louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05606952: Color Doppler to Confirm Epidural Catheter Positioning in Parturient
Official title: Color Doppler to Confirm Epidural Catheter Positioning in Parturient, Would it Help
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to calculate the sensitivity and specificity of using color Doppler with pulsed wave Doppler to accurately detect the position of epidural catheter

Detailed description: patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35.All patients will be sitting to receive their epidural analgesia for labor pain.

A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. patients will be divided into two groups Group (C) control these are the patients with BMI less than 35 and Group (O) for patients with BMI more than 35. All patients will be sitting to receive their epidural analgesia for labor pain.

A 2.5 to 5 MHz curvilinear probe (Sonosite X-porte, Fujifilm industries) will be used to detect the desired level usually between L3-4 or L4-5. Initially a parasagittal oblique interlaminar view will be obtained and by tilting it medially to visualize the laminae and interlaminar spaces. Starting by the sacral image, counting will start detecting the L5-S1, L4-L5 and L3-L4 levels. After marking the level another imaging in the transverse view will be attempted at the previous levels then the anesthetist will detect the posterior complex (ligamentum flavum, epidural space and dura) and anterior epidural complexes and according to the anesthetist preference a level will be This is followed by a test dose of 10 ml 0.125% bupivacaine and patient controlled epidural analgesia will be started by the following protocol (0.0625% bupivacaine) Smith Medical ASD,Inc. in intermittent dose (10 ml will be injected by the machine every 30 minutes.

Eligibility criteria: Inclusion Criteria:

* obstetric patients admitted for epidural analgesia in the labor department suite (LDS)

Exclusion Criteria:

1. Patients suffering from coagulopathy.
2. Patients on recent anticoagulant therapy.
3. Patients suffering from sepsis or with local sepsis at the insertion site.
4. Patients with platelet count less than 100,000/dl.
5. Patient refusal.
6. Patient with known allergy to local anesthetic drugs
7. Patients delivered by forceps.
8. Patients who have undergone a cesarean section delivery.

Primary outcomes:
measure: sensitivity
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Menoufia
country: Egypt
facility: Menoufia University
Study officials:
References:
Clinical trial NCT03853252: iPS Cells of Patients for Models of Retinal Dystrophies
Official title: iPS Cells of Patients for Models of Retinal Dystrophies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Dystrophies
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-02-25
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigators are focused on inherited retinal dystrophies with an aim to further understand disease pathophysiology and to elaborate novel treatments, as, to date, there is no effective treatment to prevent blindness.

The main goal of this study is to generate human cellular models of healthy and disease retinas and perform studies to evaluate the efficiency of gene therapy approaches for different diseases.

Skin biopsies of volunteers are cultured to isolate fibroblasts that are then reprogrammed into iPS cells. Healthy and disease-specific iPS cells are then differentiated into retinal models.

This study should help to elucidate disease pathways and to provide proof-of-concept for various therapeutic approaches.


Eligibility criteria: Inclusion criteria :

* Signed informed consent and
* Choroideremia :

  * Males
  * CHM mutation
  * With multimodal Imaging anomalies in line with CHM
* All other presumed inherited retinal dystrophies with bilateral and symmetrical involvement with identified mutations in one of the Retnet gene
* All presumed inherited optic neuropathy with bilateral and symmetrical involvement with identified mutations
* And in all cases or pattern

  * Age from 5 to 70
  * with appropriate health insurance

Exclusion criteria :

* Patient under tutorship or curatorship

Primary outcomes:
measure: number of human cell models obtained
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CNMR Maolya, Genetic Sensory Diseases
state: Occitanie
Study officials:
References:
Clinical trial NCT00783952: Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation
Official title: Validation of Mixed Venous Blood Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturation and Various Local Tissue Oxygen Saturations.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mixed Venous Oxygen Saturation
Tissue Oxygenation
Keywords: Mixed venous oxygen saturation
Tissue oxygenation
Near infrared spectroscopy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-11-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to test a new way to measure the oxygen level in the mixed venous blood system (the system that carries blood collected from all over the body to the heart), which is a very important monitoring tool for the overall oxygen delivery to all our tissues. This new way measures the oxygen level in the mixed venous blood from outside the body, instead of measuring from the inside through a catheter (a thin, flexible plastic tube) that is placed by breaking the skin.

Detailed description: Study terminated because of inability to recruit subjects

Eligibility criteria: Inclusion Criteria:

* Patients already being monitored by a pulmonary artery catheter and an arterial line

Exclusion Criteria:

* Patients with severe heart failure
* Patients with carbon monoxide or thiocyanate poisoning

Primary outcomes:
measure: Determining the Accuracy of Mixed Venous Oxygen Saturation Obtained With a Novel Mathematical Equation Using Arterial Oxygen Saturations and Various Local Tissue Oxygen Saturations.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Robert Kacmarek, PhD, RRT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02177552: Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma
Official title: Study Assessing the Effects of Chemotherapy in Advanced Esophagogastric Adenocarcinoma - Carboplatin, Docetaxel and Capecitabine (CTX) or Epirubicin, Oxaliplatin and Capecitabine: a Randomised Phase 2 Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Neoplasms
Stomach Neoplasms
Keywords: Esophageal cancer
Gastric cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-06-27
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine the effects of treatment with carboplatin, docetaxel and capecitabine in patients with incurable cancer of the esophagus or stomach.


Eligibility criteria: Key Inclusion Criteria:

* Patients with histologically verified, unresectable or metastatic, HER2-negative, adenocarcinoma of the esophagus or stomach
* Men or women less than 80 years of age
* Performance status 0 or 1
* Life expectancy \>12 weeks
* Adequate organ-function
* Written informed consent

Key Exclusion Criteria:

* Prior chemotherapy for adenocarcinoma of the esophagus or stomach if the chemotherapy-free interval is less than 6 months
* Progression on first-line chemotherapy for unresectable or metastatic adenocarcinoma of the esophagus or stomach
* Chemotherapy with epirubicin, oxaliplatin, carboplatin, cisplatin or docetaxel less than 6 months before study entry
* Prior cumulative dose of \>300 mg/m2 of epirubicin
* Grade ≥ 2 side-effects from previous chemotherapy

Primary outcomes:
measure: The proportion of participants alive one year after randomisation
timeFrame: Three and a half years
Secondary outcomes:
measure: Time to progression or death due to any cause
timeFrame: Three and a half years
measure: Number of participants with grade 3 and 4 toxicities caused by treatments
timeFrame: Day 1 of every cycle and 30 days after completion of treatment
measure: Time until death due to any cause
timeFrame: Three and a half years
measure: Changes in quality-of-life
timeFrame: Three and a half years
measure: The proportion of participants who have carboplatin, docetaxel and capecitabine re-induced
timeFrame: Five years
measure: Registration of further lines of therapy
timeFrame: Five years
Other outcomes:
measure: Analysis of cmet by immunohistochemistry
timeFrame: Three and a half years
Locations:
city: Copenhagen
country: Denmark
facility: Finsen Center, Rigshospitalet
Study officials:
affiliation: Finsen Center, Rigshospitalet
name: Peter C Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petersen PC, Petersen LN, Vogelius I, Bjerregaard JK, Baeksgaard L. A randomized phase 2 trial of first-line docetaxel, carboplatin, capecitabine (CTX) and epirubicin, oxaliplatin, capecitabine (EOX) in advanced esophagogastric adenocarcinoma. Acta Oncol. 2021 Jul;60(7):948-953. doi: 10.1080/0284186X.2021.1928281. Epub 2021 Jun 4.
Clinical trial NCT00000252: Lack of Acute Tolerance Development to Effects of Nitrous Oxide - 4
Official title: Lack of Acute Tolerance Development to Effects of Nitrous Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
acute tolerance
subjective effects
psychomotor
analgesia
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine the lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Psychomotor performance
timeFrame: During inhalation
measure: Cognitive performance
timeFrame: During inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yajnik S, Zacny JP, Young CJ, Lichtor JL, Rupani G, Klafta JM, Coalson DW, Apfelbaum JL. Lack of acute tolerance development to the subjective, cognitive, and psychomotor effects of nitrous oxide in healthy volunteers. Pharmacol Biochem Behav. 1996 Jun;54(2):501-8. doi: 10.1016/0091-3057(95)02278-3.
Clinical trial NCT03516552: Comparison and Analysis of Blood Loss Formulas
Official title: Comparison and Analysis of Blood Loss Formulas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients electively scheduled for laparoscopic surgery.

Brief summary: Although it has been pointed that estimates are significantly inexact and different from each other, the actual accuracy of them has not been properly investigated and compared.


Eligibility criteria: Inclusion Criteria:

- Adults 18 - 90 yrs.

Exclusion Criteria:

* Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents).
* Surgical blood loss volume \< 200 ml.
* Requirement for surgical gauzes during surgery, including conversion to open surgical techniques.
* Transfusion of red blood cells (RBCs) during the perioperative period.
* Significant postoperative bleeding (\> 50 ml in surgical drains) or any other type of significant blood loss.
* Fluid infusions or vasoactive drugs after the first 24 postoperative hours.

Primary outcomes:
measure: Differences on blood loss estimation.
timeFrame: 72 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References:
Clinical trial NCT02427152: Pre-meal Planning and Expected Satiety
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adiposity
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lean and overweight/obese healthy volunteers

Brief summary: Obesity is considered to be caused by an imbalance between energy expenditure and energy intake. A major determinant of our daily energy intake is the size of the meals that we consume. It has been suggested that decisions about portion sizes are often made in advance, before a meal begins. This pre-meal planning is considered to especially depend on the estimated 'expected satiety' and 'expected satiation' of different foods. Further, also factors like weight concern and palatability of the food might have their influence on meal size selection. In general, it is not clear how these factors are integrated during pre-meal planning and which brain networks are involved in these decisions/this process. Thus, the investigators plan to study pre-meal planning in healthy, normal-weight and overweight/obese individuals with functional magnetic resonance imaging under different cognitive instructions including pleasure, expected satiety and self-control in terms of health consequences. The investigators will explore the neural networks involved in pre-meal planning and expect them to be modulated by the before mentioned factors. Further, the investigators plan to explore gender differences and expect that female subjects will select smaller portion sizes especially in the self-control condition as they are often more concerned about their weight/health. Finally, the investigators will explore differences between lean and overweight subjects to elucidate factors that might lead to increased meal sizes in overweight subjects.


Eligibility criteria: Inclusion Criteria:

* body mass index: 18-25 kg/m²; 25-35 kg/m²,
* right-handed,
* age: 18-35 years.

Exclusion Criteria:

* functional magnetic resonance imaging contraindications,
* claustrophobia,
* self-reported eating disorders,
* vegan or vegetarian diet, food allergies,
* intake of antidepressants,
* metabolic disorders.

Primary outcomes:
measure: Differential brain functions in reward, decision making and inhibitory control networks (brain functions will be measured by blood oxygen level dependent effects)
timeFrame: day 0
Secondary outcomes:
measure: Differential behavioral measures of portion size selection
timeFrame: day 0
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Clinic of Tuebingen, fMEG Center
Study officials:
References:
Clinical trial NCT03974152: Effects of Nicotine Salt Aerosol on Cigarette Smokers
Official title: Effects of Nicotine Salt Aerosol on Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Electronic Cigarette Use
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-06-04
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This grant compares the effects of cigarette smoking, protonated nicotine ("salt") aerosol through an Electronic Nicotine Delivery System (ENDS), and unprotonated nicotine aerosol through an ENDS on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.

Detailed description: The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use a nicotine "salt" (protonated) aerosol, relative to an unprotonated aerosol or their own brand of cigarettes.

Eligibility criteria: Inclusion Criteria:

Participants must be:

* healthy (determined by self-report)
* between 21-55 years old
* wiling to provide informed consent
* able to attend lab and abstain from tobacco/nicotine as required and agree to use designated products according to study protocol
* cigarette smokers

Exclusion Criteria:

• Women if breast-feeding or test positive for pregnancy (by urinalysis) at screening

Some study details about eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Primary outcomes:
measure: Plasma Nicotine
timeFrame: Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Paul T Harrell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05151952: Proton Therapy Medical Registry
Official title: Proton Therapy Medical Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer, Therapy-Related
Keywords: Proton therapy Additional relevant MeSH terms: Neoplasms, Secondary Primary Neoplasms, Cancer
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients with proton therapy

Brief summary: Clínica Universidad de Navarra Proton Therapy Unit is establishing a registry to capture the full radiation dosimetry delivered to the patient, baseline clinical data, and disease, toxicity and quality of life outcomes. The objectives are parameters prescribed and to have all patients treated at the proton therapy unit to be included in the registry to enable future analysis of treatment outcomes to assist in understanding, which patients can benefit from the use of protons.

Detailed description: Proton based radiation therapy has considerable dosimetric advantages over the standard photon based external beam radiation therapy, with an increased cost. Now, the clinical advantages, however, may not be identified in general, even with the improved dose distributions. In a large-scale evaluation, in time of personalized/ precision medicine, the impact of dosimetric benefit int clinical benefit meds registration studies.

Eligibility criteria: Inclusion Criteria:

* All patients treated at the proton center

Exclusion Criteria:

* Any other than what is supplied in the inclusion criteria

Primary outcomes:
measure: Outcome Mesure
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
Study officials:
References:
Clinical trial NCT02100852: TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
Official title: A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of TGR-1202, a Novel PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic leukemia.


Eligibility criteria: Inclusion Criteria:

* Confirmed Chronic Lymphocytic Leukemia (CLL)
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
* Ability to swallow oral medication

Exclusion Criteria:

* Known hepatitis B virus, hepatitis C virus or HIV infection
* Primary central nervous system lymphoma or known intracranial involvement
* Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months

Primary outcomes:
measure: Maximum Tolerated Dose acceptable for participants
timeFrame: 28 days (1 cycle of therapy)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Alabama
city: Memphis
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
Study officials:
References: