louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02024594: Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Anxiety
Clinical Cooperation
Keywords: Nitrous Oxide-Oxygen conscious sedation
Cognitive Behavioral Therapy
Children, Preschool
dental anxiety
Patient Cooperation
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 45
Sex: ALL
Minimum age (years): 36
Maximum age (years): 78
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Visiting anxious and fearful children is an inevitable prospect of the daily work of every dentist who treats pediatric patients. Dentists have been using a wide variety of non-pharmacological and some pharmacologic techniques to assist them in the management of children with anxiety. One strategy which seems promising for pain control in stressful medical situations is teaching the child to use behavioral and cognitive coping skills or a combination of both techniques. An alternative technique to non-pharmacologic approaches in children being anxious and lacking in cooperative ability is sedative technique such as nitrous oxide conscious sedation. As there is lack of studies comparing conscious sedation and combinations of cognitive-behavioral strategies in eliminating children's uncooperative behaviors and dental anxiety, the aim of this study was to compare the effectiveness of inhalation sedation with Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral therapy to reduce dental anxiety in preschool children.


Eligibility criteria: Inclusion Criteria:

* Age between3 to 6.5 year of old
* Presence of moderate to severe dental anxiety
* Parents' acceptance to cooperate in sampling process and 2 sessions of dental treatment
* Presence of at least one mandibular primary molar needed pulp treatment
* positive dental history

Exclusion Criteria:

* current episodes of medications or drug therapy
* systemic or congenital disorders
* mental retardation

Primary outcomes:
measure: change from baseline in Clinical Anxiety and Cooperation scales.
timeFrame: baseline and 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04589494: Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
Official title: Comparison Between the Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Chronic Pain
Keywords: morphine
tramadol
PD1 and PD1 ligand
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this work is looking for comparison between the effect of tramadol versus morphine on PD1 and PD1-ligand in patients with chronic cancer pain

Detailed description: The use of opioids is the mainstay in the treatment of many types of chronic pain, including cancer and non-cancer-related pain\]. Opioids are known to suppress immune function following both acute and chronic administration; however, they appear to be different according to the schedule of administration as well as the state of the organism. Programmed death-1 (PD-1, also known as CD279) belongs to the CD28 receptor superfamily. It is an inhibitory receptor, and its expression is upregulated on activated leukocytes, resulting in an inhibited immune response. PD-1 interacts with two ligands: programmed death ligand-1 (PD-L1, also referred to as B7-H1) and programmed death ligand-2 (PD-L2, also known as B7-DC). PD-L2 is expressed mainly on activated dendritic cells (DCs) and macrophages, whereas PD-L1 is distributed widely. In addition to immune cells, some subsets of tumor cells also express PD-L1 to escape from immunosurveillance. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress.

Eligibility criteria: Inclusion Criteria:

* patients with cancer pain of varying etiology,
* documented metastatic cancer, currently on step I WHO ladder and whose pain necessitates a shift to step II,
* those who have never received radiotherapy, chemotherapy, or immunosuppressive drugs, -- and in good general and nutritional condition and without infectious diseases at the time of investigation.

Exclusion Criteria:

* abnormal hepatic, renal, and pulmonary function, gastrointestinal pathology, and
* those with cerebral metastases and/or psychological disorders,
* patients with contraindication to morphine or tramadol according to their respective data sheets, and
* patients who could not complete the diary information correctly.

Primary outcomes:
measure: changes in PD1 and PD1ligand
timeFrame: baseline(0), day15 , day 30
Secondary outcomes:
measure: pain assessment
timeFrame: baseline(0), day15 ,day 30
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Shereen M Kamal, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00689494: Cervical Device Contraception-2 (Nanopaz)
Official title: Cervical Device Contraception
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Nanopaz device
Blood progesterone measure in using the device
Delivery progesterone
Progesterone levonorgestrel
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-06-03
Enrollment: 10
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Measure blood progesterone by using cervical device contraception.

Detailed description: A very small cervical device that releases small amount of progesterone 20 mcgm/day.

The target of the research is to measure blood progesterone by using the cervical device.

This small device delivers progesterone by nanotechnology method.

Eligibility criteria: Inclusion Criteria:

* 10 healthy women are candidate for hysterectomy

Exclusion Criteria:

* Women with neoplastic malignancy disease or thrombophylia

Primary outcomes:
measure: blood progesterone measure in blood
timeFrame: one to two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03102294: Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension
Official title: Inspiratory Muscle Training in Patients With Chronic Thromboembolic Pulmonary Hypertension: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Inspiratory Muscle Training
Inspiratory Muscle Weakness
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inspiratory muscle training for 8 weeks in patients with chronic thromboembolic pulmonary hypertension.

Detailed description: 32 patients with CTEPH (confirmed by right cardiac catheterization and imaging) will perform: 1) pulmonary function tests; 2) measurement of maximal inspiratory pressure (MIP) and endurance; 3) evaluation of peripheral muscle strength by isokinetic dynamometry; 4) six-minute walk test and 5) incremental and constant load cardiopulmonary exercise test (\~ 75% of maximal work-rate) with non-invasive evaluation of central hemodynamics and peripheral muscle oxygenation. Inspiratory muscle training will consist of twice daily sessions of 30 breaths (\~ 50% PiMAX, 4-5 minutes per session) for 8 weeks. The SHAM group will perform sessions of 30 breaths with no inspiratory load.

Eligibility criteria: Inclusion Criteria:

* CTEPH confirmed by RHC and imaging
* NYHA FC II-IV

Exclusion Criteria:

* Limitation to cycling
* Recent syncope or clinical deterioration

Primary outcomes:
measure: exercise capacity¨- cardiopulmonary exercise testing
timeFrame: week 8
measure: exercise capacity - 6-min walk test
timeFrame: week 8
Secondary outcomes:
measure: ventilatory responses
timeFrame: Week 8
measure: peripheral oxygenation
timeFrame: Week 8
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: SEFICE - Setor de Função Pulmonar e Fisiologia Clínica do Exercício
state: São Paul
Study officials:
References:
Clinical trial NCT03176394: Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)
Official title: Efficacy of Bladder Catheters Lubricated With a Biofilm Disruptive Gel, in Reducing Catheter-associated Bacteriuria (CAB) Compared to Standard of Care: A PILOT Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: Foley, UTI, Biofilm, DNA
Lead sponsor: Next Science TM
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Urine and/or catheter DNA analysis will be obtained at catheter insertion, 2, 5, 7 and 14 days after catheterization.

Detailed description: This is a 2-week, single-site, randomized controlled pilot study in adults requiring short-term \< 14 days catheterization. Subjects will be randomized 1:1 to either the BLASTX or SOC lubricated catheters.

Urine and catheter DNA analysis will be obtained at catheter insertion, 2 to 3 days after catheterization and at 5, 7 and 14 days if catheterization was indicated for either duration.

Informed consent discussion will be completed, ICF will be signed, prior to any study procedures.

Subjects will be included only if all of the inclusion criteria and none of the exclusion criteria have been met.

After randomization, subjects will be followed, urine samples will be collected at each scheduled visit and the catheters will be collected upon removal.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Absence of symptomatic UTI
3. Absence of upper/lower tract obstructions
4. No known allergies to the study products
5. Willing to comply with all study procedures and available for the duration of the study

Exclusion Criteria:

1. 17 years or younger
2. Symptomatic UTI
3. Presence of upper/lower tract obstructions
4. Known allergic reaction to the study products
5. Unable to provide signed and dated informed consent form

Primary outcomes:
measure: Urine microorganisms DNA analysis
timeFrame: Up to 14 days
measure: Catheter microorganisms DNA analysis
timeFrame: Up to 14 days
Secondary outcomes:
measure: Incidence of Urinary Tract Infections (UTIs)
timeFrame: 14 days
Other outcomes:
Locations:
city: Celebration
country: United States
facility: American Medical Research Institute
state: Florida
Study officials:
affiliation: Next Science
name: Susan Greco, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02986594: Diagnosis and Treatment Strategy of Recurrent Spontaneous Abortion Associated With Thrombophilla
Official title: Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thrombophilia With Recurrent Pregnancy Loss
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 600
Sex: FEMALE
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: In this clinical cohort study, the investigators observe the efficacy of low molecular weight heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Woman who had their Second miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.

Exclusion Criteria:

1. having experiencedsevere allergies, trauma history and/or operation history within 3 months
2. with a history of mental illness and/or family history of mental illness
3. limb disabled
4. taking medicine within one month
5. suffering major events or having mood swings
6. with a history of recurrent pregnancy loss
7. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine rotine)
8. Chromosome aberrations in anyone of the couple.
9. patients who have drug contraindications

Primary outcomes:
measure: D-Dimer
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: BMI in kg/m^2
timeFrame: through study completion, an average of 3 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai first Maternity and Infant health hospital, Tong Ji University
Study officials:
References:
Clinical trial NCT02902094: Drug Eluting Balloon Venoplasty in AV Fistula Stenosis
Official title: Improving Outcomes in Fistula Intervention: A Prospective, Patient Blinded, Phase 3, Randomised Controlled Trial of Drug Eluting Balloons in the Angioplasty of Native Haemodialysis Access Arteriovenous Fistula Outflow Stenosis (DeVA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Native Arteriovenous Fistula
Stenosis
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2016-09-15
Enrollment: 186
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: DeVA is a single blinded, prospective, multicentre RCT designed to determine the safety and effectiveness of a drug eluting angioplasty balloon compared with a standard angioplasty balloon in patients with symptomatic native AV fistula stenosis.


Eligibility criteria: Inclusion Criteria:

* Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis.
* Fistula has been in use for at least 1 month and is \> 6 weeks old
* Brachiocephalic AV fistula
* Brachiobasilic AV fistula
* Radiocephalic AV fistula (both proximal and distal)
* Participant \>/=18 yrs old
* Index lesion is less then the length of the DEB, and the reference vessel diameter is appropriate for treatment with the size range of DEB (4mm - 8mm diameter)
* Participant is able to give valid informed consent

Exclusion Criteria:

* Allergy to iodinated Intravenous contrast
* Allergy to Paclitaxel
* Prosthetic grafts
* Long or tandem lesions that cannot be treated with a single DEB
* Thrombosed Arterio-Venous fistulas
* Women who are breastfeeding, pregnant or intending to become pregnant
* Participants of child-bearing age who are unwilling to use a reliable form of contraception for the duration of the study.

Primary outcomes:
measure: Patency
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: Time of baseline index intervention
measure: Assisted technical success of balloon angioplasty
timeFrame: At time of baseline index intervention
measure: Successful use of fistula for dialysis
timeFrame: In the 12 months following baseline index intervention
measure: Secondary patency of the access circuit
timeFrame: In the 12 months following baseline index intervention
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: West Midlands
Study officials:
affiliation: University Hospital Birmingham NHS Foundation Trust
name: Robert Jones, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02957994: TAF Switch Study in Hepatitis B Monoinfection
Official title: Analysis of Proximal Renal Tubular Function of "Real World" Chronic Hepatitis B (CHB) Patients Who Are Suppressed on TDF and Switched to TAF
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Lead sponsor: Asian Pacific Liver Center at Coalition of Inclusive Medicine
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate various markers of renal function and bone density after the switch to Tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with Tenofovir disoproxil fumarate (TDF) .

Detailed description: The investigators have previously reported the prevalence of abnormal renal tubular reabsorption of phosphate among CHB patients treated with more than 18 months of TDF to be 48%. Renal tubular dysfunction associated with TDF may be reversible when TDF is discontinued 4. Recently, TAF 25 mg daily was shown to have comparable efficacy to TDF 300 mg with respect to viral suppression in both HBeAg positive and HBeAg negative CHB patients (studies 110 and 108) at 48 weeks of therapy. As speculated, the systemic exposure to tenofovir was significantly less in patients exposed to TAF compared to those on TDF with strikingly less effects noted in a variety of renal and bone parameters for individuals receiving TAF. Notably, however, the question remains to what if any improvements may be seen in CHB patients switched from TDF to TAF.

The investigators propose a prospective open label study to evaluate various markers of renal function and bone density in 80 CHB patients who are currently treated with TDF who are switched to TAF.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic hepatitis B (who are either HBeAg reactive or non-reactive)
* Treated with TDF with unquantifiable Hepatitis B Virus (HBV) DNA by a sensitive Polymerase chain reaction (PCR) assay for a minimum of 6 months
* No prior nucleos(t)ide exposure prior to treatment with TDF
* Treatment with TDF for a minimum of 12 months

Exclusion Criteria:

* HIV Infection

Primary outcomes:
measure: measure renal function after switch to TAF
timeFrame: one year
measure: measure bone density after switch to TAF
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fong TL, Lee BT, Tien A, Chang M, Lim C, Ahn A, Bae HS. Improvement of bone mineral density and markers of proximal renal tubular function in chronic hepatitis B patients switched from tenofovir disoproxil fumarate to tenofovir alafenamide. J Viral Hepat. 2019 May;26(5):561-567. doi: 10.1111/jvh.13053. Epub 2019 Jan 16.
Clinical trial NCT00583960: Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea
Official title: Office-based Radial Expansion Balloon Dilation of the Esophagus and Trachea
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Tracheal Stenosis
Keywords: swallowing problems
tracheal stenosis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: UCDMC Otolaryngology Voice and Swallowing Center patients

Brief summary: Retrospective chart review of UCDMC patients who have undergone esophageal or tracheal balloon dilation to record data including age, gender, diagnosis pre-and post-procedure eating assessment tool, esophagoscopy findings, tracheobronchoscopy findings, and pre-and post-procedure videofluoroscopic findings.

Detailed description: Dilation of the esophagus is performed for strictures, webs, and rings at all levels of the esophagus. Dilation of the trachea is performed for subglottic and tracheal stenosis. Radial expansion balloons have been developed by Bost Scientific Corporation for the purpose of dilating the esophagus and trachea through flexible esophagoscopies. These sequential controlled radial-expansion balloons can be introduced via a guide wire through the working channel of a 5.1 mm transnasal esophagoscope. Traditionally, otolaryngologists have performed esophageal and tracheal dilation per oral under general anesthesia. This technique allows the procedure to be performed in the office, sparing the patient the risk of anesthetics. The purpose of this study is to review the UCDMC experience with esophageal and tracheal balloon dilation using the transnasal esophagoscope.

Eligibility criteria: Inclusion Criteria:

* patients who have undergone esophageal or tracheal balloon dilation since 1/1/05
* patients who underwent an attempted dilation since 1/1/05

Exclusion Criteria:

* Younger than 18 years of age
* Those who do not meet the inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Peter Belafsky, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: