louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03109938: Comparison of Diagnostic Accuracies of Various Endoscopic Examination Techniques
Official title: Comparison of Diagnostic Accuracies of Various Endoscopic Examination Techniques for Evaluating the Invasion Depth of Lateral Spreading Tumours (LST).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with endoscopic diagnosis of lateral spreading tumours

Brief summary: Endoscopic diagnosis of lateral spreading tumours (LST) with submucosal invasion is important in guiding the treatment strategy. The use of advanced imaging is not standard clinical practice in China. A clinical trial is now under way comparing the accuracy of narrow band imaging (NBI), endoscopic ultrasonography (EUS) and magnifying chromoendoscopy (MCE) for the diagnosis of LST with submucosal invasion.

Detailed description: Endoscopic diagnosis of lateral spreading tumours (LST) with submucosal invasion is important in guiding the treatment strategy. The use of advanced imaging is not standard clinical practice in China. A clinical trial is now under way comparing the accuracy of narrow band imaging (NBI), endoscopic ultrasonography (EUS) and magnifying chromoendoscopy (MCE) for the diagnosis of LST with submucosal invasion.The final histologic diagnosis was used as the true diagnosis in the present study. By comparing the consistency of histologic diagnosis and preoperative evaluation,the diagnostic accuracies of various endoscopic examination techniques(narrow band imaging , endoscopic ultrasonography , and magnifying chromoendoscopy) was calculated respectively.

Eligibility criteria: Inclusion Criteria:

- patients older than 18 years and Less than 65 years patients with endoscopic diagnosis of lateral spreading tumours signed informed consent

Exclusion Criteria:

- patients with serious heart, brain, lung, kidney complications patients with intestinal obstruction previous therapy for colorectal cancer women in gestational and lactational period taking anticoagulants or antiplatelet medications. based on the evaluations of physicians, the patient's condition is not suitable for the clinical trial

Primary outcomes:
measure: Diagnostic Accuracies
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Key Laboratory of Gastroenterology,Department of Gastroenterology
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Key Laboratory of Gastroenterology
name: Baoping Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05538338: Platelet Rich Plasma for Insufficient Endometrium
Official title: Intrauterine Platelet Rich Plasma (PRP) Infusion for Endometrial Insufficiency: A Prospective, Double-Blind, Placebo-Controlled Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility of Uterine Origin
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.

Detailed description: Patients with a history of thin endometrium will be randomized to either an intrauterine infusion of PRP vs. a placebo infusion of normal saline. This is a double-blind, placebo controlled prospective RCT. Patients will then proceed with a frozen embryo transfer of a single euploid embryo per routine.

Eligibility criteria: Inclusion Criteria:

* Patients who have previously undergone at least 2 unsuccessful frozen embryo transfer cycles, defined as failure to achieve a sustained clinical pregnancy (visualization of intrauterine gestational sac on ultrasound or a cancelled embryo transfer cycle due to inadequate endometrial thickness
* Patients with a diagnosis of thin endometrial lining (less than or equal to 6 mm maximum thickness) during prior unsuccessful or canceled embryo transfer cycles.

Exclusion Criteria:

* Fewer than 2 prior unsuccessful or canceled frozen embryo transfer cycles.
* Most recent unsuccessful embryo transfer prior to January 1, 2017.
* Mullerian anomalies, excluding arcuate uterus
* Concurrent submucosal fibroids, unrepaired uterine defects or present indication for uterine surgery
* Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
* Failure of patient to agree to enrollment in study with written consent.
* Concurrent pregnancy
* Anticoagulation use for which plasma infusion is contraindicated
* History of thrombosis
* Thrombophilia either inherited or acquired
* Concomitant use of adjunctive therapies for proliferation. These must be discontinued upon enrollment.
* Embryo planned to be used for transfer generated from surgically obtained sperm due to a diagnosis of non-obstructive azoospermia
* Recurrent/persistent endometrial fluid in prior cycles

Primary outcomes:
measure: Endometrial Thickness during frozen embryo transfer
timeFrame: during the proliferative phase of the frozen embryo transfer cycle
Secondary outcomes:
measure: Sustained implantation rate
timeFrame: approximately 9 weeks gestational age
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT05982938: Danicopan Early Access Program
Official title: Early Access Program (EAP) for Danicopan as Add-on Treatment to SOLIRIS® or ULTOMIRIS® in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Clinically Significant Extravascular Hemolysis (csEVH)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Paroxysmal Nocturnal Hemoglobinuria
PNH
Extravascular Hemolysis
Keywords: paroxysmal nocturnal hemoglobinuria
PNH
component 5 inhibitors
C5i
intravascular hemolysis
IVH
anemia
EVH
extravascular hemolysis
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is an EAP, designed to provide early access to danicopan for participants with PNH experiencing clinically significant EVH who have failed, not tolerated, or are unable to receive other approved treatments; in the Treating Physician's opinion, the participant is not eligible for or is not able to participate in an ongoing clinical trial of danicopan or a comparable treatment; and according to the Treating Physician, the benefit of danicopan treatment outweighs the potential risks.


Eligibility criteria: Key Inclusion Criteria

* Male or female, aged 18 years and older
* Diagnosed with PNH with clinically significant EVH as defined by anemia (Hgb ≤ 9.5 g/dL) with absolute reticulocyte count ≥ 120 × 109/L.
* Currently receiving treatment with SOLIRIS® or ULTOMIRIS® for at least 6 months prior to initiation of danicopan treatment.
* Platelet count ≥ 30,000/µL without the need for platelet transfusions.
* Absolute neutrophil counts ≥ 500/µL.
* Vaccinated against N meningitidis.

Key Exclusion Criteria

* Participants who are nursing or pregnant (or women who are planning to become pregnant during treatment with danicopan).
* Laboratory abnormalities at screening, as follows:
* Alanine aminotransferase (ALT) \> 2 × upper limit of normal (ULN)
* Direct bilirubin \> 2 × ULN, with the exception of:

  * participants with increased bilirubin due to EVH in the opinion of the Treating Physician or
  * participants with documented Gilbert's syndrome
* Active bacterial or viral infection, a body temperature \> 38°C on 2 consecutive daily measures, evidence of other infection, or history of any febrile illness within 14 days prior to initiating danicopan treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01802138: A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma
Official title: A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroblastoma
Keywords: refractory/relapsed neuroblastoma patients
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 6
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We designed this study to determine the feasibility and safety of Activated T-lymphocyte cell therapy for refractory/relapsed neuroblastoma patients.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age 21 years or younger
* Histologically confirmed neuroblastoma
* Progressive disease after standard treatment or relapsed patient
* ECOG scale (ECOG-PS) ≤2
* Expected survival at least 3 months

Exclusion Criteria:

* Patients with autoimmune disease
* Patients with immunodeficiency
* Other malignancy 5 year prior to this study
* Severe organ dysfunction
* Severe allergic disease
* Severe psychiatric disorder
* Pregnancy or lactating woman

Primary outcomes:
measure: T cell count after in vitro expansion
timeFrame: up to 13 weeks
Secondary outcomes:
measure: Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Chongno-gu
Study officials:
References:
Clinical trial NCT04009538: Re-Rehabilitation in Chronic Obstrctive Pulmonary Disease
Official title: The Effect of Re-Rehabilitation in Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Smoking
Smoking Cessation
Rehabilitation; Tobacco Use
Keywords: copd
smoking
Smoking Cessation
Rehabilitation; Tobacco Use
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: COPD patient participated first and second rehabilitation program
Primary purpose: TREATMENT

Brief summary: Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.

Detailed description: Pulmonary rehabilitation (PR) program in patients with COPD reduces dyspnea perception, increases exercise capacity, improves quality of life, and reduces psychological symptoms. Unfortunately, these gains are not permanent, but disappear within 12-24 months. The aim of this study is to compare the gains of the second PR program with the first program.

Patients with COPD who participated in the second rehabilitation program in the Pulmonary Rehabilitation unit will be included in the study. Pulmonary function tests, arterial blood gases, mMRC dyspnea perception, 6-minute walking distance, disease-specific (SGRQ) quality of life and hospital anxiety depression scale values will be compared.

Eligibility criteria: Inclusion Criteria:

* Above 18 years
* Completed PR program

Exclusion Criteria:

-

Primary outcomes:
measure: Exercise Capacity
timeFrame: 6 minutes
Secondary outcomes:
measure: Respiratory Functions
timeFrame: 30 minutes
measure: Dyspnea Sensation
timeFrame: 5 minutes
measure: Disease Specific Quality of Life
timeFrame: 20 minutes
measure: Anxiety and Depression
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05456438: Effect of Tea Tree Oil and Coconut Oil on Nipple Crack Formation
Official title: Effect of Tea Tree Oil and Coconut Oil on Nipple Crack Formation in the Early Postpartum Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nipple Infection
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of the study was to determine the effect of tea tree oil and coconut oil applied to the nipples during the early postpartum period on nipple crack formation.

Detailed description: This randomized controlled experimental research included a total of 90 women in the research sample abiding by the research criteria, with 30 each in the intervention groups (coconut oil or tea tree oil application) and 30 in the control group. Women in the intervention groups applied coconut oil or tea tree oil to the nipples on the 3rd, 7th and 10th days postpartum, while the control group did not have any intervention

Eligibility criteria: Inclusion Criteria:

* Mothers who volunteered for participation, h
* aged from 18-45 years,
* with new and live birth after 37 weeks,
* without flat or small nipple problems,
* without previous breast operations,
* able to apply correct breastfeeding methods and with infants with birth weight of 2500 g and above were included in the study.

Exclusion Criteria:

* Mothers who could not breastfeed,
* had stillbirth,
* who had infants with congenital anomalies preventing breastfeeding were not included in the study.

Primary outcomes:
measure: VAS Pain score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Fatma Yıldırım
Study officials:
References:
Clinical trial NCT05765838: Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.
Official title: Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza
COVID-19
RSV Infection
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The order of the swabs performed will be decided with randomization to either of the eight combination:

1. NPS right - Nasal swab left - OPS
2. NPS left - Nasal swab right - OPS
3. Nasal swab right - NPS left - OPS
4. Nasal swab left - NPS right - OPS
5. NPS right - OPS - Nasal swab left
6. NPS left - OPS - Nasal swab right
7. Nasal swab right - OPS - NPS left
8. Nasal swab left - OPS - NPS right
9. OPS - NPS right - Nasal swab left
10. OPS - NPS left - Nasal swab right
11. OPS - Nasal swab left - NPS right
12. OPS - Nasal swab right - NPS left
Primary purpose: DIAGNOSTIC

Brief summary: This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. Citizens at an outpatient COVID19 test facility at Testcenter Danmark Valby will be invited to participate in the study on a volunteer basis. The enrolled participants will have the planned oropharyngeal swab performed in the test center and sent for a SARS-CoV-2 RT-PCR test at TestCenter Danmark, Statens Serum Institut, Copenhagen, Denmark as usual. Besides the planned oropharyngeal swab performed in the test center, the participants will have additional specimens collected in form of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs. These will all be used for the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B. Further we will measure immune mediating cytokines, chemokines, and interleukins in the different specimens. These analyses will be performed at Technical University of Denmark (DTU).


Eligibility criteria: The inclusion criterion:

A. 18 years or more of age requiring a test for COVID-19.

The exclusion criteria are :

A. Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.

B. Do not understand oral or written Danish

Primary outcomes:
measure: RT-PCR for upper airway viral diagnostics
timeFrame: 1 day
Secondary outcomes:
measure: local immunological mediators from the upper airway tract
timeFrame: 1 day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Valby COVID19 testcenter
Study officials:
References:
Clinical trial NCT04251338: Delayed Visual Maturation: Outcome and Predictive Factors
Official title: Delayed Visual Maturation: Outcome and Predictive Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed Visual Maturation
Keywords: delayed visual maturation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 71
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients seen in UZ Leuven between 1998 and 2016 with diagnosis of delayed visual maturation who meet the inclusion criteria.

Brief summary: The objectives of the study are to describe the developmental outcome in a population of children with delayed visual maturation.

Detailed description: description of the developmental outcome of children with delayed visual maturation.

Eligibility criteria: Inclusion Criteria:

* Infants (male or female) with suboptimal/absent visual contact at the age of ≥3 months, without other known general developmental delay at the time diagnosis of delayed visual contact and without anatomic ocular abnormalities at the initial ophthalmological examination.

Exclusion Criteria:

* Children with known underlying psychomotor developmental delay or epilepsy at first ophthalmic consultation.
* Children with ophthalmic (anatomical) abnormalities that explain delayed visual maturation.

Primary outcomes:
measure: delayed visual maturation.
timeFrame: 1998-2016
Secondary outcomes:
measure: Level of development
timeFrame: 1998-2016
measure: Fine and gross motor skills
timeFrame: 1998-2016
measure: ophthalmological problems
timeFrame: 1998-2016
measure: Visual acuity
timeFrame: 1998-2016
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: UZ Leuven
name: Ingele Casteels, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06773338: The Impact of Playing Tetris on Migrants' Mental Health
Official title: Does Playing Tetris Prevent the Development of Post-Traumatic Stress Disorder or Related Anxiety and Depressive Symptoms During and After Migration?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder (PTSD)
Anxiety Symptoms
Depression Symptoms
Keywords: Post-traumatic stress disorder
PTSD
Anxiety
Depression
Refugees
Asylum seekers
Migrants
Tetris
Longitudinal
Lead sponsor: Tilburg University
Sponsor class: OTHER
Collaborators: name: Stichting tot steun VCVGZ
First posted: 2025-01-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines if playing Tetris prevents the development of Post-traumatic stress disorder or related anxiety and depressive symptoms. The investigators recruit 300 participants in total in Greece and in the Netherlands. The participants are immigrants who have applied for asylum at any point in the past. The participants are asked to answer three questionnaires (on Post-traumatic stress disorder, related anxiety and depressive symptoms, and post-migration living difficulties) on a recurring basis - once every 4 weeks, 12 times in total. Half of the participants (treatment group) are randomly selected to play Tetris after completing the questionnaires. Participants in the treatment group are instructed to play Tetris for at least 15 minutes while trying to remember bad things that recently happened to them. Tetris is administered at three instances and participants in the treatment group are encouraged to play Tetris in case of experiencing any traumatic events or having any intrusive memories during the course of the study.


Eligibility criteria: Inclusion Criteria:

* Arabic-speaking immigrants of any gender who have applied for asylum in Greece or in the Netherlands, regardless of the outcome of their asylum application and their current residency status (rejected asylum seekers, recognized refugees, undocumented migrants).

Exclusion Criteria:

* Minors (under the age of 18).

Primary outcomes:
measure: Post-traumatic stress disorder
timeFrame: From enrolment to the end of the study (40 weeks)
measure: Anxiety and depression symptoms
timeFrame: From enrolment to the end of the study (40 weeks)
Secondary outcomes:
measure: Post-migration living difficulties
timeFrame: From enrolment to the end of the study (40 weeks)
Other outcomes:
Locations:
city: The Hague
country: Greece
facility: Upinion (online)
state: NL
city: The Hague
country: Netherlands
facility: Upinion/the humanity Hub
state: NL
Study officials:
References: