louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02670720: Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema
Official title: OPuS-4: An Open-label Study to Evaluate the Long-term Safety of Avoralstat in Subjects With Hereditary Angioedema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hereditary Angioedema
HAE
Keywords: BCX4161
avoralstat
HAE
hereditary angioedema
prophylaxis
Lead sponsor: BioCryst Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.


Eligibility criteria: Inclusion Criteria:

* Males and non-pregnant, non-lactating females age ≥ 18 years.
* Provide written, informed consent.
* Prior completion of an avoralstat therapeutic study OR a confirmed diagnosis of HAE Type 1 or HAE Type 2.
* Access to appropriate medication for the treatment of acute HAE attacks.
* Adequate contraception.

Exclusion Criteria:

* Females who are pregnant or breast feeding.
* Clinically significant medical condition or medical history.
* Abnormal screening ECG, laboratory or urinalysis finding that is clinically significant.
* Investigational drug exposure within 30 days (except avoralstat).
* History of or current alcohol or drug abuse.
* HIV or active HBV or HCV infection.

Primary outcomes:
measure: Proportion of subjects who discontinue due to a treatment-emergent adverse event, who experience a treatment-emergent serious AE, who experience a Grade 3 or 4 AE and who experience Grade 3 or 4 laboratory abnormalities
timeFrame: Up to 72 weeks
Secondary outcomes:
measure: Angioedema attack rate (subject-reported HAE attacks normalized for time on study)
timeFrame: Up to 72 weeks
measure: Durability in response (assessed as subject-reported HAE attacks)
timeFrame: change over time through 72 weeks
measure: Proportion of subjects who discontinue avoralstat with a reason of lack of efficacy
timeFrame: Up to 72 weeks
measure: Quality of life as determined by the EQ-5D-5L
timeFrame: Up to 72 weeks
measure: Quality of life as determined by the Angioedema Quality of Life Questionnaire
timeFrame: Up to 72 weeks
Other outcomes:
Locations:
city: Leuven
country: Belgium
city: Grenoble
country: France
city: Lille
country: France
Study officials:
affiliation: Semmelweis University
name: Henriette Farkas, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04078620: Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals.
Official title: Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Interaction
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2019-09-06
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to Surgical ICUs, zagazig University Hospital

Brief summary: Drug drug interactions is frequent in critically ill patients due to polypharmacy, different drug groups and prolonged ICU or hospital stay

Detailed description: This cross sectional study was conducted in Surgical ICU, zagazig University Hospital for 6months period.

Demographic data (age, gender),clinical history data (main diagnosis, ICU stay in days, transfer from emergency room or other departments, on mechanical ventilation or not, state of consciousness

Eligibility criteria: Inclusion Criteria:

* all patients admitted to Surgical ICUs for six months period

Exclusion Criteria:

* less than one day admission to ICU,not completed data

Primary outcomes:
measure: Severity of Drug interactions by Lexicomp interactions application
timeFrame: 6months period
measure: Severity of Drug interactions by Medescape interactions checker:
timeFrame: 6months period
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Liza Elsayed Ali
state: Sharquia
Study officials:
affiliation: Zagazig University
name: Liza Shallouf
role: PRINCIPAL_INVESTIGATOR
affiliation: Zagazig University
name: Heba Matar
role: STUDY_DIRECTOR
References:
Clinical trial NCT06635382: Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique
Official title: Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dimethyl Sulfoxide
Lead sponsor: Manipal University College Malaysia
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Dimethyl sulfoxide (DMSO) wet bonding has shown promising results in several in vitro studies. However, there are a lack of clinical trials which prove the advantages of this technique. The aim of the study is to clinically assess the effect of DMSO wet bonding on composite restoration in non carious cervical lesions.


Eligibility criteria: Inclusion Criteria:

* Two similar non carious cervical lesions (NCCLs) on the facial/labial surfaces of premolars.
* NCCLs of score 1-3 on the Smith and Knight tooth wear index.
* Favorable occlusion and teeth are in normal contact.

Exclusion Criteria:

* NCCLs on the lingual surface.
* Medically compromised individuals.
* Periodontally compromised teeth.
* Bruxism and visible wear facets in the posterior dentition.
* Fractured or visibly cracked premolars and canines.
* Known allergies to resin-based restorative materials.
* Presently undergoing orthodontic treatment.
* Abutment teeth for fixed or removable prostheses.

Primary outcomes:
measure: Fracture of material
timeFrame: From treatment to 3-6 months follow up
measure: Marginal adaptation
timeFrame: From treatment to 3-6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lopez-Frias FJ, Castellanos-Cosano L, Martin-Gonzalez J, Llamas-Carreras JM, Segura-Egea JJ. Clinical measurement of tooth wear: Tooth wear indices. J Clin Exp Dent. 2012 Feb 1;4(1):e48-53. doi: 10.4317/jced.50592. eCollection 2012 Feb.
citation: Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12.
Clinical trial NCT01838382: Pain Characteristics After Total Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myoma of Uterus
Keywords: pain
total laparoscopic hysterectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laparoscopic operative procedures have revolutionized gynecological surgery. These have several advantages: a smaller and more cosmetic incision, reduced blood loss and shorter postoperative stay, which cuts down on hospital costs. However, postoperative pain continues to be one complication, which results in an unpleasant experience for the patient and at times causes a delayed discharge. There are few studies about pain characteristics as one of laparoscopic hysterectomy complications. The purpose of this study is to investigate the prevalence and characteristics of shoulder pain, headache, abdominal pain, and back pain in patients undergoing total laparoscopic hysterectomy.


Eligibility criteria: Inclusion Criteria:

* ASA I or II
* age \>=20, \<= 80 years
* female
* patients undergoing elective total laparoscopic hysterectomy

Exclusion Criteria:

* age \< 19 years or \> 80 years
* abnormal mental status
* drug abuse
* chronic alcoholism
* immunosuppressants or steroid user

Primary outcomes:
measure: overall pain
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT06376682: EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy
Official title: Evaluation of the EPIONE Robotic System for Image-guided Percutaneous Bone Procedures a Prospective Study on Feasibility, Safety and Accuracy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bone Metastases
Fractures, Bone
Bone Tumor
Keywords: Robotic
Robotic guidance
Percutaneous
CT-guided
Bone consolidation
Thermal ablation
Lead sponsor: Quantum Surgical
Sponsor class: INDUSTRY
Collaborators: name: ICUREsearch
First posted: 2024-04-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The Epione device is an image-guided robotized device that assists the physician during CT-guided procedures.
Primary purpose: TREATMENT

Brief summary: Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures.


Eligibility criteria: Inclusion Criteria:

1. Patient ≥18 years,
2. Patient with indication of CT-guided percutaneous bone procedure under general anaesthesia validated at a multidisciplinary consultation meeting,
3. Patient who has signed an informed consent form,
4. Patient covered by a social security system,

Non-inclusion Criteria:

1. Patient with contraindication to general anaesthesia,
2. Patient undergoing a procedure without appropriate breathing control,
3. Patient scheduled for CT-guided percutaneous procedures on head and neck, including skull and cervical vertebrae,
4. Patient with medical, psychosocial or emotional conditions unable to fully understand the study protocol, give an uninfluenced informed consent, or meet the study requirements during its whole duration.
5. Pregnant or breast-feeding women,
6. Patient under legal protection (tutorship, guardianship, ...),
7. Patient already participating in another interventional clinical study.

Primary outcomes:
measure: Successful instrument insertion with the EPIONE device.
timeFrame: During procedure
Secondary outcomes:
measure: Safety of the EPIONE robotic assistance for bone percutaneous procedures
timeFrame: During the procedure and up to the 1-month follow-up visit
measure: Accuracy of the EPIONE robotic assistance for bone percutaneous procedures
timeFrame: During procedure
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy Cancer Institute
name: Baptiste BONNET
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: Nicolas STACOFFE
role: PRINCIPAL_INVESTIGATOR
affiliation: Paoli-Calmettes Institute
name: Gilles PIANA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04444882: Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care
Official title: Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasm
Keywords: postoperative complications
physiotherapy
rehabilitation
lumpectomy
sentinel node
radiotherapy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 71
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involves breast cancer patients who have undergone the following treatment: lumpectomy, sentinel node and radiotherapy.

Brief summary: To make an inventory of the physiotherapeutic care and the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment.

The investigators expect to see a lack of consultation of physiotherapists by patients despite a significant number of complications, impacting the quality of life.

Detailed description: This study is observational and descriptive. For this purpose, patients meeting the inclusion and non-inclusion criteria can answer, if they wish, to an online questionnaire after having read the information and non-opposition letter.

Eligibility criteria: Inclusion Criteria:

* Volunteer Patients
* Patients with a good command of French in order to understand the letter of information and the questionnaire.
* Patients treated at the "Couple Enfant Hospital" in Grenoble. We have chosen to take patients who have been operated on at least 3 months ago (average time of end of radiotherapy).

Exclusion Criteria:

* Patient having undergone a mastectomy or chemotherapy
* Patient with difficulties understanding, expressing or reading the French language
* Vulnerable patient or patient with impaired cognitive capacities (dementia, confusion)
* Patient subject to a legal protection measure or out of state to express her opposition (guardianship, curatorship)

Primary outcomes:
measure: Inventory of the physiotherapeutic care of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment
timeFrame: 10 minutes
Secondary outcomes:
measure: Description of the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: IFMK Saint Martin d'Hères
name: Caroline Bordin-Goffin
role: STUDY_DIRECTOR
References:
Clinical trial NCT03839082: Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
Official title: A Randomized Controlled Pilot Trial of a Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Non-alcoholic Steatohepatitis
Keywords: Mobile Technology
Weight
Nutrition
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Association for the Study of Liver Diseases
First posted: 2019-02-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will look at physical activity and nutrition in patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). The researchers will see if providing patients with NAFLD/NASH with specific physical activity and nutrition feedback as an addition to their usual clinical care helps them to lose weight and improve liver-related parameters.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH)
* Access to mobile phone/tablet/ or computer compatible with FitBit application and ability to use said device and application
* Ability to participate in physical activity

Exclusion Criteria:

* Any other form of liver disease( Alcohol related liver disease; viral hepatitis, autoimmune liver disease, hereditary forms of liver disease, etc.)
* History of decompensated cirrhosis
* Plans for invasive procedures or other regimented lifestyle programs for weight reduction
* Cardiovascular event in the previous 3 months

Primary outcomes:
measure: Percent Change in Hepatic Steatosis as Measured by Controlled Attenuation Parameter (CAP) Score
timeFrame: Baseline, 6 months,
Secondary outcomes:
measure: Percent Change in Body Weight
timeFrame: Baseline, 6 months
measure: Change in Physical Activity as Measured by International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Monica Konerman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02826382: Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041
Official title: A Preliminary Evaluation of Uptake in Bone Metastases, Biodistribution and Excretion of the Novel Radiotracer [68Ga]P15-041 by PET/CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Bone Metastases
Lead sponsor: Five Eleven Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A phase1 study to demonstrate \[68Ga\]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical \[99mTc\]MDP scan

Exclusion Criteria:

* Estimated creatinine clearance (GFR) \< 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Primary outcomes:
measure: Time course of uptake of [68Ga]P15-041 in bone metastases
timeFrame: 60 minutes post injection
measure: Time course of whole body distribution of [68Ga]P15-041
timeFrame: 3 hours post injection
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05907382: Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy Subjects
Official title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JMKX003002 in Single and Multiple Ascending Dose Randomized，Doubled-blind Phase 1 Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Safety and Tolerability
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Safety, tolerability, pharmacokinetics, and pharmacodynamics of JMKX003002 in single and multiple ascending dose randomized，doubled-blind phase 1 study in healthy subjects

Detailed description: Pharmacokinetic (PK) parameters, Pharmacodynamics

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects aged 18-45 years (inclusive);-
2. With normal or abnormal but clinically insignificant comprehensive physical examination (vital signs, physical examination), laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function test) and, 12-lead ECG;
3. Subjects who understand study procedures and methods, voluntarily participate in this trial, follow study-related instructions, and sign a written informed consent form.

Exclusion Criteria:

1. Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, psychiatric disease, or any condition that may interfere with the subject successfully completing the trial
2. Subjects with history of or current malignancy;
3. Participant who the researchers believe that there are volunteers who are not suitable for

Primary outcomes:
measure: Number of the Adverse Events that are related to the single dose treatment
timeFrame: from baseline to Day 11
measure: Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18
timeFrame: from baseline to Day 18
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Jing Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03018782: Pain Screening in Refugee Survivors of Torture
Official title: The Implementation of a Novel Pain-screening Tool in the Diagnoses of Pain Symptoms and Syndromes in Refugee Survivors of Torture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators are evaluating refugee torture survivors who are receiving services at the Weill Cornell Center for Human Rights. There are two research questions in this study: if the current standard of care results in the under or missed diagnosis of pain and pain syndromes, and if a validated pain screening tool can supplement the current standard protocol used in the assessments of survivors of torture.

Detailed description: The research plan consists of three components:

1. The Weill Cornell Center for Human Rights will coordinate with the research team regarding eligible subjects.
2. Researchers will contact potential subjects utilizing interpreter services.
3. Interested participants will be scheduled for an appointment for an examination by a pain physician and to complete the Brief Pain Inventory.

Eligibility criteria: Inclusion Criteria:

* Men and women from any country over the age of 18
* refugees receiving services from the Weill Cornell Center for Human Rights

Exclusion Criteria:

* Have not experienced torture
* Subjects whose representative does not believe that they are a good candidate for the study

Primary outcomes:
measure: Number of participants with chronic pain or pain syndromes as assessed by a non-invasive pain evaluation conducted by a pain physician
timeFrame: Day 1
Secondary outcomes:
measure: Number of participants with chronic pain or pain syndromes as assessed by the Brief Pain Inventory (BPI) Short Form
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Gunisha Kaur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Eliana Weinstein, BS
role: STUDY_DIRECTOR
References:
citation: Kaur G, Weinberg R, Milewski AR, Huynh S, Mauer E, Hemmings HC Jr, Pryor KO. Chronic pain diagnosis in refugee torture survivors: A prospective, blinded diagnostic accuracy study. PLoS Med. 2020 Jun 5;17(6):e1003108. doi: 10.1371/journal.pmed.1003108. eCollection 2020 Jun.