louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04156867: Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation
Official title: Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder of Spine
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 128
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy.

Detailed description: The study was to explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy. 128 patients with single-segmental LDH were randomly divided into discectomy with Dynesys group(group A) and simple discectomy group(group B). Both groups were evaluated by Visual Analogue Score(VAS), Oswestry Disability Index(ODI), radiological evidence of intervertebral height and range of motion(ROM) of the treated segment at pre- and post-operation. Operation duration and blood loss was recorded. The clinical outcomes and complications were evaluated afterwards. All patients received a 2-year follow-up.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria was Single-segmental LDH with low back pain and radicular pain.

Exclusion Criteria:

Exclusion criterias were lumbar stenosis(LSS), lumbar spondylolysis and degenerative spondylolisthesis, spinal deformity, lumbar surgery history, obviously osteoporosis, vertebral fracture, cauda equina syndrome, ankylosing spondylitis, tuberculosis, infection, tumor, obesity.

Primary outcomes:
measure: visual analog scale
timeFrame: 2 year
measure: Oswestry Disability Index
timeFrame: 2 year
measure: Intervertebral height
timeFrame: 2 year
measure: Range of motion(ROM)
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03930667: Closure of the Appendix Stump in Laparoscopic Appendectomy
Official title: Hem-o-lok Clips Versus ıntracorporeal Knotting for Closure of the Appendix Stump in Laparoscopic Appendectomy: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis, Surgery
Keywords: Appendicitis; Laparoscopic Surgery; Cost Effectiveness
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in terms of efficiency.

Detailed description: Performed laparoscopic surgery for acute appendicitis. Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporal knotting (Group II) in a randomize manner. Groups were compared for cost effectiveness.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute appendicitis

Exclusion Criteria:

* under 18 years of age
* other patology in addition to appendiceal pathology

Primary outcomes:
measure: cost effectiveness
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Health Sciences University, İzmir Bozyaka Training and Research Hospital, General Surgery Department, Izmir
name: Orhan Ureyen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02825667: Effectiveness of the Myofascial Therapy in the Hemophilic Arthropathy of Ankle
Official title: Randomized Clinical Study on the Effectiveness of the Myofascial Therapy in the Treatment of the Hemophilic Arthropathy of Ankle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemophilia
Keywords: Haemophilia
Ankle
Arthropathy
Pain
Range of motion
Myofascial techniques
Lead sponsor: Real Fundación Victoria Eugenia
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 65
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial to assess the efficacy of a treatment protocol applied fascial therapy in patients with hemophilic arthropathy ankle, oriented to know and describe the observed differences on the dependent variables: range of motion, pain and physical condition.

At the same time, the study will determine whether there are adverse effects or bleeding complications as a result of applied physiotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hemophilia A and B
* Adults patients
* Patients with hemophilic arthropathy of ankle diagnosed
* Patients in prophylactic treatment regimen or on demand treatment with concentrates of FVIII/FIX.

Exclusion Criteria:

* Patients without ambulation
* Patients diagnosed with other congenital coagulopathy (eg, Von Willebrand disease)
* Patients who have developed antibodies to FVIII / FIX (inhibitors)
* Patients with neurological or cognitive impairments that prevent understanding of questionnaires and test physical
* Patients that have not signed the informed consent document.

Primary outcomes:
measure: Change from baseline bleeding frequency after treatment and at 5 months
timeFrame: Screening visit, within the first seven days after treatment and after five months follow-up visit
measure: Change from baseline joint pain of ankle after treatment and at 5 months
timeFrame: Screening visit, within the first seven days after treatment and after five months follow-up visit
measure: Change from baseline joint function after treatment and at 5 months
timeFrame: Screening visit, within the first seven days after treatment and after five months follow-up visit
measure: Change from baseline range of motion after treatment and at 5 months
timeFrame: Screening visit, within the first seven days after treatment and after five months follow-up visit
Secondary outcomes:
measure: Age
timeFrame: Screening visit
measure: Weight
timeFrame: Screening visit
measure: Height
timeFrame: Screening visit
Other outcomes:
Locations:
Study officials:
affiliation: Real Fundación Victoria Eugenia
name: Rubén Cuesta-Barriuso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05137067: A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.
Official title: Effectiveness of RaproCell in Alleviating the Side Effects of Chemotherapeutic Agents, Without Adversely Impacting the Overall Success of the Agents on Cancer Cells.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lung Cancer
Prostate Cancer
Keywords: Cancer Breast Lung Prostate
Lead sponsor: Optimal Health Research
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized interventional parallel study
Primary purpose: TREATMENT

Brief summary: This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients.

Detailed description: This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients. The study will be observing the standard treatment protocol for any degradation or enhancement due to the nutraceutical.

Eligibility criteria: Inclusion Criteria:

Active breast cancer patients taking one of the studies listed drugs within the age range.

Active lung cancer patients taking one of the studies listed drugs within the age range.

Active prostate cancer patients taking one of the studies listed drugs within the age range.

-

Exclusion Criteria:

Anyone without the three types of cancer (breast cancer, lung cancer, prostate cancer) listed in inclusion criteria.

-

Primary outcomes:
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Global 10 Health Questionnaire to assess change from baseline.
timeFrame: Once a week for 3 months
measure: Symptom Assessment Questionnaire to assess change from baseline.
timeFrame: Once a week for 3 months
Secondary outcomes:
measure: Cancer antigens blood markers to assess change from baseline.
timeFrame: Once a week for 3 months.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Optimal Health Research
state: Utah
Study officials:
affiliation: Optimal Health Clinic
name: EA Jeppsen, MD
role: STUDY_CHAIR
affiliation: Optimal Health Research
name: Steven Osguthorpe, ND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01268267: Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting
Official title: Clinical Trial Protocol for Ninja 2 System With TATSU Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2010-12-30
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the performance and acceptability of an investigational blood glucose monitoring system, which includes meter and sensor strip.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age and above
* Type 1 or type 2 diabetes
* Currently self-testing blood glucose at home at least twice daily
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Currently Pregnant
* Hemophilia or any other bleeding disorder
* Employee of competitive medical device company
* Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Primary outcomes:
measure: Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
timeFrame: 2 hours
Secondary outcomes:
measure: Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
timeFrame: 2 hours
measure: Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)
timeFrame: 2 hours
measure: Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
timeFrame: 2 hours
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
Study officials:
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00141167: A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Cessation
Official title: A Twelve-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate 1 MG BID for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 250
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: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo for smoking cessation.


Eligibility criteria: Inclusion Criteria:

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects who have used bupropion, Zyban, or Wellbutrin previously.

Primary outcomes:
measure: 4 week continuous quit rate ( 4 week CQR ) for weeks 9 -12
Secondary outcomes:
measure: Continuous abstinence rate weeks 9-24
measure: Long-term Quit Rate at week 24
measure: 7 day point prevalence week 12 and 24
measure: Results of Minnesota Nicotine Withdrawal Scale
measure: Brief Questionnaire of Smoking Urges
measure: Smoking Effects Inventory
Other outcomes:
Locations:
city: Anyang-Si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Daegu-si
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Kweishan
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyuan County
city: Hualien
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Tsai ST, Cho HJ, Cheng HS, Kim CH, Hsueh KC, Billing CB Jr, Williams KE. A randomized, placebo-controlled trial of varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, as a new therapy for smoking cessation in Asian smokers. Clin Ther. 2007 Jun;29(6):1027-39. doi: 10.1016/j.clinthera.2007.06.011.
Clinical trial NCT04370067: HUNgarian COronaVirus Disease-19 Epidemiological Research
Official title: Hungarian CoronaVirus Disease-19 Epidemiological Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infection
Keywords: Coronavirus
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
Collaborators: name: Semmelweis University
name: Szeged University
name: University of Pecs
name: University of Debrecen
First posted: 2020-04-30
Enrollment: 11200
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hungarian male or female patients aged 14 and over who live in private households.

Brief summary: Hungarian CoronaVirus disease-19 Epidemiological Research

Detailed description: The planned large-scale, cross-sectional, representative population screening can show the prevalence of COVID-19 and the degree of infection and trans-infection in Hungary after more than one month of strict restriction. In addition, it can have an impact on further actions, and we can track the impact of the decisions we make by repeating the screenings.

Eligibility criteria: Inclusion Criteria:

* Hungarian male or female patients aged 14 and over who live in private households
* Inactivated social security number does not infer the exclusion of the study

Exclusion Criteria:

* Patients under the age of 14
* Patients living in institutional households

Primary outcomes:
measure: COVID-19 rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University - Heart and Vascular Center
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Pecs
country: Hungary
facility: University of Pecs
city: Szeged
country: Hungary
facility: University of Szeged
Study officials:
affiliation: Semmelweis University Heart and Vascular Center
name: Béla Merkely, PhD,DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merkely B, Szabo AJ, Kosztin A, Berenyi E, Sebestyen A, Lengyel C, Merkely G, Karady J, Varkonyi I, Papp C, Miseta A, Betlehem J, Burian K, Csoka I, Vasarhelyi B, Ludwig E, Prinz G, Sinko J, Hanko B, Varga P, Fulop GA, Mag K, Voko Z; HUNgarian COronaVirus-19 Epidemiological Research (H-UNCOVER) investigators. Novel coronavirus epidemic in the Hungarian population, a cross-sectional nationwide survey to support the exit policy in Hungary. Geroscience. 2020 Aug;42(4):1063-1074. doi: 10.1007/s11357-020-00226-9. Epub 2020 Jul 17.
Clinical trial NCT00888667: Optimal EGM Configuration for Morphology Discrimination
Official title: Optimal EGM Configuration for Morphology Discrimination
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Premature Ventricular Complexes
Keywords: ICD patients with PVCs and EGM recordings
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Unity Health Toronto
First posted: 2009-04-27
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a dual chamber ICD and frequent PVCs

Brief summary: The study will be a prospective cohort study of 20 patients recruited from site's Defibrillator Clinic patient population who are followed at the site.

Hypothesis: Among the available EGM configuration options, one is better than the others for detection enhancements purposes.


Eligibility criteria: Inclusion Criteria:

1. Patients must already have an implanted St. Jude Medical dual chamber ICD with a dual coil defibrillator lead.
2. Patients must be willing to sign an informed consent form.
3. Patients must have frequent PVCs (minimum of 30/hour)

Exclusion Criteria:

1. Known history of slow VT (under 160 bpm).
2. Patients under the age of 18 years.
3. Pregnant women.
4. Pacemaker dependent rhythm.
5. Ongoing angina pectoris.
6. Current NYHA Class 3-4 heart failure.

Primary outcomes:
measure: % morphology match
timeFrame: acute
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT05296967: Study of the Efficience of Chewing-gum to Reduce the Duration of Postoperative Ileus
Official title: Efficiency of Chewing-gum to Reduce the Duration Postoperative Ileus: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Centre Hospitalier de Cholet
First posted: 2022-03-25
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Postoperative ileus (POI) is a serious complication after surgery. While it complicates all type of surgery, it is more frequent after abdominal surgery (especially bowel or colorectal surgery).

Many studies aim to reduce the occurence of POI without efficiency. The aim of this study is to assess the efficiency of the vagal stimulation, by the mean of chewing, to reduce the duration of POI.


Eligibility criteria: Inclusion Criteria:

* patients undergoing colorectal surgery or small bowel surgery
* elective or in emergency
* open surgery or laparoscopy
* diagnosis of POI
* indication of fasting or nasogastric tube placement

Exclusion Criteria:

* contra-indication of chewing
* pregnancy

Primary outcomes:
measure: To assess the efficiency of chewing gum in reducing the duration of POI. POI is defined by the criteria of Vather from the postoperative day 1 up to day 30
timeFrame: collected each day until the end of the POI, assessed up to day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital aof Angers
Study officials:
References:
Clinical trial NCT01871467: Sargramostim for Myeloid Dendritic Cell Deficiency
Official title: Sargramostim for Myeloid Dendritic Cell Deficiency - Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dendritic Cell Deficiency
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Previous studies have demonstrated a deficiency of blood dendritic cells in patients with kidney disease that is associated with the development of viral infections after kidney transplantation. We plan to test the ability of sargramostim to increase blood dendritic cell levels in patients with kidney disease in the hopes of developing new therapies to prevent viral infections after kidney transplantation.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years \< 80 years with diagnosis of end stage renal disease and currently undergoing outpatient hemodialysis (HD) at one of the Johns Hopkins University-affiliated HD units

Exclusion Criteria:

* Age\<18or\>80years
* History of non-adherence to prescribed HD treatment
* Active drug or heavy alcohol use (defined as \> 4 drinks/day)
* Pregnancy or breast feeding
* Active infection (bacterial or viral) or clinically significant infections within the past three months (e.g. those requiring hospitalization, or as judged by the PI)
* Active malignancy (with the exception of excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or adequately treated pre- invasive cervical cancer in situ)
* Unstable cardiovascular status (angina, arrhythmias, congestive heart failure etc...)
* History of liver disease (as defined by a diagnosis of uncompensated cirrhosis) • History of lung disease (including moderate-severe chronic obstructive pulmonary disease, interstitial lung disease, or asthma)
* Known hypersensitivity to yeast-derived products
* Hemoglobin \< 10 g/dL and hematocrit \< 30%.
* Abnormal white blood cell (WBC) count at baseline (\< 3 or \> 12 x 10 cells/mm )
* Treatment with WBC growth factors (G-CSF or GM-CSF) or immunosuppressive medications (tacrolimus, cyclosporine, mycophenolate, azathioprine, corticosteroids, chlorambucil, cyclophosphamide) within 4 weeks of study (erythropoiesis-stimulating agents will be allowed)
* Treatment with lithium within 4 weeks of study

Primary outcomes:
measure: Target blood myeloid dendritic cell level of > 2.0 x 10<4>/mL
timeFrame: 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Karl L Womer, MD
role: PRINCIPAL_INVESTIGATOR
References: