louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00685386: A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholestasis
Keywords: endoscopic retrograde cholangiopancreatography
carbon dioxide
randomized controlled clinical trial
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Olympic Medical
name: National Institutes of Health (NIH)
First posted: 2008-05-28
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP).


Eligibility criteria: Inclusion Criteria:

* age \>= 18 years
* referred for ERCP for any indication at UNC Hospitals

Exclusion Criteria:

* age \< 18 years
* COPD requiring oxygen or with known CO2 retention
* any medical condition with known CO2 retention
* medical instability making the procedure unsafe
* absolute requirement for same-day second endoscopy
* ERCP performed in the OR or under GA
* inability to read or understand English
* use of chronic opiates for pain
* pregnant women

Primary outcomes:
measure: Abdominal pain (VAS).
timeFrame: pre-procedure and up to 24 hours post-procedure.
Secondary outcomes:
measure: The extent of CO2 retention.
timeFrame: Intra-procedure
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Evan S. Dellon, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dellon ES, Velayudham A, Clarke BW, Isaacs KL, Gangarosa LM, Galanko JA, Grimm IS. A randomized, controlled, double-blind trial of air insufflation versus carbon dioxide insufflation during ERCP. Gastrointest Endosc. 2010 Jul;72(1):68-77. doi: 10.1016/j.gie.2010.01.041. Epub 2010 May 20.
Clinical trial NCT03074786: Reversing the Epidemic in Africa With Choices in HIV Prevention (REACH)
Official title: A Phase 2a Crossover Trial Evaluating the Safety of and Adherence to a Vaginal Matrix Ring Containing Dapivirine and Oral Emtricitabine/Tenofovir Disoproxil Fumarate in an Adolescent and Young Adult Female Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: HIV-1-infection
Lead sponsor: International Partnership for Microbicides, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2017-03-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Phase 2a, open-label, multi-site, two-sequence, crossover, randomized trial
Primary purpose: PREVENTION

Brief summary: Participants will be randomized (1:1) to one of two sequences of a vaginal ring (VR) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg FTC/300 mg TDF oral tablets taken daily for 24 weeks. After completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. Participants will be able to choose either or neither study product every 4 weeks during the third product use period.

Detailed description: The MTN-034/IPM 045 trial is a multi-site, randomized, two-sequence, three-period, open-label, crossover Phase 2a trial. Young adult (18-21 years old) and adolescent (16-17 years old) female participants will be enrolled in a 2:1 ratio. All the enrolled participants will use both treatment regimens in sequence. All participants will be randomly assigned to one of two treatment regimen sequences to use for the first two study product use periods, and will be able to choose between treatment regimens during the third study product use period. The total length of follow-up is approximately one and a half years which includes up to 72 weeks of product use (two 24-week periods on randomized treatment regimen and one 24-week period on freely chosen treatment regimen) plus an additional week beyond the Period 3 end visit to collect data on any new or worsening AEs.

Eligibility criteria: Exclusion Criteria:

1. Become Pregnant and/or use oral PrEP outside the context of study.
2. At Screening or Enrollment, has a positive HIV test.

Inclusion Criteria:

1. Age 16 through 21 years at Enrollment, verified per site standard operation procedures.
2. Able and willing to provide adequate locator information and comply with all study procedural requirements.

Primary outcomes:
measure: Safety assessed by grade 2 or higher adverse event.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: CAPRISA, eThekwini Clinical Research Site
state: KwaZulu-Natal
Study officials:
affiliation: US National Institutes of Health (NIH)
name: Dianne M Rausch, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03142386: Osteopathic Manipulative Treatment in Oncology Patients' Management
Official title: Pain and Quality of Life Management in Oncology Geriatric Patients With Osteopathic Manipulative Treatment: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatric Oncology
Osteopathy in Other Diseases Classified Elsewhere
Keywords: geriatric oncology
pain
osteopathic manipulative treatment
quality of life
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 23
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of present study was to study the osteopathic manipulative effects on pain relief and quality of life improvement on hospitalized oncology geriatric patients. A non-randomized comparison trial was performed in Unit of Oncology Rehabilitation, Palazzolo Institute, Don Carlo Gnocchi Foundation ONLUS, Milan, Italy, from September 2015 to March 2016. 23 older oncology patients were unrolled and allocated in two experimental groups: study group (OMT group, N=12) underwent to osteopathic manipulative treatment associated to physiotherapy and control group (PT group, N = 11) underwent only physiotherapy. At enrollment (T0), 23 recruited oncology patients completed the socio-demographic forms and were evaluated, from external examiner, pain intensity and quality of life. All patients were revaluated at the end of treatment (T4) for quality of life and every week (T1, T2, T3 and T4) for pain intensity. Standard level of significance was p\<0.05.


Eligibility criteria: Inclusion Criteria:

* oncology patients
* male and female
* age≥65 years
* with a clinical prognosis of 6-24 months
* diagnosis of multifactorial hyperkinetic syndrome (i.e. metastatic surgery)
* pain intensity score higher than 3, measured with Numeric Rating Scale (NRS)

Exclusion Criteria:

* patients were receiving chemotherapy or radiotherapy treatment at the time of the study
* with mental disorders (MMSE\<10)
* the presence of infection
* anticoagulation therapy
* cardiopulmonary disease
* clinical instability post-surgery.

Primary outcomes:
measure: Pain
timeFrame: Once a week for a total 4 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: At baseline and up to 4 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Don Gnocchi Foundation
name: Chiara Arienti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arienti C, Bosisio T, Ratti S, Miglioli R, Negrini S. Osteopathic Manipulative Treatment Effect on Pain Relief and Quality of Life in Oncology Geriatric Patients: A Nonrandomized Controlled Clinical Trial. Integr Cancer Ther. 2018 Dec;17(4):1163-1171. doi: 10.1177/1534735418796954. Epub 2018 Aug 31.
Clinical trial NCT00732186: Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia
Official title: Phase Ib Study Evaluating the Safety and Exploring the Molecular and Cytogenetic Response of Combination Therapy With Dasatinib and Ipilimumab in Patients With Chronic or Accelerated Phase Chronic Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Leukemia, Myeloid, Chronic
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with CML


Eligibility criteria: Inclusion Criteria:

* Ph+ CML on dasatinib therapy
* Loss of cytogenetic or molecular response while on dasatinib therapy
* On stable dose of dasatinib for a minimum of 12 weeks and with \< 14 day interruption of treatment

Exclusion Criteria:

* Blast crisis CML
* Autoimmune disease
* Uncontrolled or significant cardiovascular disease

Primary outcomes:
measure: To evaluate the safety of ipilimumab in combination with dasatinib in CML patients with a loss of previously achieved major molecular response or a loss of previously achieved cytogenetic response to dasatinib
timeFrame: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
Secondary outcomes:
measure: To evaluate the frequency of molecular response, complete cytogenetic response and an overall efficacy signal response rate
timeFrame: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
measure: To explore the immunologic responses to combination therapy with ipilimumab and dasatinib
timeFrame: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
measure: To explore whether molecular responses to combination therapy with ipilimumab and dasatinib correlate with immunologic responses
timeFrame: At weeks 1, 4, 7, 10, 14, 18, 22, 26, 30, 34 and 38
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University Of Texas, M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03037463: Measuring Parkinson's Disease With Tear Fluid
Official title: Identification of Tear Biomarkers for Parkinson's Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson Disease
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 205
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will recruit participants with Parkinson's disease and controls from the Parkinson's Disease and Movement Disorder Center at the University of Southern California (USC) and from the surrounding community.

Brief summary: The purpose of this study is to assess whether tear secretion in patients with Parkinson's disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that will be reflected in changes in the protein composition of tear fluid, which can be measured relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be collected from Parkinson's patients, and through biochemical assays, the profile of proteins in tears will be characterized and compared to that from control subjects. The profiles will be analyzed with respect to any differences between Parkinson's patients and control subjects. If differences appear, the levels of these potential biomarkers in Parkinson's patients will be compared to the severity of their disease.


Eligibility criteria: Inclusion Criteria:

* established Parkinson's Disease for at least 6 months
* Healthy controls without neurological illness

Exclusion Criteria:

* currently taking anti-cholinergic medication
* dementia
* have an exposure to neuroleptic medications other than Quetiapine or Clozapine in the 6 months prior to screening
* have an active eye infection or have had eye surgery within 3 months prior to screening
* control subjects will be excluded if they have a history of neurological disease
* PD subjects will be excluded if they have an atypical Parkinsonian syndrome

Primary outcomes:
measure: Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
citation: Hamm-Alvarez SF, Janga SR, Edman MC, Feigenbaum D, Freire D, Mack WJ, Okamoto CT, Lew MF. Levels of oligomeric alpha-Synuclein in reflex tears distinguish Parkinson's disease patients from healthy controls. Biomark Med. 2019 Dec;13(17):1447-1457. doi: 10.2217/bmm-2019-0315. Epub 2019 Sep 25.
Clinical trial NCT05428163: Immunophenotyping of Plasma Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From Multiple Myeloma (MM) Patients
Official title: Immunophenotyping of Plasma Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From Multiple Myeloma (MM) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Immune response
Plasma cells
Multiple myeloma
Drugs targeting plasma cells
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Multiple myeloma without treatment

Brief summary: The objective of this study is to evaluate the immune profile of plasma cells and immune effector cells in paired peripheral whole blood and bone marrow samples from MM patients by standardized flow cytometry. The quantitative and/or qualitative variation of these immune effectors according to the different status of myeloma pathology (diagnosis, relapse or refractory). It is interesting to assess the extent to which a particular immune profile is associated with a better therapeutic response for a given treatment.

In addition, the study will validate the stability of the samples between T0 (\< 4 hours after sampling) and T0 + 72 hours.

Detailed description: Study the biomarkers recorded on plasma cells and normal leukocytes including T lymphocytes (naïve, effectors and memories), B lymphocytes, Treg, NK, monocytes as well as their activation markers (CD25, PD-1) in paired bone marrow and blood samples. Validate the pre-analytical stability of the samples between T0 (\< 4 hours after sampling) and T0 + 72 hours.

Secondary objectives: Validate the strategy of quantification of receptors on plasma cells by direct labeling in flow cytometry. Validate a new method for measuring receptor occupancy by a drug. Validate the pre-analytical stability of the absolute quantitative expression of the receptors and the specific marker CD138 on samples between T0 (\< 4 hours after sampling) and T0 + 72 hours.

The study will be enrolling 20 patients.

Eligibility criteria: Inclusion Criteria:

* Multiple myeloma without treatment

Exclusion Criteria:

-

Primary outcomes:
measure: immunophenotyped cells
timeFrame: day 0; day0+24hour; day 0+ 48hours; day0+72hours
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
Study officials:
affiliation: AP-HM
name: Regis Costello
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04766463: A Clinical Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.
Official title: A Phase III, Randomized, Double-Blind, Placebo- and Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-23
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with placebo and morphine in patients with acute postoperative pain following abdominal surgery


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia abdominal surgery
3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of difficult airway
2. Subjects with a history of reflux esophagitis
3. Subjects with a history of mental illness
4. Subjects with poor blood pressure control
5. Transcutaneous oxygen saturation (SpO2) \<90%
6. Random blood glucose ≥11.1mmol/L
7. Subjects with abnormal liver function
8. allergies to opioids and other medications that may be used during the trial
9. Pregnant or nursing women

Primary outcomes:
measure: the Sum of Pain Intensity Differences in Pain Score Over 24 Hours
timeFrame: 24-hours
Secondary outcomes:
measure: the Sum of Pain Intensity Differences in Pain Score Over 6、12、18 、12-18 Hours
timeFrame: 6-hours、12-hours、18-hours、12-18 hours
measure: Time of first use of remedial analgesic medication
timeFrame: 24-hours
measure: Cumulative use of remedial analgesics from 0h to 24h
timeFrame: 24-hours
measure: Participant ' satisfaction score for analgesia treatment
timeFrame: 24-hours
measure: Investigator satisfaction score for analgesia treatment
timeFrame: 24-hours
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology
state: Wuhan
Study officials:
References:
Clinical trial NCT03324763: Performances of a Fast Test for the Detection of Helicobacter Pylori Antigens in Child Stool
Official title: Study of the Performances of a Fast Diagnosis Immunochromatographic Test for the Detection of Helicobacter Pylori (H. Pylori) Antigens in Child Stool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Hôpital Cochin
First posted: 2017-10-30
Enrollment: 158
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with various digestive symptoms suggesting upper gastrointestinal tract disease consulting at Saint Antoine paediatric clinic, Saint Vincent de Paul Hospital, Lille-France.

Brief summary: The diagnostic tests used to detect Helicobacter pylori (H. pylori) infection are either direct and invasive, as in culture, histology and the rapid urease test (RUT) or noninvasive, such as serology, the 13C-Urea breathe test or the stool antigen test. However, there is no single reference method to detect the H. pylori infection reliably and accurately. The specificity of gastric biopsy cultures is 100%, but the sensitivity is lower. Histology and RUT provide excellent diagnostic accuracy, but the detection of H. pylori is decreased in cases of bleeding peptic ulcers or gastric atrophy. Therefore, it is recommended that at least two tests should agree when defining the H. pylori infection in children. Quantitative real-time polymerase chain reaction (qPCR)-based methods have been shown to be the most reliable for H. pylori detection in adults and in children. In children, the reference method for H. pylori infection detection is invasive, namely upper digestive endoscopy with gastric biopsy for histology, culture, RUT and qPCR. A noninvasive alternative to detect H. pylori antigen in stools could use a quick one-step immuno-chromatographic technique.

The aim of this study was to assess the performance of a new quick, noninvasive, one-step immuno-chromatographic, stool antigen test (ALERE Inc, Jouy-en-Josas, France) for the detection of H. pylori infection in children.


Eligibility criteria: Inclusion Criteria:

* Children \<18 years old
* All children undergoing a high digestive endoscopy with per-endoscopic gastric biopsies.
* Informed consent of parents and children

Exclusion Criteria:

* Children having received an antibiotic treatment 4 weeks before inclusion
* Children having received Proton pump inhibitors 2 weeks before inclusion
* Children having received Bismuth salts 2 weeks before inclusion

Primary outcomes:
measure: Performance of a new quick, noninvasive, one-step immuno-chromatographic, stool antigen test France) for the detection of H. pylori infection in children
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul
state: Hauts de France
Study officials:
References:
Clinical trial NCT05755763: Validity and Reliability of the Turkish St. Marks Incontinence Score
Official title: Validity and Reliability of the Turkish St. Marks Incontinence Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Pelvic Floor Disorders
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who were diagnosed with anal incontinence in our clinic will be included in the study. Persons who have difficulties in understanding and writing Turkish will be excluded from the study. Patients will fill out the St. Mark's Incontinence Score.

Brief summary: For the Turkish validity and reliability study of St.Mark's (Vaizey) Incontinence Score, which consists of 7 questions, it will be applied to 65 people diagnosed with anal incontinence after it is translated by translation-retranslation method.


Eligibility criteria: Inclusion Criteria:

* people with the complatint of anal incontinence
* being volunteered to participate

Exclusion Criteria:

- having difficulties in understanding and speaking Turkish

Primary outcomes:
measure: Turkish Validation and Reliability of St. Mark's Incontinence Score
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Atakent University Hospital
Study officials:
References: