louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00481572: Continuous Infusion of Terlipressin in Septic Shock
Official title: Continuous Terlipressin Versus Vasopressin Infusion in Septic Shock. A Randomized, Controlled, Pilot Trial. "THE TERLIVAP STUDY"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Septic Shock
Keywords: Sepsis
Septic Shock
vasopressin
terlipressin
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 45
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: The purpose of this study is to determine whether: A)the continuous infusion ultra-low dose of terlipressin (1.3 micrograms/kg/h) is able to stabilize hemodynamic in patients with septic shock, reducing the risk of adverse effects related to the bolus dose.B)the continuous infusion ultra-low dose of terlipressin may be use in lieu of vasopressin.

Detailed description: Forty-five septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation were enrolled in the study. Patients were randomly allocated to be treated with either a) a continuous terlipressin infusion (1.3 µg•kg-1), b) vasopressin (0.03 U•min-1), or c) titrated norepinephrine (control; each n = 15). In both the terlipressin and vasopressin group, norepinephrine was additionally administered to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, cytokines concentrations, were obtained at baseline and after 12, 24, 36 and 48 hours.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Septic shock
* vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

Exclusion Criteria:

* Pregnancy
* Present cardiac dysfunction
* Present or suspected acute mesenteric ischemia

Primary outcomes:
measure: Systemic and regional hemodynamics
timeFrame: during the first 48 hours from the onset of septic shock
Secondary outcomes:
measure: Markers of inflammation,organ functions,adverse effects.
timeFrame: during the first 48 hours from the onset of septic shock
Other outcomes:
Locations:
city: Rome, Viale del Policlinico 155
country: Italy
facility: Department of Anesthesiology and Intensive care of the University of Rome "La Sapienza"
Study officials:
affiliation: Departement of Anesthesiology and Intensive Care of the University of Rome "La Sapienza"
name: Andrea Morelli, MD
role: STUDY_DIRECTOR
References:
citation: Morelli A, Ertmer C, Rehberg S, Lange M, Orecchioni A, Cecchini V, Bachetoni A, D'Alessandro M, Van Aken H, Pietropaoli P, Westphal M. Continuous terlipressin versus vasopressin infusion in septic shock (TERLIVAP): a randomized, controlled pilot study. Crit Care. 2009;13(4):R130. doi: 10.1186/cc7990. Epub 2009 Aug 10.
Clinical trial NCT05246072: Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients
Official title: Effect of Combined Use of Ivermectin and Colchicine in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to investigate the efficacy of use of combination of Ivermectin and colchicine on severity and outcome Of COVID 19 infection.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent prior to performing study procedures.
* Currently hospitalized and requiring medical care for non-sever COVID-19.
* One or more of the following: (positive PCR test or positive antibodies) or (CT Chest consistent with COVID19 infection).

Exclusion Criteria:

* Tocilizumab use.
* Mechanical ventilation
* Requirement of oxygen supplementation \>8L/min on admission

Primary outcomes:
measure: length of oxygen requirement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT06720272: School-based Program for the Prevention of Rheumatic Heart Disease in Endemic Regions
Official title: Effectiveness of an Integrated Program for the Prevention of Rheumatic Heart Disease in Endemic Regions: a Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatic Heart Disease in Children
Keywords: rheumatic heart disease
valvular heart disease
prevention
streptococcal pharyngitis
rheumatic fever
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Centre for Infectious Disease Research in Zambia (CIDRZ)
name: National Academy of Medical Sciences, Nepal
name: University of Oxford
First posted: 2024-12-06
Enrollment: 6000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: PREVENTION

Brief summary: The overall objective of the PREVENT trial is to evaluate the effectiveness of an integrated, school-based program for the prevention of rheumatic heart disease (RHD) in regions with an endemic pattern of RHD.

We conduct a stepped wedge cluster randomized trial in randomly selected schools in Nepal and Zambia.

The intervention will be delivered at the level of the school and consists in the introduction of a dedicated school-nurse program providing health care through education about RHD, assessment, intervention, and follow-up of GABHS pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with RHD.


Eligibility criteria: Inclusion Criteria:

- Children aged 5-16 years

Exclusion Criteria:

* Children / primary caregivers not providing informed consent to participate
* Children not attending one of the selected schools

Primary outcomes:
measure: Rheumatic heart disease
timeFrame: The endpoint will be assessed after a minimum of 1 and a maximum of 3 years after introduction of the school nurse program.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04365972: Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic
Official title: Attention Bias Modification for Reducing Health Anxiety During the Coronavirus Pandemic: An Open Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The outbreak of the 2019 Coronavirus (COVID-19) pandemic is a major stressor leading to increased levels of anxiety, and specifically, an excessive fear of being infected and affected by the disease among major parts of the population. At the same time, the access to mental health services is limited due to the lockdown policy applied in many countries worldwide, warranting the development of home-delivered interventions aimed at reducing stress and anxiety symptoms. Attention Bias modification (ABM) has been found to be an efficacious computerized intervention to reduce anxiety symptoms. In this open pilot trial, participants reporting on elevated levels of health anxiety concerning the COVID-19 epidemic will receive one session of ABM over 5 consecutive days (5 sessions total). Symptoms of health anxiety, state anxiety, generalized anxiety, and depression will be measured at baseline and post-treatment.


Eligibility criteria: Inclusion Criteria:

* 3 or more symptoms (out of 7) reported in the COVID-19 anxiety inventory with a score of 4 or 5.
* Fluent Hebrew
* Having a PC computer at home with internet access

Exclusion Criteria:

* A diagnosis of dyslexia or other reading disability

Primary outcomes:
measure: Change from baseline of the total score of a novel COVID-19 anxiety inventory
timeFrame: up to 2 days pre-treatment and 1-2 days post-treatment
Secondary outcomes:
measure: Change from baseline of the total score of the Health Anxiety Inventory
timeFrame: up to 2 days pre-treatment and 1-2 days post-treatment
measure: Change from baseline of the total score of the State Anxiety Inventory
timeFrame: up to 2 days pre-treatment and 1-2 days post-treatment
measure: Change from Baseline of the total score of the PHQ-9
timeFrame: up to 2 days pre-treatment and 1-2 days post-treatment
measure: Change from Baseline of the total score of the GAD-7
timeFrame: up to 2 days pre-treatment and 1-2 days post-treatment
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00437372: Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients
Official title: A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Head and Neck Cancer
Pelvic Cancer
Nervous System Neoplasms
Thoracic Neoplasms
Keywords: solid tumor
central nervous system
head and neck
thorax
pelvic area
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-02-21
Enrollment: 39
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: This study is using the combination of radiation and antiangiogenic agents (agents that destroy existing blood vessels) seems to be an approach to tumor cure.

Detailed description: The combination of ionizing radiation and antiangiogenic agents seems to be a counterintuitive approach to tumor cure because oxygen is a potent radiosensitizer and a reduction in oxygen concentration would be expected following a reduction in tumor vasculature after antiangiogenic treatment.

Eligibility criteria: Inclusion Criteria:

* Minimum 2 week course of radiation therapy
* Solid tumors of the central nervous system, head and neck, thorax, and pelvis

Exclusion Criteria:

* Major surgery or radiation therapy within 4 weeks starting study treatment
* Grade 3 hemorrhage within 4 weeks

Primary outcomes:
measure: To evaluate the safety and toxicity profile of sunitinib when used with concurrent radiation therapy
timeFrame: 2 years
Secondary outcomes:
measure: To measure urine VEGF
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Adam P Dicker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00987272: Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects
Official title: A Phase III Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the CAC Model of Acute Allergic Conjunctivitis in Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Keywords: Allergies
Ocular
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-09-30
Enrollment: 267
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: The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test.


Eligibility criteria: Inclusion Criteria:

* Japanese ethnicity.
* Seasonal Allergic Conjunctivitis--asymptomatic.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (\>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - or itching \>0) at the start of any visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Ocular Itching Score
timeFrame: Day 0 of treatment: 3, 5, and 10 minutes post CAC
Secondary outcomes:
measure: Mean Total Redness Score
timeFrame: Day 0 of treatment: 3, 10, 20 minutes post-CAC
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Pamela Smith, BS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03393572: Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy
Official title: Intraperitoneal Instillation of Bupivacaine With Either Magnesium Sulphate or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy: a Prospective, Randomized, Double-blinded Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain control and their relative adverse effects.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I and II
* scheduled for laparoscopic hysterectomy

Exclusion Criteria:

* ASA physical status more than II
* Obesity (body mass index higher than 30 kg/ m2)
* History of chronic opioids intake
* Known hypomagnesaemia or hypermagnesaemia
* Chronic alcoholism
* Heart block
* Renal failure
* Patients with history of left ventricular failure
* Patients taking beta-blocking drugs
* Allergy to the study drugs
* if surgery changed to open hysterectomy,

Primary outcomes:
measure: Rescue analgesia time
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Visual analogue scale [VAS]
timeFrame: First 24 hours postoperatively
measure: Total analgesic consumption
timeFrame: First 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Elbeialy
Study officials:
References:
Clinical trial NCT00911872: EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study
Official title: EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: wrinkles
dermal filler
collagen
soft tissue augmentation
aesthetic
Lead sponsor: Solish, Nowell, M.D.
Sponsor class: INDIV
First posted: 2009-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to gather information about the immediate effects and recovery time for treatment with EVOLENCE/EVOLENCE BREEZE for soft tissue augmentation. The time it takes for patients to feel comfortable with the results, and return to their normal daily routine is also of important interest

Detailed description: The primary objective of this Investigator Initiated Study is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler. In addition, the immediate effects such as swelling, bleeding, bruising will be assessed.

Eligibility criteria: Inclusion Criteria:

* Male or Female \> 18 years of age
* Need for soft tissue augmentation as evidenced by any of the following:

  * Bilateral-aging defects \> 1 on the Modified Fitzpatrick Wrinkle Scale
  * Decrease in soft tissue volume in other areas of the face

Exclusion Criteria:

* History of positive hypersensitivity to porcine collagen-based products History of multiple food, drug, and substance allergies Autoimmune or collagen vascular disease Facial tissue augmentation within 6 months (HA) or 12 months Evolence/Evolence Breeze Botulinum-toxin A within 6 weeks Ablative laser treatments within 12 months Permanent facial implants Investigational product use within 30 days Pregnant and/or nursing woman or woman who plan to become pregnant during the study.

Primary outcomes:
measure: Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler
timeFrame: 7 Days
Secondary outcomes:
measure: the immediate effects such as swelling, bleeding, bruising will be assessed
timeFrame: 7 Days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Nowell Solish Private Practice
state: Ontario
Study officials:
affiliation: Private Practice
name: Nowell Solish, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Solish NJ. Assessment of recovery time for the collagen products Dermicol-P35 27G and 30G. J Am Acad Dermatol. 2010 May;62(5):824-30. doi: 10.1016/j.jaad.2009.08.016.
Clinical trial NCT00868504: Measuring Temperatures of Tissues During Endoscopy
Official title: Measuring Temperatures of Tumors and Normal Tissues in the GI Tract, Using a Thermocouple Sheathed in a Catheter, in the Work Canal of an Endoscope
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Undifferentiated
Keywords: GI tract
Tumors
Temperatures
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo endoscopy or colonoscopy.

Brief summary: Previous studies have indicated that tumors are warmer than the surrounding tissues. We want to ascertain that this is true for tumors in the GI tract. If so, a thermal camera in an endoscope may aid the diagnosis of tumors. The experiment entails inserting a cannula sheathed thermocouple into the work canal of an endoscope or a colonoscope. The examining physician will bring the distal end to touch the tumors he finds and their adjacent tissues, noting their respective temperatures. This experiment must be conducted before embarking on the complicated and costly project of producing a tiny thermal camera which will be able to navigate the GI tract.


Eligibility criteria: Inclusion Criteria:

* consenting adults

Exclusion Criteria:

* none

Primary outcomes:
measure: Difference of temperature between tumors and adjacent tissues
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Arie Orenstein, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stefanadis C, Chrysohoou C, Panagiotakos DB, Passalidou E, Katsi V, Polychronopoulos V, Toutouzas PK. Temperature differences are associated with malignancy on lung lesions: a clinical study. BMC Cancer. 2003 Jan 6;3:1. doi: 10.1186/1471-2407-3-1. Epub 2003 Jan 6.
Clinical trial NCT03053804: Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment Outcome, and Prognosis Prediction
Official title: Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment, Outcome, and Prognosis Prediction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: MR/PET
Non-small cell lung cancer (NSCLC)
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
First posted: 2017-02-15
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: It is a study that hypothesize that MR/PET can have better information than current CT image study, about the medical or surgical treatment outcome of lung cancer

Detailed description: The investigators analyze tumor size、ADCmean、ADCmin、DCE、SUVmax、SUVmin、etc in MR/PET study，to compare its efficacy with other image studies in tumor malignancy grade, systemic involvement detection, treatment outcome after medical target therapy and treatment outcome after surgery.

Eligibility criteria: Inclusion Criteria:

1. Age: \> 20 years old.
2. Patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy, lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated cells)
3. Patients voluntarily to join this study and signed informed consents.

Exclusion Criteria:

1. Any body metal implants (pacemaker implantation, nerve stimulator, vascular stent, aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart valves
2. Patients with claustrophobia to MRI examination
3. Patients who are reluctant to comply with follow-up and subsequent examination
4. The other condition that do not meet the inclusion criteria.
5. Pregnancy.
6. Age \< 20 years old.

Primary outcomes:
measure: Change from Baseline PET/MR parameters at 2 months after treatment
timeFrame: 2 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yeun-Chung Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: