louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01968915: Safety and Tolerability of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors
Official title: A Phase I Study of Oral LCL161 in Japanese Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: LCL161, Paclitaxel, Japanese patient, Neoplasms
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-10-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate safety and tolerability to estimate the maximum tolerated dose and/or recommended dose of oral LCL161 in Japanese patients with advanced solid tumors.


Eligibility criteria: Inclusion criteria:

1. Patients with a histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available.
2. ECOG performance status 0-1.
3. Patients must have recovered from all toxicities related to their previous treatment.

Exclusion criteria:

1. Unresolved nausea, vomiting, diarrhea or peripheral neuropathy CTCAE grade \>1.
2. History of or current interstitial lung disease or autoimmune disease.
3. History of or current impaired cardiac function or clinically significant cardiac diseases.
4. Women of child-bearing potential, unless they are using highly effective methods of contraception.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Frequency of dose limiting toxicities as a function of LCL161 during first cycle
timeFrame: First cycle (21 days)
measure: Adverse events of oral LCL161
timeFrame: From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation)
Secondary outcomes:
measure: Adverse events of oral LCL161
timeFrame: From informed consent until 28 days after end of treatment (end of treatment visit occurs within 7 days after the determination of study discontinuation)
measure: LCL161 plasma concentration and derived pharmacokinetic parameters
timeFrame: From first cycle and up to 3 cycle (each cycle is 21-day period)
measure: Paclitaxel plasma concentration and derived pharmacokinetic parameters
timeFrame: From first cycle of combination and up to 2 cycle (each cycle is 21-day period)
measure: Tumor response according to RECIST 1.1
timeFrame: Every 2 cycles for first 8 cycles, then every 3 cycles and until end of treatment (each cycle is 21-day period and end of treatment visit occurs within 7 days after the determination of study discontinuation)
Other outcomes:
Locations:
city: Nagoya-city
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Kobe-city
country: Japan
facility: Novartis Investigative Site
state: Hyogo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06201715: Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis
Official title: Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis: a Prospective, Observational Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prurigo Nodularis
Itch
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Tofacitinib, an oral pan-JAK inhibitor, mainly selective against JAK1 and JAK3.
Primary purpose: TREATMENT

Brief summary: The goal is to evaluate the efficacy and safety of tofacitinib in treating refractory prurigo nodularis.The main questions it aims to answer are

1. whether tofacitinib is effective in treating prurigo nodularis in the longpterm.
2. whether tofacitinib is safe in prurigo nodularis patients in the longpterm.


Eligibility criteria: Inclusion criteria:

1. age ≥18 years old;
2. patients diagnosed with PN with a duration of more than 6 months;
3. presence of at least 10 pruritic nodules;
4. a Worst Itch-Numeric Rating Scale (WI-NRS) score ≥7 one week before study;
5. a history of more than 2 weeks of ineffective topical glucocorticoid treatment or antihistamine therapy;
6. signed informed consent and cooperated with the follow up and complied the study protocol.

Exclusion criteria:

1. current used of biologic, systemic glucocorticoid or immunosuppressive agents; past used of jak inhibitors;
2. were pregnant or lactating;
3. abnormal findings for patients' complete blood count, liver functions, and kidney function tests;
4. presence of any infection or inflammatory; presence of active tumors or an increased risk of tumor complications；
5. systemic comorbidities that could interfere with or complicate study assessments.
6. those experiencing atopic dermatitis within 6 months were excluded from this study.

Primary outcomes:
measure: Investigator's global assessment
timeFrame: up to 12 weeks
measure: Prurigo Activity Score
timeFrame: up to 12 weeks
measure: Visual analogue scale (VAS) at week 12
timeFrame: up to 12 weeks
measure: Numeric rating scale at week 12
timeFrame: up to 12 weeks
measure: Verbal rating scale (VRS) at week 12
timeFrame: up to 12 weeks
measure: Dermatology Life Quality Index (DLQI) at week 12
timeFrame: up to 12 weeks
measure: Itchy specific quality of life (Itchy QoL) at week 12
timeFrame: up to 12 weeks
Secondary outcomes:
measure: the proportion of patients with reduction in WI-NRS by ≥4 points from baseline at week 12 and week 16.
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
References:
Clinical trial NCT05771415: Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies
Official title: Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Diseases
Keywords: Near-Infrared Spectroscopy
Placenta oxigenations
Placenta maturity
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 34
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with singleton low-risk, uncomplicated, term pregnancies anterior placental localization and abdominal wall of less than 3cm thickness. US and Doppler studies, as well as CTG and laboratory findings were normal in all study women.

Brief summary: The aim was to compare placental oxygenation in low risk, uncompli-cated, term pregnancies measured by near-infrared spectroscopy (NIRS) in relation to the placental maturity grade determined by ultrasound assessment according to Grannum scale.

The study included 34 singleton subjects divided into two groups accord-ing to placental maturation: low grade (Grannum 0-1; n=10) and high grade (Gran-num 2-3; n=24). In each study subjects, measurement was performed at two sites: (a) test site above the central part of the placenta, and (b) control site out of placenta on lower abdomen, in medial line, 3 cm from the symphysis. Student's t-test was used to compare tissue oxygenation index (TOI) values among the study groups. The normality of distribution was demonstrated by the Kolmogorov-Smirnov test.


Eligibility criteria: Inclusion Criteria:

singleton pregnancies low-risk pregnancies uncomplicated pregnancies term pregnancies (37th to 41+6 weeks of gestation) anterior placental localization abdominal wall of less than 3cm thickness.

Exclusion Criteria:

complicated pregnancies pre-term pregnancies Abdominal wall tick \> 3cm

Primary outcomes:
measure: Placental oxygenation levels
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Hormona Polyclinic
Study officials:
affiliation: Clinical Hospital Centre Zagreb
name: Mislav Mikuš, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Palermo
name: Antonio Simone Laganà, M.D. Ph.D.
role: STUDY_CHAIR
affiliation: University of Palermo
name: Andrea Etrusco, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT03632915: Pharmacokinetics of Antiepileptics in Patients on CRRT
Official title: Pharmacokinetics of Antiepileptic Drugs in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Renal Insufficiency
Renal Failure
Pharmacokinetics
Keywords: Antiepileptics
Continuous Renal Replacement Therapy
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing CRRT who are also being treated with an antiepileptic drug

Brief summary: The purpose of the study is to measure levels of any of the following AEDs (levetiracetam, phenobarbital, phenytoin, ketamine, valproic acid, lacosamide) in blood and effluent on critically ill patients receiving CRRT in order to characterize drug pharmacokinetics and optimize dosing strategies in patients on CRRT.


Eligibility criteria: Inclusion Criteria:

* Expected to be on CRRT and receive any of the following for more than 24 hrs
* Expected to survive for more than 24 hrs
* Achievement of steady state drug concentrations prior to study enrollment

Exclusion Criteria:

* Pregnancy
* Age \< 18
* Prisoner

Primary outcomes:
measure: Influence of renal replacement therapy on drug exposure (AUC of plasma concentration levels)
timeFrame: Single Dosing Interval - 12 hours
measure: Influence of renal replacement therapy on drug clearance
timeFrame: Single Dosing Interval - 12 hours
measure: Determination of drug specific sieving coefficient (SC)
timeFrame: Single Dosing Interval - 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Neeraj Badjatia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02569515: A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia
Official title: An Open-Label Study of the Tolerability and Flexibility of Multi-Dose NeoRecormon Administered by Reco-Pen in Pre-Dialysis Patients With Chronic Renal Anemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult patients 18-65 years of age
* Chronic renal failure (Stages I-III)
* No previous epoetin therapy

Exclusion Criteria:

* Poorly controlled hypertension
* History or evidence of malignancy
* Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Percentage of participantss who change to once weekly NeoRocormon
timeFrame: 10 months
measure: Percentage of participants with local intolerabilities (pain/allergic reactions)
timeFrame: 10 months
measure: Percentage of participants who withdrew due to inability to use RecoPen
timeFrame: 10 months
measure: Percentage of participants who changed dose during treatmnent
timeFrame: 10 months
Secondary outcomes:
measure: Quality of life evaluated by the Short Form 36
timeFrame: 10 months
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT00899015: Assessing Arsenic Trioxide in Young Patients With Leukemia or Lymphoma Who Were Treated on Clinical Trial NCI-00-C-0070J
Official title: Sample Analysis for Terminated Protocol 00-C-0070, Pediatric Phase I Trial of Arsenic Trioxide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Lymphoma
Keywords: recurrent childhood acute myeloid leukemia
childhood acute promyelocytic leukemia (M3)
recurrent childhood acute lymphoblastic leukemia
recurrent childhood large cell lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent/refractory childhood Hodgkin lymphoma
childhood chronic myelogenous leukemia
atypical chronic myeloid leukemia, BCR-ABL1 negative
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: RATIONALE: Studying bone marrow and blood samples from patients with leukemia or lymphoma treated with arsenic trioxide may help doctors learn more about cancer.

PURPOSE: This research study is assessing arsenic trioxide in young patients with recurrent or refractory leukemia or lymphoma who were treated on clinical trial NCI-00-C-0070J.

Detailed description: OBJECTIVES:

* To assess the pharmacokinetic and pharmacodynamic profiles of arsenic trioxide in pediatric patients treated on protocol NCI-00-C-0070J.

OUTLINE: Bone marrow or peripheral blood mononuclear cells collected during treatment on NCI-00-C-0070J are assessed for pharmacodynamics studies. Plasma cells collected during treatment are assessed for pharmacokinetics studies. Total arsenic (As), inorganic As forms (AsIII and AsV), and methylated metabolites of As are assessed.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens

  * No meningeal leukemia or lymphoma
  * No HIV-related lymphoma
  * No lymphoproliferative diseases
* Received treatment on protocol NCI-00-C-0070J
* Bone marrow or peripheral blood and serum samples collected during treatment on NCI-00-C-0070J are available

PATIENT CHARACTERISTICS:

* See NCI-00-C-0070J

PRIOR CONCURRENT THERAPY:

* See NCI-00-C-0070J

Primary outcomes:
measure: Pharmacokinetics (PK)
measure: Pharmacodynamics (PD)
measure: Correlation of PK and PD with clinical parameters, such as age, gender, and dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute (NCI)
name: Elizabeth Fox, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01029015: Pilot Trial in Sleep Laboratory Setting to Compare the Physiology of Night Time Bladder Function in Subjects With Overactive Bladder (OAB) Versus Subjects That Have Insomnia and Healthy Normal Subjects
Official title: A Pilot, Phase 4, Sleep Laboratory Study Comparing the Physiology of Nocturnal Bladder Function in Subjects With Overactive Bladder - Associated Nocturia to Subjects With Primary Insomnia and Healthy Normal Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Function
Keywords: OAB
Insomnia
Bladder function
cystometry
polysomnography
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-12-09
Enrollment: 26
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects identified through urology physicians, sleep laboratory physicians and advertising

Brief summary: This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary. After one week, subjects meeting eligibility requirements will complete a single sleep night stay in a sleep laboratory setting. During the sleep night stay, subjects will be evaluated using cystometry and polysomnography. In the morning following the sleep night stay, subjects will complete a sleep questionnaire and this will complete their participation in the study.


Eligibility criteria: Inclusion Criteria:

* Must not have a urinary tract infection
* Time in bed between 6.5 and 9 hours for at least 5 nights per week for preceding month
* Usual bed time is before midnight (24:00 hours) and typically does not vary by ± 1 hour for preceding month
* OAB subjects

  * OAB symptoms for \>= 3 months
  * Documented detrusor overactivity episodes within 6 months
* Insomnia subjects

  * Diagnosis of chronic primary insomnia
  * History of \> 1 month of waking up more than 2 times per night and being awake for more than 60 minutes per night for at least 3 months

Exclusion Criteria:

* Diagnosis of both OAB and primary insomnia
* Diagnosis of nocturnal polyuria
* Diagnosis of BPH
* BMI \>= 34

Primary outcomes:
measure: Number and proportion of voids associated with urgency
timeFrame: During night in sleep lab
measure: Number and proportion of voids associated with Detrusor Overactivity episodes within 10 minutes prior to the polysomnography (PSG) awakenings
timeFrame: During night in sleep lab
measure: Time from PSG awakening to each void in minutes
timeFrame: During night in sleep lab
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
state: North Carolina
Study officials:
affiliation: Duke University
name: Use Central Contact
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06811415: Tempromandibular Joint Reconstruction Via Computer-Assisted Surgery Simulation
Official title: Tempromandibular Joint Reconstruction Via Computer-Assisted Surgery Simulation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Temporomandibular Joint
Keywords: 3D printed templates
computer-assisted surgical simulation
costochondral graft
temporomandibular joint
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 8
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was planned to evaluate the accuracy of virtual surgical planning and three-dimensional (3D) printed templates in reconstruction of temporomandibular joint (TMJ) with costochondral graft.

Detailed description: Eight patients (15-45) years diagnosed with TMJ deformities were included. A composite skull model was obtained with data from computed tomography. A virtual surgical simulation was performed using Dolphin Imaging 11.7 Premium. Then, the virtual plan was transferred to the operative field using 3D (CAD-CAM) printed surgical template. These templates were designed by 3D printing using data from the virtual surgical simulation for optimum selection of the rib graft, accurate tailoring of chondral and costal graft and as an osteotomy guide.

The preoperative measurement including mouth opening, facial asymmetry and differences between the actual mandibular position and the virtual plan were analyzed

Eligibility criteria: Inclusion Criteria:

* TMJ deformity due to osteoarthrosis, ankylosis, injury, and pathology
* medicaly free patients

Exclusion Criteria:

* bilateral TMJ deformity
* patients medically compromised

Primary outcomes:
measure: visual analogue scale
timeFrame: 2 weeks
measure: inflammation score scale
timeFrame: 1 month
Secondary outcomes:
measure: mouth opening
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Egypt
Study officials:
affiliation: Tanta University
name: Marwa T Ibrahim, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01333215: Study of Cognitive Inhibition Disorders in Depressed Older Suicide Attempters
Official title: Etude Des Troubles de l'Inhibition Cognitive Chez le Sujet âgé déprimé Suicidant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suicide, Attempted
Cognitive Symptoms
Keywords: Suicide, Attempted
Cognitive Symptoms
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2011-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are recruited during their hospitalisation at Angers University Hospital with respect to the eligibility criteria

Brief summary: The purpose of this study is to compare the cognitive inhibition deficit among depressed older suicide attempters compared to depressed older suicide non-attempters.

Detailed description: The main objective consists in examining the association between cognitive inhibition and suicide attempt in depressed older adults (\> 65 year old).

Eligibility criteria: Inclusion Criteria:

* Age \> 65 years old
* Score of Mini-Mental State Examination (MMSE) \> 23
* Score of Hamilton Depression Scale \>27
* For Group 1 (depressed older suicide non-attempters): No history of suicide attempt
* For Group 2 (depressed older suicide attempters) : History of suicide attempt

Exclusion Criteria:

* Neurological history or medical-surgical affection in the past 3 months.
* Dependence or alcohol abuse.
* Use of neuroleptics

Primary outcomes:
measure: Cognitive inhibition deficit
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: Angers University Hospital
name: Stephane Richard-Devantoy, Mr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richard-Devantoy S, Annweiler C, Le Gall D, Garre JB, Olie JP, Beauchet O. Cognitive inhibition in suicidal depressed elderly: a case-control pilot study. J Clin Psychiatry. 2011 Jun;72(6):871-2. doi: 10.4088/JCP.10l06797. No abstract available.