louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04885595: Diagnosis of Peripheral Lung Nodules Using Cryobiopsy
Official title: Bronchoscopic Diagnosis of Peripheral Lung Nodules Using Endobronchial Ultrasound Guided Forceps and Cryobiopsy. A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung; Node
Keywords: Cryobiopsy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Since the traditional radial endobronchial ultrasound guided biopsy technique of solitary pulmonary nodules using the forceps has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryobrobe

Detailed description: This is a prospective randomized trial to assess diagnostic accuracy and safety of cryobiopsy using two different outer diameters. Included patients are 1:1 randomized to receive forceps biopsy following cryobiopsy with a 1.1mm or 1.7mm cryoprobe.

Eligibility criteria: Inclusion Criteria:

* Solitary pulmonary nodule with indication of bronchoscopic diagnostic approach
* Age between 18 and 90 years
* Written informed consent after participant's information

Exclusion Criteria:

* Age \< 18 and \> 90 years
* Lacking ability to form an informed consent (including impaired judgement, communi-cation barriers)
* Contraindication against bronchoscopy (e.g. co-morbidities)
* INR \> 2 or Thrombocytes \< 50000
* Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
* Anticoagulation with NOAK within 48 hours before biopsy
* Moderate or severe pulmonary hypertension (mPAP \> 30 mmHg, RV/RA \>30 mmHg)
* Tumors suspicious of endobronchial growth

Primary outcomes:
measure: Diagnostic yield
timeFrame: up to 1 month
Secondary outcomes:
measure: Size of harvested tissue in millimeter
timeFrame: up to 1 month
measure: Size of malign tissue in millimeter
timeFrame: up to 1 month
measure: Occurrence of bleeding events
timeFrame: up to 1 month
measure: Size of artifact-free alvoelar space in percentage
timeFrame: up to 1 month
measure: Radial endobronchial utrasound probe orientation (excentric, concentric, adjacent)
timeFrame: 1 day
measure: Occurence of pneumothorax
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University hospital Zurich
Study officials:
affiliation: University of Zurich
name: Carolin Steinack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06738095: Effect of Low-level Red-light on Ultra-high Myopia
Official title: Effect of Low-level Red-light on Ultra-high Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 57
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 100 eyes of ultra-high myopia were treated with daily low-level red-light. The age of children ranged from 3 to 16.3 years. The follow-up duration was one year. The objective was to explore the effect of daily low-level red-light on ultra-high myopia treatment


Eligibility criteria: Inclusion Criteria:

A. The age is over 3 years old and under 18 years old. B. The spherical equivalent error is ≤ -6 D diopter . D. be able to cooperate to complete various eye examinations. E. be able to attend follow-up according to the specified time. F the guardian can accompany the use of the instrument.

Exclusion Criteria:

A. Complications associated with high myopia (such as choroidal neovascularization, macular split or hole, Rhegmatogenous retinal detachment); B other macular diseases (central serous retinopathy) or other eye diseases (e.g.Glaucoma, cataract, uveitis); C complicated with photosensitivity, psoriasis, albinism, hyperactivity disorder, nephrotic syndrome and systemic erythema Immune system diseases such as lupus; D. other systemic diseases or pregnancy; E. other similar instruments have been used for treatment in the past six months.

F. can't cooperate to complete various eye examinations. G. The guardian cannot accompany the use of this instrument.

Primary outcomes:
measure: Changes in axial length
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
Study officials:
References:
Clinical trial NCT06803095: Efficacy of Walking Exercise With Dog on Tinnitus Complaints in Sleep Apnea (Obstructive Sleep Apnea)
Official title: Efficacy of Walking Exercise With Dog on Tinnitus Complaints in Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus, Subjective
Obstructive Sleep Apnea
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: there is evidence that tinnitus (chronic subjective form) is highly prevalent among patients with obstructive sleep apnea. exercise is recommneded in chronic subjective form) and obstructive sleep apnea. walking with dog increase adherence to walking to maintain continuity of physical activity

Detailed description: the total participants will be forty in number.. those participants will complain form tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree).. the particiapnts will divided to groups.. the number of subjects in each group will be 20. The groups (both groups) will follow low calorie diet.. this diet will be applied for 12 weeks.. during this period the study group will receive free walking (30 min) with dog three timmes weekly. the control group will not receive free walking with dog

Eligibility criteria: Inclusion Criteria:

* obese persons
* bilateral chronic subjective tinnitus
* mild obstructive sleep apnea (mild apnea hypopnea index)
* forty participants

Exclusion Criteria:

* body mass index more than 40 kg/m2.
* cardiovascular problems
* hepatorenal probelms
* autoimmune problems
* orthopedic probelms

Primary outcomes:
measure: tinnitus handicap inventory
timeFrame: it will be assessed after 12 weeks
Secondary outcomes:
measure: VAS of discomfort induced by tinnitus
timeFrame: it will be assessed after 12 weeks
measure: VAS of loudness of tinnitus
timeFrame: it will be assessed after 12 weeks
measure: apnea hyponea index
timeFrame: it will be assessed after 12 weeks
measure: Eporwth sleepiness scale
timeFrame: it will be assessed after 12 weeks
measure: Pittsburgh sleeping quality index
timeFrame: it will be assessed after 12 weeks
measure: Questionnaire of Depression, Anxiety, Stress Scales
timeFrame: it will be measured after 12 weeks
measure: body mass index
timeFrame: it will be measured after 12 weeks
measure: wait circumference
timeFrame: it will be measured after 12 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Cairo University
state: Giza
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04126395: An Explorative RVA of the Motor Development of Children With DCD <2y
Official title: An Explorative Retrospective Video-analysis of the Motor Development of Children With Developmental Coordination Disorder Before the Age of Two
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Coordination Disorder
Autism Spectrum Disorder
Keywords: motor development
baby
infant
motor milestones
crawling
independent walking
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 49
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: This study compares motor development in three groups of infants (controls, DCD, DCD+ASD) before the age of 2 years using retrospective video analysis of infants in home video contexts.


Eligibility criteria: CONTROLS:

Inclusion Criteria:

* Availability of video material of the child before the age of 2.
* No indication of DCD (as measured by M-ABC-2 Pc\>16 and DCD-Q)
* No indication of ASD (as measured by SRS-2 T-score ≤60 )

Exclusion Criteria:

* Medical diagnosis possibly influencing motor development (DCD, ASD, ADHD, CP, ect)
* Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
* Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)

DCD GROUP:

Inclusion criteria:

* Availability of video material of the child before the age of 2.
* Formal diagnosis of DCD provided by multidisciplinary team in Flanders
* Indication of DCD (as measured by M-ABC-2 Pc≤16 and DCD-Q)

Exclusion Criteria:

* Other medical diagnosis possibly influencing motor development (ASD, ADHD, CP, ect)
* Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
* Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)

DCD+ASD GROUP:

Inclusion criteria:

* Availability of video material of the child before the age of 2.
* Formal diagnosis of DCD and ASD provided by multidisciplinary team in Flanders
* Indication of DCD (as measured by M-ABC-2 Pc≤16 and DCD-Q)
* Indication of ASD (as measured by SRS-2 T-score \>60 )

Exclusion Criteria:

* Other medical diagnosis possibly influencing motor development (ADHD, CP, ect.)
* Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
* Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)

Primary outcomes:
measure: Observable Movement Quality Scale
timeFrame: 0-2years
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
city: Vancouver
country: Canada
facility: UBC
Study officials:
affiliation: University Ghent
name: Hilde Van Waelvelde, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00378495: Miltefosine for Brazilian Visceral Leishmaniasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Kala Azar
Keywords: miltefosine
kala azar
Brazil
Lead sponsor: AB Foundation
Sponsor class: OTHER
Collaborators: name: AEterna Zentaris
First posted: 2006-09-20
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Miltefosine will be administered to Brazilian patients with kala azar

Detailed description: Miltefosine will be administered to Brazilian patients with kala azar. Both pediatric and adult patients will be studied. Patients will be followed for 6 months.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed (untreated) visceral leishmaniasis with symptomatic disease and visualization of amastigotes in tissue samples or a positive culture.

  * Age: Group 1: 2 to 12 years; Group 2: 13 to 60 years
  * Sex: male and female patients eligible (no effort to be made to balance the study for gender)

Exclusion Criteria:

Exclusion criteria

Safety concerns:

* Thrombocyte count \<30 x 109/l;
* Leukocyte count \<1 x 109/l;
* Hemoglobin \<5 g/100 ml;
* ASAT, ALAT, AP \>3 times upper limit of normal range;
* Serum creatinine or BUN \>1.5 times upper limit of normal range;
* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary);
* Immunodeficiency or antibody to HIV;
* Severe protein and/or caloric malnutrition (Kwashiorkor, Marasmus);
* Any non-compensated or uncontrolled condition;
* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months.

Lack of suitability for the trial:

* Negative bone marrow aspirate (smear);
* Any history of prior anti-leishmania therapy;
* Any condition which compromises ability to comply with the study procedures;
* Concomitant serious infection other than visceral leishmaniasis (this would include evidence of other conditions associated with splenomegaly such as schistosomiasis or malaria).

Administrative reasons:

* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative);
* Anticipated non-availability for study visits/procedures.

Primary outcomes:
measure: cure rate at 6 months
Secondary outcomes:
measure: cure rate at 1 month
measure: safety
Other outcomes:
Locations:
city: Montes Claros
country: Brazil
facility: Universidade Estadual de Montes Claros
Study officials:
affiliation: Núcleo de Doenças Infecciosas - UFES
name: Reynaldo Dietze
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06939595: A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer
Official title: A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P51 and Keytruda in Combination With Platinum-Pemetrexed Chemotherapy in Patients With Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Non Squamous Non Small Cell Lung Cancer
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2025-04-23
Enrollment: 606
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: The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P51 and European Union (EU) approved Keytruda in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC.


Eligibility criteria: Inclusion Criteria:

* Stage IV, non squamous NSCLC
* Have not received any prior systemic anti-cancer therapy for metastatic NSCLC
* Have at least 1 measurable lesion per RECIST version 1.1

Exclusion Criteria:

* Have predominantly squamous cell histology NSCLC.
* Hypersensitivity or contraindication to any component of the study drug, pemetrexed and cisplatin or carboplatin

Primary outcomes:
measure: ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
timeFrame: Up to 34 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: ltd "Institute of Clinical Oncology"
Study officials:
References:
Clinical trial NCT06206395: Role of Multi-modality Imaging in the Assessment of Chemotherapy Related Cardiac Dysfunction Among Cancer Patients
Official title: Assiut University-Egypt
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: 2D Speckle Tracking Echocardiography
Breast Cancer
Cardiac Magnetic Resonance
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients receiving chemotherapeutic drugs with or without adjuvant radiotherapy at oncology department of Assiut University Hospital will be enrolled and imaging modalities will be performed at Assiut University Heart Hospital.

Brief summary: The field of oncology has advanced remarkably. Some of the old and new emerging cancer therapies are associated with development of cardiovascular toxicities , which may have the potential to offset the gains in survival obtained with this cancer treatment advances. Much of the focus on cardiovascular toxicities has been in the early detection of myocardial damage and prediction of cancer therapeutics-related cardiac dysfunction (CTRCD). The main strategy for these patients is timely diagnosis and treatment of high-risk individual Cardiac dysfunction associated with cancer treatment is the main cause of mortality in cancer survivors. The mortality rate is recorded to be up to 60% in the first two years after therapy. The most commonly associated drugs with cardiotoxicity are anthracycline (AC) and monoclonal antibodies (such as trastuzumab). Other new agents, such as vascular endothelial growth factor (VEGF) inhibitors, immunotherapies, and proteasome inhibitors, can also cause cardiac dysfunction .


Eligibility criteria: Inclusion Criteria:

* Cancer patients ≥ 18 years of age, and scheduled to receive chemotherapy will be included.

Exclusion Criteria:

* Contraindications to CMR (e.g.: patients with pacemakers, defibrillators or other implanted electronic devices).
* Life expectancy ≤ 12 months.
* Participating in another oncology clinical trial;
* Prior exposure to chemotherapy;
* History of active or prior cardiac disease (e.g., myocardial infarction, heart failure or base line left ventricular ejection fraction less than 55%).

Primary outcomes:
measure: Determine and compare the role of 2D speckle tracking vs. 3D echocardiography in assessment of early LV systolic dysfunction in patients receiving different chemotherapy combinations
timeFrame: up to 6 months after starting chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University-Cardiovascular department
Study officials:
affiliation: Assiut University
name: John S Johny, MSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00035295: Treatment of Patients With Major Depressive Disorder With MK0869 (0869-061)
Official title: A Double-Blind, Multicenter, Placebo-and Active-Controlled Acute and Extension Study of 2 Doses of MK-0869 in the Treatment of Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 584
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: A clinical study to determine the efficacy and safety of an Treatment of MK0869

in the treatment of depression.

Detailed description: The duration of treatment is 8 weeks.

Eligibility criteria: Patients with Major Depressive Disorder

Primary outcomes:
measure: HAMD-17 total score at week 8. Tolerability.
Secondary outcomes:
measure: CGI-I score at week 8, at least 50% reduction in the HAMD-17 total score, and Sheehan Disability Score at Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Keller M, Montgomery S, Ball W, Morrison M, Snavely D, Liu G, Hargreaves R, Hietala J, Lines C, Beebe K, Reines S. Lack of efficacy of the substance p (neurokinin1 receptor) antagonist aprepitant in the treatment of major depressive disorder. Biol Psychiatry. 2006 Feb 1;59(3):216-23. doi: 10.1016/j.biopsych.2005.07.013. Epub 2005 Oct 24.
citation: Liu KS, Snavely DB, Ball WA, Lines CR, Reines SA, Potter WZ. Is bigger better for depression trials? J Psychiatr Res. 2008 Jul;42(8):622-30. doi: 10.1016/j.jpsychires.2007.07.003. Epub 2007 Sep 7.
Clinical trial NCT01959295: Phase III Study of ASP2151 in Herpes Simplex Patients
Official title: Phase III Study of ASP2151 in Herpes Simplex Patients - A Double-blind, Placebo-controlled Study -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Simplex
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-10
Enrollment: 468
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.

Detailed description: A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

Eligibility criteria: Inclusion Criteria:

1. Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated

   * Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
   * Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region
2. Patients who can start receiving the study drug within 48 hours after onset of rash
3. Age: 20 years or older, but younger than 80 years

Exclusion Criteria:

1. Patients who are not expected to have an adequate response to oral antiviral medication
2. An extreme decline in immune function
3. Presence of serious complications
4. Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:

   * AST or ALT ≥ 2.5 x upper limit of normal
   * Platelet count \< lower limit of normal
   * Serum creatinine ≥ 1.5 mg/dL
   * Creatinine clearance \< 30 mL/min
5. Current or previous history of malignant tumor within 5 years before informed consent
6. Diagnosis of autoimmune disease
7. Evidence of bone marrow suppression

Primary outcomes:
measure: Percentage of Participants With Healing by Day 8
timeFrame: 8days
Secondary outcomes:
measure: Time to Healing
timeFrame: 29days
measure: Time to Complete Crusting
timeFrame: 29days
measure: Time to Virus Disappearance
timeFrame: 29days
Other outcomes:
Locations:
city: Sapporo
country: Japan
state: Hokkaido
city: Yokohama
country: Japan
state: Kanagawa
city: Nakano-ku
country: Japan
state: Tokyo
Study officials:
References: