louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04060316: GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery
Official title: Efficacy, Safety, and Tolerability of Adjuvant GLS-1200 Topical Nasal Spray in the Prevention of Acute Rhinosinusitis Following Functional Endoscopic Sinus Surgery (FESS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sinusitis Chronic
Keywords: Surgery
Lead sponsor: GeneOne Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-19
Enrollment: 99
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: This clinical trial will evaluate the safety, tolerability and effectiveness of GLS-1200 nasal spray in addition to the standard of care after endoscopic sinus surgery in people with chronic sinusitis.

Detailed description: Subjects will be assigned to treatment via nasal spray with either GLS-1200 or placebo in blinded manner in a 2:1 ratio. Treatment will commence 1 week post-operatively and continue for 7 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older;
* Able to provide informed consent
* Able and willing to comply with study procedures
* Elective FESS
* Able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential

Exclusion Criteria:

* Pregnancy or documentation of pregnancy by pre-operative pregnancy test
* History of primary ciliary dyskinesia
* Known allergy to quinine, quinidine or mefloquine
* Know latex allergy
* History of hematologic malignancy
* History of bone marrow transplantation
* Current or planned chemotherapy treatment for hematologic or solid tumor during study period
* FESS performed non-electively and /or in preparation for decontamination of the sinuses related to cystic fibrosis or in preparation for chemotherapy, solid organ transplantation, or bone marrow transplantation

Primary outcomes:
measure: Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment
timeFrame: Post-op through week 16 post-FESS
measure: Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment
timeFrame: Post-op through week 16 post-FESS
Secondary outcomes:
measure: Assess week 16 post-FESS Sino-Nasal Outcome Test-22 (SNOT-22) group scores change from baseline relative to treatment assignment
timeFrame: Week 16 post-FESS
measure: Assess antibiotic usage relative to treatment assignment
timeFrame: 1 week post-op through week 16
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04898816: Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures
Official title: Comparing the Effectiveness of Cyanoacrylate Tissue Adhesives and Conventional Sutures in the Closure of Intraoral Surgical Wounds- A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Lead sponsor: Melaka Manipal Medical College
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effectiveness of two materials used for intraoral wound closure after removal of impacted mandibular third molar tooth. One Group received braided black silk suture and the other group received N-butyl 2-octyl cyanoacrylate tissue adhesives.

Detailed description: Conventional method of wound closure after removal of impacted mandibular molar is by suturing the wound using braided black silk suture and allowing for primary healing. Suturing in the most posterior region of oral cavity is not easy, it requires more time and additional skills as well. Patient has to come for a second visit for removal of suture. Moreover tight sutures may lead to ischemia and necrosis.

Tissue adhesives adopts the idea of sutureless wound closure. They are even sloughed off from the surface of mucosa 7 days after the application.

This study compares the effectiveness of conventional sutures and tissue adhesives in closure of intraoral surgical wounds after removal of mandibular third molar.

Eligibility criteria: Inclusion Criteria:

* patients requiring surgical removal of mesioangular, position A impacted mandibular third molar
* clean incisions approximately 2-3 cms in length which can be approximated
* Healthy (ASAI) or patients with mild systemic disease no functional limitations
* Patients not allergic to the drugs or anesthetic agents used in the surgical protocol

Exclusion Criteria:

* Patients taking any medications that influences wound healing
* Patients on non steroidal anti inflammatory drugs
* smokers
* uncooperative patients patients allergic to cyanoacrylate

Primary outcomes:
measure: Postoperative pain
timeFrame: 1st postoperative day
measure: postoperative pain
timeFrame: 2nd postoperative day
measure: Postoperative pain
timeFrame: 3rd postoperative day
measure: Postoperative pain
timeFrame: 4th postoperative day
measure: postoperative pain
timeFrame: 5th postoperative day
measure: wound healing
timeFrame: 7th postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Melaka Tengah
country: Malaysia
facility: Melaka Manipal Medical College
state: Melaka
Study officials:
affiliation: Melaka Manipal Medical College
name: abdul K azad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03269916: Fertility and Ovarian Reserve Function in the Patient With Inflammatory Bowel Disease
Official title: Fertility and Ovarian Reserve Function in the Patient With Inflammatory Bowel - a Cross-sectional Survey and Case Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fertility Disorders
Ovarian Reserve Function
Pregnancy Outcomes
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: ECCO consensus, the fertility would decline in activity inflammatory bowel disease(IBD), because of anus lesions and pelvic abscess, or who underwent surgery, especially in patients with ileal pouch anal anastomosis (IPAA) storage.The study on fertility in inflammatory bowel disease were almost epidemiological investigation, the lack of objective evaluation of fertility, and controversial.This study will explore the fertility, ovarian reserve function and the pregnancy outcomes in patients with IBD.


Eligibility criteria: Inclusion Criteria:

1. Inflammatory bowel disease
2. 17-40 years old
3. female

Exclusion Criteria:

1. in pregnancy or lactation
2. a drug that has been or is being used known to affect ovarian function, such as cyclophosphamide
3. reproductive system diseases unrelated to disease or treatment of inflammatory bowel disease, such as hysterectomy, pelvic radiotherapy after surgery, after ovariectomy, polycystic ovary syndrome, endometriosis, ovarian granulosa cell tumor
4. other endocrine diseases, such as prolactin, hyperthyroidism, lead to endocrine disorders;
5. malignant tumor

Primary outcomes:
measure: The AMH of IBD patients is lower than that of healthy women
timeFrame: 1 month
measure: The E2 of IBD patients is lower than that of healthy women
timeFrame: 1 month
measure: The FSH of IBD patients is lower than that of healthy women
timeFrame: 1 month
measure: The AFC of IBD patients is lower than that of healthy women
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The Sixth Affiliated Hospital of Zhongshan University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital of Zhongshan University
name: Min Zhi, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT02991716: Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development
Official title: Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmia, Cardiac
Lead sponsor: NewPace Ltd
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 50
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring Intracradiac Defibrillator (ICD) implantation, Electrophysiology (EP) study or a holter monitor recording, mainly due to suspected ventricular tachy - arrhythmias

Brief summary: Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using existing, approved ECG recording devices.

Detailed description: 2 electrodes places near the sternum and 2 near the midaxillary line, simulating the expected positions of Implantable Subcutaneous String Defibrillator (ISSD) sense electrodes. reference ECG electrodes are also attached (in most cases). Approved ECG recording devices are used to record the signal continuously: During an EP session (different types) a bedside recorder, and a holter monitor is used during holter recordings. Ep session recordings are performed in order to capture different types of arrhythmia, and holter recordings are performed to observe changes in ECG morphology due to activity, position changes, circadian cycles etc. The data is saved and used in the development of the ISSD.

Eligibility criteria: Inclusion Criteria:

* Candidate for ICD implantation
* Candidate for EP study
* Candidate for 24 hour holter monitor recording

Exclusion Criteria:

* age\<18

Primary outcomes:
measure: successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
Study officials:
affiliation: JFK Medical Center, Florida
name: Vladimir Rankovic, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05378516: Placental Pathology and Inflammatory Factor Analysis of OAPS
Official title: Placental Pathology and Inflammatory Factor Analysis of Obstetric Antiphospholipid Syndrome Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antiphospholipid Syndrome in Pregnancy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women with antiphospholipid syndrome (diagnosed by experts with clinical evidence) and healthy pregnant women without antiphospholipid syndrome as a control group

Brief summary: This investigation is on placental pathological changes and inflammatory factors associated with obstetric antiphospholipid syndrome.

Detailed description: 1. To clarify the correlation between antiphospholipid antibody, ACC1 expression level, Treg cell and placental pathological changes associated with antiphospholipid syndrome. 2. Reveal that antiphospholipid antibodies affect Treg cell differentiation through the key enzyme of lipid metabolism ACC1.

Eligibility criteria: Inclusion Criteria:

1. pregnant women with antiphospholipid syndrome (diagnosed by experts with clinical evidence) and healthy pregnant women without antiphospholipid syndrome as a control group
2. consent to join this study and finish the informed consents

Exclusion Criteria:

pregnant women with other autoimmune diseases

Primary outcomes:
measure: expression of ACC1 in placenta in pregnancy with/without antiphospholipid syndrome
timeFrame: in two years
Secondary outcomes:
Other outcomes:
Locations:
city: Pekin
country: China
facility: PekingUPH
Study officials:
affiliation: Peking University People's Hospital
name: Jingjing Yang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06916416: Phase II Trial of Anti-PD-1 Antibody Treatment and Radiotherapy in Early-stage Favorable Classic Hodgkin Lymphoma
Official title: Phase II Trial of Anti-PD-1 Antibody Treatment and Radiotherapy in Early-stage Favorable Classic Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Classical Hodgkin Lymphoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 50
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: By the implementation of the anti-PD-1 antibody pembrolizumab and given its possible synergy with RT, the aim of the present trial is to develop a chemotherapy-free first-line treatment for patients with newly diagnosed early-stage favorable cHL.


Eligibility criteria: Inclusion Criteria:

* Histologically proven first diagnosis of cHL
* Stage I-II without risk factors

  * Large mediastinal mass
  * Extranodal involvement
  * Elevated erythrocyte sedimentation rate (ESR)
  * Involvement of ≥ 3 nodal areas

Exclusion Criteria:

* Central nervous system lymphoma, nodular lymphocyte-predominant Hodgkin lymphoma or composite lymphoma,
* Prior cHL-directed treatment
* Prior chemotherapy, RT or allogeneic stem cell/solid organ transplant
* Prior or concurrent disease precluding protocol treatment (for details see section 4.2)
* Pregnancy or breastfeeding
* Non-compliance

Primary outcomes:
measure: Progression Free Survival
timeFrame: PFS at 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Cologne
name: Dennis Eichenauer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03652116: Bupivacaine Verus Pethidine for Post Cesarean Section Pain Relief
Official title: Subrectal and Subcutaneous Wound Infiltration With Bupivacaine Versus Pethidine for Postcesarean Section Pain Relief: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obstetric Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to local infiltration of cesarean section wound with either bupivacaine or pethidine; with follow up of postoperative pain relief.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare between the effect of wound infiltration with bupivacaine or pethidine for post cesarean section pain relief.


Eligibility criteria: Inclusion Criteria:

* Mode of delivery: Cesarean section.
* Gestational age: 37-40 weeks.
* Type of anaesthesia: Spinal anaesthesia.
* No past history of any medical disorder or other medical complications during pregnancy.

Exclusion Criteria:

* Women with known hypersensitivity to bupivacaine or pethidine.
* Women delivered vaginally.
* Women delivered under general anaesthesia.
* Women with known neurological or psychological disease.

Primary outcomes:
measure: Postoperative wound pain: VAS
timeFrame: first 24 hours postoperatively
Secondary outcomes:
measure: Total dose of opioid drugs needed
timeFrame: first 24 hours postoperatively
measure: Incidence of nausea and vomiting
timeFrame: first 24 hours postoperatively
measure: Incidence of urine retention
timeFrame: first 24 hours postoperatively
measure: Incidence of hypotension
timeFrame: first 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain SHams Maternity Hospital
state: Abbaseya
Study officials:
affiliation: M Samy
name: Mohamed Samy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03710616: A Real-world Study to Explore Recurrence/Metastases of the NSCLC Patients and the Impact Factors of Patient Survivals
Official title: A Real-world Study to Explore Recurrence/Metastases of the Early-stage (I-IIIA) NSCLC Patients and the Impact Factors of Patient Survivals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Keywords: early-stage NSCLC, real-world evidences, patient survivals
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathologically diagnosed early-stage (I-IIIA) NSCLC patients who were operated with radical operations of the lung cancer

Brief summary: The real-world study was designed to explore recurrence/metastases of the patients with non-small cell lung cancer as measured by patient survivals and the impact factors of patient survivals.

Detailed description: The trial was designed as a real-world observational study to recruit those patients with pathologically diagnosed early-phase non-small cell lung cancer (NSCLC) who were enrolled in the clinical form 2009 to 2017 and explore recurrence/metastases of the NSCLC patients as measured by patient survivals and the impact factors of patient survivals. The study data on patient demographic characteristics, tumor biological characteristics, and clinicla treatments were collected via a retrospectively review method for evaluation of patient survivals and the relevance of clinical characteristics of the patients and patient survivals.

Eligibility criteria: Inclusion Criteria:

The patients who meet all the following inclusion criteria will be included in the study:

* The patients who were operated with radical operations of the lung cancer;
* The patients with clinical I-IIIA staging tumors;
* The pathologically diagnosed NSCLC patients;

Exclusion Criteria:

- Not be specified;

Primary outcomes:
measure: Disease-free survival rates within the configured observation periods
timeFrame: 2009-2017
Secondary outcomes:
measure: Disease-free survival rates at the configured locations and observation periods
timeFrame: 2009-2017
Other outcomes:
measure: Impact factors of disease-free survival rates
timeFrame: 2009-2017
measure: Overall rates
timeFrame: 2009-2017
measure: Rates of perioperative complications
timeFrame: 2009-2017
Locations:
city: Guangzhou
country: China
facility: Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
state: Guangzhou
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Wenhua LIANG, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01522716: Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
Official title: Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Graft-Versus-Host Disease
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2012-02-01
Enrollment: 11
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 aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.


Eligibility criteria: Inclusion Criteria:

* Chronic graft-versus-host disease, grade moderate or severe despite at least 3 months treatment with calcineurin inhibitors and steroids OR
* Chronic graft-versus-host disease, grade moderate or severe, where full treatment with calcineurin inhibitors and steroids is impossible due to intolerable side-effects

Exclusion Criteria:

* Active malignancy
* Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease

Primary outcomes:
measure: Change in disease activity according to National Institute of Health criteria
timeFrame: Baseline to 9 months
Secondary outcomes:
measure: Change in disease activity as measured by histological examination
timeFrame: Baseline to 9 months
measure: Change in self-assessed disease activity and quality of life
timeFrame: Baseline to 9 months
measure: Safety (Adverse events, infections and relapse)
timeFrame: 21 months
measure: Freedom from steroids at 1 year after MSC treatment
timeFrame: 1 year after finishing treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Hematology Center, Karolinska University Hospital Huddinge
Study officials:
References:
citation: Boberg E, von Bahr L, Afram G, Lindstrom C, Ljungman P, Heldring N, Petzelbauer P, Garming Legert K, Kadri N, Le Blanc K. Treatment of chronic GvHD with mesenchymal stromal cells induces durable responses: A phase II study. Stem Cells Transl Med. 2020 Oct;9(10):1190-1202. doi: 10.1002/sctm.20-0099. Epub 2020 Jun 23.