louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03729986: Activation Patterns of Respiratory Muscles to Loaded Inspiratory Muscle Tests in Healthy Adults Under Different Posture
Official title: Activation Patterns of Respiratory Muscles to Loaded Inspiratory Muscle Tests in Healthy Adults Under Different Posture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Accessory Muscle
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults that are willing to cooperate the measurement of this study.

Brief summary: Whether minimizing sternocleidomastoid (SCM) activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. Therefore, the purpose is to exam diaphragm and SCM activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.

Detailed description: Inspiratory muscle training usually performed in the upright sitting position. In healthy individuals, sternocleidomastoid (SCM) is rarely recruited during tidal breathing, but previous studies have demonstrated SCM activation during loaded inspiratory muscle tests in upright sitting position. Whether minimizing SCM activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. Therefore, the purpose is to exam diaphragm and SCM activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.

Eligibility criteria: Inclusion Criteria:

* age \> 20 years old
* without exercise habit (any exercise that less than 3 days/week)
* can cooperate with the measurements of this study

Exclusion Criteria:

* any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
* angina, acute myocardial infarction in the previous one month
* pregnancy
* participated in inspiratory muscle training program in the previous three months
* any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) \< 24, that will disturb the communication and cooperation of the study

Primary outcomes:
measure: Diaphragm and Sternocleidomastoid muscle activation
timeFrame: Through the completion of the loaded inspiratory muscle test condition; it would take about 3 minutes
measure: The mean median frequency of diaphragm and sternocleidomastoid muscle
timeFrame: In one minute after the completion of the loaded inspiratory muscle test condition
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy of National Taiwan University
state: Zhongzheng Dist
Study officials:
affiliation: National Taiwan University
name: Li-Ying Wang, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT04013386: Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting
Official title: Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting After Laparoscopic Sleeve Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea and Vomiting, Postoperative
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laparoscopic sleeve gastrectomy (LSG) is an emerging treatment modality among the various types of surgical approach to obesity (1). The incidence of PONV in obese patients undergoing bariatric surgery, who did not receive antiemetic prophylaxis, is high at nearly 70-80 % (2,3). Postoperatively, bariatric patients appear to suffer from nausea and vomiting more frequently than normal weight or obese patients.

Detailed description: Currently, available interventions for PONV prophylaxis, especially as monotherapy, lack universal efficacy. Use of combination therapies with different pharmacological basis is likely to bring down rates of PONV. (6) Intravenous dexamethasone (8-10mg) reduces the incidence of PONV, minimizing activity of phospholipase A2 and blocking the expression of cyclooxygenase (COX)2 mRNA that reduce production of prostaglandin and control the release of endorphins.

Aprepitant has demonstrated powerful additive effects when combined with dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV), and in the prevention of postoperative nausea and vomiting (PONV) The use of mirtazapine in the management of nausea and vomiting has been reported for both treatment and premedication

Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II
* Body mass index (BMI) ≥ 35 kg/cm-2

Exclusion Criteria:

* Patients with gastrointestinal disorders,
* Patients with significant major organ disease,
* Patients received antidepressant drugs,
* Patients received an anti-emetic drug within 48 h before surgery,
* Patients on treatment with systemic glucocorticoids within 4 weeks before surgery.

Primary outcomes:
measure: Efficacy of aprepitant/dexamethasone versus mirtazapine/dexamethasone on PONV prophylaxis after laparoscopic sleeve surgery
timeFrame: First 24 hours(h) postoperative.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
affiliation: Faculty of Medicine, Ain- shams University
name: Tarek Mohamed Ashoor, MD
role: STUDY_DIRECTOR
References:
citation: Ashoor TM, Kassim DY, Esmat IM. A Randomized Controlled Trial for Prevention of Postoperative Nausea and Vomiting after Laparoscopic Sleeve Gastrectomy: Aprepitant/Dexamethasone vs. Mirtazapine/Dexamethasone. Anesthesiol Res Pract. 2022 Apr 30;2022:3541073. doi: 10.1155/2022/3541073. eCollection 2022.
Clinical trial NCT00737386: Frequency of Parasite Infection in Hyraxes and Sandflies During Outbreak of Leishmania Tropica Epidemic in The West Bank
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cutaneous Leishmaniasis
Keywords: Leishmania tropica
Hyrax
Sandfly
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2008-08-19
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People living on regullar basis in Peduel (the site of current leishmania tropica epidemic)with and without cutaneous signs of leishmania infection

Brief summary: The objective of the project is to study the pathogenesis of Leishmania tropica infection in a focus of infection, to learn about relationship of infection in humans with ecological factors such as infection in hyraxes reservoir hosts and vector sandflies


Eligibility criteria: Inclusion Criteria:

* People living on regular basis in Peduel (the site of current leishmania tropica epidemic)with and without cutaneous signs of leishmania infection

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT03239886: Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
Official title: Imatinib Discontinuation in Patients With Chronic Myeloid Leukemia Chronic Phase With Sustained MR4log
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leukemia, Myeloid, Chronic-Phase
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-arm study; all patients will discontinue imatinib (intervention)
Primary purpose: TREATMENT

Brief summary: This study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. To be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response of 4log (RM4log) or higher for one year.

Detailed description: Patients will be followed for 2 years, with molecular monitoring, every month in the first year and then every 2 months. Imatinib will be restarted if the major molecular response (RM3log) is lost during the study or if the subject withdraw the informed consenting.

The primary objective is to measure the number of subject that sustain the major molecular response (RM3log or BCR-ABL level below 0.1%) after 2 years of follow-up.

BCR: breakpoint cluster region

ABL: abelson murine leukemia

RM3log: major molecular response, BCR-ABL level below 0.1% (IS)

Eligibility criteria: Inclusion Criteria:

* Chronic myeloid leukemia chronic-phase, defined by the World Health Organization criteria
* Treatment with imatinib for at least 36 months
* BCR-ABL levels below 0,01% (IS) or MR4log in the last 12 months

Exclusion Criteria:

* Previous allogeneic stem cell transplantation
* Previous treatment with dasatinib, nilotinib, bosutinib or ponatinib
* Imatinib dose escalation at any time, due to loss or inadequate response
* BCR-ABL mutation

IS: International Scale

MR4log: molecular response of 4log or \<0,1% (IS)

Primary outcomes:
measure: Number of subjects that remain with RM3log after imatinib discontinuation
timeFrame: 24 months
Secondary outcomes:
measure: Number of subjects that recover MR3log after imatinib reintroduction
timeFrame: 6 months
measure: Analysis of immunological profile of all subjects
timeFrame: 24 months
measure: Safety and tolerability of imatinib discontinuation
timeFrame: 24 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Centro de Pesquisa Clínica da Hematologia do HCFMUSP
state: Sao Paulo
Study officials:
References:
citation: Seguro FS, Maciel FVR, Santos FM, Abdo ANR, Pereira TDM, Nardinelli L, Rocha V, Bendit I. MR 4log and low levels of NK cells are associated with higher molecular relapse after imatinib discontinuation: Results of a prospective trial. Leuk Res. 2021 Feb;101:106516. doi: 10.1016/j.leukres.2021.106516. Epub 2021 Jan 21.
Clinical trial NCT05187286: Expanded Access for Apixaban
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-01-11
Sex: ALL
Minimum age (years): 28
Maximum age (years): 17
Standard ages: CHILD

Brief summary: This is an expanded access designed to provide access to apixaban for eligible participants.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
* Previously participated in the CV185-362 study and was on apixaban for 1 year or until treatment was no longer required

Exclusion Criteria:

* Weight less than 5 kg or greater than 35 kg

Other inclusion/exclusion criteria apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Hospital Of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04418986: Incisional Correction of Corneal Astigmatism During Phacoemulsification
Official title: Incisional Correction of Corneal Astigmatism During Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Astigmatism
Lead sponsor: Al-Rasheed University College
Sponsor class: OTHER
Collaborators: name: Baghdad Medical City
First posted: 2020-06-05
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, parallel two-arm interventional study, the patients were divided into a 1:1 ratio, the study included eyes with visually significant cataract and preoperative corneal regular astigmatism between 0.75 and 2 Diopters undergoing phacoemulsification surgery. They were divided into two groups: controls underwent phacoemulsification with on-axis incision (CCI Group), and patients underwent phacoemulsification with opposite clear corneal incisions (OCCI Group).
Primary purpose: TREATMENT

Brief summary: Today, cataract surgery is regarded as refractive surgery, mainly aiming emmetropia, and this makes eliminating corneal astigmatism is critical. Corneal astigmatism of more than 1 diopter has been reported in up to 45% of the cataract surgery candidates.

It is possible to reduce pre-existing corneal astigmatism by creating a clear corneal incision at the steep meridian of the cornea, however; creating a small incision can correct the only astigmatism up to 1 Diopter, and sometimes this method may not be easy to perform due to the location of steep meridian like the difficulty while creating a superonasal or inferonasal incision at the left eye. This approach is usually sufficient for correcting astigmatism less than 1 D in most eyes. An opposite side clear corneal incision (OCCI) could enhance the flattening effect on the cornea.


Eligibility criteria: Inclusion Criteria:

* Clear cornea
* No history of previous ocular surgery
* Central corneal thickness (CCT) \<640

Exclusion Criteria:

* Irregular corneal astigmatism or lenticular astigmatism
* Corneal opacities or pathology like Fuch's endothelial dystrophy
* Previous ocular surgeries like glaucoma surgery or PKP or pterygium excision
* Posterior segment diseases and pathology
* Complicated phacoemulsification

Primary outcomes:
measure: Mean astigmatic correction
timeFrame: After 1 month of surgery
measure: Mean surgically induced astigmatism
timeFrame: After 1 month of surgery
Secondary outcomes:
measure: Change in visual acuity
timeFrame: After 1 month of surgery
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Ghazi al-Hariri Surgical Specialties Hospital
state: Bab-Almuadham
Study officials:
References:
Clinical trial NCT03293186: Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)"
Official title: Anti-adhesive Effect and Safety of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" by Using Double-blind Test in Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adhesion
Thyroidectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 90
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: PREVENTION

Brief summary: One of most important complication of thyroid surgery is adhesion. There are many anti-adhesive materials, but none of them showed significant outcomes. The investigators planned double blind prospective study of "Thermo-sensitive Adhesion Barrier (MEDICLORE)" to reveal anti-adhesive effect of MEDICLORE. The investigators will recruit total 90 patients (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.


Eligibility criteria: Inclusion Criteria:

* planned to perform thyroidectomy due to thyroid nodule
* no evidence of distant metastasis or invasion to adjacent organ in thyroid cancer
* normal preoperative vocal cord movement
* normal preoperative laboratory study

Exclusion Criteria:

* uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy
* history of keloid or hypertrophic scar
* Graves disease or hashimoto thyroiditis patients
* aspirin or anticoagulant medication within 7 days
* radiation exposure to the head and neck
* previous operation to the neck
* history of allergic reaction to drugs
* pregnant women

Primary outcomes:
measure: Changes of postoperative adhesion will checked using answer of questionnaire that participants and physicians replied.
timeFrame: Participants will be followed from the operation to postoperative 2weeks, 3months, 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02377986: Augmenting Buried in Treasures Workshop (BIT) With In-home Decluttering Practice for Individuals With Hoarding Disorder
Official title: Augmenting Buried in Treasures Workshop (BIT) With In-home Decluttering Practice for Individuals With Hoarding Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hoarding Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 5
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: Patients participate in Buried in Treasures Workshop (BIT) that has been shown to improve symptoms of hoarding disorder. To target levels of clutter, the investigators are testing an intervention to add in-home decluttering practice to the BIT workshop.


Eligibility criteria: Inclusion Criteria:

* 18 years or older at consent
* Primary hoarding disorder, Saving Inventory Revised greater than or equal to 40.
* Clutter Image Rating Scale greater than or equal to 3 and less than or equal to 7.
* Low risk for eviction
* English speaking
* Will and able to understand and complete consent procedures

Exclusion Criteria:

* Hoarding disorder not primary
* Severely depressed individuals; Hamilton Depressions Rating Scale greater than 30 or judged clinically to be at risk of suicide with Columbia Suicide Severity Scale
* Unable or unwilling to allow study staff into home for home assessment OR a Clutter Image Rating Score of less than 2 or greater than 7.
* At risk for eviction
* Animal Hoarding or squalor of any kind

Primary outcomes:
measure: Savings Inventory Revised
timeFrame: Change from baseline at 0, 12 weeks and 18 weeks after treatment start
measure: Clutter Image Rating Scale
timeFrame: Change from baseline at 0, 12 weeks and 18 weeks after treatment start
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Columbia-NYSPI-RFMH
name: H Blair Simpson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Linkovski O, Zwerling J, Cordell E, Sonnenfeld D, Willis H, La Lima CN, Baker C, Ghazzaoui R, Girson R, Sanchez C, Wright B, Alford M, Varias A, Filippou-Frye M, Shen H, Jo B, Shuer L, Frost RO, Rodriguez CI. Augmenting Buried in Treasures with in-home uncluttering practice: Pilot study in hoarding disorder. J Psychiatr Res. 2018 Dec;107:145-150. doi: 10.1016/j.jpsychires.2018.10.001. Epub 2018 Oct 5.
Clinical trial NCT02063386: AZD1722 Open Label, Absorption Distribution Metabolism and Excretion Study
Official title: A Phase I, Single-centre, Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of a Single Oral Dose of 14C-labelled AZD1722 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Ardelyx
Sponsor class: INDUSTRY
First posted: 2014-02-14
Enrollment: 26
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To assess the absorption, distribution, metabolism and excretion of a single dose of 14C labelled AZD1722 in order to define the rates and routes of elimination of AZD1722 and if formed, metabolites.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers aged ≥50 years
* Regular daily bowel movements.
* Have a body mass index (BMI) between 18 and 32 kg/m2 (inclusive) and weigh at least 50 kg and no more than 110 kg.

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
* History or presence of GI, hepatic or renal disease including GI surgery other than appendectomy or any other condition known to interfere with the ADME of drugs.
* Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days before admission to the study centre
* Use of medications that are known to affect stool consistency and/or GI motility, including fibre supplements, anti-diarrheals, prokinetic drugs, enemas, probiotic medications or supplements; or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before admission to the study centre.
* Volunteers exposed to radiation levels above background (eg, via X-ray examination) of \>5 mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1 mSv per year of life.
* Participation in a previously radiolabelled study within the last 5 years

Primary outcomes:
measure: Percentage of radioactive dose recovered in urine and feces
timeFrame: Day 1: Pre-dose and up to 168 hours post-dose
measure: Total percentage of radioactive dose recovered from both urine and feces
timeFrame: Day 1: Pre-dose and up to 168 hours post-dose
measure: Concentration of total radioactivity in blood and plasma samples
timeFrame: Timeframe: Day 1: Predose and up to 120 hours
measure: Concentration of AZD1722 in plasma samples
timeFrame: Timeframe: Day 1: Predose and up to 120 hours
Secondary outcomes:
measure: Safety variables (adverse events, vital signs, ECGs, clinical laboratory tests)
timeFrame: up to 50 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
References: