cyrilzakka/clinical-trials huggingface dataset:
aTBS for Treatment of Depression in AUD

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for improvement of depressive symptoms and drinking behavior in individuals with alcohol dependence. In this open label study, all participants will receive accelerated theta-burst stimulation.

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive procedure and an established technology. Research utilizing rTMS in patients with alcohol use disorder has shown some promising results. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters, such as using accelerated intermittent theta-burst stimulation (aiTBS), to reduce treatment times with possible enhanced efficacy with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.

Eligibility Criteria:
1. Participant aged 18-65 years old with diagnosis of alcohol use disorder.
2. Participant may also choose to or not to take pharmacotherapy during the study period.
3. Participant has tried at least one medication in the past that has not helped the alcohol use disorder. If participants are taking medication, they must be on stable psychotropic medication or psychotherapy for at least 6 weeks prior to the study with plans to continue throughout study enrollment.
4. Participant needs to be at least one week after last alcohol/ substance use and had the last drink within one year of the beginning of the study participation.
5. Participant endorses depressive symptom(s), indicated by a MARDS score \>= 20.
6. All participants must be assigned to a psychiatrist and agree to continue to be assigned to a psychiatrist throughout study enrollment.
7. Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
Microbial Study of Sublingual Immunotherapy Spray in Patients With Allergic Rhinitis

The incidence of allergic rhinitis (AR) in Chinese adults was reported to be as high as 24.1% and 16.8% in children. The current symptomatic treatment has the disadvantage of poor efficacy and cannot change the natural course of the disease. Allergen immunotherapy (AIT) is the only causative treatment approved by the WHO, bringing a new option to patients with allergic diseases. The quality of allergen preparations is critical to the diagnosis and treatment of the disease, emphasizing the need for standardized preparations, and AIT treatment in the early stages of the disease may change the long-term progression of the disease. Recent studies have reported that the microbiome of patients with different efficacy of desensitization therapy is different and may be correlated with the clinical symptoms of patients, but no prospective studies have been reported.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18-65 years).
* Patients with canis familiari/felis domesticus/alternaria alternata allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific IgE).
* Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual spray desensitization.

Exclusion Criteria:

* Patients who refused to accept specimen and questionnaire collection.
* Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
Prospective Registry to Assess the Cath Lab Percutaneous Coronary Intervention Long-term Outcomes: a Single Center

The registry study is to obtain the state of the percutaneous coronary intervention state treatment for coronary heart disease in the center of the first hospital of sun yat-sen unversity in a real world.

The registry study is to obtain the long-term outcomes of the percutaneous coronary intervention state treatment for coronary heart disease patients in the center of the first hospital of sun yat-sen unversity in a real world. The data are collected using an uploading system through internet.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving coronal artery angiography or percutaneous coronary intervention therapy

Exclusion Criteria:

* none
Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)

The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
* Enrolled in the main parent study.
* New ulcerative colitis diagnosis (mild/moderate) or Crohn's Disease diagnosis (moderate/severe) with colonic disease with or without terminal ileum disease, already started on oral corticosteroid or aminosalicylates for induction therapy at a time following diagnostic colonoscopy.
* Clinically responsive to induction medical therapy at enrollment (Crohn's Disease participants with a weighted pediatric Crohn's Disease activity index decrease of ≥ 17.5 points or ulcerative colitis participants with a pediatric ulcerative colitis activity index decrease of ≥ 15 points).
* Ability and willingness to comply with study procedures (e.g. stool collections) for the entire length of the study.
* Willing to provide consent/assent for the collection of stool samples.

Exclusion Criteria:

* Allergy to resistant starch or excipients.
* Co-existing diagnosis with diabetes mellitus.
* Treatment with another investigational drug or intervention throughout the study.
* Current drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of an individual or legal guardian to give written informed consent.
* Requirement for antibiotic therapy as part of standard Crohn's Disease therapy (i.e. those patients with penetrating disease as manifested by intra-abdominal abscess or perianal abscess).
* Requirement of oral antibiotics for other conditions (e.g. acne).
* Participant's microbiota does not produce butyrate in response to any of the assembled panel of resistant starch as measured through the Rapid Assay of an Individual's Microbiome (RapidAIM) evaluation following enrollment.
* Requirement of therapy other than oral corticosteroid / aminosalicylates for induction therapy.
* Patients diagnosed with Inflammatory Bowel Disease-Unclassified.
* Refusal to undergo follow-up colonoscopy as part of current clinical practice guidelines for Crohn's Disease standard of care.
FC Patch Comparator Study

The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteer aged 18-35, smokers 18-30

Exclusion Criteria:

* Contraindications for using hormonal contraceptives
Gut Feeling: Understanding the Mechanisms Underlying the Antidepressant Properties of Probiotics

Previous research has suggested that probiotics can improve depressive symptoms in patients with Major Depressive Disorder (MDD), particularly when used in addition to antidepressants. The aim of this exploratory pilot study is to improve the investigator's understanding of the mechanisms underlying these effects. This study will assess the effects of an 8-week double-blind placebo-controlled probiotic intervention on the gut microbiome, inflammatory marker levels, brain activity and neurotransmitter levels in patients with MDD and their relationship to changes in mood. This study will also recruit a group of demographically-matched healthy controls for gut microbiome comparison with the MDD group (non-interventional).


Eligibility Criteria:
Inclusion criteria for MDD participants:

* aged 18-55;
* currently in a depressive episode according to DSM-5 criteria, who are currently on antidepressant treatment but remain symptomatic (HAM-D17 score \>13);
* on stable treatment regimen of an approved treatment for at least 6 weeks;
* non-smokers;
* for participants willing to take part in the neuroimaging component: right-handed, no contraindications, non-claustrophobic, weight \<126kg;

Exclusion criteria for MDD participants:

* eating disorder, bipolar disorder, schizophrenia or psychotic symptoms;
* substance dependence in the past year, except for caffeine;
* active suicidal ideation;
* use of probiotic supplements in the past 2 weeks, or regular use of a probiotic;
* use of antibiotics in the past 12 weeks;
* history of allergic reaction to any of the components of BioKult;
* history of history of a systemic medical illness;
* current presence of significant GI problems or disease or history of major GI surgery;
* pregnancy or breastfeeding;
* following a dietary regimen unrepresentative of the general population (e.g. fasting or following a specific diet);
* regular/current use of antacids, proton pump inhibitors, laxatives, antidiarrheals;

Inclusion criteria for Healthy Volunteers:

* Aged 18-55;
* No current or historic presence of depression, other psychiatric disorder or substance dependence
* No history of a systemic medical illness;
* No family history of psychiatric disorder;
* Non-smoker;
* Not used probiotic supplements in the past 2 weeks, nor regular use of a probiotic;
* Not used antibiotics in the past 12 weeks;
* No current presence of gastrointestinal disease, or history of major GI surgery;
* No reported regular/current use of antacids, proton pump inhibitors, laxatives, antidiarrheals;
* pregnancy or breastfeeding;
* not currently following a dietary regimen or dietary restrictions unrepresentative of the general population (e.g. fasting or following a specific diet);
The Movement Imagery Ability in Patients With Familial Mediterranean Fever

Motor imagery is the mental representation of movement without any doing body movement. A main function of imagery is to aid the self-regulation of thoughts, feelings, and behaviours. Studies have shown to be more effective for individuals displaying a higher level of imagery ability when using imagery to improve motor and motivational outcomes, including self-efficacy. The aim of this study is to measure the movement imagery ability in patients with Familial Mediterranean Fever and compare it with healthy individuals.

Familial Mediterranean Fever (FMF) is an autosomal recessive disease characterized by recurrent and self-limited attacks of fever associated with abdominal, chest, and joint pain. Previous studies have shown that individuals with FMF are more limited in terms of physical function than the normal population, and depression and anxiety are more common in these individuals. Being a lifetime disease, quality of life, and mental health can be affected due to serious complications such as attack frequency, disease resistance, and sometimes amyloidosis. Mental imagery is the ability to imaging the movement without doing the physical execution of the movement. During the last years, mental imagery is used in clinical practice as a tool for the treatment of chronic pain. Pain differs in patients with rheumatic diseases. Stress is one of the predictors of pain in patients with FMF. Even if the frequency is variable when attacks happen they may affect patients physically and their mental health and the ability to cope. A main function of imagery is to aid the self-regulation of thoughts, feelings, and behaviors. To use imagery for motor and motivational outcomes firstly the imagery ability levels should be measured.

Eligibility Criteria:
Inclusion Criteria:

* having had at least one attack last year
* co-operated individuals

Exclusion Criteria:

* patients with a neurological disorder,
* diagnosed with cancer,
* cognitive impairment,
* having a primary pathology of the musculoskeletal system,
* having previous imagery practice,
* having an additional rheumatic disease
Evaluation of the Plasma Cell Disorders Panel on the BD FACSLyric™ Flow Cytometer

Multi-site, prospective performance study to determine equivalency between the investigational OneFlow PCD panel on the FACSLyric system versus the final clinical diagnosis.

Hematology laboratories rely on flow cytometry technology (in addition to classic hematological methods) to aid in screening, diagnosing, and monitoring patients with hematological disorders. High speed and broad applicability of flow cytometry allows for the diagnosis and accurate focus on targets. Currently, there are no general consensus panels being used; as a consequence, the leukemia \& lymphoma (L\&L) testing remains a single-vial antibody being used, with various in-house laboratory developed tests (LDTs) being used to test patient specimens. Furthermore, the analysis of flow cytometer generated data is not standardized and requires a high level of expertise/training for interpretation of complex data. Therefore, optimized and standardized immunostaining protocols for the diagnosis, classification, and prognostic sub-classification of hematological malignancies are needed.

This Investigational panel for plasma cell disorders is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations on the BD FACSLyric flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders.

Enrollment will occur at up to 8 investigational sites . Data will be acquired from Eligible remnant/leftover specimens on the BD FACSLyric flow cytometer and evaluated by site personnel and expert analysts .

The final diagnosis and the affected cell population will be determined by site standard of care .

Analysis of data will evaluate identification of normal vs abnormal cell population of the expert \& site analysts as compared to the final diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
2. Specimen with adequate volume (approximately 300 µL) to complete protocol tests.
3. Specimen is leftover BM from routine flow cytometry laboratory testing for plasma cell disorders, other hematological disorders, non-hematological tumors, and other hematological disorders (non-malignant).
4. Specimen from a newly diagnosed or relapsed subject.
5. Specimen is stored at room temperature, upon receipt by the site.
6. Age of specimen (time of collection to start of first pre-wash): ≤24 hours.
7. Specimen collected in EDTA (K2 or K3) or heparin (sodium or lithium).
8. Specimens are from subjects irrespective of race, gender, and ethnicity.

Exclusion Criteria:

1. Specimen from healthy subject.
2. Specimen from subject \<22 years old.
3. Specimen from subject undergoing any treatment for any form of L\&L.
4. Specimen from subject with minimal residual disease (MRD) as determined by site.
5. Visibly clotted specimen.
6. Visibly hemolyzed specimen.
7. Frozen specimen.
8. Refrigerated specimen.
9. Fixed specimen.
Virtual Reality for Power Wheelchair Training

The objective of this study is to evaluate the impact of VRSim 3.0 on power wheelchair (PWC) driving skills and to obtain qualitative feedback from users on the design of the virtual reality (VR) simulator to inform device development.

A virtual reality platform may lead to better training of people with complex disabilities who desire to be power wheelchair users and thus allow them to benefit from living a more active life. A virtual reality training program could significantly impact the lives of people with disabilities by improving function, reducing abandonment of power wheelchairs, and reducing morbidity and mortality and associated costs occurring from power wheelchair accidents. This new virtual reality training program will reflect improvements in accessibility, customization, simulator sickness, ease of use, and will have report generating capabilities as compared to previous virtual reality training platforms. The investigators expect that virtual reality training will be a superior alternative to standard in-person wheelchair training.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers must be 14 years or older.
* Volunteers must have a disability that prevents them from effectively and independently using a manual wheelchair, power assist wheelchair, or scooter.
* Volunteers must be able to communicate in English, follow simple commands, and give written informed consent.

Exclusion Criteria:

* Volunteers with active seizures.
* Volunteers who have active pelvic or thigh wounds.
* Volunteers who require a test wheelchair but who exceed the weight capacity of the test wheelchair (\>300 lbs).
* Volunteers who require a test wheelchair but also require specialized seating that cannot be replicated for the training.
Comparison of Quality of Life After Discharge of the Mild and Moderate COVID-19 Patients With or Without Herbal Medicine

The purpose of this study is to see how the acute stage COVID-19 treatments by use of herbal medicine (Shen Cao Gan Jiang Tang) affect quality of life and symptoms at 3 months after hospital discharge.

According to the theory of Traditional medicine, the patient will suffer damage to Qi and Fluid in the acute phase and lead to damaged Yin and Qi in the post COVID-19 period.

The Shen Cao Gan Jiang Tang has the effect of enhance the Protective Qi, generating Fluid, is applied to treat the mild and moderate COVID-19 in the acute phase in some hospitals in Ho Chi Minh City, Viet Nam. The hypothesis is that with the use of the Shen Cao Gan Jiang Tang, the Qi and Yin will reduce the damage, so that the patient has a better quality of life and fewer post COVID-19 symptoms compared with the standard of care group

Eligibility Criteria:
Inclusion Criteria:

* Patients able to understand and fill out a questionnaire
* From full 18 to 64 years old;
* Patients with the mild and moderate COVID-19 who used Shen Cao Gan Jiang Tang in the acute phase for intervention group.
* Participants enrolled in protocol NCT05055427.
* Voluntarily consented to participate in the study

Exclusion Criteria:

* Patient who are not able to complete 100% of the questionnaire Criteria for stopping the study
* The patient cannot be contacted after 04 calls, each call is at least 06 hours apart on the survey days.
* The patient does not want to continue participating in the study.
Esophageal Manometry and Impedance Study in Obese Patients Before and During Anesthesia

The purpose of this study is to evaluate the effects of anesthesia on the esophageal body in obese patients before and during anesthesia.

Obesity is an increasing heath problem in western countries and is associated with increased risks during anesthesia.

Using high-resolution solid-state manometry the investigators aim to study esophageal pressures and measure the incidence of regurgitation of gastric contents during anesthesia induction in obese patients. The investigators aim to include 16 obese patients, with BMI \> 35, undergoing laparoscopic gastric by-pass.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* aged 18-60 years
* BMI\>35
* ASA classification I-III

Exclusion Criteria:

* Use of drugs that interfere with esophageal motility
* Gastro-esophageal reflux disease
Infant Mortality Reduction by the Mass Administration of Azithromycin

This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.

The MORDOR clinical trial funded by the Bill \& Melinda Gates Foundation in Malawi, Tanzania, and Niger demonstrated that biannual oral azithromycin distributions to children aged 1-59 months significantly reduced child mortality. The investigators hypothesize that biannual administration of azithromycin to children aged 1-11 months will reduce mortality in this age group. The aim of the project is to demonstrate that this intervention can be scaled up and produce the same benefits on mortality as those documented in smaller, more controlled studies. Since 1986, to reduce child mortality, Burkina Faso has been administering high-dose vitamin A supplementation to children aged 6-59 months on a biannual basis through the "Child Health Days" platform. The "Child Health days" are a door-to-door distribution of vitamin A coupled with screening for acute malnutrition in children aged 6-59 months and deworming of children aged 12-59 months. This approach has been successful but expensive. A new strategy implemented since September 2017 relies on community-based health workers (CBHWs) to distribute Vitamin A in rural areas, and on community-based distributors (CDs) in urban areas. Based on expert opinion and the preliminary findings of formative research conducted by the Ministry of Health and Helen Keller International, it was agreed that the Child Health Days platform was the most appropriate platform to implement the biannual administration of azithromycin to children aged 1 to 11 months.

In this trial, mortality will be measured via complete birth history which will be collected in a subset of villages in the study area before the first treatment distribution. The study team will also conduct a baseline census of the study areas for treatment coverage estimations.

Sixty villages (30 azithromycin, 30 placebo) will contribute to the macrolide resistance outcomes, where the study team will collect rectal and nasal swabs from children 1-59 months.

Eligibility Criteria:
Inclusion Criteria:

Community eligibility criteria:

* Located in one of the three selected regions: SudOuest, Centre-Ouest, Hauts-Bassins
* Verbal consent of the community leader is obtained

Inclusion criteria for children:

* Aged 1 to 11 months
* Living in one of the communities participating in the study

Exclusion Criteria:

Community exclusion criteria:

• Inaccessible or unsafe for the study team

Exclusion criteria for children:

• Known allergy to macrolides