louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01781494: Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition
Official title: Immobilization Versus Immediate Motion After Anterior Submuscular Ulnar Nerve Transposition: Affect on Flexor-pronator Integrity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cubital Tunnel Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-02-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test the hypothesis that immediate elbow motion is safe after anterior submuscular ulnar nerve transposition, and will not result in disruption of the repaired flexor pronator origin, under which the nerve is placed. The advantages of immediate elbow motion after submuscular ulnar nerve transposition for performing activities of daily living and self-care are evident, however theoretical advantages include early "gliding" of the transposed ulnar nerve with a lower risk of nerve adhesions and subsequent traction neuritis, as well as improved blood flow and quicker, more complete, recovery of nerve function.

A group of 44 consecutive patients that are determined to be candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing will be prospectively randomized to either immediate motion or long arm cast immobilization after surgery. All patients will be counseled about the two postoperative treatment options (immobilization followed by protected range of motion versus immediate range of motion), risks involved with each treatment protocol, postoperative follow-up and need for radiographs. If they choose not to participate, they will be treated by the same postoperative protocol currently used by the principal investigator: arm sling at rest for six weeks with intermittent active assisted range of motion exercises.


Eligibility criteria: Inclusion Criteria:

* Candidates for anterior submuscular ulnar nerve transposition based on history, positive findings on physical examination, and confirmatory electrodiagnostic testing in Mayo Clinic Arizona

Exclusion criteria:

* Pregnancy
* Patients who have had prior ulnar nerve surgery
* Patients with other documented neurogenic processes identified on electrodiagnostic studies (ie: peripheral neuropathy, cervical radiculopathy, carpal tunnel syndrome)
* Workman's compensation patients
* Subluxing ulnar nerve
* Elbow contracture or stiffness
* Negative electrodiagnostic studies

Primary outcomes:
measure: Change in the distance between the ligaclips on lateral elbow radiographs
timeFrame: Baseline to 3 months post-operatively
Secondary outcomes:
measure: Isokinetic strength testing of elbow flexion, forearm pronation, and wrist flexion
timeFrame: Baseline to 3 months post-operatively
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Kevin Renfree, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01780194: Lumbar Fusion Compared With Conservative Treatment in Patients With Chronic Low Back Pain: a Meta-analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comparison Between Effectiveness of Lumbar Fusion and Conservative Treatment
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2013-01-30
Enrollment: 666
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: People with chronic low back pain due to degenerative spinal conditions

Brief summary: * To determine the effect size of lumbar fusion measured by Oswestry Disability Index and compared with conservative treatment in patients with chronic low back pain.
* Meta-analysis using fixed effect model synthesis method.
* Included studies were retrieved from Medline and Cochrane CENTRAL databases since 1990.


Eligibility criteria: Inclusion Criteria:

* controlled randomized or non-randomized studies

Exclusion Criteria:

* not specified

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Turku University Hospital
name: Mikhail Saltychev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saltychev M, Eskola M, Laimi K. Lumbar fusion compared with conservative treatment in patients with chronic low back pain: a meta-analysis. Int J Rehabil Res. 2014 Mar;37(1):2-8. doi: 10.1097/MRR.0b013e328363ba4b.
Clinical trial NCT00326794: Efficacy of Shoulder Mobilisation Versus Conventional Immobilisation for Nonsurgically Proximal Humerus Fracture
Official title: Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Shoulder Fracture
Keywords: Nonsurgical proximal humerus fracture
Rehabilitation
Physiotherapy
randomised controlled trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-05-17
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Nonsurgical proximal humerus fracture is common, causing prolonged disability, for which the time to begin rehabilitation is not well determined. We assessed the feasibility and efficacy of early (within 3 days'after fracture) mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy.

Detailed description: Methods: We randomly assigned 74 patients with impacted nonsurgically treated proximal humerus fracture to receive early passive mobilisation or conventional-treatment. The primary outcome was functional assessment of the shoulder (Constant score) at 3 months. Secondary outcomes were functional assessment at 6 weeks and at 6 months, change in pain (on a visual analogue scale) and passive range of motion.

Eligibility criteria: Inclusion Criteria:

* Impacted nonsurgically treated proximal humerus fracture
* Patients over the age 20

Exclusion Criteria:

* Pre-existing shoulder pathology
* Neurological disorders of the upper limbs
* Indication for surgery of the shoulder
* Combined polytrauma
* Difficulties with language or comprehension to understand a rehabilitation program and information

Primary outcomes:
measure: The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
Secondary outcomes:
measure: Functional assessment at 6 weeks and at 6 months
measure: Change in pain (on a visual analogue scale)at 6 weeks, 3 months and at 6 months
measure: Passive range of motion at 6 weeks, 3 months and at 6 months.
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Cochin
Study officials:
affiliation: APHP
name: Marie-Martine Lefevre-colau, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05801094: A Phase I Study of QL1604 for Advanced Solid Tumors
Official title: A Phase I Clinical Study to Evaluate Safety、 Tolerability, and Pharmacokinetics of QL1604 for the Treatment of Advanced Solid Tumors - A Phase Ic Preliminary Efficacy Expansion Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.


Eligibility criteria: Key Inclusion Criteria:

* 18-75 years;
* At least one measureable lesion as defined per RECIST Version (v) 1.1
* Histologically or cytologically confirmed、failed to standard therapy or lack standard therapy(except immunotherapy) advanced solid tumors; for cervical cancer, only squamous carcinoma、adenocarcinoma、adenosquamous carcinoma could be enrolled； hepatocellular carcinoma could be enrolled by clinical diagnosis
* Adequate important organ function

Key Exclusion Criteria:

* Active autoimmune disease orautoimmune disease history
* Meningeal metastasis,or brain metastasis( except asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of \> 10 mg/day or equivalent hormone) for more than 2 weeks)
* Known hypersensitivity to protein macromolecules, and/or any of QL1604 excipients
* Radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy within 4 weeks prior to study drug (for micromolecule targeted therapy, within 2 weeks)
* Active hepaititis B or C infection
* Both HBsAg and anti-HCV Ab positive

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The First Affliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Weijian Guo, PhD
role: STUDY_CHAIR
affiliation: The First Affliated Hospital of Nanchang University
name: Jianping Xiong, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01465594: Study Comparing Urinary Diversion (Transurethral/Suprapubic) After Radical Prostatectomy
Official title: Randomized Study Comparing Urinary Diversion by Suprapubic Catheter With Transurethral Catheter in Patients After Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Catheter Complications
Keywords: Pain Measurement
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 106
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to show the technical feasibility of the suprapubic urinary diversion after endoscopic extraperitoneal radical prostatectomy (EERPE) and has a greater comfort for the patients with at least the same catheter complication rate in comparison to the urethral urinary diversion.

Detailed description: Patients are randomized 1:1 in the different arms Recording of QoL measured by visual analogue ( pain )scale,EORTC QlQ -C 30 and QLQ - PR 25 questionnaires, incontinence rate, complication rate regarding insufficiency and strictures of vesicourethral anastomoses and urinary tract infection; demand of re-catheterization due to urinary retention and demand of antispasmodics

Eligibility criteria: Inclusion Criteria:

* Adenocarcinoma of the prostate,
* Subjects treated by conventional or robotic assisted laparoscopic prostatectomy
* Be willing/able to adhere to follow up visits

Exclusion Criteria:

* Subjects treated by retropubic or perineal prostatectomy Subjects with known bladder cancer
* Contraindications for anticholinergic drugs
* Waist measurement \> 100 cm
* No written informed consent
* Age \< 18 years
* Subjects with known narrow-angle glaucoma

Primary outcomes:
measure: Superiority of suprapubic catheter after EERPE
timeFrame: 2nd postoperative day
Secondary outcomes:
measure: Comparison of QoL in both arms measured by visual analogue (pain) scale
timeFrame: 1st and 3rd until 5th postoperative day
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University Hospital, Urological department
Study officials:
affiliation: Heinrich Heine Universität
name: Christian Arsov, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01540994: Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer
Official title: Phase I/II Trial of Stereotactic Hypofractionated Radiotherapy of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Keywords: Neoplasms
Urogenital neoplasm
Genital neoplasms, male
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2012-02-29
Enrollment: 12
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Radiotherapy: phase 1/2 (but no drug, biological/vaccine or combination product used)
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.

Detailed description: External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.

Eligibility criteria: Inclusion Criteria:

* Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.

Exclusion Criteria:

* Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.

Primary outcomes:
measure: Acute and Late Genitourinary and Lower Gastrointestinal Toxicity Using the Radiation Therapy Oncology Group Acute and Late Morbidity Scales.
timeFrame: Assessed weekly during radiation (from day 1 up to 3 weeks) for acute toxicity, and every 6-12 months following completion of radiation (from 3 weeks up to 84 months) for late toxicity.
Secondary outcomes:
measure: Rate of Biochemical Disease-free Status
timeFrame: mean 41 months (range 3-84 months)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
Study officials:
affiliation: Sharp HealthCare
name: Geoffrey Weinstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426594: Real-life Experience of the Use of Isomers as METPURE XL (S (-) Metoprolol Succinate) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Coronary Disease
Keywords: Observational
Colombia
Metpure XL
Lead sponsor: Closter Pharma
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care adults

Brief summary: This is a Phase 4, observational, open study in patients who their doctor has prescribe METPURE XL (S (-)metoprolol succinate)by clinical practice. No medication was provided by the sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8.


Eligibility criteria: Inclusion Criteria:

* Patients who were prescibed with s(-)metoprolol succinate(25mg, 50mg), depending on their clinical condition and use locally approved will be eligible to participate in this study

Primary outcomes:
measure: Effect of therapy in the management of cardiovascular diseases
timeFrame: 8 weeks
Secondary outcomes:
measure: Evaluate and compare the rate of compliance with treatment
timeFrame: 8 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Country Club de Bogota
Study officials:
References:
Clinical trial NCT06341894: Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
Official title: Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Early Breast Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 1163
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.


Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 18 years-old
* Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
* Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
* Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0
* Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion
* From operation to enrollment should not exceed 12 months
* Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* metastatic disease (Stage IV) or inflammatory breast cancer
* Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
* Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
* A history of allergy to the drugs in this study；
* Unable or unwilling to swallow tablets
* History of gastrointestinal disease with diarrhea as the major symptom.

Primary outcomes:
measure: invasive Disease-free Survival (iDFS)
timeFrame: From enrollment until time of events up to 3 years
Secondary outcomes:
measure: Disease-free Survival (DFS)
timeFrame: From enrollment until time of events up to 3 years
measure: AEs and SAEs
timeFrame: From the first administration to one months after the last drug administration，up to one month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04390360: Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction
Official title: Development and Evaluation of Smartphone App for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction on Physiologic Parameter Based on the Smartphone App
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ARDS, Human
Mechanical Ventilation Complication
Humidifier Lung
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Clinical evaluation of a new educative tools (Smartphone application) based on impact of instrumental dead space reduction after initiation of protective ventilation during mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Mechanical ventilation (control,assist control or SIMV mode)
* haemodynamic stability (vasopressor \< 0.2 ug/kg/min)
* no prone position schedule in the next 2 hours following procedure inclusion
* presence of an Arterial catheter

Exclusion Criteria:

* ECMO or anticipate ECMO
* body temperature \< 36.0 for post operative patient (cardiac surgery)

Primary outcomes:
measure: PaCO2 Variation
timeFrame: 60 minutes post intervention
measure: PaCO2 Variation
timeFrame: 120 minutes post intervention
Secondary outcomes:
measure: Correlation between PCO2 variation and alveolar ventilation variation
timeFrame: 60 and 90 minutes post intervention
measure: Hemodynamic impact vs pH
timeFrame: Baseline, 30, 60, 90 and 120 minutes post intervention
measure: Hemodynamic impact vs pH
timeFrame: Baseline, 30, 60, 90 and 120 minutes post intervention
measure: Hemodynamic impact vs pH
timeFrame: Baseline, 30, 60, 90 and 120 minutes post intervention
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Study officials:
References: