cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency

This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of Prolastin-C (alpha1-proteinase inhibitor \[alpha1-PI\] \[Human\]), compared to weekly infusions of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).

The question of whether higher doses of alpha1-PI (\>60 mg/kg) are able to provide better protection to patients with alpha 1-antitrypsin deficiency is currently unknown. As a first step to address this question, the present study has been undertaken. This is a multi-center, randomized, double-blind, crossover study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of Prolastin-C, compared to weekly infusions of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency. This study is a crossover design with 2 treatment sequences:

Treatment Sequence 1: 60 mg/kg weekly infusion of Prolastin-C for 8 weeks followed by 120 mg/kg weekly infusion of Prolastin-C for 8 weeks (starting at Week 1) (total of 16 treatment weeks)

Treatment Sequence 2: 120 mg/kg weekly infusion of Prolastin-C for 8 weeks followed by 60 mg/kg weekly infusion of Prolastin-C for 8 weeks (starting at Week 11) (total of 16 treatment weeks)

Approximately 15 subjects are planned to be entered into each treatment sequence.

At Weeks 8 to 11 and Weeks 18 to 21, a total of 15 serial blood samples for each subject will be drawn for pharmacokinetic analysis. The expected duration of the study subject's participation will be approximately 25 weeks (which includes a 3-Week Screening Phase, 2-Week Washout Period \[between different alpha-1 PI treatment doses\], and a 4-Week Follow-up Period). The following safety parameters will be assessed: adverse events, pulmonary exacerbations, vital signs, pulmonary function tests, and clinical laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 70 years of age
* Have a documented diagnosis of congenital AATD
* Have a post-bronchodilator Forced Expired Volume in 1 second (FEV1) of ≥30% and \<80% and FEV1/forced vital capacity (FVC) \<70%
* If receiving alpha-1 PI augmentation therapy, be willing to discontinue the treatment for the duration of the study

Exclusion Criteria:

* Had a moderate or severe pulmonary exacerbation during the 4 weeks before the study
* History of lung or liver transplant
* Any lung surgery during the past 2 years
* Confirmed liver cirrhosis
* Elevated liver enzymes
* Severe concurrent disease
* Females who are pregnant or breast-feeding or unwilling to practice effective contraception during the study
* Infection with hepatitis A, B, or C, human immunodeficiency or parvovirus B19
* Smoking during the past 6 months
* Use of systemic steroids within 4 weeks of the study
* Use of antibiotics for an exacerbation within 4 weeks of the study
Liom Non-invasive Continuous Glucose Monitor "Clinical Demo" (niCGM)

This is a single-centre, multiple cohort, open study.

The study will include 5 cohorts. After each cohort, optimisation of the Spiden Clinical Demo 2.0 system and machine learning models may be pursued before the next cohort is started. Trial participants with type 1 or type 2 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Male or female trial participant with clinically diagnosed type 1 or type 2 diabetes for at least 1 year.
* Age between 18 and 65 years, both inclusive.
* Treated with insulin and/or oral antidiabetic drugs (OADs; type 2 only), multiple dosing insulin therapy (MDI), continuous subcutaneous insulin infusion (CSII) or a hybrid closed loop system.

Exclusion Criteria:

* Known or suspected hypersensitivity to any of the components of the Liom Clinical Demo 2.0.
* Trial participant with any injury, infection, atypical skin condition (e.g., hyperkeratosis, hyperpigmentation) of or tattoo on the wrists.
* Presence or history of a cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.
Shade Evaluation of Monochromatic Versus Polychromatic Layering Techniques Inrestoration of Fractured Incisal Angle

This clincl trial will be conducted to compare theShade Evaluation of Monochromatic versus Polychromatic layering techniques in restoration of Fractured incisal angle

The use of enamel and dentin shades allow us to reproduce anatomical features such as incisal edge translucency, halo effect, other internal colors and pigments such as craze lines, white patches, white horizontal striations .

Anterior composites usually have small filler particles to increase smoothness, nanotechnology has enabled recent advances in dental composite restorations. As a result , a different category of composite resins has emerged, known as nanocomposites.

However polychromatic layering is considered to be technique sensitive, from detection of details to proper reproduction of such fine details.

The presence of discrepancies between the classic shade guides and the actual shade of composite makes that task more difficult.

The use of monochromatic layering with only body shade can serve as a substitute for enamel and dentin, since it has an intermediate opacity between enamel and dentin , and can serve as an easier option with less technique sensitivity than polychromatic layering.

Filtek universal as claimed by the company manufacturer to have A "NaturalMatch" which is a term that describes the combination of 3M technologies and features present within 3M™ Filtek™ Universal restorative.

it contains nanofillers, pigments and proprietary low-stress monomers which gives Filtek™ Universal Restorative a combination of esthetic and universal opacity which in turn allow shade blending and making the restoration more invisible with surrounding dentition.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with fractured incisal angle.
2. Vital teeth.
3. Anterior Permanent teeth.
4. Good oral hygiene.
5. Co-operative patients approving to participate in the study.

Exclusion Criteria:

1. Non vital teeth.
2. Severe or active periodontal disease.
3. Severe medical complications.
4. Uncooperative patients
Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery

This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent.
* Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
* Subjects who are candidates for cataract surgery.
* Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening.
* Subjects must be able and willing to comply with all treatment and follow- up procedures.

Exclusion Criteria:

* Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
* Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Obesity: Prospective Evaluation of Upper Airway Obstruction and Compliance in Obese Patients in Pre and Post Bariatric Surgery

This clinical trial is a monocentric, prospective, observational and controlled trial (historical cohort control group of healthy non-obese subjects who had Nasal functional exploration for Snoring) as part of current care.

This study concerns the prevalence of obstructive sleep apnea syndrome (OSAS). OSAS is elevated in subjects with morbid obesity (BMI≥40) (on average 70%). International recommendations agree on the need to seek OSAS before bariatric surgery because of the high risk of complications.

Increased nasal resistance could also be related to a limitation of inspiratory flow due to an abnormality of the elasticity of the nasal mucosa or "nasal compliance". Adipose infiltration of the nasal mucosa may occur during obesity.

These tissue changes (decreased vaso-erectile tissue and increased adipose tissue) could modify the nasal compliance, which the decrease would be a possible factor of severity of OSAS in obese patients. Screening for an abnormality of compliance could also anticipate a difficulty of equipment for Continuous Positive Airway Pressure (CPAP) in the case of associated OSAS.

All patients who must have bariatric surgery and get in the criteria are included. They will have to do a medical checkup pre and post-operative (polygraphy + ear/nose/throat assessment (ENT) + Nasal functional exploration). They will be followed for 13 to 24 months.

The main objective of this research is to demonstrate a reduction of at least 30% of nasal compliance in a group of obese subjects (BMI\> 35) compared to a control group of healthy subjects.

The secondary objectives are to is to demonstrate an increase of 30% in resistance in patients with BMI\> 35 compared to control group and a normalization of nasal compliance 1 year after surgery when their weight is normalized (BMI \<30).

A study period of 4 years is planned.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary Patient
* Patients aged 18 years or older.
* BMI \> 35
* Patient included in the bariatric surgery protocol
* Medical checkup :polygraphy and Respiratory Functional Exploration (RFE)

Exclusion Criteria:

* Impossible to obtain a consent or age less than 18 years
* Heart / Kidney Failure
* Absence of affiliation to a Social Security scheme
* History of rhinological surgery
* Pregnancy, Breastfeeding
* Subject presenting a congenital or acquired obstructive nasal obstructive physical obstacle (obstructive deviation, craniofacial malformation)
Feasibility of Reduction in Right Sided Bowel Cancer Through Contrast Enhanced Colonoscopy

The Bowel Cancer Screening program was implemented to address the important issue of prevention and early detection of bowel cancer. Results from the first few years of screening and previous smaller studies show that while in its current form it will save many lives, there continue to be polyps and cancers in the upper large bowel (right side) that may be difficult to detect. There is some evidence that these types of polyps (serrated polyps) may be at least partly responsible for cancers missed at the initial colonoscopy and have a faster rate of growth to cancer compared to conventional polyps (adenomas). We propose to examine participants undergoing screening colonoscopy with the addition of a contrast dye ( a safe food colouring agent base already used in various bowel camera procedures in standard clinical practice). This has been shown to improve detection of conventional polyps significantly even though it is considered by some to be more time consuming (possibly taking a few minutes longer) and requiring specific training to undertake. We hope to study the feasibility of undertaking these procedures to improve detection and removal of these polyps within the bowel screening program and potentially inform further studies to assess the impact of improved detection and consequent potentially reduced incidence of interval or missed bowel cancers in longer term follow up. Thus the main aims of this feasibility study are to assess if this type of procedure would be feasible to implement and acceptable to participants, colonoscopists and the screening program and also assess any additional time or costs involved to inform the question of if a larger study should then be undertaken to conclusively prove or disprove the merits of this approach in terms of health economics, cancer detection and survival.


Eligibility Criteria:
Inclusion Criteria:

* All participants testing positive on Faecal Occult Blood Test (FOBT) in the screening program who are eligible and appropriate for an index screening colonoscopy will be offered participation in the study.
* All participants attending for a one year surveillance colonoscopy if they have undergone an index screening colonoscopy as part of the study as per current guidelines for surveillance will also be offered inclusion

Exclusion Criteria:

* Any participants not deemed fit for colonoscopy on the screening program or undergoing alternative investigation such as CT Pneumocolon or minimal prep CT scan as their index procedure instead.
* Participants who have undergone previous colorectal surgery will be excluded from the study though their standard management in the screening program will continue unchanged.
Real-world Study on the Management of Hematological Toxicities Associated With Targeted Therapies for Breast Cancer

This multicenter, real-world, observational study will retrospectively and prospectively collect real-world data related to the investigational drugs. We plan to observe 1000 patients and collect data on treatment cycles N and N+1 of the targeted therapies. Retrospective data collection is based on existing patient diagnosis and treatment records, collecting information on patients who have completed two treatment cycles before January 1, 2024. Prospective data collection is based on routine clinical treatment during the study period, collected until the end of the next cycle of treatment or early termination of the study. To observe the disease characteristics and management mode of hematological toxicity related to targeted therapies of breast cancer, and explore the possible related factors of hematological toxicity, such as age, disease subtype, cancer stage, targeted therapy regimens, etc. This study will respect the medication choices of researchers in the study, without specifying which medication to choose for treatment, dosage, mode of administration (including single drug, combination therapy, or sequential therapy), and duration of administration.


Eligibility Criteria:
Inclusion Criteria:

* · The patients signed the informed consent and voluntarily participated in the study.

  * A definite diagnosis of any type of breast cancer.
  * Receiving or has completed targeted therapies.
  * Investigator judged that the patient need to receive or had received treatment or prevention for CTIT, CIN or CRA induced by targeted therapies.

Exclusion Criteria:

* · Pregnant or lactating women.

  * Failure to understand the study or to obtain informed consent.
  * The investigator determined other situations that are not suitable for inclusion.
Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty

Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the geriatric population. Numerous studies have reported good mid and long term results of THA in patients over the age of 60 years. With the reported high success rate of this surgical intervention, the THA surgery is being performed in younger patients who have significant joint disease.

A clinical trial, using a randomized blinded design, was undertaken to compare the functional outcome of 1) alumina heads/alumina liners, and 2) alumina head/Crossfire polyethylene liners in patients 60 years of age or younger with non-inflammatory arthritis of the hip.

Subjects were assessed preoperatively and at one and five years postoperatively. Ten-year follow-up is currently underway.

The primary outcome measure is the WOMAC Osteoarthritis Index. Secondary measures were the RAND-12, as well as measurement of complication and revision rates. The patient's demand on the implant as calculated by the patient's age, weight, health status and activity level was also measured.


Eligibility Criteria:
Inclusion Criteria:

* Males or females scheduled for primary THA to treat non-inflammatory arthritis
* Less than 61 years old at time of surgery
* Able to speak and read the English language or have an available translator
* Dorr Index A or B bone quality on preoperative radiographs
* Willing and able to return for follow-up visits

Exclusion Criteria:

* Have femoral or acetabular bone deficiency requiring augmentation
* Ongoing corticosteroid use
* Dorr Index C bone quality on the preoperative radiograph
* Required a prosthesis neck length of greater than five millimeters
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID

The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.

A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing multiple femoral venous access sites and providing reduced times to ambulation compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.

Only patients with multiple access sites will be enrolled in order to support the desired indication. Randomization will be stratified to account for patients with varying numbers of access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4 access sites/patient.

Eligibility Criteria:
Inclusion Criteria:

* Acceptable candidate for an elective, non-emergent catheter-based procedure via the common femoral vein(s) using a 6 to 12 Fr inner diameter introducer sheath, with a minimum of 3 and maximum of 4 femoral venous access sites, and a maximum of 2 access sites/leg
* Anticipated prolonged bedrest (5 hours or more) and / or overnight stay

Exclusion Criteria:

* Active systemic or cutaneous infection, or inflammation in vicinity of the groin
* Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
* Know history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count \< 100,000 cells/mm3
* Severe co-existing morbidities with life expectancy less than 12 months
* Femoral arteriotomy or femoral venotomy in \< 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days
* Planned femoral venous or arterial access within next 30 days
* History of DVT, pulmonary embolism or thrombophlebitis
* Significant anemia or renal insufficiency
* BMI \> 45 kg/m2 or \< 20 kg/m2
* Unable to routinely walk at least 20 ft. without assistance
* LMWH within 8 hours before or after procedure
* Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath; \< 6 Fr or \> 12 Fr inner diameter sheath use; obvious bleeding complications or tissue tract estimated to be \< 2.5 cm deep
The CARE (Collaborative Adolescent Running Experience) Project

This study is being completed to see if participants activity levels may have an impact as a treatment for depression, or depressive symptoms.

Eligible participants will be enrolled and have an 8-week running intervention three times each week.

The study hypothesizes that adolescents with Psychiatric disorders that are experiencing depressive symptoms will participate in a supported running intervention.


Eligibility Criteria:
Inclusion Criteria:

* Psychiatric disorders that are experiencing depressive symptoms (defined by the protocol)
* Must have a smart phone
* Parents/guardians will be advised to discuss their child's participation in the intervention with the participant's primary care physician

Exclusion Criteria:

* Adolescents with unstable cardiac, pulmonary, endocrine or renal disorders
* Adolescents with previous injuries or other conditions that may impact the safety of a running intervention
A Study of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) Versus Vehicle in Dry Eye Patients

The purpose of this study is to demonstrate efficacy of Hydroxypropyl Guar Galactomannan 0.25% (HPGG) ophthalmic gel compared to Vehicle for the treatment of dry eye.

A 7-day Vehicle pre-randomization (run-in) phase during which all patients will receive 1 drop of Vehicle in each eye twice daily will precede the 21-day treatment phase, for an overall study duration of 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Must read, sign, and date an informed consent document and HIPAA privacy document.
* Diagnosis of dry eye at Visit 1 (Day 0).
* Able and willing to follow study instructions.
* Best corrected visual acuity (BCVA) of 0.6 logMAR or better in each eye as assessed using an ETDRS chart at Visit 1.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Diagnosis of Sjogren's syndrome (or suspected to have Sjogren's syndrome).
* History or evidence of ocular or intraocular surgery in either eye within the previous year.
* History or evidence of serious ocular trauma in either eye within the previous 6 months.
* History or evidence of corneal transplant or transplant variant procedures.
* History of intolerance or hypersensitivity to any component of the study medications.
* History of glaucoma or current ocular hypertension in either eye, or treatment for either condition within 6 months prior to Visit 1.
* History or evidence of corneal conditions, other than dry eye, that may affect the corneal structure.
* Use of any concomitant topical ocular medications including artificial tears during the study period.
* Females of childbearing potential if breastfeeding, unwilling to undergo urine pregnancy test at screening and upon exiting the study, have a positive urine pregnancy test at screening, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study.
* Use of RESTASIS® 0.05% or an ocular steroid within 30 days of Visit 1.
* Use of systemic medications that have not been stable for 30 days prior to Visit 1.
* Any ocular condition that may preclude the safe administration of the test article.
* Unwilling to discontinue contact lens wear at least 4 weeks prior to Visit 1, and during the study period.
* Use of punctal plugs or punctal cautery.
* Use of lid scrubs/warm compresses within 14 days of Visit 1.
* Other protocol-defined exclusion criteria may apply.