louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01991444: CGA-TAVI Registry to Evaluate the Predictive Value of a CGA in Predicting TAVI Outcomes
Official title: Registry Study to Evaluate the Predictive Value of a Comprehensive Geriatric Assessment With Regard to the Outcome of a Transcatheter Aortic Valve Implantation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
First posted: 2013-11-25
Enrollment: 72
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve in participating sites.

Routine data about the invervention (transcatheter valve Implantation) will be collected. In addition, data describing the geriatric status of the patient, including a patient questionnaire evaluating his/her Quality of life will be collected.

Brief summary: Registry study to evaluate the predictive value of a comprehensive geriatric assessment with regard to the outcome of a transcatheter aortic valve Implantation.

It will be evaluated which parts of the comprehensive geriatric assessment (CGA) are best suited to predict the therapeutic success of a heart valve Implantation in elderly ( \> 80 years) Patient. Possible participants are all Patient of 80 years or above for whom the implantation of a Edwards Sapien XT aortic valve is planned

Detailed description: Transcatheter Aortic Valve Implantation Registry with Comprehensive Geriatric Assessment

Eligibility criteria: Inclusion Criteria:

* Scheduled TAVI using Edwards SAPIEN XT Transcatheter Heart Valve
* Compliance with the indications of the instructions for use
* Age of at least 80 years
* Written informed consent

Exclusion Criteria:

* Presence of contraindications as to the Instructions for Use
* No possibility for a follow-up

Primary outcomes:
measure: Comprehensive geriatric assessment
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: predictive Value of CGA Tavi
timeFrame: baseline
measure: Score development
timeFrame: after 3 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CRCHUM Montréal
city: Florence
country: Italy
facility: University Medical Center
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Center
Study officials:
affiliation: Geriatric Cardiology and Medicine - U. of Florence
name: Andrea Ungar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ungar A, Mannarino G, van der Velde N, Baan J, Thibodeau MP, Masson JB, Santoro G, van Mourik M, Jansen S, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Maggi S, Schoenenberger AW. Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation - results from the CGA-TAVI multicentre registry. BMC Cardiovasc Disord. 2018 Jan 4;18(1):1. doi: 10.1186/s12872-017-0740-x.
Clinical trial NCT04443244: Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Masseteric Hypertrophy
Lead sponsor: Hugel
Sponsor class: INDUSTRY
First posted: 2020-06-23
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

Detailed description: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

Eligibility criteria: Inclusion Criteria:

1. Male and Female adults aged 19 or older.
2. Sighting, facilitation measurement are judged by the investigator to be the ratio of Benign Masseteric Hypertrophy.
3. Subject who understand and willing to perform with the procedures and visiting schedules of clinical trial.
4. Subject who voluntarily agree to participate in this clinical trial.

Exclusion Criteria:

1. Subject who is clinically significant facial asymmetry in visual measurement by the investigator.
2. Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
3. Subject who is deemed unable to participate in a clinical trial under the judgement of a Investigator.

Primary outcomes:
measure: Amount of change from baseline in masseter muscle thickness during maximum clenching
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Amount of change from baseline in masseter muscle thickness during maximum clenching
timeFrame: Baseline to week 4, 8, 16
measure: Rate of change from baseline in masseter muscle thickness during maximum clenching
timeFrame: Baseline to week 4, 8, 12, 16
measure: Amount of change from baseline in masseter muscle thickness during resting
timeFrame: Baseline to week 4, 8, 12, 16
measure: Rate of change from baseline in masseter muscle thickness during resting
timeFrame: Baseline to week 4, 8, 12, 16
measure: Amount and rate of change from baseline in lower face volume during maximum clenching
timeFrame: Baseline to week 4, 8, 12, 16
measure: Overall improvement of Investigator
timeFrame: Baseline to week 4, 8, 12, 16
measure: Overall satisfaction of subject
timeFrame: Baseline to week 4, 8, 12, 16
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hugel
Study officials:
References:
Clinical trial NCT00544544: Riluzole in the Treatment of Bipolar Depression
Official title: Riluzole in the Treatment of Bipolar Depression: A Study of the Association Between Clinical Response and Change in Brain Glutamate Levels as Measured by Proton Magnetic Resonance Spectroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Depression
Keywords: Bipolar
depression
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2007-10-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bipolar disorder is a common and often chronic and debilitating mental illness. The depressive phase of bipolar disorder contributes the largest portion of the disorder, and treatment resistant bipolar depression represents a significant public health problem. Recent research has suggested that bipolar depression is associated with elevated brain glutamate activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate activity, will lead to clinical improvement in patients with bipolar depression.

Detailed description: We hypothesize that riluzole will lead to significant reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D). Additionally, improvement in depressive symptoms will be associated with reduced glutamate levels in the anterior cingulate cortex, but not parieto-occipital cortex, both at day two and day 42.

Eligibility criteria: Inclusion Criteria:

* Male or female age 18-65
* Meets DSM-IV criteria for Bipolar Disorder and is currently depressed
* Current score of \>/= 18 on the Hamilton Depression Scale

Exclusion Criteria:

* Active psychotic/manic symptoms
* Lifetime history of schizophrenia or obsessive compulsive disorder
* Clinically significant medical disease
* Women who are pregnant or lactating and women who are not using a medically accepted method of contraception.

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale
timeFrame: Baseline (week 0) - week 6
Secondary outcomes:
measure: Montgomery Asberg Depression Rating Scale
timeFrame: Baseline (week 0) - week 6
measure: Young Mania Rating Scale
timeFrame: Baseline (week 0) - week 6
measure: Clinical Global Impression Scale
timeFrame: Baseline (week 0) - week 6
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Dost Ongur, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brennan BP, Hudson JI, Jensen JE, McCarthy J, Roberts JL, Prescot AP, Cohen BM, Pope HG Jr, Renshaw PF, Ongur D. Rapid enhancement of glutamatergic neurotransmission in bipolar depression following treatment with riluzole. Neuropsychopharmacology. 2010 Feb;35(3):834-46. doi: 10.1038/npp.2009.191. Epub 2009 Dec 2.
Clinical trial NCT05220644: Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the Delivery Room
Official title: Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress
Pain
Keywords: newborn
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature or term newborn in the delivery room

Brief summary: The newborn feels pain and the newborn at the end of life, in the delivery room, is potentially exposed to pain and respiratory distress.

Protocols for the management of end-of-life symptoms in the delivery room are used in current practice with very few validation studies. The protocol used in delivery rooms in Alsace uses fentanyl and midazolam intranasally. It has been used for 3 years and seems to provide satisfactory relief to newborn babies. In doing so, it seems to reassure parents about the quality of support and it seems to meet the expectations of professionals in these anxiety-provoking contexts. Scientific validation of these practices would allow wider dissemination to other maternity teams.


Eligibility criteria: Inclusion Criteria:

* Premature or term newborn
* In the delivery room
* In palliative care
* No parental opposition to data collection

Exclusion Criteria:

* Parental refusal or inability to express their consent
* Minor parents
* Very probable survival beyond the delivery room
* Impossibility of giving informed information to the subject (subject in an emergency situation, difficulties in understanding the subject, etc.)
* Subject under safeguard of justice
* Subject under guardianship or curatorship

Primary outcomes:
measure: Change in pain
timeFrame: 1 day
measure: DRFV scores
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de médecine et Réanimation du Nouveau-né - CHU de Strasbourg -France
state: Les Hôpitaux Universitaires De Strasbourg
city: Colmar
country: France
facility: Service de pédiatrie - Hôpitaux Civils de Colmar
city: Haguenau
country: France
facility: Service de pédiatrie - Hôpitaux Civils de Haguenau
city: Mulhouse
country: France
facility: Service de Néonatologie- Centre Hospitalier de Mulhouse
Study officials:
affiliation: les Hôpitaux Universitaires de Strasbourg
name: Pierre KUHN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03524144: Upper Gastrointestinal Lesions in Crohn's Disease
Official title: Upper Gastrointestinal Lesions in Crohn's Disease: a Cross-sectional Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Gastrointestinal Lesions
Crohn's Disease
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: A cross-sectional study was performed from 2017 to 2018. Consecutive Crohn's disease patients diagnosed in the Inflammatory bowel disease center of the Sixth Affiliated Hospital of Sun Yat-sen University were recruited. All patients underwent upper gastrointestinal endoscopy and biopsy by two defined endoscopists and two pathologists, the basic information were collected at the same time, in order to assess the prevalence of upper gastrointestinal involvement, and determine the role of upper gastrointestinal endoscopy in adult Crohn's disease patients, irrespective of upper gastrointestinal symptoms.


Eligibility criteria: Inclusion Criteria:

* Age is 18 years old or older
* patients with diagnosis of Crohn's disease

Exclusion Criteria:

* diagnostic data were incomplete
* patients with malignant tumor
* use of PPIs or non-steroidal anti-inflammatory drugs in the preceding 4 weeks

Primary outcomes:
measure: the incidence of different upper gastrointestinal lesions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Xiang Gao
role: STUDY_CHAIR
References:
Clinical trial NCT02122744: RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine
Official title: Randomised Placebo Controlled Trial of rTMS Quadri Pulse Over Visual Cortex for the Prevention of Chronic Migraine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Migraine
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of inhibiting rTMS QP over the visual cortex for the prevention of chronic migraine. The aim of the study is to confirm that inhibiting rTMS QP is capable to decrease the frequency of migraine and if its effect is stronger than placebo effect.

Detailed description: The investigators have already inquired if inhibiting rTMS QP over the visual cortex determines a reduction of frequency of migraine in a previous study. After 2 weekly sessions for a month, the investigators demonstrated a reduction of 47% in migraine frequency. In this study, the investigators aim to compare rTMS QP effect with the placebo effect and to evaluate if rTMS QP is capable to induce changes in VEP, CHEPS and QST.

Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse.

Exclusion Criteria:

* other diseases or contraindication for the magnetic stimulation (epilepsy, pacemaker, metallic prothesis)

Primary outcomes:
measure: Frequency of migraine
timeFrame: 12 months
Secondary outcomes:
measure: Intensity of migraine
timeFrame: 12 months
measure: Acute medication intake
timeFrame: 12 months
measure: Attack duration
timeFrame: 12 months
measure: Scores on psychological scales
timeFrame: 12 months
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Roberta Baschi
Study officials:
affiliation: University of Liege
name: Jean Schoenen, HP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liege
name: Delphine Magis, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06317844: Examination of Psychological and Physiological Pathways Linking Gratitude and Pain
Official title: Examination of Psychological and Physiological Pathways Linking Gratitude and Pain and the Moderating Effects of COMT Genotype on These Associations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pain
Positive Thinking
Emotions
Lead sponsor: Black Hills State University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-03-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to compare the effects of a brief gratitude intervention on individuals' psychological and physiological responses to acute pain. Furthermore, these associations will be examined in the context of genetic variations associated with both pain and psychological processes.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will be randomized to a behavioral writing intervention and a cold pressor task. Participants will be randomized to a gratitude or neutral writing condition.

Eligibility criteria: Inclusion Criteria:

* must be pain-free
* must be at least 18 years old

Exclusion Criteria:

* cardiovascular disease
* Raynaud's disease
* epilepsy
* being pregnant
* having a current injury to or open cut or sore on one's non-dominant hand
* history of fainting or seizures
* history of frostbite in non-dominant hand
* chronic pain conditions (e.g., fibromyalgia, neuropathy, arthritis)
* diabetes
* malignant tumor
* chronic lung disease
* liver disease
* kidney disease
* gastrointestinal diseases
* currently taking opioids

Primary outcomes:
measure: Change in Subjective Pain Ratings from Baseline to 10-minutes Post Cold Pressor Test
timeFrame: Baseline to 10 minutes post cold pressor test
measure: Differences in Pain Tolerance to Cold Pressor Test
timeFrame: Up to 1.5 minutes of Cold Pressor Test
measure: Differences in Pain Onset to Cold Pressor Test
timeFrame: Up to 1.5 minutes of Cold Pressor Test
Secondary outcomes:
measure: Differences in Pain-Related Cognition
timeFrame: Immediately after the Cold Pressor Test
measure: Differences in Autonomic Nervous System Responsivity
timeFrame: Baseline to 10 minutes post cold pressor test
Other outcomes:
Locations:
city: Spearfish
country: United States
facility: Black Hills State University
state: South Dakota
Study officials:
affiliation: Black Hills State University
name: Nathan Deichert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02306044: Bleeding Prediction in Thrombocytopenia
Official title: Bleeding Prediction in Thrombocytopenia Using Platelet Indices, Platelet Aggregometry and a Standardized Bleeding Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocytopenia
Keywords: Bleeding
Platelet indices
Platelet aggregometry
Bleeding questionnaire
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted patients with thrombocytopenia of any cause

Brief summary: The purpose of the study is to investigate whether platelet indices from automated haematology equipment, whole blood impedance aggregometry and a standardized bleeding questionnaire predict bleeding in admitted patients with thrombocytopenia of various causes.

Detailed description: Thrombocytopenia is a risk factor for bleeding, but studies concerning markers for stratification of bleeding risk among thrombocytopenic patients are lacking. This prospective observational cohort study investigates risk factor for bleeding in admitted patients with thrombocytopenia of various causes.

Eligibility criteria: Inclusion Criteria:

* Admitted patients with thrombocytopenia
* Age ≥18 years
* Platelet count below 80 x109/L

Exclusion Criteria:

* Platelet transfusion within the previous 14 days,
* surgery or trauma within the previous 7 days
* Unable to give informed consent.

Primary outcomes:
measure: Mean platelet volume
timeFrame: 30 days
Secondary outcomes:
measure: Platelet count
timeFrame: 30 days
measure: immature platelet fraction
timeFrame: 30 days
measure: Bleeding questionnaire
timeFrame: 30 days
measure: Platelet aggregation
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Odense University Hospital
name: Pernille J Vinholt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00926744: Nutrition and Exercise Intervention Study
Official title: Large-Scale Randomized Intervention Trial of Effects of Physical Activity on Incidence and Risk Factors of Cardiovascular Diseases in Healthy People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Dyslipidemia
Diabetes
Low Back Pain
Keywords: physical activity
nutrition
cardiovascular diseases
musculo-skeletal problems
Lead sponsor: National Institute of Health and Nutrition
Sponsor class: OTHER_GOV
First posted: 2009-06-24
Enrollment: 1085
Sex: ALL
Minimum age (years): 30
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present study was to clarify the effects of increase in physical activity on incidence and surrogate marker of cardiovascular diseases. The working hypothesis of the present study was that the physical activity to satisfy the Japanese guideline of Ministry of Health, Labour and Welfare is effective for the primary prevention of the lifestyle-related disease.


Eligibility criteria: Inclusion Criteria:

* Males and females
* Ages 30-64 years old

Exclusion Criteria:

* During treatment of any diseases
* Two or more metabolic risk factors

Primary outcomes:
measure: Objectively measured amount of physical activity
timeFrame: 10 years
Secondary outcomes:
measure: Surrogate measurement of lifestyle-related diseases (blood pressure, FPG, cho, etc)
timeFrame: 5 years
measure: Incidence of lifestyle-related diseases (hypertension, dyslipidemia, diabetes)
timeFrame: 10 years
measure: Incidence of musculoskeletal and joint pain
timeFrame: 1 year
Other outcomes:
Locations:
city: Shinjuku
country: Japan
facility: National Institute of Health and Nutrition
state: Tokyo
Study officials:
References:
citation: Tripette J, Gando Y, Murakami H, Kawakami R, Tanisawa K, Ohno H, Konishi K, Tanimoto M, Tanaka N, Kawano H, Yamamoto K, Morishita A, Iemitsu M, Sanada K, Miyatake N, Miyachi M. Effect of a 1-year intervention comprising brief counselling sessions and low-dose physical activity recommendations in Japanese adults, and retention of the effect at 2 years: a randomized trial. BMC Sports Sci Med Rehabil. 2021 Oct 25;13(1):133. doi: 10.1186/s13102-021-00360-7.