louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00193544: Arsenic Trioxide and Thalidomide in the Treatment of Refractory Multiple Myeloma
Official title: Phase II Trial of Arsenic Trioxide and Thalidomide in the Treatment of Patients With Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: CTI BioPharma
First posted: 2005-09-19
Enrollment: 40
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: In this trial, we plan to evaluate further the role of arsenic trioxide in the treatment of patients with refractory multiple myeloma. Arsenic trioxide will be used in combination with thalidomide. Although both drugs have a similar mechanism of action, it is likely that the mechanisms may be additive or synergistic. Since neither drug produces much myelosuppression, this combination regimen should be tolerable in patients with compromised marrow function due to involvement with myeloma and/or previous cytotoxic chemotherapy

Detailed description: Upon determination of eligibility, patients will be receive:

* Arsenic Trioxide + Thalidomide

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Confirmed diagnosis of multiple Myeloma
* Received at least one previous chemotherapy regimen at most 3 previous
* Thalidomide with or without dexamethasone without chemotherapy will not factor in to total number of regimens.
* Age at least 18 years years
* Able to perform activities of daily living with minimal assistance
* Life expectancy more than 3 months
* Adequate bone marrow, liver and kidney function
* Must give written informed consent in order to participate.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Women pregnant or lactating.
* Pre-existing moderate neuropathy
* Patients with significant underlying cardiac dysfunction
* Uncontrolled hypercalcemia
* Active serious infections not controlled by antibiotics
* History of grand mal seizures (other than infantile febrile seizures)
* Receiving other medications that prolong the QT interval.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Overall survival
measure: Time to progression
measure: Overall toxicity
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04250844: Use of Intrapyloric Botulinum Injections in Children
Official title: Use of Intrapyloric Botulinum Injections in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vomiting
Feeding Disorders
Gastroparesis
Keywords: Botulinum Toxin
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from our tertiary care center who are undergoing upper endoscopy with or without intrapyloric botulinum injections.

Brief summary: This study aims to evaluate the effect of intrapyloric botulinum toxin in children with feeding disorders.

Detailed description: Chronic vomiting and feeding difficulties are common in young children and have a negative physical and psychosocial impact for patients and families. Currently there is no straightforward treatment algorithm for these issues, and management often involves multiple medication trials and procedures. Intrapyloric botulinum toxin injection has been proposed as a treatment for nausea and vomiting in adults, but there is minimal prior research on use in children and no prior research on use in children with feeding disorders. The aims of this study are: (1) to determine the efficacy of intrapyloric botulinum toxin injection for reducing gastrointestinal symptoms in children, (2) to determine the efficacy of intrapyloric botulinum injections for improving feeding outcomes in children, and (3) to define predictors of response to intrapyloric botulinum toxin injection.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic nausea, vomiting, or feeding intolerance undergoing upper endoscopy with or without intrapyloric botulinum injections.
* Age between 30 days and 18 years.

Exclusion Criteria:

* Significant uncontrolled inflammation on upper or lower endoscopy
* Known inflammatory bowel disease
* Uncontrolled thyroid disease
* Current opioid use

Primary outcomes:
measure: Degree of improvement in quality of life
timeFrame: 4 weeks
Secondary outcomes:
measure: Degree of symptomatic improvement
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Rachel Rosen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02931344: Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss
Official title: Biomarkers in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthrtis
Obesity
Keywords: Osteoarthrtis
Obesity
Liraglutide 3 mg
Liraglutide
Biomarkers
Lead sponsor: Parker Research Institute
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864).

This substudy aims to investigate any changes in biomarkers associated with the initial 8-week weight loss intervention

Detailed description: In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counselling, after which they will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.

Eligibility criteria: Inclusion Criteria:

* Same as parent trial (NCT02905864)

Exclusion Criteria:

* Same as parent trial (NCT02905864)

Primary outcomes:
measure: Change in collagen II degradation fragment α-C2M
timeFrame: Week -8 to 0
Secondary outcomes:
measure: Change in collagen II degradation fragment β-C2M
timeFrame: Week -8 to 0
measure: Change in non-coding RNA type snoRNAs U38 and U48
timeFrame: Week -8 to 0
measure: Change in miRNA-454
timeFrame: Week -8 to 0
measure: Change in miRNA let-7e
timeFrame: Week -8 to 0
measure: Change in Nesfatin-1
timeFrame: Week -8 to 0
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute
state: Capital Region
Study officials:
References:
Clinical trial NCT05960344: The SPIRO-MOTE Study
Official title: Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: Validation and Comparison of Supervised and Unsupervised Spirometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spirometry
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited at the four participating centres: Sheffield Children's Hospital, Leeds Children's Hospital, Royal Hospital for Children (Glasgow) and Great Ormond Street Hospital (London).

Brief summary: Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: validation and comparison of supervised and unsupervised spirometry


Eligibility criteria: Inclusion Criteria:

* Male and female children aged 5 to 16 years old
* Doctor diagnosed respiratory condition, including asthma, cystic fibrosis, PCD, bronchiectasis
* Child able to perform reliable spirometry
* Family have access to a smartphone or tablet and a second device for video consultation

Exclusion Criteria:

* Significant learning difficulties
* Other reasons for being unable to do lung function tests, for example, unable to make a seal around the mouthpiece
* Informed consent/assent has not been provided
* No English speaking member of the family
* Contraindications as outlined by the ARTP, e.g. pneumothorax, haemoptysis of unknown origin, unstable cardiovascular status, recent eye surgery, vomiting or any acute disease that would interfere with the test performance, recent surgery (thoracic/abdominal)

Primary outcomes:
measure: Outcome measures from spirometry tests (1)
timeFrame: Within two weeks
measure: Outcome measures from spirometry tests (2)
timeFrame: Within two weeks
measure: Length of each standard test
timeFrame: Within two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Clinical Research Facility, Sheffield Children's Hospital
Study officials:
References:
Clinical trial NCT05900544: Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures
Official title: Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Disease
Emphysema or COPD
Breast Density
Lead sponsor: University of Montana
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Quasi-experimental
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will implement a patient-centered outcomes tool for participants in lung cancer screening programs that receive clinically important incidental findings relevant to heart, breast and lung health. The study objective is to evaluate participant response and clinical follow-up following implementation of a patient-centered incidental findings communication tool.

Detailed description: A computer assisted personal interview survey will be administered by study personnel to capture information about perceived risk, cues to action and self-efficacy among lung cancer screening participants. Participants eligible for recruitment will have had incidental findings from the low dose CT: moderate to severe CAC, grade 3 or 4 breast density, moderate to severe emphysema, or multiple incidental findings. The interview-administered survey will be conducted by telephone with responses entered by study personnel into a REDCap database. The REDCap questionnaire will be adapted to a given patient's IF status. The survey questions will be based on the Health Belief Model that has been used effectively in the context of secondary prevention. For each participant the survey will be conducted before and after system level implementation of a patient-centered incidental findings communication tool.

Eligibility criteria: Inclusion Criteria:

* Eligible for lung cancer screening program
* Presence of one of three incidental findings on low dose CT: coronary artery calcification, extensive breast density (for females), or emphysema

Exclusion Criteria:

* No incidental findings from lung cancer screening low dose CT

Primary outcomes:
measure: Precaution Adoption Process Model (PAPM) health behavior stage
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02636244: Safety and Efficacy Study of SHAPE Gel in Alopecia Areata
Official title: A Multi-Center, Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of SHAPE Gel, a Histone Deacetylase Inhibitor, in Patients With Alopecia Areata
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alopecia Areata
Lead sponsor: TetraLogic Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-12-21
Enrollment: 40
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 purpose of this study is to evaluate the efficacy and safety of SHAPE Gel applied topically to adult patients with alopecia areata of the scalp.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of scalp alopecia areata and scalp hair loss due to alopecia areata for a minimum of six months and a maximum of two years.
* Patients taking thyroid medication or hormonal therapy must be on a stable dose for 6 months and maintain such throughout the study.
* Willingness to maintain same hair style, including shampoo and hair dye, throughout the study period.
* Willingness to have a small micro dot tattoo placed to allow for photographic analysis of treatment and application of study medication.

Exclusion Criteria:

* History of systemic or cutaneous malignancy and/or lymphoproliferative disease, other than patients with: up to 3 basal cell carcinoma; up to three well differentiated cutaneous squamous cell carcinoma; and/or cervical intraepithelial neoplasm (CIN), treated successfully with no evidence of disease, and treated for greater than 6 months prior to study entry.
* Current actinic keratosis on the scalp and/or face
* Nevi or cutaneous lesions thought suspicious for malignancy.
* History of or current gastrointestinal, pulmonary, cardiovascular, genitourinary or hematological disease, CNS disorders, infectious disease or coagulation disorders that would preclude participation in and completion of study assessments.
* Positive for hepatitis B surface antigen, HIV or hepatitis C.
* Co-existent androgenetic alopecia: in males: Norwood-Hamilton stage IV, V or VI; in females: Ludwig stage II or III.
* Unwillingness to discontinue use of non-breathable wigs, weaves or shaving of scalp throughout course of study.

Primary outcomes:
measure: Response evaluated using modified Severity of Alopecia Tool (mSALT)
timeFrame: Every 4 weeks; up to 24 weeks
Secondary outcomes:
measure: Effects on quality of life using Subject Assessment of Hair Loss (SAHL)
timeFrame: Every 4 weeks; up to 24 weeks
measure: Effects on quality of life using Alopecia Areata Symptom Impact Scale (AASIS)
timeFrame: Every 4 weeks; up to 24 weeks
measure: Effects on quality of life using the Skindex-16
timeFrame: Every 4 weeks; up to 24 weeks
measure: Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
timeFrame: Every 4 weeks, up to 12 weeks
Other outcomes:
measure: Pharmacodynamic effect determined through assessment of lymphocyte subsets
timeFrame: Up to 12 weeks
Locations:
Study officials:
References:
Clinical trial NCT04031144: Ultrafiltration on Coagulation Function in Cardiac Surgery
Official title: Effect of Ultrafiltration Before Weaning From Cardiopulmonary Bypass on Post-bypass Coagulation Function in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Valve Disease
Keywords: coagulation
ultrafiltration
cardiac surgery
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with reduced clot strength before applying ultrafiltration (patients with MCF in ROTEM-EXTEM less than the cut-off value which will be determined by preliminary analyses, n=30).

ROC analysis of the preliminary data was performed and the cut-off values was 50.5 mm.

The sample size of the present study is determined by using these data. The minimum sample size to detect the observed difference by applying ultrafiltration was 25, with a 2-sided significance level of 0.05 and a statistical power of 0.80. Considering 10% of the possible loss, 28 patients will be recruited for the present study.

Patients who scheduled for elective cardiac surgery with cardiopulmonary bypass are recruited first, and the data of patients with MCF \<50.5 mm will be included to the final analysis.
Primary purpose: TREATMENT

Brief summary: To determine the effect of modified ultrafiltration, which is usually employed for reducing free water at the end of cardiopulmonary bypass (CPB), on coagulation profile in patients undergoing cardiac surgery


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB)
* maximal clot formation (MCF) in ROTEM-EXTEM is reduced

Exclusion Criteria:

* MCF \> 50.5 mm before applying ultrafiltration
* transfusion of packed RBC\> 3 units during CPB
* total ultrafiltration volume \< 250 ml
* hyperfibrinolysis (lysis% \> 10%) before applying ultrafiltration

Primary outcomes:
measure: Change of Maximal clot formation (MCF) in rotational thromboelastometry, EXTEM assay
timeFrame: 5 min-before and 5 min-after applying ultrafiltration
Secondary outcomes:
measure: Change of Clotting time (CT) in rotational thromboelastometry, EXTEM assay
timeFrame: 5 min-before and 5 min-after applying ultrafiltration
measure: Change of Maximal clot formation at 5 min (A5) in rotational thromboelastometry, FIBTEM assay
timeFrame: 5 min-before and 5 min-after applying ultrafiltration
measure: Change of Percent of lysis (lysis%) in rotational thromboelastometry, EXTEM assay
timeFrame: 5 min-before and 5 min-after applying ultrafiltration
measure: Hematocrit (Hct) change
timeFrame: 5 min-before and 5 min-after applying ultrafiltration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
References:
Clinical trial NCT00203944: International Adoption and Stress Response Study
Official title: International Adoption and Stress Response Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Keywords: Adoption
Stress Response
Child Development
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 39
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants from international adoption clinic for adoptees and U of C pediatric follow-up clinic for controls

Brief summary: This study aims to provide information about the emotional and physiological responses of post-institutionalized children in both a stressful situation (immunization) and a play situation.

Detailed description: During the last decade, international adoptions have doubled in the United States. Because many of these infants and children have experienced institutionalization and poor caretaking before their adoption, international adoptees have special medical and emotional needs that must be met by both their parents and pediatricians. Currently, most clinical information about these children has focused on their physical health status so that protocols for evaluation and treatment can be established. Some systematic research has also focused on their overall developmental status including both cognitive and motor capabilities. These studies show that most of the children are developmentally delayed upon arrival to the U.S. Furthermore, follow-up studies have found international adoptees to score (on the average) significantly lower in cognitive functioning than their nonadopted peers even after spending substantial time in their adopting homes and falling mostly within the normal range. Not surprisingly, children's level of functioning at older ages is related to the length of time spent in institutional care.

These findings are consistent with an emerging literature on the lingering effects of early adversity on children's development. Potent adverse circumstances may include the unbuffered effects of poverty, experience in an institutional setting, physical or sexual abuse, and parental negligence Regardless of the source, children who are not protected from these disadvantageous situations demonstrate changes in their behavior as well as their biophysiological regulation.

Eligibility criteria: Inclusion Criteria:

* Infants less than 1 year old
* Adopted infants
* Control group of non-adopted infants

Exclusion Criteria:

* Children greater than 1 year old

Primary outcomes:
measure: Cortisol response levels
timeFrame: At clinic visit before and after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Larry Gray, M.D.
role: PRINCIPAL_INVESTIGATOR
References: