louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05963165: Non-phonatory Exercises in Patients with Unilateral Vocal Fold Paralysis Post-thyroidectomy
Official title: Early Speech Therapy Using Non-phonatory Exercises in Patients with Unilateral Vocal Fols Paralysis After Thyroidectomy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Vocal Cord Paralysis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 56
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: Thyroidectomy is the most common iatrogenic cause of vocal fold paralysis. Patients complain of hoarseness caused by incomplete glottic closure and have effort to raise vocal intensity with consequent elevation of the larynx and/or involvement of supraglottic structures in phonation. These compensation mechanisms result in a shift of the fundamental frequency towards more serious tones or falsetto voice emissions.

The first choice treatment is speech therapy which aims to obtain better glottic closure, preventing ankylosis of the crico-arytenoid joint. In order to promote better glottic closure without risking the onset or increase of dysfunctional compensation, the idea behind this project is to propose non-phonatory adduction exercises in the first post-operative week.

The primary objective of the study is to compare patients who will perform non-phonatory exercises in parallel with medical therapy for one week and patients who will perform standard medical therapy only during the first week.


Eligibility criteria: Inclusion Criteria:

* vocal fold paralysis after thyrodectomy
* ability to sign an informed consent

Exclusion Criteria:

* Vocal fold paralysis with different etiology
* Previous history of laryngeal, pulmonary or gastric surgery
* History of vocal or laryngeal pathologies that have required therapy
* Current or previous lung disorders
* Hearing loss
* Motor or neurological deficits
* Presence of malignant diseases
* Presence of speech or reading disorders

Primary outcomes:
measure: Degree of glottic closure
timeFrame: 3 months
Secondary outcomes:
measure: Acoustic analysis (fundamental frequency)
timeFrame: 3 months
measure: Acoustic analysis (NHR)
timeFrame: 3 months
measure: Acoustic analysis (Jitter%)
timeFrame: 3 months
measure: Acoustic analysis (Shimmer%)
timeFrame: 3 months
measure: Acoustic analysis (Flow)
timeFrame: 3 months
measure: Acoustic analysis (Fhigh)
timeFrame: 3 months
measure: Acoustic analysis (intensity)
timeFrame: 3 months
measure: MPT
timeFrame: 3 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli - IRCCS
Study officials:
References:
Clinical trial NCT00613665: Safety and Immunogenicity of Chiron's Investigational H. Pylori Vaccine in Healthy Adults
Official title: Phase I, Randomized, Controlled, Single-blind, Dose-Ranging and Schedule-Finding Study of the Safety, Tolerability, and Immunogenicity of Chiron Helicobacter Pylori Vaccine in Healthy, Helicobacter Pylori-negative Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Helicobacter Pylori
Gastritis
Gastric Cancer
Gastroduodenal Ulcers
Lymphoma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine


Eligibility criteria: Inclusion Criteria:

* Healthy
* Ages 18-40
* Negative for H. pylori infection
* Contraception for females

Exclusion Criteria:

* Present or past H. pylori infection
* Medically significant gastroduodenal disease
* Recent corticosteroid use
* Bleed diathesis
* Use of antibiotics used to treat H. pylori infection

Primary outcomes:
measure: Safety measures: injection site and systemic reactions
timeFrame: 5 months
Secondary outcomes:
measure: Immunogencity measures: antigen-specific antibodies and cellular immune response
timeFrame: 5 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Universitaetsklinikum Charité
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT06381765: Serratus Plane Block and Pectointercostal Block
Official title: Comparison of Deep Serratus Plane Block with Deep Serratus Plane Block+Pectointercostal Plane Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . General anesthesia with sevoflurane and remifentanil will perform to the all patients. Postoperative pain scores, morphine consumption and complications will record till the 24.th hours.

Detailed description: ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. General anesthesia with sevoflurane and remifentanil will perform to the all patients. Patients will divide into 2 groups. Serratus plane block for group I and serratus plane block+pectointercostal block for Group II will perform bilaterally. Ultrasound guided deep serratus plane block will perform with 0,25% bupivacaine 20 ml at the midaxillary 5. rib, for Group I. At Group II, ultrasound guided deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally. Patient controlled analgesia will perform with Morphine ( 1 mg bolus+ 10 min lockout+4 hours limit 10 mg) at postoperative period. Patients will evaluate with visual analogue scale (VAS) for postoperative pain scores till the first 24.th hours. Postoperative pain scores (VAS), morphine consumption and complications will record till the 24.th hours.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients
* Female
* who will undergoing Breast reduction surgery

Exclusion Criteria:

* ASA III and over patients
* who reject to join the study
* male gender

Primary outcomes:
measure: postoperative morphine consumption
timeFrame: All the patients will follow till the postoperative 24.th hours and totally morphine consumption will record postoperative 24.th hours.
measure: postoperative visual analog scale scores
timeFrame: VAS scores will record at the first postoperative 24.th hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Çukurova University Faculty of Medicine
Study officials:
affiliation: çukurova university faculty of medicine
name: Ebru Biricik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04369365: A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic
Official title: A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed cancer diagnosis
* Ongoing systemic antineoplastic treatment irrespective of application route
* Age ≥ 18 years
* Life expectancy of at least 3 months
* Adequate renal, cardiac and liver function
* Corrected QT time (QTc) ≤ 450 ms
* Eastern Cooperative Oncology Group (ECOG) performance status of \< 3
* Capable of understanding the study and giving informed consent
* Negative COVID-19 test at study entry as measured by routine testing

Exclusion Criteria:

* Use of any investigational agent within 28 days prior to study start
* Patients with active opportunistic infections
* Pregnant or lactating women
* Women of childbearing potential and male subjects not willing to use adequate contraception methods during the study period
* Hypersensitivity to azithromycin or other macrolides
* Concurrent medication with ergotamine, theophylline, digitalis
* Inability to swallow tablets

Primary outcomes:
measure: Cumulative number of severe acute respiratory syndrome corona virus 2 (SARS-COV-2) infections
timeFrame: 12 weeks after initiation of therapy
Secondary outcomes:
measure: Number of severe COVID-19 cases
timeFrame: 12 weeks after initiation of therapy
measure: Severity of COVID-19 cases
timeFrame: 12 weeks after initiation of therapy
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 12 weeks after initiation of therapy
measure: Number of viral and bacterial infections
timeFrame: 12 weeks after initiation of therapy
measure: Number of participants with azithromycin-resistant bacterial strains in nasal swabs test
timeFrame: 12 weeks after initiation of therapy
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH Vienna, Department for Internal Medicine I, Oncology
Study officials:
References:
Clinical trial NCT02873065: Efficacy and Safety of 1-week Triple Therapy With Ilaprazole for the Eradication of Helicobacter Pylori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Eradication
Lead sponsor: Livzon Pharmaceutical Group Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compared efficacy and safety of Ilaprazole based triple regimen therapy including Ilaprazole 5mg, Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori

Detailed description: Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) ,gastritis and dyspepsia confirmed to be H.pylori positive patients in the biopsy and UBT test. For 7 days, Participants treated as Esoprazole based triple regimen therapy therapy including Esoprazole 20mg，Clarithromycin 500mg and Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing

Eligibility criteria: Inclusion Criteria:

* Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
* Subject who fully understands conditions of clinical trial.
* Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria:

* Known hypersensitivity to any component of ilaprazole, Esoprazole, Amoxicillin and Clarithromycin
* Subjects who are taking contraindicated medications for experimental and concomitant drug
* Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study
* Pregnant and/or lactating women
* Reproductive aged women not using contraception
* Uncontrolled diabetics
* Uncontrolled hypertension
* Uncontrolled liver dysfunction
* Alcoholics
* Subjects with a history of digestive malignancy within 5 years
* Subjects with a history of gastrectomy or esophagectomy
* Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
* Subjects participating in a clinical trial before another trial within 30 days
* Inconsistent judged subject by researcher

Primary outcomes:
measure: Eradication rate of Helicobacter pylori as assessed by UBT test
timeFrame: 4 weeks
Secondary outcomes:
measure: Frequency of side effects of each treatment
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04327765: Staccato® Granisetron Multiple Dose PK
Official title: A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alexza Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2020-03-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To examine the tolerability and safety of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers To characterize the pharmacokinetics of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers

Detailed description: A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers

Eligibility criteria: Inclusion Criteria:

* Healthy based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
* Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening.
* Negative urine tests for selected drugs of abuse and alcohol breath test at screening and Day 1.

Exclusion Criteria:

* Any significant medical condition

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
timeFrame: 8 days
Secondary outcomes:
measure: Measurement of Granisetron Exposure in Plasma
timeFrame: 8 days
measure: Measurement of Granisetron Maximum exposure in Plasma
timeFrame: 8 days
measure: Measurement of Granisetron Time to Maximum Exposure in Plasma
timeFrame: 8 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Celerion
name: Terry O'Reilly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05744765: Effects of Breathing Exercises on Reaction Time
Official title: Short And Long Term Effects Of Breathing Exercises on Reaction Time: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breathing, Mouth
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled, single-blind
Primary purpose: OTHER

Brief summary: The aim of the study was to investigate the short and long-term effects of breathing exercises on reaction time.

Detailed description: A total of 40 participants who volunteered to participate in the study from the students of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bandırma Onyedi Eylül University will be included in the study. Participants will be randomly divided into two groups using a simple random numbers table. The study group (15 people) will be given respiratory exercises (12 sessions). The control group (15 people) will receive no intervention. In the study, after the demographic characteristics of the participants are obtained, reaction time will be evaluated with auditory and visual reaction tests and upper extremity reaction tests. All evaluations are planned to take a total of 15 minutes.

The same assessments will be performed in both groups. To measure the long-term effect, after the initial evaluations are completed, the study group will be given a total of 12 sessions of breathing exercises for 4 weeks (3 days a week). After 4 weeks, both groups will be evaluated again. To measure the short-term effect, the respiratory exercise program will be started after the 1st evaluation in the study group, and the 2nd evaluation will be made after the first session.

Canan Demir will perform breathing exercises, and the other researchers who will evaluate will not know which group the participants are in. In this way, the study will be single-blinded.

Translated with www.DeepL.com/Translator (free version)

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* To be between the ages of 18-30
* Not having any problems that prevent breathing exercises

Exclusion Criteria:

* Acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc. origin
* Having had any injury and/or operation (trauma, surgery, fracture, etc.) in the last 6 months
* Regular medication use
* Presence of respiratory disease (asthma, COPD, etc...)

Primary outcomes:
measure: Finger reaction test
timeFrame: 4weeks
measure: Upper extremity reaction test
timeFrame: 4weeks
measure: Auditory Reaction Test
timeFrame: 4weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: BandırmaOnyediEylulU
Study officials:
References:
Clinical trial NCT00421265: Active Surveillance for Prostate Cancer With Indolent Features
Official title: Prospective Cohort Study of Active Surveillance for Prostate Cancer With Indolent Linical Features
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: prostate cancer
active surveillance
indolent features
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-11
Enrollment: 150
Sex: MALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: In patients with prostate cancer with indolent features, disease progrssion may be very slow and in many cases will never become clinically evident during the patient's lifetime. Active surveillance is a continuous process of monitoring disease characteristcs aiming to avoid the morbidity of active therapy in patients with stabe indolent parameters, while offering early detection of disease activity in others who will need active therapy to control their disease. We hypothesize that active surveillance will permit the avoidance of therapy related morbidity in the majority of appropriate patients and will be associated with maintaining their quality of life.


Eligibility criteria: Inclusion Criteria:

1. Men 65 years of age or older who were diagnosed with prostate cancer in the past 3 month prior to inclusion
2. Gleason's score of 6 or less.
3. Clinical T1C per digital rectal exam.
4. Pre biopsy PSA serum level of 6.0ng/ml or less.
5. The presence of cancer in a single biopsy core of at least 8 taken.
6. The presence of cancer in no more than 10% of the length of the core involved.
7. Patient's consent to engage in active surveillance after being informed of the benefits and potential risks of this approach as well as of alternative lines of therapy.
8. Israeli residence with the readiness to be available for the followup schedule.

Exclusion Criteria:

Patients who do not meet the above eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Dan Leibovici, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04928365: Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy
Official title: Open Prospective Clinical Trial to Develop the Computer Software (Intelligent Prognostic System) for Predicting the Efficacy of Anti-PD-1 Immunotherapy of Melanoma Patients in Routine Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Blokhin's Russian Cancer Research Center
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Open prospective clinical trial to develop the computer software (Intelligent prognostic system) for predicting the efficacy of anti-PD-1 immunotherapy of melanoma patients in routine practice


Eligibility criteria: Inclusion Criteria:

1. Morphological verification of cutaneous melanoma. Verification of metastases is not necessary
2. ECOG 0-1
3. Age of patients - 18 years and older
4. No prior chemotherapy, immunotherapy, radiation or hormonal therapy
5. Adequate contraception for women of childbearing age
6. Written consent of the patient to participate in the study

Exclusion Criteria:

1. Non-compliance with the previously listed criteria
2. Pregnancy and breastfeeding
3. Therapy with systemic corticosteroids and/or other immunosuppressants within 4 weeks before the screening or a high probability of the need for their use during the study for the treatment of intercurrent pathology
4. History of another malignancy other than the study indication under this trial within 5 years of study enrollment. Does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer, or other in situ cancers.

Primary outcomes:
measure: Overall survival
timeFrame: up to 12 months
measure: Progression free survival
timeFrame: up to 12 months
Secondary outcomes:
measure: Cytokine profile
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23
Study officials:
References: