louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00580684: Study Comparing Prevenar® to Pneumo 23 in Reducing Carriage in Children
Official title: Long-Term Efficacy of Pneumococcal Conjugate 7-Valent Vaccine Versus Plain Polisaccharide Pneumococcus Vacine in Reducing Pneumococcal Nasopharyngeal Carriage of Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccines, Pneumococcal
Vaccines, Pneumococcal Conjugate Vaccine
Keywords: pneumococcus conjugated vaccine 7 valent
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 101
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization. To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.

Detailed description: This study will require 6 months to be completed (3 months for nasopharyngeal samples collection; 3 months dor analysis). Each child will participate for a 1 day period.

Eligibility criteria: Inclusion Criteria:

* Healthy children between
* 2 to 9 years old.
* No history of antibiotic use prior 1 month of enrollment
* No history of invasive pneumococcal disease

Primary outcomes:
measure: To compare the ability of Prevnar® to Pneumo® 23 in reducing and preventing nasopharyngeal carriage of vaccine-type pneumococci one year after respective immunization.
timeFrame: 12 months
Secondary outcomes:
measure: To evaluate the rate of penicillin-resistant pneumococci in nasopharyngeal carriage.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02248584: VITAMIN E, C and ZINC IN PATIENTS WITH SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE
Official title: SUPPLEMENTATION OF VITAMIN E, C and ZINC IN PATIENTS WITH NON-MELANOMA SKIN CANCER: INFLUENCE ON OXIDATIVE STRESS AND INFLAMMATORY STATE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Neoplasms
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study was to evaluate the effects of supplementary antioxidant therapy on the levels of biomarkers and inflamatory citocines in patients with a previous history of non-melanoma skin cancer treated with surgery. This was a double-blind, randomized, placebo-controlled trial. Patients were randomized into two groups, one receiving placebo (n=34) and the other receiving supplementary antioxidant therapy (n=26) with vitamin C (50 mg), vitamin E (60 mg), and zinc (40 mg) for 60 days. Blood samples were obtained from patients, and the levels of oxidative stress biomarkers, including 8-isoprostane, nitrite, thiobarbituric acid reactive substances, and total antioxidant capacity, were measured, as well as the inflamatory citocines (IL-1, IL-6, IL-10, TNF alfa) and it was evaluated at two different times: (1) one day before the start of supplementation or placebo administration and (2) at 60 days after intervention. Statistical analyses were performed with the SAS System for Windows 9.3 program and data were analyzed using ANOVA for repeated measures test.


Eligibility criteria: Inclusion Criteria:

* patients who had non-melanoma skin cancer (squamous cell carcinoma or basal cell carcinoma) and who were treated with surgery
* age ≥20 years
* absence of comorbidities such as type 1 diabetes, severe heart disease, hepatic dysfunction, renal failure requiring dialysis, HIV infection, and melanoma skin cancer
* no history of chemotherapy or radiotherapy in the previous 6 months
* absence of severe psychiatric disease that limited comprehension
* not taking any vitamin and/or mineral supplementation.

Exclusion Criteria:

* subjects did not complete the entire course of supplemental therapy.

Primary outcomes:
measure: OXIDATIVE STRESS BIOMARKERS
timeFrame: one day before the start of supplementation or placebo administration and at 60 days after intervention
measure: INFLAMMATORY STATE
timeFrame: one day before the start of supplementation or placebo administration and at 60 days after intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Freitas Bde J, Lloret GR, Visacri MB, Tuan BT, Amaral LS, Baldini D, de Sousa VM, de Castro LL, Aguiar JR, Pincinato Ede C, Mazzola PG, Moriel P. High 15-F2t-Isoprostane Levels in Patients with a Previous History of Nonmelanoma Skin Cancer: The Effects of Supplementary Antioxidant Therapy. Biomed Res Int. 2015;2015:963569. doi: 10.1155/2015/963569. Epub 2015 Oct 5.
Clinical trial NCT05930184: Laparoscopic Guided Peri-wound Transversus Abdominis Plane Block With Bupivacaine Versus Local Wound Infiltration on Post-op Opioid Use in Laparoscopic Sleeve Gastrectomy
Official title: Comparison of Laparoscopic Guided Peri-wound Transversus Abdominis Plane Block With Bupivacaine Versus Local Wound Infiltration on Post-op Opioid Use in Laparoscopic Sleeve Gastrectomy, A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Morbid Obesity
Laparoscopic Sleeve Gastrectomy
Transversus Abdominis Plane Block
Local Wound Infiltration
Bupivacine
Opioid Use
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Periwound-TAP block using 0.25%Bupivacain 20ml and local wound infiltration using 0.25%Bupivacain 20ml
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to compare laparoscopic guided peri-wound Transversus Abdominis Plane Block and bupivacaine versus local wound infiltration effect on reducing post-op opioid use in Laparoscopic Sleeve gastrectomy. The main questions it aims to answer are:

• Can laparoscopic guided peri-wound Transversus Abdominis Plane Block reduced post operative morphine usage when comparing with local wound port site infiltration.

Participants will be randomize into 2 group

* peri-wound Transversus Abdominis Plane Block
* local wound port site infiltration


Eligibility criteria: Inclusion Criteria:

* patient undergoing LSG at Sringarind hospital as indicated by Thai guideline

Exclusion Criteria:

* Allergic/contraindicated to bupivacaine, morphine, fentanyl, NSAIDs or Nefopam
* Unable to describe pain score Opioid addict
* denied consent

Primary outcomes:
measure: Cumulative morphine use
timeFrame: 48hours after intervention
Secondary outcomes:
measure: Post op VAS pain score
timeFrame: 48hours after intervention
measure: length of hospital stay
timeFrame: within admission
measure: opioid side effect
timeFrame: within admission
measure: PACU time
timeFrame: 1day after intervention
measure: postop complication
timeFrame: 2weeks after intervention
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind hospital
state: Northeastern
Study officials:
affiliation: Khon Kaen University
name: Thanatat Panitphong, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03982784: TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy
Official title: Transmuscular Quadratus Lumborum Block for Postoperative Pain After Laparoscopic Partial Nephrectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Renal Surgery
Pain Management
Nerve Block
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay，et al. between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing laparoscopic partial nephrectomy.


Eligibility criteria: inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo laparoscopic partial nephrectomy
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)

Primary outcomes:
measure: cumulative morphine consumption 8 hours after surgery
timeFrame: at the 8 hours after surgery
Secondary outcomes:
measure: cumulative morphine consumption at other time points after surgery
timeFrame: at 0, 2, 4, 12, 24 and 48 hours after surgery
measure: The pain scores(at rest or on activity) determined by the numeric rating scale (NRS, 0-10)
timeFrame: at 0, 2, 4, 8,12, 24, 48 and 72 hours after surgery
measure: episodes of nausea and vomiting
timeFrame: within 24 hours after the surgery
measure: ambulation time
timeFrame: within the 5 days after surgery
measure: time of recovery of bowl movement
timeFrame: within the 5 days after surgery
measure: patient satisfaction with anesthesia
timeFrame: at 48 hours after surgery
measure: quality of recovery evaluated by the self-assessment 15-item quality of recovery (QoR) scale
timeFrame: at 72 hours and 120 hours after the sugery
measure: postoperative length of hospital stay
timeFrame: within 2 weeks after the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cui Xulei
state: Beijing
Study officials:
References:
Clinical trial NCT02108184: Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy
Official title: Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy of Treatment of Helicobacter Pylori Infection in Korea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: helicobacter eradication rates
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 264
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.

single center, randomized trial

1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 10 days
2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 14 days
3. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days
4. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days

1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance


Eligibility criteria: Inclusion Criteria:

* 20\~80 patients
* agreement of informed consent
* H.pylori positive (biopsy, CLO)
* Peptic ulcer disease, mucosa associated lymphoid tissue lymphoma, Post endoscopic submucosal dissection status due to early gastric cancer

Exclusion Criteria:

* H.pylori eradication history
* severe hepatic, renal, cardiac failure
* pregnancy, participant of other study

Primary outcomes:
measure: Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.
timeFrame: required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St.Mary hospital
state: Bupyung
Study officials:
References:
citation: Lim JH, Lee DH, Choi C, Lee ST, Kim N, Jeong SH, Kim JW, Hwang JH, Park YS, Lee SH, Shin CM, Jo HJ, Jang ES, Song Is, Jung HC. Clinical outcomes of two-week sequential and concomitant therapies for Helicobacter pylori eradication: a randomized pilot study. Helicobacter. 2013 Jun;18(3):180-6. doi: 10.1111/hel.12034. Epub 2013 Jan 11.
citation: Kim JS, Kim BW, Ham JH, Park HW, Kim YK, Lee MY, Ji JS, Lee BI, Choi H. Sequential Therapy for Helicobacter pylori Infection in Korea: Systematic Review and Meta-Analysis. Gut Liver. 2013 Sep;7(5):546-51. doi: 10.5009/gnl.2013.7.5.546. Epub 2013 Aug 14.
Clinical trial NCT04929184: Speech Processing in Stuttering
Official title: Speech Processing in Stuttering
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stuttering
Stuttering, Childhood
Stuttering, Adult
Keywords: Healthy children
Healthy Adults
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2021-06-18
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This research is being done to better understand stuttering, specifically how people who stutter may process and/or produce speech. Eligible participants enrolled will complete a variety of computer and speech-based tasks on up to 2 visits.

Detailed description: The study team will update the record to include the secondary identification number once the NIH has released the funds.

Eligibility criteria: Inclusion Criteria (adults who do not stutter):

* 18-65 years old
* English as primary language
* Normal speech, language, hearing, cognition

Exclusion criteria: (adults who do not stutter)

* Personal or family history of stuttering
* Major medical or psychiatric illness

Inclusion criteria: (adults who stutter)

* Aged 18-65 years
* English as primary language
* Normal speech, language, hearing, cognition (other than stuttering)
* Currently stutters

Exclusion criteria: (adults who stutter)

* Speech therapy within the past year
* Major medical or psychiatric illness

Inclusion criteria: (children who do not stutter)

* Aged 6 to 17 years
* English as primary language
* Normal speech, language, hearing, cognition

Exclusion criteria: (children who do not stutter)

* Personal or family history of stuttering
* Major medical or psychiatric illness
* Language/motor delay

Inclusion criteria: (children who stutter)

* Aged 6 to 17 years
* English as primary language
* Normal speech, language, hearing, cognition (other than stuttering)
* Currently stutters

Exclusion criteria: (children who stutter)

* Major medical or psychiatric illness
* Language/motor delay

Primary outcomes:
measure: Phase locking value (PLV) - Session 1 speech tasks
timeFrame: Session 1 (up to 4 hours)
measure: Phase locking value (PLV) - Session 2 speech tasks
timeFrame: Session 2 (up to 4 hours)
Secondary outcomes:
measure: Phase locking value (PLV) - Non-speech tasks
timeFrame: Session 1 (up to 4 hours)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: University of Michigan
name: Emily Garnett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01680484: Bitter Chocolate or Orange Juice for Non-reactive Non-stress Test (NST) Patterns
Official title: Bitter Chocolate Versus Orange Juice for Non-reactive Non-stress Test (NST) Patterns: A Randomized Prospective Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonreassuring Fetal Status
Keywords: non-stress test
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There are multiple factors affecting the variability and acceleration pattern of fetal heart rate (FHR) pattern. However, fetal activity is considered as the main determinant. Any factor decreasing fetal activity causes a decrease in FHR variability. Fetal activity may be stimulated by manual manipulation, sound, light, change in maternal position and maternal ingestion of glucose. Among those, ingestion of any kind of food or juice is most frequently practiced in outpatient settings. This is not only medical but also a social routine. In this study the investigators have chosen the two most popular so-called 'fetal accelerators', chocolate and orange juice against no intervention and tried to find any usefulness of these on non-reactive NST patterns.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancies at 36 to 41 completed gestational weeks that have a non-reactive NST pattern without decelerations.

Exclusion Criteria:

* multiple pregnancies, fetal anomaly, hypertension, intrauterine growth restriction, active labor, contractions or decelerations on NST, absence of a first or second trimester ultrasonography for accurate gestational dating, pre-gestational or gestational diabetes and known allergy to chocolate or orange

Primary outcomes:
measure: Increase in reactivity of NST
timeFrame: 30 minutes
Secondary outcomes:
measure: Increase in the maternal fetal movement perception
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Sami Ulus Maternity and Children's Training and Research Hospital
Study officials:
affiliation: Dr. Sami Ulus Maternity and Children's Training and Research Hospital
name: Sertac Esin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06767384: Diagnostic Accuracy of x Ray Kub in Diagnosing Renal Calculi Keeping CT Scan as Gold Standard
Official title: Diagnostic Accuracy of x Ray Kub in Diagnosing Renal Calculi Keeping CT Scan as Gold Standard
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Renal Calculi
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 235
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Aim is to check the Diagnostic Accuracy of x Ray Kub in Diagnosing Renal Calculi Keeping CT Scan as Gold Standard

Brief summary: In clinical practice both Xray and CT Scan KUB are reliable,however, Ctscan is superior to X ray KUB in detecting renal and ureteric calculi,the reson being stone that are missed by xray KUB are usually small and sould pass spontenously while other are usually with improper bowel preparation


Eligibility criteria: Inclusion Criteria:

* Female who will be advised X ray KUB and CT scan KUB for suspected renal \& uretrric calculi(flank pain )for \<24 hours .
* Age 18-49 years (because this is common age group for renal \&ureteric calculi).

Exclusion criteria:

* Female patients with pregnancy.
* Morbidly obese patients (Men\>129 kg women\>113kg)
* Patients with history of any abdominal trauma

Primary outcomes:
measure: multidetector computed tomography
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Mardan
country: Pakistan
facility: MTI-Mardan Medical Complex
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT06238284: HER2 Expression in Gynecological Malignant Tumors in Chongqing Area of China
Official title: HER2 Expression in Gynecological Malignant Tumors in Chongqing Area of China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Endometrial Cancer
Ovarian Cancer
HER2 Expression
Keywords: Cervical Cancer
Endometrial Cancer
Ovarian Cancer
HER2 Expression
Therapeutic efficacy
Prognosis
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with cervical adenocarcinoma (including carcinosarcoma), adenocarcinoma of uterus (including carcinosarcoma), or ovarian cancer, etc.

Brief summary: This study aims to retrospectively analyze the HER2 expression of gynecological malignant tumors in Chongqing by immunohistochemical detection, and explore the correlation between HER2 level, therapy response and prognosis based on patient clinical information.


Eligibility criteria: Inclusion Criteria:

* Patients with primary gynecological malignant tumor confirmed by histopathology
* Women aged 18-75
* The expected survival time is greater than 12 weeks
* KPS \> 60, ECOG score is 0-2
* All subjects voluntarily joined this study with informed consents, and had good compliance of follow-up

Exclusion Criteria:

* Pregnant and lactating women
* Suffering from other malignant tumors in the past 5 years
* Patients who are not suitable for this study according to the investigator's judgment

Primary outcomes:
measure: HER2 status
timeFrame: from 2023.07 to 2024.05
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: