cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 6-17 years of age
* Documented history of hypertension as defined in National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents (2004)
* Must be ≥ 21.0 kg and ≤ 100.0 kg at randomization
* Able to safely wash out previous antihypertensive therapy for 1-2 weeks

Exclusion Criteria:

* Body weight of \< 21 kg (45 lbs) or \> 100 kg (220 lbs)
* Inability to discontinue prior antihypertensive medication as required during the washout period
* Any clinically significant abnormalities or clinically noteworthy abnormal laboratory values
* Renal artery stenosis
* Current diagnosis of heart failure (NYHA Class II-IV)
* msSBP ≥ 25% above the 95th percentile for age, gender, and height at Visit 2
* Second or third degree heart block with or without a pacemaker
* Atrial fibrillation or atrial flutter at Visit 1, or potentially life threatening or any symptomatic arrhythmia during the 12 months prior to Visit 1
* Evidence of current symptomatic valvular disease

Other protocol-defined inclusion/exclusion criteria applied to the study.
Outpatient Oncology Aromatherapy for Symptom Management

The purpose of this research study is to determine whether using aromatherapy during chemotherapy infusion treatments in the outpatient Oncology setting promote relief of nausea and anxiety.

The objectives of this study are: 1. To promote relief of nausea using peppermint aromatherapy oil in an outpatient oncology setting. 2. To promote relief of anxiety using lavender aromatherapy oil in an outpatient oncology setting.

Subject Selection: Every outpatient oncology patient experiencing nausea and/or anxiety during an infusion visit will be offered hospital-approved aromatherapy of Peppermint oil or Lavender oil. If patient says yes, then they will be selected for the study and infusion nurse will notify the study co-investigators or principal investigator. Informed consent will then be obtained by co-investigators or principal investigator of the study. The consents as well as the data collection tool sheets will be numbered without identifying patient's personal information. Peppermint oil aromatherapy and/or lavender oil aromatherapy will then be administered to consented patients.

Method of Subject Identification and Recruitment: Every outpatient oncology patient experiencing nausea and/or anxiety during an infusion visit will be offered hospital- approved aromatherapy of Peppermint oil or Lavender oil. If patient says yes, then they will be selected for the study and infusion nurse will notify the study co-investigators or principal investigator. Informed consent will then be obtained by co-investigators or principal investigator of the study. The consents as well as the data collection tool sheets will be numbered without identifying patient's personal information. Peppermint oil aromatherapy and/or lavender oil aromatherapy will then be administered to consented patients.

Eligibility Criteria:
Inclusion Criteria:

All outpatient Oncology patients \> 18 years of age Non pregnant Not cognitively impaired English speaking only Patients who report nausea and/or anxiety

Exclusion Criteria:

All outpatient oncology patients \<18 years of age Pregnant Cognitively impaired Non-English Speaking Patients who do not report nausea and/or anxiety Patients with a known allergy to peppermint and/or lavender aromatherapy oil
Phase I Clinical Study of SPH4336 Tablets in the Treatment of Advanced Solid Tumors

This clinical study evaluated the safety and efficacy of SPH4336 in the treatment of advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed advanced solid tumors；
2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1；
3. Life expectancy ≥ 3 months；
4. Good organ function；
5. According to the investigator's judgment, the patient could comply with the trial protocol;
6. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).

Exclusion Criteria:

1. Received other antineoplastic therapy before the first dose；
2. Had a major surgery before the first dose of study medication or was planned to have a major surgery after starting the study medication;
3. Enroll in other clinical trials and receive treatment as a subject before initial medication;
4. Patients with allergic constitution or history of severe allergy;
5. Hepatitis B surface antigen \[HBsAg\] positive and HBV-DNA copy number ≥500 copies /ml or 100 IU/ml, HCV-Ab positive and HCV-RNA higher than the detection limit of the research center; A history of immunodeficiency;
6. Cardiac criteria: presence of factors that may cause QTc prolongation or arrhythmia such as congestive heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, and other concomitant medications known to prolong the QT interval. The presence of any unstable cardiovascular disease;
7. Hypertension that cannot be effectively controlled after treatment;
8. Have severe lung disease;
9. Pregnant and lactating women;
10. Female patients of reproductive age and male patients with a partner of reproductive age who were unwilling to use effective contraception throughout the trial;
11. Concomitant diseases that seriously endanger patient safety or affect the completion of the study according to the investigator's judgment;
12. Had a definite history of neurological or mental disorders;
13. Other circumstances considered by the investigator to be inappropriate for participation in the study.
A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis

This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 4-arm study to assess the effect of pegylated-recombinant-human interleukin-2 (rezpegaldesleukin) in adult participants with moderate to severe atopic dermatitis.

The estimated duration is 15-35 days for screening, an Induction Period of 16 weeks, a Maintenance Period from Week 16-Week 52, and a Posttreatment Follow-Up Period for an additional year up to approximately Week 104 for all patients. Patients with a response at Week 16 (end of induction therapy) will be re-randomized for the maintenance therapy period.


Eligibility Criteria:
Inclusion Criteria:

* Adults (from at least 18 years of age) with AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer prior to screening.
* AD disease severity at screening and randomization:

  * EASI of 16 or higher
  * IGA of 3 or 4
  * BSA of 10% or more
* Documented history, within 6 months prior to the screening visit, of either inadequate response or inadvisability of topical treatments.
* Able to complete patient questionnaires.
* Able and willing to comply with requested study visits and procedures.
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Prior use of systemic immune modulating therapies for AD (i.e., JAK inhibitors or biologics)
* Other skin conditions that would interfere with assessment of AD
* Treatment with a live (attenuated) immunization within 12 weeks prior to screening.
* Men and women (of reproductive potential) unwilling to use highly effective birth control and women who are pregnant or breastfeeding.
* Any malignancies or history of malignancies within 5 years prior to randomization (except for basal cell or squamous epithelial carcinomas of the skin that have been successfully treated with no evidence of metastatic disease for 3 years or cervical carcinoma in situ that has been successfully treated, with no evidence of recurrence within the 3 years prior to randomization).
* Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at screening.
* Severe concomitant illness that would in the Investigator's opinion inhibit the patient's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease.
* Concurrent participation in any other investigational clinical study.
Unified Cognitive-Behavioral Therapy (CBT) vs. Combined CBT and Dance/Movement Therapy (DMT) for Anxiety Disorders

The current pilot study will examine and compare the effectiveness of two group psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol, adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy.

In addition, change in proposed mechanism in each therapy will be examined, along with their association with change in outcome measures during therapy.

The current pilot study will examine and compare the effectiveness of two group psychotherapies for mixed anxiety disorders: 1. unified cognitive-behavioral protocol, adapted to a group format. 2. combined cognitive-behavioral and dance/movement therapy.

24 patients will be randomized to 1 of the two treatment arms and treated with 20 weekly 1.5-2 hours therapy sessions. Independent evaluator and self-reports measures will be collected at intake, pre-treatment, session by session, post-treatment and and follow-up.

Hypotheses:

1. Both groups will show effectiveness, as revealed by reduction in anxiety severity and increase in valued living.
2. Changes in process measures (proposed mechanism of change - emotion regulation, working alliance, fear of bodily sensations, bodily/movement awareness) will be predictive of change in outcome measures (anxiety severity and valued living).
3. Changes in bodily/movement awareness will be more predictive of change in outcome measures in the CBT-DMT group than in the unified protocol group.

Eligibility Criteria:
Inclusion Criteria:

* One of the following primary axis I DSM-IV-TR diagnoses: Panic disorder with or without Agoraphobia; Social Anxiety Disorder; Generalized Anxiety Disorder; Anxiety Disorder Not Otherwise Specified; Adjustment Disorder With Anxiety; Adjustment Disorder With Mixed Anxiety and Depressed Mood
* If on medication or in other types of treatments, patients must be willing to remain stable on their treatment for the duration of the acute phase of the study (5-6 months)
* Provision of written informed consent

Exclusion Criteria:

* Current or past schizophrenia, psychosis, or bipolar disorder.
* Current suicidal ideation.
* Current substance/alcohol dependence or abuse.
* Cluster A or B personality disorder.
* Pregnancy (for women).
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months


Eligibility Criteria:
Inclusion Criteria:

* History of gout
* Occurrence of ≥ 2 self-reported gout flares in the last 12 months
* Body weight no less than 50 kg
* Patients who are NOT on approved urate-lowering therapy (ULT) must have sUA ≥ 7 mg/dL
* Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL
* Serum creatinine must be \< 3.0 mg/dL and estimated CLcr ≥ 30 mL/min

Exclusion Criteria:

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* Pregnant or breastfeeding
* History of symptomatic kidney stones within the past 6 months
Comparison of Thoracic Vibration With Classical Respiratory Physiotherapy in Patients With Mechanical Ventilation

Inclusion and Exclusion Criteria: Patients aged 18-65 years who are admitted to the investigator's 3rd Stage Intensive Care Unit and are dependent on mechanical ventilation will be included. The study was planned with 80 patients. Those with known chronic illnesses such as renal insufficiency, heart failure, liver failure, diabetes mellitus, hypertension, chronic obstructive pulmonary disease etc.,; patients in intensive care for postoperative follow-up; patients with mechanical ventilation due to chest or abdominal trauma will be excluded from the study.

Patients who meet the study criteria will be evaluated by a physiotherapy and rehabilitation specialist and will be decided to be included in the respiratory physiotherapy program. The patients will be treated by two physiotherapists in the intensive care unit at random. One of the physiotherapists will perform classical respiratory physiotherapy with thoracic vibration and the other will only perform classical respiratory physiotherapy.

Patients' acute physiology and chronic health assessment II (APACHE II) scores, partial oxygen pressure(PaO2) /fraction of inspired oxygen inspired oxygen fraction (FiO2), tidal volume, minute respiratory rate, peak air pressure, mean air pressure, blood lactate levels will be recorded daily. These values will be collected in the daily routine of the illness depending on the mechanical ventilation, by recording the already performed operations to follow the patient's clinic. If the duration of the total mechanical ventilation and complications occur, the type and timing of the complications will be examined.

At the end of the study, both physiotherapy methods, APACHE II scores, PaO2 / FiO2 values, tidal volume required, minute respiratory rate, peak air pressure, mean air pressure, blood lactate levels, mechanical ventilation duration and complications will be compared statistically.


Eligibility Criteria:
Inclusion Criteria:

* Patients who accepted for Step 3 Intensive Care Unit and connected to mechanical ventilation

Exclusion Criteria:

* Patients with known chronic disease;
* Patients in intensive care for postoperative follow-up;
* Patients with mechanical ventilation due to chest or abdominal trauma
T-DOC® 5 Fr Pediatric Clinical Investigation

A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects


Eligibility Criteria:
Inclusion Criteria:

* Male and Female (Children and infants, 12 years of age and younger)
* Subjects who are scheduled and normally indicated for urodynamics testing, for any medically necessary reason as per the physician.

Exclusion Criteria:

* Subjects who suffer from bladder infections (not including subjects with asymptomatic bacteruria)
* Subjects with urethral strictures
* Subjects who require the use of a suprapubic catheter
Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery

The purpose of this study is to evaluate whether patient-centered educational material delivered before and immediately after surgery can help improve outcomes for patients undergoing colorectal surgery.

To analyze the impact of implementation of patient-centered educational material delivered the SeamlessMD® mobile application on perioperative Enhanced Recovery After Surgery (ERAS) metric completion rates among patients undergoing elective colorectal surgery. This is a non-interventional, prospective feasibility study. The planned study period will encompass adult patients (\>18 years) scheduled to undergo an elective colorectal surgery procedure at CMC-Main during the six-month period of December 2020 to May 2021. Patients enrolling in SeamlessMD will be prompted by the mobile app to electronically complete a validated quality-of-life assessment, the Quality of Recovery (QoR-15) evaluation, five days prior to surgery, three days postoperatively, and 30 days postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old)
* Scheduled to undergo an elective colorectal surgery procedure (for benign or malignant colon or rectal pathology) at CMC-Main by one of the 5 participating colorectal surgeons (Davis, Hill, Kasten, Salo, Squires)
* Ability to provide informed consent

Exclusion Criteria:

* Emergent, non-elective colorectal procedures
* Non-English speaking
Durability and Tolerability of Infliximab in Pediatric Inflammatory Bowel Disease Patients: A 10 Year Single Center Experience

There is little data published on the long term durability of infliximab in pediatric patients. In particular a focus on durable remission, frequency of dose/frequency change and switch within class. Moreover 10 years of safety experience is rarely reported in children.

The overall objective is to evaluate the persistence of infliximab as well as dosing strategies in pediatric inflammatory bowel disease (IBD) patients and safety of infliximab Regarding persistence of infliximab the investigators will be focusing on the proportion of patients who continue to have a durable response or remission to infliximab.

The investigators will be assessing this by measuring the frequency of dose escalation, proportion of patients needing frequency change and proportion of patients switched to adalimumab or certolizumab.

Safety outcomes will focus on frequency of malignancies, infections and immunogenecity


Eligibility Criteria:
Inclusion Criteria:

* All individuals who received at least 2 doses of infliximab before the age of 16 at the pediatric IBD Center at Cedars Sinai Medical Center for the treatment of Crohn's disease or ulcerative colitis Able to give consent

Exclusion Criteria:

* not exposed to infliximab
Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment

IgA nephropathy (IgAN) is a histologically defined glomerulonephritis (renal biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at least 1+) by immunofluorescence. The clinic allows excluding secondary forms (10-15%). Recurrence of this condition on the renal graft is time-dependent and confirmed in 25 to 50% of 10 years post-transplant.

The primary immunosuppressive induction regimens currently used in kidney transplantation are the anti-lymphocyte globulin (GAL) whose main target is human T lymphocytes (ATG, polyclonal) and monoclonal anti-CD25 antibodies (α chain of the interleukin receptor 2 in the surface of T lymphocytes). Due to their potent and prolonged immunosuppressive properties, the ATG may prevent or delay the recurrence on renal transplant.

The aim of this study was to evaluate the influence of induction therapy (ATG versus Basiliximab) in the cumulative incidence at 5 years of (IgAN) recurrence after a first kidney transplant.

This is a prospective, multicenter, randomized, open trial with a follow-up period of 5 years old.

Patients in the ATG arm will receive 5 antilymphocyte globulin infusions Fresenius® (rabbit immunoglobulin antilymphocyte human T-Fresenius® said ATG) from Day 0 to Day + 4 post-transplant (day 0 one dose of 4mg / kg, day 1 one dose of 4mg/kg, day2 one dose of 4mgkg, day 3 one dose of 3 m/kg and day 4 and one final dose of 3 mg/kg) and the patients in the anti-CD25 arm will receive 2 doses of 20 mg of basiliximab (Simulect®) pn day 0 and day 4 after the graft. The maintenance immunosuppressive therapy is left to the discretion of the center.

The primary endpoint will be the clinical and histological recurrence of IgAN defined by the presence of mesangial deposits of IgA (at least 1) by immunofluorescence on a biopsy of the graft triggered by the onset of proteinuria 1g/j and/or microalbuminuria greater than 300 mg / day.


Eligibility Criteria:
Inclusion Criteria:

* Free, informed, express and written.
* Diagnosis of native kidney primary IgA glomerulonephritis biopsy-proven
* First kidney transplantation (one kidney)

Exclusion Criteria:

* Panel Reactive Antibody (PRA PRA global or class I or class II PRA) over 50% on a serum before transplantation
* Multi-organ graft
* Transplants using donor limits or sub-optimal: donor age ≥ 70 years, donors in the study BIGRAS or taken heart beating donors (tested on computer infusion) or other restriction factors
* IgA glomerulonephritis secondary to HSP (Henoch-Schonlein purpura) or Systemic Lupus Erythematosus (SLE) or alcoholic cirrhosis
* History of cancer older than 5 years or with advanced cancer, but except for non-recurrent skin cancers
* Infectious diseases scalable: tuberculosis, HIV, Hepatitis B virus or Hepatitis C virus infection with viral replication and / or chronic hepatitis
* Allergy to rabbit proteins
* Severe thrombocytopenia (\<50,000 platelets/ul)
* Bacterial infection, viral and fungal uncontrolled therapeutically
* Pregnancy or lactation
Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants

The goal of this study is to investigate the preferential responses of speech neural systems in infants.

The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with children's language level (i.e. vocabulary).

Participants will be presented with synthetically modulated stimuli at three frequency scales: 4 Hz, 5 Hz and 30 Hz.


Eligibility Criteria:
Inclusion Criteria:

* be 6 or 10 months old (+/- 2 weeks)
* have received age-appropriate information on the experiment
* their legal guardians have received appropriate information and given their oral consent.

Exclusion Criteria:

* A neurological disorder (visual, auditory, motor, executive)
* Developmental delay
Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss

The purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.

After being informed about the study and potential risks, clients giving written informed consent will be enrolled as participants. Each participant will use the app to self-fit and fine-tune the study aids over 30 days. Outcome measures include speech perception tests, questionnaires and the need for support with using the app. Own-aid performance is the reference, while unaided performance is the baseline.

Eligibility Criteria:
Inclusion Criteria:

* Online client
* Daily aid use
* Bilateral aid use
* Uses P70-R or P90-R aids (same model both ears)
* Does not use earmolds
* Uses same soft tip on both aids
* Owns iPhone7/iOS12 or later
* Willing to install prototype app on own phone and use it in study
* Willing to participate in study for 30 days

Exclusion Criteria:

* Dexterity or cognitive issues that would be problematic for using the app in the study
Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients

The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.

The MTD was found in the phase I portion of this study to be oral lapatinib 1000 mg per day for each 4 week cycle and paclitaxel 60 mg/m2 weekly x 3 of a 4 week cycle and carboplatin AUC 2 weekly x 3 of a 4 week cycle.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients.
* Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease.
* Ability to swallow and retain oral medications.
* Measurable disease

Exclusion Criteria:

* Treatment with previous weekly carboplatin and paclitaxel.
* No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab.
* No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.