louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01232998: Emergency Department Patient Satisfaction Survey in the Imam Reza Hospital , Tabriz ,Iran, 2008
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Sample
Keywords: Patient Satisfaction
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 504
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The investigators want to survey Emergency Department Patient Satisfaction in the Imam Reza hospital ,Tabriz ,Iran by questionnaire form . Finally the investigators want to improve the quality services in the department based on the research result.


Eligibility criteria: Inclusion Criteria:

* all patients admitted to emergency department

Exclusion Criteria:

* patients didn't sign consent form

Primary outcomes:
measure: Patient Satisfaction
Secondary outcomes:
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Tabriz University of Medical Sciences, Daneshgah Street,
state: East Azarbijan
Study officials:
References:
citation: Boudreaux ED, Friedman J, Chansky ME, Baumann BM. Emergency department patient satisfaction: examining the role of acuity. Acad Emerg Med. 2004 Feb;11(2):162-8.
Clinical trial NCT00104598: Framing Messages for Smoking Cessation With Bupropion - 6
Official title: Framing Messages for Smoking Cessation With Buproprion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-03-02
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized study of message framing in individuals beginning a smoking cessation program utilizing bupropion SR and brief counseling, videos, and pamphlets.


Eligibility criteria: Exclusion Criteria:

* Pregnant or nursing women, or women of child-bearing potential who are not using an adequate method of contraception
* Psychiatric illnesses requiring psychotropic medications (i.e., psychosis, major depression, mania), or the presence of suicidality or homocidality
* Current use of nicotine replacement therapies (i.e., nicotine patch, gum, or lozenges, nasal spray, or inhaler), bupropion (Zyban, Wellbutrin), or marijuana or current participation in another smoking cessation treatment
* Presence of unstable medical conditions (i.e., cardiac, hepatic, renal disease, diabetes mellitus) that would make a trial of bupropion SR hazardous
* Have taken monoamine oxidase inhibitors or metoprolol succinate within the past six weeks
* History of anorexia nervosa or bulimia
* Previous hypersensitivity to bupropion
* History of alcohol or other drug dependence in the past one year
* History of seizure disorder of any etiology (i.e., brain tumor, traumatic brain injury, substance-induced seizures, etc.)
* Any finding that in the view of the principal investigator would compromise the subject's ability to fulfill the protocol visit schedule and visit requirements or put the subject at risk
* Sharing home or work environment with current or past participant
* No couples or participants who see each other every day

Primary outcomes:
measure: Smoking Cessation at 7 days
timeFrame: 7-day point prevalence abstinence
measure: Continuous Smoking Abstinence at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Substance Abuse Treatment Unit
state: Connecticut
Study officials:
affiliation: Substance Abuse Treatment Unit
name: Stephanie O'Malley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toll BA, O'Malley SS, Katulak NA, Wu R, Dubin JA, Latimer A, Meandzija B, George TP, Jatlow P, Cooney JL, Salovey P. Comparing gain- and loss-framed messages for smoking cessation with sustained-release bupropion: a randomized controlled trial. Psychol Addict Behav. 2007 Dec;21(4):534-44. doi: 10.1037/0893-164X.21.4.534.
Clinical trial NCT03624998: The Effects of Cognitive Functioning on Gait Rehabilitation
Official title: The Effects of Cognitive and Behavioral Functioning on Gait Rehabilitation in Orthopedic Patients Submitted to Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Arthroplasty
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The present study is designed to investigate whether the behavioral and cognitive functioning might predict the outcome of the rehabilitation of gait related abilities in orthopedic patients submitted to elective surgery (total hip arthroplasty). The evaluation of gait related abilities will be performed with specific physiatric tests, while cognitive functioning will be studied by means of an extended neuropsychological battery.


Eligibility criteria: Inclusion Criteria:

* Age comprised between 50 and 80 years
* Submission to total hip arthroplasty
* Admission to the local rehabilitation program
* Signature of the informed consent

Exclusion Criteria:

* Major medical issues (e.g. neurologial or neurodegenerative diseases)
* Assumption of psychiatric drugs
* Pregnancy

Primary outcomes:
measure: Relationship between the cognitive functioning and gait rehabilitation
timeFrame: The first measures will be taken at the enrollment, at 7 days after the enrollment and at 15 days after the enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Galeazzi
state: Italia
Study officials:
References:
citation: Negrini F, Preti M, Zirone E, Mazziotti D, Biffi M, Pelosi C, Banfi G, Zapparoli L. The Importance of Cognitive Executive Functions in Gait Recovery After Total Hip Arthroplasty. Arch Phys Med Rehabil. 2020 Apr;101(4):579-586. doi: 10.1016/j.apmr.2019.12.004. Epub 2020 Jan 7.
Clinical trial NCT01784198: Determination of Protein Requirements in Pregnancy
Official title: Determination of Protein Requirements in Healthy Pregnant Women Using Indicator Amino Acid Oxidation Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: pregnancy
protein requirements
Indicator Amino acid oxidation
Stable isotopes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-02-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Protein is an essential part of our diet. It is used to build muscle and body tissue, send signals throughout our body and to support the immune system. Dietary protein is even more crucial during pregnancy as it is needed for healthy growth and development of the baby. There is very minimal data available on how much additional protein is required during pregnancy. Current recommendations are based on older techniques such as nitrogen balance studies of non-pregnant adults and minimally based on pregnancy specific data. There is no scientific information regarding the amount of protein needed during different stages of pregnancy.

The investigators hypothesize that the current recommendations of protein intake during pregnancy are underestimated.

The goal of this study is to measure protein requirement in healthy pregnant women (19-35y)using a more quick and modern technique called the indicator amino acid oxidation technique (IAAO).


Eligibility criteria: Inclusion Criteria:Healthy pregnant women

* Singleton pregnancy
* Maternal age 19-35y
* In good health (free of chronic/acute disease,full range of physical mobility)
* Healthy pre-pregnancy body mass index

Exclusion Criteria:Women

* not pregnant
* Pregnant with more than one child
* Singleton pregnancy outside the age range of 19-35y
* Not in good health or have a metabolic, neurological, genetic, or immune disorder, including gestational diabetes or anemia
* smoke or consume alcohol during their pregnancy
* classified as underweight (\<18.5 kg/m2), overweight (25-30 kg/m2) or obese (\>30 kg/m2)
* allergic to eggs and egg protein
* severe nausea/vomiting throughout their pregnancy

Primary outcomes:
measure: 13 Carbon dioxide production
timeFrame: 8 hours (1 study day)
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Child & Family Research Institute
state: British Columbia
Study officials:
affiliation: Child & Family Research Institute/University of British Columbia
name: Rajavel Elango, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stephens TV, Payne M, Ball RO, Pencharz PB, Elango R. Protein requirements of healthy pregnant women during early and late gestation are higher than current recommendations. J Nutr. 2015 Jan;145(1):73-8. doi: 10.3945/jn.114.198622. Epub 2014 Sep 24.
Clinical trial NCT04443998: Mandibular Fracture Reduction Using Bone Reduction Forceps
Official title: Evaluation of Bone Reduction Forceps in Reducing Mandibular Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandibular Fractures
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Different methods have been used in reducing mandibular fractures. Bone reduction forceps provides precise reduction and stabilize mandibular fracture segments.

Detailed description: The aim of this study is to evaluate clinically and radiographically the effect of using bone reduction forceps in the reduction of isolated mandibular fractures.

10 patients complaining of isolated mandibular fractures in need of open reduction and internal fixation underwent reduction using bone reduction forceps.

The patients followed up clinically after 1 and 2 weeks, 1, 3, and 6 months postoperatively. Radiographic evaluation will be performed by computed tomography (CT) preoperatively, and cone-beam computed tomography (CBCT) will be done after 3 and 6 months

Eligibility criteria: Inclusion criteria

* Adult patients aged from 20 to 45 years will be included.
* Patients suffered from recent and uninfected.
* Patients with isolated mandibular fractures.

Exclusion criteria

* Medically compromised patients that will be not fit for surgery.
* Edentulous patients.
* Non-displaced
* Comminuted fracture with bone loss
* Old fracture, more than 3 weeks

Primary outcomes:
measure: Change in radiodensitometric measurements
timeFrame: at 3rd, 6th months
measure: change in maximal mouth opening
timeFrame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
measure: change in occlusion
timeFrame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
measure: change in pain level
timeFrame: 1 week, 2 weeks, 1 month, 6 weeks, and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT02982798: The PK Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics of the Co-administration of Metformin SR and Rosuvastatin and JLP-1310 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Hyperlipidemia
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 40
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteers

Detailed description: A randomized, open-label, single dose, crossover clinical trial

Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer, age is over 19 years Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 17.5 kg/m2 , no more than 30.5 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
* Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Systolic BP \> 140mmHG or Diastolic BP \> 90mmHg)
* AST or ALT \> X 2 UNL
* History of drug abuse or positive drug screening.
* Participation in other drug studies within 3 months prior to the drug administration.
* Whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.

Primary outcomes:
measure: AUClast of Metformin and rosuvastatin
timeFrame: 48 hours
measure: Cmax of Metformin and rosuvastatin
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References:
Clinical trial NCT00004398: Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Porphyria
Keywords: inborn errors of metabolism
porphyria
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-10-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria attacks who are also treated with a standard course of heme arginate.

II. Evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients.

Detailed description: PROTOCOL OUTLINE: This is an randomized, unblinded, multicenter study. Patients are randomized to receive heme arginate alone or both heme arginate and tin mesoporphyrin.

Patients receive a single intravenous dose of tin mesoporphyrin immediately before the first dose of heme arginate. Heme arginate is administered daily for 4 days.

Patients are followed at 3 and 6 days after treatment.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria

No chronic or subacute symptoms (present for longer than 2 weeks)

--Prior/Concurrent Therapy--

At least 3 weeks since prior treatment with heme arginate or tin mesoporphyrin

--Patient Characteristics--

Renal: Urinary porphobilinogen at least 40 mg/24 hr

Other:

* Not pregnant
* Fertile female patients must use effective contraception during and 6 months before study
* No evidence that symptoms are due to another acute illness
* No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage
* No known sensitivity to heme preparation or tin mesoporphyrin
* No other medical condition that might increase risk to patient

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Karl Elmo Anderson
role: STUDY_CHAIR
References:
Clinical trial NCT05769998: Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty
Official title: Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 210
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: PREVENTION

Brief summary: Reducing the incidence of chronic post-surgical pain after Total Knee Arthroplasty (TKA) is paramount. NOPAIN, a technology-enhanced Acceptance and Commitment-based treatment, will be developed, tested and improved for this purpose. The feasibility of NOPAIN will be evaluated in a small sample of patients listed for TKA at the IRCCS Istituto Auxologico Italiano. Potential pre-surgical and post-surgical predictors of non-response to treatment will be measured and tested using a machine learning algorithm. The results of this study will be employed to improve the content of NOPAIN or for identification of criteria for patient selection. Finally, a randomized controlled clinical trial will be performed. Patients listed for TKA will be randomized to Treatment As Usual (TAU) or to NOPAIN+TAU. Primary outcome will be time to complete pain relief, secondary outcomes will include subjective and objective measurements of quality of life and functional recovery.


Eligibility criteria: Inclusion Criteria:

* having an age between 18 and 80 years
* having a diagnosis of OA as determined by medical record review
* having undergone a Total Knee Arthroplasty

Exclusion Criteria:

* Inability to provide informed consent

Primary outcomes:
measure: Number of days for pain disappearance
timeFrame: 6 months
Secondary outcomes:
measure: Presence of chronic pain
timeFrame: 6 months
measure: Pain intensity
timeFrame: 6 months
measure: Knee pain, stiffness and physical function
timeFrame: 6 months
measure: Physical and Mental Quality of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Auxologico Mosè Bianchi
Study officials:
References:
Clinical trial NCT00524498: A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma
Official title: A Phase II Study of a Continuous Hepatic Arterial Infusion Combination Therapy With OPC-18 and 5-FU in Patients With Highly Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: OPC-18
Interferon-alpha
Fluorouracil
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of a continuous hepatic arterial infusion combination therapy with OPC-18 and 5-FU versus BST in patients with highly advanced hepatocellular carcinoma for which resection therapy or local therapy is inapplicable due to advanced vascular invasion.


Eligibility criteria: Inclusion Criteria:

* Patients who are histologically or clinically (diagnostic imaging and tumor marker) diagnosed with hepatocellular carcinoma
* Patients with a measurable lesion by contrast CT
* Patients with no remote metastasis (extrahepatic metastasis), confirmed by X-ray, CT, MRI, or other means if necessary
* Patients who have not previously received intra-arterial hepatic chemotherapy

Exclusion Criteria:

* Patients receiving the herbal medicine shosaikoto
* Patients with autoimmune hepatitis
* Patients with a history of hypersensitivity to OPC-18 or other interferon preparations

Primary outcomes:
measure: Antitumor effect (tumor size reduction)
timeFrame: every 4 weeks
Secondary outcomes:
measure: Disease control rate Overall survival Progression-free survival
timeFrame: every 4 weeks
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Chugoku region
country: Japan
city: Hokkaido region
country: Japan
city: Kanto region
country: Japan
city: Kinki region
country: Japan
city: Kyushu region
country: Japan
city: Tohoku region
country: Japan
Study officials:
affiliation: Divsion of New Product Development
name: Katsuhisa Saito
role: STUDY_DIRECTOR
References:
Clinical trial NCT01970098: A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Official title: A Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinocerebellar Degeneration
Keywords: Spinocerebellar degeneration (SCD)
Thyrotropin-Releasing Hormone (TRH)
Spinocerebellar Ataxia (SCA)
Cortical Cerebellar Atrophy (CCA)
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 374
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.


Eligibility criteria: Inclusion Criteria:

* Japanese SCD patients with mild to moderate ataxia

Exclusion Criteria:

* Patients with secondary ataxia
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Primary outcomes:
measure: SARA (Scale for the Assessment and Rating of Ataxia)
timeFrame: 24 weeks
Secondary outcomes:
measure: SF-8 (QOL)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
name: Tatsuro Takei
role: STUDY_DIRECTOR
References:
citation: Nishizawa M, Onodera O, Hirakawa A, Shimizu Y, Yamada M; Rovatirelin Study Group. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials. J Neurol Neurosurg Psychiatry. 2020 Mar;91(3):254-262. doi: 10.1136/jnnp-2019-322168. Epub 2020 Jan 14.