cyrilzakka/clinical-trials huggingface dataset:
Association Between Cardiovascular Diseases and Mental Illness

Cardiovascular diseases (CVD) are important public health concerns around the world and closely associated with the development and progression of mental illness, which in turn increases the risk of developing cardiovascular diseases. This study aimed (1) to explore the known or unknown protective and risk factors underlying this comorbidity using questionnaires; (2) to study the biomarkers (body fluid, imaging) of the participants, and to find the influence on the relationship between CVD and mental health; (3) to identify high-risk populations for mental disorders in CVD patients and to establish prediction models. (4) to establish a specialized medical database.

Patients with depression and cardiovascular comorbidities have a worse prognosis, a sharply reduced quality of life, and a much higher incidence of fatal CVD events, such as acute infarction, than patients with a single disease. However, due to the variety of potential causative factors and clinical manifestations, population variability, long duration of the disease, as well as neurological disorders of the exact causative mechanism still unclear, the psychological assessment among patients with cardiovascular diseases is remarkably inadequate studied.

In this study, two cohorts are established that include 2000 hospitalized patients and 5000 of the entire population. All individuals are screened for depression and anxiety. Those who score positive will be advised to enroll in this study. Patients are then randomized to receive collaborative care involving the patient, the patient's primary care physician, cardiologist and nurse case manager, or usual care is defined for each patient. Whole blood and serum samples are obtained from all patients, which will be measured for a panel of metabolic and inflammatory indicators. Patients in both cohorts will be monitored for depression severity and duration at 6 and 12 months after enrollment. A statistical technique is applied to determine the effect size of potential risk factors.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatient and inpatient cardiology patients, diagnosed with at least one cardiovascular disease and at least one psychological disorder
2. Cardiovascular diseases: ACS (STEMI, non-STEMI, unstable angina), arrhythmia (atrial fibrillation, atrioventricular block), heart failure (stable/unstable), hypertension, cardiomyopathy (hypertrophic, dilated)
3. Psychological disorders: structured interview diagnosed as depression, anxiety, insomnia; PHQ-9/GAD-7 score ≥ 10 points.

4．18-70 years old

Exclusion Criteria:

1. Clear suicidal ideation: PHQ-9 item 9 suicide ideation ≥ 3 points
2. Severe mental illnesses such as bipolar disorder, schizophrenia
3. Currently under psychotherapy
4. Severe cardiovascular diseases or other severe chronic life-threatening diseases
5. Refusal to participate
6. Abuse of alcoholism and drugs
7. Pregnant or breastfeeding
8. Cognitive impairment
Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment

In this prospective open clinical study, Pubertal Replacement in Boys Study (PRIBS), boys 14-16 years with delayed puberty in terms of slow pubertal progression, were randomized to SoC treatment with TE: Testostoviron depot® 75 mg intramuscularly (i.m) / month (6 injections), or low dose TU: Nebido® 250mg i.m. / 3 months (2 injections). Our goal was to implement a study similar to clinical routine.

Boys 14-16 years with pubertal delay were randomized to standard treatment with TE (Testosterone enanthat 75mg /month 6 injections)or newer treatment TU(Testosterone Undecanooat 250mg 2 injections 3 months apart) for pubertal induction. Our study PRIBS (pubertal replacement in boys study) was academically sponsored, monitored and approved by the medical products agency in Sweden. Between 2014 -08 and 2019-07 27 boys were randomized to treatment with TE (12 boys) or TU (15 boys). Testosterone levels were measured twice before study start and after 2,7,30,60,90,180 and 365 days. Boys with delayed puberty \> 14 years with morning testosterone levels 0,5 - 3 Nmol/L and testicular volume ≤ 6 mL were included.Primary Outcome was testicular enlargement ≥ 8mL after 12 months. The new treatment was considered clinically similar if the treatment result were in the 80-125% interwall of the traditional group. Fishers exact chi square test was used for this analysis. Our intention was to recruit 20 boys in each armInformed consent was signed before study start by parents and assent by the boys. PRIBS was approved by the regional ethic committee 2012-09-14 Dnr 506-12 and approved by Union Drug Regulating Authorities Clinical Trials Database EudraCT nr 2012-002337-11 and the Swedish drug authorities (Läkemedelsverket) All study personal was trained in ICH GCP (good clinical practice).

Eligibility Criteria:
Inclusion Criteria:

* • Signed informed consent

  * Two morning testosterone values (07.30-09.00) of 1-3 nmol/L and at start \< 4 mmol/L ¹
  * Testicular volume 4-6 mL bilaterally²

Exclusion Criteria:

* • Growth spurt

  * Untreated hypothyroidism, celiac disease or steroid medication
  * Training doses \> 10 hours a week
  * Use of anabolic steroids or other drugs
Apollo Overstitch, a Treat and Resect Model

The Overstitch (Apollo Endosurgery, Austin, Texas) is an FDA cleared product which attaches to a standard double channel endoscope. The Overstitch can place sutures under endoscopic guidance, with the goal of reproducing standard surgical techniques. These would include hemostasis, tissue approximation, anastomosis formation, fixation of intraluminal devices, or repair/closure of mucosal or full thickness defects such as perforations or endoscopic mucosal resection (EMR) sites. Knot tying of the endoscopically placed sutures is provided by an endoscopic cinching device that passes through the channel of the endoscope.

This feasibility trial will evaluate the ability of the Apollo suturing device (Overstitch) to endoscopically place sutures into normal mucosa, and then "tie" the sutures with the cinching device. These devices have been utilized effectively in explant, live porcine, and human cadaver colon and stomach models. In this treat and resect model, sutures would be placed in a segment of colon or stomach that is being surgically removed via open or laparoscopic technique for the treatment of benign or malignant disease. The sutures would be placed in a segment of normal mucosa remote to the pathology being surgically treated. In addition, the sutures will be placed under direct observation via laparoscopic or open visualization. After resection of the segment of colon, it will be evaluated grossly for level of suture placement, evidence of perforation, and quality of suture approximation with the cinching device.

During the colectomy procedure, the intended proximal and distal margins of resection will be determined, and the protocol will proceed only if it is fully determined that the tissue will be fully resectable. The overstitch device affixed to a standard double channel gastroscope will then be advanced transanally into the segment of planned resected colon, away from the area of disease so as to not interfere with oncologic principles or post-resection pathologic evaluation. Endoscopic sutures and knot tying cinching elements will be placed, with a limit of 15 minutes for the total procedure. The entire procedure will be closely monitored under laparoscopic or open surgical visualization. After suture placement, the surgical resection will continue as planned. The specimen will then be examined for depth of suture placement, evidence of perforation, and quality of the suture approximation with the knot tying element.

Eligibility Criteria:
Inclusion Criteria:

* The patient population in this study will be candidates of either sex, over 18' who have an established indication for a surgical procedure requiring resection of a portion of colon distal to the splenic flexure. This will include both benign and malignant diseases.

Exclusion Criteria:

* Any underlying pathology in the determination of investigator that subject cannot undergo scoping
* Sutures cannot be placed in segment of bowel that will be included in the surgical resection
* Pregnant women will be excluded from participating in this protocol
Prognosis and Course of COVID-19 Infection in Hospitalised Patients

The aim of the cohort prospective observational study is to define the major factors influencing the course of COVID-19 infections and its prognosis in hospitalised patients.

The investigators plan to include 300 patients hospitalised with COVID-19 infection.

The phone contacts with patients are due after 90 and 180 days after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalisation with COVID-19

Exclusion Criteria:

* History of hospitalisation with COVID-19 infection
* Discharge from the hospital before the end of the treatment course
* Transfer to another hospital
The Effect of 'Sniffing Position & Nasal Tip Lifting' in Nasotracheal Intubation

The goal of this prospective randomized study is to compare the effect of nasal tip lifting during nasotracheal intubation.

The question the investigators are trying to answer is: If the nasal tip is tilted, will the E-tube be more likely to enter the lower passage during nasal intubation?

There are three nasal turbinates inside the nasal cavities. Each nasal cavity is divided into four spaces from these nasal turbinates, but the two spaces separated by the upper nasal turbinate are too narrow to be clinically meaningful. So when performing nasotracheal intubation, the tube enters one of the two spaces in low part divided into the lower turbinate. The middle turbinate, unlike others, a large number of blood vessels and nerves are distributed. Therefore, less hemorrhage might occurs when the tracheal tube enters into the lower pathway below the lower turbinate because the tube would not scratching the middle turbinate.

The hypothesis of this study is that the method 'sniffing position and nasal tip lifting' increases possibility to enter into lower pathway when the tube enters the nasal cavity. The purpose of a present study was to investigate the effect of 'sniffing position \& nose' on the intranasal route of the tube.

Eligibility Criteria:
Inclusion Criteria:

* The patients who need to nasotracheal intubation for surgery.

Exclusion Criteria:

* Who doesn't agree to enroll.
* Who has severe nasal deformities.
* Who has a problem to make sniffing position or nasal tip lifting
* Who has severe nasal bleeding history.
Skills Training Within a Family-based Obesity Treatment Intervention

This study is investigating the impact of a skills training program in stimulus control of meals and snacks on zBMI. Participants will be randomized to a standard family-based obesity treatment intervention with education on child health or a standard family-based obesity treatment intervention with experiential learning about meal stimulus control strategies.

Family-based obesity treatment interventions can successfully reduce weight in children, but are often limited in the practice of skills being taught during treatment sessions.

Skills training focused on a particular behavioral strategy can provide parents with an experiential component of learning where the information learned as part of a family-based obesity treatment intervention is also practiced. Health education simply provides knowledge to a family about a topic.

Eligibility Criteria:
Inclusion Criteria:

* caregiver of child is ≥18 years of age;
* the caregiver has a child between the ages of 4 and 8 years-old who is classified as overweight (body mass index for age ≥ 85th percentile);
* the caregiver and child are able to read, speak and understand English due to delivery of the program in English;
* has transportation to the University of Delaware; and
* is willing and able to commit to the 3-month study.

Exclusion Criteria:

* the child has a medical condition impacting physical activity or eating (e.g. Type

  1 or Type 2 diabetes);
* the child have a medical condition that affects growth (e.g. Prader Willi Syndrome);
* the child is currently participating in a weight management program, and/or taking weight loss medication; or
* the caregiver or child has an inability to participate in regular physical activity.
Longo's Intervention in the Treatment of Hemorrhoids and Rectal Mucosal Prolapse

The aim of this study is to define the significance of the distance of the staple line to the dentate line of the anal canal in the efficacy of the Longo's intervention.

Is going to be carried out with patients from 18 to 70 years old with hemorrhoids in a level III and IV in the Lord scale.

In the surgery Longo's intervention would be done by two ways differing in the distance of the suture from the tobacco pouch to the anal margin (4.5 cm in the first group and 6 cm in the second group).

Eligibility Criteria:
Inclusion Criteria:

* Women and men from 18 to 70 years old
* Hemorrhoids in level III and IV in the Lord scale
* Surgery without income and conventional hospitalization

Exclusion Criteria:

* Previous hemorrhoidal intervention
* Actual anal pathology
Single Shot Intrathecal Ziconotide for Painful Neuropathy or Myelopathy

This is a phase 4 study being conducted at the Ohio State University Department of Neurology Multiple Sclerosis Research Program. The purpose of the study is to administer a single shot of intrathecal (injection into the space surrounding the spinal cord via a lumbar puncture or spinal tap) ziconotide as a test dose to patients who have chronic painful myelopathy (pain from spinal cord damage) or painful peripheral neuropathy (pain from nerve damage) that has not responded to other pain medicines.

Study Hypothesis: We intend to determine if a single shot trial (SST) of intrathecal (IT) ziconotide will temporarily reduce pain in these patients. In the proposed study, patients will receive two injections, one of which is the ziconotide and one which is a placebo. They will be blinded and not know which order they receive the treatment versus placebo. The results of this clinical trial will provide a focused examination of ziconotide efficacy and safety in patients with painful neuropathies or myelopathies that have not been effectively treated with other pain medications. Moreover, the use of a single shot trial (SST) IT injection in the outpatient setting will provide evidence for application of this technique in outpatient neurological clinical practice, thereby improving access to this specific patient population. Ziconotide is currently FDA approved for this indication and route of administration. Therefore, a study design that improves the feasibility of ziconotide trialing specifically in the neurology clinic (that is, single shot administration) is being used in order to ensure its broader use by neurologists who routinely care for neuropathy and myelopathy patients. Information from this study will also inform future studies of predictors for long term efficacy after pump placement.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women 18 years or older.
2. Neuropathic pain due to peripheral neuropathy or myelopathy
3. Duration of condition greater than 6 months
4. Inadequate control with trials of three or more analgesic agents considered standard care for treatment of neuropathic pain; treatment failure can be either due to lack of efficacy or to intolerable side effects.
5. Documented normal CK and GFR within 6 months preceding screening.
6. Baseline BPI pain severity subscale score of \>5/10

Exclusion Criteria:

1. Renal insufficiency
2. History of Myopathy or persistently elevated CK levels
3. History of prior suicide attempt or ideation
4. History of Psychosis
5. Pregnancy or breastfeeding
6. Inability or unwillingness to use contraception
7. Inability to provide consent
8. Inability to tolerate lumbar punctures
9. Receiving systemic anticoagulation therapy (eg. Coumadin)
10. Inability/unwilling to self-catheterize if indicated
11. Change (start, stop, adjust) in home medications 30 days prior to screening visit.
12. Baseline CES-D score \> 30
13. Subject has previously failed ziconotide treatment
14. Other factors that in the opinion of the PI would exclude the subject from participation in the study
Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit

The objective of this research is to evaluate the correlation between DECT and US explorations performed in a routine clinical setting for the measurement of change in tophus size in gout patients after 24 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of gout based on the ACR/EULAR 2015 criteria
* uricemia ≥6 mg/dL
* warranted introduction of urate-lowering therapy according to the ACR 2012 or EULAR 2016 criteria
* signature of the informed consent
* social insurance affiliation

Exclusion Criteria:

* pregnancy or breastfeeding
* patient under legal guardianship
Effect of Twice Daily Application of Coconut Oil in Reducing Water Loss From Skin of Premature Babies in First Week of Life

The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits even more vulnerability to the environment due to poor self regulatory heat mechanisms, paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight as water loss from their skin during the first week of life. Many strategies have been utilized by neonatologists to decrease this water loss. Edible coconut oil application on the skin acts as a non permeable barrier and can help in achieving this. Hence the investigators decided to undertake this study to objectively assess the reduction in water loss from skin after oil application.


Eligibility Criteria:
Inclusion Criteria:

All preterm babies born at the study center with birth weight \< 1500g were eligible for inclusion in the study.

Exclusion Criteria:

1. Babies with birth weight less than 750 gms at birth
2. Babies with major congenital malformations.
3. Babies with severe asphyxia, hydrops and shock.
4. Babies with congenital diseases of skin associated with skin breach or denudation of skin precluding oil application
5. Babies with preexisting skin infection such as multiple furuncles (2 or more skin areas - each limb, head, chest, abdomen and back are the individual areas that will be taken as one area)
DAOIB Combined With tDCS for Early-phase Dementia

This is a 24-week randomized, double-blind, placebo-controlled trial. We will enroll patients with aMCI or mild AD. All patients will receive 2 weeks of tDCS (5 sessions per week, 10 sessions in total) during the first 2 weeks of the study, and will also be allocated randomly to either of 2 treatment groups for 24 weeks: (1) DAOIB group; (2) placebo group. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that augmentation with DAOIB will yield better effect than tDCS alone in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild AD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
* MMSE between 10-26
* CDR 1 or 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* Severe visual or hearing impairment
Effects of Myofascial Release on Pain, Disability and Electromyography of Erector Spinae in Chronic Low Back Pain

The purpose of this study is to determine whether myofascial release techniques are effective in the improvement of pain, disability and electromyography response of lumbar muscles in patients with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* low back pain for more than 3 months

Exclusion Criteria:

* vertebra fractures
* systemic disease (spondylitis, neoplasia, infectious, vascular, endocrine or metabolic disorders)
* spinal surgery
* advanced lumbar instability
* osteoporosis (in advanced stage)
* degenerative articular disease
* acute soft tissue inflammation
* rheumatoid arthritis
* osteomyelitis
* neuromuscular disease
* lower limb musculoskeletal injuries
* radiculopathy
* cauda equine syndrome
* myelopathy
* stenosis
* structural spine deformity (kyphoscoliosis...)
* pregnancy
* abundant menstruation
* IUD carrier
* mental disease
* dermatologic disease
* skin sensitivity
* aneurysma
* corticosteroids treatment
* anticoagulant therapy
* hypertension
* diabetes
* hemophilia
* leucemia
* rejection to manual contact
Efficacy and Safety of Remimazolam Compared With Midazolam During Bronchoscopy:Randomised Controlled Trial

Objectives: Although remimazolam is an ultra-short-acting benzodiazepine with a shorter elimination half-life and faster recovery time than midazolam, studies evaluating its safety and efficacy during bronchoscopy are limited. This study compared the safety and efficacy of remimazolam with that of midazolam for bronchoscopy.

Design: A single-center, prospective randomized parallel-group study

Setting: Chungbuk National University Hospital, April 2022-June 2023.

Participants: One hundred patients were enrolled; 51 were randomly assigned to the midazolam group and 49 to the remimazolam group. Respiratory nurse specialists performed the randomization.

Interventions: Oral and laryngeal anesthesia was induced using a 4% lidocaine nebulizer prior to sedation. The vocal cords and lower airway tract were anesthetized.

Patients aged \<60 years or weighing \>50 kg received 3 mg intravenous midazolam or 5 mg remimazolam. Patients aged ≥60 years or weighing \<50 kg received 2 mg intravenous midazolam or 3 mg remimazolam. Bronchoscopy was performed under adequate sedation (MOAA/S≤3)

Main outcome measures: The primary outcome was the time from the end of the procedure to full alertness. Secondary outcomes were procedural time parameters, satisfaction profiles, and adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 years who required diagnostic or therapeutic bronchoscopy and agreed to participate

Exclusion Criteria:

* 1) pregnancy, 2) moderate-to-severe hepatic impairment and lactose intolerance 3) mechanical ventilation 4) history of tracheostomy 5) poor patient cooperation