cyrilzakka/clinical-trials huggingface dataset:
KRT-232 and TKI Study in Chronic Myeloid Leukemia

This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI).

This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.


Eligibility Criteria:
Inclusion Criteria:

* Phase 1b and Phase 2 Arms A and B: Documented TP53wt, Ph+, BCR-ABL+ CML-CP
* Phase 2 Arm C ONLY: Documented TP53wt, Ph+, BCR-ABL+ CML-AP
* Subject is resistant (relapsed or refractory) and/or intolerant to at least 1 prior TKI.
* Adults ≥ 18 years of age.
* ECOG performance status of 0 to 2
* Adequate hematologic, hepatic, and renal functions

Exclusion Criteria:

* Phase 1b and Phase 2 Arms A and B: Documented Ph+, BCR-ABL+ CML-AP
* Documented Ph+, BCR-ABL+ CML-BC
* Known T315I mutation.
* Prior treatment with MDM2 antagonist therapies.
* Intolerance to current TKI therapy.
Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis

The purpose of this study is to study the loss of vedolizumab in stool in patients with active ulcerative colitis (UC).

Patients with moderate-to-severe UC who are commencing induction therapy with vedolizumab will be enrolled into a prospective study and stool will be collected for faecal vedolizumab measurement at days 1, 4 and 7; and again at weeks 2, 6 and 14. They will also be evaluated at three time-points (weeks 2, 6 and 14) for clinical and biochemical UC disease activity as well as serum vedolizumab concentrations and anti-vedolizumab antibodies.

Primary objective

- To determine whether vedolizumab is present in significant quantities in the stool of patients receiving induction therapy with vedolizumab for active UC.

Secondary objective (s)

* To evaluate whether the presence and quantity of vedolizumab in stool can be used to predict primary non-response to vedolizumab.
* To explore whether a correlation exists between stool vedolizumab concentrations, serum vedolizumab concentrations and UC disease activity and extent.
* To determine whether there is a correlation between stool and serum vedolizumab levels and trafficking of Th1/Th17 effector memory CD4+ T-cells (the key pathogenic subset in IBD) to the colon in UC.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over, either male or female
* Moderate-to-severe UC, defined as:

  - SCCAI \> 5 and, i. A raised fecal calprotectin (\> 59 μg/g) or, ii. A raised CRP (\> 5 mg/L) or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 6 weeks of study enrollment
* Commencing vedolizumab treatment
* Sufficient English language skills to understand the patient information sheet and consent form

Exclusion Criteria:

* Contra-indication to vedolizumab (i.e. known serious or severe hypersensitivity reaction to vedolizumab or any of its excipients)
* Imminent need for colectomy (i.e. colectomy is being planned)
* Previous ileoanal pouch formation
* Active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections
Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis

Ultrasound evaluation of the temporal and axillary arteries is currently well recognized in the field of giant cell arteritis (GCA), a disease primarily affecting medium- and large-caliber vessels. Structural ultrasound abnormalities are now well described in this pathology, but their association with relapse and clinical concordance is unknown. There is currently a follow-up score (the OGUS score) for medium- and large-caliber arteries that could also predict the clinical course of the disease.

Prospective bicentric longitudinal study evaluating the association between ultrasound lesions and clinico-biological relapse in patients with giant cell arteritis.

This is a non-interventional study with patients routinely followed for their pathology and classically benefiting from temporal artery ultrasound as part of their disease. Recruitment will be facilitated by the fact that these will be "general population" patients with suspected giant cell arteritis.

The center will enroll 100 patients. The study will take place over 3 visits, including a clinical, biological and ultrasound examination. Ultrasound will not be blinded to the clinic, so we will only need one examiner in the center.

This is a study in routine care, with no additional costs and no expected constraints. The ultrasound examination will be performed as part of their routine follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patients meeting ACR 2022 criteria for giant cell arteritis.
* No opposition expressed

Exclusion Criteria:

* Patients unable to understand the protocol, under guardianship or curatorship.
* Patients not affiliated to the French Social Security system.
Early vs. Late Time-Restricted Eating in Adolescents With Obesity (EL TREA)

Determine the effectiveness of how limiting the time you eat within an early or late eating window and fasting for remainder of the day will impact weight loss and body mass index (BMI).

In adults, there is growing evidence that early TRE is more effective in improving metabolic outcomes than other forms of TRE, however it is unclear whether adolescents will be able to adhere to such recommendations. Hence, in the present study we propose a 24-week, 2-arm, parallel randomized pilot trial in 100 adolescents (age 13-18 years, all gender expressions, anticipate 65% Latino) with obesity, to test the preliminary efficacy of early vs. late TRE on glycemic profiles, weight loss, and body composition. We hypothesize that, among adolescents who can adhere to the meal timing recommendations, early TRE will result in greater improvement in metabolic endpoints than late TRE. We will test the hypothesis with 3 specific aims: Aim 1: Test the effect of early vs. late TRE on glycemic profiles and β-cell function. Aim 2: Test the effect of early vs. late TRE on obesity and body composition, and cardiometabolic risk factors. Aim 3: Test the effect of early vs. late TRE on exploratory outcomes including sleep, physical activity, and dietary intake to explore how meal timing may influence occurrence, timing, and distribution of sleep and movement as well as dietary intake and caloric distribution. This study is the first study evaluating the effectiveness of early vs. late TRE in adolescents with obesity at risk for diabetes.

Eligibility Criteria:
Inclusion Criteria:

* 12-21 years with obesity (BMI\>95th percentile)
* participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods
* baseline eating window greater than 12 hours.

Exclusion Criteria:

* diagnosis of Prader-Willi Syndrome, brain tumor, or diabetes serious intellectual disability
* previous diagnosis or subthreshold symptoms of an eating disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder)
* parent/guardian-reported physical, mental of other inability to participate in the assessments
* previous bariatric surgery
* current participation in other interventional weight loss studies.
Oxycodone User Registry (OUR)

The purpose of this study is to describe clinical and demographic characteristics of patients receiving prescription medications containing oxycodone immediate release (OXYRX), to characterize patient and prescriber perceptions of the effectiveness outcomes and tolerability of OXYRX treatment, to describe prescriber decision-making about pain management with a Schedule II opioid and to explore how prescribers identify suspected abuse of pain medications.

Real-world utility of Schedule II immediate release opioids depends on both efficacy and side effects. Few existing data sources systematically captured opioid-related side effects and their impact on patient outcomes and physician practice. This study is expected to lead to an in-depth understanding of patient and prescriber perceptions of both effectiveness and side effects associated with medications containing the most widely prescribed oral Schedule II immediate release opioid for pain management, oxycodone immediate release (OXYRX), alone (eg, Roxicodone®) or in combination (eg, Percocet®, Tylox®) in actual clinical practice. This is a prospective, multi-center, observational patient registry. Adult outpatients who have pain due to a non-cancerous condition meeting study eligibility will be enrolled. Prescribers will treat patients according to their usual practice. Prescribers will treat patients, meeting study eligibility, with OXYRX according to their usual practice.

Eligibility Criteria:
Inclusion Criteria:

* Pain requiring treatment with a Schedule II immediate release opioid within 3 days following the baseline visit
* and pain that warrants treatment with a prescription for OXYRX PRN (alone or in combination) for at least 5 days after the baseline visit

Exclusion Criteria:

* Use of any Schedule II opioid within 30 days prior to informed consent
* planned use of other opioids (Schedule II-V) while using OXYRX
* malignancy other than superficial skin cancers (ie, basal cell, squamous cell) within the past year
GRETeL: Tumor Response to Standard Radiotherapy and TMZ Patients With GBM

The purpose of this study is to better define longitudinal genomic alterations in patients with glioblastoma (GBM), and to determine if plasma circulating tumor DNA (ctDNA) or cell free DNA (cfDNA) is associated with disease recurrence, survival, tumor characteristics, and/or peripheral immunosuppression.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients newly diagnosed with malignant glioma, IDH wildtype who have undergone surgical resection for their tumor and who are planned for standard of care radiation therapy with concurrent temozolomide (i.e., at least 59 Gy in 30 fractions over 6 weeks)
* Patients must have leftover tissue available from the surgical resection of their tumor available to request for this research.
* Able to undergo MRI of brain with and without contrast
* Signed informed consent approved by the Institutional Review Board (IRB)

Exclusion Criteria:

* Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
Beverage Consumption and Fine Motor Control

The aim of this study will be to compare the effects of daily consumption of aspartame, rebaudioside a, saccharin, sucralose, and sucrose on body weight and composition in a standardized protocol. The investigators hypothesize that individual low calorie sweeteners (consumed in a beverage) differ from each other in promoting weight loss and decreased fat mass (without energy restriction or dietary guidance) based on their chemical structure.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25-40 kg/M2
* Non or rare users of LCS
* Willing to consume large volumes of beverages daily

Exclusion Criteria:

* Weight change \> 3kg in the last year
* Plan to initiate a new diet plan in the next 6 months
* Exhibit eating restraint
* Pregnant/lactating
Impact of Hemiplegia Due to Stroke on the Microarchitecture of the Bone

In hemiplegic, there is very little data on the impact of neurological deficit on the microarchitecture independent of bone mineral density and composition of the bone marrow. Rare studies have shown the relationship between some micro-architectural parameters and severity of neurological deficit. There is no study in humans on the evolution of the parameters of the microarchitecture assessed by 3D micro-tomography in the early phase of the installation of neurological deficits after stroke, in terms of a bearing bone, tibia, that a non-load bearing bones, radius.

Each patient must answer several questionnaires about their calcium intake and its ability to perform everyday tasks. They will also have 3 blood samples (15 ml each time), 3 measure of bone by 3D micro-tomography and 2 MRI examination. These examinations and sampling will take place after 30 days after stroke onset (except for MRI) and again after three months and six months after the stroke (the same day as the medical follow-up visit).

Eligibility Criteria:
Inclusion criteria

* at least 30 years
* vascular hemiplegia
* National Institute of Health Stroke Score equal 4 or greater with a motor of upper limb score greater than or equal 2 and a motor score of greater than or equal legs 2

Exclusion criteria

* Concomitant bone disease
* Endocrinopathies
* Phasic disorders understanding
* Contra-indication to MRI
Investigation of Hyposafe H02 Device in Patients With Type 1 Diabetes

This clinical study is designed to collect data for further development of a hypoglycaemia notification algorithm. In addition, information regarding safety will be collected and analysed.

H02 is an implantable continuous EEG recorder that consists of an implant and an external device. The H02 system is based on a subcutaneous EEG measurement and acquisition of the EEG signal from the implant.

Participant will have the implantable part of H02 implanted under local anaesthesia. After a healing period, the participants will start using the external part of H02. They will wear the external part of H02 as much as possible both during daytime and night-time. The participant will use their own continuous glucose monitoring (CGM) during the study as normal practice. The participants will be exposed to insulin-induced hypoglycaemia once during the study.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Type 1 diabetes diagnosed at least five years prior to inclusion in the study
* Age 18-70 years
* Impaired awareness, i.e., defined as unaware by the Pedersen-Bjergaard scale and history of at least one severe hypoglycaemia within the preceding year
* Use of continuous glucose monitoring at study start

Exclusion Criteria:

* High risk of surgical complications
* Involved in therapies with medical devices that deliver electrical energy into the area around the implant
* Infection at the site of device implantation
* Contraindications to the local anaesthetic used during implantation and explantation
* Have cochlear implant(s)
* Subject is scheduled to undergo MRI scan, ultrasound, radiation, or electrical current induced close to the implant, within 6 months after enrolment
* Severe cardiac disease
* History of stroke/ cerebral haemorrhage and any other structural cerebral disease
* Active cancer or cancer diagnosis within the past 5 years
RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)

The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care, in the context of ethmoid sinus surgery, at 14 days post-surgery.

This is a comparative study between two postoperative treatments following ethmoid sinus surgery. The purpose of this study is to compare the effect of RESPIMER® NetiFlow® solution on nasal tissue repair versus saline solution (0.9% NaCl), the standard treatment.

The type of surgery selected for this study is total endoscopic ethmoidectomy. This is a frequently used standard surgery that requires nasal cleansing for an average of 28 days. This process allows the regeneration of the nasal epithelial lining of the wound (areas of exposed bone), as well as the healing of swelling and scarring due to the surgery.

The follow up last 28 days with 4 visits (D7, D14, D21 and D28).

RESPIMER® NetiFlow® : device of class I, with CE mark, in the indication of sinus postoperative care.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between 18 and 65 years of age
* Subject in need of sinus surgery as bilateral total ethmoidectomy using an endoscopic endonasal approach whose pathology is the result of a:

  * Sinonasal polyposis alone
  * Sinonasal polyposis associated with asthma and / or intolerance to NSAIDs
* Free and informed written consent
* Member or beneficiary of a social security program

Exclusion Criteria:

* Oral corticosteroid treatment since less than 2 months
* Premenopausal women not using effective contraception (oral or intrauterine device)
* Pregnant or nursing women
* Uncontrolled diabetes (not treated or stabilized by treatment)
* HIV-positive status
* Autoimmune diseases affecting the nose and/or sinuses, immune dysfunctions (Wegener's granulomatosis, Churg-Strauss syndrome, Common Variable Immunodeficiency, sarcoidosis...), or malignant diseases (unclear histology)
* All contraindication of RESPIMER® NetiFlow®
* All diseases resulting in difficulty coughing or swallowing
* Ongoing or past radiation treatment to the head and neck
* Ongoing or recent chemotherapy (within a three-month period)
* Subjects using anticoagulants
* Subjects taking part in another study that includes an exclusion period coinciding with that of the run-in period of this study
* Subjects placed under judicial protection
* Subjects who suffer from severe physical or psychological problems and whose condition can, according to the investigator, affect compliance with the study
Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new primary care intervention "Back on Track" as compared to usual primary care in patients with non-specific chronic low back pain in which disability levels are moderate and the role of psychosocial factors to this disability is at maximum low (classified as WPN2).


Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain; defined as pain between scapulae and gluteal region, whether or not with radiation towards one or both legs, present for at least three months.
* Presence of contributing social and psychological factors, however not complex (WPN2 classification)
* Age between 18 and 65 year
* Sufficient knowledge of the Dutch language
* Acceptance towards the biopsychosocial approach instead of biomedical approach

Exclusion Criteria:

* Chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture, structural deformation, inflammatory process, radicular syndrome or cauda equina syndrome
* Pregnancy
* Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.
The Relationship Between MDSCs and NK Cells Activity of CHC Patient Treated by DAAs

Hepatitis C virus (HCV) infection is easy to chronic and can progress to cirrhosis and liver cancer. Direct-acting antiviral treatment can significantly improve the prognosis of the disease and the efficacy is seemingly not affected by a variety of viral factors. In addition, direct-acting antiviral agents therapy may affect the transformation of the immune cells and ameliorate the host immune status consequently. This study mainly investigated the relationship between Direct Acting Antiviral Treatment effect and the functional activity of myeloid-derived suppressor cells (MDSCs) and natural killer cells (NK cells) in Chronic Hepatitis C.

32 treatment-naive CHC patients and 20 healthy controls were recruited. Patients were examined before DAAs therapy (0w) and at weeks 4 (4w) and weeks 12 (12w) and weeks24 (24w) of the therapy. The percent age of myeloid-derived suppressor cells and NK cells of the peripheral blood were analyzed by flow cytometry. The investigators discuss the relationship between direct acting antiviral treatment effect and myeloid-derived suppressor cells and NK cells activity in chronic hepatitis C.

Eligibility Criteria:
Inclusion Criteria:

* Positive serum Anti-HCV antibody or serum HCV-RNA, CHC patients without any treatment

Exclusion Criteria:

* Patient has a history of clinical signs/symptoms of hepatic decompensation (Child-Pugh Grade B or C) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
* Patient has a history of hepatocellular carcinoma (HCC) or suspected symptoms of HCC, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (AFP)\>50ng/mL.
* Patient has received IFN or other immunomodulatory treatment within 52 weeks before Screening.

Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.

* Patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.

Patient has used hepatotoxic drugs within one month. Patient has overtaken alcohol (\>40g/day) or abused illicit drugs in recent one year.

* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
* Patients who co-infected with HAV, HBV, HDV, HEV,HIV(human immunodeficiency virus ) Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis C (e.g., alcoholism, autoimmune hepatitis).

History of malignancy of any organ system.
Correction of Anterior Open Bite With Skeletally Anchored Extrusion Arch

This study will aim to evaluate the effect of skeletally anchored extrusion arch on the dentofacial structures in patients with anterior open bite (AOB).

This study will be a prospective clinical study. All the patients will be treated with 0.022 inch slot Roth metal brackets. Orthodontic bands will be cemented to the maxillary first molars. Both maxillary and mandibular teeth, will be sectionally leveled and aligned with superelastic Ni-Ti archwires.

A buccal stiff sectional wire from the first molar to the canine will be added for anchorage reinforcement. Extrusion will be done by inverting a 0.017 × 0.025-inch Connecticut intrusion archwire and inserting it in the molar auxiliary tubes upside-down and miniscrew will be tied to the molar bands to act as additional indirect anchorage.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a class I or a mild class II dental relationship.
2. All permanent teeth are erupted except the third molars.
3. Mild to moderate open bite is present.
4. Normal or minimally increased facial height.
5. Low lip line.
6. No or Mild crowding.

Exclusion Criteria:

1. Patients with skeletal open bite.
2. Posterior cross bite.
3. Trauma to the maxillary incisor.
4. Patients in need to extraction due to sever crowding.