louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01252095: Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
Official title: An Open-label, Single Centre Phase I Study of the Safety and Tolerability of PG545 in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumours
Keywords: PG545
Phase I
Progen
antimetastatic
antiangiogenic
advanced cancer patients
solid tumors
solid tumours
Lead sponsor: Zucero Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Statistical Revelations Pty Ltd
name: Datapharm Australia Pty Ltd
First posted: 2010-12-02
Enrollment: 4
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: This first-in-human study aims to establish the maximum tolerated dose of PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.


Eligibility criteria: Inclusion Criteria:

* Age \>=18 years.
* Histological or cytological documentation of non hematologic, malignant solid tumour.
* Have failed at least one previous therapeutic regimen.
* Measurable disease according to RECIST 1.1.
* Life expectancy \>= 12 weeks
* ECOG Performance Status of 0 or 1
* Written, signed and dated informed consent
* Able and willing to meet all protocol-required treatments, investigations and visits.
* Have adequate organ function

Exclusion Criteria:

* Clinically significant non-malignant disease.
* Active CNS metastases.
* Subjects with uncontrolled diabetes.
* History of clinically significant adverse drug reaction to heparin or other anti-coagulant agents
* History of immune-mediated thrombocytopaenia or other platelet abnormalities or other hereditary or acquired coagulopathies.
* Concomitant use of aspirin (\> 150 mg/day), NSAIDs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose prophylactic use), heparin within two weeks prior to randomisation, or other anti-platelet drugs.
* History of severe allergic, anaphylactic or other significant adverse reaction to radiographic contrast media
* Known seropositivity to the human immunodeficiency virus (HIV)
* Women who are pregnant or breast-feeding.
* Women of child-bearing potential and male subjects who are partners of women of childbearing potential who are unable or unwilling to practice a highly effective means of contraception.
* Active substance abuse
* Subjects who have received an investigational agent within 28 days prior to Cycle 1 Day 1.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) Based on DLT
timeFrame: Following first 1 month cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Linear Clinical Research Ltd
state: Western Australia
Study officials:
affiliation: Head of Department, Medical Oncology, Sir Charles Gairdner Hospital
name: Michael Millward, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03646695: ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
Official title: ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with macular hole \<400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes

Detailed description: Patients with macular hole with a diameter larger than 400µm have better sucess with ILM flap transposition, but there are no data published examining the outcome of macular hole with a diameter \<400µm. Therefore, patients with macular hole with a diameter \<400µm will be randomized for ILM flap transposition and ILM peeling for surgical repair of macular holes

Eligibility criteria: Inclusion Criteria:

* macular hole with a diameter \<400µm

Exclusion Criteria:

* Prior ILM peeling

Primary outcomes:
measure: closure of the macular hole
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
Study officials:
affiliation: Head of Department of Ophthalmology, Professor, Principal Investigator
name: Oliver Findl, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04762095: The Effect of Mindfulness Stress Reduction Program on Menopausal Complaints and Quality of Life
Official title: The Effect of Mindfulness Stress Reduction Program on Menopausal Complaints and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Women
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 113
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Research is quasi-experimental
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was conducted to determine the effect of the mindfulness stress reduction program (MBSR) applied to postmenopausal women on menopausal complaints and quality of life. The population of the study was 2626 women and the sample was composed of 55 experimental and 63 control groups, totally 118 women. The data of the study were collected using Personal Information Form, Mindful Attention Awareness Scale (MAAS), Menopausal Symptoms Assessment Scale (MSAS) and Menopause Specific Quality of Life Scale (MYQOL).

Detailed description: Aim: The study was conducted to determine the effect of the mindfulness stress reduction program (MBSR) applied to postmenopausal women on menopausal complaints and quality of life.

Materials and Methods: Research is quasi-experimental. The population of the study was 2626 women and the sample was composed of 55 experimental and 63 control groups, totally 118 women. The data of the study were collected using Personal Information Form, Mindful Attention Awareness Scale (MAAS), Menopausal Symptoms Assessment Scale (MSAS) and Menopause Specific Quality of Life Scale (MYQOL). In the study, an 8-week Mindfulness Stress Reduction Program was applied to the women in the experimental group. In the study, mid-test and post-test (MAAS, MSAS, MYQOL) were applied 8 and 16 weeks after the pre-test. Descriptive statistics, independent groups t test, chi-square test, ANOVA, Mauchly's test and Cronbach Alpha analysis were used to evaluate the data.

Eligibility criteria: Inclusion Criteria:

Being in menopause

* Not having any diagnosed psychiatric disease or using medication,
* Not using or not using hormone replacement therapy.

Exclusion Criteria:

* Having entered menopause with surgical methods,
* Not attending at least two group programs.

Primary outcomes:
measure: mindfulness stress reduction program reduces menopausal symptoms
timeFrame: UP TO 16 WEEKS
measure: Mindfulness stress reduction program improves quality of life
timeFrame: UP TO 16 WEEKS
Secondary outcomes:
Other outcomes:
Locations:
city: Elaziğ
country: Turkey
facility: NURDİLAN
state: Eyalet/Yerleşke
Study officials:
References:
Clinical trial NCT01839695: Safety and Efficacy of Valiant Mona LSA Stent Graft System
Official title: Valiant Mona LSA Stent Graft System Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Aortic Aneurysms
Keywords: Thoracic Aneurysm
Endovascular Aortic Repair
TEVAR
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2013-04-25
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: The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to assess safety and performance of the device acutely and at 30 days.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age.
* The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
* Subject must be considered a candidate for revascularization of the LSA.
* Subject has a DTA which will require coverage of the LSA
* Subject's anatomy must meet the anatomical criteria to receive that implanted device

Exclusion Criteria:

* Subject has had previous endovascular repair of the ascending and/or descending thoracic aorta.
* Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 2.0 mg/dL
* Subject is a pregnant female.
* Enrollment in another clinical study
* Subject has had a cerebral vascular accident (CVA)or myocardial infarction (MI) within 3 months.
* Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
* Subject has a known allergy or intolerance to the device components.
* Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

Primary outcomes:
measure: Primary Safety Observation - Rate of Major Adverse Events (MAEs)
timeFrame: 1 month
measure: Primary Effectiveness Observation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institute
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: London
country: United Kingdom
facility: St George's Vascular Institute, St. George's Hospital
Study officials:
affiliation: The Cleveland Clinic
name: Eric Roselli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roselli EE, Arko FR 3rd, Thompson MM; Valiant Mona LSA Trial Investigators. Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms. J Vasc Surg. 2015 Dec;62(6):1465-71.e3. doi: 10.1016/j.jvs.2015.07.078. Epub 2015 Oct 23.
Clinical trial NCT05441995: Cryotherapy Efficacy During Pulp Therapy of the Mandibular First Permanent Molars in Children
Official title: Cryotherapy Efficacy in 9 to17-year-old Children During Endodontic Treatment of the Mandibular First Permanent Molars With Symptomatic Irreversible Pulpitis: a Randomized Parallel Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cryotherapy Effect
Irreversible Pulpitis
Pain
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 140
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to assess the efficacy of cryotherapy application on the success of inferior alveolar nerve block (IANB) in reducing pain during pulp therapy of the mandibular first permanent molars with irreversible pulpitis (IP) in children age from 7 to 16 years. The null hypothesis (H0) supposed no difference in pain intensity during pulp therapy of primary molars with IP anesthetized with IANB with and without cryotherapy application. The secondary aim was to evaluate the children's behavior before and after pulpectomy in the two groups.


Eligibility criteria: Inclusion Criteria:

* Healthy children aged 9-17 years who were categorized as class I or II according to the ASA classification.
* Cooperative children (rate 3 or 4 according to Frankl behavior rating scale)
* Presence of a vital mandibular first permanent molar with SIP, the tooth should show deep caries or dental restorations with a history of spontaneous lingered pain precipitated by thermal stimuli. To confirm the diagnosis of irreversible pulpitis, early response to electric pulp and thermal testing was performed.
* No radiographic changes with at least two-thirds of the root must be evident.

Exclusion Criteria:

* Children with severe emotional, intellectual, and behavioral difficulties.
* Necrotic pulp of primary molars.
* Unrestorable crowns
* Positive history of gingival swelling, abnormal mobility, and fistulous tract.
* Presence of radiographic signs of periapical and/or furcation radiolucency, and pathological resorption.

Primary outcomes:
measure: Pain intensity
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University
state: El Minya
Study officials:
References:
Clinical trial NCT04505995: Azacitidine and Homoharringtonine in JMML
Official title: Efficacy of Concomitant Use of Azacitidine and Homoharringtonine in Children With Juvenile Myelomonocytic Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: JMML
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
name: Taian City Central Hospital
name: The Affiliated Hospital of Qingdao University
name: The Second Hospital of Hebei Medical University
name: Children's Hospital of Hebei Province
First posted: 2020-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Juvenile myelomonocytic leukemia (JMML) has a poor prognosis in general, with hematopoietic stem cell transplant (HSCT) remaining the standard of care for cure. Azacitidine and homoharringtonine, which exhibited a anticancer mechanism and has been widely used in patients with relapse/refractory acute myeloid leukemia (AML). However, the efficacy of these agents has not been elucidated in children with JMML. The primary objective is to assess the treatment effect on response rate in this subject population.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed JMML, with PB and BM confirming diagnosis prior to informed consent signature, with one of the following:

  1. somatic mutation in PTPN11
  2. somatic mutation in KRAS
  3. somatic mutation in NRAS and HbF % \> 5x normal value for age
  4. clinical diagnosis of neurofibromatosis Type 1.

Exclusion Criteria:

* 1. Any condition that would prevent the subject from participating in the study.

  2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if participated in the study.

  3. Any condition that confounds the ability to interpret data from the study.

Primary outcomes:
measure: Juvenile Myelomonocytic Leukemia (JMML) response rate at end of 4 Months
timeFrame: Up to 4 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
state: Tianjin
Study officials:
References:
Clinical trial NCT01033695: Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes
Official title: Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymph Nodes
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Liver Cancer
Keywords: Endoscopy
Endoscopic Ultrasound
Endoscopic Sonoelastography
Cancer
Interobserver agreement
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for EUS examination on the basis of a malignant indication.

Brief summary: Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When planning the optimal therapy in patients with upper gastrointestinal malignancies it is essential to know the exact lymph node stage. Recently endoscopic sonoelastography(ES) has been added to conventional EUS examination and may provide complementary information to distinguish benign for malignant lymph nodes.

The N-stage relates to the treatment choice and the prognosis, and it is therefore of particular interest to know the interobserver agreement in operator dependent techniques. This study evaluate the interobserver agreement of EUS and ES evaluation og lymph nodes.


Eligibility criteria: Inclusion Criteria:

* the presence of a lymph node more than 10mm in diameter (short axis) detected during the EUS examination

Exclusion Criteria:

* inadequate ES images were obtained by one of the observers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Centre for Surgical Ultrasound
Study officials:
name: Michael H. Larsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06825195: Evaluation of Fingertip Precision Pinch Force in Fibromyalgia Patients
Official title: Evaluation of Fingertip Precision Pinch Force During Carrying in Fibromyalgia Patients.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Force Measurement
Isokinetic
Muscle Strength
Keywords: Fibromiyalgia
Muscle Strength
Fatigue
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients with fibromyalgia diagnosis and no accompanying rheumatological disease

Brief summary: This study aims to evaluate the force used by fibromyalgia patients during a task compared to healthy volunteers and to evaluate its relationship with fatigue seen in these patients.

Detailed description: Fatigue is a common symptom in fibromyalgia patients and it is known that these patients have decreased muscle strength compared to healthy volunteers. The aim of this study was to evaluate whether the minimum force to be applied during carrying is different in fibromyalgia patients compared to healthy volunteers.

Eligibility criteria: Inclusion Criteria:

-Female patients diagnosed with fibromyalgia between the ages of 18-70

Exclusion Criteria:

* Those whose treatment has been changed in the last month
* Those with shoulder, elbow, wrist and hand diseases that may cause pain in the dominant upper extremity
* Those with carpal or cubital tunnel syndrome
* Those with a history of orthopedic surgery in the dominant extremity
* Those with uncontrolled metabolic disease
* Those with B12 deficiency

Primary outcomes:
measure: minimum pinch force
timeFrame: November 2024- January 2025
measure: maximum pinch force
timeFrame: November 2024- January 2025
measure: % Minimum/maksimum pinch force
timeFrame: November 2024- January 2025
Secondary outcomes:
measure: isokinetik muscle strength
timeFrame: November 2024- January 2025
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi
Study officials:
References:
Clinical trial NCT03491995: A Unique Regimen for Treatment of Helicobacter Pylori Infection
Official title: A Unique Quadruple Regimen for of Helicobacter Pylori
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Helicobacter Infections
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori.

However, the efficacy of this triple regimen has been seriously challenged, and they are gradually becoming ineffective

Detailed description: Growing rates of treatment failure are observed worldwide and the eradication rate of triple therapy has declined over the past few decades. Helicobacter pylori infection has become increasingly resistant to traditional first line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates .So there is a considerable interest in evaluating new antibiotic combinations and regimens .

Eligibility criteria: Inclusion Criteria:

* Patients aged older than 21 years Presenting by Dyspepsia Infected by H. pylori (as proved by positive stool antigen test) Agreed to participate in the study and signed the consent

Exclusion Criteria:

* Patients who have received treatment with proton pump inhibitors within 2 weeks, NSAID or antibiotics within 4 weeks before study entry Patients who had received H pylori treatment before. Patients presenting by upper gastrointestinal bleeding Pregnant females Patients who have significant gastrointestinal, renal, hepatic, cardiovascular, metabolic, hematological disease.

Primary outcomes:
measure: Number of patients with eradicated Helicobacter infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Head of Hepatology and infectious diseases dept.-Cairo University
name: Ayman Yousry, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hepatology and infectious diseases dept.-Cairo University
name: Walied El-Hossary, MD
role: STUDY_DIRECTOR
affiliation: Internal Medicine dept.-Alazhar University
name: Mohamed Alboraie, MD
role: STUDY_CHAIR
affiliation: Hepatology and Infectious diseases- Tanta University
name: Sherief Abd-Elsalam, MD
role: STUDY_CHAIR
affiliation: Hepatology and Infectious diseases- Tanta University
name: Asem Elfert, Prof
role: STUDY_CHAIR
affiliation: Internal Medicine-Assuit University
name: Hussein A Elamin, Prof
role: STUDY_CHAIR
affiliation: Internal Medicine- Mansoura University
name: Mohamed Adel Elbasiony, MD
role: STUDY_CHAIR
References: