louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05585489: Individualization of Music-based Cueing During Gait in Parkinson's Disease.
Official title: Individualization of Music-based Cueing During Gait in Parkinson's Disease. An Exploratory Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait Disorders, Neurologic
Parkinson Disease
Lead sponsor: Henri Mondor University Hospital
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 10
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: Spatio-temporal correction of the step is a key component of gait rehabilitation in Parkinson's disease. Walking rehabilitation techniques using visual or auditory cueing of the cadence or step length have been tested to prevent or correct the lack of consistency of the step. An auditory cue of the duration of the step, encouraging it to be extended according to patient own capacities during gait has been proposed. The cue is integrated into music and is presented in an open-loop approach.

The present study aimed to evaluate the effect of the individual music-based cueing of the step length on gait in Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Idiopathic Parkinson's disease based on UKPDSBB criteria
* 10-meter walking comfortable speed between 0,30 and 1,10 m/s
* Capacities to walk with shoes during at least 20 minutes without assistance
* Signature of informed consent

Exclusion Criteria:

* Non-affiliation to Social Security
* Person under protection (e.g. under protection of justice)
* Auditory disorders without treatment
* Cognitive disorders that limit the understanding of the study according to the medical investigator
* Other neurological or orthoêdic disorders that addect walking
* Participating in another Category 1 or 2 interventional clinical study for the duration of the trial

Primary outcomes:
measure: Step length
timeFrame: Before and just after the intervention (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Créteil
country: France
facility: Laboratoire Analyse et Restauration du Mouvement
Study officials:
References:
Clinical trial NCT06647589: Acceptance and Commitment Therapy for Religious OCD
Official title: Efficacy of Acceptance and Commitment Therapy on Religiously Oriented Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder (OCD)
Keywords: scrupulosity
religion
acceptance and commitment therapy
obsessive-compulsive disorder
OCD
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 10
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: The purpose of the study is to examine the effects and feasibility of a specific form of psychotherapy, acceptance and commitment therapy (ACT), on religiously oriented obsessive and compulsive disorder (OCD).


Eligibility criteria: Inclusion Criteria:

* 18 years old
* Meet cutoff scores for scrupulosity

Exclusion Criteria:

* Presence of psychotic symptoms within six months of screening
* Current suicidal/homicidal plan/intent and/or a suicide/homicide attempt within 6 months of screening
* Non-suicidal self-injury within 6 months of screening
* Narcotics use within 3 months of screening
* Purging/restricting behavior within 3 months of screening.

Primary outcomes:
measure: Scrupulosity Obsessions and Compulsions Scale
timeFrame: At baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
measure: Experiential Avoidance Rating Scale
timeFrame: At baseline, 4 weeks, 8 weeks, and post-intervention (12 weeks)
Secondary outcomes:
measure: Centrality of Religiosity Scale - Interreligious 20
timeFrame: Pre and post intervention which in general lasts 12 weeks
measure: Yale-Brown Obsessive and Compulsive Scale - Self Report
timeFrame: Pre and post intervention which in general lasts 12 weeks
measure: Patient Health Questionnaire - 9
timeFrame: Pre and post intervention which in general lasts 12 weeks
measure: Generalized Anxiety Disorder - 7
timeFrame: Pre and post intervention which in general lasts 12 weeks
measure: The Intrinsic Spirituality Scale
timeFrame: Pre and post intervention which in general lasts 12 weeks
measure: Psy-Flex
timeFrame: Pre and post intervention which in general lasts 12 weeks
measure: Almost Perfect Scale - Revised
timeFrame: Pre and post intervention which in general lasts 12 weeks
measure: The Alcohol Use Disorders Identification Test
timeFrame: Pre and post intervention which in general lasts 12 weeks
measure: National Institute on Drug Abuse Screener
timeFrame: Pre and post intervention which in general lasts 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00809289: Phase 1 Thorough QT (TQT) Study in Young Healthy Volunteers
Official title: A Randomized, Multiple Dose, Placebo and Active Controlled 3-way Crossover Study to Investigate the Effects of Esreboxetine on QTc Interval in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fibromyalgia
Keywords: Thorough QT/QTc study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This Phase 1 study will assess the effects of esreboxetine on the heart. In particular the effects on a specific electrocardiogram (ECG) measurement called QTc will be measured.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged 18 to 55 years
* Body mass Index of approximately 18 to 30kg/m2
* Informed consent document signed by the subject or a legally acceptable representative
* Subjects who are willing and able to comply with the scheduled visits, treatment tests, laboratory tests, and other study procedures

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic psychiatric, neurologic or allergic disease or clinical findings at screening
* Conditions possibly affecting drug absorption
* 12-lead ECg demonstrating QTc \> 450ms or any other clinically significant abnormalities at screen
* Positive urine drug screen
* Hypersensitivity to moxifloxacin
* Unwilling or unable to comply with the lifestyle guidelines in the protocol Treatment with an investigational drug within 3 months or 5 half lives (whichever is longer) preceding the first dose of study medication

Primary outcomes:
measure: To assess whether multiple dose administration of esreboxetine has the potential to affect QTc in healthy volunteers
timeFrame: Up to 24 hours
Secondary outcomes:
measure: To asses the the relationship between plasma concentrations of esreboxetine and its effects, if any on the QTc interval
timeFrame: Up to 24 hours
measure: To assess the effects of a positive control (moxifloxacin) on QTc interval in healthy volunteers
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04293289: Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Official title: Phase 1 Clinical Trial of Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Melanoma
Angiosarcoma
Keywords: BNCT
Boron Neutron Capture Therapy
Borofalan
Melanoma
Angiosacronoma
skin cancer
Lead sponsor: Cancer Intelligence Care Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stella Pharma Corporation
First posted: 2020-03-03
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate treatment dose will be determined.


Eligibility criteria: Inclusion Criteria:

1. Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
2. Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
3. Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor
4. Patients with lesions in the head, neck, chest, or extremities
5. Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration

Exclusion Criteria:

1. Patients with obvious disseminated lesions
2. Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion.
3. Patients with active lesions / active multiple cancers in addition to the target lesion
4. Patients with infections that require systemic treatment.
5. Patients with active implantable medical devices
6. Patients with a history of BNCT treatment

Primary outcomes:
measure: The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)
timeFrame: 90 days
Secondary outcomes:
measure: The incidence of adverse events and failures
timeFrame: 180 days
measure: Tumor shrinkage ratio, tumor best shrinkage ratio
timeFrame: 30, 60, 90, 180 days
measure: Response rate
timeFrame: 30, 60, 90, 180 days
measure: Progression-free survival
timeFrame: 30, 60, 90, 180 days
measure: Survival length
timeFrame: 30, 60, 90, 180 days
measure: Best response rate for target lesion
timeFrame: 30, 60, 90, 180 days
measure: Progression-free period
timeFrame: 30, 60, 90, 180 days
measure: Period until chronic adverse event
timeFrame: 30, 60, 90, 180 days
Other outcomes:
Locations:
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
Study officials:
References:
Clinical trial NCT01851889: Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure.
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All heart failure patients with CF-LVAD at University Hospital of Copenhagen, Rigshospitalet.

Brief summary: The purpose of the trial is to identify factors which can be used as guidance when optimizing continuous-flow left ventricular assist device (CF-LVAD) settings.

The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed ie ΔPCWP/RPM ≠ ΔLVEDD/RPM.

The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under ramp testing in a cohort of "continuous-flow left ventricular assist device" heart failure patients.


Eligibility criteria: Inclusion Criteria:

* Heart failure patients with HeartMate II (HM II) followed as outpatients at The Heart Centre at University Hospital of Copenhagen, Rigshospitalet.
* Age \> 18 years.
* Heart failure in stable phase without the need for intravenous inotropic therapy.
* Ischemic or non-ischemic cardiomyopathy.
* Signed informed consent.

Exclusion Criteria:

* Unstable patients with the need for intravenous inotropic therapy.
* Current hospitalization.
* Implantation of HM II less than one month ago.

Primary outcomes:
measure: Pulmonary capillary wedge pressure in mmHg.
timeFrame: On trial day.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital Rigshospitalet.
state: Kbh Oe
Study officials:
affiliation: Department of Cardiology B, University Hospital Rigshospitalet.
name: Mette H Jung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology B, University Hospital Rigshospitalet.
name: Finn Gustafsson, MD, DMSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004789: Phase I/II Study of Heme Arginate and Tin Mesoporphyrin for Acute Porphyria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Porphyria
Keywords: inborn errors of metabolism
acute porphyria
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 2000-02-25
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the efficacy and safety of heme arginate in the treatment of 20 patients with acute attacks of porphyria.

II. Evaluate the efficacy and safety of heme arginate in preventing frequent exacerbations of acute porphyria in up to 15 patients.

III. Estimate the lowest effective dose of heme arginate (0.3, 1.0, or 3.0 mg/kg) in reducing porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.

IV. Evaluate the safety and efficacy of tin mesoporphyrin used in combination with heme arginate in reducing porphyrin precursors in 12 stable patients with acute intermittent porphyria in remission.

Detailed description: PROTOCOL OUTLINE: This project involves 4 studies: an unblinded multicenter treatment study, an unblinded prevention study, a controlled dose-ranging study, and a controlled drug combination dose-ranging study.

In the treatment study, participants with acute attacks of porphyria receive intravenous heme arginate daily for 4 days. Treatment may be extended to 7 days in patients with severe attacks and slow recovery; these data are analyzed separately.

In the prevention study, participants receive weekly infusions of heme arginate for 6 months. Treatment may be extended in selected cases; these data are analyzed separately. If an acute attack occurs, patients are treated with a standard course of heme arginate. Participants are followed weekly for 6 months after preventive treatment.

In the dose-ranging study, 4 groups of 3 patients are randomly assigned to standard and low-dose heme arginate infusions, administered daily for 4 days. After a washout of 4-12 weeks, patients are crossed to a second dose. In 2 of the 4 groups, patients cross between heme arginate and a normal saline control.

In the combination dose-ranging study, 4 groups of 3 patients are randomly assigned to 1 of 2 doses of tin mesoporphyrin. After a 4-12 week washout, these patients are crossed to a standard or low-dose heme arginate infusion. After a second 4-12 week washout, patients are given a combination infusion of tin mesoporphyrin followed by heme arginate.

All participants are given a special diet to prevent fluctuations in porphyrin precursors.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Well-documented acute porphyria, i.e.: Acute intermittent porphyria Variegate porphyria Hereditary coproporphyria

--Patient Characteristics--

* No pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Karl Elmo Anderson
role: STUDY_CHAIR
References:
Clinical trial NCT06733389: Peripheral Venous Pressure Variation, Pulse Pressure Variation and Pleth Variability Index for Fluid Responsiveness
Official title: Comparison of Peripheral Venous Pressure Variation, Pulse Pressure Variation and Pleth Variability Index in Predicting Fluid Responsiveness
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulse Pressure Variation
Stroke Volume Variation
Pleth Variability Index
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective hepatectomy under general anesthesia

Brief summary: Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy in patients receiving mechanical ventilation. PPV, which measures changes in arterial pressure, requires arterial puncture, which is invasive, and PVI, which detects subtle changes in oxygen saturation, requires an expensive, commercial monitoring equipment. In this study, we aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy. In addition, the investigators aimed to confirm the superiority of the indicators by comparing them with the responsiveness to fluid therapy of the PPV and PVI.

Detailed description: Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy. The investigators aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy.

Eligibility criteria: Inclusion Criteria:

* Patients voluntarily agreed and signed the written informed consent form before participating in the study
* Adults aged 19 years or older
* American Society of Anesthesiologists physical class (ASA) 1-3
* Patients scheduled for elective hepatectomy under general anesthesia
* Patients who require arterial pressure monitoring and additional peripheral venous access for routine anesthesia preparation
* Non-smokers with normal pulmonary function

Exclusion Criteria:

* Patients with abnormal findings on electrocardiogram before surgery
* Patients who cannot undergo peripheral venous puncture

Primary outcomes:
measure: Fluid responsiveness
timeFrame: intraoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi-do
Study officials:
affiliation: assistant professor
name: Insun Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02423889: Stereotactic Volumetric Radiotherapy in Prostate Cancer
Official title: Stereotactic Radiotherapy in Low Risk Prostate Cancer: a Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Hypofractionated radiotherapy
SBRT
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 28
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: This is a prospective, single arm, phase II, multicentric study. It evaluates the acute and late toxicity after stereotactic radiotherapy in low risk prostate cancer patients. All participants receive a total dose of 36.25 Gy in 5 fractions, twice a week, 7.25 Gy per fraction.


Eligibility criteria: Inclusion Criteria:

* Histology of prostate adenocarcinoma
* Age≥ 18 years
* Life expectancy≥ 10 years
* Clinical negative nodes (N0)
* No metastasis presence (M0)
* No previous pelvic radiation therapy
* Total PSA≤10 ng/ml
* Gleason score ≤ 6
* T1-2
* ≤ 3 positive biopsy at prostatic mapping
* Signed informed consent

Exclusion Criteria:

* Positive nodes (N+) or metastatic disease (M+)
* Inflammatory bowel disease, collagen- vascular disorders or active autoimmune disorders
* Anticoagulant treatment in progress
* Hip or pelvic presence of medical devices that could prevent a correct image acquisition
* Symptomatic haemorrhoidal disease
* Adverse reactions to iodinate or paramagnetic contrast media
* Previous malignant cancer, except basocellular skin tumour or other tumours healed since 5 years
* Previous pelvic radiotherapy
* Psychiatric disorder that preclude to obtain informed consent

Primary outcomes:
measure: Acute toxicity
timeFrame: up to 3 months
measure: Late toxicity
timeFrame: up to 60 months
Secondary outcomes:
measure: Disease free survival
timeFrame: up to 5 year
measure: Disease specific survival
timeFrame: up to 5 years
measure: Overall survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS AOU San Martino-IST
state: GE
city: Turin
country: Italy
facility: AO Città della salute e della scienza - Molinette
state: TO
city: Brescia
country: Italy
facility: Istituto del Radio "O. Alberti" Spedali Civili - University of Brescia
Study officials:
References:
Clinical trial NCT06277089: Curve Correction of Early Onset Scoliosis by Mehta Serial Casts
Official title: Curve Correction of Early Onset Scoliosis by Mehta Serial Casts
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Scoliosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis

Detailed description: Early Onset Scoliosis refers to various types of Scoliosis with onset before 10 years of age .In addition to spinal Deformity Progressive Scoliosis will also affect the development of thoracic cage and lungs . So Early correction is important .

Curve correction can done by operative and nonoperative techniques . Our Study include the curve correction by Mehta Serial Casts which not need for blood transfusion and has a good role in stop progression and delay the need for surgery .

Eligibility criteria: Inclusion Criteria:

* All cases with Early Onset Scoliosis up to 10 years Age presenting to Assiut University Hospitals during 2 years period .

Exclusion Criteria:

* Cases with previous spine surgery and those whose guardians refuse to participate in the study .

Primary outcomes:
measure: Difference of the scoliotic cobb angle at last cast
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Prof.dr
name: Mohammad Mostafa El Sharkawi
role: STUDY_DIRECTOR
affiliation: Prof.dr
name: Nariman Elsayed Mohammad ABOL Oyoun
role: STUDY_DIRECTOR
References:
citation: Thorsness RJ, Faust JR, Behrend CJ, Sanders JO. Nonsurgical Management of Early-onset Scoliosis. J Am Acad Orthop Surg. 2015 Sep;23(9):519-28. doi: 10.5435/JAAOS-D-14-00019.
citation: Matsumoto H, Auran E, Fields MW, Hung CW, Hilaire TS, Roye B, Sturm P, Garg S, Sanders J, Oetgen M, Levine S, Roye D, Vitale M; Pediatric Spine Study Group. Serial casting for early onset scoliosis and its effects on health-related quality of life during and after discontinuation of treatment. Spine Deform. 2020 Dec;8(6):1361-1367. doi: 10.1007/s43390-020-00175-5. Epub 2020 Aug 5.
citation: Mahajan R, Kishan S, Mallepally AR, Shafer C, Marathe N, Chhabra HS. Evolution of casting techniques in early-onset and congenital scoliosis. J Clin Orthop Trauma. 2020 Sep-Oct;11(5):810-815. doi: 10.1016/j.jcot.2020.06.034. Epub 2020 Jul 8.