cyrilzakka/clinical-trials huggingface dataset:
Risk Factors for Treatment Failure of Scabies in Autochthonous Populations of French Guiana (GUYAGALE)

Scabies is a Neglected Tropical Disease, particularly important in autochthonous populations. Treatment failures could explain the high prevalence of this disease in Amerindian and Maroon populations of French Guiana. Our main objective is to look for specific sociodemographic risk factors for treatment failure of scabies in the remote areas of French Guiana. A secondary objective is to evaluate the prevalence of scabies and its complications.

Scabies is known to be a health issue of particular importance in marginal and autochthonous populations throughout the world. French Guiana is a French territory harbouring several autochthonous populations living in remote rainforest areas. The prevalence of scabies remains high in these areas despite primary care offered by the local health centres. A prevalence of 2.5% was found in two Amerindian villages in a retrospective study in 2019. Therapeutic failures are known to be one of the main causes of a long-lasting high prevalence. In low-resources populations, socio-economic factors and promiscuity are particularly incriminated. The role played by these factors should be studied in French Guiana. Secondary complications such as impetigo and post-streptococcal glomerulonephritis should be evaluated, as they represent an important part of the global burden of scabies.

This study will be conducted from April to August 2021 in remote settlements of French Guiana. Patients will be seen during a first inclusion consultation, realized by the same investigator (RB). All patients with diagnosis of " confirmed " or " clinical " scabies according to the International Alliance for the Control of Scabies will be included in case of agreement. Patients will be treated according to the current protocol in the Health Centres for Remote Areas of French Guiana (according to the European guidelines for the treatment of scabies: two doses of ivermectin 0.2mg/kg on day 1 and day 7 ; benzyl benzoate 10% or permethrin 5% for children under 15kg or pregnant women). The follow-up consultation will take place six weeks later. The same investigator (RB) will assess treatment failure or success.

Research of etiologic factors associated with treatment failure; multicentric regional sample

Category 3 Non-Interventional Human Person Research (RIPH 3)

Eligibility Criteria:
* Inclusion criteria :

  * Confirmed or clinical scabies according to the criteria of the International Alliance for the Control of Scabies
  * Agreement to answer to the follow-up questionnaire
  * Agreement to come back for a six-weeks follow-up consultation.
* Exclusion criteria:

  * Patient with possible diagnosis of scabies, not fulfilling the criteria for " confirmed " or " clinical " scabies
  * Refusal of the questionnaire or the follow-up consultation
Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography

The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient it at least 18 years old
* The patient has been admitted for an MRI examination of the pelvic region, for any reason

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breast feeding
* There is a contra-indication for MRI (pacemaker, claustrophobic patient)
* The patient has had previous pelvic surgery
Childhood Cancer Survivors' Knowledge of Diagnosis,Treatment and Risk of Late Effects: Specialized Survivorship Clinic

This two-part research study will compare childhood cancer survivors receiving specialized follow-up care in the REACH for Survivorship clinic to patients receiving routine follow-up care.


Eligibility Criteria:
Inclusion Criteria:

* Treatment for primary malignancy per risk-adapted protocol
* Age ≤ 21 years at time of diagnosis
* Currently alive without evidence of disease
* Off therapy for no more than 15 years

Exclusion Criteria:

-Patients who have received a bone marrow transplant
Liraglutide in Acute Minor Ischemic Stroke or High-risk Transient Ischemic Attack Patients With Type 2 Diabetes Mellitus

The purpose of this study is to assess the safety and efficacy of glucagon-like peptide-1 (GLP-1) analogue liraglutide in the treatment of acute minor stroke (National Institute of Health stroke scale, NIHSS ≤ 3) or high-risk transient ischemic attack (TIA) (ABCD2 score ≥ 4 ) patients with type 2 diabetes mellitus.

The treatment arm will receive the starting dose of liraglutide of 0.6mg/d subcutaneously once daily, and the dose will be increased to 1.8mg/d in two weeks, and then continue to administrate this dose for 90 days. The control arm will not use liraglutide. Other types of GLP-1 analogues or degraded by dipeptidyl peptidase-IV (DPP-IV) inhibitors will be prohibited. Study visits will be performed at day 7, day 30±3 and at 90±7 day.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (male or female ≥ 50 years);
* Acute ischemic stroke patients (NIHSS ≤ 3 at the time of randomization) with type 2 diabetes mellitus within 24 hours of symptoms onset;
* High-risk TIA patients (ABCD2 score ≥ 4 at the time of randomization) with type 2 diabetes mellitus within 24 hours of onset;
* First stroke, or prior stroke without sequel (mRS score ≤ 1) and does not affect the NIHSS score;
* Informed consent signed.

Exclusion Criteria:

* Diagnosis of hemorrhage brain disease on baseline head CT;
* Iatrogenic and cardiogenic stroke;
* Patients receiving thrombolysis or endovascular treatment;
* Use of a GLP-1 analogue or any dipeptidyl peptidase-IV (DPP-IV) inhibitor within the 3 months prior to screening;
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC);
* Patients with pancreatitis or previous history of pancreatitis, inflammatory bowel disease and gastroparesis;
* Pregnant, lactating women,or patients who are likely to have a pregnancy and plan to have one;
* Allergic to liraglutide or excipients;
* Congestive heart failure (NYHA class III-IV);
* Severe liver and kidney dysfunction (AST/ALT is 3 times higher than the normal upper limit, serum creatinine is 3 times higher than the normal upper limit);
* Patients with malignant tumors who are expected to have a survival period of less than three months;
* Participated in other clinical trials of drugs within 3 months;
* Researchers believe that patients who are not suitable for this clinical study.
Anterior Tibiotalar Arthrodesis With Blade Plate Fixation

The aim of this study is to evaluate the clinical and radiographic outcomes of patients who have previously undergone tibiotalar arthrodesis using an anterior approach with blade-plate fixation for tibiotalar arthritis secondary to injury to the articular surface of the distal tibia.


Eligibility Criteria:
Inclusion Criteria:

* All patients whom have undergone anterior ankle arthrodesis with a blade plate construct, performed by a single surgeon, between January 2003 and July 2011 at the University of Utah or Primary Childrens Medical Center (PCMC) will be eligible for inclusion.

Exclusion Criteria:

* Any patient who is not 18 years of age or older will not be eligible for the study.
Internet Delivered CBT for Body Dysmorphic Disorder

To evaluate if Internet delivered cognitive behavior therapy is an efficacious treatment when compared to a control group consisting of supportive therapy.


Eligibility Criteria:
Inclusion Criteria:

* outpatient
* ≥ 18 years
* primary diagnosis of BDD according to the DSM-5
* BDD-YBOCS ≥20
* regular access to a computer with Internet access and skills to use the web.

Exclusion Criteria:

* psychotropic medication changes within two months prior to the treatment,
* completed CBT for BDD within the last 12 months,
* other primary axis I diagnosis
* current substance dependence
* lifetime bipolar disorder or psychosis
* suicidal ideation
* Axis II diagnosis that could jeopardize treatment participation,
* other current psychological treatment that could affect BDD symptoms
* A serious medical illness that precludes participation in the study
Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)

Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years old before signing the informed consent.
* Subjects must have previously failed to at least one kind of intravesical therapy, including but not limited to BCG, gemcitabine, etc.
* Subjects refuse or are intolerant to BCG therapy.
* Subjects must have completed a standard TURBT surgery within 6 weeks before the first dose of the study drug and have no evidence of residual tumors in the surgical field.
* Tumor tissue samples from TURBT must be provided (≥5 slides), along with relevant pathological reports.
* Histological and pathological diagnosis of urothelial carcinoma (with a major component \>50%) , with the confirmation of no-muscle invasion.
* Subjects must be categorized as high-risk NMIBC
* Subjects refuse or are intolerant to radical cystectomy.
* Clinical non-metastatic bladder cancer (N0, M0) determined by CT scan.
* Adequate function of heart, bone marrow, liver, and kidney.
* ECOG 0-1
* Subjects must be willing to take highly effective contraception during the study and 180 days after the last dose of 9MW2821 (a negative serum pregnancy test result within ≤7 days before enrollment for the female).

Exclusion Criteria:

* History of muscle invasive or metastatic bladder cancer.
* History of other malignancies within 3 years.
* Other systemic anti-cancer therapies within 3 weeks before the first dose of the study drug.
* Surgery (such as TURBT) or radiotherapy for bladder lesions within 2 weeks before the first dose.
* Hypersensitivity reactions to certain components of 9MW2821 or similar drugs.
* Persistence of adverse reactions caused by prior anti-tumor therapy before the first dose, does not recover to grade 1 and below, according to NCI-CTCAE v5.0.
* Active systemic infections that require treatments within 7 days before the first dose.
* Severe cardiovascular diseases within 6 months before the first dose.
* History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
* History of autoimmune diseases.
* Serum virology tests: positive results for HBsAg or HBcAb, with positive HBV-DNA copies (≥500IU/mL); positive HCV-Ab results, with positive HCV-RNA results; positive HIV-Ab results.
* Prior treatment with drugs targeted Nectin-4 or MMAE-conjugated ADC.
Impact of a Loading Dose of Caspofungin in Invasive Candidiasis in ICU Patients

Echinocandins are the drug of choice in severe candida infections. Efficacy of echinocandins is related to concentration and area under the curve (AUC) of the drug.

Available pharmacokinetic studies found that concentration of echinocandins mainly caspofungin is sub-optimal in severe candida infections in intensive care unit (ICU) patients.

Higher dose of caspofungin has been proven to be safe in critically ill patients but its impact on the ability to reach PK/PD target is unknown.

The aim of this study is to evaluate the impact of a loading dose of caspofungin on PK/PD parameters within the first 24-hours.

Invasive fungal infections are associated to a high mortality rate in ICU, partly because of a delayed treatment.

PK/PD targets for caspofungin are the peak concentration over minimal inhibitory concentration (MIC) ratio which should reach 10 and the area under the inhibitory curve (AUIC) which should be over 200. High distribution volume in ICU patients and increase of MICs due to extensive use of antifungal agents make optimal concentration difficult to obtain. High doses up to 150mg of caspofungin have been reported to be safe. Thus, in our unit, a loading dose of 140mg of caspofungin is a standard practice but was never rigorously evaluated.

The aim of the present study is to measure the impact of a loading dose of 140mg of caspofungin on the pharmacokinetic parameters in the first 24 hours of treatment.

The AUIC and maximal concentration (CMax) / (MIC) according to the recovered yeasts will be measured. The investigators also planned a Monte-Carlo simulation using MICs obtained from clinically relevant candida strains isolated in Bichat and Grenoble hospitals in order to evaluate the percentage of patients appropriately treated within the first 24 hours according to Candida species and previous use of antifungals.

Recovered strains from epidemiological studies will be used for PKPD modelling and will use s. A second Monte-Carlo simulation will be done using data from the Amarcand 2 study.

All MICs will be determined using E-test ( Biomerieux® KIT's) without specifying any breakpoints as MICs and not breakpoints per se will be used.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in intensive care
* Age\> 18 years
* Patient with a central catheter
* Patient with invasive mechanical ventilation
* Patient receiving more than 0.1 mcg / kg / min of adrenaline or noradrenaline
* Patient treated for proven (positive blood cultures or positive specimen obtained during a surgical or percutaneous puncture) or suspected (risk factor, extra digestive colonization, absence of other uncontrolled bacterial infections, candida score\> 3) invasive candidiasis.
* Patient affiliated to medical insurance

Exclusion Criteria:

* Expected length of stay under 48H
* Age \<18 years
* Pregnant or breastfeeding women
* Limited or sustained life support therapy
* Patient unable to legally consent
* History of Allergy, hypersensitivity or intolerance to echinocandins or Drug excipients
Efficacy of Different Ablation Strategies for Controlling Atrial Fibrillation

This study involves treatment for atrial fibrillation (AF)-the most common heart condition in the US-where the upper chambers of the heart beat very fast and in a disorganized manner. This can be felt as palpitations, tiredness, shortness of breath and passing out, plus can lead to stroke, damage to the heart muscle and a shorter life span. Study participants will receive a common treatment for atrial fibrillation called radiofrequency ablation (RFA), where small lesions or "burns" are made inside the heart to cut off the abnormal impulses that cause AF. The purpose of this study is to compare the effectiveness of three different common ablation strategies in patients with persistent or permanent AF. Subjects will be randomized (like drawing straws) to be treated with one of the three strategies to see if there is a difference in how well atrial fibrillation is controlled after treatment.

In most cases, AF originates where the pulmonary veins (PV) enter the left upper chamber of the heart, known as the left atrium (LA). Common to the procedure in each arm of the study is pulmonary vein isolation (PVI) or ablation of tissue around the pulmonary vein entrances. After PVI, the procedure continues with ablation in other areas of the LA where similar abnormal impulses are found. The three strategies for continuing with ablation after PVI are described in the "Arms" section below.

Eligibility Criteria:
Inclusion Criteria:

* All patients of age ≥ 30 years, undergoing their first ablation procedure that meet ACC / AHA defined criteria for persistent or permanent AF will be eligible to participate in the study. This includes patients with a history of AF episodes lasting at least 7 days or requiring at least 2 cardioversions.

Exclusion Criteria:

1. Patients with paroxysmal AF (self-terminating episodes lasting \< 7 day)
2. Patients who have had a previous AF ablation procedure
3. Pregnancy
4. Failure to obtain informed consent
5. Less than 30 years old
An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic Pancreatic Cancer

The outcome of pancreatic cancer is extremely poor. NCCN guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen, but the response rate is unacceptably low. PD-1 blockade has been developed to a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. This one-arm, phase I/II study is designed to assess the safety and efficacy of Manganese primed combined therapy of anti-PD-1 antibody and chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histologically proven local advanced/metastatic pancreatic cancer
2. ≥ 18 years old.
3. Life expectancy of at least 6 months.
4. Eastern Cooperative Oncology Group performance status 0-2.
5. Subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria.
6. Subjects with Anti-PD-1 antibody treatment history are eligible which must be resistance.
7. Adequate organ function.
8. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Prior organ allograft.
4. Women who are pregnant or breastfeeding.
5. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
6. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
The Effectiveness of Global Postural Reeducation on Alzheimer Disease Patients

This research study is developed on an experimental design with randomized controlled intervention were participated 135 subjects with AD including 45 of the control group. It lasted 6 months with pre-post tests (T0-T1) executed before and after six months of treatment. By having in focus the evaluation of GPR therapy effects on cognitive, proprioceptive, depressive, autonomy, gait and life quality of the above mentioned subjects.

In order to assess the cognitive abilities of the patients a cognitive test was administered which acts through a scale concerning depression and mood evaluation as well as a questionnaire was developed aiming to evaluate the examined subjects' functional abilities: Mini Mental State Examination (MMSE), Quality of Life in Alzheimer Disease (QoL-AD), geriatric Depression Scale (GDS), Barthel Index (BI), Neuropsychiatric Inventory (NPI), Tinetti Scale (TS).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease
* Older than 40 years of age
* Male and female
* Intellectual disability
* Cognitive impairment
* Able to do daily activities on his own
* No presence of any other neurological and psychological disease
* No presence of brain tumors

Exclusion Criteria:

* No presence of Alzheimer's Disease
* Under 40 years old
* Presence of brain tumors
* Neurological patients
* Presence of psychiatric disease
* Depression symptoms
* Presence of neuromuscular disease
* Ictus
* Aggressive patients
Local Anesthesia and Analgesics in Endodontic Pain

For patients with a toothache, is pain relief after root canal procedure improved using long acting local anesthetic and analgesics? The purpose of this clinical trial is the investigate the effect of long acting local anesthetic with 1 of 4 oral medication groups, on post-operative endodontic pain.

Patients (n=220) presenting to the University of Minnesota Endodontic clinic, with moderate to severe pain from toothache requiring root canal treatment ,will be invited to participate in the study. The endodontic treatment is NOT part of the research. Patients will complete pain evaluation forms and take 2 doses of prescribed medication. Normally after a root canal procedure, patients will be suggested to take over-the-counter ibuprofen if needed, or prescribed an analgesic if they are having severe pain. We will be randomizing patients in double blind manner to receive regular or long acting local anesthesia and post-op medications (placebo or 1 of 3 analgesics), with the patient evaluating their pain before starting root canal (pre-treatment pain), after root canal, after analgesics and during the following day.

Eligibility Criteria:
Inclusion Criteria:

18-65 y.o. American Society of Anesthesiologists physical classification I or II Can understand and complete pain evaluation forms tooth pain (\>3 out of 10) needing root canal Ability to read and provide informed consent Must be able to swallow tablets

Exclusion Criteria:

Allergy/intolerance to analgesics (ibuprofen, naproxen, vicodin) Patients who are pregnant Patients currently on pain medications for an unrelated condition Patients unwilling to fill out pain scales Liver or kidney disease Unable to understand and complete consent form and pain evaluation forms

-
Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing

To indicate the efficacy of Fecal microbiota transplantation (FMT) for the treatment of Ulcerative colitis (UC), The investigators design a multicenter, randomized controlled trial to perform FMT through colonic transendoscopic enteral tubing (TET) way, and evaluate the efficacy and safety of FMT for patients with moderate or severe UC.

1. Patients with moderate to severe UC will be screened (Mayo\>6）.
2. Participants will be divided into control and study groups by double blind.
3. Control group and study group will receive a colonic endoscopy evaluation. And a TET tube will be fixed at ileocecum.
4. Enema with 5-ASA 4g/day for 7days by TET will be performed as basic therapy for both control and study group. Study and control group will be given with fecal microbiota suspension and equal volume of saline by TET for three times every other day in one week.
5. The follow-up will be performed at 1 week, 4 weeks and 12 weeks after first treatment. All the participants will receive a endoscopy evaluation at 12 weeks. Clinical remission, clinical improvement and safety are the primary endpoint at 12 weeks; Intestinal microbiota changing is recognized as the secondary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Active, moderate to severe severity (Mayo score more than 6)
* Safety using history of 5-ASA.
* Able to undergo endoscopy examination.

Exclusion Criteria:

* Immunosuppressive drugs and glucocorticoids using in 4 weeks
* Antibiotic using in 7 days
* High risk of toxic megacolon
* Colon cancer or neoplasia in pathophysiology
* Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)