louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00767169: Bisphosphonate-coated Dental Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Edentatio (Toothlessness)
Keywords: Edentatio (Toothlessness)
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2008-10-06
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dental implants (screws for fastening false teeth) have been coated with bisphosphonates (drugs that slow down removal of bone). Patients get one such screw and one without coating, by a surgeon who does not know which is which. The screws are compared by measuring how well fixed they are by a vibration measuring technique, and x-rays. The hypothesis is that the bisphosphonates will improve fixation.


Eligibility criteria: Inclusion Criteria:

* Need for at least 2 dental implants, which are to be inserted in bone of reasonably similar quality.

Exclusion Criteria:

* Systemic or immunologic disease, alcoholism, uncontrolled diabetes and smoking.
* Local exclusion criteria were: previous tumour, trauma and surgery.
* Also patients with Cawood \& Howell class IV - VI maxilla-bone were excluded.

Primary outcomes:
measure: Increase in resonance vibration frequency (ISQ units) from insertion to abutment connection as compared to the control in the same patient.
timeFrame: 6 months
Secondary outcomes:
measure: Marginal resorption on x-rays
timeFrame: 1 year
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Department of Oral & maxillofacial surgery, University Hospital.
Study officials:
affiliation: Linkoeping University
name: Per Aspenberg, MD, PhD
role: STUDY_CHAIR
References:
citation: Abtahi J, Tengvall P, Aspenberg P. A bisphosphonate-coating improves the fixation of metal implants in human bone. A randomized trial of dental implants. Bone. 2012 May;50(5):1148-51. doi: 10.1016/j.bone.2012.02.001. Epub 2012 Feb 10.
Clinical trial NCT04188769: Effect of Local Pressure on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
Official title: Effect of Local Pressure Application on Muscle Activity and General Relaxation in Persons With Hypertonia Following Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Deep Pressure
Muscle Activity
General Relaxation
Stroke
Hypertonia, Muscle
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effect of - both constant as intermittent - local application of deep pressure on muscle activity and general relaxation in persons with hypertonia following stroke.

Detailed description: This study will be carried out in 20 persons with hypertonia following stroke. There will be one single test occasion, during which 6 test trials will be performed in random order. Deep pressure will be applied by means of a Johnstone air splint, that will be (1) not inflated, (2) inflated constantly, or (3) inflated intermittently. Each of these 3 inflation conditions will be performed twice, i.e. with and without a non-hemiplegic arm movement (triggering hypertonia at hemiplegic side).

Eligibility criteria: Inclusion Criteria:

* subacute stroke (\<6 months)
* hypertonia (Modified Ashworth Scale score of ≥2 for arm flexors at the hemiplegic side)

Primary outcomes:
measure: EMG of biceps brachii
timeFrame: through study completion, an average of 5 months
measure: EMG of triceps brachii
timeFrame: through study completion, an average of 5 months
measure: EMG of pectoralis major
timeFrame: through study completion, an average of 5 months
measure: MyotonPRO measurement of pectoralis major muscle tone
timeFrame: through study completion, an average of 5 months
measure: heart rate
timeFrame: through study completion, an average of 5 months
measure: heart rate variability
timeFrame: through study completion, an average of 5 months
measure: respiratory rate
timeFrame: through study completion, an average of 5 months
measure: subjective rating of hypertonia
timeFrame: through study completion, an average of 5 months
Secondary outcomes:
measure: MyotonPRO measurement of pectoralis major elasticity
timeFrame: through study completion, an average of 5 months
measure: MyotonPRO measurement of pectoralis major stiffness
timeFrame: through study completion, an average of 5 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
Study officials:
References:
Clinical trial NCT06515769: Use of Thermography for the Prevention and Diagnosis of Rheumatic Foot
Official title: Use of Thermography for the Prevention and Diagnosis of Rheumatic Foot
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatoid Arthritis
Rheumatoid Arthritis RA
Rheumatic Diseases
Keywords: Rheumatic foot
Rheumatoid Arthritis
Rheumatic diseases
Thermoghrapy
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Selected patients will be healthy subjects and subjects with more than 5 years of rheumatoid arthritis who wish to voluntarily participate in the study.

Brief summary: The aim of this observational study is to establish normal thermographic parameters in patients with rheumatoid arthritis, in order to prevent and diagnose rheumatic foot using thermography. The main question to be answered is: What are the normal thermographic parameters in rheumatic foot?

If there is a comparison group: the researchers will compare the thermography of the foot in healthy subjects and in subjects with rheumatoid arthritis to see if there are any alterations in the thermographic image.

Patients who wish to participate in the study will undergo a thermographic study of the foot, which does not entail any risk to their health.


Eligibility criteria: Inclusion Criteria:

* Patients with rheumatoid arthritis of more than 5 years\&#39; duration
* Healthy patients without diagnosed systemic disease
* Patients between 40 and 80 years of age

Exclusion Criteria:

* Patients who are pregnant or may become pregnant
* Patients with degenerative diseases or significant cognitive impairment
* Patients with rheumatic diseases without a diagnosis of rheumatoid arthritis

Primary outcomes:
measure: NORMAL PARAMETERS IN THERMOGRAPHY IN PATIENS WITH HEALTHY FOOT
timeFrame: One measurement will be taken at the start of the study and another measurement the following 6 month.
Secondary outcomes:
measure: NORMAL PARAMETERS IN TERMOGRAPHY IN PATIENS WITH RHEUMATIC FOOT
timeFrame: One measurement will be taken at the start of the study and another measurement the following 6 month
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University of Seville
Study officials:
References:
Clinical trial NCT03736369: Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)
Official title: A Multi-Center, Randomized, Double-Blind, Active-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erosive Esophagitis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2018-11-09
Enrollment: 263
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.


Eligibility criteria: Inclusion Criteria:

* Adults between 20 and 75 years old based on the date of written agreement
* Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days

Exclusion Criteria:

* Those who have undergone gastric acid suppression or gastric, esophageal surgery
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

Primary outcomes:
measure: Cumulative healing rate of erosive esophagitis at 8week by endoscopy
timeFrame: at 8week
Secondary outcomes:
measure: Cumulative healing rate of erosive esophagitis at 4week by endoscopy
timeFrame: at 4week
measure: Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
timeFrame: at 4week and 8week
measure: Quality of Life assessment using GERD-HRQL(GERD-Health related quality life)
timeFrame: at 4week and 8week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
Study officials:
References:
Clinical trial NCT02320669: Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
Official title: Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Congenital Heart Defects
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 220
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.


Eligibility criteria: Inclusion Criteria:

1. Informed consent obtained
2. Male and female patients \<5 months (152 days) of age
3. Patients undergoing cardiopulmonary bypass

Exclusion Criteria:

1. Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)
2. Trisomy 13 and 18
3. Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
4. Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
5. Prior participation in the clinical trial

Primary outcomes:
measure: Time To Extubation
timeFrame: 30 days
Secondary outcomes:
measure: ICU Length of Stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Children's Hospital
state: California
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Michael Portman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Portman MA, Slee AE, Roth SJ, Radman M, Olson AK, Mainwaring RD, Kamerkar A, Nuri M, Hastings L; TRICC Investigators. Triiodothyronine Supplementation in Infants Undergoing Cardiopulmonary Bypass: A Randomized Controlled Trial. Semin Thorac Cardiovasc Surg. 2023 Spring;35(1):105-112. doi: 10.1053/j.semtcvs.2022.01.005. Epub 2022 Jan 31.
Clinical trial NCT02206269: China Alair System Registry Study-CARE Study
Official title: Registry of Bronchial Thermoplasty (BT) Procedures in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Lead sponsor: BSC International Medical Trading (Shanghai) Co., Ltd.
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 225
Sex: ALL
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: The real world patient polulaiton who undergo BT in China

Brief summary: The objective of this Registry is to collect real-world outcome data for bronchial thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic despite taking standard of care maintenance medications.

Detailed description: Data will be used to confirm the impact of BT on safety, effectiveness, quality of life, and the anticipated reduction in healthcare utilization events and cost by way of a reduction in severe asthma exacerbations.

Eligibility criteria: Inclusion Criteria:

1. Patient is an adult aged 18 years or older with severe persistent asthma who remains symptomatic despite taking standard of care maintenance medications.
2. Patient is able to read, understand, and sign a written Informed Consent to participate in the Registry and able to comply with the study requirements.
3. Patient is able to undergo bronchoscopy in the opinion of the Investigator or per hospital guidelines and as described in the Alair System Directions for Use (DFU).

Exclusion Criteria:

1. Patient has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator).
2. Patient has any other medical condition that would make them inappropriate for study participation, in the Investigator's opinion.

Primary outcomes:
measure: Incidence of severe asthma exacerbations following BT with the Alair System.
timeFrame: 1 year
Secondary outcomes:
measure: Quarlity of life of Patients
timeFrame: 1 year
measure: Health care utilization
timeFrame: 1 year
measure: FEV1
timeFrame: 1 year
measure: Serious respiratory adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: BSC International Medical Trading (Shanghai) Co., Ltd.
state: Shanghai
Study officials:
affiliation: China-Japan Friendship Hospital
name: Jiangtao Lin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00828269: Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C (0000-123)
Official title: Evaluation of RNA Quality and the Reproducibility of Gene Expression Profiling From Liver Tissue Obtained by Fine Needle Aspiration in Patients With Chronic Hepatitis C.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Keywords: Patients with Chronic Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the quality of the RNA and the reproducibility of gene expression profiling from liver tissue samples obtained by fine needle aspiration.


Eligibility criteria: Inclusion Criteria:

* Patient has chronic hepatitis C (Genotype 1)
* Patient has the ability to avoid use of anticoagulants, nonsteroidal anti-inflammatory drugs and aspirin for at least 5 days before the liver biopsy

Exclusion Criteria:

* Patient has received any approved or investigational drugs for the treatment of hepatitis C in the six months before the liver biopsy
* Patient has HIV or Hepatitis B virus
* Patient has been diagnosed with liver cancer
* Patient has evidence of cirrhosis on any previous liver biopsy
* Patient has confirmed alcohol abuse in the last 12 months
* Patient has participated in any investigational drug study within 90 days before the current study

Primary outcomes:
measure: To evaluate the probability that fine needle aspiration of the liver results in RNA suitable to conduct gene expression tests.
timeFrame: 5 weeks
Secondary outcomes:
measure: Comparison of qPCR and microarray signature from patients with no or minimal fibrosis to that from patients with moderate to advanced fibrosis.
timeFrame: 5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04461769: Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep
Official title: Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sleep
Sleep Hygiene
Lead sponsor: Brain Electrophysiology Laboratory Company
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: First night adaptation sleep; second and third nights (one week apart) stimulation or placebo control (order randomized).
Primary purpose: TREATMENT

Brief summary: This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo control provided no stimulation. The primary endpoint was duration of N3 sleep during the night. Thirteen normal adults completed the study (before the study was terminated because of COVID-19), and usable data were obtained from ten. The synchronizing stimulation resulted in significantly longer N3 sleep compared to placebo.

Detailed description: Previous studies have demonstrated successful synchronization of SOs with slow TES pulses. However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3, F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from frontal neocortex. In the present study, we hypothesized that transcranial electrical stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3 sleep. Furthermore, based on our computational modeling with this more optimal targeting of the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1 or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* history of seizures
* epilepsy
* brain trauma or injury
* insomnia
* sleep apnea
* medications that may affect the EEG.

Primary outcomes:
measure: N3 Duration
timeFrame: Measured during the night of sleep (typically 8 hours)
Secondary outcomes:
measure: N3 Percentage
timeFrame: Measured during the night of sleep (typically 8 hours)
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Brain Electrophysiology Laboratory Company
state: Oregon
Study officials:
References:
Clinical trial NCT06114069: Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth
Official title: Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis Survival
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were classified into 2 groups:

1. Group I; 4 patients received 4-implant supported fixed prosthesis.
2. Group II; 4 patients received 6-implant supported fixed prosthesis.
Primary purpose: TREATMENT

Brief summary: the aim of the study to compare the anterior maxillary bone index changes for patient rehabilitated with implant supported fixed prosthesis opposed by natural teeth


Eligibility criteria: Inclusion Criteria:

* 1. All patient wearing a maxillary implant supported overdenture or implant supported fixed restoration and mandibular natural teeth or fixed restoration within natural dentition.

  2. All patients were unsatisfied by the maxillary restoration and presented clear preference for a better prosthesis.

  3. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.

  4. At least one year passed after the last restoration. 5. At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna).195 This was detected by a tentative jaw relation.

Exclusion Criteria:

* 1. Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.

  2. Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders which might affect implant lifespan.

  3. Long term immunosuppress and corticosteroid drug therapy. 4. Patient with abnormal habits as clenching and bruxism. 5. Smoking patient. 6. Uncooperative patients. 7. Neuromuscular diseases. 8. Patient with problems in TMJ.

Primary outcomes:
measure: anterior area index
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Amr Saeed
state: DK
Study officials:
References:
Clinical trial NCT03224169: Implementation of Directly Observed Hand Hygiene in Residential Care Home for the Elderly: a Cluster Randomized Trial
Official title: Implementation of Directly Observed Hand Hygiene in Residential Care Home for the Elderly: a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multidrug Resistant Organisms
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To screen the prevalence of multidrug resistant organisms among the resident in the residential care home for the elderly, and assess the practicability of directly observed hand hygiene in this setting.


Eligibility criteria: Inclusion Criteria:

* Residents living the residential care home for the elderly and able to give consent

Exclusion Criteria:

* Those who cannot give consent

Primary outcomes:
measure: Environmental contamination
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Vincent Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: