louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01434420: Triple Negative Breast Cancer: Study of Molecular and Genetic Factors
Official title: Triple Negative Breast Cancer: Study of Molecular and Genetic Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: triple negative breast cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2011-09-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Most of the TN is part of the basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.

Breast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. They would be much more frequent in the TN group. However, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis.

The purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters.

The 5 years relapse-free survival will also be estimated.


Eligibility criteria: Inclusion Criteria:

* women \> 18
* non metastatic breast cancer
* triple negative
* 5 years follow-up
* signed informed consent

Exclusion Criteria:

* other cancer (except in situ)
* metastases at diagnosis
* impossibility of follow-up

Primary outcomes:
measure: incidence of BRCA1/2, PALB2, PTEN, PALB2 mutations
timeFrame: up to 1 month
Secondary outcomes:
measure: molecular profiles
timeFrame: up to 1 month
measure: years relapse-free survival
timeFrame: at 5 years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre jean Perrin
city: Marseille
country: France
facility: Hopital La Timone
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jean-Marc EXTRA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00043420: CPG 7909 in Patients With Cutaneous T-Cell Lymphoma
Official title: A Phase I/II Open Label, Multi-Center Study For The Evaluation Of Pf-3512676 (CPG 7909) In Patients With Stage Ib To Iva Cutaneous T-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lymphoma, T-Cell, Cutaneous
Keywords: immunotherapy, lymphoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2002-08-12
Enrollment: 42
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: To assess the effect of CPG 7909 Injection on Cutaneous T-cell lymphoma and the safety of CPG 7909 Injection in patients with this cancer.


Eligibility criteria: Inclusion Criteria:

Patients 18 years or older with biopsy (histopathologically) confirmed cutaneous T-cell lymphoma (limited to mycosis fungoides (MF)) who have had prior therapy with at least one and no more than 3 systemic treatments.

Exclusion Criteria:

Patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) \< 60 will be excluded.

Primary outcomes:
measure: Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs
timeFrame: 24 weeks
measure: Efficacy: Evaluate tumor response as measured by the Composite Assessment of Index Lesion Disease Severity (CA). The primary endpoint will be the overall tumor response rate as assessed by the CA.
timeFrame: 24 weeks
Secondary outcomes:
measure: Secondary efficacy endpoints include disease response assessed by the PGA, duration of overall response, duration of CCR, duration of PR, time to response and time to progression of disease.
timeFrame: indeterminate
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.
citation: Kim YH, Girardi M, Duvic M, Kuzel T, Link BK, Pinter-Brown L, Rook AH. Phase I trial of a Toll-like receptor 9 agonist, PF-3512676 (CPG 7909), in patients with treatment-refractory, cutaneous T-cell lymphoma. J Am Acad Dermatol. 2010 Dec;63(6):975-83. doi: 10.1016/j.jaad.2009.12.052.
Clinical trial NCT00164320: Project TEAM: Teaching HIV Prevention in the HIV Clinic
Official title: Project TEAM: Teaching HIV Prevention in the HIV Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the TEAM prevention intervention delivered by a physician and an HIV-positive counselor is effective. It is hypothesized that those who receive the intervention will report a higher reduction in risky sex than those who were in the standard-care condition.


Eligibility criteria: Inclusion Criteria:

* 1) 18 years or older, 2) HIV-infected, 3) Sexually active, 3)Receiving HIV primary care at participating clinic, 4) Can communicate in English or Spanish, 5) No previous enrollment in the TEAM study or intervention.

Exclusion Criteria:

* 1) Participation in a similar study run by the TEAM PI.

Primary outcomes:
measure: Self-reported unprotected (without condoms)anal or vaginal sex with HIV-negative or unknown-status persons.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Dogan Eroglu, PhD.
role: STUDY_DIRECTOR
affiliation: University of Miami
name: Lisa Metsch, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05299320: Postural Control in Covid-19
Official title: Covid 19 and Postural Sway: A Comprasion of SARS-CoV-2 and Healthy Sedentary Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Performance
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with covid-19 and Have not had covid 19 before

Brief summary: This study was planned to investigate how much the anaerobic performance of individuals who experienced fatigue with Want (Wingate) affected their postural sway parameters.

Detailed description: The postural sway parameters of the individuals will be evaluated using the "Kistler Force Plate" and the anaerobic values will be evaluated using the Wingate Anaerobic Strength Test and the "Excalibur Sport Ergometer" device. The data obtained will be compared with the data of patients with and without Covid-19 disease using appropriate statistical methods.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-30, - Being a volunteer - Having had Covid 19 in the last 3 month

Exclusion Criteria:

* Presence of neurologic and oncologic disease - Presence of orthopedic surgery - Presence of active Covid 19 disease - Any cardiopulmonary disease

Primary outcomes:
measure: Postural Sway
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karamanoglu Mehmetbey University
city: Karaman
country: Turkey
facility: Karamanoğlu Mehmetbey University
Study officials:
affiliation: Tarsus Universty
name: Ayşenur Gökşen, PhD
role: STUDY_CHAIR
References:
citation: Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
Clinical trial NCT00592020: Short Transverse Versus Conventional Hockey Stick Incision in Kidney Transplantation
Official title: "Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Keywords: kidney
transplantation
minimal invasive
short transverse
hockey stick
incision
quality of life
planned kidney transplantation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 50
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: Today the minimal invasive access is used for a lot of different operations. This technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection).

Especially patients under immunosuppressive therapy could benefit from this technique. First results in minimally invasive kidney transplantation indicate that it may be performed quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical complications. Another retrospective study showed lower rates of hernia, abdominal wall relaxations, and a better postoperative cosmetic.

The aim of this study is to compare the classic hockey stick incision with a minimal invasive incision in a randomized clinical trial.


Eligibility criteria: Inclusion Criteria:

* Age equal or over 18 years
* Sole kidney transplantation
* Consent form

Primary outcomes:
measure: QoR (Quality of Recovery) - Score
timeFrame: preoperative, day 1/3/5/7 postoperative
Secondary outcomes:
measure: Quality of Life by SF (Short Form) 36
timeFrame: preoperative, day 7, week 4, month 6 postoperative
measure: Operation time
timeFrame: intraoperative
measure: Warm ischemic time
timeFrame: intraoperative
measure: Postoperative pain measured by VAS (visual analog scale) and amount of analgesia
timeFrame: day 1/2/3/4/5/6/7 postoperative
measure: Surgical complications
timeFrame: day 7, week 4, month 6, month 12 postoperative
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: University Hospital Inselspital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Uta Herden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00517920: Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Official title: An Open-Label, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2007-08-17
Enrollment: 44
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: Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC)

Detailed description: An Open-label, Phase 2 study of efficacy and tolerability of ABT-869 in advanced hepatocellular carcinoma (HCC)

Eligibility criteria: Inclusion Criteria

* Subject must be greater than or equal to 18 years of age
* Subject must be diagnosed with unresectable or metastatic HCC
* Subjects must have a measurable lesion by RECIST on CT scan in at least one site which has not received radiation
* Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
* No other active malignancy within the past 5 years

Exclusion Criteria

* Subject has received targeted VEGF/PDGF/TKI therapy. Prior Avastin is allowed
* Subject has Child-Pugh grade Class C hepatic impairment
* The subject has proteinuria Common Toxicity Criteria (CTC) grade \> 1 as measured by routine urinalysis or 24 hour urine collection during screening assessment
* Subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure \> 100 mmHg or systolic blood pressure \> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention
* The subject has a documented left ventricular Ejection Fraction \< 50%
* Subject is receiving therapeutic anticoagulation therapy

Primary outcomes:
measure: Progression-Free Rate
timeFrame: Week 16
measure: Objective Response Rate
timeFrame: Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 7726
state: Pennsylvania
city: Toronto
country: Canada
facility: Site Reference ID/Investigator# 7169
city: Vancouver
country: Canada
facility: Site Reference ID/Investigator# 5837
city: Singapore
country: Singapore
facility: Site Reference ID/Investigator# 5235
city: Singapore
country: Singapore
facility: Site Reference ID/Investigator# 5611
city: Taipei
country: Taiwan
facility: Site Reference ID/Investigator# 6265
Study officials:
affiliation: AbbVie
name: Justin Ricker, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00229320: Short Term Group Therapy for OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-09-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Assessing OCD before and after group therapy


Eligibility criteria: Inclusion Criteria:

* OCD
* Eligibility to participate in group therapy

Exclusion Criteria:

* PTSD
* Suicidal thoughts
* Psychotic state
* Severe hostile personality disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Tel Aviv University
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03276520: Randomized Diagnostic Trial Comparing Ethylglucuronide and Ethanol
Official title: Filling the Gap Between Lab and Clinical Impact: an Open Randomized Diagnostic Trial Comparing Urinary Ethylglucuronide and Ethanol in Alcohol Dependent Outpatients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: ethyl glucuronide, biomarker, diagnostic randomized trial
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Background: Alcohol use disorders represent a major health burden. Efforts aiming at reducing alcohol-related harm include early detection of those with risky drinking habits as well detection of early relapse in patients with alcohol dependence who are detoxified and committed to abstinence. Recently, ethyl glucuronide has been proved to be a good biomarker for the detection of recent drinking. However, to date, no randomized diagnostic trial has tested its impact on drinking outcomes. The aim of this study was to assess, with a randomized design, the implications of ethyl glucuronide screening on alcohol outcomes, compared to screening with a low-sensitivity biomarker such as ethanol.

Methods: alcohol dependent outpatients were randomized to either 24 weeks of continuous screening with ethyl glucuronide or ethanol. Patients were aware of screening methods and results. After 24 weeks, all participants were screened with ethyl glucuronide. Self-reports were also gathered. A logistic regression model was performed comparing the rate of ethyl glucuronide positive results at study end between groups. Generalized estimating equations were performed to evaluate the descending rate of EtG positive patients in the EtG group, measured month to month.


Eligibility criteria: Inclusion Criteria:

* subjects had to be diagnosed of alcohol dependence according to DSM-IV, they had to undergo regular urine screening as part of their treatment and be willing to give informed written consent.

Exclusion Criteria:

* conditions rendering patients unable to complete study procedures

Primary outcomes:
measure: ethyl glucuronide positive rate
timeFrame: after six months of ongoing urine screening
measure: descending of Etg positive rates in the Etg group
timeFrame: six months of ongoing urine screening
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04593420: Treatment of Aggressive Prostate Cancer in Real Life: Initiation, Schedule and Management of Triptorelin Treatment.
Official title: Treatment of Aggressive Prostate Cancer in Real Life: Initiation, Schedule and Management of Triptorelin Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 817
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 786 subjects presenting a prostate cancer histologically confirmed and eligible to start triptorelin treatment for at least 12 months will be included in the study. They should also be able to complete a self-questionnaire.

Brief summary: The purpose of the protocol is to describe the proportion of subjects treated continuously with triptorelin during 12 months following treatment initiation. This study will take place at 187 locations (approximately) in France.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Histologically confirmed prostate cancer
* Triptorelin to be initiated in its labelled indication for a planned total duration of at least 12 months; decision to start triptorelin was made voluntarily by the physician as part of routine medical practice, prior to the inclusion in the study
* Ability to understand and complete questionnaire,

Exclusion Criteria:

* Previously received a hormonal therapy during the last 6 months before inclusion,
* Simultaneously participates in a clinical trial.

Primary outcomes:
measure: Proportion of subjects treated continuously with triptorelin for the 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Planned total duration of triptorelin treatment
timeFrame: Baseline, 6 months, 12 months
measure: Primary reasons of choice of planned total triptorelin treatment duration
timeFrame: baseline, 6 month, 12 months
measure: Parameters that influence the planned total duration of triptorelin treatment
timeFrame: Baseline
measure: Parameters that influence the modification of the planned total duration of triptorelin treatment
timeFrame: 12 months
measure: Formulation and administration route of triptorelin prescribed
timeFrame: baseline, 6 and 12 months
measure: Description of the reasons of choice of formulation and administration route of triptorelin prescribed
timeFrame: baseline
measure: Parameters that influence the choice of formulation and administration route of triptorelin prescribed
timeFrame: baseline
measure: Description and change at each follow-up visit from baseline
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Ipsen Central Contact
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02330120: Effects of Dexmedetomidine and Propofol on Pulmonary Mechanics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abnormal Respiratory Airway Resistance
Keywords: peak airway pressure
airway resistance
sedation
intensive care
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary mechanics in intensive care patients.

Detailed description: The aim of this study is to compare the effects propofol and dexmedetomidine on pulmonary mechanics. Sixty patients mechanically ventilated in intensive care unit are included in this study. Patients are divided into two random groups, Group P (propofol) and Group D (dexmedetomidine). Propofol infusion 0.5-2 mg/kg/h is given to Group P patients and dexmedetomidine infusion 0.2-0.7 mcg/kg/h is given to Group D patients for sedation. Initial blood gas analysis, airway resistance (cmH2O/L/sec), positive end-expiratory pressure (PEEP, cmH20), frequency (breath/min), tidal volume (mL/min), minute volume (mL), peak airway pressure (cmH20), compliance (mL/cmH20), endtidal CO2 (mmHg), SvO2 (%) values are recorded. This parameters are evaluated with Drager Evita 4 ventilator and recorded on 5th,15th,30th,45th ve 60th minutes . Sedation is observed using Riker and Ramsey Sedation-Agitation Scale. Compliance of patients to mechanical ventilation is observed and recorded.

The primary outcome measures are airway resistance and peak airway pressure. Secondary outcome measure is sedation score.

Eligibility criteria: Inclusion Criteria:

* The patients mechanically ventilated in intensive care unit

Exclusion Criteria:

* Patients with contraindications for using propofol and dexmedetomidine

Primary outcomes:
measure: airway resistance
timeFrame: 60 minutes
measure: peak airway pressure values
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
References:
citation: Fernandes FC, Ferreira HC, Cagido VR, Carvalho GM, Pereira LS, Faffe DS, Zin WA, Rocco PR. Effects of dexmedetomidine on respiratory mechanics and control of breathing in normal rats. Respir Physiol Neurobiol. 2006 Dec;154(3):342-50. doi: 10.1016/j.resp.2006.02.002. Epub 2006 Mar 9.
citation: Bang SR, Lee SE, Ahn HJ, Kim JA, Shin BS, Roe HJ, Sim WS. Comparison of respiratory mechanics between sevoflurane and propofol-remifentanil anesthesia for laparoscopic colectomy. Korean J Anesthesiol. 2014 Feb;66(2):131-5. doi: 10.4097/kjae.2014.66.2.131. Epub 2014 Feb 28.