cyrilzakka/clinical-trials huggingface dataset:
Study to Explore the Effective Doses and to Assess the Safety and Efficacy of Hypidone Hydrochloride Tablets

The objective of this study is to evaluate the safety and efficacy of Hypidone Hydrochloride tablets in treatment of patients with major depressive disorder (MDD) by evaluating the change of MADRS total scores from baseline to week 6.

A total of 240 major depressive disorder (MDD) subjects between the ages of 18-65 who have current major depressive disorder diagnosed by DSM-5 will be recruited, Eligible patients will be randomized with a 1:1:1:1 ratio into the 4 treatment arms to receive either Hypidone Hydrochloride tablets or placebo, and will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessment.

The subjects will accept the drug treatment twice daily orally for 6 weeks. During the treatment follow up will occur at 8±1 days after treatment, 15±1 days after treatment, 29±2 days after treatment , 43±2 days after treatment to evaluate the safety and efficacy of the drug.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatient or Inpatient, 18-65 years old, male or female
2. Current major depressive disorder diagnosed by DSM-5, single episode(296.21, 296.22, 296.23), or recurrent episode(296.31, 296.32, 296.33)
3. Montgomery-Åsberg Depression Rating Scale (MADRS) total scores in both Screening and Baseline ≥ 26
4. The first item of MADRS in both Screening and Baseline ≥ 3
5. CGI-S in both Screening and Baseline ≥ 4
6. Able to provide written informed consent forms

Exclusion Criteria:

1. Subjects accord with other mental disorders diagnosed by DSM-5
2. Subjects who attempted to suicide, or who presently have a high risk of suicide, or with the tenth item (Suicidal ideation) of C-SSRS ≥ 3
3. Baseline total scores compared with the screening period, the reduction rate of MADRS ≥ 25%
4. Subjects with serious or uncontrolled cardiovascular disease, liver disease, kidney disease, blood disease, endocrine disease, respiratory disease
5. Subjects with clinically significant ECG abnormal (Male QTcF ≥ 450 msec, Female QTcF ≥ 470 msec)
6. Treatment with a MAOI within the 2 weeks prior to the first dose of trial medication
7. Practicing 2 different treatment methods of antidepressants as recommended dose of full course (≥6 weeks)
8. Subjects who have had a Vagus Nerve Stimulation (VNS) device implanted, or who have received Modified Electric Convulsive Therapy (MECT) or Transcranial Magnetic Stimulation (TMS) within 3 months of Screening, or who received light treatment, laser treatment, acupuncture and other Chinese medicine treatment, biofeedback treatment within 2 weeks of Screening
9. Subjects with a history of true allergic response to more than 1 class of medications
10. Subjects who participated in a clinical trial within the last 30 days
Patient-ventilator Asynchrony During Noninvasive Ventilation Assessed Using Diaphragm Ultrasonography

Fifteen healthy subjects under non-invasive ventilation will be have a recording of surface electromyogram, measurements of airway flows and pressures as well as a continuous ultrasound. The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator.

These records will help to assess the agreement between the detection of asynchronies using electromyography of the respiratory muscles (technique of reference) and the diaphragmatic echography. We will also compare the respective performance of two techniques of diaphragmatic exploration (excursion and thickening of the diaphragm). A sensitivity of Ultrasound technique of at least 90% will be interpreted as a satisfactory index of concordance.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer (male or female)
* Free and Informed Consent

Exclusion Criteria:

* Known pregnancy, parturient or nursing mother
* Minor under 18 years of age
* Major incapable
* Non-affiliation to the social security scheme
* Any history of respiratory pathology
Factors Associated With Perioperative Outcomes in Non-emergency Surgery

This epidemiological study investigates the association of recent stroke, acute coronary syndrome or pneumonia and adverse perioperative outcomes following elective non-cardiac and cardiac surgery using routinely collected UK primary and secondary care patient data.

Previous studies have identified prior stroke, heart attack or current diabetes mellitus and anaemia as important risk factors for adverse outcomes following surgery. Recent heart attacks are associated with greater risks than older ones. While recent data suggests that newer strokes impart significantly greater risk than older strokes, there is a lack of concordance on the literature on this, despite the plausibility of the finding. Despite knowledge that prior pneumonia has long-term health risks, there is a lack of data on whether prior pneumonia influences perioperative risk or whether the time interval from pneumonia to surgery affects this relationship. Furthermore while diabetes mellitus and anaemia are known to be important perioperative risk factors, the relationship between haemoglobin concentration or HbA1c levels and perioperative outcomes is unclear. The aim of this epidemiological study is to explore these associations with perioperative risk in the United Kingdom Clinical Practice Research Datalink (with linkage to Hospital Episode Statistics data and Office of National Statistics mortality data).

The research aims are:

1. To investigate the association between three recent acute medical events (stroke, pneumonia and MI) and adverse perioperative outcomes following non-cardiac and cardiac surgery.
2. To investigate the association between time-elapsed between acute medical events (stroke, pneumonia and MI) and adverse perioperative outcomes following non-cardiac and cardiac surgery.
3. To investigate numerical risk thresholds for haemoglobin and HbA1c that could predict adverse perioperative outcomes following non-cardiac and cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergone a non-cardiac or cardiac elective procedure between 1/01/2004 and 31/12/2013

Exclusion Criteria:

* None
Evaluating New Mexico's Recidivism Reduction Program

A a multi-site trial to measure the efficacy of the Recidivism Reduction Program, a prison based, twenty-one module reentry program operated by the New Mexico Department of Corrections.

The New Mexico Department of Corrections Recidivism Reduction Program (RRP) is designed to provide offenders with knowledge and skills that are transferable to the community setting and to address issues that offenders will invariably face upon release to the community. Transitional coping skills, offender expectations upon release, family issues, and dealing with authority figures are a few of the challenges facing offenders upon reintegration. The Recidivism Reduction Program is aimed at preparing offenders for the potential obstacles that they may encounter upon release to the community and providing them skills to overcome the challenges that they will face. The RRP curriculum focuses on belief systems, self-esteem, and rational thinking. The RRP is a twenty-one module clinician-led program (approximately 100 hours) delivered in a group setting within months of release. Outcomes focus on measures of transition readiness, successful transition into the community, and recidivism.

Eligibility Criteria:
Inclusion Criteria:

* Inmates who have six months prior to release
* Inmates housed at one of the four experimental prisons
* Inmates willing to participate in the Recidivism Reduction Program

Exclusion Criteria:

- Housed in security Level 4 or 5
A Study of Real-world Treatment Patterns and Outcomes in Chinese Advanced NSCLC Patients Who Previously Received at Least 2 Line Treatments

This study will retrospectively collect data of patients with advanced non-small cell lung cancer who have received at least 2 line treatment to investigate treatment patterns, relevant outcomes, and biomarkers detection patterns in Chinese patients with Actionable Genomic Alterations (AGA) or non-AGA.


Eligibility Criteria:
Inclusion Criteria:

1. Participants aged ≥18 years when diagnosed with advanced NSCLC.
2. Histologically or cytologically confirmed stage IV NSCLC.
3. For non-AGA participants , second- or third-line systemic treatment occurred between September 1, 2019 and December 31, 2022, and participants received corresponding immunotherapy in the first or second line.
4. For AGA participants , second- or third-line systemic treatment occurred between September 1, 2019 and December 31, 2022. Among them, participants with documented positive result for EGFR, ALK, or ROS1 testing received corresponding targeted therapy in the first or second line.

Exclusion Criteria:

This study excludes participants who met any of the following criteria.

1. Having records of participation or past participation in clinical trial for lung cancer within the data collection period of the study.
2. Participants with a concomitant cancer at the time of diagnosis of NSCLC (except for non-metastatic non-melanoma skin cancers, in situ or benign neoplasms). Occurrence of cancer within 5 years after NSCLC diagnosis will be considered as secondary cancer.
3. Histology of the tumor is small cell lung cancer, neuroendocrine in origin, or a mixed histologic type with small cell and non-small cell lung cancers.
4. Participants with significantly missing medical record data or patients deemed inappropriate for inclusion by investigators.
Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.

Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Vivatlac Baby). Vivatlac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed for infantile colic according to Wessel's criteria

Exclusion Criteria:

* previous treatment with probiotic or synbiotic
* previous treatment with antibiotics
Prediabetes Intervention With Tea

The goal of this interventional study is investigating the effect of the daily consumption of olive leaves tea on glycemic control of individuals diagnosed with pre-diabetes. The hypothesis of this study is that the integration of olive leaf tea on daily food consumption will favors glycemic control and ameliorate insulin resistance in individuals with pre-diabetes.

This study is a triple-blinded, randomized, placebo-controlled trial with parallel assignment

Eligibility Criteria:
Inclusion Criteria:

At least one of three glycemic criteria for pre diabetes as defined by 2022 American Diabetes Association (ADA) guidelines:

* Fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mml per liter);
* Plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mml per liter);
* Glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mml per mole).

Exclusion Criteria:

* Current use of medication for lowering blood cholesterol, glucose or hypertension;
* History of chronic or severe diseases that may affect study outcomes or limit study participation;
* Pregnancy and breastfeeding
Positive Psychological Interventions for Patients With Multiple Sclerosis

This study aims to determine the effectiveness of positive psychological interventions on the quality of life and well-being levels of patients with multiple sclerosis.Two groups will be selected as intervention and control groups. An intervention method consisting of three good things in life and gratitude activities, each lasting two weeks, was determined for the intervention group. An activity was planned for control group participants to write their daily routines.

People with Multiple Sclerosis (MS) face numerous physical and mental symptoms as well as emotional and social challenges. The fact that the disease usually occurs in young adulthood, when individuals are most productive, causes disability, its unpredictable and variable nature, and the lack of a known treatment make it difficult to live with MS and accept the disease. The physical, cognitive, behavioral and social changes that occur with the disease affect daily life activities, well-being. and greatly affects the quality of life. There are various interventions developed to improve the adaptation processes of individuals diagnosed with a chronic disease such as MS, to prevent and reduce psychiatric symptoms, and to increase quality of life and well-being. One of the intervention approaches is positive psychological interventions from the field of positive psychology. Positive psychological interventions are a psychosocial intervention method based on the systematic completion of certain activities aimed at increasing positive emotions, thoughts and behaviors. Since the interventions focus on strengthening positive mental states rather than reducing psychological symptoms, they also have an advantage over traditional interventions in that they can be applied to both sick and non-patients. However, it appears that positive psychological intervention studies have just begun to be implemented in patients with MS. In our country, no study has been found using positive psychological intervention in MS patients. This study aims to determine the effectiveness of positive psychological interventions on the quality of life and well-being levels of patients with multiple sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS by a neurologist according to McDonald criteria
* Having at least 1 year of MS history
* Expanded Disability Status Scale (EDSS) score measured by the neurology clinic is \<3.5
* Being between the ages of 18-65 being literate
* Ability to communicate in Turkish
* Volunteering to participate in the study

Exclusion Criteria:

* Having an MS attack and using corticosteroid medication for the last 3 months
* A score of 21 or less on the Montreal Cognitive Assessment (MoCA) test
* Having a mental or organic disability in communicating
* Being diagnosed with any chronic disease other than MS
* Using psychotropic medication or continuing psychotherapy
* Not having or being able to obtain a phone that can connect to the internet
Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy

Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT).

The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients
* Patients \>= 18 years
* Patiebts with diagnosis of acute DVT and who have an indication for anticoagulation therapy for at least 12 weeks, who are willing to participate in this study and are available for follow-up

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.
Comparing Early Versus Elective Colonoscopy

This multi-center, randomized controlled trial study is planned to include 162 outpatients with onset of acute lower gastrointestinal bleeding to compare the rate of identification of stigmata of recent hemorrhage (SRH), and other clinical outcomes, including the 30-day rebleeding rate, between 'early' colonoscopy and 'elective' colonoscopy.

All patients will receive early colonoscopy or elective colonoscopy, but they do so by different timing.

Early colonoscopy will be performed within 24 h of the initial visit. Elective colonoscopy will be performed between 24 and 96 h after the initial visit.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged ≥ 20 years, presenting with moderate-to-severe hematochezia or melena within 24 h of arrival, defined as (i) more than three occurrences of hematochezia within 8 h, (ii) hemorrhagic shock, or (iii) requiring transfusion.
2. Provision of signed and dated informed consent form.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Patients with hematemesis, black vomiting, or melena.
2. Patients with upper gastrointestinal bleeding, diagnosed by nasogastric tube or upper endoscopy.
3. Patients who have impossible consumed the oral bowel preparation solution.
4. Patients who have undergone computed tomography.
5. Patients who have been diagnosed with peptic ulcer diseases within the previous 10 days.
6. Ulcerative colitis or Crohn's disease patients.
7. Patients who have undergone abdominal surgery within the previous 10 days.
8. Patients who have undergone polypectomy, endoscopic mucosal resection, or endoscopic submucosal dissection of the lower gastrointestinal tract within the previous 10 days.
9. Patients with suspected perforation or peritonitis.
10. Patients with suspected intestinal obstruction.
11. Patients with hemorrhagic shock refractory to infusion or blood transfusion.
12. Patients who have undergone total colectomy.
13. Patients with suspected disseminated intravascular coagulation.
14. Patients with end-stage malignant disease.
15. Patients with severe cardiac failure.
16. Patients with active thrombosis.
17. Patients with severe respiratory failure.
18. Pregnant patients.
Effectiveness of Supportive Psychotherapy Through Internet-Based Teleconsultation on Psychological and Somatic Symptoms, Neutrophil-Lymphocyte Ratio, and Heart Rate Variability in Post Covid-19 Syndrome Patients

The goal of this clinical trial is to learn about the effectiveness of supportive psychotherapy in post covid-19 syndrome patients. The main questions it aims to answer are:

1. What is the effect of supportive psychotherapy on psychological and somatic symptoms in post covid-19 syndrome patients?
2. What is the effect of supportive psychotherapy on the neutrophil lymphocyte ratio in post covid-19 syndrome patients?
3. What is the effect of supportive psychotherapy on heart rate variability in post covid-19 syndrome patients?

Participants will be given supportive psychotherapy in the form of an online group for 3 times a week with a duration of psychotherapy ranging from 1 - 2 hours per session.

Researchers will compare the supportive psychotherapy group to education group as control. The control group will be given education about Post Covid-19 syndrome in the form of an online group for 3 times a week with a duration of around 1 - 2 hours per session.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over
* Patients confirmed positive for SARS CoV-2 by molecular testing (SARS CoV-2 RT-PCR, naso-oropharyngeal swab) at least 3 months before recruitment, with symptoms and effects lasting for at least 2 months and not explained by alternative diagnoses other
* Patients with or without comorbidities: diabetes mellitus, hypertension, tuberculosis, asthma, chronic obstructive pulmonary disease, chronic kidney disease, heart disease, chronic liver disease, malignancy, nervous system disease, patients with vulnerability, patients with disabilities.
* Patients can communicate and are willing to be interviewed, fill out questionnaires and psychotherapy.
* The patient is willing to fill out and sign an informed 1 sheet of consent to participate in the study

Exclusion Criteria:

* Psychosis
* Can not access internet for psychotherapy
* Not willing to take part in the research
The Improving ATTENDance to Cardiac Rehabilitation Trial

The benefits of cardiac rehabilitation are well known. However, despite center based cardiac rehabilitation (CBCR) representing guideline-based care for patients with cardiovascular disease, most patients do not complete the maximum number of sessions allowed by third party insurance payers. As such, many patients may not be receiving the full clinical benefit ascribed to CR. This study will assess the efficacy of an innovative approach to CR delivery on attendance by combining both center-based and remote- or home-based CR sessions. The intervention group combines center-based CR and remote-/home-based CR and is tailored to the individual needs of each patient, accomplished with the assistance of an easy-to-access telecommunications methodology (telemedicine)


Eligibility Criteria:
Inclusion Criteria:

1. Has agreed to participate in CR and has experienced a cardiac event (myocardial infraction, coronary revascularization, heart valve surgery, or cardiac transplant in the past 6 months; diagnosed with chronic, stable AHA/ACC stage B or C heart failure or Canadian class 0-2 stable angina pectoris)
2. Lives in or plans to remain in the greater Detroit, MI area for the next year
3. Age 18-85 years of age
4. Agrees to attend at least one CBCR session
5. Agrees to scheduling at least 2, up to 3, CR sessions (either CBCR or HYCR)/wk
6. Has demonstrated to research staff their ability to access and connect to the internet via smart phone or tablet and already has access to satisfactory home- or community-based exercise equipment

Exclusion Criteria:

1. Received a left ventricular assist device, receiving continuous inotropic support (e.g., milrinone), or undergoing hemodialysis
2. Angina at rest or with a low functional capacity (\< 2 METs)
3. Advanced cancer, advanced risk for falling, limiting cognitive impairment, or other advanced disorder that limits participation in CR

   1. Advanced risk for falling will be assessed by 5X sit-to-stand test, with a cut-off score of \>15 seconds
   2. Cognitive assessment will be completed using the Mini-Cog instrument, with a cut-off score \< 3 used to exclude potential subjects.
4. Severe arrhythmia unless adequately treated (e.g., implantable cardiac defibrillator)
5. Pregnant or plan to become pregnant in the next year.
6. Major cardiovascular procedure or hospitalization planned in the next 6 months
7. Less than 12 month life expectancy
8. Participation in another clinical trial that interferes with iATTEND participation, follow-up, data collection, exercise capacity or quality of life.