louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06055621: Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
Official title: Evaluation of DASATINIB Monotherapy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 35
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 goal of this clinical trial is to learn about the efficacy of DASATINIB monotherapy in acute myeloid leukemia patients refractory to VENETOCLAX-AZACITIDINE. The main question it aims to answer is to assess the tumor response after 2 cycles of DASATINIB monotherapy treatment for patients with chemotherapy-ineligible acute myeloid leukemia refractory to VENETOCLAX-AZACITIDINE therapy.

Participants will be given DASATINIB treatment up to 3 months. Response will be assessed by a myelogram and a complete blood count at the end of every cycle. Follow up will last 6 months.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of AML except Philadelphia chromosome-positive AML (Ph+) and acute promyelocytic leukemia (AML M3)
* Age ≥ 18 years
* ECOG ≤3
* VEN-AZA refractory defined as no response after two cycles of VEN-AZA whatever the dose and the treatment duration
* Signed informed consent form
* Affiliation to a social security system, or beneficiary of such a system

Exclusion Criteria:

* Patient eligible to a targeted therapy having a market authorization
* Central nervous system involvement
* Heart failure
* Liver failure
* Kidney failure
* Contraindication to DASATINIB
* Positive for HIV (detectable viral load), Hepatitis B or C
* Pregnant or breastfeeding woman
* No efficient contraception for the women of childbearing age
* Emergency situation person or not able to express his/her informed consent
* Patient under a legal protection measure (adult under guardianship, curatorship or safeguard of justice)
* Inability to undergo the clinical trial medical follow-up for geographical, social or psychological reasons

Primary outcomes:
measure: tumor response
timeFrame: 2 months
Secondary outcomes:
measure: response rates
timeFrame: 3 months
measure: Time to response
timeFrame: 3 months
measure: Duration of relapse-free period
timeFrame: 3 months
measure: Event-free survival
timeFrame: 3 months
measure: Overall survival
timeFrame: 3 months
measure: Occurrence of Adverse Events
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
References:
Clinical trial NCT03579121: Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
Official title: Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative/Postoperative Complications
Keywords: pharmacogenomics
preoperative evaluation
perioperative opioid use
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects meeting inclusion/exclusion criteria will undergo pharmacogenomic testing. A pharmacist will review the pharmacogemic report and make recommendations for patients in the interventional group. The anesthesiologist and orthopedic surgeon will use that information for preoperative clinical decisions related to anesthesia and analgesia.
Primary purpose: SCREENING

Brief summary: The researchers are conducting this study to see if pharmacogenomic testing before surgery helps the doctor to choose which medications will work best for the patient.

Detailed description: Participants, undergoing total knee replacements, will be randomized into two groups. Both groups will receive pharmacogenomics (PGx) testing preoperatively. The PGx guided group will have their results reviewed by the clinicians during their treatment and the results may guide clinical decisions. The control group results will be sealed until completion of treatment and clinicians will not have access to this information. These participants will undergo standard treatment dosing and medication selection.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary total knee arthroplasty
* Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.

Exclusion Criteria:

* Patients with a current diagnosis of chronic pain
* Patients requiring narcotics for greater than one week prior to surgery
* Patients with chronic kidney disease with a pre-op creatinine greater than 1.5
* Patient preference or need for spinal anesthesia rather than general anesthesia
* Patient planned for robotic surgical approach

Primary outcomes:
measure: Change in Overall Benefit of Analgesic Score (OBAS)
timeFrame: baseline, 48 hours following PACU discharge
Secondary outcomes:
measure: Change in prescription pattern for postoperative pain control.
timeFrame: baseline, 48 hours following PACU discharge
measure: Change in Opioid requirements
timeFrame: baseline, 48 hours following PACU discharge
measure: Changes in opioid use perioperatively based on pharmacogenomic testing
timeFrame: baseline, 48 hours following PACU discharge
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Molly B Kraus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00269464: Chronic Schizophrenia With Obsessive-Compulsive Symptoms: Comorbidity or a Subtype?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Obsessive Compulsive Disorder
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-12-23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Time perspective: RETROSPECTIVE

Brief summary: Evaluating the prevalence and characteristics of obsessive-compulsive (OC) symptoms in patients with chronic schizophrenia


Eligibility criteria: Inclusion Criteria:

* Schizophrenic patients
* Schizophrenic patients with OCD

Exclusion Criteria:

* Organic problems

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv University
name: Joseph Zohar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05287464: International Multicentric Study ARON-1
Official title: International Multicentric Study ARON-1
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Renal Cell Carcinoma (mRCC)
Keywords: immunotherapy
mRCC
immuno-combinations
artificial intelligence technology
real-world data
Lead sponsor: Hospital of Macerata
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 1220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients treated with first-line immuno-combinations for metastatic RCC

Brief summary: The ARON-1 Study is designed as an International Multicentric Retrospective Study to collect global experiences with the use of immuno-combinations in patients with metastatic RCC.

Two Supplementary Studies (ARON-1α and ARON-1β) have been designed. The ARON-1α Supplementary Study has been designed to investigate for the presence of genomic signatures from tumor samples of patients treated with first-line immuno-combinations for advanced RCC. The ARON-1β Supplementary Study has been designed to charaterize the immune cell populations and assess their relationship with the clinical outcome of mRCC patients treated with first-line immuno-combinations


Eligibility criteria: Inclusion Criteria:

* Patients aged \>18y
* Cytological or Histologically confirmed diagnosis of clear cell or non-clear cell RCC
* Histologically or radiologically confirmed diagnosis of metastatic disease
* First-line treatment with nivolumab plus ipilimumab or nivolumab plus cabozantinib or pembrolizumab plus axitinib or pembrolizumab plus lenvatinib or avelumab plus axitinib or atezolizumab plus bevacizumab

Exclusion Criteria:

* Patients without histologically confirmed diagnosis of RCC
* Patients without histologically or radiologically confirmed metastatic disease
* Patients treated with immuno-combinations not included in the list reported in the Inclusion Criteria Section

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: March 31th, 2022
measure: Overall Survival (OS)
timeFrame: March 31th, 2022
measure: Overall Response Rate (ORR)
timeFrame: March 31th, 2022
Secondary outcomes:
measure: Efficacy of immuno-combination in the elderly populaton
timeFrame: May 31th, 2022
measure: Efficacy of immuno-combinations in patients with different metastatic sites (i.e. bone and brain metastases)
timeFrame: May 31th, 2022
measure: Prognostic role of smoking attitude and obesity in RCC patients treated with different immuno-combinations
timeFrame: May 31th, 2022
measure: Efficacy of different immuno-combinations in patients with non-clear RCC
timeFrame: September 30th, 2022
Other outcomes:
Locations:
city: Macerata
country: Italy
facility: Ospedale di Macerata, UOC Oncologia
Study officials:
References:
Clinical trial NCT00511264: Laparoscopic Ultrasound Guided Tissue Sampling in Patients With Cancer of the Upper Gastrointestinal Tract
Official title: Prospective Evaluation of the Impact of Laparoscopic Ultrasound (LUS) Guided Fine-Needle Aspiration or Tru-Cut Biopsy in Patients With Upper GI Tract Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Liver Cancer
Keywords: Laparoscopy
Ultrasound
Cancer
Biopsy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2007-08-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Laparoscopic Ultrasound (LUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When a suspect lesion is visualized during LUS a biopsy should be provided in order to differentiate between benign and malignant lesions. A new system for LUS guided biopsy has been developed, but how often these biopsies are clinically relevant (i.e. changing patient management)and how reliable are these biopsies are unknown.

The study hypothesis is that LUS guided biopsies are accurate and clinically relevant in the pre-treatment evaluation of patients with upper gastrointestinal tract cancer.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven upper GI tract cancer
* Laparoscopic Ultrasound indicated during pre-treatment evaluation

Exclusion Criteria:

* Patients unfit for surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Surgery, Odense University Hospital
Study officials:
affiliation: Department of Surgery, Odense University Hospital
name: Michael B Mortensen, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06798064: Expanded Access Using Allogeneic Bone-marrow Derived Human Mesenchymal Stem Cells (Allo-hMSC) for a Individual Parkinson's Disease Subject
Official title: Expanded Access Using Allogeneic Bone-marrow Derived Human Mesenchymal Stem Cells (Allo-hMSC) for a Individual Parkinson's Disease Subject
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Parkinson Disease
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2025-01-29
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is a expanded access use of allogeneic bone marrow-derived mesenchymal stem cells for a single subject with moderate Parkinson's disease that has progressed.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Mya Schiess, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01379664: Volatile Anesthetic Choice and Duration of Hospitalization: A Quality Improvement and Cost-control Project
Official title: Volatile Anesthetic Choice and Duration of Hospitalization: A Quality Improvement and Cost-control Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duration of Hospitalization
Keywords: Sevoflurane
Isoflurane
volatile anesthetic
duration of hospitalization
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 1584
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Preliminary retrospective data suggest that the relatively soluble but inexpensive volatile anesthesia isoflurane prolongs the duration of hospitalization compared to the less soluble but more expensive anesthetic sevoflurane. Even a small reduction in the duration of hospitalization would easily compensate for the modest additional cost of sevoflurane. The investigators therefore propose to test the primary hypothesis that duration of hospitalization is longer with isoflurane than sevoflurane.

The investigators will also test the secondary hypotheses that: 1) pain scores are greater in patients recovering from isoflurane than sevoflurane anesthesia; and, 2) opioid consumption is greater after isoflurane than sevoflurane anesthesia. All statistical analyses will be adjusted for age, gender, race, baseline risk, 9 and procedure.


Eligibility criteria: Inclusion Criteria:

* Must have surgery in G operating room suite

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes:
measure: Time-weighted Average Verbal Rating Pain Score
timeFrame: up to 72 hours after surgery
measure: Total Intraoperative Opioid Consumption
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01158664: What is the Influence of a Different Thread Pitch Design on Bone Remodelling Around Conical Southern Oral Implants?
Official title: A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Keywords: dental implants
different tread pitch design
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-07-08
Enrollment: 56
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: Patients who need more than 2 dental implants will be treated by the same implant type (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en 1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is registered around these implants. The role of the thread pitch design will be investigated.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Periodontally-healthy or periodontally-treated patients
* Smokers are included
* All types of prosthetic indications are accepted but 2 IBT type implants with different threads have to be placed in one patient on the same day. Implants can be connected or not connected in the same jaw.

Exclusion Criteria:

* All other contra indications for implant surgery
* Guided bone regeneration or use of any substitutes
* No implantation in regenerated or augmented bone
* No immediate loading cases

Primary outcomes:
measure: To document the outcome of bone remodeling around IBT implants
timeFrame: 3 years after implantation
Secondary outcomes:
measure: To clinically and radiographically document the placement of both IBT implant thread types in the same patient
timeFrame: over 2 years
measure: 3. Outcome differences will be detected per implant center, per treated area in the mouth, per case of prosthetic rehabilitation
timeFrame: over 2 years
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Hugo De Bruyn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00201864: Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
Official title: Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Postmenopausal
Women
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-09-20
Enrollment: 40
Sex: FEMALE
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 trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.


Eligibility criteria: Inclusion Criteria:

* Proven breast cancer
* Metastatic or locally advanced breast cancer
* Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (\>10% staining by immunohistochemistry)
* Postmenopausal status
* No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* Adequate organ function
* Exclusion Criteria:
* No prior Exemestane or Fulvestrant
* Uncontrolled intercurrent illness including but not limited to:

  * ongoing or active infection
  * symptomatic congestive heart failure
  * unstable angina pectoris
  * cardiac arrhythmia
  * myocardial infarction within the last 3 months
  * psychiatric illness/social situations that would limit compliance with study
* Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.
* Presence of bleeding diathesis or coagulopathy, patients requiring coumadin

Primary outcomes:
measure: Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.
timeFrame: Every 2 cycles up to 2 years
Secondary outcomes:
measure: Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)
timeFrame: Every 2 cycles, up to 1 year
measure: Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant
timeFrame: Day 7 and Day 120
measure: Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels
timeFrame: Prestudy, Day 7 and Day 120
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ewa Mrozek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mrozek E, Layman R, Ramaswamy B, Schaaf L, Li X, Ottman S, Shapiro CL. Phase II trial of exemestane in combination with fulvestrant in postmenopausal women with advanced, hormone-responsive breast cancer. Clin Breast Cancer. 2012 Apr;12(2):151-6. doi: 10.1016/j.clbc.2012.01.003.
Clinical trial NCT04588064: 18F-FDG and 68Ga-FAPI PET/CT in Lung Adenocarcinoma
Official title: Comparison of 18F-FDG and 68Ga-FAPI PET/CT in Patients with Lung Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Adenocarcinoma
18F-FDG
68Ga-FAPI
PET/CT
Keywords: Lung Adenocarcinoma
FDG
FAPI
PET/CT
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants with lung adenocarcinoma undergo contemporaneous 68Ga-FAPI and 18F-FDG PET/CT for tumor staging before treatment.
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 68Ga-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in lung adenocarcinoma, compared with 18F-FDG PET/CT.

Detailed description: Participants with lung adenocarcinoma underwent contemporaneous 18F-FDG and 68Ga-FAPI PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy. In addition, the investigators further investigate the performance of 68Ga-FAPI PET/CT for differentiating invasive adenocarcinoma from adenocarcinoma in situ (pre-invasive lesion) or minimally invasive adenocarcinoma in participants with solitary ground-glass opacity nodules.

Eligibility criteria: Inclusion Criteria:

* (i) aged ≥ 18 years, with newly detected GGNs ≤ 3 cm on LDCT and suspected to be lung cancer, and with no prior treatment;
* (ii) who accepted undergoing paired 18F-FDG and 68Ga-FAPI-46 PET/CT, with completion within one week of each other;
* (iii) with planned surgical resection within one month after PET/CT examinations;
* (iv) with an ability to provide informed consent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) without surgical treatment;
* (ii) receiving antitumor treatment prior to surgery;
* (iii) whose postoperative pathology revealed adenocarcinoma beyond stage IA or benign pulmonary lesions;
* (iv) with concurrent diagnosis of other malignant tumors;
* (v) with poor image quality or lesions difficult to measure.

Primary outcomes:
measure: Cut-off value of SUVmax
timeFrame: 30 days
Secondary outcomes:
measure: The area under the receiver operating characteristic (ROC) curve (AUC), accuracy, sensitivity, specificity, p-value [indicating accuracy exceeding the No-Information Rate], and kappa value
timeFrame: 30 days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital of Xiamen University, Fujian, China
name: Long Sun, PhD
role: STUDY_DIRECTOR
References: