louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04063111: Role of Vacuum in Open Fracture Tibia Grade III Type B
Official title: ROLE OF VACUUM ASSISTED CLOSURE IN OPEN TYPE III B TIBIAL FRACTURES
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Fracture of Tibia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: - Evaluate the role of VAC in decreasing the time needed for soft tissue coverage and definitive fixation in open IIIB tibial fractures

Detailed description: * Open fractures are injuries in which the skin and soft-tissue integument are disrupted and the underlying bone is exposed to the external environment. This communication results in contamination by microorganisms that can cause deep or superficial infection. Impaired vascularity, devitalized tissue, and loss of skeletal stability are all factors leading to increased susceptibility to infection after open fracture \[1, 2\].
* Current protocols for treating open fractures include early administration of antibiotics, timely surgical debridement, skeletal stabilization, sterile dressing, systemic support, and establishment of soft-tissue coverage in a wound environment that is clean \[3, 4-8\].
* VAC is being used to obviate the need for, or enhance the success of, free-flap coverage in open fractures that are significant enough to preclude primary closure, delayed primary closure, or healing by secondary intention. VAC device and its components, which in a closed system expose the open wound bed to negative pressure. This pressure removes edema or hemorrhage, mechanically pulls on the wound edges, decreases in wound surface area, improves circulation, and enhances proliferation of granulation tissue that filled the soft tissue defect, enhance debridement of wound debris, reducing the need for costly free-flap transfers. VAC devices have been used in many surgical disciplines but only recently have become popular in orthopedics \[7, 9,\].

Eligibility criteria: Inclusion Criteria:

* - Gustilo Type III B open fractures of the tibia \[10\].
* Skeletal mature patients.

Exclusion Criteria:

* - Bone defect more than 5 cm Gustilo Type III B open fractures of the tibia.
* Medical commodities that make the patient unfit for surgery. (e.g. Liver Cell Failure, liver cirrhosis, renal failure )

Primary outcomes:
measure: - Time for definitive soft tissue coverage
timeFrame: baseline
Secondary outcomes:
measure: - The type of soft tissue reconstruction
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Cherubino M, Valdatta L, Tos P, D'Arpa S, Troisi L, Igor P, Corradi F, Khan U. Role of Negative Pressure Therapy as Damage Control in Soft Tissue Reconstruction for Open Tibial Fractures. J Reconstr Microsurg. 2017 Oct;33(S 01):S08-S13. doi: 10.1055/s-0037-1606542. Epub 2017 Oct 6.
Clinical trial NCT00468793: Traditional Versus ScvO2 Guided Perioperative Fluid Therapy
Official title: Randomized Clinical Study of Traditional Versus ScvO2 Guided Perioperative Fluid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perioperative Care
Keywords: central venous saturation
bowel surgery
morbidity
intravenous infusions
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2007-05-03
Enrollment: 240
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: Perioperative goal directed fluid therapy by means of an esophageal doppler has been shown to reduce morbidity and length of stay. In this study patients undergoing elective bowel surgery will be randomised to traditional fluid therapy with crystalloids versus fluid boluses guided by central venous oxygen saturation. The primary outcome will be complications after surgery.


Eligibility criteria: Inclusion Criteria:

* Elective bowel surgery,
* Able to give informed consent

Exclusion Criteria:

* Coagulation defect,
* Renal failure,
* Valvular stenosis

Primary outcomes:
measure: Postoperative morbidity
timeFrame: postoperative day 30
Secondary outcomes:
measure: serum creatinine
timeFrame: postoperative day 3
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Gro Østgaard, M.D., PH.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00154193: Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
Official title: A 12-month Study to Investigate the Correlations Between Cyclosporine Microemulsion C2 Levels (High, Medium and Low) and AUC0-4 With Regard to Outcome in de Novo Heart and Lung Transplantation - Identification of Target Cyclosporine Microemulsion C2 Levels.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart and Lung Transplant
Keywords: Heart transplant, lung transplant, renal function, cyclosporine C2 Levels
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2 levels to outcome (renal function and incidence of acute rejections)


Eligibility criteria: Inclusion Criteria:

* Patients receiving a first heart or bilateral or single lung transplant
* Patients for whom a triple maintenance immunosuppressive therapy consisting of cyclosporine microemulsion, steroids and mycophenolate mofetil (MMF)/ enteric-coated mycophenolate sodium (EC-MPS ,(or azathioprine) is indicated.

Exclusion Criteria:

* Multi-organ transplants or previously transplanted organs
* Patients with the need of more than two cyclosporine microemulsion dosages per day

Other protocol-defined inclusion/exclusion criteria may applied

Primary outcomes:
measure: The average number of treated acute cardiac and lung graft rejection per patient during the first 12 months post transplant
measure: The measured Glomerular Filtration Rate (GFR) at 3 and 12 months post-transplant
Secondary outcomes:
measure: Incidence of treated acute rejections
measure: Incidence of biopsy-proven acute cellular rejections
measure: Patient and Graft survival rates
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Iversen M, Nilsson F, Sipponen J, Eiskjaer H, Mared L, Bergan S, Nystrom U, Fagertun HE, Solbu D, Simonsen S. Cyclosporine C2 levels have impact on incidence of rejection in de novo lung but not heart transplant recipients: the NOCTURNE study. J Heart Lung Transplant. 2009 Sep;28(9):919-26. doi: 10.1016/j.healun.2009.05.022.
Clinical trial NCT06716593: Trajectory of Body Composition Identifies LAGC with Cachexia Following NACT
Official title: Trajectory of Body Composition Identifies Locally Advanced Gastric Cancer with Cachexia Following Neoadjuvant Chemotherapy (FJMUGS-2411)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced Gastric Cancer
Trajectory
Keywords: locally advanced gastric cancer
neoadjuvant chemotherapy
cachexia
CT
adjuvant chemotherapy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data were collected from 600 consecutive patients diagnosed with locally advanced gastric cancer (cT2-4NanyM0) between 2010, and 2021, identified at 5 tertiary hospitals

Brief summary: This longitudinal, multicentre cohort study included LAGC patients treated with NACT between 01/2010-12/2021. BC measurements including skeletal muscle mass (SMM) and total adipose tissue area (TATA) were evaluated by computed tomography at the third lumbar vertebra at baseline and follow-up imaging. Unsupervised latent class growth mixed models were applied to distinguish potential longitudinal SMM and TATA trajectories for identifying cachexia. The primary study endpoint was overall survival (OS), with secondary endpoints including Recurrence-free survival (RFS), objective response rate (ORR) and safety. Multiple Cox proportional hazards models were used to calculate adjusted hazard ratios (HRs) for survival.

Detailed description: This is a retrospective, longitudinal, multicenter, real-world cohort study

Eligibility criteria: Inclusion Criteria:(1) locally advanced gastric cancer (cT2-4NxM0) with clinical staging before neoadjuvant chemotherapy, (2) no history of other malignant tumors, (3) no evidence of distant metastasis or invasion of adjacent organs, and (4) patients who underwent radical gastrectomy following neoadjuvant chemotherapy.

-

Exclusion Criteria: (1) history of gastric surgery; (2) acute cardiovascular disease (such as cerebrovascular or coronary artery injury) within the past three months; (3) emergency surgery; (4) active infection or severe systemic immunodeficiency; and (5) incomplete serological, computed tomography, or anthropometric data.

-

Primary outcomes:
measure: 3-year overall survival; 5-year overall survival
timeFrame: 3 years or 36 months; 5 years or 60months
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-Ming Huang, M.D. FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01034293: Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning
Official title: Effect of Feeding Frequency on Glucose and Insulin Metabolism and Substrate Partitioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin
Glucose Metabolism
Keywords: feeding frequency
insulin metabolism
glucose metabolism
substrate partitioning
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Nederlandse Zuivel Organisatie
First posted: 2009-12-17
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of feeding frequency on glucose and insulin metabolism and substrate partitioning.


Eligibility criteria: Inclusion Criteria:

* BMI: 18.5-25 kg/m2 (lean)
* Gender: Male
* Age: subjects has to be older than 18 and including 35 years old
* Caucasian

Exclusion Criteria:

* Metabolic abnormalities such as:

  1. Lactose intolerant
  2. Diabetes Mellitus
  3. Hypertension
  4. Hypotension
  5. Cardiovascular diseases
  6. Asthma and other obstructive pulmonary diseases
  7. Elevated fasting blood glucose level

Primary outcomes:
measure: Glucose and insulin metabolism
timeFrame: 24 h
Secondary outcomes:
measure: Substrate partitioning and metabolic markers
timeFrame: 24 h
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University of Maastricht
state: Limburg
Study officials:
affiliation: Maastricht University
name: WHM Saris, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munsters MJ, Saris WH. Effects of meal frequency on metabolic profiles and substrate partitioning in lean healthy males. PLoS One. 2012;7(6):e38632. doi: 10.1371/journal.pone.0038632. Epub 2012 Jun 13.
Clinical trial NCT02435693: Pharmaceutical Care Program for Type 2 Diabetes Mellitus
Official title: Evaluation of Pharmaceutical Care Program for Type 2 Diabetes Mellitus in Dhule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DIABETES MELLITUS, TYPE 2
Keywords: pharmaceutical care
Lead sponsor: R. C. Patel Institute of Pharmaceutical Education & Research
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 600
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of Pharmaceutical Care Program for Type 2 diabetes mellitus in Dhule

Objectives:-

1. To evaluate Pharmaceutical care program in Type2 diabetics.
2. To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus.
3. To study the prevalence of Type2 diabetics cases in Dhule.
4. To study the Assessment of different type of adverse drug reactions (ADRs). In Type2 diabetics.
5. To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.
6. To study the impacts of Pharmaceutical care program on glycemic control in patients with Type-2 Diabetes Mellitus.
7. To study the Drug utilization pattern in Type-2 Diabetes Mellitus in civil hospital Dhule.
8. To compare the efficiency of Pharmaceutical care program and drug in patients with Type-2 Diabetes Mellitus.
9. To study the Pharmaco-economic evaluation in Type-2 Diabetes Mellitus patient's.
10. To increase the patient compliance and positive attitude of patients towards the diabetes disease by counseling.

Detailed description: To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus.

To study the prevalence of Type2 diabetics cases in Dhule. To study the Assessment of different type of adverse drug reactions (ADRs). In Type2 diabetics.

To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.

Eligibility criteria: Inclusion Criteria:Inclusion Criteria:

* Patients with type 2 diabetes mellitus of either
* Patients with HbA1c more than 7% and
* Patients with blood sugar level more than 140 mg / dl

Exclusion Criteria:

* Patient with end stage kidney disease.
* Patient with heart failure.
* Patient with chronic Diabetes problem and orthopedic problem

Primary outcomes:
measure: Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded: Fasting blood glucose measurements recorded (mg/dl).Postprandial bloodglucoseRecorded
timeFrame: 24 weeks
Secondary outcomes:
measure: Quality of Life score
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Dhule
country: India
facility: Tabrej Aj Mujawar
state: Maharashtra
Study officials:
affiliation: muhs
name: tabrej aj mujawar, mpharm
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03307993: Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
Official title: Interventional, Open-label, Positron Emission Tomography (PET) Study Investigating the Brain Receptor Occupancy of Idalopirdine in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Lu AE58054
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2017-10-12
Enrollment: 3
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the brain receptor occupancy of idalopirdine in patients with Alzheimer's disease (AD)


Eligibility criteria: Inclusion Criteria:

* The patient has probable AD diagnosed according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) criteria.
* The patient has had a positive amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD.
* The patient has a Mini Mental State Examination (MMSE) score at screening of at least 15 and no greater than 22.
* The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinic visits during the study and answer questions about the patient.
* The patient is a man or woman of at least 50 years of age and has a body mass index (BMI) ≥ 18.5 kg/m2.

Exclusion Criteria:

* The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD including but not limited to Lewy body dementia, fronto-temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, major head trauma, primary or secondary cerebral neoplasia or systemic medical diseases that are, in the investigator's opinion, likely to affect central nervous system functioning and may influence the outcome or analysis of the scan results.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Primary outcomes:
measure: 5-HT6 Receptor Occupancy (RO)
timeFrame: Treatment day 10 (24 hours post dose)
measure: Idalopirdine plasma concentration (CPET)
timeFrame: Prior to and after PET scan on treatment day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT04870593: What Works to Get the Elderly Vaccinated Against COVID-19? Experimental Evidence From India
Official title: What Works to Get the Elderly Vaccinated Against COVID-19? Experimental Evidence From India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Covid19
Lead sponsor: National Bureau of Economic Research, Inc.
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 3006
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: COVID-19 poses a substantial risk to elderly populations; understanding how to get elders vaccinated against the virus is therefore a policy priority. An experiment with elders in Tamil Nadu, India will be used to evaluate interventions policymakers might use to raise vaccination rates amongst the elderly. The particular interventions being tested are: calling elders to inform them about vaccination; encouragement of a "buddy system," whereby elders are accompanied to the vaccination site by another adult who could also get the vaccine; and seeding vaccination information with "gossips," individuals who elders identify as being good at spreading information in the elders' communities. The interventions are phone-based, and can be implemented quickly and at low cost. This makes them promising strategies the Tamil Nadu government and other governments could use to vaccinate elderly populations against COVID-19.


Eligibility criteria: Inclusion Criteria:

* At least 55 years of age
* Has phone number

Exclusion Criteria:

- Not part of the experiments registered under protocol IDs 223749 or 172020

Primary outcomes:
measure: Received at least one shot
timeFrame: 8 weeks after intervention
measure: Received two shots
timeFrame: 8 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: JPAL SA at IFMR
state: Tamil Nadu
Study officials:
References:
Clinical trial NCT01543893: Effect of Personal Versus Video Instruction in Elastic Resistance Exercise on Technical Execution (IRMA05)
Official title: Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Disorders
Keywords: neck pain
shoulder pain
resistance training
Lead sponsor: National Research Centre for the Working Environment, Denmark
Sponsor class: OTHER_GOV
Collaborators: name: Novo Nordisk A/S
First posted: 2012-03-05
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Resistance training is widely used in training and rehabilitation. During recent years elastic resistance training has become increasingly popular for preventing or relieving neck/shoulder/arm pain among sedentary employees. While most research studies documenting positive effects of such interventions have used training instructors, most training in practice does not use an instructor but rather depends on information from other sources such as the internet. Here the investigators examine - in a outcome assessor blinded randomized controlled trial - the effect of 2 weeks elastic resistance training for the neck/shoulder/arm with personal versus video instruction on technical execution.


Eligibility criteria: Inclusion Criteria:

* neck or shoulder pain

Exclusion Criteria:

* blood pressure above 160/100 mmHg
* pregnancy
* life-threatening disease

Primary outcomes:
measure: Technical execution
timeFrame: 2 weeks after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National Research Centre for the Working Environment
Study officials:
affiliation: Professor
name: Lars L Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05580393: Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis
Official title: Molecular Characterization of Blastocystis Isolates From Human by Restriction Fragment Length Polymorphism (RFLP) Analysis in Sohag Governorate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blastocystis Infections
Keywords: Blastocystis
colorectal cancer
irritable bowel syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: samples will be collected from outpatients with any age \& sex groups from different locations (cities and villages).

Brief summary: Blastocystis is an anaerobic unicellular protozoal parasite infecting the gastrointestinal tract of humans and a wide range of animals. It is one of the most common enteric microorganisms with higher prevalence rates in developing than in developed countries. Feco-oral is the main route of transmission where low socioeconomic conditions, poor hygienic practices, close contact with animals, and drinking contaminated water act as major risk factors. Infection with Blastocystis was demonstrated in both symptomatic and asymptomatic people. For a long period, Blastocystis was considered a commensal organism with no pathogenic role, but recently, many studies linked it to different gastrointestinal symptoms such as nausea, diarrhea, and abdominal pain. Association with irritable bowel syndrome and colorectal cancer was also reported.

This study aims to:

- Identify subtypes of human Blastocystis isolates in Sohag by using RFLP-PCR and provide additional information on the molecular epidemiology of this parasite in our locality.


Eligibility criteria: Inclusion Criteria:

* Patients from outpatient clinics, Sohag hospitals.

Exclusion Criteria:

* Patients received antiparasitic drugs in the last two weeks

Primary outcomes:
measure: The number of cases with subtypes of human Blastocystis isolates in Sohag
timeFrame: 14 weeks following the startpoint of the study.
Secondary outcomes:
measure: The number of cases with Blastocystis infection is recorded.
timeFrame: 14 weeks following the startpoint of the study.
Other outcomes:
Locations:
Study officials:
References: