louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03529149: TCD Monitoring Technology Guides the Precise Control of Blood Pressure After EVT
Official title: TCD Monitoring Technology Guides the Precise Control of Blood Pressure After EVT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigators hypothesized that the precise regulation of blood pressure based on the changes of cerebral blood flow parameters under TCD monitoring can better improve the state of cerebral blood flow, reduce the risk of early neurological deterioration and improve the prognosis of the patients.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* accept EVT treatment within 6 hours of symptoms onset;
* In selected patients with AIS within 6 to 16 hours of last known normal who have LVO in the anterior circulation and meet other DAWN or DEFUSE 3 eligibility criteria..
* In selected patients with AIS within 6 to 24 hours of last known normal who have LVO in the anterior circulation and meet other DAWN eligibility criteria.

Exclusion Criteria:

* Pre - onset mRS\>2;
* severe dementia;
* threatening life diseases (such as malignant tumor, etc.);
* non acute ischemic cerebrovascular disease patients undergoing selective intravascular treatment;
* related sound window closure can not be monitoring with TCD.

Primary outcomes:
measure: early neurological deterioration
timeFrame: 72 hours
Secondary outcomes:
measure: prognosis of nerve function
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00154349: Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia
Official title: Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Philadelphia Chromosome Positive Acute Lymphocytic Leukemia
Keywords: Ph+ALL
imatinib mesylate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 8
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia (ALL).


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed diagnosis of ALL.
* Patients confirmed to be Ph chromosome positive or bcr-abl gene positive.
* Patients in relapse
* Patients refractory to initial remission induction therapy
* Patients ineligible for initial remission induction therapy
* Patients with an ECOG Performance Status Score from 0 to 2
* Serum creatinine concentration of not more than 2 × the upper limit of the normal range (ULN)
* AST (SGOT) and ALT (SGPT) of not more than 3 × ULN. In patients with hepatic dysfunction from leukemic involvement, AST (SGOT) and ALT (SGPT) should be not more than 5 × ULN
* Serum bilirubin level not more than 3 × ULN

Exclusion Criteria:

* Patients with findings indicative of leukemic involvement of the central nervous system
* Patients with any serious concomitant medical condition (e.g., poorly controllable infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure, poorly controlled diabetes mellitus, mental disorder)
* Patients expected to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug
* Patients having received any hematopoietic stem cell transplantation who have a Grade 3 or 4 GVHD.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: 3 month hematological response rate
Secondary outcomes:
measure: Duration of hematological response
measure: Survival
measure: Cytogenetic response in every 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00962949: The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
Official title: The Renin-Aldosterone Axis in Postural Tachycardia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postural Orthostatic Tachycardia Syndrome (POTS)
Keywords: POTS
Orthostatic intolerance
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-08-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the role of the renin-angiotensin-aldosterone in the pathophysiology of postural tachycardia syndrome, and to provide an insight about the disease process in this disorder.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center criteria
* Age between 18-64 years
* Male or females are eligible
* Able and willing to provide informed consent
* Healthy control subjects with no major medical problem (including postural tachycardia syndrome), free of medications during the study

Exclusion Criteria:

* Overt cause of postural tachycardia e.g., dehydration
* Inability to give or withdraw informed consent
* Pregnancy
* Hypertension (BP \> 140/90)
* Significant co-morbid condition
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol

Primary outcomes:
measure: Mean Arterial Blood Pressure Change
timeFrame: 1 hour
Secondary outcomes:
measure: Plasma Renin Activity
timeFrame: 1 hour
measure: Aldosterone Level
timeFrame: 1 hour
measure: Cortisol Level
timeFrame: 1 hour
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
References:
citation: Mustafa HI, Raj SR, Diedrich A, Black BK, Paranjape SY, Dupont WD, Williams GH, Biaggioni I, Robertson D. Altered systemic hemodynamic and baroreflex response to angiotensin II in postural tachycardia syndrome. Circ Arrhythm Electrophysiol. 2012 Feb;5(1):173-80. doi: 10.1161/CIRCEP.111.965343. Epub 2012 Jan 13.
Clinical trial NCT06146049: Exploring Clinical Study Experiences of People With Post Traumatic Stress Disorder
Official title: Examination of Participation Trends and Engagement Patterns of Participants in Post Traumatic Stress Disorder Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Post Traumatic Stress Disorder
Keywords: Post Traumatic Stress Disorder
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post traumatic stress disorder patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.

Brief summary: Participation in post traumatic stress disorder observational study serves as a crucial contribution to advancing medical knowledge and refining the care provided to individuals facing similar health challenges.

The primary objective centers on a meticulous examination of trial completion rates and voluntary withdrawals within this distinct patient population.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of post traumatic stress disorder
* No prior treatment for post traumatic stress disorder
* Willing and able to provide informed consent.

Exclusion Criteria:

* Enrolled in another research study
* Psychiatric or behavioral illness
* Inability to provide written informed consent

Primary outcomes:
measure: Rate of patients who decide to enroll in a post traumatic stress disorder clinical research.
timeFrame: 3 months
measure: Number of post traumatic stress disorder study participants who remain in clinical study until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Casarin J, Ielmini M, Cromi A, Lagana AS, Poloni N, Callegari C, Ghezzi F. Post-traumatic stress following total hysterectomy for benign disease: an observational prospective study. J Psychosom Obstet Gynaecol. 2022 Mar;43(1):11-17. doi: 10.1080/0167482X.2020.1752174. Epub 2020 Apr 22.
citation: Lai X, Chen J, Li H, Zhou L, Huang Q, Liao Y, Krewski D, Wen SW, Zhang L, Xie RH. The incidence of post-traumatic stress disorder following traumatic childbirth: A systematic review and meta-analysis. Int J Gynaecol Obstet. 2023 Jul;162(1):211-221. doi: 10.1002/ijgo.14643. Epub 2023 Jan 19.
citation: Cenkner DP, Asnaani A, DiChiara C, Harb GC, Lynch KG, Greene J, Scott JC. Neurocognitive Predictors of Treatment Outcomes in Cognitive Processing Therapy for Post-traumatic Stress Disorder: Study Protocol. Front Psychol. 2021 Jan 26;12:625669. doi: 10.3389/fpsyg.2021.625669. eCollection 2021.
Clinical trial NCT01901549: Renal Denervation in Patients After Acute Coronary Syndrome
Official title: Renal Denervation in Patients After Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Arterial Hypertension
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2013-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to evaluate the effect of renal denervation to decreasing blood pressure and left ventricle remodeling progression in patients after acute coronary syndrome.


Eligibility criteria: Inclusion Criteria:

* acute Q negative myocardium infarction (during first 14 days)
* non stable angina
* significant stenosis
* BP \> 140/90 torr. during more than 1 year

Exclusion Criteria:

* absence of arterial hypertension
* Thrombolysis during previous 24 hours
* indications for CABG

Primary outcomes:
measure: cardiovascular death
timeFrame: 1 year
measure: myocardium infarction
timeFrame: 1 year
measure: stroke
timeFrame: 1 year
measure: repeat revascularization
timeFrame: 1 year
Secondary outcomes:
measure: blood pressure changes
timeFrame: 1 year
measure: CCS and NYHA
timeFrame: 1 year
measure: heart rhythm disturbances
timeFrame: 1 year
measure: intima-media index
timeFrame: 1 year
measure: IVS thickness
timeFrame: 1 year
measure: restenosis
timeFrame: 1 year
measure: diastolic disfunction
timeFrame: 1 year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02559349: Gut Microbiota And Radiotherapy
Official title: Gut Microbiota And Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Tumor
Keywords: Stereotactic Body Radiotherapy
SBRT
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients receiving SBRT to a lung tumor

Brief summary: A pilot, single arm, single center study to determine the feasibility of obtaining stool samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the gut microbiota and to obtain preliminary data about possible correlation of baseline composition and changes in gut microbiota with tumor response, local control, and development of pneumonitis/other side effects.


Eligibility criteria: Inclusion Criteria:

* Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a lung lesion (either presumed or biopsy-proven NSCLC
* Age 18 years old or older
* Patient capable of giving informed consent

Exclusion Criteria

* Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
* Active infection with oral temperature \>100°F
* Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration
* Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4).
* Confirmed or suspected HIV, HBV or HCV
* Chronic constipation (bowel movements less frequent than every other day)
* Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (recurrent) or Helicobacter Pylori infection (untreated)
* Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time
* Patients on anti-diarrheal medications
* Patients on probiotics

Primary outcomes:
measure: Number of subject providing stool samples
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Edgar Ben-Josef, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01306149: Natural History of Mineral Metabolism Parameters and Protein-bound Toxins in Incident Peritoneal Dialysis Patients
Official title: Natural History of Biochemical Parameters of Mineral Metabolism and Protein-bound Uremic Retention Molecules in Incident Peritoneal Dialysis Patients: a Longitudinal Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Peritoneal Dialysis
Keywords: biochemical parameters
mineral metabolism
protein-bound uremic retention solutes
incident PD patients
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Incident peritoneal dialysis patients

Brief summary: The aims of this study are

1. To evaluate the natural history of plasma concentrations and renal and peritoneal clearances of small water-soluble uremic retention molecules (URM), 'middle molecules', and protein bound URM in incident peritoneal dialysis (PD) patients.
2. To evaluate the natural history and determinants of the generation rate of URM originating from bacterial protein fermentation in PD patients.
3. To evaluate the natural history of biochemical parameters of mineral metabolism in incident PD patients.


Eligibility criteria: Inclusion Criteria:

* Incident PD patients, defined as patients who started on PD as first renal replacement therapy less than 8 weeks before inclusion
* written informed consent
* age \> 18 years old

Primary outcomes:
measure: natural history of clearances and serum parameters of mineral metabolism and protein-bound toxins
timeFrame: 15 years
Secondary outcomes:
measure: determinants of generation rate of uremic retention solutes
timeFrame: 15 years on average
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital
state: Vlaams-Brabant
Study officials:
affiliation: University Hospital, Leuven, Belgium
name: Pieter Evenepoel, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04584749: Lidocaine as an Anesthetic Adjuvant in Liver and Gastric Laparoscopic Surgery
Official title: Lidocaine as an Anesthetic Adjuvant in Upper Abdominal Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a phase IV, randomized, double-blind, two-arm, parallel-group clinical research trial
Primary purpose: TREATMENT

Brief summary: The aim is to analyze the effect of intravenous lidocaine administration on postoperative opioid use in patients undergoing upper abdominal cancer surgery. Specifically, those patients undergoing gastric cancer surgery and liver cancer surgery using a laparoscopic approach

Detailed description: In a recent Cochrane Library review, despite the apparent positive results reported by intravenous administration of lidocaine as a perioperative analgesic adjuvant, the quality of the evidence is low, since the studies carried out to date present small samples, great variability in the designs and different surgical techniques studied.

More studies will be needed to help improve the grade and quality of evidence in the management of acute postoperative pain and its role in opioid sparing, an especially beneficial effect in tumor pathology For this reason, the investigators have designed a randomized, double-blind, phase IV clinical trial with two treatment arms, parallel groups, in which 96 patients who underwent liver and gastric cancer surgery through laparoscopic approach participated.

This study will include 2 different population groups: patients undergoing liver cancer surgery and patients undergoing gastric cancer surgery

Eligibility criteria: Inclusion Criteria:

* Men and women over 18 years of age scheduled for gastric or liver cancer surgery through a laparoscopic approach at the University of Girona Dr Josep Trueta.
* Accept and sign the informed consent

Exclusion Criteria:

* decline participating in the study at any stage of its development.
* History of allergic or adverse reactions to Amide-type anesthetics.
* Pregnancy or lactation period
* Diagnosis of Child-Pugh stage B or C liver failure.
* Acute renal failure (GFR \<60 ml / min).
* Concomitant treatment with opioids for chronic pain.
* Any condition that, in the clinical judgment of the researchers, may interfere with the object of the research.

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 Hours
Secondary outcomes:
measure: Incidence of nausea and vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Dr Josep Trueta
Study officials:
affiliation: Hospital Dr Josep Trueta
name: Guillem Pla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03779906: Thyroid Function of Pediatric Subjects Following Isovue® Administration
Official title: A Prospective, Multicenter Observational Study to Evaluate Thyroid Function of Pediatric Subjects From Birth to 3 Years Exposed to ISOVUE® (Iopamidol Injection)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypothyroidism
Keywords: hypothyroidism
ISOVUE
Iodinated Contrast Agent
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 17
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the required radiologic procedure as part of their standard of care.


Eligibility criteria: Inclusion Criteria:

* Is male or female from 0 to 3 years of age;
* Is scheduled to undergo a radiologic examination that requires intravascular administration of ISOVUE as part of his/her standard of care;
* Has normal baseline thyroid function tests (TSH, total T3, total T4, and fT4) performed at a local laboratory with blood sample obtained within one week prior to ISOVUE administration;
* Written informed consent is obtained from the subject's parent(s) or legally acceptable representative(s) (according to local regulations) who are willing to comply with the protocol requirements.

Exclusion Criteria:

* Has any known allergy to one or more of the ingredients of ISOVUE;
* Has been diagnosed with congenital hypothyroidism;
* Has undergone radiation treatments to the head or neck;
* Is currently on thyroid replacement therapy;
* Is on therapy with dopamine or any treatment which may affect the thyroid function testing results;
* Has been exposed to any topical iodinated product within 30 days prior to enrollment in the present study;
* Has been exposed to an iodinated contrast agent within 1 year prior to enrollment in the present study, including any administration of iodinated contrast agents during placement of a central line;
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.

Primary outcomes:
measure: Abnormal thyroid function
timeFrame: Day 1 to 2 months
Secondary outcomes:
measure: Hypothyroidism
timeFrame: Day 1 to 2 months
measure: Thyroid hormone replacement therapy
timeFrame: Day 1 to 12 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Children's Hospital and Medical Center
state: Nebraska
Study officials:
affiliation: Bracco Corporate
name: Mary Luigia Storto, MD
role: STUDY_DIRECTOR
References: