louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02280499: Multicenter Clinical Observation PROMOS®
Official title: Multicenter Clinical Observation PROMOS®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary and Secondary Omarthrosis
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 87
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: Primary care clinic

Brief summary: Overall study design:

This study is a prospective, multicenter, postmarket clinical observation to validate the PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder arthroplasty in terms of radiographic and clinical performance as well as long-term survivorship over 10 years.

Detailed description: Primary objective:

Radiological and clinical loosening rates of the glenoid and humeral components must be comparable or below the rates of other well documented state-of-the-art shoulder systems with cemented glenoid components. Complications occurring intra- or postoperatively will be assessed and sub-classified in their relation to the implant.

At the end of the observation, a long-term survival rate will be calculated according to Kaplan-Meier with revision due to aseptic loosening as the end-point.

Secondary objectives:

The Constant Murley score and the ASES clinical evaluation are used for documenting the improvement in pain, function and range of motion. For the patient's subjective view of improvement in function a patient self-assessment form is used.

Eligibility criteria: Inclusion Criteria:

* patient has no general medical contraindication to surgery
* informed consent to participate in the observation signed by the patient
* routine radiographic assessment is possible
* patient is likely to comply with study follow-up requirements
* primary total- or hemi-shoulder-arthroplasty to the affected side, unilateral or bilateral

Exclusion Criteria:

* acute shoulder trauma
* tumor / malignoma
* avascular necrosis
* late stage rotator cuff disease
* Charcot joint disease or other severe neurosensory deficits
* high comorbidity
* previously failed shoulder arthroplasty
* fracture sequelae of proximal humerus
* hypersensitivity to the implant materials used
* addictive disorders such as alcohol or drug abuse
* severe spinal disorders
* bacterial infections

Primary outcomes:
measure: Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components
timeFrame: up to 10 years
Secondary outcomes:
measure: Constant Murley Score
timeFrame: 10 Years
measure: ASES Shoulder Score Index
timeFrame: 10Years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00821899: Bone Marrow Autotransplantation in Type 1 Diabetes
Official title: Regeneration of Insulin Production in Patients With Type 1 Diabetes by Autologous Bone Marrow Blood Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: diabetes type 1
bone marrow transplantation
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project evaluates the effectiveness of the administration of autologous bone marrow blood in patients with brittle type 1 diabetes mellitus to restore insulin secretion. After mobilization of hematopoietic progenitors (G-CSF) during 3 days, 50 to 90 mL of bone marrow blood will be obtained by multifunction in the posterior iliac crest. The material obtained will be implanted into the pancreas through the magna pancreatic artery after femoral catheterization.


Eligibility criteria: Inclusion Criteria:

* diabetes type 1 patients
* 18 to 50 years of age
* more than 5 years of evolution of the disease
* brittle diabetes (HbA1c \> 8.5 % with intensified treatment or severe hypoglycemia episodes

Exclusion Criteria:

* history of cancer
* hematologic alterations
* infectious disease positivity (HIV, HCV etc.)
* diabetic nephropathy
* cardiac failure
* liver disease
* autoimmune systemic disease
* allergy to iodine contrast or anesthesia

Primary outcomes:
measure: Evaluate glycosylated hemoglobin 1,3,6, and 12 months after autologous bone marrow blood administration.
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate number of hypoglycemias 1,3,6, and 12 months after autologous bone marrow blood administration.
timeFrame: 12 months
measure: Evaluate insulin dose 1,3,6, and 12 months after autologous bone marrow blood administration.
timeFrame: 12 months
measure: Evaluate GADab titers and treatment tolerance 1,3,6, and 12 months after autologous bone marrow blood administration.
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Enric Esmatjes
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Esmatjes Enric, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Esmatjes E, Montana X, Real MI, Blanco J, Conget I, Casamitjana R, Rovira M, Gomis R, Marin P. Regeneration of insulin production by autologous bone marrow blood autotransplantation in patients with type 1 diabetes. Diabetologia. 2010 Apr;53(4):786-9. doi: 10.1007/s00125-010-1660-9. Epub 2010 Jan 26. No abstract available.
Clinical trial NCT01811199: Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels
Official title: Dexamethasone Reduces Postoperative Emesis by Decreasing PGF2α and LTC4 Levels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Cancer
Breast Cancer
Keywords: Thyroid cancer
Breast cancer
Dexamethasone
Emesis
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing thyroidectomy and mastectomy

Brief summary: Hypothesis: Dexamethasone reduces postoperative emesis in thyroidectomy and mastectomy patients.

Detailed description: This study has been done to further study the effectiveness of dexamethasone in the prevention of postoperative emesis after breast and thyroid surgery and at the same time, the mechanism of action was investigated. In this prospective, randomized controlled trial it was hypothesized that corticosteroids exert their antiemetic effects in postoperative period via plasma prostaglandin F2 alpha (PGF2 α) and plasma leukotriene C4 (LTC4) inhibition.

Eligibility criteria: Inclusion Criteria:

* breast and thyroid cancer patients no neoadjuvant treated no NSAID or steroid usage heallthy volunteers, signed the informed consent

Exclusion Criteria:

* ones who did not sign the consent form NSAID or steroid users

Primary outcomes:
measure: Number of participants will be evaluated to show effect of dexamethasone in reducing postoperative emesis
timeFrame: up to 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
Study officials:
affiliation: Marmara University
name: A.Ozdemir Aktan, MD,prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06866899: Axillary Block or Wide-awake Local Anesthesia for Complex Regional Pain Syndrome (CRPS) Following Common Hand Surgeries
Official title: Comparison of Axillary Block Regional Anesthesia and Wide-awake Local Anesthesia No Tourniquet (WALANT) Anesthesia in the Incidence of Complex Regional Pain Syndrome (CRPS) Following Common Hand Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CRPS
Walant
Axillary Block
Keywords: CRPS
flare reaction
WALANT
axillary block
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 98
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: atients diagnosed with and operated on for Dupuytren contracture (DC), De Quervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), or trigger finger (TF)

Brief summary: Flare reaction, characterized by excessive erythema, stiffness, and edema postoperatively, can lead to complex regional pain syndrome (CRPS) when pain is present. This study compares flare and CRPS incidence following hand surgeries performed under regional anesthesia with axillary block (RAAB) and WALANT (Wide-Awake Local Anesthesia No Tourniquet).

Detailed description: This two-center prospective study included patients undergoing Dupuytren contracture (DC), DeQuervain tenosynovitis (DQS), carpal tunnel syndrome (CTS), and trigger finger (TF) surgeries under RAAB or WALANT. Diagnostic criteria for flare and CRPS (pain, weakness, scar issues, erythema, and swelling) were assessed, and comorbidities were noted. The incidence of flare reactions and CRPS was compared for RAAB and WALANT.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with and operated on for Dupuytren contracture (DC),
* Patients diagnosed with and operated on for De Quervain tenosynovitis (DQS),
* Patients diagnosed with and operated on for carpal tunnel syndrome (CTS),
* Patients diagnosed with and operated on for trigger finger (TF)

Exclusion Criteria:

* Patients operated under general anesthesia,
* Patients operated with other types of regional anesthesia (eg: supraclavicular block),
* Patients operated with other types of local anesthesia (only prilocaine or bupivacaine)
* Patients less than 3 months follow up

Primary outcomes:
measure: CRPS severity score (CSS)
timeFrame: Postoperative first month
measure: CRPS severity score (CSS)
timeFrame: Postoperative third month
Secondary outcomes:
measure: Flare reaction
timeFrame: Postoperative first month
measure: Flare reaction
timeFrame: Postoperative third month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
state: Altındağ
Study officials:
References:
Clinical trial NCT02882399: Shortystrap Effectiveness in the Treatment of the Pathology Pubic and Abdominal Pathology in Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pubic and Abdominal Pathology
Keywords: athletes
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The pubic and abdominal pathology is common among athletes. It leads to a shutdown of physical activity for several months, and requires rehabilitative care, or surgery for a permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of sports.


Eligibility criteria: Inclusion Criteria:

* Male
* Sports practicing physical activity at least 3 hours per week
* Practicing a team sport with a major part of running (football, rugby, ...)
* Presenting a pubic and abdominal pathology for at least 4 weeks
* In primary consultation
* Age from 18 to 40 years
* Informed consent signed

Exclusion Criteria:

* Professional athlete
* Cyclist
* Having already received usual medical treatment (anti-inflammatory treatment and rest)
* Introducing another disease requiring treatment with NSAIDs
* Allergy neoprene
* Contraindications to performing MRI (claustrophobia, any metal device, pacemaker, etc.)
* Simultaneous participation in another biomedical research
* Major person under legal protection (backup justice, trusteeship, guardianship), person deprived of liberty.

Primary outcomes:
measure: Evaluation of pain using a scale Feretti
timeFrame: Day 15
Secondary outcomes:
measure: Evaluation of pain using a visual analog scale
timeFrame: Day 15, Day 30 and Day 60
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Rennes
name: Pierrick GUILLEMOT, Md
role: STUDY_DIRECTOR
References:
Clinical trial NCT03914599: Protective Genetic Factors Against Neurological Diseases
Official title: Protective Genetic Factors Against Neurological Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Disorder
Healthy Control
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurology clinic for participants with a diagnosis of a neurological disorder and fliers will be posted for healthy controls

Brief summary: NIH Precision Medicine Initiative, started in May 2018, will enroll one million people through an online portal. It hopes to identify genetic variants affecting a variety of human phenotypic outcomes. A giant set of data like this may enable an association of genetic variants with a certain phenotype. However, the association is often compromised due to the collection of phenotypic data that is not well controlled or standardized creating "noisy" data. These phenotypic "noises" can be largely eliminated in clinical studies with stringent criteria and standardization of outcome measurements.

In this study, by looking mainly at genetic information and nerve conduction speed, we hope to eliminate the extra "noises" in the data set. Eliminating the extra "noises" should allow us to be able to determine if there are genetic differences between neurological disorders and healthy controls, and if these genetic differences can be attributed to the speed of the nerve conduction.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of a neurological disorder - Inherited Peripheral Neuropathy, Charcot Marie Tooth, Multiple Sclerosis, or Parkinson's Disease
2. Healthy volunteers with no history of medical conditions known to afflict the nervous system will be recruited as normal controls.
3. Age 18-100 (Inclusive)
4. Able to undergo MRI
5. Medically Stable

Exclusion Criteria:

1. Any subject unwilling to undergo genetic testing (DNA sampling)
2. Any subjects with history of peripheral nerve diseases or conditions known to affect the CNS, such as diabetes, stroke, thyroid disease, chemotherapy, renal failure, etc.

Note: This study holds no additional risk for pregnant women and they will not be excluded.

Primary outcomes:
measure: Association of human genetic variants with the fastest conduction speed in normal controls
timeFrame: 5 years
measure: The cluster of genetic variants associated with the fastest conduction velocity in normal controls versus those altered in patients with neurological diseases will be characterized
timeFrame: 5 years
measure: To test if the genetic variants associated with the fastest CV in the PNS protect some patients with CMT1A from developing severe disabilities
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References:
Clinical trial NCT01012999: A Dosing and Efficacy Study of Intra-nasal Sufentanil for Moderate to Severe Pain
Official title: Pain Control and Patient Satisfaction: a Dosing Study to Determine a Safe and Effective Dose of Intra-nasal Sufentanil to Treat Emergency Department Patients With Moderate to Severe Pain Due to Extremity Trauma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Pain
Opiate
Keywords: acute pain, intranasal, sufentanil,
Acute pain control with an intranasal opiate
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the appropriate dose and effectiveness of intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to severe pain due to broken bone(s) in the arm or leg.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older;
* isolated traumatic injury to upper or lower extremity;
* alert and oriented to name, date, place; patient has a numeric pain score of 5 or higher;
* speaks English as their primary language;
* female patients are on birth control, menopausal, or are sterile (hysterectomy, tubal ligation)

Exclusion Criteria:

* injury isolated to a finger or toe;
* previous nasal or sinus surgery; chronic nasal problem;
* acute nasal problem (ie epistaxis, upper respiratory infection, sinusitis);
* pregnant; prisoner; allergy to sufentanil, fentanyl, or alfentanil; history of analgesic abuse or dependency;
* presence of other painful injuries; systolic Blood Pressure less than 100 mm Hg;
* patient seems or is confused or has a head injury; room air oxygenation less than 95%;
* patient has chronic obstructive pulmonary disease, severe asthma, oxygen-dependent pulmonary disease;
* impaired hepatic or renal function (obtained clinically or by history);
* weight more than 230 lbs (100 kg);
* alcohol or drug intoxication (per patient admission or clinical assessment of physician);
* elderly (\> 70 years)

Primary outcomes:
measure: Pain Relief at Thirty Minutes
timeFrame: 30 min post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: University of Utah
name: Robert Stephen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01487499: Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)
Official title: Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung cancer in two fashions:

1. to implement a prospective clinical trial to test the feasibility and efficacy of intralesional chemotherapy as consolidative therapy immediately following standard systemic chemotherapy and radiation therapy for patients with limited stage SCLC by comparing tumor growth and survival rates of the treatment group and compare the outcomes to historical controls
2. to implement a prospective clinical trial to test the feasibility and efficacy as measured by tumor growth and survival rates of intralesional chemotherapy for patients with recurrent SCLC after standard treatment.

Detailed description: Subjects will receive standard of care treatment for SCLC with added treatment of Cisplatin injection via endobronchial ultrasound aided bronchoscopy a total of four times. Outcome measurements of tumor growth and survival will be compared to subjects receiving standard of care treatment only.

Eligibility criteria: Inclusion Criteria: Competent adult English speaking subjects

* With limited stage SCLC who have completed standard of care treatment who are responders with no evidence of disseminated disease other than CNS metastasis,
* With recurrent disseminated SCLC after standard of care treatment with symptoms related to central tumor obstruction,
* With recurrent limited stage SCLC with mediastinal/hilar recurrence not previously treated with intratumoral cisplatin

Exclusion Criteria:

* Subjects who do not meet the inclusion criteria
* Subjects who, in the opinion of the investigator, are at risk undergoing a bronchoscopy

Primary outcomes:
measure: Solid Tumor Growth After Completion of Interventional Bronchoscopies
timeFrame: 18 months
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 18 months
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michael A. Jantz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03185299: Impact of Reinforced Education by Video on the Quality of Bowel Preparation
Official title: Impact of Reinforced Education by Video on the Quality of Bowel Preparation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Preparation Scale
Adenoma Detection Rate
Keywords: Polyp detection rate
Adenoma detection rate
Boston Bowel Preparation Scale
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of reinforced education by Video on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. Reinforced education groups received additional education via reminders by video 2 days before colonoscopy. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.


Eligibility criteria: Inclusion Criteria:

* outpatients aged 18-80 years
* referred for routine diagnostic colonoscopy
* with access to the educational video themselves or through close family members living in the same household were eligible.

Exclusion Criteria:

1. pregnancy or breastfeeding
2. allergy to purgatives
3. suspected intestinal obstruction, stricture, or perforation
4. hemodynamic instability
5. impaired swallowing reflex or mental status
6. severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure
7. illiteracy
8. history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery
9. participation declined.

Primary outcomes:
measure: Boston Bowel Preparation Scale
timeFrame: 2 days
Secondary outcomes:
measure: Polyp detection rate
timeFrame: 2 days
measure: Adenoma detection rate
timeFrame: 2 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Yu, Prof
role: STUDY_CHAIR
References:
citation: Rice SC, Higginbotham T, Dean MJ, Slaughter JC, Yachimski PS, Obstein KL. Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial. Am J Gastroenterol. 2016 Nov;111(11):1564-1571. doi: 10.1038/ajg.2016.450. Epub 2016 Oct 18.