cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa

The purpose of this study is to investigate a treatment to enhance the healing of acute and chronic nonhealing cutaneous wounds, such as the erosions experienced by patients with Epidermolysis Bullosa (EB), by the known activity of thymosin beta 4 (Tβ4). Funding Source - FDA Office of Orphan Product Development (OOPD).

EB is a group of genetic diseases characterized by skin-blistering and lesion-formation after minor trauma to the skin. This family of disorders, most of which are inherited, range in severity from mild to the severely disabling and life-threatening. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent form signed by the patient or patient's legal representative; also, if the patient is under the age of majority but capable of providing assent, signed assent from the patient
* Diagnosis of junctional or dystrophic EB.
* Patients who present with Hallopeau-Siemens subtype may be enrolled.
* At least one active, unroofed EB erosion on the limb or on the trunk.
* Lesion size 5 to 50 cm2, inclusive.
* Stable lesion present for 14-60 days before enrollment.
* More that one member in a family can be enrolled as long as that member is treated to a different cohort with an assurance that the study medication will not be shared.
* No clinically significant abnormalities (Grade 2 or higher on the National Cancer Institute \[NCI\] toxicity scale) on Screening laboratory tests, except for the following specific laboratory threshold result: albumin must be 2 g/dL or higher; hemoglobin must be 8 g/dL or higher.

Exclusion Criteria:

* Clinical evidence of local infection of the index (targeted) lesion.
* Use of any investigational drug within the 30 days before enrollment.
* Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.
* Use of systemic or topical steroidal therapy within the 30 days before enrollment.Inhaled steroids are allowed.
* Use of systemic antibiotics within the 7 days before enrollment.
* Current or former malignancy.
* Arterial or venous disorder resulting in ulcerated wounds.
* Diabetes mellitus.
* Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)
Self-Management for Amputee Rehabilitation Using Technology

The purpose of this study is to determine the effect of 6 weeks of the SMART Program on the walking capacity and confidence of individuals with unilateral lower limb amputation (LLA). Our primary hypothesis is that SMART can improve walking capacity in individuals with LLA. Our secondary hypothesis is that SMART can improve ambulation confidence, body function, depression, body image, pain, balance confidence, activities of daily living, satisfaction with life and habit formation for skin monitoring and prosthetic cleaning in individuals with LLA. A post-intervention one on one interview will be conducted to understand SMART acceptability. The entirety of the study, including intervention administration, assessment, and interviews will be conducted online.

Participants will receive an online link to access the SMART platform. Online training on using the SMART platform will be provided for participants. Participants will be asked to complete one education module per week at their own convenience and weekly online meetings with a peer over the 6-week intervention period. The educational modules include psychological adaptation, residual limb management, nutrition/weight control, managing a prosthetic limb, managing chronic conditions and enhancing mobility. The modules include instructional movies, goal setting logs, and quizzes. A module can be stopped or "re-wound" at any point, and the participant's place and work-to-date is automatically saved. The SMART platform will be asynchronously monitored through a web portal by the trainer, who will be a PhD candidate in Rehabilitation Sciences and observe participant progress and provide feedback if required. If there is no online activity within a 7-day (consecutive) period, the trainer will contact the participant to inquire the reasons for inactivity and troubleshoot any problems including technical issues. Clinical outcomes measures will be collected at two timepoints (T1 \& T2). A post-intervention one on one interview will be conducted to explore SMART acceptability.

Eligibility Criteria:
Inclusion Criteria:

1. adults who are 19 years of age or older.
2. individuals who are post unilateral transtibial/transfemoral amputation and casted an initial prosthesis within the past year.
3. English speaking.
4. living in British Columbia or Ontario, Canada.
5. have access to an internet connectable device (e.g., computer or tablet)

Exclusion Criteria:

1) people who are unable to use SMART program (e.g., visual, auditory, cognitive, or physical impairments)
Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®

The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.

Cook Medical has reported thrombus formation with or without occlusion of the Zenith Alpha Spiral-Z®. The purpose of this study is to measure the extent of thrombus formation and occlusion of these stent graft limbs in patients with aortic aneurysms treated at St. Olavs Hospital in 2017, 2018 and 2019. Information is collected from the Norwegian registry for vascular surgery (NORKAR), electronic patient journal and the picture archiving and communication system (PACS). The total number of included patients is estimated to be approximately 100.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have received endovascular treatment with the Zenith Alpha Spiral-Z® for an aortic aneurysm
* The endovascular procedure was performed at St Olavs Hospital from January 2017 until December 2019

Exclusion Criteria:

* None
Pyruvate Kinase Deficiency Global Longitudinal Registry Substudy of Protocol AG348-C-008

This is a substudy of Study AG348-C-008, an observational, longitudinal, multicenter, global registry that aims to better understand the longitudinal clinical implications of pyruvate kinase deficiency (PK deficiency). The primary purpose of this study is to describe the cognition of participants with PK deficiency, as objectively measured by the Cogstate Brief Battery (CBB).


Eligibility Criteria:
Inclusion Criteria:

* Participant must be ≥18 years of age;
* Participant must be enrolled in Study AG348-C-008.
Glycaemic Index and Substrate Metabolism

Substrate metabolism during exercise can be influenced by various nutritional regimes. The effectiveness of the different nutritional regimes, which differ in their carbohydrate content, will be investigated not only by functional tests but also the measurement of the mechanistic processes in the muscle will be explored.

Magnetic resonance (MR), better known as magnetic resonance imaging (MRI), has been widely used in clinical practice as a non-invasive imaging technique. Importantly, in addition to producing anatomical images, an MR scanner also offers the possibility to measure the concentrations of a number of metabolic products. This is done through a technique known as magnetic resonance spectroscopy (MRS).

This research project asks the following questions:

* Can a diet containing carbohydrates with a low glycemic index achieve the same adaptations in basic endurance/fat metabolism as a high fat, low carbohydrate (ketogenic) diet?
* Does a high-fat, low-carbohydrate diet, compared with a high-carbohydrate diet, prevent improvements in performance in the submaximal and maximal range?
* What is the effect of diets with different carbohydrate content and variable glycemic index on endurance performance in a half marathon and a time trial?
* How do the diets with different carbohydrate content and variable glycaemic index affect the energy and glycogen stores in the muscles?

In active recreational athletes, the objectives are: (1) to investigate the effects of different diets with variable carbohydrate content and glycaemic index on substrate metabolism, (2) to determine the effects of the different diets on energy stores using multinuclear dynamic magnetic resonance spectroscopy, and (3) to measure the effects of the different diets on endurance performance.


Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Age between 18 and 40 years
* Recreational active in leisure time (2-3x/week physical activity)
* Motivation for performance testing and structured training plan
* Interest in different diets
* no acute or chronic illnesses

Exclusion Criteria:

* Contraindications to physical exercise according to ACSM (American College of Sports Medicine) guidelines
* Age \<18 or \>40 years
* Taking medication that could influence the measurements or that is prohibited in training and/or competition according to the WADA (World Anti-Doping Agency) Code
* Competitive athlete with own training plan
* Experience with intervention diets

MRI-specific exclusion criteria:

* Claustrophobia
* Cardiac pacemaker
* cochlear implant
* subcutaneous injection system
* Stents, metal implants, braces, piercings, tattoos
* Body weight of more than 180 kg or BMI of more than 37 kg/m2
A Six-Week Safety Study of an Investigational Ophthalmic Solution

The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to comply with study protocol and follow protocol instructions.
* Adequate birth control methods for the duration of the study.
* Best-corrected visual acuity (BCVA) of 55 or greater in each eye.
* Willing to avoid contact lens wear during each of the study visits; contact lens wear also should be stable and consistent for 1 month prior to Visit 1 and expected to remain the same for the study duration.
* Willing and able to sign an Informed Consent form.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential that are pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
* Evidence of contact lens care solution related ocular surface damage or giant papillary conjunctivitis (GPC).
* Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye or have had any ocular infection within 30 days prior to Visit 1.
* Using systemic medication(s) on a chronic dosing regimen for less than 30 days or changed dosage of this medication within 30 days prior to Visit 1.
* Current or past history of glaucoma or ocular hypertension.
* History of retinal detachment, diabetic retinopathy, or progressive retinal disease.
* Presence of ocular conditions that may affect the study outcomes.
* Corneal conditions affecting the corneal structure.
* History or evidence of any ocular surgical procedure within 1 year prior to Visit 1.
* Current or recent medical conditions that, in the opinion of the Investigator, would preclude safe participation in the study.
* Prior, current, or anticipated use of ophthalmic agents other than investigational product during study participation.
* Participation in any investigational study within 30 days prior to Visit 1 or concomitantly with this study.
* Known contraindications or hypersensitivities to any of the study medications or their components.
* Other protocol-specified exclusion criteria may apply.
Metabolic Control Before and After Supplementation With Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes Patients

Recent data suggest that the trillions of bacteria in the investigators gastrointestinal tracts (gut microbiota) can function as an environmental factor that modulates the amount of body fat. Obese individuals have an altered gut microbiota and germ-free mice are resistant to developing diet-induced obesity and have lower fasting insulin and glucose and improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus strain in fermented milk for 12 weeks reduced adiposity and body weight in obese adults, possibly by reducing lipid absorption and inflammatory status. However, there are no studies to the investigators knowledge that address whether probiotic supplementation improves glucose metabolism in type 2 diabetes patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with a duration \> 6 months
* Abdominal obesity
* HbA1c 50-80 mmol/mol
* Written informed consent
* Stated availability throughout the study period

Exclusion Criteria:

* Autoimmune diabetes eg type 1 diabetes
* Psychiatric illness or cancer diagnosis
* No foreseeable need of treatment with corticosteroids or antibiotics
* Inflammatory bowel disease
* Administration of antibiotics 4 weeks before inclusion
* Administration of probiotics 2 weeks before inclusion
* Participation in other clinical trials
A Combined Psycho-pharmacological and Brain Imaging Study of Human Sexuality

The current study combines a molecular genetic perspective, self report and brain imaging to the study of human sexuality in control subjects and individuals from a sexual disorder clinic. The investigators hypothesize that the variability in components of the brain dopaminergic system expressed in the mesolimbic reward system can explain variability in human sexuality, especially in desire and pleasure associated with sex.

We intend to combine molecular genetics of the dopamine receptors (D2, D3 D4 and D5) and brain imaging using 11 C Raclopride in Positron Emission Tomography (PET). 11 C Raclopride is a ligand which binds to the dopamine receptor D2 and can measure dopamine release during pleasure or anticipatory reward associated with sex. The current proposal will measure changes in DRD2 receptor occupancy using 11 C Raclopride following explicit visual sexual desire cues in healthy control subjects and individuals who suffer from sexual dysfunction. This is in order to determine how individual genotypes modulate dopamine release in vivo in the human brain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers and patients
* Age 21-65
* Male or female

Exclusion Criteria:

* Psychiatric diagnosis/psychosis
* Neurological damage associated with loss of consciousness
* Infectious disease HIV
* Herpes
* Syphilis
* Hyperactivity treated with ritalin
* Pregnant women
* Under age
Prevalence of Attention Deficit Disorder Among Patients With Constitutional Growth Delay

The aim of the our study is to investigate whether there is an increased incidence of ADHD ( based on self reports and questionnaires) among children with short stature due to constitutional growth delay (CGD) in comparison with children with Familial short stature.

Filling out the study questionnaire by ADHD diagnosed and suspected children (have a positive DBDRS (Disruptive Behavior Disorders Rating Scale Questionnaire) result) who were referred to the pediatric endocrine clinic of our hospital for short statue evaluation. The study questionnaire will be filled by child's guardian.

The study and the DBDRS questionnaires will be filled only after obtaining an informed consent.

The required data including growth statistics, age at puberty, bone age and other relevant data will be collected from the child's medical records.

The data on patients will be processed anonymously.

Eligibility Criteria:
Inclusion Criteria:

* undergo evaluation and follow-up due to short stature caused by either CGD or Familial short stature

Exclusion Criteria:

* Children with short stature due to other reasons such as hormonal disorders (thyroid disorders, growth hormone deficiency), genetic syndromes
SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia

Although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently. Dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), have been shown to be clearly superior to more commonly measured static preload variables, such as pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The reliability of dynamic indexes in monitoring the volume status and predicting fluid responsiveness have been validated. Fluid optimization guided by SVV and PPV is beneficial to hemodynamic stability and can decrease mortality and reduce postoperative complications. However, the usefulness of dynamic indexes in elderly patients has not been previously investigated. This study aimed to evaluate whether dynamic indexes PPV and SVV can reliably predict fluid responsiveness in elderly patients, and to determine their thresholds in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* 1.Patients undergoing gastrointestinal surgery 2.Age between 18 and 80 3.ASA I \~II. 4.BMI 18 \~ 24 kg/m2

Exclusion Criteria:

* 1.arrhythmias 2.intracardiac shunts 3.severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral vascular obstructive disease 7.receiving long-term treatment with vasopressors.
Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

An enhanced recovery program has been developed to provide for colon cancer patients faster and more personalized postoperative treatment. Most of the previous studies have showed that the efficacy of the enhanced recovery program on both subjective and objective physical recovery of patients. However, such studies are rarely conducted in South Korea. The purpose of this study is to evaluate the feasibility and efficacy of a postoperative enhanced recovery program in patients who underwent laparoscopic colon cancer surgery at a tertiary hospital in Korea.


Eligibility Criteria:
Inclusion Criteria:

* Eligibility rule of enrollment
* ECOG 0-2
* Pathologically diagnosed colon cancer
* Stage I-III
* No functional disturbance in liver, kidney, bone marrow
* Informed consent

Exclusion Criteria:

* Emergent operation
* Obstructive or perforated cancer
* Rectosigmoid or rectal cancer
* Synchronous tumor
* Uncontrolled psychiatric or neurologic problems
* Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
* Renal dysfunction (Cr ≥2mg/dl)
* Recent MI, CVA, nitrate medication
Effect of Preoperative Oral Carbohydrates on Quality of Recovery

Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.To assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery.

Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.

Eligibility Criteria:
Inclusion Criteria:

1. ASA (I/II)
2. Laparoscopic cholecystectomy.
3. KAROFSKY PERFORMANCE SCALE \>70,
4. No history of major operation

Exclusion Criteria:

1. DM patients
2. GE reflux Hx patients.
3. No- compliance,
4. Previous Abdominal Surgery History
CO-ADAPT: Adaptive Environments and Conversational Agent Based Approaches for Healthy Ageing and Work Ability

The purpose of this study is to identify effective methodologies to help people improve their ability to adapt to psychological stress.

The subjects involved will follow a Stress Management Training (SMT) to learn some techniques to manage stress in the workplace and to increase the effectiveness of the intervention will use an APP and a Conversational Agent (CA) an Artificial Intelligence (AI).

The purpose of the smartphone Application (APP) and CA will be to help people identify their thoughts, help them understand their emotions and the events that generated them.

The data collected and analyzed will be integrated into artificial intelligence to improve understanding of what people are writing.

Based on these analyses, it will be possible to identify the many different variables that interact in cases where a subject shows signs of stress related to adapting to change in the work environment and possible resilience factors that contribute to decreasing the state of stress.

Tests will be administered at the beginning, at the end of the meetings, and 3 months after the end of the sessions. Subjects will be divided into various groups to understand whether APP and CA have a significant impact in increasing psychological well-being and stress coping strategies.

Eligibility Criteria:
Inclusion Criteria:

* whitecollar
* Normal or moderate levels of anxiety and stress
* A sufficient level of education to understand study procedures and be able to communicate with site personnel
* at least 40 to 70 years old

Exclusion Criteria:

* High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
* Current use of narcotics or other substances
OCTA and Polypoidal Choroidal Vasculopathy

To investigate the structural and vascular features of choroid in patients affected by PCV after Ranibizumab intravitreal injection.

Polypoidal choroidal vasculopathy represents a distinct form of choroidal neovascularization.

The study investigated the changes in choroidal vascular network after anti-VEGF therapy using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.

Eligibility Criteria:
Inclusion Criteria:

* age older than 60 years
* diagnosis of polypoidal choroidal vasculopathy
* absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* absence of significant lens opacities, low-quality OCT-A images.

Exclusion Criteria:

* age older than 80 years
* absence of diagnosis of polypoidal choroidal vasculopathy
* presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* presence of significant lens opacities, low-quality OCT-A images.