louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04377724: Spread and Course of COVID-19 Infections
Official title: Longitudinal Serological Study on the Spread and Course of COVID-19 Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Virus Disease
Lead sponsor: ETH Zurich
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 2910
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohort consists of initially healthy volunteers, all employees or students of ETH. Inclusion into the longitudinal study will be carried out in strict response to the STOP safety concept of the Safety, Security, Health and Environment administrative department of ETH.

Brief summary: The overall goal is to study the immune response to SARS-CoV-2 infection over the period of one year in the blood of a representative cohort of ETH students/employees.


Eligibility criteria: Inclusion Criteria:

* ETH employee or ETH student and their family members living in the same household at the start of the study
* Between 18 and 64 years of age at the start of the study
* Signed informed consent

Exclusion Criteria:

* Age over 64 years at the start of the study
* In quarantine or self-confinement at the start of the study
* Active COVID-19 infection at the start of the study:

  * Diagnosed with a laboratory test
  * Suspected based on typical symptoms such as fever (\>38°C), acute pulmonary ex-acerbation or sudden loss of gustatory taste
* The following medical condition

  * With continuous steroid therapy/ chemotherapy/immunsuppressive therapy
  * In treatment for cancer
  * With severe autoimmune disease

Primary outcomes:
measure: seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens
timeFrame: 12 months
Secondary outcomes:
measure: the property of peripheral blood mononuclear cells before and after an infection with SARS-CoV-2 as opposed to other pathogens
timeFrame: 12 months
measure: the property of IgM and IgA antibody titers against the nucleocapsid protein of SARS-CoV-2 in symptomatic as well as asymptomatic COVID-19 infections over the course of time following an infection
timeFrame: 12 months
measure: the immune response to common-cold (corona)virus and influenza virus infections in patients with COVID-19 infections
timeFrame: 12 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: ETH
Study officials:
affiliation: ETH Zurich
name: Jörg Goldhahn, MD
role: STUDY_CHAIR
affiliation: ETH Zurich
name: Susanne Ulbrich, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: ETH Zurich
name: Markus Stoffel, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04685824: Visual Telerehabilitation in AMD Patients
Official title: Visual Rehabilitation in Macular Degeneration: a Pilot Study on Biofeedback Training and Home-based Mobile Virtual-reality Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Macular Degeneration
Keywords: Visual rehabilitation
Oculus Go
Virtual-reality
Biofeedback
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Following the degeneration of the macula and the loss of central vision, the patients naturally relocate the fixation point for high visual acuity peripherally, in an eccentric and healthy part of the retina (PRL), to compensate for visual impairments. However, in many cases, the PRL lands on a sub-optimal retinal area and becomes useless. Modern low-vision rehabilitation procedures for AMD patients include biofeedback training (BFT) to relocate the PRL to a healthy retinal patch and acquire better fixation skills. This study seeks to combine BFT with home-based immersive virtual-reality audiovisual stimulation and measure feasibility and potential effectiveness on oculomotor control and visual perception.


Eligibility criteria: Inclusion Criteria:

* Dry-AMD.
* BCVA \> 20/160.
* Ability to follow the visual and auditory stimuli and training instructions.
* Auditory test positive at 50Hz 25-60dBHL.
* Home Wi-Fi access.

Exclusion Criteria:

* Wet AMD.
* Both eyes with media opacity that impairs microperimetry testing.
* Inability to perform during testing and training.
* Psychoactive drugs consumption.
* 3 consecutive VRISE scores \< 25 at inclusion.
* History of vertigo or dizziness
* Prior vision rehabilitation interventions.

Primary outcomes:
measure: Feasibility of home-based IVR audiovisual stimulation
timeFrame: 18 months
Secondary outcomes:
measure: Visual Acuity
timeFrame: from baseline to end of follow-up at 7 months
measure: Retinal Sensitivity
timeFrame: from baseline to end of follow-up at 7 months
measure: Fixation stability
timeFrame: from baseline to end of follow-up at 7 months
measure: Contrast Sensitivity
timeFrame: from baseline to end of follow-up at 7 months
measure: Reading Speed
timeFrame: from baseline to end of follow-up at 7 months
measure: Quality of Life Scores
timeFrame: from baseline to end of follow-up at 7 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Krembil Research Institute/Toronto Western Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT06170424: Retrospective Analysis of Spray Skin Treats for Severe Burns
Official title: A Real-world 10-year Single Center Experience With Spray Skin in the Treatment of Extensive Severe Burns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morality
Skin Graft Complications
Keywords: spray skin, severe burn, microskin grafting
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: severe burns patients with \> 50% TBSA

Brief summary: This study investigated the efficacy of novel approach spray skin for extensive severe burns treatment.

Detailed description: Burns are a global public health problem. This study investigated the efficacy of novel approach spray skin (autologous skin cell suspension combined with split-thickness skin grafting, STSG) for extensive severe burns treatment.

We performed a real-world retrospective analysis of extensive burns patients (\> 50% TBSA) from our hospital last 10 years.

Eligibility criteria: Inclusion Criteria:

* patients with \> 50% TBSA

Exclusion Criteria:

* died within 1 week after admission
* admitted to hospital more than 1 week after injury

Primary outcomes:
measure: survival rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: complication of skin graft
timeFrame: the take rate in the postoperative day 30, 60, 90
measure: length of hospital
timeFrame: through study completion, usually no more than 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Burn Surgery, The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Jiayuan Zhu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00476424: A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects
Official title: A Pharmacokinetic Study of Once Daily Efavirenz 400 mg Versus 600 mg in Thai HIV-1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: once daily Efavirenz 400 mg
PK once daily Efavirenz 400 mg versus 600 mg
Treatment Experienced
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Thailand
First posted: 2007-05-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Pharmacokinetic study of once daily Efavirenz 400 mg versus 600 mg in Thai HIV-1 infected subjects.

Detailed description: Efavirenz Pharmacokinetic evaluation supports once-daily dosing (T1/2 is 10-52 hours). The recommended dosage of efavirenz in combination with nucleoside reverse transcriptase inhibitor (NRTI) and/or protease inhibitor (PI) is 600mg orally, once daily.

In Thai populations, many ARV levels are very high. We believe that 600 mg efavirenz is too high for Thai people and would like to see the pharmacokinetic data and safety and efficacy of efavirenz at 400 mg.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years of age or older with HIV-1 infection
* Who are on stable PI-based highly active antiretroviral therapy and have HIV-1 RNA \<50 copies/ml within 6 months.
* No active opportunistic infection.
* Sexually active subjects must be willing to use an effective form of birth control.
* Able to provide written informed consent.

Exclusion Criteria:

* Pregnant or breast-feeding females are excluded.
* Inability to understand the nature and extent of the study and the procedures required.
* ALT/ AST more than 5x upper limit
* Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of concomitant medication that may interfere with the pharmacokinetics of efavienz
* History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
* Active drug abuse

Primary outcomes:
measure: Assess whether the low dose efavirenz is not inferior to the standard dose of efavirenz in terms of plasma concentration
timeFrame: 6 weeks
Secondary outcomes:
measure: Access efavirenz plasma level after discontinuation of this medication
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
name: Kiat Ruxrungtham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04401124: Status of Management of Surgery in Beijing During COVID-19
Official title: A Descriptive Study on the Proper Management of Gastrointestinal Surgeries During the COVID-19 Pandemic, With an Emphasis on the Alteration of Surgical Protocol and Workflow
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Colorectal Cancer
Gastrointestinal Disease
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking University People's Hospital
name: Peking University Third Hospital
name: Chinese PLA General Hospital
name: Beijing Hospital
name: Xuanwu Hospital, Beijing
name: Peking Union Medical College Hospital
name: Beijing Chao Yang Hospital
name: Peking University Cancer Hospital & Institute
name: China-Japan Friendship Hospital
name: Peking University Shougang Hospital
First posted: 2020-05-26
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at surgical ER, and patients in gastrointestinal wards

Brief summary: This is a multi-centered, retrospective, observational study aimed at observing the current status of the management of gastrointestinal surgery during the COVID-19 pandemic, particularly the changes on surgery protocols and other key aspects of surgical workflow, so as to share experience with colleagues both domestic and abroad.


Eligibility criteria: Inclusion Criteria:

* All patients arriving at surgical emergency and all patients receiving gastrointestinal surgeries in participating centers from 2020.1.1\~2020.3.31.

Exclusion Criteria:

* None

Primary outcomes:
measure: treatment of fevers at arrival
timeFrame: 1 day
measure: treatment of post-operative fevers
timeFrame: 1 day
measure: assorted surgical parameters
timeFrame: 1 day
Secondary outcomes:
measure: hospitals' protection measures and extent of implementation
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhongtao Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05212324: Management of Congenial Clasped Thumb
Official title: Different Modalities in Management of Congenial Clasped Thumb
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthopedic Disorder
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: when the patient diagnosed in our outpatient clinic as congenital clasped thumb we will prepare him or her to the operation after full investigation.

surgical procedure through the skin incision designed to widen the web by flap then by do fractional lengthening of flexor policis longus tendon transfer ot extensor policis longus tendon

Brief summary: Congenital clasped thumb is a rare progressive flexion and adduction deformity presenting with heterogenous congenital abnormalities.(1, 2) It is confused with trigger finger deformity due to fixated flexion deformity of the thumb. In congenital trigger finger entrapment is present at A1 pulley level due to fusiform enlargement of flexor pollicis longus tendon

Detailed description: The main problem is the deficient extensor tendon mechanism of thumb due to functional and structural causes. \\

Although in congenital clasp finger deformity there are thumb flexion deformity due to extensor tendon insufficiency and muscle and skin contractions at flexor and thenar regions.

In congenital clasped thumb success of treatment depends on lesion type. Although successful results have been obtained with splinting and conservative treatment, several reconstruction methods are used due to secondarily developed contractures in neglected cases. Tendon transfers are useful in hypermobile thumb cases who have both extensor and opponents tendon deficiency.

Eligibility criteria: Inclusion Criteria:

1. Congenital clasped thumb
2. Cerebral palsy
3. Arthrogryposis
4. Under age of eight years old.

Exclusion Criteria:

* 1- Congenital trigger thumb. 2- Neglected adducted thumb. 3- Post traumatic extensor tendon injury. 4- Neglected congenital clasped thumb.

Primary outcomes:
measure: improved hand grip degree
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Shreve M, Chu A. Pediatric Thumb Flexion Deformities. Bull Hosp Jt Dis (2013). 2016 Mar;74(1):97-108.
Clinical trial NCT00421824: Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Official title: Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-01-12
Enrollment: 108
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: Primary:

* To assess complete pathological response rate of both strategies.

Secondary:

* Safety profile
* To assess downstaging rate of both strategies.
* To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
* To compare time to progression and overall survival of both strategies.


Eligibility criteria: Inclusion Criteria:

* Patients with rectal adenocarcinoma.
* Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or,
* Rectal tumour at distal third, or
* Tumours spread more than 5 mm in perirectal fat
* Functional state ECOG ≤ 2.
* Good hematological, hepatic and renal function

Exclusion Criteria:

* Previous pelvis radiotherapy.
* Previous antitumoural chemotherapy
* Pregnant or breastfeeding women.
* Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months.
* History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer.
* Clinically significant cardiovascular disease
* Confirmed peripheral neuropathy.
* Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication.
* Blood disorders.
* Intercurrent non-controlled or severe infections.
* Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Response rate
timeFrame: from the signature of Informed Consent up to the end of the study
Secondary outcomes:
measure: Relative dose intensity
timeFrame: from the signature of Informed Consent up to end of the study
measure: Disease free survival
timeFrame: from the signature of Informed Consent up to end of the study
measure: Overall survival
timeFrame: from the signature of Informed Consent up to end of the study
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: José Mª Taboada, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03927924: High-intensity Focused Ultrasound Study
Official title: Evaluation of the Effectiveness of High-intensity Focused Ultrasound for the Treatment of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Focal Therapy
High-intensity focused ultrasound
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 5
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the structures in the proximity. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the significant lesion, resulting in disease cure and improved functional outcome. Among the different options of focal therapy, high-intensity focused ultrasound (HIFU) is one of the most commonly employed energy sources. It exerts its effect through thermal and mechanical destruction of cancer tissue. This study aims at assess the effectiveness of such treatment in prostate cancer management.

In this study, investigators evaluate the early oncological outcome and objective functional outcome of patients undergoing HIFU for the treatment of localized intermediate risk prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Visible index lesion(s) on MRI
* Index lesion(s) greater than 0.5 cm3
* Found to have localized low-risk or intermediate-risk prostate cancer after MRI-USG fusion targeted biopsy and saturation biopsy:

  1. Clinical tumour stage T2, or
  2. Gleason score 7, or
  3. PSA 20 ng/ml

Exclusion Criteria:

* Prostate size larger than 50 ml
* Patients unfit for contrast MRI exam
* Patients with previous treatment of prostate cancer
* Patients with previous surgery on the prostate
* Patients with active urinary tract infection
* Patients with bladder pathology including bladder stone and bladder cancer
* Patients with urethral stricture
* Patients with neurogenic bladder and/or sphincter abnormalities
* Fail to give informed consent

Primary outcomes:
measure: Absence of Prostate Cancer on Biopsy
timeFrame: 3 months
Secondary outcomes:
measure: Change in Urodynamic
timeFrame: 3 months and 6 months
measure: Change in Urinating Symptom Score
timeFrame: 3 months and 6 months
measure: Presence of Significant Prostate Cancer
timeFrame: 3 months
measure: Change in Prostate specific antigen (PSA)
timeFrame: 3 months and 6 months
measure: Pain score
timeFrame: Post treatment (day 1)
measure: Change in Prostate Symptom Score
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT01704534: A Proof of Concept Study to Evaluate the Effectiveness of Ustekinumab in Hidradenitis Suppurativa
Official title: A Prospective Proof of Concept Study to Evaluate the Potential Efficacy of Ustekinumab in Patients With Moderate to Severe Hidradenitis Suppurativa (Acne Ectopica)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis suppurativa
Acne ectopica
Inverse acne
Ustekinumab
Stelara
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag B.V.
First posted: 2012-10-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether ustekinumab is effective in the treatment of moderate to severe hidradenitis suppurativa.

Detailed description: An open label prospective study is performed to investigate the effectiveness and safety of ustekinumab in hidradenitis suppurativa. Twenty patients will be included. They will receive ustekinumab 45 or 90 mg on weeks 0-4-16-28. Patients will be followed up untill week 40.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Hidradenitis suppurativa Hurley stage II or III
* No response to conventional local and oral antibiotics, or immunnesuppressive medication, or TNF-alpha inhibitors or surgery
* The patient has to be able to complete a dutch questionnaire
* Informed consent must be obtained

Exclusion Criteria:

* Not able to complete a Dutch questionnaire
* Pregnancy or breast feeding
* Active hepatitis B or C infection, HIV or tuberculosis
* Treatment with biologics or other immunosuppressive medicine in the previous 3 months
* Malignancies in the last 10 years with the exception of basal cell carcinoma
* Demyelinating disorders
* Heart failure
* Known allergy to ustekinumab or to its preservatives
* Live vaccins in the next 3 months Sever liver or renal failure

Primary outcomes:
measure: Change in Sartorius score
timeFrame: 76 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Barbara Horváth, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: