louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01095705: Hypnosis for Transesophageal Echocardiography
Official title: Utility of Hypnosis for Transesophageal Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Discomfort
Keywords: Hypnosis
Transesophageal Echocardiography
Efficiency of Hypnosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-03-30
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the additive value of hypnosis to improve patient comfort during transesophageal echocardiography (TEE).

Detailed description: TEE is a widely used diagnostic test in cardiovascular medicine. However, the test may be a source of discomfort to the patient. Patient intolerance of the echocardiography probe limits the duration of the procedure and therefore its diagnostic success. Current strategies to reduce patient discomfort involve global anesthesia, which carries its own side effects and risks of adverse events. Hypnosis may reduce patient discomfort without impairing alertness. The main goal of this study is to determine the additive value of hypnosis to improve patient comfort during TEE.

Eligibility criteria: Inclusion criteria:

* Patient with indication for a Transesophageal Echo (TEE)
* Patient competent to provide written informed consent

Exclusion criteria:

* Patient not subscribed to French Social Security System
* Patient non-French speaking
* Age \< 18 years
* Follow-up not possible
* patient declared non competent to give informed consent for the study
* History of severe personality disorder
* Patient with a psychiatric treatment started 30 days before the exam
* Patient pregnant or breast-feeding
* Emergency TEE
* Other indication for general anesthesia

Primary outcomes:
measure: Level of patient comfort
timeFrame: at Day 0
Secondary outcomes:
measure: Rate of procedure failure or non-diagnostic study
timeFrame: at Day 0
measure: Duration of the procedure
timeFrame: at Day 0
measure: Quality of the procedure as assessed by the operator
timeFrame: at Day 0
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital LARIBOISIERE Cardiologie - Laboratoire d'Échocardiographie Doppler
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: François TOURNOUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000305: Amphetamine Cocaine Interaction Study - 2
Official title: Amphetamine Cocaine Interaction Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Texas
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate results of d-amphetamine - cocaine (pharmacology) interaction study.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: John Grabowski, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02715505: Safety and Exploratory Efficacy of HSC835 in Patients With Inherited Metabolic Disorders (IMD)
Official title: A Single-arm, Open-label, Study to Evaluate the Safety and Exploratory Efficacy of HSC835 in Patients With Inherited Metabolic Disorders (IMD) Undergoing Stem Cell Transplantation After Reduced Intensity Conditioning
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Inherited Metabolic Disorders IMD
Keywords: Hurler syndrome, MLD, Krabbe, cALD, Hematopoietic Stem Cell Transplantation (HSCT)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the safety and exploratory efficacy of using HSC835 in patients with Inherited Metabolic Disorders (IMD) undergoing stem cell transplantation.

Detailed description: This phase II study is designed to assess the safety of the Novartis product HSC835 and its ability to achieve donor blood stem cell engraftment in patients with certain Inherited Metabolic Disorders who undergo stem cell transplantation. A reduced intensity conditioning will be used prior to transplantation. Patients with Hurler syndrome, MLD, Krabbe or cALD could be eligible for this study.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Hurler syndrome, Metachromatic leukodystrophy (MLD), Globoid cell leukodystrophy (Krabbe) or Cerebral adrenoleukodystropy (cALD) -Adequate organ function -Availability of eligible donor material

Exclusion Criteria:

* Availability of a matched-related donor who is not a carrier of the same genetic defect -Active infection at screening -Prior myeloablative transplant -Pregnant or nursing women and women of child bearing potential unless using highly effective contraception methods. For the pediatric population, female patients of child bearing potential who do not agree to abstinence or agree to use highly effective contraception methods -Sexually active male patients unless using condoms as contraception -Human Immunodeficiency virus (HIV) infection

Primary outcomes:
measure: Incidence of infusional toxicities
timeFrame: 48 hours
measure: Incidence of neutrophil recovery
timeFrame: 42 days
measure: Incidence of graft failure
timeFrame: 42 days
Secondary outcomes:
measure: Time to neutrophil recovery
timeFrame: 42 days
measure: Time to platelet recovery
timeFrame: 180 days
measure: Number of patients with grade II-IV acute graft versus host disease (aGVHD)
timeFrame: 100 days
measure: Number of patients with chronic graft versus host disease (cGVHD)
timeFrame: 1 and 2 years
measure: Incidence of death
timeFrame: 100 days, 1 year and 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00746005: Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele
Official title: Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2008-09-03
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the short term effects of a pharmacological dose of fish oil on cognitive performance and on cerebral blood flow. Furthermore, we want to investigate whether carriers of the APOEε4 allele respond differently to fish oil treatment compared to non-carriers.


Eligibility criteria: Inclusion Criteria:

* Men and women
* Diagnosed as having amnestic MCI: based on specific memory disturbances (cut-off of 1 sd, single or multiple domain amnestic MCI, according to Busse A et al37)
* Presence of a principal caregiver willing to assist for a successful participation
* Informed consent signed

Exclusion Criteria:

* Current or recent (\<4 weeks) use of fish oil supplements
* Consumption of fish more than 2 times/week
* Current use of dementia (Alzheimer) medication
* Current use of acenocoumarol or other anti-thrombotic drugs (because of the high dose of fish oil)
* Serious liver disease
* Use of more than 4 glasses of alcohol per day
* Unable to participate as judged by the responsible medical physician
* Allergy to fish(oil)
* Swallowing problems
* Participation in another clinical trial less than 2 months before the start of the trial or at the same time

Primary outcomes:
measure: cognitive performance
timeFrame: baseline and after 4 weeks
Secondary outcomes:
measure: blood flow-velocity in the middle cerebral arteries (assessed with TCD) and cortical tissue oxygenation, cerebral autoregulation, cerebral blood volume (assessed with NIRS
timeFrame: baseline and after 4 weeks
Other outcomes:
Locations:
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
Study officials:
References:
Clinical trial NCT04055805: Health and QoL in Oncological Patients: Management of Bone Pathology in Italian Citbl Population
Official title: Health and Quality of Life in Oncological Patients: Management of Bone Pathology in the Italian Citbl (Cancer Treatment Induced Bone Loss) Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Osteoporosis
Keywords: Aromatase Inhibitors
Bone pathology
QoL
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women affected by breast cancer in menopause or with secondary amenorrhea arising from the initiation of oncologic treatments

Brief summary: Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy


Eligibility criteria: Inclusion Criteria:

* Patients willing to provide the Informed consent to participate to the study
* Women aged 18-75 years
* Patients having breast cancer, with no phenotype restrictions
* Patients in natural and stable menopause
* Patients having secondary amenorrhea, that arose after the initiation of oncologic treatment, since at least 12 months or 6 months with FSH\> 40 U/I

Exclusion Criteria:

* Patients with advanced cancer and/or bone metastases and/or visceral metastases
* Patients with severe renal insufficiency and/or in dialysis and patients affected by severe endocrine disorders

Primary outcomes:
measure: Results from some questionnaires related to patients QoL, rated from 1 to 10.
timeFrame: 26-32 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
state: RM
Study officials:
References:
Clinical trial NCT00662805: Pharmacovigilance Study to Evaluate Safety of SERETIDE in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A 2-year Observational Study to Evaluate Safety of Seretide 50/500μg Twice Daily Administered by DISKUS, in Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: pharmacovigilance
COPD
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 762
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Planned: 1000 / Recruited: 771 / Analyzed: 771 A target enrolment of approximately 1000 subjects is planned, at outpatient sites. Any subject with COPD who has an indication to receive Salmeterol + Fluticasone 50/500mcg twice daily at the discretion of the investigator and has met all the inclusion criteria, may take part in the study.

Inclusion criteria

* Outpatient diagnosed with COPD (Criteria of the British Thoracic Society or NHLBI/WHO Global initiative for Chronic Obstructive Lung Disease)
* FEV1 \< 50% of the one predicted at treatment start and/or
* History of repetitive COPD exacerbations and/or
* Patient remains symptomatic despite regular bronchodilator therapy

Brief summary: Primary objective: Evaluation of the safety of Seretide discus administration in subjects with COPD. Treatment duration: 2 years. Study has 3 phases: Screening phase (visit 1), treatment phase (visits 2-5. In the case of AE, there will be another visit (visit 6) as a follow up visit - follow up phase.


Eligibility criteria: Inclusion Criteria:

* Subject should fulfill criteria for the subscription of SERETIDE as these are mentioned in SPC.

Exclusion Criteria:

* Hypersensitivity to Salmeterol + Fluticasone or any of its excipients
* Pregnancy, lactation or scheduled pregnancy during the observational period of the study
* Serious illness/disease, not adequately controlled, or with a potential to interfere with the patients' participation in the present study, according to the investigator/physician's judgment.

Primary outcomes:
measure: The change in markers of increased cardiovascular risk (e.g proinflammatory and prothrombotic markers, microalbuminuria)
timeFrame: 104 weeks
Secondary outcomes:
measure: Trough FEV1, FVC and FEV1/ FVC ratio
timeFrame: every 26 weeks
measure: Health status as determined using the St George's Respiratory Questionnaire (SGRQ)
timeFrame: every 26 weeks
measure: Laboratory assessment including levels of appropriate cardiovascular markers (e.g. CRP, Fibrinogen, PAI-1) and established risk factors, as well as detection of microalbuminuria
timeFrame: every 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03799705: Genetic Variants in Nicotinamide Adenine Dinucleotide (NAD) Synthesis Pathway
Official title: Identifying Genetic Variants in Nicotinamide Adenine Dinucleotide (NAD) Synthesis Pathway in Patients With Congenital Malformations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vacterl Association
Congenital Malformation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 132
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A US population consisting of adults with VACTERL, adults and offspring with a family history of VACTERL, and women with a history of miscarriage and/or congenital malformations.

Brief summary: Researchers are trying to identify versions of genes as well as factors in subjects blood associated with certain types of congenital malformations(CMs). This study will help the researchers to better understand family traits that contribute to CMs.


Eligibility criteria: Inclusion Criteria:

1. Adults with confirmed or putative diagnosis of VACTERL association;
2. Families (mother, father, biological offspring) with a history of VACTERL-associated malformations
3. Gravid or non-gravid women with a history of miscarriage and/or offspring with non-VACTERL-associated malformations
4. Willingness to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection

Exclusion Criteria:

1) Parents of non-biological children 3) Children with congenital malformations associated with an identifiable environmental or lifestyle exposure 4) Children with congenital malformations associated with confirmed chromosomal disorders 5) Failure to abstain from red meat, meat products, chicken, peanuts, or brewer's yeast (including beer) at least 24 hours prior to blood and urine collection.

Primary outcomes:
measure: Genetic variants
timeFrame: 2 years
measure: Targeted metabolomics
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Myra Wick, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04900805: Temperature Variation During Meditative Practices
Official title: Studies of Physiological Effects During Practices of Alternative Mediicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Istituto Nazionale Biostrutture e Biosistemi
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with experience in meditative practice

Brief summary: The temperature on selected points of the hands has been monitored during meditative practices. The practitioner is in complete rest for the time of the measure, and only mental activity is carried out. The purpose is to verify if the heat sensation, that is normally felt, is a real, measurable physiological effect, or if it is just a subjective feeling. Quantitative data analysis is foreseen.

Detailed description: Qigong is a traditional Chinese method for wellness and healing. During practice, which is based on the Qi circulation, it is usual to feel warmth, especially at the hands. The main purpose of this study is to verify if the sensation of heat is not just a subjective feeling but is a real, measurable physiological effect. Quantitative information will be hopefully derived from a simple data analysis. The study will be extended also to deep prayer meditation.

The measurement sessions will consist of two periods of practice separated by one pause period, to ensure that the temperature variation is not due to spurious effects.

T type thermocouples will be used for the temperature measurements, with sensors in the form of small copper disk. The thermocouples will be connected to a data logger, and the results analyzed. The sensors will be positioned in different points of the hands, either on the palm and on the dorsum. The Laogong (PC8) acupuncture point will be preferentially chosen, because is a very important point, from the energetic point of view, of the Traditional Chinese Medicine. and because the sensation of heat is more acute in this point. Other points will be also measured, and compared with the Laogong.

Eligibility criteria: Inclusion Criteria:

. Experience in meditative practice

Exclusion Criteria:

-

Primary outcomes:
measure: Temperature variation during meditative practice
timeFrame: 1 hour
Secondary outcomes:
measure: Comparison of temperature variation in different points of the hands
timeFrame: 1 hour
Other outcomes:
Locations:
city: Roma
country: Italy
facility: INBB
Study officials:
affiliation: Istituto Nazionale Biostrutture e Biosistemi
name: Stefano Lagomarsino
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02109705: Porphyromonas Gingivalis and Alzheimer's Disease
Official title: Porphyromonas Gingivalis - a Responsible Pathogen in Alzheimer's Disease?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Dementia
Periodontitis
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2014-04-10
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 Patients with Dementia (30 with Alzheimer's and 30 with another Dementia) 30 cognitive healthy patients

Brief summary: With this study the investigators would like to analyze the the role of periodontal disease and especially the role of Porphyromonas gingivalis in initiation and progression of Alzheimer's Disease.


Eligibility criteria: Inclusion Criteria:

* age 40-70
* caucasian origin
* dementia (Alzheimer's or other dementia)
* cognitive healthy (need for spinal anesthesia)

Exclusion Criteria:

* use of antibiotics within las 6 months
* pregnancy
* another illness explaining the symptoms in a better way
* smoking (\>10 cigarettes)
* patients who have a legal custodian

Primary outcomes:
measure: Cmax Antibody Levels against Gingipains
timeFrame: Baseline
Secondary outcomes:
measure: Cmax Beta-Amyloid
timeFrame: Baseline
Other outcomes:
measure: Cmax: Periodontal pathogens
timeFrame: Baseline
measure: U enzyme activities
timeFrame: Baseline
measure: Cmax: inflammatory cytokines
timeFrame: Baseline
Locations:
city: Muenster
country: Germany
facility: Department of Periodontology
Study officials:
affiliation: Department of Periodontology
name: Oliver Laugisch, Dr med dent MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03127605: Inotuzumab Ozogamicin - PF-05208773
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-04-25
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Inotuzumab Ozogamicin Expanded Access Program


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: