louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01685970: Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy
Official title: Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colonoscopy
Keywords: Bowel preparation
colonoscopy
polyethylene glycol
picosulfate
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2012-09-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG.

The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.

Detailed description: Split-dose PEG (4L) regimens is a standard regimen for bowel preparation because it has better preparation quality and tolerability than single dose 4L PEG regimens. However, although patients drink each 2L separately, the total volume of 4 L PEG is still quite burdensome volume to ingest. In addition, in split dose method, night dose of day before the procedure make patient to suffer from sleep disturbance because of frequent diarrhea and abdominal discomfort.

The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Adult outpatients who undergo afternoon colonoscopy for screening, surveillance or with symptoms

Exclusion Criteria:

* pregnancy,
* breast feeding,
* prior history of surgical large bowel resection,
* severe medical condition such as severe cardiac,
* hepatic, or
* renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),
* significant gastric paresis or gastric outlet obstruction or ileus,
* known or suspected bowel obstruction or perforation,
* drug addiction or major psychiatric illness,
* allergy to PEG and refusal to participate in the study

Primary outcomes:
measure: Quality of bowel preparation
timeFrame: 3 months
Secondary outcomes:
measure: Tolerability
timeFrame: 3 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital, Inje University College of Medicine
Study officials:
affiliation: Haeundae Paik Hospital, Inje University College of Medicine
name: Tae Oh Kim, Ph D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01012570: The Effect of Adalimumab on the Bone Microstructure in Crohn's Disease (CD) Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Crohn's Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients cohort of the University Hospital Zurich

Brief summary: The investigators will study the effect of Adalimumab on the bone microstructure.

* Trial with medicinal product


Eligibility criteria: Inclusion criteria:

* CDAI \> 220 und \< 450
* Biologika naiv
* CD seit \> 6 Monaten

Exclusion criteria:

* other TNF-Blocker
* Steroids \> 40 mg
* Malignoma in der Anamnesis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT02272049: Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults
Official title: Use of Hyperpolarized 129 Xe MR Lung Imaging in Children and Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Respiratory Disorders
Keywords: Respiratory
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal population of children and adults and in adults and also in children with respiratory compromise due to a variety of diseases.

Detailed description: Hyperpolarized 129Xe will be produced, by trained staff, using a polarizer housed at Cincinnati Children's Hospital Medical Center. Individual imaging sessions will be done on a single day and will involve administration of (maximum) 1 liter doses (less for children) for up to four MRI scans. Subject will inhale hyperpolarized xenon gas and hold breath for up to 16 seconds during the MRI scans. In addition to 129 Xe MRI, a series of anatomical conventional proton MR images may also be collected. Follow up phone calls will be done one day and 30 days from the MRI date.

Eligibility criteria: Inclusion Criteria:

* Ages 6 and up
* Participant must be able to hold breath for up to 16 seconds

Exclusion Criteria:

* History of heart defect
* Pregnancy or positive pregnancy test
* History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month
* Symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week
* Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula
* Participant is claustrophobic and unable to tolerate the imaging.
* Standard MRI exclusions (metal, implants)

Primary outcomes:
measure: Correlation of ventilated volume predictions obtained with 129Xe MRI vs. 1H MRI
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jason C. Woods, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05239949: Effects of Hypopressive Exercises in Comparison With Routine Pelvic Floor Exercises in Women With Urinary Incontinence
Official title: Effects of Hypopressive Exercises in Comparison With Routine Pelvic Floor Exercises in Women With Urinary Incontinence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
Pelvic floor exercises
Hypopressive exercises
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to compare the effects of hypopressive exercises with routine pelvic floor exercises in improving the frequency and severity of urinary incontinence in women and also to enhance their quality of life as it worsens after childbirth, pregnancy, and in older age.

Detailed description: A randomized control trial study will be conducted in which patients with urinary incontinence will be assigned to group 1 that will receive hypopressive exercises with electrical muscle stimulation (EMS) and patients in group 2 will receive pelvic floor exercises with EMS.

The intervention will be applied (3 days/week) for 8 weeks. Four sets of 10 repetitions with a 3-minute interval between each set will be performed for group 1 in an upright position while four sets of 10 repetitions with a 2-minute interval between each set will be performed for group 2 in the sitting position.

Eligibility criteria: Inclusion Criteria:

* Women aged between 20 to 65 years
* Gynecologist and urologist diagnosed patients
* Participants not engaged systematically in sports or physical activities(≤ sessions per week, ≤ weeks per week)

Exclusion Criteria:

* If participants had hypertension or any serious mental disease
* Pregnancy or up to 2 months postpartum
* Urge fecal incontinence or vaginal pain
* Underwent any physiotherapy for urinary incontinence before
* Any kidney disease

Primary outcomes:
measure: International Consultation Incontinence Questionnaire Short Form (ICIQ-SF)
timeFrame: 8th week
measure: International Impact Questionnaire, Short Form (IIQ-7)
timeFrame: 8th week
measure: Medical, Epidemiologic and Social aspects of Aging Questionnaire (MESA Questionnaire)
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhmmad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT05743049: Collection of Circulating Biomarkers in Pancreatic Cancer
Official title: Protocol to Permit Collection of Circulating Biomarkers in Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2023-02-24
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: known or suspected diagnosis of pancreatic adenocarcinoma

Brief summary: This protocol will involve collection of blood samples from patients with a diagnosis of pancreatic adenocarcinoma for evaluation of circulating biomarkers.


Eligibility criteria: Inclusion Criteria:

* The subject must have a known or presumed diagnosis of pancreatic adenocarcinoma
* The subject must be a patient of the University of Pennsylvania
* The subject must be able to provide informed consent
* The subject must be 18 years of age or older

Exclusion Criteria:

. Subjects who have any clinically significant psychiatric, social, or medical condition that, in the opinion of the investigator, could increase the patient's risk, interfere with protocol adherence, or affect the patient's ability to give informed consent are ineligible to participate in the study.

Primary outcomes:
measure: To create a comprehensive system to collect, catalogue and store blood specimens from subjects with pancreatic cancer for future research use.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: To create a computerized clinical data set from subjects with pancreatic cancer that contains information related to the subject's general health, disease status, treatments, and response.
timeFrame: Through study completion, an average of 1 year
measure: To integrate the data and specimens to permit the most informative clinical-biologic research platform.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center, University of Pennsylvania
name: Mark O'Hara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911636: 5 Fractions of Pelvic SABR With Intra Prostatic SABR
Official title: 5 Fractions of Pelvic SABR With Intra Prostatic SABR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stereotactic Ablative Radiation(SABR) 35 Gy in 5 fractions, once weekly to prostate with simultaneous intraprostatic boost to the MR detected nodule up to 50Gy + 25 Gy in 5 fractions, once weekly simultaneously to seminal vesicles (SV's) and pelvic lymph nodes + 6-18 months of ADT

Detailed description: SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma (centrally reviewed)
* High- tier intermediate risk defined as:

PSA 10-20ng/ml AND (T2b-2c OR Gleason 7 )

• High-risk prostate cancer, defined as at least one of: T3, OR Gleason 8-10, OR PSA \> 20 ng/mL

* Willing to give informed consent to participate in this clinical trial
* Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire

Exclusion Criteria:

* Prior pelvic radiotherapy
* Contra-indication to radical prostate radiotherapy e.g. connective tissue disease or inflammatory bowel disease
* Contraindication to prostate MRI
* Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
* Diagnosis of bleeding diathesis
* Large prostate with significant arch interference on TRUS after 3 months of neoadjuvant ADT.
* Previous TURP
* Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) \>20
* Significant medical co-morbidity rendering patient unsuitable for general anesthetic
* No evidence of castrate resistance (defined as PSA \< 3 ng/ml while testosterone is \< 0.7nmol/l. Patients could have been on combined androgen blockade but are excluded if this was started due to PSA progression.
* Definitive extrapelvic nodal or distant metastatic disease on staging investigations.

Primary outcomes:
measure: To document the number of patients with grade 3 or higher acute urinary and/or bowel toxicity using the Common Terminology Criteria for Adverse Events (CTCAE v4.0) criteria
timeFrame: 3 months after accrual target is reached
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05588336: Intrathecal Morphine for Thoracoscopic Surgery
Official title: Comparison of the Effects of Intrathecal Morphine at Two Different Doses in Thoracoscopic Lung Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: postoperative analgesia
pain score
side effect
morphine
intrathecal
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 46
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: Thoracic surgery is one of the surgeries where postoperative pain is intense. In this study, the investigators aimed to compare the efficacy of two different intrathecal morphine doses administered for postoperative analgesia according to patients' ideal body weight.

Detailed description: Patients who underwent video-assisted thoracic surgery were divided into two groups: 10 mcg/kg and 7 mcg/kg intrathecal morphine for postoperative analgesia. Intraoperative and postoperative hemodynamic variables, postoperative morphine consumption, postoperative pain scores, side effects and additional analgesic requiretment were recorded.

Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* ASA class I and II
* Video-assisted thoracoscopic surgery

Exclusion Criteria:

* \< 18 years old
* ASA class \> II
* Serious hepatic, cardiac, renal, metabolic, endocrine diseases
* Coagulation disfunction
* Allergy to any of the study drugs
* Pneumonectomy
* Infection in the lumbar region

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: systolic arterial blood pressure
timeFrame: change from baseline systolic blood pressure at 150 minutes
measure: diastolic arterial blood pressure
timeFrame: change from baseline diastolic blood pressure at 150 minutes
measure: mean arterial blood pressure
timeFrame: change from baseline mean arterial blood pressure at 150 minutes
measure: heart rate
timeFrame: change from baseline heart rate at 150 minutes
measure: side effects
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
References:
Clinical trial NCT01680549: Pain Control With Total Knee Replacement
Official title: Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.

Detailed description: Being able to understand and better control pain in patients undergoing total knee arthroplasty will help in many different areas of medicine. Gabapentin is one pain control modality that has been used by many different orthopaedic surgeons with excellent retrospective results. Gabapentin, however, has never been studied, to the investigators knowledge, in a prospective randomized fashion in the United States for total knee arthroplasty. This study will be the first of its kind to truly compare the effects of gabapentin, a drug that has been proven safe in many other areas of medicine, with placebo for total knee arthroplasty by analyzing post-operative narcotic usage, function and sleep quality.

Eligibility criteria: Inclusion Criteria:

* • Age \> 25 years old

  * Primary osteoarthritis of the knee
  * Must be undergoing unilateral total knee arthroplasty
  * Anesthesia assesment score I, II, or III

Exclusion Criteria:

* Severe joint malalignment (defined as varus/valgus angle \> 20 deg)

  * Use of gabapentin pre-operatively
  * History of chronic pain (currently under treatment)
  * History of substance abuse
  * Impaired kidney function (defined as creatinine \> 1.5)
  * Epilepsy (currently on medication for treatment)
  * Known allergy to Gabapentin
  * Known history of depression or suicidal thoughts and behaviors
  * Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of care.

Primary outcomes:
measure: Patient Pain Scores
timeFrame: 3 days
Secondary outcomes:
measure: Narcotics Consumption
timeFrame: 3 days
measure: Knee Range of Motion
timeFrame: 3 days
measure: Patient Restfulness
timeFrame: 3 days
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: TTUHSC Orthopaedic Surgery MS 9436
state: Texas
Study officials:
affiliation: TTUHSC dept. Orthopaedic Surgery
name: George W Brindley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00977249: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users
Official title: Varenicline for Long-term Nicotine Replacement Therapy (NRT) Users. A Double Blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Tobacco Dependence
Keywords: long term nicotine gum use
varenicline
adverse effects
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2009-09-15
Enrollment: 200
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: Primary aim: Will varenicline be better than placebo to get long-term users of NRT to stop?

Secondary aim: To assess in details some side effects of varenicline i.e. nausea and abnormal dreams.

Detailed description: 100-200 long-term users of NRT will be enrolled in a placebo, controlled, randomized trial with varenicline or placebo for 12 weeks to stop the use of NRT.

Assessments consist of carbon monoxide in expired air, p-cotinine, body-weight, questions about craving, nausea and dreams. Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) and secondary result is not smoking and not using NRT at 12 months. Secondary aims, is a more detailed assessment of nausea and dreams; well-known side effects of varenicline and secondary results are a qualitative description of nausea and dreams.

Eligibility criteria: Inclusion Criteria:

* Long-term, daily NRT users (except nicotine patch) (\>11 months) ex-smokers that are willing to try to stop the use of NRT and adhere to this protocol.
* More than 4 pieces of nicotine gum/ sublingual tablets/ lozenges/ per day, OR more than 3 inhaler cylinders per day, OR
* more than 10 puffs of nasal spray per day.

Exclusion Criteria:

* Age \< 18 years,
* CO Smokers,
* Pregnant and lactating women,
* Used varenicline before,
* Not able to cooperate,
* Other significant diseases that might influence the trial (such as moderate -severe cardiac disease, lung cancer,) in expired air \> 7 ppm.

Primary outcomes:
measure: Primary result is percent not using NRT and not smoking at 12 weeks (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml
timeFrame: 12 weeks +/- 1 week
Secondary outcomes:
measure: is not smoking and not using NRT at 12 months (point prevalence last 7 days) verified by self-declaration combined with a CO < 8 ppm and a p-cotinine < 15 ng/ml
timeFrame: 12 months +/- 3 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Gentofte Hospital
state: Hellerup
Study officials:
affiliation: Gentofte Hospital
name: Philip Tønnesen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tonnesen P, Mikkelsen K. Varenicline to stop long-term nicotine replacement use: a double-blind, randomized, placebo-controlled trial. Nicotine Tob Res. 2013 Feb;15(2):419-27. doi: 10.1093/ntr/nts146. Epub 2012 Sep 27.