louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03867695: SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy
Official title: SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Video Assisted Thoracoscopic Surgery
Lobectomy
Pain Post Operative
Regional Anesthesia
Keywords: Serratus plane block
Analgesia after VATS
Lobectomy VATS
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS.

Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine.

The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.


Eligibility criteria: Inclusion criteria:

* All patients undergoing lobectomy VATS
* Older \> 18 years
* Patients who meet criteria of ASA 1 to 3 class

Exclusion criteria:

* Patient's refusal to participate in the study
* Psychiatric disorder (impossibility to collect the informed consent)
* Patient under juridical protection
* On going an other study
* Non balanced epilepsy
* 3 grade auriculo-ventricular heart block without pacing
* Severe hepatocellular insufficiency
* Anti arrhythmic treatment : class III of the Vaughan William's classification
* Pregnant patient or/and breastfeeding
* History of opioid abuse
* Allergy to local anesthetic drug or opioids

Primary outcomes:
measure: Total intravenous morphine consumption (mg) in the PACU and department.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Bob HEGER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00062595: Vitamin K and Bone Turnover in Postmenopausal Women
Official title: Vitamin K and Bone Turnover in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Menopause
Vitamin K
Bone turnover
Bone Density
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Eisai Co., Ltd.
First posted: 2003-06-12
Enrollment: 375
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This one year study of the K vitamers phylloquinone (K1) and menatetranone (MK4) will study supplementation effects on bone turnover and bone density. Women at least 5 years postmenopause with normal bone density who do not use estrogen therapy or the following medications may be eligible:

alendronate (Fosamax), risedronate (Actonel), pamidronate (Aredia), etidronate (Didronel), zoledronate (Zometa), teriparatide (Forteo), raloxifene (Evista), tamoxifene, warfarin (Coumadin), anti-seizure medications, prednisone, or oral steroids. Eligible subjects will take calcium and vitamin D (Citracal) twice a day for the first two months and through-out the study. After the first two months, subjects are randomized to the K1, MK4 or placebo groups. Return visits occur at 1, 3, 6 and 12 months. Fasting blood and urine is collected at each visit and bone density is performed at 3 study visits.


Eligibility criteria: * Female, 5 years postmenopause.
* Ambulatory.
* Community dwelling.
* Able to ingest calcium and vitamin D supplements.
* Willing to restrict vitamin K intake.
* Stable thyroid dose if appropriate.
* No history of hyperthyroidism, hyperparathyroidism or other metabolic bone diseases.
* Absence of hardware in hip and spine.
* History of malignancy within the last five years.
* Not currently using coumadin or warfarin.
* Vitamin D supplements must be less than 800 IU daily.
* Have not used estrogen or other bone-altering medications (see list in study description) within the last year.
* No history of liver disease or malabsorption.
* No known allergy to vitamin K.
* Have not participated in an investigational drug trial within the last month.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Osteoporosis Clinical Research Prog.
state: Wisconsin
Study officials:
References:
citation: Kumar R, Binkley N, Vella A. Effect of phylloquinone supplementation on glucose homeostasis in humans. Am J Clin Nutr. 2010 Dec;92(6):1528-32. doi: 10.3945/ajcn.2010.30108. Epub 2010 Sep 29.
Clinical trial NCT01725295: Neurostructural Integration Technique for Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia treatment
physical therapy
hydrotherapy
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2012-11-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fibromyalgia is a common cause of widespread musculoskeletal pain. The investigators have found that our patients seem to benefit from a soft tissue physical therapy called neurostructural integration therapy (NST). The purpose of this study was to compare NST to hydrotherapy which is already used to manage fibromyalgia symptoms.

Detailed description: Twenty female patients who met the American College of Rheumatology diagnostic criteria for the classification of FM were enrolled in the study. Patients were randomly allocated to receive either hydrotherapy or NST. Patient evaluations were performed at baseline, six weeks, three months, and six months. Primary outcome measures included the SF-36 quality of life questionnaire, the Fibromyalgia Impact Questionnaire and the Total Myalgic Score. Duration of morning stiffness and duration of weekly aerobic exercise as reported by the participants were secondary outcome measures. Statistics analysis was performed by standard parametric and non parametric methods.

Eligibility criteria: Inclusion Criteria:

* Any patient who fulfills ACR diagnostic criteria for fibromyalgia

Exclusion Criteria:

* Patients with established ischemic heart disease, uncontrolled hypertension or diabetes, hypothyroidism, severe depression

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Mater Misericordiae Hospital
Study officials:
References:
Clinical trial NCT06389695: Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients
Official title: Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of a Single Dose of Gallium [68Ga]-NYM032 Injection Prepared by Kit for the Preparation of the 68Ga-NYM032 Injection in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Lead sponsor: Norroy Bioscience Co., LTD
Sponsor class: INDUSTRY
First posted: 2024-04-29
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted


Eligibility criteria: Inclusion Criteria:

1. Patients with pathologically confirmed prostate cancer;
2. Age range from 18 to 75 years old (including 18 and 75 years old);
3. ECOG score of 0 or 1;
4. Expected life ≥ 6 months；
5. The subjects agree to take effective contraceptive measures during the study period and for at least three months after the diug administration;
6. The subjects are able to maintain good communication with the researchers；understand and follow the requirements of this study and sign an informed consent form before the start of relevant research operations.

Exclusion Criteria:

1. Known or suspected to be allergic to the investigational drug or any of its components;
2. Accepting other investigational drugs upon enrollment, or within 5 biological half-lives of the drug at enrollment, or within 30 days after its last administration, whichever is longer;
3. Those who have used any radioactive therapy medication within 90 days before investigational drug administration, or have received any radioactive diagnostic medication within 3 days before investigational drug administration;
4. Planned androgen deprivation therapies use, any therapeutic intervention for the prostate cancer and use of folate supplements during the study;
5. Plan to arrange surgery and other invasive interventions within 2 days after the injection of the investigational drug；
6. Ongoing toxicity \>grade l from previous standard or investigational therapies；
7. Patients with active infections during screening;
8. Those who have no guarantee of being able to lie down quietly in the examination cabin during a PET examination, or those who suffer from claustrophobia and cannot cooperate in a PET examination:
9. Other situations where the researchers believe that the subject is not suitable for inclusion in this study.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Affliated Hospital of Jiangnan University
state: Jiangsu
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT02934295: Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies
Official title: Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Rubeola
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.


Eligibility criteria: Inclusion Criteria:

* Women over 18
* Rubella serology negative, ambiguous or weakly positive during a first prenatal consultation and for which the second determination of the immunity anti rubella is necessary after 18 weeks of pregnancy
* Accepting the rubella vaccination after the childbirth;
* Accepting a blood test, during a postnatal consultation, 6 in 8 weeks after vaccination, to verify their immunity towards the virus of the rubella.
* Affiliated to a social security scheme
* Having given a written consent

Exclusion Criteria:

* Rubella contracted since the first serology realized during the first prenatal consultation
* Autoimmune pathologies
* Intolerance / allergy known about a previous vaccination whatever it is
* Immunosuppression (HIV, transplants)
* Injection of multivalent immunoglobulins (except anti-D)

Primary outcomes:
measure: Level of Anti-Rubella Antibody, E1
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital Antoine-Béclère
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Olivier Picone
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Brousse
name: Christelle VAULOUP-FELLOUS, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06249295: Postoperative Oral Cryotherapy in Sore Throat and Daily Life
Official title: The Efficacy of Postoperative Oral Cryotherapy in Sore Throat and Daily Life in Patients With Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive sleep apnea syndrome
oral cryotherapy
pain
daily life
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies ,and then intervened in the post-surgical period using oral cold therapy (ice lolly in the mouth), while the control group received general routine care.
Primary purpose: TREATMENT

Brief summary: The purpose of this study will to evaluate the degree of postoperative sore throat and Life Impairment changes in patients with sleep apnea who underwent da Vinci robotic arm surgery as an intervention of oral cryotherapy.

Detailed description: An experimental study was conducted with 32 patients in the experimental group and 32 patients in the control group. The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies,and then intervened in the postsurgical period using oral cold therapy (ice lolly in the mouth),while the control group received general routine care. The control group received regular care. The assessment tools included the Pain Profile Scale and the Life Impairment Scale, and the assessment period was from the first day to the 14th day after the operation.

Eligibility criteria: Inclusion Criteria:

* (1)Admission age is 18 years or above, conscious, able to communicate in Mandarin and Taiwanese, and willing to be measured and fill out the questionnaire after explaining the process and purpose of the study.
* (2) The study was conducted in hospitalised patients diagnosed with sleep apnea who underwent surgery.

Exclusion Criteria:

* (1) Diagnostic diagnosis of the disease not clearly known.
* (2) Patients with unclear consciousness.
* (3) Patients who have been diagnosed with mental illness before the diagnosis of the -
* disease or recently diagnosed with mental illness.
* (4) People with paraplegia or low behavioural ability.
* (5) Patients who have suffered a stroke.

Primary outcomes:
measure: sore throat
timeFrame: up to 2 weeks
Secondary outcomes:
measure: daily life
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Chung Shan Medical University
name: Hsiang Chu Pai, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03486795: Dual Site-Dual Channel Non-invasive Brain Stimulation for Motor Function in Healthy Subjects
Official title: Effect of Dual Site-Dual Channel Non-invasive Brain Stimulation for Recovery of Motor Function in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: transcranial direct current stimulation
motor function
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 27
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of dual site-dual channel non-invasive brain stimulation for recovery of motor function in healthy subjects. Simultaneous dual site-dual channel stimulation was applied by using two sets of transcranial direct current stimulation devices. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) Dual stimulation: i) anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex, ii) anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 2) M1 stimulation: anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex; 3) PMC stimulation: anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area. 4) sham stimulation


Eligibility criteria: Inclusion Criteria:

* healthy subjects with age over 19 years old

Exclusion Criteria:

* history of disorders involving central nervous system
* patients with severe medial or psychiatric disease

Primary outcomes:
measure: Changes in motor evoked potential
timeFrame: Baseline and after intervention (approximately 30 minutes)
Secondary outcomes:
measure: Changes in sequential motor task
timeFrame: Baseline and after intervention (approximately 30 minutes)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT07008495: Testicular Sperm Retrieval Rate After Varicocele Ligation in Men With Non Obstructive Azoospermia
Official title: Testicular Sperm Retrieval Rate After Varicocele Ligation in Men With Non Obstructive Azoospermia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-obstructive Azoospermia
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 50
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A varicocele is an abnormal dilatation and tortuosity of the veins of the spermatic cord. Although varicoceles are common in the general population and are frequently found on routine physical examinations, they represent the most common correctable cause of male factor infertility.

Male factor infertility affects up to half of all couples struggling to conceive, and 10-20% of men evaluated for infertility are found to be azoospermic.

Detailed description: Generally, azoospermia is classified as obstructive azoospermia (OA) or non-obstructive azoospermia (NOA). While OA is obviously caused by obstruction, NOA has many possible causes and is more difficult to manage.

Non-obstructive azoospermia (NOA) is most often a result of primary testicular dysfunction, Varicoceles are found in 20% of the general male population, in up to 40% of men with infertility, and specifically 4.3-13.3% of men with NOA.

The role of varicoceles in NOA has not been fully elucidated. The current best practice statement on the evaluation of azoospermic males from the AUA acknowledges that impaired spermatogenesis associated with varicoceles may be reversible but does not give a clear recommendation for management.

The primary advantage of varicocelectomy in cases of NOA is the possibility of getting motile sperms in the ejaculate. Other benefit of varicocele repairs in azoospermic men is that there are increased success rates of assisted reproductive techniques (ART) such as intracytoplasmic sperm injection (ICSI) or testicular sperm extraction (TESE).

Eligibility criteria: Inclusion Criteria:

* Men with non obstructive azoospermia.
* Clinically palpable varicocele ( unilateral or bilateral ).

Exclusion Criteria:

* Known cases of obstructive azoospermia.
* Non palpable varicocele.
* Uncorrectable female causes of infertility.
* genetic abnormalities like klinefelter syndrome.

Primary outcomes:
measure: Sperm retrieval rate
timeFrame: Two Weeks
Secondary outcomes:
measure: fertility rate
timeFrame: 3 months from the operation
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University Hospital
state: South Valley
Study officials:
affiliation: Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt
name: Gamal A. Alsagheer, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01808495: Function and Modulation of Fibulin-1 Assembly in Nucleus of Corneal Fibroblasts
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Function of Mitomycin C in Cornea
Keywords: Human corneal fibroblasts
Fibulin-1
Nuclear accumulation
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The original cell sources were collected from the donors with more than 20 years old following penetrating keratoplasty. After successfully amplified from the residual corneal rim following penetrating keratoplasty in the previous projects, human corneal fibroblasts (HCFs) were reserved in liquid nitrogen tank and were thawed for this study under in vitro cultivation and application.

Brief summary: The purpose of this study is to investigate the role of nuclear Fibulin-1 (FBLN1) in Human Corneal Fibroblasts under treatment of mitomycin C (MMC).


Eligibility criteria: Inclusion Criteria:

* The frozen storage cells in liquid nitrogen were amplified from the residual corneal rim of the donors with more than 20 years old following penetrating keratoplasty.

Exclusion Criteria:

* The donors were younger than 20 years old.

Primary outcomes:
measure: Modification of nuclear Fibulin-1 accumulation in suppressing gene expression
timeFrame: 3 days post mitomycin C treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Tsan-Chi Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: