louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03693352: Functional Residual Capacity Measured by Capnography in Ventilated Patients
Official title: Effect of Positive End-expiratory Pressure on Functional Residual Capacity Measured by Volumetric Capnography in Mechanically Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Physiological Phenomena
Lead sponsor: Hospital Privado de Comunidad de Mar del Plata
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing general anesthesia for laparoscopic surgery

Brief summary: Changes in body position during anesthesia can alter functional residual capacity and gas exchange. The monitoring of such changes in functional residual capacity is difficult at the bedside. The present study was designed to determine if volumetric capnography can detect changes in the functional residual capacity during surgery.

Detailed description: This is a prospective and observational study designed to test the reliability of the capnodynamic equation to determine changes in functional residual capacity measured during anesthesia. The investigators will studied 40 mechanically ventilated patients undergoing general anesthesia. Functional residual capacity will be continuously measured in a non invasive way using expired carbon dioxide. Changes in functional residual capacity with standard modification in body positioning (Trendelenburg or anti-Trendelenburg position) and ventilatory settings wiil be tested.

Eligibility criteria: Inclusion Criteria:

* Written Inform Consent
* Programmed surgery
* Laparoscopic surgery
* Supine position

Exclusion Criteria:

* Emergency surgery
* Chronic respiratory disease
* Active smoking

Primary outcomes:
measure: Functional Residual Capacity Measured by Capnography in Ventilated Patients
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mar del Plata
country: Argentina
facility: Hospital Privado de Comunidad
state: Buenos Aires
Study officials:
affiliation: Hospital Privado de Comunidad de Mar del Plata
name: Gerardo Tusman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Albu G, Wallin M, Hallback M, Emtell P, Wolf A, Lonnqvist PA, Gothberg S, Petak F, Habre W. Comparison of static end-expiratory and effective lung volumes for gas exchange in healthy and surfactant-depleted lungs. Anesthesiology. 2013 Jul;119(1):101-10. doi: 10.1097/ALN.0b013e3182923c40.
citation: Tusman G, Wallin M, Acosta C, Santanera B, Portela F, Viotti F, Fuentes N, Hallback M, Suarez-Sipmann F. Positive end-expiratory pressure individualization guided by continuous end-expiratory lung volume monitoring during laparoscopic surgery. J Clin Monit Comput. 2022 Oct;36(5):1557-1567. doi: 10.1007/s10877-021-00800-2. Epub 2021 Dec 29.
Clinical trial NCT06255652: Oral Versus Intravenous Antibiotic Prophylaxis Before Obstetric and Gynecological Procedures
Official title: Oral Versus Intravenous Antibiotic Prophylaxis Before Obstetric and Gynecological Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Site Infection
Keywords: SSI
Lead sponsor: Sohag University
Sponsor class: OTHER
Collaborators: name: Randers Regional Hospital
First posted: 2024-02-13
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patient Pregnant For gynaecological procedure

Brief summary: Oral versus intravenous antimicrobial prophylaxis for the prevention of surgical site infection for elective cesarean section and gynacological procedures

Detailed description: the aim of the current study is to compare the efficacy of prophylactic intravenous (cephradine) and oral antibiotic (cephradine) for the prevention of surgical site infection in the elective obctetric and gynecological procedures

Eligibility criteria: Inclusion Criteria:

- Cesarean section Gynaecological procedure Exclusion Criteria Immunocompromised patient

-

Primary outcomes:
measure: proportion of patients with any SSI within 30 days after surgery
timeFrame: July 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university hospital
Study officials:
affiliation: Sohag University
name: Hatem Awaga Awaga, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05701852: Motivational Behavioral and Functional MRI Impairment in Patients With Chronic Neuropathic Pain
Official title: Motivational Behavioral and Functional MRI Impairment in Patients With Chronic Neuropathic Pain
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Pain
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2023-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be proposed to patients followed at the pain treatment center or in neurosurgery for chronic neuropathic pain, of peripheral or central origin.

Controls will be recruited among the patients' companions and the staff of the Adolphe de Rothschild Foundation Hospital.

Brief summary: The main hypothesis of this study is that the alteration of the reward circuitry underlying the motivational deficit in chronic pain patients compared to healthy subjects results in a decrease in the capacity for reward learning. The fMRI studies have shown that this type of learning depends on the dopaminergic system innervating key regions of the reward system.


Eligibility criteria: Inclusion Criteria:

* For cases: patients managed in the neurosurgery department or at CETD for chronic neuropathic pain, of central or peripheral origin.
* For controls: matched to a case on age (±5 years) and sex

Exclusion Criteria:

* Neurodegenerative or inflammatory neurological pathology
* Clinical depressive syndrome
* High doses of opioid treatment (greater than 100 mg/day of morphine equivalent)
* Impaired judgment or inability to receive information that does not allow the performance of behavioral tasks
* Absolute contraindication to MRI (e.g. pacemaker, implantable pacemaker, metallic intra-orbital foreign body)

Primary outcomes:
measure: To compare reward learning ability in patients with chronic neuropathic pain compared with an age (±5 years) and gender-matched control population
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00201552: Statin and PAF in Patients With Pacemaker
Official title: Atorvastatin Decreases Atrial Fibrillation Burden in Patients With Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Statin could decrease AF burden

Detailed description: Statin could decrease AF burden in patients with PAF.

Eligibility criteria: Inclusion Criteria:

* Patients with pacemaker

Exclusion Criteria:

* Patients with hepatic dysfunction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jiunn-Lee Lin, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01683552: Aprepitant in the Management of Biological Therapies-related Severe Pruritus
Official title: Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ITCH
Keywords: ITCH
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological therapy-induced pruritus.

Detailed description: Investigators enroll patients affected by solid tumors which present itch refractory to standard treatment ("refractory group") and patients who did not receive any treatment for pruritus ("naïve group"). The intensity of itch will be evaluated with Visual Analogue Scale (VAS) score. In the refractory group Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) will be administered after at least 1 week of standard systemic treatment. In the naïve group, Aprepitant will be administered after the first onset of severe pruritus. The primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive and refractory group.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed diagnosis of solid tumor
* treatment with anti-EGFR antibodies or TKIs
* first onset of severe pruritus during treatment (≥7 on Visual Analogue Scale (VAS) score)

Exclusion Criteria:

* oral treatment with antimycotics during 4 weeks preceding enrolment
* topical treatment during the previous 2 weeks
* concomitant,chronic renal or hepatic insufficiency , skin infection or dermatitis.

Primary outcomes:
measure: Severity of ITCH
timeFrame: once before aprepitant administration; 7 days after the first dose of aprepitant, and once a week until the end of biological therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Campus Bio-Medico of Rome University
Study officials:
affiliation: Campus Bio-Medico of Rome University
name: Daniele Santini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santini D, Vincenzi B, Guida FM, Imperatori M, Schiavon G, Venditti O, Frezza AM, Berti P, Tonini G. Aprepitant for management of severe pruritus related to biological cancer treatments: a pilot study. Lancet Oncol. 2012 Oct;13(10):1020-4. doi: 10.1016/S1470-2045(12)70373-X. Epub 2012 Sep 18.
Clinical trial NCT03738852: Mechanisms for Restoration of Hypoglycemia Awareness
Official title: Mechanisms for Restoration of Hypoglycemia Awareness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type1 Diabetes Mellitus
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-11-13
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess if using the hypoglycemic clamp and functional magnetic resonance imaging (fMRI) scanning in hypoglycemia unaware and aware T1DM patients and healthy controls have showed distinct differences in patterns of brain responses. In particular, T1DM patients who are aware of hypoglycemia (T1DM-Aware) have greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas hypoglycemia unaware T1DM patients (T1DM-Unaware) show no detectable changes in brain reward regions during hypoglycemia.

Detailed description: To assess the following: 1) if these differences are driven purely by recurrent hypoglycemia or by other closely linked factors (e.g. glycemic variability); 2) the molecular and metabolic mechanisms by which unawareness leads to the suppression of central nervous system (CNS) activity in the context of hypoglycemia; and 3) whether hypoglycemia avoidance using continuous glucose monitor restores central nervous system (CNS) activation and metabolism toward normal levels and offers a therapeutic approach to more effectively combat neurocognitive dysfunction associated with intensive treatment of T1DM patients.

Eligibility criteria: Inclusion Criteria:

* Ages \> 18 years
* Healthy, non-diabetic control or T1DM
* BMI \> 18.0

Exclusion Criteria:

* Creatinine \> 1.5 mg/dL
* Hct \< 35% for females, \< 39% for males
* ALT \> 2.5 X ULN
* untreated thyroid disease
* uncontrolled hypertension
* neurologic disorders
* untreated depression or change in antidepressant regimen in last 3 months
* use of any anxiolytic medications (benzodiazepine) or antipsychotic medications
* greater than 5% change in weight in last 3 months
* malignancy
* current or recent steroid use in last 3 months
* illicit drug use
* significant complications related to diabetes (peripheral neuropathy, proliferative retinopathy)
* inability to enter MRI (per standard MRI safety guidelines)
* for women: pregnancy or breastfeeding

Primary outcomes:
measure: Brain Glucose Levels
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation (YCCI) Church Street Research Unit (CSRU)
state: Connecticut
Study officials:
affiliation: Yale University
name: Janice Hwang, Hwang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03486652: Rheumatological Manifestations in Inflammatory Bowel Diseases
Official title: Rheumatological Manifestations in Inflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 70
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: Any patient with inflammatory bowel diseases complaining of rheumatological manifestations clinical examination with espicial emphysis on the joints.

Brief summary: IBD-related arthropathy is one of a group of inflammatory arthritides considered as seronegative spondyloarthropathies, a group of disorders that also includes ankylosing spondylitis, psoriatic arthritis, reactive arthritis, and undifferentiated SpA. IBD-related SpA is mainly characterized by axial involvement but may also be associated with peripheral symptoms, such as synovitis, dactylitis, or enthesitis


Eligibility criteria: Inclusion Criteria:

* any patient with inflammatory bowel diseases complaining of rheumatological manifestations

Exclusion Criteria:

* chronic hepatitis (c) patients
* Rheumatoid factor positive patients
* psoriatic patients.
* systemic lupus.

Primary outcomes:
measure: the prevalence of rheumatological manifestations in cases of corhn's and ulcerative colitis
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01046552: Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones
Official title: Preoperative Versus Intraoperative Endoscopic Sphincterotomy for Management of Choledocholithiasis and Cholecystolithiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Stones.
Keywords: Choledocholithias
Common bile duct stones
Endoscopic retrograde cholangiopancreatography
endoscopic sphincterotomy
Preoperative
intraoperative
Laparoscopic common bile duct exploration
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2010-01-12
Enrollment: 210
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP.

210 were included but only 198 patients were randomly divided into two groups; PES/LC (100 patients) and LC/IOES (98 patients).

The total hospital stay were significantly shorter in the group of LC/IOES


Eligibility criteria: Inclusion Criteria:

* patients with gallstones and common bile duct stones

Exclusion Criteria:

* contraindications to ercp

contraindication to laparoscopy

biliary pancreatitis

refusal to participate

Primary outcomes:
measure: clearance of stones from the common bile duct
timeFrame: 6 months
Secondary outcomes:
measure: bile duct injuries, retained stones, hospital stay, surgical time, conversion to open cholecystectomy
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ahmed Abdel-Raouf El-Geidie
state: Dakahlia
Study officials:
References:
Clinical trial NCT03348852: Association Between Functional Changes in the Brain and the Perception of Pain in Patients With Inflammatory Bowel Diseases (IBD) - Measured With Functional Magnetic Resonance Imaging.
Official title: Assoziation Zwischen Funktionellen Gehirnveränderungen Und Der Schmerzwahrnehmung Bei Patienten Mit Chronisch entzündlicher Darmerkrankung Mittels fMRT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the study the investigators aim to test whether transcranial direct current stimulation (tDCS)-induced pain reduction is in association with functional changes in the brain measured with functional magnetic resonance imaging (fMRI) in patients with chronic inflammatory bowel diseases (IBD).

Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases, which is in association with changes in the brain measured via fMRI.


Eligibility criteria: Inclusion Criteria:

* Inflammatory bowel disease
* Chronic pain (more than 3 months)
* Pain (VAS \> 3/10)

Exclusion Criteria:

* Contraindication to transcranial direct current stimulation
* Contraindications to functional magnetic resonance imaging (fMRI)
* Pregnancy
* Sever internal or psychiatric condition

Primary outcomes:
measure: Functional and/or structural changes in the brain measured with cerebral MRI
timeFrame: 2 week
measure: Changes in pain measured with visual analogue scale
timeFrame: 2 weeks
measure: Changes in perception of pain measured with an algometer (pain pressure threshold)
timeFrame: 2 weeks
Secondary outcomes:
measure: Changes in questionnaire "quality of life"
timeFrame: 2 weeks
measure: Changes in functional symptoms
timeFrame: 2 weeks
measure: Changes in activity indices
timeFrame: 2 weeks
measure: Changes in pain catastophizing scale
timeFrame: 2 weeks
measure: Changes in inflammation biomarker (blood - C-reactive protein)
timeFrame: 2 weeks
measure: Changes in inflammation biomarker (stool - calprotectin)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine
Study officials:
affiliation: Charite University
name: Magdalena S Prüß-Volz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05631652: Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
Official title: Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Lead sponsor: EnteraSense Limited
Sponsor class: INDUSTRY
First posted: 2022-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of the investigation is to evaluate the feasibility of detecting blood in healthy volunteers after ingestion of autologous blood mixed with water.

Detailed description: A total of 10 healthy volunteers were recruited to undergo a testing procedure. Subjects were instructed to ingest the PillSense Capsule with 100mL of water. The position of the capsule in the stomach was verified by fluoroscopy. Subjects were then asked to sequentially drink (every 5min) 2 mixtures containing 25mL of water and 25mL of their own blood obtained from a peripheral vein. The PillSense result ("blood detected" or " blood not detected") was recorded on Clinical Report Form after 5 minutes from capsule ingestion and after 5 minutes from the ingestion of both mixtures containing blood.

Subjects were followed-up for capsule passing.

Eligibility criteria: Inclusion Criteria:

1. Age 18 -60 years
2. Ability to give written informed consent

Exclusion Criteria:

1. Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure \<100 mmHg,heart rate \> 100 / min)
2. Known current stenosis of the GI tract
3. Presence of pacemaker or other implantable electronic device
4. Dysphagia or difficulties in swallowing pills the size of the capsule
5. History of achalasia or known esophageal dysmotility
6. History of gastroparesis
7. History of severe constipation (1 bowel movement per week or less)
8. Healthy volunteers who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation
9. Active psychological issues preventing participation
10. Stomach bezoar
11. History of severe esophagitis
12. History of Crohn disease
13. History of diverticulitis
14. History of bowel obstruction
15. Suspected gastrointestinal tumor disease
16. Planned MRI investigation (MRI needed before the capsule is excreted)

Primary outcomes:
measure: Device ability to detect the absence of blood
timeFrame: within 30 minutes
measure: Device ability to detect the presence of blood
timeFrame: within 30 minutes
Secondary outcomes:
measure: Ability to ingest the capsule
timeFrame: within 30 minutes
measure: Absence of device-related adverse event
timeFrame: up to 4 weeks
measure: Absence of device-related adverse event
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institut klinické a experimentální medicíny (IKEM),
Study officials:
References: