cyrilzakka/clinical-trials huggingface dataset:
Long-term Outcomes of Patients After Coronary Bifurcation Stenting

The purpose of this study is to assess the long-term clinical outcomes after stenting bifurcation coronary artery lesions, and to determine whether simple or more complex techniques are associated with a better clinical outcome. We will also assess the risk factors associated with poorer clinical outcomes

Coronary artery disease affecting the branch points of coronary arteries (bifurcation lesions) has a higher rate of restenosis after angioplasty than disease in regions not involving branch points. Post-procedural angiographic outcomes and in-hospital outcomes have been documented for a variety of techniques, but none have examined the long-term clinical outcomes.

Long-term clinical outcomes are important from the patients point of view and also determine the use of resources. Knowledge of the long-term outcomes from the various techniques used to treat bifurcation lesions would be important in determining guidelines for the treatment of bifurcation lesions. If simple techniques offer similar or better outcomes than more complex strategies, then this would justify simpler techniques such as main vessel stenting that would use less resources, expose the patient to less radiation, and contrast related to prolonged angioplasty procedures.

Comparisons: We will compare the long-term outcomes of simple versus complex stent techniques, and determine other risk factors for long-term outcome

Eligibility Criteria:
Inclusion Criteria:

* de novo coronary artery lesion in a main branch with at least a 50% stenosis
* lesions involve the ostium of a side branch artery
* main branch and side branch with reference diameters of at least 2mm
* at least one stent used to treat the lesion

Exclusion Criteria:

* restenosis lesions
* reference side branch artery less than 2mm diameter
* multiple bifurcation lesions
Multimodal Imaging in the Study of Disorientation in the Hospital

The purpose of this study is to investigate whether markers of brain structure and function from MRI are associated with different levels of spatial orientation and gait parameters in people with mild cognitive impairment or dementia due to Alzheimer's disease when walking through a real world environment.

This is an experimental cross-sectional study which primarily aims at identifying characteristic features of spatial disorientation among people with mild cognitive impairment and dementia. The features of interest are motion and physiological related changes that occur during instances of spatial disorientation, which will be derived from wearable sensors.

Additionally, brain structure and functional connectivity changes associated with different levels of spatial orientation and gait parameters will also be investigated through resting-state functional imaging.

Eligibility Criteria:
Inclusion Criteria:

* 50 years and above
* Mini mental state examination (MMSE) ≥ 12 \< 28 points for experimental group
* Mini mental state examination (MMSE) ≥ 28 points for control group
* Sufficient knowledge of German to understand participant information, declaration of consent and questionnaires
* Dated and signed declaration of consent
* Sufficient mobility and motivation to participate in the study

Exclusion Criteria:

* Less than 50 years
* Significantly impaired vision or hearing
* Severely reduced mobility: cannot move around independently (even with aids)
Emotional Awareness and SElf-regulation for Depression in Patients With Hypertension (EASE) Study

The purpose of this study is to adapt and then evaluate the feasibility, acceptability, and efficacy of a telephone-based intervention (UPLIFT: Using Practice and Learning to Increase Favorable Thoughts) for individuals with elevated depressive symptoms and hypertension. UPLIFT is a group-based intervention that is delivered over 8 weekly sessions for 1 hour/week by phone.

Aim 1 of this study is to adapt UPLIFT using qualitative focus groups and individual interviews and to test the adapted UPLIFT program in a single-arm design. Aim 2 of this study is a randomized controlled trial (RCT) that will compare the effects of the adapted UPLIFT program to usual care (UC) and to test mediators and moderators of the effects of UPLIFT.

Once 16 participants are enrolled (to form 2 groups of 8 patients each), an independent study staff member will determine participants' group assignments. The randomization sequence will be created a priori by Dr. Keith Goldfeld (biostatistician) by using a computer-generated list of random numbers with stratification by antidepressant medication use and baseline levels of depressive symptoms (PHQ scores \<10 and ≥10).

UPLIFT: Eligible participants will complete 8 weekly group sessions by phone. The intervention builds cognitive-behavioral and mindfulness skills to help reduce depressive symptoms. Each hour-long weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment.

Usual care: Subjects randomized to UC will be advised to seek help from their primary care physician (PCP) or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study. All treatments received over the course of the study for the UC group and outside of the study (for the intervention group) will be assessed at each time point.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypertension based on the criteria in the ICD-9/-10
* Mild to moderate depressive symptoms (PHQ-9 ≥ 5)
* English-speaking
* If taking depression medications, medications must stable for the past 6 weeks (no change to type or dose)
* Willing to provide informed consent, be audio-recorded, and comply with all other aspects of protocol

Exclusion Criteria:

* Moderate to severe depressive symptoms (PHQ-9 ≥ 15)
* Current substance abuse
* Current eating disorder
* Self-harm within the past 3 months
* Current obsessive-compulsive disorder
* Current anxiety disorder (e.g., PTSD, panic disorder)
* Active suicidal ideation
* History of or current diagnosis of psychosis
* Significant cognitive impairment (mini mental state examination score ≤ 20)
* History of previous training in mindfulness
* History of more than 8 sessions of cognitive behavioral therapy
* Counseling more frequently than once per month
Treatment of Pneumonia, Diarrhoea and Fever in Children by Community Health Workers

The investigators propose to test the feasibility and acceptability of community health workers (ASHAs and ANMs) being able to treat sick children in the community. There is a national policy for treatment for children aged 2-59 months with illnesses such as pneumonia, diarrhea and fever by community health workers (CHWs), this policy has not been implemented as yet in Haryana. This research will identify barriers and opportunities for use of CHWs as treatment sources.

Using indepth interviews, focus group discussions and other qualitative research methods barriers and opportunities for promoting use of ASHAs as a treatment source for diarrhea, pneumonia and fever will be identified. An intervention package which includes training of ASHAs and ANMs to treat uncomplicated cases of pneumonia, diarrhea and fever, ensuring they have required supplies, creating awareness in community and monitoring and supervising the treatment provided by them will be implemented in primary health centre areas in Haryana, India. ASHAs will treat cases of fast breathing pneumonia with amoxicillin and refer children with danger signs or chest indrawing pneumonia. Three rounds of cross sectional surveys will be conducted to ascertain prevalence of morbidity, careseeking and hospitalizations in children aged 2 to 59 months.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-59 months with uncomplicated pneumonia or diarrhoea or fever

Exclusion Criteria:

* Refusal for participation
* Diarrhea with dehydration
* Danger signs
* Chest indrawing pneumonia
ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection

Efficacy and Safety of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.

A multi-center, randomized, double-blind, placebo-controlled phase IIc clinical trial of ALA-PDT in patients with cervical intraepithelial neoplasia grade 2 (CIN2) in p16-positivity and high-risk HPV infection.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women, 18-45 years of age
* Satisfactory the colposcopy examination (cervical transformation zone types: Type 1 or 2) at screening, and CIN2 as verified by cervical biopsy and p16-positivity within the last 3 months
* Intense desire to retain the cervical structure or function
* High-risk (including probably/possibly carcinogenic) HPV-DNA (i.e. 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 or 82) positive within the last 3 months
* Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial;no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
* Signed written informed consent

Exclusion Criteria:

* Atypical glandular cells (AGS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
* Invasive carcinoma possibility or lesions extending to the vaginal wall
* Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
* Undiagnosed vaginal bleeding within the last 3 months
* With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
* With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions or long-term glucocorticoid or immunosuppressants exposure; patients with malignant tumors within the last 5 years
* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase \> 3 upper limit of normal \[ULN\], or total bilirubin \> 1.5 ULN, or serum creatinine or blood urea nitrogen \> 1.5 ULN)
* History of treatment with systemic antivirals (continued for ≥ 14 days) within the last 3 months
* Pregnancy or nursing
* Participation in any clinical studies within the last 30 days
* Poor compliance or inability to complete the trial
* Subjects that the investigators judged to be not suitable to participate the study besides above
MRI to Assess the Effects of Dysautonomia and Chronic Nausea on Brain Transmitters

The purpose of this research study is to better understand what causes dysautonomia and how this affects blood pressure and pulse. Dysautonomia is a condition of the autonomic nervous system. It is associated with fluctuations in blood pressure and pulse and may cause symptoms of nausea and belly pain, fatigue, excessive thirst, lightheadedness, dizziness, feelings of anxiety or panic, and fainting. A common example of dysautonomia is postural orthostatic tachycardia syndrome or POTS. Sometimes symptoms worsen when people move from lying down to standing, called orthostatic intolerance. We would like to learn more about the link between orthostatic intolerance and nausea. While medications currently used to treat orthostatic intolerance and nausea have proven to be effective in some patients, this may not be the best treatment for everyone as long term use could pose certain risks including high blood pressure. In order to provide a more focused and safer treatment for patients suffering from nausea and orthostatic intolerance, we have looked at how the blood pressure, pulse, and certain blood tests change during a tilt table test. This test helps to create the same circumstances that patients with orthostatic intolerance experience when they stand. To better understand if some of these problems are associated with the brain, we will study MRI in patients with dysautonomia compared to children without dysautonomia. This information may allow us to use alternative and safer treatments in the future.


Eligibility Criteria:
Inclusion Criteria:

* subjects who have completed tilt autonomic testing
* subjects from 9 - 18 years of age

Exclusion Criteria:

* subjects who have a metabolic, mechanical, or mucosal inflammatory cause which has been defined to explain their gastrointestinal symptoms
* Patients with cardiac or cardiovascular disease, malignancy, psychiatric illness, neurodevelopmental delay, or other co-morbid conditions
* Patients with with pacemakers, implanted devices, or any other MRI contraindications will be excluded from this study.
Efficacy and Safety of BI 10773 in Combination With Insulin in Patients With Type 2 Diabetes

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.


Eligibility Criteria:
Inclusion criteria:

1. Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation
2. Male and female patients with a diagnosis of Type 2 Diabetes Mellitus treated with a stable dose of basal insulin with or without concomitant metformin and / or sulfonylurea.
3. Glycosylated hemoglobin A1c (Type A, subtype 1c) of \>7.0% and \< or = 10% at Visit 1 (screening)
4. Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study)
5. Age \> or =18 years at Visit 1 (screening)
6. BMI \< or = 45 kg/m2 (Body Mass Index) at Visit 1 (screening)

Exclusion criteria:

1. Patients with poorly controlled hyperglycemia
2. Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy
3. MI, stroke, or TIA within 3 months prior to obtaining informed consent
4. Impaired hepatic or renal function; gastric surgery; cancer within the last 5 years; blood dyscrasias

6. Treatment with other anti-diabetics, anti-obesity medications, steroids or thyroid hormones, participation in another trial with an investigational drug 7. Pre-menopausal women on insufficient birth control 8. Alcohol or drug abuse
As an Early Indicator Biomarker of Prognosis and Mortality in Children With Sepsis and Septic Shock: suPAR

The sepsis and septic shock remain major causes of child morbidity and mortality, despite the use of modern antibiotics and resuscitation therapies. Recent interest has focused on biomarkers for early diagnosis, and evaluation the outcomes of sepsis; but there is a still lack of early diagnosis and timely intervention for sepsis in the emergency department (ED). The primary aim was to investigate the role of C-Reactive Protein(CRP), Procalcitonin(PCT), soluble-urokinase plasminogen activator receptor(suPAR) and Presepsin in the early stratification of patients with sepsis. The usefulness of pediatric Sequential Organ Failure Assessment (pSOFA) for predicting of the mortality and the rate of PICU admission in children with septik shock were also investigated. This prospective pilot study was conducted at academic pediatric ED between September 2017-June 2018. All children who met sepsis criteria admitted to ED were involved to study. They kept following up after ED management and their blood samples were taken upon admission on day 0, 1, 2, 4 and 7. The definition made as sepsis, severe sepsis and septic shock. At the same period, 100 healthy children chosen as the control group. The patient characteristics, clinical features, diagnosis, co-morbidities, source of infection, laboratory results (CRP, PCT, lactate, suPAR and Presepsin) and treatments were recorded. The pSOFA score was calculated during first hour of admission. Length of stay in ED and hospital was noted. The main outcome measure was in 7 and 30-day mortality.


Eligibility Criteria:
Inclusion Criteria:

* \<18 years
* Admitted to emergency department with sepsis

Exclusion Criteria:

* \>18 years
* Diagnosed non-sepsis
Behavioral Therapy Combined With Carbidopa/Levodopa for the Treatment of Cocaine Dependence

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effectiveness of levodopa and carbidopa in treating cocaine dependent individuals. In addition, this study will examine the effects of incentive rewards for treatment compliance.

Cocaine is a strong central nervous system stimulant that is widely abused throughout the United States. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Levodopa is a medication that is used alone or in combination with carbidopa to treat Parkinson's disease. The purpose of this study is to determine the possible interactions between behavioral interventions and carbidopa/levodopa in order to treat cocaine dependent individuals.

This study will last 12 weeks and will involve two phases. The first phase will include three therapy conditions: 1) clinical management only, 2) clinical management and relapse prevention therapy, and 3) clinical management, relapse prevention therapy, and contingency management. All of the conditions in the first phase will be evaluated incrementally under active and placebo conditions while participants receive carbidopa/levodopa.

The second phase of the study will examine the contingency management procedure applications. Each of the three contingency management procedure applications targets specific behaviors that, when reinforced, may interact with carbidopa/levodopa to produce clinical benefits. Participants will receive relapse prevention therapy combined with a contingency management procedure that targets clinic attendance, medication compliance, and cocaine abstinence. Study visits will occur weekly throughout the study. In addition, participants will complete a one-year follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for current cocaine dependence
* Provides at least one positive urine test for cocaine during study screening
* Good general health, based on a physical exam, lab tests, and an electrocardiogram
* Reads and writes English at a sixth grade level

Exclusion Criteria:

* Current Axis I depressive, psychotic, or anxiety disorder
* Currently in jail
* Pregnant or breastfeeding
* Requires certain medications
Comparison Study of Compression Devices Used in Transradial Coronary Angiography

The transradial route is used in 90% of the coronary angiograms performed at Oslo University Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to achieve hemostasis. Patients and staff will benefit from using a device that yields safe and painless hemostasis.

Patients will be randomly assigned to receive either the standard compression device (control group, A) or a recently developed compression device (experimental group, B). The study will be designed as a non-inferiority, prospective randomized controlled trial, with outcome measures being patient comfort during compression time and complication rates. Complications that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow up visit. Hematomas or bleeds from the puncture site after application of the compression device will also be classified as complications.

The aim of the study is to investigate whether the new device, RY-STOP is non-inferior compared to the standard device, when considering the outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary angiograms via the transradial route

Exclusion Criteria:

* Patients who have a long way to travel for the follow up, ultrasound scan
* Patients that do not understand Norwegian
* Patients presenting with acute ST segment elevation myocardial infarction (STEMI)
Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.

Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).
* Age 18-80
* Available for follow-up for the duration of the study
* Written informed consent.

Exclusion Criteria:

* Sphincter defect visible on anal ultrasound.
* Pregnancy.
* Rectal prolapse or inflammatory bowel disease.
* Recent (within 6 months) anal surgery except for haemorrhoids.
* Anorectal sepsis.
* Anticoagulant medication or bleeding diathesis.
Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects

The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects

This is a 2-part study with each part is an open-label study in healthy adult subjects.

Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods of Day 1\~7 and Day 13\~19.

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
* Be able to complete the study according to the trail protocol.
* Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.
* Male subjects and must be 18 to 45 years of age inclusive.
* Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive.
* Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

* Use of \>5 cigarettes per day during the past 3 months.
* Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies).
* History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
* Donation or loss of blood over 450 mL within 3 months prior to screening.
* 12-lead ECG with clinically significant.
* Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.
* Subjects deemed unsuitable by the investigator for any other reason.