louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00265031: HD12 for Advanced Stages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hodgkin´s Lymphoma
Keywords: Hodgkin´s Lymphoma
advanced stages
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2005-12-13
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study is designed to test (1) whether the BEACOPP dosage can be reduced to baseline in the last 4 cycles without loss of effectiveness, and (2) whether consolidating irradiation is necessary following effective chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Hodgkin´s lymphoma (histologically proven)
* CS(PS) IIB with one or both of the risk factors:

  1. bulky mediastinal mass (\> 1/3 of maximum transverse thorax diameter)
  2. extranodal involvement
* CS(PS) III, IV
* written informaed consent

Exclusion Criteria:

* Leukocytes \<3000/microl
* Platelets \<100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) \< grade 2

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Cologne
name: Volker Diehl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borchmann P, Haverkamp H, Diehl V, Cerny T, Markova J, Ho AD, Eich HT, Mueller-Hermelink HK, Kanz L, Greil R, Rank A, Paulus U, Smardova L, Huber C, Dorken B, Nerl C, Krause SW, Mueller RP, Fuchs M, Engert A. Eight cycles of escalated-dose BEACOPP compared with four cycles of escalated-dose BEACOPP followed by four cycles of baseline-dose BEACOPP with or without radiotherapy in patients with advanced-stage hodgkin's lymphoma: final analysis of the HD12 trial of the German Hodgkin Study Group. J Clin Oncol. 2011 Nov 10;29(32):4234-42. doi: 10.1200/JCO.2010.33.9549. Epub 2011 Oct 11.
citation: von Tresckow B, Kreissl S, Goergen H, Brockelmann PJ, Pabst T, Fridrik M, Rummel M, Jung W, Thiemer J, Sasse S, Burkle C, Baues C, Diehl V, Engert A, Borchmann P; German Hodgkin Study Group. Intensive treatment strategies in advanced-stage Hodgkin's lymphoma (HD9 and HD12): analysis of long-term survival in two randomised trials. Lancet Haematol. 2018 Oct;5(10):e462-e473. doi: 10.1016/S2352-3026(18)30140-6.
Clinical trial NCT06120231: Pulse-Width Modulation
Official title: Pulse-width Modulation During Pedicle Screw Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Fusion
Spinal Stenosis
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The overarching aim of this project is to modulate the pulse-width during stimulation of pedicle screws and record the response thresholds associated with each PWM setting. During this initial phase of the investigation, no further data will be collected.

Detailed description: In vivo electrical stimulation of pedicle screws is a well-documented modality for evaluating potential breach of the pedicle wall. However, previous research has focused primarily on the stimulation threshold intensity required to elicit a neurophysiological response. Other stimulation parameters, such as pulse-width, remain uninvestigated. The goal is to obtain data on the pulse-width vs. CMAP relationship.

Eligibility criteria: Inclusion Criteria:

* A patient will be eligible for study participation once they have been booked for a surgery involving pedicle screw placement and intraoperative neuromonitoring.

Exclusion Criteria:

* The study excludes neonates, minors, pregnant women, prisoners and cognitively impaired patients.

Primary outcomes:
measure: CMAP response under three different pulse-width settings
timeFrame: Within operating room upon completion of pedicle screw placement. 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Health
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Linton Evans, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04895631: 18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas
Official title: 18F-Fluorocholine Positron Emission Tomography (PET) for the Detection of Parathyroid Adenomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hyperparathyroidism, Primary
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 140
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective single arm single center Phase III study evaluating the ability of 18F-fluorocholine to detect the location of parathyroid adenomas.

Detailed description: PRIMARY OBJECTIVE:

I. To investigate the performance (accuracy) of 18F-fluorocholine PET in the detection of hyperfunctioning parathyroid glands in surgical patients with biochemically proven primary hyperparathyroidism.

OUTLINE:

Participants will receive a single dose of 18F-Fluorocholine at the time the participant undergoes a single imaging study using 18F-fluorocholine. Study related procedures will end after the study visit. Participants who undergo subsequent parathyroidectomy, will have the results reviewed and compared to the results from the imaging study

Eligibility criteria: Inclusion Criteria:

* Age \>= 13 years.
* Biochemically proven hyperparathyroidism and an indication for surgery.
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Current Pregnancy.
* Patients unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

Primary outcomes:
measure: Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using sestamibi imaging
timeFrame: Up to 1 year
measure: Proportion of participants with true-positives (sensitivity) of 18F-Fluorocholine PET using predefined threshold
timeFrame: Up to 1 year
Secondary outcomes:
measure: Detection rate of 18F-fluorocholine PET
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Hope, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00469131: Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparative Study Between Tacrolimus + MMF and Tacrolimus + Steroid
Official title: Randomized Comparative Study on Effects of Immunosuppression on HCV Recurrence After Living Donor Liver Transplantation - Comparison Between Tacrolimus + MMF and Tacrolimus + Steroid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Liver Cirrhosis
Keywords: liver transplantation,
HCV recurrence,
immunosuppression
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Kyoto University
First posted: 2007-05-04
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare immunosuppression protocol of tacrolimus + MMF with that of tacrolimus + steroid for preventing recurrence of hepatitis C after living donor liver transplantation.


Eligibility criteria: Inclusion Criteria:

* Recipient of living donor liver transplantation for HCV-related cirrhosis

Exclusion Criteria:

* ABO blood type incompatible transplant case
* Renal dysfunction (serum creatinine \>2.0 mg/dL)
* WBC \< 1,000/mm3
* Hemoglobin \< 8 g/dL
* Platelet \<30,000 /mm3

Primary outcomes:
measure: Event-free survival time at the end of first year after living liver transplantation.
timeFrame: 1 year
Secondary outcomes:
measure: HCV-RNA value, patient survival, recurrence-free survival, rate of interferon therapy induction, rate of steroid pulse for rejection, chronic rejection
timeFrame: 1 year
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
affiliation: Kyoto University Hospital
name: Shinji Uemoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Takada Y, Kaido T, Asonuma K, Sakurai H, Kubo S, Kiuchi T, Inomata Y, Isaji S, Tsumura H, Teramukai S, Matsubara Y, Sakabayashi S, Uemoto S. Randomized, multicenter trial comparing tacrolimus plus mycophenolate mofetil to tacrolimus plus steroids in hepatitis C virus-positive recipients of living donor liver transplantation. Liver Transpl. 2013 Aug;19(8):896-906. doi: 10.1002/lt.23679.
Clinical trial NCT06641531: Prevalence of Abnormal Pap Smear
Official title: Prevalence of Abnormal Pap Smear in Sohag University Hospital Outpatient Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervix Cancer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Non pregnant sexually active women aged from 21 to 60 years old.

Brief summary: This study aims to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.

Detailed description: This study aims to evaluate prevalence of abnormal Pap smear among sexually active women of reproductive age attending Sohag university hospital outpatient clinic. Participating women will be subjected to accurate history taking regarding age, parity, Body mass index, contraceptive use, menstrual history, and duration of marital life, frequency of previous marriages if any, and the status of cervix by per-vaginal examination of the patients.

The patient put in dorsal lithotomy position and place the feet in stirrups or on foot rests . then, the physician will insert a cusco speculum into the vagina to hold vaginal wall open . The specimens will be collected as follows; firstly, the speculum will be inserted without lubricant. Any mucous, discharge or blood will be removed with dry cotton. A wooden spatula will be used for sampling ectocervix which will be rotated 360 degrees. For sampling endocervix, A brush or a swab will be rotated only 90 degrees as the circumferential bristles will be in contact with the entire surface the moment the brush is inserted.

The samples will be applied to the slides which will be encoded and immediately fixed in 95% ethanol and the samples will be transferred to pathology department to be stained by the standard Papanicolaou stain . The Bethesda System will be used for cytological interpretation.

Eligibility criteria: Inclusion Criteria:

* Non pregnant sexually active women aged from 21 to 60 years old.
* Patients who didn't have their pap smear done in last 3 years .
* Patient who had previous abnormal pap smear and coming for follow up.

Exclusion Criteria:

* Women who were diagnosed cervical cancer that was treated.
* Women who underwent total hysterectomy.
* Women who are pregnant.
* Patients whose pap smear was done in last 3 years with reassuring results.

Primary outcomes:
measure: number of abnormal pap smear among sexually active women of reproductive age attending sohag university hospital outpatient clinic.
timeFrame: From October 2024 to April 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
Study officials:
References:
Clinical trial NCT05413031: Comparing Relative Motion Splint With Static Splint After Hand Extensor Tendon Repair
Official title: Treatment of Finger Extensor Tendon Rupture - Comparison Between Static and Relative Motion Splints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Tendon Injury
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different splints are used after hand extensor tendon repair (including relative motion splint, static splint, etc.) There is no consensus regarding the benefits of either one.

The aim of this study is to compare clinical outcomes after using different orthoses and rehabilitation methods after hand extensor tendon repair.

Patients are randomly assigned after signing consent to either immobilization with a static splint or a relative motion splint. Patients are examined after 2 and 5 months postoperatively for finger range of motion, grip strength, and DASH questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patients with hand extensor tendon tear in zones 4-7 after surgical repair, that are able to sign a consent form.

Exclusion Criteria:

* patients that did not arrive for a follow-up meeting after 2 months.

Primary outcomes:
measure: Fingers range of motion
timeFrame: 2 months after surgical repair
measure: Fingers range of motion
timeFrame: 5 months after surgical repair
measure: Grip strength
timeFrame: 2 months after surgical repair
measure: Grip strength
timeFrame: 5 months after surgical repair
measure: The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: 2 months after surgical repair
measure: The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: 5 months after surgical repair
Secondary outcomes:
measure: Fingers range of motion
timeFrame: The change between 2 and 5 months after surgical repair
measure: Grip strength
timeFrame: The change between 2 and 5 months after surgical repair
measure: The Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: The change between 2 and 5 months after surgical repair
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center
Study officials:
References:
Clinical trial NCT00656331: The Pleiotropic Effects of Atorvastatin When Combined With Common Antihypertenisve Medications.
Official title: The Pleiotropic Effects of Atorvastatin When Combined With Common Antihypertenisve Medications: A Comparison of Amlodipine and Hydrochlorothiazide
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2008-04-11
Enrollment: 0
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 purpose of this study is to compare the effects of the cholesterol medication taken with each blood pressure medication alone on heart disease risk factors including blood pressure, cholesterol, inflammation, blood sugar control, blood vessal function, and other heart disease risk factors.


Eligibility criteria: Inclusion Criteria:

* mild hypertension and high cholesterol

Exclusion Criteria:

* diabetes and heart disease

Primary outcomes:
measure: PAI-1
timeFrame: study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: UNMHSC
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Kathleen Colleran, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04674631: The Effect of Neuropathic Pain in Patients With Combat-related Extremity Injury
Official title: The Effect of Neuropathic Pain on Quality of Life, Depression and Sleep in Patients With Combat-related Extremity Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 98
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 98 patients with combat-related extremity injury

Brief summary: It has been suggested that veterans with chronic pain might be at increased risk for the development of depression, anxiety and post-traumatic stress disorder. To date, most of the published studies have focused on chronic pain as a whole, and there are limited studies examining association of neuropathic pain with psychological comorbidity and quality of life.Combat related extremity injury significantly influences the patients' quality of life and psychological state. In this context, the purpose of this study is to illustrate to what extent neuropathic pain influences the quality of life, depression level and sleep quality of patients with combat-related extremity injury.

Detailed description: A total of 120 patients with combat-related extremity injury and 60 age and BMI-matched healthy controls will be participated in this cross-sectional study. The presence of neuropathic pain will be evaluated using Leeds assessment of neuropathic symptoms and signs (LANSS) questionnaire. The impact of pain on health-related quality of life will be assessed using the 36-Item Short Form Survey (SF-36). Beck Depression Scale (BDS) will be used to evaluate depression status of the patients. Quality of sleep will be assessed using the Pittsburgh Sleep Quality Index (PSQI).

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-65 years who had previous history of combat-related extremity injury

Exclusion Criteria:

* Previous history of the cervical or lumbosacral radiculopathy, any known rheumatic disease or neurologic or endocrine disorders, excessive alcohol consumption and vitamin B12 deficiency

Primary outcomes:
measure: Short Form Survey (SF-36)
timeFrame: through study completion, an average of one and a half months
measure: Beck Depression Scale (BDS)
timeFrame: through study completion, an average of one and a half months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: through study completion, an average of one and a half months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Merve Orucu Atar
state: Cankaya
Study officials:
affiliation: Gaziler PMR, Training and Research Hospital, Department of PMR
name: Merve Orucu Atar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03676231: Study of SGM-1019 in Patients With Nonalcoholic Steatohepatitis (NASH)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SGM-1019 Administered for 12 Weeks in Subjects With F1-F3 Nonalcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Lead sponsor: Second Genome
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 9
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: This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of SGM-1019 in subjects with fibrosis stage 1-3 (F1-F3) NASH.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 18 to 75 years, inclusive
* Elevated ALT
* F1-F3 NASH
* BMI ≥ 25

Exclusion Criteria:

* Use of prohibited medication/supplements
* Poorly controlled type 2 diabetes
* Hepatic decompensation
* Chronic liver disease
* Planned surgeries/procedures

Primary outcomes:
measure: Evaluation of Safety and Tolerability - Treatment-emergent Adverse Events
timeFrame: 12 weeks
Secondary outcomes:
measure: Evaluation of Pharmacokinetics - PK
timeFrame: 12 weeks
measure: Evaluation of Pharmacodynamics - Labs
timeFrame: 12 weeks
measure: Evaluation of Phamacodynamics - MRI
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Second Genome Clinical Site 405
state: Arizona
city: Tucson
country: United States
facility: Second Genome Clinical Site 406
state: Arizona
city: Panorama City
country: United States
facility: Second Genome Clinical Site 403
state: California
city: Lakewood Ranch
country: United States
facility: Second Genome Clinical Site 409
state: Florida
city: Flowood
country: United States
facility: Second Genome Clinical Site 410
state: Mississippi
city: Kansas City
country: United States
facility: Second Genome Clinical Site 404
state: Missouri
city: Fayetteville
country: United States
facility: Second Genome Clinical Site 408
state: North Carolina
city: Clarksville
country: United States
facility: Second Genome Clinical Site 407
state: Tennessee
city: Austin
country: United States
facility: Second Genome Clinical Site 402
state: Texas
city: San Antonio
country: United States
facility: Second Genome Clinical Site 401
state: Texas
Study officials:
affiliation: Second Genome
name: Matthew W McClure, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06991231: The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty
Official title: The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty - A Randomized Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-Operative Pain
Total Knee Arthroplasty
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-05-27
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy of cryoablation use on patient-reported outcomes (PROMs) and opioid consumption following total knee arthroplasty. This is a randomized study that will involve a 1:1 randomization to total knee arthroplasty +/- cryoablation.


Eligibility criteria: Inclusion Criteria:

* Patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis.
* Patients have been medically cleared and scheduled for surgery

Exclusion Criteria:

* Patients with cold-related conditions (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, and Raynaud's disease)
* Surgery for fracture, infection, or malignancy

Primary outcomes:
measure: Opioid Consumption during Post-Procedural Follow-Up Period
timeFrame: Month 3 Post-Operation (Approximately Week 8-9)
measure: Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.) Score
timeFrame: Month 3 Post-Operation (Approximately Week 8-9)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua Rozell, MD
role: PRINCIPAL_INVESTIGATOR
References: