louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00346294: An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
Official title: An Open-Label Study to Assess the Rate of Failure of an Enbrel® (Etanercept) SureClick™ Auto-injector in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Device
Auto-injector
SureClick
Enbrel
Etanercept
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
First posted: 2006-06-29
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label, single arm study to estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.


Eligibility criteria: Inclusion Criteria: - Diagnosis of rheumatoid arthritis

* RA subjects
* 18 years or older
* Currently taking etanercept in pre-filled syringes for at least 4 weeks
* Subjects must give written informed consent
* Subjects must be able to read and write in English Exclusion Criteria: - Subject is not using adequate contraception
* Subject is pregnant or breast feeding
* Significant concurrent medical diseases

Primary outcomes:
measure: To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector in RA subjects.
timeFrame: 22 Days
Secondary outcomes:
measure: To estimate the rate of failure of the Enbrel® SureClick™ Auto-injector at the subject level in RA subjects.
timeFrame: 22 Days
measure: To determine the rate of failed drug deliveries (as opposed to device failures).
timeFrame: 22 Days
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03623594: Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis
Official title: Abdominal Trunk Function After Surgical Repair of Abdominal Rectus Muscle Diastasis: Outcome Measured With the Abdominal Trunk Function Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectus Abdominus; Diastasis, Complicating Delivery
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
First posted: 2018-08-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Repair of the abdominal rectus diastasis with a double row plication using absorbable Quill
Primary purpose: TREATMENT

Brief summary: There is insufficient evidence regarding the benefit from surgical reconstruction of post-partum abdominal rectus muscle diastasis. The purpose of this study is to evaluate the abdominal trunk function preoperatively and postoperatively in a group of women undergoing surgery for abdominal rectus muscle diastasis.

Detailed description: There is little evidence regarding the various treatment options of abdominal rectus muscle diastasis in post-partum women. The lack of evidence may, to a great extent, be explained by the lack of uniform criteria for assessing the trunk function and how the trunk function affects the ability to perform daily activities. To be able to evaluate the condition with symptomatic ARD a more comprehensive, multimodal instrument is therefore needed.

In collaboration with the surgical clinic and the physiotherapy clinic at Södersjukhuset a multimodal examination test was developed with the purpose to be able to evaluate the full picture of the condition.

The purpose of this study was to evaluate the effect of surgical reconstruction of post-partum abdominal rectus muscle diastasis in women with insufficient improvement after adequate physical training using a novel multimodal evaluation tool.

Eligibility criteria: Inclusion Criteria:

* Non-smoking women
* BMI \<35
* Inter-recti distance \>3cm
* Lack of response to standardized core stabilizing training
* \>1 year since last partus
* No intention of further pregnancies

Exclusion Criteria:

* Inability to quit smoking
* BMI \>35
* Inter-recti distance \<3cm
* \<1 year since last partus
* Further pregnancies not excluded

Primary outcomes:
measure: Abdominal Trunk Function assessed with Disability Rating Index (DRI)
timeFrame: One year
Secondary outcomes:
measure: Health-related quality of life: SF-36
timeFrame: One year
measure: Urogenital distress rated with Urinary Distress Inventory Short Form (UDI-6)
timeFrame: One year
measure: Urinary stress incontinence rated with IIQ-7.
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Gabriel Sandblom, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03377894: Sharp Versus Blunt Uterine Incision Expansion
Official title: Comparison Between Blunt Versus Sharp Expansion of Uterine Incision at Lower Segment Cesarean Section as Regards the Intra-operative Blood Loss & Postoperative Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cesarean Section Complications
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: comparison between blunt versus sharp expansion of uterine incision at lower segment cesarean section in primigravida as regards the intra-operative blood loss \& postoperative pain

Detailed description: the study includes 200 pregnant women, primigravidas, at term who underwent elective transverse lower segment Cesarean section for the first time among the age group of 20 - 37 years with a singleton pregnancy.

The patients are divided randomly into two groups as follows:

* Group (A): undergoing blunt uterine incision expansion
* Group (B): undergoing sharp uterine incision expansion

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy.

Exclusion Criteria:

* previous PID
* any medical or psychiatric
* patients with BMI ≥ 40
* multigravidas
* chronic analgesia use,
* allergy to analgesics,
* multiple pregnancies are also excluded

Primary outcomes:
measure: post operative pain
timeFrame: one hour after cs
measure: intraoperative bleeding
timeFrame: from skin incision till skin closure
measure: The operative time is recorded in minutes
timeFrame: from skin incision till skin closure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainiy Hospital
Study officials:
References:
Clinical trial NCT02137694: Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer
Official title: Comparison of the Urinary and Vaginal Auto-takings for the Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test
Keywords: Papillomavirus
Vaginal auto-takings
Urinary test
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 460
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results transmitted to the women and to the doctors of consultation. In case of positive test (15 %), the patients are directed to a gynecologist. Confrontation with the cytological data when available (Group 1) .


Eligibility criteria: Inclusion Criteria:

* All the 25-65-year-old women requiring a screening and seen in consultation of the departments targeted by the CHRU of Brest

Exclusion Criteria:

* Women except age limit, refusal to participate, hysterectomy, pregnancy and post-therapeutic follow-up.

Primary outcomes:
measure: Research for human Papillomavirus by vaginal auto-takings and urinary test
timeFrame: 6 months
Secondary outcomes:
measure: The global logistic of the study
timeFrame: 6 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Landerneau
country: France
facility: Hôpital Ferdinand Grall
Study officials:
affiliation: CHRU Brest
name: Christopher PAYAN, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04443894: Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?
Official title: Acute & Chronic Post-mastectomy Pain: Can PECS Block Alter the Geography?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immediate and Chronic Pain After Mastectomy Managed With PECS Block or Local Infiltration
Keywords: pain
mastectomy
PECS
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 40
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: Post mastectomy pain management is of crucial importance for patients' rehabilitation and quality of life. PECS block is used for acute and chronic post mastectomy pain management. Surgical infiltration is also used in this field. Patients in our study are divided in two groups receiving PECS block or surgical infiltrationbefore incision. Multimodal analgesia is indispensable according to recent guidelines for enhanced postoperative recovery. Pain scores will be assessed during the first 24h postoperatively and at 3 months after surgery.

Detailed description: Patients are randomly assigned to 2 groups, PECS block or surgical infiltration group. Patients assigned to PECS group will receive 30cc of ropivacaine 0,375% where 10cc will be injected between pectoralis major and pectoralis minor and 20cc between pectoralis minor and serratus anterior muscle under ultrasound guidance. Patients assigned to surgical infiltration group will receive 30cc of ropivacaine 0,375% injected by the surgeon. Local aneshetic is administered in both groups after the induction of general anesthesia and before incision. Pain will be assessed at 1, 12, 24h after surgery and at three months after surgery communicating by telephone. Post operative analgesia includes paracetamol 1gr, parecoxib 40 mg (as required) and tramadol as rescue analgesia (1 mg/kg iv up to 3 times daily). Chronic pain will be assessed after 3 months as for prevalence and neuropathic characteristics.

Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* ASA physical status I-III
* elective partial mastectomy

Exclusion Criteria:

* refusal of patient participation or inability to participate to the study

  * known allergic reaction to drugs included in the study design
  * contraindiations of performance of peripheral regional anesthesia
  * diabetes melitus or known neurological disorder
  * chronic pain disorders under therapy with opioids or other analgesic drugs for chronic pain
  * all male patients
  * all patients not speaking the Greek language

Primary outcomes:
measure: intensity of acute postoperative pain
timeFrame: 24 hours
Secondary outcomes:
measure: intensity of chronic pain
timeFrame: 3 months
measure: Prevalence of chronic neuropathic pain
timeFrame: 3 months
measure: Prevalence of chronic neuropathic pain
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Study officials:
References:
Clinical trial NCT04194294: Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery
Official title: Intravenous Lidocaine Reduces Remifentanil and Propofol Requirements Without Altering the Electrical Stapedial Reflex Threshold in Pediatric Cochlear Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Bahteem Specialized Hospital
First posted: 2019-12-11
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The stapedius reflex protects the ear from the loud noise. The measurement of the intraoperative electrically evoked stapedial reflex threshold (ESRT) during pediatric cochlear implants (CIs) is used to confirm that the implant is functioning correctly and determine the maximum comfortable level . Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil exacerbates postoperative pain and increased opioid consumption.

Detailed description: Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil exacerbates postoperative pain and increased opioid consumption.

Eligibility criteria: Inclusion Criteria:

ASA I and II children

Exclusion Criteria:

uncontrolled hypertension, diabetes mellitus, liver disease, kidney disease, heart disease, allergy to lidocaine

Primary outcomes:
measure: Remifentanil consumption
timeFrame: at the end of the surgey
Secondary outcomes:
measure: ESRT responses
timeFrame: After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9),
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04894994: FLX475 in Combination With Ipilimumab in Advanced Melanoma
Official title: Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Melanoma
Keywords: Neoplasms
Ipilimumab
Antineoplastic Agents
Immunological
Lead sponsor: RAPT Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 6
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: This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed cell death ligand 1 (anti-PD-L1) agent.

The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.


Eligibility criteria: Inclusion Criteria:

* Stage IV or unresectable Stage III advanced melanoma
* Prior treatment with at least 2 months of anti-PD-(L)1 agent
* Measurable disease at baseline
* Tumor available for biopsy

Exclusion Criteria:

* History of allergy or severe hypersensitivity to biologic agents
* History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immunotherapy
* Prior treatment with ipilimumab or other (cytotoxic T-lymphocyte-associated antigen 4) CTLA-4 antagonists

Primary outcomes:
measure: Objective Response Rate
timeFrame: Approximately 1 year
measure: Safety and Tolerability as Measured by Number of Participants That Experienced Other Adverse Events
timeFrame: Approximately 3 weeks
measure: Safety and Tolerability as Measured by Number of Participants That Experienced Serious Adverse Events
timeFrame: Approximately 3 weeks
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Approximately 1 year
measure: Overall Survival (OS)
timeFrame: Approximately 1 year
measure: Plasma Concentrations of FLX475
timeFrame: Approximately 1 year
measure: Pharmacodynamic (PD) Markers
timeFrame: Approximately 1 year
measure: Tumor Control
timeFrame: Approximately 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Saint Louis
country: United States
facility: Washington University School of Medicine St. Louis
state: Missouri
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: RAPT Therapeutics, Inc.
name: William Ho, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02857894: Genetic Factors of Idiopathic Polypoidal Vasculopathies in the ATM Gene (Ataxia Telangiectasia Mutated)
Official title: Identification of the Predisposing Genetic Factors of Idiopathic Polypoidal Vasculopathies in the ATM Gene (Ataxia Telangiectasia Mutated)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Choroidal Neovascularization
Keywords: Polypoidal choroidal vasculopathy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with polypoidal choriodal vasculopathy

Brief summary: Polypoidal choriodal vasculopathy (PCV) is an ophthalmologic disease, characterized by vascular abnormalities of the walls of small choroidal vessels, reproducing the specific aspect of polyps (cluster aspect). PCV is one of the "boundary-forms" of age related macular degeneration.

These vasculopathies can be idiopathic. Following the radiotherapy treatments of active and occult-typed neovessels in Age-Related Macular Degeneration (ARMD), 10% of the patients would present typical polypoidal vasculopathic lesions. These polypoidal secondary lesions have been induced by radiotherapy treatment and may show an increased sensibility to radiation in these patients.

Such an increase of radiosensibility is noticed in ataxia telangiectasia syndrome, in relation to the ATM gene mutations. The secondary or idiopathic polypoidal vasculopathic lesions are to be brought closer to telangiectasias in Ataxia Telangiectasia. Considering the iatrogenic component of radiotherapy in the secondary forms of ataxia telangiectasia, it seems legitimate to search for predisposing variants to polypoidal vasculopathies in the ATM gene.

Considering the frequency of PCV worldwide, it seems important to identify the predisposing genetic factors of the ATM gene. These biomarkers to the pathology might enable us to offer prevention (reinforced protection against radiations, including light) and to develop therapeutics (recruitment of other kinases, ATM's partners, in the stability and cellular control of DNA).


Eligibility criteria: Inclusion Criteria:

* Adult caucasian patient
* Polypoidal choriodal vasculopathy
* Informed written consent

Exclusion Criteria:

* History of cephalic radiotherapy
* Absence of affiliation to social security or universal health coverage (CMU)

Primary outcomes:
measure: Variants in the ATM gene
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rotchschild
Study officials:
affiliation: Fondation Ophtalmologique A. de Rothschild
name: Martine MAUGET FAYSSE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00762294: Anastrozole and Letrozole
Official title: Effect Of Anastrozole And Letrozole On Bone Turnover Markers And Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
arimidex
femara
bone health
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Connecticut Breast Health Initiative
First posted: 2008-09-30
Enrollment: 25
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women receiving treatment for breast cancer, who will be starting Arimidex or Femara

Brief summary: Aromatase Inhibitors (AI) are effective for secondary prevention of breast cancer and may soon replace tamoxifen as first-line therapy in the treatment of hormone-sensitive breast cancer. However, because these medications produce a marked reduction in serum estrogen levels, this is likely to result in an increased rate of bone loss and risk of developing osteoporosis and fractures in postmenopausal women treated with these agents. Indeed, substantial bone loss has been reported in several large clinical trials of AIs. Osteoporosis drugs are available that could prevent this loss, but they have frequent side effects and are expensive. Thus, treating all women receiving AIs might not be the most appropriate and cost-effective approach. A better approach might be to select women at highest risk of bone loss and only treat them with antiresorptive agents.

The proposed pilot study will evaluate women who receive anastrozole or letrozole therapy, are receiving adequate amounts of calcium and vitamin D and have baseline normal or moderately low bone mass in order to determine if early changes in bone turnover markers correlate with bone loss at one year. If data from this pilot protocol support our hypothesis, then we would propose a larger trial to confirm it. The ultimate aim is to predict which women are at higher risk of bone loss and therefore treat them earlier with bone-sparing agents, while those with lower risk could be monitored on conservative therapy.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with diagnosis of breast cancer - have not started Arimidex or Femara yet, but will be starting .

Exclusion Criteria:

* History of metastasis
* History of chronic kidney
* Liver GI disease
* Disorders affecting calcium metabolism

Primary outcomes:
measure: bone density
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: bone markers
timeFrame: baseline, 1 month, 3 month, 6 month, 12 month
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut HEalth Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Pamela Taxel, MD
role: PRINCIPAL_INVESTIGATOR
References: