louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00457587: Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma
Official title: Präklinische Studie Zur Etablierung Einer Immuntherapie für Das Nebennierenrindenkarzinom - Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adrenocortical Carcinoma
Cushing's Syndrome
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
First posted: 2007-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adrenocortical carcinoma

Brief summary: Adrenocortical carcinoma (ACC) is a rare and heterogeneous malignancy with poor prognosis. Surgical resection of the tumor is the treatment of choice. However, even after complete resection more than 80 % of patients will experience recurrence of disease. Therefore, new treatment options are urgently needed. This pre-clinical study try to lay the foundations for a successful immunotherapy in patients with ACC.


Eligibility criteria: Inclusion Criteria:

* patients with histological proven adrenocortical carcinoma
* healthy persons as control group
* Life expectancy \> 6 months

Exclusion Criteria:

* autoimmune diseases
* severe clinical condition

Primary outcomes:
measure: To find reasonable antigens for a vaccination therapy in ACC
timeFrame: day of blood sampling
measure: To investigate the role of tumor-induced suppression in ACC
timeFrame: NA, in vitro study
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Dept. of Medicine I, University of Wuerzburg
Study officials:
affiliation: University of Wuerzburg
name: Martin Fassnacht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Landwehr LS, Altieri B, Schreiner J, Sbiera I, Weigand I, Kroiss M, Fassnacht M, Sbiera S. Interplay between glucocorticoids and tumor-infiltrating lymphocytes on the prognosis of adrenocortical carcinoma. J Immunother Cancer. 2020 May;8(1):e000469. doi: 10.1136/jitc-2019-000469.
Clinical trial NCT04266587: ACTH Stability on Whole Blood
Official title: Adrenocorticotropic Hormone Stability on Whole Blood
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ACTH
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: ACTH is a peptide secreted by pituitary gland and plays an important role in regulating cortisol secretion. ACTH is determined in plasma by immunoassays using specific antibodies. Its determination is difficult because of instability in whole blood. Several factors which influence ACTH stability in blood before analysis have been identified: temperature, hemolysis, time to centrifugation and presence of protease inhibitors. Published results on ACTH whole blood stability seem contradictory.

The objective of this study is to evaluate the effect of aprotinin in 10 healthy volunteers. ACTH measurements will be performed on cobas e602 (Roche Diagnostics, Mannheim, Germany).


Eligibility criteria: Inclusion Criteria:

* Adult patient aged 18 to 60,

Exclusion Criteria:

* Adult with insufficient venous capital for blood collection

Primary outcomes:
measure: ACTH concentration in plasma
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Francois FRAISSINET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06333587: Minimally Invasive Treatments of the Thyroid
Official title: Multicenter International Prospective Analysis on Minimally Invasive Treatments of the Thyroid (MIPA- MITT) of of Micropapillary Thyroid Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Papillary Thyroid Microcarcinoma
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 270
Sex: ALL
Minimum age (years): 18
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 thyroid diseases suitable for "Minimally Invasive Treatments of the Thyroid (MITT)" as potential alternative to surgery

Brief summary: This is a prospective cohort study to test Minimally Invasive Treatments of the Thyroid (MITT) as potential alternative to surgery in patients with Papillary Thyroid MicroCarcinoma (PTMC)

Detailed description: Image-guided thermal ablations have been successfully applied in the treatment of several type of tumors, and have been recently proposed as a potential alternative to surgery also in patients with thyroid diseases, and named "Minimally Invasive Treatments of the Thyroid (MITT)". These minimally invasive treatments, compared to surgical treatment have similar efficacy, fewer complications, better quality of life, and better cosmetic outcomes. These procedures allow precise delivery of the heat locally to the lesion, sparing the surrounding thyroid tissue, and thus minimizing the invasiveness of the treatment and the impact on thyroid function.

This study aim to establish a prospective registry of the cases of patients treated with MITT for a Papillary Thyroid MicroCarcinoma (PTMC), in order to validate the safety of the procedure and to set the basis for collecting long term results in a large cohort of patients.

Eligibility criteria: Inclusion Criteria:

* Patients \> 18years
* Patients with diagnosis of papillary thyroid microcarcinoma, citologically proven, suitable for MITT.
* Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
* Patients must be accessible for follow-up

Exclusion Criteria:

* Tumors \> 1 cm, other citological type, refusal of MITT, unsuitable for MITT, unmanageable coagulative disorders
* Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study

Primary outcomes:
measure: The proportion of patients with major complications occurring within one month after the date of intervention
timeFrame: 1 month
Secondary outcomes:
measure: Percentage of patients with local recurrence at 10 years
timeFrame: 10 years
measure: Percentage of patients with distant metastasis at 10 years
timeFrame: 10 years
measure: Percentage of patients died at 10 years
timeFrame: 10 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Giovanni Mauri
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03979287: Interferential Current and Therapeutic Exercise Program in Chronic Neck Pain
Official title: Efficacy of a Interferential Current and Therapeutic Exercise Program in Subjects With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Chronic Neck Pain
Interferential Current Electrotherapy
Therapeutic Exercise
Physical Therapy
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: To analyze the number of sessions needed to achieve a positive impact after combining interferential current therapy and therapeutic exercise, compared with therapeutic exercise alone, on self-reported pain, disability and range of motion in subjects with chronic neck pain.

Design: A randomized, single-blind, controlled trial. Subjects: Patients between 18 and 65 years old, with idiopathic chronic neck pain.

Methods: The experimental group who will perform a combined treatment using Interferential current therapy and therapeutic exercise for two weeks. The control group will receive the same program of therapeutic exercise during the same period of time.


Eligibility criteria: Inclusion Criteria:

* Nonspecific mechanical neck pain (chronic neck pain diagnosed by a physician)
* Age between 18 and 65 years old
* Both males and females
* Non apprehension to electrotherapy (determined by the Personal Psychological Apprehension scale- EAPP)
* Self-reported pain higher than 2 in the 11-point Numeric Pain Rating Scale

Exclusion Criteria:

* Metallic implants in the vertebral column
* Apprehension to electrotherapy (a score \>45 points in EAPP)
* Cervicogenic headache
* Cervicogenic Dizziness
* Neck pain associated with neurological deficits
* Unexplained fever
* Cervical surgery associated to persistent pain
* Specific diagnostics (cervical myelopathy, cervical stenosis, osteomyopathy)
* Other diagnostics such as visceral pain referred to the neck or non-cervical cause.
* Involvement in litigation
* Manual treatment for the neck-shoulder area in the last month before data collection

Primary outcomes:
measure: Neck pain intensity
timeFrame: From baseline to immediately after treatment
measure: Disability
timeFrame: From baseline to immediately after treatment
Secondary outcomes:
measure: Range of movement (ROM)
timeFrame: From baseline to immediately after treatment
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: University of Sevilla
Study officials:
affiliation: Physiotherapy Department, University of Seville, spain
name: Alberto Heredia-Rizo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04010487: Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis
Official title: A Multi-omics Study on the Pathogenesis of Malignant Transformation of Adenomyosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenomyosis
Endometrial Cancer
Ectopic Endometrial Tissue
Eutopic Endometrium
Genomics
Transcriptomics
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes two groups patients (about 22 cases in each group):

* Patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA)
* Patients pathologically diagnosed with adenomyosis

Brief summary: This study is to explore the driving genes and the molecular mechanism of malignant transformation of adenomyosis. This study acquired the formalin fixed paraffin-embedded (FFPE) tissue of patients pathologically conformed endometrial carcinoma arising in adenomyosis (EC-AIA) treated at Peking Union Medical College Hospital from July 15, 2017 to July 15, 2019. The formalin fixed paraffin-embedded tissues from patients pathologically diagnosed with adenomyosis during this time period were also included as control specimens. The eutopic endometrium, normal adenomyosis tissue, and EC-AIA tissue were harvested from the FFPE tissue from patients with EC-AIA. The normal eutopic endometrium and normal adenomyosis tissue were obtained by laser microdissection. The driving genes and potential molecular mechanism of EC-AIA will be found by the technology of whole exome sequencing and transcriptomics (RNA-sequencing).


Eligibility criteria: Inclusion Criteria:

* Pathological confirmed diagnosis with atypical hyperplasia and malignant transformation of adenomyosis glandular epithelium (including endometrioid, serous and clear cell carcinoma), with or without concurrent endometrial carcinoma
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all the inclusion criteria.
* The formalin fixed paraffin-embedded (FFPE) tissue was not acquired at the required time period.
* The patients enrolled had accompanied some other kinds of carcinoma (such as ovarian cancer, cervical cancer, primary peritoneal cancer).
* Patients had cancer history of certain organ (such as colorectal cancer, gastric cancer, etc.)

Primary outcomes:
measure: Frequencies of somatic driving mutations
timeFrame: One year
measure: Frequencies of alteration of RNA expression
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00946387: To Demonstrate the Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions
Official title: A Relative Bioavailability Study of Ondansetron HCl 24 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nausea
Vomiting
Keywords: Antiemetic
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 26
Sex: ALL
Minimum age (years): 22
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability study of Ondansetron HCl 24 mg tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Soran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02779387: Reproductive Outcome of EM Treated by GnRH-a Associated With Laparoscopy
Official title: Efficacy of Laparoscopic Surgery Combined With GnRH-a in the Treatment of Endometriosis Associated Infertility: A Multicenter, Prospective, Randomized-control-trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility Associated With Endometriosis
Keywords: GnRH-a
endometriosis
efficiency
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 1184
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, randomized-control-trial. This study select 1184 Infertile patients associated with endometriosis diagnosed by laparoscopy surgery. Patients are going to be divided into two groups according to 1:1 ratio randomly assigned to receive GnRH-a. Cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted reproductive treatment rate, miscarriage rate, live birth rate will be recorded.


Eligibility criteria: Inclusion Criteria:

* Infertile patients
* Endometriosis I-II phase：according to Revised American Society for Reproductive Medicine classification of endometriosis: 1996
* BMI:19-28 kg/㎡
* Ovarian reserve function is normal（M2-5：bilateral antral follicles≥6 FSH：5-12U/ml）

Exclusion Criteria:

* Male factor causes infertility
* hydrosalpinx or salpingemphraxis
* Uterine malformation
* Uterine cavity lesion
* Contra-indications for GnRH-a
* not willing to participate

Primary outcomes:
measure: Cumulative pregnancy rate
timeFrame: 18 month after surgery
measure: Time interval between surgery and natural pregnancy
timeFrame: 18 month after surgery
measure: miscarriage rate
timeFrame: 18 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00484887: Characterization of Explanted Hernia Meshes From Human Subjects: A Multi-Center, Prospective Study
Official title: Characterization of Explanted Hernia Meshes From Human Subjects: A Multi-Center, Prospective Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pathological Conditions, Signs and Symptoms
Hernia
Keywords: Hernia mesh
Implanted mesh material
Explanted mesh material
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Washington University School of Medicine
name: University Hospitals Cleveland Medical Center
First posted: 2007-06-11
Enrollment: 272
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: Surgical patients at the University of Missouri Healthcare system.

Brief summary: This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data.

Detailed description: This study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. We will have evidence that our current options are not only inadequate but can lead to complications. One of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data. The objectives of this study are to establish the largest collection of explanted mesh materials in the country; demonstrate by common testing utilized by materials engineers, that in vivo exposure of mesh to the oxidants produced by phagocytosis may lead to chain scission, production of free radicals, and overall degradation of the material both physically and chemically; test mesh materials for a decrease in compliance, which would account for a tendency of mesh to stiffen while in the body reducing abdominal mobility and leading to chronic pain; characterize the histologic reaction of tissues to mesh; and utilize de-identified patient demographics to identify possible clinical characteristics which affect mesh degradation.

Eligibility criteria: Inclusion Criteria:

* Adults (persons 18 and older)
* Previous placement of hernia mesh material
* Current need for excision of previous mesh placement or current need for intra-abdominal surgical procedure

Exclusion Criteria:

* No retained mesh prosthetic
* Non surgical candidate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospital and Clinics
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Bruce Ramshaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01978587: Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
Official title: A Phase 1, Open-label, Sequential Crossover Study to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia in Chronic Kidney Disease
Keywords: End-stage Renal Disease
Hemodialysis
Pharmacokinetics
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis


Eligibility criteria: Inclusion Criteria:

* Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
* Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit

Exclusion Criteria:

* Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission
* Uncontrolled hypertension at the Screening Visit or Day -1

Primary outcomes:
measure: Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis
timeFrame: Days 1 to 4 and 8 to 11
measure: tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis
timeFrame: Days 1 to 4 and 8 to 11
measure: AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis
timeFrame: Days 1 to 4 and 8 to 11
measure: t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis
timeFrame: Days 1 to 4 and 8 to 11
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: 14 days
measure: Vital signs and ECG (electrocardiogram)
timeFrame: 14 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
state: Minnesota
Study officials:
affiliation: Akros Pharma Inc.
name: Hideyuki Yamamoto
role: STUDY_CHAIR
References: