louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06835907: Baclofen for Anxiety and Alcohol Use Disorder (AUD): an Open Label Study
Official title: Investigating the Efficacy of Baclofen in Patients with Alcohol Use Disorder (AUD) and Comorbid Anxiety Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Keywords: Alcohol use disorder (AUD)
Baclofen
Anxiety
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to determine the efficacy of baclofen for the treatment of alcohol use disorder (AUD) in patients with or without comorbid anxiety symptoms. The main questions it aims to answer are:

* Do we see more abstinent days after the study period in patients with high anxiety symptoms compared to low anxiety symptoms?
* Do we observe additional differences between patients with high- and low anxiety symptoms in: any drinking at the end of treatment (yes/no), number of patients who respond to treatment, anxiety score reduction, autonomic responses, craving scores, drinking motives and side effects?

Participants already taking baclofen as part of routine clinical care for treatment of AUD will be asked to answer several questionnaires over a 6 week study period.


Eligibility criteria: Inclusion Criteria:

* Meeting DSM-5 criteria for AUD
* Able to understand and provide written consent
* Already receiving baclofen or started with baclofen at start of hospitalization
* Therapeutic desire towards alcohol abstinence

Exclusion Criteria:

* Concurrent substance use disorder other than nicotine or cannabis
* Clinically significant psychiatric illness that requires pharmacotherapy, unless stable and no changes in medication has been made in the last 30 days
* Clinically significant medical diseases that may pose a risk to continuing baclofen use
* Pregnant or currently breastfeeding women

Primary outcomes:
measure: Number of days abstinent
timeFrame: Weekly during 6 week study period
Secondary outcomes:
measure: Any drinking
timeFrame: After 6 week study period
measure: Treatment response
timeFrame: After 6 week study period
measure: Autonomic symptom responses
timeFrame: At start and after 6 week study period
measure: Craving scores
timeFrame: Weekly for the VAS and bi-weekly for the DDQ during the 6 week study period
measure: Anxiety score reduction
timeFrame: At start and after 6 week study period
measure: Drinking motives
timeFrame: At start of 6 week study period
measure: Side effects
timeFrame: Weekly during 6 week study period
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Cleo L Crunelle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03342209: Utility of High Flow Nasal Cannula in CO Toxicity
Official title: Determination of Half-life of the Carboxyhemoglobin Level and Utility of High Flow Nasal Cannula in Carbon Monoxide Toxicity in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carbon Monoxide Poisoning
Environmental Exposure
Keywords: carbon monoxide toxicity
high flow nasal cannula
emergency department
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 35
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: determination of the half-life of COHb in CO-poisoned patients with high flow nasal oxygen therapy in the ED.

Detailed description: Carbon monoxide (CO) poisoning is common and potentially fatal environmental emergency which requires immediate attention. It is responsible for up to 40,000 emergency department (ED) visits and 5000 to 6000 deaths per year, making it one of the leading causes of poisoning death in the United States. The management options for CO poisoning are limited to high flow oxygen by face mask or hyperbaric oxygen treatment. While half-life of carboxyhemoglobin (COHb) in a patient treating with high flow oxygen via a nonbreathing face mask is 90 minutes, it becomes 30 minutes with hyperbaric oxygen treatment (HBO).

The hypothesis of this study is using high flow nasal oxygen therapy in the CO poisoning may be more effective and safer treatment method comparing to standard oxygen therapy in the ED. Also, it may be a safe promising alternative of hyperbaric oxygen therapy.

The aim of the study is to determine the half-life of COHb in CO-poisoned patients with high flow nasal oxygen therapy in the ED.

Eligibility criteria: Inclusion Criteria:

* The patients who are admitted to the emergency department with CO poisoning with a CoHB level of \>10%.
* The patients who accept to participate in the study.

Exclusion Criteria:

* The patients who are \<18 years old.
* The patients who need mechanical ventilation
* The patients who are implemented oxygen more than 30 minutes before the ED admission
* The patients who will be transferred to the hyperbaric oxygen center before the CoHB levels are decreased to the half.

Primary outcomes:
measure: Half life of COHb
timeFrame: between 20 and 120 minutes
Secondary outcomes:
measure: Adverse Events
timeFrame: between 0 and 120 minutes
measure: Device Comfort
timeFrame: Between 0 and 120 minutes
measure: Flow Rate Tolerability
timeFrame: Between 0 and 120 minutes
measure: Flow Temperature Tolerability
timeFrame: Between 0 and 120 minutes.
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
state: Izmit
Study officials:
affiliation: Kocaeli University
name: Elif Yaka, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Kocaeli University
name: İbrahim U Özturan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01089309: Effect of Aldosterone Blockade on Arterial Compliance
Official title: Effect of Aldosterone Blockade on Metabolic Parameters and Arterial Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arterial Stiffness
Arterial Elasticity
Keywords: Aldosterone Blockade
Arterial elasticity
Glycemic control
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-03-18
Enrollment: 51
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study investigated the long-term (12 months) effect of spironolactone treatment on glucose homeostasis, metabolic parameters and vascular properties.


Eligibility criteria: Inclusion Criteria:

1. patients with type 2 diabetes mellitus

Exclusion Criteria:

1. history of unstable angina, myocardial infarction (MI), cerebrovascular accident (CVA)
2. major surgery within the six months preceding entrance to the study
3. unbalanced endocrine disease
4. any disease that might affect absorption of medications
5. plasma creatinine \>2.5 mg/dl
6. elevation of liver enzymes to more that twice the upper normal limit
7. plasma potassium levels \>5.5 mg/dl

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson Medical Center
Study officials:
References:
Clinical trial NCT00289809: TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients
Official title: A Perspective Phase I and II Trial of Liposome-encapsulated Doxorubicin (TLC D-99) in Combination With Ifosfamide in Patients With Metastatic Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sarcoma, Soft Tissue
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2006-02-10
Enrollment: 36
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: The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response

Detailed description: The Maximum Tolerated Dose of the combination was determined and the Phase I terminated.

Then, Phase II study started.

Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy
* Age \>/=18 yrs
* PS \</=2
* Disease detectable almost for 1 dimension
* Life expectancy \>/=3 mos
* Minimum 4 wks from last radiotherapy
* Adequate medullary, liver, and renal functions
* Normal LVEF
* Written Informed Consent

Exclusion Criteria:

* Pregnant or breast-feeding patients
* Serious concomitant disease or not controlled infections

Primary outcomes:
measure: Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide
timeFrame: Definition of TDL
measure: Phase II: Response rate (CR/PR or SD)
timeFrame: Tumor assessment
Secondary outcomes:
measure: Phase II: time to progression, duration of response, overall survival
timeFrame: Tumor assessment, follow-up
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05762809: Kinesiophobia After Anterior Cruciate Ligament Reconstruction.
Official title: Kinesiophobia After Anterior Cruciate Ligament Reconstruction.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kinesiophobia
ACL Injury
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 144
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Anterior cruciate ligament (ACL) rupture is a serious trauma with long-term consequences to the athlete. Psychological and physiological factors may negatively affect patient recovery and increase reinjury rate after anterior cruciate ligament reconstruction (ACLR), and development of kinesiophobia is also possible.

Detailed description: Anterior cruciate ligament (ACL) rupture is a serious trauma with long-term consequences to the athlete. Return to sports at the pre-injury level after anterior cruciate ligament reconstruction (ACLR) is reported between 55 and 83%. Psychological and physiological factors can negatively affect patient recovery and increase reinjury rate after ACLR. In daily practice, surgeons and physiotherapists see athletes struggling to improve muscle strength and complaining of a lack of self-confidence and fear of reinjury during their progress to return to sports.

Kinesiophobia in ACLR patients is used to determine fear of pain, lack of self-confidence, and fear of reinjury. Patients with self-reported fear are less active, have decreased muscle function, and increased risk of a second ACL injury. Lower rates of return to sports are reported in athletes with kinesiophobia after ACLR. To measure kinesiophobia, the self-reported Tampa Scale of Kinesiophobia (TSK-17) test is widely used. The original TSK was developed and described by Miller et al. in 1991. In ACLR patients, the risk of developing fear was previously measured in a large systematic review of 2175 patients, in which 514 (24%) reported a psychological reason for not returning to sports.

Eligibility criteria: Inclusion Criteria:

* Patients underwent ACLR by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019.

Exclusion Criteria:

* Patients with revision ACLR, bilateral ACLR, and postoperative infections were excluded from the study.

Primary outcomes:
measure: KOOS
timeFrame: 1 week
Secondary outcomes:
measure: Body mass index
timeFrame: 1 week
measure: Oxford Knee Score (OKS) scoring
timeFrame: 1 week
measure: Tampa Scale of Kinesiophobia (TSK-17)
timeFrame: 1 week
measure: Quadriceps and hamstring muscle isokinetic strength
timeFrame: 1 week
measure: Single-leg hop test
timeFrame: 1 week
measure: Y-balance test
timeFrame: 1 week
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
Study officials:
affiliation: Tartu University Hospital
name: Leho Rips, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02298309: Test and Treat TB: A Proof of Concept Trial in South Africa
Official title: Test and Treat TB: A Proof of Concept Trial in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: TB
HIV
Test and Treat
Linkage
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: AIDS Healthcare Foundation
First posted: 2014-11-21
Enrollment: 4815
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is (1) to establish the feasibility, yield, and clinical impact of a "Test \& Treat TB" strategy on a mobile HIV screening unit in South Africa and (2) to assess the cost and cost-effectiveness of this mobile, integrated HIV/TB screening strategy for maximizing linkage to TB care and treatment completion.


Eligibility criteria: Inclusion Criteria:

* English or Zulu speaking
* presenting for screening at mobile unit
* voluntarily undergoing HIV testing
* able and willing to give informed consent
* willing to share HIV and TB test results
* willing to attend one of six local clinics for treatment
* access to a mobile phone

Exclusion Criteria:

* pregnant

Primary outcomes:
measure: Number of patients who complete tuberculosis treatment
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of mobile testers screened for tuberculosis
timeFrame: 20 months
measure: Proportion of eligible participants able to produce sputum samples
timeFrame: 20 months
measure: Prevalence of TB among those tested
timeFrame: 20 months
measure: Prevalence of tuberculosis and rifampin resistance
timeFrame: 20 months
measure: Distribution of TB symptoms ascertained from TB symptom screen questionnaire
timeFrame: 20 months
measure: Proportion returning to the mobile tester for TB test result
timeFrame: 20 months
measure: Linkage to TB care (first visit to a local TB treatment site ascertained from clinic record)
timeFrame: 1 month
measure: ART initiation date as documented by clinic record for those HIV co-infected
timeFrame: 6 months
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: iThembalabantu Clinic/AIDS Healthcare Foundation
state: KwaZulu-Natal
Study officials:
affiliation: Massachusetts General Hospital
name: Ingrid V Bassett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bassett IV, Forman LS, Govere S, Thulare H, Frank SC, Mhlongo B, Losina E. Test and Treat TB: a pilot trial of GeneXpert MTB/RIF screening on a mobile HIV testing unit in South Africa. BMC Infect Dis. 2019 Feb 4;19(1):110. doi: 10.1186/s12879-019-3738-4.
Clinical trial NCT05179109: Robotic Versus Laparoscopic Surgery for Deep Endometriosis
Official title: Robotic Versus Laparoscopic Surgery for Severe Deep Endometriosis: a Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Deep Endometriosis
Surgery
Keywords: Endometriosis surgery
Deep endometriosis surgery
Robotic surgery
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, controlled clinical trial with an allocation ratio of 1:1.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome.

Detailed description: The objective of this prospective, randomized trial is to examine whether robot-assisted laparoscopy is superior compared to conventional laparoscopy as regards to patient outcome at 6, 12 and 24 months postoperatively, measured by questionnaires concerning the pain symptoms and disease-related quality-of life.

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologists physical status classification) 1-3
* Diagnosed deep endometriosis (MRI)
* Patient has symptoms
* Operative treatment is indicated
* Patient is able to give informed consent

Exclusion Criteria:

* ASA \> 3
* Recurring rectosigmoid endometriosis

Primary outcomes:
measure: NRS (Numeric rating scale) Score for pain
timeFrame: Immediately postoperatively (24 hours) and 6, 12 and 24 months postoperatively
Secondary outcomes:
measure: Intraoperative measures
timeFrame: Up to 300 minutes (intraoperative)
measure: Factors concerning ERAS (Enhanced recovery after surgery)
timeFrame: Up to 7 days (Hospital stay)
measure: Cost
timeFrame: Primary hospital stay and 24 months, for both study groups.
measure: Complications
timeFrame: 30 days
measure: Endometriosis-related quality-of-life
timeFrame: 6, 12 and 24 months
measure: General 15 dimensional health-related quality-of-life questionnaire
timeFrame: 6, 12 and 24 months
measure: Sexual quality-of-life questionnaire
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Northern Ostrobothnia Hospital District
Study officials:
affiliation: Oulu University Hospital, Department of Obstetrics and Gynecology
name: Sari Koivurova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terho AM, Makela-Kaikkonen J, Ohtonen P, Uimari O, Puhto T, Rautio T, Koivurova S. Robotic versus laparoscopic surgery for severe deep endometriosis: protocol for a randomised controlled trial (ROBEndo trial). BMJ Open. 2022 Jul 18;12(7):e063572. doi: 10.1136/bmjopen-2022-063572.
Clinical trial NCT03190109: Bone Age Determined by Ultrasound (BAUS) in Brazilian Control Children
Official title: Analyses of Bone Age Determined by Ultrasound in a Cohort of Brazilian Control Children and Adolescents: Comparison With Conventional Bone Age Determined by X-Ray
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Control, Population
Keywords: bone age measurement
skeletal age measurement
ultrasound
x-Ray
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: normal control school students

Brief summary: Aiming to validate the use of bone age determined by ultrasound (BAUS) in Brazilian children, normal control students will be studied. X-Ray bone age (RXBA) and BAUS will be determined in 500 children and adolescents of both genders, with chronological age varying from 6-16 years.

Concordance analysis and the correlation between both BA determination methods will be performed.

Detailed description: Bone age is a valuable method to recognize the maturation status of development and growth. Classical analyses is performed by using the Greulich and Pyle X-Ray measurement. Such analyses have some restrictions such as intra- and inter observer variability, and variable synchronicity of bone maturation.

Bone age determined by ultrasound (BAUS) has been indicated as a fast and reproducible method, allowing decimal BA determination and avoiding the need for X-Ray.

Our aim is to validate the BAUS method in Brazilian normal controls. School students of both genders, with age varying from 6 to 16 years will be included.

Eligibility criteria: Inclusion Criteria:

* absence of chronic illness and drug ingestion

Exclusion Criteria:

* any chronic disease or medicine use
* body mass index: \< -2SDS or \> +2SDS
* stature : \< -2SDS or \> +2SDS

Primary outcomes:
measure: bone age determination by ultrasound (BAUS)
timeFrame: chronological ages between 6 and 16 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Santa Casa SP - School of Medical Sciences
state: SP
Study officials:
affiliation: Full Professor. Head of Pediatric Endocrinology Unit
name: Carlos A Longui, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00447109: Time Interval for Changing Closed System Suction Catheters, Effect on Ventilator Associated Pneumonia
Official title: Endotracheal Suction With or Without Daily Changes of Closed System Suction. Effect on Ventilator Associated Pneumonia and Cost
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Ventilator Associated
Closed System Suction Catheter
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
Collaborators: name: Deakin University
First posted: 2007-03-14
Enrollment: 344
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 was to compare the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.

Detailed description: Comparison(s): the incidence of ventilator-associated pneumonia between two groups of patients randomised to have closed system suction catheter changes every 24 hours and patients having closed system suction catheter changes every seven days or as required.

Eligibility criteria: Inclusion Criteria:

* Aged greater than 18 years
* Mechanically ventilated for more than 24 hours

Exclusion Criteria:

* Admitted from other hospital already mechanically ventilated
* Massive haemoptysis
* Previously received mechanical ventilation

Primary outcomes:
measure: ventilator-associated pneumonia
Secondary outcomes:
measure: length of hospital
measure: intensive care stay
measure: duration of mechanical ventilation
measure: hospital mortality
measure: number of acquired organ system derangements
measure: cost of the closed system suction catheters
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
Study officials:
affiliation: Deakin University
name: Lauren J McTier
role: PRINCIPAL_INVESTIGATOR
References: