louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02651298: CO2-laser Treatment for Caesarean Section Scars
Official title: Fractional CO2-laser Treatment of Caesarean Section Scars - A Randomized Controlled Split-scar Trial With Long Term Follow-up Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cicatrix
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Lumenis Be Ltd.
First posted: 2016-01-08
Enrollment: 12
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fractional Co2-laser for treatment of mature caesarean section scars.

Detailed description: Randomized split scar study to document improvement of caesarean section scars as compared to untreated control scar.

Eligibility criteria: Inclusion Criteria:

* mature caesarean section scar

Exclusion Criteria:

* systemic uncontrolled disease
* recent or current cancer
* smoking
* keloid formation
* wounds or local disease int treatment area
* pregnancy or lactation

Primary outcomes:
measure: patient observer scar scale
timeFrame: up until 6 months post treatment
Secondary outcomes:
measure: erythema measured by reflectance
timeFrame: 1 months post treatment
measure: pigmentation measured by reflectance
timeFrame: 1 months post treatment
measure: erythema measured by reflectance
timeFrame: 3 months post treatment
measure: pigmentation measured by reflectance
timeFrame: 3 months post treatment
measure: erythema measured by reflectance
timeFrame: 6 months post treatment
measure: pigmentation measured by reflectance
timeFrame: 6 months post treatment
measure: histology of scar tissue
timeFrame: 3 months post treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Haedersdal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04901598: Physical Activity Level, Aerobic Capacity and Dietary Habits Among a Cohort of Females With Premenstrual Syndrome
Official title: Physical Activity Level, Aerobic Capacity and Dietary Habits Among a Cohort of Females With Premenstrual Syndrome: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premenstrual Syndrome
Keywords: physical activity level, aerobic capacity and dietary habits in PMS
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: females with PMS will participate in this study with ages ranging from 20 to 35 years

Brief summary: The aim of the study is to investigate the physical activity level, aerobic capacity and dietary habits among a cohort of females with premenstrual syndrome

Detailed description: premenstrual syndrome can be defined as a recurrent disorder that occurs every month in the luteal phase of the menstrual cycle, and subside with the onset of menstruation. It is characterized by a complex set of symptoms, which include physical, psychological and behavioral changes with varying severity. This can interfere with the lives of females. Physical exercise improves PMS through rising endorphin levels, reducing adrenal cortisol symptoms, leading to lesser anxiety, depression and greater pain tolerance, as previous studies showed that it was effective in decreasing pain as well as mental and physical symptoms of PMS. Recently, lifestyle changes have gained more importance than pharmacotherapy. Lifestyle changes include many methods including diet regulation and exercise. 30 minutes of aerobic exercise is recommended for at least 3 days per week to contribute to the regulation of both body composition, mood and to improve physical symptoms. Evidence suggests that it can be helpful in reducing symptoms.

Eligibility criteria: Inclusion Criteria:

* 1-suffering from PMS (as determined by PMS scale) 2-Their ages range from 20 to 35 years 3-Having regular menstrual cycle

Exclusion Criteria:

* 1-Smoking 2-Following any special diet 3-Taking any medication 4-History of chronic disease 5-Having any psychiatric or gynecological problems

Primary outcomes:
measure: Assessment of premenstrual syndrome
timeFrame: 5 minutes
Secondary outcomes:
measure: aerobic test
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Nisreen Ashraf
Study officials:
References:
citation: Hofmeister S, Bodden S. Premenstrual Syndrome and Premenstrual Dysphoric Disorder. Am Fam Physician. 2016 Aug 1;94(3):236-40.
citation: Biggs WS, Demuth RH. Premenstrual syndrome and premenstrual dysphoric disorder. Am Fam Physician. 2011 Oct 15;84(8):918-24.
Clinical trial NCT01904045: PEL-1235_REN-0176-I (Pelicon)
Official title: A Multicentre, Prospective, Non-Interventional Study to Assess the Intra-patient Variability of Tacrolimus Once and Twice Daily After Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunosuppression After Kidney Transplantation
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient clinic

Brief summary: Aim of this study is to investigate whether in patients following kidney transplantation (\>6 months after transplantation), the intra-patient variability of levels of tacrolimus is comparable after administration of tacrolimus twice daily (Prograf) to tacrolimus once daily (Advagraf), with each regimen for 3 months.


Eligibility criteria: Inclusion Criteria:

* signed written informed consent
* male or female patient ≥ 18years of age
* Patient has received a kidney transplantation at least 6 months prior to inclusion into the study
* No acute rejection episodes for at least 3 months
* PRG through level and dosing stable for at least 1 month
* Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study

Exclusion Criteria:

* Acute rejection episodes within the last 3 months prior to study entry
* Unstable PRG trough level or dose change in the month before study entry
* History of noncompliance to medical regimens
* Patients unwilling to or unable to comply with the protocol
* Treatment with another investigational product during this study or during the last 30 days prior to study start

Primary outcomes:
measure: Intrapatient variability of tacrolimus through level
timeFrame: pre-dose, 1 h post dose and 3 h post dose for 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Munic
country: Germany
facility: Klinikum rechts der Isar, Department of Nephrology
state: Bavaria
Study officials:
References:
Clinical trial NCT02147145: Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)
Official title: Prospective Database of Gastrointestinal Stromal Cell Tumors (GISTs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Cell Tumors
Foregut Subepithelial Lesions
Keywords: GIST
endoscopy
endoscopic ultrasound
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2014-05-26
Enrollment: 187
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 patients (\>18 years of age) referred for EUS evaluation of incidentally discovered foregut SEL at a two tertiary care centers between 8/2008 and 8/2012.

Brief summary: Specific Aim 1: To determine patient compliance with a GIST surveillance program Hypothesis: Patient compliance with a GIST surveillance program will be low.

Specific Aim 2: To determine if EUS features of GIST, particularly maximum size, change significantly during a surveillance program.

Hypothesis: EUS features of GIST, particularly maximum size, will not change significantly during a surveillance program.

Specific Aim 3: To determine if EGD measures of GIST size correlate well with EUS measures of GIST size.

Hypothesis: EGD measures of GIST size will correlate well with EUS measured of GIST size.


Eligibility criteria: Inclusion Criteria:

* presenting for EUS with an indication for a SEL in the stomach or esophagus
* at least 18 years of age
* able to provide informed consent

Exclusion Criteria:

* no subepithelial lesion in the stomach or esophagus'
* less than 18 years of age
* unable to provide informed consent

Primary outcomes:
measure: Determine the natural history of small (< 30 mm) SELs discovered evaluated by EUS.
timeFrame: 3 years
Secondary outcomes:
measure: Determine the degree of patient compliance with surveillance recommendations.
timeFrame: 3 years
measure: Describe the diagnostic yield of EUS±FNA in evaluating SELs.
timeFrame: 2 weeks
measure: Compare SEL size estimation based on EUS, EGD and computer tomography (CT).
timeFrame: 1 day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT02902198: Taste Physiology in Obese Volunteers Before and After Bariatric Surgery
Official title: Taste Physiology in Obese Volunteers Before and After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective is to investigate neuro-anatomical correlates of gastrointestinal taste stimulation by means of functional MRI before and after bariatric surgery. Intragastric administration of glucose, monosodium glutamate, chloroquine and placebo is followed by functional brain MRI in obese humans before and 3 months after surgery.


Eligibility criteria: Inclusion Criteria:

* morbidly obese patients (BMI min 35kg/m2) scheduled for bariatric surgery
* right handed

Exclusion Criteria:

* cardiovascular disease
* neurologic/psychiatric disorders

Primary outcomes:
measure: Effect of tastants on cerebral blood flow measured by functional brain MRI
timeFrame: changes from baseline to one hour after treatment
Secondary outcomes:
measure: Effect of tastants plasma glucagon-like peptide (GLP-1) concentrations
timeFrame: changes from baseline to one hour after treatment
measure: Effect of tastants plasma ghrelin concentrations
timeFrame: changes from baseline to one hour after treatment
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hopital Basel
Study officials:
affiliation: University Basel
name: Christoph Beglinger, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT00995098: Early Enteral Nutrition for Severe Acute Pancreatitis
Official title: The Impact of Early Enteral Nutrition on the Clinical Outcomes of Severe Acute Pancreatitis Patients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Necrotizing Pancreatitis
Keywords: Acute severe pancreatitis
nutritional support
enteral nutrition
parenteral nutrition
Lead sponsor: Sichuan Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
First posted: 2009-10-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is increasing evidence that indicates early enteral nutrition may be associated with improved outcome in acute pancreatitis patients. However, most of the clinical trials regarding this targeted mild to moderated pancreatitis patients. In regard to severe acute pancreatitis (SAP) patients, current results from randomized control trials (RCTs) are inconclusive. The researchers of this study aim to investigate the impact of early enteral nutrition on the clinical outcomes of SAP patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of severe acute pancreatitis
* Consent informed

Exclusion Criteria:

* Diabetes mellitus
* Allergy for any ingredient of PN or EN regimen
* Pregnancy

Primary outcomes:
measure: All cause mortality
timeFrame: Three months
Secondary outcomes:
measure: Pancreatic sepsis
timeFrame: Three months
measure: Length of hospitalization
timeFrame: From admission to discharge
measure: Operation ratio
timeFrame: From admission to discharge
measure: Cost of hospitalization
timeFrame: From admission to discharge
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Academy of Medical Sciences
name: Bin Cai, M.D
role: STUDY_DIRECTOR
affiliation: Sichuan Academy of Medical Sciences
name: Hua Jiang, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Academy of Medical Sciences
name: Jun Zeng, M.D
role: STUDY_CHAIR
References:
citation: Marik PE, Zaloga GP. Meta-analysis of parenteral nutrition versus enteral nutrition in patients with acute pancreatitis. BMJ. 2004 Jun 12;328(7453):1407. doi: 10.1136/bmj.38118.593900.55. Epub 2004 Jun 2.
citation: Meier R, Beglinger C, Layer P, Gullo L, Keim V, Laugier R, Friess H, Schweitzer M, Macfie J; ESPEN Consensus Group. ESPEN guidelines on nutrition in acute pancreatitis. European Society of Parenteral and Enteral Nutrition. Clin Nutr. 2002 Apr;21(2):173-83. doi: 10.1054/clnu.2002.0543. No abstract available.
citation: McClave SA, Chang WK, Dhaliwal R, Heyland DK. Nutrition support in acute pancreatitis: a systematic review of the literature. JPEN J Parenter Enteral Nutr. 2006 Mar-Apr;30(2):143-56. doi: 10.1177/0148607106030002143.
Clinical trial NCT03349398: Uncut Roux-en-Y vs Roux-en-Y
Official title: Uncut Roux-en-Y vs Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uncut Roux-en-Y
Roux-en-Y
Gastric Cancer
Keywords: Uncut Roux-en-Y
Roux-en-Y
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Uncut Roux-en-Y vs Roux-en-Y reconstruction after distal gastrectomy for gastric cancer

Detailed description: To search which is the better reconstructions by comparing and analyzing the advantages and disadvantages between Uncut Roux-en-Y and Roux-en-Y reconstructions after laparoscopy-assisted distal gastrectomy for gastric cancer.

Method: It's a prospective study including all patients underwent laparoscopy-assisted distal gastrectomy (LADG) in the First Hospital of Jilin University. All surgical procedures will be performed by the single surgery team, which is leaded by professor Wang Quan. The reconstruction method will be selected randomly from Uncut Roux-en-Y and Roux-en-Y anastomosis preoperatively without distinct indications. All clinical data, operation data, perioperative complications and related physiological indexes after surgery will be compared.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of distal gastric cancer
* underwent laparoscopy-assisted distal gastrectomy

Exclusion Criteria:

* have simultaneously other cancer
* have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
* have upper gastrointestinal surgery
* can't bear the gastric tube
* the period is too late or the tumor is too large to carry on a laparoscopy assisted radical distal gastrectomy

Primary outcomes:
measure: the incidence of Roux stasis syndrome
timeFrame: 3 month after surgery
Secondary outcomes:
measure: the incidence of other complications after operation
timeFrame: one month after surgery
measure: the quility of life according to the RGB standards
timeFrame: 12 month after surgery
Other outcomes:
Locations:
city: Ch'ang-ch'un
country: China
facility: the First Hospital of Jilin University
state: JI Lin
Study officials:
affiliation: The First Hospital of Jilin University
name: Quan Wang, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06776198: Precision Therapy Based on Immune Microenvironment by Transcriptome Sequencing of Osteosarcoma, a Prospective, Multi-cohort Exploratory Clinical Study
Official title: Precision Therapy Based on Immune Microenvironment by Transcriptome Sequencing of Osteosarcoma, a Prospective, Multi-cohort Exploratory Clinical Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteosarcoma
Transcriptome
Tumor Microenvironment
Precision Medicine
Keywords: osteosarcoma
transcriptome
tumor microenviroment
precision medicine
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Initially treated osteosarcoma

Brief summary: Bagaev et al. have identified four tumor microenvironment (TME) subtypes that are conserved across diverse cancers and correlated with immunotherapy response in melanoma, bladder, and gastric cancers. They provided a visual tool revealing the TME subtypes integrated with targetable genomic alterations, which provided a planetary view of each tumor that can aid in oncology clinical decision making. We aim to use this tool to prospectively analyse the biopsy specimens of osteosarcomas to identify their TME subtypes so as to deliver appropriate treatment strategy if these osteosarcomas experience disease progression afterwards. We will compare the past sequencing date stored in PKUPH bank so as to compare the event-free survival(EFS) of these patients to check the Superiority of this method later.


Eligibility criteria: Inclusion Criteria:

* (i) patients who have been suspected for osteosarcoma with enough clinical or radiographic information;
* (ii) patients who have evaluable lesions to resect or follow;
* (iii) patients who are planned to be operate with enough flesh specimens for this study.

Exclusion Criteria:

* (i) clinical information was not complete;
* (ii) lost to follow-up.

Primary outcomes:
measure: Event-free Survival (EFS)
timeFrame: 2 year
Secondary outcomes:
measure: Event-free Survival (EFS) for the second time
timeFrame: 2 year
Other outcomes:
measure: Correlation with some DNA target expression
timeFrame: 1 year
Locations:
Study officials:
References:
citation: Bagaev A, Kotlov N, Nomie K, Svekolkin V, Gafurov A, Isaeva O, Osokin N, Kozlov I, Frenkel F, Gancharova O, Almog N, Tsiper M, Ataullakhanov R, Fowler N. Conserved pan-cancer microenvironment subtypes predict response to immunotherapy. Cancer Cell. 2021 Jun 14;39(6):845-865.e7. doi: 10.1016/j.ccell.2021.04.014. Epub 2021 May 20.
Clinical trial NCT06959498: Long-term Survival of THA After Pelvic and/or Femoral Osteotomy
Official title: Long-term Survival of THA After Pelvic and/or Femoral Osteotomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hip Arthropathy Associated With Other Conditions
Hip Dysplasia
Survival, Prosthesis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients, with no age limit, operated in the Centre Chirurgical Emile Gallé, Nancy, France, between 1998 and 2010

Brief summary: Analyze the long-term clinical and radiological outcomes of total hip arthroplasty (THA) in patients with hip dysplasia treated by pelvic osteotomy, femoral osteotomy, shelf acetabuloplasty, or a combination of these interventions, performed during childhood or early adulthood. The aim is to understand the impact of these early interventions on THA survival and long-term joint function.


Eligibility criteria: Inclusion Criteria:

* patients who underwent THA between 1998 and 2010 and had a prior surgical treatment for hip dysplasia (pelvic, femoral osteotomy, shelf acetabuloplasty or combined osteotomy)

Exclusion Criteria:

-

Primary outcomes:
measure: survival
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00541398: Antipsychotic Polypharmacy: Prevalence, Background and Consequences
Official title: Antipsychotic Polypharmacy: Prevalence, Background and Consequences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Antipsychotic polypharmacy
Schizophrenia
Implementation of clinical guidelines
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: National Board of Health, Denmark
First posted: 2007-10-10
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary purpose of the study is to investigate whether an intensive educational intervention can reduce the use of antipsychotic polypharmacy. It is hypothesised that the use of antipsychotic polypharmacy is, in some degree, dependent on non-patient related factors.

Detailed description: Several surveys have shown a high prevalence of antipsychotic polypharmacy (concomitant prescription of at least 2 different antipsychotics) among patients with schizophrenia even though international guidelines recommend monotherapy.

From register data areas with differences in the prevalence of antipsychotic polypharmacy will be identified. Two high prevalence areas will be randomized to either control or intervention area. In the intervention area an intensive educational intervention consisting of outreach visits with a multifaceted approach will be carried out with the duration of 1 year.

Differences in health staff related factors such as knowledge and attitude towards clinical guidelines will be assessed with a questionnaire before and after the intervention in the intervention area as well as in the low prevalence area at baseline.

Medical records data describing the use of antipsychotic polypharmacy will be collected. With register data health economic issues will be assessed.

Eligibility criteria: Inclusion Criteria:

* The intervention is not aimed directly to the patients but their health care providers.
* Patients with schizophrenia (F2\* diagnosis according to ICD-10) taking antipsychotic medication and their health care providers in the specified areas will enter the study:
* The patients will enter with data from their medical record, register data and a few exploring interviews while the health staff will enter with their questionnaire data.

Primary outcomes:
measure: Prevalence of antipsychotic polypharmacy
timeFrame: 1 year
Secondary outcomes:
measure: Questionnaire assessment of non-patient related factors. Medical records data. Cost-effectiveness analysis.
timeFrame: 1 year
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: CNSR
Study officials:
affiliation: University of Copenhagen
name: Birte Glenthøj, Professor
role: STUDY_DIRECTOR
References: