louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03954171: Platino-resistance in Ovarian Cancer
Official title: Platino-resistance in Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epithelial Ovarian Cancer
Keywords: Epithelial Ovarian Cancer
Platinum based-chemotherapy
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prospective, monocentric study aiming to identify factors involved in platinum based-chemotherapy resistance in patients with epithelial ovarian cancer (all stages).

Patients will receive treatment (platinum based-chemotherapy) according to the standard practices.

A prospective database and an associated biological collection will be performed during 5 years:

* For each patient: clinical, biological, epidemiological and therapeutic treatment data will be collected during the standard therapeutic care.
* Biological samples (blood samples, tumor biopsy specimens and ascites samples) will be collected for all patients. These samples will be collected at the same time as those taken in standard practice (no additional biopsy will be performed for the study).

Study participation of each patient will be 5 years.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Epithelial ovarian cancer at initial diagnosis (all stages)
3. Curative treatment (exeresis surgery) not yet initiated excepted neo-adjuvant treatment
4. Indication of platinum based-chemotherapy
5. Patient affiliated to the french social security system
6. Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure

Exclusion Criteria:

1. Non-epithelial ovarian tumor, borderline ovarian tumor
2. Patient with recurrent disease
3. Exploratory surgery not performed at the "Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT-O)"
4. Pregnant or breastfeeding women
5. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
6. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)

Primary outcomes:
measure: The rate of patients alive without progression
timeFrame: 5 years for each patient
Secondary outcomes:
measure: The time to onset of platinum based-chemotherapy resistance
timeFrame: 5 years for each patient
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
Study officials:
References:
Clinical trial NCT00233571: A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis
Official title: A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 796
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: The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis


Eligibility criteria: Inclusion Criteria:

* Completion of a previous D2E7 study
* Subject is in good health (Investigator discretion) with a recent stable medical history

Exclusion Criteria:

* Former enrollment in this trial (DE018)
* Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast feeding or considering becoming pregnant.

Primary outcomes:
measure: Clinical response indicators
timeFrame: 5 years
Secondary outcomes:
measure: Safety parameters
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Hartmut Kupper, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01087671: Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost to Preservative Free Tafluprost Eye Drops
Official title: Ocular Signs and Symptoms in Patients With Ocular Hypertension or Open-angle Glaucoma Switched From Preserved Latanoprost 0.005% Eye Drops to Preservative Free Tafluprost Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Open-Angle Glaucoma
Lead sponsor: Santen Oy
Sponsor class: INDUSTRY
First posted: 2010-03-16
Enrollment: 185
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: The purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (Xalatan) to preservative free Tafluprost eye drops.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication.
* Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.

Primary outcomes:
measure: Assessment of changes in ocular symptoms and signs
timeFrame: From Screening (Visit 1) to12 weeks.
Secondary outcomes:
measure: Secondary outcome measures include the assessment of safety and quality of life parameters.
timeFrame: From Screening (visit 1) to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: State Educational Establishment of Higher Professional Education "Russian State Medical University of Federal Service on Surveillance in Healthcare and Social Development of Russian Federation"
name: Evgeniy Egorov, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01098071: Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)
Official title: Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adenoids
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 34
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To document the short term \& long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause \> 50% obstruction of the posterior choanae).


Eligibility criteria: Inclusion Criteria:

* 2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy \> 50% of posterior choanae.

Exclusion Criteria:

* adenoids hypertrophy \< 50% of posterior choanae

recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.

Primary outcomes:
measure: Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score
timeFrame: Baseline and Week 12
measure: Degree of Posterior Choana Obstruction at Baseline and Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Severity of Rhinorrhea at Baseline and Week 12
timeFrame: Baseline and Week 12
measure: Severity of Nasal Congestion at Baseline and Week 12
timeFrame: Baseline and Week 12
measure: Severity of Nasal Itching at Baseline and Week 12
timeFrame: Baseline and Week 12
measure: Severity of Sneezing at Baseline and Week 12
timeFrame: Baseline and Week 12
measure: Severity of Eye Symptoms at Baseline and Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
References:
citation: Bitar MA, Mahfoud L, Nassar J, Dana R. Exploring the characteristics of children with obstructive adenoid responding to mometasone fuorate monohydrate: preliminary results. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):931-7. doi: 10.1007/s00405-012-2155-8. Epub 2012 Aug 22.
Clinical trial NCT00359671: Treatment With MK6592 and an Anti-cancer Drug in Patients With Advanced Solid Tumors (6592-001)
Official title: Phase I Study Evaluating MK6592 in Combination With Docetaxel in Adult Patients With Relapsed or Refractory Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-08-02
Enrollment: 38
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: A study to evaluate safety and tolerability of MK6592 in combination with an anti-cancer drug in adult patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Patients with advanced solid tumors (metastatic or local) unresponsive to standard therapy, progressed on standard therapy, or no standard therapy exists. No limit to the number of prior treatment regimens
* Patients may be fully active without physical restrictions, ambulatory with restrictions on strenuous physical activity, or ambulatory and capable of self-care but not work activities (i.e., Eastern Cooperative Oncology Group performance status of greater than or equal to 2)
* Demonstrates adequate organ function (liver, kidneys, hematologic)

Exclusion Criteria:

* Chemotherapy or radiation therapy within 2 weeks of dosing; or unresolved side effects(s) from prior treatment regimen
* Participation in an investigational study within 14 days of dosing
* Primary central nervous system tumor
* Active brain or spinal cord metastases. Patients who completed a course of therapy for CNS metastases may be eligible if considered clinically stable for 3 months prior to study entry
* Symptoms from fluid in the abdomen or around the lungs
* Requires certain drugs or other products known to be metabolized by the liver enzyme CYP3A4

Primary outcomes:
measure: Safety and tolerability of MK6592 alone and in combination with docetaxel
timeFrame: 6 Months
Secondary outcomes:
measure: Observance of objective tumor responses in patients treated with MK6592 combined with docetaxel
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01854671: Investigating the Effect of a Prenatal Family Planning Counseling Intervention Led by Community Health Workers on Postpartum Contraceptive Use Among Women in the West Bank
Official title: Investigating the Effect of a Prenatal Family Planning Counseling Intervention Led by Community Health Workers on Postpartum Contraceptive Use Among Women in the West Bank
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus: Contraceptive Counseling
Focus: Postpartum Contraception
Keywords: postpartum contraception
contraceptive counseling
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
Collaborators: name: Society for Family Planning Research Fund
First posted: 2013-05-15
Enrollment: 176
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to measure the difference in proportion of postpartum women using contraception after a Community Health Worker (CHW) family planning educational intervention compared to women who receive standard care in the West Bank district of Ramallah and Al-Bireh.

Primary hypothesis: Postpartum contraceptive use will increase in women who receive a dedicated family planning counseling intervention delivered by CHWs during antenatal care compared to women receiving usual care.


Eligibility criteria: Inclusion Criteria:

* Women attending the MoH Ramallah or Al-Bireh clinic for antenatal care and 34-38 weeks pregnant at enrollment
* Planning delivery at an MoH hospital
* Able and willing to be contacted by phone or home visit

Exclusion Criteria:

* Women less than 34 weeks pregnant or non-pregnant
* Planning delivery at a private or NGO hospital
* Unwilling to be contacted for follow-up after enrollment

Primary outcomes:
measure: Self-reported contraceptive use
timeFrame: 6 months post-partum
Secondary outcomes:
measure: Intent to use contraception in the future
timeFrame: 6 months postpartum
measure: Non-desire to use contraception
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Ramallah and Al-Bireh
country: Palestinian Territories, Occupied
facility: Palestinian Ministry of Health Maternal Child Health Clinics (Ramallah and Al-Bireh)
state: West Bank
Study officials:
affiliation: Planned Parenthood League of Massachusetts
name: Principal Investigator, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05754671: Perceptual Assessment of the Tracheoesophageal Voice
Official title: PERCEPTUAL EVALUATION OF THE TRACHEO-OESOPHAGEAL VOICE: ITALIAN VALIDATION OF THE SUNDERLAND TRACHEOESOPHAGEAL PERCEPTUAL SCALE (I-SToPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheo-Esophageal Fistula Following Tracheostomy
Keywords: voice prosthesis
perceptual evaluation
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Aim of this study was to validate the Sunderland Tracheoesophageal Perceptual Scale (SToPS) in Italian language by checking the inter- and intra-rater reliability.

The validation of the tool involved the following steps: 1) Translation and adaptation of the SToPS into Italian language; 2) Recruitment of participants (43 laryngectomized patients with a voice prosthesis and 12 health professionals - 6 speech and language therapists (SLTs) and 6 Ear, Nose, and Throat (ENTs) surgeons - classified into experienced or not at assessing voice; 3) Recording of patients' speech samples; 4) Perceptual evaluation of recorded speech samples (test and re-test) performed by the 12 health professionals; 5) Statistical analysis (quadratic weighted Cohen Kappa and weighted Kappa of Light coefficients).

SLTs with specific experience in tracheo-esophageal and laryngeal voice rated more reliably than the others raters. For all groups of raters, the inter-rater agreement was worse than the intra-rater one for 9/10 parameters. Exclusively for experienced SLTs, only the "Impairment of social acceptability" parameter reached a good level of inter-rater agreement.

In conclusion, the Italian version of SToPS can be considered a reliable tool. As in the original version, expert SLTs may be considered the optimal judges for tracheoesophageal voice assessment.


Eligibility criteria: Inclusion Criteria:

* native Italian speakers;
* ability to produce TE voice.

Exclusion Criteria:

* reading difficulties;
* presence or suspicion of disease recurrence;
* other communication problems not related to Total laryngectomy.

Primary outcomes:
measure: Reliability
timeFrame: 4 months
Secondary outcomes:
measure: Training
timeFrame: 4 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli - IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Lucia D'Alatri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854971: Efficacy Study of TKcell in Advanced Colorectal Cancer
Official title: Evaluating the Safety and Efficacy of Combination Therapy With FOLFOX-4 and TKcell Therapy Versus FOLFOX-4 Alone in Patients With Recurrent, Unresectable and Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Colorectal Cancer
Keywords: NKCell
FOLFOX-4
advanced or unresectable colorectal cancer
Lead sponsor: Binex
Sponsor class: INDUSTRY
First posted: 2009-03-03
Enrollment: 86
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine efficacy of NKCell in colorectal cancer


Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Diagnosis of histologically confirmed adenocarcinoma of the colorectal
* ECOG performance status of 0 - 2
* At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥2cm in physical examination
* Adequate liver, renal, bone marrow functions as evidence by the following;
* Absolute neutrophil count \> 1.5 x 109/L; platelets \> 7.5 x 109/L; Bilirubin less than 2 mg/dL ASAT and/or ALAT \< 5 UNL; serum creatinine ≤ 2 ULN
* Minimum life expectancy of 12 weeks
* Effective contraception for both male and female subjects if the risk of conception exists

Exclusion Criteria:

* Brain metastasis and/or leptomeningeal disease (known or suspected)
* Previous chemotherapy for gastric cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment.
* Previous oxaliplatin-based chemotherapy
* Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization and chemotherapy
* HIV antibody (+), Chronic hepatitis
* Uncontrolled infection
* Concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal therapy not indicated in the study protocol except for contraception
* Clinically relevant coronary artery disease, history of myocardial infarction, high risk of uncontrolled arrhythmia
* Known hypersensitivity reaction to any of the components of the treatment.
* Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
* Participation in another clinical study within the 30 days before randomization
* Significant disease which, in the investigator's opinion, would exclude the subject from the study

Primary outcomes:
measure: Determine response rate
timeFrame: within study period
Secondary outcomes:
measure: Determine safety of combination,time to treatment failure, overall survival time
timeFrame: within study period
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea
state: Banpo-dong
Study officials:
affiliation: The Catholic Medical Center
name: Seok-Goo Cho, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01428271: Comparison Between the Expected Site of Sacral Hiatus by Conventional Method and the Real Site by Ultrasonography for Caudal Block in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Herniorraphy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-09-02
Enrollment: 80
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 0-72 months who are scheduled to undergo elective inguinal herniorraphy under general anesthesia

Brief summary: Caudal block is one of the most useful and popular regional block in pediatric anesthetic practice. Successful caudal block depends on the proper placement of a needle through sacral hiatus by following anatomical landmarks. The sacrum and the position of sacral hiatus are extreme variable anatomical structure. Generally, the equilateral triangle located between the apex of the sacral hiatus and posterior superior iliac spines is used in determining the location of the sacral hiatus as the conventional method. Previous study demonstrated that the triangle formed between the apex of the sacral hiatus and the posterior superior iliac spines was found to have the features of an equilateral triangle in adult. There is no study about the efficacy of the conventional method using the equilateral triangle in children. In this study, the investigators will compare between the expected site of sacral hiatus by conventional method using the equilateral triangle and the real site of the sacral hiatus confirmed by ultrasonography for caudal block in children.


Eligibility criteria: Inclusion Criteria:

* Children aged 0-72 months
* patient whho are scheduled to undergo elective inguinal herniorraphy under general anesthesia

Exclusion Criteria:

* The history of prematurity
* he histories of the infection, tumor, and operation in sacrum 3. The history or suspicion of meningomyelocele

Primary outcomes:
measure: the expected site of the sacral hiatus by convential method
timeFrame: approximately 5 minutes after general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Senoglu N, Senoglu M, Oksuz H, Gumusalan Y, Yuksel KZ, Zencirci B, Ezberci M, Kizilkanat E. Landmarks of the sacral hiatus for caudal epidural block: an anatomical study. Br J Anaesth. 2005 Nov;95(5):692-5. doi: 10.1093/bja/aei236. Epub 2005 Sep 9.