louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05638542: Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp
Official title: Comparison of Expression of Carcinogenesis-related Molecular Markers in the Patients With Colon Cancer and Polyp
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Colorectal Adenoma
Keywords: Carcinogenesis
Sex difference
Tumor location
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visited Seoul National University Bundang Hospital for gastrointestinal symptomes or regular check-ups, and agreed to participate.

Brief summary: A study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.

Detailed description: The chromosomal instability (CIN) pathway, the CpG island methylator phenotype (CIMP) pathway and the microsatellite instability (MSI) pathway are three major carcinogenesis pathways to colorectal cancer (CRC). In this study, the investigators aimed to investigate distinctive molecular features of carcinogenesis pathways among healthy control, colorectal adenoma, and CRC and compare their molecular progression according to patients' sex and tumor location as well as disease stage.

Eligibility criteria: Inclusion Criteria:

* Control group: subjects with no evidence of colorectal adenoma or colorectal cancer
* Colorectal adenoma group: Patients with colorectal adenomas greater than or equal to 10 mm in diameter according to the endoscopic presentation as well as histological validation of colorectal adenoma.
* Colorectal cancer group: Patients whose biopsy specimen is histologically confirmed as colorectal adenocarcinoma

Exclusion Criteria:

* Subjects age under 18 years
* Previous history of colorectal neoplasms
* Patients with high bleeding risk or patients who must maintain anti-coagulant or anti-platelet agents
* Denial to participate in this study

Primary outcomes:
measure: The characteristics of carcinogenesis-related molecular markers in colorectal adenoma and CRC
timeFrame: through study completion, an average of 1 year
measure: Fecal microbiota analysis in patients with colorectal adenoma and CRC
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Nayoung Kim, M.D., Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01422642: Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis?
Official title: Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis? A Minimum of Ten Years of Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2011-08-24
Enrollment: 111
Sex: ALL
Minimum age (years): 48
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there are any clinical or ROM differences in total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.

Detailed description: We therefore hypothesized: (1) the survival of the NexGen LPS-Flex prosthesis is better than standard NexGen LPS prosthesis; (2) knee function and range of motion after clinical assessment will be better in the NexGen LPS-Flex group; and (3) the incidence of osteolysis will be lower in the NexGen LPS-Flex prosthesis than standard NexGTne LPS prosthesis.

Eligibility criteria: Inclusion Criteria:

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery

Primary outcomes:
measure: Improvement in Knee Society Knee Score
timeFrame: 10 years
Secondary outcomes:
measure: Improvement in the range of motion
timeFrame: 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hosptial
Study officials:
affiliation: Ewha Womans University School of Medicine
name: Young-Hoo Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05868642: Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Versus Tecnica Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. RCT
Official title: Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Nel Confronto Con la Tecnica Tradizionale Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. Trial Randomizzato Controllato
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia; Adverse Effect
Anesthesia, Local
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional single-shot subarachnoid anesthesia

Detailed description: This study aims to investigate whether a different hemodynamic effect is related to the injection o titrated local anesthetic for subarachnoid anesthesia versus the conventional single shot injection. The data to be recorded are blood pressure and pulse rate at different timing. As secondary outcomes the investigators will record the anesthetic level achieved using the Bromage score.

Eligibility criteria: Inclusion Criteria:

* BMI 20-40 kg/m2
* ASA 1-3
* undergoing total hip arthroplasty
* no controindications to subaracnhoid block
* able to understand and sign a written informed consensus
* METs \> o = 4

Exclusion Criteria:

* baseline SBP \< 100 mmHg

Primary outcomes:
measure: SBP change
timeFrame: 60 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
affiliation: isituto ortopedico rizzoli
name: battista borghi, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05933642: Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults
Official title: Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Kidney Injury
Keywords: Aminophylline
Furosemide
Critically ill
Adults
Intensive Care Unit (ICU)
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind, randomised, controlled trial
Primary purpose: TREATMENT

Brief summary: The goal of this RCT is to compare the effectiveness of aminophylline and furosemide combination vs furosemide alone in producing effective diuresis in critically ill adults in ICU. ICU patients with the need of improved diuresis will be recruited and given either infusion of aminophylline and furosemide combination or furosemide alone, and their hourly urine output will be monitored to compare their effectiveness.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years old and above who are admitted to the ICU of UMMC during the study period
* Oliguric patients, with the need for improved diuresis at clinician discretion - defined as urine output \<0.5ml/kg/hour

Exclusion Criteria:

* Patient refusal for participation of study
* Patients with known hypersensitivity reaction to aminophylline or furosemide
* Patients with history of tachyarrhythmias, seizures, aspartate aminotransferase or alanine aminotransferase \> 3 times normal, or hypothyroidism.

Patient with existing peptic ulcer disease or coagulopathy with INR \> 1.5

Primary outcomes:
measure: Percentage of patients with effective diuresis at 6 hours post intervention
timeFrame: 6 hours post intervention
Secondary outcomes:
measure: Percentage of patients with effective diuresis at 2 hours post intervention
timeFrame: 2 hours post intervention
measure: Mean duration of infusion to achieve effective diuresis post intervention
timeFrame: Up to 6 hours post interventions
measure: Changes in urine output at 6 hours post intervention
timeFrame: 6 hours post interventions
measure: Changes in serum creatinine at 1 day post intervention
timeFrame: 1 day post intervention
measure: Changes in serum eGFR at 1 day post intervention
timeFrame: 1 day post intervention
measure: Percentage of patients requiring Renal Replacement Therapy (RRT)
timeFrame: throughout ICU stay, an average of 1 month
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
Study officials:
affiliation: University of Malaya
name: Haw Shyan Ng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01585142: Growth of Infants Fed With BabyNes System
Official title: Assessment of Growth of Infants Fed With BabyNes System (Single-serve Formulas, Adaptative System)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-04-25
Enrollment: 33
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the growth of infants fed with BabyNes System, compared to the World Health Organization Reference, during the first four months of life.


Eligibility criteria: Inclusion Criteria:

* Healthy newborn
* Full term newborn (≥ 37 weeks gestation)
* Birth weight ≥ 2500 g and ≤ 4500 g
* Newborn from birth to 14 days of age at the time of enrollment
* The newborn's mother has voluntarily elected to exclusively formula feed her newborn
* Having obtained his/her signed legal representative's informed consentHealthy newborn infant

Exclusion Criteria:

* Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
* Newborn whose mother's BMI was abnormal (\<18.5 or \>30kg/m2) at start of pregnancy
* Newborn whose mother has diabetes of type-1 or type-2
* Newborn whose mother has a chronic infectious disease
* Newborn whose parents / caregivers cannot be expected to comply with treatment
* Newborn currently participating in another nutritional interventional clinical trial (except for vaccination studies)

Primary outcomes:
measure: z-score weight-for-age (WHO Child Growth Standards)
timeFrame: 4 months
Secondary outcomes:
measure: Growth
timeFrame: 12 months
measure: Compliance
timeFrame: 12 months
measure: Morbidity
timeFrame: 12 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitäts-Kinderspital beider Basel (UKBB)
city: Geneva
country: Switzerland
facility: Hôpital des enfants
city: Lausanne
country: Switzerland
facility: CHUV Unité de Gastroentérologie Pédiatrique DMCP-BH11
city: Luzern
country: Switzerland
facility: Pädiatrische Gastroenterologie und Hepatologie Kinderspital
Study officials:
affiliation: Pädiatrische Gastroenterologie und Hepatologie Kinderspital
name: Johannes Spalinger, Dr med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02227342: Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis
Official title: A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 3
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: Manipulation of the intestinal microbiota through FMT is a potential therapeutic target for IBD patients. Studies are now required to determine if repeated FMT can overcome the apparent immune response to FMT thereby maintaining sustained clinical improvement and remission. Prior to a large randomized controlled trial of FMT in UC we will carry out a feasibility study to determine if serial FMTs can sustain a clinical response and maintain stability of transplanted microbiota.

Detailed description: same as above

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 and \< 65 years
2. Diagnosis of UC for \> 3 months but \< 5 years prior to screening as determined by the investigators
3. Those with mild to moderate UC
4. Those who have failed maintenance therapy with stable doses of 5-ASA, azathioprine or 6 mercaptopurine (6-MP) for \> 3 months
5. Where applicable, those who are taking the following medications must be at a stable dose defined as:

   i) 5-ASA must be at a stable dose for 2 weeks ii) Prednisone up to 20 mg/d must be at a stable dose for 2 weeks iii) Budesonide up to 6 mg/d must be at a stable dose for 2 weeks iv) Azathioprine or 6-MP must be at a stable dose for \> 8 weeks
6. ability to provide informed consent
7. evidence of active inflammation

Exclusion Criteria:

1. Those whose disease is limited to the rectum (ie. proctitis)
2. Those with colectomy or diverting ileostomy
3. Those who are pregnancy or plan to be pregnant during the trial
4. Those who are breastfeeding or plan to breast feed during the trial
5. Those who are on or have previously failed a biological agent
6. Those with an active infection requiring antibiotic therapy
7. Those with positive stool cultures for known pathogens such as E coli, Salmonella, Shigella, Yersinia, Campylobacter, and Clostridium difficile toxin within 2 weeks of enrollment
8. Those with positive CMV on colonic tissue biopsy within 2 weeks of screening
9. Those with allergy to ciprofloxacin and metronidazole
10. Those with colonic mucosal dysplasia

Primary outcomes:
measure: Mayo score reduction
timeFrame: 12 and 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Dina Kao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00073242: Low-Dose Leptin and the Formerly-Obese
Official title: Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Obesity
Keywords: leptin
obesity
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-11-19
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our previous studies have demonstrated that there is substantial metabolic opposition to the maintenance of an altered body weight. Leptin is a protein secreted by fat cells and the circulating concentrations of leptin are directly proportional to fat mass. Leptin-deficiency is associated with severe obesity in rodents and in humans and the obesity is relieved by leptin administration. These studies examine the hypothesis that some of this metabolic opposition cto the maintenance of an altered body weight can be relieved by restoring circulating concentrations of the hormone leptin to the same range as at usual body weight in subjects who are maintaining a reduced body weight. The basic design of this study is to observe subjects at a 10% reduced body weight and then again at that reduced body weight while receiving physiological leptin or T3 supplementation.

Detailed description: We demonstrated a substantial metabolic resistance to maintenance of altered body weight. Leptin is secreted by fat cells in circulating concentrations that are directly proportional to fat mass. Leptin-deficiency is associated with severe obesity in rodents and in humans and the obesity is relieved by leptin administration. These studies examine the hypothesis that some of this metabolic opposition cto the maintenance of an altered body weight can be relieved by restoring circulating concentrations of the hormone leptin to the same range as at usual body weight in subjects who are maintaining a reduced body weight. The basic design of this study is to observe subjects at a 10% reduced body weight and then again at that reduced body weight while receiving physiological leptin or T3 supplementation.

Eligibility criteria: Healthy

Primary outcomes:
measure: Effects of leptin repletion on hypometabolism/hyperphagia following weight loss
timeFrame: 9 months per subject
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01053442: Absorption, Stable Isotope Appearance and Non-transferrin-bound Iron (NTBI) Profile From NaFeEDTA and Ferrous Sulphate
Official title: Absorption, Stable Isotope Appearance and NTBI Profile From NaFeEDTA and Ferrous Sulphate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Keywords: iron absorption
stable isotopes
NaFeEDTA
Non-transferrin-bound iron (NTBI)
Hepcidin
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2010-01-21
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Several iron compounds are used for fortification, including ferrous sulphate and NaFeEDTA. The absorption profile of these may differ because of differences in their dissolution in the gastrointestinal tract and in their interaction with dietary inhibitors of iron absorption. As these differences might lead result in varying reactions in the blood stream, the appearance rate of the stable iron isotope, hepcidin, non-transferrin-bound iron and total iron in the plasma will be monitored over six hours in adult women. This is relevant as a spike of absorbed iron may increase non-transferrin-bound iron and this could be pro-oxidative or increase growth of pathogens. Hepcidin is a key mediator of iron absorption and will help explain the potential differences in the plasma iron profile.

The use of stable iron isotope appearance curves to specifically detect the appearance of small amounts of absorbed iron in the blood and distinguish between circulating body iron and iron absorbed from the test meal was tested in a pilot study (EK 2008-23). This method is now used in a bigger sample to test the differences in absorption profile of ferrous sulphate, FePPi and NaFeEDTA given at fortification level with a meal.


Eligibility criteria: Inclusion Criteria:

* Serum ferritin \<60 ug/ l, haemoglobin \> 100 g/ l
* Women
* \< 65 kg body weight
* Healthy

Exclusion Criteria:

* Pregnant or lactating
* Taking iron supplements

Primary outcomes:
measure: Stable iron isotope appearance in the plasma over 8 hours
timeFrame: day 1: 0', 30', 60', 120', 240', 480', day 8 0', 30', 60', 120', 240', 480'
Secondary outcomes:
measure: Isotope incorporation with erythrocytes
timeFrame: day 22
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Laboratory of Human Nutrition
Study officials:
References:
Clinical trial NCT03394742: Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients
Official title: Effectiveness of Peer Support on Quality of Life in Recently Diagnosed Breast Cancer Patients - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Peer Group
Quality of Life
Lead sponsor: University of Jyvaskyla
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2018-01-09
Enrollment: 260
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examines effectiveness of peer support of breast cancer patients. Half of the participants received peer support via telephone in addition to usual care and another half are give the usual care only.

Detailed description: Seriously sick people need social support to maintain their quality of life. Social support may be given by peers, who have experienced the same.

In this study voluntary participants with recently diagnosed breast cancer were randomly allocated to intervention (N=130) or control (N=130) group. The intervention group received, in addition to usual care, peer support via telephone 1-5 times according to their own preference. The control group received usual care only. Peer support was given by volunteered breast cancer survivors who were educated for giving peer support.

Eligibility criteria: Inclusion Criteria:

* recently diagnosed primary breast cancer
* no other serious illnesses
* ability to communicate in Finnish or Swedish (official languages in Finland)
* ability to fill in the questionnaires

Exclusion Criteria:

* some other serious illnesses
* inability to communicate in Finnish or Swedish (official languages in Finland)
* inability to fill in the questionnaires

Primary outcomes:
measure: A change of health-related quality of life (HRQoL).
timeFrame: From baseline to 3, 6 and 12 months later.
measure: A change of health-related quality of life (HRQoL).
timeFrame: From baseline to 3, 6 and 12 months later.
Secondary outcomes:
measure: Satisfaction for life
timeFrame: Baseline and 3, 6 and 12 months later.
measure: The use of health care services
timeFrame: Baseline and 3, 6 and 12 months later.
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: University of Jyvaskyla
name: Anu Toija, MHS
role: PRINCIPAL_INVESTIGATOR
References: