louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00785382: Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
Official title: A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Pain, Pregabalin, Lyrica, Breast surgery
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2008-11-05
Enrollment: 62
Sex: FEMALE
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. Do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS and a greater QoR score in the first 24 hours after their surgery than those women who received placebo?


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesia physical status class I \& II
2. Age ¬\< 65 years
3. English-speaking
4. Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)

Exclusion Criteria:

1. Known or suspected allergy, sensitivity, or contraindication to pregabalin
2. Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
3. Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
4. History of a seizure disorder
5. Pregnancy
6. Current pre-operative therapy with pregabalin, gabapentin, or any opioid
7. Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection
8. CrCl \< 60 ml/min \[CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))\]

Primary outcomes:
measure: The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.
timeFrame: 24 hours
Secondary outcomes:
measure: NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
timeFrame: 48 hours
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK
name: Ronald B George, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06836882: Effect of Cavity Disinfectants on Post Operative Pain & Success of Partial Caries Removal
Official title: The Effect of Sodium Hypochlorite and Chlorhexidine as Cavity Disinfectants on the Post Operative Pain and Success of Partial Caries Removal in Deep Carious Lesion With Moderate Pulpitis in Permanent Teeth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulp Disease, Dental
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 159
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 investigate The Effect of Sodium hypochlorite and Chlorhexidine as cavity Disinfectants on the post operative pain and Success of Partial Caries Removal in deep carious lesion with moderate pulpitis in permanent teeth

Detailed description: Study Design: Intervention Research Question : To investigate whether the use of 2% chlorhexidine and 5.25% sodium hypochlorite can improve the clinical and radiographic outcome after partial caries removal in deep carious lesion P (Population) - Mature Permanent Mandibular molars with deep carious lesion involving inner two third of dentine I (Intervention) - - Partial caries removal using 2% chlorhexidine/5.25% sodium hypochlorite as cavity disinfectant..

C (Comparison) - Partial caries removal using saline as cavity disinfectant. O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.

-To assess incidence and reduction in pain post operatively at every 24 hours till 1 week.

Eligibility criteria: Inclusion Criteria:

1. The patient should be ≥18 years of age.
2. Restorable mature permanent 1st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement)
3. Tooth should give positive response to pulp sensibility testing.
4. Clinical diagnosis of moderate pulpitis.
5. Radiographic finding of periapical index (PAI) score ≤2.
6. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit)

Exclusion Criteria:

Presence of vertical root fracture Presence of root perforations ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists) Presence of root resorption Combined endodontic-periodontic lesions. Pregnancy

Primary outcomes:
measure: Clinical success criteria
timeFrame: 12 months
measure: Radiographic success criteria
timeFrame: 12mnths
Secondary outcomes:
measure: Pain assesment
timeFrame: 7 days
Other outcomes:
Locations:
city: Haryana
country: India
facility: Pgids Rohtak
Study officials:
affiliation: PGIDS Rohtak
name: Dr Sanjay Tewari, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01970982: Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting
Official title: A Controlled, 3-arm Parallel Group Study to Demonstrate Reduction in Exposure to Smoke Constituents in Healthy Smokers Switching to THS 2.2 or to Smoking Abstinence, Compared to Conventional Cigarettes for 5 Days in Confinement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Candidate modified risk tobacco product
Conventional cigarette
Reduced exposure
HPHCs
Confinement
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 166
Sex: ALL
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).


Eligibility criteria: Inclusion Criteria:

* Subject is Japanese.
* Smoking, healthy subject as judged by the Investigator.
* Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks, based on self reporting.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
* For women: Subject is pregnant or is breast feeding.
* For women: Subject does not agree to use an acceptable method of effective contraception.

Primary outcomes:
measure: Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)
timeFrame: 5 days
measure: Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
timeFrame: 5 days
measure: Concentration of S-phenylmercapturic Acid (S-PMA)
timeFrame: 5 days
measure: Levels of Carboxyhemoglobin (COHb)
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Higashi Shinjuku Clinic, Daito Building, 1-11-3, Okubo, Shinjuku-ku
Study officials:
affiliation: Higashi Shinjuku Clinic
name: Takuya Kunito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01085682: Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program
Official title: Application and Effectiveness Analysis of Internet-based Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Diabetes prevention
Lifestyle modification
Obesity
Impaired glucose tolerance
Diet
Physical activity
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2010-03-12
Enrollment: 59
Sex: ALL
Minimum age (years): 30
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to test the possibility of preventing or delaying the development of type 2 diabetes in individuals with impaired glucose tolerance and elevated fasting plasma glucose concentrations by internet-based diabetes prevention program.

Detailed description: Diabetes is common and rapidly increasing, because of obesity, unhealthy eating habits, and physical inactivity in Korea. Many studies reported that lifestyle modification related in the primary prevention of diabetes in multiethnic populations. The aim of this study is to determine whether internet-based interventions in those at high risk may delay the development of type 2 diabetes mellitus, and thereby reduce the incidence of cardiovascular diseases and strokes in Korean populations. In January 2008, participant recruitment began in Chung-ju city, a rural area in Korea. The subjects with impaired glucose tolerance or elevated fasting plasma glucose concentrations were selected from initial screening and then randomized to either a control or intensive lifestyle group to carry out intervention over 4 years. The primary outcome of this study is the development of diabetes by ADA criteria. To confirm the onset of diabetes, all subjects have an OGTT at the interim 6-month and each annual visit. Also, systematic evaluation examination will be done at the same time. The proportion of subjects developing diabetes in each group and the factors relating the progression will be estimated using statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Age of 30-69 years
* BMI ≥ 20 kg/m2
* Impaired glucose tolerance :

  2h postprandial glucose (75 g OGTT) 140-199 mg/dl or Impaired fasting glucose : Fasting plasma glucose 110-125 mg/dl

Exclusion Criteria:

* Diabetes at baseline
* Cardiovascular disease, cancer requiring treatment in the past 5 years, renal disease
* Unable to communicate with clinic staff, Pregnancy and childbearing

Primary outcomes:
measure: Incidence of Type 2 Diabetes Mellitus
timeFrame: one year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Chung-ju
country: Korea, Republic of
facility: Chung-ju health care center
state: Chungchungbook-do
Study officials:
affiliation: Kangnam St.Mary's hospital
name: Kun-Ho Yoon, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05691582: Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
Official title: Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rett Syndrome
Keywords: Virtual Reality
Rett Syndrome
walk
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: Associazione Italiana Rett (AIRett) O.n.l.u.s.
First posted: 2023-01-20
Enrollment: 9
Sex: FEMALE
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The main goal of this study is to investigate the tolerability to the use of the GRAIL system in subjects affected by Rett syndrome, particularly referred to:

1. Grail environment (training in dark conditions, interaction with wide and surrounding screen, positioning over the treadmill);
2. time to prepare a set of body marker in order to execute a gait analysis;
3. walking activity over treadmill, with immersive virtual reality;
4. proprioceptive stimulatione provided by the GRAIL platform;
5. cognitive-attentive span time to the activity proposed. The secondary goal is to understand if a training that avail of treadmill and virtual reality would be useful in the future in improving gait characteristics in subjects affected by Rett syndrome


Eligibility criteria: Inclusion Criteria:

* subjects affected by Rett Syndrome that are able to walk with hands support (corresponding to a score ranging from 1 to 3 in item 8 of Rett Syndrome Gross Motor Scale)

Exclusion Criteria:

* subjects unable to walk and with a complete incapacity to undestand verbal directions

Primary outcomes:
measure: Total score on the Suitability Evaluation Questionnaire (SEQ)
timeFrame: immediately after the treatment
Secondary outcomes:
measure: Gait analysis spatial parameters: temporal parameters in seconds and kinematics in degrees
timeFrame: immediately after the treatment
measure: Happiness index
timeFrame: immediately after the treatment
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea
state: Lecco
Study officials:
References:
Clinical trial NCT03332082: A Commercial Available Tooth Positioner for the Treatment of Simple Orthodontic Relapse
Official title: A Clinical Trial on the Use of a Commercial Available Tooth Positioner for the Treatment of Simple Orthodontic Relapse
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Orthodontics
Orthodontic Appliance
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 20 patients will be recruited and treated with a commercially available tooth positioner. The results will be compared with the other group from previously treated patients who were in the alignment phase of Orthodontics.
Primary purpose: TREATMENT

Brief summary: Orthodontic relapse occurs in almost 80% of Orthodontic Treatment. The only prevention to phenomenon is the use of fixed retainers or life time active retention. Unfortunately, patients do not comply and after a year of treatment, many stop wearing their retainers and Orthodontic relapse occurs.

The aim of this project is to prospectively analyze the treatment result of consecutive treated patients who have had active orthodontic relapse. 20 patients will be recruited through advertisement to the Department of Orthodontics at the University of Alabama at Birmingham (UAB). The sample will comprise of 20 patients with Class I malocclusions. The records to be collected will comprise of clinical pictures and pre and post study casts. The 3D study casts will be evaluated using the Little's Index. The results will be analyzed with the paired t-test and ANOVA, using the Statistical Analysis System (SAS/STAT®) software.


Eligibility criteria: Inclusion Criteria:

1. Permanent dentition
2. Class I malocclusion with crowding or spacing of less than 6 mm for mandibular or maxillary incisors, lower number 1's through 3's
3. Predicted compliance with device use, as determined by the investigator orthodontist
4. Good oral hygiene, as determined by the investigator orthodontist
5. At least average intelligence, as determined by investigator orthodontist

Exclusion Criteria:

1. Any medical or dental condition that in the opinion of the investigator could impact study results during the expected length of the study
2. Patient is currently using any investigational drug or any other investigational device
3. Patient plans to relocate or move within six months of enrollment
4. Allergic to acetaminophen (use of aspirin or non-steroidal anti-inflammatory drugs is excluded for patients while on the study)
5. Use of bisphosphonates, such as osteoporosis drugs, during the study
6. Pregnancy

Primary outcomes:
measure: The Little's Index
timeFrame: Movement will be recorded by capturing the start and end point of the 6 anterior teeth before and at the completion of the treatment respectively. The duration of the treatment will be up to 10 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00001782: Areas of Brain Responsible for Understanding American Sign Language
Official title: Hemispheric Lateralization of Language Receptive Function in the Deaf and in Hearing Individuals Who Learned ASL as First Language
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Mapping
Deafness
Healthy
Keywords: Deafness
Hemisphere Dominance
Language
Plasticity
Speech
rTMS
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: The human brain is made up of two halves called hemispheres. Each half of the brain is responsible for processing different kinds of information. Previous neuroimaging studies have shown that both the right and left hemispheres are involved when processing information given in American Sign Language (ASL). However, the study also showed that when processing spoken language, the left hemisphere was mostly involved.

Researchers would like to find out more about how the brain processes American Sign Language (ASL). This study is designed to determine if the right hemisphere is necessary for normal understanding of ASL.

Detailed description: The purpose of this protocol is to determine if the right hemisphere activation associated with perception of American Sign Language (ASL) in deaf subjects and in normal hearing individuals raised by deaf parents (who learned ASL before written English) is necessary for appropriate understanding of ASL.

Eligibility criteria: Subject age between 18 and 65 years.

Adult hearing offsprings of deaf parents.

Congenitally deaf individuals.

Intact hearing volunteers.

No subjects with personal or family history of seizures or other neurological or demyelinating disorders.

No pregnant women tested after urine pregnancy test.

No subjects with severe coronary disease.

No subjects with metal in the cranium except mouth.

No subjects with intracardiac lines and implanted medication pumps.

No subjects with increased intracranial pressure as evaluated by clinical means.

No subjects with cardiac pacemakers.

No subjects with an intake of neuroleptics.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Neurological Disorders and Stroke (NINDS)
state: Maryland
Study officials:
References:
citation: Neville HJ, Bavelier D, Corina D, Rauschecker J, Karni A, Lalwani A, Braun A, Clark V, Jezzard P, Turner R. Cerebral organization for language in deaf and hearing subjects: biological constraints and effects of experience. Proc Natl Acad Sci U S A. 1998 Feb 3;95(3):922-9. doi: 10.1073/pnas.95.3.922.
citation: Cohen LG, Bandinelli S, Sato S, Kufta C, Hallett M. Attenuation in detection of somatosensory stimuli by transcranial magnetic stimulation. Electroencephalogr Clin Neurophysiol. 1991 Oct;81(5):366-76. doi: 10.1016/0168-5597(91)90026-t.
Clinical trial NCT04704882: A Modified Omental Patch Work Decreases Pancreatic Fistula After Lpd
Official title: A Modified Omental Patch Work Decreases Pancreatic Fistula After Laparoscopic Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Omental Patch
Laparoscopic Pancreaticoduodenectomy
Pancreatic Fistula
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pancreaticoduodenecotmy(PD) is considered as the standard procedure for peri-amplullary or pancreatic head tumors. Laparoscopic pancreaticoduodenctomy(LPD) has been reported with minimal invasive advantages, such as small incision, less blood loss, less pain, et al. Further, some trials showed LPD got less morbidity and shorter length of stay. Pancreatic fistula is the major complication for pancreaticodupdenectomy and associated with numerous serious complications, suffering reoperation or sometimes death. The reported rate was 10% to 55%. A lot of modified procedure have been proposed to reduce pancreatic fistula. Omental flaps around anastomosis have been used to prevent post pancreaticoduodenectomy fistula or hemorrhage. However, the outcomes are controversy. A modified omental patch work has been used during LPD and the initial outcomes are good. This is a pilot study to evaluate the function of the modified omental patch work on decreasing the pancreatic fistula.


Eligibility criteria: Inclusion Criteria:

1. . Disease of periampullary or pancreatic head tumor
2. . Age: 18 years or older
3. Distant metastases are not diagnosed preoperatively.
4. . Patients who can provide written informed consent

Exclusion Criteria:

1. . Patients with severe organ disease such as cardiac disease,respiratory illness
2. . Patients with extended LPD or vessels reconstruction
3. Patients with conversion to laparotomy
4. . Patients with pregnancy

Primary outcomes:
measure: pancreatic fistula
timeFrame: 90 days
Secondary outcomes:
measure: morbidity
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
measure: Postoperative hospital stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People'S Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT04953182: Pain Modality Treatment After Hemorrhoidectomy
Official title: Around the Clock Pain Treatment Modality Offer Better Pain Control and Less Opiates Drugs Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Acute
Pain, Procedural
Keywords: Pain killers
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 5335
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that underwent elective hemorrhoidectomy

Brief summary: Hemorrhoidectomy is one of the operations that causes the greatest intensity of pain. Treatment of postoperative pain is essential for the well-being of the patient. Long-term use of opioids and different drugs can have unintended consequences.

The objective is to corroborate which pain treatment modality is better in patients after hemorrhoidectomy.

Detailed description: Patients who have undergone a hemorrhoidectomy are included in the study, the pain treatment modality is conceived by the treating surgeon or anesthesiologist. The first modality is to administer pain killers on-demand depending on visual analog scales of pain and the second modality to give pain killers on determined hours.

Eligibility criteria: Inclusion Criteria:

Elective surgery for hemorrhoids

Exclusion Criteria:

Mental retardation Incapacitated patient Under 18 years old

Primary outcomes:
measure: Pain medition
timeFrame: Immediately after the intervention/procedure/surgery
measure: Drugs Administred
timeFrame: Immediately after the intervention/procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assuta Medical Center
name: Sergio G Susmallian, MD
role: PRINCIPAL_INVESTIGATOR
References: