louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00895323: Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Official title: Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Colorectal Cancer
Keywords: stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-05-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease.

PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer.

Detailed description: OBJECTIVES:

* Assess the pharmacokinetics and tissue distribution of anti-CEA x anti-HSG bispecific monoclonal antibody TF2 in patients with colorectal cancer.

OUTLINE: This is a multicenter study.

Patients receive iodine I 131-labeled anti-CEA x anti-HSG bispecific monoclonal antibody TF2 (\^131I-TF2) IV over 10-20 minutes on day 1. Patients also undergo whole-body external scintigraphy at various times during the study.

Blood samples are collected at baseline and periodically after \^131I-TF2 infusion for pharmacokinetic studies and \^131I-TF2 biodistribution by ELISA and radioactivity measurements.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed colorectal cancer

  * Radiological documentation of disease is preferred, but not required

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Life expectancy ≥ 3 months
* WBC ≥ 3,000/mm³
* Neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Serum creatinine normal
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST/ALT \< 2 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 1 month after completion of study therapy
* No medical conditions that might prevent full participation in protocol-required testing or follow-up
* No institutionalized patients (e.g., in prisons or mental health institutions)

PRIOR CONCURRENT THERAPY:

* No concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments

Primary outcomes:
measure: Pharmacokinetics
measure: Tissue distribution
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Lombardi Comprehensive Cancer Center
name: Aiwu R. He, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02173223: A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt
Official title: A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Glaucoma
Lead sponsor: New York Glaucoma Research Institute
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 10
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. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in glaucoma patients with failed prior glaucoma filtering surgery and uncontrolled IOP who are facing further surgical intervention. Patients will be treated for 6 months in this initial trial.

B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the necessity of further surgical intervention.


Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years of either sex.
2. Patients with open-angle glaucoma with prior glaucoma filtering surgery.
3. IOP above the target range or visual field progression.
4. Have given written informed consent, prior to any investigational procedures.
5. Ability to attend for the 6-month duration of treatment.

Exclusion Criteria:

1. Closed angle glaucoma (primary or secondary).
2. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
3. Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or lubricating drops for dry eye (which may be used throughout the study).
4. Any abnormality preventing reliable applanation tonometry of the treated eye.
5. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
6. Participation in any investigational study within the past 30 days.
7. Inability to perform reliable visual field testing.
8. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
9. Self-reported poor compliance to treatment.
10. Reluctance to return for scheduled follow-up visits.
11. Patients not able to understand the nature of the study.

Primary outcomes:
measure: Effect of study drug to reduce IOP
timeFrame: 6 Months
Secondary outcomes:
measure: IOP Reduction
timeFrame: 6 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: Glaucoma Associates of New York
state: New York
Study officials:
References:
Clinical trial NCT00510523: Whole Body Vibration Therapy in Participants With MS Related Balance Deficits
Official title: Whole Body Vibration Therapy in Participants With MS Related Balance Deficits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: MS
Balance
Multiple Sclerosis
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2007-08-02
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy (WBV) on balance in participants with multiple sclerosis (MS) related balance deficits as measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke Expanded Disability Status Scale (EDSS) and the Berg Balance Score.


Eligibility criteria: Inclusion Criteria:

* Logan student, staff, or faculty or general public with a minimal of 2 year history of diagnosed Multiple Sclerosis (MS)

Exclusion Criteria:

* Visual or vestibular condition that would affect balance
* Non-Ms related systemic illness that would have an adverse effect on balance
* Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes
* Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates
* Acute thrombosis
* Severe migraine, epilepsy
* Serious cardiovascular disease, wearing a pacemaker
* Any Spinal manipulation within 48 hours
* Acute disc herniation, discopathy or spondylolysis
* Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance
* Any implanted device or prosthesis or intrauterine IUD type of device
* Pregnancy

Primary outcomes:
measure: NeuroCom Balance Master
measure: SF-EMG Nerve conduction velocity test
measure: Berg balance score
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan University, College of Chiropractic
state: Missouri
city: Chesterfield
country: United States
facility: Logan University, College of Chirpractic
state: Missouri
Study officials:
affiliation: Logan College of Chiropractic
name: Dennis Enix, DC, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Logan University
name: Dennis Enix, DC, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romberg A, Virtanen A, Ruutiainen J, Aunola S, Karppi SL, Vaara M, Surakka J, Pohjolainen T, Seppanen A. Effects of a 6-month exercise program on patients with multiple sclerosis: a randomized study. Neurology. 2004 Dec 14;63(11):2034-8. doi: 10.1212/01.wnl.0000145761.38400.65.
citation: Griffin JW. Use of proprioceptive stimuli in therapeutic exercise. Phys Ther. 1974 Oct;54(10):1072-9. doi: 10.1093/ptj/54.10.1072. No abstract available.
Clinical trial NCT01488123: Integrative Approaches for Cancer Survivorship
Official title: A Whole Systems Approach to the Study of Ayurveda for Cancer Survivorship, Project II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast, Cancer, Survivorship, Integrative, Complementary
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2011-12-08
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether a four-month manualized Ayurvedic intervention will improve quality of life in recent breast cancer survivors.

Detailed description: Cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. Few effective treatment options exist for these symptoms. Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. We aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, we aim to develop the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.

Eligibility criteria: Inclusion Criteria:

* Female breast cancer survivor who is over 1 month and less than 12 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy)
* Having received chemotherapy as part of their primary therapy for breast cancer
* Be in a complete remission
* Aged 18 years or older
* Able to read, write, and understand English
* Karnofsky Performance Status (KPS) 67 greater than 60.
* Ability to give informed consent

Exclusion Criteria:

* Having received Ayurvedic treatment within 2 months of study enrollment
* Receiving chemotherapy or radiotherapy at the time of study enrollment. Trastuzumab therapy is not exclusionary.
* Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary.
* Patients on adjuvant hormone therapy for less than 1 month

Primary outcomes:
measure: Change in quality of life over 16 weeks
timeFrame: Baseline, End of week 8, End of week 16
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco, Osher Center for Integrative Medicine
state: California
Study officials:
affiliation: University of California, San Francisco
name: Anand Dhruva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01733823: DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole
Official title: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole for Patients With Stage III-IV p16 Negative Squamous Cell Cancer (SCC) of the Larynx, Pharynx and Oral Cavity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HNSCC,Larynx, Pharynx and Oral Cavity
Lead sponsor: Danish Head and Neck Cancer Group
Sponsor class: NETWORK
First posted: 2012-11-27
Enrollment: 31
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: P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and nimorazole has been shown to improve local control. The purpose of the study i to investigate the level of co-morbidity and performance status (PS) that allows the combination of all of the above means of treatment intensification


Eligibility criteria: Inclusion Criteria:

* Squamous Cell Carcinoma head and neck cancer of the pharynx, larynx and oral cavity
* P16 negative
* T1-4
* N1-3
* M0
* Organ function and performance status allowing radical chemo-radiotherapy

Exclusion Criteria:

* None

Primary outcomes:
measure: Compliance
timeFrame: End of radiotherapy (approximately 5.5 weeks after start of radiotherapy)
Secondary outcomes:
measure: Acute toxicity
timeFrame: 2 months after end of radiotherapy
measure: Response rate
timeFrame: 2 months after end of radiotherapy
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus
state: Aarhus C
city: Odense
country: Denmark
facility: Odense
state: Odense C
city: Aalborg
country: Denmark
facility: Aalborg
city: Herlev
country: Denmark
facility: Herlev
Study officials:
affiliation: Danish Head and Neck Cancer Group
name: Jens Overgaard, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06161623: The Effect of Laughter Yoga on Perceived Stress, Work Motivation, and Mental Well-Being
Official title: The Effect of Laughter Yoga Applied to Intensive Care Nurses on Perceived Stress, Work Motivation, and Mental Well-Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Complementary Therapies
Keywords: Laughter yoga
Perceived stress
Work motivation
Mental well-being
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 66
Sex: ALL
Minimum age (years): 22
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this randomized controlled experimental study is to examine the effect of laughter yoga applied to intensive care nurses on perceived stress, work motivation, and mental well-being.

Detailed description: The study was conducted with nurses working at Manisa Celal Bayar University Hospital's Surgical Intensive Care and Anesthesia Intensive Care units between December 2022 and March 2023. The Nurse Introduction Form, Nurse Work Motivation Scale, Perceived Stress Scale, and Warwick-Edinburgh Mental Well-being Scale were used to collect data.

Eligibility criteria: Inclusion Criteria: Between 18-65 age

* Those who have worked as intensive care nurses for at least 6 months
* Those who agree to participate in the research

Exclusion Criteria:

* Those with chronic cough
* Those who have previously received laughter yoga training and practiced
* Those who had surgery within the last 3 months
* Those with diagnosed mental illness and those using medication (antidepressants, antipsychotics,anxiolytic, etc...)
* Those who have neurological diseases such as epilepsy and multiple sclerosis
* Those who have recently experienced a loss (within at least 6 months)
* Those with neurological disorders
* Those who have urinary incontinence problems
* Those who did not agree to participate in the research

Primary outcomes:
measure: Work Motivation
timeFrame: 2 weeks
measure: Perceived Stress
timeFrame: 2 weeks
measure: Mental Well-being
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Kivan Çevik Kaya
state: MANİSAYunusemre
Study officials:
affiliation: Celal Bayar University
name: Ramazan Yılmaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04831723: NEWBIE Validate: Feasibility of a New Test to Measure Glucose in Newborn Blood Spots (NBS)
Official title: NEWBIE Validate: Feasibility of a New Test to Measure Glucose in Newborn Blood Spots (NBS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Diabetes
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Portsmouth Hospitals NHS Trust
First posted: 2021-04-05
Enrollment: 10784
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Babies having a routine NBS screening test within the areas served by the Portsmouth regional screening laboratory (NHS Trusts within Hampshire, Dorset \& parts of Wiltshire)

Brief summary: The aim of this feasibility laboratory study is to evaluate whether the laboratory testing pathway for glucose screening in newborn blood spots (NBS) can be done at scale, and that the glucose test has a carefully established cut-off to define what level glucose is abnormal at day 5 of life.

The investigators aim to run this feasibility study for a period of 6 to 12 months to fully embed and test the process. This will equate to assessing glucose levels in approximately 10,000 NBS samples. The results from this study will inform a future large scale prospective screening study.


Eligibility criteria: Inclusion Criteria:

* Babies having a routine NBS screening test.
* Routine maternity care team within the area served by the Portsmouth regional screening laboratory (NHS Trusts within Hampshire, Dorset \& parts of Wiltshire)

Exclusion Criteria:

* Parent decides to opt-out of the blood glucose test feasibility study.

Primary outcomes:
measure: Normal range of capillary blood glucose in newborns at day 5 of life
timeFrame: 12 months
Secondary outcomes:
measure: Validation of laboratory procedures
timeFrame: 12 months
Other outcomes:
Locations:
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Poole
country: United Kingdom
facility: University Hospitals Dorset
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: Royal Devon and Exeter NHS Foundation Trust
name: Timothy Mcdonald
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02979223: Combination Method Using Sodium Picosulfate and Magnesium Citrate and PEG With Ascorbic Acid for Bowel Preparation
Official title: Comparison the Efficacy Depending on the Order of the Sequential Combination Method Using Sodium Picosulfate and Magnesium Citrate (PMC) and PEG With Ascorbic Acid for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bowel Preparation
Sodium Picosulfate and Magnesium Citrate
Polyethylene Glycol With Ascorbic Acid
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2016-12-01
Enrollment: 142
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to compare the efficacy depending on the order of the sequential combination method using sodium picosulfate and magnesium citrate (PMC) and PEG with ascorbic acid for bowel preparation.

The investigators designed this study as a phase II prospective randomized parallel arm clinical trial. 71 participant will be enrolled in each group (142 in total).

The primary outcome is the efficacy of bowel preparation. secondary outcomes are tolerability, side effect of the drugs, polyp detection rate and adenoma detection rate.


Eligibility criteria: Inclusion Criteria:

* Age: 20-75 Patients who visited the outpatient clinic for colonoscopy Patients who agreed to participate in this study

Exclusion Criteria:

* pregnancy, breast feeding stage 3-5 chronic kidney disease (glomerular filtration rate \< 60 mL/min/1.73m2), inability to maintain adequate fluid intake, pre-existing electrolyte disturbances, symptomatic congestive heart failure, recent (within \< 6 months) symptomatic ischemic heart disease (unstable angina or myocardial infarction).

toxic megacolon active colitis Allergic to drug altered mental status Nausea and vomiting Hyperphosphatemia glucose-6-phosphate dehydrogenase deficiency Hereditary Phenylketonuria Patients with a history of colon surgery Abdominal operation within 6 months

Primary outcomes:
measure: Successful bowel preparation (Excellent and Good in Aronchick bowel preparation score)
timeFrame: during colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Bun Kim
state: Gyeonggi-do
Study officials:
affiliation: National Cancer Center, Korea
name: Bun Kim, Dr
role: PRINCIPAL_INVESTIGATOR
References: