louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00709072: Follow-up of Children After Stuttering Treatment
Official title: Relapse Following the Lidcombe Program for Preschool Children Who Stutter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stuttering
Keywords: stuttering
relapse
Lidcombe Program
Preschool children
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2008-07-03
Enrollment: 180
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to determine the percentage and predictors of stuttering relapse following treatment with the Lidcombe Program. It will also investigate the effectiveness of sending reminder messages to parents to assist in reducing relapse.

Detailed description: Stuttering treatment becomes more time-consuming and less effective as children become older. Therefore it is crucial to prevent relapse following treatment in the early years. This study will investigate predictors of relapse and assess the effectiveness of a simple two-weekly user-friendly reminder to parents, about when and how to address any re-occurring stuttering after treatment. Results from the study may help to prevent stuttering relapse in this age group in the future.

Eligibility criteria: Inclusion Criteria:

* Completion of stage I of Lidcombe Program
* Less than 1 percent syllables stuttered at recruitment
* Means of receiving SMS email or phone reminder

Primary outcomes:
measure: percentage of syllables stuttered
timeFrame: six monthly for three years
Secondary outcomes:
measure: parent reported stuttering severity
timeFrame: six monthly for three years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Australian Stuttering Research Centre
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Mark Onslow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05040672: Evaluation of Knowledge and Practice About Prostate Cancer in Male Employees
Official title: Evaluation of Knowledge and Practice About Prostate Cancer in Male Employees of Libbs Pharmaceuticals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Libbs Farmacêutica LTDA
Sponsor class: INDUSTRY
First posted: 2021-09-10
Enrollment: 280
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: As this is a non-probabilistic or convenience (non-random) sampling, the sample size calculation is not applicable. Today there are about 1500 male employees at Libbs Pharmaceuticals and all will be invited to participate in the survey. Answers obtained from all questionnaires filled in their entirety will be included for analysis.

Brief summary: Analyze, through an online questionnaire, the knowledge and practice about the prevention and detection of prostate cancer in male employees of a pharmaceutical company.

Detailed description: In Brazil, there are still few published and current studies that explore man's attention and awareness of health. Historically, women attend medical appointments and perform routine tests more frequently than men. For this is very important Analyze, through an online questionnaire, the knowledge and practice about the prevention and detection of prostate cancer in male employees of Libbs Farmacêutica (a pharmaceutical company in Brazil).

Eligibility criteria: Inclusion Criteria:

* Male individuals included in the Libbs workforce;
* Age 18 years or older;
* Subjects who agree to participate in the study after reading and signing the Informed Consent Form.

Exclusion Criteria:

* There is no exclusion criteria

Primary outcomes:
measure: Evaluation of Knowledge and Practice About Prostate Cancer e Healthy Habits
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Augusto Figueiredo
Study officials:
References:
Clinical trial NCT02709772: Provider Alerts to Reduce Unnecessary Care
Official title: Provider Alerts to Reduce Unnecessary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physician's Role
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 10 Clinics within Stanford Health Care are randomized to receive or not receive provider alerts for 5 commonly overused tests and treatments.

Detailed description: 10 Clinics within Stanford Health Care are randomized to receive or not receive provider alerts for 5 commonly overused tests and treatments.

Thus there will potentially be 50 clinics enrolled across the 5 tests/treatment categories. However, it is expected that some clinics will meet criteria to be one of the 10 clinics in more than test/treatment category. Thus the total number of clinics involved will be between 10 and 50.

These 5 tests / treatments are taken from the Choosing Wisely list. All alerts will be provided using the electronic medical record and will be automated.

Eligibility criteria: Inclusion Criteria:

High volume clinics defined as the top 10 clinics in Stanford Health Care based on number of electronic orders.

Exclusion Criteria:

None

Primary outcomes:
measure: Number of electronic orders entered per 100 clinic patients.
timeFrame: 6 months
Secondary outcomes:
measure: Number of potential electronic alerts divided by the number of electronic orders
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Ho VT, Aikens RC, Tso G, Heidenreich PA, Sharp C, Asch SM, Chen JH, Shah NK. Interruptive Electronic Alerts for Choosing Wisely Recommendations: A Cluster Randomized Controlled Trial. J Am Med Inform Assoc. 2022 Oct 7;29(11):1941-1948. doi: 10.1093/jamia/ocac139.
Clinical trial NCT00151372: Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients
Official title: Treatment Effectiveness in Depressed Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Major Depression
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-08
Enrollment: 141
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major depression, a condition that contributes to suffering but also to poor treatment adherence leading to increased disability and morbidity. This study investigates the effectiveness of a care management intervention aimed at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability at a 28-week follow-up period.


Eligibility criteria: Inclusion Criteria:

* Chronic obstructive pulmonary disease by American Thoracic Society criteria
* Major depression by DSM-IV criteria
* 17-item Hamilton score \>14
* English speaking

Exclusion Criteria:

* Inability to give informed consent
* MiniMental score \<24
* Aphasia
* Nursing home placement after discharge

Primary outcomes:
measure: Composite Antidepressant Score Scale (CAD)
timeFrame: 28 Weeks
Secondary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: 28 Weeks
Other outcomes:
Locations:
city: West Haverstraw
country: United States
facility: Helen Hayes Hospital
state: New York
city: White Plains
country: United States
facility: Burke Rehabilitation Hospital
state: New York
city: White Plains
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: George S Alexopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01658072: Analgesia After Total Hip Arthroplasty: Peri-Articular Injection Versus Epidural Patient Controlled Analgesia (PCA)
Official title: Analgesia After Total Hip Arthroplasty: Peri-Articular Injection Versus Epidural Patient Controlled Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Total Hip Arthroplasty
Total Hip Replacement
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2012-08-06
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The best way to provide analgesia after total hip arthroplasty is hotly debated. There are two protocols in use at Hospital for Special Surgery(HSS). Both protocols have their proponents, but there are limited data for making an informed choice of protocols. For total hip arthroplasty at HSS, epidural analgesia is used most frequently as it reduces pain with physical therapy. However, epidural analgesia can be associated with nausea, pruritis, dizziness, and orthostatic hypotension. These side-effects can slow physical therapy and may prolong the time until the patient is ready for discharge. Some surgeons at HSS have decided to use a different analgesic protocol, based on a peri-articular injection. This protocol avoids epidural analgesia and systemic opioids. However, patients are given oral opioids as part of a multimodal pain therapy. The investigators propose to compare peri-articular injection to epidural patient controlled analgesia (Epidural PCA). The investigators will enroll 90 total patients (45 per study arm). The enrollment period will be approximately one year and the duration of the follow-up with study patients will be three months following their procedure.


Eligibility criteria: Inclusion Criteria:

* Patients with osteoarthritis scheduled for primary total hip arthroplasty with a participating surgeon
* Age 50 to 80 years old
* Planned use of regional anesthesia
* Ability to follow study protocol

Exclusion Criteria:

* Patients younger than 50 years old and older than 80
* Patients intending to receive general anesthesia
* Allergy or intolerance to one of the study medications
* Patients with an ASA of IV
* Patients with insulin-dependent diabetes
* Patients with hepatic (liver) failure
* Patients with chronic renal (kidney) failure
* Chronic opioid use (taking opioids for longer than 3 months)
* Patients with any prior major ipsilateral hip surgery
* Allergy to any of the medications (or adhesives) involved in the protocol

Primary outcomes:
measure: Time Until Patient is Ready for Discharge
timeFrame: Length of Hospital Stay, an expected average of 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Kethy M Jules-Elysee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00611572: GABA-glutamate Interactions and Psychosis
Official title: Contribution of Gabaergic and Glutamatergic Mechanisms to Cognitive Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognitive Dysfunction
Keywords: GABA
glutamate
NMDA
P300
MMN
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2008-02-11
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study investigates the interactions between NMDA (N-Methyl-D-aspartic acid) antagonism and GABA (gamma-aminobutyric acid) system as it relates to cognitive function assessed by ERPs (event-related potentials) in healthy volunteers.


Eligibility criteria: Inclusion criteria:

* Ages of 21-45 years from all ethnic backgrounds.
* Male or female.
* Written informed consent.

Exclusion criteria:

* DSM-IV diagnosis for a psychotic, depressive or anxiety disorder.
* A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox).
* History of abnormal EEG.
* History of severe allergies or multiple adverse drug reactions.
* Any medication that could interfere with either the safety of the study and/or the outcome measures.
* Any other conditions which in the opinion of the investigator would preclude participation in the study.
* History of major psychiatric disorder in first degree relatives.
* Current substance abuse/dependency determined by urine toxicology.
* Treatment with medications with CNS effects.
* Treatment with benzodiazepines within one week prior to testing.
* Current treatment with medications with psychotropic effects.
* Education \< 10th grade.
* IQ \< 70, MR.
* Non-English speaking.

Primary outcomes:
measure: P300 as an ERP measure
timeFrame: prospective
Secondary outcomes:
measure: MMN (Mismatch Negativity)
timeFrame: prospective
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VHA Connecticut
state: Connecticut
Study officials:
affiliation: Yale School of Medicine, Associate Professor
name: Mohini Ranganathan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05866172: HAIC Combined Withzoledronic Acid for the Prevention of Bone Metastases in Advanced HCC
Official title: A Randomized Controlled Study of Hepatic Arterial Infusion Chemotherapy of FOLFOX With or Without Zoledronic Acid for the Prevention of Bone Metastases in Advanced Hepatocellular Carcinoma Staged at BCLC C
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
zoledronic Acid
hepatic arterial infusion chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Zoledronic acid was initially used for bone metastases in various malignancies. However, it is unknown whether hepatic arterial infusion chemotherapy combined with zoledronic acid can improve overall survival of unresectable hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Unresectable HCC. For BCLC C HCC, sorafenib/lenvatinib or PD-1/L1 antibody was allowed.
* Eastern Cooperative Oncology Group performance status of 0 to 2
* with no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:
* Platelet count ≥ 75,000/μL
* Hemoglobin ≥ 8.5 g/dL
* Total bilirubin ≤ 30mmol/L
* Serum albumin ≥ 30 g/L
* ASL and AST ≤ 5 x upper limit of normal
* Serum creatinine ≤ 1.5 x upper limit of normal
* INR ≤ 1.5 or PT/APTT within normal limits
* Absolute neutrophil count (ANC) \>1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease

Primary outcomes:
measure: overall survival
timeFrame: 12 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 12 months
measure: Objective Response Rate (ORR)
timeFrame: 12 months
measure: Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05121272: Fatigue and Cognitive Demand With Aging
Official title: Fatigue and Cognitive Demand With Aging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fatigue
Keywords: sex difference
aging
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will determine the influence of a cognitive task performed during fatiguing contractions.

Detailed description: Individuals will participate in one familiarization session followed by 3 randomized experimental sessions (crossover design).

Eligibility criteria: Inclusion Criteria:

* Healthy individuals aged between 18-35 and 65-90

Exclusion Criteria:

* Metal implants or joint replacement. neuromuscular disease

Primary outcomes:
measure: force
timeFrame: Each session will take approximately 2-3 hours (total of 4 test sessions)
measure: anxiety levels
timeFrame: Each session will take approximately 2-3 hours (total of 4 test sessions
measure: arterial pressure
timeFrame: Each session will take approximately 2-3 hours (total of 4 test sessions
measure: fatigue
timeFrame: Each session will take approximately 2-3 hours (total of 4 test sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Norman
country: United States
facility: University of Oklahoma
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Hugo Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02711072: Continuous Infusion for Pain Relief
Official title: Comparaison of Continuous Infusion of Local Anesthetic and Intrathecal Morphine for Pain Management in Elective Caeserean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Regional Anesthesia
Caeserian Section
Local Anesthetic
Lead sponsor: Tunisian Military Hospital
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative analgesia. high incidence of side effects was noted. is there any alternative?


Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* 18-45 years of age, inclusive
* elective caeserean section under spinal anesthesia

Exclusion Criteria:

* - contraindications to spinal anesthesia (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
* existing neurological deficit
* inability to understand the informed consent and demands of the study

Primary outcomes:
measure: Visual Analogic Scale
timeFrame: until 48 hours postoperative
Secondary outcomes:
measure: occurrence of complications
timeFrame: 48 hours post operative
measure: total dose of morphine consumption in mg
timeFrame: during 48 hours post operative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04070872: 3-dimensional Versus 2-dimensional Laparoscopy for Hysterectomy
Official title: 3-dimensional Versus 2-dimensional Laparoscopy for Hysterectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopy
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic hysterectomy.

Detailed description: Laparoscopy is founded as a treatment of choice for benign uterine disease. The advantages of laparoscopic surgery over conventional open surgery are less pain, shorter recovery time, shorter hospital stay, and consequently faster return to normal activity as well as better cosmetic effects. However, laparoscopic surgery is more demanding compared with open surgery because operators should project three-dimensional (3D) field through a two-dimensional (2D) monitor.

However, to date, studies examining the possible benefits and drawbacks of 3D imaging system versus 2D in laparoscopic surgery have brought about conflicting results. Moreover, there have been few studies comparing the surgical outcomes of 3D and 2D laparoscopic laparoscopic hysterectomy. The aim of this study is to compare the surgical outcomes and efficacy of 3-dimensional (3D) versus 2-dimensional (2D) imaging systems in laparoscopic hysterectomy.

Eligibility criteria: Inclusion Criteria:

* Uterine myoma requiring laparoscopic myomectomy
* American Society of Anesthesiologists physical status (ASAPS) classification I-II
* absence of pregnancy at the time of surgery.

Exclusion Criteria:

* any suspicious findings of malignant gynecologic diseases,

Primary outcomes:
measure: Amount of operative blood loss
timeFrame: At the time of surgery
Secondary outcomes:
measure: Operative time
timeFrame: At the time of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital, Seoul, Republic of Korea
name: Taejong Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: