cyrilzakka/clinical-trials huggingface dataset:
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study

The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open one-arm clinical study.


Eligibility Criteria:
Inclusion Criteria:

1. A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale) or a venous leg ulcer confirmed with duplex ultrasound
2. The ulcer has been diagnosed/present for greater than 4 weeks duration.
3. Three or fewer ulcers separated by \> 3.0 cm distance
4. Post-debridement, the ulcer size must be \> 5 sq cm
5. Ankle / brachial index is between 0.7 to 1.2 and or one of the following must be present:

   1. transcutaneous partial pressure oxygen (TcPO2) \> 30 mmHg at the ankle
   2. toe pressure of \>40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
6. At least 18 years old
7. Able and willing to read and sign a voluntary written informed consent
8. Able and willing to attend scheduled follow-up visits and study related exams

Exclusion Criteria:

1. Greater than 30% reduction in wound size (DFU) or 20% reduction in VLU during first week of observation by the investigator
2. Ulcer with exposed tendon or bone
3. Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis
4. Ulcer of a non-diabetic/non-venous pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers)
5. Known severe anemia
6. Known serum albumin \< 2.5
7. Renal failure requiring dialysis
8. Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
9. Severe liver disease as defined by the treating physician or patient's primary care physician
10. Malignancy at or near the ulcer site
11. Any condition judged by the investigator that would cause the study to be detrimental to the patient
12. Presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator
13. Received another investigational device or drug within 30 days of Day 0.
14. Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment
15. Received another allograft, autograft or xenograft within 30 days of the Day 0/
16. Known allergy to equine derived tissue
17. Alcohol or drug abuse, defined as current medical treatment for substance abuse
18. Pregnant or nursing women
Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis

Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway inflammation increases the respiratory system resistances and dynamic hyperinflation. This leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease patients as in neonates, prone position (PP) improves lung function and decreases the end expiratory lung volume. The investigators hypothesized that in infants with severe bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi) and the work of breathing (WOB). The investigator designed a prospective randomized crossover study with 16 infants younger than six months who need ventilatory support by nasal continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work of breathing (product time pressure) and PEEPi will be estimated using an esophageal pressure probe in prone and supine position.


Eligibility Criteria:
Inclusion Criteria:

* Infant \< 6 months
* Admitted in the pediatric intensive care unit of the Femme-Mère-Enfant hospital, Hospices Civils de Lyon, France
* With severe acute viral bronchiolitis requiring ventilatory support (mWCAS \> 4 and/or and or FiO2\> 40% and/or hypercapnic acidosis (pH\<7.30 and/or pCO2\>8 kPa))
* Signed informed consent by the two parents or the owner of parental authority

Exclusion Criteria:

* Chronic respiratory, neuromuscular, ENT or cardiac disease
* Contraindication for placement of esophageal probe (esophageal surgery, varices, ...)
* Children requiring invasive ventilation (more than 3 significant apneas in 1 hour, decreased consciousness, ...)
* Children not affiliated to a social security scheme
Phase I/II Combination With Irinotecan- Erbitux

Part 1: To define the recommended dose of brivanib that can be safely administered in combination with Erbitux (Cetuximab) and irinotecan to subjects with advanced metastatic colorectal cancer (MCRC)

Part 2: To compare median duration of progression free survival (PFS)


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven MCRC
* Prior irinotecan allowed
* Prior Erbitux allowed

Exclusion Criteria:

* No prior brivanib
* No prior combination of irinotecan with Erbitux
* No secondary malignancies
* No anti-coagulation therapy
* No prior history of blood clots requiring anti-coagulation
MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment regimen for patients with primary AML by comparing with the traditional chemotherapy regimen, DA+AZA (Daunorubicin+Ara-Cytarabine+Azacitidine).

In this study, AML patients were randomly divided into MA+AZA treatment group and DA+AZA treatment group by conducting a prospective, multicentre, exploratory, randomised controlled study. By observing the efficacy and safety of the MA+AZA combination regimen in the treatment of primary AML, and comparing the superiority of the traditional regimen, high-quality clinical evidence was obtained, providing practical evidence to support the improvement of the intervention effect and clinical prognosis of primary AML.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow;
2. Age 18-75 years old;
3. Liver and renal function: serum total bilirubin ≤1.5 × upper limit of normal (ULN), AST/ALT \<2 × ULN, serum creatinine \<1.5 × ULN, 80 ml/min ≤ creatinine clearance ≤120 ml/min;
4. Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide \<1.5 × ULN;
5. Physical condition: ECOG score 0-2;
6. Obtained informed consent signed by the patient or family.

Exclusion Criteria:

1. Allergy or significant contraindication to any of the drugs involved in the protocol;
2. Patients with concomitant myelofibrosis;
3. Severe cardiac disease, including myocardial infarction and cardiac insufficiency;
4. Concomitant malignant tumours of other organs;
5. Patients with active tuberculosis and HIV-positive patients;
6. Other blood system diseases at the same time;
7. Pregnant or breastfeeding women;
8. Inability to understand or comply with the study protocol;
9. Previous intolerance or allergy to similar drugs;
10. Concurrent participation in other clinical studies;
11. Any other condition that prevents the study from proceeding.
Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 6 of 7)

NOTE: This is the sixth of in total 7 sub-studies related to the Ethics Committee of the Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8 arms, in total 350 participants will be assessed in all 7 sub-studies.

General study information: This is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. Primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. The risk for the participants is negligible and comparable to the risk during daily life.


Eligibility Criteria:
Inclusion Criteria:

* Normal color vision
* Right handed
* Written informed consent

Exclusion Criteria:

* Smoking
* Any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months
* Acute severe traumas
* Chronic diseases with the necessity for medication
* Use of recreational drugs
* Regular intake of medication that would affect the outcome measures
* Regular excessive alcohol use (\> 18 standard units / week)
* Transmeridian travel in the last month (crossed \> 1 time zone border)
* Night shift word during the last month
A Comparison of Collagen, Lidocaine and Saline, in Trigger Points in Masseter Muscle.

An intramusclular injection of three solutions were performed( collagen, lidocaine, saline) in musculoskeletal trigger points, in patients suffering from temporomandibular disorders(TMD). Best results were observed in collagen group: reduction of 59,2% sEMG activity of masseter muscles and 53,75% reduction of pain intensity in VAS scale.

Collagen is an important component, building myocytes and extracellular matrix of skeletal muscles. The novel treatment option for trigger point therapy and muscle regeneration in TMD patients are intramuscular collagen injections. The aim of the study was to evaluate the efficacy of intramuscular injections of Collagen MD Muscle(Guna) 2 ml, 2 ml of Lidocainum 2% without vasoconstrictor and 2 ml of Saline (0,9 % NaCl). 43 patients were enrolled to the study (17 male and 26 female, 40 +/- 3,8 years old). The masseter muscle activity was measured with sEMG Neurobit Optima 4 (Neurobit System). Visual Analogue Scale was used to determine pain intensity changes between follow-up visits in each group. Trigger points were localized with palpation of masseter muscle. Electromyographic activity of masseter muscle was measured before injections on each visit: 0, 7,14 days. In our analysis sEMG masseter muscle activity was significantly decreased: in collagen group 59,2%, in lidocainum group 39,3% and in saline group14%. Pain intensity reduction in VAS scale was 53,75% in collagen group, in lidocainum group 25% and in saline group 20,1%.

Eligibility Criteria:
Inclusion Criteria:

- sleep bruxism, DC/TMD myofascial pain, myofascial pain with referral

Exclusion Criteria:

* younger than 18years old, active orthodonctic treatment,neurological treatment, post radiotherapy, after head trauma within 2 years, patients with unsupported occlusal contacts, addicted to analgesic drugs, with the fear of needle
Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis

Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad regulated state of inflammation. For this porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in patients elder than two months old and randomized to received every day a dietetically supplement with DHA or placebo, will be done during 12 months. The trial has as a principal objective to proved if this long term supplementation could decrease in contrast with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed of cystic fibrosis over than 2 months age
* Tolerance clinical supplementation with DHA
* Clinical situation stable

Exclusion Criteria:

* Changes in the routine treatment in the 2 weeks prior to baseline
* Admission to hospital or administration of oral or intravenous antibiotics within 2 weeks before inclusion
OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
* Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

* History of refractive surgery (including LASIK procedures) within the past 2 years
* History of retinal detachment, diabetic retinopathy, or active retinal disease
* Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
* Use any of the disallowed medications during the period indicated
* History of IOP increase as a result of steroid treatment
Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery

The aim of this study is to determine the safety and efficiency of Remodulin®（Treprostinil Injection）to reduce the pulmonary arterial pressure and prevent pulmonary hypertension (PH) after Fontan operation with univentricular physiology.

PH is a significant contributor to the postoperative morbidity and mortality of congenital heart disease, especially after Fontan operation with univentricular physiology. Mild increase of pulmonary vascular resistance may lead to failure of Fontan circulation. Remodulin® has been approved for the treatment of adults with PH, but little is known about the effects in children with PH after Fontan operation. The study aim is to determine the safety and efficiency of Remodulin® to reduce the pulmonary arterial pressure and prevent PH in children after Fontan operation. Meanwhile pharmacokinetics of the drug were checked with or without the peritoneal dialysis.

Eligibility Criteria:
Inclusion Criteria:

After Fontan procedure, the criteria should be met

1. mPAP greater than 15 mmHg
2. TPG greater than 6 mmHg (exclude the obstruction of cavopulmonary anastomosis)

Exclusion Criteria:

After Fontan surgery :

1. Severe arrhythmia led to low cardiac output
2. Platelets smaller than 50,000\*109/L and obvious bleeding
Transversus Abdominis Plane Block Versus External Oblique Intercostal Plane Block for Postoperative Analgesia in Pediatrics Undergoing Open Nephrectomy

The aim of this study is to compare the ultrasound guided TAP Block and EOIP block for postoperative analgesia in pediatrics undergoing open nephrectomy.

Nephrectomy in children may also be for malignant conditions of the kidney and adrenal glands. The major indications for nephrectomy vary in different parts of the world and in different age groups and sexes with some recording more benign conditions and others more of malignancies Ultrasound-guided transversus abdominis plane (TAP) block is a relatively new technique to infiltrate regional anesthesia in which local routine anesthetics are injected between the internal oblique and transverse abdominal muscles. The purpose is to provide analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall.

External oblique intercostal plane block (EOIPB) has been reported by Elsharkawy et al. in 2021 as a significant modification of fascial plane blocks in that it may engage the upper lateral abdominal walls consistently. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , The advantage of EOIPB is that it may be performed with the patient supine. Furthermore, in comparison to serratus intercostal plane block (SIPB), it generates more extensive analgesic effects throughout the whole midline of the abdomen .

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Scheduled for open nephrectomy.

Exclusion Criteria:

* Abnormal blood coagulation.
* Scar, infection, and tumor of puncture site.
* History or family history of high malignant fever.
* Severe cardiovascular problems.
The Effects of Clonidine on the Diuretic Response in Cirrhotic Patients

To examine the effects of the addition of clonidine to diuretics on the mobilization of ascites at short-term (diuretic response and requirement of diuretics) and long-term (readmissions for tense ascites and requirement of diuretics) in cirrhotics with increased sympathetic nervous system. Secondary objectives were to study neuro-hormonal,hemodynamic effects and side effects of clonidine and diuretics.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients with ascites
* Plasma norepinephrine level \> 300 pg/mL (normal value: 185 - 275 pg/mL)

Exclusion Criteria:

* Serum bilirubin concentration above 4.5 mg/dL
* Prothrombin time below 40%
* Platelet count below 40 X 10¨9/liter
* Serum creatinine concentration above 2 mg/dL
* Gastro-intestinal hemorrhage
* Alcoholic hepatitis
* Diabetes mellitus,
* Hepatocellular carcinoma
* Respiratory or cardiac failures
* Hepatic encephalopathy
* Bacterial infection
Comprehensive Hand Repetation Intensive Strength Training on Upper Limb in Children With Cerebral Palsy

Hemiplegia is the medical term for paralysis of one side of the body This means their shoulder; arm, hand, leg and foot are all completely paralyzed.. It results in muscular wasting on the affected side, impairs gait, reduces motor abilities, and causes instability and a loss of grasping capacity. The patient\&#39;s quality of life is impacted by hemiplegia because it impairs brain and spinal cord functions Hemiplegic cerebral palsy is the type of cerebral palsy in which there is absolutely no use of one side of the body. This means their shoulder; arm, hand, leg and foot are all completely paralyzed. Hemiplegia in infants and children is a type of Cerebral Palsy that results from damage to the part (hemisphere) of the brain that controls muscle movements. This damage may occur before, during or shortly after birth. The term hemiplegia means that the paralysis is on one vertical half of the body.

The Comprehensive Hand Repetitive Intensive Strength Training (CHRIST) program is designed to provides special training for enhancing muscular strength of the upper limb.

The current study will be a randomized control trial, and data will be collected from Ittefaq Hospital Lahore Pakistan. The study will include 30 patients equally divided into two groups experimental group included 15 patients, and the control group included 15 patients and was randomly allocated. The inclusion criteria for the study will be Comprehensive Hand Repetitive Intensive Strength Training on the upper limb of CP patients with age between 6 to 12 years and both genders will be included children who have normal communication skills and cognitive function will be included and give 30 minutes per session three sessions in a week and total 30 sessions per ten weeks and to normalize muscle tone and patient able to perform ADLS.

Children having damaged musculoskeletal system including fracture of upper limb and contracture will be excluded children having undergone administration of medicine influencing muscular strength and spasticity will be excluded tools used for data collection are Jebsen-Taylor Hand Function Test and ABIL Hand for upper limb and data will be analyzed by SPSS version 26.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6 to 12 years will be included
* Both genders will be included
* GMFCS I and II
* Children who have normal communication skills and cognitive functions will be included

Exclusion Criteria:

* Children having damage to the musculoskeletal system including fracture of the upper limb and contracture will be excluded
* Children who have undergone the administration of medicine influencing muscular strength and spasticity will be excluded
Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate

The investigators will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. The participants will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36).


Eligibility Criteria:
Inclusion Criteria:

* Abnormal cervical cancer screen
* Missed appointment at BJH colposcopy clinic and need to reschedule
* Age 21 years or older
* Able to provide verbal consent
* Diagnosis of an abnormal cervical screen confirmed by cytology or pathology

Exclusion Criteria:

* Individual without a cervix
* Known diagnosis or history of cancer
* Unable to consent
Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.

The block randomization is used in this trial. Random numbers are generated by statistical analysis system(SAS) software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 1164 , and considering drop-out or withdrawal, investigators plan to enroll 1500 patients (500 in experimental group 1, 500 in experimental group 2, 500 in experimental group 3).

Eligibility Criteria:
Inclusion Criteria:

* children,aged 1 to 14 years old;
* diagnosed as pneumonia according to western medicine diagnostic criteria;
* diagnosed as TCM pneumonia with pneumonia with dyspnea and cough, meeting wind-heat blocking lungs pattern (feng re bi fei zheng), and phlegm-heat blocking lungs pattern(tan re bi fei zheng);
* disease progression within 72 hours; those whose guardians understood and assigned the informed consent;

Exclusion Criteria:

* severe pneumonia;
* complicated with other Pulmonary Disorders attack other than pneumonia;
* complicated with primary disease of heart(congenital heart disease, myocarditis, et al),liver(alanine aminotransferase(ALT),and aspartate transaminase(AST) ≥1.5 times of normal value ceiling),kidney (blood urea nitrogen(BUN) \>8.2mmol/l, or serum C reactive protein \>104umol/l,et al) and blood system (anemia) ,and those with psychopathy;
* allergic to interventional medications; those who are participating or have participated in other clinical trials in 3 months;
* those who intend to lost follow-up by practitioners' judgment.
To Compare the Octopus 311 and the Humphrey Field Analyzer 700 Series

To compare the Octopus 311 and the HFA 700 series

To compare the Octopus 311 and the HFA 700 series to evaluate reliability, reproducibility, test duration, patient preference and technician preference.

Eligibility Criteria:
Inclusion Criteria:

* Prior Visual Field

Exclusion Criteria:

* Scotopic pupil less than 3 mm