louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02783391: Pre and Per-operative Electrophysiological Cartography of Speech Area With Cortical Electrode Matrices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumoral or Epileptical Cortectomy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: New method for speech area cartography in patient individual cortical anatomy in view of improving functional area limit preservation during surgery.


Eligibility criteria: Inclusion Criteria:

* Patients needing cortectomy
* Male or female aged over 18 years
* Registered in the French social security scheme
* Signed informed consent

Exclusion Criteria:

•All categories of protected persons

Primary outcomes:
measure: electrophysiological recording
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
References:
Clinical trial NCT00916591: Prokinetic Drugs and Enteral Nutrition
Official title: Effect of Prokinetic Drugs During the Administration of Enteral Nutrition
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critically Ill
Enteral Nutrition
Keywords: gastroesophageal reflux
respiratory aspiration
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2009-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients, intubated and mechanically ventilated, 18 years or older

Brief summary: The purpose of this study is to compare the effect of two drugs that can help in the prevention of regurgitation during the administration of enteral nutrition and define which one is the most effective.

Detailed description: Two prokinetic drugs (metoclopramide and erythromycin) will be compared during the administration of enteral nutrition in critically ill patients. We would like to know which one is the most effective in preventing regurgitation and risk of aspiration, which is a common complication of enteral nutritional support. This will be evaluated by measuring gastric residue every six hours.

Eligibility criteria: Inclusion Criteria:

* critically ill patients
* intubated
* mechanically ventilated
* 18 or older age
* enterally fed

Exclusion Criteria:

* prokinetic drugs before start study
* allergy to study medication
* interactions odf study medication with other drugs
* recent gastro-intestinal surgery
* history of esophagectomy or gastrectomy
* suspicion of gastrointestinal perforation
* myasthenia gravis
* liver dysfunction
* less than 7 days in study
* gastro- or jejunostomy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZBrussels
Study officials:
References:
Clinical trial NCT03632291: Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UB-221 as an Add-on Therapy in CSU Patients
Official title: A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of UB-221 as an Add-on Therapy in Patients With Chronic Spontaneous Urticaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Urticaria Chronic
Keywords: UB-221
anti-IgE monoclonal antibody
chronic spontaneous urticaria (CSU)
Lead sponsor: United BioPharma
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

Detailed description: This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of UB-221 as an add-on therapy in patients with Chronic Spontaneous Urticaria.

Eligibility criteria: Inclusion Criteria:

* Subjects with age between 20 to 65 years old (inclusive).
* Subjects who are able and willing to provide the informed consent.
* Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above.
* Subjects diagnosed with chronic spontaneous urticaria (CSU).

Exclusion Criteria:

* History of significant diseases (other than CSU) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject is not suitable to participate in this study.

Primary outcomes:
measure: Adverse event incidence
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01804491: Motion Analysis in Patients With Hallux Rigidus
Official title: Motion Analysis in Patients With Hallux Rigidus Before and After Different Types of Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Rigidus
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with osteoarthritis in the first metatarso-phalangeal joint (hallux rigidus)

Brief summary: The aim was to investigate with a multi-segmental foot model the kinetic and kinematic in patients with a hallux rigidus, before and after different type of surgery.

Detailed description: None of the patients received surgery BECAUSE of the study. We have only performed motion analysis in patients, who were already scheduled for one of the described type of surgery (prospective group) or who already previously received one the type of surgery (retrospective group).

Eligibility criteria: Inclusion Criteria:

* patients with osteoarthritis of one or both first metatarso-phalangeal joints (hallux rigidus)
* patients after surgery due to osteoarthritis of one or both first metatarso-phalangeal joints (hallux rigidus)

Exclusion Criteria:

* previous operations on the foot and ankle
* rheumatic diseases
* relevant foot deformities other than hallux rigidus

Primary outcomes:
measure: Change of hallux range of motion
timeFrame: baseline (=1 day before surgery) and 1 y. after surgery for the prospective groups, more than one year after surgery for the retrospective groups
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Motion Analysis Laboratory of the Department of Orthopedics, Trauma Surgery and Spinal Cord Injury, University Hospital Heidelberg
Study officials:
References:
citation: Kuni B, Wolf SI, Zeifang F, Thomsen M. Foot kinematics in walking on a level surface and on stairs in patients with hallux rigidus before and after cheilectomy. J Foot Ankle Res. 2014 Feb 13;7(1):13. doi: 10.1186/1757-1146-7-13.
Clinical trial NCT05998291: Dermatitis Herpetiformis Refractory to Gluten Free Diet
Official title: Gluteenittomaan Ruokavaliohoitoon Vastaamaton Ihokeliakia
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Dermatitis Herpetiformis
Keywords: dermatitis herpetiformis, dapsone, gluten-free diet
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
name: University of Helsinki
First posted: 2023-08-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with refractory dermatitis herpetiformis

Brief summary: The main purpose of the study is to find out

1. the natural course of refractory dermatitis herpetiformis and the development of possible complications
2. the strictness of gluten-free diet treatment in refractory dermatitis herpetiformis

Detailed description: Refractory dermatitis herpetiformis refers to dermatitis herpetiformis unresponsive to gluten-free diet therapy. So far, there is very little knowledge on the course of the disease and the causes and prognosis of refractory celiac disease.

Study patients with refractory dermatitis herpetiformis will be recruited. As a control material dermatitis herpetiformis patients with good response to gluten-free dietary treatment will be recruited.

Eligibility criteria: Inclusion Criteria:

Study patients:

* Dermatitis herpetiformis diagnosis
* Dermatitis herpetiformis rash not responding to a strict gluten-free diet after at least 3 years

Control patients:

* Dermatitis herpetiformis diagnosis
* Dermatitis herpetiformis with good response to a gluten-free diet

Exclusion Criteria:

Study patients:

-Not following strict gluten-free diet

Control patients:

-Not following a strict gluten-free diet

Primary outcomes:
measure: Clinical prognosis
timeFrame: Baseline
Secondary outcomes:
measure: Dietary adherence GIP test, CDAT, TG2, TG3 and Ema antibodies, anamnesis
timeFrame: Baseline
Other outcomes:
measure: Microbiata
timeFrame: Baseline
measure: Quality of life measure DLQI
timeFrame: Baseline
measure: Quality of life measure BGWP
timeFrame: Baseline
measure: Gastrointestinal symptoms GSRS
timeFrame: Baseline
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Kaisa Hervonen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00713791: Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets.
Official title: A Phase I, Randomised, Single-blind, Single-centre, Incomplete-block Crossover, Relative Bioavailability Study in Healthy Male Subjects for ZD4054 (Zibotentan) Immediate Release Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
ZD4054
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to see how different formulations of ZD4054 (Zibotentan) are absorbed by the body. As for all clinical trials, safety and tolerability of the drug will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Normal resting 12-lead ECG with normal QTc interval (\<450 msec)
* Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening

Exclusion Criteria:

* Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
* Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
* Judgement by the investigator, that the healthy volunteer should not participate in the study

Primary outcomes:
measure: characterise and compare the plasma concentration-time profiles for ZD4054 (Zibotentan) when administered as reference oral solution formulation and as 5 solid oral formulations.
timeFrame: 00.50mins, 01.00, 01.15, 01.30, 01.45, 02.00, 02.30, 03.00, 04.00, 06.00, 08.00, 12.00, 24.00, 36.00, 48.00, 72.00, 96.00hrs
Secondary outcomes:
measure: characterise and compare pharmacokinetic parameters for ZD4054 (Zibotentan) when administered as an oral solution and as 5 solid oral formulations and to assure the safety of all healthy volunteers by assessment of vital signs, ECG, Labs, and AEs
timeFrame: 00.05, 00.10, 00.15, 00.20, 00.30, 00.40, 00.50mins, 01.00, 01.15, 01.30, 01.45, 02.00, 02.30, 03.00, 04.00, 06.00, 08.00, 12.00, 24.00, 36.00, 48.00, 72.00, 96.00hrs
measure: To assure the safety of all subjects by assessment of vital signs, ECG, clinical chemistry, haematology, urinalysis and adverse events.
timeFrame: From time of Consent to Last Visit
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: AZ Clinical Pharmacology Unit, Philadelphia, USA
name: Sylvan Hurewitz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01578291: Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram
Official title: Parent Education and Medical Play: A Comparison of Psychological Preparation Strategies for Voiding Cystourethrogram
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vesicoureteral Reflux
Keywords: Play therapy
Urinary tract infections
Children
Vesicoureteral reflux
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: The use of parent education and medical play will be able to reduce patient discomfort with potential uncomfortable medical procedures.

Children that have urinary tract infections and those diagnosed with vesicoureteral reflux undergo a procedure called a voiding cystourethrogram (VCUG) to identify and follow vesicoureteral reflux. For many children and parents this can lead to considerable distress. Pre-procedure preparation can potentially reduce anxiety and improve overall experience with the procedure.

Detailed description: Children that are evaluated medically and found to need a VCUG would be eligible for participation in this study. Children would be randomized to having play therapy or a parental education brochure. The study would have no impact on the child recieving the state of the art medical care.

Play therapy involves having the child play through the process of the study with a child life therapist, in an effort to prepare the child for the procedure. Parents/patients will be given a pre and post procedure evaluation form to objectively categorize the parental/patient perception of the experience with the study.

Eligibility criteria: Inclusion Criteria:

* Children that have been identified to need a voiding cystourethrogram

Exclusion Criteria:

* Significant medical conditions that preclude child from being able to understand play therapy or have been identified in the past to have so much discomfort from prior studies as to not be able to participate.

Primary outcomes:
measure: Does Parent Education and Medical play reduce anxiety and discomfort associated with Voiding Cystourethrogam
timeFrame: 12 months anticipated
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Childrens Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Ranjuv Mathews, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006591: Ritonavir and Agenerase Treatment for Patients Who Have Failed Previous Anti-HIV Treatment
Official title: The Safety and Efficacy of a Ritonavir-Enhanced Agenerase Regimen as Salvage Therapy in HIV-Infected Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
VX 478
Salvage Therapy
Anti-HIV Agents
Drug Monitoring
Nelfinavir
Treatment Experienced
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if treatment with an anti-HIV drug containing ritonavir and Agenerase is safe and can lower the level of HIV in the blood in patients who have failed an anti-HIV drug treatment containing nelfinavir.

Detailed description: HIV-infected patients will be treated with a ritonavir-enhanced Agenerase regimen.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are 18 years of age or older.
* Are HIV-positive.
* Have a viral load (level of HIV in the body) of more than 1,000 copies/ml.
* Have had more than 12 weeks of prior anti-HIV drug treatment.
* Have failed a previous anti-HIV treatment containing nelfinavir as the only protease inhibitor.
* Are responsive to Agenerase.
* Are able to follow study requirements.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Are intolerant to ritonavir (an anti-HIV drug).
* Have or have had problems with absorption.
* Have liver disease or damage.
* Have pancreatic disease or damage.
* Have taken any protease inhibitor other than nelfinavir.
* Are receiving investigational drugs or devices from another study.
* Are pregnant or breast-feeding.
* Currently use triazolam, astemizole, ergot medications, cisapride, midazolam, bepridil, rifampin, terfenadine, or pimozide.
* Have a bleeding disorder.
* Have previously been treated with Agenerase.
* Are receiving nonnucleosides.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Gathe, Joseph, M.D.
state: Texas
Study officials:
References:
Clinical trial NCT06284291: Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies
Official title: Use of Transcranial Magnetic Stimulation (TMS) as a Surrogate of Pathophysiology in Genetic Epilepsies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Genetic Disease
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Transcranial magnetic stimulation (TMS) uses electromagnetic induction as an efficient, painless, non-invasive method to generate a suprathreshold current at the level of the encephalon, and provide in vivo measurements of cortical excitability and reactivity at the level of the motor cortex (TMS-EMG) or the entire cortical mantle (TMS-EEG). This study proposes TMS measurements as a diagnostic tool in patients to understand mechanisms of epileptogenesis related to genetic mutations, and prognostic to guide and monitor precision treatments.


Eligibility criteria: Inclusion Criteria:

* Children aged \>3 years and adults
* Diagnosis of epilepsy with presumed or confirmed genetic etiology. Diagnosis of genetic epilepsy is made by next-generation sequencing (NGS) analysis
* or Diagnosis of primary (non-hemicranial) headache, in the absence of alterations on neuroimaging, and no known genetic condition
* Obtaining informed consent

Exclusion Criteria:

* Age \<3 years
* Presence of contraindications to TMS: history of head or eye trauma with inclusion of metal fragments, cardiac pacemaker, arrhythmic heart disease, hearing implants, implantation of drug delivery devices, piercings or tattoos with metallic ink.
* Pregnancy status

Primary outcomes:
measure: Resting motor threshold
timeFrame: 24 months
measure: SICI
timeFrame: 24 months
measure: ICF
timeFrame: 24 months
measure: LICI
timeFrame: 24 months
measure: TEP amplitude
timeFrame: 24 months
measure: TEP latency
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Meyer Children's Hospital IRCCS
Study officials:
References:
Clinical trial NCT01012791: Does Zumba Improve Cognition in Healthy APOE e4 Carriers and Noncarriers
Official title: Does Zumba Improve Cognition in Healthy APOE e4 Carriers and Noncarriers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: Zumba exercise
ApoE
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2009-11-13
Enrollment: 65
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main purpose of this study is to compare the effects on attention and memory functioning to participating in an aerobic and dance exercise called Zumba to educational program on exercise that encourages regular stretching and walking.


Eligibility criteria: Inclusion Criteria:

* Healthy women between the ages of 55-80 without cognitive complaints

Exclusion Criteria:

* History of significant health conditions

Primary outcomes:
measure: To examine the feasibility of doing exercise intervention studies in presymptomatic, at risk individuals and determine the optimal outcome measure with minimal practice effect.
timeFrame: 6 months
Secondary outcomes:
measure: To examine whether forty 60 minute sessions of Zumba are associated with cognitive changes in healthy women between 55 and 80 years of age.
timeFrame: 6 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Cynthia Stonnington, MD
role: PRINCIPAL_INVESTIGATOR
References: