louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00933010: Metabolic Syndrome Observation on a Regional Basis
Official title: Osservatorio Regionale Sulla Sindrome metabolicA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
lipids
waist circumference
HDL
hypertension
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The aim of the study is to assess the prevalence of Metabolic Syndrome in Italy on a regional basis, defined according to NCEP/ATPIII Guidelines criteria.


Eligibility criteria: Inclusion Criteria:

* Patient aged between 18 and 75 years
* Signed Informed consent
* Laboratory analysis (lipidic profile and glycemia) performed in the last year

Exclusion Criteria:

* Pregnancy or breast feeding
* Patients enrolled in clinical studies which the aim is to evaluate the efficacy and/or tolerability of anti-hypertensive and/or lipid lowering drugs
* Subjects with serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's successful participation in the study

Primary outcomes:
measure: Prevalence of Metabolic Syndrome in Primary Care Population
timeFrame: July 2009 - March 2010
measure: Concomitant presence of other CV risk factors
timeFrame: July 2009 - March 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Foligno
country: Italy
facility: Research
city: Perugia
country: Italy
facility: Research Site
city: Terni
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca S.p.A., R&D
name: Mario Mangrella
role: STUDY_CHAIR
affiliation: AstraZeneca S.p.A., R&D
name: Raffaele Sabia
role: STUDY_DIRECTOR
References:
Clinical trial NCT06684210: Study of the Clinical Effect of External Oblique Muscle Intercostal Muscle Plane Block in Abdominal Surgery
Official title: Study of the Clinical Effect of External Oblique Muscle Intercostal Muscle Plane Block in Abdominal Surgery。
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Pain
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2024-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study intends to apply external oblique intercostal muscle plane block in thoracoabdominal resection, and to explore its effect on perioperative analgesia and rehabilitation quality in patients undergoing thoracoabdominal surgery.

Detailed description: Approved by the hospital ethics committee, 60 patients undergoing thoracic and abdominal surgery were selected in this study. They were divided into experimental group (n=30) and control group (n=30). The experimental group was given 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia, and the control group was given 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia. MAP, HR and SPO2 were recorded at admission (T0), completion of induction (T1), skin incision (T2), 30min after operation (T3) and 30min after extubation (T5). The block range of nerve block in the experimental group was recorded. The VAS score and the number of patient-controlled analgesia pump were recorded 30min after extubation, 6h, 24h and 48h after operation in resting state and cough state. Postoperative adverse reactions such as respiratory depression, expectoration weakness, nausea, vomiting, and skin itching were recorded. The first time to get out of bed after operation was recorded.

Eligibility criteria: Inclusion Criteria:

* ASA Physical Status Classification of I-II Aged 18-60 years old ; Will be scheduled to undergo elective LC

Exclusion Criteria:

* Coagulation disorders, Liver/kidney disease, Abdominal surgery history, Infection in the block application area, Chronic opioid use.

Primary outcomes:
measure: Patient's postoperative pain score
timeFrame: Extubation for 30minutes, 6 hours after surgery, 24 hours after surgery, and 48 hours after surgery
Secondary outcomes:
measure: Changes in blood pressure
timeFrame: Perioperative period
measure: Changes in heart rate
timeFrame: Perioperative period
measure: Extent of action of external oblique intercostal muscle plane block
timeFrame: Ten minutes after the nerve block
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: The first hospital of Qinhuangdao
state: Hebei
Study officials:
References:
Clinical trial NCT02126410: Associations Between Self-Reported Sleep Duration and Sarcopenia in Community-Dwelling Older Adults
Official title: Associations Between Self-Reported Sleep Duration and Sarcopenia in Community-Dwelling Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community-Based Participatory Research
Aged
Sleep
Body Composition
Keywords: sarcopenia
sleep duration
body composition
skeletal muscle
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 488
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community-dwelling elderly (\>= 65 years old)

Brief summary: 1. BACKGROUNDS: Currently, elderly people comprise more than 10% of the total Taiwanese population. However, within the context of self-reported sleep duration and health risks, research into the association between sleep duration and body composition changes in older people is limited. It is important to gain an understanding of such an association of older people to estimate the public health burden.
2. OBJECTIVES: To assess the association between self-reported sleep duration and sarcopenia as well as obesity in community-dwelling older adults.
3. HYPOTHESIS: Self-reported sleep duration is associated with prevalence of sarcopenia and obesity in community-dwelling older adults.
4. DESIGN: A cross-sectional investigation.
5. SETTING: Communities in Zhongzheng district, Taipei.
6. PARTICIPANTS: Four hundred and forty-eight community-dwelling adults (224 men and 264 women) aged 65 years and older.
7. MEASUREMENTS: The investigators evaluated self-reported sleep duration by deriving from the Pittsburgh Sleep Quality Index and 7-d recall physical activity diary. Skeletal muscle mass was estimated by the predicted equation from a bioelectrical impedance analysis measurement. The Groningen Activity Restriction Scale and the Chinese Geriatric Depression Screening Scale were used to evaluate physical disability and depression, respectively.


Eligibility criteria: 1. hyper- or hypothyroidism.
2. taking prescribed medications (such as growth hormone, testosterone, or progesterone) known to alter body composition.
3. any condition that prevented them from completing our questionnaires or the functional capacity test (e.g., amputee, nonambulatory even with the use of a walker or a cane, blind, or deaf).

Primary outcomes:
measure: Skeletal muscle mass index
timeFrame: one day
Secondary outcomes:
measure: Sleep quality
timeFrame: one day
measure: Level of physical activity
timeFrame: one day
measure: Sleep duration
timeFrame: one day
measure: Body composition
timeFrame: one day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Meng-Yueh Chien, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03664310: Transdiagnostic Sleep and Anxiety Treatment
Official title: A Pilot Study and Randomized Controlled Trial of Transdiagnostic Sleep and Anxiety Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Anxiety and insomnia disorders are two of the most common and costly mental health conditions. These disorders are frequently comorbid, but current treatment approaches do not target both. To streamline treatment for these commonly comorbid conditions, a novel, computerized intervention was developed targeting a transdiagnostic factor, safety aids, which are cognitive or behavioral strategies individuals use to cope with distress associated with anxiety or insomnia, that paradoxically exacerbate symptoms. A randomized controlled trial was conducted to determine the acceptability and efficacy of this newly developed intervention. Method: Young adults (N = 61) with elevated anxiety and insomnia symptoms were randomized to receive the anxiety-insomnia intervention or a computerized control condition focused on general physical health behaviors. After the intervention, participants were followed up at one week and one month and completed self-report measures.


Eligibility criteria: Inclusion Criteria:

* 1 SD above the mean in anxiety and insomnia symptoms
* Interest in improving anxiety and sleep

Exclusion Criteria:

* Participating in another clinical trial

Primary outcomes:
measure: Safety Aid Scale
timeFrame: Month 1
Secondary outcomes:
measure: Sleep Related Behavior Questionnaire
timeFrame: Month 1
measure: Penn State Worry Questionnaire
timeFrame: Month 1
measure: Dimensional Obsessive Compulsive Scale
timeFrame: Month 1
measure: Insomnia Severity Index
timeFrame: Month 1
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Anxiety and Behavioral Health Clinic
state: Florida
Study officials:
References:
Clinical trial NCT04461210: Vulvodynia Pain Thresholds
Official title: Objective Assessment of Pain Thresholds in Women With Vulvodynia
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Vulvodynia
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-07-08
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with localized, provoked vulvodynia and healthy controls without vulvar pain or other vulvar disorders.

Brief summary: Annotated pain maps will be created showing region and size of areas sensitive to mechanical stimulus in both women affected by vulvar pain and unaffected control patients.

Detailed description: The investigators will develop annotated pain maps showing region and size of areas sensitive to mechanical stimulus. The pain maps will be created by combining IR images, photographs, and clinical input, and will be correlated with patient co-morbidities. The IR images will assess for areas of inflammation and increased skin temperature. Pain maps will be created with patient response to mechanical stimulation with a cotton swab and will be overlaid on the thermographic images. Through this combination of measurements, the investigators plan to expand the diagnostic tools used in patient care as well as on the classification of this heterogeneous disorder.

Eligibility criteria: Inclusion Criteria:

* women meeting criteria for vulvodynia women seeking care for routine gynecologic exam

Exclusion Criteria:

* women less than 18 years of age current pregnancy women with vulvar or vaginal disorder other than pain

Primary outcomes:
measure: Annotated Pain Mapping
timeFrame: 2 years
Secondary outcomes:
measure: Change in pain map after clinical intervention
timeFrame: 3 years
measure: Database Development
timeFrame: 3 years
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: UBMD Obstetrics and Gynecology
state: New York
Study officials:
References:
Clinical trial NCT04086810: An Open-Label Study of DCCR Tablet in Patients With PWS
Official title: An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Prader-Willi Syndrome
Keywords: PWS
Prader-Willi Syndrome
Lead sponsor: Soleno Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.


Eligibility criteria: Inclusion Criteria:

* Successful completion of clinical study C602, Visit 15
* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate)
* Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.

Exclusion Criteria:

* Positive urine pregnancy test (in females of childbearing potential)
* Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation
* Any new disease, condition, or circumstance, which may significantly impact subject safety

Primary outcomes:
measure: Adverse Events (Safety)
timeFrame: Baseline to Week 106
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01281410: Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation
Official title: Effectiveness of an Inspiratory Muscle Training in Patients Receiving Allogenic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inspiratory Muscle Training
Stem Cell Transplantation
Respiratory Muscle Training
Keywords: respiratory muscles
hematopoetic stem cell transplantation
inspiratory muscle training
Lead sponsor: Elisabethinen Hospital
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 106
Sex: ALL
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a monocentric, controlled randomized trial. Its an interventional method study. There is a control and an interventional group. The interventional group is receiving a specific inspiratory muscle training with "Respifit" (special device for inspiratory muscle training) during the first 30 days after allogenic stem cell transplantation.

The investigators want to show that the training group gets stronger inspiratory muscles. The investigators measure the change of PIMAX values and MVV values.


Eligibility criteria: Inclusion Criteria:

* Patients receiving allogenic stem cell transplantation
* Age 17 - 80 years old
* Informed consent

Exclusion Criteria:

* Actual pneumonia at the beginning of the trial
* Impaired vision
* Patient is not able to handle "Respifit"

Primary outcomes:
measure: Change of PI max-value from baseline at 30 days after stem cell transplantation
timeFrame: baseline and 30 days after stem cell transplantation
measure: Change of MVV-value from baseline at 30 days after transplantation
timeFrame: baseline and 30 days after stem cell transplantation
Secondary outcomes:
measure: inpatient days
timeFrame: from baseline to maximal 60 days after stem cell transplantation
measure: Incidence of pneumonia
timeFrame: from baseline to 30 days after stem cell transplantation
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Elisabethinen Hospital
Study officials:
affiliation: Elisabethinen Hospital
name: Hanns Hauser, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06116110: Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU
Official title: A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Hodgkin Lymphoma
Keywords: Chimeric antigen receptor
CAR T
CD19
CD20
Lead sponsor: Miltenyi Biomedicine GmbH
Sponsor class: INDUSTRY
First posted: 2023-11-03
Enrollment: 150
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: Patients who have received MB-CART2019.1

Brief summary: This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.

Detailed description: This is a non-therapeutic study design. After successful screening, subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART2019.1 infusion. Subjects will be assessed yearly for the occurrence of delayed adverse events (AEs), monitored for replication competent lentivirus (RCL) and assessed for long term efficacy as well as CAR-T persistence.

Eligibility criteria: Inclusion Criteria:

* Received zamtocabtagene autoleucel in a Miltenyi Biomedicine-sponsored clinical study and have either completed the study or have discontinued early from the study.
* Provided written informed consent to participate in this study.

Exclusion Criteria:

* None

Primary outcomes:
measure: The incidence of serious and non serious adverse events of special interest
timeFrame: Up to 15 years
Secondary outcomes:
measure: Number of subjects with measurable replication competent lentivirus in peripheral blood (if positive at study entry)
timeFrame: Up to 15 years
measure: Duration of zamtocabtagene autoleucel persistence
timeFrame: Up to 5 years
measure: Objective response rate
timeFrame: Up to 15 years
measure: Overall Survival
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Baltimore
country: United States
facility: University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Milwaukee
country: United States
facility: Froedtert Hospital and the Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Miltenyi Biomedicine GmbH
name: Remi Kaleta, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01050010: The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission. Preliminary Study
Official title: The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission.Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
clinical remission
synovitis
dedicated extremity MRI
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The major aim of treatment for rheumatoid arthritis is remission. Nevertheless, structural radiographic progression is observed in 15 to 20% of patient getting remission. Numerous definitions of the remission proposed by literature remain imperfect.

Recently ultrasonography and MRI seem to be helpful in diagnosis and follow-up of rheumatoid arthritis.

Studies in patients with clinical remission are reporting 75 to 90% of persistent MRI and ultrasonography synovitis, 45% of cases with synovial activity.

To our knowledge, in such case few studies showed correlation between persistent imaging synovitis and structural radiographic progression.

On the other hand, no studies with extremity dedicated RMI in patients with remission are reported.

In this preliminary study, the investigators propose to evaluate in patients with rheumatoid arthritis remission and persistent dedicated MRI synovitis the structural radiographic progression at one year.


Eligibility criteria: Inclusion Criteria:

* Earlier rheumatoid arthritis (\<1 year)
* Clinical remission (DAS 28 \<2,6 ou SDAI \<5) since 6 months before the inclusion
* Unchanged DMARds and /or biologic therapy since 6 months before the inclusion
* Unchanged corticosteroid (5 mg/day) since 3 months before the inclusion in patients treated with this therapy
* No contre-indication to the MRI

Exclusion Criteria:

* Contra-indication to MRI
* Pregnant or breast-feeding women

Primary outcomes:
measure: Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot)
timeFrame: at Month 0 (first visit) and Month 12 (last visit)
Secondary outcomes:
measure: Ultrasonography (hand, wrist and foot)
timeFrame: at Month 0 (first vist) and Month 12 (last visit)
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
city: Nice
country: France
facility: Rheumatology Department, Nice University Hospital
Study officials:
affiliation: Nice University Hospital
name: Christine ALBERT-SABONNADIERE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02650310: New Device to Maintain the Embryo Temperature During Transfer
Official title: A New System for Preventing Thermal Stress During Embryo Transfer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Embryo Transfer
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 352
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature drop, and consequently thermal stress occurs, which may compromise its future viability.

The aim of this study is to assess the possible improvement in the clinical results when the embryos are transported in a stable device to avoid the drop in temperature throughout the transfer process.

With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase in pregnancy rates.


Eligibility criteria: Inclusion Criteria:

* Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank.

Exclusion Criteria:

* Fresh cycles: transfer of fresh embryos (coming from donated or own eggs), and cryo-transfer cycles from vitrified embryos coming from own oocytes.

Primary outcomes:
measure: Ongoing Pregnancy rate
timeFrame: Ongoing pregnancy until 28th week of gestation
Secondary outcomes:
measure: Miscarriage rate
timeFrame: Loss of pregnancy up to 12 weeks of gestation
measure: Implantation rate
timeFrame: Embryo implantation after 6-7 weeks of gestation
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Instituto Bernabeu
Study officials:
References: