louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05548179: Exploring Clinical Trial Experiences of People With Leiomyosarcoma
Official title: An In Depth Study Investigating The Experiences of Patients In Leiomyosarcoma Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Leiomyosarcoma
Keywords: leiomyosarcoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Leiomyosarcoma patients who are actively considering participating in an interventional clinical trial, but have not yet completed enrollment and randomization.

Brief summary: Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about leiomyosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with leiomyosarcoma who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility criteria: Inclusion Criteria:

* Patient has self-identified as planning to enroll in an interventional clinical trial
* Patient has been diagnosed with leiomyosarcoma
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant
* ECOG score of 4

Primary outcomes:
measure: Number of patients who decide to enroll in an leiomyosarcoma clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in leiomyosarcoma clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Kantidakis G, Litiere S, Neven A, Vinches M, Judson I, Schoffski P, Wardelmann E, Stacchiotti S, D'Ambrosio L, Marreaud S, van der Graaf WTA, Kasper B, Fiocco M, Gelderblom H. Efficacy thresholds for clinical trials with advanced or metastatic leiomyosarcoma patients: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group meta-analysis based on a literature review for soft-tissue sarcomas. Eur J Cancer. 2021 Sep;154:253-268. doi: 10.1016/j.ejca.2021.06.025. Epub 2021 Jul 20.
citation: Serrano C, George S. Leiomyosarcoma. Hematol Oncol Clin North Am. 2013 Oct;27(5):957-74. doi: 10.1016/j.hoc.2013.07.002. Epub 2013 Aug 26.
citation: Kasper B, D'Ambrosio L, Davis EJ, Ingham M, Broto JM, Trent JC, van Houdt WJ, Van Tine BA. What Clinical Trials Are Needed for Treatment of Leiomyosarcoma? Curr Treat Options Oncol. 2022 Mar;23(3):439-449. doi: 10.1007/s11864-021-00928-y. Epub 2022 Mar 11.
Clinical trial NCT03466879: A User Study of SYNUS Pain Relief Made by Tivic Health Systems
Official title: A User Study of SYNUS Pain Relief Made by Tivic Health Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinus; Inflammation
Lead sponsor: Tivic Health Systems
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
First posted: 2018-03-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: At least 58 subjects suffering from sinus pain

Brief summary: Demonstrate the ability of subjects suffering from sinus pain to self-treat with the SYNUS Pain Relief device and to obtain pain relief compared to a sham/placebo device.

Detailed description: A prospective study of at least 58 recruited subjects suffering from sinus pain. At least 30 of the subjects will be randomly selected to use the SYNUS Pain Relief device, a device that uses micro-currents to stimulate major nerve fibers passing from the sinus passages through various foramina to the facial skin. Subjects will read manufacturer's provided Instructions-For-Use (IFU's) and without help from staff will proceed to self-perform the treatment. The other subjects will follow the same procedure but use a sham/placebo device with no stimulating current. Subjects will be blinded as to the device they use. Prior to and 10 minutes following the stimulation, subjects will score their pain level on a visual analogue scale.

Eligibility criteria: Inclusion Criteria:

* Be 18 years of age and older
* Present with symptoms of sinus pain and pressure
* Have an initial sinus pain score of 4 or more on the visual analogue scale
* Be able to read and understand English
* Agree to participate in the study
* Be able and willing to provide Informed Consent

Exclusion Criteria:

* Do not meet Inclusion Criteria
* Have currently a dental infection
* Have currently abnormal cranial nerve or other neurological findings or symptoms that would require prompt medical attention
* Be currently pregnant
* Have implanted electrostimulation devices including a pacemaker, a DBS or a cochlear implant

Primary outcomes:
measure: Pain reduction
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Jayakar Nayak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04099979: A Pilot Study to Explore the Role of Gut Flora in Psoriasis
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Psoriasis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Psoriasis
Psoriasis Vulgaris
Psoriasis Universalis
Psoriasis Face
Psoriasis Nail
Psoriatic Plaque
Psoriasis Diffusa
Psoriasis Punctata
Psoriasis Palmaris
Psoriasis Circinata
Psoriasis Annularis
Psoriasis Genital
Psoriasis of Scalp
Psoriasis Geographica
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older who have been diagnoed with Psoriasis

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Psoriasis.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Psoriasis

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent by patient
2. Male or female patients age 18 and older.
3. Diagnosis of Psoriasis based on PSAI of greater than or equal to 12 at screening

Exclusion Criteria:

1. Refusal by patient to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Psoriasis via Relative Abundance Found in Microbiome Sequencing
timeFrame: 1 year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: 1 year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04514679: EHR Embedded Comparative Effectiveness Studies--WWC
Official title: Randomize Everyone: Creating Valid Instrumental Variables for Learning Health Care Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Trustees of Dartmouth College
name: Patient-Centered Outcomes Research Institute
First posted: 2020-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomize Everyone is a research project to develop new informatics systems and statistical methods for supporting randomization processes in EHR systems to do comparative effectiveness research. Two demonstration projects are being conducted in the Dartmouth Hitchcock Medical Center, designed to evaluate different weight loss interventions and common practices in the treatment of chronic low back pain.

Detailed description: EHR Embedded Comparative Effectiveness Studies-WWC will be held in the Weight and Wellness Clinics at Dartmouth-Hitchcock Medical Center. This study consists of randomizing enrollees to either the dietitian/health coach appointment sequence or the health coach/dietitian appointment sequence.

Eligibility criteria: Inclusion Criteria: Adults (\>18) able to consent, with sufficient fluency in English; Initial RD and HC visits are part of routine care as recommended by the provider; willing to be randomized

Exclusion Criteria: Pregnant women; Prisoners; Children (\<18)

-

Primary outcomes:
measure: Compliance Rate
timeFrame: Baseline through approximately 2 months
measure: Percentage of Eligible Patients Participating
timeFrame: One day, during the recruitment period of October 23, 2020 to February 3, 2021.
Secondary outcomes:
measure: Change in Body Mass Index (BMI) at 30 Days
timeFrame: 30 days since baseline
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
Study officials:
References:
Clinical trial NCT07013279: Evaluate the Efficacy and Safety of DWP712 With Moderate to Severe Glabellar Lines
Official title: A Double-blind, Randomized, Active-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP712 Inj. in Subjects With Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Glabellar Lines
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 324
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of DWP712 Inj. in Subjects with Moderate to Severe Glabellar Lines


Eligibility criteria: Inclusion Criteria:

- Subjects with a facial wrinkle scale (FWS) score of ≥2 (moderate) for glabellar lines at maximum frown in the investigator's on-site assessment at screening

Exclusion Criteria:

- Subjects with glabellar lines that cannot sufficiently be improved by physical attempts, e.g., glabellar lines not flattened by hand, in the judgment of the investigator

Primary outcomes:
measure: Percentage of subjects with glabellar line improvement* rate at maximum frown based on the investigator's on-site assessment at 4 weeks after IP administration
timeFrame: At 4 weeks after IP administration
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hosptial
Study officials:
References:
Clinical trial NCT06464484: The Effects Of Probiotics On Stress Among Healthy Adults From Umm Al-Qura University At Makkah
Official title: The Effects Of Probiotics On Stress And Bowel Habits Among Healthy Adults From Umm Al-Qura University at Makkah: A Randomized Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Constipation
Anthropometry
Bowel Disease
Keywords: Probiotics
Saudi Arabia
Stress
Gut-brain axis
Gastrointestinal tract
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This intervention was a randomized, controlled trial. The participants were randomized using lottery method either to the probiotic group (PG) and the control group (CG). The probiotic group received a daily (Lactobacillus rhamnosus GG 6x10\^9 cpu) supplement for 30 days
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to study the effects of probiotic supplementation on stress levels and bowel habits in healthy Saudi adults for both males and females.

The main questions it aims to answer are:

Does probiotic supplementation decrease stress levels? Does probiotic supplementation improve bowel habits?

Researchers compared between the intervention group receiving probiotic supplements with high stress levels with a control group not receiving probiotics with high stress levels to see if probiotics decreases stress levels.

Detailed description: Participants were required to

1. Attend a visit to the nutrition clinic at Umm AL-Qura University to assess for eligibility.
2. Eligible participants were asked to sign a consent form and anthropometrics, stress, bowel habits, food records and knowledge on probiotics were collected
3. Participants were randomized based on lottery based method to an interventional or control group
4. Intervention group received 30 capsules of probiotics (Lactobacillus rhamnosus GG, 6x10\^9 cpu) to be taken once daily
5. After 30 days, all participants had to attend a second visit at the nutrition clinic at Umm Al-Qura University to assess stress levels, bowel habits and receive their incentives (discount voucher of restaurants).

Eligibility criteria: Inclusion Criteria:

* Students at Umm Al-Qura University
* Age ≥ 18 years
* Healthy individuals
* Both genders
* Saudi nationality

Exclusion Criteria:

* Diagnosed with chronic illness or/and psychiatric condition
* Consumption of medications or supplements in the previous 3 months
* Pregnant and breastfeeding
* Smoker

Primary outcomes:
measure: Stress
timeFrame: Post intervention at 30 days
measure: Bowel function
timeFrame: Post intervention at 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Umm Al-Qura University
Study officials:
affiliation: Umm Al-Qura University
name: Essra Noorwali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03686384: SVT-15652 Otic Solution for the Treatment of Otomycosis
Official title: A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of SVT-15652 Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otomycosis
Lead sponsor: Salvat
Sponsor class: INDUSTRY
First posted: 2018-09-26
Enrollment: 217
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: Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.


Eligibility criteria: Main Inclusion Criteria:

* At least 18 years of age
* Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
* Signs/symptoms of pruritus, otalgia and ear fullness.
* Debris or drainage clinically consistent with fungal infection.

Main Exclusion Criteria:

* Known bacterial otitis externa or malignant otitis externa.
* Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.
* Structural ear anomalies which may difficult the evaluation of the therapeutic response.
* Uncontrolled diabetes mellitus.
* Any infection requiring systemic antimicrobial or systemic antifungal therapy.
* Concomitant medicines that may interfere with the study evaluations.

Primary outcomes:
measure: Therapeutical Cure (Clinical and Mycological Cure)
timeFrame: Test of cure on day 24
Secondary outcomes:
Other outcomes:
Locations:
city: Orangeburg
country: United States
facility: Carolina Ear,Nose and Throat Clinic
state: South Carolina
Study officials:
References:
Clinical trial NCT01953484: Changes in Spontaneous Ventilation in Response to Changes in Extracorporeal Carbon Dioxide Removal
Official title: Changes in Spontaneous Ventilation in Response to Changes in Extracorporeal Carbon Dioxide Removal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In physiological conditions, spontaneous ventilation is controlled by blood carbon dioxide (and pH) levels. In healthy animals, extracorporeal carbon dioxide removal leads to hypoventilation or apnea (Kolobow et al., 1977). During acute respiratory insufficiency, extracorporeal carbon dioxide removal may be used to control spontaneous ventilation, limiting risks of lung damage and relieving dyspnea (Crotti et al., 2012). However, little is known about how spontaneous ventilation changes in response to changes in extracorporeal carbon dioxide removal during acute respiratory insufficiency, especially in humans.

Aim of this study is to monitor changes in spontaneous ventilation in awake patients treated with extracorporeal gas exchange support because of acute respiratory insufficiency, in response to changes in extracorporeal carbon dioxide removal.


Eligibility criteria: Inclusion Criteria:

* Acute Respiratory Insufficiency
* Extracorporeal gas exchange support
* The patient is spontaneously breathing (including assisted ventilation)

Exclusion Criteria:

- age below 18 yrs

Primary outcomes:
measure: Spontaneous ventilation
timeFrame: 30-60 minutes after changing extracorporeal carbon dioxide removal
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study officials:
References:
Clinical trial NCT03263884: Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
Official title: Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Relief
Keywords: nerve growth factor
repetitive transcranial magnetic stimulation
dorsolateral prefrontal cortex
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2017-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model.

Detailed description: This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and duration of experimentally induced muscle pain when a 5-day course of treatment is given immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic effects of left DLPFC rTMS will be related to an improved cognitive network function as assessed by electroencephalography (EEG).

Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* Speak and understand English.

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* History of chronic pain or current acute pain
* Previous experience with rTMS
* Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
* Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)

Primary outcomes:
measure: Pain relief
timeFrame: Change from baseline at 2 weeks
Secondary outcomes:
measure: Muscle soreness
timeFrame: Change from baseline at 2 weeks
measure: Patient-rated Tennis Elbow Evaluation
timeFrame: Change from baseline at 2 weeks
measure: Attention network test
timeFrame: Change from baseline at 2 weeks
measure: Pressure pain thresholds
timeFrame: Change from baseline at 2 weeks
measure: Cuff pressure algometry
timeFrame: Change from baseline at 2 weeks
measure: EEG recordings
timeFrame: Change from baseline at 1 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
state: Nordjylland
Study officials:
affiliation: Aalborg University
name: Enrico De Martino, MD
role: PRINCIPAL_INVESTIGATOR
References: