louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03274284: Chemoradiotherapy for Recurrent T1G3 Bladder Cancer
Official title: Chemoradiotherapy for Recurrent T1G3 Bladder Cancer After BCG Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bladder Cancer
Keywords: chemoradiation for
T1G3 BC
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure.

Detailed description: Non- muscle invasive bladder cancer (NMIBC) is a heterogeneous group of cancers. For most urologists the treatment of T1G3 tumor poses a dilemma of management.The spectrum of clinical behavior includes; T1 lesions that will not progress however T1G3 may be potentially lethal, associated with metastatic disease at the time of presentation.

The major goal of treatment for T1G3 BC should be bladder preservation whenever possible.

Intravesical therapy with Bacille Calmette Guerin (BCG) may decrease the recurrence rate by compared with transurethral resection of bladder tumor (TURBT) alone.

Eligibility criteria: Inclusion Criteria:

* All patients with recurrent T1G3 bladder cancer after 6 doses of BCG consenting for chemoradiation and refusing radical cystectomy

Exclusion Criteria:

* Any patients with distant metastasis or positive LN on CT or MRI.
* Patients unfit for chemoradiation

Primary outcomes:
measure: Result of chemoradiation for recurrentT1G3 BC after BCG failure
timeFrame: followup within two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Moeen3@yahoo.com
name: Ahmed Moeen
role: STUDY_DIRECTOR
References:
citation: Lambert EH, Pierorazio PM, Olsson CA, Benson MC, McKiernan JM, Poon S. The increasing use of intravesical therapies for stage T1 bladder cancer coincides with decreasing survival after cystectomy. BJU Int. 2007 Jul;100(1):33-6. doi: 10.1111/j.1464-410X.2007.06912.x.
citation: Soloway MS, Sofer M, Vaidya A. Contemporary management of stage T1 transitional cell carcinoma of the bladder. J Urol. 2002 Apr;167(4):1573-83.
Clinical trial NCT04869384: Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma
Official title: Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of Electronic Monitoring and Feedback on Adherence to Easyhaler Controller Medication in Patients with Asthma


Eligibility criteria: Main inclusion Criteria:

* written informed consent
* male and female subjects with documented diagnosis of asthma
* age 18 to 65 years
* ACT score 19 or less at screening
* treatment wih oral corticosteroids or hospital or emergency department admission due to asthma exacerbation within the past year
* subject's able to use Easyhaler inhalers and comply with study requirements

Main exclusion Criteria:

* recent (within 1 month) asthma exacerbation
* concomitant major respiratory disease which may complicate the measurement of asthma control
* \>20 pack-year history of smoking
* recent upper or lower respiratory tract infection
* pregnant or lactating female subjects

Primary outcomes:
measure: Mean weekly adherence to controller medication
timeFrame: Weekly during each of the last 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: MECS Research GmbH
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Orion Corporation Clinical Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06472284: TetraGraph in Rocuronium Infusions
Official title: Train-of-four Monitoring Using the TetraGraph Neuromuscular Transmission Monitor to Evaluate Rocuronium Infusion Requirements During Major Neurosurgical and Surgical Procedures
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, non-blinded study to evaluate rocuronium infusion requirements using the TetraGraph Neuromuscular Transmission Monitor during surgical procedures in patients less than 18 yrs. of age.


Eligibility criteria: Inclusion Criteria:

* Patients less than 18 years of age
* American Society of Anesthesiologists classification (ASA) 1-4
* Patients undergoing a surgical procedure with general anesthesia and requiring the continuous administration of rocuroniuim

Exclusion Criteria:

* Patients less than 28 days old
* Patients with history of a progressive or degenerative peripheral neurologic or neuropathic disorder
* Patients undergoing a surgical procedure in which neuromuscular blockade is not required
* Edematous patients

Primary outcomes:
measure: EMG changes
timeFrame: During the surgery (2-8 hrs.)
measure: Maximum dose of rocuronium
timeFrame: During the surgery (2-8 hrs.)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT06517784: Insulin Initiation and Adherence Behaviours: a Cross Sectional Survey of Indian HCPs & Patients With Type 2 Diabetes
Official title: Insulin Initiation and Adherence Behaviours: a Cross Sectional Survey of Indian HCPs & Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Type 2 Diabetes (T2D) and Health Care Providers (HCPs) who treat T2D patients

Brief summary: This is a cross-sectional study planned among patients with Type 2 Diabetes (T2D) and Health Care Providers (HCPs) who treat T2D patients. Study participants will be recruited through existing databases/panels to complete a 30-minute self-administered online survey. The purpose of the study is to understand the insulinization barriers and the insulin adherence behaviours of both HCPs and patients.


Eligibility criteria: Inclusion Criteria:

For patients

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Diagnosed with T2D
4. Currently seeing an HCP for T2D
5. Initiated on insulin within the past 12 months
6. Prescribed insulin on a permanent basis
7. Currently taking insulin via a vial and syringe or insulin pen

For HCP

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Primary care physician (PCP) with degree in internal medicine or general medicine, diabetologist with degree in internal medicine or general medicine plus diploma in diabetology, or endocrinologist
4. Has been in practice a minimum of 2 years
5. Diabetologist/endocrinologist: treats at least 50 T2D patients per month
6. PCP: treats at least 40 T2D patients per month
7. Currently initiates T2D patients on insulin
8. Treats 20 percent or more of T2D patients with insulin

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Primary outcomes:
measure: The barriers toward insulin initiation among HCPs & patients
timeFrame: At time of data abstraction (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Novo Nordisk India
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References:
Clinical trial NCT03400384: Trial Applying Policy to Eliminate or Reduce Inappropriate Narcotics in the General-population
Official title: Using Policy to Reduce Opioids by Educating and Empowering Patients With Chronic Non-cancer Pain: The TAPERING Randomised Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inappropriate Dose of Drug Administered
Pain, Chronic
Health Behavior
Keywords: Deprescribing
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-01-17
Enrollment: 4255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To assess the effectiveness of a government-led population-based opioid intervention on discontinuation of opioid medication in community-dwelling adults with chronic non-cancer pain.


Eligibility criteria: Inclusion Criteria:

* Adults registered to receive pharmaceutical benefits in Manitoba, who are aged 18 years and over and who have received ≥90 days supply of opioids in the 6 months prior to the trial will be included. This will ensure chronic use and episodic use of opioids will be included.

Exclusion Criteria:

* People receiving palliative care, people with cancer, and people who receive opioids in hospital. People with dementia (identified by having received a prescription for memantine or a cholinersterase inhibitor in the previous 12 months) will be excluded.

Primary outcomes:
measure: Complete cessation of opioids
timeFrame: 6 months
Secondary outcomes:
measure: Dose reduction or therapeutic switch to an alternate analgesic
timeFrame: 6 months
measure: The proportion of people achieving opioid doses below 90mg oral morphine equivalents.
timeFrame: 6 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut universitaire de gériatrie de Montréal
state: Quebec
Study officials:
affiliation: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
name: Cara Tannenbaum, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turner JP, Caetano P, Tannenbaum C. Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial. Trials. 2019 Jul 9;20(1):412. doi: 10.1186/s13063-019-3508-z.
Clinical trial NCT02416284: Compliance to the Norwegian Food-Based Dietary Guidelines in Young Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The Norwegian Directorate of Health recently published the Norwegian food-based dietary guidelines (NFBDG) in 2011. The target for the NFBDG is the general population, and the main aims of these guidelines are to promote public health and prevent chronic degenerative diseases. Reaching the healthy population is crucial as only small proportion of the general population comply to the current public dietary advice in Norway. Thus, the objective of this study is to investigate whether a multi-faceted dietary intervention could increase compliance to the NFBDG and affect biomarkers of chronic degenerative diseases in a healthy population.

Detailed description: The study was conducted as part of a master level course in Clinical Nutrition at the University of Oslo. Thus, the main objective of the study was to teach the master students about planning, conducting and analysing data from a clinical trial. The students themselves are subjects of the study, however the participation in the study was voluntary and did in no way affect the approval of the course.

Since the primary objective of the study was teaching, the study was confirmed by the "Regional Committees for Medical and Health Research Ethics" (REC) to be exempt from REC approval.

Eligibility criteria: Inclusion Criteria:

* female

Exclusion Criteria:

* serious chronic disease requiring medication
* pregnancy

Primary outcomes:
measure: Biomarker of the intake of fruits and vegetables (caroteniods in plasma (uM)
timeFrame: 2 weeks
measure: Biomarker of intake of fatty fish and low fat dairy products (fatty acids in red blood cells (fatty acid in % of FAME)
timeFrame: 2 weeks
measure: Biomarker of the intake of fruits and vegetables (total antioxidant status in plasma (RU)
timeFrame: 2 weeks
Secondary outcomes:
measure: Lipids in plasma (HDL, LDL, total cholesterol)
timeFrame: 2 weeks
measure: Blood glucose
timeFrame: 2 weeks
measure: Blood pressure
timeFrame: 2 weeks
measure: Weight (body weight in kg)
timeFrame: 2 weeks
measure: Body composition (bioelectrocal impedance analysis (BIA)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
References:
Clinical trial NCT03964584: Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life
Official title: Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life (NEPALE)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV+ Patients
Keywords: dolutegravir
dictegravir
Neurological disorder
Psychiatric disorder
HIV integrase Inhibitors
Adverse drug event
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-05-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected patients who need to initiate or modify antiretroviral therapy, and starting a combination of antiretroviral agents including dolutegravir or bictegravir.

Brief summary: The neurological and psychiatric adverse effects of antiretroviral drugs is a concern for clinicians and people living with HIV. In addition, clinical trials conducted prior to market authorization often have stric inclusion and exclusion criteria in terms of age, co-morbidity or co-medication, and the patients included in the studies are not always representative of the population for whom the drugs will be prescribed in real life. We propose a prospective cohort study to assess the occurrence of neurological and psychiatric adverse events in HIV+ patients starting an association with dolutegravir or bictegravir.

Patients will be included on the day dolutegravir or bictegravir is prescribed. Neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.


Eligibility criteria: Inclusion criteria:

* Age ≥ 18 years
* HIV-infected
* Initiation or modification of antiretroviral therapy, and starting a therapeutic combination including dolutegravir or bictegravir

Exclusion criteria:

* Intolerance to dolutegravir or bictegravir
* Addiction to a psychoactive product (drugs or medications) with the exception of amyl nitriles ("poppers") and occasional recreational cannabis
* Alcohol consumption \>10 standard drinks/week
* Active HCV coinfection
* Pregnant or breastfeeding woman

Primary outcomes:
measure: The presence of at least one of the following neurological or psychiatric disorders
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02911584: Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse
Official title: Laparoscopic Sacrocolpopexy Versus POPS in the Surgical Management of Pelvic Organ Prolapse: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Miulli General Hospital
First posted: 2016-09-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence

Exclusion Criteria:

* Age \> 70 years
* Severe cardiovascular or respiratory disease
* Pregnancy
* Previous surgical procedure for POP correction

Primary outcomes:
measure: Number of patients with anatomical correction of the prolapse
timeFrame: up to 6 months
Secondary outcomes:
measure: Rate of recurrence
timeFrame: up to 6 months
measure: Post operative quality of life
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00527384: Biomarker Analysis of Stress
Official title: Biomarker Signatures of Biological, Chemical, or Psychological Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Stress
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2007-09-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Physiological changes can occur from different types of stress as induced by an infection, an environmental toxicant exposure, or an emotional disturbance. The stress-induced effects can modify health by lessening defense mechanisms as maintained by the immune system. The ability of different forms of stress to alter physiological processes (body functions) will be assessed by monitoring the blood profile of cell numbers and functions as well as the plasma protein content. It is anticipated that the pattern of blood changes will reflect the types of stress and the degree to which body functions could be altered by the stress.

Detailed description: Blood will be collected from patients with an ongoing infection that has lead to sepsis (systemic inflammation) as a index of major stress. The blood will be analyzed for the types of proteins that could alter immune system functions and affect organ functions, including cardiovascular effects due to blood vessel changes. This will be followed by analysis of stress effects on mice and mice that have been generated with human immune cells. The ability of stress to alter blood patterns will also be examined in mice with genetic modification of metallothionein expression, which is believe to influence oxidative stress.

Eligibility criteria: Inclusion Criteria:

* Patients at Wadsworth Center with Sepsis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Wadsworth Center
state: New York
Study officials:
affiliation: Wadsworth Center
name: David A. Lawrence, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06018584: Biostimulation After Tooth Extraction
Official title: Effect of Low-Level Laser Therapy in Wound Healing and Post-Operative Pain Management of Primary Molar Teeth Ex-traction: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Wound Heal
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluated the effect of low-level laser therapy on postoperative pain and wound healing in children undergoing primary molar extractions 40children, 6-10 years of age, systemically healthy, and had atraumatic extraction indications of bilateral primary molar teeth were included in the study. A randomly selected tooth was extracted under local anesthesia in the first session. Only the clot formation on the socket was observed and photographed in the control group. Other group extractions were performed 2weeks later. The LLLT group was treated with a 980 nm wavelength Doctor Smile Wiser diode laser and photographed. Non-epithelialized surface measurements were performed with the ImageJ program. Pain assessment was performed with the Wong-Baker Pain Scale. Statistical analyses were performed with SPSS software.


Eligibility criteria: Inclusion Criteria:

* indication for tooth extraction in bilateral primary molars
* did not have any systemic disease
* the use of antibiotics and painkillers was stopped at least 12 hours ago

Exclusion Criteria:

* require complicated tooth extractions
* systemic disease
* the use of antibiotics and painkillers in 12 hours

Primary outcomes:
measure: Wound healing
timeFrame: intervention (tooth extraction) day, 3rd day and 7th day
measure: Pain score
timeFrame: intervention day (tooth extraction), 3rd day and 7th day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: