louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03183024: Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody
Official title: Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monocloncal Antibody
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Idiopathic Urticaria
Lead sponsor: Bernstein Clinical Research Center
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to determine the efficacy of benralizumab when compared to placebo in patients with chronic hives that do not respond to antihistamine treatment

Detailed description: Subjects with chronic hives that do not respond to antihistamine treatment and have hives of unknown cause will be eligible. Subjects who meet the inclusion/exclusion criteria after the run-in phase will receive 3 doses of study medication. The study also involved blood draws and a punch biopsy of a hive

Eligibility criteria: Inclusion Criteria:

* hives for over 6 weeks of unknown cause hives most days of the despite use of antihistamines

Exclusion Criteria:

* hives due to known reasons history of cancer pregnant or nursing History of HIV or Hepatitis recent parasitic infection currently or have received treatment with a monoclonal antibody

Primary outcomes:
measure: change in urticarial activity score averaged over 7 days- no units
timeFrame: through study completion, up to 7 months
Secondary outcomes:
measure: change in blood anti-FCER1 level (kU/l)
timeFrame: through study completion, up to 7 months
measure: change in blood anti-TPO level (IU/L)
timeFrame: through study completion, up to 7 months
measure: change in Blood ECP level (ug/L)
timeFrame: through study completion, up to 7 months
measure: change in blood eotaxin level (pg/ml)
timeFrame: through study completion, up to 7 months
measure: change in RNA testing
timeFrame: through study completion, up to 7 months
measure: change in skin biopsy inflammatory cell counts
timeFrame: through study completion, up to 7 months
measure: change in cytokine quantification in skin biopsy (units/mL)
timeFrame: through study completion, up to 7 months
Other outcomes:
measure: adverse events
timeFrame: through study completion, up to 7 months
measure: change in blood pressure
timeFrame: through study completion, up to 7 months
measure: change in pulse rate
timeFrame: through study completion, up to 7 months
measure: change in blood urea nitrogen
timeFrame: through study completion, up to 7 months
Locations:
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
Study officials:
References:
Clinical trial NCT05810324: 18F-FAPI PET/CT in Patients With Various Types of Cancer
Official title: The Performance of 18F-FAPI PET/CT in Patients With Various Types of Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Detailed description: Subjects with various types of cancer underwent 18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

* patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
* patients who had scheduled 18F-FAPI PET/CT scan; (iv)
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* patients with non-malignant lesions;
* patients with pregnancy;
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chang chun
country: China
facility: China-Japan Union Hospital
state: Jilin
Study officials:
affiliation: China-Japan Union Hospital, Jilin University
name: Bin Ji
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00238524: A Trial to Assess the Efficacy and Safety of SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day and 600mg/Day SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathy
Keywords: painful distal diabetic neuropathy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-10-13
Enrollment: 357
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: This trial was conducted at about 50 sites in Europe and has been clinically completed. Patients had symptoms of painful diabetic neuropathy for 6 months up to 5 years with an optimized diabetic control and at least moderate pain. Patients were not eligible with other chronic pain or any other medical or psychiatric condition, that would have jeopardized or compromised the patient's ability to participate in the trial. After a 2-week run-in phase patients were randomly assigned to one of three treatment arms. All patients who had completed the 6-week titration phase to reach their target dose entered a 12-week maintenance phase. At the end of the maintenance phase, subjects were offered the option of entering the open-label, follow-on trial. The change in pain was measured daily as well as interference of pain with sleep and general activity.


Eligibility criteria: Inclusion Criteria:

* Painful distal diabetic neuropathy

Exclusion Criteria:

* Symptoms of painful distal diabetic neuropathy for less than six months or greater than 5 years

Primary outcomes:
measure: Investigate the efficacy of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy will be determined by pain score ratings assessed in a patient's diary and at clinic visits.
Secondary outcomes:
measure: Investigate effect of lacosmide on subjects' perception of sleep, activity, quality of life, and safety, determined by rating scales assessed in a patient's diary and at the clinic visits.
Other outcomes:
Locations:
city: Monheim
country: Germany
facility: Schwarz
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Ziegler D, Hidvegi T, Gurieva I, Bongardt S, Freynhagen R, Sen D, Sommerville K; Lacosamide SP743 Study Group. Efficacy and safety of lacosamide in painful diabetic neuropathy. Diabetes Care. 2010 Apr;33(4):839-41. doi: 10.2337/dc09-1578. Epub 2010 Jan 12.
Clinical trial NCT00220324: Pearl Index Study With Low Dose Combined Oral Contraceptive
Official title: Prospective, Multicenter, Open-label, Uncontrolled Study to Investigate the Contraceptive Efficacy, Bleeding Patterns, and Safety of an Oral Contraceptive Containing 0.03 mg Ethinylestradiol and 0.125 mg Levonorgestrel (SH D00342A) Applied for 13 Cycles to Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Keywords: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 840
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Healthy women requiring contraception

Exclusion Criteria:

* Pregnant or lactating women, history or suspicion of hormone dependent tumor or any other conditions which forbid the participation.

Primary outcomes:
measure: Unadjusted Pearl Index
timeFrame: After 13 cycles of intake
Secondary outcomes:
measure: Adjusted Pearl Index
timeFrame: After 13 cycles of intake
measure: Cumulative pregnancy rate
timeFrame: After 13 cycles of intake
measure: Bleeding pattern
timeFrame: After 13 cycles of intake
measure: Cycle control
timeFrame: After 13 cycles of intake
Other outcomes:
Locations:
city: Hannover
country: Germany
state: Niedersachsen
city: Aschersleben
country: Germany
state: Sachsen-Anhalt
city: Burg
country: Germany
state: Sachsen-Anhalt
city: Egeln
country: Germany
state: Sachsen-Anhalt
city: Halberstadt
country: Germany
state: Sachsen-Anhalt
city: Halberstadt
country: Germany
state: Sachsen-Anhalt
city: Jessen
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Großpösna
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Suhl
country: Germany
state: Thüringen
city: Weida
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06873724: SPY003-207 in Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of SPY003-207 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Spyre Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Altasciences Company Inc.
First posted: 2025-03-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1, randomized, double-blind, placebo-controlled, single dose, first in human safety, tolerability, and pharmacokinetic study of SPY003-207 in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Willing and able to attend the necessary visits to the CRU, comply with all testing requirements, remain at the study site unit for the duration of the confinement period and return for the outpatient visits

Exclusion Criteria:

* Participation in more than one cohort
* Evidence of clinically significant abnormality or disease
* Known history of illicit drug use or drug abuse, harmful alcohol use or alcoholism, and/or smoking or nicotine-containing product use within 3 months prior to the first dose of study drug
* History of severe allergic reactions or hypersensitivity
* Donation or loss of \>1 unit of whole blood within 1 month prior to dosing

Primary outcomes:
measure: Treatment emergent adverse events
timeFrame: Up to 63 weeks
Secondary outcomes:
measure: Cmax
timeFrame: Up to 63 weeks
measure: Tmax
timeFrame: Up to 63 weeks
measure: t1/2
timeFrame: Up to 63 weeks
measure: AUC
timeFrame: Up to 63 weeks
measure: ADA
timeFrame: Up to 63 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Spyre Site 1
state: Quebec
Study officials:
affiliation: Spyre Therapeutics
name: Deanna Nguyen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00603824: Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)
Official title: Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Heparin-Induced Thrombocytopenia
Keywords: heparin-Induced thrombocytopenia
fondaparinux
Lead sponsor: Methodist Healthcare
Sponsor class: OTHER
Collaborators: name: University of Tennessee
First posted: 2008-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary objective is to determine if any new blood clots are formed while receiving the fondaparinux and up to one month after study enrollment. This information will be compared to a historical control.


Eligibility criteria: Inclusion Criteria:

* Male or female at least 18 years of age;
* If female of childbearing potential, negative pregnancy test result;
* Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets \< 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure;
* Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive).

Exclusion Criteria:

* Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation);
* Pregnancy or lactating;
* Blood dyscrasia other than HIT;
* History of thrombocytopenia associated with fondaparinux;
* Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned;
* Active bleeding of GI tract, GU tract, CNS or respiratory tract;
* Malignant hypertension, pericarditis, pericardial effusion, endocarditis or eclampsia;
* Inadequate laboratory facilities, inadequate support system at home, alcoholism, drug abuse, psychosis or dementia;
* Hypersensitivity or contraindication to warfarin or fondaparinux.

Primary outcomes:
measure: Platelet count recovery
timeFrame: 5 days
Secondary outcomes:
measure: Recurrent thromboembolic complications
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Methodist University Hospital
name: Bob L Lobo, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee
name: Sohail Minhas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06927024: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)
Official title: A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-04-15
Enrollment: 30
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: 30 patients will participate in a prospective randomized clinical trial to test the safety, tolerability and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting.


Eligibility criteria: Inclusion Criteria:

* Individuals age ≥18 years
* Diagnosis of Chronic Kidney Disease (CKD) stage 3-5 \[estimated glomerular filtration rate \&le;60 mL/min/1.73m2\]
* Receiving care at NYU Nephrology outpatient practice
* Able to provide informed consent

Exclusion Criteria:

* Primary ANS disorders (e.g., Parkinson's disease)
* Arrhythmias
* Implantable cardioverter-defibrillator (ICD) or pacemaker (PPM) precluding assessment of HRV (e.g., chronic atrial fibrillation)
* On maintenance dialysis (HD)
* Epilepsy
* Symptomatic bradycardia
* Presence of an implantable defibrillators
* Presence of a permanent pacemaker
* Unable to consent
* Incarcerated individuals
* Pregnant individuals

Primary outcomes:
measure: Proportion of Patients who Complete 2 Weeks of Intervention
timeFrame: Week 2
measure: Proportion of Patients who Tolerate Each Full 15-Minute Session
timeFrame: Week 2
measure: Incidence of Severe Bradycardia following taVNS Use
timeFrame: Up to Week 2
measure: Incidence of Severe Tachycardia following taVNS Use
timeFrame: Up to Week 2
measure: Incidence of Syncope following taVNS Use
timeFrame: Up to Week 2
Secondary outcomes:
measure: Proportion of eligible patients who consent to use the device for 2 weeks
timeFrame: Up to Week 2
measure: Change in High Frequency (HF) Signal from Baseline
timeFrame: Baseline, Week 2
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Qandeel Soomro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03428724: Individualized Bowel Preparation for Colonoscopy
Official title: A Randomized Clinical Trial Comparing Standard and Invidualized Bowel Preparation for Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colon Disease
Lead sponsor: Clinical Hospital Colentina
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 450
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: A randomized control trial comparing a standard bowel preparation for colonoscopy with an individualized bowel preparation strategy based on patient characteristics


Eligibility criteria: Inclusion Criteria:

* elective out-patient diagnostic or therapeutic colonoscopy

Exclusion Criteria:

* pregnant women; refusal to participate; significant comorbidities (ASA score 3 or above); suspicion of bowel perforation;

Primary outcomes:
measure: bowel preparation quality
timeFrame: 1-2 hours after completing bowel preparation
Secondary outcomes:
measure: patient comfort during bowel preparation
timeFrame: 1-2 hours after completing bowel preparation
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Bucharest
country: Romania
facility: Carol Davila Emergency Military Hospital
Study officials:
affiliation: Clinical Hospital Colentina
name: Theodor Voiosu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00070824: Functional Brain Imaging - Acupuncture and Osteoarthritis
Official title: Functional Brain Imaging - Acupuncture and Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis
Keywords: Acupuncture
SPECT
f-MRI
Functional brain imaging
RCT
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2003-10-13
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to use single photon emission computed tomography (SPECT) and functional magnetic resonance imaging (f-MRI) of the brain to study the response of both normal participants and participants with Osteoarthritis (OA) of the knee to acupuncture.

Detailed description: Recent experimental studies in both animal and humans have begun to demonstrate some measurable physiologic effects that are associated with acupuncture, suggesting the possibility of a neurophysiologic explanation. In addition, brain research continues to uncover a complex set of endogenous neurologic control systems, such that it has become clear that the brain plays a major role in the modulation of pain perception and control. If acupuncture can be demonstrated to have a consistent effect on specific areas of the brain, it will become possible to explore the potential efficacy of acupuncture based on measurable neurophysiologic responses.

Eligibility criteria: Inclusion criteria:

* Seen in an outpatient clinical setting
* Have active knee OA of \>6 months including Kellgren x-ray changes \>2 from an x-ray report \<12 months old or new x-ray interpretation
* Moderate unilateral only pain (average \>4/10 on a 0-10 likert scale) for more than 5 out of 7 days
* Have the capacity to understand the requirements of the study and complete the baseline studies in a reasonable time frame, as determined by the interviewer

Exclusion criteria:

* Having had acupuncture before (must be acupuncture naïve)
* Any history of claustrophobia that could affect the subject's ability to tolerate the f-MRI study
* Hip or ankle disease by history or exam severe enough to cause pain \>2/10 daily
* Bleeding disorder or current use of warfarin or heparin by patient history
* Other primary causes of chronic knee pain, per the referring physician, including chondromalacia patella, torn meniscus or ligament injury.

Primary outcomes:
measure: SPECT Cerebral Bloodflow
timeFrame: 24 hours
Secondary outcomes:
measure: 0-10 Numeric Rating Scale for Pain Intensity
timeFrame: 1 hour
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: John T. Farrar, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: