cyrilzakka/clinical-trials huggingface dataset:
Timing of Dilation Tracheostomy in Mechanically Ventilated Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of this study is:

* to evaluate the optimal time-point for percutaneous dilation tracheostomy in COPD patients in terms of duration on mechanical ventilation, length of stay on ICU and mortality;
* to evaluate the rate of infections and infectious complications of tracheostomized COPD patients;
* to evaluate the spectrum of pathogens in tracheostomized and intubated COPD patients;
* to evaluate the amount of sedatives used in mechanically ventilated COPD patients;
* to assess the quality of life in COPD patients tracheostomized after 3 or after 10 days.

Screening of patients following inclusion and exclusion criteria on all units of the Department of Critical Care will occur on a daily basis.

Randomization will be performed by blocks of sealed envelopes containing random numbers which are deposited at a central space within the Department of Critical Care Medicine. Randomization is performed as permuted block randomization.

Collection of baseline parameters (last/current lung function test, last/current 6-min walk test, cardiac stress test - if accessible) If not accessible, current lung function test results (at least FEV1 and FVC) are requested from the patient's general physician or pulmonologist to determine GOLD stage.

Patients randomized into the (early tracheostomy) study group, will undergo tracheostomy at the next possible opportunity but not later than 72 h after initiation of invasive ventilation. Patients of the control group will be invasively ventilated at least until Day 10.

Before tracheostomy a complete endoscopic inspection of the bronchial system will be performed routinely. Bronchoalveolar lavage fluid (BALF) will be obtained from sites of pulmonary infiltrations. In case of no radiographically or bronchoscopic detectable infiltrations BALF will be drawn from the Middle Lobe.

Primary and secondary endpoints will be analyzed at given time-points.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD (GOLD stage III or IV)
* Suspected long-time invasive mechanical ventilation due to ARF (\> 10 days)
* Informed consent of the patient or legal guardian

Exclusion Criteria:

* Severe neurological failure (such as stroke, cerebral haemorrhage etc.)
* Immunosuppressant therapy (with the exception of steroid therapy)
* Major risk of bleeding
* Intubation \> 72 h
* Contraindication for dilation tracheotomy
* Impossibility of intubation
Correlative Cohort Study on the Clinical Features and Prognosis of Drug-induced Liver Injury

This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.

This was a retrospective study of a clinical observational cohort. The patients were admitted and definitely diagnosed by liver biopsy as drug-induced liver injury from September 2014 to September 2019, in the Second Department of Liver Disease, Beijing Ditan Hospital Affiliated to Capital Medical University were enrolled, and these patients also met the RUCAM score and were clinically diagnosed as DILI. Baseline clinical data and follow-up biochemical data at 3, 6, and 12 months were collected. SPSS software was used to analyze the characteristics of clinical data and the dynamic changes of biochemical indicators. Logistic regression was used to analyze the risk factors associated with the chronicity of DILI. Bivariate Logistic regression model and ROC curve were used to obtain the clinical indicators for combined diagnosis of chronicity of DILI patients. To investigate the clinical features and prognostic factors of drug-induced liver injury.

Eligibility Criteria:
Inclusion Criteria:

* Have a clear history of taking drugs (Chinese herbal medicine and dietary supplements, NSAIDs, cardio-cerebrovascular drugs, anti-interference drugs, anti-tuberculosis drugs, hormone drugs and others);
* All patients were examined by liver biopsy Patients with clear diagnosis of drug-induced liver injury and clinical diagnosis of DILI who meet the RUCAM score.

Exclusion Criteria:

* Combined with various liver diseases, such as viral hepatitis (hepatitis A, B, C, D, E), alcoholic hepatitis, autoimmune hepatitis, metabolic hepatitis, non-alcoholic fatty liver disease;
* Combining other viral infections that may lose liver function, such as Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), and Human Immunodeficiency Virus (HIV);
* Mental illness;
* Evidence of liver tumors (liver cancer or alpha-fetoprotein\> 100 ng / ml).
Telephone Counseling: Men With Prostate Cancer & Partners

The purpose of this project is to test a telephone delivered educational support program versus an education only program for improving symptom management and quality of life in men with prostate cancer and their partners.

Eligibility Criteria for men: receiving treatment for prostate cancer,over 21 years of age, English speaking, have access to and ability to talk on the phone and have a partner willing to participate in the study. Participants can live anywhere in the United States because the intervention is telephone delivered.

Partners can be anyone the man selects (friend or relative) who is over 21 years of age, English speaking and has access to or ability to speak on the phone.

Men and their partners will be assigned to one of two groups. Each survivor will receive 8 telephone calls over an 8-week period for about 30 minutes each. Each partner will receive 4 telephone calls every other week for about 30 minutes each. We will ask everyone to complete a baseline assessment over the telephone, after the 8 weeks, and then again about 8 weeks after the second assessment.

Eligibility Criteria:
Inclusion Criteria:

* Receiving treatment for prostate cancer
* Over 21 years
* Access to and ability to talk on the phone
* Speaks English and has a partner to participate with him.
* Partners are anyone who the man chooses (friend or relative) who is over 21 years, English speaking and has access and ability to talk on the phone.

Exclusion Criteria:

* under 21 years
* Does not speak English
Risk Factors of Necrotizing Enterocolitis in Premature Newborns

With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased. NEC affects between 2 to 7% of premature infants including 5 to 22% of newborns weighing less than 1000 g.

NEC is an acquired disease, caused by inflammation of the intestinal lining. It is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.

The etiology and physiopathology are multifactorial, complex, and remain poorly understood. The mechanism of the lesions seems to involve factors including immaturity of the intestinal barrier and the immune system, microvascular imbalance, disturbed gut flora and systemic inflammation.

Despite improved knowledge about this disease, the proportion of surviving patients has not improved for several years. It frequently leads to long-term sequelae depending on the severity of the NEC and its treatment.

Early diagnosis and early treatment of NEC may reduce the risk of mortality and morbidity. The aim of this retrospective bi-centric study is to look for risk factors allowing the prediction of NEC in order to prevent and improve the early management of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Premature newborns (\< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.

Exclusion Criteria:

* Children term born (\> 37 weeks of gestation)
* Necrotizing enterocolitis during an hospitalisation outside the NICU of Nancy or Lyon
* Malformation or pre-existing digestive pathology
* Complex or severe malformative pathologies
Correlation of Mukbang Video Watching Behavior,Internet Addition and Mental Health Among Adolescent and Youth

The mental health and Internet addiction problems of adolescents and youth can not be ignored and need to be solved urgently. The behavior of watching "Mukbang" videos may be in a mediating position between the two, and its specific effects and mechanisms are still unclear. Based on the theory of use and satisfaction, this study will further explore the interactive relationship between "Mukbang" and mental health and Internet addiction from the perspective of adolescents and young Internet users. Thereby enriching research paths in related fields and providing theoretical basis for clinical mental health guidance or intervention.

Adolescence and Youth is a critical period for psychological quality training and personality shaping, and their mental health has always been the focus of health management for this population. With the rapid development of short videos and self-media, watching "Mukbang" is a behavioral way for these people to relieve anxiety, depression and other mental health problems. But watching "Mukbang" behaviors may have Internet addiction, and there is a high comorbidity rate between Internet addiction and mental health disorders. "Mukbang" is a newly developed online entertainment method. Its helpfulness in reducing psychological stress, relieving depression and other negative emotions, and the mechanism of action that aggravates the risk of Internet addiction is unknown. At present, the new crown epidemic is spreading all over the world, and the stress reactions such as fear, anxiety, sadness and anger brought to teenagers and young people will induce more psychological problems; and closed management has greatly increased the risk of such people. Internet addiction time, the detection rate of Internet addiction has also greatly increased, resulting in a serious vicious circle. Based on the theory of use and satisfaction, this research will adopt an exploratory time-series mixed design. First, qualitative research is used to explore the possible reasons and related experience of adolescents and young people watching "eating and broadcasting"; Potential related variables and quantitative indicators of watching "eating and broadcasting" behavior, further verify the correlation between "eating and broadcasting" behavior, Internet addiction and mental health; and explore the role of "eating and broadcasting" video watching behavior in mental health and Internet addiction. mediation between them. It provides a theoretical basis for promoting the healthy and psychological development of adolescents and young people, standardizing the management of "eating and broadcasting" videos, and correcting the correct guidance for preventing addiction to the Internet.

Eligibility Criteria:
Inclusion Criteria:

* Internet users aged 14-35；
* Be able to read and communicate in Chinese.

Exclusion Criteria:

* Those who cannot complete communication due to serious mental or physical diseases such as deafness, unclear consciousness caused by mental illness, etc.
Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease

Project 2 of the University of California, San Diego (UCSD) American Heart Association (AHA) Women's Health Program will assess 3-month changes in sitting time, standing time, physical activity and blood pressure in a randomized control trial (RCT). This 2-arm RCT will occur in the community with post menopausal Latina women (N=250) who spend at least 8 hrs/day sitting and have increased risk for cardiovascular disease through high BMI and other cardiometabolic risk factors. Women will be identified through the San Ysidro Health Center and assessed at the South Bay Latino Research Center.

Project 2 will address the following aims:

1. Investigate the 3 month effect of the intervention to impact the primary behavioral outcomes of sitting, standing and stepping time assessed objectively by a thigh worn inclinometer (ActivPAL) in Latinas at risk for heart disease.
2. Investigate the 3 month effect of the intervention to impact the secondary health outcomes of blood pressure, depressive symptoms, and anthropometrics.
3. Explore the psychosocial \& environmental mediators \& moderators of changes in sitting time.

Eligibility Criteria:
Inclusion criteria for RCT (n=250):

1. Postmenopausal woman, no menstruation for at least 1 year, 55+ years of age.
2. Self-identify as Hispanic ethnicity, able to read and write in English or Spanish,
3. Ambulatory, medically stable, able to give informed consent, and safely complete the protocols.
4. Body Mass Index range of 25.0-45.0kg/m2.
5. Sedentary: Average \>8 hours sitting/day, as measured by ActivPAL on 4+ days per week
6. Phone access (to receive counseling)

Prisoners will not be used for this study.

Exclusion criteria applicable only to the RCT intervention trial participants include:

1. Unable to complete the Short Physical Performance Battery.
2. Mental states that would preclude complete understanding of the protocol and compliance.
3. Active cancer or another serious chronic illness that may be associated with weight change
4. Body Mass Index \<25.0 or \>45.0kg/m2.
5. Use of insulin medications.
6. ≤ 8hr average daily sitting time, as measured by ActivPAL.
7. Participating in another clinical trial related to study outcomes (as determined by the PI).
8. Unable to wear devices
A Transdiagnostic Internet Intervention for Parents of Children With Anxiety and Depressive Symptoms

The purpose of this study is to evaluate the efficacy of a transdiagnostic, parent-led, Internet-delivered intervention in reducing child and adolescent internalizing problems.

Anxiety and depressive symptoms are common in children and adolescents. There is substantial research indicating that transdiagnostic Internet interventions are effective for adults and children with anxiety and depressive disorders; however, there is limited research on the efficacy of such programs aimed at parents of children and adolescents with anxiety and depressive symptoms. This study aims to investigate the efficacy of a transdiagnostic Internet intervention for parents of children with elevated anxiety and depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* parent of a child/ adolescent aged 6 to 14 years
* elevated internalizing problems
* have Internet access

Exclusion Criteria:

* undergoing psychotherapy/ pharmacological treatment
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)

A three part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin/metformin 50/500, 50/850 and 50/1000 mg Fixed-Dose Combination (FDC) tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I), Treatment C and D (Part II) or Treatment E and F (Part III).


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception
* Subject is in good health and is a non-smoker

Exclusion Criteria:

* Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder
* Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Subject is a nursing mother
* Subject consumes excessive amounts of alcohol or caffeine
* Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study

We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high definition white light colonoscopy will detect an increased number of nonpolypoid (flat and depressed) colorectal neoplasm.

Interval colorectal cancers diagnosed within a three year period following a clearing colonoscopy have been reported at a rate of 1 cancer/1000 person years.The majority of these cancers are likely a consequence of a missed neoplastic lesion during routine colonoscopy. Recent tandem colonoscopy studies have shown no significant difference in adenoma miss or detection rates using narrow band imaging as compared to colonoscopy using white light. However, higher detection of flat neoplastic lesions using NBI was shown in a meta-analysis and should be furthered studied, especially considering that they are thought to be a strong contributor to a false negative colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients referred for routine colonoscopy are eligible

Exclusion Criteria:

* Known Inflammatory bowel disease
* Referred for endoscopic evaluation and removal of colorectal lesion
* Personal or family history of polyposis or non-polyposis syndrome
* Presentation for emergency endoscopy
* Inability to remove polyp due to coagulopathy or thrombocytopenia
* Inability to provide informed consent
Text Message Based Maintenance Intervention

The study presents findings from a randomized clinical trial evaluating the effects of text messages encouraging short emotion regulation exercises on the course of psychopathological symptoms after inpatient treatment for depression. In this context, the study also compares the effectiveness of standardized versus personalized text messages.

Introduction: The importance of aftercare and maintenance intervention to reduce psychopathology, prevent relapses and stabilize the effects of inpatient cognitive behavioral therapy is well proven. In order to attain a high reachability rate among the patients, simple, quick and low cost methods should be used. Modern communication technologies, such as mobile phones provide this opportunity. Therefore, the current study explores how modern communication technologies can be used as a support system in psychotherapy to realize a reduced psychopathology.

Methods: A total of 150 patients participated in a transdiagnostical 6-weeks text messaging maintenance intervention. The text messages were based on emotion regulation skills. The effectiveness of different variants of the text messages was studied in a randomized controlled trial, comparing the impact on the patient's psychopathological outcome to receiving personalized text messages versus standardized text messages.

Eligibility Criteria:
Inclusion Criteria:

* good knowledge of the german language
* owning a mobile phone

Exclusion Criteria:

* brain damage
* personality disorders
Safety, Pharmacokinetics, and Pharmacodynamics of BIRT 2584 XX in Healthy Male Volunteers

To assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BIRT 2584 XX in single rising oral doses of 5 mg to 700 mg in a polyethylene glycol 400 (PEG 400) solution in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>=18 and \<=50 years
* BMI \>=18.5 and \<=29.9 kg/m2

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, haematological, oncological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Relevant history of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial, (\< 10 days prior to study drug administration or expected during the trial)
* Participation in another trial with an investigational drug (\< 2 months prior to administration or expected during trial)
* Smoker (\> 10 cigarettes or \>3 cigars or \>3 pipes/day)
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation or loss \> 400 mL, \< 1 month prior to administration or expected during the trial
* Clinically relevant laboratory abnormalities
* Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \> 110 ms or QT interval, Bazett correction (QTcB) \> 450 ms or QT interval \>500 ms
* Inability to comply with dietary regimen of study centre
* Inability to comply with investigator's instructions
Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Patients With Mild Cognitive Impairment

The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory representations. This impact of sleep on memory performance can be additionally enhanced by exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy subjects. If patients with amnestic mild cognitive impairment (MCI)- usually characterized by initial difficulties in hippocampus dependent memory functions - benefit from transcranial slow oscillatory stimulation (tSOS) during sleep as well has not been studied so far. The primary goal of the study is therefore to investigate the impact of oscillating current stimulation (tSOS) during a daytime nap on declarative memory consolidation in MCI patients.


Eligibility Criteria:
Inclusion Criteria:

* amnestic and amnestic plus MCI-patients:

  1. Concern reflecting a change in cognition reported by patient or informant or clinician (i.e., historical or observed evidence of decline over time)
  2. Objective evidence of memory impairment; additional cognitive domains may be affected as well;
  3. Preservation of independence in functional abilities
  4. no dementia
* age: 50-90 years

Exclusion Criteria:

* untreated severe internal or psychiatric diseases
* epilepsy
* other severe neurological diseases eg., previous major stroke, brain tumour
* dementia
* contraindications to MRI