cyrilzakka/clinical-trials huggingface dataset:
Music Therapy in Obsessive Compulsive Disorder

Previous studies have highlighted the potential therapeutic benefits of receptive individual music therapy as an adjunct to standard care, in a variety of psychiatric ailments including mood and anxiety disorders. However, the role of music in the treatment of obsessive compulsive disorder have not been investigated to date. The present study therefore aimed to investigate the efficacy of music therapy as an adjunct to standard treatment, on obsessions in patients with treatment-naïve OCD. Moreover, given the fact that a significant proportion of patients with OCD have other comorbid mood or anxiety disorders, the question of whether therapeutic benefits of music could be expanded to also affect concurrent depressive and anxiety symptoms was explored.


Eligibility Criteria:
Inclusion Criteria:

* were at least 18 years or older;
* had axis I diagnosis of OCD according to the criteria delineated by the diagnostic and statistical manual of mental disorders - fourth edition diagnosed by an experienced psychiatrist
* had not received treatment previously for the disorder
* agreed to partake in the study

Exclusion Criteria:

* refused to partake in the study
Retrospective Study in Patients With Metastatic Renal Cancer Treated With TKI Sequence (Tyrosine Kinase Inhibitors of VEGFR) - mTOR- Axitinib Inhibitors or Anti-VEGF Antibody -Inhibiteurs mTOR - Axitinib

Describe in patients with metastatic kidney cancer treatment modalities with the type sequences: TKI - mTORi - Axitinib or VEGF mAb - mTORi - Axitinib.


Eligibility Criteria:
Inclusion criteria:

* Patient with metastatic kidney cancer (all histological types)
* Male or female aged (e) of 18 or more
* Patient has been treated or under treatment with axitinib (Inlyta®) in the third line after the first line of targeted TKI therapy and after mTORi in 2nd line, or
* Patient receiving the treatment sequence VEGFmAb - mTORi - axitinib For living patients: patient informed and having given oral consent

Exclusion criteria:

* Patient who received more than one line of antiangiogenic therapy in the metastatic phase before initiation of treatment with axitinib (except patients in the study Pisces) Patient received a second line treatment with TKI Patient refused to participate in the study
Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections

The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and comparator in complicated urinary tract infection

This is a Phase 2, multicenter, prospective, randomized, double-blind, comparative efficacy and safety study of IV CXA 101 versus IV ceftazidime for 7 to 10 days.

Subjects are followed up 6 to 9 days after the last dose of study drug to assess clinical signs and symptoms of infection. A Late Follow Up evaluation (21 to 28 days after the last dose of study drug) occurs for those subjects who respond to therapy. The primary assessment of effectiveness is the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of study). An additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females 18 to 90 years of age, inclusive.
2. Pyuria (white blood cell \[WBC\] count \> 10/µL in unspun urine or ≥ 10 per high power field in spun urine)
3. Clinical signs and/or symptoms of cUTI, either of:

   a. Pyelonephritis, as indicated by both of the following: i. Fever (oral temperature ≥ 37.8°C); ii. Flank pain or costovertebral angle tenderness;

OR

b. Complicated lower UTI, as indicated by both of the following: i. At least one of the following new or worsening symptoms:

* Dysuria;
* Frequency;
* Suprapubic pain;
* Urgency

ii. At least one of the following complicating factors:

* Male gender;
* Current bladder instrumentation or indwelling urinary catheter that is expected to be removed during the course of IV study drug administration;
* Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration;
* Urogenital surgery within 7 days preceding administration of the first dose of study drug;
* Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine.

Exclusion Criteria

1. Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial
2. Concomitant infection requiring systemic antibacterial therapy in addition to IV study drug therapy at the time of randomization. Drugs with only gram-positive activity (e.g. vancomycin, linezolid) are allowed
3. Complete, permanent obstruction of the urinary tract
4. Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal CFU/mL)
5. Suspected or confirmed perinephric or intrarenal abscess
6. Suspected or confirmed prostatitis
7. Known ileal loop or vesico-ureteral reflux
8. Women who are pregnant or nursing
Stereotactic Body Radiation Therapy (SBRT) for Unresectable Liver Metastases

This is a Phase II study to determine the efficacy of SBRT to treat liver metastases in patients with Colorectal Adenocarcinoma, Carcinoma of the Anal Canal and Gastrointestinal Neuroendocrine Tumors that are not amenable to surgery. Patients should have no evidence of extra-hepatic disease or have disease that is planned to be treated with curative intent.

Therefore, SBRT is being considered as a potentially curative procedure.


Eligibility Criteria:
Inclusion Criteria:

* Karnofsky Performance Scale (KPS) equal or greater than 70
* 1 to 4 liver metastases with an individual maximum diameter of up to 5 cm
* Lesions considered unresectable or patients considered unfit for surgery
* Histology of the primary tumor: colorectal adenocarcinoma, carcinoma of the anal canal or gastrointestinal neuroendocrine tumors.
* Absence of evidence of extra-hepatic disease or extra-hepatic disease to be treated with curative intent.
* Minimum interval of 2 weeks between systemic chemotherapy and SBRT.
* Adequate bone marrow function defined as:
* absolute neutrophils count \> 1,800 cells / mm 3
* platelets \> 100,000 cells / mm 3
* hemoglobin \> 8.0 g / dl ( transfusion or other intervention accepted)

Exclusion Criteria:

* Concomitant chemotherapy
* Prior radiotherapy to the upper abdomen
* Pregnancy
* Underlying Cirrhosis
* Active hepatitis or clinically significant liver failure
* Prior invasive neoplasm except for non-melanoma skin cancer, or unless more than five years without evidence of disease
* Severe Comorbidity
* Current anticoagulant treatment
Changes in Inhibition and Valuation After Eating

An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. This project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of binge eating, purging, and restriction.

The overarching goal of this project is to test a neurocomputational model of BN that incorporates learning and decision-making components of control. The study combines functional magnetic resonance imaging (fMRI), computational modeling, and real-time mobile assessments to examine the influences of acute fasting and eating on brain function and associated control-related updating and effort-valuation processes in BN. More specifically, the study has the following main objectives: 1) To determine the influence of eating on control-related prediction updating in BN.; 2) To determine the influence of eating on control-related cognitive effort valuation in BN; 3) To use state-specific neural activation to predict BN symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 to 45 years
* Current BMI greater than or equal to 18.5kg/m2 but under 30kg/m2
* Right-handed
* English-speaking

Additional Inclusion Criteria for Women with Bulimia Nervosa:

* Meet DSM-5 criteria for bulimia nervosa

Exclusion Criteria:

* Medical instability
* Ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation
* Shift work
* Pregnancy, planned pregnancy, or lactation during the study period
* Allergy to any of the ingredients in or unwillingness to consume the standardized meal or unwillingness to drink water during the fasting period
* Any contraindication for fMRI
Evaluation of the Safety, Performance, and Tolerability of the Sacromesh® Medical Device in the Treatment of Prolapse by Promontofixation in a Population of Patients Followed Over the Long Term.

An observational, multicenter study with retrospective recruitment and two data collection methods, one retrospective (medical records) and the other prospective (questionnaires).

Patients who meet the inclusion criteria and have none of the non-inclusion criteria will be selected using the computer database of each investigating center. Data from consultation visits and surgery data will be collected and filled in the observation books.

The patient will be contacted by the investigators to collect data on quality of life and the existence or absence of pain associated with implant placement at follow-up.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for participation in the study are as follows:

• Patient who underwent surgery to place the Sacromesh® medical device for a prolapse cure, between 2009 and 2018 in one of the investigation centres participating in the study.

• Patient who has read the information note and has not formulated an -opposition.

• Adult patient with full mental capacity/capability

Exclusion Criteria:

• Patient under guardianship or curatorship

• Patient hospitalized at time of inclusion

• Patient with an adjacent pathology that may strongly interfere with her quality of life and VAS score.

* Patients with mental psychological pathology
Different Metabolic Effects of Statins

The investigators hypothesize that pravastatin and rosuvastatin may have different metabolic effects in hypercholesterolemic patients.


Eligibility Criteria:
Inclusion Criteria:

* Low-density lipoprotein cholesterol levels\>130

Exclusion Criteria:

* Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
Using an Adaptive Rower for People Using Motorized Wheelchairs

The goal of this clinical trial are to determine the feasibility and impact of an adaptive rower exercise intervention for adults who use motorized wheelchairs for mobility.

The main question\[s\] it aims to answer are:

1. What is the impact on participant's cardiovascular endurance, and perception of mobility and quality of life?
2. Is the intervention feasible, acceptable and safe?

examine feasibility of the adaptive rower intervention through measures of acceptability, adherence, intensity and safety for adults who use motorized wheelchairs for mobility.

Participants will complete 12 sessions of 10-20 minutes of supervised and coached moderate to vigorous activity using the adaptive rower over a seven week period. Participants will complete pre- and post- outcome assessments of cardiovascular fitness, and outcome surveys,

A rolling prospective clinical trial with a target population of 10 participants in the Columbia, South Carolina area will evaluate the impact of the adaptive rower on cardiovascular fitness, participant perception and feasibility for people who use motorized wheelchairs.

Participants will be screened for inclusion/exclusion criteria, perform initial outcome measures and instructions on rowing in the first visit, and then have 12 exercise sessions over 6 or 7 weeks, followed by a final visit for final outcome measures. All research will occur at the University of South Carolina Rehab Lab in the public health research center building.

Over the 6-7 week intervention period, participants will exercise approximately two times per week, with two additional visits available in week 7 for any missed sessions to fulfill the 12-visit dosage. Session data will include measures of heart rate, 0-10 Borg rate of perceived exertion (RPE), and power output (rower output in watts). The session goal is to maintain moderate-vigorous intensities (5-8 on the Borg RPE scale) with individually modifiable intervals of work and rest with the goal of 10-20 minutes of moderate-vigorous physical activity total per session depending on the individual's initial fitness levels (as judged by self-reported activity level and performance on the initial six-minute arm test) and progressed as able. After completing the intervention period, participants will return for final evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Use a motorized wheelchair for mobility
* Able to perform a rowing motion with upper extremities with or without grip aids

Exclusion Criteria:

* Existing pressure sores
* Increasing pain with rowing motion
* Unstable angina
* Uncontrolled arrythmia
* Acute illness with fever
* Blood pressure above 180/100 mmHg
A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies

Primary Objective:

To assess the safety and pharmacokinetics preliminarily of the dose of intravenous (IV) aflibercept used in western studies in combination with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) given intravenously every 2 weeks in Chinese patients with solid tumors.

Secondary Objectives:

* To make a preliminary assessment of antitumor effects of the combination of FOLFIRI plus aflibercept in patients with measurable disease (RECIST 1.1).
* To evaluate the immunogenicity of IV aflibercept.

Total duration of the study per patient is in the range of 17 to 29 weeks.

This trial is being conducted in China, where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".

Eligibility Criteria:
Inclusion criteria:

- Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable for which FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) treatment is appropriate

Exclusion criteria:

* Treatment with chemotherapy, hormonal therapy, radiotherapy, surgery, or an investigational agent within 28 days
* Eastern Cooperative Oncology Group (ECOG) \>1
* Need for a major surgical procedure or radiation therapy during the study
* Diagnosis of squamous-cell lung cancer
* Cumulative radiation therapy to \> 25% of the total bone marrow
* History of brain metastases
* Inadequate organ and bone marrow function
* Uncontrolled hypertension
* Evidence of clinically significant bleeding diathesis or underlying coagulopathy
* Prior FOLFIRI treatment but have not been appropriate for safety reasons
* Patients with known Gilbert's syndrome

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Evaluation of Non-invasive Endothelial Function in Children Sickle by Vascular Ultrasound

Sickle cell disease (SCD) is an inherited disorder characterized by recurrent painful crises with ischemia resulting from vascular occlusion. Adults with SCD have increased arterial stiffness and reduced flow-mediated dilation (FMD), due to impaired release of substances such as nitric oxide.

The present study assess the vascular properties of carotid and brachial arteries in children with SCD compared with a control group without cardiovascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

Sickle cell group :

* Children with sickle cell syndrome (SS or SC)
* Children hospitalized in the hematology unit (day hospital)
* The girls set must have had a negative pregnancy test.
* One of the two holders of parental authority must have signed consent form
* Children affiliated to a social security scheme or equivalent

Control group : Children recruited in a previous study :

* Holders of parental authority affiliated to a social security scheme
* Children recruited during the balance of a heart murmur or a vasovagal reaction
* Children whose cardiological examination is normal
* Children having no cardiovascular risk factor

Exclusion Criteria:

Sickle cell group :

* Children with intercurrent diseases such as obesity, intra uterine growth retardation (IUGR), hypertension, renal failure, infectious diseases (including HIV, Hepatitis C) or chronic inflammatory
* Children who have sickle cell crisis there is less than 1 month.

Control group :

Children with intercurrent diseases: obesity, IUGR, hypertension, renal failure, infectious diseases (including HIV, Hepatitis C) or chronic inflammatory
The Impact of Different Feeding Modes on Patients With Intracerebral Hemorrhage

This was a multicenter, prospective, randomized controlled clinical trail involved tracheostomized patients with Intracerebral Hemorrhage.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding vs Nasogastric Tube Feeding in Tracheostomized Patients with Intracerebral Hemorrhage. The main questions it aims to answer are:

Compared to Nasogastric Tube Feeding, can the Intermittent Oro-esophageal Tube Feeding better improve the nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit of Patients with Intracerebral Hemorrhage Compared to Nasogastric Tube Feeding, is the Intermittent Oro-esophageal Tube Feeding safer.

Participants will be divided into two groups randomly, with different nutritional support respectively.

Safe and efficient enteral nutrition support for tracheostomized patients with intracerebral hemorrhage continues to be a challenge. Nasogastric tube feeding has been the mainstay in China but has a significant risk of adverse events. Intermittent oro-esophageal tube feeding is an established enteral nutrition mode that can be used to replace Nasogastric tube feeding. This study reports the clinical effect of Intermittent oro-esophageal tube feeding vs Nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage receiving basic medical treatment and comprehensive rehabilitation therapy.

However, in the field of intracerebral hemorrhage combined with tracheostomy, research on Intermittent oro-esophageal tube feeding is still relatively limited. Therefore, this study was carried out to explore the clinical effect of Intermittent oro-esophageal tube feeding vs. Nasogastric tube feeding in tracheostomized patients with intracerebral hemorrhage, mainly on nutritional status, extubation of tracheostomy tube, pulmonary infection, neurological deficit, and intervention-related adverse events.

Eligibility Criteria:
Inclusion Criteria:

* meeting the diagnostic criteria for Intracerebral Hemorrhage.
* with placement of a tracheotomy tube.
* requiring enteral nutrition support.
* age over 18 years.
* able to cooperate with treatment and questionnaire investigation.

Exclusion Criteria:

* combined with tumors in the head, neck, esophagus, or gastrointestinal tract
* an abnormal structure observed in the oral, pharyngeal, nasal regions or esophagus
* with unstable vital signs or severe dysfunction of organs including heart, liver, lungs, or kidneys
* with severe hemorrhagic disease or bleeding tendency;
* with contraindications for enteral nutrition
* with dysphagia caused by non-stroke-related reasons in the past
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)

This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab. The study lasted about 52 weeks and included up to 18 visits.


Eligibility Criteria:
Inclusion Criteria:

* Participants weighing \>10 kg
* Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
* Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
* Participants must have evidence of UC extending proximal to the rectum
* Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC

Exclusion Criteria:

* Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis
* Participants must not have had surgery to remove part of their colon
* Participants must not have current evidence of toxic megacolon
* Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening endoscopy
* Participants must not have had an inadequate response to Interleukin-12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)
Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.

This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9 months.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed tumor
* documented evidence of carcinoid syndrome
* life expectancy of at least 6 months
* previous positive octreotide scan
* received stable doses of octreotide injections
* performance status of 0-2 on the ECOG performance scale

Exclusion Criteria:

* poorly differentiated or high grade neuroendocrine tumor
* significant cv, hepatic, renal or other disease