cyrilzakka/clinical-trials huggingface dataset:
BTL-9000 Low Level Laser Therapy for the Waist Circumferential Reduction

Prospective, two-arm, randomized study of the effectiveness of the BTL-9000 LLLT in achieving 3 cm or greater average waist circumferential reduction in LLLT group of subjects relative to the base line and 1 cm or greater reduction relative to the average waist circumferential reduction of the Placebo group.

Prospective, randomized, blinded, two-arms study of waist circumferential reduction following 5 once-a-week treatments. One arm is the LLLT group of 25 subjects who are treated with the BTL-9000 LLLT and the other arm is the Placebo group of 15 subjects treated with the sham device. The objective of the study is to demonstrate the effectiveness of the BTL-9000 LLLT treatment in achieving average post-treatment waist circumferential reduction of 3 cm or greater across the waistline relative to the baseline assessment and of 1 cm or greater than the average waist circumferential reduction of the Placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18-70 years of age of both gender with excess adipose tissue in the abdomen area

  * Body Mass Index (BMI) of 25 to 35 kg/m2.
  * Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
  * Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation.

Exclusion Criteria:

* Diabetics dependent on insulin or oral hypoglycemic medications
* Known cardiovascular disease such as arrhythmias, congestive heart failure
* Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
* Prior surgical interventions for body sculpting of abdomen such as liposuction
* Medical, physical or other contraindications for body sculpting/ weight loss
* Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
* Any medical condition known to affect weight levels and/or to cause bloating or swelling
* Active infection, wound or other external trauma to the area to be treated
* Pregnant, breast feeding, or planning pregnant before the end of the study
* Serious mental health illness
* Photosensitivity disorder to 660 nm light
* Active or recurrent cancer or current chemotherapy and/or radiation treatment
Safety, Tolerability, Pharmacokinetics, and Food Effect of BLU-782 in Healthy Adults

The main objectives of this study are to assess the safety, tolerability, pharmacokinetics (PK), and food effect of BLU-782 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Medically healthy
* Non-smoker
* Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2
* No clinically significant cardiac history
* No current electrocardiogram (ECG) abnormality
* Female must not be of childbearing potential

Exclusion Criteria:

* History of or current mental or legal incapacitation or major emotional problems
* History or current clinically significant medical/psychiatric condition/disease
* History of any illness that, in the opinion of the Investigator, might impact the results of the study or pose an additional risk to the participant
* History or current alcoholism/drug abuse
* History or current allergy to the study drug or a similar drug
Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder

This randomized controlled trial (RCT) with 470 patients diagnosed with Borderline Personality Disorder (BPD) aims to investigate the effectiveness of the unguided digital therapeutic alivis for patients with BPD as defined in DSM-5. Inclusion criteria are: male, female or non-binary, age 18-65 years, diagnosis of BPD (confirmed by SCID-5-PD), borderline severity score (cut-off) of ≥ 1.07 on the Borderline Symptoms List 23 (BSL-23), stable treatment (psychotherapy, medication, no treatment, ...) for at least 30 days at the time of inclusion, consent to emergency plan for suicidal crises, consent to participation, and sufficient German language skills. Exclusion criteria are: Plans to change in treatment (psychotherapy, medication, ...) in the upcoming 6 months after inclusion, comorbid diagnosis of substance use disorder or lifetime diagnosis of psychotic disorder, physical condition that can cause severe psychiatric symptoms, acute decompensation of mental health, BMI \&lt;15, and prior use of the digital intervention priovi.

Patients will be randomized and allocated to either an intervention group, in which they will receive access to alivis in addition to treatment as usual (TAU; n=235), or to a control group, in which they will receive access to TAU (n=235).

The primary endpoint will be BPD symptoms with three months post-allocation (T1) being the primary timepoint for assessment of effectiveness. Six (T2) and twelve (T3) months post-allocation will be used as follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, anxiety symptoms, costs caused due to the patient's BPD, social functioning, health-related quality of life, and patient activation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of BPD
* Borderline severity score (cut-off) of ≥ 1.07 on the BSL-23
* Stable treatment (e.g., psychotherapy, medication, no treatment) for at least 30 days at the time of inclusion
* Consent to emergency plan for suicidal crises
* Consent to participation
* Sufficient knowledge of the German language

Exclusion Criteria:

* Plans to change treatment (e.g., psychotherapy, medication) in the upcoming 6 months after inclusion
* Comorbid diagnosis of substance use disorder
* Lifetime diagnosis of psychotic disorder like schizophrenia or schizoaffective disorder (except non-transitory paranoid ideas that can be concomitant with BPD and in which the ability to test reality is mostly preserved)
* Diagnosis of a physical condition that can cause serious psychiatric symptoms
* Acute decompensation of mental health symptoms, e.g. acute manic state or acute suicidality
* BMI \&lt; 15
* Current psychiatric day-care or inpatient treatment
* Prior use of the digital intervention priovi
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Subjects With Active Axial Spondyloarthritis Including Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis

The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).


Eligibility Criteria:
Inclusion Criteria:

* Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
* In the opinion of the Investigator, the study participant is expected to benefit from participation in this extension study
* Study participant completed AS0010 (NCT03928704) or AS0011 (NCT03928743)

Exclusion Criteria:

* Female study participants who plan to become pregnant during the study or within 20 weeks following final dose of Investigational Medicinal Product (IMP). Male study participants who are planning a partner pregnancy during the study or within 20 weeks following the final dose
* Study participants who meet any withdrawal criteria in AS0010 or AS0011. For any study participant with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder study, the Medical Monitor must be consulted prior to the study participant's entry into AS0014
* Study participant has a positive or indeterminate interferon gamma release assay (IGRA) in AS0010 or AS0011, unless appropriately evaluated and treated
Competency-based Training in Problem Management Plus: a Randomized Controlled Trial

The proposed study in Nepal will evaluate if non-specialists participating in Equip-based Problem Management Plus training show greater competencies compared to non-specialists participating in standard Problem Management Plus training. The proposed study is a randomized controlled trial with mixed-methods components evaluating both quantitative outcomes and qualitative outcomes among non-specialists participating in the training and their trainers.

There is increasing recognition of the high burden of psychological distress among populations around the world. Increasingly, non-specialists (persons who do not have expertise in formal mental health training) are being used to deliver psychological services. There is a long history of successful implementation of psychological services by non-specialists in Nepal. Recently, a cluster randomized controlled trial of Problem Management Plus showed modest benefit over enhanced care as usual in southeastern Nepal. A recent initiative by the World Health Organization is being rolled out to improve the competencies of non-specialists participating in Problem Management Plus and similar trainings. This initiative is Ensuring Quality in Psychological Services (Equip). The proposed study in Nepal will evaluate if non-specialists participating in Equip-based Problem Management Plus training show greater competencies compared to non-specialists participating in standard Problem Management Plus training. The proposed study is a randomized controlled trial with mixed-methods components evaluating both quantitative outcomes and qualitative outcomes among non-specialists participating in the training and their trainers.

Eligibility Criteria:
Inclusion Criteria:

* No prior mental health professional training
* Literate in Nepali

Exclusion Criteria:

* Any prior mental health professional training
A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

A study of CM313 in subjects with systemic lupus erythematosus

This is a multi-center, randomed, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, Pharmacokinetics and preliminary anti-tumor activity.

About 40 patients who meet eligibility criteria will be randomized 4:1 to receive either CM313 or matched placebo, intravenous infusion.

The treatment period includes single dosing and multiple dosing period, in which CM313 and placebo will be adminitrated intravenously, once every 1 week.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old ≤ age ≤ 65 years old.
* Positive autoantibody serology test at screening.
* Contraception.
* Voluntarily sign the ICF.

Exclusion Criteria:

* With central nervous system disease caused by or not caused by SLE within 8 weeks before the first dose of study drug.
* Possibly active Mycobacterium tuberculosis infection.
* With the history of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation.
* Heavy drinking in the 3 months prior to screening.
* With depression or suicidal thoughts.
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome

The present study will examine the role of circulating RNA complexed with autoantibodies and immune complexes and its role in activation of inflammatory pathways in patients with primary Sjogren's syndrome. The study will be conducted in a subset of Sjogren's patients who have elevated levels of autoantibodies and a pattern of elevated interferon-stimulated gene expression in blood cells. A number of biochemical and clinical parameters will be analyzed to determine the potential therapeutic utility of nuclease therapy in Sjogren's syndrome.

This is a multi-center, double-blind, placebo-controlled study to evaluate the impact of 8 intravenous infusions of RSLV-132 in 28 patients with primary Sjogren's syndrome. Each of the subjects will be randomized 3:1 (active:placebo) and will receive 8 infusions of 10 mg/kg of RSLV-132 or placebo as follows on days:

• 1, 8, 15, 29, 43, 57, 71, and 85

Potential subjects will be screened to assess their eligibility to enter the study within 60 days prior to study entry (i.e., prior to Baseline visit). Following Baseline evaluations on Day 1, subjects will receive their first infusion of RSLV-132 or placebo. Subjects will return to the research unit for follow-up visits as described in Appendix A.

Dose selection rationale: The dose level was chosen based on safety and tolerability data from Protocol 132-02 (multiple ascending dose study in SLE patients). Additionally, in a 6-month toxicology study in cynomolgus monkeys, 50 mg/kg of RSLV-132 was administered by IV infusion weekly. No dose-limiting toxicity was noted, therefore the No Observed Adverse Effect Level is at least 50 mg/kg, providing at least a 5-fold safety margin for this study.

RSLV-132 shall be prepared for each subject from individual stock vials provided by Sponsor. Details of dilution, dose preparation, and administration instructions will be provided in the Study Drug Reference Guide. The dose for each individual shall be based on the subject's body weight.

Eligibility Criteria:
Inclusion Criteria:

1. Meet 4 of 6 criteria of 2002 American-European Consensus Group (AECG) criteria for Primary Sjogren's Syndrome
2. Presence of anti Ro autoantibodies
3. Presence of interferon signature

Exclusion Criteria:

1. Use fo hydroxychloroquine within 30 days of baseline
2. Use of cyclophosphamide within 180 days of baseline
3. Use of oral corticosteroids greater than 10 mg/day
4. Known IgG4-related disease
Respiratory Muscle Training in Stroke Swallowing Disorders

Clinical randomized clinical trial to assess the effectiveness of incorporating inspiratory and expiratory muscle training (IEMT) in the rehabilitation of stroke patients with dysphagia in terms of functional outcomes, comorbidities, survival and quality of life.

This project also incorporates a longitudinal study to assess the clinical impact of dysphagia on body composition and nutritional status in stroke patients.

Stroke is a major cause of morbidity and mortality worldwide. Stroke can lead to varying degrees of oropharyngeal dysphagia (25-85% of patients) and respiratory muscle dysfunction associated with an increase in medical complications such as bronchoaspiration, malnutrition and death. Dysphagia is present in a significant proportion of patients admitted to Rehabilitation (up to 85% depending on series) in stroke. Standard swallow therapy consists of educational intervention aimed to improve self-management of dysphagia and protect the airway, oral exercises to improve lingual praxis, and compensatory techniques based on videofluoroscopic findings. Recent studies suggest that IEMT can improve swallowing efficacy and reduce eventual bronchoaspiration events.

Nutritional status appears in 9-67% of patients with acute and subacute stroke and has an impact on functional outcomes and provides information about the risk of hospitalization and death. Stroke patients are at risk of developing malnutrition because of neurologic impairments related to feeding (chewing, deglutition and self-feeding) that can result in a poor food intake. To date, there is only few studies on prevalence and influence of malnutrition in stroke.

Eligibility Criteria:
Inclusion Criteria:

* First-ever Ischemic or haemorrhagic stroke
* Time since stroke onset: 1 month
* Dysphagia confirmed by videofluoroscopic study with a score \>3 in the 8-point Penetration Aspiration Scale.
* Mini-mental State Exploration \> 24)

Exclusion Criteria:

* Aphasia
* History of cardiopulmonary disease; neurologic condition other than stroke and metabolic disease
* Medical treatment with potential effect on muscle structure and function
Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Pediatric Subjects

The primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks.

A second purpose is to evaluate the safety of the drug.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of common warts
* Ages between 3 to 11

Exclusion Criteria:

* Other types of wart(s), ie. plantar
* Currently participating in another clinical study
* Chronic viral hepatitis B or C
Study of Patients With Acute Renal Failure on CVVH

Acute kidney failure is common in children in the Pediatric Intensive Care Unit (PICU). You are being asked to participate in this study because your child is being treated for kidney failure with continuous veno-venous hemofiltration (CVVH). CVVH is a continuous, gentle form of removing excess fluids and small wastes from the blood, similar to kidney dialysis (artificial kidney). It is an accepted therapy for temporary support of kidney failure. In some patients with acute kidney failure, beginning CVVH is followed by a temporary decrease of urine output. The reason why this happens is currently unknown. The purpose of this study is to determine why this happens.

Acute renal failure is common in children in the pediatric intensive care unit. Renal replacement therapies such as peritoneal dialysis (PD), intermittent hemodialysis (IHD), and continuous venovenous hemofiltration (CVVH) have been used in the management of acute renal failure. CVVH is becoming increasingly utilized in pediatric acute renal failure. However, in patients who have acute renal failure, the institution of CVVH is often followed by a progression to oliguria or anuria. The underlying pathophysiology of this change is unknown. We believe that this progression is influenced by changes in the renin-angiotensin axis, cytokine response, and other modifiers of renal hemodynamics. By serially measuring components of those systems, this study will attempt to elucidate the pathophysiology of the decreased urine output seen with institution of CVVH. Once this process is understood, future studies should focus on prevention and treatment of this complication.

General Hypothesis

The decrease in urine output seen after the initiation of CVVH is associated with increased angiotensin converting enzyme (ACE) levels, increased renin activity, increased angiotensin II levels, increased atrial naturetic peptide (ANP) levels, increased endothelin-1 levels, increased arginine vasopressin (AVP) levels, and alterations of cytokine levels and modulators of apoptosis.

Eligibility Criteria:
Inclusion Criteria:

The general goal of patient selection is to enroll all children for whom CVVH is instituted.

Inclusion criteria:

Age

* 6 months -18 years old
* Patients less than 6 months of age on ECMO (addendum #1)

Indication for CVVH: including, but not limited to :

* Acute Renal Failure
* Oliguria
* Anuria
* Hyperkalemia
* Severe acidemia
* Azotemia
* Pulmonary Edema
* Uremic complications
* Severe electrolyte abnormalities
* Drug overdose with a filterable toxin
* Anasarca
* Rhabdomyolysis

Exclusion Criteria:

* Age

  * Less than 6 months old (unless on ECMO)
  * Greater than 18 years old Weight
  * Less than 5 kilograms (unless ON ECMO) Location
  * Cardiac Intensive Care Unit
  * Neonatal Intensive Care Unit

Non-adherence:

Inability or unwillingness of the legal guardian to provide consent or inability or unwillingness of the child to provide assent
Effect Of Music Integrated Phonological Awareness Program On Preschool Cochlear Implant Users

The aim was to observe the effect of the music integrated phonological awareness program on preschool cochlear implant users and to compare the phonological awareness skills of the study group with the control group before and after the online training.

This study was designed to determine the benefit of music integrated phonological awareness programs for children using cochlear implants. In addition, the phonological skills and language skills of children using cochlear implants and children with normal hearing were compared in the pre and post-training results. Test of Early Language Development (TELD-3), The Phonological Awareness Scale of Early Childhood Period (PASECP), Mismatch Negativity (MMN) was used in this study.

This study was carried out with follow-up patients in the Audiology, Language and Speech Disorders Clinic of xxx University - Medical Faculty, Department of Otorhinolaryngology. The study was performed with the approval of Ethics Committee, and written informed consent was obtained from all patient families (138955/ July 2021). There are 9 female and 14 male cochlear implant users in the study group; 9 female and 14 male children with normal hearing in the control group. Children ranging in age from 5 to 7 who also have 5-6 years old language skills without any neurological problems were included in the study. Cochlear implant mappings of all children were checked before the training.

SPSS 25.0 (IBM) was used for statistical analysis. Pre and post-training comparisons of The Phonological Awareness Scale of Early Childhood Period, SMRT, and Mismatch Negativity tests were analyzed with the Wilcoxon test. The correlation of numerical measurements with each other was examined with Spearman Correlation. The differences in the numerical measurements used in the research according to the binary demographic categories were analyzed with the Mann-Whitney U test. The differences according to the multiple categories were analyzed using the Kruskal Wallis H test. The significance level (α=0,05) was used.

Eligibility Criteria:
Inclusion Criteria:

* For children with hearing loss
* Bilateral severe sensorineural hearing loss
* Having unilateral or bilateral cochlear implants,
* Having a chronological age in the range of 5-7 years,
* Not having started primary school.
* Using the cochlear implant and regularly
* To receive regular training in the auditory rehabilitation center

For children with normal hearing:

* To have normal hearing,
* To have receptive and expressive language skills compatible with the chronological age in the language test to be performed.
* Not starting primary school

Exclusion Criteria:

* In case of not having any without being accepted for control and study,
* Having additional disability
* Using drugs affecting the auditory system