louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04283903: Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases
Official title: Metabolomic and Proteomic Fingerprinting in Peri-implant Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peri-implant Mucositis
Peri-Implantitis
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: According to a study with a similar design on periodontitis (Barnes et al. 2009), twenty-five patients with at least one implant with peri-implantitis and one implant with peri-implant mucositis (Berglundh et al. 2018) will be selected in Complutense University of Madrid for PICF collection, before any treatment is provided. This will be done with the aim of excluding potential inter-individual variability in the metabolomic and proteomic profile of PICF.

Brief summary: Due to the limited efficacy of its treatment modalities, there is a stringent need to improve the prevention and early diagnosis of peri-implantitis. In fact, to date clinical and radiographic tools are not able to discern which patients are going to develop peri-implantitis and, among the ones already with peri-implantitis, which ones are currently loosing bone and which ones are going to progress.

This project aims to analyze for the first time the whole large scale proteome and metabolome of peri-implant crevicular fluid (PICF) with an integrated approach from implants with peri-implant diseases.

Twenty-five patients with at least one implant with peri-implant mucositis and one implant with peri-implantitis will be selected. For each of the selected participants, the PICF from an implant with peri-implant mucositis and from an implant with peri-implantitis will be sampled two different times before treatment. One year after the corresponding treatment is provided, the PICF of the treated implants with peri-implantitis will be sampled again.

Both proteomic and metabolomic profiling of the samples will be carried out. The most important strength of this project will be the ability to evaluate together the whole proteome and the whole metabolome and to integrate them in the same framework.


Eligibility criteria: Inclusion Criteria:

* At least one implant with peri-implant mucositis and one with peri-implantitis

Exclusion Criteria:

* Previously treated implants to be included

Primary outcomes:
measure: Peri-implant diseases presence
timeFrame: Baseline (cross-sectional part)
measure: Disease resolution of peri-implantitis
timeFrame: 1-year after treatment (longitudinal part)
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Department of Periodontology, University Complutense Madrid, Spain
Study officials:
References:
Clinical trial NCT05868603: Effect of Different Remineralization Gels
Official title: Effect of Different Remineralization Gels on the White Spot Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: White Spot Lesion
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 45
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to treat white spot lesions that occur after orthodontic treatment.

Different gels will be used for remineralization. The study will consist of 45 people between the ages of 15-18. 45 people will be divided into 3 groups.

Detailed description: Oral hygiene training will be given to each group and a toothpaste containing 1450 ppm fluoride will be given to brush their teeth twice a day.

Essix appliance with reservoir will be made by taking impressions from 30 patients. Remineralization gel will be put into the Essix appliance for 5-7 minutes twice a day for one month.

Eligibility criteria: Inclusion Criteria:

* Patients aged 15-18 years,
* Presence of white point lesions,
* Volunteering to participate in the research.

Exclusion Criteria:

* Not having received orthodontic treatment,
* Having a developmental anomaly affecting the enamel,
* Being allergic to milk,
* Having a syndrome affecting the oral cavity.

Primary outcomes:
measure: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP)
timeFrame: 4 weeks
Secondary outcomes:
measure: Calcium glycerophosphate
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03164603: NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors
Official title: A Phase 1 Study of NLG802 for Adult Patients With Recurrent Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Lumos Pharma
Sponsor class: INDUSTRY
First posted: 2017-05-23
Enrollment: 26
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 Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor cancer (including glioblastoma)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic and organ function

Exclusion Criteria:

* Active or history of medically significant autoimmune disease
* Cytotoxic therapy or investigational agent use within 28 days
* Human immunodeficiency virus (HIV), active hepatitis B or C
* Untreated brain metastases
* Known QT interval prolongation
* Use of concomitant medications with high risk of causing Torsades des Pointes.
* Use of immune suppressive agents within 30 days
* More than one active malignancy at the time of enrollment

Primary outcomes:
measure: Percentage of patients with dose-limiting toxicities
timeFrame: 28 Days
measure: Percentage of patients with adverse events
timeFrame: From Screening until 30 days after last dose (up to approximately 2 years)
Secondary outcomes:
measure: Pharmacokinetics: Serum concentrations (Cmax/Steady State)
timeFrame: 21 Days
measure: Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as Determined by the Investigator
timeFrame: From Screening until disease progression, death, new anti-cancer therapy, or premature study withdrawal (up to approximately 3 years)
measure: Percentage of Participants With Progression Free Survival (PFS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
Study officials:
References:
Clinical trial NCT02070003: Perioperative Recovery of Moods, Opioids, and Pain Trial (PROMPT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Cessation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 104
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 investigators aim to characterize the relationship between changes in emotional distress, opioid use, and pain throughout surgery and recovery. Additionally, the investigators aim to compare the effectiveness of post-surgical motivational interviewing and physician-guided opioid weaning vs. usual care on reducing persistent opioid use. Overall, the proposed research will advance knowledge regarding the role of psychological factors contributing to persistent opioid use after surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18+
* Undergoing a scheduled surgery
* English speaking
* Ability and willingness to complete questionnaires and assessments.

Exclusion Criteria:

* Any conditions causing inability to complete baseline, telephone and internet assessments (e.g. education, cognitive ability, mental status, medical status)at the discretion of the investigator.
* Known Pregnancy
* Elevated Suicidality as assessed by an answer of 2 or greater on question 9 of the Beck Depression Inventory assessing suicidal thoughts.
* Coexisting Chronic Pain Disorder of moderate severity in area other than surgical target

Primary outcomes:
measure: Trial Feasibility - The proportion of people consented who complete the study in the group to which they were randomized
timeFrame: Duration of the study - up to 2 years per participant
Secondary outcomes:
measure: Efficacy - time to opioid cessation
timeFrame: Duration of the trial - Up to 2 years per participant
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Jennifer Hah, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hah JM, Trafton JA, Narasimhan B, Krishnamurthy P, Hilmoe H, Sharifzadeh Y, Huddleston JI, Amanatullah D, Maloney WJ, Goodman S, Carroll I, Mackey SC. Efficacy of motivational-interviewing and guided opioid tapering support for patients undergoing orthopedic surgery (MI-Opioid Taper): A prospective, assessor-blind, randomized controlled pilot trial. EClinicalMedicine. 2020 Oct 16;28:100596. doi: 10.1016/j.eclinm.2020.100596. eCollection 2020 Nov.
Clinical trial NCT01487603: Feasibility of Evaluating Gene Alteration Analysis Using Samples Obtained by EBUS-TBNA in Patients With Lung Cancer
Official title: Feasibility of Evaluating Gene Alteration Analysis Using Samples Obtained by EBUS-TBNA in Patients With Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Patients
undiagnosed enlarged
lymph nodes
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung cancer

Brief summary: Lung cancer is the leading cause of death in the world. Overall 5-year survival rate is fewer than 10% and the effectiveness of conventional chemotherapy is limited. The new knowledge shows the correlation between genetic alteration and effective of chemotherapy. Therefore non-surgical modalities to obtain tumor specimens for genetic alteration analysis are particularly critical in lung cancer, since many patients have advanced disease at the time of first presentation, and are therefore not eligible for radical surgery. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) samples obtained during diagnosis of lung cancer can be used for molecular analysis that will predict response to treatment and prognosis. In this study, we will detect specific target molecules related to the effectiveness of treatment (surgery, chemotherapy, radiotherapy) and prognosis in patients with lung cancer using EBUS-TBNA samples and its combined with xenograft technology.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older.
* Patients with confirmed or suspected lung cancer who require EBUS-TBNA as part of their staging investigations of the mediastinum will be considered for the trial.
* Patients with undiagnosed enlarged lymph nodes in the mediastinum suspicious for lung cancer in which a tissue diagnosis is required.

Exclusion Criteria:

* Patients who are deemed on clinical grounds not to be medically fit for a bronchoscopy.
* Patients where there is a high clinical suspicion of lymphoma.

Primary outcomes:
measure: The primary objective of this study is to perform gene alteration analysis using samples obtained by EBUS-TBNA in lung cancer patients.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: UHN
name: Kazuhiro Yasufuku, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05025943: Omega-3 Fatty Acid Dietary Intervention (O3DI)
Official title: Omega-3 Fatty Acid Dietary Intervention for Dyslipidemia of Obesity in Children 10 to <18 Years of Age: O3DI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 19
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Elevated cholesterol, including triglyceride levels, can lead to the development of cardiovascular disease in adulthood. A diet that is rich in omega-3 fatty acids (O3FA) can improve triglyceride levels in a way that is safe and does not require medication.

This is a single-center, prospective, unblinded, randomized-controlled dietary intervention study to assess the impact of an omega-3 fatty acid diet compared to a standard lifestyle intervention on serum triglyceride in patients with hypertriglyceridemia. The study consists of an 8-week dietary treatment period followed by an 8-week observation period.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients who are 10 -17 years of age
2. BMI greater than or equal to the 85th percentile
3. Clinical serum triglyceride level \>150 mg/dl and \< 500 mg/dl performed between 3 months and 1 week prior to study visit 1
4. Ability to follow the study procedures and adhere to the diet counseling recommendations
5. Written parental permission and assent are obtained prior to any research procedures

Exclusion Criteria:

1. Type 2 DM (hemoglobin A1C \>6.6%)
2. Isotretinoin use
3. Chronic kidney disease (CKD)
4. Uncontrolled hypothyroidism
5. Warfarin use
6. Liver disease (NAFLD is allowed)
7. Renal disease
8. Corticosteroid use
9. Omega-3 fatty acid use (prescription or supplement)
10. Allergy to fish and/or nuts
11. Currently pregnant or planning to become pregnant during the course of this trial - confirmed by date of LMP/querying family
12. Any significant medical condition which the investigator believes would interfere with participation in this study

Primary outcomes:
measure: change in serum triglyceride level after an 8-week diet intervention compared to baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: change red blood cell omega-3 fatty acid content / index after an 8-week diet intervention compared to baseline
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Cardiac Center, Nemours Children's Hospital Delaware
state: Delaware
Study officials:
affiliation: Nemours Cardiac Center, Nemours Children's Hospital Delaware
name: Carissa Baker-Smith, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02012543: Effect of Agar Administration on Defecation and Fecal Condition in Chronic Constipated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: constipation, agar
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The administration of agar jelly may increase the number of defecation and the volume of feces, and then may improve fecal condition in chronic constipated patients.

Detailed description: Each subject eats one cap of agar jelly shortly before having dinner every day for 4 weeks.

At 0, 7th, 14th, 21th, and 28th day , the frequency of defecation and defecation condition is assessed.

Eligibility criteria: Inclusion Criteria:

* subjects take laxatives.

Exclusion Criteria:

* subjects underwent abdominal surgery.

Primary outcomes:
measure: the condition of feces
timeFrame: 4 weeks
Secondary outcomes:
measure: the number and amount of defecation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
state: Nagano
Study officials:
affiliation: Showa Inan General Hospital
name: Akira Horiuchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00276003: INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
Official title: INST Phase II Trial of Gemcitabine and Irinotecan in Patients With Relapsed or Refractory Lymphoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Cancer
Keywords: Lymphoma-Non Hodgkins
Phase II
Gemcitabine
Irinotecan
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-01-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objectives

* Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.

Secondary objectives

* Assess progression free survival in these patients treated with this regimen.
* Assess toxicity of this regimen in this group of patients.

Detailed description: The purpose of the study is to see how well patients with relapsed or refractory lymphoma respond to treatment with Gemcitabine and Irinotecan. Patients on this study take part because they have relapsed or refractory lymphoma. Additionally, the study will assess treatment-related side effects and time until disease progression or recurrence.

Eligibility criteria: Inclusion Criteria:

1. Patients with a histologic diagnosis of non-HIV related B-cell NHL or Hodgkins disease are eligible.
2. Patients should have documented evidence of refractory or relapsed NHL or Hodgkins disease for inclusion.
3. Patient should have received 1 or more prior chemotherapeutic regimens for relapse, and should have completed last course of treatment at least 3 weeks prior to enrollment.
4. The patient must have bidimensionally measurable or evaluable disease.
5. Age \> 18 years.
6. ECOG Performance status \< 2
7. Informed consent.
8. ANC \> 1.5, platelet count \> 100K, creatinine\< 2.0, bilirubin \< 3
9. Female patients must have a negative pregnancy test.

Primary outcomes:
measure: Assess the response rate in patients with recurrent or refractory B-cell NHL or Hodgkins disease, treated with the combination of the gemcitabine and irinotecan.
timeFrame: 3 years
Secondary outcomes:
measure: Assess progression free survival in these patients with this regimen.
timeFrame: 3 years
measure: Assess toxicity of this regimen in this group of patients.
timeFrame: 3 years
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Lovelace Sandia Health Systems Dept of Hematology
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Ian Rabinowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07012590: Morphine and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Open Subcostal Renal Surgeries
Official title: Morphine and Dexmedetomidine as Adjuvants to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Open Subcostal Renal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morphine
Dexmedetomidine
Adjuvants
Bupivacaine
Ultrasound
Erector Spinae Plane Block
Open Subcostal Renal Surgeries
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 147
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the analgesic efficacy between morphine and dexmedetomidine as adjuvants to bupivacaine in ultrasound-guided erector spinae plane block for open subcostal renal surgeries.

Detailed description: The postoperative pain that occurs because of the wide flank incision ranges from a moderate to severe intensity and, in some patients, can become chronic.

The erector spinae plane block (ESPB) is a novel interfascial plane technique, aiming to block the dorsal and ventral rami of the spinal nerves to provide visceral and somatic multi-dermatomal analgesia of the cervical, thoracic, and lumbar levels.

Adjuvants to local anesthetics, such as morphine and dexmedetomidine, can be used to improve the quality and duration of peripheral nerve block effects.

Eligibility criteria: Inclusion Criteria:

* Patient's approval.
* Age: 20 - 65 years.
* Physical Status: American Society of Anesthesiologists (ASA) I \& II.
* Patients undergoing open subcostal renal surgeries.

Exclusion Criteria:

* Patient refusal.
* Age: \>65 and \<20 years.
* Allergy to Dexmedetomidine, local anesthetics, systemic opioids, and any of the drugs included in the multimodal perioperative pain protocol.
* Patient with coagulation disorders.
* Chronic pain syndromes and patients with chronic opioid use are defined as use of regular daily doses of systemic narcotics for the past 6 months before the surgery.
* Body mass index of 35 kg/ m2 or more.
* Physical Status: American Society of Anesthesiologists (ASA) III \& IV.
* Local infection or sepsis at the site of injection.

Primary outcomes:
measure: Degree of pain
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Duration of sensory block
timeFrame: Intraoperatively
measure: Time to first rescue analgesia
timeFrame: 48 hours postoperatively
measure: Total opioid consumption
timeFrame: 48 hours postoperatively
measure: Heart rate
timeFrame: 48 hours postoperatively
measure: Mean arterial pressure
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References: