louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06019507: A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation
Official title: A 60 Month, Single-arm, Proof-of-concept Study to Induce Allogeneic Tolerance in Deceased Donor Liver Transplant Recipients Using Siplizumab, an Anti-CD2 Antibody in Combination With Cyclophosphamide and Splenectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Liver Transplantation
Lead sponsor: ITB-Med LLC
Sponsor class: INDUSTRY
First posted: 2023-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Able to understand the study requirements and provide written informed consent before and study assessment is performed
* Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant
* Male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of MMF

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Subjects with a history of TB or latent TB infection
* Subjects with a history of cancer

Primary outcomes:
measure: Number of Liver Transplant Recipients off of immunosuppression Therapy.
timeFrame: 30 months
Secondary outcomes:
measure: The Incidence of adverse events and serious adverse events
timeFrame: 30 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Huddinge
Study officials:
affiliation: ITB-MED
name: Kellie Kennon, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT02930707: TAP Block With Magnesium Sulfate Added to Local Anesthetic in Abdominal Hysterectomy
Official title: Efficacy and Safety of Magnesium Sulfate Added to Local Anesthetic in TAP Block for Postoperative Analgesia Following Total Abdominal Hysterectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Keywords: magnesium sulfate
postoperative pain
TAP block
total abdominal hysterectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Major abdominal surgeries are associated with severe abdominal pain, which can affect respiratory and cardiac functions, if insufficiently managed. This increases the incidence of post-operative morbidity.

The objective of this study was to detect the efficacy and safety of magnesium sulphate as an adjuvant to the analgesia offered by local anesthetic in ultrasound guided TAP block in patients undergoing total abdominal hysterectomy.


Eligibility criteria: Inclusion Criteria:

* weight: 50- 85 kg.
* ASA score: I-III
* scheduled for total abdominal hysterectomy

Exclusion Criteria:

* history of relevant drug allergy.
* coagulation disorders.
* opioid dependence.
* sepsis.
* psychiatric illnesses that would interfere with perception and assessment of pain.

Primary outcomes:
measure: total postoperative morphine consumption
timeFrame: postoperative 24 hours
Secondary outcomes:
measure: postoperative pain
timeFrame: postoperative 24 hours
measure: first request of rescue analgesia
timeFrame: postoperative 24 hours
measure: side effects
timeFrame: postoperative 24 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Abd-Elsalam KA, Fares KM, Mohamed MA, Mohamed MF, El-Rahman AMA, Tohamy MM. Efficacy of Magnesium Sulfate Added to Local Anesthetic in a Transversus Abdominis Plane Block for Analgesia Following Total Abdominal Hysterectomy: A Randomized Trial. Pain Physician. 2017 Nov;20(7):641-647.
Clinical trial NCT04843007: Alvopem® (Pemetrexed) Safety Assessment
Official title: Alvopem® (Pemetrexed) Safety Assessment in Patients With Non-small Cell Lung Cancer and Malignant Pleural Mesothelioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Malignant Pleural Mesothelioma
Keywords: NSCLC; Observational study; pemetrexed; PMS; Safety
Lead sponsor: NanoAlvand
Sponsor class: INDUSTRY
First posted: 2021-04-13
Enrollment: 199
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer and malignant pleural mesothelioma were included in the study.

Brief summary: The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma. No control groups were included in the study design.

The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).

Detailed description: The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma.

Data was gathered in one booklet, which had 6 different periods. The patients' information assessed after each injection, every 3 weeks. These booklets were completed by designated physicians.

The primary objective of this study was safety assessment, including the incidence and intensity of AEs and serious adverse events (SAEs).

This study was single arm and the sample size of this study was 199 patients.

Eligibility criteria: Inclusion Criteria: Patients diagnosed with non-small cell lung cancer and malignant pleural mesothelioma under chemotherapy regimens with Alvopem® were enrolled in the study.

Exclusion Criteria: There were no exclusion criteria for this study.

Primary outcomes:
measure: Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE))
timeFrame: This outcome was assessed throughout the study, up to 18 weeks (6 chemotherapy cycles). The duration of treatment was at the physicians' discretion based on the patient's condition
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Research Institute of Tuberculosis and Lung Disease (NRITLD)
name: Adnan Khosravi, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06230107: The Effects of Nutritional Intervention in Participants With Eating Disorders.
Official title: Nutritional Therapeutic Intervention in Eating Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Binge-Eating Disorder
Binge Eating Disorder Associated With Obesity
Eating Behavior
Eating Disorder
Keywords: eating disorders
binge eating disorder
eating behavior
eating disorder
Lead sponsor: Sao Jose do Rio Preto Medical School
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2024-01-30
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: quantitative, prospective, longitudinal and experimental
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effects of nutritional intervention in eating disorders. Participants underwent an intervention without a control group over 8 weeks. This study aims to provide the maximization of nutritional rehabilitation and support changes in the construction of food autonomy, through a food and nutritional intervention.

Detailed description: Analyze the impact of nutritional intervention on changes in dietary habits, episodes of binge eating, body image dissatisfaction, quality of life and anthropometric data (weight, BMI and waist circumference) of participants with BED. This quantitative, prospective, longitudinal and experimental study recruited 82 participants diagnosed with Obesity and BED. The intervention was divided into 8 individual weekly meetings, guided by Mindful eating session, nutritional educational dynamics, cooking workshop, food sensory analysis and applications of questionnaires (Body Image Scale - BSQ; Binge Eating Scale - BES; Quality of Life Scale - WHOQOL BREF). The meetings occurred from October to November 2023.

Eligibility criteria: Inclusion Criteria:

* individuals diagnosed with BED who are available to participate

Exclusion Criteria:

* individuals without a diagnosis of BED who are available to participate; who cannot attend meetings; with clinical changes; who have difficulty answering the questionnaires

Primary outcomes:
measure: Episodes of Binge Eating {Binge Eating Scale (BES} (0 to 48 points)}.
timeFrame: 8 weeks
measure: Body Image Dissatisfaction {Body Shape Questionnaire (BSQ) (34 to 204 points)}.
timeFrame: 8 weeks
measure: Quality of Life {Quality of LifeScale WHOQOL BREF) (0 to 100%)}.
timeFrame: 8 weeks
measure: Weight (kg).
timeFrame: 8 weeks
measure: Body Mass Index (kg/m²).
timeFrame: 8 weeks
measure: Waist circumference (cm).
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São José do Rio Preto
country: Brazil
facility: Tatiana Palotta Minari
state: São Paulo
Study officials:
affiliation: State Faculty of Medicine in São José do Rio Preto
name: Tatiana Palotta Minari, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04723407: Assessment of the Psychological Impact of the COVID19 (SARS-CoV-2) Pandemic on Patients With Chronic Inflammatory Rheumatism
Official title: Assessment of the Psychological Impact of the COVID19 (SARS-CoV-2) Pandemic on Patients With Chronic Inflammatory Rheumatism According to a Management Strategy in the Rheumatology Department of Limoges University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatism
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with chronic inflammatory rheumatism followed in the rheumatology department of the CHU de Limoges

Brief summary: Patients with chronic inflammatory rheumatism (RIC) or autoimmune diseases, rheumatoid arthritis and spondyloarthritis, are regularly monitored in consultation as part of a "treat to target" strategy with rapid adaptation of treatments to the activity of their disease. according to French recommendations.

They are treated with immunosuppressive drugs: disease-modifying treatments with very often methotrexate, associated with biotherapies or targeted therapies (JAK inhibitors) They can also be treated transiently or over the long term with corticosteroids. These treatments expose them to greater infectious risks, especially with regard to COVID19.

The objective is on the one hand to assess the impact of the Covid 19 pandemic on general state of health of these patients and the evolution of their disease and on the other hand to prioritize the optimal care of these patients by including in the context of maintaining the pandemic reduction rules, modern telemedicine technologies.


Eligibility criteria: Inclusion Criteria:

All patients with chronic inflammatory rheumatism followed in the rheumatology department of the CHU de Limoges.

Exclusion Criteria:

Patients who object to the use of their data.

Primary outcomes:
measure: post-traumatic stress
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Département de Rhumatologie
Study officials:
References:
Clinical trial NCT01700907: Optimization of Desflurane in Elderly Patients
Official title: Optimization of Desflurane in Elderly Patients Compared With Sevoflurane: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Postoperative Cognitive Dysfunction
Keywords: Postoperative cognitive dysfunction
elderly patients
long surgery
Lead sponsor: Sapporo Medical University
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Various issues had been pointed out when undergoing the anesthesia for elderly patients with sevoflurane, such as delayed emergence, post-operative trouble with swallowing.

Desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the better emergence, along with the recent progress on optimization of delivered amount of anesthesia.

The purpose of this study is to compare the time to emergence in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).

Detailed description: The objectives of this study is to compare the time to emergence and quality of recovery in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "Aisys®" (GE Healthcare Japan).

Inclusion Criteria:

- Elderly patients (\>= 65 yr-old), long operation (\> 4hours), abdominal surgery patients

Exclusion Criteria:

- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI\>35)

Eligibility criteria: Inclusion Criteria:

- Elderly patients (\>= 65 yr-old), long operation (\> 4hours), abdominal surgery patients

Exclusion Criteria:

- Liver dysfunction, Renal dysfunction, preoperative dementia Neurosurgery patients, Cardiac surgery patients, obese patients(BMI\>35)

Primary outcomes:
measure: The Time From the End of Anesthesia to Extubation
timeFrame: Within 60 minutes after the end of anesthesia
Secondary outcomes:
measure: The Time From the End of Anesthesia to Eye Opening
timeFrame: Within 60 minutes after the end of anesthesia
measure: The Time From the End of Anesthesia to Following Commands
timeFrame: Within 60 minutes after the end of anesthesia
measure: Cognitive Function
timeFrame: 24 hrs pre and postoperatively
measure: The Incidence of Postoperative Delirium
timeFrame: from 15 minutes to 48 hrs postoperatively
Other outcomes:
Locations:
city: Sappro
country: Japan
facility: Sapporo Medical University, School of Medicine
state: Hokkaido
Study officials:
affiliation: Sapporo Medical University, School of Medicine
name: Michiaki Yamakage, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00855907: Fatty Liver in Inflammatory Bowel Disease (IBD) Patients
Official title: Prevalence of Fatty Liver in Inflammatory Bowel Disease (IBD) Patients and Mechanisms Related to Inflammation and Fatty Liver
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Inflammatory Bowel Disease
Fatty Liver
Keywords: IBD
inflammatory bowel disease
fatty liver
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be recruited.

Brief summary: Fatty liver is known to be one of the most frequent liver pathologies in IBD patients (35-40%). Despite this fact, there are only few publications that evaluated the prevalence of fatty liver in IBD patients. Moreover, the pathogenesis of this phenomenon in IBD has not been widely investigated.

The paradox of lean patients and fatty liver can be explained by high use of steroids, by rapid weight loss, and by the abundance of TNFα cytokine in IBD patients that causes insulin resistance.

The aim of the study:

To evaluate the frequency of fatty liver in a cohort of IBD patients and to learn its risk factors.

Methods:

One hundred consecutive IBD patients treated at the Tel Aviv Sourasky Medical Center will be recruited.

Patients will fill up a questionnaire regarding their disease, demographic data, other co-morbidities and medications and risk factors for metabolic syndrome.

Each patient will undergo blood examinations in order to assess inflammation, and metabolic status. Fatty liver will be assessed by liver ultra-sonography.


Eligibility criteria: Inclusion Criteria:

* IBD patients above the age of 18 years old, suffering from the disease for at least one year.

Exclusion Criteria:

* Pregnant women,
* Patients suffering from ulcerative colitis after total colectomy,
* HIV patients,
* Patients suffering from other chronic liver disease,
* Patients suffering from cancer currently or in the past, OR
* Patients suffering from any other chronic severe diseases.

Primary outcomes:
measure: inflammation and metabolic status
timeFrame: first visit
measure: Assessment of Fatty liver
timeFrame: first visit
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical center
Study officials:
References:
Clinical trial NCT01555307: Effectiveness of Exercise Programs Following Total Hip and Knee Joint Arthroplasty
Official title: Effectiveness of Exercise Programs Following Total Hip and Knee Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip and Knee Joint Osteoarthritis
Hip and Knee Joint Arthroplasty
Keywords: total hip arthroplasty
total knee arthroplasty
balance exercises
force plate
berg balance scale
timed up and go test
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 82
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate the effectiveness of balance exercises added to typical joint range of motion and muscle strengthening exercises on balance in patients following total hip or knee joint arthroplasty

Detailed description: Rehabilitation program following total hip and knee joint arthroplasty typically focus on joint range of motion and muscle strengthening exercises. Although the balance ability of these patients tends to be reduced, leading to limitations in mobility and activities of daily living, clinicians often assume that strength and joint range of motion exercises will ultimately lead to improvement in balance, making the typical exercise programs appropriate. However, the feasibility and effectiveness of introducing balance specific exercises during the post-operative period is unclear.

Eligibility criteria: Inclusion Criteria:

* Patients with primary unilateral total hip or knee joint arthroplasty.
* Patients who had been advised to weight bear as tolerated following surgery.

Exclusion Criteria:

* Patients who had been advised by their surgeon to remain non-weight bearing or partial weight bearing on the operated leg or unoperated leg.
* Patients with neurological conditions such as hemiplegia, peripheral neuropathy, Parkinsons disease, multiple sclerosis, or spinal cord compression that might affect balance.

Primary outcomes:
measure: Berg balance scale
timeFrame: Day 0 and Week 5
Secondary outcomes:
measure: Timed Up and go test
timeFrame: Day 0 and Week 5
measure: Western Ontario McMaster Universities Osteoarthritis Index
timeFrame: Day 0 and Week 5
measure: Activity-specific Balance Confidence Scale
timeFrame: Day 0 and Week 5
measure: Force platform
timeFrame: Week 5
Other outcomes:
Locations:
city: London
country: Canada
facility: School of Physical Therapy, University of Western Ontario
state: Ontario
Study officials:
affiliation: Western University, Canada
name: John Kramer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02220907: Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes
Official title: Long-term Administration Study of MT-2412 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: MT-2412
MP-513
TA-7284
Teneligliptin
Canagliflozin
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2014-08-20
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of co-administration of Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and have inadequate glycemic control.


Eligibility criteria: Inclusion Criteria:

* Men or women age ≥20 years old
* HbA1c of ≥7.0% and \<10.5%
* FPG of ≤ 270 mg/dL
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before treatment period

Exclusion Criteria:

* Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
* Patients with serious diabetic complications
* Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with severe hepatic disorder or severe renal disorder.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 52 Weeks
Secondary outcomes:
measure: Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)
timeFrame: Baseline, 52 Weeks
measure: Change From Baseline in Fasting Plasma Glucose Level
timeFrame: Baseline, 52 Weeks
measure: Percentage Change in Body Weight From Baseline
timeFrame: Baseline, 52 Weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Research site
city: Chugoku
country: Japan
facility: Research site
city: Hokkaido
country: Japan
facility: Research site
city: Kanto
country: Japan
facility: Research site
city: Kyushu
country: Japan
facility: Research site
city: Tohoku
country: Japan
facility: Research site
Study officials:
affiliation: Tokyo University
name: Takashi Kadowaki, MD
role: STUDY_DIRECTOR
affiliation: Kyoto University
name: Nobuya Inagaki, MD
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Kadowaki T, Inagaki N, Kondo K, Nishimura K, Kaneko G, Maruyama N, Nakanishi N, Watanabe Y, Gouda M, Iijima H. Long-term safety and efficacy of canagliflozin as add-on therapy to teneligliptin in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):77-84. doi: 10.1111/dom.13038. Epub 2017 Jul 31.