louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03195556: Augmentation of Limb Perfusion With Contrast Ultrasound
Official title: Augmentation of Limb Perfusion With Contrast Ultrasound
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our laboratory has discovered that ultrasound (US) imaging together with clinically approved microbubble ultrasound contrast agents can augment limb tissue perfusion. These observations have been made in mice with and without peripheral artery disease (PAD), and also in humans where high power contrast enhanced ultrasound (CEU) was used to measure perfusion but was found also to augment perfusion by almost 2-fold. The latter human studies were performed with ultrasound protocols designed for perfusion imaging and not for flow augmentation. In this study, we will measure the degree to which limb perfusion is augmented with specific therapeutic CEU settings that are still within the FDA-approved limits with regards to US power and contrast dosing.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 y.o.
* For PAD subjects: known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index or angiography and a Rutherford symptom class of 4-6.

Exclusion Criteria:

1. Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[NYHA class IV or LVEF \<30%\]).
2. Pregnant or lactating females
3. Hypersensitivity to any ultrasound contrast agent
4. Known atrial septal defect or large right to left shunt.
5. Hemodynamic instability (hypotension with systolic BP \<90 mm Hg, need for vasopressors)
6. Evidence for ongoing myocardial ischemia
7. For normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).

Primary outcomes:
measure: Change in blood flow at 10 min
timeFrame: 10 min post-therapeutic ultrasound cavitation.
measure: Change in blood flow at 60 min
timeFrame: 60 min post-therapeutic ultrasound cavitation
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
References:
citation: Mason OR, Davidson BP, Sheeran P, Muller M, Hodovan JM, Sutton J, Powers J, Lindner JR. Augmentation of Tissue Perfusion in Patients With Peripheral Artery Disease Using Microbubble Cavitation. JACC Cardiovasc Imaging. 2020 Mar;13(3):641-651. doi: 10.1016/j.jcmg.2019.06.012. Epub 2019 Aug 14.
Clinical trial NCT07025356: Observational Study of the the Use of a Trigeminal Vagal Nerve Stimulator in the Routine Care of Native Americans With Diabetic Neuropathy Pain. Pain Scores, Drug Use and Glucose Measurements Will be Assessed
Official title: Combined Minimally Invasive Vagal Cranial Nerve and Trigeminocervical Complex Peripheral Nerve Stimulation In Severe Painful Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Neuropathy With Neurologic Complication
Keywords: Vagus
diabetic neuropathy
auricular
stimulation
Lead sponsor: Vagus Nerve Society
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Native American Population with Diabetic Neuropathy pain

Brief summary: This is an observational study that will follow patients in the course of routine care and measure pain levels, glucose assessments and drug utilization for native American patients with diabetic neuropathy

Detailed description: Patients with diabetic neuropathy pain will have an NS100 device implanted for chronic diabetic neuropathy pain consistent with onlabel indication. All patients will be followed for 90 days post implant to measure improvements in pain, drug utilization and glucose levels.

Eligibility criteria: Inclusion Criteria:

* Diabetic Neuropathy Pain History of failed treatment WIlling to follow blood glucose and pain scores for 90 days

Exclusion Criteria

* Bleeding diathesis Pregnancy Cardiac monitoring device Implantable Neurostimulator Inability to give informed consedn

Primary outcomes:
measure: Pain scores over time
timeFrame: 90 days
Secondary outcomes:
measure: glucose levels will be measured over time
timeFrame: 90 days
Other outcomes:
Locations:
city: Pine Ridge
country: United States
facility: Continuum of Care Clinic
state: South Dakota
Study officials:
affiliation: Vagus Nerve Society
name: Claire Marie Rangon, MD PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT07011056: A Phase III Clinical Study of Purinostat Mesylate for Injection in Patients With Diffuse Large B-cell Lymphoma
Official title: A Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of the Purinostat Mesylate for Injection (PM) Compared to Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Recurrent and Refractory Diffuse Large B-cell Lymphoma
Lead sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-06-08
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to evaluate the differences in objective response rate and overall survival between the Purinostat mesylate for injection and selinexor, as assessed by blinded independent central review (BICR), in patients with relapsed or refractory diffuse large B-cell lymphoma.

.The participants in the experimental group will receive treatment with Purinostat mesylate for injection. The dosage is 11.2 mg/m2. Each administration cycle consists of intravenous administration on days 1, 4, 8, and 11. A 21-day period constitutes one treatment cycle, and the total treatment cycle lasts for 6 cycles.

.Participants in the control group will receive selinexor treatment. The recommended dose is 60 mg per dose, taken orally on days 1 and 3 of each week (for example, Monday and Wednesday, or Tuesday and Thursday), and a 4-week period constitutes one treatment cycle.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years, no gender restrictions;
2. Histologically-confirmed DLBCL, Participants must have relapsed or failed to respond to at least two lines of prior systemic therapy (2-5 lines);
3. Participants must have measurable disease;
4. ECOG≤2;
5. Adequate organ function

Exclusion Criteria:

1. Pregnancy or breastfeeding;
2. Previous history of transplantation;
3. Double/Triple Hit B cell lymphoma;
4. Patient with known active infection, or reactivation of a latent infection;
5. Any serious diseases that investigator deems inappropriate to participate.

Primary outcomes:
measure: The Overall Survival
timeFrame: week 96
Secondary outcomes:
measure: The PFS assessed by BICR AND Investigator according to Lugano 2014
timeFrame: week 96
measure: The ORR assessed by BICR and Investigator according to Lugano 2014
timeFrame: week 96
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02477956: Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients
Official title: Impact of Monthly High Dose Oral Cholecalciferol on Serum 25 Hydroxy Vitamin D Levels in Bariatric Surgery Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Morbid Obesity
Vitamin D Deficiency
Keywords: vitamin D
obesity
bariatric surgery
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bariatric surgery patients tend to have malabsorption of many micronutrients such as B12, Iron and vitamin D postoperative. So in this study, a monthly high dose of vitamin D3 is giving to patients with their routine supplements and followed up for 6 months.

Hypothesis:Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a significant rise in serum vitamin D levels compared to the subjects taking only the usual vitamin D protocol.

Detailed description: Sun exposure and supplement use questionnaire:

A registered dietitian asked each subject for information on sun exposure, vitamins, medications, and any other supplement usage before each blood sample was taken.

Lab analysis included serum hydroxy vitamin D levels pre and 3 months postoperative.

Descriptive statistics which include both the means and standard deviations were calculated on the study variables. A paired sample t-test was used to determine if there was a significant difference in mean values pre and post vitamin D supplementation. An independent sample t-test was used to assess for significant differences in group (control vs. vitamin D supplement) means. A p-value \< 0.05 was considered statistically significant. Statistical analyses were done using SPSS Version 21 (SPSS, Chicago, III, USA).

Eligibility criteria: Inclusion Criteria:

* morbidly obese and eligible for bariatric surgery

Exclusion Criteria:

* under 18 and over 60 years of age
* elevated serum vitamin D and calcium
* pregnant and lactating women

Primary outcomes:
measure: Impact of monthly high dose oral cholecalciferol on serum 25 hydroxy vitamin D levels in bariatric surgery subjects
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: David Syn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University
name: Mallory Boylan, PhD
role: STUDY_DIRECTOR
affiliation: Texas Tech University
name: Hadil Subih, PhD
role: STUDY_CHAIR
affiliation: Texas Tech University
name: Shannon Owens, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04894656: Intestinal Permeability and Gastroparesis
Official title: Assessing Intestinal Barrier Function and Permeability in Patients With Gastroparesis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastroparesis
Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate potential mechanisms that could lead to the development of a condition known as gastroparesis.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18-75 years old).
* Men and women.
* Patients with gastroparesis.

Exclusion Criteria:

* Patients will be excluded from the study if symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), GERD, esophagitis, eosinophilic esophagitis or H. pylori.
* Patients with uncontrolled diabetes mellitus (hemoglobin A1C \> 10).
* Patients with prior surgery to the esophagus, stomach or duodenum.
* Patients taking opioids, steroids, anti-histamines, immunosuppressive agents, NSAIDs, or mast cell stabilizing agents within the prior 3 months.
* Patients currently prescribed aspirin or aspirin regimens for other clinical reasons.
* Patients with known allergies to lactulose: mannitol will be excluded.

Primary outcomes:
measure: Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.
timeFrame: through study completion, approximately 3-4 days
Secondary outcomes:
measure: Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.
timeFrame: through study completion, approximately 3-4 days
measure: Measure serum levels of immune markers (e.g., IL-1,4,6,10,12,13,18; zonulin, CRP, TNF-alpha, tryptase,) in GP patients and compare to healthy controls.
timeFrame: One time measurement
measure: Quantitate different duodenal cell types (e.g., mast cells (CK117), eosinophils, enterochromaffin, intraepithelial lymphocytes (IELs) and CCK-containing cells) in patients with GP using biopsies from both the D1 and D2 duodenal segments.
timeFrame: through study completion, approximately 3-4 days
measure: Assess the relationship of GP symptoms to intestinal permeability, using validated questionnaires, and to histopathological changes.
timeFrame: through study completion, approximately 3-4 days
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: David Cangemi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02279056: Randomized Controlled Trial of a Self-help Book for Insomnia in Patients With Co-morbid OSA and Insomnia
Official title: A Randomized Controlled Trial (RCT) of a Self-help Book for Insomnia in Patients With Co-morbid Obstructive Sleep Apnea (OSA) and Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Insomnia
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2014-10-30
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea (OSA) is a common sleep disorder treated with continuous positive airway pressure (CPAP). Some OSA patients also suffer from co-morbid insomnia. CPAP treatment may be complicated in patients with co-morbid insomnia. This project evaluates the effects of a self-help book for insomnia in patients being treated with CPAP for OSA.

Detailed description: This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia in patients with obstructive sleep apnea (OSA) and co-morbid insomnia. 180 patients are randomized to either receive the self-help book (90 patients) or sleep hygiene advice (90 patients). Patients fill out questionnaires about sleep and health both at baseline and after three months. Furthermore, CPAP compliance and OSA severity will be evaluated after three months of CPAP use. The aim is to evaluate whether the self-help book will improve sleep parameters and CPAP compliance.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with OSA and scheduled for CPAP treatment.
* Having co-morbid insomnia.

Exclusion Criteria:

* Less than 18 years of age
* Not fluent in Norwegian

Primary outcomes:
measure: Insomnia severity
timeFrame: 3 months
Secondary outcomes:
measure: CPAP compliance
timeFrame: 3 months
measure: Sleep apnea severity
timeFrame: 3 months
measure: Insomnia prevalence
timeFrame: 3 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Hordaland
Study officials:
affiliation: University of Bergen
name: Bjørn Bjorvatn, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03594656: Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease
Official title: Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Lingzhi
Traditional Chinese Medicine
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 288
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lingzhi(Ganoderma) is widely used in traditional Chinese medicine. Previous studies indicated that Lingzhi was safe, well tolorated, and improved symptoms as an add-on therapy to levodopa in early Parkinson's disease(PD) patients. Here the investigators design a multicenter, randomized, double-blind, placebo-controlled, delayed-start trial to evaluate the effects of Lingzhi on modifying disease progression in untreated PD patients.


Eligibility criteria: Inclusion Criteria:

* Meeting the criteria for "Probable Parkinson's disease" according to 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease
* Aged 30-80 years
* Hoehn-Yahr Stage≤2
* UPDRS Part III subscores ranging from 10 to 30 points
* Disease duration of 5 years or less
* Untreated with antiparkinsonian drugs for at least two weeks preceding the trial
* Willing to sign the written informed consent

Exclusion Criteria:

* Atypical or secondary parkinsonism
* With psychiatric symptoms or a history of psychiatric diseases
* With cognitive impairment(MMSE score\<24)
* Major liver or kidney dysfunction
* Participating in other clinical trials within 3 months preceding the current trial

Primary outcomes:
measure: Changes in UPDRS Part III subscores
timeFrame: 72 weeks
measure: Changes in Schwab-England scores
timeFrame: 72 weeks
measure: Ratios of subjects in need of additional antiparkinsonian drugs
timeFrame: 72 weeks
Secondary outcomes:
measure: Changes in ADAS-COG scores
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital of Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital of Capital Medical University
name: Erhe Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04145856: Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico
Official title: Efficacy of the Combination Therapy With Alverine-simeticone and i3.1 Probiotic Formula in the Quality of Life of Patients With IBS-D or IBS-M in Hospital Juarez Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: Probiotic
Antispasmodic
Rome-IV
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2019-10-31
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized study evaluates the usefulness of the I31 probiotic formula, alone or in combination with alverine/simethicone, against placebo, in the treatment of diarrhea-predominant or mixed irritable bowel syndrome

Detailed description: Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits. Disordered bowel habits are typically present (ie, constipation, diarrhea, or a mix of constipation and diarrhea), as are symptoms of abdominal bloating/distention.

I31 is a probiotic formula composed of strains Pediococcus acidilactici CECT7483 and Lactobacillus plantarum CECT7484 and CECT7485, previously shown to improve quality of life in patients with IBS of Caucasian descent.

Alverine/simethicone is a combination of two drugs: Alverine citrate relaxes muscle cramps that occur in the intestine in conditions such as irritable bowel syndrome and diverticulosis. Simethicone is an antifoam administered orally. Reduces gas formation and facilitates its elimination from the digestive tract

Eligibility criteria: Inclusion Criteria:

* Subjects attending Hospital Juarez de Mexico with a diagnosis of diarrhea-predominant or mixed irritable bowel syndrome (IBS-D and IBS-M), according to Rome-IV criteria (Lacy et al. Gastroenterology 2016), providing Informed Consent.

Exclusion Criteria:

* Unexplained weight loss, blood in feces, anemia.
* Use of systemic antibiotics, NSAIDs, antipsychotic or prokinetic medication in the 3 weeks before study initiation.
* Pregnant or lactating women.
* History of gastrointestinal cancer.
* Suspicion of coeliac disease, inflammatory bowel disease (IBD), endometriosis or pelvic inflammatory disease.
* History of abdominal surgery within 2 years (3 months if appendectomy or herniorraphy)
* BMI below 18
* Known allergy to any of the components in the treatments

Primary outcomes:
measure: Disease-specific quality of life (QoL)
timeFrame: 6 weeks
Secondary outcomes:
measure: Abdominal Pain
timeFrame: 6 weeks
measure: Diarrhea
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ciudad de Mexico
country: Mexico
facility: Hospital Juarez de Mexico
state: Cdmx
Study officials:
affiliation: Hospital Juarez de Mexico
name: Nuria Lopez Perez, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05989256: Developing a Model to Predict Inpatient Hypoglycemic Episodes
Official title: Developing a Model to Predict Inpatient Hypoglycemic Episodes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypoglycemic Events
Hyperglycemic Therapy
Keywords: diabetes
hypoglycemia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will create a new model to predict hypoglycemic events in diabetic inpatients on anti-hyperglycemic therapy using retrospective data with the goal of developing a model that will accurately predict hypoglycemic episodes in the patient population - piloting the risk score that was developed in the context of EndoTool being rolled out at the institution, to determine the feasibility and acceptability of viewing the risk score in the Electronic Health Record

Detailed description: Design a model to predict hypoglycemic episodes in real time, rather than retrospectively identifying high risk patients who experienced a hypoglycemic event at some point during their hospitalization, as has been done prior. Potential predictors of hypoglycemia identified in prior work and additional predictors identified by the clinical team to develop a discrete-time multinomial logistic regression model to predict hypoglycemic events in real time. The risk score then will be piloted in the context of our institution's EndoTool Subcutaneous implementation determine the feasibility and acceptability of viewing the risk score in the Electronic Health Record

Eligibility criteria: Inclusion Criteria:

* Providers taking care of adult patients (18 years and older) on the selected medical floors who are receiving anti-hyperglycemic medications on the chosen services (EndoTool and risk score implementation) and comparison groups (one group with EndoTool implementation and the other group without EndoTool implementation)

Exclusion Criteria:

* Providers not on the chosen services

Primary outcomes:
measure: EndoTool Utilization Rates
timeFrame: day 90
measure: Glucose Monitoring Team (GMT) Consult Utilization Rates
timeFrame: day 90
measure: Provider satisfaction scores
timeFrame: day 90
measure: Inpatient hypoglycemia event rates
timeFrame: day 90
Secondary outcomes:
measure: Number of Inpatient hospitalizations with a hyperglycemic event
timeFrame: day 90
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Matthew Gorris, MD
role: PRINCIPAL_INVESTIGATOR
References: