louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06648785: Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients with GI Malignancies
Official title: Modified Capecitabine and Oxaliplatin (mCAPOX) for Patients with GI Malignancies
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: GI Cancers
Keywords: capecitabine
oxaliplatin
GI
chemotherapy
fluoropyrimidine
modified schedule
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot/feasibility design with tolerability and toxicity as primary endpoints and response as exploratory endpoint. Standard drug dosages utilized with no dose finding component to this study.
Primary purpose: TREATMENT

Brief summary: This study is a single arm, non-randomized feasibility study with tolerability and toxicity evaluation as primary endpoints which seeks to determine if a modified administration schedule of capecitabine with oxaliplatin will result in less toxicity than standard FOLFOX or CAPOX regimens.


Eligibility criteria: Inclusion Criteria:

* Patient with GI malignancy
* Provider plans non-curative intent treatment with either CAPOX or FOLFOX (mFOLFOX6) at standard dosages for \>3 months NOTE: Patient is not required to have radiologically measurable disease. NOTE: Planned administration of other anti-cancer medications (eg bevacizumab, epidermal growth factor receptor antibodies, immunotherapy, tyrosine kinase inhibitors) is allowed.

Exclusion Criteria:

* Patients not meeting standard hematologic parameters for chemotherapy administration as follows:

  * Absolute neutrophil count (ANC) ≥ 1500
  * Platelet count ≥ 100,000 Patients not meeting standard liver function parameters for chemotherapy administration as follows:
  * AST ≤ 5x ULN
  * ALT ≤ 5X ULN
  * Total Bilirubin ≤ 1.5X ULN Patients not meeting standard renal function parameters for chemotherapy administration as follows:
  * Serum Creatinine ≤ 1.2 or creatinine clearance ≥ 30 ml/min NOTE: Planned administration of another cytotoxic chemotherapy (eg irinotecan) is an exclusion.

Primary outcomes:
measure: Tolerability
timeFrame: 115 days
measure: Toxicity
timeFrame: 115 days
measure: Neuropathy
timeFrame: 2-4 months after therapy
measure: Cytopenias
timeFrame: 115 days
Secondary outcomes:
measure: Tumor response
timeFrame: 115 days
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT05103085: Screening for Hepatitis C Using a Rapid Diagnostic Orientation Test (TROD) in Patients Over 50 Years Old in the Digestive Endoscopy Department of the Europeen Hospital Marseille
Official title: Screening for Hepatitis C Using a Rapid Diagnostic Orientation Test (TROD) in Patients Over 50 Years Old in the Digestive Endoscopy Department of the Europeen Hospital Marseille
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 5000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 50 and over hospitalized in the digestive endoscopy department

Brief summary: Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the French High Authority of Health, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular drug users, people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who are or have beenincarcerated .

French government recommendations aim to achieve elimination of hepatitis C virus HCV (as early as 2025) and since April 2018 the European Hospital Marseille is engaged in this battle and organizes every year "the day without hepatitis" in the hospital.

Since 2017, direct-acting antiviral treatments have become available in France to all patients infected with HCV, regardless of the degree of severity of their disease. These treatments are effective in more than 95% of cases and, in 2019, 18,000 people were cured. As of today, it is estimated that there are still 110,000 people likely to be treated in France. Among them, 75,000 are unaware of being HCV positive, people who need to be tested.

With one of the largest volumes of digestive endoscopic examinations in France, the European Hospital Marseille may be a significant source of screening for hepatitis C.

Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in the endoscopy department at the European Hospital Marseille.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 50
* Giving free and informed written consent
* Being affiliated with or benefiting from a social security scheme

Exclusion Criteria:

- Patient unable to express consent

Primary outcomes:
measure: Number of patients aged 50 and over tested positive for chronic viral hepatitis C during gastrointestinal endoscopy.
timeFrame: 16 months
Secondary outcomes:
measure: Number of patients who refuse viral screening
timeFrame: 16 months
measure: Investigation and identification of potential risk factors in patients diagnosed positive for chronic viral hepatitis C
timeFrame: 16 months
measure: Number of viremic patients without risk factor
timeFrame: 16 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Européen Marseille
Study officials:
References:
Clinical trial NCT02119585: Analysis of Respiratory System Mechanics and Inflammatory Response During Orthotopic Liver Transplantation (SPPLIT Trial)
Official title: Observational Study to Analyze Respiratory System Mechanics Changes and Inflammatory Responses During Orthotopic Liver Transplantation (SPPLIT Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Liver Diseases
Keywords: orthotopic liver transplantation
ischemia reperfusion syndrome
cytokines
respiratory system elastance
lung elastance
chest wall elastance
shunt
dead space
acute respiratory failure
atelectasis
pleural effusion
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with end stage liver diseases undergoing to liver transplantation

Brief summary: During orthotopic liver transplantation (OLT), respiratory system function may be severely impaired for several reasons including anaesthesia effects, hyperdynamic volume state with fluid overload and ischemia reperfusion injury. In particular, reperfusion syndrome is characterised by the release of several inflammatory mediators such as cytokines and oxygen free radicals which may contribute to alveolar endothelial barrier dysfunction. The object of this study is to investigate the respiratory system mechanics impairment in its partitioning between lung and chest wall.

We hypothesize that impairment of respiratory system mechanics (of both lung and chest wall) occurs after reperfusion phase of liver. This impairment is associated with the systemic inflammatory response following liver reperfusion.


Eligibility criteria: Inclusion Criteria:

* orthotopic liver transplantation
* valid informed consent

Exclusion Criteria:

* Age \< 18 yrs

Primary outcomes:
measure: Elastance of Respiratory System, Lung and Chest Wall
timeFrame: at 90 minutes after liver reperfusion
measure: Elastance of Respiratory System, Lung and Chest Wall
timeFrame: at 3 hours after liver reperfusion
measure: Elastance of Respiratory System, Lung and Chest Wall
timeFrame: at 24 hours after liver reperfusion
Secondary outcomes:
measure: Acute respiratory failure
timeFrame: 28 days
measure: Ventilator free days
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: hospital length of stay
timeFrame: 28 days
measure: Inflammatory mediators in plasma samples
timeFrame: baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
measure: Inflammatory mediators in urine samples
timeFrame: baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
Study officials:
References:
Clinical trial NCT01223885: Camel's Milk as a Safe Alternative in Cow's Milk Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cow's Milk Allergy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: By performing a challenge with camel's milk in patients who are allergic to cow's milk, the investigators will examine if camel's milk is a safe alternative for these patients.


Eligibility criteria: Inclusion Criteria:

* Proved cow"s milk allergy

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Development of allergic symptoms after graded oral challenge with camel's milk
timeFrame: 3 hours follow-up after completion of the challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Allergy Unit, Meir Medical Center
Study officials:
References:
Clinical trial NCT06661785: Interlocking Polyetheretherketone Implants for Orbital Floor Reconstruction
Official title: Interlocking Polyetheretherketone Patient-Specific Implants for Orbital Floor Reconstruction
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Large Orbital Floor Fracture
Keywords: orbital reconstruction
Interlocking PEEK
Patient specific implant
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with large orbital floor fracture were reconstructed with interlocking polyetheretherketone patient-specific implant and will be evaluated clinically and radiographically

Detailed description: Twenty two patients with large orbital floor fracture will be included in this study. Patients will be received, examined and managed at the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Full clinical examination and radiographic examination using multi axial C.T Scan for proper diagnosis and treatment planning. DICOM files will be imported into surgical planning software and used for fabrication of interlocking polyetheretherketone patient specific implant which will be ready for sterilization and insertion. After written informed consent from the patient, the surgery will be done under G.A, either infraorbital or transconjunctival incision will be done according to the case. Follow up: All patients will be examined clinically for hypoglobus, enophthalmos, ocular motility and diplopia during 2nd week, 1st month and 6 months \& radiographically for orbital volume immediately and 6 months postoperatively

Eligibility criteria: Inclusion Criteria:

* Patients with large orbital blow out fracture either isolated or combined with other fracture
* Patients willing for surgical operation and follow up
* Patients with no contraindications for surgical intervention

Exclusion Criteria:

* Patients who are not fit for G.A
* Uncooperative patients

Primary outcomes:
measure: Hypoglobus
timeFrame: 2 weeks
measure: Enophthalmos
timeFrame: 2 weeks
measure: Orbital volume
timeFrame: 2 weeks
measure: Ocular motility
timeFrame: 2 weeks
measure: Diplopia
timeFrame: 2 weeks
Secondary outcomes:
measure: Hypoglobus
timeFrame: 6 months
measure: Enophthalmos
timeFrame: 6 months
measure: Orbital volume
timeFrame: 6 months
measure: Ocular motility
timeFrame: 6 months
measure: Diplopia
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry, Tanta University
Study officials:
affiliation: Tanta University, Egypt
name: Maram N Breshah, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University, Egypt
name: Rafic R Beder, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06856785: Management of Non-Organic Dysphonia in Adults.
Official title: Resonance Tube Voice Therapy Versus Smith Accent Therapy in The Management of Non-Organic Dysphonia in Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Dysphonia
Resonance Tube Voice Therapy
Smith Accent Method Therapy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of a semi-occluded vocal tract training program, "Resonant Tube Therapy," versus the "Traditional Smith-accent Method" on the quality of voice in patients with Non-Organic "Functional" dysphonia.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with non-organic functional dysphonia with or without Minimally Associated Pathological lesions and referred for voice therapy. The diagnosis was based on the results of the routine clinical assessment of cases of voice disorders by a phoniatrician in the voice clinic.
* Patients 'ages between 15 - 60 years old.
* Native speakers of Arabic.
* Language comprehension adequate for the task.

Exclusion Criteria:

* Patients with organic voice disorders.
* Patients with aphonia or Phon asthenia.
* Females within the week of their menstrual cycle or menstruating at the time of data collection to control for the possible hormonal effects or premenstrual water retention on voice quality.
* History of severe respiratory allergies, thyroid pathologies, neuro-motor impairment, hearing impairment, psychiatric problems and physically limiting diseases that might interfere with study completion.
* Those on any regular medication that might affect voice quality.
* Speech disorders.
* Cigarette smoking, alcohol, or drug abuse for the past 5 years.
* Patients with previous micro laryngeal surgery.
* Patients with gastrointestinal reflux disease.

Primary outcomes:
measure: Voice quality improvement in functional (non-organic) dysphonia adult patients
timeFrame: 12 weeks following end of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine Sohag University
Study officials:
References:
Clinical trial NCT05975385: Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Official title: Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholecystitis, Acute
Cholelithiasis
Nausea, Postoperative
Vomiting, Postoperative
Pain, Postoperative
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial. Group 1 - Acupuncture Group 2 - No acupuncture
Primary purpose: TREATMENT

Brief summary: The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.


Eligibility criteria: Inclusion Criteria:

1. Patient ages 18-64
2. American Society of Anesthesiology Physical Status I, II or III
3. Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital

Exclusion Criteria:

1. Scheduled open cholecystectomy - excluded due to increased levels of pain in open procedures
2. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
3. Allergy to any of the standard anesthetic agents
4. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
5. Patient or surgeon refusal

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24 hours
measure: Total opioids used
timeFrame: 24 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub Hospital
state: Texas
Study officials:
References:
Clinical trial NCT00910585: Coaching in Childhood Asthma
Official title: Phase 4 Study of Case Management and Environmental Control in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: childhood
asthma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2009-06-01
Enrollment: 191
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Asthma among low-income, minority children remains a prime example of health disparities that are resistant to change. Demonstrations of reductions in disproportionate hospitalizations in controlled trials are limited. We performed a controlled clinical trial of an Asthma Coach to reduce hospitalizations among low-income, African American children.


Eligibility criteria: Inclusion Criteria:

* Mothers of children with asthma 2-8 years of age and hospitalized for an acute exacerbation, with Medicaid insurance, and living in St. Louis City

Exclusion Criteria:

* Other respiratory disease present

Primary outcomes:
measure: Rehospitalization
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Robert Strunk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05811585: PMCF Study for ADEPT® in LaparoscopicGynecologic Surgery
Official title: Post-Market Clinical Follow-up Study for ADEPT® in Laparoscopic Gynecologic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adhesion
Keywords: laparoscopic gynecologic surgery
adhesion-related morbidities
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population will consist of patients who underwent an index laparoscopic gynecologic surgery (performed at least 2 years prior to the start of the study) during which ADEPT (4% icodextrin solution) was used as an irrigant during the index laparoscopic gynecologic surgical procedure and as an intraperitoneal instillate for the reduction of adhesions.

Brief summary: Postoperative adhesions develop in most patients after gynecologic surgery, likely resulting in significant morbidity, complications, and considerable increases in healthcare costs. Good surgical techniques, including a minimally invasive approach, may reduce adhesions and minimize the abovementioned complications. The agents for prevention or reduction of adhesion formation are placed inside the abdominal cavity, and especially in the pelvic cavity, which contains the female reproductive organs. ADEPT Adhesion Reduction Solution, hereinafter referred to as ADEPT, is intended for use as an intraperitoneal instillate for the reduction of adhesions following gynecological laparoscopic surgeries. The objective of this study is to evaluate the effectiveness and safety of ADEPT by detecting the incidence of adhesion-related morbidities (adhesion-related readmissions, including reoperations) after laparoscopic gynecologic surgery through a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart.


Eligibility criteria: Inclusion Criteria:

* Adult female patients who, at the time of surgery, were ≥ 18 years of age and who had undergone an index laparoscopic gynecologic surgery at least 2 years prior to the start of the study.
* Patients in whom ADEPT® was used as an irrigant during the index laparoscopic gynecologic surgical procedure and as an intraperitoneal instillate for the reduction of adhesions following laparoscopic surgery.

Exclusion Criteria:

* Patients who had frank infection in the abdominopelvic cavity at the time of the surgery.
* Patients who were pregnant or nursing at the time of the surgery.

Primary outcomes:
measure: Incidence of hospital readmissions directly or possibly related to adhesions
timeFrame: Within 2 years of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texas Fertility Center
state: Texas
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg
Study officials:
References: