louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03177668: Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
Official title: Phase I/II Clinical Study of YS110 in Patients With Malignant Pleural Mesothelioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Pleural Mesothelioma
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine tolerability, safety, and pharmacokinetics of YS110 intravenous administration in patients with malignant pleural mesothelioma and to preliminarily examine the anti-tumor effect of YS110.


Eligibility criteria: Inclusion Criteria:

* Patient with male or female aged ≥ 20 (and aged \< 75 in Phase 1 part)
* Patients whose malignant pleural mesothelioma was histologically confirmed
* Patients who have advanced pleural mesothelioma that are refractory to existing anti-tumor drugs and who have no other standard therapies which should be prioritized
* Patients whose most recent major surgery (except exploratory thoracotomy or laparotomy) or drug or radiation therapy for malignant tumors, if any, was at least 4 weeks ago (at least 12 weeks ago for immunotherapy) at the subject enrollment
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 or less

Exclusion Criteria:

* Patients whose toxicity findings in the previous treatment (antineoplastic agents) have not been yet restored
* Patients with tumor lesions in central nervous system confirmed in MRI or CT

Primary outcomes:
measure: Status of onset of Dose Limiting Toxicity (DLT)
timeFrame: 18 days
measure: Disease Control Rate (DCR)
timeFrame: 6 months
measure: Progression Free Survival (PFS)
timeFrame: Assessed for duration of study participation which is estimated to be 18 months
measure: Response Rate (RR)
timeFrame: Assessed for duration of study participation which is estimated to be 18 months
measure: Overall Survival (OS)
timeFrame: Assessed for duration of study participation which is estimated to be 18 months
measure: LCSS-Meso
timeFrame: Assessed for duration of study participation which is estimated to be 18 months
measure: EORTC QLQ-C30
timeFrame: Assessed for duration of study participation which is estimated to be 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Research Site
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Nobuo Kanai
role: STUDY_DIRECTOR
References:
Clinical trial NCT01115868: Prevascar in African Continental Group Scarring
Official title: An Exploratory, Single Centre, Randomized, Placebo Controlled, Assessor Blind Clinical Trial to Assess the Effects of Intradermal Administrations of Prevascar on Scarring in Human Subjects of African Continental Ancestral Origin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Scarring
Lead sponsor: Renovo
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is considerable variation in scarring, within and between people, and between different ethnic groups. Individuals with more pigmented skin are more prone to severe scarring than those traditionally termed white. Prevascar is being developed by Renovo for use as a potential treatment for reducing scarring.

Renovo's histological analysis of wounds and scars in human non drug studies demonstrates an increase in wound and scar width in subjects of African Caribbean ancestry over a 12 month period.

It is hypothesised that IL-10 may be a potentially beneficial therapy for the reduction of scarring in Non Caucasians of African-Caribbean ancestry.

This Renovo clinical trial will be carried out primarily to establish the effects of four doses of Prevascar on 1cm incisional and excisional scars in subjects of African Continental Group ancestry, as compared to placebo, and to further investigate the safety and tolerance of intradermally injected Prevascar in wounds.


Eligibility criteria: Inclusion Criteria:

* Afro-Caribbean male and female subjects between 18 and 85 years of age.

Exclusion Criteria:

* Subjects who on direct questioning or examination have history or evidence of keloid scarring.
* Subjects who have evidence of any past or present clinically significant medical condition that would impair wound healing or trial assessments
* Subjects with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
* Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
* Female subjects who are, or who become pregnant up to and including Day 0 and/ or who are lactating.
* In the opinion of the Investigator, a subject who is not likely to complete the trial for whatever reason.

Primary outcomes:
measure: To assess the effects of Prevascar on resultant scars
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Renovo Clinical Trials Unit
state: Greater Manchester
Study officials:
References:
Clinical trial NCT05938868: Low Intensity Pulsed Ultrasound Versus Low Level Laser Therapy Post Dental Implant
Official title: Efficacy of Low Intensity Pulsed Ultrasound and Low Level Laser Therapy on Osseointegration and Soft Tissue Healing Following Dental Implant Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant
Surgical Dental Prostheses
Dental Implantation
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
Collaborators: name: Al Hayah University In Cairo
First posted: 2023-07-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the significance difference between low intensity pulsed ultrasound (LIPUS) versus low-level laser therapy (LLLT) on osseointegration, soft tissue healing, pain pressure threshold and oral health related quality of life in patients post dental implant surgery.


Eligibility criteria: Inclusion Criteria:

1. Adult Patients.
2. Both sexes will be contributed in the study.
3. Non-smokers.
4. Patients who needed dental implant in the maxillary or in the mandible.
5. Bone height and width no less than Class III bone quality assessed clinically and radiologically.

Exclusion Criteria:

1. Medically compromised patients as Uncontrolled diabetes mellitus.
2. Patients indicated for bone graft at the implant site.
3. Patients under chemotherapy or radiotherapy in facial region.
4. Poor oral hygiene.
5. Patients with any history of temporomandibular joint disorders.
6. Patients with any other periodontal and oral surgeries

Primary outcomes:
measure: Changes in Osseointegration
timeFrame: Changes in Osseintegration immediately postoperative, after 6 weeks and after 3 months
measure: Changes in soft tissue healing
timeFrame: Changes in soft tissue healing immediately postoperative, after 6 weeks and after 3 months
Secondary outcomes:
measure: Changes in Pain pressure threshold
timeFrame: Changes in Pain pressure threshold immediately postoperative, after 6 weeks and after 3 months
measure: Changes in oral quality of life
timeFrame: Changes in oral quality of life immediately postoperative, after 6 weeks and after 3 months
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Cairo University
name: Amal Abd El-Baky, Ph.d
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Badr University
name: Osama Gouda, Ph.D
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Hussein Mogahed, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01418768: Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
CAT
Rehabilitation
chronic obstructive pulmonary disease GOLD III/IV
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 50
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there is a change in the CAT-score after an inpatient rehabilitation of three weeks and if it correlates with other common parameters.


Eligibility criteria: Inclusion Criteria:

* inpatient rehabilitation in Schön Klinik Berchtesgadener Land
* stable COPD(GOLD severity III and IV with and without respiratory insufficiency)

Exclusion Criteria:

* severe exacerbation in the last four weeks
* acute coronary syndrome
* unability to cooperate

Primary outcomes:
measure: Change in CAT-score
timeFrame: day 1 to day 21
Secondary outcomes:
measure: Change in 6 minutes walking distance
timeFrame: day 1 to day 21
measure: Change in Short-Form 36
timeFrame: day 1 to day 21
measure: Change in Hospital Anxiety and Depression Scale
timeFrame: day 1 to day 21
measure: Change in diffusing capacity
timeFrame: day 1 to day 21
measure: Change in forced expiratory volume in 1 second (FEV1)
timeFrame: day 1 to day 21
measure: Change in Body Mass index
timeFrame: day 1 to day 21
measure: Change in basal energy rate
timeFrame: day 1 to day 21
measure: Change in BODE-Index
timeFrame: day 1 to day 21
measure: Change in St. George's Respiratory Questionaire
timeFrame: Day 1 to day 21
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
Study officials:
References:
Clinical trial NCT00309868: Study of Nesiritide in Diastolic Heart Failure.
Official title: A Study of the Acute Hemodynamic and Myocardial Effects of Nesiritide in Diastolic Heart Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diastolic Heart Failure
Keywords: heart catheterization
echocardiogram
nesiritide
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Scios, Inc.
First posted: 2006-04-03
Enrollment: 20
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: We hypothesize that nesiritide will have favorable effect in decreasing heart filling pressures and echocardiogram studies.

Detailed description: In previous studies, patients with systolic heart failure were given nesiritide and had reduced heart filling pressures. The FDA has approved nesiritide for these patients.

Between one-third and one-half of patients with heart failure have diastolic heart failure. Few of these patients have been studied while receiving nesiritide.

A study is needed to test nesiritide on this specific type of heart failure.

Patients will undergo a heart catheterization and heart biopsy. Patients will then be transferred to the intensive care unit for monitoring. An echocardiogram will be obtained, followed by an infusion of nesiritide for 24 hours. At the completion of the infusion, a repeat echocardiogram will be obtained.

Eligibility criteria: Inclusion Criteria:

Elevated heart filling pressure. Ejection fraction \>45%. Blood pressure \>90. Physician feels that the patient needs intravenous medication for heart failure.

-

Exclusion Criteria:

Patients receiving intravenous medication. Patients with significant heart disease or who are unstable. Patients with kidney failure or severe heart valve disease.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Marc J S, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05062668: Efficacy and Safety of iStent Inject and Inject W in the Management of Primary Open-angle Glaucoma
Official title: Efficacy and Safety of iStent Inject and Inject W in the Management of Primary Open-angle Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: POAG
MIGS
Keywords: POAG
iStent inject
MIGS
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Central Hospital Saint Quentin
First posted: 2021-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There are two groups, the first group is the iStent group. The investigators took all the POAG patients operated at the CHU of Amiens or the CH of Saint-Quentin of a combined cataract and iStent inject or inject W surgery from January 2018 to September 2020. The second group is the control group of POAG patients operated only on cataract during the same period.

Brief summary: Primary open-angle glaucoma (POAG) is a chronic eye disease in which the only validated treatment is to lower intraocular pressure (IOP). It is the 2nd leading cause of blindness worldwide. The iStent® inject and inject W is an implantable device that is part of a new entity of so-called minimally invasive glaucoma surgery whose goal is to lower IOP with minimal tissue disruption in order to avoid the complications of conventional glaucoma surgery. This surgery is used in conjunction with cataract surgery in France. The primary objective is to study the 1-year efficacy and safety of combined cataract and iStent inject and inject W in the management of POAG in an observational, retrospective, controlled study of a cohort of POAG patients undergoing cataract surgery only.


Eligibility criteria: Inclusion Criteria:

* patient who have undergone combined phacoemulsification surgery and insertion of at least one iStent® for chronic open-angle glaucoma in the ophthalmology department of the Amiens University Hospital or the Saint-Quentin University Hospital (iStent® group).
* patient who have undergone simple phacoemulsification surgery in a patient with chronic open-angle glaucoma in the ophthalmology department of the Amiens University Hospital (control group).
* patient with Chronic open-angle glaucoma confirmed by gonioscopic examination, visual field, optical coherence tomography of the optic nerve, fundus examination, pachymetry and intraocular air pressure and/or applanation.

Exclusion Criteria:

* acute angle closure glaucoma,
* chronic angle closure glaucoma,
* uveitic glaucoma,
* traumatic glaucoma,
* exfoliative glaucoma.
* Previous filtering surgery on the operated eye.
* Intraoperative complication.

Primary outcomes:
measure: variation of IOP (in mmHg) between both groups
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Nord
Study officials:
References:
Clinical trial NCT06624072: A Study in Healthy People to Compare 2 Different Formulations of Nerandomilast Tablets When Taken With or Without Food
Official title: Relative Bioavailability of Two Different Formulations of Nerandomilast and Investigation of the Food Effect on New Formulation Following Oral Administration in Healthy Adult Male and Female Subjects (an Open-label, Randomised, Single-dose, Three-way Crossover Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to investigate two different formulations of nerandomilast and the effect of food on the pharmakokinetics of the new formulation following oral administration.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m² (inclusive)
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: up to 5 days
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 5 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: Humanpharmakologisches Zentrum Biberach
Study officials:
References:
Clinical trial NCT01801072: Seizure Prophylaxis in Aneurysm Repair
Official title: Seizure Prophylaxis in Aneurysm Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intracranial Aneurysms
Seizure
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility. The study will be extended to June 2024 to allow for a 5 year follow up of the last enrolled patient in June, 2019.


Eligibility criteria: Inclusion Criteria:

* Adult (≥18 years)
* Presence of intracranial aneurysm (with or without rupture)
* Treating surgeon has recommended surgical repair of the aneurysm

Exclusion Criteria:

* History of seizures within last 10 years
* History of epilepsy
* History of prior stroke
* Currently prescribed medication with anti-epileptic activity (keppra, dilantin, tegretol, lamictal, topamax, etc.)
* Brain tumor
* Pregnant or nursing woman
* Known levetiracetam allergy

Primary outcomes:
measure: Incidence of Seizure
timeFrame: 5 years from procedure
Secondary outcomes:
measure: Duration of Seizure
timeFrame: To compare duration of seizure in each randomization group
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Aditya S Pandey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05105672: A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervical Cancer
Official title: A Single-Arm, Single-Center Phase II Clinical Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in The Treatment of Stage IIA2 To IVA (2018 FIGO) Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Uterine Cervical Neoplasms
Sintilimab
Lead sponsor: The Affiliated Hospital of Xuzhou Medical University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 20
Sex: FEMALE
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 is a single-arm, single-center phase II clinical study to explore the efficacy and safety of sintilimab combined with concurrent chemoradiation therapy as treatment in women with locally advanced cervical cancer.


Eligibility criteria: Inclusion Criteria:

* Has high-risk locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3 or FIGO 2018 Stages IIA2-IVA.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1
* Adequate hematological, renal and hepatic functions:Hemoglobin \> 9.0 g/dl; Neutrophils \> 2000 cells/μl; ANC \> 1.5 × 10\^9/L;Platelets \> 100 × 10\^9/L;

Exclusion Criteria:

* Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
* Has a known history of Human Immunodeficiency Virus (HIV) infection.
* Prior malignancies (other than curable non-melanoma skin cancer) within 5 years

Primary outcomes:
measure: Overall response rate
timeFrame: 1 year
Secondary outcomes:
measure: Progression free survival
timeFrame: Time from diagnosis of disease to disease progression or death due to any cause
measure: Overall survival
timeFrame: Time from diagnosis of disease of treatment until death due to any cause
measure: Incidence of ADRs and tolerance
timeFrame: 1 years
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Longzhen Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: