louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02833467: Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA
Official title: A Prospective Study of Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma
Non-small-cell Lung Cancer
Thoracic Neoplasms
Keywords: Circulating Tumor DNA
Heterogeneous
Multiple primary lung cancer
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: San Valley Biotechnology Incorporated
First posted: 2016-07-14
Enrollment: 45
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: Multiple or multifocal primary lung cancer patients who underwent surgery

Brief summary: Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate the feasibility and application value by using NGS into identifying genomic mutations in multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients

Detailed description: Tumor samples originating from clinically considered multiple or multifocal primary lung cancer patients were available for mutational analysis. DNA and RNA were extracted from fresh tumor tissue or formalin-fixed, paraffin-embedded (FFPE) tissue. A series of cancer-related genomic alterations including single nucleotide variations (SNVs), short insertions and deletions (InDels), copy number variations (CNVs) and gene rearrangements were identified by a comprehensive NGS Panal . High frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddPCR).

Eligibility criteria: Inclusion Criteria:

* Patients must have given written informed consent
* Histopathologically confirmed NSCLC
* Considered multiple or multifocal primary lung cancer by clinical criteria

Exclusion Criteria:

* Malignant tumor history within the past 5 years
* Patients who received any treatment prior to resection
* Insufficient tumor tissue or blood sample

Primary outcomes:
measure: The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing
timeFrame: 18 months
Secondary outcomes:
measure: The concordant and discordant frequency of genomic results between tumor tissue and circulating tumor DNA in multiple primary lung cancer patients
timeFrame: 18 months
measure: The relationship between disease free survival and genomic results in multiple primary lung cancer patients
timeFrame: 5 years
measure: The relationship between overall survival and genomic results in multiple primary lung cancer patients
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Kezhong Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Jun Wang, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03153267: Duration of Doxycycline Treatment in EM Patients
Official title: Duration of Doxycycline Treatment in Patients With Erythema Migrans (EM). A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema Chronicum Migrans
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
First posted: 2017-05-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with erythema migrans.


Eligibility criteria: Inclusion Criteria:

* solitary erythema migrans

Exclusion Criteria:

* pregnancy or lactation
* immunocompromised
* serious adverse event to doxycycline
* taking antibiotic with antiborrelial activity within 10 days
* multiple erythema migrans or extracutaneous manifestations of lyme borreliosis

Primary outcomes:
measure: Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days
timeFrame: At 12 months after enrollment.
Secondary outcomes:
measure: Comparison of nonspecific symptoms in patients with erythema migrans and control subjects
timeFrame: At 12 months after enrollment.
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical centzer Ljubljana
Study officials:
affiliation: University Mecical Centre Ljubljana
name: Daša Stupica, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stupica D, Collinet-Adler S, Blagus R, Gomiscek A, Cerar Kisek T, Ruzic-Sabljic E, Veluscek M. Treatment of erythema migrans with doxycycline for 7 days versus 14 days in Slovenia: a randomised open-label non-inferiority trial. Lancet Infect Dis. 2023 Mar;23(3):371-379. doi: 10.1016/S1473-3099(22)00528-X. Epub 2022 Oct 6.
Clinical trial NCT00652067: Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)
Official title: IND for One Patient to Receive Clofazamine for Treatment of MAI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Mycobacterium Avium-Intracellulare
Keywords: Mycobacterium avium-intracellulare
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2008-04-03
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single patient

Brief summary: This protocol is an single patient IND to provide clofazamine to treat one patient who has MAI and is resistant to or can not tolerate standard of care. The drug is not otherwise available.


Eligibility criteria: Inclusion Criteria:

* Treatment of one patient with MAI

Exclusion Criteria:

* No other patients will be treated

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Margaret Pisani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03557567: NGS Strategy Effectiveness in Molecular Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Osteochondroma
Osteogenesis Imperfecta
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
name: Regione Emilia-Romagna
First posted: 2018-06-15
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 400 DNA samples coming from MO and OI patients (including either dominant and recessive forms) will be included in the study (250 affected by MO and 150 by OI).

Brief summary: The coming out of Next Generation Sequencing (NGS) technologies, with documented advantages and reduced costs respect to Sanger sequencing, has provided new appealing approaches to diagnostic testing. Despite this, its use for routine diagnostic purposes requires certification in terms of reliability, as well as a cost-effectiveness evaluation.

To test the feasibility of using the Ion Torrent Personal Genome Machine (PGM) in clinical diagnosis, we assessed its performance to detect point mutations and big rearrangements previously identified with standard techniques. The diagnostic accuracy and the cost-effectiveness will be evaluated by Health Technology Assessment (HTA) analyses.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Multiple Osteochondroma
* Clinical diagnosis of Osteogenesis Imperfecta

Primary outcomes:
measure: Assessment of the accuracy of the Ion Torrent PGM platform for genetic variant detection (Diagnostic sensitivity evaluation)
timeFrame: at 30 months
measure: HTA analysis to assess the cost-effectiveness, organizational and social implications of a screening strategy based on the IonPGM platform
timeFrame: at 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02999867: Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Patients With Type 2 Diabetes
Official title: Effect of Triticale, Mung Bean and Adzuki Bean Intervention on Metabolic and Nutritional Status of Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 180
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to evaluate short term effect of triticale, mung bean and adzuki bean intervention for health improvement in patients with type 2 diabetes.

Detailed description: The study will evaluate the effect of triticale, mung bean and adzuki bean on metabolic and nutritional status of patients with type 2 diabetes after 30 days of intervention. Patients will be assigned to control or intervention group (A diet including triticale and mung bean; B diet including adzuki bean). Blood and urine samples will be collected at baseline and after 30 days of intervention.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients between the ages of 30 and 65 years
2. patients has been diagnosed as type 2 diabetes mellitus
3. Patients who like to be followed up for 2 months.

Exclusion Criteria:

1. Women in pregnancy or lactation.
2. Individuals with a history of severe kidney disease, cardiovascular disease, stroke, cancer, or psychological disorders.

Primary outcomes:
measure: response to the dietary intervention by the change from baseline in blood glucose at 30-day
timeFrame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in lipid profile at 30-day
timeFrame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in insulin resistance at 30-day
timeFrame: baseline and 30 d
Secondary outcomes:
measure: response to the dietary intervention by the change from baseline in renal function at 30-day
timeFrame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in liver function at 30-day
timeFrame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in inflammation result at 30-day
timeFrame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in folic acid absorption at 30-day
timeFrame: baseline and 30 d
measure: response to the dietary intervention by the change from baseline in iron absorption at 30-day
timeFrame: baseline and 30 d
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Department of Nutrition, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
name: Yanping Liu, master
role: STUDY_DIRECTOR
References:
Clinical trial NCT03677804: Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the Ozaki Technique
Official title: Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the OZAKI Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Keywords: aortic valve reconstruction
OZAKI technique
autologous pericardium
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) in Universitätsspital Basel/ Switzerland since September 2015.

Brief summary: The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure (Aortic valve reconstruction using autologous pericardial tissue) at the department of cardiac surgery/ University Hospital Basel/ Switzerland.

Detailed description: The reconstruction of the aortic valve using autologous pericardium, applying the technique Ozaki et al., published first in 2011 provides potential benefits due to the missing necessity of oral anticoagulation and its use in patients with small aortic annuli, because of the huge orifice area. There is a need of more data to evaluate the significance of this technique in the treatment of aortic valve stenosis and regurgitation. The department of cardiac surgery/ University Hospital Basel/ Switzerland started to use this technique in September 2015. The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure.

Eligibility criteria: Inclusion Criteria:

* aortic valve reconstruction using autologous Pericardium (OZAKI technique)

Exclusion Criteria:

* missing informed consent

Primary outcomes:
measure: Change in aortic transvalvular gradient measured by transthoracic echocardiography
timeFrame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
Secondary outcomes:
measure: occurence of death
timeFrame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
measure: occurence of cardiac re-surgery
timeFrame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
measure: occurence of stroke
timeFrame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Herzchirurgie University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Oliver Reuthebuch, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koechlin L, Schurr U, Miazza J, Imhof S, Maurer M, Erb J, Gahl B, Santer D, Berdajs D, Eckstein FS, Reuthebuch O. Echocardiographic and Clinical Follow-up After Aortic Valve Neocuspidization Using Autologous Pericardium. World J Surg. 2020 Sep;44(9):3175-3181. doi: 10.1007/s00268-020-05588-x.
Clinical trial NCT04812704: Protein Supplements in Association With Prehabilitation Program for Cancer Patients Before Surgery
Official title: Suppléments protéinés en Association d'un Programme de préhabilitation Avant la Prise en Charge Chirurgicale d'un Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Surgery
Prehabilitation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 2
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: The aim of study is to analyse the feasibility of the use of nutritionnal complements after exercices before surgery for cancer.

Body composition, muscle function and muscle mass will be analyse too.

Detailed description: A prospective study will be carried out including adult patients with neoplasia who should benefit in their therapeutic strategy from oncological surgery. About fifty patients will be recruited in the oncology / surgery department at the Saint-Luc University Clinics in Brussels. Patients will be assessed at the initial consultation and after the pre-habilitation period, ie the day before the operation.

Dietary monitoring will be carried out in parallel with a physical and respiratory preparation program (prehabilitation) and the intake of protein nutritional supplements in the form of powder to be diluted will be carried out after each exercise session.

Eligibility criteria: Inclusion Criteria:

* patient with operable cancer
* patient inform consent
* min 18 years old
* french or english speaking

Exclusion Criteria:

* neuromuscular pathology
* cardiorespiratory or orthopedic pathology that prevents physical activity
* cognitive or psychiatric disorders

Primary outcomes:
measure: Adhesion rate of the use of nutritionnel complements after exercices before surgery for cancer
timeFrame: 3 weeks
Secondary outcomes:
measure: Body composition (lean and fat mass)
timeFrame: Once at the inclusion and once the day before surgery (3 weeks)
measure: Muscle function
timeFrame: Once at the inclusion and once the day before surgery (3 weeks)
measure: Nutritional biological markers
timeFrame: Once at the inclusion
measure: Antropometric markers - height
timeFrame: Once at the inclusion and once the day before surgery (3 weeks)
measure: Muscle strength
timeFrame: Once at the inclusion and once the day before surgery (3 weeks)
measure: Antropometric markers - weight
timeFrame: Once at the inclusion and once the day before surgery (3 weeks)
measure: Antropometric markers - BMI
timeFrame: Once at the inclusion and once the day before surgery (3 weeks)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Yannick Deswysen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04785404: Primary Versus Secondary Closure of Stoma-Reversal Skin Wound
Official title: Primary Versus Secondary Closure of Stoma-Reversal Skin Wound: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infection
Keywords: skin closure
stoma reversal
Lead sponsor: Ayub Teaching Hospital
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be randomly distributed to two groups. Group A patients will have skin wounds stithed after stoma reversal while in secondary closure group B, wound will be allowed to heal by secondary intention
Primary purpose: TREATMENT

Brief summary: to compare infection rate stoma reversal skin wound after primary or secondary closure

Detailed description: There will be two groups. In group A, skin will be stitched with prolene while in group B skin will be left open to follow up till 1 month and wound observed for infection according to CDC guidelines.

Eligibility criteria: Inclusion Criteria:

* . All patients who undergo ileostomy or colostomy reversal will be included

Exclusion Criteria:

* included patients with reversal of stoma through laparatomy, post-operative anastomotic leak and co-morbidities like diabetes, Chronic liver disease, chronic kidney disease etc

Primary outcomes:
measure: surgical site infection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: Ayub teaching hospital
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Ayub Teaching Hospital
name: Zanib Javed, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01406704: Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH
Official title: Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: NASH (Non-alcoholic Steato-hepatitis)
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-08-01
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis).

Detailed description: Duration: 24 week-intervention Study Group: Four arms

* Control: no intervention
* Rosiglitazone: rosiglitazone (8 mg/day)
* alpha-lipoic acid: alpha-lipoic acid (1800 mg/day)
* Rosiglitazone/alpha-lipoic acid: combination of rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)

Eligibility criteria: Inclusion Criteria:

* the patients with pathologically proved NASH (non-alcoholic steato-hepatitis)

Exclusion Criteria:

* alcohol consumption \> 20g/day
* viral hepatitis B and C
* autoimmune hepatitis
* Wilson's disease
* hemochromatosis
* alpha-1 antitrypsin deficiency
* breast-feeding or pregnant females
* subjects planning to become pregnant
* severe comorbid medical conditions (such as severe cardiac, pulmonary, renal or psychological problems)
* those not consenting for the study

Primary outcomes:
measure: Histological evaluation
timeFrame: 24 weeks
Secondary outcomes:
measure: Biomechanical measurement
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Kun Ho Yoon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00162604: Prophylactic Antibiotic Treatment During Vaginal Repair
Official title: Antibiotikaprofylakse Ved Vaginalplastik
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Prolapse
Cystocele
Rectocele
Enterocele
Keywords: Prophylactic antibiotic
Postoperative infections
Uterine prolapse grade I - II
cystocele
rectocele
enterocele
defects of the perineal body
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prolapse of the uterus, bladder and rectum is a common condition in multiparous and/or elderly women. The number of operations for vaginal repair is increasing in Denmark, but there is no consensus or evidence found about the efficiency of prophylactic antibiotics intraoperatively concerning postoperative infections.

The objective of this randomized, controlled trial is to investigate the significance of prophylactic antibiotic treatment in vaginal repair operations.


Eligibility criteria: Inclusion Criteria:

* Women ages 18+ with uterine prolapse grade I - II and/or cystocele and/or rectocele and/or enterocele grade I - II and/or defects of the perineal body, in whom there is medical indication for vaginal repair, but no indication for vaginal hysterectomy or transvaginal suspension of the vaginal vault after prior hysterectomy.

Exclusion Criteria:

* Patients allergic to cefuroxime.
* Patients in whom a vaginal hysterectomy or a transvaginal suspension of the vaginal vault or other major surgery is planned, where prophylactic antibiotic treatment is standard.
* Patients suffering from physical or mental disorders that will not allow them to give informed consent.
* Pregnant and nursing women.

Primary outcomes:
measure: primary endpoint: no infections (urinary tract infections, pneumonia,wound infections, infected haematomas, etc.) within 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Marianne Ottesen, M.D, Ph.D
role: STUDY_DIRECTOR
References: