louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04554199: Brain and Cognitive Function of Patients With RPD
Official title: Evaluation of Changes in Brain Activity and Cognitive Function of Diabetic Patients Wearing Removable Partial Dentures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Missing Posterior Occlusal Contact
Keywords: Removable partial dentures
Electro-encephalogram
Mini mental state examination
Controlled type 2 diabetes.
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 30
Sex: MALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the influence of restoring lost posterior occlusal contacts with removable partial denture (RPD) on the brain activity and cognitive function in controlled type 2 diabetic patients


Eligibility criteria: Inclusion Criteria:

* Loss of posterior occlusal contact unilaterally or bilaterally in both maxilla and mandible.
* No previous partial dentures experience.
* Nonsmokers.
* Skeletally Angle's class I.
* Controlled type 2 diabetes.

Exclusion Criteria:

* History of brain diseases (e.g. cerebral infarction, and Alzheimer's).
* Neuromuscular disorders.
* Temporomandibular joint disorder.
* Psychiatric illness.
* Participants with parafunctional oral habits.

Primary outcomes:
measure: Brain activity measurement in controlled type 2 diabetic patients wearing RPD.
timeFrame: For each participant the RPD should be worn for one month.
measure: Cognitive function assessment in controlled type 2 diabetic patients wearing RPD.
timeFrame: For each participant the RPD should be worn for one month.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
state: Dokki
Study officials:
References:
Clinical trial NCT03740399: Effect of Modified 45-degree Head-up Tilt Position in Cesarean Operation to the Success of Spinal Anesthesia
Official title: Effect of Modified 45-degree Head-up Tilt Position in Cesarean Operation to the Success of Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Regional Anesthesia Morbidity
Keywords: sitting position
lateral decubitus position
spinal block
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated.

Detailed description: 180 patients in ASA I-II risk group between the ages of 18-50 will be included in the study.The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated. Anatomical features of height, weight, block application of the patients will be recorded.

Eligibility criteria: Inclusion Criteria:

* caesarean section
* 18-50 years old
* ASA I-II risk

Exclusion Criteria:

* heart failure
* patient's refusal
* thrombocytopenia
* coagulation disorder
* heart valve diseases

Primary outcomes:
measure: spinal anesthesia success
timeFrame: spinal anesthesia success will be 15 minutes in intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
state: Centrum
Study officials:
affiliation: Trakya University
name: Sevtap Hekimoglu Sahin, Proffesor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01243099: Prospective Study to Assess DES Re-endothelization in BMS Restenosis and De-novo Lesions
Official title: Des Re-Endothelization for In-StEnt ResTenosis. The DESERT Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Coronary Artery Disease
Silent Myocardial Ischemia
In-stent(BMS)Restenosis
De-novo, Atherosclerotic, Coronary Lesions
Lead sponsor: S.M. Misericordia Hospital
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 31
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: Paziente affected by either stable coronary artery disease or silent myocardial ischemia

Brief summary: The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is supported by two different observations: first, when a DES is implanted to treat a BMS restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly characterized by extracellular matrix with a regular surface. In this case stent malposition is less likely to occur compared to atherosclerotic lesion whose surface is often more irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is implanted to treat restenosis, reendothelialization is likely to occur earlier. If this hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES implantation on BMS restenosis with a clinical advantage in terms of bleeding risk. Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES; thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and to benefit from a shorter period of dual antiplatelet therapy.


Eligibility criteria: Inclusion Criteria:

Patients suitable for implantation of everolimus-eluting stents (Xcience V, Xience Prime) because of stable/unstable angina or silent myocardial ischemia due to:

* Group A: single BMS restenosis (\> 50% of luminal diameter)
* Group B: single de-novo lesion (\> 50% of luminal diameter)

Exclusion Criteria:

* contraindications to dual antiplatelet therapy
* acute myocardial infarction within the previous 48 hours
* significant left main coronary artery disease
* reference vessel diameter \< 2.5 mm,
* hemodynamic instability
* chronic kidney disease with serum creatinine \> 2 mg/dl
* pregnancy
* allergy to contrast agent, everolimus, aspirin, clopidogrel
* life expectancy \< 24 months
* patients with possible low adherence to medical therapy

Primary outcomes:
measure: Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up.
timeFrame: Measured will be assessed six-month after coronary angioplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Grosseto
country: Italy
facility: Misericordia Hospital
Study officials:
References:
Clinical trial NCT05705999: Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT, a Double-blind, Randomized, Controlled Study
Official title: Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT, a Double-blind, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tourette Syndrome
Keywords: Tourette Syndrome
Comprehensive Behavioral Intervention for Tics
Transcranial Magnetic Stimulation
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: University of Florida
name: Tourette Association of America
First posted: 2023-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study will investigate the clinical and neurophysiological effects of repetitive transcranial magnetic stimulation (rTMS) followed by comprehensive behavioral intervention for tics (CBIT) in adult patients with Tourette's Syndrome (TS). Two groups of moderate disease severity will be randomized to receive active or sham rTMS targeted to the supplementary motor area (SMA) followed by eight CBIT sessions. The change in tic frequency and severity (primary outcome) and neurophysiological changes (secondary outcome) will be compared between the two groups. The central hypothesis is that low frequency rTMS will augment the effects of CBIT through favorable priming of the SMA network.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Diagnosis of Tourette Syndrome
* Moderate Tic Severity at baseline

Exclusion Criteria:

* Presence of metallic objects or neurostimulators in the brain
* Pregnancy
* History of active seizures or epilepsy
* Contraindications to receiving fMRI
* Inability to participate in CBIT due to other underlying cognitive or medical condition

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: Through study completion, an average of 3 months
measure: Modified Rush Videotape Tic Rating Scale (mRVTRS)
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: WVU RNI
state: West Virginia
Study officials:
affiliation: WVU RNI
name: Jessica Frey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00154999: The Predictors of the Neonatal Hyperbilirubinemia
Official title: The Predictors of the Neonatal Hyperbilirubinemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperbilirubinemia, Neonatal
Keywords: hyperbilirubinemia
free radicals
Health neonate
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY
Time perspective: PROSPECTIVE

Brief summary: The oxygen tension increases more than 3 times from fetus to neonate. The oxidant stress happens. And it will cause the destruction of RBC. So, we propose that the ROS may play an important role of neonatal hyperbilirubinemia. There is strong association between the bilirubin level and ROS levels at 3 days old in our pilot study.

Detailed description: The incidence of neonatal jaundice is higher in Eastern population than western people. The bilirubin comes from the destruction of RBC which heme is released and catabolized. If the bilirubin enters into the brain and deposits in basal ganglion, it will cause apoptosis of the neuronal cells, that is so called kernictrus, which is the major complication of the neonatal jaundice. However, the bilirubin has its own antioxidant protective effect. Many clinical or basic studies tried to find out the relationship of bilirubin and reactive oxygen species (ROS) in recent years.

The American Association of Pediatrics proposed the management principle of neonatal jaundice in 1994. It postponed the management criteria of neonatal jaundice Besides, early discharge (before 48 hour-old) was the trend in many countries. It may be dangerous because the neonatal jaundice appears after 48 hour-old. Whether the criteria and the trend will cause the elevation of the incidence of kernictrus, is always the major concern of clinicians. So, searching factors to predict neonatal hyperbilirubinemia causes the interest of many investigators. The predictors are divided into risk-factor based and normogram based. But they are still not suitable for all populations.

Eligibility criteria: Inclusion Criteria:

* Health neonate

Exclusion Criteria:

* perinatal insults prematurity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Hung-Chieh Chou, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05183399: Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries
Official title: Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries in Thoracic, Abdominal, and Pelvic Arteries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iatrogenic Vessel Injury
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with traumatic or iatrogenic vessel injuries in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries ) with a reference vessel diameter ranging from 4.0 to 12.0mm.

Brief summary: The purpose of this study is to confirm device efficacy and safety of the GORE® VIABAHN® Endoprosthesis (hereafter "VB device") for the treatment of traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries).


Eligibility criteria: Patients with traumatic or iatrogenic vessel injuries in thoracic, abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and pulmonary arteries ) with a reference vessel diameter ranging from 4.0 to 12.0mm.

Primary outcomes:
measure: Technical Success
timeFrame: Day 1 to 1 Month
Secondary outcomes:
measure: Safety
timeFrame: Day 1 to 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00518999: Emotional and Cognitive Abilites of Schizophrenia Patients at Various Time Points
Official title: Emotional and Cognitive Abilites of Schizophrenia Patients at Various Time Points
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: cognition, attention, memory, executive functions, illness-awareness, insight.
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2007-08-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Longitudinal investigation of cognitive, emotional and illness awareness of schizophrenia outpatients (Shalvata Mental Health Center). The study uses computerized assessment of cognitive functioning and questionnaire to assess performance of patients assessed in the past as part of a routine clinical assessment.


Eligibility criteria: Inclusion Criteria:

1. Schizophrenia diagnosis by a senior psychiatrist (according to DSM-4 criteria).
2. Age between 18-65 (male and female).
3. Prior cognitive assessment in the Emotional-Cognitive Research Laboratory (Shalvata Mental Health Center)
4. Signed informed consent by participants.

Exclusion Criteria:

1. Hospitalization at the time of experiment.
2. A history of brain-injury or other neurological condition precluding participation in the study.
3. Guardianship.
4. Current alcohol or drug abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shalvata Mental Health Center
name: Hilik Levkovitz, MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03575299: Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells
Official title: Clinical Study on Adoptive Treatment of Multidrug Resistant Pulmonary Tuberculosis With Allogeneic γδT Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multi-drug Resistant Tuberculosis
Keywords: MDR-TB
Allogeneic γδT cells
adoptive treatment
Lead sponsor: Jinan University Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Third People's Hospital
First posted: 2018-07-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Brief summary: Allogeneic γδT cells from healthy donor will be administrated intravenously to patients with the MDR-TB，and then the safety and efficacy of γδT cells will be evaluated.

Detailed description: All patients with multi-drug resistant pulmonary tuberculosis will be assigned into 2 groups(study group and control group)，both groups will receive conventional treatment. Allogeneic γδT cell will be administrated intravenously to patients in the study group (but not the control group) every two weeks for 6 months

Eligibility criteria: Inclusion Criteria:

1. Aged 18-50 years old, male or female;
2. Informed consent;
3. Patients with multidrug-resistant tuberculosis diagnosed by positive sputum smear and tubercle bacillus culture.

Exclusion Criteria:

1. AIDS, hepatitis B and other viruses, bacterial infections;
2. Patients with other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system diseases, mental diseases, neurological diseases, and vascular circulatory diseases;
3. Others After being evaluated by clinicians participating in this project, it is not suitable to participate in immune cell therapy;
4. Those who do not agree to be included.

Primary outcomes:
measure: sputum smear
timeFrame: 6 months
Secondary outcomes:
measure: Sputum tubercle bacillus culture
timeFrame: 6 months
measure: Fecal microbiome analysis
timeFrame: 6 months
measure: Assessment of immune function
timeFrame: 6 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
state: Guangdong
Study officials:
affiliation: Partner
name: Guofang Deng, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liang J, Fu L, Li M, Chen Y, Wang Y, Lin Y, Zhang H, Xu Y, Qin L, Liu J, Wang W, Hao J, Liu S, Zhang P, Lin L, Alnaggar M, Zhou J, Zhou L, Guo H, Wang Z, Liu L, Deng G, Zhang G, Wu Y, Yin Z. Allogeneic Vgamma9Vdelta2 T-Cell Therapy Promotes Pulmonary Lesion Repair: An Open-Label, Single-Arm Pilot Study in Patients With Multidrug-Resistant Tuberculosis. Front Immunol. 2021 Dec 15;12:756495. doi: 10.3389/fimmu.2021.756495. eCollection 2021.
Clinical trial NCT01895699: The Effect of Contrast Agent on Endothelial Function in Healthy Men
Official title: The Effect of Contrast Agent on Endothelial Function in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contrast Agent
Endothelial Function
Cytokines
Apoptosis of Endothelial Progenitor Cell
Free Radical
Alpha-lipoic Acid
Keywords: Contrast agent
endothelium
Free radical
Alpha lipoic acid
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Contrast medium is essential for diagnosis of many diseases. However, recent studies showed that contrast agents can induce renal injury and is associated with poor long-term clinical outcome, especially in diabetes. To date, no data are available on the relationship between contrast medium and endothelial function. Endothelial dysfunction is known to precede atherosclerosis and is considered a risk marker for future development of cardiovascular disease. Therefore, we hypothesized that contrast agents may induce endothelial dysfunction in healthy men. In addition, we hypothesized that contrast induced endothelial dysfunction via free radicals. Thus, we also test alpha-lipoic acid whether or not protect endothelial dysfunction induced by contrast agents.


Eligibility criteria: Inclusion Criteria:

* healthy men
* 20 yr \< = age \< = 30 yr
* 20 \< = body mass index \< = 25

Exclusion Criteria:

* age \< 20 yr or \> 30 yr
* dysfunction for liver, renal, and heart.
* other diseases such as diabetes, hypertension, thyroid disease

Primary outcomes:
measure: The endothelial dysfunction and the protective role of alpha-lipoic acid
timeFrame: 6 months
Secondary outcomes:
measure: The apoptosis of endothelial progenitor cell
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan General Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT04628299: Effects of the Myofascial Induction Technique Versus a Control Laser
Official title: Effects of the Myofascial Induction Technique Versus a Control Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Diseases
Myofascial Pain
Lead sponsor: Mayuben Private Clinic
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to determine the effectiveness of myofascial Induction effects on plantar pressures variables. Forty healthy subjects will be recruited for a simple blind clinical trial. All subjects will be randomly distributed in two different groups: control group (sham Laser) and experimental group (myofascial Induction). Outcome measurements will be foot plantar pressure area (footprint) by a validated platform. Two trials will be recorded before and after intervention in standing position.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals without pain.

Exclusion Criteria:

* Previous lower extremities surgery
* History of lower extremities injury with residual symptoms within the last year
* Evidence of a leg-length discrepancy of more than 1 cm
* Evidence of balance deficits

Primary outcomes:
measure: Plantar pressure measure
timeFrame: Register a plantar pressures of foot print in standing position of 30 seconds
Secondary outcomes:
measure: Plantar surface measure
timeFrame: Register a plantar surface area of foot print in standing position of 30 seconds
Other outcomes:
Locations:
city: San Sebastián De Los Reyes
country: Spain
facility: Mayuben Clinic
state: Madrid
Study officials:
References: