louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06189859: Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy
Official title: Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Achalasia
Achalasia Cardia
Keywords: achalasia
POEM
ELECTROSURGERY
SPRAY COAGULATION
PERORALENDOSCOPIC ESOPHAGEAL MYOTOMY
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 52
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: Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Spray coagulation has been anecdotally favored by many endoscopists due to its high coagulation power and assumed safety. Recently, Precisect mode has been developed, it has theoretical advantages of very minimal tissue penetration and minimal to no charring effect. In this trial, the investigators compare the efficacy and safety of both electrosurgical modes in POEM procedures.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing POEM procedure for any esophageal motility disorder
* Esophageal motility disorder confirmed by high-resolution manometry and gastroscopy

Exclusion Criteria:

* Esophageal varices
* Esophageal neoplasms
* Non-correctable coagulopathy
* Failure to provide an informed consent

Primary outcomes:
measure: Speed of endoscopic submucosal dissection
timeFrame: during the procedure
Secondary outcomes:
measure: Intraprocedural Bleeding
timeFrame: during the procedure
measure: Significant Intraprocedural bleeding
timeFrame: during the procedure
measure: Other Adverse events
timeFrame: during the procedure
measure: Total procedure duration
timeFrame: during the procedure
measure: Endoscopic submucosal tunneling duration
timeFrame: during the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: hany shehab
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00761059: Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning
Official title: Prospective, Placebo-Controlled Blinded Clinical Trial to Study the Efficacy of Orally Administered Glucose 20% for Relieving Pain During Nasopharyngeal Suctioning in Preterm Infants > 1500g Under CPAP-Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Keywords: analgesia
infant, premature
glucose
nasopharyngeal suctioning
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. Glucose 20% has been shown to have an analgesic effect when administered to preterm infants previous to some painful procedures (i.e blood sampling).

In this clinical trial the efficacy of orally administered Glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a cross-over design and is to include 40 patients.


Eligibility criteria: Inclusion Criteria:

* Preterm newborns (\>1500g birth weight) up to a gestational age of 36+6 weeks
* CPAP respiratory therapy
* Parents' given written consent

Exclusion Criteria:

* Diseases complicating neuromuscular evaluation.
* Drug abuse by the mother
* Administration of other analgetic or sedative drugs within the previous 48h.
* Participation in another interventional clinical trial within 4 weeks before the beginning of this trial.

Primary outcomes:
measure: The PIPP-Score, a validated pain-score, is used to measure the patient's pain
timeFrame: during nasopharyngeal suctioning
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Neonatology, Children's Hospital, University of Cologne
Study officials:
affiliation: Neonatology, Children's Hospital, University of Cologne
name: Christoph Huenseler, Dr med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04109859: Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
Official title: Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Jaundice
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Increased production of vasodilating substances such as NO plays an important role in the development of vasoplegic syndrome caused by obstructive jaundice.Methylene blue plays a role in raising blood pressure by inhibiting the vasodilator Nitric Oxide (NO)

Detailed description: The level of circulating hydrogen sulfide (H2S) in patients with obstructive jaundice is significantly increased. As a direct opener of KATP channels in vivo, H2S also has diastolic peripheral vasculature . H2S participates in the occurrence of vasoplegic syndrome in patients with obstructive jaundice by interacting with NO. However, it is unclear whether methylene blue can relieve vasoplegic syndrome in patients with obstructive jaundice by inhibiting the vasodilating effect of substances such as H2S and NO.

Therefore, this clinical study intends to include patients with obstructive jaundice, using randomized, controlled, prospective study to explore the effect of methylene blue on the occurrence of vasoplegic syndrome, organ function and prognosis in patients with obstructive jaundice.

Eligibility criteria: Inclusion Criteria:

1. Age: 18\~70 years old;
2. ASA grade I\~III;
3. Ability to comply with research protocols;
4. Patients with obstructive jaundice: patients with total bilirubin greater than 50umol/L;
5. Voluntarily participate in the study and sign the informed consent form. -

Exclusion Criteria:

1. ASA IV\~V grade;
2. women during lactation and pregnancy;
3. Patients with severe heart disease or lung disease before surgery;
4. Participating in other trials in the last 2 months;
5. Those whose mental state cannot cooperate, who suffer from mental illness, have no self-control, and cannot express clearly;
6. Those who refuse to sign the informed consent form. -

Primary outcomes:
measure: Acute physiology and chronic health evaluation IIScore sheet
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: ChongQing
country: China
facility: department of anesthesia, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China
state: Chongqing
Study officials:
affiliation: Professor of department of anesthesia, Southwest Hospital
name: Jiaolin Ning, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01491659: A Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
Official title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect and Safety of Idoform Plus on Bowel Side Effects in Healthy Subjects Treated With Amoxicillin/ Clavulanate
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diarrhoea
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Danisco/Dupont
First posted: 2011-12-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is hypothesized that Idoform plus will recuce the occurence of gastrointestinal side effects related to the use of antibiotics


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers 18-70 years of age
* Subjects with normal gastrointestinal function
* Subjects willing to provide written informed consent

Exclusion Criteria:

* Subjects receiving antibiotic treatment within three months prior to inclusion in the study
* Pregnancy or planned pregnancy
* Breast feeding
* Subjects who are allergic to beta-lactam antibiotics, amoxicillin / clavulanate or its components
* Subjects with known renal insufficiency
* Subjects using products containing probiotics, fibers and/or prebiotics
* Subjects using proton pump inhibitors
* Subjects using H2 antagonists
* Subjects using antacids frequently

Primary outcomes:
measure: Occurence of Antibiotic Associated Diarrhea
timeFrame: 17 days
Secondary outcomes:
measure: Duration of Antibiotic Associated Diarrhoea
timeFrame: 17 days
measure: Occurrence of Antibiotic Associated Loose Stools (Types 5,6 or 7 on the Bristol Stool Chart) at Least Once During a Day
timeFrame: 17 days
measure: Presence of Gastrointestinal Symptoms (Abdominal Pain; Bloating/Distension; Nausea/Upset Stomach), and the Severity of Each Symptom
timeFrame: 17 days
measure: Changes in the Gut Microbiota Composition
timeFrame: 17 days
measure: Changes in Markers of Antibiotic Resistance
timeFrame: 17 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01802359: A Study to Evaluate the Safety and Effectiveness of Mirodenafil in Korean Patients With Erectile Dysfunction
Official title: Post-Marketing Surveillance of Bravonto in Korea
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Mirodenafil
Bravonto
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 379
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with erectile dysfunction and prescribed mirodenafil on demand.

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of mirodenafil in participants with erectile dysfunction.

Detailed description: This is a non randomized (the study medication is not assigned by chance), open-label (all participants and study staff know the identity of the treatment), multi-center, prospective (looking forward using observations collected following participant enrollment), and non-comparative study in which participants with erectile dysfunction will be observed to evaluate the safety and effectiveness of mirodenafil for 12 weeks. Safety evaluations will include assessment of adverse events, and record of concomitant medications. The study will be conducted in Korea.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with erectile dysfunction
* Participants prescribed mirodenafil on demand

Exclusion Criteria:

- Participants who have administered mirodenafil for other than an approved indication

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: International Index of Erectile Function
timeFrame: Baseline (Week 0), Week 4, Week 8, and Week 12
measure: Sexual Encounter Profile
timeFrame: Baseline (Week 0), Week 4, Week 8, and Week 12
measure: Global assessment Questionnaire
timeFrame: Baseline (Week 0), Week 4, Week 8, and Week 12
measure: Number of participants with adverse events
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT06564259: Relationship Between Serum β2-Microglobulin and Infiltration of CD8+ in the Tumor Tissue of Hodgkin's Lymphoma Patients
Official title: The Relationship Between Serum Beta-2 Microglobulin (sB2M) Levels and CD8+ Cell Infiltration in Hodgkin Lymphoma Tissues: Impact on Chemotherapy Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin Lymphoma
Keywords: serum Beta-2 Microglobulin, CD8+ cells, Hodgkin lymphoma, Predictive value, Chemotherapy.
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included a cohort of 144 patients newly diagnosed with Hodgkin lymphoma. Patients were between the ages of 14 and 71 years, with an almost balanced representation of both genders. All participants had a confirmed Hodgkin lymphoma diagnosis based on histopathological examination. The study population reflected a diverse range of disease stages and subtypes, providing a comprehensive understanding of the relationship between pre-treatment Beta-2 Microglobulin (B2M) levels, CD8+ cell infiltration, and chemotherapy response in this patient population.

Brief summary: In newly diagnosed Hodgkin lymphoma patients, pre-treatment Beta-2 Microglobulin (B2M) levels will be measured. A thorough baseline assessment will be performed using CT imaging, and tumor tissue samples will be collected for Immunohistochemical (IHC) analysis to quantify CD8+ cell infiltration. Patients will be closely monitored throughout their treatment, with a follow-up CT scan at the end of therapy to evaluate therapeutic response. This study aims to investigate the correlation between pre-treatment B2M levels and CD8+ immune cell infiltration in tumor tissues, assessing their potential as predictive markers for chemotherapy response.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed patients with Hodgkin lymphoma
* No prior history of malignancy
* Absence of primary or secondary immunodeficiencies

Exclusion Criteria:

* Patients who have previously undergone treatment
* Patients with acute or chronic infections
* Patients with renal disorders
* Individuals with autoimmune diseases
* HIV-positive patients

Primary outcomes:
measure: Therapeutic response
timeFrame: 2-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University
Study officials:
affiliation: Tishreen University
name: Firas Hussien, Prof.
role: STUDY_CHAIR
affiliation: Tishreen University
name: Maram Bilal, Prof.
role: STUDY_DIRECTOR
affiliation: Tishreen University
name: Hasan Khalil, Ms
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00638859: Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
Official title: Evaluation of the Safety, Pharmacokinetics, Efficacy, and Acceptability of HMR3647 20 mg/kg qd for 5-7 Days With Community-Acquired Pneumonia (CAP) in Children (Multicenter, Open Label, Noncomparative Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Keywords: Community-Acquired pneumonia
CAP
children
Child
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5-7 days in children with community-acquired pneumonia (CAP).

Secondary objectives are to assess Pharmacokinetics, Efficacy and Acceptability of telithromycin 20 mg/kg qd for 5-7 days in children with CAP.


Eligibility criteria: Inclusion Criteria:

* Subjects who are weighing 40 kg or less. If female, premenarchal status is required.
* Subjects who are diagnosed with CAP based on chest X-ray showing the presence of a new infiltrate, clinical symptoms, and laboratory findings.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
Secondary outcomes:
measure: Clinical efficacy: change in the symptoms and signs
measure: Acceptability: compliance and willingness to take medication
measure: Pharmacokinetics: plasma concentrations of telithromycin
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02023359: Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer
Official title: Observational Study of Everolimus in Combination With Exemestane in Postmenopausal Patients With Hormone Receptor-positive, HER 2-negative Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Advanced breast cancer
Everolimus
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women with HR-positive, HER2-negative advanced breast cancer who are treated with everolimus and exemestane according to the approved SmPC will be included in the study.

Brief summary: An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination. The objective of the study is to assess the safety pattern of everolimus in a real world setting.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with HR-positive, HER2-negative advanced breast cancer who are treated with everolimus and exemestane according to the approved Summary of Product Characteristics (SmPC).
* Patients who started treatment after approval of this indication but before the initiation of this study can be retrospectively included, provided that they have systematically been assessed for adverse events.
* The decision to treat the patient with everolimus and exemestane must be independent of the patient's participation in the study.
* The patient must provide signed Informed Consent before any data can be captured.

Exclusion Criteria:

- No formal exclusion criteria

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 2.5 years
Secondary outcomes:
measure: Progression free survival
timeFrame: Up to 2.5 years
measure: Overall response rate
timeFrame: Up to 2.5 years
measure: Clinical benefit rate
timeFrame: Up to 2.5 years
measure: Overall survival
timeFrame: Up to 2.5 years
measure: Time on treatment with everolimus
timeFrame: Up to 2.5 years
measure: Reason for stopping treatment with everolimus
timeFrame: Up to 2.5 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital, Clinical Research unit Department of oncology, Klinik Kirurgi-kræft, Hobrovej 18-22
city: Esbjerg
country: Denmark
facility: Onkologisk Afdelning, SVS Esbjerg
city: Odense
country: Denmark
facility: Department of Oncology, Odense University Hospital
Study officials:
References:
Clinical trial NCT02794259: tDCS Effects on GABA Concentration and Brain Functional Connectivity in Older Adults of Retirement Age
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on GABA Concentration and Brain Functional Connectivity in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Older Adults
Keywords: GABA concentration
tDCS
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Physikalisch-Technische Bundesanstalt Institut Berlin (PTB)
First posted: 2016-06-09
Enrollment: 24
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether anodal tDCS over the left M1 leads to a decrease of GABA concentration and alterations of functional brain connectivity in older people, compared to sham tDCS.


Eligibility criteria: Inclusion Criteria:

* unobtrusive neuropsychological screening
* age: older adults of retirement age: ≥66 years

Exclusion Criteria:

* Mild cognitive impairment (MCI) or other neurological diseases.
* History of severe alcoholism or use of drugs.
* Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
* Contraindication for MRI (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).

Primary outcomes:
measure: GABA concentration assessed by magnetic resonance spectroscopy (MRS) after anodal tDCS adjusted for baseline levels
timeFrame: assessed immediately before and after a 15-min stimulation time
Secondary outcomes:
measure: GABA concentration assessed by MRS before and after cathodal tDCS adjusted for baseline levels
timeFrame: assessed immediately before and after a 15-min stimulation time
measure: Resting-state functional connectivity changes
timeFrame: assessed during a 15-min stimulation time
measure: Genotyping of learning related polymorphisms
timeFrame: assessed during baseline screening
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stagg CJ, Bachtiar V, Amadi U, Gudberg CA, Ilie AS, Sampaio-Baptista C, O'Shea J, Woolrich M, Smith SM, Filippini N, Near J, Johansen-Berg H. Local GABA concentration is related to network-level resting functional connectivity. Elife. 2014 Mar 25;3:e01465. doi: 10.7554/eLife.01465.
citation: Bachtiar V, Near J, Johansen-Berg H, Stagg CJ. Modulation of GABA and resting state functional connectivity by transcranial direct current stimulation. Elife. 2015 Sep 18;4:e08789. doi: 10.7554/eLife.08789.
citation: Amadi U, Allman C, Johansen-Berg H, Stagg CJ. The Homeostatic Interaction Between Anodal Transcranial Direct Current Stimulation and Motor Learning in Humans is Related to GABAA Activity. Brain Stimul. 2015 Sep-Oct;8(5):898-905. doi: 10.1016/j.brs.2015.04.010. Epub 2015 May 1.