louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05816980: Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients
Official title: External Beam Radiotherapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Recurrence
Radiation Toxicity
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2023-04-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients are enrolled according to protocol criteria for hyperfractionated IMRT re-irradiation.
Primary purpose: TREATMENT

Brief summary: This study investigates the potential benefit of re-irradiation of patients with locally advanced rectal recurrences, by a prospective phase II clinical, imaging and translational research study.

Detailed description: The overall purpose of this trial is to evaluate the efficacy of re-irradiation of patients with locally advanced rectal cancer (LRRC) recurrences who previously received pelvic irradiation. Patients with potentially resectable LRRC will be treated with hyperfractionated Intensity-Modulated Radiotherapy consisting of 40.8 Gy in 1.2 fractions twice daily with concomitant oral capecitabine followed by surgery, when feasible.

Eligibility criteria: Inclusion Criteria:

* Locally recurrent rectal cancer
* Previous pelvic RT for rectal cancer and surgery
* Potentially resectable by MRI and palpation by MDT evaluation
* Absence of non-resectable distant metastases by PET-CT
* Age ≥ 18
* Adequate organ function
* Acceptable bowel and bladder function
* Acceptance for TR sampling

Exclusion Criteria:

* Central small recurrences deemed immediate resectable
* Previous radiotherapy \<12 month prior to recurrence
* Non-resectable systemic or regional disease
* Unable to undergo MRI or PET-CT
* Medical comorbidities precluding radical surgery

Primary outcomes:
measure: Resection rate
timeFrame: At surgery
Secondary outcomes:
measure: Physician reported Toxicity
timeFrame: Acute and late toxicity evaluations during and at 6,12 and 36 months post surgery
measure: QoL assessment according to QLQ-CR29
timeFrame: Pre-treatment and 12 months post surgery
measure: QoL assessment according to EORTC QLQ-C30
timeFrame: Pre-treatment and 12 months post surgery
measure: Recurrence rate
timeFrame: Rate of re-recurrence at 6, 12 and 36 months post surgery.
measure: Comparative dose planning study
timeFrame: The VMAT plans generated before treatment start (baseline) is compared to IMPT plans.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Aarhus University Hospital, Depart. Oncology
name: Karen-Lise G Spindler, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00631280: Does Active Parent Involvement in Deliberation and Choice Improve Medication Persistence for Their Child With ADHD
Official title: Response Variability in Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Keywords: Decision Aid
Informed Choice
Adherence
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-03-07
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether active parent involvement in deliberation and choice improves subsequent medication persistence for their child with ADHD.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with ADHD based on DSM-IV criteria
* Enrolled in school-setting
* No learning disability
* No past use of psychoactive medication

Exclusion Criteria:

* Do not meet DSM-IV criteria for ADHD
* Not enrolled in school-setting
* Presence of learning disability
* History of brain injury
* Past use of psychoactive medication

Primary outcomes:
measure: Number of days covered with medication as determined by pharmacy refill records
timeFrame: one year
Secondary outcomes:
measure: Decisional Conflict
timeFrame: immediately after intervention or control condition delivered
measure: Decisional Regret
timeFrame: immediately after intervention or control condition delivered
measure: Satisfaction with Information about Medicine
timeFrame: immediately after intervention or control condition delivered
measure: Working Alliance Inventory
timeFrame: immediately after intervention or control condition delivered
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: William Brinkman, MD, MEd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03825380: Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
Official title: Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Glaucoma
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2019-01-31
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.


Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated.
* Both eyes with diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* History of trauma, infection, clinically significant inflammation within the 3 previous months.
* Uncontrolled diabetic patient.
* Pregnancy or breast feeding.

Primary outcomes:
measure: Intra-Ocular Pressure
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: Hospital
Study officials:
References:
Clinical trial NCT03742180: Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy
Official title: A Prospective Randomized Trial of Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Elective Bilateral Myringotomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators aim to compare intranasal dexmedetomidine in a dose of 1ug.kg-1 with sublingual ketorolac in a dose of 1mg.kg-1 on postoperative behaviour in those children undergoing BMT during their PACU stay

Detailed description: Data were analyzed through SPSS (Statistical Package for Social Sciences), Program version 22. Distribution of data was first tested by Shapiro test. Data were presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, an unpaired t-test was used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test was used. Fisher's exact test was used for comparison of categorical data. The P value ≤ 0.05 was considered as the level of statistical significance.

A prior G power analysis was done. Using the results obtained from previous studies (14- 18) and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 60 patients per group was calculated. A drop out 10% of cases is expected, so; 33 cases per group will be required

Eligibility criteria: Inclusion Criteria:

* ASA physical status I- II.

Exclusion Criteria:

* History of ketamine
* History of NSAID
* History of allergies
* Any bleeding disorders
* History of GIT bleeding
* Those who will undergo other procedures in addition to bilateral myringotomy

Primary outcomes:
measure: duration of analgesia
timeFrame: time from administering the study solution till the time for the first rescue analgesic] during first 24 hours
Secondary outcomes:
measure: Postoperative pain score
timeFrame: For 24 hours after surgery
measure: Heart rate
timeFrame: for 2 hours after the start of surgery
measure: systolic blood pressure
timeFrame: for 2 hours after the start of surgery
measure: Number of patients received rescue analgesics
timeFrame: For 24 hours after surgery
measure: Degree of sedation
timeFrame: For 24 hours after surgery
measure: Nausea and vomiting
timeFrame: For 24 hours after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
state: DK
Study officials:
References:
Clinical trial NCT05819580: Studying the Clinical Trial Experiences of Patients With Mesothelioma
Official title: Mesothelioma Clinical Trials Review: Examining Patient Experiences in Mesothelioma Clinical Trials to Identify Influencing Factors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mesothelioma
Keywords: mesothelioma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mesothelioma patients who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.

Brief summary: Medical research participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical study may make it more difficult for patients to take part or see it through.

The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future mesothelioma patients during clinical trials.


Eligibility criteria: Inclusion Criteria:

* Must have a medical diagnosis of mesothelioma that has been confirmed by a physician.
* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.
* Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

* Pregnant or lactating woman
* Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.
* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results

Primary outcomes:
measure: Rate of patients who decide to enroll in a mesothelioma medical study.
timeFrame: 3 months
measure: Number of mesothelioma patients who remain in clinical trial until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Sinn K, Mosleh B, Hoda MA. Malignant pleural mesothelioma: recent developments. Curr Opin Oncol. 2021 Jan;33(1):80-86. doi: 10.1097/CCO.0000000000000697.
citation: Jakobsen JN, Sorensen JB. Review on clinical trials of targeted treatments in malignant mesothelioma. Cancer Chemother Pharmacol. 2011 Jul;68(1):1-15. doi: 10.1007/s00280-011-1655-3. Epub 2011 May 7.
citation: Lau B, Boyer M, Lee JH, Kao S. Clinical Trials Eligibility of Patients With Malignant Pleural Mesothelioma: Use of Novel Therapies and Outcomes. Clin Lung Cancer. 2020 Jul;21(4):378-383.e1. doi: 10.1016/j.cllc.2020.01.007. Epub 2020 Mar 7.
Clinical trial NCT03905980: Risk Factors for Primary Cesarean Section in Egypt
Official title: Evaluation of Risk Factors for Primary Cesarean Section in Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: woman carrying their first pregnancy

Brief summary: women in their first pregnancy evaluated till delivery for associated risk factors for cesarean delivery

Detailed description: Evaluation of maternal , fetal, delivery place and health care provider rules to determine route of delivery in women during their first pregnancy

Eligibility criteria: Inclusion Criteria:

* women in their first pregnancy
* Delivery between 37 and 42 weeks
* Singleton pregnancy _ cephalic presentation

Exclusion Criteria:

* women asked for CS on demand

Primary outcomes:
measure: route of delivery in primigravida
timeFrame: at delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Professor
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03674580: Impairment of the Cognitive Flow in the Development of a Depressive Disorder and Suicidal Ideas
Official title: Impairment of the Cognitive Flow in the Development of a Depressive Disorder and Suicidal Ideas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide
Keywords: suicidal patients;psychiatry
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 67
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: Suicidal patients followed at the Hospital Rene Dubos

Brief summary: The study consists in estimating the mental load (cognitive saturation) and the production of driving cognition to suicidal patients.

Detailed description: The study consists in testing two big general hypotheses:

* In the first place, that suicidals presents a mental load (cognitive saturation) and an activity pain behaviour of their space of the thought by extremely painful peripheral cognitive movements (impression that the brain is saturated of thoughts, turbulences, internal movements)
* Secondly, that suicidals produces a surplus of representations of action, such takes out that their vision of the world is saturated of a not integrable kinaesthetic imaging by the subject.

Eligibility criteria: Inclusion Criteria:

* Patients followed within the framework of an ambulatory follow-up post-emergencies(post-urgent matters).
* Knowledge of the French language
* patient who have signed of the form of consent,
* patient presenting one anxio-depressive disorder(confusion) with or without suicidal episode.

Exclusion Criteria:

* Not compatible health with the signing of the protocol,
* the not knowledge of the French language,
* patient who have refused the protocol.

Primary outcomes:
measure: Mental load (calm or turbulence of the spirit) - test of the aquarium
timeFrame: 5 days
Secondary outcomes:
measure: Moral pain - Analog Visual Scale Battery
timeFrame: 5 days
measure: Suicidal thoughts - Analog Visual Scale Battery
timeFrame: 5 days
Other outcomes:
Locations:
city: Pontoise
country: France
facility: CH Rene Dubos
state: Val d'Oise
Study officials:
affiliation: Rene Dubos Hospital
name: BAUDOIN Thierry, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03640780: Practical Pattern of Surgical Timing of Childhood Cataract in China
Official title: Practical Pattern of Surgical Timing of Childhood Cataract in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cataract
Keywords: surgical timing
cataract extraction
IOL implantation
childhood cataract
real-world data
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 2421
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital-based

Brief summary: In the current study, the investigators analyzed the surgical RWD of 2,421 children with childhood cataracts from the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH) at the Zhognshan Ophthalmic Center and proposed data-based clinical experience for the timings of cataract extraction and IOL implantation.


Eligibility criteria: Inclusion Criteria:

* childhood cataracts present at the ZOC at the first time age: 0-18 years

Exclusion Criteria:

* complicated with other type of cataracts

Primary outcomes:
measure: Surgical age
timeFrame: 2005-2014
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00970580: A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer
Official title: A Phase 1b, Open-Label, Dose-Escalation Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Keywords: BIIB022
Stage IV
Taxol
Stage IIIB
Carboplatin
Paclitaxel
Non Small Cell Lung Cancer
Treatment Naive
Anti IGF1R
NSCLC
Open Label
IGF1R
Paraplatin
Cytotoxic
Mitotic Inhibitor
Taxane
Alkylating agent
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2009-09-02
Enrollment: 18
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 determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.


Eligibility criteria: Inclusion Criteria:

* Age \>/= 18 years old
* Treatment-naive Stage IIIB/IV Non-Small Cell Lung Cancer
* ECOG Performance Status 0 or 1

Exclusion Criteria:

* History of another primary cancer within 3 years
* Any prior or concurrent investigational or standard therapy for treatment of NSCLC
* Prior anti-IGF-1R therapy
* Unstable diabetes

Primary outcomes:
measure: To evaluate the safety and tolerability of BIIB022 in combination with paclitaxel and carboplatin
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Resesarch Site
state: California
city: San Diego
country: United States
facility: Resesarch Site
state: California
city: Denver
country: United States
facility: Resesarch Site
state: Colorado
Study officials:
References:
Clinical trial NCT00693680: Zinc Supplementation of Imipramine Therapy
Official title: The Role of Zinc in Therapy of Unipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Keywords: depression
antidepressant treatment
zinc
placebo
Lead sponsor: Polish Academy of Sciences
Sponsor class: OTHER
Collaborators: name: Jagiellonian University
First posted: 2008-06-09
Enrollment: 60
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: Examination of the effect of zinc supplementation on imipramine therapy in major depression.

Detailed description: A placebo-controlled, double blind study of zinc supplementation in imipramine therapy was conducted in sixty, depressed patients fulfilling the DSM-IV criteria for major depression without psychotic symptoms. After a one week washout period, patients were randomized into two groups treated with imipramine and receiving once daily either placebo (n=30) or zinc supplementation (n=30) for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* patients with fulfilled DSM-IV criteria for moderate or severe depressive episode
* one week washout period without any pharmacotherapy

Exclusion Criteria:

* psychotic symptoms

Primary outcomes:
measure: To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)
timeFrame: 12 weeks
Secondary outcomes:
measure: To assess unwanted side effects in both groups
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Psychiatry, Collegium Medicum, Jagiellonian University
Study officials:
affiliation: Department of Psychiatry, Collegium Medicum
name: Andrzej Zieba, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nowak G, Siwek M, Dudek D, Zieba A, Pilc A. Effect of zinc supplementation on antidepressant therapy in unipolar depression: a preliminary placebo-controlled study. Pol J Pharmacol. 2003 Nov-Dec;55(6):1143-7.
Clinical trial NCT06724380: Detection of Health Risk Situations in the Anesthesia Consultation.
Official title: Detection of Health Risk Situations in the Anesthesia Consultation.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Procedures, Operative
Lead sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients evaluated in person at the preoperative anesthesia consultation for a scheduled surgery indication.

Brief summary: This study aims to estimate the proportion of patients seen in the anesthesiology consultation for planned surgery in whom a previously unknown health risk situation is detected (e.g., obesity, anemia, etc.).


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 50 years.

  * Indication for elective surgery.
  * In-person preoperative evaluation in the scheduled Anesthesiology consultation.

Exclusion Criteria:

* Indication for non-deferrable urgent surgery.
* Pregnant women.
* Pre-surgical visit outside the anesthesia consultation.
* Incomplete preoperative evaluation, as indicated in the final section (preoperative judgment) of the anesthesia visit report.

Primary outcomes:
measure: unknown health risk situation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vilafranca del Penedés
country: Spain
facility: Consorci Sanitari Alt Penedés-Garraf
state: Barcelona
Study officials:
References: