cyrilzakka/clinical-trials huggingface dataset:
The Prevalence of Obesity For Schizophrenia Inpatients in Taiwan

This study is the first hospital-based, cross-sectional study to discuss the prevalence of obesity among 710 inpatients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis as ICD 295
2. Living in rehabilitation ward during 2010/03/22\~2010/04/02

Exclusion Criteria:

none
Secondary Care - Continuous Glucose Monitoring

Introduction and objective: The current state of glucose monitoring includes the use of A1C, self-monitoring of blood glucose (SMBG), and continuous glucose monitoring (CGM). CGM technology has got the potential to revolutionize diabetes care in the near future striving to optimal diabetes management and tight glucose control. Until very recently, this determination could only be achieved by the attainment of multiple capillary blood glucose determinations each day and/or measuring hemoglobin A1C. Those methods are not accurate in cases of unrecognized hypoglycemia, unrecognized nighttime events or in cases of large swings in blood glucose. Our aim is to analyze the benefit of tracking patterns of glucose values by using professional CGM technology used for "blinded" collection of glucose data retrospectively in patients with T2DM in secondary care- diabetologist clinic.

STUDY DESIGN: An observational, multicenter, cross-sectional study. A total of 20 diabetologist from four Croatian regions will recruit up to ten subjects of both sexes from May 2018 till the end of May 2019, diagnosed with type 2 diabetes mellitus at least one year prior to study entry, aged ≥40 years, with only basal insulin in therapy and with clinical suspicion of hypoglycemia or with disproportion in actual glycaemia and hemoglobin A1c findings. Sociodemographic, laboratory (HbA1c, fasting and postprandial glucose, total cholesterol, and high density cholesterol, and low density cholesterol, triglyceride and serum creatinine) and habits data will be collected.

SETTING: Totally 100 of patients will be included. At diabetologist office each patient wear the device (iPro™2 Medtronic) subcutaneously for up to 7-days and return it to the office for download. Patients only see the CGM data after it's been analyzed by the healthcare professional. A CGM device is to be set and take off by the diabetologist. Before the study start all diabetologist who are not familiar to the method will have a short education. Study period is seven days and includes screening before study entry and two visits. On Day 1, after screening and signing the informed consent, the CGM device is applied. Patient is instructed to keep a 7 day diary with four daily standard SMBG along with the data on eating, physical exercise, drugs. On Day 7, CGM device is taken off and the data from iPro2 is uploaded to PC. At the end, each patient fills a short query on satisfaction while wearing CGM.

Eligibility Criteria:
Inclusion Criteria:

* T2DM diagnosed at least one year prior to study entry
* Only basal insulin in therapy
* Patients' ability to understand and answer the questionnaire by themselves
* Signed informed consent

Exclusion Criteria:

* Known coagulopathy
* Oral anticoagulants in therapy
* Skin disease that enables continuous glucose monitor device application
* Febrile illness
* Patient's inability to physically visit a general practitioners office
* Patient's inability to answer the questionnaire by themselves
A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes

The purpose of this study is to determine treatment effects in patients with retinal pigment epithelium detachment (PED) in relation to Age Related Maculopathy (AMD). Patients with newly diagnosed PED without choroidal neovascularisations (CNV), will be randomized to either treatment or observation. The treatment group will first be given injections with anti Vascular Endothelium Growth Factor (anti-VEGF). If the injections do not have any effect, Verteporfin Photodynamic Therapy (PDT) will be given. All patients will be followed for a period of 2 years. It is hypothesized that treatment stops the progression of the disease and stabilizes the vision in this subgroup of patients with AMD.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 50 years
* Pigment epithelium detachment in an eye not earlier treated with anti-VEGF or verteporfin PDT.
* ETDRS Best Corrected Visual acuity 20/32 - 20/400

Exclusion Criteria:

* Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy, Previous subfoveal focal laser photocoagulation involving the foveal center, History of vitrectomy, submacular surgery, or other surgical intervention for AMD.
* CNV, Subfoveal fibrosis or atrophy in study eye.
* Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma) or require medical or surgical intervention during the study. Active intraocular inflammation in the study eye.
An Adaptive Treatment Strategy for Adolescent Depression-Continuation

Aim 1: Assess the feasibility and acceptability of the personalized continuation treatment strategy.

Aim 2: Estimate variances of primary and secondary outcomes with the continuation treatment.

Aim 3: Conduct exploratory hypothesis-generating analyses to inform further development of the personalized continuation treatment strategy to be tested in a subsequent R01 proposal.

Male and female adolescents (ages 12-18) will be eligible for the study if they completed acute phase treatment and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \< 3)). Adolescents will enter continuation treatment having either received 12 sessions of IPT-A, 16 sessions of IPT-A, or 12 sessions of IPT-A plus fluoxetine.This is a continuation of the study "An Adaptive Treatment Strategy for Adolescent Depression (PTAD)" NCT01802437

Eligibility Criteria:
Inclusion Criteria:

* Adolescents and parents must be English-speaking
* Completed acute phase treatment (NCT01802437) and showed at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \< 3)).

Exclusion Criteria:

- Did not completed acute phase treatment (NCT01802437) or did not show at least a partial response to treatment (CGI-I of minimally improved or better (CGI-I \< 3)) to acute phase treatment.
Value of MRI in Congenital Heart Disease

Congenital heart disease (CHD) is the most prevalent congenital anomaly and a major cause of infant morbidity and mortality. It encompasses various cardiac chamber anomalies.

CHD diagnosis relied on clinical information from auscultation and heart sounds, with X-rays providing indirect information. Since the 1970s, echocardiography has become the primary diagnostic tool due to its direct, safe, and portable nature, capable of defining anatomy and estimating hemodynamics. However, echocardiography has limitations, While CT provides valuable anatomical details, it lacks hemodynamic information and involves ionizing radiation. MRI, on the other hand, excels in both anatomical and functional analysis, offering detailed hemodynamic evaluations of blood flow through valves, great vessels, and septal defects.

Congenital heart disease (CHD) is the most prevalent congenital anomaly and a major cause of infant morbidity and mortality. It encompasses various cardiac chamber anomalies such as septal defects, valvular lesions, and outflow tract anomalies. Advances in diagnostic tools, medical management, and surgical techniques have significantly improved survival rates, with over 90% of children with complex CHD living into adulthood. As of 2012, the prevalence of CHD was estimated at 3000 per million, and in the U.S., the number of adults with complex CHD increased from 110,000 in 1968 to 270,000 in 2010.

Historically, CHD diagnosis relied on clinical information from auscultation and heart sounds, with X-rays providing indirect information. Since the 1970s, echocardiography has become the primary diagnostic tool due to its direct, safe, and portable nature, capable of defining anatomy and estimating hemodynamics. However, echocardiography has limitations, including a restricted window of visualization.

Previously, CT and MRI faced challenges due to cardiac motion artifacts, but advancements in rapid imaging and high-resolution technology have improved their diagnostic capabilities. While CT provides valuable anatomical details, it lacks hemodynamic information and involves ionizing radiation. MRI, on the other hand, excels in both anatomical and functional analysis, offering detailed hemodynamic evaluations of blood flow through valves, great vessels, and septal defects.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children who diagnosed or suspected congenital heart diseases
* Infants and children who can tolerate sedation or general anesthesia

Exclusion Criteria:

* patients with contraindications to MRI as pacemaker or defibrillator
* patients unable to tolerate sedation or anesthesia
A Study of GC1111 in Hunter Syndrom Patients

The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Hunter syndrome
* Male at the age of ≥ 5
* Adequate abilities (including 6-MWT) to participate in this study in the opinion of the investigator.
* Voluntarily signed written informed consent to participation in this study
* Consent to contraception

Exclusion Criteria:

* Prior treatment with iduronate-2-sulfatase ERT
* History of bronchotomy, bone marrow trasplanation, or cord blood transplanation.
* Known hypersensitivity reactions to any of the components of the invetigational product
* Prior or planned administration of other investigational products within 30 days before treatment with the investigational product in this study or duirng this study.
* Unable to perform 6-MWT.
* Female
Single-Sided Deafness and Asymmetric Hearing Loss

The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.

The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.

Eligibility Criteria:
Inclusion Criteria:

* Five years of age or older at the time of implantation
* Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
* Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear
* Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less
* Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
* Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
* Fluent in English

Exclusion Criteria:

* Duration of profound hearing loss of 10 years or more
* Absence of cochlear development or non-functionality of cochlear nerve
* Other retrocochlear hearing loss
* Evidence of severe cochlear malformation (i.e., common cavity or ossification)
* External or middle ear infection
* Suspected developmental or cognitive concern
* Other medical contraindication for surgery or anesthesia
A Comparative Investigation of Efficacy and Complications in Light and Deep Chemical Peels

Chemical peeling involves applying substances to the skin to induce controlled damage, which promotes the regeneration of fresh skin cells and enhances the skin's appearance.

This study will be a cross-sectional analysis with a sample size of 112 patients.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females aged 18-35 years.
* Willing to provide informed consent and follow the treatment protocol.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Active skin conditions (e.g., acne, eczema).
* Use of medications that affect skin healing.
* Known allergies to chemical peel substances.
Multi-scale Modeling of Breast Conserving Therapy

The proposed study is a single-center, prospective, pilot, observation study to tabulate and measure the changes that occur during treatment and healing for breast conserving therapy (BCT) in women with non-metastatic breast cancer for comparison to the multiscale model of breast lumpectomy and healing in order to identify targets for improving BCT. The study will be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer undergoing BCT. Subjects will be enrolled in the study during the 3 weeks prior to receiving their BCT surgery and will be followed for six months after the BCT surgery. A total of 6 visits (not including the surgery) are planned.

This is a single-center, prospective, pilot observation study. Eligible subjects who enroll in this study will begin at the time of informed consent, which will occur during the pre-operative, surgical evaluation time. Once consented, a 3-dimensional 180° camera surface image will be taken and a pain-scale score will be completed. Data from the medical history will be recorded. As standard of care, the surgery will be scheduled and performed. Following surgery, a series of 5 standard of care visits will occur over the subsequent 6 months, that will include research measures of local ultrasound x5 and 3-dimensional surface imaging x3. The pain scale score will be administered pre and post ultrasound on the 5 post-operative visits. A judging of the cosmesis will take place at weeks 10 and 26 by independent surgeons. The participant's role in the study will be completed after the week 24 visit.

Eligibility Criteria:
Inclusion Criteria:

1. Adult females ≥ age 30 years
2. Have early stage (Stage I, II), non-metastatic breast cancer
3. Planned to receive BCT
4. Have received a pre-operative mammogram within 30 days of surgery
5. Have received pre-operative magnetic resonance imaging (MRI) within 30 days of surgery
6. Planned to receive post-surgery radiotherapy by whole breast radiotherapy
7. Signed informed consent form prior to any research assessment

Exclusion Criteria:

1. Adult females younger than 30 years of age
2. Previous breast cancer
3. Neo-adjuvant therapy for breast cancer
4. Pregnant or nursing females
5. Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug
Fluorouracil, Semustine, and Vincristine Compared With BCG in Treating Patients With Dukes' B or Dukes' C Colon Cancer That Has Been Removed By Surgery

RATIONALE: Drugs used in chemotherapy, such as vincristine, fluorouracil, and semustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as BCG, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether combination chemotherapy is more effective than BCG in treating colon cancer that has been removed by surgery.

PURPOSE: This randomized phase III clinical trial is studying giving fluorouracil together with semustine and vincristine to see how well they work compared with giving BCG in treating patients with Dukes' B or Dukes' C colon cancer that has been removed by surgery.

OBJECTIVES: I. Obtain information to define subsets of colon cancer patients at high risk of recurrence. II. Correlate pathologic and biologic parameters with disease-free interval and survival. III. Determine the value of surgical and ancillary techniques in management of colon cancer. IV. Compare disease-free interval and survival after curative resection vs. chemotherapy with 5-fluorouracil/methyl-CCNU/vincristine vs. BCG immunotherapy. V. Relate the total lymphocyte count to the course of the disease. VI. Determine the feasibility of conducting a trial employing immunotherapy in a surgical adjuvant setting. VII. Identify appropriate future protocols based on data generated in the study.

OUTLINE: Randomized study for patients with Dukes Stage B and C disease only. All patients with Dukes A and D lesions enter Arm I. Arm I: No therapy following surgery. Arm II: 3-Drug Combination Chemotherapy. 5-Fluorouracil, 5-FU, NSC-19893; Methyl-CCNU, MeCCNU, NSC-95441; Vincristine, VCR, NSC-67574. Arm III: Immunotherapy. BCG-Pasteur, BCG, NSC-B116328.

PROJECTED ACCRUAL: Protocol closed February 1984.

Eligibility Criteria:
DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria
Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria

Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with urticaria


Eligibility Criteria:
Inclusion Criteria:

* All the patients who:

  * haven't treatment experience of epinastine product entered the survey;
  * have urticaria

Exclusion Criteria:

* Alesion® Dry Syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Dry Syrup in package insert. However, it was unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey was drug utilization study to observe actual use in any patients. Therefore exclusion criteria are not set in the protocol
Impact of COVID-19 Infection and Confinement on Diabetic Ulcer Management and Amputation Risk

In the context of the COVID-19 pandemic, a number of factors, including the lockdown that was imposed to limit the spread of infection, the fear of being contaminated during hospital consultations and the difficulty in accessing general practitioners may have led to delays in the referral of patients to facilities specialized in the management of diabetic ulcers. Since the beginning of the coronavirus pandemic and during the first lockdown, we observed a clear decrease in hospitalizations and consultations for diabetic ulcers. Patients who had regular follow-up for the management of their diabetic ulcers cancelled their scheduled appointments for fear of being contaminated in the hospital. It is feared that the current epidemic context has favored the delay of referral of patients with diabetic ulcers to specialized facilities, with consequences on the prognosis of these patients and the risk of lower limb amputation.

In this context, this project aims to evaluate the impact of confinement on emergency hospitalizations for foot wounds and the effects on the risk of amputation during the lockdown and the three months following the end of the lockdown.

Our hypothesis is that the lockdown led to a decrease in hospitalizations for foot wounds, resulting in a delay in the management of these patients, and potentially leading to an increase in the number of amputations in the three months following the end of the lockdown.

In parallel, we will also study the impact of confinement on deferrable hospitalizations (glycemic imbalance, assessment of diabetic complications...) or theoretically non-deferrable (diabetic comas, ketoacidosis, diagnosis of type 1 diabetes, acute coronary syndrome, stroke...) of diabetes mellitus. This will allow us to evaluate whether our findings relative to diabetic ulcers could be extended to other complications of diabetes.


Eligibility Criteria:
Inclusion Criteria:

Diabetic subjects with hospital stays in France, 2017 to 2020.

Exclusion Criteria:

Absence of diabetes
Improving Sleep After TKA Using Mirtazapine and Quetiapine

Use of mirtazapine and quetiapine for improvement of sleep quality after TKA

Background After knee replacement surgery there is a loss of quantity and quality of sleep. Loss of sleep is associated with increased pain perception. Subsequently, patients use more analgesic medication and it takes them longer to fully recover from surgery. Low doses of the tetracyclic antidepressant mirtazapine and the neuroleptic quetiapine are nowadays off-label prescribed for insomnia and improve length and quality of deep sleep phases. Quetiapine and mirtazapine could improve sleep after knee replacement surgery and improve patient recovery. This placebo-controlled, randomized, double-blind study investigates the effect of quetiapine and mirtazapine on functional recovery after total knee arthroplasty.

Methods This is a prospective, single center, double-blinded randomized controlled trial. 165 patients with knee osteoarthritis scheduled for total knee arthroplasty will be randomly allocated to a low-dose quetiapine (LDQ), a low-dose mirtazapine (LDM) group or a placebo group. Outcomes will be evaluated at baseline, 2, 4, 6 and 12 weeks after surgery. Functional outcome after total knee arthroplasty is measured using a patient related outcome measure through the Oxford Knee Score (OKS). In order to measure postoperative sleep quality, patients will be monitored using the Leeds Sleep evaluation questionnaire (LSEQ). Furthermore, pain is registered using a visual analogue scale (VAS), weekly opioid use is monitored, and general health status is reported through the EQ-5D. Analyses will be conducted on an intention-to-treat basis using logistic and linear mixed regression models. This trial complies with the SPIRIT guidelines for randomized controlled trials.

Discussion This study will provide clinicians with evidence whether quetiapine contributes to rehabilitation of patients undergoing fast-track knee replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* Indication for TKA

Exclusion Criteria:

* use of benzodiazepines
* use of anti-depressants
* use of oxycodone
* patients diagnosed with obstructive sleep apnea syndrome, severe respiratory insufficiency, or myasthenia
* a known hypersensitivity to mirtazapine, quetiapine and/or related to the gelatinous (placebo) capsule
* insufficient understanding of the Dutch language.
Nasoseptal Double Flap Versus Rescue Flap in Endoscopic Transsphenoidal Pituitary Surgery

This paper investigates the outcomes of two surgical techniques-nasoseptal double flap and nasoseptal rescue flap-used in endoscopic transsphenoidal surgery for pituitary tumors. The nasoseptal flap technique has significantly reduced the incidence of postoperative Cerebrospinal Fluid (CSF) leaks but can cause nasal morbidity.

The study aims to compare nasal morbidity and function between the two techniques in patients undergoing this type of surgery. Each patient's nasal morbidity, olfaction, and postoperative complications will be assessed using various tools.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with symptomatic pituitary macroadenoma
* Tumor size ≥ 2 cm

Exclusion Criteria:

* -Absent sphenoid pneumatization.
* Temporal or frontal extension.
* Recurrent pituitary tumor after previous surgery.
* Previous nasal surgery.
* Associated nasal disease e.g. rhinosinusitis.
* Unfit for general anesthesia.
* Refusal of surgical intervention or signing consent.