louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02051764: Imaging Characteristics of a Follow-up 18F-AV-1451 Scan
Official title: An Open Label, Multicenter Study, Evaluating the Imaging Characteristics of a Follow-up 18F-AV-1451 Scan in Subjects Who Have Had a Prior 18F-AV-1451 Scan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-01-31
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate the imaging characteristics of flortaucipir in subjects with a previous flortaucipir scan in order to assess the rate of change of tau deposition over time.


Eligibility criteria: Inclusion Criteria:

* Have a previous 18F-AV-1451 brain scan
* Can tolerate up to two Positron Emission Tomography (PET) imaging sessions and a Magnetic Resonance Imaging (MRI) scan
* Ability to provide informed consent

Exclusion Criteria:

* Current clinically significant psychiatric disease
* Are claustrophobic
* Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
* Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session

Primary outcomes:
measure: Change in Tau Deposition
timeFrame: baseline scan and at least 6 months after baseline scan
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Center for Clinical Imaging Research, Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Avid Radiopharmaceuticals, Inc.
name: Chief Medical Officer
role: STUDY_CHAIR
References:
Clinical trial NCT04876664: Evaluation of Continuous Non Invasive Blood Pressure With Adult Volunteers
Official title: Clinical Evaluation of Continuous Non-Invasive Blood Pressure Monitors With Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A study to collect data recorded by devices for cNIBP evaluation purposes.

Detailed description: The study is going to be conducted to collect data from the devices used in the study for future AMS engineering purposes as deemed appropriate by the Sponsor.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female, aged 18 years or older (≥18 years);
* Willing and able to give informed consent for participation in the study;
* Able and willing to comply with all the study requirements.

Exclusion Criteria:

* Who is pregnant or lactating;
* Who is a smoker;
* Who has consumed alcohol in the last 24 hours;
* Who has been previously diagnosed with Ataxia or balance disorder;
* Who has been previously diagnosed with Raynaud's disease/ syndrome/ phenomenon;
* Who has been previously a diagnosed cardiovascular condition requiring medication or has an internal pacemaker;
* Who has an injury, deformity, A-V fistula, or other characteristic limiting the placing of cuffs on arms/fingers;

Primary outcomes:
measure: Data collection of NIBP measurement
timeFrame: through study completion, average of one day
Secondary outcomes:
measure: Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues
timeFrame: through study completion, an average of one day
Other outcomes:
Locations:
Study officials:
affiliation: VTT
name: Juha Pärkkä
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06532864: Qigong Exercise and Sleep Quality
Official title: Effects of Qigong Exercise and Mawangdui Guiding Technique on Sleep Quality in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Keywords: sleep quality
older adults
Lead sponsor: Hunan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to experimental and control groups. The experimental group performed Mawangdui Guided Technique exercises, which consisted of five 45-minute sessions per week for 12 weeks. The control group maintained a routine of sleep education in addition to their daily activities.
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate whether 12 weeks of practicing Mawangdui Guiding Technique has an improvement effect on subjective sleep quality, objective sleep quality, and daytime fatigue in older adults in a healthcare hospital.


Eligibility criteria: Inclusion Criteria:

* Aged sixty years and above; continuous residence in the participating healthcare hospitals for more than six months
* Conscious, with basic visual and auditory perception, communication, and cognitive functioning
* Voluntary enrollment in this study and signing of the informed consent form.

Exclusion Criteria:

* Individuals who have suffered a sudden accident, emergency surgery, or a rapid deterioration of a long-term medical condition
* Individuals who have recently been involved in other rehabilitation activities and who play sports on a regular basis
* Individuals who are unable to participate in physical activity (e.g., patients suffering from major diseases of the liver, kidneys, heart, brain, or blood system)
* Individuals suffering from deep venous thrombosis; individuals with musculoskeletal problems with signs of limitation of movement (e.g., unsettled broken bones, pelvic fractures)
* Individuals with preexisting psychiatric conditions (such as personality disorders, psychosis, and so on); and individuals with symptoms of severe depression.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: baseline; 4 weeks; 12weeks
measure: Insomnia Severity Index
timeFrame: baseline; 4 weeks; 12weeks
measure: Polysomnography
timeFrame: baseline; 4 weeks; 12weeks
measure: Flinders Fatigue Scale
timeFrame: baseline; 4 weeks; 12weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Healthcare Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT03276364: The Impact of Point-of-Care Ultrasound
Official title: The Impact of Point-of-Care Ultrasound Performed by Trainees to Improve the Prediction of Fluid Responsiveness in Patients With Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound
Shock
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Beth Israel Medical Center
First posted: 2017-09-08
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Could undergo both a POCUS and bioreactance assessment within 6 hours of admission from the emergency department or transfer from a medical floor.
* Shock was defined as either systolic blood pressure less than 90 mmHg or 40 mmHg below baseline, necessity for vasopressors to maintain mean arterial pressure greater than 65 mmHg, or any evidence of acute organ hypoperfusion that was evident at the time of study enrollment as judged by the treating physician.
* The patient needed to be in shock at the time of POCUS and bioreactance testing at time of enrollment in order to be included.

Brief summary: Point-of-care ultrasound (POCUS) has been found to be useful for aiding in the prediction of fluid responsiveness. It is unknown if trainees can effectively utilize this tool to improve their assessment of fluid responsiveness.

In this prospective, observational study, pulmonary and critical care fellows are asked to make 2 assessments of fluid responsiveness in adults with shock: (1) based on clinical exam alone (Clinical) and (2) after performing a POCUS (Clinical + US). The accuracy of their pre- and post-ultrasound assessments are compared using a bioreactance monitor and passive leg raise test as the gold standard of fluid responsiveness in this study.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 or older admitted to the MICU with a diagnosis of shock while a fellow was on duty.

Exclusion Criteria:

* None

Primary outcomes:
measure: Fluid responsiveness
timeFrame: Immediately subsequent to performance of a point-of-care ultrasound exam
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01800864: Leptin Biology in Adipose Tissue
Official title: Leptin Biology in Adipose Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Leptin is a fat hormone which acts in maintaining energy balance. However, leptin levels are high in obese subjects indicating resistance to the actions of leptin. High leptin levels have been associated with increased cardiovascular and metabolic risks, but it is not clear if increased leptin or leptin resistance contributes to the increased cardiovascular risk. Further, even though leptin receptors are present in fat tissue, leptin's role in fat tissue functions are not completely investigated in humans. Based on preliminary data the investigators hypothesize that resistance to leptin action in obese adipose tissue is responsible for altering the expression of adipose tissue proteins which contribute to the development of cardiovascular and metabolic dysfunction. To test this hypothesis the investigators propose a novel study directed at investigating the leptin dependent changes in adipose tissue protein expression using adipose tissue obtained from lean and obese human subjects


Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years
2. BMI BMI ≤25 (lean) or \>30 kg/m2 (obese)
3. Going to undergo a surgical procedure where omental and subcutaneous adipose tissue may be biopsied.

Exclusion Criteria:

Inability to provide written informed consent.

-

Primary outcomes:
measure: Changes in adipose tissue protein expression in response to leptin treatment
timeFrame: Baseline and after 24 hours of leptin treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend K Somers, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00964964: A Trial Assessing Changes in Blood Sugar and the Number of Periods Where Supplementation of Carbohydrate is Needed to Treat Low Blood Sugar, During Two Different Treatment Regimens of NN1250 in Type 1 Diabetics
Official title: A Trial Assessing the Number of Hypoglycaemic Episodes and Glycaemic Variability During Two Different Regimens of SIBA 200 U/ml in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim is to compare changes in blood sugar and the number of periods where carbohydrate supplementation is needed to treat low blood sugar, during two different treatments with NN1250 (insulin degludec), a soluble insulin basal analogue (SIBA) in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus for at least 12 months
* Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive)

Exclusion Criteria:

* Donation or loss of more than 500 ml blood or plasma within three months prior to this trial
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) or not able or willing to refrain from smoking and the use of nicotine gum or transdermal nicotine patches during the in-house periods
* Prior or current treatment with metformin or thiazolidinediones

Primary outcomes:
measure: Total number of periods where carbohydrate supplementation is needed during the treatment
timeFrame: Assessed every day of the two in-house stays of nine days
Secondary outcomes:
measure: Frequency of adverse events (AEs)
timeFrame: Assessed every day of the two in-house stays of nine days and one follow-up by telephone
measure: Number of periods with low blood sugar during treatment
timeFrame: Assessed every day of the two in-house stays of nine days and one follow-up by telephone
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01887964: Effect of Resistant Starch (Type-4) on Metabolic Syndrome
Official title: Dietary Fiber Intervention in Hutterite Population of South Dakota With and Without Signs of Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Diabetes
Obesity
Cardiovascular disease
Metabolic syndrome
Lead sponsor: South Dakota State University
Sponsor class: OTHER
First posted: 2013-06-27
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Metabolic syndrome is a condition characterized by excess body weight, large waist circumference, high cholesterol and glucose in the blood, and hypertension. People with metabolic syndrome are at increased risk for heart diseases. Research shows benefits of regular fiber intake in metabolic syndrome. However, due to altered taste and texture of the high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients. This study is designed to find if blinded-substitution of regular wheat flour in domestic kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4), minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from wheat.


Eligibility criteria: Inclusion Criteria:

- Any individual aged 18-80 years

Exclusion Criteria:

* Pregnant
* Lactating
* Requires special diets or dietary regimens
* On long term antibiotic therapy
* Diagnosed with gastrointestinal diseases (Irritable Bowel syndrome, Crohn's disease or Colitis)
* Immune compromised
* Have cancer

Primary outcomes:
measure: Changes in metabolic syndrome risk components
timeFrame: 26 weeks
Secondary outcomes:
measure: Changes in anthropometric outcomes
timeFrame: 26 weeks
measure: Changes in blood lipid profile
timeFrame: 26 weeks
measure: Changes in blood glucose indices
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Brookings
country: United States
facility: South Dakota State University
state: South Dakota
Study officials:
affiliation: South Dakota State University
name: Moul Dey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Dakota State University
name: Bonny Specker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dhakal S, Dey M. Resistant starch type-4 intake alters circulating bile acids in human subjects. Front Nutr. 2022 Oct 20;9:930414. doi: 10.3389/fnut.2022.930414. eCollection 2022.
Clinical trial NCT06896864: Cochlear Implantation Experience
Official title: Cochlear Implantation in Assiut University Hospital Experience
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cochlear Function Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases implanted between 2014-2024 Patients who regularly use their cochlear implant device as recommended.

Brief summary: Evaluating the effectiveness and outcomes of cochlear implants in individuals with hearing loss,identifying common complications or risks associated with cochlear implantation, including device failure, surgical complications, or issues related to the patient's anatomy


Eligibility criteria: Inclusion Criteria:

* Patients with severe to profound bilateral sensorineural hearing loss who were candidates for CI.

Patients who regularly use their cochlear implant device as recommended.

Exclusion Criteria:

* Non-Sensorineural Hearing Loss - Non-Functional Auditory Nerve - . Severe Mental or Cognitive Impairments

Primary outcomes:
measure: Post-Surgical Complication Rate: Infection, device failure,Measures auditory progression
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05092802: The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment
Official title: An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Refractory Primary Brain Tumors With BRAF Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Brain Tumor, Primary
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation


Eligibility criteria: Inclusion Criteria:

* Age\>=18Y
* Good Organ Function
* Expected survival time ≥ 3 months
* Refractory primary brain tumors with BRAF mutation that have been diagnosed
* Unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy
* ECOG score 0-1;

Exclusion Criteria:

* Previous treatment with BRAF inhibitors or MEK inhibitors
* A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery
* Severe active infections requiring systemic anti-infective therapy
* Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

Primary outcomes:
measure: ORR
timeFrame: from first dose to the last patient was followed up for 6 month
Secondary outcomes:
measure: PFS
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，an average of about 1 year
measure: DOR
timeFrame: from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first)，an average of about 1 year
measure: OS
timeFrame: from the first dose to the time of death due to any cause，an average of about 2 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Cancer Hospital Affiliated to Shandong first medical University
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Jinming Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04784702: Smoking Cessation in Patients After Coronary Angiography
Official title: Smoking Cessation in Patients After Coronary Angiography - Self-achieved and Supported With Cytisine and Its' Effect on Platelet Aggregation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stable CAD and ACS admitted to the catheterization laboratory in the Department of Cardiology, Grochowski Hospital, Warsaw, Poland

Brief summary: OBJECTIVES The goal of this study is to evaluate the self-achieved smoking cessation supported with cytisine smoking cessation and its' on platelet aggregation and prothrombotic state in patients after coronary angiography and PCI.

BACKGROUND Cigarette smoking is a major risk factor of coronary artery disease (CAD). Smoking cessation is one of the most cost-effective intervention in lifestyle. Self-reported rates of smoking cessation are reasonably low. Cytisine is promising drug in support of smoking cessation. Smoking affects various components leading to arterial thrombosis, and the effect of smoking cessation on prothrombotic state and platelet aggregation is still under investigation GOAL To assess rates of smoking cessation in patients after coronary angiography and PCI and factors influencing success in smoking cessation To assess feasibility, safety and efficacy of cytisine in smoking patients To assess effect of smoking cessation on platelet aggregation in patients treated with clopidogrel and on prothrombotic state.

METHODS A prospective nonrandomized observational study of patients after coronary angiography.


Eligibility criteria: Inclusion Criteria:

* Patients after coronary angiography or PCI,
* Aged 18 years or older,
* Smoking at least 10 cigarettes a day

Exclusion Criteria:

• Pregnancy

Criteria may vary in substudies

Primary outcomes:
measure: Platelet aggregation in patient treated with clopidogrel after smoking cessation
timeFrame: 30-days
Secondary outcomes:
measure: Prothrombotic state
timeFrame: 30-days
measure: Cotinine
timeFrame: 30-days
measure: Thrombin potential
timeFrame: 30-day
measure: Thrombomodulin
timeFrame: 30-days
measure: PAI-1
timeFrame: 30-days
measure: P-selectin
timeFrame: 30-days
measure: PF-4
timeFrame: 30-days
measure: Thromboglobulin
timeFrame: 30-days
Other outcomes:
measure: Smoking cessation
timeFrame: 30-days, 6-months, 12-months
measure: Cytisine as smoking cessation aid
timeFrame: 30-days
Locations:
Study officials:
References: