rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya
Status: Not yet recruiting

This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants.

Eligibility:
- EligibilityCriteria: Inclusion Criteria  Age 18 years or older Negative pregnancy test at screening Willingness to use contraception (hormonal or barrier) during the 5-day study dosing phase if of childbearing age (less than 50 years of age) Ability and willingness to provide informed consent.  Exclusion Criteria  Current pregnancy or breastfeeding status History of total hysterectomy Known allergy to Artesunate. Have a medical comorbidity that in the opinion of the investigator would interfere with study participation. Currently receiving artemisinin-based agents for malaria treatment or completed artemisinin-based treatment within the previous 3 days. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Female - GenderBased: Yes - GenderDescription: Women are eligible - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms
Status: Recruiting

Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.

Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Volunteer Adults (Age 18-50) Diagnosis of Multiple Sclerosis Expanded Disability Status Scale (EDSS) 0-6,5 Lower urinary track symptoms (Urinary incontinence, urgency, nocturia and/or urinary frequency) Diagnosis of bladder disfunction with Urodynamic study within 1 months  Exclusion Criteria:  Age less then 18 Pacemaker or implantable defibrillator usage Diabetic polyuria Bleeding diathesis or severe bleeding tendency Pelvic floor disfunction or nerve damage effecting tibial nerve Currently pregnant or planning pregnancy Active urinary infection Active malignancy Severe mental disability Cognitive deficit Expanded Disability Status Scale (EDSS) greater than or equal to 7 Unable to attend to TPTNS treatment 2 times a week Urodynamic findings of bladder outlet obstruction Surgical history because of urinary incontinence Urologic surgical history because of lower urinary track disfunction or symptoms Diagnosis of prostatic enlargement Diagnosis of pelvic organ prolapse - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
Prognostic Significance of ctDNA in HL
Status: Recruiting

Specific somatic mutations using ctDNA will be analyzed in predefined subgroups of cHL (e.g., age <60 and ≥ 60 years, EBV). These mutations will be correlated with response to the treatment in the first line, in the relapse, during brentuximab vedotin and/or nivolumab treatment. Circulating tumor DNA will be correlated with the extent of tumor mass and chemo/radiotherapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients ≥ 18 years with newly histologically confirmed classical Hodgkin lymphoma (cHL) will be enrolled signing the informed consent  Exclusion Criteria:  Pacients without signing the informed consent - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients ≥ 18 years with new HL, all patients will undergo standard diagnostic procedures and will be divided based by stages and risk factors. Patients below 60 years will be divided into 3 treatment risk groups and treated according to the standard recommendations explained as well as elderly patients (see study groups). Younger relapsed patients will be treated with salvage platinum-based chemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT). Relapses after ASCT in younger patients or after at least two lines of chemotherapy in elderly patients will be treated with brentuximab vedotin (up to 16 cycles) or nivolumab until progression. - SamplingMethod: Probability Sample
The Influence of Complex Correction of Dental and Musculoskeletal Systems on the Frequency of Relapses of Functional Disorders in Patients With Dental Pathologies.
Status: Not yet recruiting

In influence of complex correction of dental and musculoskeletal systems on the frequency of relapses of functional disorders in patients with somatic pathologies: a randomized pilot study there will be two groups: Group 1 (control group): Patients in this group will receive standard treatment aimed solely at correcting malocclusions or restoring the integrity of the dentition without interfering with the musculoskeletal system.

Group 2 (experimental group): Patients will receive comprehensive treatment, including not only dental correction of bite or restoration of the integrity of the dentition, but also correction of disorders of the musculoskeletal system.

The endpoints will be :

Primary endpoint:

• Frequency of relapses and repeated requests for correction of disorders bite or restoration of the integrity of the dentition within 12 months after treatment.

Secondary endpoints:

Change in pain intensity measured by visual analog scale (VAS).
Improvement of functional indicators of the temporomandibular joint, including range of motion.
Improved quality of life, assessed using the OHRQoL (Oral Health Related Quality) scale All endpoints will be evaluated within 12 months.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed malocclusion or dentition insufficiency, confirmed by a dentist.  Presence of diseases of the musculoskeletal system, confirmed orthopedist or rheumatologist. Acquired limb deformities (for example, flat feet, valgus or varus deformity). Deforming dorsopathies (kyphosis, lordosis, scoliosis, osteochondrosis). Consent to participate in the study and follow the treatment protocol. Sufficient general physical and mental fitness to participate in the study  Exclusion Criteria:  Systemic diseases affecting bone metabolism (eg osteoporosis).  Progressive neurological diseases. Current treatment with steroids or immunosuppressive drugs. Presence of malignant neoplasms. Psychiatric disorders that prevent compliance protocol. Pregnancy or lactation period. Carrying out dental or orthopedic treatment in recent 6 months. Skeletal malocclusions. Diseases of the temporomandibular joint. Congenital pathologies of the musculoskeletal system. Arthropathy. Systemic connective tissue diseases. Biomechanical lesions of the musculoskeletal system. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult
Precision Vaginal Microbiome Transplantation in Women With Bacterial Vaginosis
Status: Not yet recruiting

The aim of this study was to explore the efficacy and safety of a new vaginal microbiome transplantation technique, using Lactobacillus cispatus from healthy donors as a treatment of bacterial vaginosis.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  1. History of sexual behaviour 2.18-55 years old 3. Women were diagnosed as bacterial vaginosis  Exclusion Criteria:  During pregnancy, or within 8 weeks after delivery; presence of systemic diseases (such as SLE, malignant tumors, etc.) - HealthyVolunteers: No - Gender: Female - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
Beta-Blocker Influences on Inflammatory and Neural Responses to Stress
Status: Not yet recruiting

The purpose of this study is to map the neural and molecular mechanisms underlying psychological stress-induced changes in inflammation which could reveal new targets for intervention to reduce the risk of cardiovascular disease.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Ages 18-30 years Right-handed Fluent in English reading, writing, and speaking at least at a 10th grade level Body mass index (BMI) less than or equal to 35 kg/m^2  Exclusion Criteria:  Assessed as screening, reassessed at Session I:  Non-removeable metal devices/implants/objects in the body Severe claustrophobia (assessed by self-report) Currently pregnant Left-handed Body mass index (BMI) greater than 35 kg/m^2 History of fainting spells or any heart condition History of or present low resting heart rate (< 60 BPM) and/or low blood pressure (systolic blood pressure < 80mmHg) Self-reported physical illnesses: diabetes, cardiovascular diseases, high blood pressure, inflammatory bowel diseases, rheumatoid arthritis, asthma, autoimmune disease, Crohn's disease, ulcerative colitis, lupus Any self-reported diagnosed mental illness Current use of prescription medications Current or recent regular nicotine/tobacco use (cigarettes, e-cigarettes, vape, chewing tobacco, nicotine gum) Current regular (daily or almost daily) recreational drug use = 4 or more times per week  Instructed against during Session I, reassessed at Session II:  Received any vaccine within the past two weeks Severe sleep disturbance (3-4 hours of sleep loss) the night before Session II Vigorous physical activity on the day of Session II Acute illness or allergy symptoms on the day of Session II Usage of over-the-counter medications on the day of Session II Usage of recreational drugs within 48 hours of Session II Usage of alcohol on the day of Session II - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 30 Years - StdAgeList: Adult
Surveillance of HFMD in Pediatric Outpatients
Status: Recruiting

The aims of this prospective multicentric study is to determine the types of enteroviruses (EVs) responsible for hand, foot and mouth disease (HFMD) or herpangina in children seen within an ambulatory setting :

to detect an EV-A71 epidemic or another type associated with atypical forms of the disease at an early stage
to describe and compare the epidemiological, demographic, clinical and virological characteristics of these infections between the different types of EV.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Children aged 0 to 10 years presenting with HFMD or herpangina  Exclusion Criteria:  Refusal to participate by holders of parental authority Refusal to participate for children over 3 years of age - HealthyVolunteers: No - Gender: All - MaximumAge: 10 Years - StdAgeList: Child - StudyPopulation: Children aged between 0 and 10 years seen for HFMD/Herpangina by one of the paediatric investigators.  HFMD is defined by the presence of at least two of the following clinical signs:  a vesicular or non-vesicular rash on :  the palms of the hands soles of the feet, or the buttocks knees or elbows, mouth or perioral ulcers, vesicular or non-generalized eruption.  Herpangina is defined by the presence of oral ulcers located mainly in the posterior part of the oral cavity: palate, uvula. - SamplingMethod: Non-Probability Sample
Kidney Transplantation From Donors With HIV: Impact on Rejection and Long-Term Outcomes (Expanding HOPE Kidney)
Status: Not yet recruiting

This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participant meets local criteria for kidney transplant. Participant is able to understand and provide informed consent. Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA. Participant is ≥ 18 years old. Cluster of differentiation 4 (CD4+) T-cell count: ≥ 200/μL within 16 weeks of transplant. HIV-1 RNA < 50 copies/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements > 200 copies/mL. Participant is not suffering from significant wasting (e.g. body mass index <21) thought to be related to HIV disease. Participant meets with an independent advocate.  Exclusion Criteria:  Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of > 1 month, or primary central nervous system (CNS) lymphoma. Participant is pregnant or breastfeeding. Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Recovery Levels of Depression Patients and Caregiver Psychoeducation
Status: Recruiting

To determine the effect of psychoeducation given to patients and caregivers on patients' depression and recovery levels, caregivers' emotional expression and family burden levels.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patient selection criteria included in the sample for the research; Being 18 years or older Receiving inpatient treatment with a diagnosis of F32 (Depressive Disorder) or F33 (Recurrent Depressive Disorder) Does not have a developmental disorder Without psychotic features Not having communication problems Being at least a primary school graduate Caregiver selection criteria included in the sample for the research; Being 18 years or older Being the primary caregiver of the patient Being at least a primary school graduate  Exclusion Criteria:  • Patient selection criteria for exclusion from the sample for the research;  DSM-V Axis I comorbidity Caregiver selection criteria for exclusion from the sample for the research; With mental retardation or psychotic disorder Having speech and hearing disorders It was created as having one of the diagnoses of a cognitive disorder such as delirium, dementia, or amnestic syndrome. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult
Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine
Status: Not yet recruiting

Following the results of the phase 1b and the phase 3 studies, Venetoclax/Azacitidine (VEN/AZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.

Venetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN/AZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit/risk profile of treatment. Early access to treatment in France is close to real-life setting condition.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive chemotherapy Treatment in the named-patients program (ATU)  Exclusion Criteria:  Treatment with VEN-AZA for previously treated AML  Prior treatment for preexisting hematological malignancies other that AML, including AZA is not an exclusion criteria HYDROXYCARBAMIDE given for AML is not an exclusion criteria AZA started before VEN for AML is not an exclusion criteria Opposition to data collection - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult Patients with de novo AML, ineligible for intensive chemotherapy, which received VENAZA in the ATU program between 02/15/2021 and 06/30/2021 - SamplingMethod: Probability Sample
Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery
Status: Not yet recruiting

Dento-maxillary dysmorphoses are defined as an anomaly in the relative growth of the maxilla and/or mandible. They lead to functional disorders (i.e., disturbances in chewing or oral communication) and aesthetic issues with psychological repercussions on self-esteem, affecting the quality of life of these patients. The multidisciplinary treatment involves orthodontics (duration = 18-24 months), orthognathic surgery involving the maxillary and/or mandibular bone (at 12 months), immediately followed by physiotherapy (duration = 3 months). One main goal after surgery is the recovery of month opening to restore an appropriate orofacial function. Motor imagery (mental rehearsal of a movement without actually moving) is effectively used in athletes and in rehabilitation mainly neurological but so far has not been investigated in maxillofacial rehabilitation. Considering that the effectiveness of rehabilitation is increased when physical and mental practices are combined, this leads to propose this study aiming to investigate whether the addition of motor imagery of the maxillofacial region to maxillofacial physiotherapy (based on a practice of physical therapeutic exercises) modifies the recovery of maximum mouth opening, other ranges of motion, jaw function, and quality of life in patients after orthognathic surgery compared to the addition of a control cognitive task [watching a non-emotional content film or filling out a crossword or Sudoku grid] to maxillofacial physiotherapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Volunteer after orthognathic surgery of the mandible alone or concurrently with the maxilla. Consent to participate to the study after receiving clear, loyal and appropriate information. Aged ≥ 18 years. Health care beneficiary  Exclusion Criteria:  Patient who has undergone maxillary surgery alone (e.g., LeFort I) or genioplasty. Indeed, both of these surgeries typically have a favorable and rapid recovery without the need for maxillofacial physiotherapy. Patient unable to imagine a maximum mouth opening movement (i.e., score = 1, no mental image / no sensations) on the 5-point Likert scale used during the administration of the Tongue Month Imagery Questionnaire (TMIQ). Ongoing participation in another research that aim to evaluate an intervention likely to improve the neurological or functional recovery introducing an experimental bias. Patients not undergoing rehabilitation in the study centers. Patients under guardians, curators, or legal protection. Pregnant or lactating patients. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma.
Status: Recruiting

Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. The aim of this study is to evaluate the MRI imaging characteristics of the peritumoral area (PTA) and to correlate this information to pathological findings.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs  Exclusion Criteria:  Severe hepatic dysfunction Severe renal dysfunction Severe heart failure myocardial infarction and stroke within 90 days Hyperreactivity against contrast agents Pregnancy - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs at our Institution, able to express informed consent. - SamplingMethod: Non-Probability Sample
A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes
Status: Recruiting

The primary objective of this study is to evaluate the long-term safety of Dorzagliatin in a larger population of type 2 diabetes mellitus patients by collecting the post-marketing clinical safety data of Dorzagliatin.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  -  Patients must meet all of the following inclusion criteria to be eligible for this study:  Male or female ≥ 18 years of age at the time of signing the informed consent form; Patients with type 2 diabetes mellitus diagnosed at screening; Patients who have been prescribed Dorzagliatin according to the package insert and physician's judgment (the prescription should be made before enrolling the patient in this study and is independent of the enrollment decision); Willingness to participate in the study and sign written informed consent.  Exclusion Criteria:  -  Patients will not be eligible if they meet any of the following criteria:  Other types of clinically diagnosed diabetes, such as type 1 diabetes or other special types of diabetes; Patients who, in the opinion of the investigator, are at risk of allergy or intolerance to any component of Dorzagliatin; Patients who, in the judgment of the investigator, cannot complete or are not suitable for this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
The ROAMM-EHR Study
Status: Recruiting

In recent years, mobile health (mHealth) apps have promised improved monitoring of health conditions to improve clinical outcomes. The objective of this study is to conduct a pilot randomized clinical trial (RCT) to evaluate the impact of using remotely collected patient generated health data (PGHD) from older patients undergoing bypass surgery due to chronic limb threatening ischemia. The hypothesis is that integrating PGHD with an EHR system will help providers manage post-surgical symptoms and thus improve post-operative mobility and quality of life health outcomes.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  age >= 60; Patients with chronic limb threatening ischemia who are undergoing re-vascular surgery [endovascular or open re-vascularization (bypass)].  Exclusion Criteria:  High risk of post-surgical amputation based on study physician judgement, non-english speaker, diagnosis of an age-related dementia (e.g. Alzheimer's Disease); unable to communicate because of severe hearing loss; uncorrectable vision impairment that compromises clinical assessments or would cause a safety concern, other significant co-morbid disease that in the opinion of the investigators and study physician would impair the ability to participate in the study or be a safety concern - HealthyVolunteers: No - Gender: All - MinimumAge: 60 Years - MaximumAge: 100 Years - StdAgeList: Adult, Older Adult