cyrilzakka/clinical-trials huggingface dataset:
Additive Anti-inflammatory Action for Critically Ill Patients With Cardiovascular Surgery (Xuebijing) IV

XueBiJing, a Chinese herbal derived therapeutic, has been approved to treat severe infections (sepsis) in critically ill patients (China Food and Drug Administration; Beijing, China, Number Z20040033). Cardiopulmonary bypass (CPB) will produce large amounts of inflammatory mediators and oxygen free radicals, which causes the lipid peroxidation damage and mononuclear cell migration, thus aggravating organ inflammation and damage. Therefore, exploring new methods to prevent and alleviate organ injury caused by CPB is an important topi in clinical practice. However, little knowledge is regarding the effect of Xuebijing injection on CPB-related organ injury. To answer these questions, the authors conducted this randomized trial to compare XueBiJing with placebo in critically ill patients with cardiovascular surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who received cardiovascular surgery fulfilled three or more of the following criteria:

   * Pao2/Fio2 ratio less than or equal to 250mm Hg,
   * Respiratory rate greater than or equal to 30 breaths/min,
   * Blood urea nitrogen greater than 20mg/dL,
   * WBC count \< 4,000 cells/mm3 or \>15 000 cells/mm3 not due to other causes,
   * Core temperature \< 36°C or \>38.5°C,
   * Receiving treatment with vasopressors at therapeutic doses after adequate fluid resuscitation,
   * radiographic findings of new pulmonary infiltrate(s).
2. Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Pregnant and lactating women.
2. Allergic to Xuebijing and its ingredients, or have severe allergies.
3. Mental illness with poor compliance.
4. Severe primary disease (active pulmonary tuberculosis, asthma, cystic pulmonary fibrosis, pulmonary sarcoidosis, pulmonary interstitial fibrosis, unresectable tumors, blood diseases, Alzheimer s disease, or HIV).
5. Participation in other clinical trials in the previous 30 days.
6. Patients who are unsuitable for participation or unable to participate in this trial according to the judgment of the investigators (existing risk of potential medical disputes, and severe heart failure limiting the amount of liquid intake).
Antibiotic Regimens Tailored by Clinical Pharmacist Suppored by Intensivist Enhanced Rational Use of Antibiotics

adding pharmaceutical services to patient care and changing the professional activity of pharmacists from drug-focused to patient-oriented care,in the current study, clinical pharmacists will be assigned to monitor pharmacotherapy regimens, participate in patient care, and cooperate in educating the staff and evaluating care.

During the intervention period, the pharmacist attended daily unit rounds with ICU intensivist with a focus on optimization of antibiotic regimens. Pharmacist consultative services were also available by phone calls 24 hours x 7 days if needed. For every patient surgical prophylactic antibiotic initiated immediately before surgery and continued for 48 hours following surgery. Antibiotic therapy had given as either directed or empiric. Directed therapy was defined as treatment of a documented infection based on culture and sensitivity. Empiric therapy was defined as any antibiotic therapy administered when no documented infection was present, and the patient had clinically suspected infection following surgery. Empiric antibiotic administration was required in majority of our SICU patients. Antibiotics had given after exclusion of allergy by history and intradermal sensitivity test.

Eligibility Criteria:
Inclusion Criteria:

* all admitted patients to the ICU between age 18-80 years old

Exclusion Criteria:

* Patient admitted for less than 24 hours (including deaths and transfers) will be excluded from the study.

Pediatric patients weighted less than kilograms.
Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis.

The problem posed is the possibility of objectively assessing facial muscle mobility.

Today, in patients with facial paralysis, the assessment of the deficit is carried out using a subjective scale such as the House Brackman \[1\] or EMG scale of the facial nerve but does not distinguish each muscle individually . Objective measurements of skin muscles such as thickness and volume, in preoperative assessment of a facial paralysis rehabilitation surgery, would be useful in order to choose the most appropriate surgical technique. Indeed, too much amyotrophy will contraindicate hypoglosso-facial anastomosis (VII-XII) and it will be preferable to propose a temporal elongation myoplasty or a reinfused free muscle flap.

Similarly, it would be useful to be able to objectively evaluate the recovery of muscle function after facial allo-transplantation.

Although electromyography has been developed since the work of Duchenne de Boulogne, little research has been carried out on the development of noninvasive methods to objectively characterize in vivo skin muscles (variation, position, orientation, morphometry). The main morphometric data of the skin muscles come from anatomical dissections.

Imaging of the skin muscles has not been specifically developed. Some studies have been carried out to visualize these muscles in MRI 1.5 Tesla in pathologies such as myasthenia gravis, facial paralysis, and labio-alveolo-palatine clefts for example.

The originality of the project is to develop a method allowing to establish a quantitative correlation between the movements of the face and the muscular changes. This correlation will be achieved by associating muscular morphological data derived from MRI acquisitions and cutaneous deformations resulting from clinical examinations. This non-invasive approach should make it possible to establish objective and reproducible indicators in patients with facial paralysis sequelae.


Eligibility Criteria:
Inclusion Criteria:

* Subject, for which a diagnosis of facial paralysis has been made, female or male, over 18 years of age.

Exclusion Criteria:

* Pregnancy and lactation,
* a patient with a contra-indication to MRI (Claustrophobia, Pace Maker, Neurosurgical Clips, Vascular Clips, Cardiac Valves, V.peritoneal Valves, Cochlear Implant, Neuro-Stimulator, Intra-Orbital Metal Shards (Articular Prosthesis, Dental Prosthesis, Contact Glass, Insulin Pumps, Intrauterine Device, Tattoo, Piercing / Implants.))
Effective Treatment of Jak1/3 Inhibitor in Blau Syndrome

To investigate the effectiveness of the JAK 1/3 inhibitor tofacitinib in treating Blau syndrome and explore the association between various clinical and genetic features and therapeutic responses within the cohort.

Blau Syndrome (BS) is a monogenic systemic autoinflammatory disease characterized by dominantly inherited granulomatous inflammation due to mutations in nucleotide-binding oligomerization domain 2 gene (NOD2). Traditionally associated with a clinical trial of arthritis, dermatitis, and uveitis, recent observations have expanded its recognized manifestations to include systemic inflammatory features, skin or cutaneous vasculitis, and multi-organ involvement. Despite the rarity of BS, significant advances have been made through multi-center collaborations. Current studies, primarily retrospective, highlight the clinical diversity of BS, including cases with disease-causing NOD2 mutations but lacking the typical clinical trial . In response to gaps in understanding of BS's pathogenic mechanisms, the investigators initiated a retrospective observational study to collect detailed clinical data and perform whole exome sequencing, specifically targeting NOD2 mutations and STAT3 rs2293152 phenotypic variations to explore their relationships with therapeutic responses.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must conform to the characteristic triad of granulomatous arthritis, uveitis, and dermatitis, or the characteristic non-caseous granuloma of BS indicated by skin or synovial biopsy;
2. Whole exon detection indicated characteristic mutations of NOD2 gene

Exclusion Criteria:

1. Patients with autoimmune diseases, including but not limited to lupus erythematosus, Sjogren's syndrome, vasculitis, ankylosing spondylitis, myositis, dermatomyositis, rheumatoid arthritis, etc.;
2. combined with other neoplastic diseases, such as lymphoma, leukemia, etc.
Early Supplementation for Cow's Milk Allergy Prevention

Cow's milk allergy (CMA) is a common food allergy in infants and young children that can have a significant impact on the individual and their family due to dietary restrictions, risk of nutritional deficiencies, social limitations, and decreased quality of life. It also represents a financial burden for families and healthcare resources.

There is an ongoing debate about the significance of early exposure to cow's milk proteins within hours or days after birth and its relationship to the risk of developing CMA later in life. Current recommendations for early introduction of cow's milk proteins in infants who cannot be breastfed vary and are inconsistent due to a lack of clear evidence. This knowledge gap underscores the need for further research to provide a definitive understanding of the relationship between early exposure to cow's milk proteins and the development of CMA, which will ultimately inform evidence-based prevention strategies to improve the health and well-being of affected individuals and their families.

This trial aims to investigate whether early supplementation with various nutritional interventions (cow's milk formula \[CMF\], amino acids formula \[AAF\], donor human milk \[DHM\], or high-pressure processed "pascalized" donor human milk \[DHM-P\]) could serve as an effective strategy for the primary prevention of CMA in breastfed neonates.

This study is an open-label randomized, controlled, head-to-head trial with four parallel arms and allocation 1:1:1:1.


Eligibility Criteria:
Inclusion criteria:

1. Healthy newborns of mothers who express the intention to exclusively breastfeed for first 6 months of infant's life
2. Full-term infants (defined as gestational age of at least 37 weeks)
3. Infant birth weight at least 2500 g and ≤ 4500 g
4. Age at enrolment \<24 h of life
5. Regardless of any atopic condition in parents
6. Written informed consent of the caregiver

Exclusion criteria:

1. Infants of parents who intend to partially or fully formula feed
2. Serious congenital anomalies or any other medical condition that would preclude the consumption of any of the study formulas, or interfere with nutrition or growth
3. Contradictions to exclusive breastfeeding
4. Multiple pregnancy
Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial

The aim of our study is to evaluate the effect of use of prophylactic vaginal progesterone on the incidence of severe preterm delivery, defined as delivery before 33+6 weeks in women with a short cervical length of 15mm.

BACKGROUND The results of randomized studies have shown that the prophylactic use of progesterone in women who previously delivered prematurely reduces the risk of recurrence. Asymptomatic women found to have a short cervix (\< 15 mm) at mid-gestation are at greatly increased risk for spontaneous early preterm delivery and it is uncertain whether in such women the risk is reduced by progesterone.

METHODS Cervical length was measured by transvaginal sonography at 22 (range 20-25) weeks in 24,620 pregnant women attending for routine antenatal care. The cervix was 15 mm or less in 413 (1.7%), and 250 (60.5%) of these women participated in a randomized study of vaginal progesterone (200 mg per night) vs identical-looking placebo, between 24 and 34 weeks. Primary outcome was the frequency of spontaneous delivery before 34 weeks (238 days) of pregnancy. Analysis was performed according to the intention-to-treat principle.

Eligibility Criteria:
Inclusion Criteria:

* All women with singleton or twin pregnancies attending for routine ultrasound examination at 20-25 weeks of gestation with a short cervical length (\<15 mm).

Exclusion Criteria:

* Women with major fetal abnormalities,
* Painful regular uterine contractions, or history of ruptured membranes or cervical cerclage in-situ were excluded from screening.
Compare the Agility Exercise and Resistance Exercise on Physical Function and Stability in Osteoporotic Women

Osteoporosis weakens bones with age, increasing fracture risk. Exercise improves physical function and reduces falls, crucial for preventing osteoporotic fractures, especially with balance, resistance, and multi-component training. Agility exercise, integrating various aspects like aerobic, strength, balance, and cognitive tasks, is promising for fall prevention in older adults, though its effectiveness in osteoporosis is not extensively studied.

This study compares agility and resistance exercise impacts on physical function and balance stability in postmenopausal osteoporosis. Fifty-one women (average age: 68±6.3y, BMI: 22.3±2.7 kg/m2) were divided into agility exercise (AG), resistance exercise (RG), and control groups (CG) through purposive sampling. AG and RG received added intervention training once a week for 2 hours over 12 weeks. Main outcomes included physical function and balance stability measured through various tests.

Main activities of agility training group (AG): Use rope ladders and cones to perform multiple tasks of direction changes, acceleration and deceleration of footsteps, hand and foot coordination and spatial orientation training.

Main activities of resistance training group (AG): Resistance training for upper and lower limb muscles and core muscles, including squats, use of elastic bands, and simple bars.

Eligibility Criteria:
Inclusion Criteria:

* women with osteoporosis( diagnosed with DXA, T-score≦-2.5 in L-spine or hip)
* postmenopausal, more than 50 years old,

Exclusion Criteria:

* unable to attend the training sessions due to physical problems
* had joined previous exercise program
Dietary Influences On Caries Index Among Sudanese And Egyptian Adult Population

the objective of this study is to compare the caries index between Sudanese and Egyptian adult Population in patients with different diet habits and different oral hygiene state in range of (18-40) years old

A main factor for planning any preventive program is to accurately assess a person's risk of developing a caries.

There is a relative lack of data pertaining to adults in the developing world in general and in Sudan in particular. Most of the studies focused on school children.

Many people in Sudan do not receive regular dental care and have acute problems when seen by a dentist. In Sudan the dentist-to-patient ratio is 1:33,000 compared with approximately 1:2,000 in most industrialized countries. Relative to the size of the Sudanese population, there are very few dentists and this restricts access to regular dental care. Other factors which influence dental. Attendance in Sudan include the lack of public funding for oral healthcare and dental insurance schemes to ameliorate the cost of care. For this reason, insufficient awareness of the culture of selecting suitable foods to preserve the health of the mouth and teeth, as prevention is better than treatment .

The study will help the clinician to compare the incidence of caries between different nationality they have different diet habits ,food traditions , and they have different education and cultural levels as these factors can reflect the health care system , and to determine the effect of these factors clearly on dental caries It also allow the clinician to develop the most suitable preventive treatment plan for each patient by evaluating the main causative factor to patient and to eliminate that factor so that we can arrest an ongoing active lesion and prevent developing a new lesion at lowest therapeutic cost.

The patient will be informed in the same visit about the causative factor of the carious lesion in general, the role of diet in particular and instructed about the suggested treatment plan ,to change the lifestyle to the better and strengthen the concept of "prevention is better than treatment"

Eligibility Criteria:
Inclusion Criteria:

* Patients should be in range of 18-40 years old.
* Patient should have good periodontal health.
* Sudanese and Egyptian population

Exclusion Criteria:

* Patient below 18 years and above 40 years old
* Nationality other than Egyptian and Sudanese
Comparison of Optical Coherence Tomography Angiography Microvascular Changes in Primary Open Angle and Primary Angle Closure Glaucoma

This work aims to study the peripapillary and macular microvascular changes in primary open angle and primary angle closure glaucoma using Optical Coherence Tomography Angiography (OCTA).

After approval of the local institutional ethics committee and local institutional review board, all patients presenting to the outpatient clinic of the department of Ophthalmology in the universities has been subjected to routine ophthalmological examination including: best corrected visual acuity (BCVA), Slit-lamp evaluation of anterior segment, IOP by Goldmann applanation tonometer, Gonioscopy using gonio contact lens, Fundus examination by indirect opthalmoscope with history taking focusing on positive family history of glaucoma after a detailed informed consent was signed by eligible patients and investigated by OCTA of the Peripapillary and Macular vascular density on presentation using AngiVue (Optovue, Inc., Fremont, CA, USA).

Data analysis performed using the Statistical Package of Social Science (SPSS) software version 22 in windows 7 (SPSS Inc., Chicago, IL, USA) Simple descriptive statistical analysis in the form of numbers and percentages of qualitative data, and arithmetic means as central tendency measurement, standard deviations as a measure of dispersion of quantitative parametric data.

For quantitative parametric data: Independent samples test was used to compare quantitative measures between two independent groups, One-way analysis of variance ANOVA test used to compare quantitative measures between more than two independent groups of quantitative data with the benferroni Post-HOC to test the significance between each two groups, Paired t-test used to compare two dependent quantitative data.

For qualitative data Chi square test used to compare between two or more than two qualitative groups.

Bivariate Pearson correlation test to test the association between variables The probability value (P-value) \< 0.05 was considered as statistical significant

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Fulfilling Diagnostic criteria of PACG patients :occluded angle by gonioscopy in which \> 180˚ of trabecular meshwork cannot be seen , IOP\>21, Optic disc and RNFL damage due to glaucoma
* Diagnosed POAG patient: open anterior chamber angle ,IOP\>21 ,Optic disc and RNFL damage due to glaucoma
* Healthy patient: normal anterior chamber, open angle and normal fundus.

Exclusion Criteria:

* History of other causes of optic neuropathy.
* History of systemic diseases. (HTN, DM, Cardiac).
* Previous ocular surgeries or Laser iridotomy.
* Poor quality of OCTA image less than 4/10.
* Refractive errors \> 6 diopters sphere, \>3 diopter cylinder
* Poor cooperation or fixation with the OCTA examination.
* Secondary causes of glaucoma
* Media opacity that interfere with quality of image (dense cataract,corneal opacity,...)
* Previous acute attack of ACG
The Role of Willingness of Participation in Cardiology Trials on the Survival of Patients

It has been shown retrospectively that participation and even the willingness improves the survival of patients after myocardial infarction or heart failure. We aimed to prospectively analyse the role of participation in cardiology trials on the survival of patients in a high volumen tertiary center.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalisation due to acute myocardial infarction, and or heart failure
* Singed informed consent

Exclusion Criteria:

* Previous participation in any clinical study
* Haemodinamically instable, shock, intubation
* Pregnancy, breast feeding
Effects of Obstructive Sleep Apnea and/or Cigarette Smoking on Endothelial Function

The hypothesis of this study is that either obstructive sleep apnea (OSA) or cigarette smoking (CS) exposure would produce oxidative stress and inflammation leading to endothelial injury, and the combined exposure would be additive or synergistic.


Eligibility Criteria:
Inclusion Criteria:

* No acute illness
* No hospitalization in past 4 weeks
* Absence of medical comorbidity such as hypertension, ischemic heart disease, diabetes and hyperlipidemia, renal impairment, vasculitis or Raynaud's syndrome, peripheral vascular disease especially Buerger's disease, aortic disease (aortic aneurysm or dilatation), cancer, thrombocytopenia, coagulation disorder or other chronic medical illness

Exclusion Criteria:

* Mentally incapacitated
Mifamurtide (L-MTP-PE) for High-Risk Osteosarcoma

The purpose of this study was to collect information regarding the safety and tolerability of mifamurtide (liposomal muramyl tripeptide phosphatidyl ethanolamine; L-MTP-PE).

The drug being tested in this study is called mifamurtide (L-MTP-PE; liposomal muramyl tripeptide phosphatidyl ethanolamine). Mifamurtide is being used to treat people with osteosarcoma, a form of cancer.

This was a patient-access study that looked at adverse events, disease progression, and overall survival in study participants.

The study enrolled 205 patients, of whom 204 were treated with mifamurtide intravenously at a dose of 2 mg/m2 twice weekly (at least 3 days apart) for 12 weeks, and then weekly for an additional 24 weeks, for a total of 48 doses in 36 weeks (following surgery for primary or metastatic disease).

This study was conducted in the United States. Participants could receive treatment for up to 9 months. This study was previously mis-categorized as an interventional study.

Eligibility Criteria:
Inclusion Criteria:

1. Had signed informed consent/assent. Voluntary participation in the pharmacokinetic portion of the compassionate access protocol was included in the informed consent but not required for compassionate use participation.
2. Had diagnosis of high grade osteosarcoma with relapsed or recurrent disease, locally or metastatic, with disease not completely resectable or who were unable to complete recommended chemotherapy due to toxicity: relapse, recurrence local or metastatic; unable to have standard surgical resection; abbreviated chemotherapy regimen secondary to toxicity (e.g. hypophosphatemia from ifosfamide, cardiotoxicity from doxorubicin, renal dysfunction from methotrexate, ifosfamide, or cisplatin.)
3. Aged 2 ≤ 50 years.
4. Had adequate hematopoietic function as demonstrated by: 1) Absolute Neutrophil Count (ANC) \> 750/microL; Hemoglobin (Hb) \> 8 g/dL; Platelets \> 30,000/microL.
5. Had adequate hepatic function as documented by 1) ALT \< 2.5 x upper limit of normal (ULN) for age; 2) total bilirubin ≤ 1.5 x ULN for age.
6. Had adequate renal function as demonstrated by: 1) Creatinine clearance or radioisotope glomerular filtration rate \> 70 mL/min/1.73 m\^2; OR, 2) Serum creatinine ≤ 2x ULN for age.
7. Had absence of concurrent active acute infection (i.e., afebrile).
8. In females of child bearing potential (not menopausal for 12 months or no previous surgical sterilization), had a negative pregnancy test. All sexually active participants used an effective means of contraception. Such means included oral contraceptives, Lupron Depot, DepoProvera, and condom with diaphragm and spermicidal jelly.
9. Performance status: Lansky 50-100% (≤ 16 years of age); OR, Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky 50-100% (\>16 years of age).

Exclusion Criteria:

1. Had chronic use of corticosteroids or other immunosuppressive agents.
2. Was pregnant or breast-feeding.