louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01078350: Consent for Obtaining Additional Tissue at the Time of a Diagnostic Biopsy
Official title: Consent for Obtaining Additional Tissue at the Time of a Diagnostic Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Hodgkin Disease
Keywords: Lymphoma
Hodgkin Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 93
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are having a tissue procedure done as part of their standard oncology work-up will be eligible to be consented on this study.

Brief summary: This study is designed to collect tissue samples that may aid in the treatment and learning about various oncology diagnosis.

Detailed description: The purpose of this study is to provide a mechanism to obtain tissue specimens to be used for experimental studies before the exact histologic diagnosis is known.

Eligibility criteria: Inclusion Criteria:

* Subjects who are having a tissue procedure done as part of their standard oncology work-up will be eligible to be consented on this study.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Further analysis
timeFrame: at collection time
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Neyssa Marina
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01608750: The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia
Official title: The Efficacy of Pantoprazole Treatment in Patients With Functional Dyspepsia: Randomised, Double-blind, Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nonulcer Dyspepsia
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to evaluate the effectiveness of proton pump inhibitor (PPI) treatment in patients with functional dyspepsia.


Eligibility criteria: Inclusion Criteria:

* aged 18-45 years with symptoms of dyspepsia,
* no evidence of organic disease.

Exclusion Criteria:

* Patients with alarm symptoms,
* Severe concomitant illness,
* Pregnancy or lactation,
* Alcohol or drug abuse,
* Use of aspirin or other non-steroidal anti-inflammatory drugs antibiotics, H2 receptor blockers, bismuth, or proton pump inhibitors in the preceding two weeks

Primary outcomes:
measure: Effectiveness of pantoprazole treatment in patients with functional dyspepsia measured by symptoms scale.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem medical faculty
Study officials:
References:
Clinical trial NCT06027450: Good Use of Normal Human ImmunoGlobulins (NHIg): Feasibility of Integrating the Criteria of Hierarchy During of NHIg Dispensations
Official title: Bon USage Des ImmunoGlobulines Humaines Normales (IgHN) : Faisabilité de l'intégration Des critères de la hiérarchisation Lors Des Dispensations d'IgHN - BUS-IG
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Immunoglobulins
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with NHIg for one of the following 3 indications between 01/10/2021 and 31/12/2021: TIP, CDIP and SID

Brief summary: Supply of Normal Human Immunoglobulins (NHIg) has been in steady tension for almost 15 years in the world. The scarcity of raw material, manufacturing time by industries, and increase consumptions are some of the causes. These phenomena has been accentuated for two years in the context of pandemic.

Faced these difficulties, the french National Medication Security Agency (ANSM) , in collaboration with health professionals and patients associations concerned, established a hierarchy of indications of NHIg to prioritize NHIg for patients without therapeutic alternative (2013 and 2019). Its use is sometimes complex, particularly in the indications where the use of NHIg must combine clinico-biological criteria and/or previous treatment lines.


Eligibility criteria: Inclusion Criteria:

* Patients treated with NHIg for one of the following 3 indications between 01/10/2021 and 31/12/2021: TIP, CDIP and SID.
* Patients 18 years of age and older

Exclusion Criteria:

* Patient Objection
* Patients treated with NHIg- for another indication

Primary outcomes:
measure: Number of patients with clinical and biological information in the medical record
timeFrame: At inclusion
Secondary outcomes:
measure: Adequacy rate between NHIg indications noted in patients files and ANSM prioritization criteria
timeFrame: At inclusion
measure: Number of patients prescribed treatment out of hierarchy
timeFrame: At inclusion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03268850: Living Kidney Donor Lost Wages Trial
Official title: Living Donor Lost Wages Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Keywords: LDKT
Live donor transplantation
Kidney transplantation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Candidates will be randomized 1:1 to the LW-A or LW-B arm, with stratification for race. The investigators will prepare the randomization schedule using permuted blocks of randomly varying size to limit predictability and imbalances in arm assignment throughout the study. KT candidates will be informed of group assignment immediately after consenting to the study.
Primary purpose: OTHER

Brief summary: This study aims to evaluate the effectiveness of offering reimbursement for living donor lost wages on the rate of live donor kidney transplantation.

Detailed description: Live donor kidney transplantation (LDKT) accelerates the path to transplantation and yields superior outcomes compared to dialysis and deceased donor kidney transplantation (KT). However, the annual number of LDKTs has declined over the last decade, particularly among minority and low-income patients. The investigators hypothesize, and have preliminary data to support, that the financial impact on living donors (LDs) is a major contributor to the LDKT decline and for persistent racial disparities in LDKT rates. Many LDs have substantial non-reimbursed direct and indirect costs, most notably the loss of income or wages following surgery. In this study, the investigators will: (1) evaluate the effectiveness of offering reimbursement for LD lost wages on the LDKT rate; (2) examine whether offering reimbursement for LD lost wages reduces known racial disparities in LDKT; and (3) determine whether study outcomes differ significantly by maximum reimbursement amount for LD lost wages.

Eligibility criteria: Inclusion Criteria:

* For KT patients:
* Chronic Kidney Disease (CKD) stage 4/5
* Approved for kidney transplant (KT) listing or active on KT waiting list
* For patients listed at multiple centers: primary listing at Beth Israel Deaconess Medical Center (BIDMC)
* For LDs:
* Their KT candidate is enrolled in the trial

Exclusion Criteria:

* For KT patients:
* KT candidate has a potential LD approved, with surgery scheduled
* Listed for multi-organ transplantation
* Temporarily unavailable (TU) status on KT waiting list
* Current enrollment in another study to increase LDKT likelihood
* For LDs:
* Not residing in the US

Primary outcomes:
measure: Effectiveness of wage reimbursement on LDKT rate
timeFrame: 1 year
measure: Effect of wage reimbursement on racial disparities in LDKT
timeFrame: 1 year
measure: Difference between reimbursement arms
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: BIDMC Transplant Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT04444050: Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants
Official title: Randomized, Double-Blind, Placebo-Controlled Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986331 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-06-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety, tolerability, drug levels and drug effects of single and multiple oral doses of BMS-986331 versus placebo in healthy participants and healthy Japanese participants.


Eligibility criteria: Inclusion Criteria:

* No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
* A body mass index of 18 - 32 kg/m2, inclusive
* Women and men must agree to follow specific methods of contraception, if applicable

For J-MAD Part 3

* Must be Japanese (both biological parents are ethnically Japanese)

Exclusion Criteria:

* Women who are of childbearing potential
* Women who are pregnant or breastfeeding
* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
* Any surgery within 12 weeks of study drug administration

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 13 months
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 46 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 46 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 46 days
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Up to 17 days
measure: Time to reach Cmax in plasma (Tmax)
timeFrame: Up to 17 days
measure: Area under the plasma concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed [AUC(0-T)]
timeFrame: Up to 17 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Local Institution - 0001
state: California
city: Lenexa
country: United States
facility: ICON (LPRA) - Lenexa
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02720250: Omega-3 Fatty Acids Enriched Food and Microvascular Reactivity
Official title: Effect of Omega-3 Fatty Acids Enriched Chicken Eggs Consumption on Microvascular Reactivity and Lipid Profile in Young Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Omega-3 Polyunsaturated Fatty Acids
Keywords: omega-3 fatty acids, microcirculation, laser Doppler flowmetry, lipid profile
Lead sponsor: Josip Juraj Strossmayer University of Osijek
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Previous studies have shown that omega-3 fatty acid pills intake have beneficial effect on vascular health in overweight and/or hypertensive patients.

However, there is a lack of studies showing the effect of everyday consumption of omega-3 fatty acids enriched food (not pills) on lipid profile and microvascular reactivity in healthy population.

This study aimed to determine the effect of omega-3 enriched chicken eggs consumption on microvascular reactivity and lipid profile in young healthy subjects.


Eligibility criteria: Inclusion Criteria:

- healthy volunteers

Exclusion Criteria:

* oral contraceptives
* drugs that could affect endothelium
* hypertension
* coronary artery disease
* diabetes
* hyperlipidaemia
* renal impairment
* cerebrovascular and peripheral artery disease

Primary outcomes:
measure: microvascular reactivity
timeFrame: Three weeks
Secondary outcomes:
measure: lipid profile
timeFrame: Three weeks
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology
Study officials:
affiliation: Faculty of Medicine, University of Osijek, Croatia
name: Ines Drenjancevic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cavka A, Cosic A, Jukic I, Jelakovic B, Lombard JH, Phillips SA, Seric V, Mihaljevic I, Drenjancevic I. The role of cyclo-oxygenase-1 in high-salt diet-induced microvascular dysfunction in humans. J Physiol. 2015 Dec 15;593(24):5313-24. doi: 10.1113/JP271631. Epub 2015 Dec 7.
Clinical trial NCT01173250: Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Familial Adenomatous Polyposis
Keywords: total proctocolectomy with ileal pouch anal anastomosis with and without ileostomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2010-08-02
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical operation for management of ulcerative colitis and familial adenomatous polyposis. The addition of diverting ileostomy may reduce septic complications. In this randomized study the investigators compare two groups of patients with stapled ileoanal pouch one of them had diverting ileostomy and in the other this step is omitted.


Eligibility criteria: Inclusion Criteria:

* patients having total proctocolectomy with ileal pouch anal anastomosis.

Exclusion Criteria:

* hypoalbuminemia
* prolonged steroid use
* anemia
* anastomosis under tension
* leak with air test
* bleeding
* poor vascular supply of anastomosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05883150: Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment
Official title: Intranasal Versus Nebulized Midazolam in Behaviuor Modification of Preschool Children Undergoing Dental Treatment: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dental Sedation
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 68
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the current study is to compare the effect of intranasal versus nebulized route of administration of midazolam as moderate sedative agents in preschoolers undergoing dental treatment.


Eligibility criteria: Inclusion Criteria:

* Frankl scale score 2.
* ASA I or II physical status.
* Dental intervention under local anesthesia not requiring more than 30 minutes.
* No previous dental experience.
* Parent/guardian's written consent.

Exclusion Criteria:

* Dental treatment indicated under general anesthesia.
* Presence of facial or nasal deformities.
* History of neurological or cognitive alterations.
* Mouth breathers

Primary outcomes:
measure: Behavior rating
timeFrame: throughout the sedation session
Secondary outcomes:
measure: Onset of sedation
timeFrame: during the sedation procedure (after drug administration until reaching satisfactory sedation)
measure: Level of sedation
timeFrame: during the sedation procedure (after drug administration until reaching satisfactory sedation)
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Faculty of Oral and Dental Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt
Study officials:
affiliation: Kafrelsheikh University, Kafrelsheikh, Egypt
name: Amira A ElKhatib, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Yousr Nader, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05164250: Compassionate Use (CU) of REGN5458 for Patients With Relapsed or Refractory Multiple Myeloma (MM)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Multiple Myeloma
Keywords: Relapsed, Refractory
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-12-20
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide Compassionate Use' of REGN5458 for Patients with Relapsed or Refractory Multiple Myeloma

Detailed description: Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03090750: Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure
Official title: What is the Effect of Using Aromatherapy to Reduce Anxiety in Patients Undergoing Invasive Radiologic Procedures?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anxiety
Anxiety Preoperative
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if using aromatherapy (Lavender or Bergamot) will lower anxiety in patients having invasive Radiology procedures. First, the level of anxiety is assessed prior to the procedure using a questionnaire. Then, patients are given the aromatherapy treatment during the pre-procedure period. Then, the same questions are asked to determine how anxious the patient is after the aromatherapy and before going into the procedure room. After the procedure, patients are asked to evaluate the process of the study.


Eligibility criteria: Inclusion Criteria:

* Scheduled for Myelogram or IR invasive procedure at investigative site

Exclusion Criteria:

* Incapable of giving informed consent
* Requiring pre-medication for scheduled procedure
* Allergy to lavender or bergamot
* Asthma (type of breathing related condition)
* COPD (Chronic Obstructive Pulmonary Disorder - breathing disease)
* Respiratory issues requiring oxygen therapy

Primary outcomes:
measure: Anxiety level of patients
timeFrame: Immediately prior to invasive radiologic procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Christine A Becker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06583850: Chronic Neck Pain: Mobility, Sleep, Function
Official title: Evaluation of Pain, Cervical Mobility, Sleep Quality and Functional Status in Individuals with Chronic Neck Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Neck
Keywords: pain
neck
range of motion
sleep quality
functional status
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic neck pain and healthy controls

Brief summary: The goal of this observational study is to compare pain, cervical mobility, sleep quality, and functional status between individuals with chronic neck pain (CNP) and healthy individuals. The study focuses on understanding the complex relationships between these factors in individuals with CNP, with the aim of providing insights that could contribute to more effective rehabilitation strategies.

The main questions it aims to answer are:

* How pain, cervical mobility, sleep quality, and functional status differs between individuals with and without chronic neck pain?
* What is the relationship between functional status and cervical mobility and sleep quality in individuals with chronic neck pain?


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 55 years.
* Chronic neck pain (CNP) persisting for longer than 3 months (for the CNP group).
* Volunteering participation in the study.
* Healthy controls, including relatives of CNP participants.

Exclusion Criteria:

* History of neck trauma or other cervical spine conditions (e.g., radiculopathy).
* Prior surgical interventions involving the head, face, cervical spine, upper or lower extremities, or cervical disc herniation.
* Degenerative spinal conditions.
* Use of analgesics, anti-inflammatory medications, or muscle relaxants within the previous week.
* Presence of rheumatological or cardiovascular diseases, chronic neurological or psychiatric disorders, substance abuse, anemia, or diabetes.

Primary outcomes:
measure: The Neck Disability Index
timeFrame: Baseline
measure: Pittsburgh Sleep Quality
timeFrame: Baseline
measure: Visual analog scale
timeFrame: Baseline
measure: Range of motion
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Atlas Univercity
state: Hamidiye
Study officials:
References: