louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05842421: Imaging Methods for the Diagnosis of Non-melanoma Skin Cancer and Its Precursors
Official title: Imaging Methods Like Dermoscopy, Optical Coherence Tomography, in Vivo Reflectance Confocal Microscopy and 3D Total Body Photography for the Diagnosis of Non-melanoma Skin Cancer and Its Precursors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-melanoma Skin Cancer
Keywords: dermoscopy
3D total body photography
optical coherence tomography
in vivo reflectance confocal microscopy
total body photography
non-invasive imaging
confocal microscopy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: randomized, controlled, unicentric study
Primary purpose: DIAGNOSTIC

Brief summary: Prospective, unicentric study that examines if imaging devices like total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy as an addition to clinical examination lead to a benefit for patients in the diagnosis of non-melanoma skin cancer and their precursors

Detailed description: 250 patients with lesions that are suspicious for non-melanoma skin cancer that had not yet had a biopsy, are randomized in 2 groups. The intervention group is examined with total body photography, dermoscopy, optical coherence tomography and in vivo reflectance confocal microscopy; the control group is examined with dermoscopy only. The aim of the study is to investigate whether these methods improve the early detection of non-melanoma skin cancer and their precursors. Examined are not only the differences in management of the lesions (excision, biopsy, local treatment or no treatment) and the diagnostic accuracy of the devices.

Eligibility criteria: Inclusion Criteria:

* Patients with 1 or more lesions suspicious for non-melanoma skin cancer that had not yet had a biopsy or diagnostic excision of the lesions

Exclusion Criteria:

* Patients with non-melanoma skin cancer that has already been examined with a punch biopsy or diagnostic excision
* Patients younger than 18 years
* Patients that are incapable of giving consent

Primary outcomes:
measure: Management of non-melanoma skin cancer
timeFrame: up to 24 months
Secondary outcomes:
measure: Comparison of diagnostic accuracy in optical coherence tomography and in vivo reflectance confocal microscopy in comparison to dermoscopy alone for non-melanoma skin cancer
timeFrame: up to 24 months
measure: Diagnostic accuracy of the combination of optical coherence tomography and in vivo reflectance confocal microscopy in non-melanoma skin cancer
timeFrame: up to 24 months
measure: Diagnostic accuracy of 3D total body photography
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Klinik und Poliklinik für Dermatologie, Carl Gustav Carus Dresden, Medizinische Fakultät Technische Universität Dresden
state: Saxony
Study officials:
References:
Clinical trial NCT01761721: Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics
Official title: Robot-assisted Laparoscopic Hysterectomy-RALH- Postoperative Complications, Quality of Life and Health Economics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Cancer
Treatment by Robotic Assisted Laparoscopy Hysterectomy
Keywords: Endometrial cancer (MeSH)
Robotics (MeSH)
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 139
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women suspected of endometrial cancer and treated with robot-assisted laparoscopic hysterectomy at Copenhagen University Hospital, Herlev.

Brief summary: The propose of this study is to describe recovery and experience of pain and health related quality of life after robot-assisted laparoscopic hysterectomy for women with Endometrial Cancer or Atypical Complex Hyperplasia.


Eligibility criteria: Inclusion Criteria:

Women suspected of having Endometrial Cancer or having Atypical Complex hyperplasia

* Ability to understand and speak Danish
* Ability to cooperate
* Provision of written informed consent

Exclusion Criteria:

* Having a benign condition after histopathology postoperatively
* Bing assigned to radiation or chemotherapy postoperatively

Primary outcomes:
measure: Postoperative complications Postoperative complications Postoperative complications Postoperative complications
timeFrame: 0-4 months follow-up
Secondary outcomes:
measure: Postoperative pain
timeFrame: 0-4 months follow-up
measure: Health Related Quality of Life
timeFrame: 0-4 months follow-up
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Anaesthesiology, Copenhagen University Hospital, Herlev
Study officials:
affiliation: Department of Anaesthesiology, Copenhagen University Hospital, Herlev
name: Suzanne F Herling, RN; MHSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herling SF, Moller AM, Palle C, Thomsen T. Health-related quality of life after robotic-assisted laparoscopic hysterectomy for women with endometrial cancer--A prospective cohort study. Gynecol Oncol. 2016 Jan;140(1):107-13. doi: 10.1016/j.ygyno.2015.10.024. Epub 2015 Nov 2.
Clinical trial NCT04634721: Transversus Abdominis Plan Block, Ultrasound or Laparoscopic?
Official title: Transversus Abdominis Plan Block Applied in Laparoscopic Cholecystectomies Effective By Which Method: Ultrasound or Laparoscopic?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bupivacaine
Anesthetics, Local
Anesthetics
Peripheral Nervous System Agents
Keywords: TAP block
laparoscopy
laparoscopic cholecystectomy
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Abdominal wall blocks are frequently used as part of multimodal analgesia for pain control after abdominal surgery. There are studies using the Transversus Abdominis Plane Block for postoperative pain control in laparoscopic cholecystectomies.

In this study, the investigators aimed to compare the advantages of these two methods by applying the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy with the help of postoperative USG and laparoscopy during surgery.In this study, the investigators aimed to compare the advantages of these two methods by applying the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy with the help of postoperative USG and LAPAROSCOPY during surgery.

Detailed description: A total of 60 patients aged 18-65, ASA 1-2-3, who will undergo elective laparoscopic cholecystectomy in our hospital, will be included in the study. Patients will be randomly divided into 3 groups with ultrasound (USG) guided (GROUP 1: USG) , Laparoscopic application (GROUP 2: LAP) and GROUP 3 :No-TAP blok Each group consists of 20 evil people. Written consent will be obtained by explaining the procedure to be performed before the operation to the patients. The Transversus Abdominis Plan Block will be applied to the patients by a blind anesthesiologist according to their group. The block to be made by the anesthesiologist who will apply the block procedure will be given in a closed envelope.

Eligibility criteria: Inclusion Criteria:

* ASA I,II,III
* Patients 18-65
* laparoscopic cholecystectomy

Exclusion Criteria:

* ASA III higher
* history of pain relief medication dependence
* history of substance abuse
* end stage chronic kidney disease
* advanced liver disease
* history of chronic pain -history of taking opioids or neuropathic agents regularly prior to surgery-
* BMI of 50 or over
* skin infections at the site of TAP block injection or port sites.

Primary outcomes:
measure: Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Post operative nausea or vomiting
timeFrame: 24 hours
Other outcomes:
measure: Total opioid usage
timeFrame: 24 hours
Locations:
city: Ankara
country: Turkey
facility: Ankara Şehir Hastanesi
state: Çankaya
Study officials:
References:
Clinical trial NCT00365521: Prophylactic Photodynamic Therapy to Organ Transplant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Organ Transplants
Keywords: Organ transplant patients receiving immunosuppressive therapy
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2006-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To evaluate a possible prophylactic efficacy of photodynamic therapy on the incidence of non-melanoma skin cancer, actinic keratoses, warts and keratoses in recently organ transplanted recipients.


Eligibility criteria: Inclusion Criteria:

* Organ transplant recipients.
* Age 40 years or older.

Exclusion Criteria:

* Patients younger than 40 years and older than 70 years.
* Clinical signs of skin cancer, actinic keratoses or warts at the time of inclusion.
* Previous photodynamic therapy to the skin areas investigated.
* Pregnancy or breast feeding patients.
* Patients with porphyria.
* Patients with a tendency to produce hypertrophic scars or keloids.
* Patients with known allergy to Metvix.
* Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic patients, dementia patients, mentally ill patients etc.).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Hædersdal, MD, PhD, DrMedSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01794221: The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision
Official title: The Role of 2-octyl Cyanoacrylate in Prevention of Recurrent Adhesions After Circumcision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phimosis
Adhesions
Keywords: circumcision
2 octyl cyanoacrylate
phimosis
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 422
Sex: MALE
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.

Detailed description: The objective of this study is to evaluate whether 2-octyl cyanoacrylate skin adhesive decreased the incidence of recurrent adhesions after circumcision. The investigators hypothesize that the incidence of recurrent adhesions will be decreased with use of 2-octyl cyanoacrylate skin adhesive.

Secondary Objective(s) To assess parent satisfaction and comfort level after circumcision with use of 2-octyl cyanoacrylate skin adhesive and compare to those undergoing circumcision without the use of 2-octyl cyanoacrylate skin adhesive.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing circumcision
* Only male patients under the age of 7 years will be eligible

Exclusion Criteria:

* Any patient over 7 years of age
* Previous circumcision
* Any parents who are not English language speaking

Primary outcomes:
measure: Post circumcision adhesions
timeFrame: 3-6 weeks
Secondary outcomes:
measure: Parent satisfaction and comfort level with circumcision results
timeFrame: 3-6 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital and Clinics
name: Shawn D St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000321: Methamphetamine Abuse Treatment in Patients With AIDS - 1
Official title: Methamphetamine Abuse Pharmacology in Patients With AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Substance-Related Disorders
Keywords: methamphetamine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Friends Research Institute, Inc.
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of desipramine, sertraline, and placebo on methamphetamine dependent gay men with AIDS.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Craving
measure: Retention
measure: Depression
measure: Methamphetamine use
measure: Anxiety and Depression
measure: ASI Scales (7)
measure: AIDS medical care engagement
measure: High risk sexual behaviors
measure: Mood indicators
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Frank Gawin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01297621: Physical Activity and Sexuality After Reduction Mammaplasty
Official title: Satisfaction, Physical Activity and Sexuality Outcomes in Breast Reduction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Hypertrophy
Keywords: breast hypertrophy
physical activity
sexuality
patient satisfaction
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This prospective controlled trial was designed to determine whether breast reduction may influence physical activity and sexuality of breast hypertrophy women.

Detailed description: Breast hypertrophy is a frequent condition among women; reduction mammaplasty is one of the most performed procedures in plastic surgery.Previous studies have demonstrated that breast hypertrophy is associated to back pain, and patients often complain about physical limitations due to this condition, as well as sexual impairment. Thus, this trial was designed to test the hypothesis that reduction mammaplasty may improve physical and sexual performance of breast hypertrophy patients,and patients'satisfaction with the results of the operation. Three validated tools were used: the International Physical Activity Questionnaire (IPAQ), the Female Sexual Quotient and the Breast Evaluation Questionnaire.

Eligibility criteria: Inclusion Criteria:

* breast hypertrophy
* candidate to reduction mammaplasty
* body mass index under 30Kg/m2
* women with sexual activity

Exclusion Criteria:

* pregnancy, delivery or breast feeding during the last 12 months
* body mass index over 30Kg/m2
* breast cancer history
* previous breast surgery
* smoking

Primary outcomes:
measure: physical activity
timeFrame: 6 months
Secondary outcomes:
measure: Patient's satisfaction
timeFrame: 6 months
measure: Sexuality
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital São Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Vanessa L Resende, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Miguel Sabino-Neto, MD, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Daniela F Veiga, MD, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Lydia M Ferreira, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05006521: Single and Multiple Ascending Dose Study of KN-002
Official title: Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, PK, and PD of Single Ascending Doses of KN-002 in Healthy Subjects and Multiple Ascending Doses of KN-002 in Subjects With Mild Asthma, Moderate-Severe Asthma and COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma COPD
Lead sponsor: Kinaset Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe asthma and Part 4 is a repeat dose in patients with COPD.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 - 55 years old
* Willing and able to give informed consent and comply with the study
* Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
* Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
* Pre-bronchodilator FEV1 ≥ 70 and ≥80% for Part 1 and Part 2 participants, respectively
* Pre-Bronchodilator FEV1 ≥50% predicted and ≤100% for Part 3
* Post Bronchodilator FEV1 ≥40 and ≤ 85% for Part 4

Exclusion Criteria:

* Clinically significant laboratory test abnormalities
* Clinically significant abnormal blood pressure and/or pulse rate
* Resting ECG clinically significant abnormalities
* Respiratory tract infection within 6 weeks of screening
* Positive test for active COVID-19 within 2 days prior to administration of IMP

Primary outcomes:
measure: Safety and tolerability (Parts 1, 2, 3 and 4) via an assessment of the incidence of treatment-related adverse events
timeFrame: Day 1 to 17
Secondary outcomes:
measure: Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of area under the curve (AUC)
timeFrame: Day 1 to 17
measure: Pharmacokinetics (Parts 1, 2, 3 and 4) via the determination of maximum plasma concentrations (Cmax)
timeFrame: Day 1 to 17
measure: Pharmacodynamics (Parts 2, 3 and 4) via changes in fractional exhaled nitric oxide (FeNO) levels
timeFrame: Day 1 to 17
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Medicines Evaluation Unit
Study officials:
affiliation: Medicines Evaluation Unit
name: Dave Singh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04715321: CT Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma
Official title: Computed Tomography Perfusion Parameters Predict Vascular Pattern in Hepatocellular Carcinoma: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
CT perfusion parameters
vascular pattern
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCC patients with tumor size of less than 5 cm who would receive liver resection.

Brief summary: Distinct vascular patterns (ECTC or Non-ECTC) of tumors plays an important role in tumor migration, metastasis and drug resistant in hepatocellular carcinoma (HCC). However, there is no non-invasive method to predict vascular pattern in clinical. In the present study, we prospectively assess CT perfusion parameters for evaluation of the vascular pattern in HCC.


Eligibility criteria: Inclusion Criteria:

1. age over than 18 years old
2. tumor size of less than 5 cm
3. Child-Pugh A class liver function
4. an Eastern Cooperative Oncology Group performance status of 0
5. no previous treatment for HCC
6. pathological diagnosis of hepatocellular carcinoma
7. adequate organ function (white blood cell count ≥3.0 × 109/L, absolute neutrophil count ≥1.5 × 109/L, platelet count ≥75 × 109/L, aspartate transaminase and alanine transaminase≤5 × upper limit of the normal, creatinine clearance rate of ≤1.5 × upper limit of the normal, and left ventricular ejection ≥45%)

Exclusion Criteria:

1. Patients who received antitumor therapy before recurrence, including radiotherapy, transarterial chemoembolization, tyrosine kinase inhibitor, and immune checkpoint inhibitor
2. a known medical history of HIV infection
3. pregnancy or breastfeeding
4. portal vein tumor thrombosis or hepatic vein thrombosis detected by any routine imaging modality, including ultrasonography, dynamic contrast CT and MRI
5. any evidence of tumor metastasis or prior recurrence
6. hepatic decompensation

Primary outcomes:
measure: Predictive performance of CT perfusion
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 6 months
measure: Disease-free survival (DFS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
References: