louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06393218: The Impact of Diaphragm Training on Dysphagia in Bulbar Palsy After Ischemic Stroke
Official title: The Impact of Diaphragm Training on Dysphagia in Bulbar Palsy After Ischemic Stroke: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bulbar Palsy
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding. The observation group will be given Diaphragm Training Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Detailed description: Dysphagia in patients after stroke continues to be a challenge. This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding. The observation group will be given Diaphragm Training Nutritional status, dysphagia, quality of life and depression before and after treatment were compared.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of Bulbar Palsy After Ischemic Stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* clear mind.

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

Primary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: Day 1 and day 15
Secondary outcomes:
measure: Functional Oral Intake Scale
timeFrame: Day 1 and day 15
measure: Dysphagia Handicap Index
timeFrame: Day 1 and day 15
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02563418: Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study
Official title: Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Huntington Disease
Keywords: video oculography
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-09-30
Enrollment: 60
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: The purpose of this study is to know the limits of feasibility of a reliable oculomotor record for patient with Huntington's disease.


Eligibility criteria: Inclusion Criteria:

* Corrected visual acuity \>1/10
* Aged over 18 years
* Patient with the mutation that is to say the presence of an abnormal number of trinuclide: CAG\> 38 in the first exon of the huntingtin gene.
* Total Functional Capacity Scale (CFT) ≥ 3

Exclusion Criteria:

* Patients or trustworthy person who have not given their written consent, informed and signed.
* Patients are not affiliated or who are not entitled to Social Security
* Private patients of liberty by administrative or judicial decision, or patients supervision
* Associated disease with neurological repercussions

Primary outcomes:
measure: saccadic measures with the eye tracker
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT06170918: Dose of Remimazolam in Children for Intubation
Official title: Half Effective Dose of Remimazolam to Prevent Cardiovascular Response to Tracheal Intubation When Combined With Fentanyl
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia
Keywords: anesthesia induction
remimazolam
tracheal intubation
median effective dose
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The initial dose is 0.4mg/kg and the dose interval is 0.2mg/kg
Primary purpose: TREATMENT

Brief summary: Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl in pediatric patients is still unknown.


Eligibility criteria: Inclusion Criteria:

* age from 3 to 12 years old
* patients scheduled for surgery under general anesthesia
* Body mass index in the range of 5% -95% of the same age group
* Consent was obtained from the patient and the family members, and an informed consent form was signed

Exclusion Criteria:

* American Society of Anesthesiologists status ≥3
* patients who cannot cooperate with intravenous anesthesia induction
* patients with risk of difficult airway
* patients who are allergic to benzodiazepines
* patients with neurological dysfunction
* Participate involved in other clinical investigators within 3 months

Primary outcomes:
measure: half effective dose for intubation
timeFrame: from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes
measure: cardiovascular response to tracheal intubation
timeFrame: from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes
Secondary outcomes:
measure: the time to loss of consciousness
timeFrame: from injection of remimazolam to loss of consciousness, at an average of 3 minutes
measure: incidence of adverse events
timeFrame: from injection of remimazolam to loss of consciousness, at an average of 3 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Fang YB, Wang CY, Gao YQ, Cai YH, Chen J, Zhang XL, Dong LQ, Shang-Guan WN, Liu HC. The safety and efficacy of remimazolam tosylate for induction and maintenance of general anesthesia in pediatric patients undergoing elective surgery: Study protocol for a multicenter, randomized, single-blind, positive-controlled clinical trial. Front Pharmacol. 2023 Feb 10;14:1090608. doi: 10.3389/fphar.2023.1090608. eCollection 2023.
citation: Kimoto Y, Hirano T, Kuratani N, Cavanaugh D, Mason KP. Remimazolam as an Adjunct to General Anesthesia in Children: Adverse Events and Outcomes in a Large Cohort of 418 Cases. J Clin Med. 2023 Jun 8;12(12):3930. doi: 10.3390/jcm12123930.
Clinical trial NCT01600118: Effect of Shock Waves on Dental Parameters
Official title: Effect of Low-energy Extracorporeal Shock Waves on Periodontal and Endodontic Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tooth Stability
Blood Flow
Keywords: tooth mobility
periodontal status
irregularity index
pulpal blood flow
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial investigates the effect of the extracorporeal shockwave therapy (ESWT) on periodontal and endodontical parameters. The ESWT is a scientifically approved non invasive method to influence bone turnover and tissue regeneration. The hypotheses of this trial are that ESWT increases the periodontal stability of orthodontically aligned teeth as well as increase the blood flow. Increasing the periodontal stability would reduce the retention phase, relapse risk and accelerate the rehabilitation of the surrounding tissues.


Eligibility criteria: Inclusion Criteria:

* healthy patients which don´t fulfill the exclusion criteria

Exclusion Criteria:

* diseases (syndroms, infections,...) which influence the bone turnover and blood flow
* medication, which influences the bone turnover and blood flow
* pregnancy

Primary outcomes:
measure: periodontal stability of orthodontically aligned teeth
timeFrame: 6 months
Secondary outcomes:
measure: pulpal blood flow
timeFrame: 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Bernhard Gottlieb University clinic of Dentistry
Study officials:
References:
citation: Sathishkumar S, Meka A, Dawson D, House N, Schaden W, Novak MJ, Ebersole JL, Kesavalu L. Extracorporeal shock wave therapy induces alveolar bone regeneration. J Dent Res. 2008 Jul;87(7):687-91. doi: 10.1177/154405910808700703.
citation: Martini L, Giavaresi G, Fini M, Torricelli P, de Pretto M, Schaden W, Giardino R. Effect of extracorporeal shock wave therapy on osteoblastlike cells. Clin Orthop Relat Res. 2003 Aug;(413):269-80. doi: 10.1097/01.blo.0000073344.50837.cd.
Clinical trial NCT02940418: Use of Stem Cells in Diabetes Mellitus Type 1
Official title: The Use of Mesenchymal Stromal Cells (MSC) in Type 1 Diabetes Mellitus in Adult Humans: Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitus Type 1
Keywords: Diabetes Mellitus
Type 1
Adipose derived mesenchymal stem cells
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus

Detailed description: Adipose derived mesenchymal stem cells (ASCs) are to be collected from blood group O donor, cells will be passaged to passage 5.

Before release the sample will be subject to our release criteria which include: testing for any bacterial or fungal growth as well as endotoxin and mycoplasma. All these tests must be negative. In addition the cell count and viability (must be more than 80%) are done before release. Surface markers documentation is done on the cells before release using flow cytometry.

The cells should be infused within 2 hours of release. The dose to is to be repeated after 6 months of a total of two doses in patients. Tests and follow up are to be one at week 12, 24 and 36 when the study is stopped.

These cells will be injected intravenously into patients newly diagnosed with type 1 Diabetes Mellitus.

Eligibility criteria: Inclusion Criteria:

1. Adult Patients with Type 1 Diabetes Mellitus.
2. Age from 18 years to 35 years either gender.
3. Duration of disease: not exceeding 3 years unless C-peptide is not less than 0.5 ng/ml
4. C-Peptide at inclusion base line should not be less than 0.5 ng/ml
5. No clinical evidence of renal, retinal, vascular or skin complications
6. Body Mass Index not exceeding 30
7. Any HbA1c
8. At least one positive antibody either anti-Glutamic Acid Decarboxylase-65 or Insulinoma-Associated-2 Autoantibodies (anti-1A2)
9. Informed Consent by patient

Exclusion Criteria:

1. Age less than 18 years and more than 35 years
2. Pregnancy
3. Married women or women expected to be married within the study period
4. History of allergy, Cancer, bronchial asthma, liver disease or hepatitis
5. Diabetic coma or pre-coma current or recent within the last 2 months
6. C-Peptide less than 0.5 ng/ml
7. Disease duration more than 3 yrs.
8. Complication mentioned in 5 above in inclusion
9. Non-consenting patient or withdrawal of consent.
10. Bleeding disorders

Primary outcomes:
measure: Safety of using allogenic ASC assessed by any adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center
Study officials:
affiliation: Cell Therapy Center
name: Abdallah Awidi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06534918: Precise Oncology Interventions in Nutrition and Training (OnPoint)
Official title: Precise Oncology Interventions in Nutrition and Training (OnPoint)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Colorectal Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Applebaum Foundation
First posted: 2024-08-02
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted nutrition and exercise program will be able to eat a healthier diet and be more physically activity.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria - Healthcare Providers

1. Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center
2. Utilize the electronic medical record for patient documentation on a regular basis
3. Willing to complete a 60-90-minute interview

Inclusion Criteria - Patients

1. 18 years of age or older
2. Any sex/gender
3. Able to provide consent
4. Able to read/understand English or Spanish
5. Diagnosis of breast, prostate or colorectal cancer, 6 months post competition of primary treatment, with no evidence of primary disease
6. Approval from treating oncologist, confirmed via email or in writing
7. Internet access on a smart phone, tablet, or computer
8. Agree to be randomly assigned to any study group

Exclusion Criteria:

1. Less than 18 years of age
2. Unable to provide consent
3. Unable to read/understand English or Spanish
4. Any contraindication for diet change or exercising as determined by physician
5. Blank
6. Engaging in \>150 minutes of moderate to vigorous physical activity on average per week for the prior month
7. Meeting the American Cancer Society diet recommendations (3 cups of vegetables or legumes, 2 cups of fruit, 2 serving whole grain per day, and limited red/processed meats, sugar-sweetened beverages, and highly processed foods) for the prior month
8. History of dementia or major psychiatric disease which would interfere with study participation
9. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
10. Eastern Cooperative Oncology Group (ECOG) score of \>2
11. Severe lymphedema as determined by physician
12. Receiving physical therapy treatment

Primary outcomes:
measure: Percentage of Survivors Who Agree to Participate
timeFrame: Up to 8 Weeks
measure: Percentage of Interventions Sessions Completed
timeFrame: Up to 8 Weeks
measure: Percentage of Participants Satisfied with the Intervention
timeFrame: Up to 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Tracy Crane, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01206218: Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
Official title: Evaluation of Customized Treatment According to BRCA1 Assessment in Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Advanced Gastric Cancer
Keywords: Gastric Cancer, BRCA1
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of customized treatment according to BRCA1 assessment in patients with advanced gastric cancer


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Female or male aged 18 years and over
* Histologic or cytologic confirmation of advanced gastric cancer
* Stage III-IV (AJCC 7th)
* ECOG: 0-2
* Have tumor sample that can be tested for BRCA1 mRNA expression
* Negative pregnancy test for women of childbearing potential
* Neutrophile granulocyte greater than 1.5×10\^9/L
* Hemoglobin greater than 10g/dL
* Platelet greater than 100×10\^9/L
* Serum bilirubin not greater than 1.5x upper limit of reference range (ULRR)
* ALT or AST not greater than 1.5x ULRR
* Creatinine clearance no less than 60ml/min

Exclusion Criteria:

* Have at least another primary malignant tumor
* Active infection
* Chemotherapy with experimental drug within 3 weeks before the start of study therapy
* Women who are pregnant or breast feeding
* Weight loss greater 10% within 6 weeks before the start of study therapy

Primary outcomes:
measure: Progression-free Survival
timeFrame: 12 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 12 months
measure: Response Rate
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Drum Tower Hospital, Nanjing University Medical School
name: Baorui Liu, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219518: Mechano-physiological Approach to Anorectal Function
Official title: Mechano-physiological Approach to Normal Anorectal Function and the Classification of Defecatory Disorders
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Constipation
Keywords: Defecography
Pelvic floor dyssynergia
Anismus
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: American College of Gastroenterology
First posted: 2005-09-22
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with no defecatory dysfunctionl

Brief summary: We hypothesize that defecatory disorders can be described in mechanical terms which would allow a mechanistic description of disorders which would in turn allow better directed biofeedback mechanisms to treat disorders of defecation.

Detailed description: Disorders of defecation are very common and the process of defecation remains poorly described. This results in a limited approach to treatment of patients, with limited success. This study will simultaneously measure multiple components of the process of defecation - the abdominal wall and perineal muscle activity, the pressure within the rectum and in the anal canal and the change in shape of the anorectal region of the colon, in order to develop a biomechanical model which can describe the normal and abnormal defecatory process. It is anticipated that, by understanding the process in these terms will allow a new approach to categorizing and describing defecation problems which in turn will lead to more specific approaches of treatment which will be tailored to individual patients. These parameters will compared in volunteers with no defecatory disorders and patients with defecatory disorders who are being referred for defecography as part of their clinical evaluation.

Eligibility criteria: Controls

Inclusion Criteria:

* Women
* No defecatory problems
* On no medication which affect bowel habits

Exclusion Criteria:

* Pregnancy

Patients

Inclusion Criteria:

* Difficulty in defecation
* Women

Exclusion criteria:

* Pregnancy
* Medication which can affect bowel movement

Primary outcomes:
measure: change in shape of anorectum during changes in intraabdominal pressure and defecation
timeFrame: start of anorectal manometry procedure until procedure end
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
name: Ann Ouyang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05926518: Anti-Xa Level With Thromboprophylactic Dosage Nadroparin in Critically Ill COVID-19 and Non-COVID-19 Patients
Official title: Evaluation of Anti-Xa Levels With Nadroparin as Thrombosis Prophylaxis in COVID-19 and Non-COVID-19 Patients Admitted at the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Therapeutic Drug Monitoring
Venous Thromboembolism
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult ICU patients (COVID-19 and non-COVID-19 patients) using nadroparin with the intention of thrombosis prophylaxis are included. Anti Xa activity is determined once per patient at least 3 days (peak level after 4th administration) after admission at the ICU and on nadroparin treatment. No randomization.

Brief summary: Primary objective The objective of this study is to compare anti-Xa levels obtained with a standard high dose thrombosis prophylaxis in COVID-19 intensive care-patients compared with anti-Xa levels obtained with a normal dose thrombosis prophylaxis in non-COVID-19 intensive care patients.

Secondary objectives

1. To determine the incidence of anti Xa levels out of range of the established target anti Xa level in both groups.
2. To determine the influence of relevant co-variates on the anti-Xa level in the COVID-19 and non-COVID-19 group.


Eligibility criteria: Inclusion Criteria:

* All COVID-19 patients \> 18 years admitted at the ICU using nadroparin in a high thrombosis prophylactic dosage of 1 dd 5700 IU or 2 dd 5700 IU sc
* All medical non-COVID-19 patients admitted at the ICU using nadroparin in a standard prophylactic dosage of 1 dd 2850 IU sc.
* Minimum estimated length of stay on the ICU of 4 days

Exclusion Criteria:

o (History of) Heparin Induced Thrombocytopenia and Thrombosis

Primary outcomes:
measure: Evaluation of anti-Xa peak level
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of anti-Xa levels within target range
timeFrame: 2 years
measure: Influence of covariates (nadroparin dosage, gender, age, weight, BMI, COVID-19, APACHE IV, vasopressor use, eGFR, fluid balance, CRP) on anti-Xa level
timeFrame: 2 years
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Monique de Maat
Study officials:
References: