cyrilzakka/clinical-trials huggingface dataset:
Corneal Confocal Microscopy to Detect Diabetic Neuropathy in Children

The overall aim of this study is to confirm the utility of corneal confocal microscopy (CCM) as a new technique to rapidly and non-invasively assess diabetic neuropathy (DN) in children. This study will be divided into two phases: Phase 1 will be a cross-sectional study of children with type 1 diabetes and normal controls, while phase 2 will be a longitudinal assessment of a subgroup of children with type 1 diabetes recruited during Phase 1.

In phase 1: To compare corneal nerve density (CND), length (CNL), and branching (CBD) by CCM between

1. children with type 1 diabetes for 5 years or more to children without diabetes;
2. children with type 1 diabetes with and without evidence of diabetic neuropathy;
3. to examine the relationship between CND, CNL \& CBD and known risk factors of diabetic neuropathy

In phase 2:

1. to examine for changes in corneal nerve morphology two years after the initial CCM exam.
2. to describe the evolution of diabetic neuropathy based on clinical symptoms, neurological deficits, and other tests of nerve dysfunction.
3. to assess if changes in corneal nerve morphology correlate with changes in nerve conduction velocity and autonomic testing.
4. To examine the risk factors associated with progression of diabetic neuropathy in our pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* CASES: Children with Type 1 Diabetes 8 to 18 years old followed at the Alberta Children's Hospital Diabetes Clinic with a duration of diabetes of at least 5 years.
* CONTROLS: Healthy children aged 8 to 18 years.

Exclusion Criteria:

* Patients with known history of corneal abnormality, trauma, or surgery
* Any other cause of neuropathy
* Individuals with uncontrolled hypothyroidism
* Individuals with celiac disease
* Other serious chronic illnesses besides diabetes
* Inability to cooperate with testing
* Families unwilling to provide written informed consent
Integrating Machine Learning for Prognostic Prediction in Stage I NSCLC by CT Images and Pathological Factors

The investigators retrospectively collected the participants with stage I non-small cell lung cancer (NSCLC) patients resected between January 2010 to December 2020 for training and internal validation. The Clinical data, preoperative clinical information, laboratory results and CT images were collected. The investigators also collected the disease-free survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and expanded outward by 3mm to obtain the peritumor tissue. PyRadiomics was used to extract the radiomic features. LASSOcox and rsf were used to select the features. we developed a machine learning-based integrative prognostic model that utilizes radiomic and pathological variables as input using LOOCV framework. And it was further tested on the internal and external cohorts. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC), IBS, DCA.


Eligibility Criteria:
Inclusion Criteria:

patients with stage I NSCLC (ninth AJCC edition) who underwent curative R0 resections between January 2010 and December 2020 -

Exclusion Criteria:

1. absence of enhanced CT
2. history of lung cancer or synchronous lung cancers
3. follow-up records ≤3 Months
4. carcinoma in situ (CIS) or minimally invasive NSCLC
5. death within 30 days of surgery
6. no pathological slides or reports
Homeopathic Cold Medicine for Children

The purpose of this study is to determine if a commercially available homeopathic cold remedy for children is effective in providing relief from cold symptoms in children 2-5 years old. It is postulated that children will have relief of symptoms after receiving a dose of the cold remedy


Eligibility Criteria:
Inclusion Criteria:

* Children 24-59 months old
* Cold/cough symptoms of \<7 days duration
* Diagnosed with upper respiratory tract infection by physician or nurse practitioner
* Parent who speaks and reads English

Exclusion Criteria:

* Use of chronic medication other than multivitamins
* History of asthma
* Medication other than acetaminophen or ibuprofen
* Use of homeopathic remedy within preceding 30 days
* Only 1 participant per family
ImageReady(TM) MR Conditional Pacing System Clinical Study

The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with the Conditions of Use included in the Boston Scientific MRI Technical Guide


Eligibility Criteria:
Inclusion Criteria:

* Subject must have the ImageReady System as their initial (de novo) pacing system implant
* Subject has a Class I or II indication for implantation of a single or dual chamber pacemaker according to the ACC/AHA/HRS, or ESC guidelines, as appropriate per geography
* Subject is able and willing to undergo an MRI scan without intravenous sedation
* Subject is willing and capable of providing informed consent (which can include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
* Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

* Subject has or has had any pacing or ICD system implants
* Subject has any MR Unsafe implants or devices with an unknown MR status, including MR Unsafe sternal wires, neurostimulators, biostimulator, metals or alloys, per labeling of each implant
* Subject has any MR Conditional implants or devices that impact the ability to conduct this protocol
* Subject needs or will need another MR scan within 14 weeks of system implant, other than that required by the SAMURAI Study
* Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
* Subject has a mechanical tricuspid heart valve
* Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries\* that are not in conflict and do not affect the following:

  * Schedule of procedures for the SAMURAI Study (i.e. should not cause additional or missed visits);
  * SAMURAI Study outcome (i.e. involve medications that could affect pacing thresholds);
  * Conduct of the SAMURAI Study per GCP/ ISO 14155:2011/ local regulations
* Subjects with documented permanent or persistent AF where the physician intends to implant a dual chamber pulse generator (single chamber VVIR pulse generators are acceptable)
* Subject is currently on the active heart transplant list
* Subject has documented life expectancy of less than 12 months
* Women of childbearing potential who are or might be pregnant at the time of study enrollment or ImageReady MR Conditional Pacing System implant (method of assessment upon physician's discretion)
* Subjects currently requiring dialysis
Study Evaluating Changes In Mammographic Breast Density

The objective of the study is to evaluate quantitative changes in mammographic breast density from baseline to 24 months in postmenopausal women receiving daily doses of either BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, Raloxifene or placebo. The primary endpoint in this study is the change in mammographic breast density between baseline and month 24 for each group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed all scheduled evaluations in protocol 3115A1-303-WW.
* Completed 24 months of treatment in protocol 3115A1-303.
* Had a mammogram at the baseline visit and at the month 24 visit in protocol 3115A1-303, and both are original films that are technically acceptable for reading.
* Was at least 80% compliant with test article administration during protocol 3115A1-303.

Exclusion Criteria:

* Had a mammogram at either baseline or month 24 during the 3115A1-303 study that was technically unsatisfactory.
* One or both mammograms were digitized when they were obtained during the 3115A1-303 study.
* Had more than one mammogram at either the baseline or month 24 visit of study 3115A1-303.
Analysis of Spatiotemporal Gait Parameters in Patients With Megaprosthesis.

The main objective of the study is to evaluate spatiotemporal parameters of gait in tumoral patients with megaprosthesis of the distal femur.

Patients with distal femoral prostheses treated at La Fe Hospital in Valencia were evaluated and compared with healthy controls. A radiographic study was conducted in cases using telemetric imaging to assess the percentage of remaining bone and the long length limb discrepancy following surgical intervention. Additionally, a gait analysis was performed using the BTS device to obtain objective gait parameters. The gait assessment was conducted with a non-invasive portable device, the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), which was placed at the S1 level to collect spatio-temporal gait data. The data were analyzed in relation to the values in healthy patients.

Eligibility Criteria:
Inclusion Criteria:

* Megaprosthesis of the distal femur
* Tumor cause
* Surgery at Hospital la Fe.
* Traditional stem or biological ossteointegration system
* Minimum postoperative follow-up period of 3 months

Exclusion Criteria:

* Neurological alterations prior to the intervention that affect the lower limbs or general movement.
* Patient incapable of ambulation due to progression of his/her pathology
* Patient at home with palliative treatment for advanced tumor disease
* Any ipsilateral or contralateral prosthesis.
* Infectious or traumatic cause
Dehydroepiandrosterone Effects on HIV-1 Replication

This study's purpose is to learn how dehydroepiandrosterone (DHEA) affects the HIV virus, the immune system, hormone levels, body composition and quality of life.


Eligibility Criteria:
Inclusion criteria:

* Evidence of HIV-1 infection
* HIV RNA \<50 copies/mL
* Stable antiretroviral treatment regimen for at least 8 weeks
* Age 18 years or older
* Normal pap smear and mammograph within 1 year (females)
* Normal prostate-specific antigen level with in one year, age adjusted (males)

Exclusion criteria:

* Active opportunistic infections or malignancy other than localized cutaneous KS lesions
* Concurrent or prior use within the past 8 weeks of DHA, testosterone, other anabolic steroids, corticosteroids, megestrol acetate, growth hormone, IL-2, or thalidomide
* Diagnosis of AIDS Dementia Complex (stage II or higher)
* Active substance abuse (e.g., alcohol or injection drugs)
* Evidence of severe liver dysfunction or hepatic transaminases greater than 3x the upper normal limit
* Pregnant or breast-feeding
* History of endocrinologically-responsive tumors (e.g., breast, ovarian, uterine, or prostatic cancer, or malignant melanoma)
Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis

Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses. At present, no prediction marker for GDM in early pregnancy is accepted. There is still a lack of recognized early predictors. This study was designed to identity valuable biomarkers for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed according to the latest ADA standard. Urinary samples were collected in the first (\<12 weeks), second (24\~28 weeks) and third (32\~weeks) trimester of pregnancy. Urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal analysis; 15 cases of GDM women and 15 cases of age matched control women were used for difference analysis.


Eligibility Criteria:
Inclusion Criteria:

-Pregnant women （\<12 weeks）

Exclusion Criteria:

* with renal dysfunction
* urine routine examination abnormalities for twice
* history of urinary and reproductive system diseases
* with other chronic diseases
Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators

Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. ICD therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of ICD shocks.

The safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of ICD shocks has been investigated previously in a placebo-controlled study in patients with ICDs. These results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.


Eligibility Criteria:
Inclusion criteria:

* Currently have an ICD implanted
* Have had a documented episode of symptomatic arrhythmias that triggered a spontaneous ICD shock within 180 days of randomization.
* If the ICD implant is recent, the patient must have had a documented episode of sustained arrhythmias or cardiac arrest within 42 days before implantation of the ICD

Exclusion criteria:

* have severe heart failure
* have a current diagnosis of psychosis
* use illicit drugs
* abuse alcohol
* if female, are currently breast feeding, or plan to become pregnant during the study
* are currently taking antiarrhythmic drugs or other drugs that prolong the QTc interval (a measurement taken from the ECG)
* creatinine \>2.5 mg/dL (221 mmol/L)
* potassium \<4.0 mEq or \>5.5 mEq
* have a neutrophil count (ANC) \< 100 mL (low count of a type of white blood cell) at time of randomization
* have 2 or more consecutive QTc values \>440 msec
The Impact of Distress on the IVF Outcome

Stress is a primary reason why in vitro fertilization (IVF) patients drop out of treatment, and it may have a detrimental impact on pregnancy rates, yet there is minimal published research on the efficacy of structured skills-based psychological interventions with assisted reproductive technology (ART) patients. The objective of this study is to determine if women who are randomized to a mind/body (MB) program prior to starting their first IVF cycle will have higher pregnancy rates than controls (C).

This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes 143 women ages 40 and below scheduled to undergo their first IVF cycle. Subjects are randomized via computer generated random numbers table to a 10 session mind/body program or a control group and followed for two IVF cycles. The primary outcome measure is clinical pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* Female Boston IVF infertility patient
* Age 21-40 years
* Day 3 FSH level 12 mIU/ml or below
* Day 3 E2 level 80 pg/ml or below
* Using own eggs (not an egg donor)
* Daily access to the internet
* Able to read, understand, and sign the informed consent in English

Exclusion Criteria:

* Prescription antipsychotic medication
* Diagnosis of borderline or narcissistic personality disorder
* Previous participation in a MB group
Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children

This study aims to compare the recurrence rates of Esomeprazole and Lansoprazole in triple combination therapy to eradicate H.pylori infection in children. The participants were divided into two groups, those who received Esomeprazole and those who received Lansoprazole

H. pylori eradication therapy is still contentious. A treatment that is uncomplicated, well-tolerated, and boasts an efficiency rate of more than 80% is recommended.

PPIs are a type of acid-sensitive drug which is most beneficial in preventing the degradation of drugs in the stomach. In developing countries, Esomeprazole and Lansoprazole were mainly selected as a drug of choice. Major influential factors such as Esomeprazole's additional antioxidant ability, are comparable to vitamin C. This is due to its ability to scavenge Diphenyl Picrylhydrazyl (DPPH) free radicals at low concentrations. Lansoprazole also possess similar ability, albeit needs a slightly higher concentration to reach a similar effect. In terms of IC50 values, both drugs have a substantial advantage over vitamin C, earning them the title of 'potentially ideal' agents in the treatment algorithm. Furthermore, numerous studies mention that children better tolerate PPIs.

Eligibility Criteria:
Inclusion Criteria:

* Subject has positive clinical symptoms (gastrointestinal pain, nausea, vomiting, hematemesis, or melena)
* Subject had been diagnosed with H.pylori infection prior to endoscopy and rapid urease testing

Exclusion Criteria:

* subject has a history of using antibiotics or non-steroidal anti-inflammatory medicines (NSAIDs) within 14 days prior to surgery
* subject has a concomitant systemic disease (e.g., renal failure, liver cirrhosis, cancer, etc.) that could theoretically affect the subject's response to treatment
* Incomplete triple pharmacologic treatment due to the subject's lack of medication adherence
A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer

PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumors (excluding SCLC and retinoblastoma) or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition; tumors must express Rb
* Adequate blood cell counts, kidney function and liver function and and ECOG score of 0, 1, or 2.
* Patients may have to have tumor biopsy before and after treatment.

Exclusion Criteria:

* Prior stem cell or bone marrow transplant
* Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse
* Active or unstable cardiac disease or history of heart attack within 6 months
Propofol Spinal Procedural Sedation for Cesarean Section

Patient's safety and satisfaction are major concerns of anesthesiologists and obstetricians. According to evidence, guidelines and quality markers, regional anesthesia is preferred over general anesthesia in obstetric surgery. A high level of anxiety is present in obstetric patients preoperatively. Patients with high anxiety tend to prefer general anesthesia for cesarean section. The anxiety can be reduced variably by non-pharmacologic and pharmacologic methods. The evidence supports the benefits of procedural sedation for distressed, anxious pregnant women.

Propofol provides short onset, rapid predictable action, anxiolysis and amnesia and it is more effective than benzodiazepines. Using propofol infusion in low doses during spinal injection in CS did not adversely affect the Apgar scores or the neurological and adaptive fetal outcomes. The general consensus is that procedural sedation is not a routine for spinal interventions, but required for anxious patients. Our hypothesis is that, with the high prevalence of maternal anxiety during cesarean section, ensuring painless comfortable spinal anesthesia may increase the acceptance rate of regional anesthesia during cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective cesarean section,
* Age: 18 - 40 years,
* American Society of Anesthesiologists I - III,
* Patients may present any of the following conditions:
* Respiratory diseases as bronchial asthma
* Hepatic compromise,
* Preeclampsia,
* Anemia with hemoglobin 10 g/dl,
* Previous sections,
* Obese with BMI more than 35%,
* Any criteria of difficult intubation, Compromised fetus as premature delivery, History of complications or non-satisfaction after general anesthesia during previous cesarean section,

Exclusion Criteria:

* Patients refusing to participate in the study,
* Known psychiatric disease,
* Addiction medications,
* Communication barrier,
* Absolute or relative contraindication for spinal anesthesia,
* Bad obstetric history, complicated pregnancy, congenital fetal anomaly.
Establishment of Precise Nutrition Management Scheme for Patients With Prediabetes Based on Nutrigenomics

With the aging of population and the change of lifestyle, the prevalence of prediabetes is increasing year by year. Nutritional factors are one of the important environmental factors in the occurrence and development of abnormal glucose metabolism. The medical nutritional treatment of diabetes is recommended as the cornerstone of diabetes treatment by various guidelines. With the development of nutrigenomics, it has been found that genes related to the absorption, metabolism, distribution and excretion of various nutrients are related to diabetes. This study intends to conduct precision nutrition intervention for prediabetic patients based on nutritional genes, and evaluate the effectiveness and safety of these nutritional interventions.


Eligibility Criteria:
Inclusion Criteria:

1. OGTT: 6.1 mmol/L ≤ fasting plasma glucose \< 7.0 mmol/L and（or）7.8 mmol/L ≤ 2 hour plasma glucose \< 11.1 mmol/L and (or) 5.7% ≤ HbA1c\< 6.5%.
2. 18 ≤ Age \<70.

Exclusion Criteria:

1. Patients who can be diagnosed with diabetes mellitus.
2. Patients applying antidiabetic drugs, glucocorticoids, and other drugs that have an effect on blood glucose.
3. Females during pregnancy or lactation.
4. Patients with gastrointestinal disorders, psychiatric disorders, autoimmune disorders, tumors, etc.
5. Patients with acute cardiovascular and (or) cerebrovascular diseases within 6 months prior to study participation.
6. Patients with hepatic dysfunction (ALT, AST, or total bilirubin ≥ 2 times the upper limit of normal), renal dysfunction (creatinine \> the upper limit of normal), and cardiac dysfunction (NYHA class III and IV).
Effective Treatment of Posttraumatic and Postoperative Edema

Edema control after ankle- and hindfoot fractures is important. Multi-layer compression bandages or A-V Impulse compression may are more effective in reducing edema than ice.

After ankle- and hindfoot fractures, edema has a major impact on the time point of surgical intervention and may increases the risk of wound complications and infection postoperatively. Effective treatment of edema, therefore, is of great importance. The aim of this study was to evaluate the efficacy of the multi-layer compression therapy and of the A-V Impulse compression (AVI) in reducing ankle- and hindfoot edema as compared to the standard treatment with ice.

Eligibility Criteria:
Inclusion criteria:

* Age 18-65 years
* Inpatients
* Acute ankle- or hindfoot fractures (malleolar-, calcaneus-, talus-, and pilon- tibial fractures) including fractures temporary stabilized with an external fixator)
* No walking aids before trauma
* Written informed consent
* Monotrauma
* Preoperative and/or postoperative edema
* Preoperative inclusion

  * if delay of surgery due to ankle edema
  * if fracture stable enough for temporary removal of orthesis

Exclusion criteria:

* Diabetes Mellitus
* Lymphedema
* Peripheral arterial occlusive disease (PAD)
* Decompensated heart failure or renal insufficiency
* Acute bacterial infection
* Severe osteoporosis
* Pathological fractures
* Known tumors
* Postthrombotic syndrome
* Thrombosis
* Open fractures
* Polytrauma, cerebral trauma
* Neurological deficiencies
* Diuretics
* Pregnancy
* Alcohol or drug abuse
* Psychological disorders