cyrilzakka/clinical-trials huggingface dataset:
Feasibility Trial for Real-time Identification of the Ureters With a Methylene-blue

This is a non-randomized prospective, open label, single site study to evaluate the feasibility of recruitment for the use of an Investigational Endoscopic Fluorescence Imaging System, PINPOINT, in intraoperative bilateral visualization of ureters using intravenous injection of methylene blue. Feasibility of urine sample collection during surgery will also be assessed.

Background - During certain abdominal surgeries there is difficulty in finding the ureters, which act as a conduit for urine from the kidneys to the bladder. If the ureters are sectioned during surgery this causes great suffering for the patient and increased costs for the hospital and the National Health Service. Even experienced surgeons are at risk of causing this dreaded complication.

Methylene blue can emit a fluorescent signal and highlight the ureters in real time during surgical procedures. A study is necessary to evaluate the effectiveness of methylene blue fluorescence to identify the ureters during surgery.

Methods - In this study, patients undergoing abdominal surgery with high risk for ureter complications will be included. The feasibility of recruitment of these patients will be assessed using a screening log. Included patients with receive intraoperative methylene blue injection in increasing doses. Urine samples will be taken to establish the conversion of methylene blue to leucomethylene blue.

Expected results - the investigators expect to define the recruitment rate of the patient group of interest and to identify the causes for non recruitment. Secondary outcomes are ureteric identification and conversion of methylene blue to leucomethylene blue.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Scheduled for a surgery where routine ureter identification is used
* Have signed an approved informed consent form for the study
* Be willing and able to comply with the study protocol

Exclusion Criteria:

* Known allergy or history of adverse reaction to methylene blue
* Taking an antidepressant including, but not limited, to selective and non-selective serotonin reuptake inhibitors, or a psychiatric medication
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Renal dysfunction defined as estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2
* Has participated in another investigational study within 30 days prior to surgery
* Pregnant or lactating subjects
* Subjects who, in the Investigator's and/or designee's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results
Prevalence of Blood Pressure Complications During Cesarean Section in Pre-eclamptic Patients (HOPE)

Preeclampsia (PE) is an obstetric placental vascular pathology with a prevalence of 2 to 5% of pregnant women. It is defined by learned societies by the association of high blood pressure (BP≥140/90mmHg) and proteinuria \&amp;gt; 0.3g/day. The last French Maternal Mortality Report 2024 places cardiovascular complications among the main causes of maternal death. PE has an increasing number of deaths in 2016-2018 and significant preventability (66%).

Cesarean sections in pre-eclamptic patients are difficult procedures and, do not benefit from any specific recommendations. Cesarean section is promptly performed under regional anesthesia by spinal anesthesia or spinal anesthesia with combined epidural, techniques that cause maternal arterial hypotension with consequences for the baby.

These hypertensive patients, often on antihypertensives, challenge the anesthesiologist to manage the hemodynamic balance between the risk of arterial hypotension generated by the anesthesia corrected by vasoactive amines and the risk of major hypertension secondary to their management. The major risk in these patients with low platelet counts is hemorrhagic stroke.

Our study is an observational, bi-centric study between the maternity wards of the Clermont Ferrand and Lille University Hospitals.

It consists of collecting data prospectively on all pre-eclamptic patients undergoing a non-urgent cesarean section.

The objective is to observe the management of hemodynamics and calculate the prevalence of complications such as maternal hypotension and/or hypertension through the implementation of non-invasive monitoring (ClearSight).

Patients meeting the inclusion and non-inclusion criteria may be included in the study by an investigator after having given a non-opposition agreement after having received clear and fair information about the study.

In any case, the care of patients participating in the study will not be modified in any way compared to the usual practices of the services.


Eligibility Criteria:
Inclusion Criteria:

* Pre-eclamptic patient according to the criteria defined by SFAR 2020.
* Indication of organised or semi-urgent cesarean section (Green or Orange code).
* Adult patient, benefiting from a social security system.
* Oral non-opposition to participation in the study.

Exclusion Criteria:

* Urgent Cesarean (Red code).
* Patient refusal.
* Patient does not understand French.
* Individual protection measures : guardianship, curatorship.
Omitting Drains After Repair of Peptic Ulcer Perforations

. This study aimed to evaluate ERAS application outcomes via omitting the intraabdominal drains compared to regular using of the drains in patients undergoing perforated duodenal ulcer repairs in emergency abdominal surgeries.

Patients will be randomly assigned into two groups. In Group A : the investigators will put intraabdominal drains, and in Group ,thd investigators will not put any intraabdominal drains. Our primary outcomes will be hospital stayl engthand pain score;Data analysis packages will be SPSS version 21 Qualitative data will be presented by number and percentage, quantitative data by mean, standard deviation, median and interquartile range.

Eligibility Criteria:
Inclusion Criteria:

- Patients older than 18 years with perforated peptic ulcer who underwent exploratory laparotomy or laparoscopy and repair with omental pedicle techniques will included in the study.

Exclusion Criteria:

* preoperative shock on admission.

  * Delayed presentation more than 24 hours.
  * known malignant gastric ulcers confirmed by histopathology.
  * the presence of neuropsychiatric disease, pregnant and lactating women.
  * predisposing factors for impaired wound healing (e.g., currently using immunosuppressive agents, or chronic use of steroids), the presence of HIV/AIDS.
  * Intraoperative findings consistent with malignant ulcers. • American Society of Anesthesiologists grade III/IV, or had an alternative perioperative diagnosis. • Ulcer size more than 2 cm in diameter.
Sensory Integration Versus Bobath on Hand Function in Hemiplegia

Hand skills do not develop in isolation; it is the result of neurologic development, physiologic maturation and adaptation, and functional development of learned patterns of motion and motor learning Hand skills in HCP are very complex and sensitive as it considered the main issue in playing and achieving milestones, so identification of this problem and its solution is very essential and play a miserable rule in adaptive response which is a basis of child's occupation. so, the current study is conducting to investigate the difference between sensory motor integration approach and bobath technique on hand function as manual dexterity, fine motor precision and fine motor integration on children with hemiplegic cerebral palsy

Sensory integration therapy is the therapeutic mechanism of pediatrics through sensory augmentation which involves the child in enriched playful tasks, promoting a meaningful motor response. The sensory integration theories assume that an affected sensory reception would result in a defect or delay in the development of milestones among children with motor disorders.

The bobath approach provided a new reference aimed to normalize tone and facilitate volitional and automatic movement which tailors based on the patient's individual problems and situational context to manage problems with movement against gravity and postural control Participants will be assigned randomly into two groups of equal number (study group 1 and study group 2 )26 child in each group

* Study group "1" will receive regular physical therapy in addition to sensory motor integration for 45 minutes/time ,3 days per week for 3 months Treatment program included two parts: tactile sensation and proprioception stimulation programs. Each of them accounted half of the session
* Study group"2" will receive regular physical therapy in addition to bobath therapy for 45 minutes/time 3 days per week for 3 months in the form of:

  1. Preparation phase
  2. Intervention program (Movement facilitation \&Functional training) base line assessment and after three months re assessment will be taken for both groups using surface electromyography and Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition

Eligibility Criteria:
Inclusion Criteria:

1. Age ranges from 6 to 12 years.
2. Both genders.
3. Diagnosis of hemiplegia.
4. Level II-III on Manual Ability Classification System (MACS)
5. Spasticity grade 2 to 3 on Modified Ashworth Scale (MAS)
6. Level II-III on Gross Motor Classification System (GMCS)

Exclusion Criteria:

1. Significant mental or psychological problems.
2. Significant visual/auditory problem.
3. Botox injection and/or surgery of the affected upper limb in the past 12 months.
4. Surgical procedures of the affected upper limb.
5. Fixed deformities in the affected upper limb.
6. Comorbid physical diseases such as myopathy, neuropathy, and other central and peripheral nervous system disorders.

   -
Chidamide With R-CHOP Regimen for DLBCL Patients

It's a prospective, single arm, open label phase II clinical trial, in which the safety and efficacy of Chidamide plus R-CHOP regimen is accessed in de novo DLBCL patients, who have received 2 courses of R-CHOP but only achieved PR or whose MRD tests for ctDNA revealed positive results.

abbreviation: R-CHOP: the chemo-therapy regimen composed of Rituximab, cyclophosphoamide, etoposide, vincristine and prednisone.

PR: partial remission; MRD:minimal residual disease;


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results;
2. Age between 18 to 75 years old;
3. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2;
4. No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment;
5. Life expectancy no less than 6 months
6. The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures;
7. IPI mark\>1.

Exclusion Criteria:

1. History of autologous stem cell transplantation;
2. History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer;
3. With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases;
4. Lymphoma originated in the central nervous system;
5. Left ventricular ejection fraction ≦50％
6. Abnormal lab results in enrollment:

   1. Neutrophil count: \<1.5\*109/L；
   2. Platelet count \<75\*109/L；
   3. AST or ALT \>2 times the upper limit of normal level，AKP and total bilirubin \>1.5 times the upper limit of normal level;
   4. serum creatinine \>1.5 times the upper limit of normal level;
7. Other uncontrolled medical conditions which the investigators think might influence the results of the trial;
8. Patients with mental illnesses or other diseases that might not comply with the trial plan;
9. Women during pregnancy or lactation;
10. HIV positive patients;
11. HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative;
Cardiometabolic Effects of Pecans as a Snack

A randomized, 2-arm, parallel trial will be conducted to examine the effect of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.

A randomized, 2-arm, parallel trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, compared to a diet typically consumed by participants intake (devoid of nuts) on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control. Participants will be randomized to pecans or control for 12-weeks. Outcome assessments will be measured at baseline and 12-weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25-40 kg/m2
* ≥ 1 criterion for metabolic syndrome (i.e., waist circumference ≥ 94 cm men or ≥ 80 cm women; triglycerides ≥150 mg/dL; HDL-cholesterol ≤ 40 mg/dL men or ≤ 50 mg/dL women; systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100 mg/dL) at screening

Exclusion Criteria:

* Current use of tobacco-containing products or (≤6 months) cessation
* Allergy/sensitivity/intolerance/dislike of study foods
* Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year
* Individuals who have had a cardiovascular event (heart attack, revascularization, stroke), or have a history of heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis.
* Type 1 or type 2 diabetes
* Unstable weight ≥10% body weight for 6 months prior to enrollment
* Systolic Blood pressure \>160 mmHg for systolic pressure and/or diastolic blood pressure \>/100 mmHg for diastolic pressure at screening
* Fasting blood glucose ≥126 mg/dL at screening
* Triglycerides ≥350 mg/dL at screening
* Taking any medications known to affect lipids, blood pressure, or blood glucose levels
* Diagnosed inflammatory conditions or taking prescribed , taking any chronic anti-inflammatory medications (\>1 time per week over the past 3 months)
* Use of antibiotics within the prior 8 weeks
* Taking supplements (e.g., psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals known to affect study outcomes and not willing to cease for the duration of the study
* Individuals consuming \>14 alcoholic drinks/week, and not willing to avoid alcohol consumption for 48 hours prior to test visit
* Pre-menopausal women who do not have a regular menstrual cycle of 25-35 days
* PI discretion
Identification and Semi -Quantification of ER/PR Proteins Expression

The purpose of the study is the identification and quantification of proteins expression level in breast cancer tissues.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples.

The anti ER/PR Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the progesterone (PR) and estrogen (ER) expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the ER/PR test is indicated as an aid in the assessment of the hormones status of breast cancer patients. While the ER/PR kit provides the antibodies that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.

Eligibility Criteria:
Inclusion Criteria:

* Women having breast cancer

Exclusion Criteria:

* others
Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears

Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries that occur in physically active individuals. Despite advances in minimally invasive surgical reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength can persist even after patients return to full activity and can place them at considerable risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic interventions to prevent muscle atrophy is needed to advance the care of patients who suffer from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays an important role in promoting muscle growth and protecting muscle from atrophy. While GH therapy has shown promise in protecting immobilized muscle from various models of disuse atrophy, it remains unknown whether GH can help to restore strength and protect against the loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe return to play of patients that suffer ACL tears, and help to prevent the long-term OA and reduction in quality of life that occur after these traumatic knee injuries.


Eligibility Criteria:
Inclusion Criteria:

* Males between the ages of 18 and 35
* Have acute unilateral complete ACL tears with or without bucket handle medial meniscus tears that occurred within the past 6 months
* Consent to undergo an ACL reconstruction by an orthopaedic surgeon using a patellar tendon or hamstring autograft
* Will be performing supervised post-operative rehabilitation at UMHS MedSport at Dominos Farms

Exclusion Criteria:

* Patients who are undergoing a revision ACL reconstruction
* Had a previous injury to the involved knee
* Have an allergy to recombinant GH
* Have a BMI\<20 or \>35
* Have a growth disorder of bones or connective tissue, type 1 diabetes mellitus, type 2 diabetes mellitus, or who have a history of carpal tunnel syndrome, trigger finger, myopathy, cancer, endocrine disorder, hypertension or rheumatologic disorder.
* Systolic blood pressure \>140mm Hg or diastolic blood pressure \>90mm Hg, or with resting heart rate \>110 BPM or \<40 BPM at screening.
* Additionally, because GH is currently listed as a banned substance by the World Anti-Doping Agency (WADA), National Collegiate Athletics Association (NCAA) and most professional sports agencies, we will exclude patients who are current collegiate, professional or elite athletes.
Spectroscopic Evaluation of Middle Ear Infection

Otitis media is more common in young children and it is estimated that 75% of all children experience at least one episode before the age of three. Otitis media is one of the common pediatric diagnoses and recurrent episodes account for the most commonly performed surgical procedure. Despite this a high degree of inaccuracy exists in diagnosis of this condition which depends on subjective assessment of the ear drum via direct visualization using an otoscope. Researchers can use LED-based multi wavelength light absorption and scattering measurements for the analysis of ear drum and the middle ear.

The research can use low energy LED signal light sent into the ear canal to measure the tissue optical properties including the absorption of the light signal and the amount of signal that will be backscattered by the tissue components. These measurements will then be analyzed using a microprocessor to determine presence of fluid or inflammation of the eardrum.

Eligibility Criteria:
Inclusion Criteria:

1. Male/ female at all age- newborn to adult.
2. Non- pregnant woman.
3. Diagnose of middle ear infection and plan for surgery procedure.

Exclusion Criteria:

1. Pregnant woman
2. Incompetent adults (i.e. individuals with cognitive impairment)
3. No diagnose of middle ear infection and no plan for surgery procedure.
4. Adults with cognitive impairment and children of parents that are cognitively impaired and thus are unable to consent will be excluded from the study.
Efficacy and Safety of Viusid in Patients With Nonalcoholic Steatohepatitis

The purpose of the study is to evaluate whether Viusid, a nutritional supplement, in combination with diet and exercise improve the histological results (steatosis, necro-inflammatory activity and fibrosis) in comparison with diet and exercise, during 24 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis)
* Age between 18 and 70 years
* Ability to provide informed consent
* Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)

Exclusion Criteria:

* Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency)
* Pregnancy or lactation
* Decompensated cirrhosis
* Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery
* Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil
* Fasting glucose levels greater than 250 mg per deciliter (13.3 mmol per liter)
* Contraindication to liver biopsy
* Refusal to participate in the study
* Concomitant disease with reduced life expectancy
* Severe psychiatric conditions
* Drug dependence
AZD1152 in Patients With Advanced Solid Malignancies-Study 3

The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 7-day infusion every week and every 2 weeks in patients with advanced solid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of a solid, malignant tumour

Exclusion Criteria:

* Participation in an investigational drug study within 21 days prior to entry or who have not recovered from the effects of an investigational study drug
* Treatment with radiotherapy/chemotherapy with 4 weeks of first dose
* Recent major surgery within 4 weeks prior to entry to the study
Implantable Cardioverter-Defibrillator Use in the VA System

Despite being a proven life-saving intervention in appropriately selected individuals, multiple studies continue to demonstrate low implantation of defibrillators in potential candidates. Based upon prior research, a major barrier to low utilization is low referral of potential candidates by healthcare providers. In this study, via brief clinical reminder placed in the electronic medical record, we ask healthcare providers who have not referred potential candidates for defibrillator the reasons for this decision and provide them with the tools for referral if appropriate.


Eligibility Criteria:
Inclusion Criteria:Meeting published criteria for receipt of an implantable cardioverter defibrillator Exclusion Criteria:provider is not affiliated with the VA health care system