louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06026995: Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells
Official title: Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Lymphoma
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
Collaborators: name: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
First posted: 2023-09-07
Enrollment: 174
Sex: ALL
Minimum age (years): 18
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 is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for lymphoma and multiple myeloma.


Eligibility criteria: Inclusion Criteria:

1. 18-65 years old, regardless of sex;
2. Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation;
3. KPS score ≥70;
4. creatinine clearance rate ≥ 50mL/min, total bilirubin level \< 1.5mg/dL, ALT and AST \< 2 times the upper limit of normal value;
5. Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L;
6. Patients can tolerate chemotherapy;
7. No active infection before chemotherapy;
8. The patient voluntarily participated in this trial and signed the informed consent form;
9. The researcher thinks that the subjects can benefit.

Exclusion Criteria:

1. Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation;
2. Serious or uncontrolled virus infection: HIV, syphilis positive;
3. Severe dysfunction of internal organs;
4. severe mental or nervous system diseases;
5. allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli;
6. pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period;
7. The researcher judges other subjects who are not suitable to participate.

Primary outcomes:
measure: The proportion of patients with CD34+ cells ≥2×106/kg
timeFrame: 28 days
Secondary outcomes:
measure: CD34+cell count
timeFrame: 28 days
measure: Acquisition times
timeFrame: 28 days
measure: Mobilization time
timeFrame: 28 days
measure: Hematopoietic reconstruction time after transplantation
timeFrame: 3 months
measure: complication
timeFrame: 3 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT06431295: Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements
Official title: Human Performance Evaluation of a Digital Visual Acuity Device: Visual Acuity-001
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this research is to validate and determine the accuracy of the experimental device when measuring visual acuity versus our standard visual acuity measurements and to gather voice recordings of letters to help build a special system that recognizes spoken letters.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years) who come to Ophthalmology Clinic.
* Willing and able to provide consent.

Exclusion Criteria:

* Individuals \< 18 years of age.
* Unable to provide consent.

Primary outcomes:
measure: Number of times the experimental device when measuring visual acuity agreed with standard visual acuity measurements
timeFrame: Baseline
Secondary outcomes:
measure: Voice samples
timeFrame: Baseline
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Antonio Forte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06624995: Chatbot on the Prevention of Postoperative Complications
Official title: Comparison of Traditional Nurse-led Education and Chatbot on the Prevention of Postoperative Complications After Major Visceral Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Visceral Surgery Complications
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 214
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Major visceral surgery encompasses a broad range of operations with a wide variety of procedures that fall under this category. The majority of patients undergoing major visceral surgery often present with cancer and other medical comorbidities and are put at an elevated risk of a large number of medical and surgical postoperative complications

Detailed description: Complications following major visceral surgery are relatively common and are estimated to occur in 18-23% of patients . The management of complications is challenging for both the elderly patient and the perioperative team, and adds considerably to the cost of care particularly when further interventions involve readmission, unplanned admission to an intensive care unit, interventional radiology and/or an unplanned return to theatre. With the advancement of online patient portals, the use of internet to seek for health information is already a common phenomenon; Chatbot may become a more significant source of information for patients.

Eligibility criteria: Inclusion Criteria:

* Patients aged 60 years old and above, both sex, scheduled for elective major visceral surgery, able to communicate in the local language, and without any cognitive impairment.

Exclusion Criteria:

* Elderly patients with a history of major psychiatric disorders, patients with a history of previous major visceral surgery, and patients who were unable to provide informed consent will be excluded from the study.

Primary outcomes:
measure: postoperative morbidity
timeFrame: patient will be evaluated at three time points: 24 hour postoperative; 48 hours postoperative , and 30 days postoperative.
Secondary outcomes:
measure: Geriatric anxiety
timeFrame: will be measured at three time points: 90 to 120 minutes before the preoperative consultation (baseline ); after 7 days postoperative, and after 30 days postoperative
measure: quality of life
timeFrame: will be measured at two time points : at baseline (preoperative ) and after 30 days postoperative
measure: usability of using chatbots
timeFrame: 4 weeks postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00772395: Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty
Official title: Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bone Loss
Keywords: Periprosthetic bone loss risedronate bisphosphonates
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2008-10-15
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?

Detailed description: Periprosthetic bone loss after total hip arthroplasty is the main factor in limiting the longevity of implants used for treatment of osteoarthritis. Bone loss leads to implant destabilization. Bisphosphonates, given for approximately 6 months after THA man prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthesis loosening. We perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss around a uncemented femoral stem.

Eligibility criteria: Inclusion Criteria:

* Patients on the waiting list for a total hip arthroplasty
* Primary osteoarthritis
* Osteoarthritis secondary to congenital dislocation of the hip

Exclusion Criteria:

* Rheumatoid arthritis
* Bisphosphonate treatment
* Osteomalacia
* Hypocalcemia
* Previous surgery of the affected hip

Primary outcomes:
measure: Can risedronate given once weekly for 6 months prevent periprosthetic bone loss up to 2 years after uncemented total hip arthroplasty
timeFrame: 4 years
Secondary outcomes:
measure: Can risedronate reduce migration of a uncemented femoral stem
timeFrame: 4 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Orthopaedic department, Danderyd Hospital
Study officials:
affiliation: Department of clinical sciences at Danderyd hospital
name: Olof G Sköldenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00553995: Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction
Official title: Effect of Physical Inactivity on Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Insulin Resistance
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Physical inactivity induces vascular dysfunction and glucose intolerance during five days of bed rest. This study will investigate the effects of salsalate on these responses. Subjects will be randomized to treatment with salsalate or placebo for four days prior to initiation of bed rest. Vascular function in the brachial artery will be determined by ultrasound prior to treatment and before and after the 5-day bed rest protocol. We hypothesize that treatment with salsalate will be associated with protection again the development of glucose intolerance and vascular dysfunction in this setting.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Pregnancy
* History of Coronary Artery Disease
* Diabetes Mellitus
* Hypertension
* Cigarette smoking
* History or family history of deep vein thrombosis or pulmonary embolism
* Abnormal renal function
* Liver function tests greater than two times the upper limit of normal
* Anemia
* Use of viagra or other PDE5 inhibitor
* Hypercholesterolemia
* Aspirin allergy/sensitivity
* Asthma with nasal polyps
* Peptic ulcer disease/Gastrointestinal bleeding
* Any ongoing drug treatment

Primary outcomes:
measure: Reactive hyperemia in the femoral artery
timeFrame: 5 days
Secondary outcomes:
measure: Reactive hyperemia in the brachial artery
timeFrame: 5 days
measure: Oral glucose tolerance test
timeFrame: 5 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Naomi Hamburg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03169595: Epithelioid Hemangioma of Bone And Soft Tissue
Official title: Epithelioid Hemangioma of Bone And Soft Tissue: a Benign Tumor With Metastatic Potential
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epithelioid Hemangioma of Bone
Epithelioid Hemangioma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with epithelioid hemangioma of bone and soft tissue treated in a single institution

Brief summary: The controversy surrounding epithelioid hemangioma diagnosis stems from its somewhat aggressive clinical characteristics, including multifocal presentation and occasional lymph node involvement.

The investigators reviewed the clinicopathologic and radiologic characteristics of bone and soft tissue epithelioid hemangioma in patients treated at our institution with available tissue for molecular testing.

The hypothesis is that epithelioid hemangioma may present with multifocal involvement and rare loco-regional lymph node metastasis, but it remains a benign tumor with excellent prognosis.

Detailed description: The investigators retrospectively reviewed patients treated for epithelioid hemangioma of the bone and soft tissue in a single insitution. The purpose of this study is to evaluate the pathological, clinical, and radiological characteristics of epithelioid hemangioma arising within bone and soft tissue, in the first cohort of cases where the definitive diagnosis is supplemented by molecular techniques.

The hypothesis is that the improved knowledge regarding this rare entity can more definitively elucidate the benign biology of epithelioid hemangioma.

Eligibility criteria: Inclusion Criteria:

* patients with epithelioid hemangioma of bone and soft tissue in the extremities and pelvis

Exclusion Criteria:

* patients with epithelioid hemangioma of bone and soft tissue in the spine

Primary outcomes:
measure: Multifocal presentation of patients with epithelioid hemangioma of bone and soft tissue without producing a fatal outcome
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Davide Donati, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03164395: The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Atrial Fibrillation
Official title: The Efficacy of Single Coil Defibrillation Leads for Internal Cardioversion of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
implantable cardiac defibrillator
cardioversion
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in block fashion to either internal or external cardioversion
Primary purpose: TREATMENT

Brief summary: This study seeks to determine the efficacy of single coil defibrillation leads for cardioversion of persistent atrial fibrillation.

Detailed description: This study seeks to compare the efficacy of single coil defibrillation leads for the internal cardioversion of atrial fibrillation as compared with cardioversion by external defibrillation pads. It is known that dual coil leads are effective for atrial cardioversion, but the presence of the SVC defibrillation coil allows for selection of shock vector that more reliably incorporates the majority of atrial tissue compared to a single right ventricular lead. For a variety of reasons single coil defibrillation leads are now implanted in the majority of patients requiring placement of implantable cardiac defibrillators, and many of these patient's will later develop atrial fibrillation and potentially require cardioversion. Currently, there is no clear consensus on how to approach cardioversion in these patient's and both external and internal methods are used. Internal cardioversion may be ineffective exposing patient's unnecessarily to repeated shocks and battery depletion. External cardioversion may carry a small risk of damaged to the CIED.

The investigator's goal is to identify patient's referred for cardioversion for atrial fibrillation who also have an implanted cardiac defibrillator with a single coil defibrillation lead and randomize them to either external or internal cardioversion.

Eligibility criteria: Inclusion Criteria:

* greater than 18 years of age
* persistent atrial fibrillation and have been recommended by your primary cardiologist to undergo cardioversion
* have an implantable cardiac defibrillator

Exclusion Criteria:

* over the age of 99
* pregnant
* prisoner

Primary outcomes:
measure: Acute Conversion of Atrial Fibrillation to Sinus Rhythm
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Samy C Elayi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04591795: Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II
Official title: Efficacy and Safety of Sahastara Remedy Extract Capsules in Treating Primary Osteoarthritis of the Knee Compared With Diclofenac (Clinical Trial Phase II)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Sahastara
Osteoarthritis
Herbal Medicine
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study efficacy and safety of Sahastara 95% ethanolic extract capsules compared to treatment Primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (Phase II).

Detailed description: Sample size 66 volunteers

The patients were divided randomly into 2 treatment groups. The patients in group 1 received the SHT extract 300 mg/day (1 capsule of 100 mg SHT extract three times daily before meals). The patients in group 2 received diclofenac sodium 75 mg/day (1 capsule of 25 mg diclofenac three times daily after meals). In addition, the patients in both groups received 20 mg of omeprazole, 1 capsule before breakfast for protects of Gastrointestinal adverse effects.

Eligibility criteria: Inclusion Criteria:

* No pregnancy
* No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
* No Supplementary food and/or Vitamin during the study Able to follow suggestion during the study

Exclusion Criteria:

* Uncontrolled Hypertension (BP\>140/90 mm.Hg.) BMI \> 30
* Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
* On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline

Primary outcomes:
measure: Pain score 1
timeFrame: 28 day
Secondary outcomes:
measure: Pain score 2
timeFrame: 28 day
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mr. NARIN KAKATUM
state: BKK
Study officials:
affiliation: faculty of Medicine, Thammasat University
name: Associate Professor Arunporn Itharat, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00290095: Quality of Life in Patients With Multiple Myeloma
Official title: Quality of Life in Patients With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Quality of Life
Keywords: Multiple Myeloma
Quality of Life
Response Shift
Clinically Important Difference
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2006-02-10
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Multiple Myeloma in all fases in the south and east of Norway

Brief summary: The purpose of this study is to determine Clinically important difference and Response shift in quality of life in patients with Multiple Myeloma.

Detailed description: Multiple myeloma is a plasma cell tumor with an annual incidence of 6 pr. 100 000. In the absence of curative treatment, the aim of the therapy is not only to induce an objective response and a prolongation of survival but also to improve the patients quality of life.

This project will raise two problems which make QoL-data hard to interpret

1. In a clinical trial where many patients are included, statistically significant differences are obtained. However, there is widespread agreement that p-values do not indicate whether a particular finding has clinical significance because statistical significance does not necessarily equate to a meaningful difference or change in QoL. A crucial task for clinicians in interpreting trial-based QoL results is to determine if the observed change is clinically important to the patient.
2. When measuring changes in QoL in a pretest-posttest design,response shift can affect results. Patients with advanced disease can report surprisingly good QoL.Including response shift into quality of life research would allow a better understanding of changes in the QoL that patients report.

Eligibility criteria: Inclusion Criteria:

* Multiple Myeloma
* Age \> 18 years
* Informed consent

Exclusion Criteria:

* Terminal illness with life expectancy less than 3 months
* Unable to fill in a questionnaire in norwegian

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevaal University Hospital
Study officials:
affiliation: Ullevål University Hospital, Norway
name: Finn Wisløff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kvam AK, Wisloff F, Fayers PM. Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma. Health Qual Life Outcomes. 2010 Aug 3;8:79. doi: 10.1186/1477-7525-8-79.