louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01899209: Surgical Treatment of Obstructed Defecation Syndrome
Official title: Obstructed Defecation Caused by Rectal Intussusception and Rectocele:STARR Versus Laparoscopic Ventral Rectopexy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sensation of Inadequate Defecation
Rectal Prolapse
Rectocele
Keywords: Obstructed Defecation
Rectal rectocele
Intussusception
STARR
Ventral Rectopexy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
Collaborators: name: University of Bologna
First posted: 2013-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures has been introduced to treat patients affected by this disease. The most used are STARR and ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.


Eligibility criteria: Inclusion Criteria:

* Patients affected by Obstructed Defecation with ODS score \>11
* Symptomatic rectal Intussusception and/or defecographic finding of rectocele\>2 cm
* Failure of at least 6 months of medical therapy
* Exclusion of neoplasm by rectosigmoidoscopy/colonoscopy

Exclusion Criteria:

* Patients affected by complete rectal prolapse
* Patients affected by slow transit constipation
* Patients affected by anismus
* Patients affected by pelvic organ prolapse
* Patients with previous rectal or anal surgery

Primary outcomes:
measure: Functional result
timeFrame: 12 months
Secondary outcomes:
measure: Anatomical result
timeFrame: 12 months
Other outcomes:
measure: Quality of life and safety
timeFrame: 12 months
Locations:
city: Bologna
country: Italy
facility: University Hospital
Study officials:
References:
Clinical trial NCT06167109: NBI Combined With MRI to Guide CTV Optimization in Eccentric Nasopharyngeal Carcinoma
Official title: Endoscopic NBI Combined With MRI to Guide the Optimization of Clinical Target Volume Delineation in Eccentric Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-center clinical trial in eccentric nasopharyngeal carcinoma (NPC) patients. The aim of this study is to evaluate the efficacy and safety of NBI combined with MRI-guided optimized CTV compared with conventional CTV, and to compare the radiotherapy-related adverse events and quality of life between the two groups.

Detailed description: All patients with eccentric nasopharyngeal carcinoma were selected on the basis of MRI findings and NBI endoscopy was performed in these patients. The patients were enrolled if both NBI endoscopy and MRI showed eccentric NPC. Patients with contralateral tissue mucosal abnormalities detected by NBI and confirmed by biopsy were excluded. Then the patients were randomly divided into an experimental group (Optimized CTV) or a control group (Conventional CTV) to evaluate the efficacy and safety of the two groups, as well as radiotherapy-related adverse events.

Eligibility criteria: Inclusion Criteria:

1. Males and females ≥18 years of age;
2. ECOG Performance Status 0,1 or 2;
3. Pathologically diagnosed as nasopharyngeal carcinoma;
4. Pretreatment nasopharynx and neck MRI imaging;
5. Nasopharyngeal suspected lesions were examined by NBI endoscopy;
6. Meeting the definition of eccentric NPC with ipsilateral (affected side) staging of T1-4 and contralateral (healthy side) staging of T0;
7. Patients evaluated without contraindications to radiotherapy;
8. Voluntary participation in clinical research, and signed informed consent.

Exclusion Criteria:

1. Patients who did not successfully undergo all three examinations (MRI, NBI, and endoscopic biopsy);
2. Other rare pathological types, such as adenocarcinoma;
3. Patients with tumor invasion of the clivus;
4. Patients whose contralateral retropharyngeal lymph nodes met the diagnostic criteria;
5. Invasion of paranasal sinuses (except simple sphenoid invasion).

Primary outcomes:
measure: Acute adverse reactions
timeFrame: 3 months
measure: Control rate of non-irradiated area
timeFrame: 36 months
Secondary outcomes:
measure: Local recurrence-free survival(LRFS)
timeFrame: 36 months
measure: Progress-free survival(PFS)
timeFrame: 36 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
Study officials:
affiliation: Chongqing University Cancer Hospital
name: Ying Wang, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02676609: Impact of Food Carbohydrate and Insulin Dose Computing by on Smart Phone on Glucose Control in Patients With Diabetes
Official title: Assessment of the Impact of Food Carbohydrate and Insulin Dose Computing by an Application on Smart Phone on Glucose Control in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Smart phone application
carbohydrate counting
meal insulin dose
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
First posted: 2016-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: During this study, we will assess a new smart phone application which aims at helping patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients, already trained to carbohydrate counting, will be recruited among those who have been using this method daily for at least 6 months. They will complete two one-month study phases, using the application in one phase and counting carbohydrate and insulin doses without the application in the other phase, with randomized order of each phase. Visits are scheduled at the start and at the end of each phase to collect data on glucose control and insulin doses. Questionnaires assessing health-related quality of life and ability of self-management of diabetes will also be filled by patients before and after each study phase.

Detailed description: During this study, we will assess a new smart phone application which aims at helping patients with Type 1 diabetes to compute food carbohydrates and meal insulin doses. Patients, already trained to carbohydrate counting, will be recruited among those who have been using this method daily for at least 6 months.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes since more than 1 year
* Basal-bolus insulin regimen since more than 6 months
* Daily practice of food carbohydrate counting since more than 6 months
* HbA1c level below 12%

Exclusion Criteria:

* Type 2 diabetes
* No ability to use a smart phone
* Pregnancy or lactation
* Severe psychiatric disorders
* Eating disorders
* Alcohol abuse or recreational drug use

Primary outcomes:
measure: 2-hour postmeal blood glucose values between 80 and 180 mg/dl
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean 2-hour postmeal blood glucose level
timeFrame: 4 weeeks
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Lapeyronie
state: Hérault
Study officials:
affiliation: University Hospital, Montpellier
name: Eric Renard, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03191409: Interaction Research on Cognitive Impairment and Emotional Disorder in End-stage Renal Disease
Official title: Interaction Research on Cognitive Impairment and Emotional Disorder in End-stage Renal Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End-stage Kidney Disease
Brain Damage
Keywords: cognitive impairment
ESRD
functional MRI
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xidian University
First posted: 2017-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ESRD patients before dialysis initiation

Brief summary: End stage renal disease (ESRD) is the last stage (stage 5) of chronic kidney disease (CKD). Abnormalities of cognitive function and high levels of depression or anxiety incidence are characteristic of hemodialysis patients. In this research project, the investigators subject in ESRD patients starting hemodialysis as the carrier. Based on the longitudinal research design, using multimodal neuroimaging data，combining with the interact relationship between changes of brain morphology, the dysfunction of resting-state and-task state with cognitive impairment and abnormal emotions.Establish brain structure-function change model associated with dialysis progression, Explore imaging markers of central and disease development characteristics in ESRD patients. the investigators attempt to clarify the core mechanism of kidney-brain axis damage, thus provide evidence for early cognitive-behavioral therapy to CKD patient.


Eligibility criteria: Inclusion Criteria:

1. Age 18-50 years;
2. ESRD patients who will start hemodialysis
3. High quality MRI scan;
4. dextromanual

Exclusion Criteria:

1. Diabetes,Brain tumor,brain trauma
2. Neuropsychiatric disease

Primary outcomes:
measure: change in cognitive function
timeFrame: Change from Baseline to 3 Months after dialysis
Secondary outcomes:
measure: Change in brain MRI
timeFrame: Change from Baseline to 3 Months after dialysis
Other outcomes:
Locations:
city: XI'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: First affiliated hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References:
Clinical trial NCT03074409: The Modulatory Effect of Oxytocin on Interoception
Official title: The Modulatory Effect of Oxytocin on Interoception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interoception
Keywords: Oxytocin
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 83
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to investigate oxytocin's effects on interoception and whether these effects vary as a function of different emotional valence.

Detailed description: The present study will use a double-blind, between-subject, placebo-controlled design to investigate the modulatory effect of oxytocin on interoception and whether this effect will vary as a function of emotional valence. In Experiment 1, subjects will perform a heartbeat detection task and the group differences between oxytocin and placebo groups of the interoceptive accuracy and neural activity in the core interoceptive network will be investigated. In Experiment 2, subjects will be asked to watch emotional faces while perform the heartbeat detection task. Investigators will examine whether oxytocin's effects on interoception will be varied as a function of different emotional valence.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Subjects reported having any neurological problems, psychiatric illness or drug or alcohol abuse and none were currently taking any form of medication and had not drunk any caffeine-containing beverages on the day of the experiment.

Primary outcomes:
measure: Heartbeat Detection (Interoception) Accuracy
timeFrame: 45 minutes after oxytocin/placebo treatment
measure: Interoceptive Network Activity
timeFrame: 45 minutes after oxytocin/placebo treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595309: Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Official title: Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 on Long Term Immunogenicity. An Uncontrolled, Open-label Phase 3 Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.


Eligibility criteria: Main Inclusion Criteria:

* Healthy adults who completed the primary immunization in study IC51 309
* Male and female healthy subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

• History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence

Primary outcomes:
measure: Seroconversion Rate
timeFrame: at Month 12 after booster
Secondary outcomes:
measure: Safety and Adverse Events
timeFrame: up to Month 12 after booster
measure: Seroconversion
timeFrame: at D28 and Month 6 after booster
measure: Geometric Mean Titer
timeFrame: D28, Month 6 and Month 12 after booster
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
city: Vienna
country: Austria
facility: Zentrum für Reisemedizin, Dependance für klinische Studien
city: Berlin
country: Germany
facility: Berliner Zentrum Reise- und Tropenmedizin
Study officials:
affiliation: Valneva Austria GmbH
name: Susanne Eder
role: STUDY_DIRECTOR
References:
citation: Eder S, Dubischar-Kastner K, Firbas C, Jelinek T, Jilma B, Kaltenboeck A, Knappik M, Kollaritsch H, Kundi M, Paulke-Korinek M, Schuller E, Klade CS. Long term immunity following a booster dose of the inactivated Japanese Encephalitis vaccine IXIARO(R), IC51. Vaccine. 2011 Mar 21;29(14):2607-12. doi: 10.1016/j.vaccine.2011.01.058. Epub 2011 Feb 1.
Clinical trial NCT00818909: Systane Clinical Experience Study
Official title: Study to Evaluate the Physical Effect of SYSTANE QID in People That Have Moderate to Severe Dry Feeling Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndrome
Keywords: Dry eye
Systane
Moderate to severe dry eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-01-08
Enrollment: 941
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the physical effect of SYSTANE QID in people that have moderate to severe dry eyes and to establish doctor confidence to prescribe Systane.


Eligibility criteria: Inclusion Criteria:

* moderate to severe dry feeling eyes

Exclusion Criteria:

* None

Primary outcomes:
measure: corneal and conjunctiva staining score
timeFrame: 4 weeks
Secondary outcomes:
measure: Tear film break up time
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03555409: Clinical Feature and Treatment of Microsporidial Keratoconjunctivitis
Official title: Clinical Feature and Treatment of Microsporidial Keratoconjunctivitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microsporidial Keratoconjunctivitis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Microsporidia keratoconjunctivitis diagnosed at the National Taiwan University Hospital (NTUH)

Brief summary: The purpose of this project was to analysis the causes, pathogenesis, diagnostic modalities and treatment outcomes of microsporidial keratoconjunctivitis.

Detailed description: Microsporidia comprise a diverse group of obligate spore-forming intracellular eukaryotic pathogens first described in immunocompromised patients. Many species of microsporidia are found in aquatic environments, and they are considered as waterborne pathogens.Microsporidia are opportunistic pathogens that are reported to cause infections in various organs, including the eyes. The ocular appearance of this infection can manifest as corneal stromal keratitis or a superficial punctate keratoconjunctivitis. In particular, the characteristic feature of microsporidial keratoconjunctivitis is multiple whitish, slightly elevated epithelial lesions in conjunction with acute conjunctivitis. Awareness of microsporidial keratoconjunctivitis is increasing, and the number of cases reported is on the rise. This study was a retrospective case series of patients diagnosed as microsporidial keratoconjunctivitis. The purpose of this project was to analysis the causes, pathogenesis, diagnostic modalities and treatment outcomes of microsporidial keratoconjunctivitis

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as microsporidial keratoconjunctivitis

Exclusion Criteria:

* Patients diagnosed as bacterial or viral keratoconjunctivitis

Primary outcomes:
measure: Full chart records of the patients who diagnosed as microsporidial keratoconjunctivitis
timeFrame: 2018/6/1-2019/5/31
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: I-Jong Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02395809: Transcutaneous Posterior Tibial Nerve Stimulation for Treatment of Chronic Anal Fissure
Official title: Randomized Clinical Trial of Transcutaneous Electrical Posterior Tibial Nerve Stimulation Versus Lateral Internal Sphincterotomy for Treatment of Chronic Anal Fissure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Anal Fissure
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lateral internal sphinterotomy (LIS) is the gold standard against which all treatments are compared with a healing rate over 92%. However, the most serious complication of this procedure is anal incontinence. To overcome these problems, continued efforts are being tried to find less invasive treatments modalities for anal fissure that is as effective as surgical therapy with lower morbidity.

Detailed description: Sacral nerve stimulation has been recently tried for management of chronic anal fissure with promising results. However, the technique described is invasive with the need for surgically implantable expensive stimulator electrodes.

The aim of this study was to evaluate the efficacy of posterior tibial nerve stimulation (PTN) by transcutaneous electrical nerve stimulation (TENS) and to compare it to the conventional LIS. This non-invasive technique has been proved to be of acceptable results in treatment of fecal incontinence and urinary incontinence.

Eligibility criteria: Inclusion Criteria:

* Consecutive symptomatic adults affected by chronic anal fissure were enrolled in the study.

Exclusion Criteria:

1. patients younger than 18 years;
2. patients with laterally located or painless fissures;
3. concurrent fistula or significant hemorrhoidal disease;
4. inflammatory bowel disease;
5. Diabetes mellitus;
6. pregnancy;
7. neurological disease;
8. spinal cord lesions,
9. use of cardiac pacemaker. Males and females were considered for inclusion.

Primary outcomes:
measure: number of patients with clinical improvement of symptoms
timeFrame: one year
Secondary outcomes:
measure: number of patients with post-procedure anal incontinence according to Pescatory grading and scoring index for anal incontinence
timeFrame: one year
measure: Number of patients with improvement of constipation according to Wexner constipation score
timeFrame: one year
measure: Anal pain scores on VAS
timeFrame: one month
measure: Post-procedure patient satisfaction on VAS
timeFrame: one year
measure: Number of patients with healed anal fissure
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References:
citation: Youssef T, Youssef M, Thabet W, Lotfy A, Shaat R, Abd-Elrazek E, Farid M. Randomized clinical trial of transcutaneous electrical posterior tibial nerve stimulation versus lateral internal sphincterotomy for treatment of chronic anal fissure. Int J Surg. 2015 Oct;22:143-8. doi: 10.1016/j.ijsu.2015.08.033. Epub 2015 Aug 24.
Clinical trial NCT02978209: Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris
Official title: Double Blinded Randomized Clinical Study of Carbamide as Moisturizer in Ichthyosis Vulgaris
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ichthyosis Vulgaris
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A randomized double blinded clinical trial will be conducted comparing the effect of two simple basic moisturizers only different in the concentration of carbamide (urea). The concentrations of carbamide will be tested are 0 and 7.5, respectively. The study will be conducted as a split-body-study and will contain two arms randomized to comparing 0 and 7.5 % carbamide, respectively. Approximately 20 patients with at least clinically verified Ichthyosis Vulgaris will be enrolled to each study arm. The effect of the moisturizers will be assessed by clinical examination (score), patients assesment of effect and measurement of transepidermal water loss (TEWL) and other skin parameters.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with Ichthyosis Vulgaris

Exclusion Criteria:

* All other forms of Ichthyosis

Primary outcomes:
measure: Skin dryness
timeFrame: 2-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Dermatology, Aarhus University Hospital
Study officials:
affiliation: Associate professsor
name: Uffe Koppelhus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dorf ILH, Lunen MS, Koppelhus U. Effect of topical treatment with 7.5% urea in Ichthyosis Vulgaris: A randomized, controlled, double blinded, split body study evaluating the effect of urea cream compared to the vehicle (moisturizing) cream. Skin Health Dis. 2021 Sep 14;1(4):e65. doi: 10.1002/ski2.65. eCollection 2021 Dec.