louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05920811: Patient Satisfaction for Digital Versus Conventional Maxillary Obturator
Official title: Patient Satisfaction With Conventional Maxillary Obturator Versus Fully Digital Fabricated With 3D Printing: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillofacial Prosthesis User
Keywords: maxillary obturator, selective laser melting
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evidence regarding the performance of digital obturators totally fabricated using 3D printing is insufficient. This prospective randomized crossover study aimed to evaluate patient satisfaction with conventional maxillary obturator and totally full digitally fabricated obturator. Patient satisfaction was evaluated using two scales: The Obturator Functioning Scale" and "The Patient and operator-centered outcomes were assessed through two visual analog scale (VAS) questionnaires.

Detailed description: The use of digital technologies in the fabrication of maxillofacial prostheses has been described. Additive manufacturing offers a more convenient and more efficient process with reduced material waste compared with traditional subtractive technique. Although Prosthetic rehabilitation with Conventional maxillary obturator prosthesis fabricated with a casted metal framework using, heat-cured acrylic resin can restore oral function and facial esthetics following maxillectomy. But it is time-consuming and labor-intensive. Multiple sources of errors can accumulate during the laboratory steps, resulting in a misfit of the framework. In this study All patients received a conventional obturator for 6 months, after a washout period of one week, they use the digital one. The Obturator Functioning Scale" and "The Patient and operator-centered outcomes were assessed through two visual analog scale (VAS) questionnaires.

Eligibility criteria: Inclusion Criteria:

* patients with hemimaxillectomy defect (Aramany class 1)
* almost edentulous mandible with healthy remaining teeth,
* mouth opening is not less than 25 mm, intact soft palate
* participants were not exposed to radiotherapy or chemotherapy in the previous year

Exclusion Criteria:

* patients with physical or mental disorders.
* patients still receiving radio or chemotherapy

Primary outcomes:
measure: obturator functioning scale
timeFrame: 6 months
measure: patient outcome the treatment time, on the self-perception of the applied impression protocol in terms of general convenience, anxiety, taste, nausea sensation and possible pain sensation.
timeFrame: 6 months
measure: operator outcome
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: marwa Mohammed Amer
state: ElGharbia
Study officials:
affiliation: Tanta University
name: marwa M Amer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03786211: IANB Success Rate With and Without Panoramic Help
Official title: The Success of the Inferior Alveolar Nerve Block Anesthesia With Alveolar Nerve Localization by Using of Panoramic Radiography in Comparison to Routine IAN Block Anesthesia: RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Anesthesia
Anesthesia; Functional
Keywords: Mandible
Anesthesia
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Since it is difficult to achieve anesthesia in lower jaw and the success rate of IANB is low and there are a lot of anatomic variations for the location of inferior alveolar nerve in different races, investigators decided to compare the success rate of inferior alveolar nerve block, with and without using a panoramic radiograph in Bandar Abbas population, and see if using a panoramic radiograph can increase the preciseness of the injection.

Detailed description: This is a double blinded cross-over randomized controlled trial study conducted on all the patients of the dental clinic indicated for bilateral extraction or filling.

The randomization method is block balanced randomization. All patients will ask to fulfill the ethical Form. This form acquired demographic information (e.g. age, sex) about patients. A panoramic radiograph will take from those who matched the inclusion criteria and signed the agreement. Then a tooth from one side will be treated and the tooth from the other side of the mouth will treat at least 2 weeks later by the same dentist.

Eligibility criteria: Inclusion Criteria:

* Patients indicated for bilateral tooth extractions of fillings.
* Physically and mentally healthy patients who could express their pain.
* having panoramic radiograph from the past six months for other dental purposes.

Exclusion Criteria:

* sensitive to the regular anesthetics containing epinephrine.
* patients with acute or chronic pericoronitis.
* pregnancy
* trismus

Primary outcomes:
measure: Number of participants with good Anesthesia
timeFrame: 30 minutes after injection
Secondary outcomes:
Other outcomes:
Locations:
city: BandarAbbas
country: Iran, Islamic Republic of
facility: Dental clinic of BandarAbbas faculty of dentistry
state: Hormozgan
Study officials:
affiliation: Persian Gulf Oral and Dental Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
name: Hossein Dabbagh, Md, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00615511: Efficacy of Pregnenolone in Patients With Schizophrenia
Official title: Efficacy of Pregnenolone in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
schizoaffective disorder
negative symptoms
cognition
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2008-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Four-month trial of pregnenolone or placebo, as an additional medication, to treat negative symptoms and cognitive decline in schizophrenia. After four months the scores on the negative symptom scale should be lower and the scores on the cognitive tests should be higher than they were at study entry, compared with people who do not take any additional medication.

Detailed description: Pregnenolone is a steroid health supplement which is readily available in health food stores. We are using it in this study at higher doses than you would normally take as a health supplement because preliminary studies have indicated that negative symptoms improve and certain aspects of cognition improve at these doses. We do not require you to stop your existing treatment in order to enter the study. After four months we will test your symptoms and cognition and ask if you would like to continue taking pregnenolone, at no cost, in a follow-up study designed to determine the long-term costs and benefits of taking pregnenolone.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Diagnosis of schizophrenia or schizoaffective disorder
* No new medication for past 3 months and stable dose for past 4 weeks
* SANS (Negative symptom) score of 20 or above

Exclusion Criteria:

* Significant dementia or head trauma.
* Seizure during past year.
* Substance dependence in past 6 months or positive urine drug screen.
* History of hormone-sensitive cancer such as breast, testicular, prostate, ovarian or uterine cancers.
* Steroid metabolism disorder, e.g.Cushings or Addison's disease.
* Taking steroids other than birth control or post-menopausal hormones.
* Women who are pregnant or nursing.

Primary outcomes:
measure: SANS - Scale for the Assessment of Negative Symptoms
timeFrame: every month for 4 months
Secondary outcomes:
measure: Quality of Life
timeFrame: every two months for four months
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: University of Medicine & Dentistry of New Jersey- University Behavioral HealthCare
state: New Jersey
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: White Plains
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jason J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02569411: Contacting Authors to Retrieve Individual Patient Data
Official title: Contacting Authors to Retrieve Individual Patient Data: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Response Rates
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 129
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this study is to examine the impact of incentivizing authors of RCTs that are eligible for a systematic review and meta-analysis, versus usual contact strategies to obtain original IPD


Eligibility criteria: Inclusion Criteria:

* Corresponding authors of RCTs included in our previous and updated systematic reviews

Exclusion Criteria:

Primary outcomes:
measure: Proportion of Authors Who Provided Complete IPD
timeFrame: June 2016 - October 2016
Secondary outcomes:
measure: Time Taken to Obtain the IPD Between Initial Request and Authors' Provision
timeFrame: June 2016 - October 2016
measure: The Completeness of the IPD Received
timeFrame: June 2016 - October 2016
Other outcomes:
Locations:
Study officials:
References:
citation: Veroniki AA, Ashoor HM, Le SPC, Rios P, Stewart LA, Clarke M, Mavridis D, Straus SE, Tricco AC. Retrieval of individual patient data depended on study characteristics: a randomized controlled trial. J Clin Epidemiol. 2019 Sep;113:176-188. doi: 10.1016/j.jclinepi.2019.05.031. Epub 2019 May 30.
citation: Veroniki AA, Straus SE, Ashoor H, Stewart LA, Clarke M, Tricco AC. Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial. Trials. 2016 Mar 15;17(1):138. doi: 10.1186/s13063-016-1238-z.
Clinical trial NCT04016311: A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions
Official title: A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure
Quality of Life
Fluid Restriction
Interdialytic Weight Gain
Hemodialysis
Mindfulness
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention and wait list control groups with rolling admission.
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to find out whether mindful drinking/eating activities can improve quality of life and help make it easier for people on dialysis to follow their fluid restrictions. The pilot study is a randomized controlled trial with an intervention group and a wait list control group, randomized by cohort days. The intervention occurs during dialysis sessions once a week for 4 weeks. During each intervention session, participants are guided through a mindful eating exercise focused on foods recommended for controlling thirst (e.g., hard candy, frozen grapes) and a mindful drinking exercise. Participants are asked to practice mindful drinking/eating at least once daily at home.


Eligibility criteria: Inclusion Criteria:

* Receiving hemodialysis
* Able to speak English

Exclusion Criteria:

* Missed more than one dialysis treatment in the past month

Primary outcomes:
measure: Total Score for Kidney-Disease Quality of Life Short Form v1.3
timeFrame: 4 weeks
measure: Interdialytic Weight Gain (IWG)
timeFrame: 4 weeks
Secondary outcomes:
measure: Mindful Eating
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT00004811: Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Histoplasmosis
Sporotrichosis
Blastomycosis
Keywords: blastomycosis
fungal infection
histoplasmosis
immunologic disorders and infectious disorders
rare disease
sporotrichosis
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: University of Alabama at Birmingham
First posted: 2000-02-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the tolerance of patients with blastomycosis, histoplasmosis, and sporotrichosis to different doses of itraconazole (R51,211).

II. Determine levels of itraconazole in serum and other body fluids. III. Assess the course of illness during itraconazole therapy. IV. Determine the dosage of itraconazole that is safe and well tolerated by 80%-90% of patients and estimate the potential of this dosage for use in future comparative trials.

Detailed description: PROTOCOL OUTLINE: This is a study to estimate the optimal dose of oral itraconazole. Patients are treated at 1 of 3 doses of itraconazole; the starting dose for each patient is determined at entry.

Therapy is administered daily for 3-6 months. Patients with progressive disease may be treated at the next higher dose; there may be only 1 such increase. Concurrent systemic and topical antifungals are prohibited.

Patients are followed at 1, 3, 6, and 12 months.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Culture-proven fungal disease, i.e.: Chronic cavitary histoplasmosis Extrapulmonary histoplasmosis, e.g., mucosal disease Blastomycosis Sporotrichosis Positive culture after last dose of any prior therapy Requires antifungal therapy with amphotericin B or ketoconazole No fungal meningitis No central nervous system disease No immediately life-threatening disease --Prior/Concurrent Therapy-- At least 1 month since therapy for same disease No more than 2 mg/kg prior amphotericin B (total dose) No more than 2 mg/kg prior ketoconazole (total dose) No concurrent immunosuppressives, including: Corticosteroids Azathioprine Cytotoxic agents --Patient Characteristics-- Hepatic: AST no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Bilirubin no greater than 3 mg/dL Other: No acquired immunodeficiency syndrome No pregnant or nursing women Effective contraception required of fertile women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: William Dismukes
role: STUDY_CHAIR
References:
Clinical trial NCT05870111: Citicoline in Youth Alcohol Use Disorder
Official title: Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder
Keywords: Citicoline
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate how citicoline, an over-the-counter supplement, versus a placebo pill (i.e., an inactive pill) affects the immune system, brain, and cognition in adolescents who may use alcohol.


Eligibility criteria: Inclusion:

Age 16 to 22.

Call study team for additional screening and information.

Primary outcomes:
measure: Peripheral Cytokine: IL-1B
timeFrame: 4 weeks of treatment
measure: Peripheral Cytokine: IL-6
timeFrame: 4 weeks of treatment
measure: Peripheral Cytokine: TNFα
timeFrame: 4 weeks of treatment
measure: Brain Metabolite: N-acetyl-aspartate
timeFrame: 4 weeks of treatment
measure: Brain Metabolite: Choline
timeFrame: 4 weeks of treatment
measure: Neurocognition: Behavioral impulsivity
timeFrame: 4 weeks of treatment
measure: Neurocognition: Cognitive Flexibility and Attention
timeFrame: 4 weeks of treatment
measure: Neurocognition: Inhibitory Control and Attention
timeFrame: 4 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT00849511: Melatonin for Migraine Prevention
Official title: Melatonin for Migraine Prevention (The MMP-study): A Randomized, Double-blind, Cross-over, Placebo-controlled Study of Melatonin in Prophylactic Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: Migraine prevention
Crossover
Melatonin
Lead sponsor: Nordlandssykehuset HF
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2009-02-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The circadian system with its centre in the hypothalamus is involved in migraine pathophysiology. Whether it plays a pivotal role is not clarified. The investigators postulate that a destabilized circadian system may increase migraine attack susceptibility, and that stabilization by supplying melatonin a migraine preventive effect will be achieved.

A previous open label study has shown effects that certainly warrant a placebo controlled study.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 65 years, both male and females.
* Migraine present for at least 1 year and fulfilling diagnostic criteria that conform to those of the International Headache Society (HIS) \[2\] but otherwise healthy.
* Attacks of migraine should occur 4-6 times per month, there should be no regular use of other drugs, and the patient has to be able to differentiate between migraine headache and non-migrainous headache.
* Preventive drugs for migraine should not have been used the last three months.
* Conventional acute attack treatment is accepted, but not sporadic use of other drugs like hypnotics and anxiolytics.
* Residence of North-Norway.

Exclusion Criteria:

* Medication overuse headache, chronic migraine.
* Pregnant and breast feeding women.
* Patient with either serious co-morbidity or conditions requiring medical treatment or caution.
* Psychiatric disease.

Primary outcomes:
measure: Migraine attack frequency
timeFrame: 8 weeks
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index score
timeFrame: 8 weeks
measure: Night time sleep quality
timeFrame: 8 weeks
measure: Point prevalence of insomnia
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bodø
country: Norway
facility: Departement of Neurology, NLSH HF
city: Tromsø
country: Norway
facility: Departement of Neurology
Study officials:
References:
citation: Peres MF, Zukerman E, da Cunha Tanuri F, Moreira FR, Cipolla-Neto J. Melatonin, 3 mg, is effective for migraine prevention. Neurology. 2004 Aug 24;63(4):757. doi: 10.1212/01.wnl.0000134653.35587.24. No abstract available.
Clinical trial NCT04290611: a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY
Official title: Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Neuropathy
Epilepsy
Encephalopathy
Keywords: Drug-induced neurotoxicity
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 500000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with enzalutamide for prostate cancer or other solid tumors

Brief summary: Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Detailed description: Enzalutamide are responsible of a wide range of side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with enzalutamide

Eligibility criteria: Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2020 Adverse events reported were including any MedDRA terms Patients treated with enzalutamide reported in the WHO database.

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity

Primary outcomes:
measure: Number of patients with neurological adverse events with significant over-reporting enzalutamide
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière
Study officials:
References: