louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03266575: Pulmonary Rehabilitation in End-Stage Liver Disease
Official title: Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End Stage Liver Disease?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Liver Disease
Keywords: Frailty
Sarcopenia
Pulmonary Rehabilitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized to pulmonary rehab vs home based exercise rpogram
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program

Detailed description: Participants will be randomized into two groups. The Pulmonary Rehabilitation group will undergo exercise under a supervised setting for a total duration of 12 weeks. Patients will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session. Exercises will be supervised by physiotherapists or exercise physiologists. Compliance and performance will be monitored by the trainer. They will receive a pedometer for home use. The Home based program group will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Patients will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands.

Eligibility criteria: Inclusion Criteria:

* wait listed for liver transplantation with poor 6 MWT

Exclusion Criteria:

* age \< 18 years
* recent hospitalization (within 14 days) due to decompensation, variceal bleeding in the previous 1 month
* large esophageal varices without primary prophylaxis
* active excessive alcohol intake (in the previous 3 months)
* current overt uncontrolled hepatic encephalopathy
* hepatopulmonary syndrome with uncontrolled hypoxia
* portopulmonary hypertension
* inability to perform exercise
* marked symptomatic comorbidities (cardiac, pulmonary, renal).

Primary outcomes:
measure: Change in 6 minute walk test
timeFrame: baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kymberly D Watt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01807975: Forced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis Obliterans Syndrome
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry).


Eligibility criteria: Inclusion Criteria:

* Patients of more than 18 year-old.
* Patients with cardiopulmonary transplant or bilateral lung transplant.
* Clinically stable patients

Exclusion Criteria:

* Patients already diagnosed with bronchiolitis obliterans.
* Respiratory infection.
* Acute graft rejection.
* Mechanical complications (bronchial dehiscence, pneumothorax, pleural effusion).
* Iatrogenic pneumopathy.
* Inability to perform Respiratory function test.

Primary outcomes:
measure: Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode).
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital FOCH
state: Ile de France
Study officials:
References:
Clinical trial NCT00219375: Study of Sivelestat Sodium Hydrate in Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS) in Japan
Official title: Efficacy and Safety of Sivelestat Sodium Hydrate in Acute Lung Injury Associated With Systemic Inflammatory Response Syndrome, Compared With the Conventional Treatment in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Lung Injury
Systemic Inflammatory Response Syndrome
Keywords: sivelestat sodium hydrate
acute lung injury
systemic inflammatory response syndrome
Elaspol
Acute Lung Injury (ALI) Associated With Systemic Inflammatory Response Syndrome (SIRS)
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 649
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the efficacy and safety of sivelestat in patients with acute lung injury associated with systemic inflammatory response syndrome. The results will be compared to the study with conventional treatment without sivelestat.


Eligibility criteria: Inclusion Criteria:

1. Patients with systemic inflammatory response syndrome (SIRS)
2. Patients with acute lung injury (ALI) assessed using the criteria specified by the American-European Consensus Conference
3. Within 72 hours of onset of lung injury
4. Other inclusion criteria as specified in the protocol

Exclusion Criteria:

1. Already administrated Sivelestat before enrollment in the study
2. Neuromuscular disease that impairs spontaneous ventilation
3. Severe central nervous system disease
4. Bone marrow transplant
5. Lung transplant
6. Severe chronic liver disease
7. Neutropenia (neutrophil count: below 1000/mm3)
8. Other exclusion criteria as specified in the protocol

Primary outcomes:
measure: Ventilator free days (VFD)
timeFrame: 28 days
Secondary outcomes:
measure: 28-day period survival rate, weaning rate from mechanical ventilation, intensive care unit (ICU) discharge rate, lung injury scores
timeFrame: 28 days
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu Region Facility
city: Chugoku
country: Japan
facility: Chugoku Region Facility
city: Hokkaido
country: Japan
facility: Hokkaido Region Facility
city: Hokuriku
country: Japan
facility: Hokuriku Regional Facility
city: Kanto
country: Japan
facility: Kanto Regional Facility
city: Kinki
country: Japan
facility: Kinki Region Facility
city: Kyushu
country: Japan
facility: Kyushu Region Facility
city: Shikoku
country: Japan
facility: Shikoku Region Facility
city: Tohoku
country: Japan
facility: Tohoku Region Facility
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader, Development Planning
role: STUDY_DIRECTOR
References:
Clinical trial NCT05694559: Connecting Black Families in Houston, Texas to Hereditary Cancer Genetic Counseling, Genetic Testing, and Cascade Testing by Using a Simple Genetic Risk Screening Tool and Telegenetics
Official title: Connecting Black Families in Houston, Texas to Hereditary Cancer Genetic Counseling, Genetic Testing, and Cascade Testing by Using a Simple Genetic Risk Screening Tool and Telegenetics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To identify Black individuals who are eligible for genetic testing through trusted community organizations, and to connect Black individuals and their families to genetic testing and counseling so that they can know their cancer risk and how to decrease it.

Detailed description: Primary Objectives:

* To identify 300 Black families, at least one individual per family, eligible for genetic testing using our validated simple genetic risk screening tool (GRST) 1, via collaboration with trusted community organizations. For individuals eligible for genetic testing, we will counsel them about genetic testing, including reviewing GRST results, explaining why they are eligible for genetic testing as part of standard-of-care, explaining what this entails, offering on-site or remote genetic testing, and explaining that they will be connected to a genetic counselor if they have a pathogenic mutation (PV) of a variant of unknown significance (VUS), including resources for family cascade genetic testing.
* To provide genetic testing to 150 Black individuals and families and provide genetic counseling and risk reduction resources to individuals with a PV or VUS, including cascade genetic testing for their family members.

Eligibility criteria: Inclusion Criteria:

* Any participant over 18 years old who self-identifies as Black or African-American and signs an informed consent form, also referred to as the 'Permission to Contact' form, to be part of our study.

Exclusion Criteria:

None

Primary outcomes:
measure: genetic risk screening tool (GRST) questionnaire
timeFrame: through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: MD Anderson Cancer Cneter
name: Banu Arun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05296759: Botulinum Toxin Type A in Diabetic Peripheral Neuropathy
Official title: A Comparative Study Of Botulinum Toxin Type A Versus Conventional Oral Therapy As A Second Line Treatment Of Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Neuropathies
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Diabetes mellitus is commonly complicated by diabetic peripheral neuropathy. Due to common side effects and poor tolerance to medication, poor adherence to medication is common in diabetic peripheral neuropathy. Botulinum toxin A intradermal injection has proved efficacy in cases of diabetic peripheral neuropathy however there is a need to compare its effect with other lines of treatment. The aim of the study was to compare botulinum toxin type a verses conventional oral treatment as a second line treatment of painful diabetic peripheral neuropathy. This study was conducted as a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. Patients were divided randomly into 3 groups. First group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with botulinum toxin A.

Detailed description: This study is a comparative study on 30 patients with type 2 diabetes mellitus proved by nerve conduction study on carbamazepine. Patients were divided randomly into 3 groups.

First group was add on duloxetine, second was add on gabapentin and the third group was injected intradermal with Botulinum toxin A. Base line Assessment before treatment and follow up assessment as performed The treatment options were explained to the patients and the choice of Botulinum toxin A Intradermal injection was the patient own decision based on inability to be tolerate or adhere to oral treatment.

Eligibility criteria: Inclusion Criteria:

* diabetic patients type 2 were included on single line of treatment with carbamazepine

Exclusion Criteria:

* any sever medical condition that might interfere with the results.

Primary outcomes:
measure: visual analogue score
timeFrame: 1 week ,4 weeks,12 weeks
measure: Pittsburgh sleep quality index
timeFrame: 1 week ,4 weeks,12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: faculty of medicine Alexandria university
Study officials:
References:
Clinical trial NCT07025759: Effects of Peripheral Magnetic Stimulation on Cortical Excitability in Healthy Individuals
Official title: Effects of Peripheral Magnetic Stimulation on Cortical Excitability in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Individuals
Keywords: Peripheral Magnetic Stimulation
Cortical Excitabilty
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the immediate effects of different parameters (frequency, intensity, and pulse number) of peripheral magnetic stimulation (rPMS) on cortical excitability in healthy individuals. Using a randomized, double-blind crossover design, the research aims to identify optimal stimulation protocols for modulating neural activity. Outcomes include measurements of motor-evoked potentials (MEPs), intracortical inhibition (ICI), and facilitation (ICF). Findings may enhance non-invasive therapeutic strategies for neurological disorders.

Detailed description: This clinical trial is a crossover trial comparing 9 single-session rPMS protocols over the extensor carpi radialis muscle, testing three frequencies (1Hz, 10Hz, 25Hz), intensities (90%, 100%, 110% of resting motor threshold) across sequential phases.

Participants: Healthy adults (18-40 years) undergo pre-/post-intervention assessments: cortical (MEPs, ICI/ICF) excitability.

Design: Crossover, double-blind.

Analysis: ANOVA or Friedman tests (SPSS v20.0; α=0.05).

Significance: Clarifies parameter-specific neuromodulatory effects, guiding future rehabilitation protocols for neurological conditions.

Ethics: Approved by Federal University of Pernambuco's ethics committee (Resolution 466/12). Data stored securely for 5 years.

Eligibility criteria: Inclusion criteria: Healthy adults aged 18-40 years, both sexes, right-handed (confirmed via Edinburgh Handedness Inventory), and for females, consistent use of contraceptive medication to mitigate hormonal influences on nervous system excitability.

Exclusion criteria: Pregnancy; history of seizures or epilepsy; metallic implants in the head, spine, face, or heart; diagnosed neurological or musculoskeletal conditions interfering with assessments or interventions; or use of substances altering nervous system excitability.

Primary outcomes:
measure: Cortical excitabilty
timeFrame: Baseline (T0), immediately post-stimulation (T1), 15 minutes (T2), and 30 minutes (T3) post-stimulation.
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
References:
Clinical trial NCT03956459: Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer
Official title: Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: FDG-PET
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prospective, monocentric study aiming to evaluate the PET-CT (Positron Emission Tomography - Computed Tomography) scanner performances to detect infra-centimetric lesions in two groups of patients with cancer and of different BMI (Body Mass Index) classes (BMI ≤ 25 and BMI \> 25).

For each patient, two consecutive PET-CT scanner will be performed using the "Discovery MI" and "Discovery IQ" PET-CT scanner systems.

Virtual lesions will then be created on images obtained. Images will be interpreted by two independent observers.

The study participation of each patient will be a maximum of 24 hours.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old.
2. A patient with a cancer for which a FDG-PET (fluorodeoxyglucose-positron emission tomography) must be performed according to the standard practices
3. OMS ≤ 1, Karnofsky Index \> 70.
4. Negative pregnancy test at inclusion.
5. Patient able to maintain a lying position in a strict supine position twice.
6. Patient affiliated to a Social Health Insurance in France.
7. Patient who has signed informed consent prior inclusion in the study and before any specific procedures for the study.

Exclusion Criteria:

1. Patient with unbalanced diabetic
2. Patient with a formal contraindication usual for certain imaging procedures (severe claustrophobia, wearing a heart valve, pacemaker, etc.)
3. Pregnant or breastfeeding woman
4. Any psychological, family, geographical or sociological condition that does not allow medical follow-up and/or procedures provided for in the study protocol to be respected
5. Patient protected by law

Primary outcomes:
measure: Relative rate of virtual lesions detected by each system ("Discovery MI" and "Discovery IQ")
timeFrame: 24 hours for each patient
Secondary outcomes:
measure: Rate of Inter-observer concordance in radiological images interpretation
timeFrame: 24 hours for each patient
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
Study officials:
References:
Clinical trial NCT01716559: An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy
Official title: Multicenter, Observational Study to Evaluate NeoRecormon Treatment in Anemic Patients Suffering From Non-myeloid Malignancy Receiving Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Anemic patients with non-myeloid malignancy

Brief summary: This observational, prospective, multicenter study will evaluate the treatment response rate and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy. In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be collected for 16 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Presence of solid-tumor or non-myeloid malignancy
* Patients receiving chemotherapy
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Patients require NeoRecormon

Exclusion Criteria:

* Hypersensitivity to the drug
* Uncontrolled hypertension
* Female patients if pregnant and/or lactating

Primary outcomes:
measure: Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Mean Change From Baseline in Hemoglobin Level up to Week 16
timeFrame: Baseline, Week 4, Week 8, Week 12, and Week 16
measure: Percentage of Red Blood Cell Transfusion-free Participants
timeFrame: Up to Week 16
measure: Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy
timeFrame: Up to Week 16
measure: Number of Participants With Adverse Events and Serious Adverse Events
timeFrame: Up to Week 16
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Kaposvár
country: Hungary
city: Szolnok
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02050659: Omentectomy in Radical Gastrectomy for Gastric Cancer Trial
Official title: Omentectomy in Radical Gastrectomy for Gastric Cancer Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Omentum
Stomach Neoplasms
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with a castric carcinoma who received an in potentially curative gastric resection

Brief summary: In patients with gastric cancer, traditionally a complete omentectomy is performed as part of a radical gastrectomy with a modified D2 lymph node dissection. The omentectomy increases operation time significantly, especially in laparoscopic procedures. Patients remain more vulnerable for peritoneal infections and intestinal adhesions following omentectomy. Furthermore one can debate whether a complete omentectomy is indicated from an oncologic viewpoint. In the present study we prospectively evaluated the presence of tumor load in the greater omentum of patients with potentially curative gastric cancer.


Eligibility criteria: Inclusion Criteria:

* an in potentially curative gastric cancer
* age \> 18 year

Exclusion Criteria:

* palliative resection
* age \< 18 year

Primary outcomes:
measure: tumorload in the greater omentum
timeFrame: at the time of pathologic investigation
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
Study officials:
References:
citation: Jongerius EJ, Boerma D, Seldenrijk KA, Meijer SL, Scheepers JJ, Smedts F, Lagarde SM, Balague Ponz O, van Berge Henegouwen MI, van Sandick JW, Gisbertz SS. Role of omentectomy as part of radical surgery for gastric cancer. Br J Surg. 2016 Oct;103(11):1497-503. doi: 10.1002/bjs.10149. Epub 2016 Aug 23.