louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04936464: Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
Official title: Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence: A Sham-Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urge Incontinence
Overactive Bladder
Keywords: tibial nerve stimulation
transcutaneous electrical nerve stimulation
overactive bladder
urgency urinary incontinence
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: American Urogynecologic Society
First posted: 2021-06-23
Enrollment: 99
Sex: FEMALE
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 single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.


Eligibility criteria: Inclusion Criteria:

* ≥ 6 episodes urgency incontinence on 3-day voiding diary
* Duration of symptoms ≥ 3 months
* Off antimuscarinic or 3-adrenoreceptor agonist therapy for 2 weeks
* No known neurologic disease
* Ability to complete home sessions and clinic follow up
* Ability to complete voiding diaries
* Internet access and proficiency
* English or Spanish-speaking

Exclusion Criteria:

* Pregnant
* Known or suspected urinary retention
* Symptomatic urinary tract infection unresolved at the time of randomization
* Recurrent urinary tract infection (≥ 3/12 months)
* Bladder pain syndrome
* Known or suspected advanced (stage III or IV) pelvic organ prolapse
* Neurogenic bladder
* Current or prior bladder malignancy
* Current or previous use of bladder Botox injections, percutaneous tibial nerve stimulation, or sacral neuromodulation
* Pacemaker or other implantable device
* Disease affecting lower extremities
* Bilateral metallic lower limb implant
* Incarceration

Primary outcomes:
measure: Overactive Bladder Questionnaire (OAB-q)
timeFrame: 12 weeks
Secondary outcomes:
measure: Voiding diary
timeFrame: 12 weeks
Other outcomes:
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: 12 weeks
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente San Diego
state: California
Study officials:
affiliation: University of California San Diego/Kaiser Permanente San Diego
name: Nemi M Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02856464: Prophylactic DLI for the Prevention of Relapse Post HSCT in Patients With High Risk Myeloid Malignancy
Official title: A Phase II Prospective Trial of Prophylactic Donor Lymphocyte Infusions for the Prevention of Relapse Post HSCT in Patients With High Risk Myeloid Malignancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Leukemia, Myeloid, Acute
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 124
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: The trial will be conducted as a multicentre open label, randomised prospective phase II clinical trial in patients with high risk myeloid malignancies.

The primary objective is to evaluate whether prophylactic donor lymphocyte infusions (DLI) delivered as part of a planned schedule improves the disease free survival of patients with myeloid malignancies.


Eligibility criteria: Patient Inclusion Criteria

1. Haematological cancer which can be one of the following

   1. Acute Myeloid Leukaemia (AML) if Intermediate or High risk in CR1
   2. AML if favourable risk in CR2
   3. Patients with AML or MDS with residual cytogenetic or molecular disease pre-HSCT
   4. CMML
   5. Myelodysplastic Syndrome (MDS) defined by an IPSS category int-1 or higher with \<5% blasts at the time of randomisation following cyto-reduction if necessary
   6. Secondary MDS or AML; defined as arising from antecedent haematological disease or secondary to prior chemotherapy.
2. Patients with sibling or 9/10 or 10/10 HLA matched unrelated donor
3. Patients receiving alemtuzumab based reduced intensity conditioned HSCT
4. Age \>/=18 years
5. Able to comprehend and give informed consent

Patient Exclusion Criteria

1. Patients with \>5% blasts at time of HSCT
2. Patients eligible for myeloablative (Bu/Cy of Cy/TBI) HSCT protocols
3. Patients with myelofibrosis
4. Patients with hypersensitivity to alemtuzumab, melphalan, fludarabine or busulphan
5. ECOG performance status \> 2
6. Patients who are pregnant or lactating

Primary outcomes:
measure: Disease free survival
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02404064: Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter?
Official title: Laparoscopic Appendectomy for Uncomplicated Appendicitis: Does Antimicrobial Prophylaxis Really Matter? Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appendicitis
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare surgical site infection (SSI) rate in patients undergoing laparoscopic appendectomy for acute uncomplicated appendicitis and treated with single dose regime of antibiotics versus group of patients undergoing laparoscopic appendectomy without antibiotics treatment. Patient will be given either single dose of perioperative antibiotics or no antibiotics before surgery.

Detailed description: Laparoscopic appendectomies are performed by one of the 6 institutional attending surgeons. US and/or abdominal CT scans are obtained as clinically necessary to make the diagnosis of appendicitis. All of the appendectomies are initiated laparoscopically. Postoperative orders are controlled via a standard electronic order set for all operations.

Patients found to have acute uncomplicated appendicitis at appendectomy will be randomized to either single dose of perioperative antibiotics /On the second post-operative day the patient who has no fever and tolerating a regular diet, will be discharged home without oral antibiotics. On the post-operative, day seven after surgery all patients will be examined in the outpatient clinic on the presence of surgical site infection. then will be followed for a 30 days after surgery .

Eligibility criteria: Inclusion Criteria:

* Established diagnosis of acute appendicitis based on clinical examination, US and/or computed tomographic (CT) scan, and acute uncomplicated appendicitis at laparoscopic appendectomy.

Exclusion Criteria:

* Patients with a documented allergy to any of the medications in the trial.
* Those with an abscess identified by computed tomographic (CT) scan before surgery are not included in the study

Primary outcomes:
measure: The main target-point of the study is surgical site infection (SSI), defined according to the Centers for Disease Control (CDC).
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: haemek medical center
name: Dan Hershko, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02492464: Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial
Official title: Double-blind, Randomized Clinical Trial on the Middle-term Effect of the Red Yeast Rice Intake on Endothelial Function and Arterial Stiffness in Subjects With Suboptimal LDL-cholesterol Level in the Context of the Mediterranean Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a double-blind randomized clinical trial carried out on subjects with suboptimal control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R) apparatus)


Eligibility criteria: Inclusion Criteria:

* LDL-cholesterol between 130 and 190 mg/dL

Exclusion Criteria:

* Secundary prevention for cardiovascular disease
* Type 2 diabetes
* Assumption of lipid-lowering drug or dietary supplements
* Previous intolerans to read yeast rice including dietary supplements

Primary outcomes:
measure: Flow mediated dilation (FMD) change from the baseline to the end of treatment period
timeFrame: 6 months
Secondary outcomes:
measure: 12 hour fasting LDL-cholesterolemia change from the baseline to the end of treatment period
timeFrame: 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S. Orsola-Malpighi University Hospital
state: BO
Study officials:
References:
citation: Cicero AF, Morbini M, Rosticci M, D''Addato S, Grandi E, Borghi C. Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects. Ann Nutr Metab. 2016;68(3):213-9. doi: 10.1159/000445359. Epub 2016 Apr 8.
citation: Cicero AFG, Fogacci F, Bove M, Veronesi M, Rizzo M, Giovannini M, Borghi C. Short-Term Effects of a Combined Nutraceutical on Lipid Level, Fatty Liver Biomarkers, Hemodynamic Parameters, and Estimated Cardiovascular Disease Risk: A Double-Blind, Placebo-Controlled Randomized Clinical Trial. Adv Ther. 2017 Aug;34(8):1966-1975. doi: 10.1007/s12325-017-0580-1. Epub 2017 Jul 7.
Clinical trial NCT01156064: Confocal Laser Endomicroscopy in Digestive Diseases
Official title: Confocal Laser Endomicroscopy in Digestive Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Digestive System Diseases
Keywords: Endoscopy
Confocal laser endomicroscopy
Digestive Diseases
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2010-07-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of a tertiary referral hospital

Brief summary: Confocal laser endomicroscopy (CLE) is a newly endoscopic device that enables microscopic view of the digestive tract. The purpose of this study is to determine if confocal laser endomicroscopy can improve detection of digestive disease include inflammation, dysplasia, and early cancer, and if confocal laser endomicroscopy has competitive advantage, compared with other device such as Narrow Band Imaging and Autofluoresecence Imaging.

Detailed description: Advances in endoscopy have led to imagining of the details of digestive mucosa. Novel techniques such as Narrow Band Imaging (NBI) assisted magnification endoscopy, Auto Fluorescence Imaging (AFI) or confocal laser endomicroscopy could, however, improve the endoscopic detection.In this research we describe the combined use of these three techniques in patients with digestive disease.

Eligibility criteria: Inclusion Criteria:

* Subjects over 18 years of age
* Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included

Exclusion Criteria:

* Under 18 years of age.
* Pregnancy or breast feeding
* Allergy to the fluorescent contrast agent fluorescein sodium
* Coagulopathy or bleeding disorder
* In emergency or life-threatening situations(eg. acute gastrointestinal hemorrhage, and gastrointestinal obstruction or perforation)
* impaired renal function, allergic asthma,
* Cognitively impaired.
* Residing in institutions (eg. prison, extended care facility)
* Have language barriers (eg. illiterate, dysphasic)

Primary outcomes:
measure: Diagnostic yield for neoplasia of CLE vs. standard endoscopy
timeFrame: one year
Secondary outcomes:
measure: Diagnostic yield for neoplasia of CLE vs. NBI/AFI
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: China PLA General Hospital
state: Bejing
Study officials:
affiliation: Chinese PLA General Hospital
name: Yunsheng Yang, MD
role: STUDY_CHAIR
References:
citation: Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.
Clinical trial NCT01712464: Modulation of Reinforcement Learning
Official title: Modulation of Reinforcement Learning and Neuronal Activation in Ventral Stratum by Oxytocin - a Pilot Study at Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impact of Oxytocin on Social Learning
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2012-10-23
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to examine the modulation of neuronal and behavioural parameters of social reinforcement learning.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 26 years
* male
* IQ\>80
* written informed consent
* proband understands character, extent and individual consequences of the study
* competent persons who are able to follow the instructions of the study personnel
* for ASD patients: assured ASD diagnosis, comply of the ASD criteria ADI-R/ADOS-G

Exclusion Criteria:

* prosopagnosia
* anaphylaxis of oxytocin or other chemical substances
* metal inside the body or other contraindications of mri scan
* physical illness which can affect the examinations or endanger the proband
* actual or assumed drug or alcohol abuse
* persons who are accommodated in an institution because of court or administrative order
* persons with a relationship of dependence to the sponsor or investigator
* healthy probands: psychiatric disorder according to ICD-10-WHO F at the moment and in history, continuous drug-intake at time of measurements
* patients with ASD: psychiatric disorder according to ICD-10-WHO F (except ASD disorder in patient group) during the last 12 month being not treated, continuous drug-intake at time of measurements (psychotropic medication), exception: stimulants used for treatment of attention disorders, if they can come off for the measurements

Primary outcomes:
measure: Bold Signal in nucleus accumbens
timeFrame: 1 Day
Secondary outcomes:
measure: Bold signal in ventral tegmental areal
timeFrame: 1 Day
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universtiy Hospital Aachen
state: Northrhine-Westfalia
Study officials:
affiliation: University Hospital, Aachen
name: Martin Schulte-Rüther, Dr. rer. nat
role: STUDY_DIRECTOR
References:
Clinical trial NCT00568464: Study on VCD/IE in the Patients With Ewing's Sarcoma Family of Tumors (ESFT)
Official title: Phase II Study of VCD/IE in the Treatment of the Patients With Ewing's Sarcoma Family of Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ewing's Sarcoma
Keywords: ESFT (Ewing's sarcoma family of tumors)
Response rate
TTP
OS
Toxicity
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial was to evaluate the efficacy and tolerability of the sequential therapy of VCD/IE in the patients with ESFT.

Detailed description: 80-90% patients of ESFT will develope disease progression during the period of local treatment (surgery or radiation). The survival has been improved in these 30 years due to chemotherapy. VCD/IE is widely used in the world for the patients with ESFT, but it is rarely used in China due to its high dosage.

Eligibility criteria: Inclusion Criteria:

* Age range 10-65 years old
* Histological confirmed ESFT
* No previous therapy
* ECOG performance status less than 2
* Life expectancy of more than 12 weeks
* Normal laboratory values: hemoglobin\>8.0g/dl, neutrophil\>2×109/L, platelet \> 80×109/L, Hb \> 80×1012/L, serum creatine \< 1×upper limitation of normal(ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN

Exclusion Criteria:

* Pregnant or lactating women
* Received treatment for the disease previously
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis and bone marrow involvement
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* History of allergy to the drugs in this trial
* Abnormal LVEF level

Primary outcomes:
measure: Response Rate
timeFrame: every two cycles
Secondary outcomes:
measure: Toxicity
timeFrame: every cycle
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00811564: An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 148
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: A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects


Eligibility criteria: Inclusion Criteria:

1. Be at least 18 years of age;
2. Give written informed consent;
3. Be in good general health as determined by your doctor;
4. Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
5. If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
6. Understand the study instructions, and be able to follow the study instructions; and
7. Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Exclusion Criteria:

1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
2. Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
3. Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit

Primary outcomes:
measure: Intraocular Pressure (IOP) at Week 12
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Slingerlands
country: United States
state: New York
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Katz LJ, Rauchman SH, Cottingham AJ Jr, Simmons ST, Williams JM, Schiffman RM, Hollander DA. Fixed-combination brimonidine-timolol versus latanoprost in glaucoma and ocular hypertension: a 12-week, randomized, comparison study. Curr Med Res Opin. 2012 May;28(5):781-8. doi: 10.1185/03007995.2012.681036. Epub 2012 Apr 25.
Clinical trial NCT00353964: Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery
Official title: A Multi-Center, Randomized, Double Masked, Placebo and Active Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of rEV131 2.5 Mg/mL, rEV131 1.25 Mg/mL, rEV131 0.625 Mg/mL, for the Treatment of Ocular Inflammation After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ocular Inflammation
Lead sponsor: Evolutec Group
Sponsor class: INDUSTRY
First posted: 2006-07-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of three concentrations of rEV131, a new investigational anti-inflammatory agent, compared to placebo (an inactive substance) and an FDA approved anti-inflammatory agent in patients with ocular inflammation who have undergone cataract extraction with intra-ocular lens implantation.


Eligibility criteria: Inclusion Criteria:

* be male or female who has undergone unilateral cataract extraction by phacoemulsification (PHACO) method with implantation of a posterior chamber intraocular lens

Exclusion Criteria:

* have unstable glaucoma
* have an active bacterial and/or viral infection
* use any ocular or systemic anti-inflammatory agents within 1 week prior to enrollment and for the duration of the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: North Andover
country: United States
facility: ORA Study Sites
state: Massachusetts
Study officials:
affiliation: Evolutec Group
name: Wynne Weston-Davies, MD
role: STUDY_DIRECTOR
References: