louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00414180: Bupropion SR for Treating Smokeless Tobacco Use
Official title: Bupropion SR for Treating Smokeless Tobacco Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smokeless Tobacco
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: West Virginia University
First posted: 2006-12-21
Enrollment: 225
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: To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.

Detailed description: CONTEXT: No pharmacotherapies have been shown to increase long-term (\&#8805; 6 month) tobacco abstinence rates among smokeless tobacco (ST) users, although bupropion SR has demonstrated potential efficacy in pilot studies.

OBJECTIVE: To determine the efficacy and safety of bupropion SR for tobacco abstinence among ST users compared with placebo.

DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial conducted between August 2003 to May 2005 at two research centers with a 12-week treatment period and follow-up of smoking status to week 52.

INTERVENTION: Bupropion SR titrated to 150 mg twice daily or placebo for 12 weeks plus weekly behavioral interventions.

Main Outcome Measures: The primary endpoint was 7-day point-prevalence tobacco abstinence rate at week 12. Secondary outcomes included the prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* used ST daily for at least one year
* in good general health
* willing to complete all study procedures

Primary outcomes:
measure: 7-day point-prevalence tobacco abstinence rate at week 12
Secondary outcomes:
measure: prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Lowell C. Dale, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05451680: Negative-pressure Wound Therapy on Full-thickness Skin Grafts of the Lower Leg
Official title: A Randomized Study on the Effect of Negative-pressure Wound Therapy on Below-the-knee Skin Cancer Graft Reconstruction Complications
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin Tumor
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled study
Primary purpose: TREATMENT

Brief summary: This randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.

Detailed description: Annually, 12 000 skin cancers are diagnosed in Finland. This randomized controlled non-sponsored trial evaluate if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications. 60 patients over 18 years of age are included and randomly assigned to either the negative pressure-treatment group or the conventional treatment group. At the control appointment one-week postsurgery, graft take is documented as a primary outcome and any complications (necrosis, infection, hematoma/seroma) and adverse events (pain, skin reactions) as secondary outcomes. Adverse events are evaluated by a phone call 3 weeks postsurgery and based on medical records 3 months postsurgery.

Eligibility criteria: Inclusion Criteria:

* from referrals received by the Unit, or from patients undergoing follow-up who have skin cancer (basal cell carcinoma, squamous cell carcinoma or melanoma) or suspected skin cancer below the knee

Exclusion Criteria:

* Toe lesion, bleeding disorder, severe dementia, critical peripheralischemia, or skin disease that is expected to impair wound healing, such as pyoderma gangrenosum

Primary outcomes:
measure: Graft take
timeFrame: 3 months
Secondary outcomes:
measure: Adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS Iho- ja allergiasairaala
Study officials:
References:
Clinical trial NCT03445780: Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection
Official title: Comparison of Distraction Methods for Pain Relief of Trigger Finger Injection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Trigger Finger
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the best distraction mechanism during trigger finger injection in the outpatient setting. Temporary discomfort from the needle prick is highly feared by patients and is often accompanied by significant acute pain and distress during routine corticosteroid injection in the orthopedic outpatient setting. This study aims to examine 4 different distraction methods and their efficacy in reducing perceived pain, which will be evaluate using the VAS (visual analog pain score.) The three distraction methods will be ethyl chloride spray, adjacent pinch, ethyl chloride spray and pinch, and "screen" or looking away method.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Trigger Finger

Exclusion Criteria:

* Allergies to lidocaine, betamethasone, infection, pregnancy, 3 prior injection to the digit

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) Score
timeFrame: 1 Minute, 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Eitan Melamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01864980: Intra-operative Monitoring of Blood Loss
Official title: Monitoring of Intraoperative Blood Loss: Benefit of Continuous Noninvasive Haemoglobin Monitoring?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Undetected Intraoperative Blood Loss
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-05-30
Enrollment: 30
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: 30 adult patients scheduled for surgery associated with undetected, i.e., difficult to reliably monitor intraoperative blood loss

Brief summary: Certain types of surgery are associated with occult blood loss, which is hard to detect intraoperatively by intermittent conventional, invasive Hb concentration measurements using the clinical standard of Hb monitoring by satellite laboratory analysis (Hbsatlab). The investigators want to see whether continuous non-invasive transcutaneous Hb measurement using a finger sensor (SpHb), (a) reduces the total time (area under the curve, AUC) a patient's Hb is below a predetermined transfusion threshold (HbAUC) for administration of red blood cell concentrate (RBC), and (b) prevents a decrease in total oxygen delivery (DO2) possibly associated with transfusion below a critical haemoglobin concentration. Furthermore, the investigators want to study if SpHb monitoring changes the timing of RBC administration and reduces the need for intra- and post-operative RBC transfusion.


Eligibility criteria: Inclusion Criteria:

* Patients at the age of 18 years or older, planned for elective surgery at-risk for undetected blood loss.
* American Society of Anesthesiologists (ASA) classification I, II, III, IV

Exclusion Criteria:

* Patient refusal
* Emergency surgery

Primary outcomes:
measure: HbAUC
timeFrame: during operation
Secondary outcomes:
measure: blood transfusions
timeFrame: intra- and post operative up to 48h
Other outcomes:
measure: DO2
timeFrame: intraoperative
measure: serum concentrations of high-sensitive troponin T
timeFrame: post operative up to 48h
measure: serum concentrations of lactate
timeFrame: intra- and post operative up to 48h
measure: StO2
timeFrame: intraoperative
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University of groningen,University Medical Center Groningen
name: Michel M.R.F. Struys, Prof.dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01768780: Efficacy of Peripheral Nerve Stimulator in Assessing Sensory Nerve Block Level of Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Surgery-lower Leg Surgery
Keywords: spinal anesthesia
peripheral nerve stimulator
sensory block level
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Various methods are used to assess the level of anesthesia block after spinal anesthesia. Among them, ice cubes, alcohol swabs, and needles are commonly used in the clinical setting, but ice is limited by difficulties with management and transportation, and needle assessment has problems owing to the risk of pain, infection, and injury to the patient.

Hence, the alcohol swab is commonly used in practice. However, the absence of pain is more important in the surgical process, and assessing the pain block level is more feasible in practice than assessing the sensory nerve block level using the alcohol swab.

Therefore, it seems to be better to use the peripheral nerve stimulator for the accurate assessment of the pain block level. This has the advantage of continuous measurement of the block level, which can be used in a practical manner in conjunction with the surgical incision.

Hence, the author compared the conventional method using the alcohol swab with the use of the peripheral nerve stimulator to determine which method is more practical in the measurement of spinal anesthesia block level.


Eligibility criteria: Inclusion Criteria:

* The study subjects were adult patients, 20-65 years old, who were going to have orthopedic surgery on the infrapatellar area with spinal anesthesia planned and who fell under the American Society of Anesthesiologist physical status classifications of 1 or 2.

Exclusion Criteria:

* Patients who could not read or understand the consent materials or who had pregnancy, hypertension, diabetes, a defect in blood coagulation, cardiovascular disease, or administration of cardiovascular medications were excluded from the study.

Primary outcomes:
measure: Efficacy of peripheral nerve stimulator as checking sensory block level after spinal anesthesia
timeFrame: Changes of sensory block level at 5 minutes, 10 minutes, 15 minutes, 20 minutes after pinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT03482180: Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
Official title: A Multi-Center, Randomized, Double-Blind, Parallel Phase III Study to Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Calcium Monotherapy While LDL-C is Properly Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemias
Lead sponsor: Kuhnil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 215
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine variation rate of Non-HDL with KI1106 comparison Atorvastatin monotherapy.

Detailed description: Randomly assigned to two groups (KI1106 or Atorvastatin monotherapy) after 4 weeks run-in period and prescribed KI1106 or Atorvastatin for 8 weeks.

Eligibility criteria: Inclusion criteria:

* Screening Visit

  * Age: 20-80
  * High risk for cardiovascular disease according to NCEP APT III
  * TG≥300mg/dL and 160mg/dL\>LDL-C≥100mg/dL for subjects who were not taking statins for 4 weeks
  * 500mg/dL\>TG≥200mg/dL and LDL-C\<110mg/dL for subjects who were taking statins for 4 weeks
* Baseline Visit

  * 500mg/dL\>TG≥200mg/dL
  * LDL-C\<110mg/dL
  * Reduction of LDL-C comparing screening visit

Exclusion criteria:

* The patient has histories of acute artery disease within 3 months
* The patient has histories of operation revasculariation or aneurysm within 6 months
* The patient has histories of unexplained myalgia or diagnosed myalgia or rhabdomyolysis
* The patient has histories of effect able disease to the procedure and clinical trial result

Primary outcomes:
measure: Variation rate of Non HDL-C
timeFrame: 8 weeks
Secondary outcomes:
measure: Variation rate of TG
timeFrame: 4 weeks, 8 weeks
measure: Variation rate of Non HDL-C
timeFrame: 4 weeks
measure: Variation rate of TC
timeFrame: 4 weeks, 8 weeks
measure: Variation rate of LDL-C
timeFrame: 4 weeks, 8 weeks
measure: Variation rate of VLDL-C
timeFrame: 4 weeks, 8 weeks
measure: Variation rate of Apo A-I
timeFrame: 4 weeks, 8 weeks
measure: Variation rate of Apo B
timeFrame: 4 weeks, 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: manager
name: kyungshun Shin, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT04788680: Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function
Official title: Assessment of the Effects of Non-calorie Sweeteners on Gut Barrier and Inflammatory Markers Compared to Those of Sugars in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Endotoxemia
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants receive all interventional diets
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to determine the effect of non-nutritive sweeteners on intestinal barrier function and inflammatory markers in healthy subjects in comparison to mono- and disaccharides.

Detailed description: In the intervention study normal weight participants will receive beverages sweetened with non-nutritive sweeteners, mono- and disaccharides for a defined number of days. Before and after intervention parameters of intestinal barrier function will be assessed.

Eligibility criteria: Inclusion Criteria:

* No known history of metabolic diseases/disorders
* BMI \<25 kg/m2

Exclusion Criteria:

* Food allergies or intolerances (esp. fructose intolerance and malabsorption)
* Chronic disease of the gastrointestinal tract
* Renal insufficiency
* Taking drugs affecting lipid or glucose metabolism

Primary outcomes:
measure: Changes in parameters of intestinal barrier function.
timeFrame: 1 week
measure: Changes in inflammatory markers.
timeFrame: 1 week
Secondary outcomes:
measure: Changes in blood pressure.
timeFrame: 1 week
measure: Changes in markers for glucose metabolism.
timeFrame: 1 week
measure: Changes in markers for glucose metabolism.
timeFrame: 1 week
measure: Changes in blood lipid levels.
timeFrame: 1 week
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
References:
Clinical trial NCT06780280: Walking With Overground Robotic Exoskeletons to Improve Arrousal in Individuals With Disorders of Consciousness
Official title: Walking With Overground Robotic Exoskeletons to Improve Arrousal in Individuals With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Traumatic Brain Injuries
Keywords: TBI, disorders of consciousness, walking, exoskeletons
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 25
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: This proposed study will examine a walking intervention to promote changes in conscious state in individuals with disorders of consciousness (DoC) due to acquired brain injury (ABI). Recent practice guidelines highlight the need to develop interventions to arouse patients with DoC, as current treatment options are scarce with limited to low-quality pharmaceutical and electrical stimulation approaches to improve outcomes. New data indicates patients with chronic DoC may benefit from therapeutic intervention prioritizing repeated multimodal sensory (i.e., simultaneous vestibular, proprioceptive, and visual) input, but likely not attain comparable functional recovery to those who demonstrate early command following ability. Interventions activating pathways of the cerebral consciousness network may leverage a substrate for recovery. We hypothesize that walking in an overground robotic exoskeleton (ORE) is safe, feasible, and will simultaneously stimulate endogenous cognitive and automatic pathways associated with walking5 to promote changes in behavioral performance in individuals with DoC.

Detailed description: The objective of this study is to evaluate the safety, feasibility and tolerability of using ORE therapy with individuals who meet criteria for DoC during inpatient rehabilitation while evaluating changes in behavioral performance, neurophysiology, and physiologic response to training. DoC numbers are very small so our goal is to gather this pilot data to support a future multi-site efficacy study with other TBIMS Center partners.

Eligibility criteria: Inclusion Criteria:

* Individuals with DOC who are receiving inpatient rehabilitation

Exclusion Criteria:

-

Primary outcomes:
measure: Adverse Events and feasibility
timeFrame: four weeks
Secondary outcomes:
measure: Coma Recovery Scale-Revised
timeFrame: four weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02607280: DS-5565 Phase III Study for Renal Impairment in Japanese Subjects
Official title: A JAPANESE, PHASE 3, OPEN-LABEL, 14-WEEK STUDY OF DS-5565 IN PATIENTS WITH PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY WITH RENAL IMPAIRMENT OR POST-HERPETIC NEURALGIA WITH RENAL IMPAIRMENT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Peripheral Neuropathic Pain
Post-herpetic Neuralgia
Keywords: Diabetic peripheral neuropathic pain
post-herpetic neuralgia
renal impairment
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: CMIC Co, Ltd. Japan
First posted: 2015-11-18
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigate the safety and efficacy of DS-5565 in Japanese subjects with Diabetic Peripheral Neuropathic Pain (DPNP) with renal impairment or Post-Herpetic Neuralgia (PHN) with renal impairment.

Detailed description: The primary objective is the safety and tolerability of DS-5565 in Japanese subjects with moderate to severe renal impairment.

Eligibility criteria: Inclusion Criteria:

* At screening, creatinine clearance (using the Cockcroft-Gault equation): 15-59 mL/min
* At screening, a pain scale of ≥ 40 mm
* Type 1 or type 2 diabetes mellitus at screening (for patients with diabetic peripheral neuropathic pain DPNP only)-. Painful distal symmetric polyneuropathy (for patients with DPNP only)
* post-herpetic neuralgia PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening (for patients with PHN only)

Exclusion Criteria:

* HbA1c (National Glycohemoglobin Standardization Program) \> 10.0% (for patients with DPNP only)
* Previous use of neurolytic block (for patients with PHN only)

Primary outcomes:
measure: Change From Baseline in Average Daily Pain Score (ADPS) at Each Week
timeFrame: Baseline to Week 14
Secondary outcomes:
Other outcomes:
Locations:
city: Kamakura-shi
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References:
citation: Baba M, Takatsuna H, Matsui N, Ohwada S. Mirogabalin in Japanese Patients with Renal Impairment and Pain Associated with Diabetic Peripheral Neuropathy or Post-Herpetic Neuralgia: A Phase III, Open-Label, 14-Week Study. J Pain Res. 2020 Jul 17;13:1811-1821. doi: 10.2147/JPR.S255345. eCollection 2020.