cyrilzakka/clinical-trials huggingface dataset:
A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers

This open-label, fixed sequence, two-period study will assess the effect of multiple dose carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of 3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose of RO4917838 on Day 16.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy male volunteers, 18-65 years of age inclusive
* Body mass index (BMI) 18-30 kg/m2 inclusive

Exclusion Criteria:

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic or psychiatric disease, or cancer
* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Native Asians or subjects with Asian racial origin
Evaluating the Efficacy and Safety of of HSK44459 in People With Idiopathic Pulmonary Fibrosis

This study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria:

1. IPF based on 2022 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan taken before or during screening period and if available surgical lung biopsy.
2. Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by the investigator prior to screening. if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy.

2. Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 3. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin \[Hb\]) ≥ 25% of predicted normal at screening period.

4. Patients have to be either:

1. not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart anti fibrotic therapy.
2. on stable therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period.

Exclusion Criteria:

1. Clinically significant airways obstruction (Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC) \< 0.7) at screening.
2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
3. Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined).
4. Lower respiratory tract infection requiring antibiotics within 2 weeks prior to screening and/or during the screening period.
5. Major surgery (major according to the investigator's assessment) performed within 3 months prior to screening or planned during the course of the trial. (Being on a transplant list is allowed).
6. History of malignancy within 5 years prior to screening.
7. Any suicidal behavior within 2 years prior to screening (i.e. actual attempts, interrupted attempts, abandoned attempts, or prepared actions or attitudes).
Study of Multifrequential Impedancemetry in Pulsatile Tinnitus

This study intended to search for a relationship between the multifrequential admittancemetry and the pulsatile tinnitus.

The multifrequency admittancemetry is known to reflect several parameters of the middle ear and the external ear. More recently it appears to also reflect some parameters of the inner ear, such as the perilymph pressure. Furthermore, investigators do not know exactly the physiopathology of pulsatile tinnitus that are from veinous etiology. Modifications of the perilymphatic pressure could be implicated. Investigators intended to search for a relationship between these both theories.

Investigators will include every patient that consult to Ear, Nose and Throat unit of Bordeaux University Hospital with a pulsatile tinnitus trouble, and perform multifrequential admittancemetry. If a radio-surgical intervention is scheduled for a venous stenosis, the test will also be performed test after the surgery.

If there is no surgical intervention, no follow-up will be required.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Unilateral or bilateral pulsatile tinnitus
* Pulsatile tinnitus \> 1 month old
* Affiliated or beneficiary of by social security system

Exclusion Criteria:

* Otological surgery, excluding trans-tympanic aerators in childhood with closed eardrum
* Middle ear abnormality (any type of partial or total filling of the middle ear) noted on otoscopy or subsequent MRI scan
* Abnormal eardrums excluding tympanosclerosis
* Non-pulsatile tinnitus
* Conductive hearing loss with abolition of stapedial reflexes
* Minor patient
* Major protected
* Abnormal tympanometry at 226 Hz
* Presence of rotatory vertigo
* Opposition to participation expressed by patient
Pursestring Wound Closure vs "Gunsight" Skin Incision and Closure Technique to Reverse Stoma

The use of temporary stomas has been demonstrated to reduce septic complications after colorectal cancer surgery, especially in high-risk anastomosis; therefore, it is necessary to reduce the number of complications secondary to ostomy takedowns, namely wound infection. The aim of this study is to compare the rates of superficial wound infection, healing time and patient satisfaction after pursestring closure vs "gunsight" skin incision and closure technique closure.


Eligibility Criteria:
Inclusion Criteria:

* loop colostomy
* end colostomy

Exclusion Criteria:

* other stomy
A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

The purpose of this study is to investigate the safety and efficacy of multiple dose levels of the investigational product (study drug), IPI-145, in combination with methotrexate compared to methotrexate alone in subjects with active moderate-to-severe Rheumatoid Arthritis.

This Phase 2 study is designed to examine the efficacy and safety of multiple dose levels of IPI-145 in subjects with active moderate-to-severe Rheumatoid Arthritis receiving a background stable dose of methotrexate. The study will employ a randomized, double-blind, placebo-controlled, parallel design.

Approximately 316 adult subjects who meet all eligibility criteria at Screening will be randomized at Baseline in a 1:1:1:1 ratio to one of 4 dose groups.

All treatments will be administered twice a day (BID). After randomization, subjects will enter a 12-week Treatment Period, where study drug (IPI-145 or placebo) will be self-administered BID as an outpatient. During the Treatment Period, subjects will return to the clinic for efficacy and safety assessments every 2 weeks. Following Treatment Period completion at Week 12, subjects will enter a 3-week Follow-up Period which includes one clinic visit approximately 3 weeks after the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of Rheumatoid Arthritis for at least 6 months
* Active disease, based on Screening clinical and laboratory criteria, despite taking methotrexate for at least 3 months

Exclusion Criteria:

* Pregnant or lactating females
* Previous failure or inadequate response to \>2 biologic disease-modifying anti-rheumatic drugs (DMARDs)
* Concurrent DMARD treatment other than methotrexate, sulfasalazine, chloroquine, or hydroxychloroquine
* Treatment with \> 10 mg daily prednisone (or equivalent) or more than one non-steroidal anti-inflammatory drug
Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 yrs with open-angle glaucoma or ocular hypertension
* Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

* Uncontrolled medical conditions.
* Subjects who wear contact lenses.
* Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
* Subjects who have a history of chronic or recurrent inflammatory eye disease.
Quantitative Study of Prevalence and Vulnerability Factors of Active Cyber Sexuality Among Teenagers in West Normandy

This study evaluates prevalence of active cybersexuality among teenagers (15-17 old) in West Normandy and find different factors of vulnerability that could induce this behaviour. Selection of teenagers in different schools (general, professional, agricultural, reintegration structure).

the teen completes a questionnaire at the beginning of sexual education session. This questionnaire put in an anonymous box. After, there is a debate on the subject with the speaker, teenager ask questions about sexuality.

Eligibility Criteria:
Inclusion Criteria:

* all of teenagers participate a sexual education session

Exclusion Criteria:

* \<15 old and 18 old and more
* the school doesn't want to participate
* one parent refuses that his adolescent participate. If requested exclusion, the group to which belongs the child is excluded
* teenager refuses to participate
Modifications to Radical Prostatectomy: Feasibility Study

This study aims to determine whether surgeons at Memorial Sloan-Kettering Cancer Center are able to randomize patients to test modifications of surgery to remove the prostate. Surgery to remove the prostate is known as a "radical prostatectomy". Surgeons know many things about the best way to do a radical prostatectomy. However, there is disagreement about some aspects of surgery. Two modifications of surgery to remove the prostate (radical prostatectomy) identified for this study include Irrigation, and Fascial Suturing.

Two aspects of the operation may vary, fascial suturing and urethral irrigation. For each aspect, surgeons will use their clinical judgment as to the best interests of the patient. In other words, if there are clear reasons to use or avoid a fascial suturing approach, the surgeon will act accordingly; similarly, if there is a clear reason to irrigate or avoid irrigating the urethra, the surgeon can make the appropriate clinical decision. If the surgeon is unsure as to which approach to take, then the randomization scheme will be followed.

All of the surgeons who are taking part in this study have used these techniques at different times. However, they are unsure as to the best approach. Sometimes, they use different treatments with different patients.

Irrigation. Cancer cells can spill during surgery and this can cause cancer to return ("recur"). Some surgeons believe that "irrigating" could help stop spilling of cancer cells. "Irrigating" means washing the surgical area with sterile water and sucking the water back up through a tube. As a result, surgeons vary as to how they irrigate. In this study, we will examine irrigation of the urethra. This is the part of the body that carries urine from the bladder to the penis.

Fascial suturing. Surgeons believe that what happens to the urethra can affect the risk of incontinence. This is when a patient cannot control urine, and drips or leaks urine. One idea is that additional stitches ("sutures") to the connective tissue ("fascia") could be helpful, but this is not known for sure.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for radical prostatectomy for the treatment of prostate cancer with one of the consenting surgeons at MSKCC.

Exclusion Criteria:

* Prior treatment for prostate cancer: radiation, hormonal therapy, chemotherapy or focal therapy.
Crossed Education in Relation to Muscle Mass in Patients Operated of Clavicular Fracture

The immobilization process after an operation or injury in the upper extremity causes a loss of muscle mass and strength of 0.2% and 1.3% per day, respectively. Currently, the use of cross-education, which is unilateral training in the uninjured limb, during the immobilization period, is expanding, demonstrating a magnitude of strength gain in the immobilized limb from 8% to 77% of the mean of strength of the trained limb. Despite the evidenced benefits of cross-education in unilateral injuries such as distal radius fracture, anterior cruciate ligament injury, and knee replacement, very little is known about this effect in shoulder immobilization after clavicle fracture.

Objective: To determine the effectiveness of cross-education training through eccentric strength exercises compared to concentric-eccentric after the 6-week immobilization period and after 12 postoperative weeks in relation to muscle mass, strength, and functionality in patients operated of clavicular fracture.

Hypothesis: Cross-education training through eccentric strength exercises produces greater effects compared to concentric-eccentric training during the immobilization period and after 12 postoperative weeks, in relation to muscle mass, strength and functionality in patients operated for clavicle fracture.

Methodology: An experimental, randomized, single-blind study will be carried out, in which 39 men from 18 to 40 years of age will be recruited, who are awaiting surgery for clavicle fracture. They will be divided into three groups: control group (Standard Kinesic Therapy 12 weeks after immobilization of 6 weeks, n=13), concentric-eccentric group (concentric-eccentric strength training in the uninjured limb during the 6-week immobilization period + Standard Kinesics Therapy, n=13) and group eccentric (eccentric strength training on the uninjured limb during the 6-week immobilization period + Standard Kinesics Therapy, n=13).

Expected results: It is expected to observe a gain in muscle mass and strength in the trained limb and a maintenance/gain of muscle mass and strength in the groups that perform cross-training during the immobilization period, presenting the greatest benefit in the group that performs training eccentric force.

Eligibility Criteria:
Inclusion Criteria:

* Men from 18 to 40 years old, diagnosed with radiographically verified clavicle fracture and awaiting surgical procedure. They have a body mass index of not less than 18.5 and not more than 29.9 kg/m2 and sign an informed consent.

Exclusion Criteria:

* Patients with previous injuries, pathological fracture or polytrauma
* Patients who report pain, a history of rotator cuff tear or surgery in the non-injured upper extremity.
* Patients with uncontrolled cardiovascular diseases.
* Any history of neurological problems in the upper extremities.
* Use of nutritional supplementation (leucine, glutamine, casein, whey-protein, fatty acids and creatine) and/or Hormonal Replacement Therapy.
Investigation of the Effect of Erector Spinae Plane Block on Systemic Immuno-Inflammatory Index

Erector spinae plane block (ESPB) is a novel interfascial block technique first described by Forero in 2016. It has been reported to be effective in various clinical indications. In ESPB, local anesthetic is injected between the deep fascia of the erector spinae muscle and the transverse process of the vertebra, allowing cephalocaudal spread along the erector spinae muscle. The goal of the injection is to provide sensory blockade by affecting the anterior rami of the spinal nerves in the region.

ESPB has been used during breast and axillary lymph node surgeries to manage postoperative pain. In addition to tumor cells, immune and inflammatory cells such as neutrophils, platelets, and lymphocytes contribute to the dissemination and invasion of tumor cells into the peripheral circulation. Noninvasive biomarkers such as serum inflammatory markers are increasingly valued for their simplicity and predictive potential. Platelets have been shown to facilitate epithelial-mesenchymal transition of tumor cells; neutrophils support tumor adhesion via growth factors such as VEGF and proteases; lymphocytes play a role in modulating the host immune response to malignancy.

The systemic immune-inflammatory index (SII), calculated as (platelet count × neutrophil count) / lymphocyte count, is a relatively new composite marker that reflects immune and inflammatory responses. It has been evaluated as a prognostic biomarker in several cancer-related studies.

Postoperative pain and surgical stress activate systemic inflammatory responses. ESPB is performed as part of postoperative analgesia in patients undergoing breast cancer surgery under general anesthesia, based on voluntary participation. The aim of this study is to evaluate the effect of ESPB on postoperative SII levels in comparison to other analgesia modalities.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 18-75 years
* ASA (American Society of Anesthesiologists) physical status I-II
* Undergoing unilateral breast cancer surgery under general anesthesia
* Volunteered to participate in the study and signed informed consent

Exclusion Criteria:

* Allergy or contraindication to local anesthetics
* Coagulopathy or on anticoagulant therapy
* Infection at the injection site
* History of chronic pain or opioid use
* Neurological or psychiatric disorders affecting pain perception
* Refusal to receive regional anesthesia
Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder

This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).

This is a multi-center open-label, long-term study in LBD subjects with RBD and/or VHs. Eligible subjects who completed a previous nelotanserin VH or RBD study and choose to participate in this open-label study will receive 20, 40, 60, or 80 mg nelotanserin once daily for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with LBD who completed a previous nelotanserin VH or RBD study

Exclusion Criteria:

* Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia

This is a Phase I, open-label, dose escalation study of UCART123 administered intravenously to patients with newly diagnosed CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined in the ELN adverse genetic risk group (2017). The purpose of this study is to evaluate the safety and clinical activity of multiple infusions of UCART123 and to determine the Maximum Tolerated Dose (MTD).


Eligibility Criteria:
Main Inclusion Criteria:

* Patients newly diagnosed with CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined as per ELN guidelines (Döhner et al., 2017)
* Eastern Cooperative Oncology Group performance status of 0 or 1
* No prior gene or experimental cellular therapy
* No organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy
The Role of Cognitive Control in the Transdiagnostic Conceptualization of "Intrusive Thoughts"

The investigators are examining whether difficulties with cognitive control (i.e., the ability to stop one's thought process and shift attention) is a common problem across three types of repetitive, negative thinking: obsessions (as seen in obsessive compulsive disorder, OCD), worries (as seen in generalized anxiety disorder, GAD), and ruminations (as seen in major depressive disorder, MDD).

The primary aims of this study are to utilize self-report and behavioral measures to examine whether cognitive control is a common factor across three types of repetitive negative thinking (RNT): obsessions in OCD, worries in GAD, and ruminations in MDD. Specifically, the investigators aim to test whether individuals with obsessions, worries, and depressive ruminations demonstrate impaired cognitive control on executive functioning neuropsychological tasks (i.e., response inhibition, set shifting, attentional disengagement) relative to individuals without any psychiatric diagnoses. Additionally, the investigators will examine whether these deficits are associated with self-report measures of RNT as well as in vivo responding during a laboratory paradigm designed to induce intrusive thinking. Findings could inform psychological treatment of these problematic intrusions using novel transdiagnostic approaches.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (age 18+)
2. Intrusive thoughts group: Clinically significant intrusive thought in the domain of obsessions, worries, or depressive ruminations with a score above the clinical mean (≥ 37) on the trait repetitive negative thinking measure (Perseverative Thinking Questionnaire, PTQ)
3. Non-psychiatric control (NPC) group: A score 1 SD below the community mean (≤ 15) on the trait repetitive negative thinking measure (PTQ)
4. Sufficient fluency of English to understand study procedures and questionnaires
5. Ability to provide informed consent.
6. Comfortable and capable of using a computer and completing reaction-time tasks.

Exclusion Criteria:

1. Acute psychosis, mania, or suicidality
2. Diagnosis of post-traumatic stress disorder (PTSD; in order to preserve diagnostic clarity of the domains of intrusive thoughts under investigation)
3. Serious neurological disorder or impairment (e.g., brain damage, blindness), attention deficit hyperactivity disorder (ADHD), intellectual disability, or autism.
Impact of DOlutegravir+Lamivudine Simplification on HIV-1 Reservoirs

For a few years, there has been a keen interest of clinicians and patients for "lighter" antiretroviral strategies based on two- or even single drug regimens rather than the canonical triple therapy, both as initial and maintenance therapy, despite the possibility that ongoing viral replication may occur in some patients under triple-therapy.

We will therefore propose such simplification strategy (DTG/3TC) while maintaining triple-therapy (DTG/ABC/3TC) in a control group and will perform an in depth analysis of the replication-competent reservoir in blood and in tissues as well as measurements of residual viremia and immune chronic activation/inflammation.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected adults receiving cART for at least 2 years
* DTG/3TC/ABC as cART regimen in the previous 6 months.
* CD4 counts higher than 200 cells per μL and virological suppression for at least 2 years (plasma HIV RNA \<20 copies per mL)

Exclusion Criteria:

* hepatitis C or B co-infection
* unstable liver disease
* renal impairment (estimated glomerular filtration rate \<50 mL per min),
* gastrointestinal disorders that would affect the absorption of study treatment
* current use of drugs with significant interactions with dolutegravir
* current use of drugs with an impact on inflammation such as steroids.
* hospitalization for acute illness within the previous 8 weeks
* Pregnancy or breastfeeding.
* Known resistance to DTG or 3TC
* Active tuberculosis
* Anal or rectal lesions impeding rectal biopsies
* Decreased platelets count or coagulation disorder.