louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04803851: Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer
Official title: Anlotinib Plus Anti-PD-1 Antibody AK105 as Third or More-line Therapy for Advanced Pancreatic Cancer: a Prospective, Single-arm, Open-label, Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Anlotinib
Anti-PD-1 Antibody
Advanced Pancreatic Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to explore the clinical efficacy of Anlotinib combined with Anti-PD-1 antibody AK105 in the treatment of third- and above -line advanced pancreatic cancer patients, in order to find a better therapy strategy for pancreatic cancer patients.


Eligibility criteria: Inclusion Criteria:

* locally advanced or metastatic pancreatic cancer (PC),
* histologically or cytologically proven diagnosis of adenocarcinoma or adenosquamous carcinoma,
* failed to second-line chemotherapy for PC,
* 18-75 years of age,
* an Eastern Cooperative Oncology Group performance status score of 0 to 1,
* adequate organ functions

Exclusion Criteria:

* had received PD 1 /CTLA 4 antibody treatment
* had received anti-VEGFR inhibitors or antibodies

Primary outcomes:
measure: Disease control rate (DCR) based on RECIST v. 1 1
timeFrame: 6 weeks
Secondary outcomes:
measure: Objective response rate (ORR) based on RECIST V. 1.1
timeFrame: 6 weeks
measure: Progression free survival (PFS) measured from the date of anlotinib plus AK105 initiation to the time of progression
timeFrame: 6 weeks
measure: Overall survival (OS) measured from the date of anlotinib plus AK105 initiation to the time of death of any cause
timeFrame: 6 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT05784077: PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF
Official title: Prevalenza Delle Apnee Notturne e Riduzione Dei Fattori Promotori Nella Fibrillazione Atriale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Osa Syndrome
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients between 18 and 75 years of age, male and female, who come to the study centre between January 2019 and January 2023 with a diagnosis of atrial fibrillation and a recurrence (or first episode) in the previous year and who can undergo polysomnography

Brief summary: This study aims to identify how many patients who have atrial fibrillation, also have sleep apnoea. This is important because sleep apnoea can be a trigger to atrial fibrillation and it can be corrected with a simple intervention. Therefore it is important to understand its prevalence (how many patients with atrial fibrillation are affected by it). Also, obesity and sleep disorders are often associated, therefore the evolution of atrial fibrillation is studied in patients who also have obesity and have lost weight compared with patients who did not loose any weight or are not obese. As medications or therapy are not changed, this is an observational study.


Eligibility criteria: Inclusion Criteria primary outcome:

* 1 episode of atrial fibrillation in the previous year

Inclusion Criteria secondary outcome:

* BMI \> o = 27Kg/m2
* AHI \>30 o con 15\<AHI\<30 associated with other symptoms (sleeplessness, uncontrolled hypertension and cerebral events)

Exclusion Criteria:

* Ejection Fraction \<50%
* HFpEF not related to atrial fibrillation.
* coronary artery disease
* valvular cardiomyopathy
* patient already in treatment for sleep apnoea
* hyperthyroidism

Primary outcomes:
measure: Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation
timeFrame: Baseline and at 3, 6, 12, 24 and 36 months
measure: Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation
timeFrame: Baseline
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline and at 3, 6, 12, 24 and 36 months
measure: Change in incidence of atrial fibrillation recurrencies
timeFrame: Baseline and at 3, 6, 12, 24 and 36 months
measure: Change in quality of life
timeFrame: Baseline and at 3, 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
References:
Clinical trial NCT00308477: A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Branch Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Macular Degeneration
Macular Edema
Branch Retinal Vein Occlusion
Keywords: eye diseases
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2006-03-29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone for the treatment of macular edema associated with branch retinal vein occlusion.


Eligibility criteria: Inclusion Criteria:

* Macular edema resulting from branch retinal vein condition
* The criteria for visual acuity and macular thickness are met

Exclusion Criteria:

* History of glaucoma
* Diabetic retinopathy
* Known steroid-responder
* Use of systemic steroids
* Use of Warfarin/Heparin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Gunma
country: Japan
city: Hokkaido
country: Japan
city: Kagawa
country: Japan
city: Kyoto
country: Japan
city: Mie
country: Japan
city: Miyazaki
country: Japan
city: Osaka
country: Japan
city: Shiga
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Sanwa Kagaku Kenkyusho Co., Ltd.
name: Clinical Study Group, Clinical Development Dept.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05764577: DIEP Flap Surgery and Intraabdominal Pressure
Official title: Intraabdominal Pressure Increases Peri-operatively in Patients Undergoing DIEP Flap Reconstruction: A Prospective Study Linking High IAP to Non-fatal Lung Embolism in One Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraabdominal Hypertension
Breast Neoplasms
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 13
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females undergoing secondary DIEP flap breast reconstruction. Performance status ASA 1-2

Brief summary: Aim: The primary aim of this study is to test if closure of the abdominal donor site increases the Intraabdominal Pressure (IAP) in women undergoing secondary Deep Inferior epigastric perforator (DIEP) flap breast reconstruction.

Materials and method: By an Unometer, attached to a standard catheter in the bladder, we measured the intravesical pressure as a surrogate marker for the IAP, at baseline, immediate after- and 24 hours after abdominal skin closure, for 13 patients.


Eligibility criteria: Inclusion Criteria:

* Females undergoing secondary DIEP flap breast reconstruction.
* Performance status 1-2

Exclusion Criteria:

* Performance status above 2.
* Untreated hypertension or atrial fibrillation

Performance status evalutated using American Society of Anaesthesiologists' (ASA) classification of Physical Health.

Primary outcomes:
measure: Changes from Baseline in intraabdominal pressure at timepoint immediate after- and 24 hours after abdominal skin closure.
timeFrame: Baseline, immediate after- and 24 hours after abdominal skin closure
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: University hospital Aalborg
state: North Jutland
Study officials:
References:
Clinical trial NCT02053077: Risk Identification of the GlucoTab System in Routine Use
Official title: A Study to Identify Risks in Routine Use of the GlucoTab System for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at General Wards
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 150
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: non-critically ill patients with type 2 diabetes at general wards

Brief summary: Identification of risks of the GlucoTab system in routine use.

Detailed description: A study to identify risks in routine use of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.

Eligibility criteria: Inclusion Criteria:

* informed consent obtained after being advised of the nature of the study
* type 2 diabetes or new-onset hyperglycaemia which require s.c. insulin therapy during hospital stay
* diabetes therapy supported by GlucoTab system

Exclusion Criteria:

* type 1 diabetes mellitus
* intravenous insulin therapy
* hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
* gestational diabetes or pregnancy
* known or suspected allergy to certain insulin types, named in the user manual
* total parenteral nutrition (TPN)
* any mental condition rendering the patient incapable of giving his consent

Primary outcomes:
measure: Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes:
measure: Efficacy: Blood Glucose During Hospital Stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1 week
measure: Usability: Coverage of the GlucoTab
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Thomas R. Pieber, Univ.Prof.Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01981577: Subthalamic Nucleus Connectivity in Parkinson's Disease With Ultra-high Field Magnetic Resonance Imaging
Official title: Ultra-high Field Imaging of the Cortico-striato-subthalamic Functional and Structural Connectivity to Improve Deep Brain Stimulation Surgery in Parkinson's Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Subthalamic Nucleus
Ultrahigh field Magnetic Resonance imaging
Functional connectivity
Structural connectivity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
First posted: 2013-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Parkinson's patients scheduled for deep brain stimulation surgery at Maastricht University Medical Center
* Healthy volunteers from a community sample

Brief summary: The purpose of this study is to investigate the segregation of the subthalamic nucleus into its motor and non-motor regions in patients with Parkinson's disease and healthy controls with the aid of ultra-high field magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

Both groups:

* Mental competence

Group 1:

* Parkinson's disease patients scheduled for deep brain stimulation surgery

Group 2:

* Age and gender matched volunteers

Exclusion Criteria:

Both groups:

* Head injury
* Stroke
* Other neurological diseases other than Parkinson's disease
* Metallic prostheses or pacemaker in the subject's body or other contra indications for MRI

Group 1:

* Inability to abstain from dopaminergic drug use

Group 2:

* Parkinson's disease
* Use of medication affecting the central nervous system

Primary outcomes:
measure: Voxels of the subthalamic nucleus that are structurally or functionally connected to the motor cortex.
timeFrame: One measurement, consisting of 1 MRI scan of 1 hour
Secondary outcomes:
measure: Strength of the structural and functional connectivity between the subthalamic nucleus and the motor cortex.
timeFrame: One measurement, consisting of 1 MRI scan of 1 hour
measure: Brain areas structurally and functionally connected to the stimulation zone of the optimal electrode of operated Parkinson's patients.
timeFrame: One measurement, consisting of 1 MRI scan of 1 hour
measure: Brain areas that show an activation pattern measured with functional magnetic resonance imaging, that is correlated to a motor task.
timeFrame: One measurement, consisting of 1 MRI scan of 1 hour
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Yasin Temel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02133053: Application of Ectoin Allergy Nasal Spray in Comparison to Beclomethasone Nasal Spray
Official title: Non Interventional Study of Ectoin Allergy Nasal Spray Compared to Beclomethasone Nasal Spray
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
Ectoine
bitop
Ectoin
Lead sponsor: Bitop AG
Sponsor class: INDUSTRY
First posted: 2014-05-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Allergy Nasal Spray. In addition the effectiveness and safety shall be compared to a Beclomethasone nasal spray. The patient applies Ectoin® Rhinitis Nasal Spray or Beclomethasone nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.


Eligibility criteria: Inclusion Criteria:

* Diagnosed allergic rhinitis during the observational period

Exclusion Criteria:

* Contra indications according to the label

Primary outcomes:
measure: Change in Total Nasal Symptom Score
timeFrame: Time Frame: day 1, day 7, day 14
Secondary outcomes:
measure: Change in palatal itching score
timeFrame: Day 1, 7 and 14
measure: Efficacy and tolerability assessment by the patients and by the investigator
timeFrame: day 7 and 14
measure: Change in quality of life assessed by Rhinitis Quality of Life Questionnaire
timeFrame: Day1 and Day 14
Other outcomes:
Locations:
Study officials:
affiliation: HNO Praxis Elmshorn
name: Uwe Sonnemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01944553: Robotic-assisted Pedicule Screw Placement
Official title: A Prospective Study on the Feasibility of Pedicle Screw Placement in the Lumbar Level With a New Robotic-assisted System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Degenerative Spinal Disease
Keywords: Spine
Accurancy
Robotic
Screw placement
Degenerative
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Medtech S.A.S
First posted: 2013-09-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to evaluate the feasibility of using the robotic assisted device ROSA™ for pedicle screws placement. This device is currently used in cranial neurosurgery but its applications can be extended to other fields, such as spinal surgery. In the future, the use of ROSA™ in pedicle screw placement could increase the accuracy and safety of surgery for the patient.

Detailed description: The medical device subject of this research is the surgical robot ROSA™ designed for cranial surgery, and used here in another application, spinal surgery - more specifically for the placement of pedicle screws.

It is intended for spine surgeons to treat diseases requiring the placement of pedicle screws through posterior open surgery approach or minimally invasive surgery.

The system allows the precise guidance of instruments as defined by the surgeon on patient radiological images. The expected performance is a good rate of pedicle screws placement, increasing the performance observed with the conventional method. This system can be transported from one operating room to another, and stored in a storage room.

It interfaces with the most common intra -operative surgical imaging systems (mobile C-arms available at Montpellier University Hospital). Further versions of the device will enable the use of 3D intra-operative imaging systems such as the O-arm from Medtronic.

The main objective of the study is to evaluate the feasibility of using the robot ROSA™ for pedicle screws placement. In this study, the robot will be used with an open surgery approach, which is a first step in demonstrating the potential of the robot.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from lumbar back pain for more than 3 months
* Consent signed

Exclusion Criteria:

* pregnant patient
* patient nursing

Primary outcomes:
measure: accurancy of pedicle screw placement
timeFrame: during the surgery
Secondary outcomes:
measure: operative time / irradiation doses
timeFrame: During the surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier Hospital
Study officials:
References:
Clinical trial NCT00397553: Insulin Glulisine, Diabetes Mellitus Type 1
Official title: Multicenter, Open, Non-randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-09
Enrollment: 104
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: To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus, Type 1
* HbA1c 6.5-11.0%
* BMI \<35 kg/m²

Exclusion Criteria:

* Diabetes mellitus, Type 2

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

Primary outcomes:
measure: HbA1c
timeFrame: 52 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 26 weeks
measure: Fasting Blood Glucose
timeFrame: 26 weeks
measure: Fasting Blood Glucose
timeFrame: 52 weeks
measure: Post-prandial glycemia (2 hour after breakfast)
timeFrame: 26 weeks
measure: Post-prandial glycemia (2 hour after breakfast)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Marina Atarshchikova, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03397953: Vinorelbine for Recurrent ACLC
Official title: Phase II Study of Vinorelbine for Children With Recurrent Anaplastic Large Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anaplastic Large Cell Lymphoma
Vinorelbine
Keywords: Anaplastic Large Cell Lymphoma
Childhood
Adolescent
Recurrent
Treatment
Lead sponsor: Children's Cancer Group, China
Sponsor class: NETWORK
First posted: 2018-01-12
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficiency and safety of vinorelbine in the treatment of relapsed / advanced ALCL in children and adolescents.

Detailed description: Anaplastic large cell lymphoma (ALCL) is a rare non-Hodgkin's lymphoma, around 30% patients would get relapse. Vinorelbine(Navelbine) is a third-line treatment option for Hodgkin's disease(HD) after transplantation failed, while both HD and ALCL express CD30. When ALCL recurred, vinblastine monotherapy was used and the 5-year EFS up to 30%, 5-year OS up to 60%. In China vinblastine is unavailable. Vinorelbine is very similar to vinblastine in molecular formula, and is available in China. From November 2016 to March 2017, two patients with recurrent ALCL were recruited in the Department of Hematology and Oncology, Shanghai Children's Medical Center. They received vinorelbine monotherapy and achieved clinical remission (PET CR) at 8 weeks. One patient with bone marrow recurrence showed negative ALK / NPM by PCR . Based on this, the investigators will expand the sample to further investigate the therapeutic efficiency and safety of vinorelbine in children and adolescents with ALCL.

Eligibility criteria: Inclusion Criteria:

Children and adolescents with a clear diagnosis of recurrent / progressive ALCL at Shanghai Children's Medical Center or other centers since September 2017 include:

* Diagnosed as ALCL, already received first-line treatment, but get disease progression;
* After receiving ALCL treatment has got CR then diagnosed relapse, need for pathological diagnosis.

Exclusion Criteria:

* Patients with other systemic diseases, severe infections or critically illness.

Primary outcomes:
measure: Event free survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
measure: Safety statistics: adverse reactions during the trial through NCI CTCAE version 4.0.
timeFrame: 2 years
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Yijin Gao, MD
role: PRINCIPAL_INVESTIGATOR
References: