louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05247684: AK112 Neoadjuvant/Adjuvant Treatment for Resectable NSCLC
Official title: Phase II Clinical Study of AK112, an Anti-PD-1 and VEGF Bispecific Antibody, Alone or in Combination With Chemotherapy for the Neoadjuvant/Adjuvant Treatment of Resectable Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Resectable Non-small Cell Lung Cancer
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: AK112, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable NSCLC

Detailed description: Phase II clinical study of AK112, an anti-PD-1 and VEGF bispecific antibody, alone or in combination with chemotherapy for the neoadjuvant/adjuvant treatment of resectable non-small cell lung cancer

Eligibility criteria: Inclusion Criteria:

1、18 to 75 years old

2、Be able and willing to provide written informed consent and to comply with all requirements of study participation

3、Histologically confirmed resectable stage II-IIIB NSCLC

4、Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

5、Has adequate organ function

6、All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.

Exclusion Criteria:

1. Is currently participating in a study of an investigational agent or using an investigational device
2. Has an active autoimmune disease that has required systemic treatment in the past 2 years
3. Has an active infection requiring systemic therapy
4. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected)
5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
6. Has received a live virus vaccine within 30 days prior to first dose of study treatment
7. Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment.

Primary outcomes:
measure: Incidence and severity of adverse events (AE)
timeFrame: Up to approximately 2 years
measure: rate of surgical delays
timeFrame: Up to approximately 2 years
measure: abnormal laboratory findings of clinical significance
timeFrame: Up to approximately 2 years
measure: MPR
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: R0 resection rate
timeFrame: Up to approximately 2 years
measure: Tumor descending stage rate
timeFrame: Up to approximately 2 years
measure: pCR
timeFrame: Up to approximately 2 years
measure: OS
timeFrame: Up to approximately 2 years
measure: EFS
timeFrame: Up to approximately 2 years
measure: ORR
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02879084: Variations in Retinal Nerve Fiber Layer Thickness During Uncomplicated Anterior and Intermediate Uveitis
Official title: Variations in Retinal Nerve Fiber Layer Thickness During Uncomplicated Anterior and Intermediate Uveitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Uveitis
Intermediate Uveitis
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult of 18 years old or more with anterior or intermediate uncomplicated uveitis

Brief summary: This study investigates the variations in the retinal nerve fiber layer (RNFL) thickness during uncomplicated anterior and intermediate uveitis, respectively. The objectives are to 1 ) confirm the RNFL thickening during an uncomplicated anterior uveitis as described in the literature, 2) measure the RNFL thickness during an uncomplicated intermediate uveitis specifically and 3) describe the variation in time of RNFL thickness during the two types of uveitis.

Detailed description: Thirty six individuals (18 with anterior uveitis and 18 with intermediate uveitis) will be recruited at the Centre universitaire d'ophtalmologie du CHU de Québec. RNFL thickness will be measured with optical coherence tomography at 3 times. For anterior uveitis, the RNFL thickness will be measured at presentation, 1 week and 4 to 6 weeks. For intermediate uveitis, the RNFL thickness will be measured at presentation, 4 to 6 weeks and 4 months. The initial thickness will be studied for each type of uveitis and progression over time will be studied also for each type of uveitis.

Eligibility criteria: Inclusion Criteria:

* 18 years old or more
* anterior uncomplicated uveitis or intermediate uncomplicated uveitis

Exclusion Criteria:

* history of uveitis in the past, other than the actual uveitis
* history of ophthalmologic pathology with potential impact on retinal nerve fiber layer thickness
* optic nerve or macular clinically apparent edema
* history of glaucoma or other optic neuropathy
* suspected or confirmed multiple sclerosis
* ocular hypertension (intraocular pressure more than 22 mmHg)
* reduced optical coherence tomography signal (lower than 7) on the Cirrus HD-OCT

Primary outcomes:
measure: Retinal Nerve Fiber Layer Thickness in anterior uveitis
timeFrame: At time 0
measure: Retinal Nerve Fiber Layer Thickness in intermediate uveitis
timeFrame: At time 0
measure: Change from Baseline Retinal Nerve Fiber Layer Thickness in anterior uveitis
timeFrame: at 4 to 6 weeks
measure: Change from Baseline Retinal Nerve Fiber Layer Thickness in intermediate uveitis
timeFrame: at 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec
Study officials:
affiliation: Centre de recherche du CHU de Québec : Université Laval
name: Simon Couture, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03997084: Patent Foramen Ovale Closure Reduce in SCUBA-divers
Official title: Patent Foramen Ovale Closure Reduce in SCUBA-divers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Foramen Ovale
Decompression Illness
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all Swedish patients who had had catheter-based PFO-closure

Brief summary: It has been proposed that there would not be an increased risk of DCI after closure of the interatrial communication, i.e. patent foramen ovale (PFO).


Eligibility criteria: Inclusion Criteria:

* catheter-based PFO-closure because of DCI

Exclusion Criteria:

-

Primary outcomes:
measure: Dives
timeFrame: 2017-01-01 until 2019-01-01
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03678584: Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
Official title: Chaetoglobosin A Supplementation to ICSI Handling Medium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banoon IVF Center
name: Qena Fertility Center
First posted: 2018-09-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Chaetoglobosin A serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Chaetoglobosin A during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes.


Eligibility criteria: Inclusion Criteria:

* All ICSI participants agreed

Exclusion Criteria:

-

Primary outcomes:
measure: Oocyte Survival after ICSI
timeFrame: two days
Secondary outcomes:
measure: Fertilization rate
timeFrame: 6 days of culture
measure: Rate of top-quality embryo
timeFrame: 6 days of culture
measure: blastocyst formation and quality
timeFrame: 6 days of culture
measure: blastocyst utilization rate
timeFrame: 6 days of culture
measure: clinical pregnancy rate
timeFrame: 7 weeks
measure: Implantation rate
timeFrame: 7 weeks
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center, IbnSina Hospital
Study officials:
References:
Clinical trial NCT04553484: Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods.
Official title: Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: D012039
D001775
Lead sponsor: Semler Scientific
Sponsor class: INDUSTRY
First posted: 2020-09-17
Enrollment: 657
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 45 Years and older Female and Male

Brief summary: Measuring Cardiovascular Performance Using Common Methods in subjects.

Detailed description: This study will conduct measurements of cardiovascular performance by echocardiography (Echo), Brain Natriuretic Peptide (BNP) blood serum levels and blood flow by volume plethysmography (VP) in subjects who meet the AHA/ACC criteria for screening for peripheral arterial disease (PAD).

Eligibility criteria: Inclusion Criteria:

* At least 50 Patients from New York Heart Association (NYHA) Class 1 (One or more AHA Risk Factors, asymptomatic), ≤75% (36) Male, ≥25% (12) Female
* At least 50 Patients from NYHA Class 2 (symptomatic), ≤75% (36) Male, ≥25% (12) Female

Exclusion Criteria:

* Subjects on mechanical ventilation.
* Subjects who require decisions by a medical power of attorney.
* Subjects unable to safely perform forced expiration.
* Subjects with known technically difficult (TDS) trans-thoracic echocardiographic windows.

Primary outcomes:
measure: Feasibility of Performing Echo, BNP, and VP on Human Subjects.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Macon
country: United States
facility: Middle Georgia Heart and Vascular Center
state: Georgia
city: Lincoln
country: United States
facility: Integrated Cardiology Group, LLC, d/b/a Bryan Heart
state: Nebraska
city: Houston
country: United States
facility: JF Southwest Heart Clinic, P.A.
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
Study officials:
affiliation: Semler Scientific
name: Jim Kermode
role: STUDY_DIRECTOR
References:
Clinical trial NCT03206684: To Evaluate the Efficacy and Safety of PEG-rhG-CSF（Jinyouli®） in Reducing Neutropenia in Patients With Cervical Cancer
Official title: A Prospective, Open, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF in Reducing Neutropenia in Patients With Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cervical Cancer
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Prospective, open, randomized, controlled clinical study to evaluate the efficacy and safety of PEG-rhG-CSF(PEGylated recombinant human granulocyte stimulating factor injection) in reducing neutropenia during TP(docetaxel+cisplatin) regiment simultaneous radiochemotherapy and adjuvant chemotherapy in patients with cervical cancer


Eligibility criteria: Inclusion Criteria:

1. Age ≥18, ≤70 years old;
2. Cervical cancer patients diagnosed by histopathology;
3. Need to receive multi-cycle radical concurrent radiochemotherapy;
4. FN risk \> 20% if rhG-CSF was not accepted; High risk factors associated with FN and planed to use the same protocol in subsequent cycles(docetaxel+cisplatin regimen)；
5. Performance status score(KPS)≥70;
6. No obvious blood system disease,absolute neutrophil count（ANC）≥ 1.5×10\^9/L, platelet count≥80×10\^9 /L, hemoglobin（Hb）≥75 g/L, and no bleeding tendency;
7. The patient signs the informed consent.

Exclusion Criteria:

1. With infection difficult to control, or received system antibiotic treatment within 72 h before chemotherapy;
2. Any bone marrow abnormalities and other hematopoietic ;
3. Had received bone marrow or hematopoietic stem cell transplantation within 3 months;
4. with other malignancies not cure, or with brain metastases;
5. Liver function tests:total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≥2.5 times normal upper limit.
6. Renal function tests: serum creatinine (Cr)\> 1.5 times normal upper limit;
7. Allergic to the drugs or other genetic engineering biological products from Escherichia coli;
8. Suffering from mental or neurological disorders;
9. Investigator think it is not suitable for recruiting.

Primary outcomes:
measure: Incidence of III/IV neutropenia
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of FN
timeFrame: 3 months
measure: Proportion of chemotherapy dose adjustment
timeFrame: 3 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
name: Mei Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02574884: Identification of Viral Variants Involved in the Transmission of Hepatitis C and Characterization of Antigenic and Functional Properties of Their Envelope Glycoproteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study consists to Identify viral variants involved in the transmission of hepatitis C and characterize the antigenic and functional properties of their envelope glycoproteins at very early stage of infection (before seroconversion).


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* agree to participate in this study (signing the consent form or information form signed and letter of no objection for subjects contaminated by blood exposure).

These criteria are specific to contaminated subjects:

* primary infection before development of HCV antibody (seroconversion): nucleic acid testing positive in the absence of HCV antibodies.

These criteria are specific to individual sources :

* HCV antibody positive.

Exclusion Criteria:

* refusal to participate
* private about freedom
* under guardianship
* under justice
* minor or major person unable to consent

Primary outcomes:
measure: HCV serological markers
timeFrame: up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: Chru de Tours
Study officials:
References:
Clinical trial NCT02502084: Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
Official title: Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Lead sponsor: 3NT Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-20
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

Detailed description: The rationale behind this feasibility study is to show that accessing and visualization of the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in patients suffering from symptoms attributable to sinusitis is feasible; This is an essential step in the development of a system that will later allow visualization, sampling, and treatment of the sinuses via the natural sinus ostium during the patient's first office visit in a minimally invasive manner while enabling treatment by lavage, and minimizing radiation exposure, antibiotic use, multiple office visits, and cost.

Eligibility criteria: Inclusion Criteria:

* Male or female patient indicated for primary FESS procedure by the ear, nose and throat (ENT) specialist
* Patient age: adult (\>18 years old)
* Patients in general good health in the opinion of the investigator as determined by medical history physical examination
* A patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent

Exclusion Criteria:

* A patient with nasal polyposis
* A patient indicated for tumor excision
* Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
* Patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic Coumadin treatment)
* Pregnancy
* Patients with previous FESS surgery

Primary outcomes:
measure: Safety assessed by unanticipated device-related adverse events
timeFrame: During hospital stay, up to 1 day
Secondary outcomes:
measure: Performance assessed by anatomical landmarks reached and visualized will be recorded
timeFrame: During procedure, up to 3 hours
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
References:
Clinical trial NCT05618184: Quality of Life Among Hungarian Women with Urinary Incontinence
Official title: Health-related Quality of Life Among Hungarian Women with Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: Quality of life
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 18 years or older who are able to read and write Hungarian.

Brief summary: The aim of this study is to assess the prevalence of urinary incontinence among Hungarian women. In addition to that, we aim evaluate the health related quality of life among Hungarian women with urinary incontinence and to culturally adapt the following questionnaires for the Hungarian population: Incontinence Impact Questionnaire - Short Form (IIQ-7) and King's Health Questionnaire (KHQ).


Eligibility criteria: Inclusion Criteria:

* Woman
* Age 18 and above
* Providing consent to participate
* Ability to read and write Hungarian

Exclusion Criteria:

* Respondents who are unable to complete the online survey due to illiteracy
* Man

Primary outcomes:
measure: International Consultation of Incontinence Questionnaire - Short Form
timeFrame: Baseline
measure: King's Health Questionnaire
timeFrame: Baseline
measure: Incontinence Impact Questionnaire short form
timeFrame: Baseline
Secondary outcomes:
measure: Short-Form-36
timeFrame: Baseline
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pécs
state: Baranya
Study officials:
affiliation: University of Pecs
name: Márta Hock, Habilitation
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02128984: Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children
Official title: Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Failure to Thrive
Malnutrition
Keywords: Malnutrition
Dietary supplement
Nutritional supplement
Symbiotic formula
DHA
Cystic Fibrosis
Failure to Thrive
Lead sponsor: Laboratorios Ordesa
Sponsor class: INDUSTRY
Collaborators: name: Quantum Experimental
name: Peruvian Clinical Research
First posted: 2014-05-01
Enrollment: 109
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a nutritional supplement is effective in the treatment of malnutrition in pediatric patients with failure to thrive or cystic fibrosis.

Detailed description: This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind study to evaluate the effect of a nutritional supplement on nutritional status in children with failure to thrive or cystic fibrosis. Patients will be randomized to receive either a symbiotic formula with DHA and antioxidants or a standard formula.

Eligibility criteria: Inclusion Criteria:

* Malnutrition (P / T \<-1 SD) by intake deficit without organic disease (failure to thrive) and / or patients diagnosed with Cystic Fibrosis).
* Age \>= 1 year.
* Stable patients
* No antibiotherapy in the last 30 days
* Inform consent signed (parent/legal representative)

Exclusion Criteria:

* Patients with allergy / intolerance to cow's milk proteins
* Metabolically unstable patient
* Patients with metabolic intolerance to carbohydrates
* Patients with severe disease in the last 30 days

Primary outcomes:
measure: Changes in inflammatory response
timeFrame: At 3rd and 6th months
Secondary outcomes:
measure: Changes in nutritional status
timeFrame: At 3rd and 6th months
measure: Changes in microbiota profile
timeFrame: At 3rd and 6th months
measure: Changes in Interleukin levels
timeFrame: At 6th month
measure: Incidence of Infections
timeFrame: At 1st, 3rd and 6th months
Other outcomes:
measure: Tolerability of the formula
timeFrame: At 1st, 3rd and 6th months
Locations:
city: Lima
country: Peru
facility: Instituto Nacional de Salud del Niño
state: Breña
city: Coslada
country: Spain
facility: Hospital de Henares
state: Madrid
city: Cartagena
country: Spain
facility: Hospital Universitario Santa Lucía
state: Murcia
city: Almería
country: Spain
facility: Hospital de Torrecárdenas
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References: