louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01891695: OPSCC N0 Nodal Control With Reduced IMRT
Official title: A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Oropharyngeal Squamous Cell Carcinoma (OPSCCA)
HPV (Human Papillomavirus)-Associated
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering.

The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.

Detailed description: A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx.

Eligibility criteria: Inclusion Criteria:

* patient must be clinically referred for radiation for stage I-IVb OPSCCA
* tumor must be HPV-associated p16+
* patient must be able to lie flat and tolerate immobilization systems

Exclusion Criteria:

* patients may not be receiving any investigational agents
* prior radiation to head and neck
* any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years
* any major medical, psychiatric, or neurologic illness
* pregnant or breastfeeding women

Primary outcomes:
measure: N0 Nodal Control Rate
timeFrame: Up to 3 years post treatment
Secondary outcomes:
measure: Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck
timeFrame: Up to 3 years post treatment
measure: Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck
timeFrame: Up to 3 years post treatment
measure: Dose Volume Histograms (DVH)
timeFrame: Up to 3 years post treatment
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Paul W Read, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06827795: An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
Official title: An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spine Surgery
Lead sponsor: Surgify Medical Oy
Sponsor class: INDUSTRY
Collaborators: name: North Shore University Hospital
First posted: 2025-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research study is to:

test the usability and performance of the medical device Surgify Halo ™ in revision spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Halo™in comparison to the usual drill bit used in spine surgery ( Rosen burr).

This medical device is available for its indications for shaping and removal of hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures.

The target is to enroll 30 participants in this study.


Eligibility criteria: Inclusion Criteria:

* Disease of the spine or head requiring surgery with bone removal

  * Ability to understand the purpose and risks of the study and to give written informed consent
  * Age 21-85 years

Exclusion Criteria:

* Previous surgery in the same area

  * Abnormalities of bone tissue
  * Vulnerable patients (such as prisoners, Individuals with limited or no reading skills, decisionally impaired persons, persons in nursing homes, patients in emergency), and pregnant women
  * Allergy or hypersensitivity to medical-grade stainless steel or any alloying components
  * Problems with blood clotting

Primary outcomes:
measure: Usability and performance of the medical device Surgify Halo ™ in revision spine surgery
timeFrame: From enrollment to the end of the surgery until the end of the stay in the recovery room.
Secondary outcomes:
Other outcomes:
Locations:
city: New York City
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
References:
Clinical trial NCT05344495: Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome:
Official title: Efficacy of Median Nerve Hydrodissection by Hyalase Versus Midazolam in the Treatment of Carpal Tunnel Syndrome: A Randomized, Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pain, Neuropathic
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing efficacy of hyalase and midazolam in median nerve entrapement neuropathy


Eligibility criteria: Inclusion Criteria:

* adult patients (30 - 70 years old) complaining of carpal tunnel syndrome of 3 month duration or more , diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study refractory to medical treatment for 2 months .

Exclusion Criteria:

* Diabetic patients
* Pregnant population .
* Refusal to participate

Primary outcomes:
measure: pain score
timeFrame: 6 months
Secondary outcomes:
measure: Boston questionnaire
timeFrame: 6 months
measure: median nerve sonogrphy
timeFrame: 6 months
measure: Nerve electrophysiology
timeFrame: 6 months
Other outcomes:
Locations:
city: ALMinya
country: Egypt
facility: Mina Raouf
state: Minia
Study officials:
References:
Clinical trial NCT03549195: TMTP1 Targeting Micro-metastasis LN in Laparoscopic SLN Detection in Cervical Cancer
Official title: Novel Tumor Targeted Fluorescent Peptide TMTP1-ICG Mapping in Laparoscopic Sentinel Micro-metastasis Lymph Node Detection in Cervical Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Sentinel Lymph Node
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators aimed to determine the validity of the investigator's novel tumor targeted fluorescent peptide TMTP1-ICG to increased accuracy of laparoscopic SLN mapping


Eligibility criteria: Inclusion Criteria:

* Without childbearing requirements at the time of consent.
* FIGO stage IB1, IIA1 cervical cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.
* Subject has provided written informed consent.

Exclusion Criteria:

* Breast-feeding or pregnant.
* Ongoing participation in another clinical trial with an investigational drug with 3 months
* Own allergy towards ICG and/or alcohol
* Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases
* Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency

Primary outcomes:
measure: Detection rate of micro-metastasis sentinel lymph node
timeFrame: 7 days
Secondary outcomes:
measure: Sensitivity
timeFrame: 7 days
measure: Specificity
timeFrame: 7 days
measure: Incidence of adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, HUST
state: Hubei
Study officials:
References:
Clinical trial NCT06514014: Transition From Donor Milk: a Feasibility Study
Official title: Transition From Donor Milk: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preterm Birth
Nutrition, Healthy
Keywords: newborn
human milk
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Open Label Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: Preterm and very low birth weight (VLBW, \< 1,500g) infants who receive donor human milk (DHM) often experience slow postnatal growth and no clinical data is available to guide the duration of DHM for preterm infants. We hypothesize that transitioning from DHM to preterm infant formula after the first month of life is both safe and conveys improved weight and length gains and fat free mass accumulation.


Eligibility criteria: Inclusion Criteria:

1. Greater than 1,250 grams
2. At least 28 days of life
3. Diet consisting of donor human milk with/without mother's own milk

Exclusion Criteria:

1. Birth weight below the 5th percentile
2. History of necrotizing enterocolitis, spontaneous intestinal perforation, or other gastrointestinal disorder
3. Congenital anomalies
4. Care team discretion

Primary outcomes:
measure: Weight Velocity
timeFrame: 36 weeks post menstrual age
measure: Fat free mass
timeFrame: 36 weeks post menstrual age
Secondary outcomes:
measure: Bronchopulmonary dysplasia
timeFrame: 36 weeks post menstrual age
measure: Retinopathy of prematurity
timeFrame: 36 weeks post menstrual age
measure: Sepsis
timeFrame: 36 weeks post menstrual age
measure: Necrotizing enterocolitis
timeFrame: 36 weeks post menstrual age
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01766414: In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II
Official title: In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - A Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Innate Immune Response
Endotoxemia
Inflammation
Sepsis
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Prothya Biosolutions
First posted: 2013-01-11
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Excessive inflammation is associated with tissue damage caused by over-activation of the innate immune system. This can range from mild disease to extreme conditions, such as multiple organ dysfunction syndrome (MODS) and acute respiratory distress (ARDS). In marked contrast to adaptive immunity which is very sensitive to immune modulators such as steroids, the innate immune system cannot be sufficiently targeted by currently available anti-inflammatory drugs.

The investigators hypothesize that pre-treatment with C1-esterase inhibitor in a human endotoxemia model can modulate the innate immune response.

In this study, human endotoxemia will be used as a model for inflammation. Subjects will, prior to endotoxin administration, receive C1 esterase inhibitor or placebo. Blood will be sampled to determine the levels of markers of the innate immune response.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers (18-35 years old)

Exclusion Criteria:

* Relevant medical history
* Drug-, nicotine-abuses
* Tendency towards fainting
* Hyper- or hypotension
* Use of any medication

Primary outcomes:
measure: Neutrophil phenotype and redistribution
timeFrame: 8 hrs after LPS administration
Secondary outcomes:
measure: Cytokines and other markers of inflammation
timeFrame: 8 hrs after LPS administration
measure: C1-inhibitor and complement concentration and activity
timeFrame: 8 hrs after LPS administration
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University
Study officials:
affiliation: UMC Nijmegen
name: Hans Hoeven, Prof
role: STUDY_DIRECTOR
References:
citation: Tak T, Wijten P, Heeres M, Pickkers P, Scholten A, Heck AJR, Vrisekoop N, Leenen LP, Borghans JAM, Tesselaar K, Koenderman L. Human CD62Ldim neutrophils identified as a separate subset by proteome profiling and in vivo pulse-chase labeling. Blood. 2017 Jun 29;129(26):3476-3485. doi: 10.1182/blood-2016-07-727669. Epub 2017 May 17.
Clinical trial NCT00153114: PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children
Official title: PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients between the ages of 4 to 16 years.
* Adolescent female patients must not be pregnant or lactating.
* constipated according to ROME I definition
* Two or fewer bowel movements during the initial observation week.
* Absence of a stool impaction
* Bowel movement after receiving enema
* Are otherwise in good health, as judged by a physical examination.
* Parent or guardian is mentally competent to sign an instrument of informed consent

Exclusion Criteria:

* Patients with heme positive stool at baseline exam.
* Patients with fecal impaction at baseline, or after the observation period, as indicated by physical exam
* Patients with known or suspected perforation or obstruction other than fecal impaction.
* Patients who are breastfeeding, pregnant or intend to become pregnant during the study.
* Female patients of childbearing potential who refuse a pregnancy test.
* Patients with a known history of organic cause for their constipation.
* Patients with congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases).
* History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
* Use of concomitant medications that cause constipation
* Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
* Patients with known allergy to polyethyleneglycol or polyethyleneglycol containing medications.
* Patients with clinically significant elevations of TSH or abnormal plasma electrolytes.
* Patients who, within the past 30 days have participated in an investigational clinical study

Primary outcomes:
measure: Greater than 2 bowel movements per week
Secondary outcomes:
measure: Analysis of individual ROME I criteria
measure: Safety (adverse event and laboratory testing)
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
city: Morristown
country: United States
state: New Jersey
city: Pittsburgh
country: United States
state: Pennsylvania
Study officials:
affiliation: Boston Children's Hospital
name: Samuel Nurko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03165214: Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
Official title: Effectiveness of Embolization of Pelvic Veins in Treatment of Pelvic Congestion Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pelvic Congestive Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pelvic pain is defined as chronic or persistent pain perceived in structures related to the pelvis of either men or women for more than 6 months according to The International Association for the Study of Pain. In other words, chronic pelvic pain with associated ovarian vein varicosities is termed pelvic congestion syndrome and is an important but under-diagnosed condition


Eligibility criteria: Inclusion Criteria:

* Clinical symptoms of pelvic congestion syndrome documented by Doppler ultrasound
* Failed medical treatment.

Exclusion Criteria:

* Endometriosis.
* Uterine fibroids.
* Previous pelvic operations.
* Urological diseases.

Primary outcomes:
measure: The number of treated patients with different interventions
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
city: Assiut
country: Egypt
facility: Assiut Faculty of Medicine
Study officials:
References:
Clinical trial NCT00723814: Blood Pressure Monitor Clinical Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: normal
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2008-07-29
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: To monitor the blood pressure level of the patient


Eligibility criteria: Inclusion Criteria:

- IEC 60601-1-2

Exclusion Criteria:

-

Primary outcomes:
measure: monitor the diastolic and systolic
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05753514: Radial Extracorporeal Shockwave Therapy (rESWT) for Coccydynia: a Quasi-experimental Case Series
Official title: Radial Extracorporeal Shockwave Therapy (rESWT) for Coccydynia: a Quasi-experimental Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coccyx Injury
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to assess whether a pain-adapted protocol of rESWT is effective in treating coccydynia.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* VAS pain level ≥6
* Diagnosis of coccydynia (persistent pain in the coccygeal area consistent with coccydynia)

Exclusion Criteria:

* Age \<18 years
* Local or systemic neurological disease
* Rheumatological disease
* Malignant disease
* Previous spinal surgery or spinal disease
* Coagulopathies
* Pregnancy
* VAS pain level \<6
* Recent (≤6 weeks) trauma to the coccyx

Primary outcomes:
measure: Management of coccydynia
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02866214: Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
Official title: Evaluation of the Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Endothelial Dysfunction
Endstage Renal Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Purpose of this study is to determine if the Febuxostat has an effect on endothelial dysfunction on hemodialysis patients.

Detailed description: Aim of The Work:

1- Evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis patients, through detection of:

1. Primary endpoint:

   • Reduction in Asymmetrical Dimethylarginine (ADMA)
2. Secondary endpoints:

   * Assessing the change in serum High sensitivity C-reactive protein (hsCRP)
   * Assessing the change in serum Uric acid - The criteria for inclusion:

     1. Outpatients on maintenance hemodialysis.
     2. Age from 18-70 years old.
     3. Serum UA level 7.0 mg/dL or more.
     4. Stable clinical condition (no hospitalization in the previous 3 months)

The exclusion criteria:

1. Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)
2. History of hypersensitivity to febuxostat.
3. Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.
4. Participant in an another clinical trial within the past 4 weeks.
5. Judged to be unsuitable as a subject by the attending physician.

After two months , the patient will be reassessed regarding:

A. ADMA serum level. B. Change in serum hsCRP. C. Change in serum Uric acid level.

Eligibility criteria: Inclusion Criteria:

* Outpatients on maintenance hemodialysis.
* Age from 18-70 years old.
* Serum Uric Acid level 7.0 mg/dL or more.
* Stable clinical condition (no hospitalization in the previous 3 months)
* Informed consent in accordance with the Declaration of Helsinki.

Exclusion Criteria:

* Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)
* History of hypersensitivity to febuxostat.
* Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.
* Participant in an another clinical trial within the past 4 weeks.
* Judged to be unsuitable as a subject by the attending physician

Primary outcomes:
measure: Asymmetric Dimethylarginine physiological marker
timeFrame: 2 months
Secondary outcomes:
measure: Uric Acid , physiological parameter
timeFrame: 2 months
measure: High sensitivity C-reactive protein physiological marker
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References: