louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06201663: Romiplostim in Chemotherapy-Induced Thrombocytopenia
Official title: Safety and Efficacy of Romiplostim in Chemotherapy-Induced Thrombocytopenia in Children and Adolescents With Solid Malignancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chemotherapy-induced Thrombocytopenia
Solid Malignancy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prospective interventional randomized controlled trial to assess safety and efficacy of romiplostim in chemotherapy-induced thrombocytopenia in children and adolescents with solid malignancy

Detailed description: Chemotherapy-induced thrombocytopenia (CIT) frequently complicates cancer treatment causing delays in treatment and dose reduction for subsequent administration of cancer-directed treatment.

Romiplostim is a potential agent that can improve platelet counts, allowing the resumption of chemotherapy, decreasing the need for platelet transfusions, and increasing the nadir platelet counts thus improving dose intensity.

Eligibility criteria: Inclusion Criteria:

Age: 1- 18 years. Patients diagnosed with solid malignancy based on clinical, histopathological features, and /or immunohistochemical staining.

Patients with chemotherapy-induced thrombocytopenia defined as either

* severe thrombocytopenia either clinically with high bleeding score or laboratory by platelet count reaching critical level \< 20x10e9/L requiring platelet transfusion at time of chemotherapy cycle nadir.
* delayed recovery of platelet count: a platelet count of less than 100 x10e9/L for 3 weeks from the first day of chemotherapy cycle administration or the previous dose was reduced by \>20% due to low platelet count \<100×10e9/L.

Exclusion Criteria:

* Patients with second primary neoplasm.
* Patients with relapsed/refractory solid malignancy.
* Presence of primary or metastatic liver cancer.
* History of a prior symptomatic venous thromboembolic event (VTE) or arterial ischemic events.
* Patients with thrombocytopenia due to other etiologies e.g., underlying inherited thrombocytopenia.

Primary outcomes:
measure: Hematologic response
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Children's Hospital
Study officials:
References:
Clinical trial NCT03743363: Effects of Exergaming Session Frequency on Work Performance, Cognition, and Mobility in Adults Age 55 to 65
Official title: Effects of Exergaming Session Frequency on Work Performance, Cognition, and Mobility in Adults Age 55 to 65
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: balance
movement
exergaming
work performance
Lead sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 3
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim - determine the immediate and lasting effects of Exergaming frequency on work performance, health, motor, and cognitive function in clerical employees.

Detailed description: Hypothesis - In sedentary clerical workers the introduction of even 1 session / week exercise can cause lasting and correlated improvements in work, motor, and cognitive function, and effect which plateaus at 2 compared with 3 sessions / week. However, 6 months follow up would show residual effects only at the 3/week frequency in those who had become sedentary again.

Eligibility criteria: Inclusion Criteria:

* age
* active worker
* no detected neurological status

Exclusion Criteria:

* Sever heart problem
* Sever demeanor
* Alkoholism
* Drug problems

Primary outcomes:
measure: Motor function
timeFrame: 8 weeks
measure: Motor Function
timeFrame: 8 weeks
measure: MOBILITY
timeFrame: 8 weeks
measure: BALANCE Functional reach
timeFrame: 8 weeks
measure: Cognitive function
timeFrame: 8 weeks
measure: Cognitive function
timeFrame: 8 weeks
measure: Mobility
timeFrame: 8 weeks
measure: Mobility
timeFrame: 8 weeks
measure: Cognitive function
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
state: Somogy
Study officials:
References:
citation: Hortobagyi T, Deak D, Farkas D, Blenyesi E, Torok K, Granacher U, Tollar J. Effects of Exercise Dose and Detraining Duration on Mobility at Late Midlife: A Randomized Clinical Trial. Gerontology. 2021;67(4):403-414. doi: 10.1159/000513505. Epub 2021 Mar 3.
Clinical trial NCT03385863: Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages
Official title: A Multicenter Clinical Study on the Comparison of the Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infant, Newborn, NRDS
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 1500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants with RDS who received surfactant therapy were recruited from 24 hospitals between January 2011 and December 2016.

Brief summary: Since exogenous surfactant replacement therapy was first used to prevent neonatal respiratory distress syndrome (NRDS)，it has become the main method of treatment of NRDS. However, in some infants, death is inevitable despite intensive care and surfactant replacement therapy, especially in near-term and term infants. The first goal of our study is to compare the therapeutic effect of pulmonary surfactant of infants at different gestational ages and to investigate whether exogenous surfactant replacement therapy is effective for all newborns with RDS. The second goal of our study is to further analyze the risk factors and causes of RDS in early preterm infants and near term/term infants.


Eligibility criteria: Inclusion Criteria:

Infants with RDS who received surfactant therapy were recruited between January 2011 and December 2016.

Exclusion Criteria:

Infants were excluded if they had any congeni- tal malformation, inherited metabolic abnormality, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia.

Primary outcomes:
measure: therapeutic effect of pulmonary surfactant of infants at different gestational ages
timeFrame: January 1，2011 to December 30，2016
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of pediatrics, Daping Hospital, The Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital, Third Military Medical University
name: Li Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04389463: Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic
Official title: Patient Outcome of Cardiac Surgery During the COVID-19 Pandemic ; International Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Undergoing Cardiac or Thoracic Surgery
Keywords: Cardiac surgery
Postoperative outcome
COVID-19
SARS-Cov 2 infection
Postoperative complication
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing cardiac or thoracic surgery during the COVID-19 pandemic.

Brief summary: This study will describe the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic. This will focus on hemodynamic failure and organ dysfunction after surgery.

Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.

This investigator-led, non-commercial, non-interventional does not collect any patient identifiable information.

Detailed description: Performing cardiac surgery in the context of SARS-CoV2 infection is potentially at risk of marked post-operative hemodynamic failure (shock) due to the inflammatory reaction generated by the surgery and the extracorporeal circulation associated with the viral infection. In addition, in the absence of infection, 30-50% of patients will experience acute post-operative respiratory failure due to the combined effects of extracorporeal circulation and general anesthesia. The pulmonary tropism of the virus therefore is susceptible to increase in post-operative respiratory impairment.

Thus, the infection is likely to favor the occurrence of post-operative shock but also to aggravate respiratory failure and other post-operative organ failures.

Therefore, the investigators designed an observational study that aims at comparing two groups of patients:

* Cardiac or thoracic surgery patients with a negative Covid-19 PCR pre-operatively and in the 15 following days
* Cardiac or thoracic surgery patients with a positive Covid-19 PCR in the 15 days before surgery

Eligibility criteria: Inclusion Criteria:

* Adults (age ≥18 years) undergoing cardiac or thoracic surgery
* With positive PCR in the 5 days before or after cardiac/thoracic surgery.

Exclusion Criteria:

* Minors

Primary outcomes:
measure: Highest VIS (Vasoactive-Inotropic Score) in the first 12 hours postoperatively.
timeFrame: 12 hours post-operatively
Secondary outcomes:
measure: Post-operative organ failure
timeFrame: 5 days post-operatively
measure: Post-operative outcome
timeFrame: 28 days post-operatively
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT00350363: One Hour Preoperative Gatifloxacin
Official title: One Hour Preoperative Gatifloxacin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ophthalmic Surgery
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Comparison of 1 day versus 1 hour application of topical Zymar.


Eligibility criteria: Inclusion Criteria:

* ophthalmic surgery

Exclusion Criteria:

* taken antibiotics, allergic to fluoroquinolones

Primary outcomes:
measure: Number of Participant With Positive Culture
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Christopher Ta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04826263: Comparison of the Effectiveness of LLLT and ESWT in Plantar Fasciitis Treatment
Official title: Comparison of the Effectiveness of Low-level Laser Therapy and Extracorporeal Shock Wave Therapy in Plantar Fasciitis Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fascitis
Keywords: ESWT
LLLT
Exercise
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the efficacy of extracorporeal shock wave therapy (ESWT) and low-level laser therapy (LLLT) in terms of pain, disability, activity limitation, gait speed, and cadence in patients with plantar fasciitis (PF).


Eligibility criteria: Inclusion Criteria:

* Experience pain on the medial tuberosity or medial process of plantar fascia within the past one month
* Diagnosed with plantar fasciitis

Exclusion Criteria:

* arthritis in the foot or ankle
* Cardiac arrhythmia or pacemaker
* Previous foot or ankle surgery
* Cancer or tumor, acute trauma
* BMI over 40 kg/m2
* Corticosteroid injection in the last 6 months

Primary outcomes:
measure: Foot Function Index (FFI)
timeFrame: It will be reported at baseline
measure: Foot Function Index (FFI)
timeFrame: It will be reported at the end of treatment (3 weeks)
measure: Gait Speed
timeFrame: It will be reported at baseline (5 minutes after the FFI)
measure: Gait Speed
timeFrame: It will be reported at the end of treatment (3 weeks) (5 minutes after the FFI)
measure: Cadence
timeFrame: It will be reported at baseline (5 minutes after the FFI)
measure: Cadence
timeFrame: It will be reported at the end of treatment (3 weeks) (5 minutes after the FFI)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02105363: How Much Can the Thoracic and Lumbar Skin Slide?
Official title: How Much Can the Thoracic and Lumbar Skin Slide? Unrecognized Cause of Epidural Catheter Placement Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Movement of Thoracic and Lumbar Skin
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals age 0-100

Brief summary: The investigators want to determine how much the skin on the back can move left to right of the midline and also up and down, in subjects presenting for procedure or in healthy volunteers. The investigators will do measurements on the back using samples of individuals in all age groups.

It is hypothesized that an explanation to late epidural failure could be related to excess back motion in individual subjects.


Eligibility criteria: Inclusion Criteria:

1. Children age 0-17 and Adults 18 and older may participate
2. You agree to participate and sign the informed consent document

Exclusion Criteria:

1. Any type of back deformity
2. Tumor on back
3. Skin Disease on the back
4. Any condition that prevents skin measurements such as scleroderma

Primary outcomes:
measure: Lumbar skin move greater than 4 cm laterally or cephala-caudal
timeFrame: Data entered day subject participates
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson Universtiy Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Enrique Pantin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers Robert Wood Johnson Medical School
name: Ann Marie Lozano, RN, MSN
role: STUDY_CHAIR
References:
Clinical trial NCT01410435: Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease
Official title: An Open-label, Multi-Centre, Non-Randomised Extension Study to Assess the Ability to Maintain a Stable Haemoglobin and to Assess Safety of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammatory Bowel Disease
Anaemia
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
First posted: 2011-08-05
Enrollment: 39
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: Since the duration of most studies with IV iron in IBD subjects have been only 4-12 weeks studies there is a need to follow-up on long term safety and efficacy of any maintenance iron therapy.

This study represents subjects from the Lead-in Study (P-Monofer-IBD-01) on iron isomaltoside 1000 (Monofer®) to assess the long term safety of iron isomaltoside 1000 (Monofer®) and its ability to maintain stable haemoglobin in IBD subjects with Iron Deficiency Anaemia (IDA).


Eligibility criteria: Inclusion Criteria:

1. Completed the Lead-in Study or discontinued from Lead-in Study due to intolerance to oral iron.
2. Life expectancy beyond 18 months by Investigator's judgement.
3. Willingness to participate after informed consent. -

Exclusion Criteria:

1. Discontinuation from Lead-in Study (except for due to intolerance to oral therapy).
2. Any major protocol deviation in Lead-in Study.
3. Pregnancy and nursing \[To avoid pregnancy, women have to be postmenopausal, surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, Intrauterine Devices (IUD), contraceptive injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches\].
4. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study.
5. Patients with a Harvey-Bradshaw Index \>8 or Partial Mayo Score (excluding Endoscopy Sub-score) \>6 at End of Study Visit of Lead-in Study.

   -

Primary outcomes:
measure: Long term efficacy
timeFrame: Baseline to month 12
Secondary outcomes:
measure: Long term safety
timeFrame: Baseline to month 12
Other outcomes:
Locations:
city: Austria
country: Austria
facility: Austria
city: Hungary
country: Hungary
facility: Hungary
Study officials:
References:
Clinical trial NCT00259935: A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors
Official title: A Study to Determine the Bioequivalence of an Oral Formulation of Topotecan Containing the Drug Substance Manufactured by New Process Relative to the Current Study Formulation of Topotecan in Patients With Advanced Solid Tumors (4C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer, Small Cell
Keywords: Any Solid Tumor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the bioequivalence of the new oral capsule formulation to the currently used oral capsule formulation of topotecan.


Eligibility criteria: Inclusion Criteria:

* Subjects with advanced solid tumors.
* At least 4 weeks since last chemotherapy, radiotherapy, biologic therapy or surgery.
* Subjects must be free of post-treatment side effects.

Exclusion Criteria:

* Women who are pregnant or lactating
* Subjects with uncontrolled emesis, regardless of etiology, active infection.

Primary outcomes:
measure: Comparison of blood levels of topotecan following oral and IV dosing; blood samples will be drawn on Day 1 and Day 8 of Courses 1 and 2.
timeFrame: Days 1, 8
Secondary outcomes:
measure: Assessment of clinical laboratory tests, cardiac monitoring and disease progression. Comparison of blood levels of topotecan when taken orally with and without food; blood samples will be drawn on Day 1
timeFrame: Up to 38 days
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Morgantown
country: United States
facility: GSK Investigational Site
state: West Virginia
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05718635: Perforator Mapping and Optimizing Design of the Lateral Arm Flap
Official title: Perforator Mapping and Optimizing Design of the Lateral Arm Flap: Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coverage of Soft Tissue Defects
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to optimize the design of lateral arm flap. Colored duplex will be done for all Participants and compared to intra operative findings.

flap modification (Supra facial) dissection to lateral arm flap will be done and the results will compared to the ordinary method of dissection.


Eligibility criteria: Inclusion Criteria:

* adult patients

Exclusion Criteria:

* children injury to pedicle

Primary outcomes:
measure: numbers of perforators
timeFrame: two years
measure: site of perforators
timeFrame: two years
measure: Size of perforators
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Faculty of Medicine
Study officials:
References: