louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05300867: Robotic Rehabilitation Treatment of Stroke Patients
Official title: Robotic Rehabilitation Treatment of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Stroke, Ischemic
Keywords: balance
soft exoskeleton
walk
robotic
Lead sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 2
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Storke results in severe deterioration in quality of life and exercise. Severe disorders need to be treated as soon as possible and they need to be rehabilitated quickly in order for motor functions to develop properly. In the acute / subacute phase, patients are given robotic treatment. In addition to the study of mtoros functions, the study of gait and codination is the primary result. Patients treated with soft exoskeleton receive 15 treatments and movement testing is performed continuously. Members of the control group receive standard rehabilitation therapy. After 3 weeks, both groups will participate in a control study and then in a repeat control study at week 6. Our main goal is to compare the results and determine the efficiency of the robotic device.


Eligibility criteria: Inclusion Criteria:

post stroke 6MWT : 120\> minimum after stroke 3 days

Exclusion Criteria:

Sever heart problem sever demeanor alcoholism drug problems

Primary outcomes:
measure: Qualiti of life measured by Barthel index
timeFrame: 3 weeks
measure: gait/functional test
timeFrame: 3 weeks
measure: gait/functional test
timeFrame: 3 weeks
measure: balance test
timeFrame: 3 weeks
measure: postural control test
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaposvár
country: Hungary
facility: Dr. Tollár József
state: Somogy
Study officials:
References:
Clinical trial NCT04872140: Effect of Iron-fortified Pea Powder on Exercise Performance
Official title: Effect of Low-phytate Pea Powder With High Iron Bioavailability on Iron Status of Female Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron-deficiency
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are being randomized to three groups for the 8-week intervention:

1. Pea power with high iron bio-availability
2. Regular pea powder
3. Placebo (maltodextrin)
Primary purpose: TREATMENT

Brief summary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study assesses the impact of an pea protein supplement with high iron bio-availability on iron status and exercise performance.

Detailed description: Female endurance athletes are susceptible to iron deficiency due to poor iron intake from diets or possibly because of destruction of red blood cells during foot-strike hemolysis. This study will evaluate the impact of 8-weeks of iron supplementation through consumption of a pea-protein power that has high iron bio-availability due to low phytate levels. This will be compared to consumption of regular iron protein powder and maltodextrin placebo by randomizing participants to three groups. Participants will be assessed at baseline and after 8 weeks of supplementation for exercise performance (maximal aerobic capacity and a 5 km time trial running test), blood levels of ferritin and hemoglobin, and body composition (fat mass and lean tissue mass).

Eligibility criteria: Inclusion Criteria:

* Female
* Regularly participate in aerobic endurance training

Exclusion Criteria:

* Any contra-indications to exercise testing as determined with the "Get Active Questionnaire"

Primary outcomes:
measure: Change from baseline in ferritin levels
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Change from baseline in maximal aerobic capacity
timeFrame: Up to 8 weeks
measure: Change from baseline in exercise time trial performance
timeFrame: Up to 8 weeks
measure: Change from baseline in hemoglobin levels
timeFrame: Up to 8 weeks
measure: Change from baseline in lean tissue mass
timeFrame: Up to 8 weeks
measure: Change from baseline in fat mass
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Philip Chilibeck, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05982340: Endogenous Lithium Clearance in Acute Kidney Injury
Official title: Endogenous Lithium Clearance in Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury Due to Sepsis
Proximal Tubule Function
Lithium Clearance
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients and healthy controls

Brief summary: Critically ill patients are at high risk of developing acute kidney injury (AKI). Lithium is freely filtrated at the glomerulus and almost completely reabsorbed in the proximal tubule, which provides a quantitative estimation of proximal tubule reabsorption. The investigators hypothesized that endogenous lithium reabsorption is impaired in the early stages of critical illness.

Investigators would like to study 10 ICU patients with AKI diagnosed, 10 patients without AKI, and 10 healthy controls.

Detailed description: Blood and urine samples will be obtained at 08:00, 14:00 and 20:00 during one day. Renal clearance of creatinine (CCr) and lithium will be calculated.

Eligibility criteria: Inclusion Criteria:

* ICU patients diagnosed with AKI, without AKI and healthy controls

Exclusion Criteria:

-

Primary outcomes:
measure: Renal lithium clearance
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
state: Troms
Study officials:
affiliation: University Hospital of North Norway
name: Lars MG Ytrebø, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04567940: ENRED@TE. Social Support in Southern Spain. Interventional Study
Official title: ENRED@TE. Social Support in Southern Spain. Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Isolation
Keywords: Social isolation
Social support
Loneliness
Family support
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 210
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective to be achieved is to find out if the perceived social support, the perceived loneliness, the perceived social isolation and the family support of those over 65 years of age improve after participating in the Enréd@te project carried out by the Spanish Red Cross (CRE).


Eligibility criteria: Inclusion Criteria:

* People over 65 years
* Not institutionalised

Exclusion Criteria:

* Participants of other programs
* Difficulty responding to measurement scales due to language barriers
* Legal incapacitation
* People with a residence of less than 3 months in the city

Primary outcomes:
measure: Social isolation
timeFrame: 6 months
measure: Loneliness
timeFrame: 6 months
Secondary outcomes:
measure: Detection of risk situations or social problems
timeFrame: 6 months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Maimónides Biomedical Research Institute of Córdoba
state: Cordoba
Study officials:
References:
Clinical trial NCT00127140: A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)
Official title: A Phase I Clinical Study of MK0683 in Patients With Malignant Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-05
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral vorinostat in patients with malignant lymphoma.


Eligibility criteria: Inclusion Criteria:

* Patients who relapsed after complete or partial response, or ineffective in previous chemotherapy

Exclusion Criteria:

* Patients with history of chemotherapy, antibody therapy, radiotherapy, during the previous 4 weeks (6 months for radioisotope-labeled antibody)
* Any uncontrolled concomitant illness
* Are pregnant or breast-feeding
* Serious drug or food allergy

Primary outcomes:
measure: Number of participants Experiencing Dose-Limiting Toxicities (DLTs)
timeFrame: Up to 21 days
Secondary outcomes:
measure: Area Under the Curve (AUC) of Vorinostat After Single Oral Dosing
timeFrame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose on Days 1 and 17
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Watanabe T, Kato H, Kobayashi Y, Yamasaki S, Morita-Hoshi Y, Yokoyama H, Morishima Y, Ricker JL, Otsuki T, Miyagi-Maesima A, Matsuno Y, Tobinai K. Potential efficacy of the oral histone deacetylase inhibitor vorinostat in a phase I trial in follicular and mantle cell lymphoma. Cancer Sci. 2010 Jan;101(1):196-200. doi: 10.1111/j.1349-7006.2009.01360.x. Epub 2009 Sep 10.
Clinical trial NCT06491940: Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan
Official title: Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan on Proteinuria in Diabetic Nephropathy Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Proteinuria
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Losartan, an angiotensin II receptor blocker, has already been established as a treatment for diabetic nephropathy due to its ability to reduce blood pressure and mitigate the progression of kidney damage. However, the addition of a diuretic like hydrochlorothiazide may offer synergistic benefits in reducing proteinuria by addressing both the underlying renal pathology and potential volume overload in these patients. The current study aims at determining and comparing the role of losartan alone vs hydrochlorothiazide plus losartan in reducing proteinuria in diabetic nephropathy patients.


Eligibility criteria: Inclusion Criteria:

* Patients of both genders with ≥18 years of age.
* Presence of proteinuria/albuminuria at time of screening.
* Creatinine clearance of 30 mL/min or higher.

Exclusion Criteria:

* A systolic blood pressure of 180 mm Hg or higher, a diastolic blood pressure of 110 mm Hg or higher.
* Presence of a second primary renal disease in addition to diabetic nephropathy.
* Patients with type 1 diabetes.
* A history of a cardiovascular or cerebrovascular event within 3 months before inclusion.
* Serum potassium of 6.0 mmol/L or higher.
* Transplantation or immunosuppressive treatment.
* Contraindication for the use of losartan or hydrochlorothiazide.
* Pregnancy or lactation.

Primary outcomes:
measure: Reduction of proteinuria
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bahawalpur
country: Pakistan
facility: Medical department, Bahawal Victoria Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT03193840: Posterior Wall Osteotomy for Old Acetabular Fracture
Official title: Surgical Treatment of Old Acetabular Fracture With Posterior Wall Osteotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Procedure, Unspecified
Keywords: old acetabular fracture; posterior wall osteotomy
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Posterior wall osteotomy would be conducted to manage the old acetabular fracture. The outcome was reviewed to assess the feasibility of the surgical procedure.

Detailed description: More and more patients with old acetabular fracture were admitted in our institution during the past years. There is little literature especially depicts the therapeutic principle of the kind of damage. Posterior wall osteotomy would be conducted to eliminate the fragments or callus from the hip joint. Then, the deformed healing acetabulum could become mobile and the reduction may be achieved. However, the surgical procedure is technique demanding and some intraoperative risk may be accompanied.

Surgical time, blood loss, complication and fracture healing would be reviewed to assess the feasibility of the surgical procedure. The function outcome is evaluated with HHS score at the follow up.

Eligibility criteria: Inclusion Criteria:

* acetabular fracture
* no surgical procedure has been obtained over 3 weeks
* deformed healing
* receive posterior wall osteotomy
* completed more than one year follow-up

Exclusion Criteria:

* accompanied with other fracture
* pathological fracture
* reject the posterior wall osteotomy

Primary outcomes:
measure: frecture union time
timeFrame: 4 months
Secondary outcomes:
measure: complication
timeFrame: 1 month
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Hebei Medical University Third Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Zhiyong Hou
state: Hebei
Study officials:
affiliation: Third Hospital of Hebei Medical University Department of Orthopaedic Surgery
name: Zhiyong Hou
role: STUDY_CHAIR
References:
Clinical trial NCT05289440: Esketamine Administration on Recovery Quality After Radical Mastectomy
Official title: The Effect of Esketamine on the Quality of Recovery After Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esketamine and the Quality of Recovery
Keywords: Esketamine
The quality of recovery
Lead sponsor: Anqing Municipal Hospital
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 105
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Some studies have reported that intravenous esketamine reduce postoperative pain intensity. The investigators investigated whether esketamine could improve the the quality of recovery after modified radical mastectomy.

Detailed description: A total of 111 patients were randomly allocated into 3 groups. Patients in group LE received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin. Patients in group HE received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin. Patients in group CON received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status
* Scheduled for elective modified radical mastectomy

Exclusion Criteria:

* Severe respiratory disease
* Renal or hepatic insufficiency
* History of preoperative psychiatric
* Preoperative hypertension
* Preoperative history of chronic pain

Primary outcomes:
measure: Quality of recovery scores (QoR-15)
timeFrame: 1 day after operation
Secondary outcomes:
measure: Pain visual analogue scale scores
timeFrame: The first 48 hours after operation
Other outcomes:
Locations:
city: Anqing
country: China
facility: Department of Anqing Hospital Anesthesiology
state: Anhui
Study officials:
References:
Clinical trial NCT05892640: Low-Salt Diet Effect on Th17-Mediated Inflammation and Vascular Reactivity in Psoriasis
Official title: Effects of Low Salt Dietary Intake on Th17-Mediated Inflammation and Vascular Reactivity in Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis Vulgaris
Keywords: Diet, Sodium-Restricted
Psoriasis
Laser-Doppler Flowmetry
Microcirculation
Endothelium
Lead sponsor: Josip Juraj Strossmayer University of Osijek
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Psoriasis presents an independent cardiovascular risk factor characterized by chronic low-grade systemic inflammation and oxidative stress which altogether might lead to endothelial dysfunction. It has been reported that increased oxidative stress has a pivotal role in high dietary sodium-induced endothelial dysfunction. Previous studies on sodium accumulation in psoriatic skin lesions and the sodium-induced augmentation in Th17 immune response, raise the question on the complex interplay between sodium and psoriasis, especially in the context of cardiovascular morbidity.

This study aimed to investigate the effect of a 2-week low-salt diet on endothelium-dependent and endothelium-independent cutaneous microvascular vasodilation and Th17-Mediated Inflammation in patients with psoriasis vulgaris.


Eligibility criteria: Inclusion Criteria:

* patients with diagnosed psoriasis vulgaris
* subjects do not use topical corticosteroid therapy for at least 2 weeks before inclusion in the study and 2 weeks during the study
* subjects do not use systemic or biological therapy for at least 3 months before and 2 weeks during the study.

Exclusion Criteria:

* age \< 18 years
* existence of other immune-mediated diseases (with the exception of autoimmune thyroid diseases and psoriatic arthritis - people with these comorbidities can be included)
* malignant diseases
* current infectious diseases and allergic reactions within 6 weeks before the start of the study

Primary outcomes:
measure: Microvascular endothelial function
timeFrame: 2 weeks
measure: Frequency of peripheral T helper 17 (Th17) and regulatory lymphocytes (Treg) among parent lymphocytes sub-population
timeFrame: 2 weeks
Secondary outcomes:
measure: Microvascular non-endothelial function
timeFrame: 2 weeks
measure: Relative amount of serum- and glucocorticoid-induced kinase 1 (SGK1) in peripheral blood mononuclear cells
timeFrame: 2 weeks
measure: Serum Protein Concentration of Pro- and Anti-Inflammatory Cytokines
timeFrame: 2 weeks
measure: 24-hour natriuresis
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: University Hospital Osijek
Study officials:
References:
Clinical trial NCT00272740: SAKK - a Trial to Evaluate Antitumor Efficacy of Faslodex® After Aromatase Inhibitor Failure in Advanced Breast Cancer
Official title: An Open, Multicenter Phase II Trial Evaluating the Antitumour Efficacy of Faslodex® (Fulvestrant) in Postmenopausal Women With Advanced Breast Cancer Failing Non-Steroidal or Steroidal Aromatase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: breast cancer
fulvestrant
Faslodex
hormonotherapy
aromatase inhibitor failure
Advanced breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 93
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the Clinical Benefit Rate


Eligibility criteria: Inclusion Criteria:

* Histological/cytological confirmation of breast cancer
* progression under treatment with an aromatase inhibitor
* At least one measurable or non-measurable lesion

Exclusion Criteria:

* Prior treatment for breast cancer with more than 2 different hormonal agents
* More than 1 chemotherapy for advanced disease
* Presence of life-threatening metastatic visceral disease

Primary outcomes:
measure: Clinical Benefit Rate
Secondary outcomes:
measure: Duration of clinical benefit
measure: Time to progression
measure: Duration of response
measure: Time to treatment failure
measure: Safety and tolerability
measure: 6. clinical benefit rate according to HER2/neu status
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Research Site
city: Aarau
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Genf
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Mendrisio
country: Switzerland
facility: Research Site
city: Milano
country: Switzerland
facility: Research Site
city: St.Gallen
country: Switzerland
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Switzerland Medical Director, MD
role: STUDY_DIRECTOR
References: