louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04818658: The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration
Official title: The Preformed Metal Crowns Placed Using the Hall Technique Versus the Conventional Restoration: A 5-year Retro-prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Caries; Dentin
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 26
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients aged 5-8 years treated with preformed metal crowns using Hall Technique and compomer restoration

Brief summary: The aim of this study is to compare the survival rate of the conventional restorations with the Hall Technique in carious primary molars.

Detailed description: comparing the survival rate of the conventional restorations with the Hall Technique in carious primary molars.

Eligibility criteria: Inclusion Criteria:

* patients aged five to eight years at the time of dental treatment,
* patients attending follow-up appointments
* patients with compomer restoration and Hall restoration in their teeth
* patients with matching the extent of caries in the two groups

Exclusion Criteria:

* patients not attending follow-up appointments
* patients without both treatment

Primary outcomes:
measure: The survival rate of Hall Technique and Compomer Restorations
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahcesehir University
Study officials:
affiliation: Bahçeşehir University
name: Betul Sen Yavuz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03790358: Mood Effects of Serotonin Agonists
Official title: Mood Effects of Serotonin Agonists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effects of very low doses of serotonergic agonists on depressed mood in human volunteers.


Eligibility criteria: Inclusion Criteria:

* English fluency
* High school level education
* BMI between 19 and 30

Exclusion Criteria:

* Diagnosed medical condition
* women who are nursing, pregnant, or plan to become pregnant within 3 months
* History of psychotic disorder or family history of psychotic disorder

Primary outcomes:
measure: Change From Baseline in Profile of Mood States (POMS)
timeFrame: End of study (Baseline - time 0 and approximately 8 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Matthew Bona
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References:
citation: Bershad AK, Preller KH, Lee R, Keedy S, Wren-Jarvis J, Bremmer MP, de Wit H. Preliminary Report on the Effects of a Low Dose of LSD on Resting-State Amygdala Functional Connectivity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Apr;5(4):461-467. doi: 10.1016/j.bpsc.2019.12.007. Epub 2019 Dec 20.
citation: Bershad AK, Schepers ST, Bremmer MP, Lee R, de Wit H. Acute Subjective and Behavioral Effects of Microdoses of Lysergic Acid Diethylamide in Healthy Human Volunteers. Biol Psychiatry. 2019 Nov 15;86(10):792-800. doi: 10.1016/j.biopsych.2019.05.019. Epub 2019 Jun 3.
Clinical trial NCT05703958: Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Official title: An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Proximal Humeral Fracture
Fracture Dislocation
Non-Union Fracture
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2023-01-30
Enrollment: 151
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing ORIF surgery who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer

Brief summary: The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.


Eligibility criteria: Inclusion Criteria:

* Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate
* Patient is willing to participate by complying with pre- and postoperative visit requirements
* Patient is willing to agree to be followed for up to 10 years following their index surgery
* Patient is willing and able to review and sign a study informed consent form

Exclusion Criteria:

* Osteomyelitis of the proximal humerus or scapula
* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
* The patient is unwilling or unable to comply with the post-operative care instructions
* Alcohol, drug, or other subtance abuse
* Any disease state that could adversaly affect the function or longevity of the implant
* Patient is pregnant
* Patient is a prisoner
* Patient has a physical or mental condition that would invalidate the results

Primary outcomes:
measure: Smart Score
timeFrame: Through study completion, an average of 1 per year
measure: Sane Score
timeFrame: Through study completion, an average of 1 per year
measure: ASES
timeFrame: Through study completion, an average of 1 per year
measure: Quick DASH
timeFrame: Through study completion, an average of 1 per year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Grossman School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Abhishek Ganta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04007458: Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder
Official title: Maine Lung Cancer Coalition: Using CHWs for the Annual Lung Cancer Screening Reminder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Screening
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 396
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomly assigned to one of the following two groups:

1. Control Group:

o Annual reminder letter only

1. Intervention Group:
2. Annual reminder letter and Community Health Worker proactive outreach
Primary purpose: SCREENING

Brief summary: This research study will test whether support from a Community Health Worker (CHW) to address barriers to annual LDCT screening will result in an increased number of patients who receive the annual screening as per the recommended standard of care compared to passive outreach using a reminder letter.

Detailed description: This research study is a randomized controlled trial comparing phone outreach by a trained Community Health Worker (CHW) following a reminder letter to the reminder letter alone for patients who are at least a month overdue to have a routine annual low dose CT scan (LDCT) screening for lung cancer. CHWs will be able to identify and address barriers to accessing screening for those patients randomized to that arm of the study. Outcomes that will be measured include scheduling and completing the LDCT as well as agreeing to a referral for tobacco treatment.

Eligibility criteria: Inclusion Criteria:

* 30 or more pack years of tobacco use
* If no longer using tobacco, no more than 15 years since last use
* At least 13 months since last low dose CT scan screening

Exclusion Criteria:

* Development of serious medical condition that would preclude treatment of lung cancer if found
* Death since baseline screen

Primary outcomes:
measure: Completed low dose CT scan
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Scheduled low dose CT scan
timeFrame: through study completion, an average of one year
measure: Tobacco counseling
timeFrame: through study completion, an average of one year
measure: Maine Tobacco Helpline Referral
timeFrame: trhough study compeltion, an average of one year
Other outcomes:
Locations:
city: Augusta
country: United States
facility: MaineGeneral Medical Center
state: Maine
Study officials:
References:
Clinical trial NCT04779658: Laparoscopic Essure Device Removal
Official title: Essure Removal for Device-attributed Symptoms: Quality of Life Evaluation Before and After Surgical Removal
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contraception
Keywords: Essure device removal
Quality of life
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 90
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: Women who underwent Essure_ device removal by salpingectomy, between February 2017 and August 2018.

Brief summary: In recent years, several symptoms have been attributed to Essure, including pelvic pain and other general symptoms. Consequently, an increasing number of patients request Essure removal for alleged adverse reactions to the device.

Study Objective: To evaluate the quality of life of patients who underwent Essure_ device removal and morbidity of this surgery.

Design: Prospective observational cohort study. Setting: Academic hospitals of La Conception, Marseille, and Arnaud-de-Villeneuve, Montpellier, France.

Patients: Women who underwent Essure_ device removal by salpingectomy, between February 2017 and August 2018.

Methods : The following information have been collected during preoperative clinics: demographic data, medical history, clinical symptoms attributed to the Essure device, time between Essure sterilization and early symptoms, time between the beginning of symptoms and surgical removal. Follow-up visits have benne scheduled at one month and three months post-operation. The evolution of symptoms was collected during the follow-up visit at three months based on clinical reports and a dedicated questionnaire. Evaluation of Quality of life have been evaluated thanks to SF36 and HAD questionnaires. Alle these patients will be contacted by phone call to assess to evolution of symptoms and to complete SF 36 and HAD questionnaires.

Hypothesis : Recovery of symptoms due to ESSURE device and improvement of quality of life after surgery.


Eligibility criteria: Inclusion criteria:

* age \>18 years old
* symptoms related to ESSURE device
* salpingectomy for ESSURE removal

Exclusion criteria:

- Exclusion criteria were failure to perform a complete removal of the Essure and second surgery to remove fragments left behind from a previous procedure.

Primary outcomes:
measure: Evaluation of quality of life after ESSURE removal
timeFrame: Preoperative
measure: Evaluation of quality of life after ESSURE removal
timeFrame: three-months post-operative
Secondary outcomes:
measure: Evaluation of morbidity of ESSURE removal
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Martha DURAES, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00685958: Japanese Safety and Efficacy Study of Enoxaparin in Patients With Hip Fracture Surgery
Official title: Multicenter, Non-comparative, Open-label Study to Evaluate the Safety and Efficacy of Enoxaparin Sodium (RP54563) 20 mg Bid for 14 Days in Patients With Hip Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Fractures
Keywords: Blood thinner
enoxaparin
hip fracture surgery
bleeding
thromboembolism
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-05-29
Enrollment: 54
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 purpose of this study is to evaluate the effects of enoxaparin on bleeding and venous blood clots in patients with hip fracture surgery.


Eligibility criteria: Inclusion Criteria:

* femoral neck inside or outside fracture

Exclusion Criteria:

* any major surgery on lower limbs within 3 months
* clinical signs of deep vein thrombosis
* use of non-steroidal anti-inflammatory drugs
* severe hepatic disease or renal insufficiency

Primary outcomes:
measure: bleeding events
timeFrame: 28 days
Secondary outcomes:
measure: incidence of venous thromboembolism
timeFrame: 28 days
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi- Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02854358: Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Xerostomia
Head and Neck Cancers
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2016-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of the most common side effect of radiation therapy among patients with HNC. Mouth dryness significantly impairs patients' quality of life (QOL).

HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their beneficial effects in recent studies, we decided to design a randomized, controlled clinical trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation induced xerostomia


Eligibility criteria: Inclusion Criteria:

* patients with head and neck cancer who had grade 1 and 2 xerostomia (based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0) and finished radiotherapy at least two months before the study(22).

Exclusion Criteria:

* history of connective tissue disorder (e.g., Sjogren) other medical causes of xerostomia (such as diabetes, bowel and renal diseases), using antidepressants drugs, recurrence of cancer, end stage cancer, pregnancy, lactation history of hypersensitivity or allergy to A. digitata and M. sylvestris

Primary outcomes:
measure: changes in patients' quality of life
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Heydarirad G, Rezaeizadeh H, Choopani R, Mosavat SH, Ameri A. Efficacy of a traditional Persian medicine preparation for radiation-induced xerostomia: a randomized, open-label, active-controlled trial. J Integr Med. 2017 May;15(3):201-208. doi: 10.1016/S2095-4964(17)60333-9.
Clinical trial NCT04946058: Hybrid Mathieu Urethroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Penile Hypospadias (Disorder)
Keywords: distal hypospadias
Mathieu urethroplasty
modified
urethral plate
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 43
Sex: MALE
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: the aim is to study the results of simple modification of classic Mathieu urethroplasty to increase the scope of cases candidates for that procedure.

Detailed description: background: Distal hypospadias repair is one of most frequent surgical interventions in pediatric age group. Successful hypospadias repair should provide a functional penis and good cosmesis. Mathieu urethroplasty is one of the most popular techniques used. Authors aimed at performing a modification that expanded the scope of indications and improved final cosmetic results of classic Mathieu urethroplasty.

Methods: forty-three patients with distal hypospadias were operated by hybrid Mathieu urethroplasty (HMU) during the period from March 2012 to December 2020. Creation of the peri meatal based flap was performed as Mathieu disrobed. This was followed by developing of glanular wings. The additional step was deep incision of the urethral plate. Then, urethroplasty was performed. The catheter was left in place for one to three days.

Eligibility criteria: Inclusion Criteria:

* distal penile hypospadias

Exclusion Criteria:

* sever hypospadias
* cases need redo

Primary outcomes:
measure: successful treatment of distal penile hypospadias
timeFrame: 6 moths post operative
measure: increase the scope of classic Mathieu urethroplasty
timeFrame: 6 months post operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04865458: A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Official title: A Phase I Single Arm,Open-label,Multiple Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed or Refractory B-cell Hematologic Malignancies
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 80
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: Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies


Eligibility criteria: Inclusion Criteria:

* Age is over 18 years old
* Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies
* ECOG performance status (PS) 0 \~ 1
* Expected survival of \> or = 3 months

Exclusion Criteria:

* The use of PI3Ks as the target of anti-tumor drugs progress (due to intolerance group)
* Received any other anti-cancer treatment within 4 weeks
* Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption
* Allergy, or known to have a history of allergy to the drug components

Primary outcomes:
measure: Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose
timeFrame: Dosing started until the 28th day
measure: Adverse events evaluated by NCI CTCAE 5.0
timeFrame: From the frst dose to within 30 days after the last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Li Jianyong, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Song Yuqing, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02613858: Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Encephalopathy
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Dimension Research
First posted: 2015-11-25
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic/Private Clinic

Brief summary: The Preempt study is likely to help determine the frequency of patients suffering from Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know about the Quality of life of these patients.


Eligibility criteria: Inclusion Criteria:

* Patients of either sex, 18-65 years of age, who have attended school at least till the 5th Class/Standard having an established diagnosis of liver cirrhosis without any overt symptoms at time of testing with Grade 0 of West Haven criteria.
* Patients willing to undergo the neuropsychological (NP) tests and to complete the SF-36 questionnaire for the estimation of Health Related Quality of Life (HRQOL).
* Patients willing to provide written authorization to provide data for the study.

Exclusion Criteria:

* Patients with inability to perform neuropsychometric tests and to complete the SF-36 questionnaire as decided by the physician.

Primary outcomes:
measure: Frequency of MHE in Cirrhotic patients
timeFrame: 18 months
Secondary outcomes:
measure: The predisposing factors that might be associated with MHE in all enrolled patients with cirrhosis
timeFrame: 18 months
measure: Quality of Life (QoL) of patients at baselines
timeFrame: 18 months
measure: Management of MHE currently in practice
timeFrame: 18 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Baqai Hospital
city: Lahore
country: Pakistan
facility: Fatima Memorial Hospital
city: Lahore
country: Pakistan
facility: Lahore General Hospital
city: Lahore
country: Pakistan
facility: Jinnah Hospital Lahore
city: Lahore
country: Pakistan
facility: Doctor's Hospital
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital
Study officials:
affiliation: Medical Director, Abbott
name: Raeefuddin Ahmed, MD
role: STUDY_DIRECTOR
References: