louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04365036: A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)
Official title: A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy with or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (ENKTL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: NK/T Cell Lymphoma Nos
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized, multi-center,phase Ⅲ clinical trail is to compare the safety and efficacy of sequencial chemoradiotherapy with or without toripalimab (PD-1 antibody) for newly diagnosed early-stage extranodal natural killer/T-cell lymphoma, nasal type (ENKTL)


Eligibility criteria: Inclusion Criteria:

* biopsy proved extranodal natural killer/T-cell lymphoma, nasal type;
* newly diagnosed stage I/II patients;
* at least one evaluable lesion；
* ECOG PS 0-2;
* 18-75 years; without other malignancy;
* proper functioning of the major organs.

Exclusion Criteria:

* hemophagocytic syndrome or aggressive NK cell leukemia;
* involvement of central nervous system;
* previously received treatment of chemotherapy, radiotherapy, immunotherapy or biotherapy for lymphoma；

Primary outcomes:
measure: progression free survival (PFS)
timeFrame: 3 years
Secondary outcomes:
measure: complete remission (CR) rate
timeFrame: From the start of treatment with the interventions until 6 months
measure: overall response rate (ORR)
timeFrame: From the start of treatment with the interventions until 6 months
measure: overall survival (OS)
timeFrame: 3 years
measure: recurrence-free survival (RFS)
timeFrame: 3 years
measure: event free survival (EFS)
timeFrame: 3 years
measure: disease-free survival (DFS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT01125436: A Trial of Vitamin D Therapy in Patients With Heart Failure
Official title: A Randomized Placebo Controlled Trial of Vitamin D Therapy in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Aerobic Capacity
Strength
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if vitamin D will improve physical performance in older adults with heart failure.

Detailed description: The study is designed as a short pilot study which will assess safety and efficacy of high dose Vitamin D therapy in a heart failure population.

A 6 month randomized double blind placebo-controlled trial of 50,000 units of oral vitamin D3(cholecalciferol) weekly plus 800 calcium daily vs. weekly placebo plus 800 calcium alone in 64 heart failure (HF) patients \> 50 years old. This design was chosen over a cross-over design due to the long wash-out period for vitamin D.

Eligibility criteria: Inclusion Criteria:

* New York Heart Association (NYHA) class II-IV
* Able to walk
* Serum 25OHD level 37.5 ng/ml or less
* Fully titrated on heart failure medications

Exclusion Criteria:

* Osteoporosis
* Primary hyperparathyroidism or hypercalcemia.
* Nephrolithiasis
* Hemo or peritoneal dialysis and/or creatinine of \> 2.5
* Current use of daily vitamin D greater than 400 IU, corticosteroids, parathyroid hormone (PTH), androgen or estrogen
* Current illicit drug user or \> 3 alcoholic drinks a day
* Metastatic or advanced cancer
* Myocardial infarction in the preceding 6 months
* Medications which can lower vitamin D levels or bioavailability

Primary outcomes:
measure: Peak VO2
timeFrame: change from baseline to 6 months
Secondary outcomes:
measure: Leg Proximal Muscle Strength
timeFrame: change from baseline to 6 months
measure: 6 Minute Walk Distance
timeFrame: Change from baseline to 6 months
measure: Timed Get Up and Go
timeFrame: Change from baseline to 6 months
Other outcomes:
measure: Serum Aldosterone
timeFrame: change from baseline to 6 months
measure: Plasma Renin Activity
timeFrame: change in renin from baseline to 6 months
Locations:
city: Cleveland
country: United States
facility: University Hospitals/Case Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve Univerity
name: Rebecca Boxer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00874536: Omega-3 Supplementation and Attention-deficit-hyperactivity Disorder (ADHD)
Official title: The Effect of Omega-3 Fatty Acid Supplementation on Behavior of Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
methylphenidate
omega-3
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Israel Association of Pediatricians
First posted: 2009-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is assumed that only 1/5 of children diagnosed with attention-deficit-hyperactivity disorder (ADHD) are treated. New treatment modalities are urgently needed. Omega-3 fatty acids have been used in this setting, yet results are conflicting. The parent omega-3 fatty acid alpha-linolenic acid (ALA) has only been used in one trial. 40 children diagnosed with ADHD will be randomized to consume either ALA or placebo for two months. Baseline and end assessments will include ADHD-related questionnaires and a computerized test. The investigators hypothesize that ALA supplementation will prove beneficial for children with ADHD.


Eligibility criteria: Inclusion Criteria:

* ADHD diagnosis
* informed consent

Exclusion Criteria:

* refusal of any testing
* any comorbidities
* any medication or supplement use

Primary outcomes:
measure: ADHD symptoms
timeFrame: 8 weeks
Secondary outcomes:
measure: Computerized test performance
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT02649049: Dietary Determinants in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Official title: Assessment of Dietary Intakes of Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Intake
NAFLD
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with NAFLD diagnosed using Fibroscan without any other chronic disorders.

Brief summary: Patients with NAFLD and matched controls will be asked about their demographic status, and their previous year dietary intakes using a validated FFQ.


Eligibility criteria: Inclusion Criteria:

* age more than 18
* NAFLD was diagnosed by Fibroscan and other hepatic disorders ruled out

Exclusion Criteria:

* not completing more than 10% of the questionnaire

Primary outcomes:
measure: nonalcoholic fatty liver disease diagnosed by Fibroscan
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NNFTRI clinic
Study officials:
References:
Clinical trial NCT01115049: Hexetidine and Chlorobutanol for Lesions Due to Prostheses
Official title: Evaluation of the Efficacy of a Hexetidine- and Chlorobutanol-based Mouthwash in the Symptomatic Treatment of Oral Lesions Due to Removable Prostheses: a Prospective, Randomized, Triple-blind Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Mucositis
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 44
Sex: ALL
Minimum age (years): 37
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objectives: The study aimed at assessing the efficacy of a new mouthwash in treating oral lesions due to removable prostheses.

Methods: The present prospective randomized clinical trial was performed on 44 patients. The experimentation lasted for 4 weeks and 4 operators participated. The effects of the mouthwash were evaluated subjectively and objectively, with questionnaires, Visual Analogic Scales and clinical examinations. The results were statistically analyzed. The following variables were recorded: presence of mucosal lesions due to incongruous removable prostheses and lasting of pain after rinsing.

Detailed description: The aim of the present prospective, randomized, triple-blind controlled clinical trial was to evaluate the efficacy of an innovative mouthwash (emulsion) in the treatment of lesions of oral mucosae due to removable prostheses. The tested preparation contained two active molecules: a topical antiseptic (0.1% hexetidine) and a local anesthetic (0.5% chlorobutanol).

Eligibility criteria: Inclusion Criteria:

* Use of removable partial or complete dentures;
* Presence of lesions of oral mucosae due to dentures;
* Absence of any concomitant local or systemic pathology;
* Absence of pregnancy or breastfeeding;
* Negative allergic anamnesis;
* Negative anamnesis for recurrent aphthous stomatitis;
* No taking medicines with potential pharmacologic interactions with molecules to be tested;
* No taking antibiotics and/or painkillers for at least 6 months before entering the experimentation;
* Good oral hygiene with a full-mouth plaque score ≤25%;
* Non smoking or light smoking (≤10 cigarettes/day) status.

Exclusion Criteria:

Missing one or more of the above described conditions automatically excluded a subject from the study.

Primary outcomes:
measure: Number of participants with adverse events as a measure of tolerability
timeFrame: Weekly
Secondary outcomes:
measure: Pain scores on the visual analogue scale
timeFrame: Weekly
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University "Federico II", Department of Prosthodontics
Study officials:
affiliation: University "Federco II" of Naples, Italy
name: Fernando Zarone, MD, DDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03482349: RCT Comparing Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
Official title: A Prospective Randomized Clinical Trial (RCT) Comparing Functional and Radiographic Outcomes of Robotically-Assisted vs. Manually-Executed Total Knee Arthroplasties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 152
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will explore if there are any difference in functional outcomes between two different surgical procedures for total knee replacement: robot-assisted versus manually-executed total knee arthroplasty.

Detailed description: Although total knee arthroplasty (TKA) is an effective treatment for end-stage knee arthritis, improvements in surgical technique remain a necessity. Contemporary designs have bolstered durability, but longer life expectancies have placed an even greater emphasis on survivorship. Additionally, patient satisfaction remains an issue.

A prospective randomized clinical trial (RCT) is proposed to compare robotically-assisted versus manually executed primary (TKAs). This study is designed to address the major short-term clinically important issues between the two types of procedures with special emphasis on functional outcome. Patients will be randomized to receive either a robotically-assisted or a manually-executed primary TKA.

Eligibility criteria: Inclusion Criteria:

* Include all patients who are surgical candidates for primary TKA with unilateral osteoarthritis
* All eligible male or female patients between the ages of 20 years to 100 years old
* All included study participants must be able to give an informed consent.

Exclusion Criteria:

* Significant femoral or tibial deformity due to congenital or traumatic etiologies, inflammatory arthritis, post-septic arthritis, osteomyelitis, prior infection of knee joint, osteoporosis, dislocated or fragmented patella
* The presence of infections, highly communicable diseases (e.g. AIDS), active tuberculosis, venereal disease, hepatitis.
* Significant neurological or musculoskeletal disorders or disease that may adversely affect normal gait or weight bearing.
* Presence of previous prosthetic knee replacement devices (of any type)
* Metastatic disease
* Psychiatric illness
* Drug or alcohol abuse
* Body mass index (BMI) \> 40 kg/m2

Primary outcomes:
measure: Radiographic Parameters
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew P Abdel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04086849: Analysis of Patterns of Recurrence in Head and Neck Cancer Using Clinicopathomic Markers
Official title: Analysis of Patterns of Recurrence in Head and Neck Cancer Using Clinicopathomic Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Neoplasm
Squamous Cell Carcinoma of Head and Neck
Keywords: radiomics
pathomics
head and neck cancer
biomarkers
machine learning
artificial intelligence
squamous cell carcinoma
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll women and men with a pathologically-confirmed diagnosis of early-stage oral cavity or oropharyngeal squamous cell carcinoma that undergo surgery to excise the tumor.

Brief summary: Here, the investigators will develop a clinicopathomic assay from biomarkers obtained from digital pathologies of resected whole-mount oral cavity and oropharyngeal squamous cell carcinoma (OCSCC and OPSCC) specimens with the goal of administering personalized novel image-guided therapies immediately after primary surgical management in OCSCC and OPSCC patients. The primary aim is to determine the association between clinicopathomic biomarkers and LRR. The secondary aim is to develop a clinicopathomic risk score (assay) such that a decision-support tool can be used by physicians for measuring the benefit of additional therapies (i.e. conventional chemotherapy +/- radiation or administering dose-escalated chemoradiation) in the adjuvant setting to reduce LRR rates.

Detailed description: The proposed study is significant for developing personalized treatments. The proposed research will yield high rewards to patients by providing additional information to clinicians for better prognostication and potentially adapting adjuvant treatments to improve the survival of patients with OCSCC or OPSCC.

Eligibility criteria: Inclusion Criteria:

* Participants must be men and women age 18+
* Confirmed diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
* Participants must have received or will undergo surgery to excise the primary oropharyngeal tumor.

Exclusion Criteria:

* Participants who had other primary cancers prior to oral cavity or oropharyngeal cancer

Primary outcomes:
measure: Time to locoregional recurrence
timeFrame: Up to 60 months
Secondary outcomes:
measure: Time to distant metastasis
timeFrame: Up to 60 months
measure: Time to death
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: William Tran, MRT(T), PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02603549: Pituitary Function and Spontaneous Intracranial Hypotension
Official title: Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Hyperprolactinemia
Spontaneous Intracranial Hypotension
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 100
Sex: ALL
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: Patients with Spontaneous intracranial hypotension (SIH)

Brief summary: Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for spontaneous intracranial hypotension, leading to positional headache patterns. Typical magnetic resonance imaging findings include subdural fluid collections, enhancement of pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the brain (SEEPS). Because pituitary hyperemia has been documented in cases of spontaneous cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the investigators would like to like to assess the clinical manifestations and neuroimaging abnormalities of SIH patients with regard to the pituitary gland. Specifically, the investigators are looking to analyze the compression of the pituitary stalk and conduct a systemic evaluation of pituitary function in SIH patients.


Eligibility criteria: Inclusion Criteria:

* Male or female patients
* Age 18 years and older
* Diagnosis of SIH:
* LP
* Brain MRI (SEEPS)

Exclusion Criteria:

* Pregnant and post-partum females
* Nursing mothers
* Patients with potential hyperprolactinemia due to:
* Hypothyroidism,
* Chronic renal disorder
* Liver disease (including cirrhosis)
* Primary or secondary amenorrhea
* Polycystic Ovary Syndrome
* Seizure disorder
* Illicit drug use

Primary outcomes:
measure: Comparing the levels of prolactin pre and post treatment
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Vivien Bonert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schievink WI. Spontaneous spinal cerebrospinal fluid leaks and intracranial hypotension. JAMA. 2006 May 17;295(19):2286-96. doi: 10.1001/jama.295.19.2286.
citation: SCHALTENBRAND G. Normal and pathological physiology of the cerebrospinal fluid circulation. Lancet. 1953 Apr 25;1(6765):805-8. doi: 10.1016/s0140-6736(53)91948-5. No abstract available.
citation: Mokri B. Cerebrospinal fluid volume depletion and its emerging clinical/imaging syndromes. Neurosurg Focus. 2000 Jul 15;9(1):e6. doi: 10.3171/foc.2000.9.1.6.
Clinical trial NCT02361749: Botulinum Toxin Injection Versus Anal Myectomy in Management of Idiopathic Constipation
Official title: Comparative Study Between Botulinum Toxin Injection and Myectomy in Treatment of Idiopathic Constipation in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Idiopathic Constipation
Functional Constipation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Chronic idiopathic constipation is most common cause of Constipation in childhood with numerous cases in Egypt. Numerous conservative measures were tried but many fail. Surgical options include Longitudinal Myectomy of the muscle or injection of Botulinum toxin. Objectives: Comparative study between Botulinum toxin injection and Myectomy in treatment of Idiopathic Constipation

Detailed description: Functional constipation (chronic idiopathic constipation) is most common cause of constipation in pediatric age group. Many cases try conservative treatment but fail to respond. These cases are treated by surgical longitudinal myectomy of the anal sphincter. Now, there have been many trials of trying injection of botulinum toxin to relax the sphincter as a treatment of functional/idiopathic constipation.

In this study, the investigators will compare the results of botulinum toxin injection versus surgical myectomy to treat functional/idiopathic constipation in children.

Eligibility criteria: Inclusion Criteria:

* Children with Idiopathic constipation

Exclusion Criteria:

* Hirschsprung's disease or Anorectal malformations

Primary outcomes:
measure: Absence of insufficient Rome III Diagnostic criteria (0-1 criterion)
timeFrame: 2 years
Secondary outcomes:
measure: Decrease in Rome III Diagnostic criteria score
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Pediatric Hospital
Study officials:
affiliation: Cairo University
name: Mohamed Seoudi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keshtgar AS, Ward HC, Sanei A, Clayden GS. Botulinum toxin, a new treatment modality for chronic idiopathic constipation in children: long-term follow-up of a double-blind randomized trial. J Pediatr Surg. 2007 Apr;42(4):672-80. doi: 10.1016/j.jpedsurg.2006.12.045.
citation: Irani K, Rodriguez L, Doody DP, Goldstein AM. Botulinum toxin for the treatment of chronic constipation in children with internal anal sphincter dysfunction. Pediatr Surg Int. 2008 Jul;24(7):779-83. doi: 10.1007/s00383-008-2171-3. Epub 2008 Apr 29.
citation: Hata Y, Sasaki F, Uchino J. Sphincteromyectomy and sphincteroplasty in chronic constipation with megarectum. J Pediatr Surg. 1988 Feb;23(2):141-2. doi: 10.1016/s0022-3468(88)80143-x.
citation: Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.