cyrilzakka/clinical-trials huggingface dataset:
Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis

Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB). The ESP block is a technique that involves injecting an anesthetic medication into the muscles of the lower back on both sides of the spine. Previous studies have shown that ESPB application led to a reduction in opioid use, and there is one pediatric case report of ESPB use in two patients undergoing PSF. However, there is still lack of evidence that the ESPB technique is feasible and effective in the pediatric patient population.

The present study is designed to be the first randomized controlled trial to evaluate the role of ESPB in pediatric spinal fusion surgery and the role of ESPB within an enhanced recovery pathway.


Eligibility Criteria:
Inclusion Criteria:

* Age 10-19 years old
* Patients undergoing multilevel posterior spinal instrumentation and fusion
* Undergoing surgery for correction of adolescent idiopathic scoliosis
* Patients under the care of participating surgeons
* English Speaking

Exclusion Criteria:

* Patients younger than 10 years old or older than 19 years old
* Neuromuscular scoliosis
* Patient under the care of non-participating surgeon performing the procedure
* History of chronic opioid therapy (longer than 4 weeks) to treat back pain attributed to scoliosis tolerance, as defined by Centers for Disease Control (CDC) criteria (more than 60 oral morphine equivalents (OME) daily for over 2 weeks)
* Chronic pain conditions necessitating neuromodulating medications (gabapentin, pregabalin)
* Allergy, intolerance, or contraindication to any protocol component/study medication/technique
* Patient or parent refusal
* Non-english speaking
Effect of PlayStation Distraction in the Dental Setting

The aim of the study was to assess whether the behavior, anxiety, and dental pain of pediatric patients during dental treatment improves when a video game is played as method of distraction.

global behavior Parental perception of patients' anxiety Patient's anxiety dental pain Heart Rate

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 6-8 years.
* Patients who required a minimum of 2 visits for restorative treatment.

Exclusion Criteria:

* Patients with reduced audiovisual capabilities.
* Patients with psychological disorders.
New Protocol With Diluted Citrate in Continuous Techniques

The investigators designed a monitoring and control table of a citrate treatment on a specific monitor. This is the Baxter "Prismaflex" monitor, with 8.2 software version. Dialysis bath liquids marketed by Baxter: Biphozyl are used. Citrate liquid (1:18) Regiocit is used.

The dialysis treatment monitor (CVVHD) is programmed, with a blood / citrate pumps at a rate of 1:10 (1 ml / min of blood: 10 ml / h of dialysis fluid) The starting dose of citrate will be 3.5 mmol / l and the calcium compensation will be 100% Working hypothesis: The patient undergoing citrate anticoagulation according to the designed algorithm will respond with ion stability and pH during the treatment, in addition to achieving an effective cleaning process.

Study design: quasi-experimental design. two groups:

1. Usual protocol with Multifiltrate monitor and citrate (136 mmol/l)
2. Intervention group. New protocol with Prismaflex monitor and citrate (18 mmol/l)

Study population Inclusión/exclusion criteria:

Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau Hospital with the Intensive Medicine medical team, who require citrate anticoagulation in continuous dialysis therapy and are treated with Baxter "Prismaflex" monitor.

Patients who meet the criteria described above will be followed up in this study.

Expected sample size:

It is estimated that with 24/12 (group1/2) patients will be enough to achieve our goal

Methodology. Information sources:

The start of the treatment with Baxter citrate will be given according to the patient's need and subject to a basic medical decision. From here the research team will enter. The investigation team will never influence the medical decision.

Since such a treatment is started, the main investigator will assign a number to the dialysis circuit and will be followed, every six hours, for the most important variables. The rest of the variables will be collected at least once a day and according to the patient's situation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (regardless of their underlying pathology), who develop acute renal failure, admitted to the ICU of St Pau with the medical team of Intensive Medicine, who require anticoagulation with citrate in continuous dialysis therapy and are treated with the Baxter monitor.

Exclusion Criteria:

* parenteral nutrition
* pregnancy
* cardiac surgery
* coronary patients
Evaluating Dyspnea in Autoimmune Myasthenia Gravis "why Am I Short of Breath?"

Individuals with MG (IwMG) experience shortness of breath that may be activity-related, occur at rest and even happen during sleep. Dyspnea is a complex, multidimensional and multifactorial symptom involving sensory perception, cognition and emotion. Identifying the cause(s) of dyspnea in MG may assist in finding therapeutic strategies, reducing discomfort, improving QoL and potentially limiting respiratory deterioration and incidence of MG crisis.

MYaResp is a prospective observational, cross-sectional study to evaluate dyspnea in adults with autoimmune myasthenia gravis.

Study aims include to:

* Describe the characteristics of dyspnea in IwMG
* Understand contributing factors and factors associated with dyspnea in IwMG including the relationship between patient-reported dyspnea, disease severity and functional limitations.
* Determine the most effective tests to identify the causes and contributing factors of dyspnea

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* Confirmed diagnosis of autoimmune MG
* Shortness of breath in daily life: score 1 or 2 on the respiration item on the MG- activities of daily living score
* Signed consent form
* Affiliated to or beneficiary of a social security scheme

Exclusion Criteria:

* Known Pregnancy
* Known respiratory disorder (other than MG)
* Recent (within past 4 weeks) respiratory infection
* Current MG crisis or exacerbation (necessitating increase in MG medication \&/or hospital admission)
* No dyspnea - score 0 or 3 on the respiration item on the MG- activities of daily living score
* Severe cognitive impairment/guardianship
A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.


Eligibility Criteria:
INCLUSION CRITERIA:

* Participant must be ≥ 18 years at the time of screening.
* Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
* Provision of a tumour tissue sample obtained prior to CRT
* Documented tumour PD-L1 status by central lab
* Documented EGFR and ALK wild-type status (local or central).
* Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy
* Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
* Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
* WHO performance status of 0 or 1 at randomization
* Adequate organ and marrow function

EXCLUSION CRITERIA:

* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease.
* Mixed small cell and non-small cell lung cancer histology.
* Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
* Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
* Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
* Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
* History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis - diagnosed in the past 6 months prior to randomization.
* Active or prior documented autoimmune or inflammatory disorders (with exceptions)
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Ivermectina Colombia (IVERCOL)

A parallel, prospective, double-blind, placebo-controlled clinical trial will be conducted in the population affiliated to EPS SURAMERICANA S.A. with positive test for antigen and PCR for SARS-CoV-2. Participants will be randomly assigned in a 1: 1 ratio to the intervention group or the control group using a sequence of random numbers. The patients included will be those with less than 7 days from the onset of symptoms, and without evidence of serious disease.

One group will be assigned oral ivermectin therapy at a dose of 600 mcg/kg every 12 hours for 5 consecutive days, and the other group will received placebo. A minimum sample size of 483 patients for each arm was calculated to observe differences. All randomized patients will be included in the analysis according to the randomization arm (intention-to-treat analysis).

The primary objective is to evaluate the efficacy of ivermectin in the prevention of severe disease, reduction in the rate of hospitalization, reduction of ICU stay, and mortality. This evaluation will be carried out up to 28 days after the intervention begins. Given the public health emergency, the study is expected to be completed in a period of 6 months from the INVIMA approval.


Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years.
* Patients with positive antigen test or RT-PCR for SARS-CoV-2.
* Patients with less than 7 days from symptoms onset.
* Patients with indication for outpatient management.
* Patients with mild disease according to the official guide "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 8)": Subjects with mild symptoms, with or without radiological signs of pneumonia, with oxygen saturation\>90% . - Able to provided consent to participate.

Exclusion Criteria:

* Patients who at the time of admission require hospitalization and / or supplemental oxygen.
* Known history of allergy to ivermectin.
* Known medical history of liver disease.
* Belong to another clinical trial evaluating the efficacy of an investigational drug against COVID-19.
* The following comorbidities:

  * Immunosuppression or HIV.
  * Acute or chronic kidney failure.
  * Current neoplasia.
* Currently use of warfarin, erdafitinib, or quinidine.
* Have received vaccination for SARS-CoV-2.
* Ivermectin consumption prior to inclusion in the research protocol.
* The patient does not accept the conditions of home care and monitoring.
* The patient desists from participating in the study.
* Women in pregnancy or breastfeeding.
China Cimicifuga Trial of Climacteric Complaint Control

This study is designed to determine whether an extract of Cimicifuga Foetida L. is safe and efficacious to relieve the climacteric symptoms of Chinese women

Extracts of Cimicifuga Racemosa (black cohosh) have been widely used in North America and Europe for decades for the treatment of menopause related problems, either as nutritional supplements or as pharmaceutical products. Previous clinical trials had shown that an extract of Cimicifuga Foetida L.(Ximingting, Luyepharm), which was standardized to have similar components of an extract of Cimicifuga Racemosa, was safe and efficacious to relieve the climacteric symptoms and signs in Chinese women who were recruited according to criteria categorized by theory of Traditional Chinese Medicine.We are interested to know whether it may have the same efficacy and safety profiles when judged with method and standard commonly accepted in western medicine.

Eligibility Criteria:
Inclusion Criteria:

* Having climacteric symptoms with hot flushes \>= 3 time per day
* Score of Kupperman Index at baseline \>= 20
* In addition to these criteria, women who had menopause longer than 2 months but less than 12 months, with FSH \> 15U/L were enrolled into the perimenopausal group. Women having menopause longer than 12 months but less than 5 years, with FSH \>= 40U/L and E2 \<= 30pg/ml, were assigned into early staged postmenopausal group.

Exclusion Criteria:

* Having history of hysterectomy
* Having HRT within 6 weeks
* Having other drugs or nutritional supplements of relieving climacteric symptoms within one week
* Having psychological counseling within one week
* Having medical history of estrogen-dependent tumors
* The result of pap smear exam at stage III and above
* Having an uterine leiomyoma lager than 4 cm
* The endometrial thickness lager than 0.5 cm
* Having abnormal cardiac, liver or kidney functions
* Having abnormal thyroid function
* Having hypertension, diabetes and coronary heart diseases that were not under control
* Pregnant or suspected pregnant woman
* Having severe mental disorders that inhibit to understand the research purpose
* Other conditions the investigators believed not suitable for enrollment
Assessment of Carotid Artery Stenosis and Lower Limb Peripheral Ischemia Prior to CABG

From our experience among Egyptian population in our institution, there is an increased prevalence of hidden subclinical peripheral artery disease along with carotid artery affection. Thus, increasing the risk of post-operative morbid complications.We aim to evaluate routine/ non-selective carotid and peripheral arterial screening in asymptomatic patients undergoing coronary artery bypass grafting in the Egyptian populationIt is a prospective, non-randomized, comparative study including two groups of patients. The study will start from the day of approval of the ethical committee. It will include 260 patients, on basis of "all new comers". Patients will be examined and classified as "high-risk" group (ɳ = 130) or "low-risk" group (ɳ=130).

All patients will have the "routine" preoperative investigations along with evaluation of extracranial carotid system by non-invasive carotid duplex and lower limb arterial system by non-invasive bilateral lower limb arterial duplex.


Eligibility Criteria:
Inclusion Criteria:

1. The acceptance of the patients to participate in the study in the form of a written consent.
2. Patients of both sexes.
3. Three vessels disease for CABG.
4. Patients' age: from 35 to 75 years old.
5. Elective, isolated, primary cases of CABG.
6. Patients with ejection fraction above 40%.
7. Inclusion criteria for the high-risk group will include:

   1. Patients with preoperative history of cerebrovascular events or symptoms suggestive of CVS eg.TIA, transient blindness in one eye, Dizziness, Confusion, Drowsiness, Headache, Temporary inability to speak or move.
   2. Carotid bruit
   3. Left main stem coronary artery disease
   4. Presence of other peripheral vascular disease

Exclusion Criteria:

1. Patients refusing to participate in the study.
2. Age 76 years or above
3. Morbid obese patients (body mass index more than 35).
4. Patients who underwent coronary stenting before.
5. Patients who underwent previous cardiac operation before.
6. Patients with impaired renal functions (serum creatinine \> 1.5 mg/dl, blood urea \> 100 mg/dl and K+ \> 5 meq/L).
7. Patients with preoperative hemoglobin \< 9 gm/dl, white blood cells \> 15,000 cells/mcl,platelets count \< 140,000 per microliter.
8. Patients with rhythm defects by electrocardiography (ECG).
9. Patients with preoperative O2 saturation \< 90 % by pulse oximetry.
Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.

This study investigates nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females.

This study represents the first time to use nanotechnology structured water magnalife in urology and to test its effects against lower urinary tract infections (UTI) in females. Urinary tract infection (UTI ) is the second most common bacterial infection, affecting women at a much higher frequency than men. There is a higher rate of recurrence of UTI, and a recurrent infection will follow 25-35% of initial UTI episodes within 3-6 months.

Intermittent or prolonged low dose antibiotic therapy has been used to treat and prevent recurrent UTI. Emerging of resistance to antimicrobial agents, enormous economic burden, and the side effects of antibiotics have led to the search for an alternative non-antibiotic prophylaxis of recurrent UTI. Nanotechnology structured water is a new type of drinking water that has been prepared using different types of energy fields and electromagnetic fields to produce this structured water, which has new and different characteristics from the ordinary water.

In the current study, the efficacy of nanotechnology structured water magnalife was compared with low-dose Trimethoprim and bottled drinking water for the prevention of recurrent UTI.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 2 (two or more than two) UTI in the last 6 months
* ≥ 3 (three or more than three) UTI in the last 12 months

Exclusion Criteria:

* immunotherapy
* radiotherapy
* malignancy
* steroids
* chronic infections
* chemotherapy
* immunosuppressive drugs
* anatomical abnormality of the urinary tract
* surgical operation the urinary tract
Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma

This randomized, controlled trial (RCT) compares the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation alone, with 3 minutes MMC application or with a single layer coverage of amniotic membrane. Outcomes include intraocular eye pressure (IOP), postoperative glaucoma medication and complications. AGV implantation site will be superior or inferior based on indication and these groups will be randomized separately.


Eligibility Criteria:
Inclusion Criteria:

* patients with refractory glaucoma

Exclusion Criteria:

* children under 7 years old
* adults above 75 years old
* uncooperative patients
* patients underwent the operation for second time
* patients with major operation with AGV
Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients

The AFERBIO study will evaluates safety and potential benefit of AferBio® in patients with non-small cell lung cancer undergoing at least a second-line palliative monochemotherapy. AferBio® is a fermented supplement in powder form obtained through biotechnological processes developed in Brazil. In this double-blind placebo-controlled randomized clinical trial, participants starting a new palliative regimen will be allocated to AferBio® or placebo. The primary aim will be to compare health-related QOL scores among the arms of the study over time.


Eligibility Criteria:
Inclusion Criteria:

* Age above or equal to 18 years, and below 75 years;
* Diagnosis of metastatic or recurrent NSCLC, beginning second-line palliative mono-chemotherapy treatment;
* Functional capacity (ECOG-PS) grade 0 - 2;
* Adequate hematological, kidney and liver function, as follows:

  * Total neutrophil count ≥ 1500/μL
  * Platelet count ≥ 100.000/μL
  * Hemoglobin ≥ 9 g/dL
  * Serum bilirubin ≤ 1.5 × upper limit of normal (ULN)
  * Patients with confirmed Gilbert's syndrome and serum bilirubin ≤ 3 × ULN
* Aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min based on the Cockcroft-Gault equation:

  (140 - age) × (weight in Kkg) × (0.85) 72 × (serum creatinine in mg/dL)
* Absence of any emotional, family-related, sociological, or geographic condition that can potentially hamper adherence to the study protocol and the follow-up schedule;
* Capacity and willingness to adhere to the study visits and tests, and to adhere to the protocol, according to the researcher's evaluation.

Exclusion Criteria:

* Tube feeding, gastrostomy- or jejunostomy;
* Uncontrollable vomiting;
* Sexually active women of reproductive age, except for those who underwent surgical sterilization (e. g., tubal ligation);
* Intestinal obstruction or sub-obstruction;
* Known allergy to any of the components of the investigational product;
* Malabsorption syndrome or other condition that could interfere with enteric absorption;
* History of inflammation of the small or large intestine, previous or currently active (such as Crohn's disease or ulcerative colitis);
* Chronic diarrhea of any cause;
* Diagnosis of any chronic disease that, in the researcher's opinion, will interfere with the participation in the study;
* Known diagnosis of HIV -infection;
* Diagnosis of any chronic disease that changes the immune system and significantly increases the risk of infection;
* The need to use G-CSF already in the first chemotherapy cycle;
* Severe neuropsychiatric disease that prevents the patient from completing the study questionnaires, determined at the researcher's discretion.
Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes

A randomised controlled, open-label trial in an unselected cohort of pregnant women with type 1 or type 2 diabetes allocated to insulin Fiasp® or insulin NovoRapid® during pregnancy and lactation.


Eligibility Criteria:
Inclusion criteria

* Women, age ≥ 18 years
* Duration of type 1 diabetes (or mature onset of diabetes in the young) ≥ 12 months
* Type 2 diabetes (any duration)
* Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks
* Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or Neutral Protamine Hagedorn insulin and willing to continue routine treatment modality
* Women with type 1 diabetes using an insulin pump compatible with trial products
* Women with type 2 diabetes treated with diet, oral antidiabetic therapy or pre-mixed insulin before pregnancy and willing to change to trial medication according to randomization or to an appropriate long-acting insulin analogue, as indicated
* Proficiency in Danish to understand oral and written information

Exclusion criteria

• Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator