cyrilzakka/clinical-trials huggingface dataset:
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent.
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.
Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital With Biobanking

This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis.

It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.


Eligibility Criteria:
Inclusion Criteria:

* Major patient with systemic sclerosis defined according to the EULAR 2013 criteria (see Appendix 1)
* Patient evaluated within the framework of the reference center for rare autoimmune diseases of the CHU of Brest.
* Patient affiliated to the social security system
* Patient having signed a written informed consent.

Exclusion Criteria:

* Minor
* Patient under legal protection (guardianship, curatorship)
* Refusal to participate
* Patient unable to consent
* Pregnant or breastfeeding woman
* Hemoglobin (Hb) level \< 7g/dl
The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II

Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.

Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study.

The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.


Eligibility Criteria:
Stage 1 subjects: Spinal cord injury subject

Inclusion Criteria:

* Clinical diagnosis of spinal cord injury \< 2 years

Stage 2 subjects: Incomplete spinal cord injury subject

Inclusion Criteria:

* Clinical diagnosis of incomplete spinal cord injury
* ASIA classification:B, C, or D

Stage 3 subjects: Spinal cord injury subjects with high muscle tone

Inclusion Criteria:

* Clinical diagnosis of spinal cord injury.
* ASIA classification: A, B, C, or D
Iron Absorption From Iron-enriched Aspergillus Oryzae

Ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly possibly leading to higher concentrations of non-transferrin bound iron which induces oxidative stress. The objective of this study was to determine how quickly iron enters into blood stream from the iron-enriched Asperigillus oryzae (AspironTM, ASP) in contrast to ferrous sulfate. Seventeen healthy, female subjects (18-35 y) were randomized, double blind, cross-over experimental design with three treatments: 10 mg iron as FeSO4 and ASP as well as 20 mg iron as ASP.

In a double-blinded cross-over design, 17 research participants were randomly given one of three iron-treatments : ferrous sulfate (10mg), AspironTM (10mg), and AspironTM (20mg). Each iron treatment was given with a test meal consisting of cabbage, green peas, green beans, soy sauce, peanut oil, 40 g baby carrots, steamed rice, and orange juice. Each subject consumed a meal with one of the three iron supplements in a random order and all participants consumed the three supplements 2 weeks in between each treatment. Prior to consuming the test meal with iron supplement for each treatment, blood was collected for baseline serum iron measuremt. Following consumption of the meal with iron, subsequent blood draws were taken every 30 minutes over the time period of 4 hours to assess the incease in serum iron. Ferritin, hepcidin, iron , and c-reactive protein concentrations were measured in the serum at baselime. After two weeks other treatments were administered to each participant. The serum iron response curves for each treatment were constructed and the area under the curve (AUC) was calculated with the change of serum iron from baseline.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant
* Non-lactating
* Non-smoker
* Not taking medications
* Not taking dietary supplements (vitamins or minerals)
* No history of gastrointestinal conditions

Exclusion Criteria:

* Any history of gastrointestinal conditions
* On medications that interfere with iron absorption
* Unwilling to stop taking dietary supplements (vitamins or minerals)
* Pregnant
* Lactating
* Smoker
MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive

To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.


Eligibility Criteria:
Inclusion criteria

1. Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay).
2. Recipients of heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with basiliximab and CsA-ME as primary immunosuppression.

Exclusion criteria

1. Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ.
2. Kidneys from non-heart beating donors.
3. ABO incompatibility against the donor.
4. Patients with panel reactive antibodies of \>50% at most recent assessment prior to transplantation and /or prior graft lost due to immunological reasons in the first six months post-transplantation or patients who are considered to be at increased risk of acute rejection by the principal investigator Additional protocol defined inclusion/exclusion criteria may apply.
NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration

Three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with periodontitis.
* plaque index and bleeding index of \< 30%.
* periodontal lesions with pocket probing depth \> 5 mm.
* intrabony defect \> 3 mm.
* intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall.

Exclusion Criteria:

* patients with systemic diseases that contraindicated treatment.
* third molars.
* teeth with incorrect endodontic or restorative treatment.
Pneumoniae Epidemiology Study in China

To determine the proportion of hospitalized pneumonia cases in children aged 60 months or less associated with vaccine-preventable Streptococcus pneumoniae serotypes (4, 6B, 9V, 14, 18C, 19F, 23F).

Subjects meeting the eligibility criteria, including parental informed consent to collect clinical-epidemiological information, will have a deep respiratory aspirate specimen to determine the etiology of the lower respiratory tract infection. Clinicians may obtain other diagnostic specimens, such as pleural fluid, lung tap, cerebrospinal fluid, nasopharyngeal culture, or serum for serological assays, as indicated clinically. The chest radiograph will be taken and read locally according to predetermined criteria and by staff radiologists trained in radiographic criteria for pneumonia. Bacterial isolates other than Streptococcus pneumoniae will be identified according to standardized procedures. S. pneumoniae isolates will be transported to central laboratories for confirmation of identity, serotyping and antibiotic resistance testing, using standard techniques. Serotype will be determined using type-specific sera (Quellung reaction). Antibiotic susceptibility to penicillin, cefuroxime, ceftriaxone, erythromycin, Amoxycillin, Ofloxacin, Vancomycin, and imipenem be conducted using E-test according to standardized procedures at the central facilities.

Eligibility Criteria:
Inclusion Criteria:

* Age, 60 months or less
* Meets study criteria for clinical pneumonia
* All the examination are/can be done within (before or after) 72 hours to enrollment time
* Informed consent obtained from parent or guardian

Exclusion Criteria:

* Received any pneumococcal vaccine in the past
* Current or underlying conditions that would pose a hazard in obtaining the deep respiratory aspirate (e.g., bleeding diathesis, severe respiratory compromise and others as determined by clinician) Aspirates may be obtained from patients who are intubated
* Any other medical condition that in the opinion of the clinician/investigator would pose a hazard to the child by participating in the study
* Children with recurrent pneumonia will enter into the study on only one occasion
Carpal Tunnel Syndrome, Right/Left Judgement

The discrimination of the right/left side of the body is related to the integrity of the motor and somatosensory areas at the cortical and subcortical levels. Although some studies have shown that there may be an effect on the right/left representation at the cortical and subcortical levels in cases that cause severe neuropathy and neuropathic pain, this effect has not been proven in milder neuropathies. In this study, the effect on right/left side discrimination will be investigated even in cases with carpal tunnel syndrome. Additionally, the investigators aimed to assess the relationship between right/left discrimination and symptom severity.

The left/right discrimination is a motor imagery task that involves viewing images of a body part and determining whether each image belongs to the left or right side of the body or if it rotates towards it. Some studies have shown that there may be an effect on the right/left representation at the cortical and subcortical levels in cases that cause severe neuropathy and neuropathic pain, this effect has not been proven in milder neuropathies, such as carpal tunnel syndrome. In this study, the relationship between right/left decision accuracy will be compared with control subjects. The investigators will assess the relationship between right/left judgment and symptom severity, two-point discrimination, and handgrip force.

The hypothesis of the study are:

1. The right/left discrimination accuracy is less than the control subjects.
2. Right/left discrimination is in relationship with symptom severity, two-point discrimination, and handgrip force.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a duration of symptoms associated with unilateral CTS of at least 3 months
* Participants with clinically and nerve conduction study confirmed carpal tunnel syndrome
* All participants will be right-hand dominance and diagnosed with carpal tunnel syndrome on the same side
* Participants with MOCA score minimum 26.

Exclusion Criteria:

* Severe visual impairment that may prevent performing the test
* Polyneuropathy
* Cervical spine surgery history
* Presence of abnormal cervical spine, shoulder, and elbow joint examination findings
* Patients with any history of surgery for the upper extremity
* Congenital/Developmental upper extremity malformations
* Central nervous system disease
* Antihistaminic, gabapentinoids, antiepileptics, methylphenidate, modafinil, neuroleptics use
Effects of Training Dose on Computerized Cognitive Training in Patients With Cognitive Impairment

The goal of this observational study is to explore the optimal dose of computerized cognitive training in patients with cognitive impairment. The main questions it aims to answer are:

* Is there an optimal dose of computerized cognitive training for patients with cognitive impairment?
* Is the optimal dose different in patients in different age populations? Participants enrolled in the study took a reported computerized cognitive training program and the training data were analyzed for exploring the optimal dose.

The researchers will compare the different dose groups to see if there is an optimal dose for the highest improvement in cognitive abilities.

The researchers will additionally compare two age groups (aged younger than 60y or aged 60y and older) to see if the optimal doses in the two groups are different.

Background: Computerized Cognitive Training (CCT) is a form of digital therapeutics that uses computerized cognitive tasks to train patients with cognitive impairment caused by various neurological or psychiatric diseases. CCT has been shown to slow the progression of cognitive impairment in early-stage dementia, particularly in working memory. However, there is a lack of research on the optimal training dose for people with cognitive impairment. Previous meta-analyses have explored the types, delivery methods, and training dose of cognitive training in healthy older adults and those with dementia risk factors, but not in those with cognitive impairment.

Objectives: The study aimed to explore the dose-response relationship of CCT and estimate the optimal daily and weekly dose for people with cognitive impairment.

Participants and methods: the study is a retrospective cohort study and will enroll 21845 patients with cognitive impairment. The exposures in the study are different doses of cognitive training in a week and the outcome is the improvement in cognitive abilities in a week. The weeks with the same training dose of different patients will be classified into one group of exposure. The mixed effects model will be used to estimate the optimal dose.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cognitive impairment.
* Patients who took computerized cognitive training in 2017-2022.
* age ≥ 40 years
* Training duration ≥ 2 weeks

Exclusion Criteria:

* with moderate to severe dementia, cancer, unstable systemic diseases, or psychiatric diseases
MEDICLAS Study (Metabolic Effects of Different Classes of AntiretroviralS)

This is a randomized prospective study into metabolic adverse events during different types of initial antiretroviral therapy in HIV-1-infected men.

This is a randomized prospective study into metabolic adverse events during initial antiretroviral therapy in HIV-1-infected men. The following regimens are compared: lopinavir-ritonavir + Combivir and lopinavir-ritonavir + nevirapine (nucleoside reverse transcriptase inhibitor \[NRTI\]-sparing). Prior to the start of therapy and 3, 12, 24, and 36 months thereafter the distribution of body fat and bone density (bioelectrical impedance analysis \[BIA\], computed tomography \[CT\] and dual energy x-ray absorptiometry \[DEXA\]), lipid spectrum, mitochondrial DNA (peripheral blood mononuclear cells \[PBMCs\] and adipose tissue biopsies) and vascular measurements are performed. In addition, insulin sensitivity is measured in a subgroup of sixteen individuals by using a hyperinsulinemic euglycemic clamp and performing microvascular measurements. The aim of the study is to obtain prospective insight into the occurrence of various aspects of metabolic adverse events on the one hand and to compare an NRTI-containing therapy with an NRTI-sparing therapy on the other hand. The hypothesis is that in the NRTI-sparing arm, less metabolic and vascular changes are observed than in the NRTI containing regimen.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 18 and 70 years.
* No prior use of antiretroviral therapy
* Indication for antiretroviral treatment according to common standards

Exclusion Criteria:

* Female sex
* Body mass index (kg/m2) \> 35.
* Known history of diabetes mellitus or hyperlipidemia
* Use of coenzyme A reductase inhibitor or fibric acid derivative in the last 6 weeks before inclusion
* Use of the following medication: systemic corticosteroids, thiazide diuretics, calcium-entry blockers, angiotensin-converting inhibitors, nitrates
* Use of nandrolone or testosterone
* Any disorder or condition which can be expected to lead to lessened compliance with the study protocol.
A Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks

In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%. This stems from the prevalence of trainee operators coupled with the non-specific nature of loss-of-resistance. In the current randomized trial, we will set out to compare conventional and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease the failure rate of thoracic epidural blocks.


Eligibility Criteria:
Inclusion Criteria:

* the patients undergoing thoracic epidural catheter insertion for thoracic and abdominal surgery or rib fractures with American Society of Anesthesiologists (ASA) classification 1-3 and body mass index between 18 and 35

Exclusion Criteria:

* adults who are unable to give their own consent
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, or International Normalized Ratio ≥ 1.4)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
* allergy to local anesthetic (LA)
* pregnancy
* prior surgery in the thoracic spine
EZETROL® Re-examination Study (MK0653-175)(COMPLETED)

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of EZETROL® through collecting the safety information according to the Re-examination Regulation for New Drugs.


Eligibility Criteria:
Inclusion Criteria:

* Participants Who Receives EZETROL® In Usual Medical Practice
Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia

The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.

This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6, 9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally. Adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug.

Eligibility Criteria:
Inclusion Criteria:

* Patient meets the criteria for schizophrenia
* Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
* Patient is healthy on the basis of a physical examination and vital signs at screening
* Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study

Exclusion Criteria:

* Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
* Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
* Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
* Patients judged to be at high risk for adverse events, violence, or self-harm
* Patients with known hypersensitivity to paliperidone ER or to risperidone
* Patients with a current use or known history (over the past 6 months) of substance dependence
Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients.

For breast cancer patients receiving chemotherapy regimens, the use of a validated emesis (nausea and vomiting) risk calculator will provide superior anti-emetic (nausea and vomiting) control compared with "standard" anti-emetic regimen. The risk calculator has the potential to provide more individualized anti-emetic regimen by decreasing the use of toxic/costly anti-emetics in patients at low risk and possibly more importantly enhancing the appropriate anti-emetic regimen in patients at high risk.


Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed invasive breast cancer (stage I-III)

Scheduled to receive neoadjuvant or adjuvant intravenous anthracycline with cyclophosphamide-based chemotherapy;

Able to consent and fill study forms

Exclusion Criteria:

Received previous chemotherapy

Symptoms of nausea or vomiting at baseline (disease related)

On chronic anti-emetic therapy

On daily corticosteroids prior to initiation of chemotherapy

Allergic to steroids, 5HT3 or NK-1

Uncontrolled diabetes

Medical or psychiatric illness that would interfere with patients' ability to complete the diary
A Study of Aripiprazole in Patients With Schizophrenia in General Psychiatric Practices

The purpose of this clinical research study is to evaluate the overall effectiveness of 8 week of aripiprazole treatment.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia or schizoaffective disorder being treated as outpatients,no response to past antipsychotic treatment and patients who symptoms are notoptimally controlled defined as CGI- S\<7

Exclusion Criteria:

* pregnant or breastfeeding,patients at risk for committing suicide,diagnosis of mood disorders, delirium, dementia and other cognitive disorders,patients treatment resistant to otherantipyschotic medications and treatment with a long acting psychotic in which the last dose was within 3 months of treatment phase