louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03375242: Safety and Efficacy of Xalkori ROS1
Official title: XALKORI ROS1+NSCLC DRUG USE INVESTIGATION
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-12-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients

Brief summary: The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.


Eligibility criteria: Inclusion Criteria:

* patients with unresectable progressive/recurrent NSCLC who are naive to XALKORI and whose tumor is ROS1 gene positive

Exclusion Criteria:

* Patients with past history of hypersensitivity to any of the ingredients of XALKORI

Primary outcomes:
measure: The incidence of adverse drug reactions in this surveillance.
timeFrame: 52 weeks
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 12, 24, 52 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer local country office
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03224442: Soft Tissue Evaluation Around Implants Using Prf or a Palatal Pedicle
Official title: Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Soft Tissue Augmentation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.

Detailed description: Immediate implant will be place and followed by soft tissue augmentation by PRF or palatal pedicle and the primary outcome is the pink esthetic score

Eligibility criteria: Inclusion criteria

1. Absence of periodontal disease or a periapical infection
2. Adequate native bone to achieve implant primary stability
3. The need for a single-tooth replacement in the anterior maxilla (from the second bicuspid to the second bicuspid), subsequent to an inevitable tooth extraction.

Exclusion criteria

1. Systemic conditions/disease that contraindicated surgery
2. Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
3. Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
4. Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
5. Patients who have inadequate interarch space for the prosthetic part.

Primary outcomes:
measure: Pink Esthetic Score
timeFrame: 5 months
Secondary outcomes:
measure: facial gingival thickness
timeFrame: 5 months
measure: mid-buccal gingival level
timeFrame: 5 months
measure: interproximal gingival level
timeFrame: 5 months
measure: - width of keratinized gingiva (KG
timeFrame: 5 months
measure: Crestal bone loss
timeFrame: 5 months
measure: Implant stability
timeFrame: 5 months
measure: Pain
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05212142: A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia
Official title: A Strategy to Prevent the Recurrence of Dental Disease in Children Receiving Dental Treatment With General Anesthesia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 74
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of a preventive strategy in increasing return to follow up and recall appointments.


Eligibility criteria: Inclusion Criteria:

1. parent with child (patient) planned for dental treatment with general anesthesia (GA)
2. parent of a child (patient) age less than six
3. parent of a child (patient) with health status of healthy (American Society of Anesthesiologists (ASA) I or II).

Exclusion Criteria:

1. parents/guardians who chose not to participate in the study
2. parents who spoke a language other than English or Spanish
3. Parents of a child (patient) with special health care needs or patients of ASA III or IV status

Primary outcomes:
measure: Change in parental self-efficacy (PSE)
timeFrame: Baseline to 2 weeks
measure: Change in parent oral health knowledge
timeFrame: Baseline to 2 weeks
measure: Follow up return rate
timeFrame: 2 weeks
measure: 3-month recall return rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Jayakumar Jayaraman, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01431742: Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain
Official title: An Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain
Low Back Pain
Keywords: buccal soluble film
Pain
Back Pain
Low Back Pain
Buprenorphine
Analgesics, Opioid
Analgesics
Lead sponsor: BioDelivery Sciences International
Sponsor class: INDUSTRY
First posted: 2011-09-12
Enrollment: 0
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: This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back pain.

BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant and non-nursing female aged 18 or older
* History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 \[11 point NRS\] reported during screening following discontinuation of current pain medication (opioids and NSAIDs) AND currently taking ≥10 mg oral morphine equivalent/day for ≥2 weeks
* Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and laboratory results so as to comply with all study procedures
* Female subjects of childbearing potential must be using a recognized effective method of birth control
* Written informed consent obtained prior to any procedure being performed

Exclusion Criteria:

* Cancer related pain
* Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
* Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit
* History of severe emesis with opioids
* Clinically significant sleep apnea in the judgment of the investigator

Primary outcomes:
measure: Mean change in pain intensity
timeFrame: Baseline up to approximately Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Marietta
country: United States
state: Georgia
Study officials:
affiliation: BioDelivery Sciences International
name: Andrew Finn, PharmD
role: STUDY_CHAIR
References:
Clinical trial NCT01603342: A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers
Official title: A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Haemostasis
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-05-22
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to determine the feasibility of demonstrating a quantifiable change from baseline in punch biopsy-induced bleeding durations and blood loss volumes in healthy subjects after receiving clopidogrel anti-platelet therapy.


Eligibility criteria: Inclusion Criteria:

* PT within normal laboratory range

Exclusion Criteria:

* The receipt of any investigational drug within 1 month prior to this trial
* Use of anti-coagulation or anti-platelet therapy-defined as vitamin K antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or NSAIDs within 30 days prior to trial
* African-American race
* Weight above or equal to 160 kg
* Recent diagnosis of any illness that would be present concomitant to trial period

Primary outcomes:
measure: Bleeding duration measured in minutes
timeFrame: From onset of bleeding till the end of the bleeding
Secondary outcomes:
measure: Blood volume reported in millilitres
timeFrame: From onset of bleeding till the end of the bleeding
measure: Adverse events, including special attention to bleeding complications
timeFrame: From day 0 to days 11-17
measure: Change in coagulation-related parameters
timeFrame: From baseline to 15 minutes after biopsy B1
Other outcomes:
Locations:
city: Neptune
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06434142: Wear Assessment of Novel PEEK Telescopic Attachment for Overdenture
Official title: Wear Assessment of Novel PEEK Telescopic Attachment for Implant Retained Mandibular Overdenture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attachment Disorder
Stress Disorder
Keywords: Telescopic attachment
Attachment Wear
Zirconia
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 20
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the wear of Zirconia-PEEK versus cobalt-chromium-PEEK telescopic attachments for implant retained complete mandibular overdenture. The wear of Zirconia-PEEK telescopic attachments can affect the retention of implant retained complete mandibular overdenture.

Detailed description: Twelve completely edentulous patients were randomly chosen for implant retained telescopic overdentures construction and divided into two groups, where group I was a patient with zirconia copy, and group II was with cobalt chromium CoCr copy. The PEEK was constructed for both groups as a secondary coping telescopic attachment for the denture. The wear measurements of PEEK were performed optically by using a USB digital microscope with a built-in camera connected to a compatible personal computer at different intervals of baseline, 3, 6, and 9 months. The data was statistically analyzed and compared using student t-test, ANOVA, and Post Hoc Test.

Eligibility criteria: Inclusion Criteria:

* completely edentulous
* free from any dental or systemic diseases

Exclusion Criteria:

* medically ill fit patient
* female patient

Primary outcomes:
measure: the mean wear values
timeFrame: at baseline
measure: the mean wear values
timeFrame: after 3 months interval
measure: the mean wear values
timeFrame: after 6 months interval
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hamada Zaki Mahross
Study officials:
References:
Clinical trial NCT00650442: Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal System
Official title: Evaluation of the Adhesion Quality and Primary Dermal Irritation Potential of an Alternate Second Generation Estradiol Transdermal Systems in Normal Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: MylanPharma
Sponsor class: UNKNOWN
First posted: 2008-04-01
Enrollment: 39
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The primary objective of this study was to compare the adhesive quality of the current Mylan estradiol placebo transdermal system, with that of an alternate second generation Mylan estradiol placebo transdermal system following a single system application. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.


Eligibility criteria: Inclusion Criteria:

1. Age: 40-66 years.
2. Sex: Females only.
3. Weight: At least 52 kg (115 lbs) and within 20% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN DERMAL SAFETY STUDY PROTOCOLS).
4. All subjects should be judged normal and healthy during a prestudy medical evaluation (physical examination, laboratory evaluation and 12-lead ECG) performed within 14 days of the initial patch application.

Exclusion Criteria:

1. Institutionalized subjects will not be used.
2. Any prior history of skin diseases (eczema, psoriasis, atopic dermatitis).
3. Damaged skin in or around test sites that include sunburn, uneven skin tones, tattoos, scars or other disfigurations of the test site.
4. Abnormal and clinically significant laboratory test results:

   1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN DERMAL SAFETY STUDY PROTOCOLS).
   2. Abnormal and clinically relevant ECG tracing.
5. Subjects who have received an investigational drug within 30 days prior to the initial patch application and/or participated in any transdermal system test for irritation or sensitization within the last 4 weeks.
6. Allergy or hypersensitivity to any tapes or adhesives (ex. band-aids, medical tape).

Primary outcomes:
measure: Transdermal Adhesion
timeFrame: within 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Kendle International Inc.
state: West Virginia
Study officials:
affiliation: Kendle International Inc.
name: Thomas S Clark, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03999242: Charcot Leyden Crystals in Pathology
Official title: Clinical Significance of Charcot-Leyden Crystals in Bronchial and Sinonasal Pathological Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: nasal polyposis
rhinosinusitis
Charcot Leyden Crystals
Eosinophils
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients seen at our institution

Brief summary: Charcot Leyden crystals (CLC) are sometime reported in pathological reports of airway or sinonasal samples but their clinical significance remain elusive. The investigators organized a retrospective analysis of all consecutive patients with CLC seen at our institution between 1986 and 2019

Detailed description: In recent years, improved knowledge of eosinophilic inflammation has led to the approval of biologics aimed at inhibiting the pathways of eosinophilic activation, notably via the interleukin 5 pathway in eosinophilic asthmatic patients uncontrolled despite receiving maximum doses of standard drugs. These treatments showed efficacy in asthmatic patients with a high level of eosinophils in their induced sputum (\> 3%) and the criteria were extended to those with circulating eosinophilia (\> 300 / mm3). Eosinophils are therefore an important biomarker for phenotyping asthmatic patients. The Charcot-Leyden crystals are a reflection of the presence of eosinophils, and are sometimes found in some pathological samples. It is hypothesized that the presence of Charcot-Leyden crystals, a reflection of tissue eosinophilia, is a predictive factor for the efficacy of anti-IL5 biotherapies in patients with severe eosinophilic asthma.

Eligibility criteria: Inclusion Criteria:

* Having Charcot Leyden Crystals in a pathological sample

Exclusion Criteria:

* Having Charcot Leyden Crystals in a pathological sample taken outside the airways the nose and the sinus

Primary outcomes:
measure: 'Level of asthma control/severity according to GINA stepwise approach
timeFrame: Baseline (day 0)
measure: 'Level of asthma control/severity according to GINA stepwise approach
timeFrame: Baseline (day 0) to Month 12
Secondary outcomes:
measure: Cumulative annualized dose of inhaled and systemic corticosteroids
timeFrame: Baseline (day 0) to Month 12
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Arnaud Bourdin, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05576142: Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
Official title: Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Asthma in Children
Dental Caries
Periodontal Diseases
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients addressing to the Pediatric clinic of Fondazione IRCCS Policlinico San Matteo, Pavia, Italy for medical care.

Brief summary: The aim of the study was to evaluate if there were differences in oral findings between patients diagnosed with allergic rhinitis and/or asthma and a control group of health people.

Detailed description: The aim of the study was to evaluate if there were differences in oral findings between patients diagnosed with allergic rhinitis and/or asthma and a control group of health people. At the oral evaluation, the following indexes were calculated: PSR, Periodontal Screening and Recording; PI, Plaque Control Record and DMFT, Decayed Missing Filled Teeth Index. Absence or presence of mouth breathing was also recorded. Linear regressions were calculated to compare the oral findings with gravity of allergic rhinitis, to asthma compensation and to asthma treatment.

Eligibility criteria: Inclusion Criteria:

* age 5-14 years old
* presence of allergic rhinitis diagnosed according to ASIA guidelines and/or presence of asthma diagnosed according to GINA guidelines

Exclusion Criteria:

* refuse to participate to the study
* presence of systemic diseases that could alter oral conditions (Sjögren syndrome, celiac disease, calcium disorders).

Primary outcomes:
measure: PSR - Periodontal Screening and Recording (Landry and Jean, 2002)
timeFrame: Baseline
measure: PCR - Plaque Control Record (O' Leary et al., 1972)
timeFrame: Baseline
measure: DMFT - Decayed Missing Filled Teeth Index (WHO, 2013)
timeFrame: Baseline
measure: Mouth breathing
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06198842: Low Dose Treosulfan Based Conditioning Regimen and PTCy in HSCT for Nijmegen Breakage Syndrome
Official title: Clinical Open-label Phase 2 Study of Low Dose Treosulfan Based Conditioning Regimen Efficacy in Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide for Children Nijmegen Breakage Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nijmegen Breakage Syndrome
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in HSCT with post-transplant cyclophosphamide in Nijmegen breakage syndrome

Detailed description: Nijmegen breakage syndrome (NBS) is a DNA repair disorder. The only curative option for combine immunodeficiency in NBS is allogeneic hematopoietic stem cell transplantation (HSCT). Standard myeloablative conditioning regimens in DNA repair disorders lead to increased morbidity and mortality after HSCT. Low doses of alkylators are used to reduce toxicity rates, which, however, increase the risks of mixed chimerism and graft failure. The data of treosulfan usage in NBS are sparse. To evaluate the safety and efficacy of low dose treosulfan based conditioning regimen in NBS, treosulfan 21g/m2 in combination with fludarabine 150mg/mg, thymoglobulin (Genzyme) 5mg/kg and rituximab 100mg/m2 will be used from day -6 to -1 day, followed by stem cell infusion and post-transplant cyclophosphamide 25mg/kg/day (+3,+4 day) for GVHD prophylaxis. The primary endpoint is event-free survival, where graft failure, death, and malignancies are considered as events.

Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥ 3 months and \< 21 years
2. Patients diagnosed with NBS eligible for an allogeneic HSCT
3. Signed written informed consent signed by a parent or legal guardian

Primary outcomes:
measure: Event-free survival
timeFrame: 3 years after HSCT
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years after HSCT
measure: Cumulative incidence of engraftment
timeFrame: 100 days
measure: Cumulative incidence of graft failure
timeFrame: 3 years
measure: Cumulative incidence of viral infections
timeFrame: 1 year
measure: Cumulative incidence of acute graft versus host disease
timeFrame: 1 year
measure: Cumulative incidence of chronic graft versus host disease
timeFrame: 3 years
measure: Incidence of early organ toxicity
timeFrame: 100 days
measure: Cumulative incidence of transplant related mortality
timeFrame: 3 years
measure: Incidence of long-term toxicity
timeFrame: 3 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: HSCT department
Study officials:
References: