cyrilzakka/clinical-trials huggingface dataset:
Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

The safety and efficacy of Caltriol on mild proteinuria (\<1.0g/d) reduction in CKD patients.

Proteinuria is not only a capital sign of kidney disease, but also a marker of chronic kidney disease (CKD) progression. Emerging evidence in patients with CKD show that vitamin D and its analogs can reduce proteinuria or albuminuria in the presence of angiotensin-converting enzyme inhibithion. While some of the studies reported that vitamin D receptor activation has been associated with increased serum creatinine and reduced estimated glomerular filtration rates. Therefore, the investigators plan to conduct a randomized clinical study to evaluate the efficacy and safety of Calcitriol in the treatment of mild proteinuria (\<1.0g/d) CKD patients,which has no specific treatment at present.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-75 years
* clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis
* proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month
* estimated glomerular filtration rate (eGFR)\>60ml/min/1/73m2
* corticosteroid and immunosuppressive agents withdrawal for at least 6 months
* normal blood pressure
* serum intact parathyroid hormone (iPTH) level \>20pg/mL
* corrected serum calcium level \< or = 2.55 mmol/L
* serum phosphorus level \< or = 1.68 mmol/L
* 24 hours urinary calcium excretion level \< or = 7.5 mmol
* not receive treatment of vitamin D or its analogue within 6 months
* willigness to give written consent and comply with the study protocol

Exclusion Criteria:

* history of sensitivity or allergy to calcitriol or other vitamin D analogs
* pregnancy, lactating women
* history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
* history of malignancy
* history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases
* patients receiving drugs contains of calcium
* patients receiving cimetidine, trimethoprim, or other drugs which can increase tubular creatinine reabsorption
* participation in any other trials within 1 month
* history of non-compliance
Effect of Functional Chewing Training on Tongue Thrust and Drooling in Children With Cerebral Palsy

This study examined the effect of Functional Chewing Training(FuCT) on tongue thrust and drooling in children with cerebral palsy.

Children were divided into two groups: The FuCT group and control group receiving classical oral motor exercises. Each group received training for 12 weeks. Oral motor assessment was performed. Chewing performance level was determined with the Karaduman Chewing Performance Scale(KCPS). Tongue thrust severity was evaluated with the Tongue Thrust Rating Scale(TTRS). The Drooling Severity and Frequency Scale(DSFS) was used to evaluate drooling severity and frequency. The evaluations were performed before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with cerebral palsy
* aged between 4-6 years
* fed by orally
* had tongue thrust

Exclusion Criteria:

* children who were unable the sitting position
Using the PHQ-9 and GAD-7 as Feedback Instruments in Brief Psychotherapy

This study will assess the effects of client feedback, using the Patient Health Questionnaire - 9 and Generalized Anxiety Disorder 7-Item Scale, on depression and anxiety in individuals undergoing brief psychotherapy. Client feedback allows therapists to monitor treatment progress in real time. Identifying an easily accessible treatment intervention, which utilizes commonly used scales, that potentially enhances the effect of brief psychotherapy and improves treatment outcomes is a valuable endeavor with clear implications for therapy practices. It is hypothesized that clients who complete these scales each session will show greater symptom improvement than clients who do not complete the scales.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Disorder, Generalized Anxiety Disorder, or Adjustment Disorder

Exclusion Criteria:

* Require a higher level of care than brief psychotherapy, or have been diagnosed with an intellectual disability, personality disorder, substance use disorder, or major medical illness
Effects of SEMG Biofeedback With Core Muscle Strengthening Exercises and Kinesiotaping on Diastasis Recti in Post-partum Women

Diastasis Rectus Abdominis is quite common during and after pregnancy. Abdominal core strengthening exercises have been proven to be very effective in reducing Inter rectus distance, however, the role of Biofeedback EMG assisted exercises in Diastasis Rectus have been poorly understood.

This study is a Randomized Control Trial in which posr-partum females with diastasis recti will be recruited into a control and two experimental groups. In control group, patients will receive standard conservative treatment, whereas, in first experimental group, participants will receive core strengthening exercises with kinesiotaping; and in second experimental group, core strengthening exercises with kinesiotaping will be assisted by SEMG biofeedback. Patients will be evaluated pre and post-treatment for Inter rectus distance, abdominal strength and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Post-partum women aged 18-40 years
* Post-partum females from 6 to 24 months
* Diastasis rectus abdominus distance more than 2cm at any of 3 levels
* Primiparous or multiparous
* Spontaneous vaginal delivery and LSCS

Exclusion Criteria:

* Having skin sensitivity to taping
* Open abdominal wounds
* Abdominal skin diseases
* Abdominal hernia
* Other abdominal or back surgical history
* Any heart or respiratory conditions
* Neurological diseases
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

This will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the United States of America (USA) and Canada to evaluate the efficacy and safety of a fixed dose of SC BMT versus placebo on an as-needed basis under conditions of home use in premenopausal women with HSDD (with or without decreased arousal).

The study will consist of 2 phases: (1) Core Study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or BMT 1.75 mg SC via an autoinjector; and (2) Extension Phase: a 52-week open-label treatment period during which all subjects will receive BMT 1.75 mg.

Primary Objective

• To evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Secondary Objectives

* To evaluate the efficacy of BMT in premenopausal women in the double-blind Core Study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction.
* To evaluate the safety of BMT in premenopausal women in the double-blind Core Study.
* To evaluate the safety of long-term therapy with BMT in the open label Extension Phase.
* To evaluate the efficacy of long-term therapy with BMT in the open-label Extension Phase.

Eligibility Criteria:
Main Inclusion Criteria:

* Has met diagnostic criteria for HSDD for at least 6 months
* Is willing and able to understand and comply with all study requirements
* Has a normal pelvic examination at screening

Main Exclusion Criteria:

* Subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results
* Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial
Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence

Cytomegalovirus is the most important opportunistic infection after kidney transplant, with increased in mortality, morbidity and higher costs of transplantation. Despite the favorable efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus, mycophenolate and prednisone, or the investigators local common regimen, tacrolimus, azathioprine and prednisone, this combinations are associated with higher incidence of cytomegalovirus infection, disease and recurrence.

Namely, sirolimus use is associated with decreased risk of cytomegalovirus infection/disease, and there is not a prospective cohort to evaluate the conversion to sirolimus efficacy to decrease the cytomegalovirus infection recurrence.

Given this, the investigators propose a study of their own initiative that attends local needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus recurrence after kidney transplant.

This protocol is a prospective, randomized, single center, designed to evaluate incidence of cytomegalovirus recurrence infection/disease in two immunosuppressive regimens, after the first episode of cytomegalovirus: (1) conversion of azathioprine or mycophenolate to sirolimus, in a regimen wih low doses tacrolimus and prednisone; ( 2) Maintenance of the current regimen during the first episode of cytomegalovirus infection ( azathioprine or mycophenolate, in combination to tacrolimus or prednisone). Our hypothesis is that conversion from azathioprine or sodium mycophenolate to sirolimus, with low doses of tacrolimus, and prednisone results in lower recurrence of cytomegalovirus infection/disease in kidney transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

* Adult kidney transplant recipients \> 18 y.o.
* Kidney Transplant recipients, after the first episode of cytomegalovirus infection, using the current immunosuppressive regimen: azathioprine or mycophenolate, tacrolimus and prednisone.

Exclusion Criteria:

* Re-transplant;
* Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or class II;
* Acute rejection episode in the last 30 days, or episode \> 2A in the Banff criteria;
* GFR (MDRD) \< 40 ml/min;
* Proteinuria \> 0,5 g/l;
* Hemoglobin \< 10 g/l and/or leucocytes \< 4000 cels/mm3 and/or platelets \< 150.000 cels/mm3;
* Triglycerides \> 500 mg/dl with or without use of fibrate;
* Cholesterol total \> 300 mg/dl with or without use of statin;
* Hepatic abnormalities;
* Significant periphery edema;
* Pulmonary abnormalities or breast x-ray abnormalities;
* Hyper sensibility to sirolimus formula;
Combination Treatment for Augmenting Language in Children With ASD

The study will consist of two main elements: the enrollment of 72 children aged 6-11 years with ASD and low language competency to receive a thrice-weekly one hour language intervention for 12 weeks; and, beginning at the same time, subjects will be equally randomized to receive either aripiprazole (Abilify) (flexibly dosed from 2-10 mg per day) or placebo for 12 weeks.

Following screening for eligibility and baseline, study visits will be scheduled three times per week, with 2 sessions on-site at UCLA and one at home for parent training (allowing flexibility, as needed); study physician visits will occur once weekly for 6 weeks, then biweekly. Screening procedures may be completed in one or two visits, and measures obtained in other UCLA clinical or research setting may be used if assessments were done within one month of screening. Major outcome assessments will occur at baseline (Week 0), mid-point (Week 6), and final week (Week 12) by study personnel blind to visit number and drug group assignment; minor assessments will occur weekly along with study physician assessments occurring weekly for side effect and compliance checks. EEG will occur at or prior to baseline and at Visit 36 (Wk12). Arrangements will be made to transfer participants to standard clinical care following visit 36. Six months after visit 36, families will be seen for final follow-up assessments of language usage, social communication, overall functioning, health and ongoing treatment.

Eligibility Criteria:
Inclusion criteria:

* boys and girls ages 5-11 years;
* criteria for autistic disorder or PDD-NOS as defined by DSM-IV-TR and confirmed by clinical examination and ADI-R, ADOS;
* low language usage as defined by \<30 functional words obtained from a natural language sample, parent report, and standardized tests;
* present placement in a comprehensive educational/intervention setting.

Exclusion criteria:

* any medical condition that would interfere with intervention outcomes during a 12 week study period (eg., active seizures within 3 months);
* genetic disorders such as Fragile X, Down syndrome, or tuberous sclerosis;
* sensory impairments such as deafness or blindness;
* existing or anticipated need for concomitant psychotropic medication (specifically stimulants, atomoxetine) during study participation( allowed medication include: antidepressants, anticonvulsants, guanfacine, clonidine, supplements, melatonin, diphenhydramine);
* severe aggression or self-injurious behavior;
* DQ \<18 months as assessed by the Leiter-Revised or Mullen.
Influence of Educational Stimuli From the Pé-de-Meia Program on Delay Discounting Propensity

The goal of this randomized clinical trial is to investigate how the Stay-and-Complete School Incentive Savings, part of the Pé-de-Meia Program, affects decision-making among low-income high school students, particularly their tendency towards delay discounting. This concept describes the preference for immediate gratifications over larger future rewards. The main questions it seeks to answer are:

Can exposure to the specific educational stimuli of the Pé-de-Meia Program alter students' propensity for delay discounting? How do different levels of delay discounting influence students' decision-making regarding their studies and the utilization of the program's incentives?

Participants will:

Engage in a modified version of the Iowa Gambling Task (IGT), a computerized game that simulates decision-making under uncertainty, adapted to reflect the stimuli and choices related to the Pé-de-Meia Program.

Complete questionnaires that measure their propensity for delay discounting and gather demographic and socioeconomic information.

Researchers will compare the outcomes among groups of students exposed to different types of stimuli (aligned with the program's objectives, contrasting, and a control group without modifications) to see if the specific financial and educational incentives of the Pé-de-Meia Program influence how students value immediate rewards compared to future benefits. This study is expected to contribute to the improvement of public educational policies, encouraging school retention and promoting the educational success of low-income adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Low-income high school students in the public system, registered in CadÚnico

Exclusion Criteria:

* Students with a formal psychological or psychiatric diagnosis
Assessment of PFM Strength and Function After Radiotherapy Treatment in Women with Pelvic Cancers

Assessment the effect of radiotherapy treatment on pelvic floor muscles in women with pelvic cancers

Evaluate the impact of radiotherapy treament on pelvic floor muscles strength and function in women with cervical and rectal cancers

Eligibility Criteria:
Inclusion Criteria:

* women between 30 -50 years old
* diagnosed with cervix or rectal cancers
* married
* will be treated with preoperative radiotherapy for at least 5 weeks
* had not any pelvic operations in the past

Exclusion Criteria:

* un married women
* Age below 30 or above 50 years old
* has another type of pelvic tumors
* has any metastasis
* had any pelvic surgeries
* will be treated with short course radiotherapy
A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

The purpose of this study is to evaluate the efficacy and safety of ibrutinib + venetoclax (I+V) and ibrutinib monotherapy regimens in which dosing of ibrutinib is either proactively reduced or reactively modified in response to adverse events (AEs).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) as per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 diagnostic criteria
* For ibruinib + venetocIax (I+V) cohorts: eastern cooperative oncology group (ECOG) performance status of 0-1. For ibrutinib monotherapy cohorts: ECOG performance status of 0-2
* Measurable nodal disease by computed tomography (CT), defined as at least 1 lymph node greater than and equal to (\>=) 1.5 centimeters (cm) in longest diameter
* A participant using oral contraceptives must use an additional contraceptive method
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or until 1 month after last dose or per local label if more conservative (for example, 3 months in European Union or Canada and 1 month in United States)

Exclusion Criteria:

* Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura, such as those participants with a declining hemoglobin level or platelet count secondary to autoimmune destruction within the 4 weeks prior to first dose of study treatment, or the need for prednisone greater than (\>) 20 milligrams (mg) daily (or corticosteroid equivalent) to treat or control the autoimmune disease
* Known bleeding disorders (example, von Willebrand's disease or hemophilia)
* Stroke or intracranial hemorrhage within 6 months prior to enrollment
* Known or suspected Richter's transformation or central nervous system (CNS) involvement
* Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class II, III, or IV congestive heart failure as defined by the New York Heart Association Functional Classification
Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up.

Boston2018 post-market clinical study is a prospective, randomized, non-inferiority study to assess the efficacy and adverse events of the Solyx™ Single Incision Sling (SIS) System compared to the gold-standard Obtryx™ II Sling System, in patients with stress urinary incontinence (SUI) and long-term follow-up (5 years).

Randomized prospective non-inferiority study, in which we evaluate patients with stress urinary incontinence (SUI) who undergo surgical treatment consisting of a minimal incision in the suburethral area of the vaginal mucosa for a mesh insertion in order to:

Main Objective:

To compare the continence rate (objective) between Solyx and Obtryx II meshes in patients with SUI. This rate will be determined by an effort test.

Secondary Objectives:

* To compare the continence rate (subjective) between both meshes.
* To compare variations in Pad-Test.
* To asses patient satisfaction.
* To evaluate both techniques regarding quality and sexual life modifications.
* To compare both techniques regarding early complications (up to 30 days post implantation).
* To compare the appearance and persistence of late complications (from 30 days onwards).

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with symptomatic stress urinary incontinence candidates for stress-free bands
* Age \> or = 40 years
* informed consent signed by the patient

Exclusion Criteria:

* patients who are pregnant or wish to become
* patients who need anticoagulant
* active vaginal or urinary infection
* previous surgical interventions for the treatment of incontinence
* body mass index \> 35
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients

The purpose of this study it to compare the efficacity of isatuximab when combined to carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with multiple myeloma already treated with 1 to 3 prior lines of therapy.

The duration of the study for a patient will include a period for screening of up to 3 weeks. Patients will be treated until disease progression, unacceptable AE, or patient decision to stop the study treatment. After study treatment discontinuation, patients will have follow-up visits until the analysis of overall survival.

Eligibility Criteria:
Inclusion criteria:

* Participants with MM previously treated with prior 1 to 3 lines and with measurable serum M-protein (\>= 0.5 gram/deciliter) and/or urine M-protein (\>= 200 milligram/24 hours).

Exclusion criteria:

* Participants previously pretreated with carfilzomib, who never achieved at least one minor response during previous therapies and/or last previous therapy completed within 14 last days.
* Participants with serum free light chain (FLC) measurable disease only.
* Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2.
* Participants with inadequate biological tests.
* Participants with myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or transient ischemic attack within last 6 months, and/or left ventricular ejection fraction lower than 40%.
* Participants with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated.
* Participants with known acquired immunodeficiency syndrome related illness or human immunodeficiency virus requiring antiretroviral treatment, or hepatitis A, B, or C active infection.
* Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Inflammatory Markers Dynamics in Response to Extra-corporeal Membrane Oxygenator Decannulation

Extracorporeal membrane oxygenation (ECMO) aim at providing cardiac, respiratory support, or both. The use of ECMO could be associated with systemic inflammatory response syndrome (SIRS) at the time of initiation or the time of decannulation. There is an existing evidence to state that clinical criteria of SIRS accompany decannulation. We aim at proving this relation through studying the inflammatory markers changes before and after decannulation. The investigators will study all participants who require ECMO support in the heart hospital, all patient will be subjected to clinical evaluation of the SIRS criteria plus studying the inflammatory makers that will include IL1, IL2, IL6 and TNF before and after decannulation. Participants will be divided based on the SIRS criteria into 2 groups and both groups will be compared using Chi-Square analysis (Fisher tests if small sample size) or two tailed t-test, as appropriate


Eligibility Criteria:
Inclusion Criteria:

* ALL ECMO patients candidates for decannulation

Exclusion Criteria:

* patients who have identified sepsis prior to decannulation, febrile patients, patient who receive steroids and patient who die within 48 hours after ECMO decannulation.