louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00213993: Topical Antiperspirant for Hand-Foot Syndrome
Official title: Topical Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome) Associated With Capecitabine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Palmar-plantar Erythrodysesthesia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 14
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: The objectives of this study are to evaluate the effectiveness of an antiperspirant in preventing or attenuating the severity of palmer-plantar erythrodysesthesia associated with the Food and Drug Administration (FDA)-approved doses of capecitabine. The hypothesis is that cytotoxic compounds in sweat will be prevented from being deposited in the skin and causing chronic toxicity.


Eligibility criteria: Inclusion Criteria:

* Has not previously received a regimen that includes 5-fluorouracil
* \> 18 years old
* No known allergy or intolerance to Ban Unscented Roll-On Antiperspirant

Exclusion Criteria:

* \< 18 years of age

Primary outcomes:
measure: reduction in palm and/or sole pain
timeFrame: after each of first four cycles of chemotherapy
Secondary outcomes:
measure: evaluation of utility of digital photography in the following palmar-plantar erythrodysesthesia (PPES)
timeFrame: after each of first four cycles of chemotherapy
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Paul R Hutson, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03526393: Construction of the Training Mode Adjustable Equipment Sitting Volleyball
Official title: Construction of the Training Mode Adjustable Equipment Sitting Volleyball
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Training
Lead sponsor: University of Mogi das Cruzes
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The individual adapted sport modalities concentrate most of the technological development for equipment and auxiliary devices, the collective modalities need implements that aid in the development of training and the game.

Detailed description: The individual adapted sport modalities concentrate most of the technological development for equipment and auxiliary devices, the collective modalities need implements that support, in the development of training and the game. It was developed equipment to assist in the training of technical fundamentals and to improve the efficiency of the motor gesture required for the practice of sitting volleyball in athletes with physical disabilities. Ten athletes, sitting volleyball players, were selected to perform a set of technical fundamentals and their variations. Lift the ball (with two variations), attack and serve, and reception. After the analysis of the movements the equipment was elaborated and constructed based on the measurements made with the athletes, such as contact height with the ball, perimeter, speed and parabola.

Eligibility criteria: Inclusion Criteria:

* Have functional classification in national or international level,
* Practice experience of sitting volleyball mode of at least five years
* Participate in weekly training at least three times a week.

Exclusion Criteria:

* Non-acceptance of the athlete to participate in the survey
* Does not have the functional classification for the practice of sport

Primary outcomes:
measure: Ball lifting
timeFrame: 10 minutes
Secondary outcomes:
measure: Attack and loot
timeFrame: 10 minutes
measure: Pass training
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Mogi das Cruzes
country: Brazil
facility: Silvia Regina Matos da Silva Boschi
state: São Paulo
Study officials:
affiliation: University of Mogi das Cruzes
name: Silvia R Boschi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04381793: Treatment of CFS & Fibromyalgia With Recovery Factors
Official title: Treatment of CFS & Fibromyalgia With Recovery Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Fatigue Syndrome
Lead sponsor: Practitioners Alliance Network
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open pilot study to assess efficacy and antibody effects
Primary purpose: TREATMENT

Brief summary: The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome

Detailed description: Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum

Eligibility criteria: Inclusion Criteria:

* Meet ACR 2010 amended Fibromyalgia criteria or CDC CFS Criteria Overall well being score of 5 of less (on 0-10 VAS)

Exclusion Criteria:

Pregnant Clotting disorders

-

Primary outcomes:
measure: VAS
timeFrame: 6 weeks
Secondary outcomes:
measure: antibody titres
timeFrame: 10 weeks
measure: FIQ-R
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kailua
country: United States
facility: Jacob Teitelbaum MD
state: Hawaii
Study officials:
affiliation: Woman's Hospital in Vancouver
name: Gaetano Morello, ND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03769493: Mobile After-Care Intervention to Support Post-Hospital Transition (MACS)
Official title: Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization (MACS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Keywords: Medication adherence
Treatment adherence
Ecological momentary assessment
Ecological momentary intervention
Coping skills
Psychiatric Hospitalization
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-12-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An uncontrolled open trial approach will be used in which all participants receive the MACS app.
Primary purpose: TREATMENT

Brief summary: This study examines the feasibility and acceptability of a mobile device-delivered app, called Mobile After-Care Support (MACS), to improve patients' coping and treatment adherence following a hospitalization related to their psychotic-spectrum disorder.

Detailed description: In the open trial, all participants will receive a study-developed app to be used on a mobile phone. This app will support the use of healthy coping skills post-hospitalization, as well as help participants adhere to their discharge treatment plan. This phase is intended to inform the feasibility and acceptability of the app in preparation for a future randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

1. Currently hospitalized
2. DSM-5 criteria for psychotic disorder (schizophrenia or schizoaffective disorder)
3. 18 years or older
4. Prescribed oral antipsychotic medication upon discharge
5. Ability to speak and read English

Exclusion Criteria:

1. Alcohol/drug use disorders at moderate or severe level
2. Planned discharge to supervised living setting or participation in formal outpatient adherence programs (e.g., medication packaging)
3. Pregnancy or other medical condition (e.g., dementia) contraindicating use of antipsychotic medications.

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 1 month
Secondary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: 1 month
measure: Brief Adherence Rating Scale (BARS)
timeFrame: 1 month
measure: Maastricht Assessment of Coping Strategies (MACS)
timeFrame: 1 month
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital & Brown Universit
name: Brandon A Gaudiano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Ethan Moitra, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moitra E, Park HS, Gaudiano BA. Development and Initial Testing of an mHealth Transitions of Care Intervention for Adults with Schizophrenia-Spectrum Disorders Immediately Following a Psychiatric Hospitalization. Psychiatr Q. 2021 Mar;92(1):259-272. doi: 10.1007/s11126-020-09792-9.
Clinical trial NCT01095393: National Data Bank for Rheumatic Disease Registry Study of Safety in Patients With Rheumatoid Arthritis Treated With Cimzia® or Disease-modifying Antirheumatic Drugs (DMARDs)
Official title: National Data Bank for Rheumatic Disease (NDB) Registry Study of Safety in Rheumatoid Arthritis (RA) Patients Treated With Certolizumab Pegol (CZP; Cimzia®) and Non-biologic Disease-modifying Antirheumatic Drug (DMARD) Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Certolizumab Pegol
CZP
Cimzia®
NDB
registry
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: National Data Bank for Rheumatic Diseases (NDB)
First posted: 2010-03-30
Enrollment: 12500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatologist referral or patient direct enrollment

Brief summary: Observational registry to assess the longer-term risk of serious infections and malignancies reported with TNFα-blocker therapy, as well as the longer-term risk of cardiovascular and thromboembolic events in adult Rheumatoid Arthritis (RA) patients treated with Cimzia® as compared to non-biologic DMARD-treated controls.


Eligibility criteria: Inclusion Criteria:

* RA and started treatment with certolizumab pegol (Cimzia®; CZP) or non-biologic DMARD within the last 6 months

Primary outcomes:
measure: Number of participants with lymphoma
timeFrame: 6 years
Secondary outcomes:
measure: Number of participants with serious infections
timeFrame: 6 years
measure: Number of participants with non-lymphoma malignancies
timeFrame: 6 years
measure: Number of participants with cardiovascular events
timeFrame: 6 years
measure: Number of participants with thromboembolic events
timeFrame: 6 years
Other outcomes:
Locations:
Study officials:
affiliation: National Data Bank for Rheumatic Disease
name: Frederick Wolfe, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02691793: Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors
Official title: Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Refractory Solid Tumors
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 1
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive, FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.

To investigate the efficacy and safety of Sunitinib in patient with Refractory solid tumor.


Eligibility criteria: Inclusion Criteria:

* Provision of fully informed consent prior to study specific procedures.
* Patients must be \>= 19 years of age
* RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
* ECOG Performance status0-2
* Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
* Adequate Organ Function Laboratory values

  * Absolute neutrophil count \>= 1.5 x 109/L, Hemoglobin \>= 9g/dL, Platelets\>=100 x 109/L Bilirubin \<= 1.5 x upper limit of normal AST/ALT \<= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine\<= 1.5 X UNL
* Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
* Adequate heart function

Exclusion Criteria:

* Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \<= 5 years.
* Has known active central nervous system(CNS) metastases
* Has an active infection requiring systemic therapy
* Pregnancy or breast feeding
* Patients with cardiac problem
* Any previous treatment with sunitinib

Primary outcomes:
measure: progression-free survival
timeFrame: 24 months
Secondary outcomes:
measure: overall response rate
timeFrame: 24 months
measure: Time to progression
timeFrame: 24 months
measure: overall survival
timeFrame: 24 months
measure: Number of subjects with adverse events as a measure of safety
timeFrame: 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul, Korea, Republic Of
Study officials:
References:
Clinical trial NCT00804193: Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis
Official title: A Double-blind, Randomized, Parallel-group, Vehicle-controlled, Multi-center Study to Evaluate the Safety and Clinical Equivalence of a Generic Ciclopirox Olamine Topical Suspension to Reference Ciclopirox Topical Suspension 0.77% in the Treatment of Tinea Pedis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinea Pedis
Keywords: Tinea Pedis
Ciclopirox Olamine
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 553
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.


Eligibility criteria: Inclusion Criteria:

* Male or female at least 10 years of age, and otherwise healthy
* Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
* In good health with no clinically significant disease that might have interfered with study evaluations
* Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.

Exclusion Criteria:

* History of hypersensitivity or allergy to ciclopirox
* Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
* Had a history of dermatophyte infection unresponsive to antifungal treatment
* Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
* Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
* Was unwilling to sign the informed consent
* Female who was pregnant or lactating

Primary outcomes:
measure: Proportion of Subjects in Each Treatment Group With Therapeutic Success
timeFrame: 6 weeks
Secondary outcomes:
measure: Proportion of Subjects With Mycological Cure
timeFrame: 6 weeks
measure: Proportion of Subjects With Clinical Cure
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00536393: Treatment of Disseminated High Grade Lymphoma
Official title: Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Lymphoma
Keywords: diffuse larg cells lymphoma
chemotherapy
toxicity
diffuse high grade lymphoma
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
First posted: 2007-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interest of the use of pegylated liposomal doxorubicin (caélyx)

Detailed description: R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.

Eligibility criteria: Inclusion Criteria:

* high grade lymphoma
* disseminated
* \> 60 years old and \< 75
* informed consent signed
* cardiac state compatible with antracyclin
* ECOG \</= 2

Exclusion Criteria:

* patients \> 75 years old
* Cardiac insufficiency

Primary outcomes:
measure: hematologic toxicity
timeFrame: 6 months
Secondary outcomes:
measure: response rate
timeFrame: 6 months
measure: EFS and OS
timeFrame: 6 months
measure: Cardiac toxicity
timeFrame: 6 months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Clinique Victor Hugo
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Guillaume CARTRON, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02472093: A New Rehabilitation Tool in Fibromyalgia
Official title: A New Rehabilitation Tool in Fibromyalgia: Efficacy of Perceptive Rehabilitation Versus Group Exercises on Pain and Function: a Clinical Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Pain
Keywords: Postural exercise
Back pain
Tender points
Fibromyalgia
Perceptive rehabilitation
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the investigators study was to measure reductions in chronic pain in female patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with perceptual surfaces to a group exercises rehabilitation. Fibromyalgia is a generalized chronic pain condition that is usually accompanied by fatigue, sleep disturbance and psychological and cognitive alterations.


Eligibility criteria: Inclusion Criteria:

* fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 1990 and 2010)
* Subjects aged between 18 and 60 years
* visual analog scale (VAS) for pain \> 5

Exclusion Criteria:

* presence of concomitant autoimmune diseases
* psychiatric disorders
* other causes of chronic pain
* other diseases that prevented physical loading
* severe scoliosis or kyphoscoliosis
* surgery of the spine
* vertebral fractures
* sciatic pain
* tumors
* enrolled in another type of physical therapy program
* myocardial infarction
* lower extremity arterial disease
* major neurological problems
* diabetes
* gastrointestinal disease
* chronic respiratory disease
* kidney disease
* poor vision

Primary outcomes:
measure: Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
measure: Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Umberto I Hospital, Sapienza University of Rome
name: Vincenzo Maria Saraceni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03978793: MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users
Official title: MyTPill: A Novel Strategy to Monitor Antiretroviral Adherence Among HIV+ Prescription Opioid Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-positive Individuals
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: University of Miami
name: The Miriam Hospital
name: Massachusetts General Hospital
name: National Institute on Drug Abuse (NIDA)
name: Florida International University
First posted: 2019-06-07
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV+

Brief summary: This study compares several different antiretroviral adherence measures, including digital pills, in HIV+ individuals who are maintained on opioid analgesics.

Detailed description: This study compares digital pills, electronic pill bottles, self-report, and dried blood spots, in measuring adherence to antiretroviral medications containing emtricitabine and tenofovir.

Eligibility criteria: Inclusion Criteria:

* HIV+, Viral load \>200copies/mL, on single pill containing TDF/FTC, receiving prescription for opioid analgesics

Exclusion Criteria:

* Severe renal or hepatic disease
* Hypersensitivity to silver, magnesium, or zinc following oral use
* Pregnancy
* non-English speaking
* History of Crohn's disease or Ulcerative Colitis
* History of bowel surgery, gastric bypass, or bowel stricture
* History of gastrointestinal malignancy or radiation to the abdomen.

Primary outcomes:
measure: Dried blood spots
timeFrame: six months
measure: Adherence per two different electronic adherence measures
timeFrame: Six months
Secondary outcomes:
measure: Pill counts
timeFrame: Six months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: Ohio State University
name: Edward W Boyer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bischof JJ, Chai P, Mohamed Y, Padappayil R, Merchant RC, Boyer EW, Rosen R, Reyes-Gibby CC, Viamonte M, W Carrico A. MyTPill: study protocol for a cross-over randomised controlled trial comparing novel strategies to monitor antiretroviral adherence among HIV+ prescription opioid users. BMJ Open. 2023 Jan 10;13(1):e062805. doi: 10.1136/bmjopen-2022-062805.