louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06328803: Impact of Active Breathing Exercises on Respiratory Rhythm Disorders in Stroke Patients
Official title: A Randomized Controlled Trial to Explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Detailed description: A growing body of literature indicates the existence of a highly stable, coordinative relation between respiration and oropharyngeal swallowing in healthy adults. The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Eligibility criteria: Inclusion Criteria:

* diagnosed with Respiratory Rhythm Disorder
* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* 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: Yale Pharyngeal Residue Severity Rating Scale
timeFrame: day 1 and day 15
measure: Fiberoptic Endoscopic Dysphagia Severity Scale
timeFrame: day 1 and day 15
measure: Murray Secretion Scale
timeFrame: day 1 and day 15
measure: Swallowing Quality of Life
timeFrame: day 1 and day 15
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_CHAIR
References:
Clinical trial NCT01968603: Weight Gain in Surgically Treated Adult-onset Craniopharyngioma
Official title: Weight Gain in Surgically Treated Adult-onset Craniopharyngioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult-onset Craniopharyngioma
Postoperative Weight Gain
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult-onset patients with craniopharyngioma undertaking primary surgery in the investigators' institution

Brief summary: The aim of the study was to describe postoperative weight change in adults undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.

Detailed description: Morbid obesity, intractable weight gain due to hypothalamic damage, is a common and troubling complication in patients undergoing surgery for craniopharyngioma combined or not with radiotherapy, with an incidence of 23\~62% in pediatric patients. It has a major negative impact on metabolic and cardiovascular health and quality of life in long-term survivors. Identifying patients at higher risks for developing postoperative weight gain is of great importance in preventing obesity and taking early actions in this population. Though a lot of previous studies have been made in pediatric patients and several factors, such as hypothalamic involvement, higher body mass index (BMI) standard deviation score (SDS) at diagnosis, age at diagnosis and hydrocephalus requiring a shunt, have been identified as risk factors for postoperative weight gain, data on this important morbidity in adult-onset patients are sparse, especially in Chinese population. Therefore, the investigators are going to undertake a retrospective evaluation of postoperative weight change in adult-onset patients undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.

Eligibility criteria: Inclusion Criteria:

adult-onset, aged 18 years or more; pathologically confirmed craniopharyngioma; primary surgery performed at our hospital; at least 3 months of follow-up including body weight measurement; ambulatory (since lack of ambulation may predispose to weight gain); not receiving supraphysiologic doses of glucocorticoid (e.g. hydrocortisone, prednisone, or dexamethasone to exceed 12mg/m2•d hydrocortisone equivalent) for more than 2 months after tumor therapy.

Exclusion Criteria:

Childhood-onset, \<18 years old; Inconsistent pathology; Without follow-up records in the investigators' institution.

Primary outcomes:
measure: percentage of postoperative weight gain
timeFrame: 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology and Metabolism
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Li yi ming
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00520403: A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
Official title: An Open-label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Standard Therapy on Progression-free Survival in Patients With Metastatic Renal Cell Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-08-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* metastatic renal cell cancer of predominantly clear cell type;
* \>=1 measurable lesion.

Exclusion Criteria:

* prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for metastatic renal cell cancer;
* ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily treatment with aspirin (\>325mg/day);
* clinically significant cardiovascular disease.

Primary outcomes:
measure: Percentage of Participants With Disease Progression or Death
timeFrame: Days 0, 91, 182, 273, 365, 456, and 547
measure: PFS - Time to Event
timeFrame: Days 0, 91, 182, 273, 365, 456, and 547
Secondary outcomes:
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline and Cycles 3, 6, 9, 13, and 17
measure: Overall Survival (OS)
timeFrame: Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Dessau
country: Germany
city: Erlangen
country: Germany
city: Frankfurt
country: Germany
city: Halle
country: Germany
city: Hannover
country: Germany
city: Jena
country: Germany
city: Kassel
country: Germany
city: Kiel
country: Germany
city: Leipzig
country: Germany
city: Magdeburg
country: Germany
city: Rehling
country: Germany
city: Stuttgart
country: Germany
city: Weiden
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06405503: Impact of Primary Language on Treatment and Outcomes in Inflammatory Bowel Disease
Official title: Impact of Primary Language on Treatment and Outcomes in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Inflammatory Bowel Disease
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Yale University
First posted: 2024-05-08
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our target population will include adult subjects (ages 18 and older) with confirmed IBD who do and do not identify English as their primary language. These subjects will be either new or returning patients seen in the outpatient clinics at either the Yale New Haven Hospital system or the University of Texas at Austin affiliated hospitals or clinics. Men and women and persons of all races and ethnicities will be encouraged to participate in an equal basis.

Brief summary: A thorough discussion of treatment options to manage inflammatory bowel disease (IBD), including the risks and benefits of each class of medication, can be a complex discussion and time consuming. Having to use a translator adds an additional layer of time and complexity to these discussions as well as potential misunderstanding. Further, in addition to language, cultural differences can also play into treatment acceptance.

This study aims to determine the impact of primary language on the selection of treatment for IBD and on disease outcomes.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years of age
* Confirmed diagnosis of IBD (CD, UC or indeterminate colitis)
* Willing to provide consent for participation
* Managed at an outpatient clinic either the Yale New Haven Hospital system or the University of Texas at Austin Hospital system.

Exclusion Criteria:

* Patients \<18
* No confirmed diagnosis of IBD
* Not planning to continue care at either study site (i.e. presenting for a consultation only)
* Unwilling to provide signed consent

Primary outcomes:
measure: Current use of advanced therapy
timeFrame: baseline
Secondary outcomes:
measure: IBD-related disease complications
timeFrame: 6 months
measure: IBD-related disease complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Medical School at the University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT03289403: The Role of Immunomodulatory Treatment in Success of ICSI in Patients With Autoimmune Thyroiditis
Official title: The Role of Immunomodulatory Treatment in Success of ICSI in Patients Who Have Infertility With Autoimmune Thyroiditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Autoimmune Thyroiditis
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the work is to determine whether the use of immunomodulatory drugs could improve the reproductive of outcome of infertile patients who have autoimmune thyroiditis with positive autoimmune antibodies undergoing IVF-ET.


Eligibility criteria: Inclusion Criteria:

* Infertility patients who have autoimmune thyroiditis With positive autoimmune thyroiditis and TSH level above 2 IU.

Exclusion Criteria:

* All patients who have other autoimmune diseases especially antiphospholipid syndrome, hepatitis c viral disease.

Patients who have any medical disorders ( eg. D.M. HTN .Epilepsy ....)

Primary outcomes:
measure: The Number of Participants Who Achieved clinical Pregnancy
timeFrame: 6 weeks after embryo transfer
Secondary outcomes:
measure: The Number of Participants Who Achieved Ongoing Pregnancy
timeFrame: 18 weeks after embryo transfer
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Aljazeera (Al Gazeera) hospital
Study officials:
affiliation: Aljazeera (Al Gazeera) hospital
name: Ahmed M Sayed, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT02764203: ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial
Official title: ChOcolate COnsumption And Blood Pressure (COCOA-BP): A Wearable Devices Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Blood Pressure
Keywords: Dark Chocolate
Blood Pressure
Wearable Devices
Digital Health
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-05-06
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The COCOA-BP Trial is designed to assess the impact of 50g daily dark chocolate intake on blood pressure and compare outcome data derived from wearable/digital health devices to data derived from standard methods. Additionally, the usability of the wearable technology will be evaluated.

Detailed description: The COCOA-BP Trial is a prospective, single-center, single-arm, Boston Scientific volunteer trial, designed to assess the impact of 50g daily dark chocolate intake on blood pressure and compare outcome data derived from wearable/digital health devices to data derived from standard methods. Additionally, the usability of the wearable technology will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age
* Subject has an iPhone (5 or higher)
* Subject is willing to comply with all trial requirements
* Subject understands the trial requirements and procedures and provides written informed consent before any trial-specific procedures are performed

Exclusion Criteria:

* Anyone part of the study execution team cannot be part of the trial
* Current smoker or history of smoking in the last 5 years (including E-cigarettes)
* Diabetes mellitus including those managed by diet alone
* Medically treated hypertension
* Diagnosed with persistent or frequent irregular heart beat (e.g. atrial flutter, atrial fibrillation)
* Permanent pacemaker or defibrillator implanted
* Subject is a women who is pregnant
* Known allergy to chocolate or cacao products
* Known allergy to skin adhesives

Primary outcomes:
measure: Change in resting systolic blood pressure after daily dark chocolate
timeFrame: 14 days after daily consumption of dark chocolate
Secondary outcomes:
measure: Correlation of physical activity (steps) to resting blood pressure and heart rate
timeFrame: daily, for four weeks
measure: Comparison of blood pressure derived from wearable digital health devices to data derived from standard methods
timeFrame: End of week two and end of week four
measure: Comparison of heart rate derived from wearable digital health devices to data derived from standard methods
timeFrame: End of week two and end of week four
Other outcomes:
Locations:
Study officials:
affiliation: Sponsor GmbH
name: Thomas Christen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03420703: Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy
Official title: The Effect of Erector Spinae Plane Block on Postoperative Pain Following Laparoscopic Cholecystectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: erector spinae plane block
laparoscopic cholecystectomy
postoperative pain
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented application of this blockade into practice at the clinic. Main purpose of this study is to evaluate the analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* 25 - 75 years of age
* ASA I - II
* Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* obesity
* ASA III - IV
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs

Primary outcomes:
measure: 24h morphine consumption
timeFrame: for postoperative 24 hour
Secondary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: 24 hour
measure: Pain
timeFrame: 24h
Other outcomes:
Locations:
city: İzmit
country: Turkey
facility: Kocaeli University Hospital
state: Kocaeli
Study officials:
References:
Clinical trial NCT00061503: Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular Hypertension
Official title: A Double-Masked, Placebo-Controlled, Paired Comparison Study of the Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-05-30
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: The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).


Eligibility criteria: * Subjects 18 years of age or older
* of either sex
* of any race
* diagnosed with ocular hypertension or open angle glaucoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Call for Details
country: United States
facility: Alcon Call Center
state: Nebraska
Study officials:
References:
Clinical trial NCT03775603: Comparison of TOFscan and TOF-Watch SX in Pediatric Neuromuscular Function Recovery
Official title: Comparison of TOFscan and TOF-Watch SX in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-12-14
Enrollment: 37
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general anesthesia with neuromuscular blockade in children

Brief summary: Comparison of TOFscan and TOF-Watch SX for monitoring of neuromuscular blockade function in children

Detailed description: TOF ratio of TOFscan when TOF-Watch SX shows TOF ratio 0.7 with rocuronium in children during general anesthesia

Eligibility criteria: Inclusion Criteria:

* patients need neuromuscular blockade

Exclusion Criteria:

* contraindication of rocuronium

Primary outcomes:
measure: TOF ratio of TOFscan
timeFrame: intraoperative during anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Hee-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yhim HB, Jang YE, Lee JH, Kim EH, Kim JT, Kim HS. Comparison of the TOFscan and the TOF-Watch SX during pediatric neuromuscular function recovery: a prospective observational study. Perioper Med (Lond). 2021 Dec 10;10(1):45. doi: 10.1186/s13741-021-00215-2.
Clinical trial NCT01876303: Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma
Official title: Genetic Epidemiology of Ewing's Sarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-06-12
Enrollment: 1650
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Ewing Sarcoma meeting other criteria.

Brief summary: This clinical trial studies genetic biomarkers from saliva samples in patients with Ewing sarcoma. Studying samples of saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the association between the length of Ewing sarcoma breakpoint region 1-Friend leukemia virus integration 1 (EWS-FLI1) fusion protein binding sites (microsatellites) and risk of Ewing's sarcoma (ES).

II. To determine the frequency and commonality of Caucasian ancestral markers in cases of ES self-identified as non-Caucasian (African-American, Asian, Hispanic).

III. To determine the association between genomic variants in ES-related genes and hernia development (i.e. the integrin signaling pathway) and risk of ES.

OUTLINE:

Genomic DNA is extracted from participants' saliva samples and analyzed for expression of EWS-FLI1 and other ES-target genes.

Eligibility criteria: Inclusion Criteria:

* The patient is enrolled on ACCRN07
* The patient has a diagnosis of Ewing Sarcoma (International Classification of Diseases \[ICD\] code morphology 9260; topography C40.0-C41.9, C76.0-C76.8, C80.9) and is registered with Children's Oncology Group (COG) by a North American member institution
* The patient must be diagnosed with Ewing sarcoma between December 24, 2007 and December 31, 2015
* The patient must have at least one biological parent alive and willing to participate
* All questionnaire respondents must understand English or Spanish
* Concomitant treatment on a therapeutic trial is not required

Primary outcomes:
measure: Main effect of gene polymorphisms
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Joshua Schiffman, MD
role: PRINCIPAL_INVESTIGATOR
References: