louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04628806: Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells
Official title: Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells in Patients With Advanced or Metastatic Tumors.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma Stage IV
Sarcoma
Squamous Cell Carcinoma
Pancreatic Cancer Stage IV
Prostate Cancer
Breast Cancer Stage IV
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Klinikum rechts der Isar, TU München, (TUM), Munich, Germany.
First posted: 2020-11-16
Enrollment: 120
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: oncological patients treated at a tertiary center

Brief summary: This study investigates the ability of heat shock protein HSP70 to isolate and quantify circulating tumor cells (CTCs) in patients with advanced or metastatic tumors.

CTCs will be isolated from peripheral blood before antineoplastic treatment and again after three months. Isolation using HSP70 will be compared with standard CTC isolation by EpCAM.

Additionally, imaging parameters of the primary tumor (if available) and metastases will be analysed and correlations between molecular alterations and imaging parameters will be assesed.


Eligibility criteria: Inclusion Criteria:

* Metastatic malignant melanoma (stage IV)
* Metastatic or unresectable pancreatic adenocarcinoma (stage III or IV)
* Metastatic breast cancer
* Metastatic sarcoma
* Metastatic squamous cell carcinoma of the cervix uteri, head and neck region, vulva, anus or penis
* hormone-refractory prostate cancer

Exclusion Criteria:

* psychiatric disorders that impede adequate informed consent

Primary outcomes:
measure: Radiographic response to initial treatment
timeFrame: 3 months after study enrollment
Secondary outcomes:
measure: Correlation between number of CTC isolated with HSP70 compared to EpCAM
timeFrame: 3 months (at both CTC assessment timepoints)
measure: Correlation between differential expressed radiommic parameters between primary tumor and metastases and genetic alterations of the primary tumor and CTCs
timeFrame: 3 months (at both CTC assessment timepoints)
measure: Progression free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Radioonkologie und Strahlentherapie
Study officials:
affiliation: Charité
name: Sebastian Zschaeck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05616806: Long COVID-19 Intervention Using Digital Health & Technology
Official title: Project LIGHT - Long COVID-19 Intervention Using Digital Health & Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Long COVID
Distress Tolerance
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2022-11-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current study seeks to pilot test the iENDURE (Enhancing Distress tolerance to Uplift motivation in Recovery) intervention among 10 participants with Long COVID (Coronavirus Disease) symptoms. Following informed consent procedures, participants will complete a brief baseline assessment of self-report measures. Participants will then engage in the iENDURE intervention (described below) for 4 weeks. At the end of the intervention period, participants will complete another brief assessment of self-report measures and a qualitative interview about their experience with the program. Participants will be compensated for completing the baseline and post-intervention assessments


Eligibility criteria: Inclusion Criteria:

* Must be over 18 years of age
* Must speak English proficiently
* Must own a text-enabled device
* Diagnosis (self-reported) of COVID-19
* Diagnosis (self-reported) of Long-COVID symptom(s)
* Must be able to provide written, informed consent

Exclusion Criteria:

* Not fluent in English
* Limited mental capacity or inability to provide informed written consent

Primary outcomes:
measure: Client Satisfaction Score (CSQ-8)
timeFrame: 4 weeks
measure: System Usability Score (SUS)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: Kirsten Langdon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01209806: The Effects of Moviprep With Simethicone on Colonic Bubbles
Official title: The Effects of Moviprep With Simethicone on Colonic Bubbles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bubbles in Colon at Time of Colonoscopy
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2010-09-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine whether the administration of PEG along with simethicone will reduce the incidence of colonic bubbles that interfere with polyp detection.

Detailed description: evaluating if simethicone is better than placebo at decreasing gas in the colon at time of colonoscopy so that it is easier for the endoscopist to see polyps

Eligibility criteria: Inclusion Criteria:

-Elective outpatients undergoing colonoscopy using split dose PEG-ELS with sodium ascorbate and ascorbic acid

Exclusion Criteria:

* Unable or unwilling to give informed consent
* Age \< 18 years
* Pregnant
* Breast feeding
* Established or suspected gastroparesis
* Pseudo-obstruction - established or suspected
* Severe constipation (\< 1 BM a week)
* Bowel obstruction
* Greater than 50% resection of colon
* Chronic nausea or vomiting
* Consumed \> 100% standard dose of PEG-ELS (i.e. more than 2L)
* G6PD deficiency
* PEG allergy
* Significant psychiatric illness

Primary outcomes:
measure: Efficacy - Entire colon
timeFrame: At time of colonoscopy
Secondary outcomes:
measure: Efficacy - Right colon
timeFrame: At time of colonoscopy
measure: Adenoma detection
timeFrame: at time of colonoscopy
measure: Flushing
timeFrame: at time of colonoscopy
measure: Tolerance
timeFrame: during prep ingestion
measure: Safety
timeFrame: at time of colonoscopy
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: David Kastenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04566406: Pheochromocytoma and Hemodynamic Instability
Official title: Risk Factors for Hemodynamic Instability During Laparoscopic Pheochromocytoma Resection - Single Centre Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pheochromocytoma
Hypertension
Surgery
Keywords: pheochromocytoma
laparoscopy
haemodynamics
surgery
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy

Brief summary: The aims of our study were to define perioperative HI during laparoscopic adrenalectomy for pheochromocytoma, assess the incidence of perioperative HI, and identify predictive factors of perioperative HI in our group of patients.

Detailed description: The study was a retrospective observation of consecutive patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy between years 2003 and 2019.

Eligibility criteria: Inclusion Criteria:

* patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy

Exclusion Criteria:

* bilateral tumour
* no histopathological result
* neoplastic spread

Primary outcomes:
measure: Number of Participants with Hemodynamic Instability (n, %)
timeFrame: intraoperative
Secondary outcomes:
measure: Number of Complications in Patients (n, %)
timeFrame: Within 30 days after surgery
measure: Number of Cardiovascular Complications in Patients (n, %)
timeFrame: Within 30 days after surgery
Other outcomes:
measure: Length of hospital stay (days)
timeFrame: Up to 30 days
measure: Duration of anaesthesia (min)
timeFrame: Intraoperative
measure: Duration of surgery (min)
timeFrame: Intraoperative
measure: Patients needing blood transfusion, n (%)
timeFrame: Intraoperative
measure: Mean intraoperative blood loss (ml)
timeFrame: Intraoperative
measure: Number of participants who required intraoperative vasodilators administration (n, %)
timeFrame: Intraoperative
measure: Number of participants who required intraoperative vasopressors administration (n, %)
timeFrame: Intraoperative
measure: Patients with episodes systolic blood pressure >200 mmHg (n, %)
timeFrame: Intraoperative
measure: Patients with episodes systolic blood pressure >180 mmHg (n, %)
timeFrame: Intraoperative
measure: Patients with episodes systolic blood pressure >160 mmHg (n, %)
timeFrame: Intraoperative
measure: Number of participants who required postoperative vasopressorss administration (n, %)
timeFrame: Within 24 hours after surgery
Locations:
Study officials:
References:
Clinical trial NCT04180306: PEWS Implementation in an LMIC Setting
Official title: Implementation of Pediatric Early Warning Scores and a Context-adapted Resuscitation Training Course to Improve Outcomes in an LMIC Pediatric Inpatient Oncology Ward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncology
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 1850
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The PEWS implementation study will be undertaken with the following objectives:

1. Assess the effectiveness of implementation of PEWS and resuscitation training to identify patients at risk for clinical deterioration and to impact the frequency of clinical interventions made by treating providers on these patients.
2. Assess the effectiveness of implementation of PEWS and resuscitation training to impact time sensitive clinical interventions made on patients at risk for clinical deterioration.
3. Assess the impact of implementation of PEWS and resuscitation training on length of stay for patients admitted to the pediatric oncology ward.


Eligibility criteria: Inclusion Criteria:

* Patients eligible for the study are defined as pediatric patients (between birth and 12 years of age) admitted and subsequently discharged from the pediatric oncology ward in Beit Jala, Palestine and Gaza City, Palestine between March 2019 to June 2020

Exclusion Criteria:

* Patients will be excluded if they are not admitted to inpatient status. No oncology outpatients such as those in the infusion program will be included.

Primary outcomes:
measure: Elevated Pediatric Early Warning Score (PEWS)
timeFrame: 1 year
Secondary outcomes:
measure: Time to antibiotics
timeFrame: 1 year
measure: Time to IV fluid bolus
timeFrame: 1 year
measure: Volume of IV fluids
timeFrame: 1 year
measure: Length of stay
timeFrame: 1 year
Other outcomes:
Locations:
city: Bethlehem
country: Palestinian Territory, occupied
facility: Beit Jala Hospital
city: Gaza City
country: Palestinian Territory, occupied
facility: Rantisi Hospital
Study officials:
affiliation: Boston Children's Hospital
name: Michelle Niescierenko, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01351506: Effect of Body Weight Change to Surgical ICU Outcomes
Official title: Effect and Determinant Level of Admission Body Weight and Daily Weight Change and Prognoses of Critically and High Risk Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Weight
Weight Change
Keywords: Body weight
Body mass index
Weight change
ICU outcomes
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 465
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: All admitted ICU patients which expected survive more than 24 hours.

Brief summary: Aims of study

1. Effect of daily weight change upto 7 days from ICU admission to outcome of treatment in 28 days
2. Determination cut point of maximum weight change to outcome treatment

Detailed description: Study type : Prospective observational study Location : General surgical intensive care unit Inclusion criteria : All admission patient with expected survive more than 24 hours Exclusion criteria : Patient died within 24 hours or who could not be weighed.

Eligibility criteria: Inclusion Criteria:

* All admitted ICU patients expected survive more than 24 hours

Exclusion Criteria:

* All expected ICU patients survive less than 24 hours
* All patient cannot be weighed.

Primary outcomes:
measure: In Hospital Mortality
timeFrame: within 28 days after ICU admission to dead
Secondary outcomes:
measure: Re Intubation Within 72 Hours
timeFrame: ICU complications up to 28 days after ICU admission
measure: Acute Kidney Injury
timeFrame: Acute kidney injury
Other outcomes:
Locations:
city: Muang Chiang Mai
country: Thailand
facility: Department of Surgery, Faculty of Medicine, Maharaj Nakorn Chiang Mai hospital
state: Chiang Mai
Study officials:
affiliation: Chaing Mai University
name: Kaweesak Chittawatanarat Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chittawatanarat K, Pichaiya T, Chandacham K, Jirapongchareonlap T, Chotirosniramit N. Fluid accumulation threshold measured by acute body weight change after admission in general surgical intensive care units: how much should be concerning? Ther Clin Risk Manag. 2015 Jul 27;11:1097-106. doi: 10.2147/TCRM.S86409. eCollection 2015.
Clinical trial NCT03512106: The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
Official title: The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arterial Hypertension
Keywords: Arterial Hypertension
Acupuncture
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 86
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Chinese traditional acupuncture will be applied.
Primary purpose: TREATMENT

Brief summary: There are few studies in the treatment of hypertension employing acupuncture as a blood pressure regulating technique. The Ministry of Health synthesized the inclusion of integrative and complementary practices within the Unique Health System, such as acupuncture. Our objective is to verify the effect of the acupuncture session on hypertensive patients, measured through ambulatory blood pressure monitoring (ABPM). In this way two groups of patients will be selected in a randomized clinical trial. In the first group, Chinese traditional acupuncture will be applied and in the second group the acupuncture sham will be applied.

Detailed description: Acupuncture as therapy is the subject of conflicting opinions on its effectiveness in scientific means, because in spite of its long existence as a therapeutic tool, raises doubts on the standards of Western science model. In addition, there are few studies in the treatment of hypertension employing Acupuncture as a blood pressure regulating technique. The Ministry of Health synthesized the inclusion of integrative and complementary practices within the Unique Health System, such as Acupuncture. The World Health Organization (WHO) recognizes its effectiveness, having its own concept in the energy imbalance that alter the organic, mental and emotional part addressing a current issue proposing to groundbreaking research. The objective is to verify the effect of the acupuncture session on hypertensive patients, measured through ambulatory blood pressure monitoring (ABPM). In this way two groups of patients will be selected in a randomized clinical trial. In the first group, Chinese traditional acupuncture will be applied and in the second group the acupuncture sham will be applied.

Eligibility criteria: Inclusion Criteria:

* patients enrolled in stage I to III of systemic arterial hypertension
* signing the free and informed consent term

Exclusion Criteria:

* patients who do not agree to participate in the study
* patients with systolic pressure values greater than 180 mmHg or diastolic pressure above 110 mmHg
* patients with important comorbidities

Primary outcomes:
measure: Ambulatory Blood Pressure Monitoring
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01062906: Intravenous Lidocaine for Laparoscopic Cholecystectomy
Official title: The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Opioid Consumption
Keywords: intravenous lidocaine
postoperative pain
laparoscopic surgery
opioids
opioids side-effects
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic, antithrombotics and neuroprotective properties. In a previous study conducted in patients undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and fentanyl, intraoperative i.v. infusion of lidocaine spared opioids consumption in the recovery room by 30%.

The purpose of this study was to determine if an i.v. infusion of lidocaine without intraoperative opioids would reduce the amount of fentanyl to the same extent and opioids-related side effects.


Eligibility criteria: Inclusion Criteria:

* patients undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* age \<18 yr or \> 85 yr,
* ASA physical status 3 and greater, history of hepatic failure (Child \& Pug A-C),
* renal failure (creatinine outside the normal range) or cardiac failure (NYHA I-IV),
* Adams-Stoke syndrome,
* severe degrees of sinoatrial, atrioventricular or intraventricular block,
* organ transplant,
* diabetes mellitus type 1 and 2,
* morbid obesity (BMI \> 40),
* chronic use of opioids and beta-blockers,
* known seizures,
* severe mental impairment,
* allergy to local anesthetics and to all the medications used in the study, or
* inability to understand pain assessment.

Primary outcomes:
measure: Fentanyl consumption (measured as fentanyl equivalents -mcg)
timeFrame: postoperative day 0 (day of surgery before beeing discharged home) and 24 hr after the end of surgery
Secondary outcomes:
measure: Pain, Static and Dynamic
timeFrame: On postoperative day 0 (day of surgey before beeing discharged home) and 24 hrs after the end of surgery
measure: Opioids side-effects
timeFrame: On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre, Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Healt Centre, Department of Anesthesia
name: Franco Carli, MD, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.
Clinical trial NCT00874406: Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Official title: Preoperative Transhepatic Arterial Chemotherapy in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: colorectal cancer
liver metastasis
neoadjuvant chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 100
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: The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.

Detailed description: We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and overall survival as evaluated by intent-to-treat analysis.

Eligibility criteria: Inclusion Criteria:

* age \<= 75 years
* resectable liver metastasis
* remnant liver volume \>= 70%
* without other organ metastasis or peritoneum metastasis
* without contradiction of cardiac and pulmonary diseases

Exclusion Criteria:

* age \> 75 years
* unresectable liver metastasis
* remnant liver volume \< 50%
* with other organ metastasis or peritoneum metastasis
* with contradiction of cardiac and pulmonary diseases

Primary outcomes:
measure: progression free survival
timeFrame: 5 years after operation
Secondary outcomes:
measure: overall survival
timeFrame: 5 years after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: department of general surgery, zhongshan hospital, fudan university
name: jianmin xu, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: