louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06972680: Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene Brachial Plexus Block: A Bayesian Phase I/II Trial
Official title: Determination of the Optimal Volume of 0.5% Bupivacaine Liposome in Single-Injection Interscalene Brachial Plexus Block: A Bayesian Phase I/II Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Shoulder Arthroscopy
Keywords: Interscalene brachial plexus block
Phrenic nerve block
Lead sponsor: Affiliated Hospital of Jiaxing University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective arthroscopic shoulder surgery at Jiaxing University Affiliated Hospital.

Brief summary: This single-center, prospective, single-arm, Bayesian phase I/II clinical trial evaluates the incidence of HDP following ISB in shoulder arthroscopy and determines the optimal volume of a single injection of liposomal bupivacaine.

Detailed description: Based on the ISB being the optimal nerve block for post-arthroscopic shoulder surgery analgesia and the potent analgesic effect of bupivacaine liposomes, this study aims to explore the optimal volume of a single ISB injection of bupivacaine liposomes in shoulder arthroscopy using the Bayesian Optimal Interval Design, with the goal of achieving the same analgesic effect while minimizing the incidence and duration of HDP to the greatest extent.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years and above;
* ASA classification I-III;
* Undergoing arthroscopic rotator cuff repair, capsular tightening, acromioplasty, synovectomy,.

Exclusion Criteria:

* History of pulmonary disease;
* Abnormal coagulation function or coagulation disorders;
* History of local anesthetic allergy;
* Infection, lesion, or history of cervical disease at the block site;
* Pregnancy;
* Refusal to participate in the study or inability to communicate;
* Long-term use of opioids;
* Body mass index \>35 kg/m2;
* History of nerve injury, paralysis, or paresis.

Primary outcomes:
measure: Hemidiaphragmatic paresis incidence rate(Phase Ⅰ)
timeFrame: Perioperative
measure: Success rate of interscalene brachial plexus block (Phase II)
timeFrame: Perioperative
Secondary outcomes:
measure: Hemidiaphragmatic paresis incidence rate
timeFrame: Perioperative
measure: Lung function
timeFrame: Perioperative
Other outcomes:
Locations:
city: Jiaxing
country: China
facility: Jiaxing University Affiliated Hospital
state: Zhejiang
Study officials:
affiliation: Jiaxing University Affiliated Hospital
name: Mingzi An, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03067480: Comparison of 3 Versus 6-Month Use of CGMS in Non-Insulin Using T2DM Patients
Official title: Comparison of 3 Versus 6-Month Use of Professional Continuous Glucose Monitoring in the Treatment of Poorly Controlled, Non-Insulin Using T2DM Patients in a Primary Care Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: T2DM (Type 2 Diabetes Mellitus)
Continuous Glucose Monitoring
Lead sponsor: East Tennessee State University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2017-03-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine whether 3-month versus 6-month professional CGM utilization improves time spent in target range of 70-140mg/dl in patients with poorly controlled T2DM not treated with insulin.

Detailed description: Patients not receiving any insulin treatment with an HbA1c ≥ 7.5% before their scheduled primary care appointment will be invited to participate in the study and wear professional CGM for at least 3 days at either 3 intervals (baseline, 3-month and 6-month) or 2 intervals (baseline and 6-month). After removal, the downloaded report will provide quantitative data to determine the percent of time spent in the target range. The 6-month data will be analyzed to determine if frequency of professional CGM wear positively affects time spent in target range.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older with a diagnosis of T2DM with a scheduled office visit with primary care provider within the next 4 weeks
2. Last 2 HbA1c values between 7.5 - 10% measured in the last 12 months
3. Treated with non-insulin therapies or therapeutic lifestyle changes
4. Never worn professional CGM or have not worn in last 12 months
5. Willing to perform requirements needed for professional CGM

Exclusion Criteria:

1. Current or previous treatment with any insulin within 3 months at baseline

Primary outcomes:
measure: Time Spent in Target Range
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
Study officials:
affiliation: East Tennessee State University
name: Rick Hess, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05675280: Iron Deficiency and TTG Normalization
Official title: The Association Between Iron Deficiency at Diagnosis, Female Sex and Tissue Transglutaminase Antibody Normalization in Pediatric Celiac Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease in Children
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 118
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients diagnosed with Celiac disease

Brief summary: The investigators conducted a retrospective, observational cohort study which enrolled CD subjects aged 2-18y, diagnosed between Jan 2016 and Dec 2020. Demographic and laboratory data were collected at diagnosis and 1y after adherence to GFD. ID was determined according to hemoglobin and ferritin levels. The investigators compared CD subjects with and without ID at CD diagnosis in relation to TTG normalization at 1y.


Eligibility criteria: Inclusion Criteria:

* Children (male and female) diagnosed with CD
* Age 2-18y

Exclusion Criteria:

* Total IgA deficiency
* Anemia due to other causes - anyone with anemia and normal or elevated ferritin levels (e.g. thalassemia, spherocytosis)
* Other chronic conditions increasing the risk of anemia or falsely elevated ferritin (e.g. inflammatory bowel disease, chronic kidney disease, infection)

Primary outcomes:
measure: TTG normalization
timeFrame: 1 year from gluten free diet initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir medical center
Study officials:
affiliation: Meir Medical Center
name: Eyal Zifman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05764980: Neurovisual Function in CHARGE Syndrome
Official title: Assessment Study of Neurovisual Function in CHARGE Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CHARGE Syndrome
Keywords: CHARGE syndrome
Visual function
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of all ages with molecularly confirmed CHARGE sidnrome

Brief summary: The rationale of the study is to analyze visual function and correlate them with adaptive functions in patients with CHARGE syndrome in order to identify a pattern of specific indicators to enable better patient care

Detailed description: CHARGE syndrome is a malformative condition characterized by coloboma in about 70-95% of patients. This anatomical abnormality results in severe visual impairment that strongly affects the characterization of the disability profile.

Although the ocular anatomical deficits associated with the syndrome have been extensively described in the literature, coloboma being a major criterion for diagnosis, little is reported about the characteristics of visual function, such as acuity, visual field ocular motility, and other features.

Patients with CHARGE syndrome have multiple sensory deficif often accompanied by intellectual disability, which often makes the classical methods used in ophthalmologic evaluation inapplicable. According to the few studies in the literature, visual acuity in patients with CHARGE syndrome is often severely impaired with mean values below 20/60 (McMain et al 2008; Nishina et al 2012; Russell-Eggitt et al. 1990; Stromland et al. 2005; Tellier et al. 1998) However in opposition to the recurrent pessimistic findings resulting from ophthalmologic assessment in clinical practice, such patients present with good visual and adaptive abilities in daily life.

The rationale of the study is to analyze visual function and correlate them with adaptive functions in patients with CHARGE syndrome in order to identify a pattern of specific indicators to enable better patient care

Eligibility criteria: Inclusion Criteria:

Patients with molecularly confirmed CHARGE syndrome.

Exclusion Criteria:

Patients with CHARGE syndrome that has not been molecularly confirmed

Primary outcomes:
measure: To demonstrate the correlation between severity of anatomical impairment and neurovisual ability.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli Irccs
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Giuseppe Zampino, medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06490380: HRD Status Reference Standard Based on WGS
Official title: A Collaborative Project Aimed to Establish a WGS-based Reference Standard for Evaluating the Analytical Performance of HRD Status Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes for Food and Drug Control, China
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2024-07-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ovarian cancer patients received first-line PARPi maintenance therapy

Brief summary: When evaluating the analytical performance of homologous recombination deficiency (HRD) status testing, there is currently no widely accepted reference standard. Therefore, a collaborative project was initiated to establish a HRD status reference standard for the industry. Although there is no genotyping strategy that is universally recognized as the most accurate for evaluating HRD status, whole-genome sequencing (WGS) is one of the best candidates.

Detailed description: * Primary objective: To establish a HRD status reference standard based on WGS.
* Secondary objective: To validate the analytical performance of panel HRD status using WGS HRD status as reference standard.
* Exploratory objective 1: To explore how methylation of selective genes correlate with WGS HRD status and efficacy.
* Exploratory objective 2: To explore how HRR gene mutations correlate with WGS HRD status and efficacy.
* Exploratory objective 3: To set up a harmonized bioinformatic analysis workflow for WGS HRD status.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age at diagnosis
* Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
* High-grade serous or high-grade endometroid histological type
* FIGO stage II, III, or IV
* Complete response or partial response following completion of first-line adjuvant chemotherapy
* PARPi administered as first-line maintenance therapy

Exclusion Criteria:

* First-line surgery not conducted
* Total round of first-line chemotherapy (neoadjuvant and adjuvant) less than 5
* First-line PARPi maintenance therapy initiated beyond 12 weeks after last dose of chemotherapy
* Genotyping quality-control failed

Primary outcomes:
measure: Progression-free survival
timeFrame: Up to 42 months
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
References:
Clinical trial NCT04732780: Avoidance of Hyperglycaemia in People With Type 1 Diabetes
Official title: Avoidance of Hyperglycaemia in People With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes
Hyperglycaemia
Psychology
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: Imperial Health Charity
First posted: 2021-02-01
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with type 1 diabetes under the care of Imperial College Healthcare NHS Trust

Brief summary: This study aims to learn more about avoidance of hyperglycaemia in adults with type 1 diabetes. People who attend a type 1 diabetes clinic will be invited to complete a number of self-report questionnaires and a survey. A subsection of people who experience avoidance of hyperglycaemia will be invited to take part in an interview in order to gain a more in-depth understanding of this issue.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes of at least 6 months duration

Exclusion Criteria:

* Inability to understand or write in the English language
* Pregnant women
* Unable to participate in the study due to other factors, as assessed by the Chief Investigators

Primary outcomes:
measure: Hyperglycaemia Avoidance Scale
timeFrame: Baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline
measure: State Trait Anxiety Inventory - Trait Subscale
timeFrame: Baseline
measure: Hypoglycaemia Fear Survey 2 - Behaviour Subscale
timeFrame: Baseline
measure: Problem Areas in Diabetes 5
timeFrame: Baseline
measure: Hypoglycaemia Fear Survey 2 - Worry Subscale
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Nick Oliver
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06101680: RhabdomYolyse in Intensive caRe
Official title: RhabdomYolyse in Intensive caRe
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rhabdomyolysis
Keywords: rhabdomyolysis
child
Intensive Care
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with severe rhabdomyolysis (\> 5000 UI/L) hospitalized in intensive care unit.

Brief summary: Analysis of the outcome of patients \< 18 years old, treated in an intensive care unit for severe rhabdomyolysis, regardless of etiology (renal failure rate, death rate, organ replacement rate)


Eligibility criteria: Inclusion Criteria:

* CPK \> 5000 UI/L
* Care in Pediatric Intensive Care Unit
* Age \< 18 years old

Exclusion Criteria:

* Parental refusal

Primary outcomes:
measure: Use of renal remplacement therapy
timeFrame: 7 days after admission in intensive care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Reanimation Pediatrique
Study officials:
affiliation: CHRU Nancy
name: Arnaud Wiedemann, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04655560: Understanding Barriers and Facilitators to the Participation of Women Living With HIV in Clinical Trials : a Mixed-method Study (EVA)
Official title: Understanding Barriers and Facilitators to the Participation of Women Living With HIV in Clinical Trials : a Mixed-method Study (EVA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV
Clinical trials
Women
qualitative study
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
First posted: 2020-12-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women living with HIV

Note: ethnicity will not represent a selection's criteria. However, special care will be payed to assure a certain heterogeneity in the sample concerning this aspect.

Brief summary: To identify the most important barriers and facilitators to the participation of cisgender women living with HIV in clinical trials (perceived and real) and to establish possible mechanisms leading to refusal of trial participation. Specifically, psychosocial factors and/or cultural environments that enhance or undermine HIV-positive cisgender women's participation. These can include social inclusion, confidence in research, perceived personal vulnerability, cultural, familial and professional environment.

The investigators expect to propose pragmatic solutions to enhance participation of HIV-positive cisgender women in clinical trials.


Eligibility criteria: Inclusion Criteria:

* Cisgender women
* Adult (\>18 years) HIV-infected
* Informed consent documented by signature
* Patients under stable antiretroviral therapy
* French speaking (sufficient fluency for a conversation)

Exclusion Criteria:

* Having participated in a previous qualitative study about Cure Trials acceptability among HIV patients
* Incapable of discernment

Primary outcomes:
measure: Evaluation of barriers and facilitators to the participation of women in clinical trials (HIV) through a questionnaire
timeFrame: through study completion, an average of 1 year
measure: Evaluation of mechanisms leading to refusal of trial participation through a questionnaire
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Offering solutions for a better inclusion of HIV-women in clinical trials - qualitative study
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
References:
Clinical trial NCT06090760: Mindfulness Intervention and Online Social Networking
Official title: Mindfulness Intervention on Wellbeing During OSN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Lead sponsor: Education University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2023-10-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: waitlist control
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to examine (a) the effects of mindfulness-based intervention on wellbeing including psychological, social, and emotional wellbeing, depressive symptoms, and stress and (b) the extent to which demographics, OSN use, and mindfulness mediate these effects.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old

Exclusion Criteria:

* have not complete the application form

Primary outcomes:
measure: Social Media Engagement
timeFrame: 8 weeks
measure: Well-being
timeFrame: 8 weeks
measure: Emotion
timeFrame: 8 weeks
measure: Depression
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Ngar-sze Lau
Study officials:
affiliation: The Education University of Hong Kong
name: Michelle Gu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00847860: Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions
Official title: Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vascular Dementia
Stroke
Keywords: cognition
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Otsuka Pharmaceutical Co., Ltd.
First posted: 2009-02-19
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
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 evaluate the efficacy of PDE-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors.


Eligibility criteria: Inclusion Criteria:

1. Age ranging from 40 to 80 years
2. After newly ischemic stroke from 3 months to 2 years
3. Brain CT or MRI shows stroke lesions and white matter lesions, ARWMC(Age Related White Matter Change)\>=4
4. Moderate or mild cognitive deficits: MMSE 12-26
5. Vascular or mixed dementia: Hachinski ischemic score\>4
6. Moderate or mild disability: MRS\<=4,NIHSS\<20
7. Informed consent

Exclusion Criteria:

1. Definitive diagnosis of dementia prior to the stroke
2. Cerebral hemorrhage in the past
3. Cerebral embolism result from cardiogenic embolus
4. Critically ills: MRS\>4,NIHSS\>=20
5. Bed-ridden patient who is hardly discovered newly stroke
6. patient with sever cardiac, hepatic or nephric complication
7. dementia caused not by vascular lesions
8. other diseases disturb the cognitive evaluation
9. susceptibility to varieties of allergen
10. abstain from Cilostazol or Asprin
11. antiplatelet treatment, anticoagulation or fibrinolysis are needed because of other diseases
12. rejected to participate by the patient or the family

Primary outcomes:
measure: changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth
timeFrame: one year
Secondary outcomes:
measure: stroke recurrence, other vascular ischemic events, bleeding events
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Shanghai
country: China
facility: Shanghai Hua Shan Hospital
state: Shanghai
Study officials:
affiliation: Peking University First Hospital
name: Huang Yining, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwan J, Hafdi M, Chiang LLW, Myint PK, Wong LS, Quinn TJ. Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD012269. doi: 10.1002/14651858.CD012269.pub2.