louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01454635: Analisis of Facors Involved in Antidepressant Treatment Response of Major Depressive Disorder
Official title: Treatment Response Study of Sertraline to Treat Japanese Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
treatment response
selective serotonin reuptake inhibitor
Lead sponsor: Showa University
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to predict and visualize sertraline treatment response in major depressive disorder with clinical symptoms, demographic and stress state, personality, eight genetic polymorphisms at baseline.

Detailed description: While only about 50% of patients respond to first treatment in major depressive disorder, 30-40% did not remit after continuous 1 year treatment. However, patients must remain on their prescribed medications for at least 4 weeks without knowing whether the particular antidepressant will be effective. Studies have suggested a number of predictors of treatment response, but varying degrees of success and nearly all with poor prognostic sensitivity and specificity. The investigators investigated clinical symptoms, demographic and stress state, personality and genetic polymorphisms in patients of major depressive disorder treated with sertraline and performed multivariate analysis to extract the predicting factors. Moreover, the investigators tried to visualize weight of variables and pathway one another.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Major Depressive Disorder
* Must be able to swallow tablets

Exclusion Criteria:

* pregnant
* breastfeeding

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa
Study officials:
affiliation: Showa University
name: Yuji Kiuchi, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00100035: Polarity Therapy for American Indian Caregivers of Dementia Patients
Official title: Polarity Therapy for Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stress
Depression
Anxiety
Keywords: Caregivers
Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of polarity therapy (PT), a complementary and alternative medicine treatment, in American Indian caregivers living in the Pacific Northwest.

Detailed description: The caregivers of people with dementia experience high levels of stress and are at particularly high risk for physical and mental illness. Although stress and illness are serious problems among American Indian caregivers in the Northwest, few studies have concentrated on this population. PT is a treatment that involves awareness of one's energy field and touch therapy; it has been shown to provide several physiological, biological, and psychological benefits. This study will determine whether PT is more effective than respite from caregiving in reducing stress, anxiety, and depression and improving health function and overall quality of life in American Indian caregivers.

Participants will be randomly assigned to receive either eight weekly sessions of PT or 3 hours of weekly respite from caregiving for 8 weeks. At the beginning of the study and at Weeks 4 and 8, participants will complete questionnaires and self-report scales on stress, anxiety, depression, and quality of life. In addition, heart rate variability and levels of cortisol will be measured at study entry and Weeks 4 and 8.

Eligibility criteria: Inclusion Criteria:

* Caregiver of a family member with dementia for at least 4 hours a day
* American Indian

Exclusion Criteria:

* Nerve disorders caused by diabetes
* Use of beta blockers

Primary outcomes:
measure: Perceived stress
Secondary outcomes:
Other outcomes:
Locations:
city: Olympia
country: United States
facility: Center for World Indigenous Studies
state: Washington
Study officials:
affiliation: Center for World Indigenous Studies
name: Leslie E. Korn, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02228135: The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tonsillectomy
Adenotonsillectomy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 9843
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who have had tonsillectomy or adenotonsillectomy

Brief summary: This is a retrospective chart review looking at the effect of dexamethasone dosing on post-tonsillectomy hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a tonsillectomy
* Patients undergoing an adenotonsillectomy

Exclusion Criteria:

* All patients with a known history of bleeding or clotting disorders, as well as those patients who had presented to Nationwide Children's Hospital main operating room for control of PTH but had their initial tonsillectomy/adenotonsillectomy at an outlying facility will be excluded from the study.

Primary outcomes:
measure: Dexamethasone Dosage
timeFrame: once at start of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT01043796: Evaluation of Insecticide Treated Nets and Wall Liners for the Prevention of Malaria
Official title: Malaria Transmission Consortium: The Added Effects of Insecticide Treated Materials, Artemisinin-containing Combination Treatments, and Larviciding on Malaria Transmission and Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: Insecticide treated wall liners
Insecticide treated nets
Incidence cohort
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Kenya Medical Research Institute
name: Bill and Melinda Gates Foundation
First posted: 2010-01-07
Enrollment: 1730
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether insecticide treated wall liners, in combination with insecticide treated nets, reduce the incidence of malaria infections compared to insecticide treated nets alone.

Detailed description: Insecticide treated nets (ITNs) have been shown to reduce malaria related morbidity and mortality and are increasingly being scaled up throughout sub-Saharan Africa. However, ITNs alone are unlikely to reduce transmission to zero in most settings and additional vector control tools are necessary. One new promising strategy is the use of insecticide treated wall liners (ITWLs). These are textiles treated with an insecticide that are used to line the inner walls of houses. The wall liners are considered a long-lasting alternative to indoor residual spraying which is also used for malaria vector control but is expensive to implement.

Within 6 pairs of villages, we plan to randomly allocate one village in each pair to receive either ITNs or ITNs plus ITWLs. Households will be randomly selected from each village and all children between the ages of 6 months and 11 years will be enrolled in a cohort study. The children will be cleared of existing infections and then followed monthly until they are found to be infected with malaria. The study will last for 6 months and will demonstrate whether the ITWLs provide additional protection against malaria over that provided by the use of ITNs.

Eligibility criteria: Inclusion Criteria:

* Age 6 months up to 11 years
* Living in the study area and remaining in the study area for the duration of the study
* Informed consent provided by parents

Exclusion Criteria:

* No informed consent
* Living outside the study area, or likely to move outside study area
* Severely ill and unlikely to be able to complete study

Primary outcomes:
measure: Incidence of new malaria infections
timeFrame: Monthly
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute
state: Nyanza
Study officials:
affiliation: Centers for Disease Control and Prevention
name: John E Gimnig, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05185596: Prehospital TEE in Cardiac Arrest
Official title: Feasibility of Prehospital Trans Esophageal Echocardiography in Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Echocardiography, Transesophageal
Out-of-Hospital Cardiac Arrest
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Berufsrettung Wien
First posted: 2022-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study shall investigate the feasibility of prehospital performed trans-esophageal echocardiography in out of hospital cardiac arrest.

The investigators will include ten patients undergoing advanced life support in this study and determine if it is possible to acquire adequate trans-esophageal images within 10 minutes after arrival of the study team on scene.

Detailed description: Out of hospital cardiac arrest (OOHCA) remains a leading cause of death in Austria.

Current guidelines recommend to address potentially reversible causes for OOHCA early to improve survival and some of these causes can be recognized using echocardiography. The usefulness of trans-thoracic echocardiography during OOHCA seems to be limited as image acquisition may prolong now flow time and image quality is variable. These limitations might be overcome with trans-esophageal echocardiography.

The investigators will investigate the feasibility of prehospital performed trans-esophageal echocardiography in ten OOHCA patients undergoing advanced life support.

In addition to routine care by paramedics and emergency physicians, a dedicated expert in emergency ultrasound will perform trans-esophageal echocardiography in these patients.

Primary outcome parameter: Is it possible to obtain trans-esophageal images of the heart within 10 minutes after arrival of the study team?

Eligibility criteria: Inclusion Criteria:

* adult patients undergoing advanced life support for out of hospital cardiac arrest

Exclusion Criteria:

* patients who should undergo rapid transport to the hospital with ongoing CPR (ECMO candidates, pregnant, trauma, obvious reversible which can be treated in hospital only)
* known esophageal pathology contraindicating TEE
* no definite secure airway present (endotracheal intubation, tracheostomy)

Primary outcomes:
measure: Time to obtain images of the heart
timeFrame: 10 minutes
Secondary outcomes:
measure: Hands off times
timeFrame: 10 minutes
measure: Hindering of advanced life support measures
timeFrame: 10 minutes
measure: Trans esophageal echocardiography related complications
timeFrame: 10 minutes
measure: Image quality
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Thomas Hamp, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02104596: Intraarticular Xylitol Injections for Knee Osteoarthritis
Official title: Intraarticular Xylitol Injections for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 96
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Intraarticular injections of isotonic Xylitol solution will improve pain in patients with knee osteoarthritis (OA).


Eligibility criteria: Inclusion Criteria:

* Age over 45
* Tibiofemoral osteoarthritis
* OA stage 2-3 on xray
* Pain VAS \> 40mm
* No NSAIDs for 3 weeks
* No analgetics for 38 hours

Exclusion Criteria:

* Pain VAS \> 80mm
* Pain VAS in contralateral knee \> 40mm
* Inflammatory arthritis
* Severe effusion
* Posttraumatic osteoarthritis
* Unstable knee
* Isolated patellofemoral disease
* Paracetamol hypersensitivity

Primary outcomes:
measure: Pain - visual analogue scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References:
Clinical trial NCT05439096: Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Primary Dysmenorrhea
Official title: Comparative Effects of Functional Exercise Versus High Frequency Transcutaneous Electrical Nerve Stimulation on Pain and Sleep Quality in Students With Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Functional Exercise
High Frequency
Transcutaneous Electrical Nerve Stimulation
Primary Dysmenorrhea
Menstrual Pain
Randomized Control Trial
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the impacts of utilitarian exercise versus high frequency anscutaneous Electrical Nerve Stimulation on pain and sleep quality in students with primary dysmenorrhea.

Detailed description: A Randomized Control Trial study will be directed at Riphah International University Faisalabad after synopsis approval. The Purposive examining method will be utilized to enlist the patients. Patients will be enrolled according to the pre-characterized criteria. Sample size for this examination is 40 females (18 yrs - 30 yrs) as per determination measures. The patients of one group will recieve exercise therapy and patients of other group will recieve high frequency Transcutaneous Electrical Nerve Stimulation. The patient's result will be assessed following a month of treatment . Informed consent will be taken from each patient. Data entry and analysis will be done with Statistical Package of Social Sciences version 20.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed instance of primary dysmenorrhea
2. Age somewhere in the range of 18 and 30 years,
3. A history of lower stomach torment for in excess of 6 periods.
4. Moderate or serious torment, with a numeric rating scale (NRS) score ≥5 out of 10.
5. No elective treatment including TENS inside multi month before enlistment in the investigation; and
6. Provision of educated agree preceding enlistment in the examination.

Exclusion Criteria:

1. Pregnant or Breastfeeding,
2. History of medical procedure of the lower midsection,
3. Heart sickness,
4. Cancer,
5. Severe mental problems.
6. Those who couldn't utilize TENS, for instance, in view of a lasting pacemaker or skin infection.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 12th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT01734096: Renal Response to Lower Body Negative Pressure in Pre-hypertensive States
Official title: Effect of Lower Body Negative Pressure and Angiotensin II Receptor Blockade on Renal Hemodynamic, Neuro-hormonal and Tubular Response in Pre-hypertensive States: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Obesity
White Coat Hypertension
Resistant Hypertension
Keywords: hypertension
obesity
white coat hypertension
resistant hypertension
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2012-11-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether in pre-hypertensive and hypertensive states such as white coat hypertension, obesity related hypertension or resistant hypertension, renal function is more sensitive to orthostatic stress.


Eligibility criteria: Inclusion Criteria:

* BMI \> 30 Kg/m2 (obesity group)
* office BP \>140/90 and daytime ambulatory blood pressure \<135/85 (white coat hypertension group) _daytime abpm \>135/85 mm Hg or nighttime abpm 120/70

Exclusion Criteria:

* History of allergic reaction
* Diabetes type 1 or type 2
* History of renal artery stenosis
* Acute illness

Primary outcomes:
measure: sodium excretion
timeFrame: after one hour of lower body negative pressure
Secondary outcomes:
measure: glomerular filtration rate
timeFrame: after one hour of lower body negative pressure
Other outcomes:
measure: renal plasma flow
timeFrame: after one hour of lower body negative pressure
Locations:
city: Lausanne
country: Switzerland
facility: Service of nephrology and hypertension
state: VD
city: Lausanne
country: Switzerland
facility: Service of nephrology and hypertension
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Gregoire Wuerzner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Vaudois
name: Michel Burnier, MD
role: STUDY_CHAIR
References:
citation: Vakilzadeh N, Petrovic D, Maillard M, Favre L, Grouzmann E, Wuerzner G. Impact of obesity with or without hypertension on systemic haemodynamic and renal responses to lower body negative pressure. Blood Press. 2021 Feb;30(1):67-74. doi: 10.1080/08037051.2020.1829963. Epub 2020 Oct 19.
citation: Vuignier Y, Grouzmann E, Muller O, Vakilzadeh N, Faouzi M, Maillard MP, Qanadli SD, Burnier M, Wuerzner G. Blood Pressure and Renal Responses to Orthostatic Stress Before and After Radiofrequency Renal Denervation in Patients with Resistant Hypertension. Front Cardiovasc Med. 2018 May 23;5:42. doi: 10.3389/fcvm.2018.00042. eCollection 2018.
Clinical trial NCT05675696: Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
Official title: Assessment of Occult Lung Stress During Lung Protective Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-01-09
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: OTHER

Brief summary: The present study will utilize esophageal manometry to measure the presence and magnitude of persistent patient effort during lung protective ventilation, allowing identification and mitigation of occult lung stress.


Eligibility criteria: Inclusion Criteria:

* Intubated with a diagnosis of ARDS and expected to be ventilated for ≥ 48 hours
* Meets Berlin criteria for ARDS, with or without underlying chronic lung disease
* Triggering breaths on the ventilator
* Treating medical team agrees with patient participation

Exclusion Criteria:

* Known or suspected esophageal abnormalities, craniofacial abnormalities, or upper GI bleed
* Shock that requires ≥ 2 vasopressors
* pH on arterial blood gas ≤7.25
* Minute ventilation ≥ 14L/min
* Known or suspected pneumothorax, pneumomediastinum, and/or subcutaneous emphysema
* Severe ARDS with P/F ratio \<60
* Pregnancy
* Currently receiving extracorporeal membrane oxygenation (ECMO) therapy
* Decision to withhold life-sustaining treatment
* Patients who are not expected to survive for 24 hours
* Lack of informed consent

Primary outcomes:
measure: Transpulmonary Driving Pressure
timeFrame: Up to Hour 2 (Day 1)
measure: Driving Pressure
timeFrame: Up to Hour 2 (Day 1)
measure: Work of Breathing (WOB)
timeFrame: Up to Hour 2 (Day 1)
measure: Pressure-Time Product (PTP)
timeFrame: Up to Hour 2 (Day 1)
Secondary outcomes:
measure: Lung Compliance (C, l)
timeFrame: Up to Hour 2 (Day 1)
measure: Chest Wall Compliance (C, cw)
timeFrame: Up to Hour 2 (Day 1)
measure: Respiratory System Compliance (C, rs)
timeFrame: Up to Hour 2 (Day 1)
measure: Oxygen Saturation
timeFrame: Up to Hour 2 (Day 1)
measure: PaO2/FiO2 (P/F) Ratio
timeFrame: Up to Hour 2 (Day 1)
Other outcomes:
Locations:
city: New York
country: United States
facility: Tisch Hospital
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Beno Oppenheimer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06013696: Bleach and Urine Color in UC Patients Using 5ASA
Official title: The Effect of Household Bleach on Urine Color Among Pediatric Ulcerative Colitis Patients Treated With 5-aminosalicylic Acid
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Hematuria
Urine
5-Aminosalycilic acid
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effect on urine color by adding household bleach to fresh urine sample among pediatric UC subjects treated with 5ASA

Detailed description: The aim of this study is to evaluate the effect on urine color by adding household bleach to fresh urine sample among pediatric UC subjects treated with 5ASA.

Eligibility criteria: Inclusion Criteria:

1. UC patients in remission

Exclusion Criteria:

1. Acute UC exacerbation defined as Pediatric ulcerative colitis activity index (PUCAI) ≥10
2. Any acute or chronic renal disease, either present or past
3. Chronic hypertension, either present or past
4. Regularly receiving other medication that may cause nephrotoxicity - Non-steroidal anti-inflammatory drugs, acetaminophen, anti-epileptics, and antibiotics.
5. Pregnancy

Primary outcomes:
measure: Change is urine color
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: Eyal Zifman, MD
role: PRINCIPAL_INVESTIGATOR
References: