louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00252031: DBT in Borderline Personality Disorder
Official title: Dialectical Behavioral Therapy for Patients With Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
BPD
Dialectical Behavior Therapy
DBT
Lead sponsor: Bronx VA Medical Center
Sponsor class: FED
First posted: 2005-11-11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects will receive a 6-month course of DBT, consisting of one 90-minute group and one 60-minute individual session per week as well as telephone availability of the individual therapist.


Eligibility criteria: Inclusion Criteria: Is a male or female between 18 and 60 who meets criteria for Borderline Personality Disorder and has had at least 2 prior instances of suicidal or parasuicidal behavior. Either is off psychotropic drugs or is on a stable medication regimen. (During the study, psychotropic medications will be prescribed by a psychiatrist in the Mood and Personality Disorders Group.)

Exclusion Criteria: Meets criteria for Schizophrenia, Bipolar Disorder, Mental Retardation or current or recent Substance Dependence. Subjects also should not currently be in individual psychotherapy. (Case management and work therapy programs are allowed.)

Primary outcomes:
measure: Measures of parasuicidal behavior, suicidal ideation, mood and emotion, dissociation and health care utilization at baseline, 3 months, 6 months and 9 months
Secondary outcomes:
measure: Measures of cognitive processing at baseline and 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx VA Medical Center
state: New York
Study officials:
affiliation: Bronx VA Medical Center/Mount Sinai School of Medicine
name: Marianne Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02967731: 480 Biomedical Sinus Drug Depot
Official title: An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Sinusitis
Lead sponsor: Lyra Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CS.
* Female study subjects of child-bearing potential must have a negative pregnancy test and must agree to not become pregnant during the course of the study.
* The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site.
* The study subject agrees to comply with all study requirements

Exclusion Criteria:

* Known history of intolerance to corticosteroids.
* Oral-steroid dependent condition.
* Having had corticosteroids with potential systemic effect (e.g., oral, parenteral, or high dose topical) 1 month prior to screening visit.
* Subjects with acute or chronic intracranial or orbital complications of chronic rhinosinusitis (e.g., brain abscess, related problems with eyes or central nervous system).
* Known history of hypothalamic pituitary adrenal (HPA) axial dysfunction or having morning serum cortisol level at screening outside of normal range.
* Previous pituitary or adrenal surgery.
* History or diagnosis (in either eye) of glaucoma, ocular hypertension, or cataracts.
* Recent participation in another clinical trial within 1 month of screening visit.
* Subjects currently participating in an investigational drug or device study.

Primary outcomes:
measure: Product related serious adverse events from baseline visit to 4 weeks post procedure
timeFrame: 4 weeks post procedure
Secondary outcomes:
measure: Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
city: Melbourne
country: Australia
facility: Monash Medical Center
city: Auckland
country: New Zealand
facility: University of Auckland
Study officials:
References:
citation: Douglas RG, Psaltis AJ, Rimmer J, Kuruvilla T, Cervin A, Kuang Y. Phase 1 clinical study to assess the safety of a novel drug delivery system providing long-term topical steroid therapy for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Apr;9(4):378-387. doi: 10.1002/alr.22288. Epub 2019 Jan 15.
Clinical trial NCT02399631: Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery
Official title: Implementation of an Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Cancer
Keywords: Perioperative treatment
Laparoscopic surgery
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An enhanced recovery program has been developed to provide for colon cancer patients faster and more personalized postoperative treatment. Most of the previous studies have showed that the efficacy of the enhanced recovery program on both subjective and objective physical recovery of patients. However, such studies are rarely conducted in South Korea. The purpose of this study is to evaluate the feasibility and efficacy of a postoperative enhanced recovery program in patients who underwent laparoscopic colon cancer surgery at a tertiary hospital in Korea.


Eligibility criteria: Inclusion Criteria:

* Eligibility rule of enrollment
* ECOG 0-2
* Pathologically diagnosed colon cancer
* Stage I-III
* No functional disturbance in liver, kidney, bone marrow
* Informed consent

Exclusion Criteria:

* Emergent operation
* Obstructive or perforated cancer
* Rectosigmoid or rectal cancer
* Synchronous tumor
* Uncontrolled psychiatric or neurologic problems
* Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
* Renal dysfunction (Cr ≥2mg/dl)
* Recent MI, CVA, nitrate medication

Primary outcomes:
measure: Length of hospital stay
timeFrame: 30 days post-operatively
measure: Actual hospital stay
timeFrame: 30 days post-operatively
Secondary outcomes:
measure: Readmission rate
timeFrame: 30 days from time of surgery
measure: 30-day morbidity
timeFrame: 30 days from time of surgery
measure: 30-day mortality
timeFrame: 30 days from time of surgery
measure: Quality of life
timeFrame: up to 30days from time of surgery
measure: Nutritional status
timeFrame: up to 30days from time of surgery
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Gyu seog Choi
Study officials:
affiliation: Kyunpook National Univercity Medical Center
name: Gyu-Seog Choi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06555731: Ultra Rapid GEnome Sequencing
Official title: Long-read Human Genome Sequencing in 72 Hours: "Ultra Rapid GEnome Sequencing"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Whole Genome Sequencing
Keywords: Next Generation Sequencing
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with no known progressive or chronic diseases

Brief summary: Next-generation sequencing (NGS) has revolutionized the field of genomics, allowing the detection of genetic abnormalities for diagnostic or therapeutic purposes. Turnaround times for exome or genome sequencing results have decreased to an average of 3 to 6 months.

An increasing number of diagnostic and therapeutic fields are benefiting from the advancements in ultra-rapid sequencing. In some situations, a shorter turnaround time may be useful for making therapeutic and/or interventional management decisions.

This study aims to explore the feasibility of very rapid whole-genome sequencing, ultra-rapid genome sequencing (URGES) in 72 hours, that could benefit patients with cancer or rare diseases.

Detailed description: * Blood sample (5 ml)
* Extraction of genomic DNA from lymphocytes
* Ultra-rapid genome sequencing (48 hours for a whole genome), using the PromethION P2 Solo sequencer (Oxford Nanopore Technologies)
* Bioinformatics analysis of raw high-throughput sequencing data with SeqOne platform
* Medical interpretation of molecular data: NGS data must be interpreted by a multidisciplinary decision-support team to determine mutation actionability and identify potential "drivers"

Eligibility criteria: Inclusion Criteria:

* No known progressive or chronic diseases
* Consent for participation
* Affiliation to a social security system

Exclusion Criteria:

* Unable to understand
* Pregnant or breastfeeding women
* Subject under protection of the adults (guardianship, curators or safeguard of justice)

Primary outcomes:
measure: Time (in hours) for long read human genome sequencing and data interpretation
timeFrame: 72 hours
Secondary outcomes:
measure: Sequencing coverage
timeFrame: 72 hours
measure: Sequencing depth
timeFrame: 72 hours
measure: Number of variants called appropriately or not
timeFrame: 72 hours
Other outcomes:
Locations:
city: Levallois-Perret
country: France
facility: Institut Rafaël
state: Ile-De-France
Study officials:
References:
Clinical trial NCT06679231: Stress Balls in Gynecologic Exams: A Patient Comfort Trial
Official title: Improving Patient Experience in Gynecologic Examinations With a Stress Ball: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic
Keywords: pain
women health
pap-smear
anxiety
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Women's anxiety about gynecological examinations causes them to skip examinations during this process. Research shows that women with high levels of anxiety are more likely to feel pain. Women who can manage their anxiety can increase their satisfaction by reducing pain levels during the examination . The stress ball has the potential to improve the patient experience by reducing these anxieties. This will positively affect women's willingness to participate in gynecological examinations and follow-up processes.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-35,
* Being literate, knowing and understanding Turkish,
* Don't have a pap-smear test for the first time,

Exclusion Criteria:

* Presence of chronic pain in the pelvic region,
* Presence of a condition in the wrists that prevents squeezing the stress ball,
* Congenital malformation of the cervix, .Having a known diagnosis of a serious psychiatric illness.

Primary outcomes:
measure: Reduction of pain
timeFrame: 30 minutes after application
Secondary outcomes:
Other outcomes:
Locations:
city: Ağrı
country: Turkey
facility: Ağrı Training and Research Hospital
Study officials:
References:
citation: Nguyen L, Lamarche L, Lennox R, Ramdyal A, Patel T, Black M, Mangin D. Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review. J Obstet Gynaecol Can. 2020 Sep;42(9):1138-1146.e2. doi: 10.1016/j.jogc.2019.09.014. Epub 2019 Dec 25.
Clinical trial NCT03567031: Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia
Official title: Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, General
Infant
Keywords: Pediatric Anesthesia
Near-Infrared Spectroscopy
End-Tidal CO2
Cerebral Blood Flow
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 60
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cerebral blood flow is measured in each patient at 3 different, controlled levels of end-tidal CO2
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims at assessing cerebral blood flow variations following expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia.

Detailed description: The study aims at assessing cerebral blood flow (measured with Near-Infrared Reflectance Spectroscopy - NIRS - and transcranial Doppler - DTC) variations following end-tidal expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia performed according to standards of care.

Eligibility criteria: Inclusion Criteria:

* Age \< or = 6 months
* ASA class \< or = 3
* General anesthesia required for surgery

Exclusion Criteria:

* No parental consent
* Emergency surgery
* Preexisting neurological condition
* Hemodynamic instability
* Preexisting hypoxemia and/or hypercapnia
* Laparoscopy or thoracoscopy, if expected EtCO2 level achieving would require unsafe ventilation parameters

Primary outcomes:
measure: NIRS variation
timeFrame: 5 to 10 minutes
Secondary outcomes:
measure: DTC variation
timeFrame: 5 to 10 minutes
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Sainte Justine's Hospital
state: Quebec
Study officials:
affiliation: Sainte Justine's Hospital
name: Bruno Greff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sainte Justine's Hospital
name: Ossam Rhondali, MD
role: STUDY_DIRECTOR
affiliation: Sainte Justine's Hospital
name: Jose Luis Martinez, MD
role: STUDY_CHAIR
affiliation: Sainte Justine's Hospital
name: Chantal Crochetière, MD
role: STUDY_CHAIR
affiliation: Sainte Justine's Hospital
name: Valérie Gaspard, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04051931: The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients
Official title: The Copmparison of Accuracy of PtcCO2 and in PetCO2 in COPD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stable and acute axcerbation COPD patients

Brief summary: The pathophysiological characteristics of COPD is irreversible airflow restriction which may influence the gas exchange and cause the abnormal PaO2 and PaCO2. Assessment of the partial arterial pressure of carbon dioxide (PaCO2 ) is the 'gold standard' for the evaluation of the adequacy of alveolar ventilation.Method used mostly nowadays : arterial puncture which is accurate but is invasive 、painful、 non-dynamic and there is risk of infection and tissue、nerve damage. Noninvasive measurement methods (Most commonly used)： end-tidal CO2（ ETCO2）、 transcutaneous CO2(TcCO2). They all can monitor the PaCO2 dynamically、 noninvasively, but is existence of controversy of the accuracy. So the investigators want to compare the accuracy of these two noninvasive methods for assessment of PaCO2.


Eligibility criteria: Inclusion Criteria:

* COPD patients

Exclusion Criteria:

* hemodynamics is unstable;
* any other lung disease despite COPD；
* other diseases influencing experiments: Cognitive impairment disease、 mouth and nose trauma.

Primary outcomes:
measure: concordance between the values of PetCO2 and PaCO2 measured at the same time
timeFrame: 1 hour
measure: concordance between the values of PtcO2 and PaCO2 measured at the same time
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT01957631: Comparing Steroid Injections and Platelet Rich Plasma Injections in the Treatment of Plantar Fasciitis
Official title: Steroid Injections vs. Platelet Rich Plasma Injections in Patients With Plantar Fasciitis: A Comparison of Clinical and Ultrasound Findings
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Plantar Fasciitis
Keywords: Plantar Fasciitis
Steroid
Platelet rich plasma
Injection
Ultrasound
Lead sponsor: King Hamad University Hospital, Bahrain
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 0
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: In cases of Plantar Fasciitis not responding to conservative management, minimally invasive techniques may be used. These include platelet rich plasma injections and corticosteroid injections. Corticosteroids have long been used for symptomatic relief. However there are growth factors present in PRP injections that contribute to the healing of the pathology, and not just symptom control.

A single blind, prospective, randomized, comparative, control study will be performed. The study population consists of a total of 80 participants. They will be randomly assigned to receive either a corticosteroid injection, or a platelet rich plasma injection. Data will be collected through questionnaires and ultrasound findings. Patients will have a follow up at 3, 6, 12, and 24 weeks after they receive their injection.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18+
* Patients with Plantar Fasciitis for at least 6 months which has not responded to 6 weeks of conservative therapy
* Patients with a visual analogue score (VAS) of more than 5 in the morning
* Patients must be able to understand the informed consent and have the ability to follow up.

Exclusion Criteria:

* Patients who have had repeated corticosteroid injections within the past 3 months, or have taken a non-steroid anti inflammatory drug during the 1 week prior to receiving an intervention
* BMI \> 40
* Patients with a previous foot deformity
* Patients who have had previous foot surgery
* History of anemia (Hb \< 7)
* Confirmed diagnosis of neuropathy
* Patients who have the inability to follow up

Primary outcomes:
measure: Pain Score
timeFrame: 6 months
Secondary outcomes:
measure: Ultrasound findings
timeFrame: 3 months
Other outcomes:
Locations:
city: Muharraq
country: Bahrain
facility: King Hamad University Hospital
Study officials:
affiliation: King Hamad University Hospital, Bahrain
name: Ahsan J Butt
role: PRINCIPAL_INVESTIGATOR
affiliation: King Hamad University Hospital, Bahrain
name: Aamina M Khan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01601431: The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
Official title: The Utility of Cap Colonoscopy in Increasing Adenoma Detection Rate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Adenoma
Keywords: Screening colonoscopy
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a research study about the usefulness of transparent cap during screening colonoscopy. The purpose of the research is to test the usefulness of adding small cap to the tip of the colonoscope. the investigators hypothesis is that Cap assisted colonoscopy will improve the detection of adenomatous polyps (polyps which can become colon cancer later on) in comparison to the standard colonoscopy.

Detailed description: This is a prospective, randomized trial comparing the adenoma detection rate between Hispanic patients undergoing a screening colonoscopy with a conventional colonoscope or with a cap-assisted colonoscopy. The aims of the study are:

1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.
2. Compare the overall polyp detection rate between Hispanic patients undergoing a screening colonoscopy with and without cap.
3. Compare the cecal intubation rate and cecal intubation time between standard colonoscopy and cap assisted colonoscopy.
4. Compare the complication rate between standard colonoscopy and cap assisted colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Adult Hispanic patients (18-80) who are undergoing colonoscopy for screening or surveillance purposes.

Exclusion Criteria:

1. Patients younger than 18 yrs old or older than 80 yrs.
2. Patients with a prior history of colonic surgeries
3. Patient with Crohns colitis or ulcerative colitis.
4. Patient with prior history of colon cancer
5. Patient with poor bowel preparation

Primary outcomes:
measure: ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center at El Paso
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Mohamed O Othman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01718431: Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition
Official title: Prebiotics as Means to Modulate Colonic Events, With the Purpose to Increase Beneficial Effects on Metabolism, Satiety and Cognition.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Metabolic Syndrome
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2012-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims at investigating the impact of colonic fermentation of intrinsic indigestible carbohydrates in cereal whole kernels after three days consumption, on metabolic variables and cognition. The study is performed in healthy, normal to slightly over-weight test subjects.


Eligibility criteria: Inclusion Criteria:

* BMI 19-28 kg/m2

Exclusion Criteria:

* gastrointestinal diseases
* metabolic disorders
* tobacco/snuff user
* antibiotic/probiotic treatment

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of the test meal
timeFrame: Post-prandially after breakfast, 0-150 min
Secondary outcomes:
measure: Cognitive performance
timeFrame: Post-prandially after breakfast, 0-210 min
measure: Subjective satiety
timeFrame: post-prandially after breakfast, 0-150 min
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Applied Nutrition and Food Chemistry, Lund University
Study officials:
affiliation: Lund University
name: Anne Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilsson AC, Johansson-Boll EV, Bjorck IM. Increased gut hormones and insulin sensitivity index following a 3-d intervention with a barley kernel-based product: a randomised cross-over study in healthy middle-aged subjects. Br J Nutr. 2015 Sep 28;114(6):899-907. doi: 10.1017/S0007114515002524. Epub 2015 Aug 11.