louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04925908: Exclusive Breastfeeding in Infants of Mothers Infected With Novel Coronavirus
Official title: Evaluation of Exclusive Breastfeeding Within the First Six Months in Infants of Mothers Infected With Novel Coronavirus: 1-year Experience of a Single Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Breastfeeding, Exclusive
Newborn Morbidity
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 338
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants who were born to mothers with suspected/proven COVID-19

Brief summary: COVID-19 pandemic emerges an issue for breastfeeding.Earlier in pandemic mothers who had COVID-19 were separated from their babies due to insufficient data but this approach was abandoned due to the lack of transmission via breastmilk.However, where mothers with COVID-19 are cohorted in the same room, they still have to be isolated from their babies following the birth.Investigators aimed to evaluate rate of exclusive breastfeeding(EB) within first 6 months among mothers who were isolated from their babies due to COVID-19.

Detailed description: COVID-19 pandemic emerges an issue for breastfeeding.Earlier in pandemic mothers who had COVID-19 were separated from their babies due to insufficient data but this approach was abandoned due to the lack of transmission via breastmilk.However, where mothers with COVID-19 are cohorted in the same room, they still have to be isolated from their babies following the birth.To our knowledge, there is no study regarding this subject to-date.Therefore, investigators aimed to evaluate rate of exclusive breastfeeding(EB) within first 6 months among mothers who were isolated from their babies due to COVID-19.

Eligibility criteria: Inclusion Criteria:

* Infants who were born to mothers with suspected or evident COVID-19
* Accepted to participate with an informed consent of parents

Exclusion Criteria:

* Congenital abnormalities
* Chromosomal abnormalities
* Contraindication for breastfeeding
* Declined to participate

Primary outcomes:
measure: Exclusive breastfeeding
timeFrame: 6 months
Secondary outcomes:
measure: Disease status
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Kucukcekmece
Study officials:
References:
Clinical trial NCT01042808: Isentress Re-examination Study (MK-0518-115)
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy of ISENTRESS in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
HIV Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-01-06
Enrollment: 996
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-1 Infected adults

Brief summary: This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Isentress through collecting the safety and efficacy information in usual practice according to the Re-examination Regulation for New Drugs.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria: Inclusion Criteria:

* HIV-1 Infected Adults
* Treated with Isentress 400 mg tablet within local label during the enrollment period

Exclusion Criteria:

* Contraindication to Isentress according to the local label

Primary outcomes:
measure: Percentage of patients with any adverse experience which occurs during treatment or within 14 days following cessation of treatment
timeFrame: up to 14 days after last treatment
measure: Proportions of patients with HIV-1 RNA levels of less than 50 milliliter
timeFrame: 6 months after treatment +/- 2 weeks
measure: Proportions of patients with HIV-1 RNA levels of less than 400 copies per milliliter
timeFrame: 6 months after treatment +/- 2 weeks
measure: Change from baseline in CD4 cell count and overall efficacy evaluation by investigator (success, failure, or nonassessible)
timeFrame: 6 months after treatment +/- 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05821608: Heads up Messages to Increase Call Pick-up Rates
Official title: Evaluating the Impact of 'Heads up' Messages on Call Pick-up Rates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Various: Health Insurance Members That Could Benefit From Being Connected to a Specialist, e.g., Orthopedic Doctor to Treat Back Pain
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study aims to investigate whether notifying health insurance members about an upcoming call can increase their pick-up rates. The study will randomize participants into three groups: control group (no message), treatment group 1 (message variation 1), and treatment group 2 (message variation 2). The primary outcome of interest is the call pick-up rate, and the study will also examine the message opt-out rates for the two different messages.


Eligibility criteria: Inclusion Criteria:

* The study will include members enrolled in the health insurers' Relay Texting system due to receive an outreach call during the study timeframe.
* Enrollment in the study will end when we meet our enrollment target (N=2000)

Primary outcomes:
measure: Number of participants who pick up the phone call
timeFrame: The time between the second and first call attempt may vary but will be less than 10 days.
Secondary outcomes:
measure: Percentage of participants who opt out of future text messages
timeFrame: We will consider a member as opted out if they opt out of messages within 24 hours of receiving a message as part of the study.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02585908: Safety and Efficacy of γδ T Cell Against Gastric Cancer
Official title: γδ T Cell Immunotherapy for Treatment of Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gastric Cancer
Lead sponsor: Beijing Doing Biomedical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, safety and effects of γδT cells on human gastric cancer are going to be investigated.

Detailed description: PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and CIK, they will be infused to the patients as immunotherapy.

Eligibility criteria: Inclusion Criteria:

1. Age:30-75
2. Karnofsky performance status \>50
3. Diagnosis with gastric cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Patients who have a life expectancy of at least 12 weeks
6. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
2. Known human immunodeficiency virus (HIV) infection.
3. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
4. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
5. Pregnancy

Primary outcomes:
measure: Reduced size of the tumor.
timeFrame: up to one year
Secondary outcomes:
measure: Safety, as measured by the rate of adverse events and serious adverse events
timeFrame: up to two years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Luoyang
country: China
facility: First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Huaian
country: China
facility: Huai'An First People'S Hospital
state: Jiangsu
city: Hangzhou
country: China
facility: Hangzhou Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Beijing Doing Biomedical Co., Ltd.
name: li gangyi, master
role: STUDY_CHAIR
References:
Clinical trial NCT02441608: Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
Official title: Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Irritability
Skin Sensitization
Lead sponsor: Kley Hertz S/A
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.


Eligibility criteria: Inclusion Criteria:

* Age between 18 to 60 years old;
* Skin types: I (light caucasian) or III (light brown);
* Intact skin where the product will be applied;
* Agreement to comply with the test procedures and attend the clinic in the days and fixed times for medical assessments and application and reading of dressings
* Signature of informed consent form

Exclusion Criteria:

* Pregnancy and lactation
* Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
* Diseases that cause immune suppression;
* Use of photosensitizing drugs;
* History or photodermatoses activities;
* Personal or family history of photoinduced skin cancer;
* Presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic keratoses;
* Intense sun exposure in the experiment area Use of new drugs and/or cosmetics during the experiment;

  * Previous participation in a study with the same product under test;
  * Relevant medical history or current evidence of alcohol or other drugs abuse;
  * Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
  * Sponsor's employees involved in the study, or close family member of an employee involved in the study;

Primary outcomes:
measure: Photoirritation as measured through the use of dressings containing tested product and placebo
timeFrame: 05 days
measure: Photosensitization as measured through the use of dressings containing tested product and placebo
timeFrame: 32 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06836908: CCSV - Post Market Clinical Follow-up Study
Official title: Chest Compression Synchronized Ventilation (CCSV) - an Exploratory Post Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: WEINMANN Emergency, Medical Technology GmbH & Co. KG
name: Berufsrettung Wien
First posted: 2025-02-20
Enrollment: 98
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: Adult out-of-hospital cardiac arrest patients in Vienna

Brief summary: The main goal of this observational study is the evaluation of Chest Compression Synchronized Ventilation (CCSV) regarding oxygenation in terms of PaO2 assessed by routine blood gas analysis, hemodynamic effects, 30-day outcome and safety in comparison to Intermittent Positive Pressure Ventilation (IPPV) as data in humans is sparse especially in direct comparison to other ventilation modes.

Cardiac arrest patients in Vienna, Austria will be preclinically randomized (IPPV and CCSV) and ventilated accordingly during CPR. Differences in oxygenation, decarboxylation, systemic perfusion and cerebral oxygenation, the patient's 30-day outcome as well as ventilator-associated adverse events (e.g., pneumothorax) will be recorded and analyzed.


Eligibility criteria: Inclusion Criteria:

* OHCA
* Correct endotracheal intubation (seen by capnography)
* The patient is being treated by the Vienna Emergency Medical Services within the scope of emergency ventilation.
* MEDUMAT Standard from Weinmann Emergency is used.
* Mechanical ventilation is performed according to the specified indications.

Exclusion Criteria:

* Patients eligible for eCPR (as defined by the standard operating procedure of the Emergency Medical Service Vienna)
* Patients recovering (reaching sustained ROSC) before starting mechanical ventilation or in the first three minutes of it
* Any other mechanical ventilation during the ongoing CPR before study inclusion
* Traumatic cardiac arrest
* Suspected or known pregnancy
* Clinically suspected (tension-)pneumothorax

Primary outcomes:
measure: Oxygenation
timeFrame: 24 months
Secondary outcomes:
measure: Decarboxylation
timeFrame: 24 months
measure: systemic perfusion
timeFrame: 24 months
measure: patient outcome
timeFrame: 27 months
measure: ventilator-associated adverse events
timeFrame: 27 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Department of Emergency Medicine, Medical University of Vienna
name: Sebastian Schnaubelt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02761408: ALDH2 Mutation in Taiwanese Head and Neck Cancer
Official title: Correlation Between Radiation Dermatitis/Mucositis and ALDH2 Mutation in Taiwanese Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dermatitis
Mucositis
Keywords: Head and neck cancer
Asian
ALDH2
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-05-04
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Locally advanced Taiwanese head and neck squamous cell carcinoma patients who intend to accept primary chemoradiation or surgery with adjuvant chemoradiation, without previous treatment

Brief summary: The purpose of this study is to evaluate the effect of ALDH2 mutation in radiation associating dermatitis or mucositis in head and neck cancer patients who accept chemoradiation therapy

Detailed description: * One-site audit. The enrolled subject is confirmed by PIs

  ◦◦Source data is compared to external data sources medical records, either paper or electronic case report forms.
* NCI CTCAE v5.0 for AE records
* Patient recruitment according to inclusion criteria: 1. Newly diagnosed locally head and neck squamous cell carcinoma; 2. Apply for primary chemoradiation or adjuvant chemoradiation; 3. Signed informed consent
* Sample size assessment: 60 subjects will be included in one year for total 120 subjects
* Missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results
* Fisher's exact test is for category comparison. Kaplan-Meier analysis is for survival analysis. AE grades will be analyzed according to NCI guideline. Two-side p \< 0.05 is suggested significant.

Eligibility criteria: Inclusion Criteria:

* Age \>20, \<70
* Newly diagnosed head and neck squamous cell carcinoma
* Tissue proved
* Signed informed consent
* Suitable for chemoradiation

Exclusion Criteria:

* Uncontrolled underlying diseases
* Allergy to chemotherapy
* Uncontrolled skin diseases or mucosa diseases
* Previously radiation therapy over head and neck
* Combined with other cancer currently

Primary outcomes:
measure: Number of participants with treatment-related adverse events assessed by CTCAEv5.0
timeFrame: 6 months after the end of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cancer Center, Taipei Veterans General Hospital
Study officials:
affiliation: Cancer Center, Taipei Veterans General Hospital
name: Ling-Wei Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04320108: ESWT for Shoulder Pain in Patients With Brain Damage
Official title: The Effects of Extracorporeal Shockwave Therapy (ESWT) for Shoulder Pain in Patients With Brain Damage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Damage, Hypoxic
Stroke
Brain Tumor
ICH
Keywords: Extracorporeal shockwave therapy
Brain damage
Pain
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (ESWT) for upper extremity pain related to spasticity in patients with spinal cord injury.

Detailed description: 6 times of ESWT (3,000 pulses per time, low energy under 0.3 mJ/mm\^2, tolerable range) on subscapularis and lesser and greater tuberlces of humerus to reduce pain in patients with brain damage

Eligibility criteria: Inclusion Criteria:

* Brain damaged patient confirmed in the brain image
* 1 month after brain damage
* Pain in hemiplegic shoulder areas more than 4 points on the numerical scale (NRS)
* Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)
* Age: 20 and older
* Person who has agreed in writing to decide his or her participation and comply with the precautions

Exclusion Criteria:

* Pain due to trauma
* Injection treatments two weeks before participating in the study
* Severe coagulopathy (excluding antiplatelet use)
* Impaired cognition

Primary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Secondary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Up to 4 weeks (baseline, 2 weeks + 1 day, 4 weeks)
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center
Study officials:
affiliation: Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
name: MinYoung Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03382808: Emotion Recognition Training in Antisocial Violent Offenders With Psychopathic Traits
Official title: Emotion Recognition Training in Antisocial Violent Offenders With Psychopathic Traits
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychopathy
Violent Aggressive Behavior
Emotional Problem
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2017-12-26
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Impaired recognition of affective facial expressions has been conclusively linked to antisocial and psychopathy. However, little is known about the modifiability of this deficit. This study aims to investigate whether and under which circumstances the proposed perceptual insensitivity can be addressed with a brief implicit training approach.


Eligibility criteria: Inclusion Criteria:

* Confirmed ASPD diagnosis
* PCL-Score available
* arrested for committing violent crimes

Exclusion Criteria:

* Insufficient knowledge of the German language
* Diagnosed with schizophrenia
* Substance abuse
* Neurological disease (e.g. epilepsy)
* Mental retardation

Primary outcomes:
measure: Animated morph task
timeFrame: change from pre-treatment to post-treatment after 8 weeks
Secondary outcomes:
measure: Unconscious processing of affective facial expressions during interocular suppression in a breaking Continuous flash suppression paradigm
timeFrame: pre-treatment, after 8 weeks (post-treatment)
measure: Eye-Tracking
timeFrame: pre-treatment, after 8 weeks (post-treatment)
measure: Ambivalence Task
timeFrame: pre-treatment, after 8 weeks (post-treatment)
measure: Emotional search paradigm
timeFrame: pre-treatment, after 8 weeks (post-treatment)
measure: Affective prosody
timeFrame: pre-treatment, after 8 weeks (post-treatment)
measure: Multifaceted empathy test
timeFrame: pre-treatment, after 8 weeks (post-treatment)
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen
state: Baden Würrtemberg
Study officials:
affiliation: University Hospital Tuebingen
name: Michael Schönenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schonenberg M, Christian S, Gausser AK, Mayer SV, Hautzinger M, Jusyte A. Addressing perceptual insensitivity to facial affect in violent offenders: first evidence for the efficacy of a novel implicit training approach. Psychol Med. 2014 Apr;44(5):1043-52. doi: 10.1017/S0033291713001517. Epub 2013 Jul 1.
citation: Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.