louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06405412: Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
Official title: Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Achalasia
Keywords: Peroral Endoscopic Myotomy
anesthesia
Esophageal Achalasia
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this retrospective cohort study, 50 patients diagnosed with achalasia who applied to the Gastroenterology department of Ümraniye Training and Research Hospital between October 2021 and February 2024 and were indicated for POEM treatment will be included.

Brief summary: The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery.

Detailed description: The primary purpose of this study is to define mild, medium and severe risk groups for malnutrition by using preoperative albumin values and MUST score in achalasia patients planned for POEM operation, and to determine the relationship of malnutrition/degree as well as demographic characteristics and comorbidities with postoperative respiratory and renal complications.

The secondary aim of this study was to determine persistent respiratory and renal outcome at 3 months after POEM procedure.

Eligibility criteria: Inclusion Criteria:

* Criteria for inclusion in the study:
* Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians
* ASA 1-3
* Between the ages of 18-80

Exclusion Criteria:

* Criteria for exclusion from the study:
* Those with a known history of active lung infection, advanced COPD, or respiratory failure
* Patients with EF below 40%, severe ischemic heart failure, presence of valve disease
* Those with bleeding diathesis and severe thrombocytopenia (limit 30-50 thousand)
* severe kidney dysfunction
* In the presence of known intolerance or allergy to certain medications for sedation, analgesia, or both
* Pre-existing increased intracranial pressure
* Having a BMI \>30
* Severe uncorrected hypovolemiaHistory of radiotherapy to the esophagus
* History of mucosal resection or ablation in the area where POEM will be applied
* Presence of cirrhosis and portal hypertension.

Primary outcomes:
measure: cardiorespiratory advers events
timeFrame: up to 12 weeks
measure: postoperative renal complications
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Malnutrition condition
timeFrame: up to 12 weeks
measure: escart score
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Education and Research hospital
Study officials:
References:
Clinical trial NCT06207812: Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis
Official title: Long-term Outcomes Associated With Juvenile-onset Mycosis Fungoides and Lymphomatoid Papulosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphomatoid Papulosis
Mycosis Fungoides
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 100
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: Participants with juvenile-onset mycosis fungoides

Brief summary: To follow up with all our participants with juvenile-onset mycosis fungoides, check on their status, and ask them or their parents about long term outcomes associated with their condition.

Detailed description: Primary Objective -To characterize the long-term outcomes associated with juvenile-onset mycosis fungoides (jMF) and lymphomatoid papulosis (lyp). The study will consider metrics such as 5-year and 10-year overall survival, and overall disease activity.

Secondary objective

-To characterize treatments and associated comorbidities.

Eligibility criteria: Inclusion Criteria:

-To be eligible, participants had to be diagnosed with jMF or lyp before age 20. In the case of participants below the age of 18, parents and not the children will be contacted for participation (children are exempt from participation as their parents may answer our study questions).

Exclusion Criteria:

-Participants older than 20 years of age at diagnosis

Primary outcomes:
measure: Safety and adverse events (AEs)
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Julia Dai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02901912: Comparison of Gut Microbiota in Sedentary and Active Women
Official title: Effect of Diet and Exercise in the Gut Microbiota of Premenopausal Women:Correlation With Inflammatory and Oxidative Stress Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sedentary
Keywords: physical activity
sedentarism
fecal enzymatic activity
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy women who do not perform exercise at all or practice at least 3 hours of exercise per week

Brief summary: Gut microbiota comparison of active and sedentary women

Detailed description: Observational study comparing gut microbiota of people who did not practice any physical exercise (sedentary) with the gut microbiota of people who at least practice exercise a minimum of 3 hours per week but they were not professional athletes. Since the hormonal status and gender are factors that influence gut microbiota, this study has been conducted in premenopausal women.

Eligibility criteria: Inclusion Criteria:

* healthy women

Exclusion Criteria:

* Smokers, pregnant, vegetarian, vegan, taking antibiotics in the last 3 months, any kind of disease, body mass index\>25

Primary outcomes:
measure: Physical activity
timeFrame: 7 days
Secondary outcomes:
measure: Gut microbiota
timeFrame: One year
measure: Diet
timeFrame: 6 months
Other outcomes:
Locations:
city: Villaviciosa de Odón
country: Spain
facility: Mar Larrosa
state: Madrid
Study officials:
affiliation: Universidad Europea de Madrid
name: Mar Larrosa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06670846: Management of Preoperative Anxiety in Children: Could a Lollipop Be the Solution?
Official title: Management of Preoperative Anxiety in Children: Could a Lollipop Be the Solution?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety, Preoperative
Keywords: anxiety
children
anesthesia
distraction
midazolam
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 63
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Chidren were randomized into two groups to receive either intranasal midazolam at 0.3 mg/kg (group M) or distraction using a lollipop (group L) 15 minutes before entering the operating room
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate the effectiveness of distraction using a lollipop versus premedication with intranasal midazolam to manage preoperative anxiety in pediatric anesthesia.

Detailed description: Participants were randomized into two groups to receive either intranasal midazolam at 0.3 mg/kg (group M) or distraction using a lollipop (group L) 15 minutes before entering the operating room. The anesthetic technique was standardized: a peripheral intravenous line, intravenous induction (propofol and fentanyl), airway management with an age-appropriate IGEL mask, and maintenance with sevoflurane. Anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS) before and after premedication. The investigators also evaluate the level of sedation upon entering the operating room, the quality of parent separation, acceptance of the facemask during induction, and emergence of agitation using the Pediatric Anesthesia Emergence Delirium Scale (PAEDS).

Eligibility criteria: Inclusion Criteria:

* Age \> 4 ans , ASA 1 ou 2

Exclusion Criteria:

* Children who rejected premedication - The occurrence of perioperative complications

Primary outcomes:
measure: anxiety
timeFrame: immediatly before premedication and 15 minutes after premedication
Secondary outcomes:
measure: agitation
timeFrame: 10 minutes after extubation
measure: parent separation
timeFrame: 15 minutes after premedication
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Bechir Hamza hospital
Study officials:
References:
Clinical trial NCT03518346: Use of Virtual Reality Game Playing During Venipuncture
Official title: Use of Virtual Reality Game Playing During Venipuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Development Delay
Typical Development
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 12
Sex: ALL
Minimum age (years): 8
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate the impact of using virtual reality, VR, game playing on successful completion and reduction of distress and pain in pediatric venipuncture, and to increase adherence in obtaining the desired blood volume.

Detailed description: Participants will be randomly assigned using a random number generator to either the virtual reality condition, or to the standard procedure that includes using books and/or watching movies as a standard method of distraction.

Participants will take part in the study during their scheduled research venipuncture. The venipuncture lasts approximately 15-30 minutes. Pre and post venipuncture questionnaires for both participant and parent will take 15 minutes to complete. Total study time is between 30 and 45 minutes. Questionnaires completed by research personal will take 15 minutes to complete.

Eligibility criteria: Inclusion Criteria:

1. Participants aged 8-19 years old that are receiving a blood draw as part of their ReCHARGE evaluation
2. History of distress or refusal of blood draws or similar medical procedures OR
3. Parent or child endorsement of fear, anxiety, concern or adherence in past blood draw during the recruitment phone call, consent or child evaluation will be offered the potential of the VR intervention OR
4. Endorsement of anxiety or concerns with medical procedures on an in house phlebotomist blood draw screening form will also be used as inclusion criteria.

Exclusion Criteria:

1. History of seizures.
2. Vision loss or significant visual impairment to the degree that the participant is unable to see the activity and features of the VR game.

Primary outcomes:
measure: Attempting vs. Refusing Venipuncture
timeFrame: 2 years
Secondary outcomes:
measure: Blood volume
timeFrame: 2 years. Collected once on each participant: immediately following injection
measure: Pain Scale
timeFrame: 2 years. Collected once on each participant: immediately following injection
measure: Satisfaction Survey
timeFrame: 2 years. Collected once on each participant: immediately following injection
measure: Fear Scale
timeFrame: 2 years. Collected twice on each participant: before and immediately following injection
measure: Time to Achieve Optimal Blood Volume
timeFrame: 2 years. Collected on each participant: during venipuncture procedure
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis MIND Institute
state: California
Study officials:
affiliation: University of California, Davis
name: Julie Schweitzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03426046: Treatment of Immature Permanent Teeth With Three Different Pulp Capping Materials With Partial Pulpotomy
Official title: Partial Pulpotomy Treatment Of Immature Permanent Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caries, Dental
Keywords: Biodentine
Cariously exposed pulp
MTA
Partial pulpotomy
Image J Software
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial is to compare partial pulpotomy treatments with Biodentine®, calcium hydroxide (CH) and Mineral Trioxide Aggregate (MTA) in cariously exposed asymptomatic young permanent teeth clinically and radiographically for 1 year and evaluate root developments with Image J Software Program. The null hypothesis of this study is Biodentine® will promote healing with high success rates and induce root development more than CH and MTA.

Detailed description: The purpose of this study was to evaluate clinical and radiographical success of three different materials in partial pulpotomy treatment. 50 patients with 54 asymptomatic, cariously exposed young permanent mandibular molar teeth were included to the study. The teeth were randomly divided into three main groups which were; calcium hydroxide, MTA and Biodentine® and finally restorated with stainless steel crowns. Pain, percussion sensitivity, palpation sensitivity of soft tissue around the tooth, root development, presence of lesion, integrity of lamina dura were evaluated clinically and radiographically during 12 months and recorded for each. Also, Image J Program with Turbo-Reg plug in was used for standardization of the radiographs and to determine the increase in root length.

Eligibility criteria: Inclusion Criteria:

* Deep dentine caries with pulp exposure

Exclusion Criteria:

* Pulp exposure without hemorrhage control

Primary outcomes:
measure: Root development
timeFrame: 12 months
Secondary outcomes:
measure: Clinical Evaluation
timeFrame: 12 months
measure: Radiographical Evaluation
timeFrame: 12 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry
Study officials:
affiliation: Gazi University, Faculty of Dentistry, Department of Pediatric Dentistry
name: Alev Alacam, DDS, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06700746: Efficacy of Dextrose Prolotherapy Compare With ESWT in the Treatment of Chronic Rotator Cuff Tendinopathy
Official title: Efficacy of Dextrose Prolotherapy Compare With Extracorporeal Shock Wave Therapy in the Treatment of Chronic Rotator Cuff Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rotator Cuff Tendinopathy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 24
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: To compare the efficacy of dextrose solution injection with ESWT for pain reduction in rotator cuff tendinopathy.

Additionally, secondary objective is to evaluate DASH and active range of motion of shoulder joint


Eligibility criteria: Inclusion Criteria:

* Chronic shoulder pain for at least 3 months
* Unilateral affected side
* History of unsuccessful conservative treatment
* Age 18 years or older

Exclusion Criteria:

* Rotator cuff complete tear
* Local or generalized arthritis
* Previous shoulder surgery
* Previous history allergy to local anesthesia
* Pregnancy
* Current infectious or tumorous disease
* Dysfunction in the neck or thoracic region of both
* Coagulation disturbance

Primary outcomes:
measure: VAS score
timeFrame: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
Secondary outcomes:
measure: Function DASH score
timeFrame: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
measure: Shoulder ROM
timeFrame: Assessment at baseline, three weeks, six weeks, three months and six months after the end of the treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Physical medicine and rehabilitation
Study officials:
affiliation: Mahidol University, Ramathibodi Hospital
name: Songsuda Roongsaiwatana, M.D.
role: STUDY_DIRECTOR
References:
citation: Hauser RA, Lackner JB, Steilen-Matias D, Harris DK. A Systematic Review of Dextrose Prolotherapy for Chronic Musculoskeletal Pain. Clin Med Insights Arthritis Musculoskelet Disord. 2016 Jul 7;9:139-59. doi: 10.4137/CMAMD.S39160. eCollection 2016.
citation: Galasso O, Amelio E, Riccelli DA, Gasparini G. Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomized, placebo-controlled trial. BMC Musculoskelet Disord. 2012 Jun 6;13:86. doi: 10.1186/1471-2474-13-86.
Clinical trial NCT01049646: Interaction of Apelin and Angiotensin in the Systemic Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renin Angiotensin System
Keywords: renin-angiotensin system
apelin
systemic haemodynamics
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The apelin-APJ system is a relatively new discovery. It has generated interest in part due to it's apparent ability to counteract the renin-angiotensin system, which is frequently overactive in many cardiovascular disease.

Apelin improves that pumping ability of the heart and we wish to know if this action persists in the presence of increased levels of angiotensin II.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Healthy volunteers

Exclusion Criteria:

* Lack of informed consent
* Age \< 18 years,
* Current involvement in other research studies,
* Systolic blood pressure \>190 mmHg or \<100 mmHg
* Malignant arrhythmias
* Renal or hepatic failure
* Haemodynamically significant aortic stenosis
* Severe or significant co morbidity
* Women of childbearing potential.

Any regular medication

* Previous history of any cardiovascular disease

Primary outcomes:
measure: Cardiac output
timeFrame: 90 mins
Secondary outcomes:
measure: Systemic haemodynamics
timeFrame: 90mins
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc
Study officials:
References:
citation: Barnes GD, Alam S, Carter G, Pedersen CM, Lee KM, Hubbard TJ, Veitch S, Jeong H, White A, Cruden NL, Huson L, Japp AG, Newby DE. Sustained cardiovascular actions of APJ agonism during renin-angiotensin system activation and in patients with heart failure. Circ Heart Fail. 2013 May;6(3):482-91. doi: 10.1161/CIRCHEARTFAILURE.111.000077. Epub 2013 Mar 21.
Clinical trial NCT06651346: Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma from ERCP-directed Biliary Samples
Official title: Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma from ERCP-directed Biliary Samples
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cholangiocarcinoma
Keywords: ERCP
Cytology
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 100
Sex: ALL
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: Patients with indeterminate biliary strictures or masses who are already undergoing ERCP with biliary tissue sampling in the form of biliary brushings or biopsies

Brief summary: Cholangiocarcinoma is a malignancy that is most-often diagnosed with ERCP-directed cytology brushings of the biliary tree, but the yield on this cytology has been previously shown to only be 5%-40%. Additionally, the vast majority (approximately 80%) of patients are not diagnosed until they are surgically unresectable (due to late stage at time of diagnosis), at which point there is no chance for cure and their only options are palliative. Therefore, better diagnostic modalities are needed. Plectin is a structural protein located inside of most cells, but it has been shown to be expressed on the cell surface of malignant cells in the pancreaticobiliary tract. The investigators hypothesize that ERCP-guided biliary samples can provide cells and immunohistochemical staining can detect cell surface plectin in patients with cholangiocarcinoma. This would be a novel diagnostic tool which could greatly reduce the time to diagnosis. A previously performed study pilot study at the University of Virginia (unpublished) showed that ERCP-directed biliary biopsies in patients with known cholangiocarcinoma had positive plectin immunohistochemistry, thus showing this is possible. In this current study, patients with a biliary stricture or tumor who are already undergoing ERCP as part of their routine clinical care (i.e. no procedures will be done exclusively for this research study) will undergo an additional biopsy and/or brushing to be assessed for cell-surface plectin expression via immunohistochemistry. The investigators hypothesize that plectin immunohistochemistry will have a higher sensitivity for cholangiocarcinoma than biopsies and/or brushings (cytology) alone.


Eligibility criteria: Inclusion Criteria:

* Biliary stricture or mass seen on imaging; already undergoing ERCP as part of their routine clinical care

Exclusion Criteria:

* Age \< 18 years old; inability to consent

Primary outcomes:
measure: Positive plectin staining on IHC from ERCP-directed biliary samples
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: