louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04989205: Community Based Cannabis Cessation Program
Official title: Examining a Community Based Intervention for Cannabis Smoking Cessation in Norway - an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannabis Use
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: City of Oslo
name: Municipality of Kristiansand
name: Norway Centre for Addiction Research
First posted: 2021-08-04
Enrollment: 102
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target group was individuals who engaged in regular or daily cannabis use, and who were motivated to quit cannabis.

Brief summary: The study examined a community based cannabis cessation program in Norway (CCP). The CCP uses a combination of cognitive therapy and psychoeducation and covers the normal withdrawal period for cannabis smoking cessation (up to 8 weeks), comprising \~15 individual sessions. From 2005 onwards, the CCP was implemented as a low-threshold community-based program in several Norwegian municipalities, e.g., Kristiansand, Fredrikstad and Oslo. The study had an observational one-group pre- / post test design. Outcomes was changes in cannabis use, mental distress, well-being, social network and sense of coherence (SoC) measured post-intervention (T2) and at a 3 months follow-up (T3).


Eligibility criteria: Inclusion Criteria:

* Severity of Dependence Scale (SDS) score ≥4

Exclusion Criteria:

* polydrug use where cannabis was not the predominating substance of use
* psychiatric comorbidity that was perceived as too severe to handle at the community-based centers

Primary outcomes:
measure: Cannabis use
timeFrame: Changes from baseline to post-treatment and follow-up, on average 5 months
Secondary outcomes:
measure: Mental distress
timeFrame: Changes from baseline to post-treatment and follow-up, on average 5 months
measure: Well-being
timeFrame: Changes from baseline to post-treatment and follow-up, on average 5 months
measure: Social network
timeFrame: Changes from baseline to post-treatment and follow-up, on average 5 months
measure: Sense of Coherence (SoC)
timeFrame: Changes from baseline to post-treatment and follow-up, on average 5 months
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
facility: Social Services, Fredrikstad Municipality
city: Kristiansand
country: Norway
facility: Kristiansand Municipality, Cannabis Cessation Program
city: Oslo
country: Norway
facility: City Centre Outreach Service, Agency for Social and Welfare Services
Study officials:
affiliation: Addiction Unit, Sørlandet Hospital, Kristiansand
name: John-Kåre Vederhus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vederhus JK, Rorendal M, Skardal M, Naess MO, Clausen T, Kristensen O. Successful outcomes with low-threshold intervention for cannabis use disorders in Norway - an observational study. PLoS One. 2022 Jun 16;17(6):e0269988. doi: 10.1371/journal.pone.0269988. eCollection 2022.
Clinical trial NCT02622698: Oral Protein Supplementation Following Non-bariatric Surgery
Official title: A Randomized Trial of Oral Protein Supplementation Following Non-bariatric Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein Supplementation
Lead sponsor: Eisenhower Army Medical Center
Sponsor class: FED
Collaborators: name: Medical Nutrition USA, Inc.
First posted: 2015-12-04
Enrollment: 62
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: Investigators performed a randomized controlled trial of 62 patients undergoing elective abdominal operations. The treatment group was provided a liquid protein supplement and instructed to take a dose three times daily for the first 20 postoperative days. Investigators followed patients for six months and compared wound healing and changes in weight and laboratory values.


Eligibility criteria: Inclusion Criteria:

* patients scheduled to undergo abdominal surgery \[cholecystectomy, ventral hernia repair, colectomy, non-bariatric gastric surgery, appendectomy, small bowel resection, lysis of adhesions, liver resection, splenectomy, proctectomy, stoma construction, pancreatic surgery, duodenal surgery, adrenal surgery, renal surgery, or cystectomy\]

Exclusion Criteria:

* Age less than 18 years
* Pregnant
* Abdominal surgery within the past 6 months
* Inability to attend follow-up appointments for at least 6 months
* Liver failure (Child-Pugh Class B or C) or kidney failure (glomerular filtration rate (GFR) less than 30).

Primary outcomes:
measure: Change in weight
timeFrame: Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months
Secondary outcomes:
measure: Wound healing
timeFrame: Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months
measure: Change in white blood cell count (1x10 3/ uL)
timeFrame: Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months
measure: Change in total protein (g/ dL)
timeFrame: Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months
measure: Change in albumin (g/ dL)
timeFrame: Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months
measure: Change in prealbumin (mg/ dL)
timeFrame: Preoperative, and then postoperative at 1-2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02876198: Study of the Modification of the Retinal Nerve Fiber Layer in Patients Treated With Intravitreous Injection of Anti-VEGF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Neovascularization
Keywords: Retinal neovascularization
Anti-VEGF
Retinal Nerve Fiber Layer (RNFL)
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-23
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited during a consultation in ophtalmology after prescription of an anti-VEGF treatment.

The study will not change the patient's usual care schedule. Only a different analysis of the images obtained by SD -OCT will be performed, and a gonioscopy will be carried out systematically the inclusion of patient and 12 months.

The data for the study will be collected at the inclusion visit and at the final visit of the study at 12 months.

Brief summary: The intra-vitreous injection (IVT) of anti-VEGF (vascular endothelial growth factor) is currently the standard treatment for retinal neovascularization. The VEGF stimulates endothelial cells' proliferation and migration. It also increases microvascular permeability. If the VEGFs have proven their efficiency in the decrease of choroidal neovascular proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown. Knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in the area of the head of the optic nerve, a vasoconstriction induced by the anti-VEGF may have an incidence on the loss of retinal nerve fibers.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old
* Patients treated with anti-VEGF according to the French summary of product characteristics (SPC)
* Patients who have been informed of the trial and who are not opposed to participate in the study

Exclusion Criteria:

* Patients presenting a retinal condition, including the optic nerve
* Patients treated with anti-VEGF in both eyes
* Pregnant women
* Lack of affiliation to social security or universal health coverage

Primary outcomes:
measure: change in RNFL's thickness in the nasal quadrant of the optic nerve after intra-vitreous Injection of Anti-VEGF
timeFrame: Change from baseline RNFL's thickness at Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Pole Vision du val d'Ouest
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rotchschild
city: Strasbourg
country: France
facility: Centre médical et chirurgical de la rétine
Study officials:
References:
Clinical trial NCT01023698: Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters
Official title: Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neovascular
Keywords: Diabetic retinopathy
Diabetic macular edema
Panretinal photocoagulation
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in a single session using low fluence parameters?


Eligibility criteria: Inclusion Criteria:

* untreated Proliferative diabetic retinopathy

Exclusion Criteria:

* Previous photocoagulation

Primary outcomes:
measure: Stabilization of proliferative diabetic retinopathy
timeFrame: 2010
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Asociacion para Evitar la Ceguera en México
name: Maria A Martinez-Castellanos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644098: Effect of a Soluble Fibre Blend and Medium Chain Triglycerides on Body Composition and Cardiometabolic Risk Factors
Official title: The Effect and Dose-response of Soluble Fibre Blend and Medium Chain Triglycerides (MCT) on Body Composition and Cardiometabolic Risk Factors in Overweight and Obese Adults: a Double-blind, Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: People Who Are Overweight or Obesity
Lead sponsor: Canadian Center for Functional Medicine
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2008-03-26
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether the addition of capsules containing soluble fibre complex emulsified with medium chain triglycerides and taken before with meals will lead to a significant amount of weight loss, reduced glycemic volatility and diminished cardio metabolic risk factors in overweight and obese individuals when compared to a placebo control.

We believe that those participants taking 3-6 capsules per day of the treatment capsules over a 14 week period will loose a significant amount of weight compared to the placebo group.


Eligibility criteria: Inclusion Criteria:

* BMI 27 - 35 kg/m2

Exclusion Criteria:

-

Primary outcomes:
measure: weight loss
timeFrame: baseline, biweekly and final visit
Secondary outcomes:
measure: glycemic volatility and cardio metabolic risk factors
timeFrame: baseline and final visit
Other outcomes:
Locations:
city: Coquitlam
country: Canada
facility: Canadian Center for Functional Medicine
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Timothy Durance, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06913998: The Prevalence and Impacts of Nudix Hydrolase 15 (NUDT15) Gene Variants in Taiwanese Inflammatory Bowel Disease
Official title: The Prevalence and Impacts of Nudix Hydrolase 15 (NUDT15) Gene Variants in Taiwanese Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Neutropenia
Nudt15 Deficiency
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included participants who are diagnosed with inflammatory bowel disease at National Taiwan University Children's Hospital and agree to have blood test for NUDT15 gene evaluation.

Brief summary: The study will include participants who were diagnosed with inflammatory disease and followed up at National Taiwan University Children's Hospital. The investigators will check the NUDT15 gene test, if the participant agrees to do an additional blood test. The result of the gene test will be analyzed and compared with other clinical data.

Detailed description: In inflammatory bowel disease (IBD), thiopurines play an important role in maintenance of steroid-free remission but possess risk of life-threatening neutropenia, which is associated with gene variants of NUDT15 in Asians. In order to better incorporate thiopurines in clinical practice, the investigators aim to summarize the prevalence and impacts of NUDT15 variation in IBD in Taiwan. The study will include participants who were diagnosed with inflammatory disease and followed up at National Taiwan University Children's Hospital. The investigators will check the NUDT15 gene test, if the participant agrees to do an additional blood test. The result of the gene test will be analyzed and compared with other clinical data.

Eligibility criteria: Inclusion Criteria:

* Participants who are diagnosed with inflammatory bowel disease.

Exclusion Criteria:

* Participants who refused to have blood test for NUDT15 gene evaluation.

Primary outcomes:
measure: Neutropenia
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT05855798: Ketamine and Magnesium in Erector Spinae Plane Block
Official title: Comparison of Analgesic Effects of Magnesium Sulphate and Ketamine Added to 0.5% Bupivacaine for Erector Spinae Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Analgesia
Keywords: erector spinae plane block
magnesium sulphate
ketamine HCl
bupivacaine
analgesia
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 60
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 this study, it will aimed to evaluate the effect of magnesium sulfate and ketamine HCl added to local anesthetic on postoperative pain management in the ultrasound-guided erector spina plane (ESP) block in patients will undergo video-assisted thoracoscopic surgery.

Detailed description: Patients who will undergo lung resection with elective video-assisted thoracoscopic surgery will be included in the study. After routine monitoring, general anesthesia induction, and intubation with a double-lumen tube, patients who are placed in a lateral position will receive an ESP block at the T5 level, accompanied by ultrasonography, for postoperative analgesia.

For this purpose; Group I (control group) 0.5% bupivacaine 20 ml, Group II 0.5% bupivacaine 20 ml+150 mg MgSO4, Group III 0% ,5 bupivacaine 20 ml+2 mg/kg ketamine HCl will be administered. In all groups, the total volume will completed to 25 ml with 0.9% NaCl.

After surgery, hemodynamic values (heart rate, systolic and diastolic blood pressure), oxygen saturation, VAS scores (at rest and effort), Ramsey sedation score, patients satisfaction scores, PCA morphine consumption, additional analgesic requirements, and side effects will be recorded.

Eligibility criteria: Inclusion Criteria:

* lung resection with video-assisted thoracoscopy,
* voluntarily agree to participate in the study,
* over 18 years old,
* ASA I-III

Exclusion Criteria:

* ASA\>III
* Coagulation disorders or anticoagulant agent therapy,
* Allergy or hypersensitivity to any drug to be will be used in the study,
* Epilepsy,
* High intracranial pressure,
* Unwillingness to participate in the study
* Inability to use the PCA device

Primary outcomes:
measure: pain scores
timeFrame: Change from baseline pain scores at 24 hours
measure: morphine consumption
timeFrame: Change from baseline morphine consumption at 24 hours
Secondary outcomes:
measure: side effects
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
References:
Clinical trial NCT02361398: Individualized PEEP Setting by EIT in Patients With ARDS
Official title: Individualized Positive End Expiratory Pressure(PEEP) Setting by EIT in Patients With Acute Respiratory Distress Syndrome(ARDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: the PEEP Setting of ARDS
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators conducted a pilot study to compare the effect of Positive End Expiratory Pressure(PEEP) setting guide by lung electrical impedance tomography(EIT) and ARDS-net PEEP-FiO2 table on survival in subjects with mild/severe Acute Respiratory Distress Syndrome(ARDS).


Eligibility criteria: Inclusion:

1. acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)\<300 and PEEP \>5cmH2O
2. Body mass index \< =40
3. Written inform consent

Exclusion:

1. pregnant，intracranial hypertension
2. left ventricular dysfunction (EF\<25% )
3. Patients with end-stage conditions(death expected within 90 days)

Primary outcomes:
measure: survival
timeFrame: 28-day
measure: Arterial oxygenation
timeFrame: 72h
Secondary outcomes:
measure: length of ICU stay and mechanical ventilated day
timeFrame: 28days
measure: pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days;
timeFrame: 7days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
state: Beijing
Study officials:
affiliation: Department of Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
name: Yun Long, MD
role: STUDY_DIRECTOR
References:
citation: He H, Chi Y, Yang Y, Yuan S, Long Y, Zhao P, Frerichs I, Fu F, Moller K, Zhao Z. Early individualized positive end-expiratory pressure guided by electrical impedance tomography in acute respiratory distress syndrome: a randomized controlled clinical trial. Crit Care. 2021 Jun 30;25(1):230. doi: 10.1186/s13054-021-03645-y.
Clinical trial NCT02930798: Sun Protection Factor Assay (SPF Assay 203/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
Secondary outcomes:
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT04806698: Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia
Official title: Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia, Progressive
Children, Only
Lead sponsor: Menicon Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the long-term efficacy of the Menicon Z Night orthokeratology contact lens in controlling the progression of childhood myopia

Detailed description: This prospective, controlled, parallel, longitudinal study compared the axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group over a 7-year period.

Eligibility criteria: Inclusion Criteria:

* Be 6 to 12 years of age, both ages inclusive
* A low-to-moderate level of myopia (between -0.75 and -4.00 D) and of astigmatism (≤ 1.00 D)
* Neophyte contact lens wearer
* Be successfully fitted with spectacles or orthokeratology contact lenses
* Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye
* Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits
* White European ethnicity

Exclusion Criteria:

* Systemic or ocular disease affecting ocular health
* Use of any systemic or topical medications that could affect ocular physiology or contact lens performance
* Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated
* CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs
* Aphakic, amblyopic, and atopic individuals
* Refractive astigmatism ≥ ½ spherical refraction
* Previous contact lens wear

Primary outcomes:
measure: Axial length
timeFrame: Seven years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R, Sugimoto K. Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia. Curr Eye Res. 2017 May;42(5):713-720. doi: 10.1080/02713683.2016.1221979. Epub 2016 Oct 21.