louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03321955: Ziconotide as First-Line IDT
Official title: Prospective Study of Conservative Ziconotide Dosing as a First-Line Intrathecal Drug Therapy for Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 13
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: The primary objective of this study is to prospectively examine outcomes in 12 patients using ziconotide Intrathecal Drug Therapy(IDT) as first-line monotherapy with the use of an algorithm of slow titration for dosing. The use of Prialt has demonstrated fewer and less serious associated adverse effects as compared to IDT morphine, especially when titrated slowly. We will use an average Numerical Rating Scale as our primary outcome and the Oswestry Disability Index(ODI), Beck Depression Inventory (BDI), Pain Catastrophizing Scale (PCS), Clinical Global Impression of Change Scale including binary satisfaction measures(CGIC), Lawton-Brody Instrumental Activities of Daily Living(IADL) and Short Form-36 as secondary outcome measures.


Eligibility criteria: Inclusion Criteria:

1. Must be eligible for implantation of an intrathecal analgesia programmable pump system using ziconotide IT.
2. Must be 18 years of age or older for all points of data collection.
3. Must be diagnosed with neuropathic pain secondary to a clear etiology. Acceptable etiologies including but not limited to diabetic neuropathy, small fiber neuropathy, and post herpetic neuropathy.

Exclusion Criteria:

1. Must not have or been previously implanted with a programmable pump system.
2. Untreated mental illness including depression or anxiety determined by preoperative psychological evaluation.
3. Active substance abuse determined by preoperative urine drug screen.
4. Unwillingness to decrease oral medications at screening.
5. Any prior use of intrathecal analgesia besides trialing

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: Baseline, 3, 4, 6, 8, 9, 10, 12 week and 4, 5, 6 and 12 months
Secondary outcomes:
measure: Oswestry Disability Index Scale
timeFrame: Baseline, 12 weeks, 6 month, 12 month
measure: SF (Short Form) - 36
timeFrame: Baseline, 12 weeks, 6 month
measure: IADL(Instrumental Activities of Daily Living)
timeFrame: Baseline, 12 weeks, 6 month, 12 month
measure: Beck Depression Inventory
timeFrame: Baseline, 12 weeks, 6 month, 12 month
measure: Pain Catastrophizing Scale
timeFrame: Baseline, 12 weeks, 6 month, 12 month
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
References:
Clinical trial NCT05589155: Efficacy of Using Mobile Health Applications for Health
Official title: Efficacy of Using Mobile Health Applications for Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Keywords: diabetes
mhealth
ehealth
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and type II diabetes outcomes in type 2 diabetics. This study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with type II diabetes for at least 3 months
* Between the age of 18-64
* BMI ≥ 25
* Monitors blood glucose regularly (at least once per day)
* Owns or has access to a bathroom weight scale
* Owns a smartphone and willing to download mobile app

Exclusion Criteria:

* Does not check blood glucose at least once per day
* On medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications.

Medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are oka

Primary outcomes:
measure: Effectiveness of mHealth apps at changing bodyweight assessed by bodyweight measurements over 6 months
timeFrame: 6 months
measure: Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire
timeFrame: 6 months
measure: Long term change in diabetes via A1c
timeFrame: 6 months
measure: Long term change in diabetes via fasting blood glucose
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References:
Clinical trial NCT06948955: Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors
Official title: Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Keywords: Solid Tumors
Sunitinib
Bezuclastinib
Gastrointestinal Stromal Tumors
Lead sponsor: Cogent Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.


Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent and commit to recommended EAP assessments.
* ≥18 years of age.
* Able to swallow tablets.
* Histologically confirmed locally advanced, metastatic, and/or unresectable GIST.
* Intolerant to imatinib or received prior imatinib therapy for treatment of advanced, metastatic, and/or unresectable GIST that resulted in disease progression.
* Meet clinically acceptable local laboratory results.

Exclusion Criteria:

* Patients who are eligible for and capable of participating in and/or enrolled in an on-going bezuclastinib clinical trial.
* Prior or known intolerance to sunitinib.
* Patients who have previously participated in a bezuclastinib clinical trial.
* Patients with persistent \> Grade 2 toxicities from prior therapy.
* Known PDGFR driving mutations or known SDH deficiency.
* Pregnant or currently breastfeeding.

Other protocol-defined criteria apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cogent Biosciences, Inc.
name: Rachael Easton, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04172155: Pulmonary Rehabilitation and Self-esteem in Patients With COPD
Official title: Effects of Pulmonary Rehabilitation on Self-esteem in Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients admitted to a pulmonary rehabilitation program

Brief summary: the aim of this study is to evaluate the evolution of self-esteem during a pulmonary rehabilitation program, in COPD patients.


Eligibility criteria: Inclusion Criteria:

* Patient with stage 2 to 4 (A to D) COPD admitted to a pulmonary rehabilitation program
* Patient aged 18 or over
* Patient able to consent and having signed a consent form

Exclusion Criteria:

* Patient with pain, osteoarthritis or shoulder surgery
* Patient with a history of Pneumonectomy, lobectomy less than 6 months old
* Refusal of participation
* Patient with an inability to complete a pulmonary rehabilitation program in totality
* Pregnant or breast-feeding women
* Patient under tutorship or curatorship

Primary outcomes:
measure: PSI-6
timeFrame: PSI-6 is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
Secondary outcomes:
measure: 6MWT
timeFrame: the 6MWT is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
measure: HAD
timeFrame: HAD is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
measure: SGRQ
timeFrame: SGRQ is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
Other outcomes:
measure: MMRC
timeFrame: MMRC is measured at the biginning and at the end of the pulmonary rehabilitation program (4 weeks)
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Morlaix
country: France
facility: CH Pays de Morlaix
Study officials:
References:
citation: Fox, K.R. et Corbin, C.B.The Physical Self-Perception Profile : Devlopment and Preliminary Validation. Journal of Sport and Exercise Psychology, 11(4), p. 408 430, 1989
citation: Ninot G, Moullec G, Desplan J, Prefaut C, Varray A. Daily functioning of dyspnea, self-esteem and physical self in patients with moderate COPD before, during and after a first inpatient rehabilitation program. Disabil Rehabil. 2007 Nov 30;29(22):1671-8. doi: 10.1080/09638280601055949.
Clinical trial NCT00629655: A Spinal Functional Magnetic Resonance Imagine (fMRI) Study of Resting-State, Motor Task and Acupoint Stimulation
Official title: A Spinal fMRI Study of Resting-State, Motor Task and Acupoint Stimulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Infarction
Keywords: fMRI
spinal cord
human
health
cerebral infarction
healthy
Lead sponsor: China Rehabilitation Research Center
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Finance, China
name: Capital Medical University
First posted: 2008-03-06
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: group 1: male residents of Beijing group 2: male stroke patients of Beijing Boai hospital

Brief summary: The spinal cord is a very important part of the central nervous system. fMRI can be applied to observe functional status of the human spinal cord. Under different conditions, the investigators will see different types of fMRI signals within the spinal cord. In resting state, the investigators might see active/inactive signals, too.


Eligibility criteria: Inclusion Criteria (for healthy people):

* Chinese male residents
* right handed
* no history of psychological/psychotic problems
* no history of important diseases

Exclusion Criteria (for healthy people):

* with factors which make subjects unsuitable to receive MR examination
* history of important diseases

Inclusion Criteria (for patients):

* Chinese male patients with ischemic stroke (CT/MRI scan confirmed)
* right handed
* at least 1.5 months from onset of stroke
* ability to follow complex commands

Exclusion Criteria (for patients):

* hemodynamic instability
* history of dementia
* inability to give consent because of impaired cognition or receptive aphasia
* diseases in spine/spinal cord
* with factors which make subjects unsuitable to receive MR examination

Primary outcomes:
measure: fMRI
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Boai Hospital
state: Beijing
Study officials:
affiliation: China Rehabilitation Research Center
name: Pengxu Wei, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03721055: Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor
Official title: 18F-(2S,4R)4-Glutamine PET/CT in Imaging Patients With Malignant Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Metastatic Cancer
Metastatic Brain Cancer
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-(2S,4R)4-fluoroglutamine, a glutamic acid derivative, to image patients with malignant tumor. \[18F\]Fluoroglutamine PET may provide additional information that help diagnose and stage cancer patients.


Eligibility criteria: Inclusion Criteria:

* Age between 18-79;
* The patient must be able to give informed consent;
* Patients can finish PET/CT scan without tranquilizers;
* Patients with pathology-proven cancer or a tumor highly suspected to be malignant ;
* Lesions can be measured and assessed at the RECIST 1.1 standard;
* No chemotherapy, radiotherapy or immune/biologic therapy,or biopsy were allowed between the 18F-FDG and the 4-\[18F\]Fluoroglutamine PET/CT.

Exclusion Criteria:

* Pregnant or lactating patients;
* Inability or refusal to have at least one peripheral intravenous line for intravenous access;
* From assays obtained \<2 weeks prior to study enrollment（ULN：the upper limit of normal value ）:Bilirubin\>1.5\*ULN,AST/ALT \>2.5 \* ULN, Albumin\< 3 g/dl, GGT \> 2.5 x ULN if ALP\> 2.5 x ULN, Creatinine\>1.5\*ULN or creatinine clearance \<60ml/min；
* Patients with a history of allergic reaction to this drugs or its analogues；
* patients with poor compliance;
* Acute major illness

Primary outcomes:
measure: Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer
timeFrame: up to three years
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: up to 30 days after the F-Gln imaging
measure: ASCT2 expression levels in tissue samples
timeFrame: up to three years
measure: The correlation between 18F-(2S,4R)4- glutamine PET/CT imaging and prognosis in malignant tumors
timeFrame: up to three years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06037655: Chemotherapy Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable BTC
Official title: Gemcitabine/Cisplatin Combined With Adebrelimab and Mecapegfilgrastim in Neoadjuvant Treatment of Potentially Resectable Biliary Tract Carcinoma, A Single-arm Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Biliary Tract Neoplasms
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim in neoadjuvant treatment of potentially resectable Biliary Tract Neoplasms.

Detailed description: After being informed about the study and potential risks, patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be receive Gemcitabine/cisplatin combined with Adebrelimab and Mecapegfilgrastim three weeks a cycle, surgery was performed after 4 cycles.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Age ≥ 18 years，≤ 75 years
* Patients with untreated resectable locally advanced biliary tract cancer (BTC) who are difficult to directly resecte surgically
* Ability to provide written informed consent prior to participation in any study-related procedure
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* At least one, not previously irradiated, measurable lesion according to RECIST (version 1.1).
* Adequate organ function

Exclusion Criteria:

* Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
* Known history of a serious allergy to any monoclonal antibody
* Any active malignancy prior to the start of treatment
* Active or history of autoimmune disease
* Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
* Pregnant or lactating women

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 18 weeks
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 2 years
Other outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years
measure: Pathological Complete Response Rate (pCR)
timeFrame: 18 weeks
measure: Major Pathological Response Rate (MPR)
timeFrame: 18 weeks
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiangcheng Li
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Xiaofeng Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02710955: SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
Official title: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation


Eligibility criteria: Inclusion Criteria:

* Infants :

  * Aged ≤ 5 months old
  * fully formula fed
  * with at least 5 episodes of regurgitation per day, for at least a week

Exclusion Criteria:

* Breast fed infants
* Infants presenting symptoms of a complicated gastroesophageal reflux
* Infants presenting intestinal disorders

Primary outcomes:
measure: Number of episodes of regurgitation per day
timeFrame: 14 days
Secondary outcomes:
measure: Regurgitation score assessed through Vandenplas score
timeFrame: 14 and 90 days
measure: Stools frequency over 72h
timeFrame: 14 and 90 days
measure: Stools consistency assessed through Bristol Stool form Scale
timeFrame: 14 and 90 days
measure: Weight expressed in z scores according to the WHO Child Growth Standards
timeFrame: 90 days
measure: Height expressed in z scores according to the WHO Child Growth Standards
timeFrame: 90 days
measure: BMI expressed in z scores according to the WHO Child Growth Standards
timeFrame: 90 days
measure: Head circumference expressed in z scores according to the WHO Child Growth Standards
timeFrame: 90 days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Yvan Vandenplas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01772914: Copeptin Changes After Food Intake
Official title: Copeptin During a Standardized Oral Glucose Tolerance Test and a Mixed Meal Tolerance Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Adults
Copeptin
Keywords: Copeptin
eating
glucose tolerance test
mixed meal test
physiological
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults

Brief summary: The purpose of this study is to determine whether copeptin levels are affected by food intake.


Eligibility criteria: Inclusion Criteria:

* Aged over 18 years

Exclusion Criteria:

* Intake of any kind of medication (except birth control pill)
* BMI \>30 kg/m2
* Evidence of any acute illness
* History of chronic illness
* Pregnancy
* Known galactosemia or maltose malabsorption
* Baseline glucose level \>5.5 mmol/l Baseline sodium level \<135 mmol/l or \>145 mmol/l

Primary outcomes:
measure: Changes in copeptin levels after intake of a oral glucose tolerance test- and a mixed meal tolerance test liquid
timeFrame: 30, 60, 90, 120, 180 minutes after intake of the test liquids
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
name: Mirjam Christ-Crain, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walti C, Siegenthaler J, Christ-Crain M. Copeptin levels are independent of ingested nutrient type after standardised meal administration--the CoMEAL study. Biomarkers. 2014 Nov;19(7):557-62. doi: 10.3109/1354750X.2014.940504. Epub 2014 Sep 16.
Clinical trial NCT01384214: Effect of Botulinum Toxin Type A on Swallowing in Patients With Cervical Dystonia
Official title: Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients With Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Torticollis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-06-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cervical dystonia
* Successfully completed Allergan study MedAff BTX-0616 with 16 weeks since last botulinum toxin Type A injection
* In need of additional botulinum toxin Type A injections

Exclusion Criteria:

* Surgery or spinal cord stimulation for cervical dystonia
* Previous injections of phenol or alcohol for cervical dystonia

Primary outcomes:
measure: Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)
timeFrame: Baseline, Week 2
Secondary outcomes:
measure: Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score
timeFrame: Week 4
measure: Physician Assessment of Cervical Dystonia Severity
timeFrame: Week 4
measure: Global Assessment of Benefit by Physician
timeFrame: Week 4
measure: Global Assessment of Benefit by Patient
timeFrame: Week 4
measure: Patient Visual Analog Assessment of Pain
timeFrame: Week 4
Other outcomes:
Locations:
city: Zagreb
country: Croatia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: