louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04072588: Sacrospinous Ligament Fixation and Lateral Suspension Operations
Official title: Comparison of Transvaginal Sacrospinous Ligament Fixation and Lateral Suspension Operations in the Treatment of Vaginal Cuff Prolapse in Hysterectomized Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prolapse
Cuff
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 80
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is transvaginal sacrospinous ligament fixation and the other is lateral suspension. The investigators will form study groups of patients who underwent these two operations.

Brief summary: Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is transvaginal sacrospinous ligament fixation and the other is lateral suspension. the investigators want to compare the results of patients undergoing these two operations. Thus, the difference between surgical methods will be investigated.

Detailed description: Patients with symptomatic vaginal cuff prolapse will be operated; There will be two kinds of operation. After the operations, the patients will be followed up, a questionnaire will be applied to the postoperative patients and some questions will be asked. Pelvic examinations will also be performed and they will be evaluated for recurrence and complication. At the end of the study, the data of both groups will be compared and their superiority to each other will be shown.

Eligibility criteria: Inclusion Criteria:

* Patients who had previously undergone hysterectomy for benign causes
* Patients with symptomatic vaginal cuff prolapse during hysterectomy follow-up
* And for this, patients scheduled for operation

Exclusion Criteria:

* Patients with chronic diseases or medications that interfere with the operation
* Patients with oncology operated for malignant cause
* Non-localized patients with vaginal cuff prolapse

Primary outcomes:
measure: recurrence
timeFrame: 1 years
measure: complications
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT01688388: Single Fraction Intraoperative Radiotherapy
Official title: Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Invasive Ductal and Invasive Lobular Breast Carcinoma
Stage 0 Breast Carcinoma
Stage I Breast Carcinoma
Stage II Breast Carcinoma
Keywords: Breast Cancer
Carcinoma
Radiotherapy
Intraoperative Radiotherapy
IORT
Lead sponsor: St. Joseph Hospital of Orange
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 250
Sex: FEMALE
Minimum age (years): 41
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.

Detailed description: For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it) followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.

Eligibility criteria: Inclusion Criteria:

* Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma in situ
* Age \> 40 years
* Karnofsky performance status \> 70%
* Tumor. Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm
* Nodal Status: preoperatively N0
* Clear surgical margins: R0
* All grades G1 - G3
* Any hormonal receptor and HER-2 status
* Informed consent

Exclusion Criteria:

* Gender: male
* Tumor size: more than 2.5 cm
* Nodal status greater than or equal to N1 pathologically
* Multicentricity
* Previous radiotherapy to the involved breast
* Karnofsky Index \< 70%
* Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
* Distant metastases
* Pregnancy in woman of child bearing age
* Unable to provide written consent

Primary outcomes:
measure: Toxicity Assessment
timeFrame: 5 years
Secondary outcomes:
measure: Cosmetic Evaluation
timeFrame: 5 years
measure: Recurrence Assessment
timeFrame: 5 years
Other outcomes:
Locations:
city: Orange
country: United States
facility: St. Joseph Hospital of Orange
state: California
Study officials:
affiliation: St. Joseph Hospital of Orange
name: Lawrence Wagman, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04352088: Immune Response Features in Allergic Airway Diseases
Official title: Investigation of Phenotypes, Endotypes and Immune Response Features in Allergic Airway Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Rhinitis
Allergic Asthma
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with allergic rhinitis with or without asthma and healthy individuals for control group.

Brief summary: This study aims to investigate immune mechanisms and phenotypes and endotypes of allergic airway diseases - allergic rhinitis and allergic asthma. Pathogenesis of these diseases are not fully investigated yet. Patients with the same disease have different dominant symptoms, course of the disease and response to treatment. Moreover, there is a hypothesis about united airway disease suggesting that allergic rhinitis and allergic asthma is different manifestation of the same disease. This led to assumption of phenotypes and endotypes. This classification which still is not unified can let to prescribe personalized treatment for every patient.


Eligibility criteria: Inclusion Criteria:

* Hypersensitivity to house dust mites
* Allergic rhinitis with or without mild to moderate asthma

Exclusion Criteria:

* Acute or chronic infections
* Use of systemic immunosupresants (wait 1 month)
* Use of systemic or local antihistamines (wait 1 week)
* Use of intranasal steroids (wait 1 month)
* Oncological or active autoimmune diseases

Primary outcomes:
measure: Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups.
timeFrame: 2 hours
measure: Cytokines level in nasal lavage and peripheral blood after nasal provocation test in different groups.
timeFrame: 22 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos
Study officials:
References:
Clinical trial NCT03318588: Intravitreous CytokinE Level in pAtient With retiNal Detachment
Official title: Intravitreous CytokinE Level in pAtient With retiNal Detachment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Detachment
Keywords: Retinal detachment
Photoreceptor apoptosis
Cytokine
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from the department of Ophthalmology (Nancy University Hospital)

Brief summary: Photoreceptor apoptosis is the basis for permanent visual loss in a number of retinal disorders including age-related macular degeneration (AMD) and retinal detachment (RD). Thus, despite tremendous advances in vitreoretinal surgery and management of rhegmatogenous RD leading to a primary reattachment rate over 95%, some patients show poor visual recovery because of photoreceptor apoptosis.

Physiologically, microglial cells (resident macrophages) are present only in the inner retina. The subretinal space, located between the retinal pigment epithelium (RPE) and the photoreceptor outer segments (POS), is devoid of all mononuclear phagocytes and form a zone of immune privilege. In AMD, several studies showed a strong association between subretinal mononuclear phagocytes infiltration and advanced forms of AMD. Experimental work in mice suggest that this infiltration plays an important role in the pathogenesis of this condition by producing inflammatory cytokines.

RD-induced photoreceptor apoptosis might result from similar mechanisms. The aim of this study is to determine the cytokine profile in vitreous samples from patients with RD and to compare it with those from control patients with macular hole.


Eligibility criteria: Inclusion Criteria:

* Patients with primary retinal detachment requiring vitrectomy
* Patients with idiopathic macular hole requiring vitrectomy

Exclusion Criteria:

* History of retinal detachment or intraocular inflammatory diseases

Primary outcomes:
measure: Intravitreous cytokine levels
timeFrame: up to one month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Brabois Hospital
Study officials:
affiliation: Brabois Hospital, Department of Ophthalmology
name: Jean-Baptiste CONART, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conart JB, Blot G, Augustin S, Millet-Puel G, Roubeix C, Beguier F, Charles-Messance H, Touhami S, Sahel JA, Berrod JP, Leveillard T, Guillonneau X, Delarasse C, Sennlaub F. Insulin inhibits inflammation-induced cone death in retinal detachment. J Neuroinflammation. 2020 Nov 26;17(1):358. doi: 10.1186/s12974-020-02039-1.
Clinical trial NCT02742688: Effect of Intake of Pyrus Pyrifolia Var. Culta(Makino) NaKai Peel Extract on Body Fat and Blood Lipid.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Obesity
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Pyrus pyrifolia var. culta(Makino) NaKai peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females 19-65 years old
* BMI(body mass index) 25\~29.9 kg/m\^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women)
* Able to give informed consent

Exclusion Criteria:

* BMI(body mass index) ≥ 30 kg/m\^2
* Significant variation in weight(more 10%) in the past 3 months
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.

Primary outcomes:
measure: Changes in body fat mass
timeFrame: 8 week
Secondary outcomes:
measure: Changes in percent body fat
timeFrame: 8 week
measure: Change in fat free mass
timeFrame: 8 week
measure: Change in body mass index
timeFrame: 8 week
measure: Change in weight
timeFrame: 8 week
measure: Change in total cholesterol
timeFrame: 8 week
measure: Change in triglyceride
timeFrame: 8 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University
Study officials:
References:
Clinical trial NCT05285488: Impact of Distance Meditation on Non-attachment to the Self and Identity Threat
Official title: Impact of Distance Meditation on Non-attachment to the Self and Identity Threat
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meditation
Keywords: non-attachment to the self
identity threat
meditation
focused attention
contemplation
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Meditation is widely recognized for its benefits on both physical and psychological health and more particularly on the prevention of depression relapse. However, despite a lot of literature showing its efficacy, the mechanisms of action underlying its benefits have yet to be specifically identified and empirically tested.

to understand these mechanisms actions, it is essential to distinguish meditative practices. Three different categories of meditation can be distinguished: "Attention Family", "Constructive Family" and "Deconstructive Family" with specific effects for each.

Detailed description: The aim of the study is to compare effects of two types of meditation (focused attention and contemplation) on non-attachment to the self and identity threat.

Eligibility criteria: Inclusion Criteria:

* male or female
* aged of 18 and more
* without diagnosed psychiatric pathology
* not practicing meditation
* agreeing to participate in the study

Exclusion Criteria:

- less than 18 years old

Primary outcomes:
measure: non-attachment to the self
timeFrame: week 6
Secondary outcomes:
measure: Identity threat
timeFrame: week 6
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims-Champagne-Ardenne
state: Grand-Est
Study officials:
References:
Clinical trial NCT04196478: Role of Color Doppler Ultrasonography in Assessment of Vascular Access Surveillance in Hemodialysis Patients.
Official title: Role of Color Doppler Ultrasonography in Assessment of Vascular Access Surveillance in Hemodialysis Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arteriovenous Fistula
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Sample size was calculated using Epi-Info 7 software. According to the results of previous study conducted at renal dialysis unit of Assiut university hospital (7) the most common complication occurred in haemodialysis access (A-V fistula) was infected A-V access (23.8%). Based on this prevalence the minimum required sample size for current study is 84 patients.

Following assumptions were used to calculate this sample:

Target population size = 120 (as number of new haemodialysis patients is 100-120 each year).

N.B: in this study we will include all eligible cases at renal dialysis unit of Assiut university i.e., patients of last year (total coverage sample)

Brief summary: The aim of this study is to provide an overview of the possible applications of DUS during the maturation and postoperative follow-up of vascular access, with particular emphasis to establish a relationship between doppler Ultrasound parameters including:

1. Flow volume.
2. Outflow vein diameter.
3. Outflow vein depth.
4. Resistive index.


Eligibility criteria: Inclusion Criteria:

* ESRD patients on dialysis with heamodialysis vascular access with adult age group (18 years and above).

Exclusion Criteria:

* Patients with chronically occluded vascular access with failed surgical or interventional attempts.

Primary outcomes:
measure: Maturation of arteriovenous fistulas
timeFrame: 6 weeks duration follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05839678: How to Differentiate and Treat Cystic Laesions in the Anterior Mediastinum (DETECTION)
Official title: How to Differentiate and Treat Cystic Laesions in the Anterior Mediastinum (DETECTION)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cysts
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: The Netherlands Cancer Institute
First posted: 2023-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cysts in the anterior mediastinum

Brief summary: Multicenter trial about anterior mediastinal cysts


Eligibility criteria: Inclusion Criteria: cysts in the anterior mediastinum

* Thymic cysts
* Bronchogenic cysts
* Pericardial cysts
* Cystic thymoma
* Cystic teratoma

Exclusion Criteria:

* Patients \<18 years old
* Patients without radiological imaging
* Patients without approval for follow-up

Primary outcomes:
measure: Percentage correctly diagnosed cystic laesions
timeFrame: 2000-2022
Secondary outcomes:
measure: Patient characteristics, complications, comborbidities
timeFrame: 2000-2022
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
state: Limburg
Study officials:
References:
Clinical trial NCT03177278: A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin
Official title: A Phase 1, Open-Label Study to Assess the Metabolism, Excretion, and Mass Balance of [14C]-Plazomicin Following a Single IV Infusion in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Achaogen, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2017-06-06
Enrollment: 6
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-center, open label, non-randomized metabolism, excretion, and mass balance study of a single IV infusion of \[14C\]-plazomicin in healthy, adult male subjects.


Eligibility criteria: Key Inclusion Criteria:

* Medically healthy, with no clinically significant medical history, physical examination findings, vital signs or ECG findings

Key Exclusion Criteria:

* Use of tobacco- or nicotine-containing products
* Has received radio-labeled substances or has been exposed to radiation sources within 12 months of dosing or is likely to receive radiation exposure or radioisotopes within 12 months of dosing such that participation in this study would increase their total exposure beyond the recommended levels considered safe
* History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease
* History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus
* History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness

Primary outcomes:
measure: Sum of percent of total radioactivity recovered in urine and feces relative to the administered radioactive dose minus any radioactivity lost due to emesis
timeFrame: 15 days
measure: Total radioactivity concentration equivalents in plasma and blood
timeFrame: 15 days
measure: Plazomicin concentrations in plasma and urine
timeFrame: 15 days
Secondary outcomes:
measure: Incidence and severity of adverse events
timeFrame: 21 days
measure: Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)
timeFrame: 1 day
measure: Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)
timeFrame: 4 days
measure: Physical examination
timeFrame: Screening
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Clinical Site
state: Nebraska
Study officials:
affiliation: Achaogen, Inc.
name: Shyeilla Dhuria
role: STUDY_DIRECTOR
References:
Clinical trial NCT01873378: GnRH Agonist Pretreatment in Hysteroscopic Myomectomy
Official title: Surgical Effects of GnRH Agonist Pretreatment on Cold Loop Hysteroscopic Myomectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Myoma
Keywords: Uterine myoma
GnRHa
Hysteroscopy
Cold loop
Lead sponsor: Azienda Ospedaliera S. Maria della Misericordia
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary outcome of this study is to assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic therapy in terms of distension liquid absorption and duration of the procedures.


Eligibility criteria: Inclusion Criteria:

* submucous myoma diagnosed by vaginal ultrasonography and confirmed by diagnostic hysteroscopy
* premenopausal status

Exclusion Criteria:

* present or past history of cancer
* pregnancy
* presence of associated multiple polyps
* presence of \> 2 myomas
* associated nonhysteroscopic surgical procedures

Primary outcomes:
measure: To assess if the GnRHa administration before cold loop hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical procedure.
timeFrame: Just finished the surgical procedure.
Secondary outcomes:
measure: Minutes (surgical procedure time), milliliters (fluid absorption during the procedure).
timeFrame: Just finished the surgical procedure.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Arbor Vitae Endoscopic Centre
Study officials:
affiliation: University of Perugia, Perugia, Italy
name: sandro gerli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Favilli A, Mazzon I, Grasso M, Horvath S, Bini V, Di Renzo GC, Gerli S. Intraoperative Effect of Preoperative Gonadotropin-Releasing Hormone Analogue Administration in Women Undergoing Cold Loop Hysteroscopic Myomectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2018 May-Jun;25(4):706-714. doi: 10.1016/j.jmig.2017.11.011. Epub 2017 Nov 24.