cyrilzakka/clinical-trials huggingface dataset:
Impact of Acute Normovolemic Hemodilution on Blood Viscosity

Acute normovolemic hemodilution (ANH) has long been employed for reducing allogenic blood transfusion for cardiac surgery, and hydroxyethyl starch has been used as an intravenous replacement fluid during ANH procedure. However, possible impact of ANH employing HES on blood viscosity and oxygen delivery have not been well investigated in patients undergoing off-pump coronary artery bypass (OPCAB) surgery .

Anesthesia is induced and maintained by using propofol-remifentanil-rocuronium in OPCAB surgery (n=21). ANH is performed by using 5 ml/kg of blood salvage and administering 5 ml/kg of balanced HES 130/0.42 (Tetraspan™) for 15 min during vascular graft harvesting. For the present study, three arterial blood samples (3 ml each) are taken before (Sample 1) and after ANH (sample 2 and 3) and they are stored in 3 tubes. Sample 3 (in tube) undergoes further 30% in-vitro dilution by adding 1-1.5 ml HES. By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at low shear rate (5/sec) of the three samples are determined. By using a formula with blood viscosity and hematocrit, tissue O2 delivery index (TODI, = hematocrit/viscosity at 5/sec) is calculated.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing off-pump coronary artery bypass graft surgery

Exclusion Criteria:

* Preoperative anemia
* LV ejection fraction \< 50%
Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

This study will examine the impacts of two different methods of managing MS-related spasticity of the lower limbs. Both interventions will be presented via video teleconference in group classes consisting of exercises to reduce spasticity.

Now online since COVID-19

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of definite MS by 2010 updated McDonald Criteria
* Age 18 or older
* Able to walk 25 feet with any assistive devices (Patient Determined Disease Steps 0-6)
* Fluent in written and spoken English, as materials are not validated in languages other than English.
* Presence of self-reported lower extremity spasticity that is interfering with daily activities or sleep, using the this definition: Have spasticity in your legs with unusual tightening of muscles that feels like leg stiffness, jumping of the legs, a repetitive bouncing of the foot, muscle cramping in the legs, or the legs going out tight and straight or drawing up.
* All women that meet the above criteria
* Only Veteran men that meet the above criteria

Exclusion Criteria:

* Any uncontrolled medical or mental condition that would limit participation or completion of the study
* Any self-reported musculoskeletal or neurological condition other than MS that is known to cause spasticity
Antimicrobial Photodynamic Therapy in Patients With Periodontal Disease and Type 2 Diabetes Mellitus

Objectives: This study aimed to determine the effect of concomitant antimicrobial photodynamic therapy (aPTD) on periodontal disease and glycaemic control in patients with type 2 diabetes mellitus (T2DM).

Clinical Relevance: aPTD is a noninvasive adjunctive therapy that can positively influence the periodontal treatment outcome.

Numerous studies confirm that diabetes mellitus increases the risk of gingivitis and periodontitis. However, periodontal disease also impairs glycaemic control in people with diabetes mellitus via inflammatory mediators.

Methods:

Twenty-four patients with T2DM were enrolled in the study. Periodontal tissue status and periodontal disease were assessed by measuring probing pocket depth (PPD), bleeding on probing (BOP), clinical attachment loss (CAL), plaque index (PI) and sulcus bleeding index (SBI). Glycated haemoglobin A1c (HbA1c) was measured. To determine the presence of the following periodontal pathogenic bacteria Aggregatibacter actinomycetemcomitans, Prevotella intermedia, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola, subgingival plaque samples were taken from two periodontal pockets with the greatest PPD using paper tips. Patients were randomly divided into the test and control group. In the test group, complete oral disinfection was performed in combination with aPTD. In the control group, only complete oral disinfection was performed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 75 years
* Diabetes Mellitus type 2 with an HbA1c value \> 7.0%,
* At least ten teeth in the Maxilla and Mandible
* At least four teeth with a probing pocket depth ≥ 5 mm and bleeding on probing.

Exclusion Criteria:

* Antibiotic treatment in the last four months
* Periodontal treatment in the last six months
* Any change in Antihyperglycaemic treatment three months prior to participation
* Pregnant women
* Lactating women
* Smokers
* Former smokers who had stopped smoking less than five years before participation
Desarda Repair for Inguinal Hernia

Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced as a pure tissue repair with no need for mesh. In other words; the complications which may arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the efficacy of this new repair and compare it to the standard Lichtenstein repair.


Eligibility Criteria:
Inclusion Criteria:

* inguinal hernia

Exclusion Criteria:

* recurrent inguinal hernia
* giant inguinal hernia
* mental disorder
* refusal to participate
Daily and Weekly Iron Supplementation in Infants

This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months.

This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Normal birth weight and term infants will be enrolled at 6 months based on the inclusion criteria. Eligible participants will be assessed at baseline, including anthropometry, dietary intake, and biochemistry (hemoglobin, iron status, vitamin A status, and inflammation). Participants will then be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months. Participants will be followed up at 9 months for the same assessments and will receive weekly iron supplementation for another 3 months. Participants will be followed up at 12 months and the same assessments will be performed. After that, participants will go back to the routine health care service, weekly iron supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy infant, aged 6 months ± 2 weeks
* Having a birth weight between 2,500 and 4,000 grams
* Being born full term (37 to 41 weeks of age + 6 days)
* Having hemoglobin ≥ 10.5 g/dL
* Being planned to breastfeed with complementary food and/or complementary foods with formula milk

Exclusion Criteria:

* Infants with chronic illnesses or thalassemia clinical signs such as anemia, enlarged liver, or spleen (if parental history suggests the child is at risk of developing a thalassemia disease that may not show clinical symptoms)
* Previously or currently taking an iron supplement
The Psychosocial Effect of Thoughts of Personal Mortality on Cardiac Risk Assessment by Medical Students

This study was designed to examine if provoking thoughts of mortality among medical students can influence cardiac risk assessments depending on the religion of the target patient.

This study was designed to examine whether and how provoking thoughts of mortality among medical students can influence cardiac risk assessments depending on the religion of the target patient.

Eligibility Criteria:
Inclusion Criteria:

* medical students

Exclusion Criteria:

* non-medical students
FLOX in Combination With Cetuximab in First-line Treatment of Colorectal Cancer

The main objective of this trial is to explore the effect of combining an established chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab, in which FLOX is given continuously or intermittently, compared to standard FLOX without cetuximab.


Eligibility Criteria:
Inclusion Criteria:

Histology and staging disease:

* Histological proven adenocarcinoma of the colon or rectum;
* At least one measurable metastatic disease
* If only one metastatic lesion and no S-CEA elevation, histology is mandatory;
* Availability of tumour sample for EGFR assessment.

General conditions:

* Age \>18 and \< 75 years;
* WHO performance status: life expectancy of more than 3 months;
* Adequate haematological function
* Adequate renal and hepatic functions
* Written informed consent

Exclusion Criteria:

Prior therapy:

* No prior chemotherapy for advanced/metastatic disease;
* No adjuvant chemotherapy the last 6 months before inclusion;
* No previous oxaliplatin;

Prior or current history:

* No current indication for resection with a curative intent;
* No evidence of CNS metastasis;
* No current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
* No current history of chronic diarrhoea;
* No peripheral neuropathy;
* No other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies);
* No past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix;

Concomitant treatments:

* No concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation;
* No concurrent treatment with any other anti-cancer therapy;

Other:

* Not pregnant, no breast feeding
* Fertile patients must use adequate contraceptives
* Not include patients clearly intending to withdraw from the study if not randomised in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar or geographic reasons.
Evaluating a Physical Activity Index for Assessment and Counseling for Breast and Colon Cancer Survivors

The purpose of this research study is to determine whether using the physical activity index screener, exercise coaching, and self-monitoring will increase physical activity and reduce time spent sitting or being inactive in patients who had breast or colon cancer.

To assess the feasibility (participation rate, adherence, and retention) of the Physical Activity Index (PAI) intervention in breast and colon cancer survivors supported by exercise coaching and self-monitoring tools.

Eligibility Criteria:
Inclusion Criteria:

* Survivors of breast or colon cancer (stages 0-III) diagnosed within the last three years prior to enrollment.
* Completed primary treatment (surgery, chemotherapy, and/or radiation) at least 3 months prior to enrollment.
* At least 50 years of age or older.
* Access to internet or cellular plan for video calls.
* Being willing and able to comply with the approved protocol and able to sign an IRB-approved informed consent document directly, remotely or via electronic consent.
* Able to read and speak English

Exclusion Criteria:

* Participants with metastatic disease.
* Participants with recurrence or diagnosis of a different cancer.
* Participants receiving treatment other than maintenance therapy for their primary cancer (breast or colon).
* Participants has prior conditions that contraindicate exercise as determined by treating physician.
* Participants has gross cognitive impairment as determined by treating physician.
Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry

The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS System in the treatment of Parkinson's disease.

The utilization of Image Guided Programming (IGP), and other commercially available programming features, used as planning tools for the programming of patients with Boston Scientific's Vercise DBS System are also evaluated.

Additionally, the utilization of the DBS Illumina 3D feature that may be used for the programming of patients with Boston Scientific's Vercise DBS Systems is also evaluated.

The purpose of this registry is to compile characteristics of world-wide outcomes for the use of Boston Scientific's commercially available Vercise DBS system in the treatment of Parkinson's disease.

Subjects' improvement in disease symptoms and overall Quality of life will be assessed during the study following DBS and compared with baseline. Additionally, the utilization of Image Guided Programming (IGP) when used as a planning tool for programming of patients is also evaluated.

Eligibility Criteria:
Key Inclusion Criteria:

* Meets criteria established in locally applicable Vercise System Direction for Use
* At least 18 years old

Key Exclusion Criteria:

* Meets any contraindication in the Vercise System locally applicable Directions for Use

Subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of GXT.
Sham Controlled Study of Renal Denervation for Subjects With Uncontrolled Hypertension

To demonstrate that non-invasive renal denervation is safe and shows a net difference in blood pressure reduction when compared to sham in subjects with uncontrolled hypertension.

This study is a sham controlled, double blind study of subjects with uncontrolled hypertension consisting of two arms, sham and therapy. Bilateral renal denervation will be performed non-invasively using the Kona Medical Surround Sound System which delivers focused ultrasound therapy to ablate the nerves surrounding the renal artery utilizing real time ultrasound for targeting and tracking.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age and no more than 90 years of age
2. Average SBP ≥ 160 mmHg
3. 24 hour average ABPM daytime SBP ≥ 135 mmHg.
4. No medication changes for a minimum of 1 months prior to screening.
5. At minimum, subject must be on at least three antihypertensive medications, with one being a diuretic, and each must meet one or more of the following full dose criteria:

   1. Highest labeled dose according to medication's labeling;
   2. Highest usual dose per clinical guidelines JNC-7;
   3. Highest tolerated dose; and/or
   4. Highest appropriate dose for the subject per the PI's clinical judgment.
6. Subject has two functioning kidneys.
7. Subject has an eGFR value of ≥ 30 ml/min/1.73 m² (MDRD formula).

Exclusion Criteria:

1. Subject has any secondary cause of hypertension
2. Subject has evidence of clinically significant renal artery stenosis as determined by flow rate, velocity and Doppler analysis on ultrasound
3. Subject has kidney stones that are of a size and location that are determined at discretion of the investigator to potentially interfere with treatment
4. Subject has a history of intra-abdominal surgery within the past six months
5. Subject has heterogeneities in the kidney such as large cysts or tumors that are determined at discretion of the investigator to potentially interfere with treatment.
6. Stenotic valvular heart disease for which BP reduction would be hazardous as determined by referring physician.
7. MI, unstable angina, or CVA in the prior 6 months.
8. Known severe primary pulmonary HTN
9. Subject has a history of myocardial infarction, unstable angina pectoris, or cerebrovascular accident within the last six months.
10. Subject has hemodynamically significant valvular heart disease.
11. Subject has BMI over 40 km/m\^2
12. Subject has a target treatment depth over 13 cm.
13. Subject has anatomy that precludes treatment with the Kona Medical Surround Sound System.
14. Subject is pregnant, nursing, or intends to become pregnant during the trial period.
15. Subject is currently enrolled in other potentially confounding research.
16. Subject has any condition that, at the discretion of the investigator, would preclude participation in the trial.
17. Subject is unable, or unwilling, to comply with the protocol-required follow-up schedule
Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection

This is an observational study that does not change routine care.

The primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the Antibiofilmogramme test, and the relapse of the infection for patient with orthopaedic device-related infection.

The secondary objectives are:

A. Investigate the role of antibiogram-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in orthopaedic device-related infection management.

B. Investigate the capacity of S. aureus isolates to form biofilm in presence/absence of antibiotics.

C. Create an S. aureus strain collection for future ancillary studies

Eligibility Criteria:
Inclusion Criteria:

* The patient must have been informed and received a non-opposition consent form
* Patient with a monomicrobial S. aureus bone and joint infections
* Patient with prosthetic or orthopaedic device

Exclusion Criteria:

* Bone and joint infection from pressure ulcer, vascular injury or diabetic foot ulcer
* Polymicrobial prosthetic joint infection
* The patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding study
* Patient is under judicial protection, under tutorship or curatorship
* The patient expresses his opposition to participate to the study
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient or breastfeeding
* Emergency situation precluding correct study implementation
Comparison of Patient Work of Breathing and Tidal Volumes With High Flow Nasal Cannula Oxygen Therapy and NIV (Non-Invasive Ventilation) After Extubation in the ICU.

This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age: 18 years
* planned extubation decided by the physician in charge of the patient after success of weaning trial
* patients at high risk of reintubation according to the following criteria: patient older than 65 years, or those having any underlying chronic cardiac or lung disease
* Hypoxemia defined by PaO2/FiO2 \< 300 mmHg under mechanical ventilation before extubation

Exclusion Criteria:

* Duration of mechanical ventilation prior to extubation \< 24h
* Contraindication to NIV
* Contraindication to nasogastric tube
* Do-not-reintubated order at time of extubation
* People under legal protection
* Opposition to participate
Transfusion-Transmitted Cytomegalovirus Prevention in Neonates

To evaluate the capacity of intravenously administered cytomegalovirus (CMV)-immune globin (CMVIG) to immunize high risk premature infants against CMV infections.

BACKGROUND:

Premature infants who require multiple blood transfusions have a 15-30 percent incidence of cytomegalovirus infections. Many of these infections result in severe disease, with a mortality of about 20 percent. In theory, the infection could be avoided by using blood and blood products exclusively from CMV antibody negative donors. The use of such blood is impractical because it would require the rejection of approximately 40 percent of all blood donors. Studies had suggested that passively acquired antibody could reduce the incidence of disease in exposed neonates. This provided the rationale for the use of passive immunization with hyperimmune globin in premature infants likely to require multiple transfusions. Lots of high titer CMV immune globulin suitable for intravenous administration were prepared using a technique of screening outdated blood bank plasma for units with high levels of antibody to CMV.

DESIGN NARRATIVE:

Randomized, double-blind. Subjects received either prophylactic CMVIG-intravenously or a placebo. Infants were followed for up to 12 weeks after discharge. Total sample size was expected to be 650.

The study completion date listed in this record was inferred from last publication listed in the Citations section of this study record.

Eligibility Criteria:
Neonates at high risk for transfusion-transmitted CMV infection. The neonates were either premature, of low birth weight, or had respiratory distress requiring the presence of an umbilical catheter.
Successful Pregnancy and Delivery After AOA

Artificial oocyte activation with strontium chloride or calcium ionophore improves fertilization, embryo quality, pregnancy and delivery rate in women who showed complete fertilization failure or low fertilization rates


Eligibility Criteria:
Inclusion Criteria:

* Fertilization rate was less than 30% after conventional ICSI.
* Fertilization rate was less than 50% after ICSI with calcium ionophore.
* Repeated complete fertilization failure or low fertilization rates following ICSI in previous cycles

Exclusion Criteria:

* Fertilization rate was more than 30% after conventional ICSI
* Fertilization rate was more than 50% after ICSI with calcium ionophore.
* Successful pregnancy and delivery after ICSI in previous cycles
Long-term Outcomes in Older Patients With Physical Restraint

The worldwide population is ageing. Biological sex is first and foremost a genetic modifier of disease. To prevent self-arm many techniques can be used in older patients. Among them coercive measure consisting of physical restraint (PR) is one of the techniques.

This study aims to assess the effects of the biological sex on the long-term survival after PR in geriatric patients during the initial emergency department (ED) visit.

This retrospective study included patients between November 2019 to March 2021. All consecutive hospitalized patients after emergency department visit older than 75 years with PR were included.

The population was compared according to the biological sex. One-year all-cause mortality was plotted with the Kaplan-Meier curve. Hazard ratios (HRs) for 1-year mortality were calculated using a Cox proportional hazards regression model. Mortality was monitored over a 3-year period.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive older patients ≥ 75-year-old hospitalized to the observation unit or to the ward from the ED were included from November 2019 to March 2021 if PR were mentioned in their medical records

Exclusion Criteria:

* if patients were less than 75 years old, without PR or not hospitalized. If a patient was admitted more than once, only the first episode was taken as index admission