louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04663698: The Effect of Volitional Pursed-lips Breathing
Official title: Evaluation of PLB Physiology in COPD - Untersuchung Zur Physiologie Der Lippenbremse Bei COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Pursed-lips Breathing
Resistor
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
First posted: 2020-12-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Simulation of pursed-lips breathing by defined stenoses in pulmonary function diagnostics to quantify the effect of the pursed-lips breathing

Detailed description: Since many years it is recommended for COPD patients to reduce the crossdiameter of the lips in order to improve the exhalation by means of so-called pursed-lips breathing (PLB). But the effects have never been studied quantitatively. In this study, the PLB effect is simulated during lung function diagnostics, using different sized resistors inserted into the routine mouthpiece of the flow sensor to resemble the effective airway resistances of a PLB maneuver. This prospective, randomized study includes 20 healthy subjects and 50 COPD patients, who will perform lung function testing with 4 different sized resistors.

Eligibility criteria: Inclusion Criteria:

Patients:

* COPD (GOLD I- IV)
* Stable respiratory situation that allows routine lung funtion
* capable of communication

Healthy:

* Lung Healthy
* capable of communication

Exclusion Criteria:

* Invasive Ventilation
* Other serious acute physical illnesses that require immediate intensive medical treatment
* Acute hypercapnic decompensation with a pH \< 7.35 in the capillary BGA
* Pregnancy or Nursing
* Not able to give consent
* Not willing or able to follow the study protocol

Primary outcomes:
measure: Lung function parameter FEV1
timeFrame: up to 1 hour
Secondary outcomes:
measure: PEF - expiratory Peak Flow
timeFrame: up to 1 hour
measure: RV%TLC
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Lüdenscheid
country: Germany
facility: Märkische Kliniken GmbH, Klinikum Lüdenscheid
state: NRW
Study officials:
References:
Clinical trial NCT03302598: Assessment of Relation Between Recurrence of Enterocutaneous Fistula and Preoperative C-reactive Protein Level After Complete Surgical Repair
Official title: Assessment of Relation Between Recurrence of Enterocutaneous Fistula and Preoperative C-reactive Protein Level After Complete Surgical Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enterocutaneous Fistula
Keywords: enterocutaneous fistula - C-reactive protein- surgical repair
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2017-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 56
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and prepared for definite surgical repair in the form of resection anastomosis of ECF. the investigators used preoperative serum C-reactive protein as predicting factor to recurrence and independent variable for timing of surgery.
Primary purpose: TREATMENT

Brief summary: A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and prepared for definite surgical repair in the form of resection anastomosis of ECF. The investigators used preoperative serum C-reactive protein as predicting factor to recurrence and independent variable for timing of surgery.

Detailed description: There is a controversy in timing of operation. The timing depends on clinical assessment, laboratory tests and radiological investigations. The cornerstone of this decision is to control sepsis and inflammatory condition before surgery. This issue made surgeons favor longer interval between incidence of ECF and definite surgical treatment. In some cases there may be a hidden place for infection or continuation of the inflammatory situation without clear signs, which necessitated the presence of a possible indicator helps in making the surgical decision. Serum C-reactive protein is the common inflammatory marker used to exclude inflammatory condition. Although its level is within normal range but some cases showed high recurrence rate when the level exceeded certain as the investigators believed in their study. Now the investigators can say that the perioperative serum C-reactive protein level can be used as an objective parameter for helping to make surgical decision and reduce recurrence of ECF.

Eligibility criteria: Inclusion Criteria:

* patients with ECF were included in the study

Exclusion Criteria:

* Cases submitted for surgical treatment with protecting stoma or terminal were excluded from our study. Other fistulas like perianal, pancreatic, biliary and internal fistulas were not involved due to their different nature, treatment and prognosis

Primary outcomes:
measure: C-reactive protein can be used as predicting factor for recurrence of ECF after definite surgical treatment as well as helping surgeon to take decision for proper time of operation.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01352598: Stereotactic Body Radiotherapy for Prostate Cancer
Official title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
stereotactic radiotherapy
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 84
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.

Detailed description: This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Eligibility criteria: Inclusion Criteria:

* Patient age \>= 18 years
* Zubrod performance status of 0-3
* T1-3 N0 M0 adenocarcinoma of the prostate
* Prostate volume ≤ 100 cc
* Signed study-specific consent form

Exclusion Criteria

* Extension of local tumor to involve adjacent organs other than seminal vesicles (T4)
* Prostate volume \> 100 cc
* Nodal involvement
* Metastatic disease
* Prior pelvic radiotherapy except as part of combination therapy for prostate cancer
* History of scleroderma
* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Primary outcomes:
measure: Biochemical Control Rate
timeFrame: one year
Secondary outcomes:
measure: Late Toxicity Rate
timeFrame: one year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
Study officials:
References:
Clinical trial NCT00364598: Study of Anginera in Adults With a Left Ventricular Assist Device (LVAD) as Bridge to Transplant
Official title: A Phase I Open Label Pilot Study to Obtain Tissue for Histological Analysis After Application of Anginera™ in Adults With A Left Ventricular Assist Device As A Bridge To Transplant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Heart Failure
Keywords: Anginera
LVAD
Transplant
Histology
LVAD implantation as a bridge to transplant
Lead sponsor: Theregen, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to obtain human heart tissue after treatment with Anginera to determine its effect on a variety of things that might indicate improvement in heart function. Patients who will have a left ventricular assist device (LVAD) implanted while they wait for a donated heart will be treated with Anginera. At the time of heart transplant, their diseased heart which is removed will be analyzed by microscopic examination to see what effect Anginera had.

Detailed description: This will be a prospective, multi-center, randomized, open-label, within-patient paired design study. The primary purpose is to analyze cardiac tissue obtained after application of Anginera to adults with an LVAD as a bridge to transplant, to determine effects on various markers.

Eligibility criteria: Inclusion Criteria:

* Stage D Heart Failure
* Patients having an LVAD implanted as a bridge to transplant.

Exclusion Criteria:

* Biopsy proven acute myocarditis
* Known Giant Cell Myocarditis
* Known infiltrative disease, e.g. cardiac Amyloidosis, Sarcoidosis, hemochromatosis, Fabry's Disease

Primary outcomes:
measure: To analyze cardiac tissue obtained after application of Anginera to adults with an LVAD as a bridge to transplant, to determine effects on various markers.
Secondary outcomes:
measure: Safety
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kenneth B Margulies, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Y. Joseph Woo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06726798: Prospective Cohort Study on the Safety and Efficacy of Endorobotics for Endoscopic Submucosal Dissection (Endorobotics ESD)
Official title: Prospective Cohort Study on the Safety and Efficacy of Endorobotics for Endoscopic Submucosal Dissection (Endorobotics ESD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gastrointestinal Neoplasm
Keywords: Endoscopic submucosal dissection
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is a prospective, single arm study of 30 patients recruited to undergo endoscopic submucosal dissection (ESD) with a novel robotic assisted technology. It will assess the safety and performance of robotic-assisted endoscopic submucosal dissection (ESD) of superficial gastric and colorectal lesions that otherwise cannot be optimally and radically removed by snare-based techniques. The primary outcome of the study is rate of complete (R0) resection of the neoplasia.


Eligibility criteria: Inclusion Criteria:

* Patients with endoscopic diagnosis of early gastric or colorectal neoplasia
* Patients will be recruited according to ESGE and JGES guidelines for gastric \& colorectal ESD including: 1. Lesions for which en bloc resection with snare EMR is difficult to apply; 2. Mucosal tumors with submucosal fibrosis; 3. Sporadic tumors in conditions of chronic inflammation and 4. Local residual or recurrent early carcinomas after endoscopic resection.

Exclusion Criteria:

* Informed consent not available
* Carcinoma of colon or rectum or stomach with invasion to submucosa or beyond
* Evidence of distant metastasis
* Presence of another active malignancy
* Pregnancy
* Patients unfit for general anesthesia
* Endoscopic platform cannot reach target lesion
* Patients recruited into another clinical trial.

Primary outcomes:
measure: R0 resection rate
timeFrame: 30 days
Secondary outcomes:
measure: Rate of procedural haemorrhage
timeFrame: 30 days
measure: Rate of adjunctive procedure requirement
timeFrame: 30 days
measure: All cause mortality rate
timeFrame: up to 5 years
measure: Rate of infection
timeFrame: up to 12 months
measure: Duration of procedure
timeFrame: 1 day
measure: Length of hospital stay
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References:
Clinical trial NCT02193698: Efficacy and Safety of Lenalidomide as a Treatment for Recurrent or Refractory POEMS Syndrome Trial
Official title: Single Arm Open-label Trial to Investigate the Efficacy and Safety of Lenlidomide as a Treatment for Recurrent or Refractory Crow-Fukase (POEMS) Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: POEMS Syndrome
Keywords: POEMS syndrome
lenalidomide
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.

Detailed description: This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent /refractory POEMS (Crow-Fukase) syndrome.

Eligibility criteria: Inclusion Criteria:

1. Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)
2. Recurrent or refractory Crow-Fukase syndrome.
3. Patients without severe liver or renal dysfunction.
4. Patients without severe neutropenia or thrombocytopenia.
5. Patients without clinically problematic ECG findings
6. Negative on the pregnacy test on the day 1 of cycle 1.
7. Patients who can undertake prevention of pregnancy, if necessary.
8. Patients with written informed consent.
9. Patients who are capable of ambulatory hospital visits every 4 weeks.
10. Patients with informed consent to the registration and rules of RevMate®.

Exclusion Criteria:

1. Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.
2. Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.
3. Patients who have been administered bevacizumab within 12 weeks prior to the registration.
4. Patients who could worsen acutely during the clinical trial period.
5. Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.
6. Patients with malignancies.
7. Female patients who are pregnant or desire childbearing. Males who desire fertility.
8. Patients who allergic to lenalidomide or dexamethasone.

Primary outcomes:
measure: Reduction rate of serum VEGF
timeFrame: after 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Chiba University Graduate School of Medicine Department of neurology
Study officials:
affiliation: Chiba University, Department of Neurology
name: Sonoko Misawa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02059798: Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy
Official title: Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myelopathy
Neurogenic Bladder
Erectile Dysfunction
Psychosexual Dysfunctions
Sexual Arousal Disorder
Keywords: Myelopathy
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 76
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients having cervical myelopathy, aged between 25 and 65

Brief summary: Hypotheses:

Decompressive surgery of cervical myelopathy will improve bladder function.

Decompressive surgery of cervical myelopathy will improve sexual function.

Detailed description: The investigators will enroll consecutive cohort with cervical myelopathy who are scheduled to take surgical decompression of cervical spinal cord, aged between 25 and 65.

The exams for the patients include followings

* JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy
* VAS (Visual Analog Scale) pain score
* IPSS (International Prostate Symptom Score) and IIEF (International Index of Erectile Function) in male patients
* FSFI (Female Sexual Function Index) and UDI (Urinary Distress Inventory) in female patients
* Bladder compliance, Detrusor leak point pressure, Peak detrusor pressure
* Rigidity activity unit of penis

Eligibility criteria: Inclusion Criteria:

* evidence of progression of motor or sensory nerve
* cervical myelopathy in magnetic resonance imaging

Exclusion Criteria:

* radical pelvic surgery
* pelvic irradiation
* evidence of brain damage (dementia, cerebrovascular disease)
* evidence of psychotic disorder

Primary outcomes:
measure: JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Bladder compliance
timeFrame: 6 months after surgery
Other outcomes:
measure: Rigidity activity unit of penis
timeFrame: 6 months after surgery
measure: Female sexual function index
timeFrame: 6 months after surgery
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital, The Catholic University of Korea
state: Gyeonggi-do
Study officials:
affiliation: The Catholic University of Korea
name: Ilsup Kim, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06734598: Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy
Official title: Efficacy of Botox Injection of the Masticatory Muscles in Head &Neck Cancer Patients with Trismus After Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Trismus
Head and Neck Cancer
Radiation Therapy Recipient
BOTOX
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 120
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: Trismus is a common side effect in head and neck cancer patients after radiation therapy. This project aims to explore the therapeutic effect of Botulinum toxin (Botox) injection to the masticatory muscles in the above-mentioned patients.

In this project, Botulinum toxin will be injected into the masticatory muscles (medial pterygoid and masticatory muscles), combined with oral rehabilitation exercises, to reduce the patient's masticatory muscle tension and spasm. Patient's mouth opening range, quality of life, trismus condition and pain will be evaluated to understand its efficacy.


Eligibility criteria: Inclusion Criteria:

1. Aged over 18 years old;
2. Head and neck cancer patients must have completed radiotherapy for at least 3 months;
3. Those whose mouth-opening distance is less than or equal to 3.5 cm (the functional cut-off point of trismus) and who have tightness or pain in the masticatory muscles;
4. Medical condition is stable;

Exclusion Criteria:

1. Those who have undergone surgery on their masticatory muscles;
2. Patients with obvious muscle atrophy or complete fibrosis of masticatory muscles ;
3. Those with tumor recurrence at the time of admission;
4. Those whose vital signs are unstable due to acute illness.

Primary outcomes:
measure: Maximal Incisal Opening
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01096498: Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
Official title: Open-label, Randomized, Crossover Study to Prove Bioequivalence Between Opxion® (Levonorgestrel 0.75 mg From Bayer de Mexico) and Postday® (Levonorgestrel 0.75 mg From Investigacion Farmaceutica), in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Contraception, Postcoital
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-03-31
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study.
* History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs.
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.

Primary outcomes:
measure: Least square estimator of average maximum plasmatic concentration (log transformed)
timeFrame: After 2 months
measure: Least square estimator of area under the pharmacokinetic curve (log transformed)
timeFrame: After 2 months
Secondary outcomes:
measure: Time at which maximum concentration is reached
timeFrame: After 2 months
measure: Area under the pharmacokinetic curve from time=0 to last blood sample
timeFrame: After 2 months
measure: Half life of plasmatic concentration of study drug
timeFrame: After 2 months
measure: Clearance constant of plasmatic concentration of study drug
timeFrame: After 2 months
measure: Adverse event collection
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Morelia
country: Mexico
state: Michoacán
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: