louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00328614: Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer
Official title: A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Locally advanced prostate cancer
positive lymph nodes
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Cytogen Corporation
First posted: 2006-05-22
Enrollment: 32
Sex: MALE
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 this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.

Detailed description: The likelihood of prostate cancer cells metastasizing to bone has an early and important influence on the natural history of prostate cancer. Bone-targeted therapy, when given sequentially with hormonal therapy (androgen suppression) and radiation therapy, prolongs the progression of the disease in clinically non-metastatic prostate cancer patients.

The use of Samarium-153 EDTMP in conjunction with hormonal therapy and external beam radiation therapy has never been previously evaluated in high risk clinically localized prostate cancer. Many patients with high-risk prostate cancer develop progressive disease within 2 years of therapy indicating that subclinical metastatic disease may be present at the time of initial diagnosis. In these high-risk patients, there may be a therapeutic benefit of combining hormonal therapy with external beam radiation therapy and Samarium-153 EDTMP to treat localized and subclinical bony disease, respectively.

Eligibility criteria: Inclusion Criteria:

* PSA 20-150 and Gleason score greater than or equal to 7 or clinical stage greater than or equal to T2, Gleason greater than or equal to 8, PSA less than or equal to 150
* Pathologically positive lymph nodes
* Pretreatment must be prior to study entry and prior to any hormonal therapy
* Zubrod 0-1
* Adequate hematologic function

Exclusion Criteria:

* Patients with PSA equal to or greater than 150
* Neuroendocrine features on histologic examination
* Radiologic evidence of metastatic disease
* Previous malignancy within last 5 years
* Prior pelvic radiation therapy or orchiectomy

Primary outcomes:
measure: Maximum Tolerated Dose of Samarium-153
timeFrame: 5 months (1 month HT, administration of drug, 4 months HT and RT)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Edouard Trabulsi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Davis School of Medicine
name: Richard Valicenti, MD, MA
role: STUDY_CHAIR
References:
Clinical trial NCT03699514: Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
Official title: Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Cognitive Impairment
Neurological Disorder
Keywords: Brain Network Activation (BNA™)
EEG
Cognitive Tasks
Lead sponsor: ElMindA Ltd
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who completed or will complete a BNA test with the Auditory Oddball Task, from both genders, aged 8-99 years.

Brief summary: The study is designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical assessments and BNA scores. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.

Detailed description: A multi-center study in which subjects that had completed or are completing a BNA test with the Auditory Oddball task (or other tests that will be commercially cleared at any given time), will have the option to complete additional investigational tasks and optional clinical assessments and questionnaire forms. At each site, these additional assessments will be suggested by the site's study doctor or clinician and will be collected with the site's ePRO device. The study will include up to 10,000 subjects which had completed or will complete a standard BNA test. Authorized personnel will offer the subjects to participate in the study immediately after testing or contacting subjects that had completed the test in the past. Procedure of consent will be performed by the PI or delegates.

Eligibility criteria: Inclusion Criteria:

* Completed or will complete a BNA test
* Able to speak, read and understand English sufficiently to understand the nature of the study, and to allow completion of all study assessments.
* Willingness to participate

Exclusion Criteria:

Primary outcomes:
measure: Engineering development according to clinical assessments
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Kadima Neuopsychiatry Institute
state: California
city: Chicago
country: United States
facility: Collaborative Behavioral Health, LLC
state: Illinois
city: Skokie
country: United States
facility: Collaborative Behavioral Health, LLC
state: Illinois
city: Lincoln
country: United States
facility: Alivation Health, LLC
state: Nebraska
Study officials:
References:
Clinical trial NCT01567514: Postoperative Pulpal Complications in Posterior Resin Composite Restorations Without Glass-ionomer Cement Lining
Official title: A 2-year Clinical Study on Postoperative Pulpal Complications Arising From the Absence of a Glass-ionomer Lining in Deep Occlusal Resin Composite Restorations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Keywords: Deep occlusal caries restored with resin composite
on Pit and Fissure Surface Penetrating Into Dentin
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: University of Melbourne
First posted: 2012-03-30
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on risk of pulpal complications in deep occlusal cavities with resin-based restorations.

Detailed description: Fifty three patients aged 18-30 years who had one or two deep occlusal carious lesions (≥ 3 mm in depth) in molars were recruited. Dental caries was removed and the prepared cavity was restored with resin composite using one of two restorative procedures: (1) without GIC lining; (2) with (resin-modified) GIC lining. Restored teeth were evaluated for any pulpal complications (subjective symptoms, objective signs or loss of tooth vitality) at one month (baseline), one year and two years after restoration.

Eligibility criteria: Inclusion Criteria:

* Deep dental caries on occlusal surfaces of molar teeth

Exclusion Criteria:

* Shallow and moderate-depth caries
* Caries exposed pulp

Primary outcomes:
measure: Postoperative pulpal complications
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Dentistry, Mahidol University
Study officials:
affiliation: University of Melbourne
name: Emeritus Prof. Harold Messer, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02045914: Calcium Ionophore Solution Can Increase Fertilization Rate in Patients During Intracytoplasmic Sperm Injection(ICSI) Who Have Poor Ovarian Reserve?
Official title: Effect of Calcium Ionophore Solution on Fertilization Rate During ICSI Cycles of Poor Ovarian Reserve Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fertilization Failure
Keywords: calcium ionophore
fertilization rate
poor ovarian reserve
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 162
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to evaluate calcium ionophore solution on fertilization rate of patients during intracytoplasmic sperm injection who have poor ovarian reserve

Detailed description: During ICSI cycle , female patients who have poor ovarian reserve have low oocyte numbers. So by calcium ionophore solution which we know that it can increase fertilization rate in males who have azospermia or globozoospermia. we planned to check if this solution can increase fertilization rate also in poor ovarian reserve patients?

Eligibility criteria: Inclusion Criteria:

* infertile couples who have no male factor infertility
* infertile females who are poor ovarian reserve

Exclusion Criteria:

* infertile couples who have male factor infertility
* infertile female who have endometriosis

Primary outcomes:
measure: calcium ionophore solution effect on fertilization rate
timeFrame: 18 hours
Secondary outcomes:
measure: Calcium ionophore solution increase on going pregnancy rate
timeFrame: up to 21 weeks
Other outcomes:
measure: calcium ionophore can decrease fertilization rate
timeFrame: 18 hours
Locations:
city: Adana
country: Turkey
facility: baskent university obstetric and gynecology, reproductive endocrinology and IVF unit
state: Kisla
Study officials:
affiliation: Baskent University
name: esra bulgan kilicdag, prof md
role: STUDY_DIRECTOR
affiliation: Baskent University
name: Huriye Ayse Parlakgumus, md
role: STUDY_CHAIR
affiliation: Baskent University
name: Pinar Caglar Aytac, md
role: PRINCIPAL_INVESTIGATOR
affiliation: Baskent University
name: Cok Tayfun, md
role: STUDY_CHAIR
affiliation: Baskent University
name: Bulent Haydardedeoglu, assoc Prof
role: STUDY_CHAIR
affiliation: Baskent University
name: Erhan Simsek, md
role: STUDY_CHAIR
References:
citation: Caglar Aytac P, Kilicdag EB, Haydardedeoglu B, Simsek E, Cok T, Parlakgumus HA. Can calcium ionophore "use" in patients with diminished ovarian reserve increase fertilization and pregnancy rates? A randomized, controlled study. Fertil Steril. 2015 Nov;104(5):1168-74. doi: 10.1016/j.fertnstert.2015.07.1163. Epub 2015 Sep 3.
Clinical trial NCT00631514: Interaction Between Antihypertensives and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Official title: Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: antihypertensive drugs
non-steroidal anti-inflammatory drugs
interaction
family practice
arterial blood pressure
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
Collaborators: name: Dr Ivancica Pavlicevic Family Practice Office
First posted: 2008-03-07
Enrollment: 88
Sex: ALL
Minimum age (years): 55
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: NSAIDs may increase blood pressure and blunt the effects of many antihypertensives. Members of these drug classes differ in their propensity to such an interaction.

Detailed description: To compare prospectively the effects of piroxicam, ibuprofen and acetaminophen on blood pressure control in hypertensive patients with osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* Treated hypertensives of either gender aged between 55 and 76 years
* About 50% with concomitant osteoarthritis of the hip or knee

Exclusion Criteria:

* Normotensive persons or untreated hypertensives
* Individuals outside the age limits
* General exclusion criteria (e.g. uncooperative persons, advanced malignancies, participants in other studies)

Primary outcomes:
measure: Arterial blood pressure
timeFrame: 3 months (3 individual blocks of 1 month each)
Secondary outcomes:
measure: Body weight,serum electrolytes, urinary electrolytes (Na, K)
timeFrame: 3 months (3 periods of 1 month)
Other outcomes:
Locations:
city: Split
country: Croatia
facility: Split University School of Medicine. Family Practice Department
Study officials:
affiliation: Split University School of Medicine
name: Zvonko - Rumboldt, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Pavlicevic I, Rumboldt M, Rumboldt Z. [Untoward interactions between antihypertensives and nonsteroidal anti-inflammatory drugs]. Lijec Vjesn. 2005 Jul-Aug;127(7-8):168-72. Croatian.
citation: Pavlicevic I, Kuzmanic M, Rumboldt M, Rumboldt Z. Interaction between antihypertensives and NSAIDs in primary care: a controlled trial. Can J Clin Pharmacol. 2008 Fall;15(3):e372-82. Epub 2008 Oct 24.
Clinical trial NCT00734955: An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients
Official title: An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Partial Mastectomy
Lumpectomy
Mastectomy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2008-08-14
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Breast Cancer

Exclusion Criteria:

Primary outcomes:
measure: Identification of the optical signatures of breast tissue.
timeFrame: Day of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Nimmi Ramanujam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05823155: Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis
Official title: Impact of Pre-operative Penicillin Allergy Evaluation on Surgical Prophylaxis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Penicillin Allergy
Surgical Prophylaxis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 68
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: Use of first-line pre-operative antibiotic prophylaxis is the most effective measure to optimize perioperative outcomes. However, this is often not achieved due to unsubstantiated penicillin allergy labels. Penicillin allergy evaluation, when incorporated into routine pre-operative assessment, is potentially effective in optimizing choice of surgical prophylaxis. Despite the encouraging data mentioned above, there is a lack of randomized trials or local data to support this practice.


Eligibility criteria: Inclusion Criteria:

* age 18 years or above
* planned for clean or clean-contaminated elective surgeries
* labelled allergy to penicillin group antibiotics on electronic patient record (ePR)

Exclusion Criteria:

* multiple antibiotic allergy
* history of severe cutaneous adverse reactions or other severe non-IgE-mediated hypersensitivity (e.g. haemolytic anaemia, organ dysfunction, serum sickness) due to beta-lactam antibiotics
* on systemic immunosuppressants
* pregnancy
* active or uncontrolled chronic urticaria
* mentally incompetent for informed consent

Primary outcomes:
measure: Use of first-line antibiotic
timeFrame: from the date of randomization up to 3 months
Secondary outcomes:
measure: Antibiotic related adverse events
timeFrame: from the date of randomization up to 3 months
measure: Surgical site infection
timeFrame: from the date of randomization up to 30 days
measure: Colonization of multi-drug resistant organisms
timeFrame: from the date of randomization up to 3 months
measure: Length of stay
timeFrame: from the date of hospital admission up to hospital discharge or one year whichever earlier
measure: All-cause mortality during hospital stay
timeFrame: form the date of randomization up to hospital discharge and from the date of randomization up to 3 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References:
Clinical trial NCT04395755: Impact of COVID-19 on Psychological Status in Case of IVF Interrupted or Postponed
Official title: Impact of COVID-19 Pandemic on the Psychological Status of Infertile Patients Who Had in Vitro Fertilization Treatment Interrupted or Postponed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
ART
IVF
COVID-19
Lead sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 503
Sex: FEMALE
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 IVF treatment interrupted or delayed during COVID-19 pandemic

Brief summary: Infertility is a severely distressing experience for many couples. Depression and anxiety are psychological disorders associated with infertility, and they may worsen during infertility treatments.

This study times to understand the changes in the psychological status of infertile patients who had in vitro fertilization (IVF) treatment interrupted or postponed because of the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* patients with IVF treatment interrupted or delayed during COVID-19 pandemic
* patients with signed informed consent
* patients with more than 18 years

Exclusion Criteria:

* patients with already diagnosed psychiatric disorders

Primary outcomes:
measure: Severity of anxiety
timeFrame: 1-4 weeks after communication of interrupted or delayed IVF
measure: Severity of depression
timeFrame: 1-4 weeks after communication of interrupted or delayed IVF
Secondary outcomes:
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
Study officials:
References:
citation: Alviggi C, Esteves SC, Orvieto R, Conforti A, La Marca A, Fischer R, Andersen CY, Buhler K, Sunkara SK, Polyzos NP, Strina I, Carbone L, Bento FC, Galliano D, Yarali H, Vuong LN, Grynberg M, Drakopoulos P, Xavier P, Llacer J, Neuspiller F, Horton M, Roque M, Papanikolaou E, Banker M, Dahan MH, Foong S, Tournaye H, Blockeel C, Vaiarelli A, Humaidan P, Ubaldi FM; POSEIDON (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number) group. COVID-19 and assisted reproductive technology services: repercussions for patients and proposal for individualized clinical management. Reprod Biol Endocrinol. 2020 May 13;18(1):45. doi: 10.1186/s12958-020-00605-z.
citation: Barra F, La Rosa VL, Vitale SG, Commodari E, Altieri M, Scala C, Ferrero S. Psychological status of infertile patients who had in vitro fertilization treatment interrupted or postponed due to COVID-19 pandemic: a cross-sectional study. J Psychosom Obstet Gynaecol. 2022 Jun;43(2):145-152. doi: 10.1080/0167482X.2020.1853095. Epub 2020 Nov 30.
Clinical trial NCT03704155: Effect of Botulinum Toxin Type A Associated With Physical Therapy on Children With Spastic Cerebral Palsy
Official title: Effect of Botulinum Toxin Type A Associated With Physical Therapy on the Functional Capacity of Children With Spastic Cerebral Palsy: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy, Spastic
Physical Therapy
Botulinum Toxin
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Claudia Santos Oliveira
name: Daniela Aparecida Biasotto-Gonzalez
First posted: 2018-10-12
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: Purpose: The aim of this study was investigate the effects of botulinum toxin type A (BoNT-A) associated with physical therapy on the functional capacity of children with spastic cerebral palsy (CP). Material and methods: Twenty-four children with spastic CP were concealed and randomly assigned to the Experimental Group (EG) consisting of 12 patients treated with BoNT-A and physical therapy and Control with 12 patients treated only with physical therapy. All participants were assessed through motor and functional scales (GMFM-88, Ashworth, Berg Balance Scale, TUG test and Pediatric Evaluation of Disability Inventory) at three different times: before and after 30 days of treatment as well as 3 months after the end of treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of spastic Cerebral Palsy
* Clinical diagnosis of Dynamic equine feet

Exclusion Criteria:

* Use of phenol in the last 12 months
* Neurological blocks in the last 6 months
* Clinical diagnosis of structured orthopedic deformities with surgical indications

Primary outcomes:
measure: Severity of muscle hypertonia
timeFrame: 3 months
measure: Functional balance
timeFrame: 3 months
Secondary outcomes:
measure: Functional mobility
timeFrame: 3 months
measure: Functional performance
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: