louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01738269: Elecsys HE4 Chinese Reference Value Study
Official title: A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: Ovarian cancer, HE4, normal range
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 2351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Except for samples from apparently healthy subjects, specimens for the entire clinical section are supposed to be available in banks / archives. Thus, for the most part, no prospective collection of serum should be necessary. Pseudonymized residual samples will be used. All elements of the clinical part require samples from well characterized cohorts are showed below.

1. Apparently Healthy: 300
2. Non-malignant Conditions: 650
3. Malignant Conditions: 800

Brief summary: Aim of this study is to provide specimens for establishing reference values of HE4 in an apparently healthy Chinese population using the Roche Elecsys HE4 assay tested on variety of Elecsys and cobas brand immunoassay analyzers. This reference range will be compared to population of subjects who have signs and symptoms of various benign and malignant diseases, including ovarian cancer. This reference range will also be compared to the levels of HE4 in individual subjects who have been diagnosed with ovarian cancer and are being followed longitudinally for recurrence or progression of their disease.


Eligibility criteria: Inclusion Criteria (all cohorts):

* appropriate clinical data
* normal appearance of sample
* minimum 0.5 ml volume available

Exclusion Criteria (all cohorts):

* \< 18 years of age
* insufficient volume
* insufficient clinical information
* \> 3 freeze/thaw cycles of samples
* Stored or shipped at \> 0°C
* Icteric, lipemic, hemolytic, substantial particulates

Primary outcomes:
measure: Establish reference in Chinese population
timeFrame: October 2012 - March 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China PLA General Hospital
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
city: Jinan
country: China
facility: Shandong University Qilu Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Urumchi
country: China
facility: Xinjiang Medical University Cancer Center
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical Colege of HUST
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
Study officials:
References:
Clinical trial NCT05298969: Temporalis Myofascial Flap Effectiveness
Official title: The Efficacy of Temporalis Myofascial Flap in Reconstruction of Various Cranio-maxillofacial Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Sinus Neoplasms
Keywords: Temporalis flap
Maxillofacial defects
Reconstruction
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Assessment of temporalis myofascial flap effectiveness in reconstruction of cranio-maxillofacial defects
Primary purpose: TREATMENT

Brief summary: This research is conducted as trial to improve lifestyle of patients with cranio-maxillofacial defects following major insults like trauma or tumor resection in form of speech problems or dysphagia by usage temporalis myofascial flap and assessment of it's effectiveness


Eligibility criteria: Inclusion Criteria:

* patients with:

  * TMJ ankylosis

    * Osteomyelitis following mucormycosis
    * Following tumor resection like maxillectomy or temporal bone resection
    * Following orbital exentration due to tumors or infections
    * Following massive trauma
    * Facial reanimation

Exclusion Criteria:

* • History of head \& neck embolization as it may compromise blood supply of the flap

  * Extensive tumors involving maxillary artery
  * History of head \& neck radiation or chemotherapy
  * Temporalis muscle wasting due to any reason
  * Bad general condition

Primary outcomes:
measure: Assessment of versatility of temporalis myofascial flap in reconstruction of craniomaxillofacial defects in means of flap viability, healing and epithelization
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Assessment of phonation and swallowing efficacy postoperatively
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU7
Study officials:
References:
Clinical trial NCT05818969: Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement
Official title: Effects of Hypnosis Therapy on Outcomes in Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Opioid Use
Keywords: Hypnosis
Total Knee Arthroplasty
Total Knee
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy provided during the perioperative period will lead to decreased use of opioid therapy. Patients are randomly assigned to one of two treatment groups: (I) usual care, or; (II) hypnotherapy treatment. Patients have an equal chance of being assigned to one of the two groups.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary knee arthritis, in need of a total knee arthroplasty.
* The ability to read, speak, and understand English
* The ability and willingness to use a web-based application (OBERD) on a smartphone, pad/tablet, or computer
* 18 years of age or older

Exclusion Criteria:

* Revision total knee arthroplasty
* Any knee procedure except a primary knee arthroplasty, since these procedures have shown to result on increased postoperative pain compared to primary surgery
* Patients with active cancer or receiving palliative care

Primary outcomes:
measure: Change in Perioperative Anxiety - Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day
Secondary outcomes:
measure: Change in Perioperative Pain - Knee Society Score/ Knee Injury and Osteoarthritis Scores
timeFrame: 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day
measure: Change in Opioid Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client
timeFrame: 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day
measure: Change in Anxiolytic Consumption - The Beliefs and Attitudes to Hypnosis Valencia Scale-Client
timeFrame: 7 days prior to surgery, 10 days postoperative day, 49 days postoperative day
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: Brian T Palumbo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01890369: Modulation of Muscle Protein Metabolism by Essential Amino Acids
Official title: Modulation of Muscle Protein Metabolism by Essential Amino Acids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Old Age
Keywords: Old Age
Sarcopenia
Amino Acid
Muscle
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2013-07-01
Enrollment: 32
Sex: MALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators plan to explore the ability of amino acids, the building blocks of proteins in our bodies and in the food we eat, to stimulate muscles to grow and stay strong. The investigators will investigate how rapidly after one meal the human body is ready to make use of a second meal and look at the molecular mechanisms underlying this. The investigators will look at these phenomena in older men as this group is known to be subject to a gradual loss of muscle mass and strength.

Detailed description: Muscles can stay very constant in size for much of adult life yet dramatic wasting is seen in advanced age and ill health. A better understanding of how muscles regulate their size will help design treatments to slow wasting in disease and to promote active aging. We plan to study a group of older men, \~70yrs, the age at which muscle bulk starts to decrease, to observe how the muscles respond to feeding. We will provide a drink that contains the digested products of proteins from which muscles are built. Taking blood samples and some tiny biopsies of muscle (done under local anaesthesia) will allow us to measure muscle turnover and we will be able to measure for how long after a meal muscles actively take in nutrients before becoming "full". We will also measure how long the muscle remains "full" before it returns to a state where it can again be stimulated to take in nutrients. We will also explore if leucine, one of the component parts of protein (especially in meat and dairy products) and a food widely used supplement, can promote the early re-stimulation of muscle by eating.

Eligibility criteria: Inclusion Criteria:

* Male
* 65-75yrs
* BMI 18-28

Exclusion Criteria:

* Type 2 Diabetes mellitus
* Neurological Disease
* Significant cardiac, hepatic or renal disease
* Active malignancy
* Medication inc. Corticosteroids, NSAID use, Beta adrenoblockers.

Primary outcomes:
measure: Myofibrillar Fractional Synthetic Rate
timeFrame: 6-10hrs
Secondary outcomes:
measure: Leg blood flow
timeFrame: 6-10hrs
measure: mTORC1 and AKT phosphorylation
timeFrame: 6-10hrs
measure: Muscle Protein Breakdown
timeFrame: 6-10hrs
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: School of Graduate Entry Medicine
Study officials:
affiliation: University of Nottingham
name: Philip J Atherton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01578369: Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy
Official title: Pelvic Floor Muscle Training Included in General Fitness Classes is Effective in Primary Prevention of Urinary Incontince in Pregnancy. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Urinary Incontinence
Keywords: Urinary incontinence
Pregnancy
Pelvic floor muscle training
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 169
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the effect of pelvic floor muscle training taught in a general exercise class during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.

Detailed description: Pregnancy and childbirth are known risk factors for development of female urinary incontinence (UI). Studies have found that Pelvic Floor Mucle Trainig (PFMT) is effective in preventing and reducing UI during pregnancy and after childbirth. However, in a recent study, no effect was found when PFMT were taught in a general fitness class without former palpation of the pelvic floor muscles (Bo y Haakstad, 2011).

Eligibility criteria: Inclusion Criteria:

* Nulliparous with singleton baby
* Not suffering from urinary incontinence
* Giving birth at Hospital Universitario de Fuenlabrada
* Able to comunicate in Spanish
* Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines

Exclusion Criteria:

* Multiparity
* At risk of Premature birth
* Following another exercise program

Primary outcomes:
measure: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire
timeFrame: Week 10-14 gestation (baseline), week 36-39 (after intervention)
Secondary outcomes:
measure: Change from baseline in King's Health Questionnaire
timeFrame: week 10-14 of gestation (baseline), week 36-39 (after intervention)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Politécnica de Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Rubén Barakat, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Politecnica de Madrid
name: Mireia Peláez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.
citation: Pelaez M, Gonzalez-Cerron S, Montejo R, Barakat R. Pelvic floor muscle training included in a pregnancy exercise program is effective in primary prevention of urinary incontinence: a randomized controlled trial. Neurourol Urodyn. 2014 Jan;33(1):67-71. doi: 10.1002/nau.22381. Epub 2013 Feb 6.
Clinical trial NCT00982969: The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis
Official title: The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis Among Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: tuberculosis
pneumonia
QuantiFERON-TB Gold in-tube
Tuberculin skin test
Lead sponsor: Armed Forces Capital Hospital, Republic of Korea
Sponsor class: OTHER_GOV
First posted: 2009-09-23
Enrollment: 200
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Soldiers in South Korean Army

Brief summary: The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the diagnosis of active tuberculosis in young adults group, highly clinically suspected tuberculosis.

Detailed description: Investigators will enroll prospectively all clinically and radiologically suspected tuberculosis patients from 20 to 29 years old who visited the Armed Forces Capital Hospital. Investigators will perform QFT and tuberculin skin test. Diagnosis of tuberculosis will be made by World Health Organization guideline and the physician will not know the QuantiFERON-TB Gold in-tube results before the diagnosis and anti-tuberculosis medication. Investigators will evaluate the sensitivity and specificity of QuantiFERON-TB Gold in-tube in the diagnosis of active tuberculosis among young adults.

Eligibility criteria: Inclusion Criteria:

* All clinically and radiologically suspected TB patients from 20 to 29 years old who visited the Armed Forces Capital Hospital

Exclusion Criteria:

* Soldiers who do not agree with study protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Armed Forces Capital Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Lee JE, Kim HJ, Lee SW. The clinical utility of tuberculin skin test and interferon-gamma release assay in the diagnosis of active tuberculosis among young adults: a prospective observational study. BMC Infect Dis. 2011 Apr 18;11:96. doi: 10.1186/1471-2334-11-96.
Clinical trial NCT03629769: Effects of Proxelan Somministration in Patients With Chronic Prostatitis
Official title: Effects of Proxelan Somministration in Patients With Chronic Prostatitis Cat. IIa NIH: Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Prostatitis
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Premature Ejaculation
Keywords: Prostate inflammation
CPS/CPPS
Prostatitis
Proxelan
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 30
Sex: MALE
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: The purpose of the study is to determinate the antinflammatory effects of the Proxelan on a cohort of patients affected by prostatitis'like symptoms and clinical evidence of abacterical prostatistis, trough a significative improvements of pain symptoms according to the NIH-CPSI questionnaire items, spermatozoa motility/concentration variations and the semen cytokines level decrease.


Eligibility criteria: Inclusion Criteria:

- prostatitis like symptoms for at least three months

Exclusion Criteria:

* significant post-voidal residual volume
* Meares and Stamey test suggestive for bacterial infection
* neoplasms,
* urinary stones,
* antibiotic therapy in the previous three months,
* irritable bowel syndrome,
* previous radiotherapic or chemiotherapic treatment,
* urethral stenosis,
* neurogenic bladder
* previous prostatic surgery

Primary outcomes:
measure: National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: AOUP Ospedale cisanello
state: Toscana
Study officials:
References:
citation: Galeone G, Spadavecchia R, Balducci MT, Pagliarulo V. [The role of Proxelan in the treatment of chronic prostatitis. Results of a randomized trial]. Minerva Urol Nefrol. 2012 Jun;64(2):135-41. Italian.
Clinical trial NCT04972669: The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence
Official title: The Study of Electrical Acupuncture Stimulation Therapy for Postprostatectomy Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postprostatectomy Incontinence
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 110
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: More than 50% patients underwent prostatectomy suffered from postoperative incontinence, and the effect of pelvic floor muscle training is very limited. Electrical acupuncture stimulation therapy has been demonstrated to work on other kinds of Urinary Incontinence. Before this trial, the researchers have conducted pre-experiments where electrical acupuncture stimulation therapy was conducted for few postprostatectomy Incontinence patients. On the basis of the preliminary work, this prospective, random control research aims to verify the safety and effectiveness of electroacupuncture in the treatment of postprostatectomy Incontinence.


Eligibility criteria: Inclusion Criteria:

* localized prostate cancer (stage: cT1-cT2, N0, M0)
* 4-6weeks after prostatectomy
* postprostatectomy prostate specific antigen (PSA) test below cured level
* incontinence one month after surgery
* ECOG score:0-1

Exclusion Criteria:

* history of neoadjuvant hormonal therapy
* history of transurethral resection of the prostate (TUPR)
* history of operation on pelvis
* history of incontinence before prostatectomy

Primary outcomes:
measure: Continence rate after 6 weeks of treatment
timeFrame: 3 years
Secondary outcomes:
measure: change of urine pad quantity for 24 hours after 4 courses compared with baseline
timeFrame: 3 years
measure: change of weight in kilograms of urine pad for 24 hours after 6 courses compared with baseline
timeFrame: 3 years
measure: changes of The expanded prostate cancer index composite(EPIC) score after 4-6 courses compared with baseline
timeFrame: 3 years
measure: Long-term urinary continence recovery
timeFrame: 3 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
Clinical trial NCT01487369: Special Survey of Production of Insulin Aspart Specific Antibody
Official title: Special Survey of Production of Insulin Aspart (IAsp) Specific Antibody
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 204
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes requiring insulin therapy and who had a treatment history of NovoRapid® (insulin aspart)

Brief summary: This study is conducted in Japan. The aim of this study is to collect data of production of insulin aspart specific antibody under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with diabetes requiring insulin therapy

Exclusion Criteria:

* Patients who had a treatment history of NovoRapid® (insulin aspart)

Primary outcomes:
measure: Antibody titre findings
Secondary outcomes:
measure: Hypoglycemic events
measure: Adverse events
measure: HbA1c (glycosylated haemoglobin)
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: