cyrilzakka/clinical-trials huggingface dataset:
MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)

To evaluate the safety and efficacy of MT10109L for the treatment of glabellar lines (GL) with or without concurrent treatment of lateral canthal lines (LCL) in participants with moderate to severe GL and LCL.


Eligibility Criteria:
Inclusion Criteria

• Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.

Exclusion Criteria

* Known immunization or hypersensitivity to any botulinum toxin serotype.
* Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
* History of facial nerve palsy.
* Any uncontrolled systemic disease.
* Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
* Anticipated need for surgery or overnight hospitalization during the study.
* Prior exposure to botulinum toxin of any serotype for any reason.
* Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid \[blepharoplasty\] and/or eyebrow surgery).
* Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
* Females who are pregnant, nursing, or planning a pregnancy during the study.
* Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.
Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 on Muscle Mass in Sarcopenic Subjects

The purpose of the study is to evaluate the effect of supplementation with a nutritional blend based on Omega 3 fatty acids, the probiotic leucine Lactobacillus paracasei PS23 (OLEP), on muscle mass recovery in sarcopenic patients.


Eligibility Criteria:
Inclusion Criteria:

* Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis)
* Body Mass Index between 20 and 30 Kg/m2

Exclusion Criteria:

* severe renal failure (glomerular filtration rate \< 30 mL/min)
* moderate to severe liver failure (Child-Pugh class B or C)
* endocrine diseases associated with calcium metabolism disorders (except osteoporosis)
* known psychiatric disorders
* cancer (over the past 5 years)
* hypersensitivity to any component of the investigational nutritional supplement and
* taking to protein/amino acid supplements (up to 3 months before starting the study)
* patients unable to take oral therapy
* receiving or with indication for artificial nutrition
* who had been included in another clinical nutrition trial
Patient-reported Outcomes in Bladder Cancer

Electronic reporting of patient-reported outcomes with alert algorithm will be tested in a randomized trial in bladder cancer patients undergoing chemo- or immunotherapy. The clinical endpoints will be:

* Quality of life
* Completion of treatment
* Hospital admission
* Dose reductions
* Survival

Bladder cancer is in Europe the 4th most incident cancer among men and the 7th most frequent cause of cancer death. Many patients will receive chemo- or immunotherapy in either the neoadjuvant setting or for recurrent or metastatic disease. The registration and handling of side effect is crucial in bladder cancer treatment, since the missing identification and insufficient treatment of such can lead to incomplete treatment and thereby decreased effect. It is therefore of utmost importance to develop new tools which can increase identification of the side effects and improve treatment to secure the best life expectancies for these patients.

This study will in a randomized trial using PRO-CTCAE™ questions, EORTC QLQ-C30 + QLQ-BLM30 in one arm versus standard procedure regarding side effect registration and handling in the other arm, test the effect of electronic reporting of side-effects and quality of life with a specifically developed alert-algorithm. Both study arms will include chemotherapy and immunotherapy patients as standard therapy.

Eligibility Criteria:
Inclusion Criteria:

* Urothelial carcinoma
* Initiating chemo- or immunotherapy
* No serious cognitive deficits
* Read and understand Danish
* Assigned electronic communication with health services with "E-boks"

Exclusion Criteria:

* None
Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections

This study will assess patients who have recurrent urinary tract infections and kidney stones which are not blocking the kidney or causing other problems. Currently, we don't know if taking out these stones will improve recurrent urinary tract infections or not. Patients will make a decision with their surgeon about removing or monitoring their stone(s). Whether or not their infections continue with surgery or monitoring will be noted, and this information may help to inform future treatment decisions. The purpose of this study is to assess if treatment of these asymptomatic stones affects the rate of recurrent urinary tract infections.

Urinary tract infections (UTIs) are common and have a large burden of disease at the population level. This study will assess the effectiveness of removing kidney stones in patients who have recurrent UTIs.

The role of upper urinary tract calculi in UTIs is not well understood. Although there is some evidence that some metabolic stones, such as calcium oxalate, can harbor bacteria, it is not known if this is clinically significant or if these contribute to clinical infections.

This study aims to advance the level of evidence in the treatment of non-obstructing urolithiasis in the context of recurrent UTIs.

The aim of this study is to:

1. Assess the effects of treatment of non-obstructing upper urinary tract calculi on recurrent UTIs in the first prospective observational trial in this area

Patients who meet inclusion criteria will make a decision about treating their asymptomatic stones or not with their surgeon as per usual clinical care. The primary outcome will be the rate of recurrent urinary tract infections for patients, comparing patients who did and did not have their stones treated.

Patient data is securely stored in de-identified fashion in REDCAP database, following all the secure protocols of the institutions involved. The recruitment goal is 80 patients based on power calculations to detect the effect size. Statistical analysis will be performed between the two groups, with t-test used for normally distributed numerical data and fisher's exact or chi-square tests for categorical data.

Eligibility Criteria:
Inclusion Criteria (all of the following):

* recurrent UTIs, defined as 3 positive urine cultures of specific organisms with symptoms within 12 months (or 2 positive cultures with symptoms within 6 months) prior to clinical assessment
* non-obstructing renal stone(s) on imaging within 6 months of initial visit

Exclusion Criteria:

* age \< 18 years
* pregnancy
* hydronephrosis or evidence of obstruction
* presence of a foreign body in urinary tract (e.g. Foley, ureteral stent, nephrostomy tube) at the time of UTI diagnosis
* concurrent bladder calculi
* Urinary diversion or previous surgery involving segments of bowel interposed into the urinary tract (ileal conduit, ileal ureter etc.)
Study of the Difference Between Anorexia Nervosa with a History of Psychological Trauma and Classical Anorexia Nervosa on the Neurocognitive and Neurophysiological Factors

Recent studies suggest that patients with an history of trauma may represent a specific subtype of anorexia nervosa (AM) underlined by specific neurobiological and psychopathological mechanisms. Thus, AM-T subjects would manifest cognitive (specific difficulties in executive functions), emotional (emotional disruption, impulsivity, etc.) and neurobiological (secretion of kynurenine and neurokinins in the face of stress) caracteristics different from those of AM subjects.

We will recruit a total of 100 patients with a diagnosis of anorexia nervosa in the university hospital of Montpellier : 50 patients with an history of psychological trauma and 50 patients without any history of psychological trauma

Participation consists of a half-day visit. Patients will perform clinical and neuropsychological assessments and an exposition test. During this test, participants will be exposed, for 7 minutes, to neutral, positive or negative emotional photos. Heart rate variability will be determined through a Biopac MP160 before, during and after this event. Saliva samples to measure kynurenin, tryptophan, substance P and neurokinin-1 will be collected before and directly after the test.

Eligibility Criteria:
Inclusion criteria common to the 2 groups AM-T and AM-C :

* Women Patient
* Present a diagnosis of anorexia nervosa according to the DSM-5 criteria
* Between 18 and 65 years old
* Present a BMI\> 14
* Do not present a sight problem or be corrected appropriately by wearing glasses or contact lenses.
* Be affiliated to a social security scheme, or beneficiary of such a scheme
* Be able to understand the nature, purpose and methodology of the study

Inclusion criteria specific to patients in the AM-T group:

- To have answered at least one of the grayed out items of the LEC-5, that is to say to have answered "it happened to me" to at least one of the items 1 to 13 or to item 16 "and / or having answered" I witnessed it "to at least one of items 14 and 15.

Inclusion criteria specific to patients in the AM-C group:

- Not having answered "it happened to me" or "I witnessed it" to one of the items of LEC-5

Exclusion Criteria:

* Present a severe unstable mental pathology in the opinion of the investigator
* Present active suicidal ideation
* Have consumed psychoactive substances in the last 24 hours before the assessment
* Present a severe major depressive episode incompatible with the assessment, in the opinion of the investigator.
* Present in the opinion of the investigator an unstable somatic state (eg severe metabolic disorder making it impossible or likely to impair the reliability of neuropsychological and cardiac evaluations).
* Take a drug treatment acting on the cardiovascular system
* Refusal of the patient
* Be protected by law (tutorship or curatorship).
* To be deprived of liberty by administrative decision.
Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus

maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine


Eligibility Criteria:
Inclusion Criteria:

1. patients from 18 to 80 years of age (both inclusive)
2. patients with histologically confirmed squamous cell carcinoma of the head and neck or esophagus
3. patients with local and / or regional recurrent disease or distant metastases who are refractory to or not amenable to established treatments
4. evaluable tumour deposits
5. life expectancy of at least 3 months
6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
7. patients must have given written informed consent (which must be consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)

Exclusion Criteria:

1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
2. known secondary malignancy requiring therapy
3. active infectious disease
4. brain metastases requiring therapy
5. neuropathy grade 2 or above
6. absolute neutrophil count less than 1,500/mm3
7. platelet count less than 100,000/mm3
8. bilirubin greater than 1.5 mg/dl (\> 26 μmol/L, système internationale (SI) unit equivalent)
9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
10. serum creatinine greater than 1.5 mg/dl (\> 132 μmol/L, SI unit equivalent)
11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
12. chemo-, radio- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
13. men and women who are sexually active and unwilling to use a medically acceptable method of contraception
14. pregnancy or lactation
15. treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
16. patients unable to comply with the protocol
Screening and Understanding of the Pre-diabetes: DECODIAB

The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in the population of patients with pre-diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years)
* Subjects with diabetes risk score ≥ 12 or with impaired fasting glucose: blood glucose ≥ 1.10 g/l and \< 1 .26 g/L
* And with impaired fasting glucose : blood glucose ≥ 1.10 g/l and \< 1 .26 g/L ; or blood glucose ≥ 1g/l and \< 1,1 g/L WITH HbA1C ≥ 6,5%
* Signed informed consent
* Subjects affiliated with an appropriate social security system

Exclusion Criteria:

* Fasting glycemia ≥ 1.26 g/l
* Fasting glycemia ≤ 1.10 g/l AND HbA1C \< 6,5%
* Fasting glycemia \< 1 g/l
* Subjects previously treated with oral anti-diabetic: metformin, glitazones, inhibitors of α-glucosidase, sulfonylurea, repaglinide, inhibitors of DPP-IV.
* Subjects previously treated with insulin, except gestational diabetes
* Severe coagulation disorders
* Thrombocytopenia \< 100 000/mm 3
* Severe psychiatric disorders
* Severe renal insufficiency (creatinine clearance \< 30 ml/min)
* Severe hepatic insufficiency
* Alcohol abuse (\> 30g/j)
* Contra-indication in the realization of the local anesthetic
* Subject unable to follow the study during the 5 years of follow-up
* Subject exclusion period in a previous study
Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution Combinations

The purpose of this study is to evaluate corneal staining observed after 2 hours of wear with an investigational contact lens against both PureVision contact lenses pre-cycled with Biotrue and Biofinity contact lenses pre-cycled with RepleniSH.

Subjects will be randomized in a 1:1:1:1 manner to receive one of 4 regimen sequences with lens and multipurpose disinfection solution (MPDS) combinations. The expected duration of subject participation in the study is approximately 1 week with 2 study visit days.

Eligibility Criteria:
Key Inclusion Criteria:

* Understand and sign an Informed Consent;
* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Manifest cylinder of less than or equal to 1.50 diopter (D) in each eye;
* Best corrected visual acuity (BCVA) better than or equal to 20/25 Snellen in each eye;
* Willing to stop wearing habitual contact lenses for the duration of study lens exposure and during the washout period.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any eye condition or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Eye surgery, as specified in the protocol;
* Dry eye; use of artificial tears, as specified in the protocol;
* Other protocol-specified exclusion criteria may apply.
Evaluate Clinical and Radiological Outcomes After Limb Reconstruction Using Monorail Fixator Over Intramedullary Nailing in Tibial Open Fractures With Bone Loss

Road traffic accidents (RTA) is the most common cause of open fractures of long bones, increase in RTA leading to increase of complex non-unions incidence. the Participants are usually undergoing multiple surgeries for healing or to eradicate infection, which in turn leading to loss of bone and soft tissues and require skin grafting, muscle pedicle graft or bone grafting. Sometimes the Participants end up with deformity, limb length discrepancy, joints stiffness, disuse osteoporosis and muscle atrophy after management


Eligibility Criteria:
Inclusion Criteria:

* Age from 18-60 years old.
* Open Grade II, Open Grade III (a \& b) diaphyseal fractures of Tibia (judged after primary and/or secondary to debridement).
* Bone defect \< 10 cm.
* Patients with Injury severity score (ISS) \< 17.

Exclusion Criteria:

* Massive bone defect \> 10 cm.
* Patients with ISS \> 17, polytrauma patient.
* Age \< 18 years old or \> 60 years old.
* Associated vascular injury ischemic limb.
A Preliminary Study of the Effectiveness and Tolerability of Aripiprazole in Bipolar Depression

The specific aim of this study is to obtain preliminary evidence of the acute effectiveness and tolerability of aripiprazole in the treatment of bipolar depression.


Eligibility Criteria:
Inclusion Criteria:

* subjects must have bipolar I, II or NOS disorder as defined by DSM-IV-TR; must have clinical significant depressive symptoms and have failed one or more mood stabilizer trials; may or may not be receiving antimanic or mood stabilizing medications; subjects or legally authorized representative must sign the Informed Consent document after the nature of the trial has been fully explained; if female, subjects must be postmenopausal, surgically incapable of childbearing or practicing medically acceptable effective method(s) of contraception.

Exclusion Criteria:

* subjects who do not have bipolar disorder by DSM-IV criteria; subjects with current DSM-IV Axis I diagnosis of delirium, dementia, amnesia or other cognitive disorders or a psychotic disorder; subjects with serious general medical illness; subjects who are allergic to or have demonstrated hypersensitivity to aripiprazole; women who are pregnant or nursing; subjects who have received an experimental drug or used an experimental device within 30 days; subjects who have a history of neurologic malignant syndrome.
A Study to Evaluate the Antibody Response of Influenza Vaccination Following Concomitant Exposure to Bimekizumab in Healthy Subjects

The purpose of the study is to evaluate whether administration of bimekizumab has an effect on the expected production of antibody titers to the influenza vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female aged ≥18 years and ≤55 years at the Screening Visit
* Subject must have a blood test with at least two influenza antibody titers ≤1/10 at the Screening Visit and have not developed any flu-like illness 2 weeks before the start of the study
* Female subjects of childbearing potential must not be lactating and have a negative serum pregnancy test at the Screening Visit, which is confirmed to be negative by urine testing prior to administration of bimekizumab. Female subjects of childbearing potential must agree to use a highly effective method of birth control during the study and for a period of 20 weeks after their last dose of the investigational medicinal product (IMP)
* Subject has a body weight of ≥45 kg and body mass index (BMI) between 18 and 32 kg/m2 (inclusive), at the Screening Visit

Exclusion Criteria:

* Subject has a known hypersensitivity to any excipients of bimekizumab
* Subject has a history of hypersensitivity to the influenza vaccine
* Subject is legally institutionalized or has a mental health condition or related care provision (eg, guardianship) that would impede the subject from providing voluntary informed consent to participate in the study
* Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method
* Male subjects who are planning a partner pregnancy during the study
* Subjects receiving vaccination of any kind within the 52 weeks prior to the Screening Visit or the influenza vaccination within 2 years prior to the Screening Visit. Live vaccines are not allowed during the study or for 20 weeks after the last dose of investigational medicinal product (IMP)
* Subject has a current or past history of gastrointestinal ulceration or other gastrointestinal disease, such as inflammatory bowel disease
* Subject has an active infection
* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection or human T-cell lymphotropic virus type-1 (HTLV-1)
Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy

This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain.

As above

Eligibility Criteria:
Inclusion Criteria:

* presence of symptomatic gallstones
* American Society of Anesthesiologists (ASA) score 1 or 2
* informed consent

Exclusion Criteria:

* active acute cholecystitis
* previous open upper abdominal surgery
* bleeding disorders
Study of Tocotrienol Absorption and Distribution Under Different Fat Status

Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans remains unclear especially with different fat diets.This study aimed at evaluating the absorption and distribution of tocotrienols in plasma and lipoproteins in associations with high and low fat diets. Different fat level will affect the absorption and distribution of tocotrienols

There is a possibility that the absorption and distribution of tocotrienols may occur differently compared with tocopherols, especially under different fat status

Eligibility Criteria:
Inclusion Criteria:

* male aged 22-25
* body mass index 18.5 \< X \< 30 kg/m2
* plasma cholesterol \< 5.2 mmol/L,
* TAG \< 1.7 mmol/L

Exclusion Criteria:

* history of cardiovascular disease
* diabetic
* body mass index \< 18.5 or \> 30 kg/m2
* plasma cholesterol \> 5.2 mmol/L,
* TAG \> 1.7 mmol/L
* hypertension
* currently taking Vitamin E supplement
* current use of medication
* smoking.