cyrilzakka/clinical-trials huggingface dataset:
Free for Weaning ECMO Vs Respiratory Driven Study

In its most severe form, Acute Respiratory Distress Syndrome (ARDS) may require the use of veno-venous ECMO (vvECMO). While the criteria for vvECMO indication, ECMO settings, and ventilator management are relatively well-defined after the publication of the EOLIA trial and subsequent national or international guidelines, few studies have assessed the criteria and methods for weaning from vvECMO. Besides, advances in the understanding of the pathophysiology of mechanical ventilation (MV) weaning process have led to the development of specific monitoring tools for this phase.

Schematically, respiratory drive can be evaluated via the ventilator by measuring the pressure generated during a 100-millisecond expiratory occlusion (P0.1) and respiratory efforts through the measurement of esophageal pressure variation (delta Poeso).

Recent retrospective studies conducted on COVID-19 ARDS patients supported by vvECMO suggest a longer duration of mechanical ventilation for patients whose weaning and decannulation process was "forced," i.e., performed under conditions of significant respiratory drive and effort. High values of P0.1 and delta Poeso were associated with prolonged MV duration. Self-inflicted lung injury (P-SILI) and elevated transpulmonary pressure related to these uncontrolled respiratory efforts likely explain the negative impact on MV duration.

Therefore, this randomized study proposes to assess these monitoring tools, which are regularly used in clinical practice, to guide vvECMO weaning and decannulation decisions.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18 years or older Patient whose trusted person has given consent for participation in the study
* Patient on veno-venous ECMO with weaning criteria, including:
* Resolution of the cause of ARDS
* Absence of hemodynamic instability, defined as norepinephrine dose ≤ 0.5 μg/kg/min for at least 3 hours
* Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV)
* Maximum inspiratory pressure ≤ 28 cm H2O, with a maximum driving pressure ≤ 15 cm H2O, enabling tidal volumes between 4 and 8 ml/kg of predicted body weight (PBW)
* ECMO membrane sweep flow ≤ 2 L/min
* Patient protected by social security

Exclusion Criteria:

* Contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe thrombocytopenia),
* Patient with treatment limitation at the time of inclusion,
* Patient in the time frame of exclusion from another research protocol at the time of consent signing,
* Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.
Study of the Effects of a New Infant Formula Supplemented With a Probiotic Over the Corporal Composition of Infants

This is a multicentric, randomized, blinded, controlled trial to study the effects of a new infant formula on the changes in the newborn body composition over time: weight gain, anthropometric data, incidence of infections, digestive tolerance (flatulence, vomiting and regurgitation), feces (consistency and frequency), behavior (restlessness, colic, nocturnal awakenings), count of probiotic strains of the intestinal microbiota in feces, safety and tolerability of the investigational products (measured as number, frequency and severity of adverse events in all branches of the study)


Eligibility Criteria:
Inclusion Criteria:

* Healthy children. Both sex.
* Full term infants (between 37 and 42 weeks of pregnancy).
* Birth weight between 2500 g- 4500 g.
* Single birth babies.
* BMI of the mothers before the pregnancy between 19 y 30 kg/m2.

Exclusion Criteria:

* Body weight lower than the 5th percentile for their gestational age.
* Cow's milk protein allergy and/or lactose allergy.
* Administration of antibiotics 7 days prior inclusion.
* Congenital disease or malformation that may affect the infant growth rate.

Population Description: The study population are newborns selected from primary care clinics in Spain.

Sampling Method: Not applicable

* Metabolic disease or disorders.
* Significant prenatal disease and/or serious postnatal disease before recruitment.
* Underage parents.
* Diabetic mother.
* Born from a drug abuse mother (who use abuse drugs during pregnancy).
* Parents cannot comply with study procedures.
* Subject included or that have been included in other clinical trial since his/her birth day.
Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19

To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19


Eligibility Criteria:
Inclusion Criteria:

1. The age ranges from 18 to 85 (inclusive), regardless of gender.
2. Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition).
3. Patients with symptoms of long COVID-19 3 months from the onset of COVID-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases.
4. Be expected to live longer than 1 year.
5. Volunteer to participate in this clinical study and sign the written informed consent.

Exclusion Criteria:

1. Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation.
2. T lymphocyte abnormality, HIV positive.
3. Highly allergic or have a history of severe allergy.
4. Pregnant and lactating women.
5. Patients with severe autoimmune disease history;
6. Patients with uncontrolled chronic diseases or serious complications;
7. Patients with malignant tumors;
8. Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism;
9. Patients with severe organ dysfunction
10. Other situations that the researchers think are not suitable for participating in this study
Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis

This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.


Eligibility Criteria:
Inclusion Criteria:

* Stenotic, restenotic (from PTA or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries.
* Symptomatic femoral-popliteal atherosclerosis.
* Willing to comply with all follow-up evaluations at the specified times.
* Provides written informed consent prior to enrollment in the study.

Exclusion Criteria:

* Previously implanted stent(s) or stent graft(s) in the target vessel.
* Planned use of devices other than angioplasty balloons during procedure.
* Received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure.
* Life expectancy of less than 12 months.
* Symptomatic femoral disease in the opposite limb.
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.


Eligibility Criteria:
Inclusion criteria

* Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet

Exclusion criteria

* Concurrent participation in any clinical trial (other than the Parent study)
* Unable or unwilling to comply with the requirements of the protocol
A Study of ECHELON 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures

The purpose of this study is to assess the safety and performance of the ECHELON 3000 Stapler (next generation powered stapler) and reload system in participants undergoing laparoscopic sleeve gastrectomy or lung resection procedures (Video-Assisted Thoracoscopic \[ATS\] or open approach).


Eligibility Criteria:
Inclusion Criteria:

* Adult and pediatric participants satisfying the following criteria will be considered eligible for enrollment in this study (procedures may be performed with or without a robot): Primary procedure where the ECHELON 3000 Stapler and reload system is planned to be used for tissue transection per the instructions for use (IFU) in either of the following, a) Laparoscopic Sleeve Gastrectomy; b) Lung resection procedures (VATS or open)
* Adult participants- Willingness to give consent and comply with all study-related evaluations and visit schedule
* Pediatric participants- The participant's parent/legal guardian must be willing to give permission for the participant to participate in the study and provide documented informed consent for the participants. In addition, assent must be obtained from pediatric participant who possess the intellectual and emotional ability to comprehend the concepts involved in the study. If the pediatric participant is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the study), the parent/legal guardian's documented informed consent for the participant will be acceptable for the participant to be included in the study

Exclusion Criteria:

* Physical or psychological condition which would impair study participation
* Procedure is a revision/reoperation for the same indication or same anatomical location
* A procedure where surgical stapling is contraindicated
* Concurrent treatment with medications that the investigator deems could have influence on wound healing
* Enrollment in a concurrent interventional clinical study that could impact the study endpoints
Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients with advanced kidney cancer.

This is a dose-escalation study. Initially patients receive a scout dose of iodine-131 radiolabeled chimeric monoclonal antibody G250 (131I-cG250) administered intravenously (IV) over 10 minutes to determine whole body clearance. One week later, patients receive incremental doses of 131I-cG250 IV over 10 minutes at 2-3 day intervals for 2-6 weeks,. Dose escalation begins at least 8 weeks after the last infusion of 131I-cG250. In the absence of dose-limiting toxicity in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of 131I-cG250 on the same schedule. If dose-limiting toxicity occurs in 2 of 6 patients treated at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose (MTD). Treatment continues once recovery from all toxic effects occurs, beginning 8 to 12 weeks following the last dose of 131I-cG250. Patients achieving complete remission, partial remission, or stable disease were eligible to receive up to 3 courses of treatment.

Eligibility Criteria:
Inclusion Criteria

Histologically proven renal cell carcinoma. Clinical presentation consistent with metastatic renal cell carcinoma. Bidimensionally measurable disease by conventional imaging. Patients must have been off chemotherapy or immunotherapy for at least 6 weeks prior to study entry.

Women of child-bearing age must have had a negative pregnancy test carried out the day of and prior to receiving therapy, and were asked to use effective contraception during the study.

Patients were required to be ambulatory with a Karnofsky Performance Status at least 70, Serum creatinine ≤ 2mg/dl, Serum bilirubin ≤ 1mg/d, White Blood Cells (WBC) ≥ 3,500/mm\^3, Platelet count ≥ 100,000/mm\^3, Prothrombin time \< 1.3 x control.

Exclusion Criteria

Significant prior radiation therapy to the entire pelvis and/or lumbosacral spine.

Clinically significant cardiac disease. Serious infection requiring treatment with antibiotics, or other serious illness.

Women who are pregnant or lactating. Central Nervous System (CNS) tumor involvement. Life expectancy less than 6 weeks. Hypercalcemia greater than 12.5 mg/dL or symptomatic.
Immunologic and Genetic Characteristics of Monoclonal Immunoglobulins in Patient With Tuberculosis

The purpose of this study is to determine whether the monoclonal protein in patients with tuberculosis and monoclonal gammopathy has anti-tuberculous activity, and whether genes coding their monoclonal proteins show characteristic mutations.

Monoclonal immunoglobulins arise from abnormal proliferation of a single clone of plasma cells. They are composed of a single light and/or heavy chain class, in contrast to polyclonal immunoglobulins. They may occur in malignant lymphoproliferative diseases, such as multiple myeloma, Waldenstrom's macroglobulinemia, lymphoma, chronic lymphocytic leukemia, amyloidosis, or more benign conditions such as monoclonal gammopathy of undetermined significance (MGUS). Recently we have observed monoclonal gammopathy occurring in patients with tuberculosis. Whether tuberculous infection plays a role in the production of monoclonal protein, and whether the monoclonal immunoglobulins possess anti-tuberculous activity are unknown. In the current project we plan to study: (1) whether the monoclonal immunoglobulin developed in patients with tuberculosis reacts with tuberculous antigen (using ELISA), and (2) whether the VH gene sequence analysis of such patient shows different mutation patterns (indicating the presence of intraclonal mutation variation) or not. If there is no intraclonal mutation variation, it suggests that the plasma cell clone is not under current exposure to the mutator, and the production of monoclonal gammopathy is probably not related to tuberculous infection. If, however, the VH gene sequence analysis shows the presence of intraclonal mutation variation, it indicates that the plasma cell clone is continuously under the influence of the mutator. In such case the production of monoclonal protein may be related to tuberculous infection.

Eligibility Criteria:
Inclusion Criteria:

* Monoclonal Gammopathy with Tuberculosis

Exclusion Criteria:

* No
Relationship Between Food Insecurity and Child Dental Anxiety

identifying children with dental anxiety among those who suffered from food insecurity will enable to implement preventive strategies and early intervention. The aim of this study is to examine the relationship between food insecurity, maternal psychological status and child dental behavior.

A well-trained investigator will collect data on maternal age (in years), the marital status, the educational levels of both parents and their employment status, pregnancy information, as well as family structure (whether children are living with both parents or not), number of siblings (none, one, two, or ≥three). Information on family monthly income and crowding index which is defined as the average number of people per room, excluding both the kitchen and bathrooms will be also obtained.

The level of household food insecurity will be determined using the validated Arabic version of the Household Food Insecurity Access Scale (HFIAS) which categorizes food insecurity into three levels (food secure , marginally food secure and food insecure) where the final score is given according to the sum of affirmative responses to the tool statements and the higher the score the more the level of food insecurity.

The validated Arabic version of the 14-item Perceived Stress Scale will be used to measure the self-reported level of stress among mothers of the enrolled children by assessing their feelings and thoughts during the last month. The level of child's dental anxiety will be assessed during the initial oral examination before starting any dental treatment procedures using the six-point Venham behavior rating scale which ranges from total cooperation (0) to no cooperation

Eligibility Criteria:
Inclusion Criteria:

* the selected children accompanied by their mother should fulfill the following inclusion criteria:

  * Age range 3.5-6 years
  * Having at least one tooth with dental caries indicated for dental treatment under local anesthesia other than extraction
  * Visiting the dental clinic for the first time

Exclusion Criteria:

* Children with the following criteria will be totally excluded from the study: Have any medical/neurological, communicative or developmental disorders as well as children with special healthcare needs.
Fluoride Varnish For Childsmile Nursery School Attenders

The study will compare the effectiveness of Duraphat® fluoride varnish in preventing any further dental decay among 3-4 year old children in nursery schools.

It is important to ascertain the additional preventive value that fluoride varnish may provide when applied in conjunction with other preventive measures which form part of a national dental health improvement programme targeting children at risk from dental decay. 1600 children will be recruited into the study for 2 years.

The objective of this study is to compare the effectiveness of Duraphat® fluoride varnish plus treatment as usual (TAU) with TAU only in preventing any further dental decay.

Thus the study is a clinical trial of treatment as usual (TAU) versus TAU plus fluoride varnish in the nursery school setting. TAU is the core Childsmile Nursery intervention (supervised daily toothbrushing with fluoride toothpaste, free dental packs of fluoride toothpaste, toothbrushes and advice).

Children will be screened by asking parents whether or not the child has previously been hospitalised with asthma or diagnosed with any allergies. Provided that a child has no contraindications to fluoride varnish then the child can proceed to study inclusion. On the day of the planned application, the dental nurse will carry out a risk assessment to reduce the possibility of children with oral/facial infections being included. After excluding non-eligible children, a baseline dental examination will take place, followed by randomisation into treatment as usual or treatment as usual plus fluoride varnish. This second group will receive up to four fluoride varnish applications at 6 month intervals. After two years, all study children will be offered a final dental examination.

Eligibility Criteria:
Inclusion Criteria:

* Children attending nurseries which cover significant numbers of children whose home postcode is within the most deprived quintile of postcodes as measured by the Scottish Index of Multiple Deprivation (SIMD) (Scottish Government 2011).
* Children in the first year of nursery school (known as the 'ante pre school year'). On average the children will be three years old.
* Every eligible child in participating nurseries will be invited to join the study, irrespective of the SIMD ranking of their own postcode.
* Children with or without pre-existing cavities, as the cavity can be treated through the usual primary care dental service (i.e. as part of 'treatment as usual').

Exclusion Criteria:

* Children with contraindications for the Duraphat® varnish i.e. hypersensitivity to colophony and/or any other constituents, ulcerative gingivitis, stomatitis, bronchial asthma, history of allergic episodes requiring hospital admission (e.g. asthma).
* Receipt of fluoride supplements due to a small risk of fluorosis.
* Abnormalities of the skin around the mouth, lips (e.g. cold sores) and soft tissue lesions.
The Effect of Different Force Magnitudes on Maxillary Posterior Segment Intrusion

A Randomized clinical trial comparing two different force magnitudes in maxillary posterior segment intrusion in adult patients with skeletal open bite malocclusion

This randomized controlled trial is aiming to study the effect of the different force magnitude on maxillary posterior segment intrusion. Two groups are going to be allocated and the amount and rate of intrusion will be measured and compared.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with an age range from 17 to 25.
* Skeletal open bite.
* Dental open bite that is due to overgrowth of maxillary posterior segment as seen clinically and that can be corrected without surgical intervention (a minimum of 3 mm and a maximum of 8 mm).
* Skeletal class I or mild to moderate skeletal class II that enables camouflage treatment.
* Normal incisor show on smiling (that makes the case indicated for molar intrusion and not for incisor extrusion).
* Full set of maxillary posterior dentition (first and second premolars, first molars at least).
* No previous orthodontic treatment.

Exclusion Criteria:

* Medically compromised patients.
* Patients suffering from any congenital or hereditary diseases.
* Smoking or any systemic diseases.
* Chronic use of any medications including antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.