cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation Therapy

Diabetic foot ulcers (DFUs) are a frequent clinical problem observed in diabetic patients. Properly managed, most can be cured, but many patients needlessly undergo amputations because of improper diagnostic and therapeutic approaches. The purpose of this study is to evaluate the effectiveness of a compounded, anti-infective irrigation therapy to increase the healing rates of diabetic foot ulcers and thereby provide a new therapeutic option for health care providers treating high-risk patients with DFUs regardless if secondary fungal infections are present.

Participants diagnosed with diabetes type 1 or 2 and with a documented open diabetic foot ulcer/wound with or without a secondary fungal infection will be included in this prospective, active intervention pilot study. Healing rates will be evaluated every two weeks following the initiation of study therapy up to three months. Participants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. Participants will be asked to return to clinic every two - four weeks for assessment of the ulcer and compliance with treatment.

A sample size of approximately 100 patients is estimated to have 90% power to detect 15% improvement in ulcer healing rates to 45% and 35% compared to historical benchmarks of approximately 30% for ulcers of \<6 months duration and 20% for ulcers ≥6 months duration and/or prior treatment failure, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes mellitus
* An open DFU / wound of any size (including those requiring debridement in operation room or clinic setting) with or without a secondary fungal infection
* ≥ 18 years of age
* Treatment naïve or treatment failure with oral antibiotics to current wound infection

Exclusion Criteria:

* Patients who present with untreated or on active-treatment for osteomyelitis, exposed bone, or have a life-threatening need of immediate surgery.
* Patients who are allergic to any components of the investigated product.
* Patients who have ≥ 15 shoe size
* Patients who have received IV antibiotics within the past 30 days
* Patients with HgbA1C \> 14
* Patients on active cancer treatment
* Patients needing re-vascularization of the affected area but did not receive treatment.
* Patients diagnosed with HIV/AIDs
* Patients unable or unwilling to obtain and wear off-loading footwear
Intensive Exercise to Improve Mitochondrial Dysfunction in Pediatric Obesity

Obesity and type 2 diabetes are occurring at epidemic rates in the United States and worldwide. The global burden of diabetes is estimated to double over the next 25 years. Obese children are at risk for the development of insulin resistance, relative insulin deficiency and type 2 diabetes mellitus (DM). The prevention of type 2 DM is hindered by the lack of a non-invasive predictive test, knowledge as to individual risk and effective preventative measures. There is increasing evidence that alterations in mitochondria contribute to the development of diabetes in humans. Therefore, it is important to explore mitochondrial dysfunction as a potential predictor of diabetes in children and a potential target for prevention. The aims of the proposed protocol are to determine whether an intensive exercise intervention can improve mitochondrial function in children identified as having mitochondrial dysfunction and insulin resistance. The use of a non-invasive imaging technique will allow for a functional in vivo assessment of mitochondrial activity. The investigators propose the investigation of an intensive exercise protocol designed to improve mitochondrial function in children who are insulin resistant and have documented mitochondrial dysfunction by magnetic resonance spectroscopy. The study is designed to investigate the plasticity of abnormal mitochondrial function in high risk children. In summary, the proposed projects will investigate mitochondrial function as a non-invasive predictive marker for the development of insulin resistance and type 2 diabetes mellitus in children and attempt to modify mitochondrial function with an intensive exercise intervention. The study of mitochondrial dysfunction in children may both identify those at risk for disease and provide a molecular therapeutic target for prevention and treatment.

The investigators hypothesize that children with insulin resistance and mitochondrial dysfunction who are randomized to intensive exercise versus standard lifestyle advice will show improvement in mitochondrial function and insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Girls and boys ages 10 to 18 years old
* Body mass index more than 95th percentile for age and gender
* Insulin resistance based on:

  * Fasting parameters: Fasting insulin level, HOMA IR
  * Oral glucose tolerance testing
* Mitochondrial function \> 1 median for normal based on control cohort

Exclusion Criteria:

* Underlying medical problem with potential to affect growth, pubertal development or glucose homeostasis
* Chronic medical therapy with glucocorticoids, growth hormone, estrogen, progesterone, testosterone, or other medications with the potential to alter growth, pubertal development or glucose homeostasis within the proceeding 6 months
* Personal history of DM
* Inability to have MRI scan performed due to metal prosthesis or implant
An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure

This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery called the Fontan procedure.

Congenital heart disease (CHD) is a heart problem that some children are born with. It sometimes requires a surgery called the Fontan procedure to improve the blood flow in the body. The Fontan procedure can increase the risk of the formation of blood clots in the blood vessels (called thrombosis), which might lead to death.

The study drug, rivaroxaban, is an approved treatment for preventing the formation of blood clots. It is a type of anticoagulant that prevents the blood from clotting by blocking a protein responsible for it. Rivaroxaban can increase the risk of bleeding.

A previous study suggested that the number of major bleeding episodes did not differ much while taking rivaroxaban compared to aspirin in children with CHD who had undergone the Fontan procedure. However, there is limited information available for Japanese patients.

To better understand the safety and potential risks of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world.

The main purpose of this study is to learn more about the occurrence of major bleeding or non-major bleeding in children who were treated with rivaroxaban. Major bleeding is defined as a serious or life-threatening bleeding episode that can have an impact on a person's health and requires medical attention. Non-major bleeding is defined as a type of bleeding that may negatively impact a person's health if not treated.

The data will be collected from December 2023 to June 2026. Researchers will observe each participant for up to 30 days after stopping the treatment or for a maximum of 2 years.

In this study, only available data from regular health visits will be collected. No visits or tests are required as part of this study. Researchers will use the medical records or interview the children and/or their guardians during regular visits.


Eligibility Criteria:
Inclusion Criteria:

* Patients under the age of 18 years
* Patients diagnosed with CHD who had undergone the Fontan procedure by the investigator under routine clinical practice, and must be judged appropriate for/decided to be treated with rivaroxaban by the investigator under routine clinical practice
* Informed consent form obtained from a legal representative

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice
* Contraindications according to the local marketing authorization
* Previous treatment with rivaroxaban
Study to Assess Iron Chelation Therapy in Patients With Chronic Iron Overload

This is a prospective, multicenter, non-interventional study. Findings are analyzed using epidemiological methods.

This NIS shall document the therapy of chronic iron overload in a broad patient population with either of the approved iron chelators in Germany. The choice of patients and the therapy according to the SmPC follows the clinical routine exclusively. The regular observation time per patient is 24 months.

Corresponding to the clinical routine, follow up visits can be documented after approximately 1, 3, 6, 9, 12 and 18 month with a close out visit after 24 month. In case the iron chelator is switched, the visit scheme should be passed through once again.

Eligibility Criteria:
Inclusion Criteria:

Male and female adult patients suffering from chronic iron overload

* who never received an iron chelator directly before starting an iron chelation therapy
* who received an iron chelation therapy for less than 6 month
* who interrupted an iron chelation therapy for longer than 6 months and will receive an iron chelation therapy again
* who signed the informed consent

Exclusion Criteria:

-
mHealth Physical Activity Intervention for Survivors of Adolescent and Young Adult Cancers

The purpose of this study is to examine the feasibility, acceptability, and gather preliminary data on outcomes of a 3-month mHealth intervention to promote physical activity among adolescent and young adult (AYA) cancer survivors compared to a delayed intervention control group.

Adolescent and young adult (AYA) survivors are not meeting recommended physical activity guidelines for cancer survivors, and few interventions to date have focused specifically on promoting physical activity among AYAs or capitalized on new technologies to deliver them. This is a pilot randomized controlled trial (RCT) to examine the feasibility, acceptability, and gather preliminary data on outcomes of a 3-month mHealth intervention to promote PA among AYA survivors compared to a delayed intervention control group. This project will focus on how to best integrate self-monitoring with wearable trackers, increase self-efficacy, enhance autonomous motivation, and promote social support in a mobile health behavioral intervention that promotes moderate-to-vigorous intensity physical activity (MVPA) among AYA survivors. Participants will be AYA cancer survivors (N=60), diagnosed at age 15 or older and currently age 18-39. AYA cancer survivors will be recruited from the three comprehensive cancer centers in North Carolina to participate in this study. The behavioral intervention will consist of an activity tracker, Facebook group, weekly email lessons, and weekly tailored feedback emails. Assessments of objectively-measured physical activity and other outcomes will be completed at baseline, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer (excluding basal cell skin cancer) at age 15 or older
* Currently age 18-39
* Are 0 to 10 years post active cancer treatment (i.e., current hormonal treatments or maintenance therapies are permissible)
* Able to speak, read and write English
* Have access to the Internet and computer on at least a weekly basis
* Possession and usage of an Internet e-mail address or willingness to sign up for a free email account
* Have active Facebook account
* Willing to be randomized to either arm

Exclusion Criteria:

* History of heart attack or stroke within past 6 months
* Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
* Have a pre-existing medical condition(s) or contraindications that preclude adherence to an unsupervised exercise program, including cardiovascular disease, heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
* Are already adhering to the American Cancer Society's recommendation of ≥150 minutes of moderate-intensity exercise per week (\<150 minutes/week)
* Current participation in another physical activity or weight control program
* Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
* Plans for major surgery (e.g., breast reconstruction) during the study time frame
Does the Central Venous Puncture Needle Need to be 7 cm?

The central venous catheter (CVC) has been used for the first time in clinical use in 1921 and has been used worldwide by 2023. Although there are differences between studies, it is reported that side effects occur in approximately 5-20% of patients undergoing CVC. Common side effects include hematoma, venous puncture, arterial puncture, and pneumothorax, and horner syndrome is also reported in 5% of cases. In particular, in the case of the internal jugular vein (IJV), the possibility of puncture of the internal carotid artery is higher than that of other sites, and the puncture level also varies depending on the depth of needle insertion, which in some cases can cause very serious side effects. The incidence rate of side effects depends on the method of inserting the CVC and the skill of the operator. Previous method approached the IJV using the anatomy ladmark with the blind Seldinger technique, recently, as the use of ultrasound has become more common.

Ultra sound guided CVC insertion tecnique reduce the incidence of side effect. However, there are still major complications exist because less experiance operator inserts needle too deep without caution and only depends on the image of sonography.

Currently, the length of the needle commonly used in the CVC catheter set is 7 cm. In general, the depth from the skin to the IJV is within 1.5cm on either the right or the left, and under the premise that the needle insertion angle is 45 degrees, the distance from the skin to the IJV is within 2cm. Based on this, in previous studies, it was announced that the length of the needle required for IJV access was less than 4 cm.

The purpose of this study is to study the usefulness and safety of the method of sono-guided CVC catheter insertion by fixing the needle at a position 4 cm from the needle tip by placing the suture wing (18G, single catheter set).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who need CVC catheter for operation

Exclusion Criteria:

* Obesity (BMI \> 35)
* wound or infection exist at the puncture site
* History of long term catheter placment in the IJV
* Abnormally small size or deformity of the IJV
* Past history of difiiculty in CVC catheterization

  * If the IJV is located at a depth of 3cm or more from theskin on ultrasound evaluation
Long Term Outcome of Easophageal Atresia : Transmics Profiles in Adolescence

Oesophageal atresia (OAEA), a malformation of the oesophagus present from birth, is characterized by the interruption of the continuity of the oesophagus, which then ends in a cul-de-sac. (Source: Fimatho) An operation is then required to restore continuity to the esophagus. Although this operation enables the vast majority of children to survive the neonatal period, health problems such as gastro-oesophageal reflux, eating difficulties, respiratory problems and growth problems persist throughout life.

The aim of the project is to create a prospective cohort of adolescents aged 13/14, nested in the national AO registry. of adolescents born with esophageal atresia, including a biobank of esophageal mucosa and plasma blood samples. Once the clinical and omic data have been collected, the data will be transferred to the France Cohortes information system for analysis, in order to assess the long-term outcome of this rare disease and establish multi-omic profiles. Once the clinical data have been collected and the omics data (derived from analysis of the biobank's biological samples) have been generated, they will be analyzed by the project partners to assess the long-term outcome of OA and establish multiomic profiles. The raw data will be available on the France Cohorte platform.


Eligibility Criteria:
Inclusion Criteria:

* For the oesophageal atresia group :
* Born with oesophageal atresia (EA) in France or in French overseas departments and territories
* Anastomosis performed
* Included into the ReNaTo registry
* Aged 13 or 14 during the recruitment period
* Patient willing to comply with all study procedures and duration
* Patient will social security

For the blood sub-study :

* Upper GI endoscopy performed as part of care between 13 and 14 years of age with esophageal mucosal biopsy sampling
* Patient having given written consent to participate in the study

For the control arm:

* Upper GI endoscopy performed as part of care between 10 and 14 years of age with oesophageal mucosal biopsy sampling
* Upper GI endoscopy performed as part of care for chronic or acute digestive signs to rule out organic etiology (peptic esophagitis, gastric esophagitis, eosinophilic esophagitis or ulcer)
* Normal endoscopy and histology
* No chronic progressive disease

Exclusion Criteria:

* For the oesophagal atresia arm :
* Concurrent participation in an interventional trial and in the 3 months prior to inclusion
* Parents refusing to participate in the study

For the control arm :

* Histologically non-normal esophageal biopsy
* Parents refusing to participate in the study
* Child with known organic pathology
Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI

Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk for cognitive decline and dementia, with combinations of non-pharmacological interventions providing greatest promise for impacting cognitive aging. This, paired with limited cognitive benefits from pharmacological interventions in dementia, has shifted focus to non-pharmacological interventions administered earlier in the disease course. This application, therefore, proposes a randomized controlled trial (RCT; 12-week active intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided progressive increases in weekly step counts), computer-based cognitive training program (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults with mild cognitive impairment (MCI).


Eligibility Criteria:
Inclusion Criteria:

* MCI diagnosis (can be self referral, will determine eligibility at baseline)

Exclusion Criteria:

* Dementia diagnosis
* Head trauma
* Neuro/psychiatric disorders
* Current substance dependence
* Sensory/mobility deficits
* No more than 1 hour of purposeful, aerobic activity/week
* Currently engaging in any other brain-stimulating computer program (No more than 1 hour a week)
LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon

Although colonoscopy with polypectomy can prevent up to 80% of colorectal cancers, a significant adenoma miss rate still exists, particularly in the right colon. Optimizing the detection of adenomas and sessile serrated lesions in the right colon is crucial to increase the effectiveness of colonoscopy in colorectal cancer prevention.

Last generation Fuji videocolonscopes incorporates the Linked Color Imaging (LCI), a recently developed technology that differentiates the red colour spectrum more effectively than White Light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. The increased colour contrast results in more accurate delineation of abnormal inflammatory or neoplastic findings of colonic mucosa. Preliminary data suggest that LCI may be improve the detection of neoplastic lesion of colon.

The investigators performe a tandem prospective study to compare the right colon adenoma miss rates of LCI colonoscopy with those of conventional white light colonoscopy.

Therefore participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back to back fashion, with standard white light (WL) and with LCI. Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first. The endoscopist are masked to group allocation until immediately before the cecum is reached. Examinations are performed with Fuji videocolonscopes series 700 (EC-760R, EC-760ZP).


Eligibility Criteria:
Inclusion Criteria:

* all outpatients referred for colonoscopy

Exclusion Criteria:

* inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) \< 2 in one colonic segment)
* previous colonic resection
* inflammatory bowel disease
* ereditary polyposic syndromes
* patients on antithrombotics precluding polyp recetion
* absence of informed consent
* inpatients or patients undergoing urgent colonscopy
Role of Transcranial Direct Current Stimulation in Appetite and Weight Control

To study the effects of transcranial direct current stimulation (tDCS) on weight and appetite.

1. To compare weight loss over one month in active tDCS group with sham tDCS group. The investigator will measure weight of every participants at the beginning of the study and one month after the last session of tDCS
2. To compare change in insulin sensitivity over one month in active tDCS group with sham tDCS group. The investigator will measure fasting insulin and glucose level, and calculate homeostatic model assessment-insulin resistance (HOMA-IR)
3. To compare change in cognitive performance as a response to food over one month in active tDCS group with sham tDCS group. The investigator will evaluate performance in a computerized task that measures executive functions under the presence of food (working memory, inhibitory control and a combination of both). The investigator will assess changes in accuracy and speed in the task under active tDCS versus sham tDCS.
4. To compare change in post-prandial glucose excursion and average meal counts per day. The investigator will use continuous glucose monitor to record the frequency and amplitude of glucose excursion.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 80 years of age
* Body mass index \> 30 kg/m2

Exclusion Criteria:

* Current participation in any other concurrent clinical trials or previous participation within 30 days before the screening visit
* Pregnancy or premenopausal women who are trying to be pregnant
* Patients who are incompetent to give consent
* Obesity due to a known secondary cause (Cushing's syndrome, hypothyroidism, etc) or a history of weight loss surgery
* Have taken any of the following medications within the past 3 months:

  * phentermine, naltrexone, bupropion, topiratmate, lorcaserin, phendimetrazine, methamphetamine, benzphetamine, diethylpropion
* Any contraindication to receive transcranial direct current stimulation (tDCS):

  * Personal or family history of seizures, epilepsy or other unexplained loss of consciousness.
  * Current or past history of skin disease or damaged skin on the scalp at the site of stimulation (i.e. eczema, skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.).
  * Prior neurosurgical procedure or radiation.
  * Known diagnosis of brain lesions, such as tumor, stroke or multiple sclerosis
  * Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, Transcutaneous Electrical Nerve Stimulation unit, ventriculo-peritoneal shunt or any metallic implant on the head.