cyrilzakka/clinical-trials huggingface dataset:
Development of a Treatment Prognosis Calculator for the Prevention of Suicide

The goal of this interventional study is to develop and test a treatment prognosis calculator to identify which service members with suicidal ideation or behavior are likely to respond well to the current standard of care treatment and which should instead receive Brief Cognitive Behavioral Therapy (BCBT) as a first-line treatment.

The main aims of the study are:

* Aim 1: To develop a novel treatment prognostic calculator to predict response to treatment as usual (TAU) and identify treatment-seeking military personnel who are unlikely to respond adequately to TAU for the reduction of suicidal ideation.
* Aim 2: To evaluate the performance of the treatment prognosis calculator in a new sample of treatment-seeking military personnel and determine whether BCBT is more effective than TAU for those patients who are predicted not to respond adequately to TAU.

Participants will receive mental health treatment as it is typically administered by their mental healthcare treatment team. Members of their mental healthcare treatment team may receive intensive training in BCBT. After their provider has received this training, they may use this treatment as part of standard of care treatment. The timing of this training will be determined randomly. Participants will complete self-report assessments at the beginning of the study (baseline) as well as 3, 6, 9 and 12 months after their participant begins. These assessments will include questions about feelings, thoughts, moods, impulses, substance use, and behavior.


Eligibility Criteria:
Inclusion Criteria:

1. female and male active duty service members;
2. =\> 18 years old;
3. engaged in mental health treatment at one of the sites at study enrollment;
4. score \>0 on the Columbia Suicide Severity Rating Scale (CSSRS) Screener-Recent, or indicated suicidal ideation on questions 4 or 5 of the Scale for Suicidal Ideation, indicating suicidal ideation within the last month;
5. able to understand and speak English;
6. able to provide consent.

Exclusion Criteria:

(1) participants with a psychiatric or medical condition that prevents them from providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication).
Effects of DL-endopeptidase Producing Probiotics on Human Intestinal NOD2 Ligands and Related Functions

Probiotics are beneficial to human gut health. We found that a DL-endopeptidase producing probiotic could repair the intestinal barrier and regulate enteritis. Thus, a population-based trial was conducted.

This trial requires the subjects to take probiotics for a certain period of time, and we will collect blood, stool and questionnaires for subsequent testing, efficacy evaluation and safety evaluation.

Eligibility Criteria:
Inclusion Criteria:

* tend to participate the trial

Exclusion Criteria:

* severe digestive symptoms, such as severe vomiting, hematochezia, bloody or tarry stool within one month before intervention; antibiotics or laxatives or probiotics or intestinal antiulcer agent within one month before intervention; previous or current treatment for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, celiac, ulcerative colitis, etc.); other chronic diseases (diabetes, kidney disease, etc.) or immunecompromising diseases or conditions (HIV/AIDS, autoimmune, hepatitis, cancer, transplant patient etc.); pregnant or lactating.
Effects of Narrative Writing Duration and Post-writing Processing Instructions on PTSD

The current study proposes to directly measure how processing after participating in written disclosure about a traumatic life event affects physical and psychological outcomes.

Previous research has established the potential for narrative writing about traumatic events to result in positive benefits for physical and psychological health. Research has also provided evidence that written disclosure may reduce post-traumatic stress disorder (PTSD) symptoms. Several mechanisms of action have been proposed to explain why written disclosure produces positive benefits, but all have focused on processes occurring during the writing session. It has been suggested, however, that additional processing may occur after the writing exercises are over, yet no research has studied the influence of this processing on outcomes. The current study proposes to directly measure how processing after participating in written disclosure affects physical and psychological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Experienced a traumatic life event (DSM-IV-TR Criterion A)
* Currently experiencing clinically significant levels of PTSD symptoms

Exclusion Criteria:

* Currently receiving psychotherapy
* On medication that is not stable (i.e. medication has been changed within the past 6 weeks)
Accuracy of Tooth Modified Scan Bodies as a Novel Technique

The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases.

I

The clinical performance of a novel scan body Tooth Modified Scan Body (TMSB) in the degree of trueness of IOS impression for full arch cases. TMSB is a scan body to which different teeth are attached directly as one piece, this may enhance the accuracy level by filling the gabs between ISB as well as acting as a stable artificial AI-easily recognized landmarks thus facilitating the scanning procedure. OS impression utilizing tooth modified scan bodies or conventional scan bodies result in the same degree of trueness as conventional verified splinted open tray impression. To our knowledge, it is the first time in the literature to utilize a novel scan body modified with directly connected teeth as artificial landmarks in vivo.

Eligibility Criteria:
Inclusion Criteria:

* Participants who had received 4-6 implants in 1 edentulous arch.
* Participants with 1-piece implant-supported complete-arch fixed dental prostheses.
* Systemically free.
* Primary implant stability exceed 72 the day of the definitive impression.

Exclusion Criteria:

* Smoker's.
* Non co-operative patients.
Yoga in Older Cardiac Patients

The goal of this clinical trial is to compare, at 3 months, the effects of a yoga intervention on physical health, including balance, muscle strength, physical activity levels, cardiac autonomic function, and physical vulnerability, as well as psychological health, including depressive symptoms and anxiety, in cardiac patients who are older than 65 years old and randomized to the intervention or control group. The main questions aim to 1) determine if yoga can improve physical health outcomes such as balance, muscle strength, cardiac function, and physical vulnerability in older adults with cardiovascular disease, and 2) determine if yoga can positively impact psychological health, including reducing depressive symptoms and anxiety in this population. Participants in the intervention group will attend yoga sessions twice a week for three months. The intervention group will be asked to complete surveys and physical function assessments at the beginning and three months later. Researchers will compare the intervention group and the control group to see if there is any difference and improvement in physical and psychological health between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* have a history of an acute myocardial infarction within the preceding year, stable angina, cardiac surgery (including heart transplantation, valve surgery, or coronary artery bypass), coronary artery angioplasty or stents, or heart failure (ejection fraction \< 35%) diagnosed in the past year
* have completed facility-based cardiac rehabilitation program (phase CR-II) within 12 months
* can read and understand English
* have no major comorbidities limiting their ability to participate in a yoga intervention
* reside in Kentucky.

Exclusion Criteria:

* have incapacitating neurologic, orthopedic, or neoplastic conditions such as stroke paralysis, terminal cancer, or a cognitive disorder
* currently practice yoga
* have no home WIiFi access
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children

single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids


Eligibility Criteria:
Inclusion Criteria:

* Prepuberal male and female outpatients, ≥ 5 and \< 12 years old in Tanner stadium I according to Investigator's assessment;
* Clinical diagnosis of mild asthma during at least two months prior to screening visit;
* Forced Expiratory Volume during the first second (FEV1) \> 80% of predicted normal values at screening visit;

Exclusion Criteria:

* Endocrinological diseases including growth impairment or other chronic diseases;
* Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids;
Clinical Study: Analysis of Glycemic Control and Satisfaction with a Connected Smart Cap in Patients with Type 1 Diabetes Mellitus

This clinical study evaluates the impact of the Cap INSULCLOCK device on glycemic control, treatment adherence, and patient satisfaction in adults with type 1 diabetes mellitus (T1DM). Despite advances in pharmacology and technology, a significant proportion of individuals with T1DM fail to achieve recommended glycemic targets, partly due to the complexity of insulin therapy and suboptimal adherence. Cap INSULCLOCK is a device that attaches to insulin pens, automatically recording injections and integrating data on glucose levels, insulin administration, food intake, and physical activity, with real-time Bluetooth transmission. Its use may enhance adherence and optimize metabolic control.

This study is a randomized, low-intervention clinical trial conducted at a single center, enrolling 42 patients, who will be randomized into two groups: one using the activated device and a control group using the device in a blinded mode. The primary objective is to assess differences in time above range (TAR \>180 mg/dL) over the last 14 days of continuous glucose monitoring (CGM). Secondary objectives include evaluating HbA1c levels, time in range (TIR), frequency of hypoglycemic episodes, and patient satisfaction. Data will be analyzed using advanced statistical methods, and the intervention is expected to improve adherence, reduce glycemic variability, and enhance quality of life in individuals with T1DM


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years or older.
* Diagnosis of type 1 diabetes mellitus (T1DM).
* Users of flash continuous glucose monitoring (FGM) sensors with \>70% of recorded data, including intake and insulin dose logs.
* Adequate therapeutic adherence, with no missed appointments in the past year.
* Time above range (TAR \>180 mg/dL) \>25%.
* Ability to provide informed consent to participate in the study.
* Access to technology for follow-up, including a smartphone with internet connectivity and compatibility with the Insulcloud app.

Exclusion Criteria:

* Current pregnancy.
* Severe acute illness.
* Exclusion criteria for the use of real-time continuous glucose monitoring (RT-CGM) systems as per the Framework Agreement of the Community of Madrid for RT-CGM use (SERMAS).
* Inability to provide informed consent or to meet the study requirements for any reason.
Vitamin C, Vitamin B1 and Steroid in Sepsis

A randomized controlled trial to test the synergic modulation effect of vitamin C, thiamine and hydrocortisone in patients with severe sepsis or septic shock.

Management of sepsis bases on three components: infection control, haemodynamic stabilization and modulation of the septic response. Many clinical trials conducted agents to block the inflammatory cascade, such as corticosteroids, anti-endotoxins antibodies, tumor necrosis factor (TNF) antagonists, interleukin-1-receptor antagonists, and so on, but none has proven effective to date. A safe, effective, ready available therapy is desperately required. Thiamine is a key co-factor for pyruvate dehydrogenase, alpha-ketoglutarate dehydrogenase, and transketolase. All the three enzymes are required to complete Krebs Cycle to prevent from lactate production. Previous studies have found thiamine deficiency to be prevalent in septic shock and other critically ill conditions. One pilot study also proved patients with septic shock and baseline thiamine deficiency would have significant lower lactate level at 24 hours after administration of thiamine. HYPRESS (hydrocortisone for Prevention of Septic Shock) study failed to demonstrate an outcome benefit from a hydrocortisone infusion in patients with sepsis. Vitamin C is a potent antioxidant that directly scavenges oxygen free radicals, can restores other cellular antioxidants and plays a role in preserving endothelial function and microcirculatory flow as well. Though previous studies suggested that hydrocortisone and vitamin C alone have little impact on the clinical outcome of patients with sepsis. Vitamin C and hydrocortisone have many overlapping and synergic pathophysiologic effects in sepsis. Both drugs are required for the synthesis of catechlamines and increase vasopressor sensitivity. Both drugs can down-regulating the production of proinflammatory mediators, increase tight junctions between endothelial and epithelial cells, preserve endothelial function and microcirculatory flow. Marik et al published their study in CHEST (June 2017) resulting the benefits of combination of Vitamin B1, Vitamin C and hydrocortisone to severe sepsis and septic shock. However, small sample size and some bias due to imbalanced baseline and study method could confound the results. Herein, we would like to lead a randomized controlled trial to test the synergic modulation effect of vitamin C, thiamine and hydrocortisone in patients with severe sepsis or septic shock.

Eligibility Criteria:
Inclusion Criteria:

* aged equal or over 20
* admitted to MICU due to severe sepsis or septic shock

Exclusion Criteria:

* Patients who are pregnant
* known history of Vitamin C , Vitamin B or hydrocortisone (or other equivalent products) allergy
Investigating Cardiovascular Adverse Events Related to Cancer Treatment

Cisplatin, anthracyclines, bleomycin and trastuzumab can cause severe cardiovascular or pulmonary toxicity. Why some patients are susceptible to extreme toxicity of cancer treatment is largely unknown. Unraveling extreme cardiovascular toxic responses in cancer patients may help understand the pathophysiology of cardiovascular toxicity of these agents and help in understanding the more subtle, long-term cardiovascular side effects that affect a larger part of cancer survivors. With induced pluripotent stem cells we will obtain patient-derived cells to recapitulate and mimic and study pathological (cardiovascular) responses and (cardiovascular) toxicity in vitro.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of these criteria:

1. any proven cancer treated with curative intent;
2. age ≥ 18 and ≤ 50 years;
3. able to comply with the protocol;
4. signed written informed consent.

There are specific inclusion criteria for every subject group:

* severe toxicity during 1 to 3 cycles of anthracyclines;
* ≥ 3 months after end of cancer treatment which included the maximum tolerable dose of anthracyclines without (severe) toxicity;
* severe toxicity within 1 to 6 cycles of trastuzumab;
* ≥ 3 months after end of cancer treatment which included a year of trastuzumab without (severe) toxicity.
* severe toxicity during 1 to 3 cycles of cisplatin;
* ≥ 1 year after end of cancer treatment which included high-dose cisplatin without toxicity;
* severe toxicity during 1 to 3 cycles of bleomycin;
* ≥ 1 year after end of cancer treatment which included high-dose bleomycin without toxicity.

Severe toxicity is defined as any of grade 3 - 4 toxicity according to CTCAE 4.03.

A potential subject who meets any of the following exclusion criteria will be excluded from participation in this study:

1. history of cardiovascular disease prior to start of cancer treatment, as evidenced by any of the following: symptomatic or treated cardiovascular disease prior to start of cancer treatment; LVEF \< 55% at any performed MUGA scan or echocardiography prior to start of cancer treatment;
2. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, or insufficient understanding of the Dutch language;
3. any contraindication for skin biopsy, including: extensive skin disorder precluding biopsy of unaffected skin; known allergy to local anaesthetics; use of anticoagulants and INR \> 3;
4. pregnant or lactating female.

   Furthermore, there are specific exclusion criteria for the control groups:
5. history of cardiovascular disease during or after cancer treatment, as evidenced by any of the following: any symptomatic or treated cardiovascular disease; LVEF \< 55% at any performed MUGA scan or echocardiography.
CRUSH STUDY: Calculating Readmission Risk by Ultrasound for Heart Failure Failure Study

This is a study to determine if two ultrasound measures (Corrected Flow Time and B-Lines) can predict patients at higher risk of readmission within 30 days of hospital discharge for decompensated heart failure.

Heart failure (HF) resulting in congestion is the leading cause for admission in persons ≥65 years of age and 20-25% of such patients are readmitted within 30 days of discharge. Efforts to treat HF are difficult without a simple method to detect early signs of congestion to direct therapy. Ultrasound can detect evidence of congestion by increased cardiac filling pressures two weeks prior to other markers of congestion such as weight gain or patient symptoms. Corrected flow time (FTc) measured by ultrasound, is an easy to perform vascular measure and correlates with cardiac filling pressures. Despite the relationship between FTc and filling pressures, this measure has never been studied in HF. The primary aim is to determine if FTc can predict patients at risk of readmission within 30 days. As a secondary aim, the investigators plan to validate a small study of patients reporting the ability of pulmonary ultrasound to predict readmissions. This study demonstrated pulmonary ultrasound was 100% sensitive and 68% specific for predicting readmission at 3 months, however this investigation was small and validation is needed. It is expected ultrasound will be able to accurately and safely predict patients who will be readmitted within 30 days of discharge. This proposal is aimed at identifying a noninvasive measure to better assess congestion from HF and predict readmissions.

Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* Being admitted for heart failure with expected hospital stay of 72 hours

Exclusion Criteria:

* Unable to provide consent
Claustrophobia and Magnetic Resonance Imaging

The objective of the study is to determine the ability of open magnetic resonance imaging (MRI) scanners to reduce claustrophobic reactions, thereby enabling more examinations of severely anxious patients. The investigators hypothesize that anxiety-based claustrophobia that prevents MR examinations without sedation can be reduced using an open MR scanner design thereby improving clinical management of those patients.


Eligibility Criteria:
Inclusion Criteria:

* Severely anxious patients with reported claustrophobia during MRI or with the inability to undergo MR examinations on conventional scanners
* Clinical indication for MR imaging of the head, spine, or shoulder.

Exclusion Criteria:

* Contraindication to MR imaging (shrapnells, pacemakers, certain unsafe implants)
* Age below 18 years
Low Laser Therapy on Facial Motor Functions Function and Synkinesis in Patients With Bell's Palsy

To determine the effects of low-level laser therapy on facial motor functions and synkinesis in patients with bell's palsy

A randomised controlled trial tested low-level laser therapy (LLLT) for bell's palsy. Lahore's Ittefaq Hospital selected 32 bell's palsy patients for the research. The Facial Disability Index (FDI), House-Brackmann Scale (HBS), and Sunnybrook Facial Grading System were used to collect data over ten months (SFG). LLLT and conventional therapy were randomly assigned to two groups. SPSS 25 compared pre- and post-treatment values of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Male female diagnosed with idiopathic Bell's palsy by physician
* age 30-60years
* Bell's palsy in patients having known history of hypertension
* Bell's palsy in patients having known history of diabetes

Exclusion Criteria:

* Participants with a middle ear infection
* parotid gland tumor
* malignant otitis external
* Tumors in the base of the lateral skull
* upper motor neuron facial palsy
* segmental muscle weakness
* and recurrent episodes of facial paralysis, polyneuropathies
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects

The primary purpose of this study is to investigate the safety and tolerability of AZD0328 following once-daily dosing for 13 days in elderly healthy volunteers and to define maximum tolerated dose.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent
* Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator

Exclusion Criteria:

* History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder
* History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity
* Intake of any prescribed medicine or St John's Wort, except for occasional paracetamol and nasal anticongestant, within 3 weeks or use of over-the-counter drugs within 2 weeks before the first administration of study drug
FSH-R : Diagnostic Application for Localized Tumors in Cancerology

FRACTal study is the first exploration of detection of FSHR as a blood biomarker for the diagnosis of cancer.

A first cohort will explore several common (e.g. breast, prostate) or rare (e.g. uveal melanoma) cancers, that are frequently treated at Institut Curie. This first cohort will include n=10 patients per histological type except for breast cancer (n=50). 100 patients are expected in this cohort.

A second cohort will explore the more promising histological type (if any) in term of incidence of detection. 100 patients are expected for this second cohort.


Eligibility Criteria:
Inclusion criteria

1. Patient diagnosed with localized cancer and corresponding to the different types explored. The cancer can be already diagnosed or not (strong suspicion)
2. Age\> 18
3. Written informed consent

Exclusion criteria

1. Previous treatment for the tumoral disease
2. Personal history of cancer diagnosis in the last 10 years
3. Pregnant and/or breastfeeding women
4. Person deprived of liberty or under guardianship (including curatorship)
5. psychiatric illness/social situation that would interfere with the protocol or limit compliance with study requirements