cyrilzakka/clinical-trials huggingface dataset:
Compassionate Use of Omegaven IV Fat Emulsion

This is a compassionate use protocol to use intravenous fish oil infusion, Omegaven®, to infants and children with parenteral nutrition-associated liver disease to enable reversal of elevated serum liver enzymes and direct bilirubin (cholestasis).

Intravenous lipids are necessary in PN (parenteral nutrition) dependent patients due to their high caloric value and essential fatty acid content. However, parenteral fat emulsions composed of soybean oils (omega 6 fatty acids) have been implicated in predisposing patients to PN associated liver disease.

It is hypothesized that by administering Omegaven®, comprised of fish oil (omega 3 fatty acids) in place of conventional soybean fat emulsion, the progression of PN-associated cholestasis may be prevented or reversed.

Eligibility Criteria:
Inclusion Criteria:

* Two consecutive direct bilirubin levels of 2 mg/dl or more in a parenteral nutrition dependent infant or child (unable to meet nutritional needs solely by enteral nutrition)
* Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
* The patient must have utilized standard therapies to prevent the progression of the liver disease including reduction/removal of copper and manganese from daily PN, trial of enteral feeding if possible, and the use of ursodiol (i.e., Actigall®).

Exclusion Criteria:

* Documented causes of chronic liver disease other than parenteral nutrition associated liver disease
* Proven severe advanced liver disease including cirrhosis on biopsy, varices, ascites.
* An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven®
* Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis
* Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
* Unstable diabetes mellitus or hyperglycemia
* Stroke, embolism, collapse and shock, recent MI
* Cholestasis due to any reason other than parenteral associated liver disease
* Active new infection at time of initiation of Omegaven®
* Hemodynamic instability
* The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).
AspergillusOne-Health: Deciphering Azole Resistance in Aspergillus Fungi Using a One Health Approach

During a two year prospective study onpatients from department's hospitals and centralized by the pneumology department Nantes CH,all respiratory clinical samples will be cultivated for Aspergillus isolation (2900Aspergillusisolates) as standard care. The azole susceptibility pattern of isolates will be determined to itraconazole, voriconazole by subculture on azole- enriched medium at 35°c as primary screen and resistance confirmed by EUCAST Reference metho.In parallel, the relevance of detecting resistance (TR34 and TR46) directly in culture-negative BAL respiratory samples by a qPCR method will be studied in an attempt to reach a greater exhaustiveness of the resistance phenomeno. In case of azole-resistant isolate,patient data such as the underlying disease,date and site of Aspergillus isolation,disease classification,previous azole drug exposure,and home and work geographic allocation,occupation of the patient will be collecte. For all other aspergillus occurrences, underlying disease, previous azole drug exposure,home and work location of the patient will be collected in an attempt to identify risk factor.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient who has given his or her consent to participate in the study
* Patient affiliated to a social security scheme
* Patient with a respiratory sample taken between 2020 and 2023 for the retrospective cohort and from 2024 for the prospective cohort in which Aspergillus has been isolated
* Patients living in the Loire Atlantique and Vendée regions

Exclusion Criteria:

* Patient under guardianship or legal protection
* Patient of no fixed adress
Do Warning Labels Decrease Soda Purchasing?

Investigators will run a field study evaluating the impact different labels have on the purchasing of sugar sweetened beverages. This field study will take place in a hospital cafeteria.

In a hospital cafeteria investigators will label all sugar sweetened beverages to evaluate their impact on purchasing.

Investigators will collect baseline data for two weeks on beverage sales at the hospital cafe. Following this data collection investigators will introduce a calorie label which reads "Each beverage contains \[lower calorie bound\]-\[upper calorie bound\] calories per container. 2,000 calories a day is used for general nutrition advice but calorie needs vary." These signs will be posted for two weeks and investigators will collect sales data. Following this intervention investigators will remove the signs and collect sales data for two weeks. At the end of this no label period, investigators will introduce the second intervention, a warning label. This label will read "WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay." This label will also be posted for two weeks and investigators will collect sales data. Investigators will then remove these signs and collect sales data for two weeks. Finally, investigators will introduce the third intervention: a warning label with graphic labels. This label will read "WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes and tooth decay." However this sign will also include a visual depiction of each health consequence. Investigators will collect sales data for this two week period. After this intervention investigators will collect sales data for an additional two weeks and then administer a brief survey to cafeteria customers to better understand their impressions of the labels.

Eligibility Criteria:
Inclusion Criteria:

* Customers of the hospital cafeteria.

Exclusion Criteria:

* None
The Proteins of the Contact Activation System

Cardiovascular diseases are important causes of morbidity and mortality in the industrialized world. Abnormalities in the coagulation system, causing a hypercoagulable state, are a known risk factor for arterial and venous thrombosis. The contact activation system is part of the coagulation system and consists of four proteins: coagulation factor XII (FXII), FXI, prekallikrein and high molecular weight kininogen (HMWK). Clinical studies indicate an important role for the contact activation system on the risk of arterial thrombosis. Furthermore, there is substantial evidence from mouse studies that FXII and FXI participate in the formation and stability of thrombi. In vitro studies show that collagen, present in the vascular wall, is able to activate FXII and hereby stimulate thrombin formation and potentiate the formation of platelet-fibrin thrombi and FXIIa is able to change the structure of fibrin clots by binding to fibrin(ogen) and by generation of additional thrombin. However, the contact system also participates in the process of fibrinolysis, which degrades thrombi.

The investigators would like to investigate the contribution of the contact activation system to the formation of thrombi. The formation of a thrombus within the vascular bed is the main cause for occlusion of an artery or vein, which can lead to an infarct such as a heart attack. Due to the other functions of the contact system it is important to fully understand how the contact system contributes to thrombus formation, before it can be used as a target in the treatment of arterial thrombosis. The aim of this study is to determine the contribution of the proteins of the contact system, mainly FXII and FXI, in the platelet mediated formation and degradation of thrombi. This will be studied in flow models (perfusion-flow model and Chandler loop), in a static model (ROTEM®) and using thrombin generation assay.


Eligibility Criteria:
Inclusion Criteria:

* Deficiency in coagulation factor XII and factor XI (factor level\<5%)
* Subjects of both gender
* Age ≥18 and ≤ 65
* Written informed consent from the subject
* Subject with a social security plan or beneficiary of such a plan.

Exclusion Criteria:

* Age below 18
* Age above 65
* Other known abnormalities of the coagulation system
* Thrombocytopenia
* Known platelet disorders
* Personal history of severe liver diseases
* Symptoms of active disease (e.g. cancer)
* The use of antiplatelet drugs
* The use of drugs that interfere with coagulation
* Ongoing diagnosed pregnancy upper 3 months
* Adult patients protected by law
* Concomitant participation to a biomedical research
Safety/Efficacy of Systane Free vs Refresh Liquigel

The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) in a specified population of dry eye patients.


Eligibility Criteria:
Inclusion Criteria:

* \>/= 3 corneal staining score using NEI scoring system.
* Need artificial tears at least some of the time.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History or evidence of ocular or intraocular surgery in either eye within the past six months.
* History of intolerance or hypersensitivity to any component of the study medication.
* Use of Restasis within 30 days of Visit 1.
* Participation in an investigational drug or device study within 30 days of entering this study.
* Other protocol-defined exclusion criteria may apply.
Study of Maternal and Fetal Cardiovascular Function in Hypertensive States of Pregnancy

The pharmacological treatment strategy is then tailored to the underlying hemodynamic phenotype of each patient. That is, rather than applying a one-size-fits-all treatment for all patients, therapy is tailored to the specific characteristics of how the cardiovascular system functions in each patient (e.g., whether the problem is more related to blood volume, vascular resistance, cardiac output, etc.). The goal is to personalize therapy to more effectively treat hypertensive states of pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Women with singleton and twin pregnancies complicated by hypertensive states of pregnancy.

Exclusion Criteria:

* Minors under 18 years of age.
* Women with mental disabilities.
* Major congenital fetal anomaly.
The Hip Fracture Surgical Approach Trial

The HIFSAT study will compare the standard direct lateral approach to hemiarthroplasty to a new muscle sparing approach (SPAIRE) in femoral neck fracture patients.

Femoral neck fractures are mostly treated with a hemiarthroplasty, where the fractured femoral head is replaced with a metal implant. The most common surgical approach to hemiarthroplasty has been the lateral approach, in which the gluteus medius tendon is partially released from the greater trochanter. Hip pain and limping is not uncommon after this approach has been used. A new surgical approach (SPAIRE) has been developed to alleviate this problem, and in this method the surgeon approaches the injured hip joint from posterior, preserving most of the muscles and tendons around the hip. This trial is designed to assess if this new SPAIRE approach leads to better results than the lateral approach in patients with femoral neck fractures.

Eligibility Criteria:
Inclusion Criteria:

* Femoral neck fracture
* Clinical indication for hemiarthroplasty
* Age over 50 years

Exclusion Criteria:

* Previous hip implants in the same hip
* Patients assessed to be in a terminal state with an expected survival of less than 1 week
* Other factors that makes follow-up impossible
Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users

The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program for clinicians. The study will use three-group approach: intervention with remote feedback (Group 1), control group (Group 2), and structured self-study (Group 3). This demonstrates how the intervention compares not only to a control, but also to the next "best alternative" - therapists sourcing web-based training materials and learning independently.

A randomized, single-blinded, two-period cross-over study design for Groups 1 and 2 will be used. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After enrollment for Groups 1 and 2 is completed, Group 3 participants will be enrolled.

Group 1 will receive the active intervention (intervention A) which will include a two-part training in wheelchair skills. For Part 1, they will review approximately 4 hours of educational videos on how to complete and teach wheelchair skills. For Part 2 they will complete a practice-feedback loop with a remote trainer providing asynchronous feedback. Group 3 will mirror Group 1 but complete only Part 1 of the training. Group 2 will receive the control intervention (intervention B) participants will review approximately 4 hours of educational videos. Participants will have 8 weeks to complete either training program. Both groups will then complete follow-up at 2 and 6 months. Following this, participants will cross over to receive the other intervention (Group 1 and 3 will receive intervention B, Group 2 will receive intervention A) and complete follow-up at 8 and 12 months.

Additionally, rehabilitation professionals who are not therapists will be able to access the training through a structured self-study (Group 4). This group will receive access to both trainings with follow-up at 2 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Practicing rehabilitation professional whose client population includes wheelchair users.
2. Willing and able to attempt practicing wheelchair skills
3. Access to a spotter(s)
4. Access to an Internet-ready device with video capabilities.
5. Speaks English

Exclusion Criteria:

1) Confident in teaching (Self-Efficacy on Assessing, Training, and Spotting \[SEATS\] item score = 5) and able to complete (WST-Q capacity item score = 2) \>50% of skills targeted by the training intervention.
Evaluation of Acacia Catechu and Low-Level Laser in the Treatmentof Stage II Periodontitis

Evaluation of Acacia catechu and Low-Level Laser in the Treatment of Stage 2 Periodontitis.

* Assess the effectiveness of A. catechu gel (local delivery) adjunctive to non surgical therapy in the treatment of stage chronic periodontitis. Clinical and biochemical evaluation.
* Compare the effectiveness of A. catechu gel (local delivery) and low-level laser adjunctive to non-surgical therapy in the treatment of stage chronic periodontitis.

Clinical and biochemical evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Motivated patient with good oral hygiene.
2. Age ranges from (30-50) years.
3. Free from any systemic disease according to the Cornell Medical Index (16).

Exclusion Criteria:

1. Patients who received periodontal treatment over the 12 months preceding the study.
2. Patients who consumed antibiotics or anti-inflammatory drugs within the last 3 months.
3. Previous or current radiation or immunosuppressive therapies.
4. Pregnant \& lactating women.
5. Patient with orthodontic appliances. Or having partial dentures.
6. Patient with parafunctional habits.
Strength Training Effects on Musculoskeletal Health

The objective here is to assess the efficacy of variable resistance muscle training on bone, sleep parameters and quality of life in healthy populations of men and women age 30 or older.


Eligibility Criteria:
Inclusion Criteria:

* 30 years or older (males or females)
* Baseline strength (e.g., can lift an office chair with no problems)
* Be willing to participate in a 6-month RCT
* Be willing to conduct daily muscle training exercises
* Be willing to maintain a food diary
* Be willing to consume \~2.2g/kg body weight daily
* Be willing to submit specimens and conduct tests 3 times over 6 months (0, 3 and 6 months)

Exclusion Criteria:

* those who consume vegan or vegetarian diets
* people with conditions like hypertension and uncontrolled non-medicated blood pressure; cardiovascular disease/heart failure (e.g., arrhythmias, unstable angina, congestive heart failure)
* COPD
* drugs that may increase fall risk or make dizzy (e.g., antidepressants, anti-seizure drugs)
* muscle disease (e.g., myasthenia gravis, myopathy, myositis)
* active hernia
* pregnancy
* muscle atrophy (e.g., Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), ALS)
* neuro degenerative disease
* limited mobility
* those who consume proteins supplements.
* Individuals who have implanted pacemakers or defibrillators
* People who suffer from: Marfan syndrome, migraine, hyperparathyroidism, metastatic bone disease, multiple myeloma
* chronic steroid use
* individuals with restrictions to movement and exercise
Efficacy and Safety of BIIB111 for the Treatment of Choroideremia

The objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of BIIB111 in participants with choroideremia (CHM).

This study was previously posted by NightstaRx Ltd. In October 2020, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Are willing and able to give informed consent for participation in the study.
* Have a documented genetically-confirmed diagnosis of CHM.
* Have active disease clinically visible within the macular region in the study eye.
* Have a BCVA of 34-73 ETDRS letters (equivalent to worse than or equal to 6/12 or 20/40 Snellen acuity, but better than or equal to 6/60 or 20/200 Snellen acuity) in the study eye.

Key Exclusion Criteria:

* Have a history of amblyopia in the eligible eye.
* Have had previous intraocular surgery performed in the study eye within 3 months of Visit 1.
* Have any other significant ocular or non-ocular disease/disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the results of the study, or the participant's ability to participate in the study.
* Have participated in another research study involving an investigational product in the past 12 weeks or received a gene/cell-based therapy at any time previously.
* Are unwilling to use barrier contraception methods, or abstain from sexual intercourse, for a period of 3 months, if treated with AAV2-REP1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
ABCA3 Gene and RDS in Late Preterm and Term Infants

Respiratory distress syndrome (RDS) is the most common respiratory cause of mortality and morbidity in very preterm infants, but it also could be seen in late preterm and term infants. Some genetic mechanisms were involved in the pathogenesis of RDS in late preterm and term infants.

ATP-binding cassette transporter A3 (ABCA3) is essential for the production of pulmonary surfactant, whose mutation is the most common monogenetic cause of RDS in newborns. It also takes a vital role on unexplained RDS (URDS) in late preterm and term infants. Some previous studies showed that URDS with homozygous or compound heterozygous ABCA3 mutations had high mortality, while different mutation types could lead to different outcomes. However, most of the study focused on URDS with ABCA3 gene mutations, and there is no evidence that URDS without confirmed gene mutations have relatively better or worse outcomes. Furthermore, all the population in previous study are non-Asian races, which indicated that all the study conclusion is not applicable in Asia.

Based on the next-generation sequencing technology, exome sequencing has been widely used in the clinic. In our neonatal intensive care unit (NICU), a clinic exome sequencing was usually performed in infants with fatal URDS. The present study was designed to compare the URDS with ABCA3 gene mutations with those without confirmed gene mutations and to establish the relationship between various ABCA3 gene mutations and variant RDS severity and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* infants ≥34 weeks' gestation
* meet the fatal respiratory distress syndrome as following: (1) manifestations and chest radiograph are compatible with RDS; (2) at least 7days on invasive ventilation with FiO2 ≥60%, or persistent hypoxemic respiratory failure on FiO2 100% regardless of duration of invasive ventilation
* undergone exome sequencing

Exclusion Criteria:

* culture-positive sepsis
* cardiopulmonary malformations
* pulmonary hypoplasia
* known surfactant mutations such as SFTPB, SFTPC, CHPT1, LPCAT1 and PCYT1B were excluded.
AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib

This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a histologically confirmed metastatic renal cell cancer (RCC) with a clear cell component
* Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification
* Measurable disease with at least one unidimensionally measurable lesion per Response Evaluation Criteria in Solid Tumor (RECIST) guidelines with modifications
* Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening
* Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria:

Disease related

* Known history of central nervous system metastases.
* Previous treatment (excluding surgery, prior cytokine-based immunotherapy and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
* Focal radiation therapy for palliation of pain from bony metastases within 14 days of enrollment.

Medications

* Currently or previously treated with sunitinib or other small molecule inhibitors of vascular endothelial growth factor (VEGF)
* Currently or previously treated with agents that neutralizing VEGF
* Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
* Currently or previously treated with agents inhibiting the mammalian target of rapamycin (mTOR)
* Current or within 30 days prior to enrollment treatment with immune modulators
* Concomitant or previous use within 30 days prior to enrollment of any strong inducer of CYP3A4
* Concomitant or previous use of amiodarone within 6 months prior to enrollment

General medical

* Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
* Major surgery within 28 days prior to enrollment or still recovering from prior surgery
* Uncontrolled hypertension as defined as diastolic \> 90 mmHg OR systolic \>150 mmHg. The use of anti-hypertensive medications to control hypertension is permitted.

Other

* Other investigational procedures are excluded
* Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)

Other inclusion/exclusion criteria may apply, per protocol.