louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06081985: Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
Official title: Efficacy of Deep Transcranial Magnetic Stimulation in Patients With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Transcranial Magnetic Stimulation
Opioid Use Disorder
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 55
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: Deep TMS to the left dorsolateral prefrontal cortex intervention to reduce craving and recurrent opioid use among patients with opioid use disorder who are abstinent for at least one week.

Detailed description: The participants will undergo baseline assessments, including rating scales and urine opioid metabolite tests. The participants will receive one of two treatments: High-frequency (10Hz, 3000 pulses per session) dTMS using a double cone coil targeting the left dorsolateral prefrontal cortex or sham stimulation. Each treatment will be preceded by a short-guided imagery (2-3 min) design to activate the relevant brain circuitry (provocation of symptoms may increase the response rate to deep TMS as was evident in the treatment of PTSD, cigarette smoking, and OCD). dTMS sessions will be conducted 10 times per week for 2 weeks, for 20 sessions. 8 weeks of patient follow-up, including clinical visits at weeks 0, 2, and 8. During this phase, subjective and objective measures of opioid use (self-report and analysis of urine samples for opioid metabolite) will be collected. Following the completion of the main part by the individual, an "open-label" treatment using the same parameters of the experiment will be offered (regardless of the treatment group).

Eligibility criteria: Inclusion Criteria:

* Age 18- 65
* Clinical diagnosis of opioid use disorder

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Mental retardation, bipolar disorder, any psychotic disorder
* Neurological diseases such as epilepsy, ischemic stroke, multiple sclerosis
* History of head trauma that resulted in loss of consciousness for ≥5 minutes and retrograde amnesia for ≥30 minutes (self-reported history)
* Any history of seizures other than febrile childhood seizures (self-reported history)
* Clinically significant hearing impairment
* Having any prosthesis, such as an implant and pacemaker.
* Illiteracy

Primary outcomes:
measure: craving
timeFrame: pretreatment, 2 weeks, and 8 weeks
Secondary outcomes:
measure: Impulsivity severity
timeFrame: pretreatment, 2 weeks, and 8 weeks
measure: Depression severity
timeFrame: pretreatment, 2 weeks, and 8 weeks
measure: Anxiety severity
timeFrame: pretreatment, 2 weeks, and 8 weeks
measure: Opioid use
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Bengu Yucens
Study officials:
affiliation: Pamukkale University Faculty of Medicine
name: Bengu Yucens
role: STUDY_DIRECTOR
References:
Clinical trial NCT02976285: Polyester Patch in Massive Rotator Cuff Repair Improves Healing
Official title: Application of a New Polyester Patch in Arthroscopic Massive Rotator Cuff Repair Significantly Improves Clinical Outcome and Tendon Integrity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: arthroscopic rotator cuff repair
patch augmentation
Lead sponsor: Etzel Clinic
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 54 patients (38 male / 16 female) 54 shoulders (29 right / 25 left) Mean patient age at the time of surgery was 65 years (range 41 - 75).

Brief summary: The purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. The investigators hypothesized that implanting this patch will improve individual shoulder function, while reducing re-tear rates compared to the current literature.

Detailed description: To evaluate this, patches were implanted into 54 shoulders and prospectively followed up clinically and radiologically.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were age greater 18 years and a RC tear involving at least two tendons, presenting a massive RC-tear as described by Gerber et al.

Exclusion Criteria:

* We excluded patients older than 75, fatty infiltration grade 4 according to Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.

Primary outcomes:
measure: Function assessed with the Constant-Murley-Score
timeFrame: 25 months
measure: Function assessed with the Subjective Shoulder Value
timeFrame: 25 months
Secondary outcomes:
measure: Tendon integrity evaluated radiologically
timeFrame: 1-35 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00140985: Antiproteinuric Efficacy of Losartan Potassium in Patients With Non-Diabetic Proteinuric Renal Diseases (0954-213)
Official title: A Randomized, Parallel, Double Blind Study of Losartan Versus Amlodipine in Patients With Mild to Moderate Hypertension and Chronic Nondiabetic Proteinuric Nephropathy: Evaluation of the Effect on Proteinuria and on the Plasmatic Levels of Growth Factors (TGFß and VEGF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 97
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: Antiproteinuric Efficacy of Losartan Potassium in Patients with Non-Diabetic Proteinuric Renal Diseases.


Eligibility criteria: Inclusion Criteria:

* Males or females at least 18 years of age with non-diabetic proteinuric renal diseases

Primary outcomes:
measure: 24h proteinuria
Secondary outcomes:
measure: Changes in the plasma and urinary levels of TGF-beta
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Praga M, Andrade CF, Luno J, Arias M, Poveda R, Mora J, Prat MV, Rivera F, Galceran JM, Ara JM, Aguirre R, Bernis C, Marin R, Campistol JM. Antiproteinuric efficacy of losartan in comparison with amlodipine in non-diabetic proteinuric renal diseases: a double-blind, randomized clinical trial. Nephrol Dial Transplant. 2003 Sep;18(9):1806-13. doi: 10.1093/ndt/gfg284.
Clinical trial NCT02804685: Effectiveness of an Exercise Protocol on Alteration of Knee Joint Position Sense in Futsal Players
Official title: Effectiveness of an Exercise Protocol on Alteration of Knee Joint Position Sense in Futsal Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proprioceptive Disorders
Knee Injuries
Athletic Injuries
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 34
Sex: MALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research presents a randomized clinical trial which evaluates the effectiveness of an exercise protocol on the knee-joint repositioning in futsal players related to a post-match muscle fatigue. Our hypothesis is the improvement of sensation in a knee in joint position before and after the match when performing our exercise program.


Eligibility criteria: Inclusion Criteria:

Must have three years of experience in futsal Must be Licensed players

Exclusion Criteria:

lower limb injuries

Primary outcomes:
measure: Joint Position Sense
timeFrame: up to 6 weeks after the end of the intervention
Secondary outcomes:
measure: Vertical jump heigh
timeFrame: up to 6 weeks after the end of the intervention
measure: Perceived exertion rate
timeFrame: up to 6 weeks after the end of the intervention
Other outcomes:
Locations:
city: Collado Villalba
country: Spain
facility: Guido Gómez
state: Madrid
Study officials:
References:
Clinical trial NCT02482285: Assessment of Frailty in Elderly Patients With Advanced Cancers
Official title: Assessment of Frailty in Elderly Patients With Advanced Cancers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 8
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced cancers

Brief summary: This study is looking at the feasibility of performing frailty assessments on elderly patients with advanced cancers

Detailed description: This study is primarily looking to see if it is feasible to assess frailty in patients age 70 years and above with advanced cancers. it is also evaluating whether there may be any correlation between these assessments and toxicity and treatment and outcome.

The assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed using timed walk, grip strength and muscle mass measurement from imaging performed as part of routine clinical care.

The assessments will be performed at baseline, week 12 and week 24.

There is the option for patients to also donate blood samples for research purposes.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of advanced carcinoma - not suitable for curative treatment
* Age 70 years or over
* seen by an oncologist for consideration of palliative systemic medical therapy and decision regarding management already made
* WHO Performance Status 0-2
* Written informed consent

Exclusion Criteria:

* Hepatocellular cancer
* Prostate cancer
* Breast cancer

Primary outcomes:
measure: Percentage patients consenting for assessments out of number approached
timeFrame: Baseline
measure: Time taken to complete assessments
timeFrame: Baseline, week 12 and week 24
Secondary outcomes:
measure: Frailty as a predictor of grade 3/4 toxicity
timeFrame: baseline
measure: Sarcopenia as a predictor of outcome
timeFrame: baseline, week 12 and week 24
measure: Quality of life EORTC QCQ 30
timeFrame: baseline, week 12 and week 24
measure: Biomarker assessment of frailty and associated factors which may include genetic analysis
timeFrame: baseline, week 12 and week 24
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne NHS Trust
Study officials:
affiliation: Newcastle University
name: Alastair Greystoke, MRCP, PhD, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05971485: Melatonin As an Analgesic in Preterm Neonate
Official title: Efficacy of Melatonin As an Analgesic in Preterm Neonate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preterm Neonate Analgesia
Keywords: Preterm
Analgesia
Melatonin
Oxidative stress
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 40
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone secreted by the pineal gland with several important functions, including regulation of the circadian rhythms, antioxidant and anti-inflammatory effects, accumulating evidence revealed that it also plays an important role in pain modulation through multiple mechanisms. The investigators aimed to evaluate the analgesic effect of enteral melatonin given 30 minutes before cannula insertion in preterm neonates by assessing Premature Infant pain Profile score (PIPP) before and 5 minutes after the procedure. Additionally, the study aimed to explore the relationship between procedural pain and oxidative stress, along with the effectiveness of pain management of melatonin by measuring Malondialdehyde (MDA), a well-accepted marker of oxidative stress, 60 minutes after the procedure.

Detailed description: This is a randomized, double-blind, controlled trial

Eligibility criteria: Inclusion Criteria:

* Preterm infant
* less than 37 weeks gestational age
* who started enteral feeding.

Exclusion Criteria:

* Multiple congenital anomalies.
* Facial malformation.
* Receiving analgesia or sedation.
* Contraindication of enteral feeding.
* Clinical or laboratory signs of sepsis.
* Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.

Primary outcomes:
measure: Evaluate the analgesic effect of melatonin in preterm
timeFrame: 5 minutes starting just before cannula insertion to 5 minutes after the procedure
measure: Malondialdehyde (MDA), marker of oxidative stress
timeFrame: 60 minutes of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine - Ain Shams University
Study officials:
References:
Clinical trial NCT02990585: Back School for Non-specific Low Back Pain (LBP) in an Urban Setting
Official title: The Effect of an 8-session Back School Versus a Single, Abbreviated Session When Looking at Non-specific Low Back Pain in an Urban Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 11
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: This study will be a comparative design between 2 groups of subjects attending classes on back education in an urban setting. Participants will be randomized to either an individual one-on-one back school session or to the 8 group sessions.


Eligibility criteria: Inclusion Criteria:

* Participants 18 years of age or older who have been suffering from non-specific LBP for at least 3 months

Exclusion Criteria:

* Additional impairments contraindicating their safe participation in the back school program, such as evidence of spinal cord pathology, cauda equina, progressive neurological damage, infection, inflammation, malignancy, fracture or a progressive, neurodegenerative disease as well as back surgery within the past year

Primary outcomes:
measure: Change in the Modified Oswestry Disability Index
timeFrame: At 4 weeks, 10 weeks, 4 months, and 7 months
Secondary outcomes:
measure: Change in the Fear Avoidance Belief Questionnaire -Physical Activity portion
timeFrame: At 4 weeks, 10 weeks, 4 months, and 7 months
measure: Change in the Numeric pain rating scale
timeFrame: At 4 weeks, 10 weeks, 4 months, and 7 months
measure: Change in the International Physical Activity Questionnaire
timeFrame: At 4 weeks, 10 weeks, 4 months, and 7 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: Marie Pepin, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00930085: Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients
Official title: Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Septic Shock
Cancer
Keywords: sepsis
septic shock
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2009-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The mortality induced by infections in onco-hematological patients is abnormally high at the acute phase of septic shock. Consequently, it is important to detect the population with a high risk of short term mortality among patients with a septic shock. The aim of this study is the evaluation of predictive proteic profile on the short term mortality in the acute phase of septic shock in cancer patients.

Detailed description: Method: Monocentric prospective study with diagnostic and prognostic expectations.

Primary objective:

Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock.

Secondary objective:

Research of clinical and biological prognostic factors.

Eligibility criteria: Inclusion Criteria:

* Patient from oncology or hematology with a septic shock
* Patient aged 18 years and older
* Inclusion within the 24 hours of the septic shock in the intensive care unit
* Signed consent according to the emergency reglementation

Exclusion Criteria:

* Pregnancy, breast feeding
* Patient with decision of care limitation
* Patient with legal protection

Primary outcomes:
measure: Identification and characterization of early proteic biomarkers predictive of short term mortality in cancer patients with septic shock.
timeFrame: 1 month
Secondary outcomes:
measure: Research of clinical and biological prognostic factors.
timeFrame: 1 month
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Djamel MOKART, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01104285: Chest Tube Drainage of Transudative Pleural Effusions Hastens Liberation From Mechanical Ventilation
Official title: Chest Tube Drainage of Transudative Pleural Effusions Hastens Liberation From Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liberation From Mechanical Ventilation
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 112 patients standard; 86 patients chest tube

Brief summary: The purpose of this study is to determine whether chest tubes to drain transudative pleural effusions helps patients come off mechanical ventilation earlier.


Eligibility criteria: Inclusion Criteria:

* Patients with transudative pleural effusion and requiring mechanical ventilation

Exclusion Criteria:

* Patients with coagulopathy

Primary outcomes:
measure: Total Days of Mechanical Ventilatory Support
timeFrame: days
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Yizhak Kupfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kupfer Y, Seneviratne C, Chawla K, Ramachandran K, Tessler S. Chest tube drainage of transudative pleural effusions hastens liberation from mechanical ventilation. Chest. 2011 Mar;139(3):519-523. doi: 10.1378/chest.10-1012. Epub 2010 Aug 5.
Clinical trial NCT00563485: Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up
Official title: Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily in the Successful Rate of Trial Without Catheter in Acute Urinary Retention With Long Term Follow up
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostatic Hyperplasia
Urinary Retention
Keywords: Benign Prostatic Hyperplasia (BPH)
Acute Retention of Urine (AUR)
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2007-11-26
Enrollment: 120
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare two alpha blockers, terazosin and doxazosin GITS, in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP.


Eligibility criteria: Inclusion Criteria:

* Aged 50 or above
* Admitted for AUR due to BPH with PVR of 500 ml or more

Exclusion Criteria:

* Previous history of TURP
* Use of alpha blockers within recent 8 months
* Renal impairment (serum creatinine \>140 umol/l)
* Poor premorbid state

Primary outcomes:
measure: Successful rate of Trial Without Catheter (TWOC) at phase 1
timeFrame: At discharge after TWOC (at the end phase one)
measure: Late failure of TWOC of, which is defined as recurrent of AUR or the need of invasive therapy among those who are successful in TWOC in phase 1
timeFrame: From the end of phase one to eight months after successful TWOC (the end of phase 2)
Secondary outcomes:
measure: Proportion of subjects with hypotension or symptoms related to hypotension after administration of treatment drug for TWOC
timeFrame: From the time of treatment drug administration to the end of phase 1
measure: Peak flow rate (Qmax), voided volume (Vcomp) and post-voided residue volume (PVR)
timeFrame: At the end of phase I (discharge after TWOC) and at the end of phase 2
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Department of Surgery, Division of Urology, North District Hospital/ The Chinese University of Hong Kong
name: Chi Wai Cheng, Dr
role: PRINCIPAL_INVESTIGATOR
References: