cyrilzakka/clinical-trials huggingface dataset:
Narrowband UVB Light Therapy to Patients With Dark Skin Types Who Have 10% of Their Body Involved With Psoriasis Vulgaris.

This study offers narrowband UVB light therapy to patients with both light and dark skin types who have 10% of their body involved with psoriasis vulgaris.

Two groups of patients, having 10% of their body surface area involved with psoriasis vulgaris, will receive narrowband phototherapy. One group will have skin type I-IV, or light skin and the second group will have dark skin, or type V-VI.

All patients will receive phototherapy, with narrowband UVB, three times a week for six weeks, or a total of 18 treatments. 6mm punch skin biopsies will be done prior to starting therapy and at the completion of the study. Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) of both groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

Patients must have stable psoriasis vulgaris, which covers at least 10% of their bodies, for at least six months. Patients can not have not been treated with narrowband UVB in the past, although other light therapies are acceptable (i.e. broadband UVB and PUVA). Patients are not allowed to receive other therapies for their psoriasis, internal and topical, while they are participating in the study. Patients may continue using non-medicated moisturizer.

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Exclusion Criteria:

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Real-world Study of Acalabrutinib

The primary purpose of this study was to describe acotinib treatment patterns among Chinese patients with CLL and MCL who received acotinib according to the label. Secondary objectives include: 1) To evaluate the safety of acotinib in Chinese patients with CLL and MCL who received acotinib according to the label. 2) Evaluate the dose of acotinib in Chinese patients with CLL and MCL who receive acotinib according to the label. 3) Describe the baseline clinical and demographic characteristics of patients with CLL and MCL who received acotinib according to the label. The exploratory objectives of the study include: 1) To describe the real-world overall survival (rwOS) of Chinese CLL and MCL patients treated with acotinib according to the label. 2) Describe the real-world clinical progression-free survival (rwPFS) of Chinese CLL and MCL patients who received acotinib according to the label. 3) Describe the real-world response rate (rwRR) in Chinese CLL and MCL patients who received acotinib according to the label.


Eligibility Criteria:
Inclusion Criteria:

* 1: Patients should be ≥18 years old at diagnosis
* 2: Diagnosed as MCL or CLL who have received at least one prior therapy and CLL patients should be enrolled after the approval of NMPA (according to Chinese label)
* 3: Eligible for acalabrutinib treatment assessed by investigators (physician's evaluation) in clinical practice
* 4: Patient/legal guardian must be able to read, understand, and sign the informed consent form (ICF)

Exclusion Criteria:

* 1: Ineligible for acalabrutinib treatment assessed by investigators (physician's evaluation)
* 2: Progression after accepting other BTKi treatment before use of acalabrutinib
* 3: Concurrent participation in another interventional clinical study
* 4: Females of childbearing potential must practice highly effective contraception during treatment of acalabrutinib, and for at least 1 week after the last dose of acalabrutinib, and have a negative urine or serum pregnancy test ≤ 7 days before the first dose of study drug(s).
* 5: No requirement to use contraception for male subjects treated with acalabrutinib. a. A sterile male is considered a highly effective contraception method for female patients. b. Males with known "low sperm counts" (consistent with "sub-fertility") are not to be considered sterile for purposes of this study.
A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus

The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T1DM for at least 1 year
* Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L)
* Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²)
* Participants should have a glycated hemoglobin of ≤9.0% at screening

Exclusion Criteria:
Somatic Symptoms in Autism Spectrum Disorder: Data Integration

Autistic patients have higher chances commorbid somatic symptoms. Therefore, it leads to more health-related concerns, such as autoimmune disease, gastrointestinal disease, cardiovascular disease, autonomic disorders. On average, autistic patient's life span is 16 years shorter than non-autistic patients. Furthermore, autistic patients are not able to convey or communicate their somatic symptoms in a clear and comprehensive manner. This leads to unable to receive proper health care in a timely manner.


Eligibility Criteria:
Inclusion Criteria:

* ASD group: diagnosed with DSM-5 autism spectrum disorder
* clinical group: anxiety, depression, somatic disorder who are non-psychotic and non-organic
* control group: healthy control without psychiatric disorder or chronic somatic symptoms
* age between 15 and 70

Exclusion Criteria:

* psychiatric disorders such as schezophrenia, mood disorder.
* major physical disorder which can be potentially lethal
* who cannot read or comprehend the survey and questionnaire
Different Fluorescein Sodium Dosage for the Detection of Gastric Intestinal Metaplasia

The purpose of this study is to assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.

Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended.

This study aims to compare the diagnostic yield of gastric intestinal metaplasia from two different fluorescein sodium dosage and assess whether lower fluorescein sodium dosage can perceive the same detection rate per patient and per lesion for the detection of gastric intestinal metaplasia.

Eligibility Criteria:
Inclusion Criteria:

* patients with dyspeptic symptoms and aged 40 years or older
* or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
* or patients with family history of gastric cancer

Exclusion Criteria:

* presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
* presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
* inability to provide informed consent
Cycle and Stroke With Biofeedback for Power Symmetry

To determine changes in power symmetry, gait symmetry, and functional outcomes for participants' poststroke (Inpatient Rehabilitation Facility) after participating in an intervention using a recumbent cycle with power biofeedback (BFB). To determine how this intervention can impact gait asymmetry, a common disorder poststroke secondary to hemiparesis. Gait asymmetry is a difficult impairment to treat because it is difficult for both therapists and patients to perceive. Training with BFB allows for quantitative data about the power production or lack of that directly impacts safety in walking, increased energy expenditure, and decreased gait speed.

Specific Aim 1 will determine the change in cycling power using BFB on a group of participants with stroke in an Inpatient Rehabilitation Facility. Specific Aim 2 will determine the effect size of the change in gait symmetry with cycling training with power BFB pre- to post-cycle intervention. Specific Aim 3 will determine the effect size of the change in functional mobility with cycling training with power BFB pre- to post-cycle intervention. Understanding the impact of cycle training with power BFB is an important step in improving stroke rehabilitation. This study is significant because it will provide data about power asymmetries in participants' early post-acute stroke and the transfer of training with power BFB to gait impairments.

Eligibility Criteria:
Inclusion Criteria:

1. they have a confirmed MCA or ACA ischemic or intracerebral hemorrhagic stroke, confirmed by CT/MRI or clinical documentation

   -AND demonstrating lower extremity hemiparesis \[\< 100 on lower limb Motricity Index24\]
2. 18 to 70 years of age
3. a Functional Ambulation Category of 2 (Dependent Level II) through 5 (Independent Level surfaces only)
4. medical clearance to participate

Exclusion Criteria:

1. contractures that limit lower limb range of motion
2. cardiovascular, respiratory or metabolic instability, including unstable angina or hypertension above 200/110 at rest
3. uncontrolled diabetes
4. severe respiratory disorders that limit exercise
5. inability to ambulate \> 150 feet prior to stroke
6. prior history of peripheral or central nervous system injury
7. moderate to severe hemispatial neglect according to the Kessler Foundation Neglect Assessment
8. major cognitive impairment preventing the capability to understand training instructions; identified by inability to follow 3-step command
9. severe aphasia preventing communication with the therapist.
Cognitive Effects of Music and Dance Training in Children

The study used a randomized controlled trial to test the efficacy of two interventions (dance and musical training) for typically developing children. Interventions were run for three weeks in local community locations. Participants were tested before and after the intervention on a battery of cognitive and behavioural measures. They were compared across groups, and to a control group who do not receive the intervention.

The purpose of the current study was to assess the influence of dance and musical training on cognitive development. Research has indicated that musical training is associated with improve cognitive functioning, although the direction of such an association is unclear. Further, it is uncertain whether any benefits are specific to musical training or can also be demonstrated with other training activities. The current study used a randomized controlled trial to assess the causal effects of dance and musical training.

Participants Monolingual children aged between six and nine years old were recruited from two local communities in Ontario, Canada. Children with developmental delays, learning disabilities, or previous arts training were excluded from the study.

Participants were randomly allocated to one of two groups

1. Dance intervention group
2. Music intervention group

To establish baseline performance levels and have a comparison, a passive control group was collected from the same towns using the same exclusion criteria.

Data analysis Difference scores were calculated for each measure by subtracting each participant's second testing session data from the first. When appropriate, iterative trimming with a 3 SD cutoff was used, by subject and by condition, to remove outliers. Results for each measure were analyzed using one-way ANOVAs (analysis of variance) for the between-subjects factor of training group (music, dance, or control).

Eligibility Criteria:
Inclusion Criteria:

* Monolingual

Exclusion Criteria:

* Developmental delays or learning disabilities
* Previous arts training (in dance, drama, or music)
Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children

This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the second dose.

Observational Objective:

* To describe and characterize adverse events occurring after vaccination with Menactra vaccine.

The study will be carried out in collaboration with the Kaiser Permanente Medical Care Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC). KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter databases that capture all medical care received by enrollees.

Vaccination will be according to routine clinical practice. Vaccination databases will be reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.

Eligibility Criteria:
Inclusion Criteria:

* Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.
Safety and Efficacy of MEE-HU Medicus

Primary objective: is evaluation of the investigational product's safety and evaluation of its effect, in combination with antimicrobial treatment, on urine culture (microbiological cure, no microbial growth on 24-48 hrs culture). The secondary objective: is evaluation of the investigational product's effect, in combination with antimicrobial treatment, on disease related symptoms (Clinical cure, disappearance of symptoms and signs).

Design: Randomized, Double blind, Placebo controlled multicenter study. Recurrent urinary tract infection patients will blindly receive MEE-HU Medicus, or matching placebo, orally, daily, for 10 days, adjunct to the empirical antibiotic.

Population: Male and female patients over 18 years old diagnosed with recurrent urinary tract infection. Sample Size: 200 patients, 100 from each center.

Eligibility Criteria:
Inclusion Criteria:

Male and female patients over 18 years old - Symptomatic urinary tract infection (pain, dysuria, frequency, urgency, fever) confirmed by urine analysis (Pyuria, which is defined as urine WBC \>10). - Negative pregnancy test and absence of vaginal discharge. - Recurrent urinary tract infection 2 times or more in the last 6 months or 3time or more in the last year. - Signed informed consent.

Exclusion Criteria Patients unable or unwilling to provide their free consent to participate in the study - Patients known or suspected to be hypersensitive to medications that will be used in the study. - Simultaneous participation in other studies. - Patients on palliative care, terminal illness. - Evidence of acute or chronic prostatitis or pyelonephritis. - History of antimicrobial use in the last 72 hrs. - Patients with renal transplantation.
Effect of Individual and Populational Determinants on End Stage Renal Disease Children Quality of Life, During Dialysis Period.

End stage renal disease (ESRD) is a severe pathology, treated by dialysis on standby of graft availability. Being under dialysis requires a recourse to pluri-weekly magazine of health care system, impacting negatively patient's quality of life (QoL) and their entourage, at a psychological, physical and social level.

Although further studies have assessed QoL in ESRD grafted children, a lack of information exists concerning patients' QoL during dialysis before graft. In addition, some limits could be listed, these studies have small samples, 50 patients at all, and only clinical determinants are studied. A larger clinical research assessing children's QoL studying individual and populational factors is necessary.

The aim of the study is to assess the influence of individual and populational determinants on children's QoL with ESRD, treated by dialysis.

Material \& Method An exhaustive inclusion of patient with ESRD treated by dialysis will be realized at 20 French Pediatrics Dialysis Centers. Inclusion criteria are i) two genders, ii) younger than 18 years old, iii) having an ESRD treated by dialysis, iv) attending at one of the French Pediatrics Dialysis Centers for treatment between the 1st September 2012 and the 31th August 2014, v) being at their fourth to sixth week of dialysis. Patients will be re-evaluated at 4th month and 7th month after first dialysis. Informed consent will be signed by patient and their mainly caregiver.

Patient's QoL will be assessed using self-administered questionnaires Kidscreen 10 and VSP-A. In addition coping (KidCope), anxiety (STAI-C, STAI-Y), personality / attachment (IPPA), optimism (Y-LOT) measures and socio-demographic data will be collected. Self-administered questionnaires will be used for assessing caregivers' Qol (SF36), anxiety (STAI-Y), coping (BriefCope situational format), health care system satisfaction (Care quality scale) and burden (Zarit Caregiver Burden Inventory). Child's QoL evaluated by caregivers will be assessed using QUALIN, Kidscreen 10 parent and VSP-Ap. In addition, socio-demographic data, urban environment and economic environment will be collected. Clinical data will be collected by health professionals.

Results expected A sample of 136 children with ESRD is expected for identifying individual and populational factors which could influence chronic dialysed children QoL, in order to propose adjustments to optimize these patients quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Minors patients treated by dialysis or on standby of graft availability

Exclusion Criteria:

* Minors patients treated by dialysis for less than 4 weeks
Feasibility and Effectiveness of a Sleep Hygiene Education Program for Sleep Issues in Breast Cancer Survivors

The proposed research will assess the feasibility and preliminary effectiveness of a Sleep Hygiene Program for Breast Cancer Survivors. Participants will complete assessments related to sleep issues, participate in a Sleep Hygiene Program, and complete another assessment post-intervention.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with breast cancer and not currently receiving active treatment in the form of chemotherapy or radiation therapy,
2. at least 18 years of age,
3. women
4. score \> 5 on the Pittsburgh Sleep Quality Index
5. Participant has a smartphone that operates on the Android or Apple platform
6. Participant is able to use the Ecological Momentary Assessment application in the morning
7. functional English fluency and literacy

Exclusion Criteria:

1. self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment.
2. Currently taking a pharmacological sleep aide
rTARUP: Long-term Analysis

The aim of the study is to assess the recurrence rate and potential long-term complications, at least 48 months, after a robotic assisted transabdominal retromuscular approach (rTARUP technique) for the repair of an umbilical hernia.

The rTARUP technique (robotic assisted transabdominal retromuscular umbilical prosthetic repair) has been introduced in the latest years for the treatment of ventral/umbilical hernias. Short-term analyses have proven that this technique can be performed safely and without complications. The technique maintains the benefits of a traditional laparoscopic approach (smaller incision, faster recovery, shorter hospital stay) and obeys mesh complications related to intraperitoneal mesh placement (adhesions, pain due to mesh fixation). An initial evaluation was conducted at our center to assess recurrence and complications 1 year after the procedure in a patient group of 203 patients. We documented 3 patients with a recurrence of which 2 of them had a laparoscopic intra-peritoneal hernia repair to treat the recurrence. Due to Covid-19 restrictions a clinical follow-up was only possible in 73% of patients. Therefore, we believe that a longer follow-up period of at least 48 months after surgery is necessary and surgically relevant to analyze the primary (recurrence rate) and secondary (long-term complications) end points of the recently introduced rTARUP technique for the treatment of ventral/umbilical hernias.

Muysoms, F., et al., Robotic transabdominal retromuscular umbilical prosthetic hernia repair (TARUP): observational study on the operative time during the learning curve. Hernia, 2018. 22(6): p. 1101-1111.

Muysoms, F., et al., Observational study with one year follow-up on robotic assisted retro-rectus ventral hernia repair (RTARUP) with a self-fixating mesh. Br J Surg, 2021. 108(Suppl 8).

Eligibility Criteria:
Inclusion Criteria:

* Patients that underwent rTARUP procedure in the period September 2016 - December 2019
* Lateral approach to the retromuscular plane/lateral single docking
* Use of Progrip self-fixating mesh

Exclusion Criteria:

* Ventral hernia on the lateral side or combined hernia (lateral and medial)
* eTEP approach to the retromuscular plane
* Use of any other mesh than Progrip self-fixating mesh.
A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors

This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are 16 to 17 years old would be enrolled after consultation with the Medical Monitor
* Histologically or cytologically documented, incurable or metastatic solid tumor or hematologic malignancy that is advanced (non-resectable) or recurrent and progressing since the last anti-tumor therapy and for which no recognized standard curative therapy exists
* Representative tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report
* Adequate hematologic and end organ function
* Measurable disease per RECIST v1.1 for participants with solid malignancies. Disease-specific criteria for participants with prostate cancer, glioblastoma multiforme (GBM), malignant lymphoma, or multiple myeloma
* For women of childbearing potential: agreement to remain abstinent or use contraceptive methods
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* For participants who will undergo serial biopsy in dose-escalation cohort, baseline tumor tissue samples should be of core needle biopsies for deep tumor tissue or organs or excisional or punch biopsies for cutaneous or subcutaneous lesions (\>/=5 millimeter \[mm\] in diameter amenable to serial biopsy)

Exclusion Criteria:

* Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases
* Known hypersensitivity to pharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
* History or risk of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis)
* History of human immunodeficiency virus (HIV) infection, active hepatitis B (chronic or acute), or hepatitis C infection
* Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
* Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1
* Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation