louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04389476: The Impact and Coping Strategy of COVID-19 Among Taiwan Society and Medical and Nursing Institutes
Official title: The Impact and Coping Strategy of Taiwan Society and Medical and Nursing Institutes Toward the Biological Disaster-- Corona Virus Disease 2019 (COVID-19) as An Example
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Psychological Impact of COVID-19
Lead sponsor: Kaohsiung Kai-Suan Psychiatric Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-15
Enrollment: 2500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Medical staff in high contact with patients 2. Other personnel in low contact with patients 3. Patients 4. Community residents.

Brief summary: The Coronavirus disease 2019 (COVID-19) had its outbreak in late 2019 in China and is considered a biological disaster. With medical organizations and staff on the frontline, the investigators should conduct assessments, for the different tiers of medical staff, patients, and community residents, on the short- term psychological and mental disabilities or danger factors that they might have faced. As such, the investigators can design and establish a set of evaluative indicators of the risks of biological disasters, and strategies to manage guide and cope, and internal/ external testing strategies. These work in guaranteeing quality and performance, and as such, establishing "Digital Platform for Integrated Research of Coronavirus disease 2019 (COVID-19)".


Eligibility criteria: Inclusion Criteria:

* 1.\>20 years old. 2. Medical staff and patients from different tiers hospitals in Taiwan. 3.Community residents in Taiwan

Exclusion Criteria:

* 1.\< 20 years old. 2. These cases who had disabilities can't complete our assessments.

Primary outcomes:
measure: Psychological impacts by CoronaVirus Disease 2019(COVID-19)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04917276: Treatment Response Prediction System of mCRC Patients Based on CTC
Official title: Treatment Response Prediction System of Metastatic Colorectal Cancer Based on Circulating Tumor Cells
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer Stage IV
Circulating Tumor Cell
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer (with lung or liver metastases) who receiving chemotherapy with or without target therapy

Brief summary: This study enrolling patients with metastatic colorectal cancer. Detecting CTC at different points in the treatment process. Descripting the molecular atlas of CTC in mCRC patients. Building and validating a response prediction system of mCTC patients.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years;

histologically proven colorectal liver metastasis

With liver-dominant disease (extrahepatic metastases limited to lung metastases)

ECOG 0-1

A life expectancy of ≥ 3 months

Adequate hematologic function: absolute neutrophil count (ANC)≥1.5×109/l, platelets≥75×109/l, and international normalized ratio (INR) ≤1.3

Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, alanine aminotransferase, aspartate aminotransferase ≤ 5x upper limit of normal, and albumin≥2.5 g/dl, serum creatinine≤2.0 mg/dl

Written informed consent for participation in the trial.

Exclusion Criteria:

* Other previous malignancy within 5 years

Have metastases other than liver and lung metastases

Receiving any treatment before first blood collection

Primary outcomes:
measure: Sensitivity
timeFrame: 1 year
measure: Specificity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03927976: Feasibility of a Culturally-Specific Video Text Cessation Intervention With AA Quitline Callers
Official title: Testing the Feasibility of a Culturally-Specific Video Text Cessation Intervention With African American Quitline Callers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Assess the feasibility and acceptability of delivering an mHealth tobacco intervention among state quitline enrollees.

Detailed description: The main objective of this study is to assess the feasibility of delivering an mHealth tobacco intervention among state quitline enrollees. This will be measured through the assessment of interest and willingness to use the video text program, and the ability to receive video text messages (i.e., has technology capable of receiving and viewing video texts. At the end of the intervention, the team will assess satisfaction and perceived helpfulness of the video-text messaging program as an indication of acceptability.

Eligibility criteria: Inclusion Criteria:

* Self-identify as African American
* Enrolled in state quitlines within the past 3 months
* Have access to SMS texting

Exclusion Criteria:

* Does not meet inclusion criteria

Primary outcomes:
measure: Feasibility as measured by interest in using Path2Quit video text program
timeFrame: Through study completion, an average of 6-weeks.
Secondary outcomes:
measure: Acceptability of intervention in terms of its Satisfaction and perceived helpfulness: 6-Week Follow-Up Questionnaire
timeFrame: 6 weeks from end of intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
References:
Clinical trial NCT00827476: Improving Human Ovarian Transplantation
Official title: Phase 1 Study to Improve Results of Human Ovarian Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Fertility Preservation
Keywords: ovary
human
transplantaion
ovarian failure
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Israel Science Foundation
First posted: 2009-01-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 5
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: we will perform xenotransplantation and in vitro culture of ovarian tissue from patients undergoing ovarian cortex cryopreservation.

Detailed description: Ovarian tissue is removed by laparoscopy and only in patients facing premature ovarian failure due to chemotherapy.Tissue for research will consist either of a small portion (\<10%) of the cortex for preservation for young women. another source of ovarian tissue for research will be obtained following consent from family of patients who have died of the disease and have previously frozen ovarian tissue.

Eligibility criteria: Inclusion Criteria:

* tissue previously obtained

Exclusion Criteria:

* no tissue available or no consent

Primary outcomes:
measure: improving folliculogenesis and oocuyte maturation after ovarian transplantation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00313027: Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation
Official title: Cervical Nodal Metastasis in Squamous Cell Carcinoma of the Head and Neck - Novel MRI, FDG-PET, and Histopathologic Correlation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Carcinoma, Squamous Cell
Head and Neck Cancers
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the value of novel non-invasive medical imaging methods for detecting the spread of head and neck squamous cell carcinoma to the lymph nodes in the neck by comparing their results to findings at the time of surgery.


Eligibility criteria: Inclusion Criteria:- Adult patients with newly diagnosed (biopsy-proven), untreated squamous cell carcinoma (SCC) of the head and neck who will undergo neck dissection as part of primary surgical therapy. Exclusion Criteria:- A prior adverse reaction to the contrast/tracer agents being used in the imaging methods being studied.

- Pregnancy.

Primary outcomes:
measure: To evaluate the performance of novel imaging methods for detecting cervical nodal metastasis.
timeFrame: pre and post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr. Billy W. Loo Jr. M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03780127: ZX008 Expanded Access Protocol
Official title: ZX008 Expanded Access Protocol - Dravet Syndrome Treatment Plan
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Dravet Syndrome
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-12-19
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 clinical trials.

Detailed description: The treatment plan consists of an up to 24-month Treatment Period. Access is via application by your health care provider and available at one of the Expanded Access treatment centers. The dose of ZX008 for the duration of the Treatment Period will range from 0.2 mg/kg/day to a maximum of 0.8 mg/kg/day, not to exceed a total daily dose of 30 mg/day; for patients concurrently being prescribed stiripentol, the maximum will be 0.5mg/kg/day, not to exceed a total daily dose of 20 mg/day.

The fenfluramine US Expanded Access Program (US EAP) is available to full-time US Residents only.

Participation in the US EAP is limited to patients currently residing in the US. Residency in the US must be for the duration of participation in the US EAP. Drug may not be shipped outside the US.

Eligibility criteria: Inclusion Criteria:

* Patient is male or female, age 2 years and older, inclusive as of Study Day 1.
* Patient is diagnosed with Dravet syndrome.
* Patient is experiencing convulsive seizures which are not controlled by current AEDs.
* Patient is receiving at least one AED and will remain on at least one AED for the duration of treatment.
* Patient has been approved for inclusion by Zogenix.

Exclusion Criteria:

* Patient requires or starts using an unacceptable or contraindicated concomitant medication.
* Patient has valvulopathy.
* Patient is at risk for pulmonary hypertension.
* Patient exclusion will be at the sole discretion of the Sponsor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Cross JH, Galer BS, Gil-Nagel A, Devinsky O, Ceulemans B, Lagae L, Schoonjans AS, Donner E, Wirrell E, Kothare S, Agarwal A, Lock M, Gammaitoni AR. Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet syndrome. Seizure. 2021 Dec;93:154-159. doi: 10.1016/j.seizure.2021.10.024. Epub 2021 Nov 2.
Clinical trial NCT02324127: Clinical Trial of Quantitative Detection Kit for Hsp90α in Hepatic Cancer
Official title: Clinical Trial of Quantitative Detection Kit for Hsp90α in Hepatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Lead sponsor: Protgen Ltd
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 1100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Detect plasma Hsp90α concentration of liver cancer patients, healthy volunteers, benign liver diseases.

Detailed description: Detect plasma Hsp90α concentration of liver cancer patients, healthy volunteers, benign liver diseases, validate accuracy, specificity and sensitivity of Hsp90α kit.

Eligibility criteria: Inclusion Criteria:

* Liver cancer patients
* Healthy volunteers,
* Benign liver diseases patients

Exclusion Criteria:

* Patients who Previously accepted radiotherapy

Primary outcomes:
measure: Hsp90α Concentration of plasma
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Medical University Cancer Institute and Hospital
state: Zhejiang
Study officials:
affiliation: The first hospital of Zhejiang province
name: Shusen Zhen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884727: Effect of ASEA on Energy Expenditure and Fat Oxidation in Humans
Official title: A Randomized, Cross-Over Clinical Trial to Evaluate the Acute Effects of ASEA on Energy Expenditure and Fat Oxidation in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Overweight
Over nutrition
nutrition disorders
energy expenditure
metabolic rate
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 15
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To test the effect of ASEA consumption on 24-hour resting energy expenditure. Hypothesis: consumption of 8-oz of ASEA water (4-oz before breakfast and 4-oz before bedtime) will significantly elevate 24-h resting energy expenditure as compared to consumption of a placebo control (salt water, same dietary intake).

Detailed description: The ASEA beverage is a special oral formulation produced from a pure saline solution containing 123 mg sodium and 129 mg chloride per 4 oz. serving. A proprietary electrolytic and catalytic process rearranges the salt water solution to mimic the redox signaling molecular composition of the native salt-water compounds found in and around human cells. Data obtained thus far, suggests the possibility that consumption of the ASEA beverage may increase energy expenditure and thus be beneficial for the treatment of obesity, however, this has not been assessed in human clinical studies. To this end, we will measure the effects of ASEA consumption on energy expenditure by indirect calorimetry using the indirect room calorimeter at the University of North Carolina (UNC) Nutrition Research Institute.

The primary outcome measures will be the change in 24-h energy expenditure and respiratory quotient in response to ASEA consumption. The secondary outcome variables will include changes in relevant peptide hormones, and norepinephrine/epinephrine and their relationship to changes in energy expenditure in response to consumption of ASEA.

Eligibility criteria: Inclusion Criteria:

* woman
* postmenopausal
* healthy
* age 50-65
* BMI 25-35 kg/m²
* exercise less than 150 minutes per week
* weight neutral for past 6 months

Exclusion Criteria:

* smoker
* exercises more than 150 minutes per week
* abuses drugs or alcohol
* vegetarian
* taking herbal supplements, attention deficit hyperactivity disorder (ADHD) medication or thyroid medication
* taking beta-blockers, steroidal anti-inflammatory medication
* taking pseudoephedrine

Primary outcomes:
measure: Resting Energy Expenditure
timeFrame: 24-hours
Secondary outcomes:
measure: Plasma Hormones
timeFrame: 0900 and 1100 hours
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Andrew G Swick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02445027: Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting
Official title: Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Primary Care
Healthy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this study is to test the feasibility and acceptability of tethered capsule Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening in the primary care practice environment.

Detailed description: 60 healthy volunteers scheduled for a routine primary care visit will be recruited and asked to swallow the OCT capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses through the esophagus, multiple images of the esophagus are acquired and later analyzed.

Eligibility criteria: Inclusion Criteria:

* Subjects must be scheduled for non-urgent appointment at primary care practice including annual wellness visits and routine follow-up appointments.
* Subjects must be over the age of 18
* Subjects must be able to give informed consent
* Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Exclusion Criteria:

* Subjects with current symptoms of dysphagia
* Subjects with any history of intestinal strictures, prior GI surgery, or history of intestinal Crohn's disease.
* Subjects with current symptoms of fever, nausea or sore throat at the time of the appointment.
* Pregnancy

Primary outcomes:
measure: Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting.
timeFrame: Approximate 20min visit (5min image acquisition)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00080327: Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia
Official title: A Placebo-Controlled Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2004-03-30
Enrollment: 370
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: A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia


Eligibility criteria: Inclusion Criteria:

* Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months

Primary outcomes:
measure: Change at endpoint in schizophrenia rating scale
Secondary outcomes:
measure: Clinical Global Improvement scale at endpoint and time to response
Other outcomes:
Locations:
city: Wallingford
country: United States
facility: Bristol-Meyers Squibb Call Center
state: Connecticut
Study officials:
References:
Clinical trial NCT00647127: Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain
Official title: Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Buprenorphine
Fentanyl
Analgesic effect
Anti-hyperalgesic effect
Experimental pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-03-31
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against experimental pain in skin, muscle and bone. The study will be performed with healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* men \> 18 years

Exclusion Criteria:

* women
* known allergy against the investigated drugs
* ongoing participation in other experiments or participation in other experiments 14 days before screening
* previously pain or psychiatric conditions
* simultaneously use of pain killers
* alcohol
* previously drug-addict or member of family with drug-addicts
* chronic constipation
* ileus
* inflammatory bowel syndrome
* abdominal surgery within the last three months

Primary outcomes:
measure: Data will be electronically recorded or written directly in case report form. Outcome measure will be a subjective rating of the pain with a visual analogue scale.
timeFrame: Continuously
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Mech Sense, Department of Gastroenterology
state: Region Nordjyllan
Study officials:
affiliation: Mech Sense, Department of Gastroenterology, Aalborg Hospital
name: Asbjoern M Drewes, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04694027: Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient
Official title: Omega-3 Fatty Acids Plus Vitamin E Cosupplementation Versus Vitamin E in Fibrocystic Breast Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mastalgia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to identify the effect of omega-3 plus vitamin E cosupplementation on mastalgia in patients with FCC and to compare its effect with that of vitamin E only.

Detailed description: 120 patients will be enrolled in the study and divided into three groups each group consisted 40 patient then the severity of mastalgia in the three groups before, through and after intervention. Radiological assessment was done before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* all females with mastalgia aged 18 to 55

Exclusion Criteria:

Pregnant and lactating women, patient who had a recent breast abscess or breast drainage, patient used omega-3 and vitamin E supplementation before the trial and postmenopausal women.

-

Primary outcomes:
measure: improvement of pain severity
timeFrame: 3 months
Secondary outcomes:
measure: improvement of radiological finding
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Rehab Sabry
state: Muslim
Study officials:
References: