louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01065402: A Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes
Official title: A Randomized, Two-Regimen, Crossover, Comparative Study to Evaluate the Efficacy and Safety of PPB-R-203-Based Meal Versus TK9-Based Meal in 20 Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
continuous glucose monitoring system (CGMS)
Lead sponsor: Pharma Power Biotec Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the efficacy of PPB-R-203-Based Meal and TK9-Based Meal on blood glucose control in 20 patients with diabetes for 2 days.

Detailed description: The MiniMed Medtronic CGMS (continuous glucose monitoring system), the first model approved by FDA, was used for subcutaneous glucose monitoring. The CGMS continually measures the glucose concentration of the interstitial fluid every 10 seconds and then stores an average glucose value for each 5 minutes period, for a total of up to 288 measurements each day.

Eligibility criteria: Inclusion Criteria:

1. Diabetes mellitus patient.
2. Aged between 20 to 65 years old.
3. Informed consent form signed.

Exclusion Criteria:

1. A recent history of drug or alcohol abuse.
2. Sensitivity to analogous product.
3. Serious cardiovascular disorders.
4. Participation in another clinical investigation study.
5. Ongoing influenza, autoimmune disease and other metabolic diseases.
6. Pregnant or lactating women.
7. Individuals are judged by the investigators or co-investigator to be undesirable as subjects.

Primary outcomes:
measure: The daily blood glucose level will be monitored by the continuous glucose monitoring system (CGMS) device Medtronic MiniMed.
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pingtung
country: Taiwan
facility: PingTung Christian Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chuang Lee Ming, Physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03063502: Pre-analytical Sample Handling Conditions and Their Effects on the Human Urine Metabolome
Official title: Pre-analytical Sample Handling Conditions and Their Effects on the Human Urine Metabolome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2017-02-24
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women will be recruited from the area surrounding the BHNRC. There are several thousand government and privately employed workers located within a 10-mile radius of the BHNRC and several residential communities from which a cohort of volunteers will be recruited. The population includes an ethnically diverse group of subjects.

Brief summary: This study evaluates how urine handling conditions can affect the concentrations of \~1,000 urine metabolites and attempts to quantify the degree of attenuation and/or potential bias in epidemiologic associations that may result from less than optimal sample handling conditions.

Detailed description: Metabolomics, the simultaneous quantification of concentrations of hundreds or thousands of metabolites simultaneously in a biological matrix, is a versatile analytical technique capable of accelerating biomarker-based discoveries in nutritional science. Recently, metabolomics has been applied to samples collected in feeding studies (1) and epidemiologic studies (2) to identify dozens of novel potential dietary biomarkers. Several large prospective cohort studies, many of which are collaborating in a metabolomics consortium led by the National Cancer Institute, have recently applied metabolomics to banked samples. This has made nutrition-related biomarkers suddenly available for tens of thousands of participants with follow-up for disease endpoints, enabling truly large-scale nutritional biomarkers and disease studies.

Eligibility criteria: Inclusion Criteria:

* Age 20 to 65 years at beginning of study.
* BMI between 18.5 and 35.0 kg/m2.

Exclusion Criteria:

* Presence of cardiovascular disease, kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes.
* Unable or unwilling to give informed consent or communicate with study staff.
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol.

Primary outcomes:
measure: Selected intensity of biochemicals identified from liquid and gas chromatography with mass ranging from 50 to 800 molecular weight.
timeFrame: on day one
Secondary outcomes:
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS, Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References:
Clinical trial NCT01521702: NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer
Official title: Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreas Cancer
Keywords: adenocarcinoma
pancreatic head
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 2
Sex: ALL
Minimum age (years): 18
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 to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy).

This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.


Eligibility criteria: Inclusion Criteria:

* resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)
* T1-3, Nx, M0 (UICC 6th version, 2002)
* infiltration of the portal vein (\<180°) is not an exclusion criterion
* cytologic or histologic confirmation of adenocarcinoma
* age \>18 years
* written informed consent

Exclusion Criteria:

* contraindication for Whipple procedure
* an infiltration \>180° of the portal vein
* abutment of the tumor to the superior mesenteric artery
* infiltration of the superior mesenteric artery or the celiac trunk
* chronic neuropathy \> grade 2
* WHO performance score \>2
* uncorrectable cholestasis (bilirubin \> 100mmol/l despite drainage attempts for more than four weeks prior to inclusion)
* female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms)
* pregnant or lactating women
* mental or organic disorders which could interfere with giving informed consent or receiving treatments
* Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer
* percutaneous biopsy of the primary tumor

Primary outcomes:
measure: progression-free survival
timeFrame: from date of randomization until date of progression, assessed up to 5 years
Secondary outcomes:
measure: histology
timeFrame: at 6 months
measure: overall survival
timeFrame: From date of randomization until date of death, assessed up to 5 years
measure: complication
timeFrame: until 6 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jean-Luc RAOUL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06387602: Comparison Between Effects of Active Release Technique and Post Isometric Relaxation on Adductor Strain in Mixed Martial Arts Fighters
Official title: Comparison Between Effects of Active Release Technique and Post Isometric Relaxation on Adductor Strain in Mixed Martial Arts Fighters
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adductor Strain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled trial and the purpose of this study is to compare the effects between active release technique and post-isometric relaxation on adductor strain in mixed martial arts fighters.

Detailed description: The purpose of this study is to compare the effects between active release technique and post-isometric relaxation on adductor strain in mixed martial arts fighters on flexibility, pain, range of motion, and functionality, in adults (age: 20-35 years )

1. Numeric pain rating scale
2. Goniometer
3. Bent Knee Fall Out Test
4. Lower extremity functional scale Data will be collected before and after the intervention protocol for each participant.

Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post-intervention scores will be recorded.

Eligibility criteria: Inclusion Criteria:

* Both male and female genders
* Ages 20-35 years
* Professional Mixed Martial Arts fighters involved in kicking, sprinting, jumping, hiking
* Grade 1 or 2 adductor strain
* Clinical adductor dysfunction (pain reproduced by palpation of the enthesis, passive stretching of the adductors, and active resisted adduction)
* Numeric Pain Rating Scale (NPRS) 1-8
* Positive Bent Knee Fall Out (BKFO test)

Exclusion Criteria:

* Any clinical or radiographic evidence of pathological involvement of the hip joint (femoroacetabular impingement: pincer and/or cam features, dysplasia)
* Grade 3 adductor strain
* History of recent fracture

Primary outcomes:
measure: Pain Intensity
timeFrame: 2 weeks
measure: Range of motion
timeFrame: 2 weeks
measure: Functionality
timeFrame: 2 weeks
measure: Flexibility
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT02379702: Metabolic Syndrome Prevalence Study
Official title: Turkey Metabolic Syndrome Prevalence Study - METSAR II
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Lead sponsor: Abdi Ibrahim Ilac San. ve Tic A.S.
Sponsor class: INDUSTRY
First posted: 2015-03-05
Enrollment: 1659
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The previous study included 4.264 patients from 47 cities and we are going to try to get in contact all those patients. Data obtained from available patients will be analysed and the change trend will be evaluated

Brief summary: Following the first study conducted to investigate the prevalence of metabolic syndrome and its components in Turkey, it was aimed to demonstrate the change in general health condition of available patients after the period of time lapsed. This study will provide important information on the social and economic dimensions of metabolic syndrome and will contribute to development of preventive programs.

Detailed description: In the first METSAR-I study conducted in 2003, metabolic syndrome screening was made by two different team. Participants were visited at their addresses and informed about the research study and gave written consent. They were invited on an empty stomach for hospital visit on the day after. Pre-trained nurses completed the forms of patients during that second visit. After 11 years, a questionnaire by telephone survey will be applied to patients who participated in the METSAR-II study. The main goal is to determine the changes of metabolic syndrome population during that period.

Eligibility criteria: Inclusion Criteria:

* Volunteers who participated in the METSAR-I study in 2003
* Patients who accepted to participate will be included the second follow up phase.

Exclusion Criteria:

None

Primary outcomes:
measure: comorbidities and changes in general health
timeFrame: 10 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
city: Ankara
country: Turkey
facility: Gazi University
city: Ankara
country: Turkey
facility: Yuksek Ihtisas Hospital
city: Istanbul
country: Turkey
facility: Istanbul Cerrahpasa University
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
city: İzmir
country: Turkey
facility: Prof. Dr. Omer Kozan
Study officials:
affiliation: Dokuz Eylul University
name: Omer Kozan
role: STUDY_DIRECTOR
References:
Clinical trial NCT05191602: The Relationship Between Drainage Fluid and Anastomotic Leakage After Colorectal Cancer Surgery
Official title: A Prospective and Analytical Study on the Detection of Early Anastomotic Leakage With Abdominal Drainage Fluid After Colorectal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anastomotic Leakage
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colorectal cancer surgery patients

Brief summary: A prospective and analytical study on the detection of early anastomotic leakage by abdominal drainage fluid after colorectal cancer surgery. pay attention to indicators including bilirubin


Eligibility criteria: Inclusion Criteria:

1) Preoperative pathologically confirmed colorectal adenocarcinoma; 2) Patients undergoing minimally invasive (robot or laparoscopic) tumor resection + bowel anastomosis; 3) Age: 18 to 80 years old; 4) Preoperative TNM staging (whole abdomen) Enhanced CT or MRI, laparoscopic exploration): cT1-3bN0-2M0; 5) Preoperative ASA score: ≤Ⅲ; 6) No history of malignant tumors and no other malignant tumors by preoperative examination; 7) Not accepted before surgery Deterministic treatment, such as radiotherapy, chemotherapy or immunotherapy; 8) No pre-existing ascites was found before and during the operation; 9) Informed consent signed by the patient or his agent

Performance status (ECOG) 0\~1

Exclusion Criteria:

1) Patients with obstructive jaundice or other congenital disorders of bile acid synthesis and metabolism; 2) Severe abdominal cavity infection and other infections; 3) A large amount of abdominal effusion was found before and during the operation; 4) Tumor was confirmed during the operation For T4b or intraoperative detection of other tumors, joint resection or distant metastasis is required; 5) Intraoperative conversion to laparotomy; 6) Intraoperative change of surgical method to perform Miles or Hartmann surgery; 7) Intraoperative and postoperative abdominal cavity Hyperthermic perfusion chemotherapy.

Primary outcomes:
measure: leakage
timeFrame: 10days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: General Surgery Center of PLA
Study officials:
References:
Clinical trial NCT04592302: The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study
Official title: The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking
Total Joint Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are current smokers having surgery for total joint arthroplasty at Rothman Orthopaedic Institute

Brief summary: The purpose of this study is to examine the impact of smoking cessation on total joint arthroplasty patients with respect to perioperative complications and outcomes. The investigators will examine patients who are asked to stop smoking in any manner they choose and also refrain from nicotine replacement therapy, and those who are allowed to continue smoking during the perioperative period for their total knee or total hip replacement.


Eligibility criteria: Inclusion criteria:

1. Primary elective total joint arthroplasty patients undergoing surgery with a Rothman Institute arthroplasty surgeon.
2. Participant is a current smoker.
3. Diagnosis of osteoarthritis, inflammatory arthritis, and post-traumatic arthritis.

Exclusions criteria:

1. Age \< 18
2. Revision surgery
3. Prior infection in hip or knee at the surgical site
4. BMI \>40 (It is currently the standard of care in our practice to require patients to have a BMI \< 40 due to an increased risk of infection. This will not represent a change in practice.)
5. Diabetics with Hgb A1C \>8 (It is currently the standard of care in our practice to require patients to have a Hgb A1C \<8 due to an increased risk of infection. This will not represent a change in practice.)
6. Patients using chewing tobacco, cigars, or other form of oral tobacco product
7. Patients using e-cigarettes or vaporizers

Primary outcomes:
measure: Wound healing
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05696002: Advanced Pelvic Surgical Oncology Database - Prospective Observational Study
Official title: Advanced Pelvic Surgical Oncology Database - Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Pelvic Cancer
Gynecologic Cancer
Colon Cancer
Keywords: Pelvic exenteration
Abdominoperineal resection
Reconstructive flap
Rectal cancer
Lead sponsor: Glasgow Royal Infirmary
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 300
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: Tertiary referral centre

Brief summary: Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.

Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study.

Detailed description: Retrospective and prospective observational study of patients undergoing advanced pelvic oncological resection for maligancy including multi visceral resection, beyond TME resection and sacrectomy/flap reconstruction/urinary reconstruction at Glasgow Royal Infirmary.

Goal is to study and report outcomes for patients to characterise and understand major complications, natural history of resectional patients and identify areas for future interventional study..

Eligibility criteria: Inclusion Criteria:

* Advanced pelvic oncological resection defined as more than 1 pelvic organ resected

Exclusion Criteria:

-

Primary outcomes:
measure: Cancer-specific survival
timeFrame: 10 years
measure: Overall survival
timeFrame: 10 years
measure: Post-operative complications
timeFrame: 10 years
measure: Quality of life (survey)
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Academic Department of Surgery, Glasgow Royal Infirmary
Study officials:
affiliation: Glasgow Royal Infirmary
name: Colin Steele, PhD FRCS
role: STUDY_DIRECTOR
References:
Clinical trial NCT05324202: New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management
Official title: New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Basal Cell Carcinoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to show that the Nd:YAG laser could be a promising alternative treatment option in the management of low-risk basal cell carcinomas with similar high efficacy rates to surgery, and low recurrence rates evaluated over a time period of one year. Reflectance confocal microscopy, optical coherence tomography and clinical examination are used prior to confirm the clinical diagnosis of the basal cell carcinoma and for premargination of the tumor. The optical coherence tomography will also be used post treatment to confirm clearance of the basal cell carcinoma and to monitor treatment response.


Eligibility criteria: Inclusion Criteria:

Patients with one or more basal cell carcinoma(s) on head, trunk or extremities

* Diagnosed clinically, with a dermatoscope and through noninvasive imaging methods such as reflectance confocal microscopy and optical coherence tomography
* H zone \<6mm, M zone \<10mm, L zone \<20mm
* Tumor thickness \<2mm
* Clearly visible margins

Exclusion Criteria:

* Pregnancy
* \<18 years of age
* Current or history of immunosuppression
* Prior-treatment of the basal cell carcinoma/ recurrent basal cell carcinomas
* History of radiation in the area of basal cell carcinoma appearance

Primary outcomes:
measure: Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas
timeFrame: 8 weeks after the treatment
measure: Recurrence Rate after Nd:YAG Laser treatment
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: 6 and 12 months after treatment
measure: Cosmetic outcome after laser treatment
timeFrame: 6 and 12 months after treatment
Other outcomes:
Locations:
Study officials:
References: