louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01603836: Study Confirms or Refutes the Hypothesis That the Autologous Bone Marrow Concentrate Together With the Allograft is a Better Alternative for the Posterolateral Fusion in Spine Surgery Than the Allograft Alone
Official title: Allograft Alone Versus Allograft With Bone Marrow Concentrate for the Healing of the Instrumented Posterolateral Lumbar Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondyloarthrosis, Spondylosis
Keywords: Lumbar spine
Posterolateral fusion
Allograft
Bone marrow concentrate
Mesenchymal stem cells
Fusion rate
Lead sponsor: Hospital Znojmo
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of autologous mesenchymal stem cell (MSCs) in form of the BMC in combination with allograft is an effective option how to enhance the Posterolateral Fusion (PLF) healing. Allograft by itself is not an effective material as a posterior onlay graft for the PLF in adult surgery.

Detailed description: The study was prospective, randomized, controlled and blinded. Eighty patients with degenerative disease of the lumbar spine underwent instrumented lumbar or lumbosacral PLF. In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.

Eligibility criteria: Inclusion Criteria:

* degenerative disc disease or degenerative spondylolisthesis

Exclusion Criteria:

* vertebral fractures,
* infections or spinal neoplasms,
* non-rigid instrumentations,
* medication affecting bone mineralization (e.g., corticosteroids),
* body mass index higher than 35,
* systemic diseases,
* blood disease and/or immunosuppressant treatment and/or dicoumarol therapy;
* immunosuppressant and/or neoplastic and/or infectious diseases.

Primary outcomes:
measure: The improvement of the fusion of the posterolateral fusion measured on X-rays
timeFrame: 12 months after the surgery
measure: The improvement of the fusion of the posterolateral fusion measured on X-rays and CT scans.
timeFrame: 24months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02054936: Evaluation of Wound Drainage After Knee or Hip Arthroplasty
Official title: Evaluation of Wound Drainage Following Rivaroxaban (Xarelto) or Warfarin (Coumadin) for Post op Venous Thromboembolism (VTE) Prophylaxis, After Knee or Hip Arthroplasty a Randomized Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Complications; Arthroplasty
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 0
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: To compare side effects and complications relating to use of warfarin or rivaroxaban, tolerance and/or toxicity of these two agents such as drop in hemoglobin post operatively, extent of bruising, quantity of wound drainage, duration of drainage, wound swelling, sub and supra-therapeutic prothrombin times, need for transfusion, and patient tolerance in two randomized groups. Return visits to the operating room, length of stay, and VTE rates will also be compared.


Eligibility criteria: Inclusion Criteria:

* All patients over the age of 18 undergoing primary hip or knee replacement by Dr. Urquhart or Dr. Hallstrom.

Exclusion Criteria:

* Patients with a contraindication to pharmacologic VTE prophylaxis such as hemophilia, Plavix use, active bleeding or prior reaction to warfarin or rivaroxaban, nursing mothers, hepatic disease, GFR \<30, use of more than 200mg of aspirin daily, and inability to continue medication or lab monitoring after hospital discharge known preoperatively.

Primary outcomes:
measure: Number of days until a dry wound
timeFrame: 90 days
measure: Amount and character of wound drainage
timeFrame: 90 days
Secondary outcomes:
measure: Number of days in the hospital postoperatively.
timeFrame: 90 days
measure: Incidence of wound infection
timeFrame: 90 days
measure: Incidence of additional operations
timeFrame: 90 days
Other outcomes:
measure: Survey assessments
timeFrame: 90 days
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
Study officials:
affiliation: University of Michigan
name: Andrew G Urquhart, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04175236: Analysis of a Short Assessment of Post Intensive Care Syndrome (PICS)
Official title: Analysis of a Short Assessment of Post Intensive Care Syndrome (PICS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postintensive Care Syndrome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patienten aged ≥ 18 years, whose intensive care treatment has already been completed from the Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum, Bad Belzig, as well as from the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Brief summary: To present a proposal for a set of outcome measurement instruments (OMIs) of post intensive care syndrome (PICS) in settings of outpatient healthcare service.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 years, whose intensive care treatment has already been completed

  * The patients were interviewed in the Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum, Bad Belzig, as well as in the pain clinic of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Exclusion Criteria:

Patients with a legal guardian or authorized representative

Primary outcomes:
measure: Post Intensive Care Syndrome (PICS)
timeFrame: 06/2018 - 11/2019
Secondary outcomes:
measure: Subjective Health I
timeFrame: 06/2018 - 11/2019
measure: Subjective Health II
timeFrame: 06/2018 - 11/2019
measure: Subjective Health III
timeFrame: 06/2018 - 11/2019
measure: Mental Health
timeFrame: 06/2018 - 11/2019
measure: Cognition
timeFrame: 06/2018 - 11/2019
measure: Physical Health
timeFrame: 06/2018 - 11/2019
Other outcomes:
Locations:
city: Bad Belzig
country: Germany
facility: Klinikum Ernst von Bergmann, Peumologisches Beatmungszentrum
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: Spies CD, Krampe H, Paul N, Denke C, Kiselev J, Piper SK, Kruppa J, Grunow JJ, Steinecke K, Gulmez T, Scholtz K, Rosseau S, Hartog C, Busse R, Caumanns J, Marschall U, Gersch M, Apfelbacher C, Weber-Carstens S, Weiss B. Instruments to measure outcomes of post-intensive care syndrome in outpatient care settings - Results of an expert consensus and feasibility field test. J Intensive Care Soc. 2021 May;22(2):159-174. doi: 10.1177/1751143720923597. Epub 2020 May 14.
Clinical trial NCT07015736: Effects of Saccharomyces Boulardii CNCM I-745 on Antibiotic-Associated Perturbation in Children Treated for Acute Respiratory Infections (RESTORE Study)
Official title: Effect of Saccharomyces Boulardii CNCM I-745 on Antibiotic-perturbed Microbiota in Children: RESTORE STUDY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Antibiotic Associated Diarrhea
Acute Otitis Media
ACUTE SINUSITIS
Keywords: antibiotic associated diarrhea
probiotic
microbiota
microbiome
Saccharomyces boulardii
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
Collaborators: name: Turkish Pediatric Probiotic Prebiotic and Microbiota Society
First posted: 2025-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the effect of co-administering the probiotic Saccharomyces boulardii CNCM I-745 with amoxicillin-clavulanic acid on the intestinal and nasopharyngeal microbiota in children diagnosed with acute otitis media or acute bacterial sinusitis. The trial will also assess the potential of the probiotic to reduce antibiotic-associated diarrhea (AAD), antibiotic associated microbiota perturbation, and the spread of antibiotic resistance genes (ARGs).


Eligibility criteria: Inclusion Criteria

Diagnosed with acute otitis medica or acute rhinosinusitis

No chronic diseases or recent antibiotic/probiotic use (past 8 weeks)

Parental consent obtained

Exclusion Criteria:

Age \<4 or \>12 years

Chronic illness or GI disorders

History of antibiotic allergy or immunocompromise

Malnutrition or obesity

Recent gastrointestinal surgery

Primary outcomes:
measure: Change in intestinal microbiota bacteria composition
timeFrame: 0, 10, 21 and 56 days
measure: Potential changes in antibiotic resistant genes (ARGs)
timeFrame: 0, 10, 21, and 56 days of study
Secondary outcomes:
measure: Change in intestinal microbiota virome composition
timeFrame: 0, 10, 14, 56 days of study
measure: Change in intestinal microbiota mycobiome composition
timeFrame: 0, 10, 14, 21 days of study
measure: Changes in nasopharyngeal microbiota composition
timeFrame: 0, 10, 21, 56 days of intervention
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
Study officials:
References:
Clinical trial NCT03176836: Li-Fraumeni Syndrome Imaging Study
Official title: Novel Approaches to Molecular and Clinical Surveillance in Li-Fraumeni Syndrome - Pilot Study.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Li-Fraumeni Syndrome
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Li-Fraumeni Syndrome (LFS) is a cancer predisposition disorder in which most affected individuals develop cancer during their lifetime. The majority of LFS patients carry a mutation in a gene called TP53, whose normal function is to control cell growth and prevent cells with damaged DNA from becoming cancerous. There is currently no way to determine when, where or what type of tumour will develop. This project will use novel techniques utilizing magnetic resonance imaging (MRI) to determine how sensitive they are at detecting very small tumors and how specific they are in terms of distinguishing malignant tumors from benign tumors.


Eligibility criteria: Inclusion Criteria:

* LFS kindreds who either carry a known TP53 mutation or are obligate mutation carriers

Exclusion Criteria:

* General contraindications for an MRI scan (ferromagnetic prostheses, pacemaker, or other implants incompatible with the magnetic field of the MR scanner), claustrophobia.

Primary outcomes:
measure: Evaluation of imaging traits on suspected tumors
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Andrea Doria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01232036: Clinical Trial to Compare the Pharmacokinetics and Pharmacodynamics After Oral Administration of Glucophage and HL-018
Official title: A Clinical Trial to Compare the Pharmacokinetic and Pharmacodynamic Characteristics and Safety After Oral Administration of Glucophage With Those After Oral Administration of HL-018 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy volunteers
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: HanAll BioPharma Co., Ltd.
First posted: 2010-11-02
Enrollment: 28
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to to compare the pharmacokinetic and pharmacodynamic characteristics and safety after oral administration of Glucophage with those after oral administration of HL-018 in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Adult males aged 19 to 50 years at screening.
* No significant congenital/chronic disease. No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
* History of known hypersensitivity to drugs including metformin.

Primary outcomes:
measure: Pharmacokinetics (AUClast and Cmax)
timeFrame: 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01209936: Hydration Factor Study for the Stayhealthy BC3
Official title: Pilot Study for the Validation of the BC3 Bioelectrical Impedance Hydration Factor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition
Keywords: Body Fat
Total body water
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2010-09-27
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This was a pilot study to validate the BC3 hydration factor which will be important for determining how well this value represents hydration status compared to assessment of total body water by D20.

Detailed description: The BC3 body composition analyzer is manufactured by Stayhealthy. It is a handheld, noninvasive bioelectrical impedance device. When held, the BC3 sends an electrical impulse through the body to determine body fat, lean mass, and total body hydration. Bio-impedance devices measure the change in electrical resistance in body tissues by using a detectable electrical signal that passes through the body. The method is based on the principle that lean body mass contains virtually all the water and conducting electrolytes in the body and provides a good electrical pathway. In contrast, fat or fat-containing tissues produce a poor electrical pathway. By inducing a low-energy, high-frequency signal, a measurement of the baseline resistance to flow of electrical current can be assessed. The resistance measurement relates directly to the volume of the conductor. Through repeated measurements and identifying other parameters (i.e. gender, weight, age and height) proprietary equations were developed that determine total body water, lean mass, and % body fat.

The purpose of this study is to validate the calculated hydration factor produced by the BC3 bioelectrical impedance device. If this value is valid and comparable to the gold standard (D20) then this hydration factor will offer a very quick and inexpensive method to determine total body hydration status using a hand-held bioelectrical impedance device.

Eligibility criteria: Inclusion Criteria:

• Men and women 18-80 years of age

Exclusion Criteria:

* Acute illness (infection, recent surgery, trauma).
* Pregnancy
* Pacemaker or defibrillator

Primary outcomes:
measure: Estimated Body Fat % for Children Aged 10-17 Years Old
timeFrame: One time point (only one day visit)
measure: Percent Body Fat in Women Aged 18-80 Years Old
timeFrame: One time point (only one day visit)
measure: Estimated Percent Body Fat for Men Aged 18-80
timeFrame: One time point (only one day visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Clinical Exercise Research Center
state: California
Study officials:
affiliation: University of Southern California
name: Edward T Schroeder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06690736: Chemokine Receptor 4 PET/CT Imaging of CXCR4-Related Diseases
Official title: Chemokine Receptor 4 PET/CT Imaging of CXCR4-Related Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CXCR4-related Disease
Tumor
Positron Emission Tomography
Metastasis
Keywords: PET/CT
Chemokine receptor 4
Pentixafor
Pentixather
Lead sponsor: Tianjin Medical University
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
First posted: 2024-11-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 68Ga/18F-Pentixafor/Pentixather positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various CXCR4-related disease patients.

Detailed description: Subjects with various CXCR4-related disease patients underwent 68Ga/18F-Pentixafor/Pentixather PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-Pentixafor/Pentixather PET/CT were calculated.

Eligibility criteria: Inclusion Criteria:

* suspected or confirmed untreated Lymphoproliferative and other CXCR4-related diseases patients
* 18F-FDG PET/CT within two weeks
* signed written consent.

Exclusion Criteria:

* pregnancy
* breastfeeding
* known allergy against Pentixafor

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04835636: Modified Diabetes Prevention Program in Ecuador
Official title: A Pilot of a Modified Diabetes Prevention Program in Quito, Ecuador
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PreDiabetes
Lead sponsor: Ohio University
Sponsor class: OTHER
Collaborators: name: Touro University, California
First posted: 2021-04-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The faculty and staff at PUCE University in Quito Ecuador were invited to participate in the study.

Brief summary: This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador.

Detailed description: This pilot study will evaluate the use of a modified (cultural and language) adaptation of the National Diabetes Prevention Program in a cohort in Quito Ecuador. People who took the program had the option to participate in the research component. All participants selected the research component.

Adaptations- the coaches will be physicians from PUCE and they will administer this program for eligible employees who have biochemical prediabetes.

The program will be modified to be able to fit within the school curriculum. The diabetes prevention program will be offered in Spanish and the content modified to better fit the cultural norms for the Quito Ecuador population.

Participants will be adults with prediabetes as screened by the CDC Diabetes Risk Test and confirmed by HbA1c.

Outcome measures will include change in mean HbA1c, change in weight, physical activity, and attendance to the program.

Eligibility criteria: Inclusion Criteria: Adults who worked at the university and had biochemical prediabetes.

-

Exclusion Criteria: Those with known diabetes, those unwilling to complete a 6 month intervention.

-

Primary outcomes:
measure: HbA1c
timeFrame: 90-120 days
Secondary outcomes:
measure: Weight change
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Ohio University/Touro University California
name: Jay H Shubrook, DO
role: STUDY_DIRECTOR
References:
Clinical trial NCT02165436: Chewing Gum Facilitates an Earlier Return to Bowel Function in Pediatric Scoliosis Patients: A Prospective Randomized Study
Official title: The Use of Chewing Gum Reduces Post-operative Ileus and Gastrointestinal Complications in Pediatric Scoliosis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 83
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of chewing gum on reducing post-operative ileus and reducing post-operative gastrointestinal symptoms in pediatric patients undergoing surgical correction of scoliosis. This study would provide minimal risk to its study population, and has the opportunity to provide a benefit to patients undergoing scoliosis surgery. If shown to be effective, this could lead to changes and improvement of the post-operative course for pediatric scoliosis patients.


Eligibility criteria: Inclusion Criteria:

* Otherwise meets criteria for surgical correction of scoliosis
* Mental capacity to understand the purpose of the study
* Idiopathic scoliosis or neuromuscular scoliosis with mild cerebral involvement
* Posterior surgery approach only

Exclusion Criteria:

* Unable to safely chew gum due to oropharyngeal issues or airway issues
* History of GI surgery (G-tube, fundoplication, ostomy etc...)
* Anterior approach

Primary outcomes:
measure: Time to return of normal bowel function.
timeFrame: 72-96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The Children's Hospital of Alabama
state: Alabama
Study officials:
affiliation: Pediatric Orthopaedic Surgery - University of Alabama At Birmingham
name: Joseph Khoury, MD
role: PRINCIPAL_INVESTIGATOR
References: