louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05882617: Patient Satisfaction With Different Numbers of Implants
Official title: Assessment of Patient Satisfaction in Completely Edentulous Patients Receiving Removable Implant Overdentures Retained by Different Numbers of Implants .A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 48
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three parallel arms one comparator and two interventions
Primary purpose: OTHER

Brief summary: the goal of this randomized controlled trial aimed to assess patient satisfaction for completely edentulous patients with implant overdenture retained by ball attachment over a single symphyseal , or four interforaminal implants when compared to two interforaminal ones

Detailed description: 48 edentulous patients were recruited and randomized to receive either 1,2 or 4 implants for a mandibular overdenture,3 months later implants were uncovered, and ball attachments were torqued, and all overdentures were picked up ,patient satisfaction questionnaires were recorded for all patients 2 weeks after pickup 3 months ,6 months, 9 months and 1year.

Eligibility criteria: Inclusion criteria

* completely edentulous patients with restorative space of 12-15 mm,
* keratinized gingiva of 5 mm

Exclusion criteria

* Exclusion Criteria:
* uncontrolled diabetes
* bruxers
* smokers

Primary outcomes:
measure: patient satisfaction for masticatory ability, mental life comfortability with dentures
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Doaa Mahmoud Elkady
city: Cairo
country: Egypt
facility: Nesma Mohamed Awaad
Study officials:
affiliation: lecturer
name: Doaa Elkady phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01960517: Feasibility Assessment of ACS Catheter
Official title: A Feasibility Assessment of a New Urinary Catheter: The Alternative Catheter System ACS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Urological
Keywords: Urinary
Incontinence
Catheter
Lead sponsor: Alternative Urological Catheter Systems Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-10
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: BASIC_SCIENCE

Brief summary: This is a single centre, non-randomised, baseline controlled, prospective pilot clinical trial to be undertaken at Rotherham General Hospital, Rotherham, UK.

The study will examine the safety and performance of a new urinary catheter, the Alternative Catheter System (ACS) (Alternative Urological Catheter Systems Ltd (AUCS), Bristol, UK) which has been developed to reduce the morbidity of long-term catheterisation and the acknowledged deficiencies of the conventional Foley urinary catheter.


Eligibility criteria: Inclusion Criteria:

1. Male or female, at least 18 years of age.
2. Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.
3. Capable of using a catheter valve to empty the bladder and able to communicate their experience with the system OR who has a carer able to fulfil these tasks.
4. Fitted with a suprapubic catheter (at least 2 weeks post insertion).
5. Ability to attend out-patient clinic at regular intervals throughout the study and able to participate for a maximum of 8 weeks.
6. History of catheter blockages, bypassing or episodes of pyrexia and bacteraemia in the last 2 months.

Exclusion Criteria:

1. \<18 years of age.
2. Pregnant or lactating females.
3. History of catheter associated septicaemia in the past month.
4. Evidence of current systemic infection.
5. Bladder pathology such as a tumour or stone \>0.5cm as determined by cystoscopy.
6. Flaccid bladder.
7. BMI\>35.
8. Current participation in another device or drug study.
9. Unwilling or unable to provide informed consent.

Primary outcomes:
measure: Retention of the ACS catheter
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rotherham
country: United Kingdom
facility: Rotherham NHS Foundation Trust, Rotherham General Hospital
Study officials:
affiliation: Rotherham NHS Foundation Trust
name: Mr Isa Idhem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04011917: Projected Prognosis as a Predictor of Short-term Outcome After Treatment of Minor Musculoskeletal Injuries in the Emergency Department
Official title: Projected Prognosis as a Predictor of Short-term Outcome After Treatment of Minor Musculoskeletal Injuries in the Emergency Department: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Diseases
Keywords: Minor Musculoskeletal Injuries
Emergency Department
Prediction outcome
Extended Scope Physiotherapists
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
First posted: 2019-07-09
Enrollment: 432
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: All patients treated by an ESP physiotherapist in the emergency room at Slagelse Hospital, Denmark, in a 3 month period +1 month follow-up will be invited to participate in this study.

Brief summary: This study describes the caseload treated by the extended scope physiotherapists(ESP) working in the emergency department at Slagelse Hospital.

Patients treated by the ESP during a 3 month period will be included in this study.

Furthermore we aim to assess if ESPs treating patients with minor musculoskeletal injuries in the ED can predict the short-term prognosis of recovery. The prediction is made at hospital discharge using a (-7/+7) numerical rating scale (-7=poor prognosis; 7=best prognosis).


Eligibility criteria: Inclusion Criteria:

* 1 Treated by an ESP for a minor musculoskeletal injury in the emergency room
* 2 Has an email address
* 3 Signed informed consent form

Exclusion Criteria:

* 1 A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., not having access to the internet, cognitive impairments etc.)
* 2 Under the influence of drugs or alcohol

Primary outcomes:
measure: Transition ratings of global perceived effect
timeFrame: 1 month after discharge
Secondary outcomes:
measure: Patient Acceptable Symptom State
timeFrame: 1 month after discharge
measure: EuroQoL questionnaire
timeFrame: 1 month after discharge
Other outcomes:
measure: VAS Pain
timeFrame: At baseline and 1 month after discharge
measure: Analgesic use
timeFrame: 1 month after discharge
measure: Follow-up treatments
timeFrame: 1 month after discharge
measure: Re-injury
timeFrame: 1 month after discharge
Locations:
city: Slagelse
country: Denmark
facility: The Emergency Department, Slagelse Hospital
state: Region Zealand
Study officials:
affiliation: Næstved-Slagelse-Ringsted Hospitals
name: Christian P Olsen, PT, Phd candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
name: Marius Henriksen, PT, PhD
role: STUDY_CHAIR
affiliation: Næstved-Slagelse-Ringsted Hospitals and University of Southern Denmark
name: Søren T Skou, PT, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05098717: End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation
Official title: End-expiratory Trans-pulmonary Pressure Guided PEEP Titration in Patients With Pulmonary Fibrosis and UIP Pattern Undergoing Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Pulmonary Fibrosis
Mechanical Ventilation Pressure High
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lung fibrosis and UIP pattern undergoing esophageal manometry and controlled mechanical ventilation for acute respiratory failure admitted to the Intensive Care Unit and Respiratory Intensive Care Unit of the University Hospital of Modena that will fulfill the eligibility criteria will be enrolled.

Brief summary: Patients with pulmonary fibrosis and associated usual interstitial pneumonia that require mechanical ventilation for acute respiratory failure experience poor clinical outcomes. This may be influenced by the unfavorable interaction between the fibrotic lung and the stress and strain stimuli generated during controlled ventilation. Although there is no consensus on how to ventilate these patients, much of the recommendations followed in clinical practice are taken from the experience on patients with acute respiratory distress syndrome. Among these, measuring the esophageal pressures and adjusting positive-end expiatory pressure to make trans-pulmonary pressures positive can decrease atelectasis, derecruitment of lung, and cyclical opening and closing of airways and alveoli, thus optimizing lung mechanics and oxygenation. The effect of this strategy on the fibrotic lung has not yet been documented. With this observational study we aim at documenting the effect of PEEP titration maneuver based on end-expiratory trans-pulmonary pressure on lung mechanics of patients with pulmonary fibrosis and UIP pattern,


Eligibility criteria: Inclusion Criteria:

* pulmonary fibrosis with UIP pattern
* subjected to endotracheal intubation and controlled mechanical ventilation for acute respiratory failure
* candidate to a trial of PEEP titration according to positive end expiratory pressure.

Exclusion Criteria:

* chest wall deformities
* chronic obstructive pulmonary disease

Primary outcomes:
measure: Lung elastance
timeFrame: 2 hours.
Secondary outcomes:
measure: P/F ratio
timeFrame: 2 hours
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico di Modena
Study officials:
References:
Clinical trial NCT01526317: A Phase 1 Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers
Official title: A Randomized, Open Label, Cross-over Clinical Trial to Investigate Pharmacokinetics and Drug Interaction of Crestor and Glucodown OR SR in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics and Drug Interaction of Crestor and Glucodown SR
Keywords: Drug interaction
Rosuvastatin
Metformin SR
Pharmacokinetic
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2012-02-03
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Glucodown(Metformin SR). Also investigate drug interaction between separate and combination administration.

Total number of subjects is 36. 6 group(6 for 1 group), 3 period, consecutive 5 day administration, 10 days washout after 5th day of administration.

All subjects take Crestor alone, Glucodown alone, Crestor+Glucodown combination during 3 each period.


Eligibility criteria: Inclusion Criteria:

* 20\~50 yrs old, healthy Korean Subjects
* Body weight \<ideal body weight±20%
* No congenital, chronic disease, No current disease
* Subjects who are diagnosed to include by medical doctor from laboratory and ECG result.
* Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion Criteria:

* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
* Subjects who have taken other medicine in recent 2\~4 weeks.
* Subjects who have a risk of hypoglycemia and imbalance in taking a diet.

Primary outcomes:
measure: AUCtau
timeFrame: 72 hr
measure: Css,max
timeFrame: 72 hr
Secondary outcomes:
measure: AUCss,last
timeFrame: 72 hr
measure: AUCss,inf
timeFrame: 72 hr
measure: Css,min
timeFrame: 72 hr
measure: Tss,max
timeFrame: 72 hr
measure: t1/2
timeFrame: 72 hr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
Study officials:
affiliation: Severance Hospital, Yonsei University
name: Kyungsu Park, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee D, Roh H, Son H, Jang SB, Lee S, Nam SY, Park K. Pharmacokinetic interaction between rosuvastatin and metformin in healthy Korean male volunteers: a randomized, open-label, 3-period, crossover, multiple-dose study. Clin Ther. 2014 Aug 1;36(8):1171-81. doi: 10.1016/j.clinthera.2014.06.004. Epub 2014 Jun 26.
Clinical trial NCT03766217: Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Official title: Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cleft Lip and Palate
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2018-12-06
Enrollment: 62
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Iliac crest autogenous bone graft is accepted as the most effective method for secondary alveolar cleft repair. However this method is associated with complications. As an alternative, mesenchymal stem cells associated with biomaterials have been used for the rehabilitation of the alveolar bone cleft of patients with cleft lip and palate. This is a RCT comparing mesenchymal stem cells obtained from autogenous deciduous dental pulp associated with biomaterials versus iliac crest autogenous bone graft for secondary alveolar cleft repair.


Eligibility criteria: Inclusion Criteria:

* non syndromic unilateral cleft lip and palate;
* age between 7 and 12 years;
* to have the jaw aligned and ready to receive the graft.

Exclusion Criteria:

* previous surgery to correct the alveolar cleft;
* have the canine erupted before grafting;
* incomplete orthodontic treatment;
* incomplete CT scan documentation.

Primary outcomes:
measure: Alveolar bone filling rate
timeFrame: 12 months
measure: Serious adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Non serious adverse events
timeFrame: 15 days; 3, 6 and 12 months
measure: Bone Tissue Engineering With Dental Pulp Stem Cells for Alveolar Cleft Repair
timeFrame: Bone tissue engineering
measure: Position of the canine tooth and formation of dental root
timeFrame: 12 months
measure: Alveolar bone filling rate
timeFrame: 6 months
measure: Serious adverse events
timeFrame: 15 days; 3 and 6 months
measure: Patient-reported outcome (PRO, including appearance, fuction and quality of life)
timeFrame: pre surgery and 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sírio-Libanes
Study officials:
References:
citation: Tanikawa DYS, Pinheiro CCG, Almeida MCA, Oliveira CRGCM, Coudry RA, Rocha DL, Bueno DF. Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients. Stem Cells Int. 2020 Mar 12;2020:6234167. doi: 10.1155/2020/6234167. eCollection 2020.
citation: Pinheiro CCG, Leyendecker Junior A, Tanikawa DYS, Ferreira JRM, Jarrahy R, Bueno DF. Is There a Noninvasive Source of MSCs Isolated with GMP Methods with Better Osteogenic Potential? Stem Cells Int. 2019 Nov 6;2019:7951696. doi: 10.1155/2019/7951696. eCollection 2019.
Clinical trial NCT05499117: Efficacy and Safety of Light Therapy in the Treatment of Non-seasonal Depressive Disorder in Chinese Population
Official title: Efficacy and Safety of Light Therapy in the Treatment of Non-seasonal Depressive
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 80
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: Depression is a kind of mental illness with high incidence, high recurrence and high disability. But so far, treatment remission rates for depression remain low. Therefore, it is necessary to develop more new treatments. Light therapy has been shown to be effective in treating depression with seasonal patterns. Although most studies have reported that light therapy is also effective in patients with depression without seasonal patterns, high-quality clinical studies are still rare and the conclusions are still controversial. In particular, it remains unclear whether light therapy is effective in treating depression without seasonal patterns in the Chinese population. In addition, there is a lack of biomarkers that predict the efficacy of light therapy.

In conclusion, this study intends to conduct an ADD-ON randomized controlled study to clarify the efficacy and safety of light therapy as synergistic therapy in patients with depression without seasonal patterns, and to screen peripheral biomarkers related to efficacy using transcriptome sequencing technology. It is expected that this study can confirm the effectiveness and safety of light therapy as synergistic therapy, provide an evidence-based basis for the research and exploration of light therapy in Chinese depression population, and provide more options for the synergistic treatment of antidepressants in Chinese depression population.


Eligibility criteria: Inclusion Criteria:

1）Meets DSM-5 criteria for major depressive disorder 2) Age 18-65; 3) HAMD-17 score ≥17; 4) No antidepressants or mood stabilizers were used at least 2 weeks before enrollment; 5) Sign informed consent.

Exclusion Criteria:

1. With seasonal pattern;
2. No previous mental disorders, personality disorders, mental retardation, neurodegenerative diseases, brain trauma, cerebrovascular diseases caused by organic diseases;
3. No previous history of alcohol or substance dependence;
4. Current serious risk of suicide (e.g., previous attempted suicide or recent suicidal behavior); 5）Present with serious, active physical diseases that may interfere with research, including vision problems and photosensitivity disorders; 6）Have received electroconvulsive therapy (ECT or MECT) or transcranial magnetic stimulation (rTMS) in the last 6 months.

Primary outcomes:
measure: remission of acute phase
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
Clinical trial NCT04847817: Important Data on COVID-19 Profile in Africa
Official title: Important Data on COVID-19 Profile in Africa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Africa
Keywords: Coronavirus infection
SARS-CoV
COVID-19
Transmission
Africa
Lead sponsor: Centre de Recherche Médicale de Lambaréné
Sponsor class: OTHER
Collaborators: name: European and Developing Countries Clinical Trials Partnership (EDCTP)
name: Leiden University Medical Center
name: Institut de recherche en santé de surveillance épidémiologique et de formation
name: Université des Sciences de la Santé
name: Armauer Hansen Research Institute, Ethiopia
name: Universität Tübingen
First posted: 2021-04-19
Enrollment: 574
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of volunteer COVID-19 patients hospitalized in referral center for COVID-19 care as well as the household contacts of these hospitalized COVID-19 patients in Gabon, Senegal and Ethiopia.

Brief summary: The purpose of this study is to Understand the natural history of Coronavirus 2019 (COVID-19) infection to better define the period of infectiousness and transmissibility and to establish biobanks of COVID-19 blood and mucosal samples.

Detailed description: In this study ,the participants will be enrolled sequentially in the COVID-19 care referral centers. The infected hospitalized patient will be identified by the physicians in hospital. After the patient has given his/her informed consent the permission will be sought from him to approach his household contacts. The household contacts will be screened, and included in the study.

Patients hospitalized and positive for COVID-19 by PCR and their household contacts of all ages and gender (40% minimum of female), will be enrolled upon receipt of written informed consent.

Eligibility criteria: Inclusion Criteria:

* Molecular (PCR) confirmed COVID-19 patients hospitalized in referral centers,
* Household contacts of hospitalized COVID-19 patient,
* Provided signed informed consent.

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: clinical and biological parameters of COVID-19
timeFrame: 14 days
measure: SARS-CoV-2 transmissibility
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Centre de Recherches Médicales de Lammbaréné
state: Moyen- Ogooué
city: Lambaréne
country: Gabon
facility: Centre de Recherches Médicales de Lambréné
Study officials:
affiliation: Centre de Recherches Médicales de Lambaréné
name: Ayôla Akim ADEGNIKA
role: PRINCIPAL_INVESTIGATOR
affiliation: Université des Sciences de Santé
name: Marielle BOUYOU-AKOTET
role: PRINCIPAL_INVESTIGATOR
References: