louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05757973: Pre-Approval Access Program for Talquetamab in Relapsed or Refractory Multiple Myeloma
Official title: Pre-Approval Access Named Patient Program for Talquetamab (JNJ-64407564) for Treating Physician Use in Relapsed or Refractory Multiple Myeloma
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Relapsed or Refractory Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-03-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this pre-approval access program is to give talquetamab monotherapy (treatment with single drug) to participants with relapsed or refractory multiple myeloma (a type of cancer that begins in plasma cells \[white blood cells that produce antibodies\] which has returned or difficult to treat) who have relapsed on or are refractory to all locally available and clinically appropriate treatment and who are not eligible for a clinical trial.

Detailed description: Talquetamab (JNJ-64407564) is a humanized immunoglobulin G4 proline, alanine, alanine (IgG4PAA) bispecific antibody designed to target G-Protein Coupled Receptor (5DGPRC5D) and cluster of differentiation 3 (CD3). Redirecting T-cells to a tumor surface antigen using bispecific antibody approaches may be an effective means to harness the immune system to destroy cancer cells expressing GPRC5D and create meaningful and long-lasting clinical responses. Talquetamab is supplied as single-dose Investigational Product (IP) vials for subcutaneous administration. Safety assessments will include adverse events, serious adverse events, adverse drug reactions, and special situations which will be reported during the duration of the pre-approval access program.

Eligibility criteria: Inclusion Criteria:

* Participant diagnosed with relapsed or refractory multiple, myeloma
* Participant exhausted all commercially approved and clinically appropriate treatment options, and is ineligible for a clinical trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01714973: Study of ST266 Versus Saline in Treating Skin Irritation From Radiation
Official title: Phase I Randomized, Blinded Safety and Efficacy Trial of Amnion-derived Cellular Cytokine Solution (ACCS) Versus Saline Sprayed on the Breast of Women Undergoing Radiation Therapy for Breast Cancer After Surgical Removal of the Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Radiation-induced Dermatitis
Lead sponsor: Noveome Biotherapeutics, formerly Stemnion
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of ST266 in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare ST266 treated burns with those treated with saline placebo controls.


Eligibility criteria: Inclusion Criteria:

* A signed IRB - approved Informed Consent;
* Women 18 - 80 years of age;
* Biopsy-proven diagnosis of breast cancer with the tumor surgically removed.
* Whole breast radiation with or without ipsilateral axilla radiation therapy recommended by her radiation oncologist.
* If a woman is of child-bearing potential, she and her partner must use an effective form of birth control.
* Willing to participate in the clinical study and comply with the requirements of the trial.

Exclusion Criteria:

* Abnormal liver or kidney function studies being greater than 2x the upper limit of normal.
* Patients on hemodialysis
* Psychiatric condition or substance abuse which in the Investigator's opinion may pose a threat to patient compliance;
* History of non-compliance with treatment or clinical visit attendance.
* Participation in an investigational trial within 30 days of study entry.
* Women who are pregnant or lactating

Primary outcomes:
measure: Adverse Events (AEs) and Significant Adverse Events (SAEs)
timeFrame: Start of therapy through six week follow-up visit
Secondary outcomes:
measure: Skin inflammation
timeFrame: start of therapy through six week follow-up visit
measure: Quality of Life (QOL)scaled responses
timeFrame: start of therapy through one year follow-up
Other outcomes:
measure: Cosmesis
timeFrame: 6 and 12 months post-treatment
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: Mark Trombetta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Noveome Biotherapeutics, formerly Stemnion
name: David L Steed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02060773: Effect of EGDT on Hepatic Perfusion in Patients With Septic Shock
Official title: Effect of EGDT on Hepatic Perfusion in Patients With Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Keywords: Septic shock
Early goal directed therapy
Fluid resuscitation
Hepatic perfusion
Indocyanine Green
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2014-02-12
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: PROBABILITY_SAMPLE
Study population: Critical patients with early septic shock admitted to ICU within 24 hours after onset

Brief summary: To observe the effect of early goal directed therapy (EGDT) on hepatic perfusion in patients with septic shock.

Hypothesis: Hepatic perfusion did not improved after EGDT in patients with septic shock.

Detailed description: Objective To observe the effect of early goal directed therapy (EGDT) on hepatic perfusion in patients with septic shock.

Methods A prospective observational study was carried out. The eligible patients were treated with the standard procedure of EGDT. The hemodynamic data were recorded. Oxygen metabolism and hepatic function were monitored. Indocyanine clearance test was applied to detect the hepatic perfusion. Hemodynamics, hepatic perfusion, oxygen metabolism and hepatic function were compared before treatment, after EGDT and 24 hours after EGDT.

Eligibility criteria: Inclusion Criteria:

1. patients with septic shock
2. at least one of the EGDT criteria not achieved
3. informed consent accepted

Exclusion Criteria:

1. ages below 18 or above 90
2. pregnancy
3. the time elapsed over 24 hours after onset of septic shock
4. chronic liver disease
5. terminal stage of disease
6. brain death
7. other types of shock
8. brain injury
9. allergic to iodine or indocyanine

Primary outcomes:
measure: ICG-PDR and R15 before treatment, after EGDT and 24 hours after EGDT.
timeFrame: 30 hours
Secondary outcomes:
measure: 28 days mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Zhongda Hospital of Southeast University
state: Jiangsu
Study officials:
References:
citation: Zhang XW, Xie JF, Liu AR, Huang YZ, Guo FM, Yang CS, Yang Y, Qiu HB. Hepatic Perfusion Alterations in Septic Shock Patients: Impact of Early Goal-directed Therapy. Chin Med J (Engl). 2016 Jul 20;129(14):1666-73. doi: 10.4103/0366-6999.185865.
Clinical trial NCT01045473: Prospective Study of Minimally Invasive Spine Surgery
Official title: Prospective Study of Minimally Invasive Spinal Fusion Surgery for the Treatment of Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Disk Disease
Spondylolisthesis
Spinal Stenosis
Degenerative Scoliosis
Keywords: MIS
Minimally Invasive Spine Surgery
Fusion
Spine
SMISS
Lead sponsor: Society for Minimally Invasive Spine Surgery
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 450
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthropedic surgeon's clinic. Neurosurgeon's clinic.

Brief summary: The population of the US is aging. They remain more active and place greater demands on their musculoskeletal system. A key problem is that pain and disability of age related spinal disorders will increase. Problems such as Degenerative Lumbar Spondylolisthesis, Degenerative Disk Disease, Spinal Stenosis and Degenerative Scoliosis are age related problems that are treated with spinal fusion when non-operative treatment fails. Traditional open surgery poses significant risk for patients in this age group. The use of minimally invasive spinal surgery techniques provides an opportunity to treat these patients with less morbidity than traditional open surgery.


Eligibility criteria: Inclusion Criteria: Inclusion Criteria:

* Patient age 21 - 90 years.
* Diagnosis of Spondylolisthesis, degenerative disk disease, and degenerative scoliosis (any curve magnitude).
* A spinal fusion is being undertaken via the minimally invasive approach.
* The patient agrees to follow-up for routine care for at least 2 years post-operatively.

Exclusion Criteria:

* Inability for post-operative follow-up

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04690673: Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique
Official title: Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples With an Electrochemical Indicator in Healthy Volunteers - a Validation Study for a Novel Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Mechanism
Healthy
Keywords: electrochemical
Paracetamol
Lipidomics
Endocannabinoid system
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy volunteers
Primary purpose: DIAGNOSTIC

Brief summary: The main objective is to assess whether a novel electrochemical tool is reliable in detecting concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples. We will recruit 12 healthy volunteers aged 18-45. They will get 1 g oral paracetamol. Paracetamol concentration will be detected from abovementioned samples at timely intervals for 24 hours, analyzed with the novel electrochemical method and compared to gold standard mass-spectrometry analysis.

Despite of extensive use, the mechanism of action of parasetamol is not completely understood. The central serotonergic system may play a role. Endocannabinoid system is a group of lipid mediators, that possibly is involved in mediating paracetamol effect to the serotonergic system. Serum lipidomic assessment can be used to study endocannabinoid metabolics. In this study we will try to assess changes in endocannabinoid system by looking into serum lipidomics in order to understand the mechanism of action of paracetamol.


Eligibility criteria: Inclusion Criteria:

* Healthy, no medication of any kind.
* Age 18-45
* BMI 18.5 - 30
* Informed consent

Exclusion Criteria:

* Pregnancy, lactation.
* prisoner
* smoking
* less than 3 months from prior blood donation or clinical pharmacological study

Primary outcomes:
measure: Comparison of Geometric Means of Cmax and AUC 0-last of Paracetamol Measured by the Novel Electrochemical Method With Mass-spectrometry in Capillary Whole Blood Samples.
timeFrame: 1 day
Secondary outcomes:
measure: Comparison of Geometric Means of Cmax and AUC 0-last of Paracetamol in Capillary With Venous Plasma (Control), Both Measured by Mass-spectrometry.
timeFrame: 12 hours
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki university hospital
Study officials:
References:
Clinical trial NCT06775873: Modified Diaphragmatic Plication Rectifies Dyspnea
Official title: Modified Diaphragmatic Plication Rectifies Dyspnea With Diaphragmatic Eventration Caused by Phrenicotomy or Injuries Involved in Extended Mediastinal Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phrenic Nerve Injury
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent mediastinal tumor resection and MDP between 2020 and 2024 at Shanghai General Hospital. All patients underwent plain chest X-ray or computed tomography (CT) scans prior to surgery to confirm diaphragmatic elevation. Each patient was followed for a minimum of six months.

Brief summary: Traditional diaphragmatic plication (DP) surgery is employed to ameliorate respiratory function in patients with diaphragmatic paralysis, which is rather complicated. This study introduces a modified method of DP. The efficacy of modified diaphragmatic plication (MDP) in preventing, treating, and relieving dyspnea in patients with phrenic nerve resection or injury due to extensive surgical intervention or local tumor invasion will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Preoperative chest X-ray suggesting diaphragmatic eventration, for which therapeutic MDP was performed;
* Mediastinal tumors encircling the phrenic nerve that could not be dissected or phrenic nerve injury occurring during intraoperative dissection, for which prophylactic MDP was performed;
* Diaphragmatic eventration and dyspnea following mediastinal surgery, for which salvage MDP was performed.

Exclusion Criteria:

* Congenital diaphragmatic deformity or diaphragmatic weakness due to poor general nutritional status;
* Morbid obesity with a BMI greater than 35 kg/m2;
* Neuromuscular diseases, including amyotrophic lateral sclerosis and myasthenia gravis;
* A history of upper abdominal surgery; and (5) Diaphragmatic calcification or fibrosis.

Primary outcomes:
measure: Effective rates of prevention of diaphragmatic elevation
timeFrame: 1 year
measure: Success in correcting diaphragmatic elevation
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
state: Hongkou Distri
Study officials:
References:
citation: Wright CD, Williams JG, Ogilvie CM, Donnelly RJ. Results of diaphragmatic plication for unilateral diaphragmatic paralysis. J Thorac Cardiovasc Surg. 1985 Aug;90(2):195-8.
Clinical trial NCT01730573: Interscalene and Combined Supra Scapular and Axillary Nerve Blocks in Rotator Cuff Repair
Official title: A Randomized Comparison of Inter Scalene and Combined Supra Scapular and Axillary Nerve Blocks for Postoperative Pain Relief in Arthroscopic Shoulder Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Rotator Cuff
Keywords: interscalene
suprascapular
axillary
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective of this study is to prospectively compare and evaluate efficacy as well as note side effects of the interscalene block and combined suprascapular and axillary nerve block for ambulatory arthroscopic rotator cuff repair.

Detailed description: Patients having elective arthroscopic rotator cuff repair will be randomized to one of the two groups.

Group 1: This group will receive Interscalene block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia.

Group 2: This group will receive Suprascapular and Axillary nerve block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia.

Performance time, quality and efficacy as well as any side-effects of the blocks will be evaluated in terms of pain scores in recovery room, after 4- 6 hours and the next morning, opioid usage and patient satisfaction.

Primary hypothesis:

• Combined Suprascapular and axillary nerve blocks provide similar postoperative analgesia as compared to interscalene block for arthroscopic rotator cuff repair.

Secondary hypothesis

• Interscalene block is associated with more side effects and complications as compared to suprascapular nerve block and axillary nerve block.

Eligibility criteria: Inclusion Criteria:

* Elective shoulder arthroscopic rotator cuff repair
* ASA I - III (American Society of Anaesthesia Classification)

Exclusion Criteria:

* ASA IV or higher ( American Society of Anaesthesia Classification)
* Obesity: BMI \>35
* Narcotic Abuse/ Drug dependency
* Major Neurologic deficits
* Allergy to local anesthetics
* Infection in the site of the puncture
* Mental impairment

Primary outcomes:
measure: Analgesic Efficacy
timeFrame: one year
Secondary outcomes:
measure: Side effects
timeFrame: 1 year
Other outcomes:
measure: Patient satisfaction
timeFrame: 1 year
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
city: London
country: Canada
facility: St. Joseph Hospital
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Shalini Dhir, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01447173: Vitamin and Asthma Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Pulmonary Function Test
Vitamin D
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study looks at how vitamin D supplement will improve the severity of asthma and lung function as well as biomarkers in asthmatic children.


Eligibility criteria: Inclusion Criteria:

* History of asthma (under control)otherwise in good general health

Exclusion Criteria:

* Poorly controlled asthma
* Taking daily multivitamin or vitamin D supplementation
* Taking oral steroid medication
* History of bronchopulmonary dysplasia or chronic lung disease, extreme prematurity, congenital heart disease, significant renal dysfunction or primary kidney disease, endocrinologic abnormalities of calcium metabolism or parathyroid disorders

Primary outcomes:
measure: Change in Pulmonary Function Test (PFT) after vitamin D supplementation
timeFrame: 4 weeks
measure: Change in Asthma Control Test (ACT) scores after vitamin D supplementation
timeFrame: 4-week
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Pediatrics Allergy Clinic at Georgia Health Sciences University
state: Georgia
Study officials:
References:
Clinical trial NCT02458027: Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2
Official title: Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2 - Are Acute Effects of Hemp Protein on Blood Glucose and Appetite Insulin-dependent?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Obesity Prevention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Harvest
First posted: 2015-05-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control.

Detailed description: The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control. The objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control.

Eligibility criteria: Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L)
* Body mass index (BMI) of 18.5-29.9 kg/m2.

Exclusion Criteria:

* Restrained eaters
* Regularly skip breakfast
* Smokers
* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.

Primary outcomes:
measure: Plasma Glucose and Insulin Concentrations
timeFrame: 0-200 minutes
measure: Appetite
timeFrame: 0-200 minutes
measure: Food Intake
timeFrame: 0-200 minutes
measure: Blood Pressure
timeFrame: 0-200 minutes
Secondary outcomes:
measure: Palatability of Treatments and Meal
timeFrame: 5-80 minutes
measure: Physical Comfort
timeFrame: 0-200 minutes
measure: Energy/Fatigue
timeFrame: 0-200 minutes
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
name: Peter Jones, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: