louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04287127: One-stage Bone Lengthening in the Management of Brachymetatarsia
Official title: Cosmetic Satisfaction and Undercorrection After One-stage Bone Lengthening in the Management of Brachymetatarsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brachymetatarsia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who presented brachymetatarsia and who underwent one stage lengthening in our department

Brief summary: Brachymetatarsia is a shortening in length of a metatarsal exceeding 5mm. This congenital anomaly most often affecting women and the second metatarsal is associated with frequent aesthetic disorders leading patients to consult. The one-time lengthening technique is described for the management of brachymetatarsia with good functional results. However, the metatarsal elongation in one time is limited to 15 millimeters, to avoid complications.

No study has presented the consequences of hypocorrection, especially cosmetic. Our hypothesis is that undercorrection (Hypocorrection) is associated with a higher rate of cosmetic dissatisfaction.


Eligibility criteria: Inclusion Criteria:

* Patients operated on for a one-time lengthening for isolated brachymetatarsia
* Major patients

Exclusion Criteria:

* Patient refusing to participate in research

Primary outcomes:
measure: satisfaction using a visual analog scale (from 0/10 to 10/10)
timeFrame: 1 day
Secondary outcomes:
measure: radiological evaluation of surgical correction
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Louis Dagneaux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02849327: Combination of Cryosurgey and NK Immunotherapy for Recurrent Pharyngeal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Recurrent Pharyngeal Cancer
Keywords: Pharyngeal cancer
Cryosurgery
NK immunotherapy
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Shenzhen Hank Bioengineering Institute
First posted: 2016-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent pharyngeal cancer.

Detailed description: By enrolling patients with recurrent pharyngeal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital, Guangzhou
name: Jibing Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04317027: Physiological Examination of New Fighting Clothing During Exposure to Exercise Under Hot Conditions
Official title: Physiological Examination of New Fighting Clothing During Exposure to Exercise Under Hot Conditions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clothing
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Medical Corps, Israel Defense Force
First posted: 2020-03-20
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The use of fighting clothing under extreme heat conditions during rest and exercise, compromises the body's ability to maintain temperature within the narrow physiological range needed for regular function, and might lead to heat injury. Beside working and fighting clothing, the fighters also wear vests used for protection and equipment carrying, which leads to substantial reduction in effective dissipation area from the central region of the body. This fact is most substantial during exercise which increases metabolic heat production rate and leads to heat accumulation and rise in body temperature. Therefore the development of new textile technologies to allow rapid cooling during intervals is of great importance.

This study is designed to physiologically examine new textile solutions, by evaluating the physiological stress induced during exercise under mild heat conditions.


Eligibility criteria: Inclusion Criteria:

* Men
* Formerly fighters
* Healthy
* Without prior diseases including heart, vessel, respiratory and metabolic diseases or known use of medications
* experience in using fighting clothing
* VO2max \> 50 ml/kg/min

Exclusion Criteria:

* Incapacity to fulfill inclusion criteria

Primary outcomes:
measure: Body temperature
timeFrame: During intervention period (2 hours test) only
measure: Heart rate
timeFrame: During intervention period (2 hours test) only
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: Ha'Merkaz
Study officials:
References:
Clinical trial NCT04935827: Seasonal Differences in Home Dialysis Uptake and Initiating Dialysis in the Hospital
Official title: Seasonal Differences in Home Dialysis Uptake and Initiating Dialysis in the Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dialysis
Peritoneal Dialysis
Hospitalizations
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-06-23
Enrollment: 400000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults with fee-for-service Medicare coverage initiating dialysis for end-stage kidney disease in the United States from 12/1/2007-11/30/2017

Brief summary: This study will investigate whether home dialysis uptake varies by the season of year. We will also investigate whether hospitalizations around the time of dialysis also vary by season of year and whether hospitalizations are associated with reduced home dialysis starts and sustained home dialysis uptake.


Eligibility criteria: Inclusion Criteria:

* Started dialysis in the USA for end-stage kidney disease from 12/1/2007-11/30/2017
* No transplant or death prior to day 90 of dialysis
* Medicare Parts A/B as primary payer 30 days prior to starting dialysis
* Valid Medicare Evidence Form (Form 2728)

Exclusion Criteria:

* As above

Primary outcomes:
measure: Type of dialysis modality at the start of dialysis
timeFrame: Day 1 of dialysis
measure: Type of dialysis modality at the end of month 3 of dialysis
timeFrame: End of month 3 of dialysis
measure: Type of dialysis modality at the end of month 6 of dialysis
timeFrame: End of month 6 of dialysis
measure: Type of dialysis modality at the end of month 9 of dialysis
timeFrame: End of month 9 of dialysis
measure: Type of dialysis modality at the end of month 12 of dialysis
timeFrame: End of month 12 of dialysis
measure: Mortality in the first year
timeFrame: 1 year of dialysis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02477527: Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
Official title: Switching From Atripla to Stribild Leads to Improvements in Central Nervous System Side Effects and Sleep Disturbances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
AIDS
Sleep Disorders
Keywords: atripla
stribild
dreams
Lead sponsor: Midtown Medical Center, Tampa, FL
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2015-06-22
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.

Detailed description: Stribild is a preferred regimen in the Department of Health and Human Services guidelines and has demonstrated non-inferiority to Atripla in treatment naïve patients out to 144 weeks (GS-102). Stribild also has statistically significant less Central Nervous System side effects, sleep disturbances and lipid elevations compared to Atripla. This study will evaluate the efficacy, safety, changes in Central Nervous System abnormalities and sleep disorders following a switch from virologically suppressed subjects on Atripla to Stribild.

Eligibility criteria: Inclusion Criteria:

* HIV+ subjects 18 years of age or older
* estimated Glomerular Filtration Rate \> 70 mL/min
* must currently be on Atripla and taking it for at least 3 months with a HIV-1 Viral Load \< 50 copies/mL
* no antiretrovirals prior to the initiation of Atripla
* baseline genotyping

Exclusion Criteria:

* pregnancy
* unable to provide informed consent
* enrolled in another study

Primary outcomes:
measure: Percentage of Patients With Viral Loads < 50 Following the Switch
timeFrame: 24 weeks
Secondary outcomes:
measure: T-cell Changes
timeFrame: 24 weeks
measure: Improvements in Central Nervous System Toxicity Score
timeFrame: 24 weeks
measure: Improvements in Sleep Disorder Score
timeFrame: 24 weeks
Other outcomes:
measure: Safety as Measured by Side Effects
timeFrame: 24 weeks
Locations:
Study officials:
affiliation: Midtown Medical Center
name: Edward W Braun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04812327: Capturing Infectious COVID-19 Asymptomatic Cases in Singapore
Official title: Capturing Infectious COVID-19 Asymptomatic Cases in Singapore
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Covid19
SARS CoV-2
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited at study sites from individuals admitted for SARS-CoV-2 isolation. Once enrolled, participants may be transferred to a different care unit, or units, throughout their time in the study depending on their medical needs.

Brief summary: This study is being conducted to assess the performance of the BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2, used in serial testing, in identification of infectious, asymptomatic individuals. This information may be used to inform development of an effective testing strategy by policy makers.

Detailed description: This multi-center, prospective, observational, diagnostic evaluation study is designed to assess the performance of the BD Veritor System in the detection of SARS-CoV-2 in asymptomatic individuals compared to viral culture and a commercially available RT-PCR assay over multiple testing time points. The study will enroll a minimum of 150 asymptomatic, adult participants who test positive for SARS-CoV-2 during community/traveler screening procedures.

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥21 years of age at the time of informed consent
2. Has a positive screening test for SARS-CoV-2 by RT-PCR
3. Is asymptomatic for COVID-19 on the day of their positive screening test (may have symptoms on the actual day of study enrollment)
4. Is expected to remain at the study site for the full 6-day study period
5. Willing and able to complete all study required procedures
6. Provision of signed and dated informed consent form

Exclusion Criteria:

1. History of frequent or difficult to control nosebleeds within the 14 days prior to study participation
2. If, at the discretion of the Investigator, involvement in the study is likely to jeopardize the subject's health or their current or future medical treatment

Primary outcomes:
measure: Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared viral culture, over multiple collection time points
timeFrame: 6 days
Secondary outcomes:
measure: Assess the performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 compared to a commercially available RT-PCR asay, over multiple collection time points
timeFrame: 6 days
measure: Assess the performance a commercially available RT-PCR assay compared to viral culture, over multiple test time points
timeFrame: 6 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Hospital Employee
name: Yen Seow Tan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06400927: Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure
Official title: Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure: A Randomized Controlled Pilot Study: ASSIST-HF SIRIO
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: East and North Hertfordshire NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Clinical and Interventional Cardiology, Sassari University Hospital, Sassari, Italy
First posted: 2024-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this pilot randomized study is to examine whether integrating the SIRIO-HF virtual assistant (VA) into the outpatient management of participants recently discharged from hospital with a new diagnosis of heart failure (HF), may reduce the need for regular medical assessment and the healthcare burden, reduce variability in healthcare, and meet with participant satisfaction, without compromising participant safety and overall care quality.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Newly diagnosed HF with New York Heart Association class II-III symptoms at discharge

Exclusion Criteria

* Known prior history of HF
* Severe comorbidities that could affect protocol adherence, in the opinion of the investigator
* Alternative diagnosis for symptoms such as chronic obstructive pulmonary disease
* Dementia or other cognitive impairment
* Currently involved in another interventional clinical trial

Primary outcomes:
measure: Acceptability of the intervention to users (participants)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stevenage
country: United Kingdom
facility: East and North Hertfordshire NHS Trust
state: Hertfordshire
Study officials:
affiliation: East and North Hertfordshire NHS Trust
name: Diana A Gorog, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03647527: Predictor Analysis of Acute Radiation Oral Mucositis in NPC Patients Treated With IMRT/TOMO Combined Chemotherapy
Official title: Predictive Factor Analysis of Acute Radiation Oral Mucositis in Nasopharyngeal Carcinoma Patients Treated With Precise Radiotherapy Technique Combined Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
acute radiation oral mucositis
intensity modulated radiotherapy
tomography radiotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between September 2016 and August 2018, consecutive patients with II-IVB nasopharyngeal carcinoma receiving intensity modulated radiotherapy or tomography radiotherapy.

Brief summary: Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, single center, and exploratory study. Two contour methods of oral mucosal will be used in this study. All detail information will be recorded prospectively. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with new precise radiotherapy (intensity modulated radiotherapy or tomography radiotherapy) by using different dosimetric parameters and clinically relevant variables.

Detailed description: To prospectively identify the predictive value of different dosimetric parameters and assess the predictors of acute radiation oral mucositis in nasopharyngeal carcinoma patients treated with intensity modulated radiotherapy or tomography radiotherapy.

Eligibility criteria: Inclusion Criteria:

1.Clinical diagnosis of nasopharyngeal carcinoma. 2.7th version American Joint Committee on Cancer (AJCC) stage II-IVB. 3.Age must above 18. 4.Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.

5.Adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

1. Treatment with palliative intent.
2. Previous malignancy.
3. Pregnancy or lactation.
4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
5. Any severe coexisting disease.

Primary outcomes:
measure: the highest grade of oral mucositis
timeFrame: oral mucocitis will be checked every day during the date of initiation of radiation therapy until the date of completion of radiation therapy, the highest grade ≥ 3 define as severe oral mubocitis, assessed up to a month and a half
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Yuanyuan Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02721927: The Use of Emergency Department by Syrian Refugees and the Increasing Cost of Health Care
Official title: The Use of Emergency Department by Syrian Refugees and the Increasing Cost of Health Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency
Keywords: refugees
Syrian
cost
visit
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult Syrian patients who visited the Emergency Department of Adiyaman University of Training and Research Hospital between 1 January 2015 and 1 January 2016 retrospectively.

Brief summary: Since the beginning of the Syria conflict in March 2011, more than 10 million Syrians were forced to leave their homes and sought refuge in neighboring countries.

Detailed description: Since the beginning of the Syria conflict in March 2011, more than 10 million Syrians were forced to leave their homes and sought refuge in neighboring countries (). In the result influx of the thousands of Syrian migrants who continue to cross into world, all the world especially the European countries faced with a huge refugee problem. Emergency medicine is play key role of being healthcare's safety net, being the last resort for those with no primary healthcare and no alternatives.

The aim of this study was to evaluate the use of Emergency Department by Syrian refugees and total and costs of their health care.

Eligibility criteria: Inclusion Criteria:

* Adult Syrian patients who visited the Emergency Department were included in the study.

Exclusion Criteria:

* Patients below 18 years of age
* Emergency Department returns during same day
* Patients with missing data in hospital medical record were excluded from the study.

Primary outcomes:
measure: Evaluate the use of Emergency department by Syrian refugees
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Adiyaman
country: Turkey
facility: Adiyaman University Research Hospital
state: Central
Study officials:
affiliation: Adiyaman University of Medical Faculty
name: Umut Gulacti
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karakus A, Yengil E, Akkucuk S, Cevik C, Zeren C, Uruc V. The reflection of the Syrian civil war on the emergency department and assessment of hospital costs. Ulus Travma Acil Cerrahi Derg. 2013 Sep;19(5):429-33. doi: 10.5505/tjtes.2013.78910.