louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05574816: Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
Official title: Evaluation of the Diagnostic Performance of a Bra Prototype to Detect Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Keywords: Breast cancer detection
impedance
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Phi-Bra is a prospective and monocentric pilot study to assess the diagnostic capability of an innovative bra prototype to detect breast cancer, compared to the current standard of care: the mammography.

The Phi-Bra prototype is designed with sensors measuring different parameters simultaneously such as impedance and temperature.

The bra will be tested on patients without breast lump (American College of Radiology (ACR) 1 et 2 Birads classification) and with breast lump (ACR 4b, c ou ACR 5 Birads classification).

The aim of this pilot study is to compare the results obtained by Phi-Bra to the ones obtained by mammography.

The Phi-Bra study is classified as clinical investigation category 4.4 based on the European Union (EU) regulation (DM 2017/745).


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75.
* No breast cancer surgery background
* Bra size : S/M or M/L

Specific criteria for the "no breast lump" cohort:

- Negative mammography result (ACR 1 a 2).

Specific criteria for the "breast lump" cohort:

- Suspicious breast lump discovered during the mammography (ACR 4b ou c ou ACR 5) and for which there is an indication of microbiopsy.

Exclusion Criteria:

* Breast cancer background (surgery or radiotherapy)
* Breast lump classified as ACR 3 ou ACR 4a during the mammography

Primary outcomes:
measure: Aria Under Receiver Operating Characteristic (ROC) Curve
timeFrame: The day of inclusion
Secondary outcomes:
measure: impedance optimal threshold
timeFrame: The day of inclusion
measure: Correlation between lump volume and device impedance
timeFrame: The day of inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Gynecologie-Obstetrique, Hopital de la Croix Rousse
city: Lyon
country: France
facility: Service de Radiologie, Hôpital de la Croix-Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Marion CORTET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02748616: C. Difficile and Ursodiol
Official title: A Clinical Trial for the Off Label Use of Ursodiol for the Prevention of Recurrent C. Difficile Colitis and Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diarrhea
Keywords: Colitis
Bile
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 9
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: In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence. Investigators will administer ursodeoxycholic acid for two months, beginning with Metronidazole and/or Vancomycin (8 to 10 days), antibiotics currently used for the treatment of acute C.Difficile infection. Ursodeoxycholic acid prevents c.difficile recurrence by (a) directly suppressing the growth of C. Difficile and (b) permitting restoration of normal fecal bile acid composition (80% deoxycholic acid) to maintain growth suppression.

Detailed description: The non-investigational reference therapies, Metronidazole, Vancomycin and fidaxomicin , are FDA-approved antibiotics currently in use today because of their effectiveness in suppressing the growth of C. difficile and therefore quickly eliminating the colitis and diarrhea. However, they do not promote the restoration of the normal bacterial flora. Therefore, when medication is stopped, the C. difficile colitis returns. In vitro findings have established that ursodeoxycholic acid is a surrogate for deoxycholic acid in preventing the growth of C. difficile, and interrupting recurrence.

Eligibility criteria: Inclusion Criteria:

* Male and female patients with recurrent C. difficile colitis
* 18 years of age and older
* Capable of giving informed consent

Exclusion Criteria:

* Patients with other gastrointestinal problems prone to cause diarrhea if they cannot be controlled for the period of the study. Lactose intolerance or gluten enteropathy are not an exclusion provide that the potential subject is asymptomatic and can be expected to adhere to the appropriate dietary regimen.
* Patients with contraindications to metronidazole or vancomycin and/or ursodiol tablets or components of the formulations.
* Patients not available for long-term follow-up (2 months) by their physician will be excluded from the study.

Primary outcomes:
measure: Percent of Patients With Return Toward a Normal Fecal Bile Acid Pattern
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Norman Javitt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02534116: A Comparison of Incisional Negative-Pressure Wound Therapy Versus Conventional Dressings Following Abdominal Surgery
Official title: A Comparison of Incisional Negative-Pressure Wound Therapy Versus Conventional Dressings Following Abdominal Surgery: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Abdominal Reconstruction
Keywords: abdominal reconstruction
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare outcomes between incisional negative-pressure wound vacuum-assisted closure (VAC) therapy versus conventional dressings following abdominal surgery.

Detailed description: This study will prospectively compare rates of wound complications using incisional negative pressure wound therapy versus conventional dressings following abdominal reconstruction.

Patients will undergo abdominal surgery (panniculectomy, abdominoplasty, ventral hernia repair, or autologous flap reconstruction using abdominal donor tissue). Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days. After this time, the wound will be assessed for signs of infection, seroma, hematoma, skin and fat necrosis, skin dehiscence, and hernia during the follow-up appointments.

Eligibility criteria: Inclusion Criteria:

* Patients included in this study are patients undergoing abdominal reconstruction, which includes panniculectomy, abdominoplasty, ventral hernia repair and patients undergoing autologous flap reconstruction using abdominal donor tissue.

Exclusion Criteria:

* Patients will be excluded from study if they have an actively infected wound involving the incision, abdominal malignancy, a history of enteric fistula formation, or a bleeding disorder.

Primary outcomes:
measure: Post Operative Wound Complications
timeFrame: Between 2 and 5 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University, Section of Plastic Surgery
state: Connecticut
Study officials:
affiliation: Yale University
name: Sarah Persing, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06699316: Prognostic Counselling in Palliative Head and Neck Cancer (ProCoPall)
Official title: Individualized Prognostic Counseling on Life Expectancy of Head and Neck Cancer Patients in the Palliative Phase
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma of Head and Neck
Keywords: Palliative Care
Life expectancy
Counseling
Quality of life
Prognosis
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2024-11-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The investigators test the effect of providing individualized prognostic information on life-expectancy to head and neck cancer patients in the palliative phase.

Detailed description: In this prospective sequential cohort study, the investigators aim to include 160 patients with a palliative diagnosis of head and neck squamous cell carcinoma, divided into two cohorts. In cohort 1, patients will receive general prognostic counselling, while in cohort 2, patients will receive individualized prognostic counselling using the recently developed prognostic model 'OncologIQ Palliative'. Cohort 2 will commence after completion of cohort 1. The primary outcome will be decisional conflict and satisfaction with the decision-making process and proactive care planning. Additionally, we will assess whether patients undergo palliative treatment and, if so, the type of treatment received. We will also evaluate overall survival, the incidence of palliative sedation or euthanasia, and quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients who received a palliative diagnosis of a squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, supraglottic larynx, glottis larynx and unknown primary.

Exclusion Criteria:

* Illiterate patients
* Insufficient knowledge of Dutch language
* Incompetent (due to i.e. mental state) to consider their own treatment choice

Primary outcomes:
measure: Decisional conflict
timeFrame: 2 weeks
measure: Satisfaction with decision making process and proactive care planning
timeFrame: 3-4 weeks
Secondary outcomes:
measure: Treatment
timeFrame: At the end of the study
measure: Survival
timeFrame: Through study completion, up to 2 years
measure: Quality of Life Score
timeFrame: Baseline and every 6-8 weeks
measure: Palliative sedation and Euthanasia
timeFrame: Through study completion, up to 2 years
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
References:
Clinical trial NCT01813916: Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis
Official title: Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
synovial fluid
hyaluronic acid
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to use the proteomic analysis of synovial fluid to perform the comprehensive investigation of the biomarker that will be useful to assign the tratment effectiveness of five weekly intra-articular HA injection.

Detailed description: The intra-articular injection with HA is an accepted therapy for OA. However, the exact regulation of HA treatment is unclear. Compared the expression SF proteome from OA patients who received HA/800 treatment or not (post and pre-HA treatment) may be possible to identify the protein that response to the HA treatment and apply this to prognosis of OA. We used two-dimensional difference gel electrophoresis (2D-DIGE) combined with matrix-assisted laser desorption ionization time of light mass spectrometry (MALDI-TOF) to determine the differentially displayed proteins in human SF. Finally, we used Western blotting and ELISA analysis to validate the potential biomarkers.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of osteoarthritis
* Accept the intra-articular HA injection therapy

Exclusion Criteria:

-

Primary outcomes:
measure: To study the protein expression of synovial fluid for hyaluronic acid therapy in osteoarthritis
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Ccj@Ntu.Edu.Tw
Study officials:
affiliation: National Taiwan University Hospital
name: Ching-Chuan Jiang, M.D.;Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03448016: [C-11]NOP-1A and Alcohol Use Disorder
Official title: Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Alcoholism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alcohol Use Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-02-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: \[C-11\]NOP-1A
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to compare \[C-11\]NOP-1A binding in recently abstinent alcohol use disorders and controls

Detailed description: This will allow for understanding brain stress and antistress mechanisms that underlie abuse of alcohol in humans

Eligibility criteria: \[A\] Alcohol use disorders (AUD)

Inclusion Criteria:

1. Males or Females
2. Fulfill DSM5 diagnosis for alcohol use disorder
3. Medically Healthy

Exclusion Criteria:

1. Pregnancy or lactation
2. Comorbid severe/major medical, psychiatric (such as bipolar and psychotic disorders, etc.,) and current comorbid drug use disorders (other than tobacco use and recreational marijuana use)
3. Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
4. Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain

\[B\]Healthy controls

Inclusion Criteria:

1. Males or females
2. Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
3. Medically Healthy

Exclusion Criteria:

1. Pregnancy of lactation
2. Medical, psychiatric or comorbid drug/alcohol use disorders
3. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
4. Currently employed as a radiation worker; or participation in radioactive drug research protocols within the previous year
5. Currently on any psychotropic medications that can influence nociceptin transmission in the brain
6. Family history of psychotic disorder, manic episode, drug and alcohol use disorder in first-degree relatives

Primary outcomes:
measure: [C-11]NOP-1A VT
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of PIttsburgh PET Facility
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05066516: The Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects
Official title: An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 48
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was conducted as a randomized, open-label, single-dose, crossover study design. All participants were randomly allocated for group A (Period 1: Individual components (ICs), period 2: FCDP) and group B (Period 1: FCDP, period 2: ICs), and each group was administered either a single dose of IN-C009 (FCDP, dapagliflozin 10mg/linagliptin 5 mg) (HK inno.N., Seoul, Korea) or co-administration of a single dose of dapagliflozin (Forxiga 10 mg, AstraZeneca, Cambridge, England, UK) and linagliptin (Trajenta 5mg, Beringer-Ingelheim, Ingelheim, Germany) after at least 10 hours of overnight fasting. After the 28 days of the washout period, the participants received the opposite treatment (Group A: IN-C009; Group B: dapagliflozin and linagliptin). The dosage of dapagliflozin and linagliptin in the study is commercially used and recommended amount for the control of T2DM currently.

On the day 1 (the day of each drug administration), the serial blood samples were drawn immediately before (0 h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for dapagliflozin), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h (for linagliptin) after the each dosing to assess pharmacokinetics of each drugs.


Eligibility criteria: Inclusion Criteria:

* age between 19 to 45 years;
* body weight more than 50 kg

Exclusion Criteria:

* a history or evidence of hepatic, renal, gastrointestinal, or hematological abnormality;
* hepatitis B, hepatitis C, syphilis, or HIV infection;
* a history of hypersensitivity to dapagliflozin and/or linagliptin;
* clinically significant allergic disease; alcohol or drug abuse;
* heavy smoker (more than ten cigarettes per day);
* use of any medication within 30 days before the start of the study that may affect the study results.

Primary outcomes:
measure: Cmax
timeFrame: 72 hours
measure: AUC
timeFrame: 72 hours
Secondary outcomes:
measure: Tmax
timeFrame: 72 hours
measure: half-life
timeFrame: 72 hours
measure: CL
timeFrame: 72 hours
measure: Vd
timeFrame: 72 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT00174616: CORE: Capecitabine, Oxaliplatin, Radiotherapy and Excision
Official title: Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective:

* Pathological complete response (ypT0N0) rate

Secondary objectives:

* Histopathological R0 resection rate
* Pathological downstaging (ypT0-T2N0) rate
* One month surgical complication rate
* Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
* Safety
* Local and distant recurrence rates
* Progression-free survival
* Overall survival


Eligibility criteria: * Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal verge)
* No evidence of distant spread
* No prior therapy for chemotherapy or radiation therapy for rectal cancer
* Patient considered locally advanced by MRI:

  * Tumour beyond mesorectal fascia, or
  * Tumour ≤ 2mm from mesorectal fascia, or
  * T3 tumour \< 5cm from anal verge
* For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
* No peripheral neuropathy \> grade1
* ECOG PS ≤ 2
* ANC \> 1,500 x 10\^9/L
* Platelets \> 100,000 x 10\^9/L
* Creatinine \< 1.5 x IULN
* Bilirubin \< 1.5 IULN
* SGPT (ALT) \< 2.5 IULN
* No pre-existing condition which would deter chemoradiotherapy
* No uncontrolled diarrhoea or fecal incontinence
* No significant small bowel (\> 200cc or 6X6X6cm) delineated within the radiation fields
* No other serious uncontrolled concomitant illness
* Informed consent signed

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: MRI staging and TME surgery
timeFrame: within 4 - 6 weeks after completion XELOX-RT
Secondary outcomes:
measure: Measure safety - NCI-CTC version 2
timeFrame: from baseline to end of study
Other outcomes:
Locations:
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Frankfurt
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Milan
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Pe Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Guildford Surrey
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jean-Philippe Aussel
role: STUDY_DIRECTOR
References: