louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00660556: ARCHIMEDES Compassionate Use Supplement
Official title: Compassionate Use Supplement to the IDE Protocol to Determine Safety and Effectiveness of the ARCHIMEDES Implantable Constant-Flow Infusion Pump System
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Pain
Keywords: Implantable pump
Intrathecal catheter
Constant flow pump
Lead sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this Compassionate Use Supplement to the IDE Protocol is to assure and monitor the safety of six Subjects (in the United States) implanted with ARCHIMEDES until all remaining implanted pumps are explanted.

Detailed description: Pain management has been a long-standing challenge to the medical community, specifically the treatment of chronic pain. On October 3, 2002, FDA approved Codman's IDE Study of Codman's Implantable Constant-Flow Infusion Pump System (ARCHIMEDES). The first Subject was implanted on February 12, 2003. Since then, ten Subjects have had the ARCHIMEDES implanted, with one Subject, implanted twice. Codman notified the FDA in 2004 that it wished to discontinue enrollment into the study \& bring it to a close because of projected slow enrollment and waning physician interest.

Codman felt there was no readily acceptable alternate therapy that would not require a pump explant first. It is possible to replace the ARCHIMEDES with another pump system, which is already approved for use in the United States. However, such an action would necessitate the removal or explant of the ARCHIMEDES, thereby exposing the Subjects to additional risks inherent in such a surgical procedure, including those associated with anesthesia. Since these Subjects have been treated with the investigational device for at least 2 years without experiencing any unanticipated adverse device effects, Codman felt that the risk of explanting the pump was significantly greater than the risk of continuing treatment with the investigational device.

It should also be noted that this pump does not have a battery and that replacement is dictated by the number of times the septum is punctured (500). This translates into approximately twenty years of therapy if the septum is punctured an average of 20 times.

FDA approved Codman's Compassionate Use Protocol in 2005.

Eligibility criteria: Inclusion Criteria:

* U. S. Subjects implanted with constant flow pump in 2003.

Exclusion Criteria:

* N/A

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: South Side Pain Solutions
state: Virginia
Study officials:
References:
Clinical trial NCT03372356: Psychosocial Screening for Neuroendocrine Tumor Patients
Official title: Psychosocial Screening for Neuroendocrine Tumor Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuroendocrine Tumors
Keywords: DT
HADS
SPBS
CD-RISC
Psychosocial Screening
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%)

Brief summary: This is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT), Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and Connor-Davidson Resilience Scale(CD-RISC). These assessments will be completed at baseline, 3 months, 6 months, 12 months and 24 months. Patients will have the option of filling out questionnaires more frequently if desired.


Eligibility criteria: Inclusion Criteria:

1. sign written informed consent form;
2. age ≥ 18 years;
3. pathologically confirmed well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%);

Exclusion Criteria:

1. \<18 years;
2. Neuroendocrine carcinoma;
3. History of psychiatric or psychologic illness;
4. History of previous cancers or cancer distress;
5. Patients with central nervous system(CNS) disorder；
6. Severe, uncontrolled medical condition that would affect patients' compliance;

Primary outcomes:
measure: DT
timeFrame: every 3 month until 24 month
Secondary outcomes:
measure: HADS
timeFrame: every 3 month until 24 month
measure: SPBS
timeFrame: every 3 month until 24 month
measure: CD-RISC
timeFrame: every 3 month until 24 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02277756: Pain in Adults With Autism Spectrum Disorder
Official title: Pain Neuromodulation in Adults With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism
Pain
Keywords: high functioning autism
endogenous modulation systems
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Pain insensibility is often described in people with autism. The aim of this study is to test the pain perception in adults with autistic spectrum disorder without intellectual disability. An experimental model of pain is used to measure endogenous modulation systems. Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint natus G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation assessed by an inspired behavior scale.

Detailed description: Adults with autism without intellectual disability (IQ \> 85) are matched with members of siblings and control group (sex and chronological age).

Pain reactivity (Visual analog scale,endogenous modulation systems, salivary cortisol, automatic nervous system and behavioral responses to thermal stimulation assessed by an inspired behavior scale.) in adult with autism is tested using an experimental model of pain. Excitatory and inhibitory modulation systems were elicited using a temporal summation test administered before and after activation of the Diffuse Noxious Inhibitory Control (DNIC) by means of a cold-pressor test.

Demographic and clinical data are also collected (sensory profile, sleep disorders and depression inventory).

Eligibility criteria: Non-specific inclusion criteria:

* intellectual quotient \>85
* consent form signed

Inclusion Criteria autism group :

* autism diagnosis (CIM 10) from multidisciplinary evaluation (ADI-r, ADOS)
* sibling without autism or developmental disorder

Non-specific Exclusion Criteria:

* chronic pain
* pregnancy, breast feeding
* consent form no signed

Exclusion criteria sibling and witness groups:

- diagnosis of autism or developmental disorder

Primary outcomes:
measure: Pain as assessed by Computerized Visual analog scale
timeFrame: one day
Secondary outcomes:
measure: salivary cortisol
timeFrame: one day
measure: Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale
timeFrame: one day
measure: heart rate variability
timeFrame: one day
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
affiliation: CHRU Brest
name: Gildas L'HEVEDER, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03638856: Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
Official title: Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Premenopausal Women Underwent to Diagnostic Hysteroscopy: Double-blind, Randomized Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Uterine Bleeding
Chronic Pelvic Pain
Infertility, Female
Keywords: Cervical priming
Diagnosis hysteroscopy
Oral Misoprostal
Premenopause
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2018-08-20
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research objective To compare effectiveness of oral Misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis Effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is not different from placebo Alternative hypothesis: : Oral Misoprostal for cervical priming in Premenopausal women underwent to diagnostic hysteroscopy is better than placebo

Detailed description: Research design Randomized double-blinded placebo-controlled trial. The investigators who assess the outcomes and the participants do not know Misoprostal group or control group. The patients are given the random concealed envelop which contains Misoprostal or placebo to take before hysteroscopy. Surgeon and the investigator whom assess patients do not know group allocation.

Eligibility criteria: Inclusion Criteria:

1. Premenopausal women
2. Patients have following indication for diagnosis hysteroscopy

   * Abnormal uterine bleeding
   * Unexplained infertility
   * Recurrent pregnancy loss
   * Chronic pelvic pain
   * Late postpartum hemorrhage
3. Patients provided written informed consent

Exclusion Criteria:

1. Postmenopausal women
2. Patients who have contraindication for Misoprostal as following

   * Allergic to Misoprostal
   * Medical illnesses such as cardiovascular diseases, Asthma, Renal disease
3. Patients who have contraindication for Hysteroscopoy as following

   * Pregnant women
   * Pelvic inflammatory disease
   * Infection at cervix and vagina
   * Cervical cancer

Primary outcomes:
measure: initial cervical diameter
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
Clinical trial NCT04684056: Laboratory Assessment of the Concentration of Direct Oral Anticoagulants in Patients With Atrial Fibrillation
Official title: Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants in Peri-operative Catheter Ablation for Patient With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oral Anticoagulant
Atrial Fibrillation
Pharmacokinetics and Pharmacodynamics
Keywords: Direct oral anticoagulants
pharmacokinetics and pharmacodynamics
Atrial Fibrillation
Rivaroxaban
Dabigatran
Edoxaban
Anti-FXa assays
Dilute thrombin time
Liquid-chromatography tandem mass spectrometry
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Asia General Hospital (http://wagh.com.cn)
First posted: 2020-12-24
Enrollment: 1864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Catheter ablation was performed under general anesthesia in patients with NVAF. Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran )were administered peri-operatively to prevent thrombotic events.

Brief summary: The incidence of thromboembolic and bleeding event associated with catheter ablation for atrial fibrillation(CAAF) varies from 0.9% to 5% during peri-operative period. Direct oral anticoagulants (DOAC) (such as Rivaroxaban, Dabigatran and Edoxaban) are gradually applied in clinical practice to prevent thrombosis events in patients with AF, but studies have shown that DOAC are also affected by surgery, an invasive procedure, sub-therapeutic, food, renal function and age. However, the pharmacokinetic and pharmacodynamic of DOAC during the peri-operative period of CAAF were lacking in China. The purpose of this study was to evaluate the pharmacokinetics and pharmacokinetics of DOAC in patients with peri-operative atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Patients with Non-valvular atrial fibrillation(NVAF) undergoing catheter ablation
* Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran)are administered peri-operatively during catheter ablation.

Exclusion Criteria:

* Patients who have taken direct oral anticoagulants or warfarin before admission.
* Cross-replacement of oral anticoagulants, such as taking dabigatran before surgery and replacing Rivaroxaban after surgery.
* Abnormal coagulation tests (prothrombin time, partial thrombin time, thrombin time, antithrombin activity).
* Pregnant and lactating women.

Primary outcomes:
measure: Incidence of thromboembolic
timeFrame: Ninety days after catheter ablation
measure: Bleeding Incidence
timeFrame: Ninety days after catheter ablation
Secondary outcomes:
measure: Death from any cause
timeFrame: Ninety days after catheter ablation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02325856: Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients
Official title: Effect of Post-dialysis Weight Evaluated With Bioimpedance Spectroscopy on Dialysis Morbidities and Clinical Outcomes in Hemodialysis Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload
Keywords: Hemodialysis
Body Composition Monitor
Lead sponsor: An Hsin QingShui Clinic
Sponsor class: OTHER
Collaborators: name: Nephrocare AsiaPacific
First posted: 2014-12-25
Enrollment: 298
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A reasonable and simple algorithm was used to guide the dry weight determination with Body Composition Monitor with the principle of Bioimpedance Spectroscopy (BCM-BIS) and analyze the feasibility of this algorithm and evaluate the influence of BCM-BIS-guided fluid management on the incidence of dialysis morbidities and clinical outcomes in maintenance hemodialysis (MHD) patients.

Detailed description: 298 MHD patients in 6 hemodialysis centers in Taiwan were enrolled in this randomized controlled study. All the participants were randomized into study group ( dry weight (DW) determined by BCM-BIS) and control group ( dry weight determined by clinical symptoms) with stratification by diabetes mellitus and centers. Body composition monitor based on bioimpedance spectroscopy (BCM-BIS) was performed monthly and concomitant biochemical data and clinical outcomes were collected. Intra-dialysis complications were recorded in every dialysis session. Primary outcome was all-cause hospitalization. Secondary outcomes included 1) complications during DW adjustment 2) intra-dialysis morbidities 3) hypertension 4) mortality 5) acute fluid overload (AFO) or cardiovascular (CV)-related events. The clinical feasibility of the BCM-BIS algorithm was also inspected. Statistical methods: a software (SAS) 9.3 was used for statistical analysis in this study. R 3.0 was used for graphic presentation of parts of the results. Relative risk, incidence rate ratio and Fisher's exact test were used to compare the discrete outcomes in both groups. Survival analysis was used for time-related events. Repeated-measured and longitudinal data were analyzed with the generalized linear mixed model (GLMM) through the procedure for continuous variables (PROC MIXED) and for discrete variables (PROC GLIMMIX) in SAS.

Eligibility criteria: Inclusion Criteria:

MHD patients with age ≥ 18 and dialysis vintage ≥ 3 months

Exclusion Criteria:

1. coronary stents or pacemaker implantation
2. metallic devices in body, such as artificial joints or pins
3. contralateral or bilateral amputations
4. pregnancy

Primary outcomes:
measure: All-cause Hospitalization
timeFrame: 1 year
Secondary outcomes:
measure: Complications During DW Adjustment
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06244056: Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
Official title: Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Stellate Ganglion Block
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A stellate ganglion block is performed by a medical professional in a sterile setting. Firstly Position of patient: Semi-lateral decubitus position, with the neck turned contralateral. Using Probe of ultrasound: Linear 6-13 MHz to guide the needle to the stellate ganglion , The skin at the injection site is cleaned with an antiseptic solution to reduce the risk of infection. A local anesthetic is injected into the skin and deeper tissues to numb the area. Needle:25G 1.5 inch or 22G 3.5 inch is inserted through the skin and deeper tissues until it reaches the stellate ganglion.Once the needle is in the correct position, 3-5 mL of local anesthetic (0.25-0.5% bupivacaine) The procedure typically takes about 15-20 minutes.
Primary purpose: TREATMENT

Brief summary: Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Detailed description: Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Eligibility criteria: Inclusion Criteria:

* Age 18 : 70 years old.
* NYHA Class III-IV Heart Failure.
* Heart failure with a reduced ejection fraction (HFrEF) LVEF ≤ 40% calculated using 2D echocardiography and Biplane Simpson's .
* Optimal tolerated Medical Therapy for Heart Failure.

Exclusion Criteria:

* Active Malignancy.
* Acute heart failure including pulmonary edema or cardiogenic shock.
* Severe, life-threatening non-cardiac disease.
* Pregnancy.
* Localized infection.
* Coagulopathy or anticoagulated patients.
* Refused this procedure.

Primary outcomes:
measure: Change of left ventricular ejection fraction (LVEF).
timeFrame: 3 month
measure: Change of NYHA classification.
timeFrame: 3 month
Secondary outcomes:
measure: Change of 6 minutes walking test.
timeFrame: 3 month
measure: Heart failure hospitalization.
timeFrame: 3 month
measure: Vascular complications and safety issues.
timeFrame: 3 month
measure: Cardiovascular death.
timeFrame: 3 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT04014556: Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema
Official title: Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema. One Year Results of a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-07-10
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: Purpose: To evaluate the role of adjuvent micropulse laser with Aflibercept injections in the management of treatment naïve centre involving DME, looking at decreased treatment burden and increased efficacy as outcomes.

Methods: This was a prospective, single centre, randomized trial that included 40 eyes (40 patients) with previously untreated centre involved DME. Patients were randomly assigned to receive either Aflibercept plus micropulse laser (group A) or Aflibercept monotherapy (group B).

Detailed description: Patients were randomly distributed in a 1:1 ratio between the two studied groups. Group A received 3 monthly injections of Aflibercept 2 mg/0.05 mL (Eylea; Bayer, Berlin, Germany) as a loading dose, followed one month later by one 577 nm yellow micropulse laser session with monthly PRN Aflibercept injections. Group B received 3 monthly injections of Aflibercept 2 mg/0.05 mL as a loading dose, followed by monthly PRN Aflibercept injections. Patients in both groups were assessed one month after the end of loading phase; At this point, group A received the micropulse laser session and started PRN Aflibercept injections, while group B started PRN Aflibercept injections without receiving the micropulse laser session. After that, both groups were followed for 12 months.

Eligibility criteria: Inclusion Criteria:

* patients were older than 18 with the clinical diagnosis of previously untreated centre involved DME documented by fluorescein angiography and central macular thickness (CMT) ≥ 300 µm on the spectral-domain OCT Best corrected visual acuity was better than 3/60 with Hb A1C less than 10%.

Exclusion Criteria:

* any previous treatment for DME, proliferative diabetic retinopathy, macular ischemia on fluorescein angiography, epiretinal membrane or tractional maculopathy on OCT, media opacity and any previous intraocular surgery with the exception of uneventful cataract surgery more than 6 months before the beginning of the study.

Primary outcomes:
measure: The number of Aflibercept injections in both groups
timeFrame: 12 months
Secondary outcomes:
measure: The changes in visual acuity in both groups.
timeFrame: 12 months
measure: The changes in central macular thickness in both groups.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05253456: Modified Second Layer Repair for Distal Penile Hypospadias
Official title: Modified Tubularized Incised Plate Urethroplasty (Snodgrass) For Distal Hypospadias Repair in a Circumcised Patient With the Use of a Derma -Dartos Flap for Second Layer Closure: Our Initial Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypospadias
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 102
Sex: MALE
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: to evaluate a modification to snodgrass technique in second layer closure of distal penile hypospadias

Detailed description: In our study, we applied a new modification by using an intervening layer of a de-epithelialized ventral derma-dartos flap for neourethral covering. we present our newly applied technique and its impact on the success rate.

Eligibility criteria: Inclusion Criteria:

* All male patient with distal penile hypospadias aged less than 18

Exclusion Criteria:

* Patients with penile rotation or hypoplastic urethral plate were excluded from the study

Primary outcomes:
measure: urethro-cutaneous fistula
timeFrame: 1 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Maher
state: القاهرة
Study officials:
References: