louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03358316: Correlation Analysis Between Rotator Cuff Tear and the Superior Migration of Humeral Head
Official title: Correlation Analysis Between Rotator Cuff Tear and the Superior Migration of Humeral Head
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotator Cuff Tear
Keywords: Rotator Cuff Tear
Magnetic Resonance Imaging
humeral migration
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients with cuff tear

Brief summary: To evaluate the association between rotator cuff tear and the proximal migration of humeral head

Detailed description: In this research, 60 patients with unilateral rotator cuff tear in Peking University People's Hospital in 2018 are planned to be recruited .They will receive Magnetic Resonance Imaging(MRI) and X-ray of the painful shoulder before enrollment in this study, the duration between the two examinations was no longer than 1 week, also there is no past history of surgery in the selected shoulders. There is no other exclusion criteria. Upward Migration Index(UMI) is the ratio between the distance of humeral head center to the lower surface of acromion, and the radius of humeral head circle. It can help to minimize the effect of anatomy difference and imaging magnification, compared with the traditional acromiohumeral distance(AHD). Then we use the Spearman correlation analysis to evaluate the relationship between UMI and fatty degeneration, rotator cuff tear size and the thickness of ruptured supraspinatus tendon from X-ray and MRI.

Eligibility criteria: Inclusion Criteria:

* Patient receive Magnetic Resonance Imaging half year before enrollment, showing supraspinatus tear
* Patient receive X-ray half year before enrollment
* the duration between the two examinations was no longer than 1 week
* no past history of surgery in the selected shoulders

Exclusion criteria:

* patients who cannot receive MRI.

Primary outcomes:
measure: Correlation between rotator cuff tear size and the superior migration of humeral head
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between rotator cuff fatty degeneration and the superior migration
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Yichong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03165916: Study to Compare the Incidence of Biliary Complications After Liver Transplantation
Official title: A Randomized Controlled Prospective Study to Compare the Incidence of Biliary Complications After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant; Complications
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized prospective study will be conducted of patients at Vanderbilt University Medical Center who undergo liver transplantation from March 2014 until approximately 120 patients are randomized. Patients will be randomized to undergo biliary reconstruction with and without stent placement.

Detailed description: The risk of biliary complications can be related to the type of liver transplant performed and the technique used for reconstruction of the bile duct. One of the main techniques of performing biliary reconstruction is a choledocholedochostomy which can be performed over an anastomotic stent. Although placement of biliary stents is routine practice in many liver transplant centers around the country, there is no clear evidence to support their use. As of now both the placement and non-placement of a stent are essentially "standard of care". In the investigators' center, many of the transplant surgeons now perform the biliary anastomosis over a pediatric feeding tube which is used as a stent. The practice of using stents in biliary anastomosis is not uniform and there are no established guidelines to support their indiscriminate application. The investigators have designed a prospective randomized trial to evaluate the effect of stent placement on biliary complications and its effect on morbidity.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* will be undergoing liver transplantation
* able to give informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Number of Participants With Biliary Complications
timeFrame: 6 months after transplantation
measure: Number of Participants With Biliary Complications
timeFrame: 12 months after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Medical Center Liver Transplant Clinic
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Andrew Scanga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060616: Validation of Hemorrhoidal Bleeding Score
Official title: Validation of Hemorrhoidal Bleeding Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhoid Bleeding
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 130
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: every patient consulting for hemorrhoidal bleeding

Brief summary: The principal manifestation of hemorrhoidal disease is bleeding; however the severity evaluation is today based on prolapsus (Goligher classification) and bleeding factor is not included.

Even if there was some rare score including bleeding in literature , none of them were validated.

The aim of the study is first validation of bleeding score .


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* consulting for hemorroidal bleeding
* accept to participate

Exclusion Criteria:

* paraplegic or hemiplegic patient
* Misunderstanding of the French language

Primary outcomes:
measure: assessment of bleeding score
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: CRC
name: Hélène BEAUSSIER, Pharm-D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06870916: Supporting Informed Decision Making About Multi-cancer Early Detection Testing
Official title: Supporting Informed Decision Making About Multi-cancer Early Detection Testing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multi-cancer Early Detection
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: To develop a new participant educational aid that can be used by participants to support informed decision-making about Multi-Cancer Early Detection (MCED) tests, which are new blood-based screening tests.

Detailed description: To develop a prototype participant educational aid that can be used by participants to support informed decision making about MCED testing. The aims of the pilot project include the following:

1. Conduct focus groups to explore preferences and concerns about MCED testing among adults of screening age.
2. Based on salient themes from focus group discussion, develop and administer surveys to explore preferences and concerns about MCED testing among adults of screening age.
3. Using findings from the focus groups and surveys, develop prototype patient educational aids about MCED testing following a user-centered design strategy.

Eligibility criteria: Inclusion Criteria:

• Recruitment and eligibility will be assessed by CCETR.CCETR staff will help distribute recruitment flyers, assess subject eligibility, and refer eligible subjects to the research team (Appendix B, C \& I).

Exclusion Criteria:

• History of cancer other than basil cell and squamous cell skin cancer, per self-report.

Primary outcomes:
measure: Safety and Adverse Events (AEs)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert Volk, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780416: Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
Official title: A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Treatment-Naïve Subjects With Genotype 1 Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C
Protease Inhibitor
Telaprevir
Peginterferon Alfa-2b
Ribavirin
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2008-10-27
Enrollment: 189
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.


Eligibility criteria: Inclusion Criteria:

* Genotype 1, chronic hepatitis C
* Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia; or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Primary outcomes:
measure: The Percentage of Subjects Achieving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
timeFrame: After 24 weeks of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Kawasaki City
country: Japan
facility: Toranomon Hospital
state: Takatsu-ku
Study officials:
affiliation: Department of Hepatology, Toranomon Hospital
name: Fumitaka Suzuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumada H, Toyota J, Okanoue T, Chayama K, Tsubouchi H, Hayashi N. Telaprevir with peginterferon and ribavirin for treatment-naive patients chronically infected with HCV of genotype 1 in Japan. J Hepatol. 2012 Jan;56(1):78-84. doi: 10.1016/j.jhep.2011.07.016. Epub 2011 Aug 7.
Clinical trial NCT06743516: External Pancreatic Stent in Pancreaticojejunostomy
Official title: The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Fistula
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 100
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: PREVENTION

Brief summary: Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend pancreatic stent in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula and to investigate its long term clinical outcomes.

Detailed description: The role of external pancreatic duct drainage in managing patients with a soft pancreas is particularly important, as these patients are at a heightened risk of developing postoperative complications. By providing an external route for pancreatic secretions, external pancreatic duct drainage may help to reduce the enzymatic activity at the anastomosis site and promote better healing.

In addition to reducing the incidence of post operative pancreatic fistula, external pancreatic duct drainage may have other potential benefits, such as decreasing the length of hospital stay, reducing the need for additional interventions, and improving overall patient quality of life. However, these potential benefits must be weighed against the risks and drawbacks of external pancreatic duct drainage, including the potential for stent-related complications and the need for an additional procedure to remove the stent.

•After being informed about the study and potential risks, all patients giving written consent. Patients who meet the eligibility requirements will be randomized in a 1:1 ratio to external pancreatic drainage group and no external pancreatic drainage group.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing pancreaticoduodenectomy (Whipple procedure) for various indications (e.g., pancreatic cancer, ampullary cancer, etc.).
* Patients with a confirmed soft pancreas texture, as determined intraoperatively by the surgeon.

Exclusion Criteria:

* Patients with a hard or fibrotic pancreas, as determined intraoperatively by the surgeon.
* Patients with severe uncontrolled comorbidities (e.g., uncontrolled diabetes, severe cardiovascular disease, renal failure).
* Pregnancy or lactation.

Primary outcomes:
measure: evidence of pancreatic fistula
timeFrame: within the first 7 days after surgery( first day, third day and fifth day)
Secondary outcomes:
measure: evidence of intra abdominal collection
timeFrame: first week, second week postoperative
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Liver and GIT hospital , Minia University
Study officials:
affiliation: Minia University
name: Saleh K Saleh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04189016: Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation
Official title: Nasal Muco-ciliary Clearance Study With and Without Salt Inhalation Via a Salt Particle Inhaler at COPD, Asthma and Healthy Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Airway Diseases
Lead sponsor: Liita Care ApS
Sponsor class: INDUSTRY
First posted: 2019-12-06
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Investigating nasal muco-ciliary clearance by scintigraphy

Detailed description: The velocity and the retention of the nasal muco-ciliary clearance is going to be investigated with a salt particle inhaler and a placebo by the method nasal scintigraphy.

The hypotheses is that nasal inhalation of salt particles enhance the nasal mucociliary clearance.

Eligibility criteria: Inclusion Criteria:

* COPD patients (all severities in chronic, stable condition)
* Asthma patients (in stable condition without acute asthma symptoms)
* Healthy subjects, incl. smokers (no chronic nasal, upper or lower respiratory diseases)

Exclusion Criteria:

* Age under 18 years
* Upper respiratory tract infection / cold within the last 3 weeks and at least 3 weeks must pass from the person has become well to the examination
* Allergic / non-allergic rhinitis (hay fever)
* Chronic sinusitis
* Acute respiratory tract infection in antibiotic therapy
* Applied salt inhalation within the past month
* Pregnant or breastfeeding women
* Nuclear medical examination within the past month
* Cannot taste saccharin

Primary outcomes:
measure: Nasal Mucociliary Clearance
timeFrame: At study day 1 and 2
measure: Nasal Mucociliary Clearance
timeFrame: At study day 1 and 2
Secondary outcomes:
measure: Spirometry
timeFrame: At the beginning and the end of study day 1 and 2
measure: Saccharin test
timeFrame: At study day 1 and 2
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Clin nuclear and physiolog dept.
Study officials:
References:
Clinical trial NCT02523716: Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity
Official title: Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypoxia
Keywords: Hypoxic conditioning
Cardio pulmonary exercise testing
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2015-08-14
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To determine if exposure of older volunteers, age 50-70y, who are healthy, but not physically active, to 7 days of mild hypoxia (15% oxygen, equivalent 2440m) will improve cardiopulmonary functional capacity.

Detailed description: Background There is an urgent need to reduce morbidity and mortality following major surgery. Bodily demands for oxygen increase after major surgery, and postoperative outcomes can be predicted by quantifying the body's ability to meet increased mitochondrial demand for oxygen using cardiopulmonary exercise testing (CPET).

Design This is a preliminary, physiological study to establish the baseline relationship between mild hypoxia exposure and cardiopulmonary function. This study will begin to examine the feasibility and potential for achieving risk modification through low-oxygen (hypoxic) conditioning, in which a safe and convenient "dose" of mild hypoxia is used to improve CPET derived variables that predict mortality following surgery.

The study will use a randomised, double blind, sham-controlled, crossover design. After a baseline CPET test, participants will be exposed to 7 days of either mildly hypoxic or normoxic air. A follow up CPET test will then be used to determine if cardiopulmonary functional capacity increased after exposure. After a two week washout period, participants will return for a second 7-day session where the alternate exposure will be given. A final follow-up CPET test will then be performed.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female individuals aged 50-70 years with sedentary lifestyles.

Exclusion Criteria:

* Known intolerance to altitude identified by the participant's clinical examination, history and pre-altitude screening completed by the research clinician.
* Non-availability and/or suitability to complete the required residential period within the altitude centre.

Primary outcomes:
measure: Change in Cardio pulmonary functional variables
timeFrame: Change in Cardio pulmonary functional variables between day 0 and day 7 in each arm of the study.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Oxford
name: Thomas Smith (Chief Investigator), MBBS, DPhil, FRCA, FAsMA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Limerick
name: Phillip Jakeman, BSc, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02696616: Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 655088 Administered by Intravenous Infusion in Healthy Male Subjects (Single-blind, Partially Randomised Within Dose Groups, Placebo-controlled, Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-03-02
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation of safety and tolerability of BI 655088 following intravenous infusion of single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088 after single dosing


Eligibility criteria: Inclusion criteria:

* Healthy male subjects
* Age of 18 to 50 years
* Body mass index (BMI) of 18.5 to 29.9 kg/m2
* Additional inclusion criteria may apply

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (including but not limited to any kind of seizures and stroke), and other relevant neurological disorders or psychiatric disorders
* Additional exclusion criteria may apply

Primary outcomes:
measure: Number of Subjects With Drug-related Adverse Events
timeFrame: up to 99 days after start of drug administration
Secondary outcomes:
measure: Maximum Measured Concentration of BI 655088 in Plasma (Cmax)
timeFrame: Up to 2016 hours. See endpoint description for a detailed timeframe.
measure: Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
timeFrame: Up to 2016 hours. See endpoint description for a detailed timeframe.
measure: Area Under the Concentration-time Curve of BI 655088 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
timeFrame: Up to 2016 hours. See endpoint description for a detailed timeframe.
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: SGS Life Science Services - Clinical Research
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: