cyrilzakka/clinical-trials huggingface dataset:
Research on the Role of Compound Probiotic Freeze-dried Powder in Improving Gastrointestinal Function

This study aims to evaluate the effect of four high-activity compound probiotic freeze-dried powders on improving gastrointestinal function, observing their regulatory effects on the gut microbiota and the incidence of adverse reactions in study participants over a 4-week intervention period.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily, in writing, sign the informed consent form, agreeing to participate in this study
2. Able to complete the study according to the requirements of the trial protocol
3. Age between 18 and 65 years old
4. Meet the diagnostic criteria for gastrointestinal dysfunction established in the "Chinese Precision Health Communication Expert Consensus on Citizen's Guide to Gastrointestinal Health"
5. Symptoms: Irregular bowel movements, loose or hard stools, abdominal bloating, belching, flatulence, severe intestinal gas, abdominal pain, acid reflux, heartburn, pain in the stomach or abdomen when hungry, nausea
6. Signs: Abdominal pain and bloating, diarrhea and constipation, indigestion, gastric acid reflux, bad breath and foul-smelling flatulence, skin problems, changes in stool color and shape -

Exclusion Criteria:

1. Use of drugs affecting the intestinal flora (including antimicrobials, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines, etc.) for more than 1 week continuously within 1 month prior to screening
2. Short-term consumption of products similar to the test substance, which affects the judgment of the results
3. Use of antibiotics during illness
4. Participants with severe systemic diseases or malignant tumors
5. Participants allergic to any components of the compound probiotic freeze-dried powder used in this trial
6. Women who are pregnant or breastfeeding, or those who have plans to conceive in the near future
7. Participants who cannot participate in the trial due to personal reasons
8. Other participants deemed unsuitable for participation by the researcher -
HEAVEN Criteria: Prediction of Difficult Airway for In- Hospital Emergency Airway Management

The HEAVEN criteria were found valid to predict difficult airways during preclinical emergency intubations in a retrospective study. The acronym stands for Hypoxemia, Extremes of size, Anatomic abnormalities, Vomit/blood/fluid, Exsanguination/anaemia, and Neck mobility issues. This is a monocentric prospective observational study to assess the validity of the HEAVEN criteria in the in-hospital setting at a level I adult and pediatric emergency university-based hospital.

Emergency intubations are prone to present a difficult airway. A difficult airway can lead to prolonged intubation time and to hypoxemia in situations where oxygenation is not possible that can finally result in hypoxic cardiac arrest and irreversible brain damage caused by hypoxic ischemic encephalopathy.

Tools to predict difficult airways are rather poor concerning specificity and sensitivity. A score to predict difficult airway developed in the pre-clinical setting are the HEAVEN criteria. The acronym HEAVEN stands for: Hypoxemia, Extremes of size, Anatomic abnormalities, Vomit/blood/fluid, Exsanguination/anaemia, and Neck mobility issues and does not need patients' cooperation. It has been recently validated in the pre-clinical emergency setting and was found to be useful.

The study aim is to evaluate if the HEAVEN criteria are suitable to be used to predict difficult airway in in-hospital emergency intubation to finally increase patients' safety during rapid sequence induction (RSI).

This prospective observational single-centre study in emergency intubation will consecutively recruit all patients of all ages who need RSI due to their medical condition performed by the staff of the Department of Anaesthesiology and Pain Medicine at the Bern University Hospital. We will record data that are gathered during routine patient care and stored primarily in the departmental anaesthesia information systems.

The primary objective is to validate if the HEAVEN criteria, an existing prehospital difficult airway prediction tool, is able to predict airways difficulties during RSI in the clinical in-hospital setting. The secondary objective is, to assess the subcomponent of the HEAVEN criteria and if differences and adaptations are needed comparing it to the prehospital setting.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients of all ages who need an in-hospital rapid sequence intubation (RSI) performed by the staff of the Department of Anesthesiology and Pain Medicine
* Given general consent or delayed obtained general consent after the procedure
* English, German or French speaking patients

Exclusion Criteria:

• Patients without informed consent
Comparison of Peripheral Perfusion Level Between Two Groups of Newborns According to Their Infectious Status Defined by the Criteria of the Center for Disease Control and Prevention (CDC)

Despite advances in medicine, secondary neonatal infection remains a continuing concern because of the associated high morbidity and mortality. The usual mechanism of infection responds to the transmission of germs by the equipment used for care (eg, catheters) and by the hands of caregivers. In preterm infants in particular, some infections can also have an endogenous source, by translocation of colonization germs present in the digestive tract.

The first line of prevention of secondary infection corresponds to compliance with the rules of hand hygiene, work surfaces and equipment carried out, the effect of which on the control of the incidence of secondary infection is regularly demonstrated. When declared, bacterial infection should be treated as quickly as possible with appropriate and effective antibiotics to preserve the healing prognosis. Compared to the infant and the larger child, clinical signs of calling are atypical and discrete. In the absence of staff trained to monitor newborns specifically, there is a real risk of discovering the existence of the infection only at an advanced stage corresponding, among other things, to circulatory collapse. This risk is not completely excluded, even with experienced practitioners, because the positive signs are rude and may go unnoticed (eg, signs of calling such as fever are rare in the newborn). Support for early diagnosis of neonatal infection by automatic monitoring systems has reduced mortality by 30% in the units where it has been applied. This is probably due to the fact that early warning made it possible to start the antibiotic treatment earlier and to complete the bacteriological diagnosis in order to better orient the therapeutic attitude. The best criteria for early diagnosis by automated systems were provided by the statistical analysis of cardiac variability, the results of the research and correspond to the standard deviation, the asymmetry and the entropy of the series d Cardiac intervals. Since microbial aggression has an impact on many vegetative variables outside of the electrocardiogram, our current research aims to determine whether the analysis of the perfusion index (PI) Which are of interest for detecting disturbances in the early stages of infection in newborns. IP corresponds to the ratio of the amplitude of the oscillating phase to the intensity of the constant part of the opto-plethysmography wave; It is obtained from signals recorded in a non-invasive manner by the same infrared sensor for pulse oximetry.


Eligibility Criteria:
Inclusion Criteria:

* Newborn of corrected age between 27 SA and 42 SA with at least 72 hours of postnatal age
* Presence of clinical or biological criteria of infection according to CDC definitions
* Absence of clinical or biological criteria for infection according to CDC definitions

Exclusion Criteria:

* Congenital malformation neurological, cardiac, respiratory, vascular and cutaneous.
* A proven episode of materno-fetal infection
Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis

The goal of this clinical trial is to test the effect of mothers' application of yogurt probiotic bacteria on relieving their young children's acute gastroenteritis in children had two to five years old. The main hypothesis is children with acute gastroenteritis who receive yogurt probiotic bacteria exhibit less diarrhea, vomiting and dehydration than those who don't.The study subjects were divided into two equal groups (probiotic study group and control group).


Eligibility Criteria:
Inclusion Criteria:

* newly admitted children with no or some dehydration and with acute gastroenteritis.

Exclusion Criteria:

* bloody watery diarrhea
Arimidex Observational: Reason for and Effect of Change From Tamoxifen

The purpose of this study is to analyse the effect on quality of life after 3 months of treatment after changing adjuvant therapy from tamoxifen to Arimidex.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Hormone sensitive breast cancer
* Patient uses tamoxifen or has stopped taking tamoxifen less than 7 days ago

Exclusion Criteria:

* Visceral metastases
* Patients with signs of progression at the moment of changing therapy
* Patients who have used other endocrine treatments for breast cancer besides tamoxifen
Influence of Meal Schedule: Gender Differences

Gender differences in the effect of meal schedule will be studied in a parallel design (10 women and 10 men). In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL water; 549 Kcal) will be administered in the afternoon, i.e. conventional schedule, and in the morning, i.e. unconventional schedule. The effect of meal schedule will be measured as the differences between the responses on both study days. Participants will be instructed to eat standard dinner the day before and to consume standard breakfast at home the day of the afternoon test. Studies will be conducted in a quiet, isolated room with participants siting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility Criteria:
Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders
Alternating DBS for Stepping Control in Parkinson's Disease

Parkinson's disease (PD) is a disabling, progressive condition characterised by severe problems with movement for which medical treatment in the longer term can be unsatisfactory. Deep brain stimulation (DBS) is a treatment, which directly stimulates the nerve cells affected inside the brain to help overcome the difficulties with movement. Classically, DBS stimulates in a manner that is constant. Many patients develop severe problems with walking, so-called freezing of gait, which can be unresponsive to constant DBS. In this study the investigators will test if left-right alternating DBS helps to improve gait problems by potentially promoting left-right alternating up- and down-modulated brain activity, which was found during walking in a previous study. The investigators will test if alternating DBS improves the ability to adjust walking speed and to walk freely compared to constant DBS.


Eligibility Criteria:
Inclusion Criteria:

* PD patients with bilateral subthalamic nucleus DBS electrodes and stimulators implanted for at least 6 months
* Able to give consent.

Exclusion Criteria:

* Lack of capacity to consent
* Cognitive impairment/lack of capacity to perform experimental task. The investigators will additionally conduct a short (10 min) quantitative assessment of cognitive function using a validated test (MMSE). Patients with a score \< 20 will be excluded from the study.
Electronic Self-management Resource Training for Mental Health

The purpose of this study is to determine whether mental health treatment disengagement may be mitigated by reducing barriers to self-management and enhancing self-management skills.

Each year, more than four million young adults (age 18-25 years old) in the U.S. receive psychotropic medication or psychotherapy as treatment for a mental illness. One in every four of these young adults will disengage from mental health treatment before significant symptom remission is achieved. Mental health treatment disengagement may be mitigated by reducing barriers to self-management and enhancing self-management skills. Electronic self-management resource training for mental health (eSMART-MH) is an innovative use of avatars-virtual persons who tailor responses to users-to improve mental health treatment disengagement.

Eligibility Criteria:
Inclusion Criteria:

* Self-report of a diagnosis depression or generalized anxiety disorder greater than six months
* Young adults 18-25 years of age
* Prescribed psychotropic medication and/or psychotherapy
* Have a documented domestic telephone number
* Able to read and understand English

Exclusion Criteria:

* Participation in the eSMART-HD parent project
Safety and Tolerability of Transcranial Direct Current Stimulation (tDCS)

Testing safety and tolerability of transcranial direct current stimulation (2 mA, 20 minutes) in four different protocols:

saline-soaked sponges electrode with electrode gel tap-water-soaked sponges tap-water-soaked-sponges + sham stimulation

Outcome measures are tolerability (comfort rating questionnaire), impedances, skin elasticity


Eligibility Criteria:
Inclusion Criteria:

* no neurological or psychiatric illness
* written informed consent

Exclusion Criteria:

* dermatologic diseases
* medication with corticoids
Lessons in Affect Regulation to Keep Stress and Pain UndeR Control (LARKSPUR R34)

Chronic pain affects millions of Americans but integrative as well as conventional treatments fall short in terms of alleviating this pain. The investigators are testing a tailored online positive affect skills intervention through a high-quality, randomized controlled trial for people with chronic musculoskeletal pain. The proposed work holds promise as an effective, low cost, easily disseminated intervention to help people cope with chronic pain, decrease depression and distress that pose barriers to optimal adherence, and potentially boost the efficacy of integrative as well as conventional pain treatments.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Current patient at Northwestern Memorial Hospital
* Seeking treatment for chronic musculoskeletal pain at the Northwestern Osher Center for Integrative Medicine. Pain will be defined as persisting for at least the past three months with an average level over the past month of at least 4 of 10 on a numerical rating scale, including back pain, neck pain/cervicalgia, knee pain, other joint pain (hips, ankles), fibromyalgia, osteoarthritis and rheumatoid arthritis.
* Fluent in the English language
* Have a working email address
* Have reliable Internet access in order to access the website online
Deep Learning-based Artificial Intelligence for the Diagnosis of Small Bowel Obstruction

The study will compare the diagnostic accuracy and time to diagnosis of computed tomography images of patients with suspected intestinal obstruction seen in the emergency room by residents and surgeons, with and without artificial intelligence.

DESIGN: This is an diagnostic study. SETTING: We developed a deep learning-based AI technology to automatically extract the intestinal tract from CT images using 5 200 CT images of 158 patients. The CT images of patients who visited the emergency department and were suspected of small bowel obstruction between June 6 and July 26, 2018, were obtained from two tertiary referral centers, which were used as the test samples. Data analysis was completed in December 2023.

PARTICIPANTS: Residents and surgeons participated in the study. INTERVENTIONS: Residents and surgeons were divided into two groups: one group read using the AI technology, and the other group read without the AI technology.

MAIN OUTCOMES AND MEASURES: Participants indicated whether or not small bowel obstruction and obstruction location. The time for diagnosis was also collected. We applied a hierarchical Bayesian model.

Eligibility Criteria:
Inclusion Criteria:

* Persons with documented consent

Exclusion Criteria:

* Persons without documented consent
A Comparative Study of Incision Closure Methods for Total Knee Replacement

The aim of the study is to compare incision closure techniques for total knee replacement using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort to identify the best approach with respect to time efficiency, cost, durability, dehiscence, microbial resistance and cosmesis.

The hypothesis is that the combined suture/adhesive approach (sutures for capsule and subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple approach will be significantly faster and of comparable durability as the conventional exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers). This is a prospective, randomized, controlled, single site, unblinded (open label) study.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria included 18 years or older
* TKA scheduled without a bilateral planned within one week of the initial surgery
* Willingness to attend prescribed physical therapy 3 times per week.

Exclusion Criteria:

* Exclusion criteria included medical conditions or personal circumstances that would prevent participation and completion of physical therapy and follow-up visits
* Current participation in another clinical trial
* Preoperative systemic infections
* Uncontrolled diabetes, or diseases or conditions known to effect the wound healing process
* Known hypersensitivity to cyanoacrylate
* Formaldehyde, or the dye D\&C Violet #2
* Prior knee hardware fixation devices
* Prior knee incisions greater than 9cm, and arthrofibrosis as evidence by limited ROM less than 80°.
An Idiographic Examination of Treatment Mechanisms in Emotion Regulation Therapy

This study is an open trial designed to examine individual changes that occur before, during, and after 12 sessions of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.

The main questions this study aims to answer are to:

1. Examine temporal patterns of ERT-specific treatment mechanisms (attention regulation, metacognitive regulation, motivation regulation, and valued living), relationships between these mechanisms and negative self-referential processing (NSRP; i.e., rumination, worry, and self-criticism) severity over time, and changes in these mechanisms in response to specific intervention strategies/modules.
2. Investigate the effect of concordance and/or discordance between therapists and clients regarding skill acquisition, treatment goals, and case conceptualizations on treatment mechanisms as well as measures of treatment outcome and satisfaction.
3. Demonstrate the preliminary efficacy of a 12-session version of ERT in reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination, self-criticism), changing ERT-specific treatment mechanisms (e.g., attention regulation), and improving quality of life and overall functioning.

Participants will:

1. Fill out an online pre-screening questionnaire and complete a structured clinical interview via Zoom Healthcare
2. Be enrolled as a patient at the Dean Hope Center for Educational and Psychological Services (DHCEPS), located at Teachers College
3. Attend 12 once-weekly telehealth ERT sessions
4. Complete 18 weekly questionnaires online via Qualtrics (two before starting treatment, 12 each week during treatment, and 4 after ending treatment).

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65
* Fluent in English (and therefore able to provide consent)
* Currently living in New York State
* Access to at least one device with internet and video-conferencing capabilities
* High self-reported worry, rumination, and/or self-criticism
* Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder

Exclusion Criteria:

* Active suicidal ideation or intent
* Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder
* Currently in therapy or receiving any type of psychosocial treatment
* Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months
* Current students at Teachers College, Columbia University
A-Part® Gel as Adhesion Prophylaxis After Major Abdominal Surgery Versus a Non-treated Group

The safety of applying A-Part® Gel intra-peritoneally under the incision in order to prevent post-surgical adhesions after median laparotomy.

Primary Objective:

• first assessment of the safety of applying A-Part® Gel as adhesion prophylaxis after major abdominal surgery by specific observation of two major complications of abdominal surgery (wound healing impairment, and/or postoperative peritonitis) in comparison to a control group.

Secondary Objectives:

* To further evaluate the safety of A-Part® Gel by comparing the incidences of adverse events between the treatment groups (with special attention to anastomosis leakage)
* To explore the efficacy of A-Part® Gel in reducing post-surgical adhesions after median laparotomy

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, who are candidates for a primary and elective median abdominal incision with a length of ≥ 15 cm 2.
* Age ≥ 18 years
* Patients who are legally capable and able to understand the nature, significance and consequences of the study and are willing and able to comply with the study protocol and the follow up
* Written informed consent obtained according to international guidelines and local law. Informed consent will be documented by the volunteer's dated signature, which will be also signed and dated by the investigator
* Patients with an expected survival time \>12 months
* For female adults of reproductive potential: Negative pregnancy test at visit 1 and sufficient contraception from time of written consent up to at least 4 months

Exclusion Criteria:

* Patients with a previous median laparotomy and any other abdominal surgery (exceptions: previous laparoscopic appendectomy, cholecystectomy, inguinal hernia repair, gynecological tube sterilisation)
* Patients with a known history of adhesions or a known history of peritonitis
* Patients with a known sensitivity to polyvinylalcohol and/or carboxymethylcellulose
* Simultaneous participation of the patient in another clinical trial or participation in a clinical trial within the last 30 days prior to signing the Informed consent form
* Patients with ASA \> 3 or emergency patients (including severe psychic diesease)
* Patients with ascites \> 200 ml
* Patients with peritoneal carcinosis or peritoneal dialysis
* Patients with a diagnosed peritonitis, intra-abdominal abscess or other intra-abdominal infection
* Patient with renal impairment (Creatinine \> 1.3 mg/dl)
* Patients with systemic immunosuppression (e.g. hydrocortisone \> 50mg daily \[oral/i.v.\] at any day or any equivalent dosage; other immunosuppressants like Azathioprin, Mycophenolatmofetil, Ciclosporin, Everolimus, Methotrexat, ect.), chemotherapy or radiotherapy within the last 2 weeks prior to surgery
* Surgical procedures or patient characteristics which require insertion of more than 2 intra-abdominal drainages
* Women within a pregnancy or breast-feeding mothers or women who wish to get pregnant within the next 4 months after surgery or women without sufficient contraceptive care