louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01069133: Study of Rifaximin in Minimal Hepatic Encephalopathy
Official title: Effect of Rifaximin Therapy on Brain Activation in Patients With Minimal Hepatic Encephalopathy Using Functional MR, MR Spectroscopy,Diffusion Tensor Imaging Microbiome and Metabolome: a Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Minimal Hepatic Encephalopathy
Keywords: minimal hepatic encephalopathy
cirrhosis
complications
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2010-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Rifaximin therapy will improve brain functioning on MRI scanning and change the microbiome and metabolome.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* cirrhosis diagnosed by clinical or biopsy grounds
* Minimal hepatic encephalopathy defined by impaired performance on at least 2 of the following: number connection tests A/B, digit symbol and block design tests (NCT-A, NCT-B, DST and BDT) compared to age and education-matched controls.
* No contraindications to MRI
* TIPS (transjugular intra-hepatic porto-systemic shunt) procedure or elective surgery planned within the next 8 weeks

Exclusion Criteria:

* Current therapy with lactulose, rifaximin or other treatment for hepatic encephalopathy.
* Prior episodes of overt HE
* MMSE \<25
* TIPS placement
* Unable to give informed consent.
* Contra-indications to MRI

Primary outcomes:
measure: brain activation on fMRI
timeFrame: 2 months
measure: Microbiome constituents
timeFrame: 8 weeks
Secondary outcomes:
measure: brain edema and brain metabolite concentration
timeFrame: 2 months
measure: Metabolome of urine and serum
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: McGuire VA Medical Center
name: Jasmohan S Bajaj, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bajaj JS, Heuman DM, Sanyal AJ, Hylemon PB, Sterling RK, Stravitz RT, Fuchs M, Ridlon JM, Daita K, Monteith P, Noble NA, White MB, Fisher A, Sikaroodi M, Rangwala H, Gillevet PM. Modulation of the metabiome by rifaximin in patients with cirrhosis and minimal hepatic encephalopathy. PLoS One. 2013;8(4):e60042. doi: 10.1371/journal.pone.0060042. Epub 2013 Apr 2.
Clinical trial NCT04519333: Mesotherapy Versus Systemic Therapy in Treating Neck Pain Related to Herniated Disc
Official title: Intradermal Mesotherapy Versus Systemic Therapy in Treating Neck Pain to Cervical Disc Herniation: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergencies
Keywords: Mesotherapy
Neck Pain
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Introduction: Neck pain is a global public health concern, that ranked 4th highest health condition in terms of disability as measured by years lived with disability. The aim of this study is to compare the efficiency of one-session mesotherapy application with systemic therapy in treating neck pain related to cervical disk herniation.

Methods: This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with neck pain related to cervical disc herniation. A mixture of thiocolchicoside, lidocaine and tenoxicamwas administered via mesotherapy in one group, and intravenous administration of dexketoprofen was applied to the other group. We compared the changes in pain intensity at 60thminute, 120thminute and 24th hours after treatment using Visual Analogue Scale (VAS),and adverse effects of the treatment methods among the study groups.


Eligibility criteria: Inclusion Criteria:

* 18 years and older age
* Admission to Emergency Department (ED) with acute cervical pain related to cervical disk herniation.

Exclusion Criteria:

* Taking analgesic drugs before admission
* Having VAS score of lower than 4 on admission
* Having diabetes mellitus
* Body mass index\>30 kg/m2
* Pregnancy
* Lactation
* Having active bleeding or bleeding disorder
* Having active or recurrent gastrointestinal hemorrhage or ulcer, or history of these conditions
* Having a serious or life-threatening condition (stroke, intracranial hemorrhage, heart attack, cardiac tamponade, pneumothorax, hemothorax, flail chest, etc.).

Primary outcomes:
measure: Change in pain intensity
timeFrame: 0-24 hours
measure: Adverse effect
timeFrame: 0-1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT03431233: Effect of Premeal Protein-bar on Food Intake
Official title: An Exploratory Study of the Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Food Intake in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: protein-enriched bar
food intake
appetite
satiety related hormones
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to explore premeal protein-enriched bar effect in food intake in healthy subjects.

Detailed description: Twenty healthy subjects will be recruited. Every subject will be randomized in 6 groups and studied on 3 separate days in random order with 1 week intervals. These participants will consume protein enriched bar, commercial cereal bar, or water followed by a standardized diet (gimbap). For study outcomes, food intake, appetite and satiety (visual analog scale), plasma glucose, and satiety related hormone will be measured. Blood sampling will be done before 15 min of breakeast, at the moment of start of breakfast (0 min), and then 30, 60, 90, 120 min. Plasma glucose levels, total/active GLP-1, ghrelin, total PYY will be measured.

Eligibility criteria: * Inclusion Criteria:

  * BMI 18.5\~35 kg/m2
  * Never diagnosed by diabetes
  * Fasting plasma glucose \<=100mg/dl and HbA1c \<6.0%
* Exclusion Criteria:

  * Those who diagnosed by Type 1 or Type 2 diabetes
  * Allergy to wheat, flour, nuts, milk
  * Pregnancy/lactation
  * AST or ALT \>2.5 times of upper normal reference range
  * eGFR \<30 mL/min/1.73m2
  * Hb \<10g/dl
  * History of GI surgery (except hemorrhoidectomy, appendectomy)

Primary outcomes:
measure: Food intake
timeFrame: 120min
Secondary outcomes:
measure: Appetite (visual analogue scale : score 1 to 10)
timeFrame: 120min
measure: Satiety (visual analogue scale : score 1 to 10)
timeFrame: 120min
measure: plasma glucose (mmol/L)
timeFrame: -15min, 0(breakfast), 30, 60, 90, 120 min
measure: plasma active/total GLP-1 (pmol/L)
timeFrame: -15min, 0(breakfast), 30, 60, 90, 120 min
measure: plasma active ghrelin (ng/ml)
timeFrame: -15min, 0(breakfast), 30, 60, 90, 120 min
measure: plasma total peptide YY (pg/ml)
timeFrame: -15min, 0(breakfast), 30, 60, 90, 120 min
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Min Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05817487: Effects of COP Exercise and HIIT on Vascular Health in Young Overweight Females
Official title: Effects of Crossover Point Exercise and High-intensity Interval Training on Vascular Health in Young Overweight Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to determine the effects of high-intensity interval training and crossover point exercise training on vascular health in young overweight women.

Detailed description: In recent years, improving cardiovascular health through exercise has become a popular research question, however, it is not clear which intensity and modes of exercise bring more benefits. Crossover point(COP) intensity has great medical potential as a personalized exercise intensity that is based on substrate utilization mode, especially in overweight and obese people.On the other hand, several studies have demonstrated that HIIT is an effective method in improving vascular endothelial dysfunction. During our study, we evaluated the vascular health changes in young overweight women who received either COP exercise or HIIT exercise for 10 weeks.

Eligibility criteria: Inclusion Criteria:

1. Female, 18-30 years old
2. Body mass index (BMI) \< 28 kg/m2 and ≥ 24 kg/m2
3. No exercise habit, and no recent new exercise plan
4. No contraindications to exercise

Exclusion Criteria:

1. Participates had an orthopedic or other condition that limited participation in daily exercise
2. Participates had a history of myocardial infarction, stroke, diabetes mellitus, chronic respiratory disease or cancer
3. Participates had smoking or alcohol behavior

Primary outcomes:
measure: brachial-ankle pulse wave velocity (baPWV)
timeFrame: 10 weeks
measure: blood pressure
timeFrame: 10 weeks
Secondary outcomes:
measure: Interleukin 6 (IL-6)
timeFrame: 10 weeks
measure: Homocysteine (HCY)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Sport University
Study officials:
References:
Clinical trial NCT04520087: Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation
Official title: Evaluation of Clinical and Radiographic Results After Surgical Treatment With Implant-free Allograft for Anterior Shoulder Dislocation: Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Shoulder Dislocation
Bone Defects
Shoulder Instability
Keywords: Implant-Free Shoulder Instability
Bone Grafting
Shoulder Instability
Glenoid
allograft
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pilot study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical and radiographic results after surgical treatment with implant-free allograft in the treatment of Anterior Shoulder Dislocation and to assess the safety of the surgery.

Detailed description: Patients will be informed about the study and potential risks. All patients giving written informed consent will undergo a screening visit to assess the eligibility criteria.

Patients who meet the eligibility requirements will perform a pre-treatment visit in order to assess their healthy state. Also, patients will undergo to the radiographic visit (RX and TX) as request by clinical practice.

All the patients will be treated with arthrotomy mini-open technique with bone allograft at the site of the shoulder lesion.

After surgery all the patients will be followed up to 24 months through clinical and radiographic visits.

Eligibility criteria: Inclusion Criteria:

* antero.inferior shoulder instability with bone loss

Exclusion Criteria:

* Patients incapable of understanding or wanting;
* Patients suffering from: rheumatic diseases, diabetes, infectious processes, congenital ligament laxity, epilepsy, severe osteoporosis.

Primary outcomes:
measure: Change from Baseline in DASH score at 24th months
timeFrame: 24 months
Secondary outcomes:
measure: Change from baseline in DASH score
timeFrame: Baseline, 1, 3, 6, and 12 months
measure: Change from Baseline in Constant score
timeFrame: Baseline, 1, 3, 6, 12 and 24 months
measure: Change from Baseline in Rowe score
timeFrame: Baseline, 1, 3, 6, 12 and 24 months
measure: Change from Baseline in EQ-5D-3L (EuroQoL) CurrentHealthAssessment:
timeFrame: Baseline, 1, 3, 6, 12 and 24 months
measure: Evaluation of the grade of the Shoulder Osteoarthritis through Kellgren-Lawrence scoring
timeFrame: 24 months
measure: Evaluation of the Allograft integration
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Enrico Guerra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01393587: A New Exogenous Marker for Diagnosis of Oxidative Stress During Laproscopic Surgery
Official title: A New Exogenous Marker for Diagnosis of Oxidative Stress During Laproscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oxidative Stress
Laproscopy
Keywords: Oxidative Stress
Laproscopy
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
Collaborators: name: Migal, Galilee Technology Center
First posted: 2011-07-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Recently, a new synthetic marker was developed, based on a molecule that is composed of Amino Acids and Linoleic Acid and Neucleic Acid, which is capable of detecting even minor changes of oxidative stress.

The investigators would like to assess the usefulness of this marker during positive pressure pneumoperitoneum, during laproscopic surgery, with or without intenstinal resection (ischemia induced by intra-abdominal pressure and vascualr compromise).


Eligibility criteria: Inclusion Criteria:

* Healthy patients undergoing elective laproscopic cholecystectomy and patients undergoing operation for tumer of large intenstine.

Exclusion Criteria:

* Patients suffering from Cardio Pulmonory and renal diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
References:
Clinical trial NCT04512287: PRP for Treatment of Peyronie's Disease
Official title: A Randomized, Double-Blind, Placebo Controlled, Crossover Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma for Treatment of Peyronie's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Peyronie Disease
Sexual Dysfunction, Physiological
Sexual Dysfunction Male
Genital Diseases, Male
Keywords: PD
PyD
PRP
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 65
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).


Eligibility criteria: Inclusion Criteria:

1. Be Male
2. Be 18 to 75 years of age (inclusive).
3. Be able to provide written informed consent
4. Have a diagnosis of PD with evidence of active or stable disease as determined by the investigator
5. Penile curvature deformity of \>30° to \<120°
6. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
2. Previous intralesional injection therapy (such as Xiaflex) for PD.
3. Previous history of priapism or penile fracture
4. PD characterized by a ventral plaque
5. Severe erectile dysfunction as characterized with an International Index of Erectile Function (IIEF) score ≤ 16
6. Actively on anticoagulation during time frame of injections (aspirin 81 mg will be eligible for therapy)
7. Hour-glass deformity
8. Unwilling to participate
9. Medically unfit for sexual intercourse as deemed by the principal investigator
10. Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
11. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.

Primary outcomes:
measure: Percentage of subjects in each group who attain degree change in penile curvature.
timeFrame: 7 months
measure: Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
timeFrame: 7 months
Secondary outcomes:
measure: Incidence of adverse events in all patients
timeFrame: Baseline, 6 months (post-intervention)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Manuel Molina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06284187: Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis
Official title: Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Pulmonary
Keywords: pulmonary tuberculosis
real-time PCR
diagnosis test
Lead sponsor: Khon Kaen Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-28
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: out patients clinic

Brief summary: BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Mycobacterial culture is the gold standard diagnostic test. Currently, a real-time polymerase chain reaction (RT-PCR) assay, such as Allplex™ MTB/MDRe Detection, Seegene is commonly used.

OBJECTIVE: To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex™ MTB/MDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture.

Detailed description: A retrospective study design of adult patients (\&gt; 15 years) with suspected pulmonary M. tuberculosis infection was conducted from January 2023 until October 2023, at Khon Kaen Hospital. Sample size was 101 cases. Sensitivity, specificity, accuracy, negative predictive value (NPV), and positive predictive value (PPV) of Allplex™ MTB/MDRe Detection, each with its respective 95% confidence interval (95% CI) were analysed with compared to MTB culture as the gold standard.

Eligibility criteria: Inclusion Criteria:

* Clinical suspected pulmonary M. tuberculosis infection
* Aged 15 years and older

Exclusion Criteria:

* Children under 15 years old
* Non-tuberculous mycobacteria (NTM) detection

Primary outcomes:
measure: Number of participants with pulmonary TB by Allplex™ MTB/MDRe
timeFrame: From enrollment to the end of diagnosis at 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Thananit Sangkomkamhang
Study officials:
affiliation: Khon Kaen Hospital
name: Kriengsak Vacharanukulkieti, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00850187: Autologous Transplantation of Mesenchymal Stem Cells (MSCs) and Scaffold in Full-thickness Articular Cartilage
Official title: Treatment of Full-thickness Articular Cartilage Defects in the Knee of Patients With Autologous Bone-marrow Mesenchymal Stem Cells and Scaffold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Knee Osteoarthritis
Keywords: Knee cartilage diseases
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
Collaborators: name: Tehran University of Medical Sciences
First posted: 2009-02-24
Enrollment: 6
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Bone Marrow Mesenchymal stem cells (MSCs) mixed with collagen I scaffold in patient with Knee cartilage defects and osteoarthritis

Detailed description: Articular cartilage defects have a weak potential for self-repair because of the reduced mitotic capacity of chondrocytes in vivo. Because some patients with articular cartilage defects may progress to osteoarthritis, such defects need to be repaired even though their exact natural course remains obscure. Traditional methods for repair, such as micro fracture, perforations, abrasion arthroplasty, have not produced consistent satisfactory long term clinical results. Transplantation of autologous bone marrow MSCs expanded in culture would be a promising approach in the repair of articular cartilage defects in human osteoarthritic knees. This method is clinically straightforward to perform because autologous cells can be readily harvested and expanded in culture without losing their capacity to differentiate into chondrocytes. The purpose of this study was to evaluate the clinical results obtained with autologous MSCs expanded in culture for the treatment of full-thickness chondral defects in human knee.

Eligibility criteria: Inclusion Criteria:

* Age 45 to 60, inclusive
* Normal axial alignment
* Stable knee-previous ligament reconstruction, if stable
* Intact articular cartilage in posterior meniscal weight-bearing zone
* Ability to understand and willingness tosign consent from
* O.C.D or OA calgran classification II,III

Exclusion Criteria:

* Pregnant or lactating
* Inflammatory arthritis
* Oral steriod, methotrexate
* Unable to follow post-operative exercise regimen or return for evaluations

Primary outcomes:
measure: Knee cartilage defects
timeFrame: 12 months
Secondary outcomes:
measure: pain
timeFrame: 12 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: Chief
name: Hamid gourabi, PhD
role: STUDY_CHAIR
affiliation: Scientific Board
name: Mohamadreza Baghaban Eslaminejad, PhD
role: STUDY_DIRECTOR
affiliation: Researcher
name: Leila Taghiyar, Msc
role: PRINCIPAL_INVESTIGATOR
References: