louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01620749: Of 18F MEL050 Using PET/CT in Metastatic Melanoma
Official title: A Phase 0 Exploratory Microdosing Study of 6-18fluoro-N-[2-(Diethylamino)Ethyl]Pyridine-3-carboxamide (18F MEL050) Using PET/CT in Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Metastatic Melanoma
Keywords: melanoma metastatic diagnosis
Lead sponsor: Cooperative Research Centre for Biomedical Imaging Development
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F MEL050 for finding sites of melanoma.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained prior to any protocol-specific procedures
* Male and female patients with histologically confirmed melanoma
* At least one site of metastatic disease, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care
* Age \>/= 18 years
* Life expectancy \>/=3 months
* ECOG performance score of 0-2

Exclusion Criteria:

* Pregnant or breastfeeding females
* Systemic anti-melanoma therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F MEL050 PET/CT scan
* Patients whose clinical care may be compromised because of the delay resulting from performance of the 18F MEL050 PET/CT scan
* Patients whose only metastatic lesion is in the Central Nervous System
* Patients with urinary incontinence or patients who cannot comfortably hold their urine for more than 90 minutes
* Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
* Patients unwilling or unable to comply with protocol and patients with a history of non compliance or inability to grant informed consent.

Primary outcomes:
measure: Safety of 18F MEL050 administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F MEL050 administration.
timeFrame: Up to 28 days following 18F MEL050 administration (+/- 7 days)
Secondary outcomes:
measure: Percentage of injected 18F MEL050 dose in organs of interest.
timeFrame: 10, 30, 60 and 120 minutes post 18F MEL050 administration
measure: Percentage of unmetabolized 18F MEL050 in plasma and urine after radiotracer administration.
timeFrame: 60, 120 and 180 minutes post 18F MEL050 administration.
measure: Absorbed organ doses and whole body dose expressed as milliSv/200MBq administered dose.
timeFrame: 10, 30, 60 and 120 minutes post 18F MEL050 administration
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Grant McArthur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05954949: Detection of Ileoanal Pouch/Reservoir Adenomas
Official title: Detection of Ileoanal Pouch/ Reservoir Adenomas by Routine Chromoendoscopy With Indigocarmine
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Adenomatous Polyps
Keywords: familial adenomatous polyposis
Ileoanal pouch/reservoir
adenomas
chromoendoscopy
indigocarmine
colectomy
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 40
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: Adults with familial adenomatous polyposis after colectomy

Brief summary: The detection of adenomas is the basis for the follow-up of patients with familial adenomatous polyposis, after colectomy, with a remnant rectum or an ileal pouch. The optimal method for the adenomas detection is not defined yet. Despite the proven effectiveness of indigo-carmine in different indications dye chromoendoscopy is not used in a consensual way at the international level. The situation of the ileal pouch is specific as adenomas have a usually flat shape and are much more difficult to identify than in the situation of a remnant rectum, even in the situation of \> 5 mm adenomas that should be resected.

Our hypothesis is that indigo-carmine can improve adenomas detection, including \> 5 mm adenomas, in patients with a an ileal pouch after colectomy improving the effectiveness of surveillance programs and potentially reducing the risk of cancer in this population.


Eligibility criteria: Inclusion Criteria:

* Patients with familial adenomatous polyposis
* Ileo-anal anastomosis with pouch reservoir
* Quality of the final preparation = 3 (excellent) on the studied area
* Films made under optimal conditions for the 3 staining methods

Exclusion Criteria:

* Patient with no familial adenomatous polyposis
* Patient without Ileo-anal anastomosis reservoir
* Insufficient quality of the final preparation \<3
* Absence of films made under optimal conditions for the 3 staining methods

Primary outcomes:
measure: Average number of ileal pouch/reservoir adenomas
timeFrame: 6 months after colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05670249: Decompressive Craniectomy in Patients With Cerebellar Infarction
Official title: Decompressive Craniectomy In Patients With Malignant Cerebellar Infarction: A Randomized, Controlled Trial in a Turkish Population (DEMCI Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebellar Stroke
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants assigned to either conservative medical or SDC group with a 1:1 allocation assignment using a random number table by co-decision of a neurologist, neurosurgeon and statistician
Primary purpose: PREVENTION

Brief summary: The investigators aimed to evaluate the outcome in participants up to 80 years of age with space-occupying cerebellar infarction treated with suboccipital decompressive craniectomy (SDC) compared to medical therapy alone.

Detailed description: This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. The primary end point was survival with favorable outcome, defined as a score of 0 to 3 on the mRS at 12 months (±30 days) after randomization (defined by a score of 0 to 3 on the modified Rankin scale (mRS), which ranges from 0 \[no symptoms\] to 6 \[death\]). Secondary outcomes included death, Barthel Index, baseline stroke severity NIHSS (National Institute of Health Stroke Scale), and SF-36 at 6 months and 1-year after randomization. The variables for subgroup analysis were age, sex, time to randomization, lesion volume, brainstem involvement, hemorrhagic transformation.

Eligibility criteria: Inclusion Criteria:

* The presence of cerebellar territory infarction with an NIHSS score ≥8.
* Initial Glasgow Coma Scale (GCS) score \<9 on admission and clinical deterioration (a score of ≥ 1 decrease on GCS score) within 48 hours from onset.
* Decrease in the level of consciousness to a score of ≥ 1 on item 1a (level of consciousness) of the NIHSS, rapid deterioration to coma.

Exclusion Criteria:

* Prestroke mRS score ≥2.
* Prestroke score on the Barthel Index \<95.
* Score on the Glasgow Coma Scale ≤6.
* Both pupils fixed and dilated.
* Any other coincidental brain lesion that might affect outcome.
* Space-occupying hemorrhagic transformation of the infarct.
* Pregnancy.
* Life expectancy \<3 years.

Primary outcomes:
measure: The primary end point was survival with favorable outcome, defined as a score of 0 to 3 modified Rankin score
timeFrame: one year
Secondary outcomes:
measure: Death
timeFrame: 1 year
measure: Barthel Index,
timeFrame: 1 year
measure: NIHSS (National Institute of Health Stroke Scale)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01462149: Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer
Official title: Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Ovarian Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2011-10-31
Enrollment: 43
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However, docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Advanced epithelial, tubal, or primary peritoneal cancer
* Cancer cells in paracentesis, thoracentesis, or laparoscopic surgery
* Less probability of complete cytoreduction
* Age: 20-80 years
* GOG performance status: 0-3
* Adequate organ function Bone marrow: ANC ≥ 1,500mm3, Platelet ≥ 100,000/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine ≤ 1.25 × UNL Liver: AST, ALT ≤ × 2.5 UNL (in case of liver metastasis, AST, ALT ≤ × 5 UNL), alkaline phosphatase ≤ 5 x UNL, bilirubin ≤ 1.5 mg/ mm3

Exclusion Criteria:

* Previous chemotherapy or pelvic radiation therapy
* Final diagnosis is other malignancies
* Coincidental Other malignancies within 5 years except carcinoma in situ of uterine cervix
* History of severe allergy
* Pregnancy, lactating woman
* Uncontrolled medial disease
* Bowel obstruction requiring immediate surgery
* Etc.

Primary outcomes:
measure: Response rate
timeFrame: 1 month after completion of study treatment
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Before each chemotherapy, an average of 3 week
measure: Disease-free survival
timeFrame: 2 years after completion of study treatment
measure: Overall survival
timeFrame: 2 years after completion of study treatment
measure: The number of participants who achieved optimal cytoreduction
timeFrame: 1 month after completion of study treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT03721549: Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Official title: Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Norovirus Infection
Lead sponsor: WCCT Global
Sponsor class: INDUSTRY
Collaborators: name: Vaxart
First posted: 2018-10-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A total of 16 eligible healthy young adults will be challenged with either the moderate or higher dose of norovirus inoculum
Primary purpose: OTHER

Brief summary: There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects. The purpose of this study is to generate the infection and illness rate and immune response data necessary for the conduct of future investigation of Norovirus vaccine studies.


Eligibility criteria: Inclusion Criteria:

* General good health, without significant medical illness, based on medical history, physical examination, vital signs, and clinical laboratories (CBC, chemistry, and urinalysis) as determined by the investigator in consultation with the research monitor and sponsor
* Available for all planned visits and to spend at least 5 days in confinement
* Confirmed blood type (A or O)
* Demonstrated to be H type-1 antigen secretor positive (by saliva test)
* Body mass index between 17 and 30 at screening
* Female subjects must have a negative pregnancy test and either use contraceptives or be sterile
* Available to return for follow-up visits following discharge from the inpatient unit and deliver stool specimens to the investigator promptly

Exclusion Criteria:

* Presence of significant medical condition
* Donation or use of blood or blood products within 4 weeks prior to challenge
* Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic
* Abnormal stool pattern
* Any gastroenteritis within the past 2 weeks
* Occupational hazards, including having daily contact with children under the age of 5, women known to be pregnant, employment in the food service industry, health care workers, etc.

Primary outcomes:
measure: Frequency of Norovirus Gastroenteritis (NVG)
timeFrame: 7 days post-challenge
Secondary outcomes:
measure: Frequency of Serious Adverse Events (SAEs)
timeFrame: 42 ± 3 days post-challenge
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: WCCT Global
state: California
Study officials:
References:
Clinical trial NCT06474949: Local Anesthetic for Plateau Fractures
Official title: Local Anesthetic for Plateau Fractures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Tibial Plateau Fractures
Keywords: tibial plateau fracture
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: PREVENTION

Brief summary: Subjects may receive an injection at the end of the surgery to fix their broken leg that may reduce their pain and hospital stay

Detailed description: Subjects will be randomized to bupivicaine or saline injection in the joint at the end of Open Reduction Internal Fixation of the tibial plateau fracture

Eligibility criteria: Inclusion Criteria:

* Age \>=18 year ,
* tibial plateau fracture undergoing Open Reduction and fixation"

Exclusion:

* allergy to bupivacaine
* Prolonged external fixator use

Primary outcomes:
measure: Pain in the knee visual analogue scale 11 point scale 0(no pain) -10 (worst pain)
timeFrame: From date of hospitalization to end of follow-up at 6 months
Secondary outcomes:
measure: Length of stay for hospitalization
timeFrame: From date of hospitalization up to one month post surgery
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Jonah Hebert-Davies
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03287349: Genomic Assessment of Patients With Severe Radiation Reactions
Official title: Genomic Assessment of Patients With Severe Radiation Reactions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation; Reaction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults with severe reactions to radiation treatment

Brief summary: Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood draw.


Eligibility criteria: Inclusion Criteria:

* Weigh at least 110 pounds
* Healthy

Exclusion Criteria:

- Pregnant

Primary outcomes:
measure: Whole exome sequencing
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kimberly Corbin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01081249: Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting
Official title: Physiologic Correlates of Perceived [Therapist] Empathy and Social-Emotional Process During Psychotherapy: Testing Oxytocin in a Cross-Over Design Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Behavior
Anxiety
Keywords: psychotherapy
Lead sponsor: MacDonald, Kai, M.D.
Sponsor class: INDIV
First posted: 2010-03-05
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Subjects-currently in outpatient mental health care--will participate in 2 psychotherapy sessions, one with oxytocin spray and one with placebo spray. Sessions will be videotaped, and cortisol and heart rate will be measured. We hypothesize that oxytocin will have positive benefits on nonverbal behavior in the therapy session, as well as have positive effects on subjective anxiety, cortisol and heart rate.


Eligibility criteria: Inclusion Criteria:

* in current mental health treatment
* male 18-65

Exclusion Criteria:

* diagnosis of schizophrenia or psychosis
* diagnosis of autism or Aspergers disorder
* active substance use disorder
* at moderate or high risk of self-harm

Primary outcomes:
measure: Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug
timeFrame: videotapes of session were reviewed and scored 1-3 months after the patient completes the study
Secondary outcomes:
measure: Salivary Cortisol
timeFrame: before drug, before session, and 20 minutes after session
measure: Heart Rate Variability (HRV)
timeFrame: continuously monitored from time before drug delivery to 20 minutes after session
measure: Subjective Ratings of Anxiety and Trust of the Therapist
timeFrame: measured before drug, immediately before session, and after the session
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kai MacDonald, MD 3368 2nd Ave Ste B
state: California
Study officials:
affiliation: UCSD
name: Kai MacDonald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Macdonald K, Macdonald TM. The peptide that binds: a systematic review of oxytocin and its prosocial effects in humans. Harv Rev Psychiatry. 2010 Jan-Feb;18(1):1-21. doi: 10.3109/10673220903523615.
citation: MacDonald K, MacDonald TM, Brune M, Lamb K, Wilson MP, Golshan S, Feifel D. Oxytocin and psychotherapy: a pilot study of its physiological, behavioral and subjective effects in males with depression. Psychoneuroendocrinology. 2013 Dec;38(12):2831-43. doi: 10.1016/j.psyneuen.2013.05.014. Epub 2013 Jun 28.
Clinical trial NCT04970849: Survey Study About Endoscopy During COVID-19 Pandemic for IBD Doctors
Official title: Patterns of Endoscopy During COVID-19 Pandemic: a Global Survey of Interventional Inflammatory Bowel Disease Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The content of survey included: The number of procedures, the indication of endoscopy, the number of patients with IBD diagnosed Covid-19, and the influence of the epidemic situation on the diagnosis and treatment of IBD.

Brief summary: Performance of diagnostic or therapeutic endoscopic procedures in inflammatory bowel disease (IBD) patients can be challenging during a viral pandemic; the main concerns being the safety and protection of patients and health care providers (HCP). The aim of this study is to identify endoscopic practice patterns and outcomes of IBD and coronavirus disease 19 (COVID-19) with a worldwide survey of HCP.

Detailed description: The 20-item survey questionnaire was sent to physician members of the American Society for Gastrointestinal Endoscopy Special Interest Group in Interventional IBD, Chinese IBD Society Endoscopy Interest Group, and the China Crohn's and Colitis Foundation. The data of the survey was collected and analyzed.

Eligibility criteria: Inclusion Criteria:

1. Doctors who are involved in the endoscopic treatment of IBD patients;
2. The endoscopist reads and signs an informed consent online. -

Exclusion Criteria:

1. Doctors who are not involved in the endoscopic treatment of IBD patients
2. Doctors who need the help of an agent, a witness, or someone else who can not complete the questionnaire independently.
3. Other conditions that the researchers considered unsuitable for inclusion or influenced the participants'ability to complete the study.-

Primary outcomes:
measure: The influence of covid-19 pandemic on endoscopic practice by IBD endoscopist
timeFrame: 1 week
Secondary outcomes:
measure: The incidence of COVID19 in IBD patients who underwent endoscopy
timeFrame: 1 week
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Second Affiliated Hospital Zhejiang University School of Medicine
state: Hangzhou
Study officials:
affiliation: 浙江大学医学院附属第二医院
name: Yan Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mao R, Liang J, Shen J, Ghosh S, Zhu LR, Yang H, Wu KC, Chen MH; Chinese Society of IBD, Chinese Elite IBD Union; Chinese IBD Quality Care Evaluation Center Committee. Implications of COVID-19 for patients with pre-existing digestive diseases. Lancet Gastroenterol Hepatol. 2020 May;5(5):425-427. doi: 10.1016/S2468-1253(20)30076-5. Epub 2020 Mar 11. No abstract available.