louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00193167: Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer
Official title: Phase II Study of Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
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: This non-randomized phase II study is designed to assess the response rate and toxicity of weekly topotecan as second-line treatment in patients with relapsed or refractory metastatic colorectal cancer.

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

* Topotecan

Eligibility criteria: Inclusion Criteria:

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

* Metastatic colorectal cancer
* One previous chemotherapy for metastatic disease
* Measurable or evaluable disease
* Able to perform activities of daily living with assistance
* Adequate bone marrow, liver, and kidney function
* All patients must give written informed consent prior to study entry.

Exclusion Criteria:

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

* Brain or meningeal involvement
* Serious active infection or underlying medical conditions
* Other active neoplasms are ineligible
* Pregnant or lactating

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: median survival
measure: one year survival
measure: toxicity
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Anthony Greco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03535467: Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation
Official title: Caregiver Burden in Stroke: Robot-Assisted Therapy vs Conventional Rehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke Rehabilitation and Caregivers
Keywords: Caregivers
Exoskeleton Device
Stroke Rehabilitation
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2018-05-24
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 18-65 years old stroke patients who are not ambulatuar and dependent to their caregivers.

Brief summary: Caregiver's burden in rehabilitation is important for both patients physical and mental health. Therefore researching caregivers burden and treatment of any depression or associated any psychological disorders of caregiver is crucial.


Eligibility criteria: Inclusion Criteria:

* Hemiplegia after stoke, Brunnstrom stages: stage 2-3 of lower limb minimum 6 months after stroke,

Exclusion Criteria:

* More than 1 stroke, aphasia, Dysphagia, other life life threatening diseases Independent ambulation

Primary outcomes:
measure: Caregiver Burden Inventory
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Taksim Research and Education Hospital
Study officials:
References:
citation: Guler MA, Erhan B, Yilmaz Yalcinkaya E. Caregiver burden in stroke inpatients: a randomized study comparing robot-assisted gait training and conventional therapy. Acta Neurol Belg. 2021 Jun;121(3):729-736. doi: 10.1007/s13760-020-01465-5. Epub 2020 Aug 10.
Clinical trial NCT01157767: Exercise Program of Breast Cancer Patients Undergoing Chemotherapy With or Without Radiation
Official title: A Feasibility Study of the Effects of a Directed Exercise Program of Breast Cancer Patients Undergoing Chemotherapy With or Without Radiation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: exercise
lymphedema
post-operative chemotherapy
post-operative radiation
10-062
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects may be identified in advance by a member of the patient's treatment team, the principal investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).

Brief summary: The purpose of this study is to study if a patients follows an exercise program specifically designed for them during the time of their treatment after surgery. Their ability to follow the program and its influence on their weight maintenance and early post-operative lymphedema rates will also be studied. Lymphedema is a condition in which excess fluid collects in tissue and causes swelling of the arm(s).


Eligibility criteria: Inclusion Criteria:

* Patients will be eligible if they have any of the following surgical procedures performed by an attending on the Breast Service:

SLNB alone Axillary lymph node dissection (ALND) alone Total Mastectomy TM (+/- reconstruction) with SLNB or ALND Breast conserving therapy (BCT) with SLNB or ALND

* Age \> 18 years
* Planned to undergo adjuvant post-operative chemotherapy with or without radiation at MSKCC and have not yet started chemotherapy

Exclusion Criteria:

* Undergoing TM or BCT without SLNB
* Having had prior breast cancer treated with surgery
* Unable to participate in a exercise program related to other medical problems
* More than 8 weeks post surgery.
* Having a concurrent cancer in addition to breast cancer
* Who have had any type of chemotherapy in the past two years

Primary outcomes:
measure: To evaluate compliance with and demonstrate the feasibility of an at-home, directed exercise program during adjuvant chemotherapy and radiation (if applicable).
timeFrame: 2 years
Secondary outcomes:
measure: To describe how this exercise program affects weight maintenance and percent body fat during adjuvant chemotherapy and radiation.
timeFrame: 2 years
measure: To describe how this exercise program affects early post-operative lymphedema rates, monitoring the strength training specifics -including the number of repetitions and sets of each exercise, frequency, and order of exercises.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alexandra Heerdt, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04184167: Role of Intermittent Fasting Before ICSI
Official title: Role of Intermittent Fasting Before Intracytoplasmic Sperm Injection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2019-12-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: intermittent fasting could have a role in infertility

Detailed description: intermittent fasting could have a role in infertility and could adjust the body weight before ICSI

Eligibility criteria: Inclusion Criteria:

* women with infertility

Exclusion Criteria:

* ovarian factor or uterine factor of infertility

Primary outcomes:
measure: the number of women who will have positive pregnancy test after ICSI
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and helwan university
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algezeera hospitaland National Research Centre ,Egypt
name: Mahmoud Alalfy, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00915967: Prevention of Neurosurgical Wound Infections
Official title: Pilot Project: Prevention of Neurosurgical Wound Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infections
Keywords: Infection
Vancomycin
Neurosurgery
Stimulator
Pump
Deep Brain Stimulation
Intrathecal Pump
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2009-06-08
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.


Eligibility criteria: Inclusion Criteria:

* deep brain stimulators (DBS)
* spinal cord stimulators (SCS)
* motor cortex stimulators (MCS)
* vagus nerve stimulators (VNS)
* peripheral nerve stimulators (PNS)

Exclusion Criteria:

* allergies to vancomycin
* immunocompromise or taking immunosuppressant drugs
* currently taking aminoglycoside antibiotics, such as amikacin, gentamicin, neomycin, streptomycin or tobramycin
* diagnosed renal failure
* currently undergoing chemotherapy
* pregnancy
* non-english speakers
* unable to return for follow-up, or unable to be contacted by telephone

Primary outcomes:
measure: Incidence of Infection That Requires Removal of the Neurosurgical Device
timeFrame: Six months post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: University Hospital, Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Department of Neurological Surgery, Oregon Health & Science University
name: Kim J Burchiel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurological Surgery, Oregon Health & Science University
name: Valerie C Anderson, PhD, MCR
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Medicine, Oregon Health & Science University
name: Stephen T Magill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller JP, Acar F, Burchiel KJ. Significant reduction in stereotactic and functional neurosurgical hardware infection after local neomycin/polymyxin application. J Neurosurg. 2009 Feb;110(2):247-50. doi: 10.3171/2008.6.17605.
Clinical trial NCT01568567: Study to Demonstrate the Safety of a Novel Powder Formulation of Lactobacilli in Adults
Official title: To Demonstrate That a Novel Powder Formulation of Lactobacillus Reuteri DSM 17938 is Safe in Adults, a Randomized, Placebo Controlled Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Safety
Keywords: safety
tolerance
lactobacillus Reuteri
Lead sponsor: Good Food Practice, Sweden
Sponsor class: INDUSTRY
Collaborators: name: BioGaia AB
First posted: 2012-04-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults.

Although the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.


Eligibility criteria: Inclusion Criteria:

* Males and females
* Age 18-65 years at visit 1
* BMI 19-29
* Hb ≥ 120 g/l for women and ≥ 130 g/l for men
* Healthy as assessed by the screening laboratory tests and blood pressure determined by the MD
* Signed informed consent and biobank consent

Exclusion Criteria:

* Participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
* Use of oral antibiotics or probiotics during 2 weeks prior to visit 1. Other probiotics other than the study products are not allowed during the study period.
* Pregnant or lactating or wish to become pregnant during the period of the study.
* Lack of suitability for participation in the trial, for any reason, as judged by the personnel at Good Food Practice AB.

Primary outcomes:
measure: Safety measured by blood chemistry parameters
timeFrame: 28 days
measure: Tolerability measured by blood chemistry parameters
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Good Food Practice Uppsala
Study officials:
affiliation: KPL Good Food Practice AB
name: Johan Olsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06359067: A Real-World Study of Bispecific Antibodies in Multiple Myeloma
Official title: A Real-World Study of Bispecific Antibodies, Teclistamab and Elranatamab, for Patients With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
Teclistamab
Elranatamab
Bispecific antibody
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with multiple myeloma treated with bispecific antibodies, teclistamab or elranatamab.

Brief summary: Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).

Detailed description: Bispecific antibody (BsAb) treatments, teclistamab and elranatamab, are newly available for patients with multiple myeloma who are refractory to all current drugs. The results are very encouraging but complicated adverse events, particularly infectious. This study analyzes survival data in patients treated with BsAb, as well as safety data, in particular the proportions and locations of infectious events. The results are compared to a control cohort. This study is multicentric on all the university hospitals of Paris (AP-HP).

Eligibility criteria: Inclusion Criteria:

* Adult ≥ 18 years old
* Patients with multiple myeloma
* Patients who received at least one administration of the following therapies: teclistamab, elranatamab

Exclusion Criteria:

- Patients opposed to the collection of their personal data

Primary outcomes:
measure: Infection rate
timeFrame: Up to 18 months
Secondary outcomes:
measure: Global survival
timeFrame: Up to 18 months
measure: Progression-free survivals
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris (AP-HP)
state: IDF
Study officials:
affiliation: Pharmacy Department, Assistance Publique-Hopitaux de Paris, Université de Paris, Paris, France
name: Jeremie ZERBIT, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05239767: A Randomized Trial of NSAID Dosing Strategies
Official title: A Randomized Trial of NSAID Dosing Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Musculoskeletal Pain
Acute Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will compare the efficacy of two different non-steroidal anti-inflammatory drugs (NSAIDs) ketorolac and ibuprofen for people with acute moderate or severe musculoskeletal pain. The investigators will also determine whether taking acetaminophen prior to the NSAID impacts efficacy


Eligibility criteria: Inclusion Criteria:

* Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
* Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity

Exclusion Criteria:

* Contraindication to NSAIDs (allergy to NSAID or allergy to aspirin without history of tolerating NSAIDs, history of gastrointestinal bleeding, daily medication for gastritis or PUD, chronic kidney disease 2-5, heart failure)
* Contraindication to acetaminophen (hepatitis or cirrhosis)
* Use of an NSAID within the previous eight hours
* Use of acetaminophen within the previous eight hours
* Chronic pain, defined as any pain on \>50% of days for at least 3 months prior to onset of acute pain
* Recurrent pain in the same body part as the presenting complaint

Primary outcomes:
measure: Failure to achieve a minimum clinically important difference
timeFrame: Two hours
Secondary outcomes:
measure: 0-10 pain score
timeFrame: One and two hours after medication administration
measure: Ordinal pain scale
timeFrame: One and two hours after medication administration
measure: Epigastric pain
timeFrame: Two hours after medication administration
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin W Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00646867: Effect of Tetrix on Alleviation of Burning,Itching Associated With Lesions of Contact Dermatitis
Official title: An Open Label Study of the Therapeutic Effects of Tetrix Cream in Allergic Contact and Irritant Contact Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Dermatitis
Keywords: Tetrix cream, contact dermatitis, effect on burning and itching
Lead sponsor: Coria Laboratories, Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine if Tetrix Cream, when applied to the skin lesions on patients with contact dermatitis, improves the symptoms of burning and itching.


Eligibility criteria: Inclusion Criteria:

1. Normal subjects with sensitivity to nickel
2. Subjects with hand eczema

Exclusion Criteria:

under 18 years of age

Primary outcomes:
measure: Improvement in symptoms of burning and itching.
timeFrame: after 14 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Dermatology Specialists, LLC
state: Kentucky
Study officials:
affiliation: Dermatology Specialists, LLC
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01510067: Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus
Official title: Prevalence and Clinical Severity of Cutaneous Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous Lupus Erythematosus (CLE)
Keywords: CLE
Lupus
Lupus Erythematosus
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 700
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: Subjects will be recruited from among the patients seen at the Autoimmune Skin Disease Clinic at the Hospital of the University of Pennsylvania and other collaborating centers.

Brief summary: The Cutaneous Lupus Erythematosus (CLE) database, established in 2006, is a multi-site database between the University of Pennsylvania and the University of Texas Southwestern (UTSW).

Detailed description: The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, treatments and quality of life associated with CLE. The CLE database incorporates the CLASI (Cutaneous Lupus Activity and Severity Index), a validated outcome measure of disease responsiveness in patients and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with CLE (cutaneous lupus erythematosus).

The CLE database has led to publication of significant studies on lupus and its clinical course, the effect of lupus on Quality of Life (QoL), including the effect of photosensitivity on QoL, and the effect of first line medications.

The CLE database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease.

Eligibility criteria: Inclusion Criteria:

* Subjects who meet the criteria for having CLE, using the Gilliam classifications, and/or a diagnosis of systemic lupus erythematosus (SLE), using the American Rheumatism Association/American College of Rheumatology criteria. Subjects must be 18 years or older.

Exclusion Criteria:

* All subjects who do not meet the criteria for having CLE. Subjects who meet the criteria for CLE but who are not yet 18 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: University of Pennsylvania
name: Victoria Werth, M.D.
role: PRINCIPAL_INVESTIGATOR
References: