregnant or lactating females. (Females who have experienced menarche will be required to take a urine pregnancy test.)
* Participant is enrolled in another research study.
* Participant or participant's guardian(s) are unable to follow instructions as required in this study.
Pizza Meal Challenge and Immunometabolism (PIMETA)

High salt intake is a major risk factor for cardiovascular events, including stroke, heart disease and kidney failure. Pizza is a popular salty food. In this exploratory pilot study, the effects of a pizza meal challenge on immunometabolism in healthy subjects will be tested.


Eligibility Criteria:
Inclusion Criteria:

- Healthy men and women

Exclusion Criteria:

* Severe, manifest illnesses in need of treatment
* Pathological lab results
* Inability to understand significance and scope of the study
68Ga PET/CT Imaging in Breast Cancer Patients

PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including breast cancer. This makes it a potentially imaging target for the detection and grading of breast cancer. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG in the same group of breast cancer patients.

PSMA has been confirmed to be over expressed in vascular endothelial cells of various malignant solid tumors, such as breast cancer and renal cancer, which can provide growth advantages for various cancers by cutting the signal molecules involved in angiogenesis. Positron emission tomography (PET) imaging using radiolabeled molecules targeting PSMA can detect a variety of non prostate cancer solid tumors such as breast cancer and glioma. According to previous studies, PSMA can detect primary and metastasis lesions of breast cancer patients, and has a higher uptake value in triple negative breast cancer and HER2 overexpressed patients. The uptake may be related to tumor grade.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients highly suggested by ultrasound or histologically confirmed;
* 68Ga-P16-093 PET/CT and 18F-FDG within two weeks;
* signed written consent.

Exclusion Criteria:

* known allergy against PSMA;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Multisensorial Information's Treatment in Autism Spectrum Disorder

Introduction:

Autism spectrum disorder is characterized by deficits in three functional domains: language and communication, social reciprocity, and the presence of restricted interests/repetitive behaviors. There's also deficits in social cognition. When having a face-to-face conversation, a listener not only hears what a speaker is saying, but also sees the articulatory gestures that accompany those sounds. Speech signals needs then a multisensory processing. Impairments in multisensory perceptual binding may be particularly relevant in ASD, given that hallmark features of the disorder include difficulties in speech, communication, and social interactions.

Objectives:

The investigator suggest that atypical multisensory processing in ASD may have an impact on speech perception and social processing.

Aims:

Methods:

This pilot study measures free recall scores in 3 lists of words presentation after 30 minutes. In the first condition (CI) words are only listening. In the second condition (CII) words are associated with a picture of a mans face. In the third condition (CIII) words are associated with a video of a man speaking. Three lists are homogeneous form words characteristics (lexical frequency, emotional valence norm, imageability). Participants were 7- to 13-year-olds typically developing children (TD) (N = 19) and ASD children (N = 19).

The investigator would create some new tools for exploring the treatment of a social information. These tools should be the closest of a ecological social interaction.


Eligibility Criteria:
Inclusion Criteria:

* Boy or girl,
* 7 - 13 years,
* Presenting a diagnosis DSM IV of disorder(confusion) of the autistic spectre: detected by the scale(ladder) ADI ( Autism Diagnostic Interview) or by TEENAGERS (Autism Diagnostic Observation Schedule): typical autistic. These patients do not answer the diagnosis of psychosis according to Kiddie-SADS,
* Upper total IQ or equal to 50, examination dating less than year before the inclusion,
* French-speaking children,
* Signature of the informed consent by the parents(relatives) and the child,
* Membership to the Social Security.

Exclusion Criteria:

* Genetic, neurological or neurosensory pathologies,
* Diagnosis of intrusive disorder(confusion) of the not specified development: TED our,
* The patients will not be included who would participate in a program or a study of reeducation in the social fitnesses.
Scalp Sampling for Fetal Surveillance

The purpose of this study is to compare lactate and total acid-base status in fetal scalp blood with lactate and total acid-base status in maternal blood and amniotic fluids to provide information on how lactate and base deficit correlates with scalp samples.

Furthermore, the investigators want to study whether angiogenic factors in fluids above may be a possible marker of asphyxia during labor.


Eligibility Criteria:
Inclusion Criteria:

* All deliveries eligible for fetal blood sampling

Exclusion Criteria:

* Non Swedish speaking
* Those who decline to participate in the study
Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration

This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010).


Eligibility Criteria:
Inclusion Criteria:

* After completion of the preceding study (A5751010)

Exclusion Criteria:

* Serious heart, kidney and/or liver disease
* Diabetic retinopathy
Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma

Treatments-related cardiotoxicity is a critical issue in long term lymphoma survivors, particularly at young age, and its early identification is important to prevent clinically relevant cardiac events. Complete echocardiographic assessment including 2-dimension global longitudinal strain (2D-GLS), seems to be an effective tools in detecting preclinical systolic changes to the cardiac function even when the ejection fraction is preserved. The aim of Cardiocare study is to investigate early detection of subclinical chemo and radiation-induced changes in left ventricular function using 2D-GLS.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of Hodgkin Disease (HD) or Primary Mediastinal B-cell lymphoma (PMBCL) or diffuse large B-cell lymphoma (DLBCL)
* Disease requiring treatment with anthracycline containing regimen only (cohort A) or anthracycline containing regimen followed by mediastinal radiotherapy (cohort B)
* Written informed consent

Exclusion Criteria:

* Age \> 70 years
* Unable to perform anthracyline containing regimen
* Previous treatment with mediastinal radiotherapy
* Kidney failure (defined as creatinine x2 UNL) or liver failure (defined as AST and ALT x2 UNL)
* ECOG PS \> 2
* Echocardiographic acoustic windows not suitable for strain evaluation
* Any other conditions or situations preventing patients to sign informed consent
Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures

Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar plate fixation of distal radius fractures with regard to the forearm pronation strength. During the early recovery period of 3 months an improvement of pronation strength and functional scorings was hypothesized for the PQ repair when compared to no repair.

Randomization of the patients in two groups ( PQ repair and no repair) and follow-up examinations after 6 and 12 weeks included bilateral isometric pronation strength measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue scale (VAS)

Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar plate fixation of distal radius fractures with special regards to the forearm pronation strength. During the early recovery period of 3 months an improvement of pronation strength and functional scorings was hypothesized for the PQ repair when compared to no repair.

Therefore the patients are randomized to group A = PQ repair and group B = no repair. Follow-up examinations after 6 and 12 weeks are scheduled included bilateral isometric pronation strength measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue scale (VAS)

Eligibility Criteria:
Inclusion Criteria:

* isolated, closed fractures of the distal radius
* fractures type A2 to B2 according to the AO fracture classification system
* primary volar locking plate osteosynthesis within 7 days after trauma

Exclusion Criteria:

* concomitant fractures of the affected upper extremity
* intra-articular distal radius fractures ( type C)
* concomitant neurovascular injuries
* preexisting neurological illnesses
* initial external fixation
Nudges to Improve Health Behaviors That Limit COVID-19 Spread

This investigation is a randomized intervention trial that evaluates behavioral nudges (BN) to increase hand washing behavior and subsequently reduce COVID-19 spreading to a targeted high-risk patient population based in Wisconsin.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Provision of signed and dated informed consent form
* Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
* Has at least 1 risk factor associated with COVID-19 documented in their electronic medical record
* Followed by (i.e., actively receiving care) from targeted MCW specialties (Internal Medicine, OBGYN, Surgery)
* Access to necessary resources for participating in a technology-based activities (i.e., internet access + mobile phone or computer to complete online survey)
* Maintains a personal address where study materials can be shipped and where participant lives full time

Exclusion Criteria:

* Previous COVID-19 diagnosis or positive COVID-19 test result documented in their electronic medical record
* Current participation in another treatment or intervention study associated with COVID-19
* Previous documented Obsessive-Compulsive Disorder diagnosis in their electronic medical record
* Non-English speaker
* Patients hospitalized or incapacitated at onset of potential enrollment
* No access to electronic platform with internet (e.g., smartphone, tablet, computer)
A Double-blind Randomized Placebo Controlled Clinical Trial Evaluating Effect of Chlorhexidine Gluconate 2% Cloth vs Placebo Cloth Baths on the Incidence of Central Line-Associated Blood Stream Infections in Outpatient Hematopoietic Stem Cell Transplant Patients

This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after hematopoietic stem cell transplant in prevention of central line associated blood stream infections. Half of the participants will use 2% CHG washcloths and other half will use placebo washcloths.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the University of Chicago Hematopoietic Stem Cell Transplant Unit for transplant
* Age 18 and up

Exclusion Criteria:

* Experienced an allergy or rash related to use of chlorhexidine washcloths or other chlorhexidine products
* Extensive open wounds
A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin

The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants.

The study is seeking the following participants:

* Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests.
* Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds).
* Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female Japanese subjects aged 18 years or older
* Body Mass Index (BMI) of 16-32 kg/m2; and a total body weight \>45 kg (100 lb)

Exclusion Criteria:

* Evidence or history of clinically significant disease or medical conditions
* Positive urine drug test or history of alcohol abuse or illicit drug use.
Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

Hypertension is the most common complication in patients with diabetes nephropathy. Strengthening blood pressure and blood sugar control is the basic treatment for patients with diabetes nephropathy. Angiotensin receptor blocker (ARB) and angiotensin-converting enzyme inhibitor (ACEI) are the first line drugs recommended in domestic and international guidelines for diabetes patients to control hypertension. As a new ARB drug, azilsartan has been found to have better antihypertensive effect than other ARB drugs. However, due to the limited sample size and study time, azilsartan has no significant advantage over other ARB drugs in terms of renal protection effect, and has not been systematically studied in diabetes nephropathy population. This study is intended to evaluate the effect of azilsartan on proteinuria and blood pressure improvement in patients with diabetes nephropathy and hypertension through clinical randomized controlled study, so as to accumulate evidence-based evidence of azilsartan in the comprehensive management of heart and kidney protection in this group of people, and promote the development of comprehensive treatment for patients with metabolic disease and renal injury combined with hypertension. This study will compare the advantages and disadvantages of azilsartan and classical ARB drug losartan potassium in terms of proteinuria, blood pressure control and renal function protection in patients with diabetes nephropathy and hypertension; We propose that the main indicator is the change of urinary albumin/creatinine ratio relative to the baseline, and the secondary indicator is the change of 24-hour urinary protein relative to the baseline; Change of blood pressure relative to baseline; Renal function, electrolyte and blood glucose.


Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 70;
* Type 2 diabetes diagnosed according to American Diabetes Association guidelines has stable blood sugar control, and glycosylated hemoglobin is less than 7.5%;
* The patient's blood pressure Systemic Blood Pressure (SBP) \>140 or Diastolic Blood Pressure (DBP) \>90 mmHg, has not taken antihypertensive drugs or is taking non-ARB/ACEI antihypertensive drugs;
* Urine albumin/creatinine ratio\>300mg/g.

Exclusion Criteria:

* Type 1 diabetes;
* The patient is considered as non-essential hypertension, such as hypertension caused by renal hypertension or endocrine disease;
* Contraindications of ARB drugs, such as pregnancy status, bilateral renal artery stenosis, allergy to ARB drugs and their excipients;
* It is expected that dialysis treatment will be carried out within 6 months;
* Patients with malignant tumors;
* Patients with mental illness;
* The researcher believes that others are not suitable for this study.