louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01149135: Low Intensity 'Blue Light' Treatment of Seasonal Affective Disorder
Official title: Randomized and Controlled Study of the Effects of Low Intensity 'Blue Light'in the Treatment of Seasonal Affective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Affective Disorder
Keywords: Seasonal Affective Disorder
phototherapy
circadian rhythms
blue enriched light
melanopsin
low intensity
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2010-06-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the most frequently investigated hypothesis of the pathophysiology underlying Seasonal Affective Disorder(SAD) or so called winter depression is a disturbance of circadian rhythms. Since the circadian system is especially sensitive for the blue portion of the light spectrum, a new light therapy device with more blue light (blue enriched polychromatic light) was tested for its efficacy to treat SAD. In chronobiological terms this light is hypothesized to be more potent in inducing non-visual effects. In the present study fluorescent tubes that emit a high portion of short wavelength light on top of the normal wavelengths are tested for its superiority in treating SAD. This blue-enriched light (colour temperature 17000 ºK) is compared to standard light treatment (5000 º K) in SAD patients.,In a earlier study it was shown that the therapeutic effect of blue enriched light were equal to standard light treatment using light in both conditions with an intensity of 10 000 lux. In the present study, blue enriched light with an intensity of 750 lux was used, because of the possible saturation effect in the former study. The investigators hypothesise that blue- enriched light with a low intensity improve the therapeutic effects of light treatment leading to a higher response or the same response in a shorter time schedule compared to standard light treatment.


Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Diagnose of Seasonal Affective Disorder, winter type according to DSM-IV SIGH SAD rating Higher then or equal to 18 on day 1
* No other treatments for mood disorder during the study
* Stay in the Netherlands during the study

Exclusion Criteria:

* Other axis-I disorders according to the DSM-IV
* Acute suicide risk
* Use of psychotropic drugs or photosensitizing drugs
* No other treatments for mood disorder during the study
* Diabetes or epilepsy
* Regular shift work

Primary outcomes:
measure: SIGH-SAD
timeFrame: weekly
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02098135: ArmeoSenso - Home Therapy and Assessment for Patients With Arm Impairments Based on Wearable Movement Sensors
Official title: Phase 1 Study of a Home Therapy and Assessment for Patients With Arm Impairments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spinal Cord Injury
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 14
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: stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality, interia sensor,

* Trial with medical device


Eligibility criteria: Inclusion criteria:

* 18 years old
* Stroke or spinal cord injury in prehistory
* Motor deficits of the upper limb (s)
* Lifting the paretic arm against gravity possible AND
* Minimum amount of movement in the horizontal plane of 20 x 20 cm
* Ability and willingness to participate in the study

Exclusion criteria:

* Severe aphasia
* Severe dementia
* Severe depression
* Relevant restriction of vision, which can not be compensated by aids (eg hemianopia)

Primary outcomes:
measure: Numbers of participant which can perform the ArmeoSenso - training.
timeFrame: 42 days
Secondary outcomes:
measure: Improvement in the Arm function
timeFrame: 42 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Divison of Neurology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Neurology
name: Andreas Luft, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wittmann F, Held JP, Lambercy O, Starkey ML, Curt A, Hover R, Gassert R, Luft AR, Gonzenbach RR. Self-directed arm therapy at home after stroke with a sensor-based virtual reality training system. J Neuroeng Rehabil. 2016 Aug 11;13(1):75. doi: 10.1186/s12984-016-0182-1.
Clinical trial NCT00586235: Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization
Official title: Registration and Fusion of Real-Time Ultrasound With CT for Lesion Localization and Characterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney or Liver Tumors
Keywords: Fusion
Ultrasound
Computed tomography
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Siemens Medical Solutions
First posted: 2008-01-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with kidney or liver tumors

Brief summary: Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization.

Detailed description: Acquire CT data and US and transducer position data (magnetic sensor system) of focal hepatic or renal lesions to serve as sample data sets for fusion algorithm development and subsequent optimization.

Optimize image fusion algorithms for use in goal. Develop registration algorithms that result in maximal lesional overlap with a clinically relevant difference in an epicenter location of ≤ 2 cm for lesional identification and, ultimately ≤ 0.3 cm for interventional procedures.

Eligibility criteria: Inclusion Criteria:

* Focal lesion involving the liver or kidney bases on CT or MRI Imaging
* Liver lesion size \>5 mm and \<5 cm in diameter or renal lesion size is \>5 mm and \<4 cm in diameter
* Age \>18 years old
* Patient has provided written informed consent

Exclusion Criteria:

* Patient with cardiac pacemaker or defibrillator
* Pregnant or lactating woman
* Patient with severe IV contrast allergy (previous reaction to IV contrast not mitigated by appropriate premedication)
* Patient unable to give informed consent

Primary outcomes:
measure: Primary Endpoints: Global Fiducial Registration Error (FRE) of real-time US and fused CT images, Target Registration Error (TRE) and distance between lesional epicenters of real-time US and fused CT images.
timeFrame: 2 years
Secondary outcomes:
measure: Secondary Endpoint: Number of coregistration attempts to realize separation of lesional epicenters of real-time US and fused CT images of ≤2 cm and the number of attempts to realize a separation of ≤0.3 cm.
timeFrame: 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew R. Callstrom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03373435: Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Official title: A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postbariatric Hypoglycemia
Lead sponsor: Eiger BioPharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-12-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This clinical study will evaluate whether taking an investigational drug called exendin 9-39 is safe, well-tolerated, and helps to prevent low blood sugar in people who have had bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).

Detailed description: This is a Phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study in patients with refractory PBH.

Participants will be randomized and assigned in a 1:1 ratio to one of two treatment arms. All participants will receive 2 dosing regimens of exendin 9-39 and matching placebo self-administered via subcutaneous (SC) injection.

Participants will undergo in-clinic mixed meal tolerance test (MMTT) provocation with concomitant blood draws and symptom assessments.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of up to 40 kg/m2
* Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior
* Diagnosis of PBH
* At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia

Exclusion Criteria:

* Other cause of endogenous hyperinsulinism other than PBH
* Metabolic or bariatric surgical procedure other than RYGB
* History of non-RYGB upper GI surgery
* Use of agents that may interfere with glucose metabolism

Primary outcomes:
measure: Postprandial Glucose Nadir
timeFrame: 3 hours following a liquid meal
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Durham
country: United States
facility: Duke Early Phase Clinical Research
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Eiger BioPharmaceuticals, Inc
name: Colleen Craig, MD
role: STUDY_DIRECTOR
References:
citation: Craig CM, Lawler HM, Lee CJE, Tan M, Davis DB, Tong J, Glodowski M, Rogowitz E, Karaman R, McLaughlin TL, Porter L. PREVENT: A Randomized, Placebo-controlled Crossover Trial of Avexitide for Treatment of Postbariatric Hypoglycemia. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3235-e3248. doi: 10.1210/clinem/dgab103.
Clinical trial NCT04744935: Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
Official title: Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Basal Cell Carcinoma
Superficial Basal Cell Carcinoma
Nodular Basal Cell Carcinoma
Keywords: Basal cell carcinoma
Superficial basal cell carcinoma
Nodular basal cell carcinoma
Optical coherence tomography
OCT
Laser
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Optical coherence tomography guided laser treatment of basal cell carcinoma

Detailed description: The purpose of this pilot study is to examine the treatment basal cell carcinoma (BCC) with laser technology under the guidance of optical coherence tomography imaging (OCT). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC. Laser treatment of BCC has limited precedent in the literature, but the addition of OCT has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. We propose to use OCT imaging to guide the laser treatment to achieve optimal efficacy with minimized side-effects.

Eligibility criteria: Inclusion Criteria:

* Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative
* Ages 18 and older
* Seeks and is scheduled for treatment of a BCC previously confirmed with biopsy

Exclusion Criteria:

Any of the following will exclude participation in the study:

* Inability to understand and/or carry out instructions
* Patients with a BCC lesion that requires excision. This would include relatively large lesions (\>2.5 cm diameter), lesions that penetrate deep into the skin beyond the depth of the OCT image capture, high risk lesions as defined by the American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
* Patients with periocular BCCs which might expose the patient to risk of damage to eyes from the laser.
* BCCs on legs due to their tendency towards poor wound healing.
* Pregnancy
* Patients unable to follow-up for the full 12 months.

Primary outcomes:
measure: Complete clearance of BCC lesion
timeFrame: 1 year
Secondary outcomes:
measure: Cosmetic outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI Health Gottschalk Medical Plaza
state: California
Study officials:
affiliation: University of California, Irvine
name: Christopher Zachary, MBBS FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01608035: Sciatic Perineural Versus Stump Catheter for Below Knee Amputation
Official title: Ultrasound Guided Sciatic Perineural Catheter vs Surgically Placed Sciatic Stump Catheter for Below Knee Amputations: Is There A Difference in Patient Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Ischemia
Phantom Limb Pain
Vascular Disease
Chronic Pain
Keywords: sciatic catheter
stump catheter
below knee amputation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 29
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine if pre-operative placement of the continuous peripheral nerve block by an anesthesiologist using ultrasound technology is more effective than a continuous peripheral nerve block placed during the surgery by a surgeon for patients undergoing a limb amputation

Detailed description: We wish to determine the most effective site for the continuous infusion of local anesthetic for patients undergoing amputation of a limb. The information we obtain from this study will help to decide the most effective manner to provide pain relief for patients in the future. The primary outcome of interest is post-operative pain relief as measured by the amount of pain-relieving medications (opioids) required by patients prior to discharge home. The secondary outcomes of interest will be pain-relieving medications (opioid) requirements during the operation, length of stay in the hospital, time required for mobility, and patient satisfaction- measured by a survey given while in hospital and 3 months later.

Eligibility criteria: Inclusion Criteria:

* undergoing a below knee amputation
* 16 years of age or older
* regional anesthetic will be used as part of the surgery

Exclusion Criteria:

* pregnant
* allergic to local anesthetic or ultrasound jelly
* a contraindication to having a peripheral nerve block catheter

Primary outcomes:
measure: Opioid consumption
timeFrame: Post-op day 0-7
Secondary outcomes:
measure: pain score
timeFrame: Post-op day 0-7 and at 3months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Jason Wilson
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Andrew N Sawka, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05797935: Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy
Official title: Evaluation of Changes in Pancreatic Fat Content Using Advanced MR Sequences in Diabetics on Dapagliflozin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatic Lipomatosis
Keywords: Dapagliflozin
Pancreatic fat
MRI
Diabetes
MRS
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2023-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Control Trial
Primary purpose: OTHER

Brief summary: The study aimed to assess changes in pancreatic fat content in people with diabetes on dapagliflozin (SGLT2 inhibitor) and beta cell function.

Detailed description: The study assessed and estimated the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks.

The investigators even estimated the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat (PDFF and MR Spectroscopy)

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years,
2. Hba1c 7-11%,
3. Renal function (MDRD) \> 30 ml/min, on glucose-lowering therapy {metformin, sulfonylureas, glinides, dipeptidyl peptidase-4 (DPP-4) inhibitors, or basal insulin} at a stable dose for at least 3 months.

Exclusion Criteria:

1. Uncontrolled hyperglycemia at screening (fasting blood glucose FBG ≥ 240 mg/dL).
2. Diabetes other than type 2 diabetes
3. Age younger than 18 years.
4. Pregnant patients or lactating.
5. Patients who refuse to give consent to be enrolled in the study.
6. Any contraindication to magnetic resonance imaging.
7. More than 5% total body weight loss within the last month.
8. Patients with moderate or severe renal impairment
9. Any contraindication to SGLT2i
10. Prior SGLT2i within the past 3 months

Primary outcomes:
measure: To assess and estimate the difference in pancreatic fat content in the patients of Type 2 Diabetes Mellitus at baseline and after taking dapagliflozin for 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: To estimate the correlation between two advanced MR techniques commonly used for quantification of pancreatic fat(PDFF and MR Spectroscopy)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Deptt of Endocrinology
Study officials:
References:
Clinical trial NCT03374735: First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study
Official title: Prospective, Multicenter, Non-controlled Study, Evaluating Safety and Performance of SETALUM™ Sealant as an add-on to Suture in Vascular Reconstruction in Patients Undergoing Carotid Enlargement Procedure Using an ePTFE Patch.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Lead sponsor: Gecko Biomedical
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.


Eligibility criteria: Inclusion Criteria:

* ≥18 years old;
* Surgical placement of an ePTFE patch for large carotid repair;
* Written informed consent given by the patient.

Exclusion Criteria:

* Known or suspected allergy or sensitivity to any test materials or reagents;
* Concomitant intake of immunosuppressive medications;
* Prior radiation therapy to the operating field;
* Previous surgical procedure performed on the same operating field;
* Current or recent (\<3months) participation in another investigational study;
* Refusal to receive blood products;
* Pregnant or breast-feeding women

Primary outcomes:
measure: Elapsed time from clamp release to hemostasis at the suture line
timeFrame: During surgical procedure
measure: All adverse events occurring from the surgical procedure to Week 12
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02325635: A Prospective Trial of an Endoscopic Quality Improvement Project
Official title: A Prospective Randomized Controlled Trial of an Endoscopic Quality Improvement Project-2 (EQUIP-2) to Improve Adenoma Detection in Screening and Surveillance Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Polyps
Keywords: Adenoma Detection
Adenoma Prediction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: GI Quality Improvement Consortium
First posted: 2014-12-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Randomized prospective multi-site validation study.

Detailed description: GI practice sites that have recently agreed to participate in the GIQuIC program will be randomized on a site-basis, to the EQUIP intervention or control.

Baseline ADR and polyp/surveillance predication accuracy will be collected for approximately 3 months.

Sites randomized to the EQUIP intervention will undergo face-to-face training by a study investigator, followed by active monitoring and feedback.

Control sites will not receive supplemental training and will be monitored by with no feedback. After completion of the study all sites will be offered the intervention (as is standard feedback in GIQuIC ).

Eligibility criteria: Inclusion Criteria:

* Endoscopy centers that are new to GIQuIC and have not yet received training
* All endoscopists performing screening and surveillance colonoscopy at the participating center will be invited to participate

Exclusion Criteria:

* Cases that involve acute indications such as bleeding and active colitis will not be included in data pool
* Patients with a family or personal history of a polyposis syndrome or with a personal history of inflammatory bowel disease will also be excluded
* Procedures that are deemed incomplete will be excluded
* Patients with surgically altered anatomy (i.e. prior colectomy) and with poor bowel preparation (Boston bowel preparation score \<5, or inadequate to exclude polyps \>5mm) will be excluded

Primary outcomes:
measure: Change in adenoma detection rates.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael Wallace, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wallace MB, Crook JE, Thomas CS, Staggs E, Parker L, Rex DK. Effect of an endoscopic quality improvement program on adenoma detection rates: a multicenter cluster-randomized controlled trial in a clinical practice setting (EQUIP-3). Gastrointest Endosc. 2017 Mar;85(3):538-545.e4. doi: 10.1016/j.gie.2016.07.042. Epub 2016 Jul 26.