louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05921552: Senior Adult Hepatobiliary Prehab Study
Official title: Feasibility of Exercise Prehabilitation Among Older Patients With Hepatobiliary Cancer Planning for Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatobiliary Cancer
Cholangiocarcinoma
Liver Metastases
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 25
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate an exercise program for individuals with hepatobiliary cancer planning for surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥65 years
* Resectable Hepatocellular carcinoma, Cholangiocarcinoma, or Liver metastasis with Liver resection planned ≥4 weeks
* ECOG 0-2
* Able to sign consent

Exclusion Criteria:

* Does not meet inclusion criteria

Primary outcomes:
measure: Percentage of Participants that Enroll and Consent - Enrollment Feasibility
timeFrame: Up to 12 Months
measure: Percentage of Participants that Complete Study Assessments - Retention Feasibility
timeFrame: Up to 3 Months
measure: Adherence - Feasibility
timeFrame: Up to 3 Months
measure: Participant Self-Reported Musculoskeletal Injuries - Safety
timeFrame: Up to 3 Months
measure: Exercise Training Safety
timeFrame: Up to 3 Months
measure: Participant Evaluation of Feasibility and Acceptability - Acceptability
timeFrame: Up to 3 Months
measure: Objective Physical Functioning and Fitness
timeFrame: At Baseline and Up to 3 Months
measure: Participant Skeletal Muscle Index (SMI)
timeFrame: At Baseline and Up to 3 Months
measure: Participants Health-Related Quality of Life
timeFrame: At Baseline and Up to 3 Months
measure: Patient Activation
timeFrame: At Baseline and Up to 3 Months
measure: Social Support
timeFrame: At Baseline and Up to 3 Months
measure: Participant Self Reported Exercise
timeFrame: At Baseline and Up to 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Mohammed Al-Jumayli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05995652: Can Shear Wave Elastography Predict the Success of ESWL: a Prospective Study
Official title: Can Shear Wave Elastography Predict the Success of Shock-Wave Lithotripsy Used in Renal Stones Treatment: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Stone
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 100
Sex: ALL
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: 1 gp of 50 pts will be subjected to ESWL and will be divided into 2 other gps success and failed

Brief summary: Can Shear Wave Elastography predict the success of Shock-Wave Lithotripsy used in renal stones treatment ? A prospective study

Detailed description: Extracorporeal shock-wave lithotripsy (ESWL) is the noninvasive treatment method that is recommended as the first choice in the treatment of small and medium sized renal stones and proximal ureteral stones.

This study is a trial to determine the predictive role of shear wave elastography in the success of ESWL management of kidney stones.

Eligibility criteria: Inclusion Criteria:

* Patients more than 18 years
* With single radiopaque renal stone
* Ranging in size from (1-1,5 cm) for ESWL.

Exclusion Criteria:

* Any urological abnormal anatomy
* Lower calyceal stone more than 1cm
* Impaired renal functions
* Uncorrected coagulopathy.
* Active UTI Pregnancy Single kidney Multiple stones

Primary outcomes:
measure: stone free rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University
Study officials:
affiliation: AinShams
name: tarek elzayat, prof.dr.
role: STUDY_CHAIR
References:
Clinical trial NCT06290752: Determining the Learning Curve for Ultrasound-guided Caudal Epidural Block
Official title: Associate Chief Physician
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residential trainee

Brief summary: mastering ultrasound-guided sacral canal block entails traversing a multifaceted learning curve characterized by anatomical intricacies, technical challenges, and patient variability. Through systematic education, deliberate practice, and clinical experience, clinicians can ascend this learning curve and harness the full potential of this innovative technique in pain management. As the landscape of regional anesthesia continues to evolve, a commitment to ongoing learning and proficiency attainment is paramount for delivering safe, effective, and patient-centered care.


Eligibility criteria: Inclusion Criteria:

* Residential training students in the first -third grade

Exclusion Criteria:

* No-resident trainees

Primary outcomes:
measure: operation time
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Yiwu
country: China
facility: Dongmei Ma
state: Zhejiang
Study officials:
affiliation: 浙江大学医学院附属第四医院
name: Dongmei Ma
role: STUDY_CHAIR
References:
Clinical trial NCT00661752: Protocol for Evaluation of Quarter-Time Cardiac Imaging: 5-Minutes Rest and 3-Minutes Stress Wide Beam Reconstruction (WBR) Versus Full-Time Filtered Back Projection (FBP)
Official title: Quarter-Time Myocardial Perfusion SPECT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Diseases
Lead sponsor: St. Luke's-Roosevelt Hospital Center
Sponsor class: OTHER
First posted: 2008-04-18
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female patients referred to St. Luke's NM lab. for clinically indicated myocardial perfusion SPECT

Brief summary: A new, innovative software image processing method, wide beam reconstruction (WBR), utilizes resolution recovery and incorporates Poisson noise-reduction into the reconstruction process of NM images. This method facilitates the reconstruction of low count density myocardial perfusion SPECT images. Preliminary research indicates that SPECT acquisition time consequently can be reduced by 60% (less than 5 minutes) for rest and by 75% (just over 3 minutes) for stress, while tomographic image quality is maintained, or even improved. Such a decrease in image acquisition time decreases patient discomfort during the tomographic acquisition, decreases the opportunity for patient motion, and improves laboratory efficiency.

Detailed description: Standard full-time SPECT will be processed using FBP and compared to 3-minute stress and 5-minute rest scans processed with WBR. The following scan parameters will be evaluated: image quality; perfusion defect extent, severity, and reversibility; transient ischemic dilatation; left ventricular end-diastolic volume; left ventricular end-systolic volume; left ventricular ejection fraction; and regional wall motion and wall thickening abnormalities. These parameters will be assessed visually by experienced Nuclear physicians (at least 2 blinded readers) and quantitatively using several different commercially available software programs.

Eligibility criteria: Inclusion Criteria:

* Patient is clinically stable
* Patient is able to tolerate additional 8 minutes of scanning
* Patient is willing to undergo additional 8 minutes of scanning

Exclusion Criteria:

* Unstable patient
* Non-consenting patient

Primary outcomes:
measure: Image quality of quarter-time WBR images is equivalent/superior to full-time FBP
timeFrame: March 2008
Secondary outcomes:
measure: Image quality of quarter-time WBR is equivalent/superior to half-time WBR
timeFrame: March 2008
Other outcomes:
Locations:
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Gordon DePuey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04794452: Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush and Manual Toothbrush
Official title: Dental Plaque Removal Evaluation and Comparison of Kid's Battery-Operated Toothbrush
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque, Dental
Lead sponsor: Church & Dwight Company, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate and compare the plaque removal efficacy of a children's battery-powered toothbrush and a children's manual toothbrush following a single brushing.

Detailed description: This is a single use, examiner blinded, randomized, two-period, cross-over, IRB-approved research study evaluating the single-use plaque removal efficacy of a new children's battery-operated toothbrush and a marketed children's manual toothbrush. This study will accept up to 60 juvenile subjects, 5-8 years of age, in anticipation that 50 subjects will complete the study. Qualified subjects with sufficient plaque, according to Rustogi Modified Navy Plaque Index (RMNPI) will be randomly assigned to one of two sequence treatment groups.

After the pre-brushing plaque evaluation at each of the evaluation visits, subjects will brush with the assigned toothbrush and toothpaste provided for timed brushing under supervision, in front of mirror.

Eligibility criteria: Inclusion Criteria:

1. 5 to 8 years
2. Be a regular manual toothbrush user.

Exclusion Criteria:

1. Have any physical limitations or restrictions which might preclude normal tooth brushing.
2. Have evidence of poor oral hygiene or rampant dental caries or presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.
3. Have fixed or removable orthodontic appliances.

Primary outcomes:
measure: Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: All Sum Research Center Ltd.
state: Ontario
Study officials:
References:
Clinical trial NCT01199952: RCT: Can a Single Counseling Phone Call Improve Contraception After an Abortion?
Official title: A Randomized Controlled Trial: Contraceptive Counseling After an Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: contraception
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2010-09-13
Enrollment: 207
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Hypothesis: Use of an effective contraceptive six weeks after abortion will be higher in the treatment group than in the control group.

Primary Aim ·To determine use of an effective contraceptive method six weeks after abortion in women who choose combined hormonal contraception (CHC) and who receive a three-week educational phone call as compared to women who do not receive the intervention.

Secondary Aims

* To describe the most common concerns and logistical problems women experience with initiating and adhering to CHC after abortion.
* To describe the concerns that lead to discontinuation or method change. \*To assess feasibility of conducting a follow-up telephone call in this population This is a randomized, controlled trial to assess the effect of a three-week follow-up phone call in women who choose combined hormonal contraception on the day of their abortion at the San Francisco General Hospital Women's Options Center. Subjects randomized to the treatment group will receive an interventional phone call three weeks after their abortion; participants randomized to the control group will not receive the call. All subjects will receive a follow-up call six weeks after their abortion to assess and compare method use between the two groups. Calls will be made at three- and six-weeks post abortion in order to give subjects enough time to initiate CHC and to assess continuation into the second month of the method. Data will be collected at baseline, during the intervention for the treatment group and during the final follow-up call for both groups. The primary outcome is use of an effective contraceptive six weeks after abortion.


Eligibility criteria: Inclusion Criteria:

* Women over the age of 15 who choose pill, patch or ring to begin after their abortion
* Women able and willing to be contacted by phone for up to 2 months after enrollment

Exclusion Criteria:

* Women who do not speak and read English or Spanish

Primary outcomes:
measure: Number of Participants Using an Effective Contraceptive Method 6 Weeks After Abortion
timeFrame: 6 weeks after abortion procedure
Secondary outcomes:
measure: Reasons for Discontinuation of Contraception
timeFrame: 6 weeks after abortion procedure
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jody Steinauer, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06412952: 68Ga-NOTA-RM26 PET/CT in Glioma Patients
Official title: 68Ga-NOTA-RM26 PET/CT in Glioma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Glioma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to investigate the value of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR) PET tracer, in the diagnosis of high WHO grade glioma and prediction the grade of glioma using positron-emission tomography/computed tomography (PET/CT).

Detailed description: The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label brain PET/ CT study was designed to assess its clinical diagnostic value in patients with glioma.

Eligibility criteria: Inclusion Criteria:

* suspected or confirmed untreated glioma patients
* signed written consent.

Exclusion Criteria:

* pregnancy
* breastfeeding
* known allergy against Pentixafor
* any medical condition that in the opinion of the investigator,may
* significantly interfere with study compliance

Primary outcomes:
measure: SUVmax
timeFrame: through study completion, an average of 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Science & Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu
role: STUDY_CHAIR
References:
Clinical trial NCT02512952: Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin vs Titanium Platelet Rich Fibrin
Official title: Treatment of Periodontal Intrabony Defects Using Autologous Platelet Rich Fibrin and Titanium Platelet Rich Fibrin: A Randomized Clinical Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Periodontitis
Keywords: Periodontal regeneration
Growth factors
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
Collaborators: name: The Oxford Dental College, Hospital and Research Center, Bangalore, India
First posted: 2015-07-31
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: To compare the effectiveness of open flap debridement (OFD) alone and OFD along with either Autologous Platelet Rich Fibrin (PRF) or Titanium Platelet Rich Fibrin (TPRF) in the treatment of intrabony defects (IBDs).

Materials and methods: Study was conducted on subjects reporting to the Department of Periodontics, The Oxford Dental College and Hospital, Bangalore. 38 subjects with 90 periodontal IBDs of moderate to severe periodontitis were selected and assigned to OFD alone (group I) or OFD with Autologous PRF (group II) or OFD with TPRF (group III). In each subject, a minimum number of two sextants were present with probing pocket depths (PPD) ≥5mm in at least three teeth.


Eligibility criteria: Inclusion Criteria:

* presence of minimum 20 permanent teeth
* age group 20-55 years
* radiographic evidence of periodontal IBDs
* probing pocket depth (PPD) \>5mm in minimum two sextants in at least three teeth
* clinical attachment (CA) loss of ≥ 3mm.

Exclusion Criteria:

* Systemically compromised subjects
* those on medications (corticosteroids/ bisphosphonate therapy) that may interfere with wound healing
* grade III tooth mobility
* smokers and alcoholic subjects
* pregnant and lactating mothers
* subjects who underwent periodontal treatment within a period of 1 year.

Primary outcomes:
measure: defect depth reduction (DDR)
timeFrame: Change from baseline to 9 months
measure: change in clinical attachment level (CAL)
timeFrame: Change from baseline to 9 months
Secondary outcomes:
measure: change in probing pocket depths (PPD)
timeFrame: Change from baseline to 9 months
measure: change in plaque index (PI)
timeFrame: Change from baseline to 9 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Government Dental College and Research Institute
state: Karnataka
city: Bangalore
country: India
facility: The Oxford Dental College
state: Karnataka
Study officials:
References:
Clinical trial NCT00544752: Indoor Temperature and Sleep Apnea
Official title: Indoor Temperature and Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea syndromes, ambient indoor temperature
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Swedish Heart Lung Foundation
First posted: 2007-10-16
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test whether different indoor temperature affect the frequency of sleep apnea.


Eligibility criteria: Inclusion Criteria:

* Obstructive sleep apnea

Exclusion Criteria:

* Central sleep apnea

Primary outcomes:
measure: Apnea hypopnea index, karolinska sleepiness scale
timeFrame: one night
Secondary outcomes:
measure: Sleep stages, sleep efficiency
timeFrame: One night
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of respiratory medicine
Study officials:
affiliation: Dept Respiratory Medicine, University Hospital, Umeå
name: Karl A Franklin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valham F, Sahlin C, Stenlund H, Franklin KA. Ambient temperature and obstructive sleep apnea: effects on sleep, sleep apnea, and morning alertness. Sleep. 2012 Apr 1;35(4):513-7. doi: 10.5665/sleep.1736.
Clinical trial NCT00367952: A Long Term, Safety Study of Apricitabine in HIV-infected Subjects
Official title: An Open Label Long Term Safety Extension Study of Apricitabine in Treatment-experienced HIV-1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infection
Keywords: HIV
apricitabine
drug resistance
reverse transcriptase
lamivudine
Lead sponsor: Avexa
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will examine how safe and effective apricitabine is when given long term (as ongoing treatment) to HIV patients who have already completed the AVX-201 trial

Detailed description: An ongoing study (AVX-201) is examining the safety and efficacy of apricitabine compared to 3TC in HIV patients who are failing therapy containing 3TC and have the presence of the M184V mutation in reverse transcriptase. This extension study (AVX-201E) is available to patients who complete the AVX-201 protocol.

Patients will continue to receive apricitabine open label for a further 96 weeks (making a total of 144 weeks from starting AVX-201) in addition to an optimised background. Safety markers and efficacy markers will be followed.

Eligibility criteria: Inclusion Criteria:

* Completed AVX-201 protocol, Plasma HIV RNA \<5000 copies/ml, CD4 cells \>50

Exclusion Criteria:

* Pregnant or breastfeeding females, withdrawal from AVX-201

Primary outcomes:
measure: Time to virological failure (DHSS definition)
timeFrame: week 144
measure: incidence of AEs and laboratory abnormalities
timeFrame: Week 144
measure: time to withdrawal due to AEs
timeFrame: Week 144
Secondary outcomes:
measure: Change from baseline HIV RNA
timeFrame: weeks 72, 96, 120, and 144
measure: Proportion of subjects with plasma HIV RNA <400 and <50 copies/ml
timeFrame: at weeks 72, 96, 120, and 144
measure: Change from baseline and change in ratio of CD4+ and CD8+ counts
timeFrame: at weeks 72, 96, 120, and 144
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Avexa (co-ordinating sites in Australia and Argentina)
state: Victoria
Study officials:
affiliation: Avexa
name: Susan W Cox, Ph D
role: STUDY_DIRECTOR
References: