louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00329589: A Trial Using Velcade Plus Chemoradiation for Central Nervous System, Head and Neck, and Cervical Cancer Patients
Official title: A Phase I Open-labeled, Dose-escalation, Safety Study of the Combination of Velcade and Chemoradiation for the Treatment of Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Brain Cancer
Head and Neck Cancer
Cervix Cancer
Central Nervous System Neoplasms
Keywords: Malignancies of the central nervous system, head and neck area
and cervix
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2006-05-25
Enrollment: 54
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: The purpose of this study is to determine the safety of Velcade when used with chemoradiation in cancer patients.

Detailed description: * To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Velcade® when administered as a twice weekly 3-5 second IV bolus every 3 weeks to patients with malignancies of the brain, head and neck and cervix who receive 2-8 weeks of chemoradiation.
* To evaluate the safety and toxicity profile of Velcade® when administered on a twice weekly (days 1, 4, 8 and 11) every 3 weeks (maximum 8 weeks) concurrent with chemoradiation.
* To evaluate tumor response

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed malignancy
* Requiring at least grade 2 weeks of radiation therapy
* Solid tumors of the central nervous system, head and neck area, and cervix
* World Health Organization (WHO) performance status equal to or less than 2

Exclusion Criteria:

* Equal to or greater than grade 2 peripheral neuropathy
* Myocardial infarction within 6 months
* Hypersensitivity to bortezomib, boron, or mannitol

Primary outcomes:
measure: To determine the safe and maximum tolerated dose of Velcade® when administered as a twice weekly 3-5 second intravenous (IV) bolus every 3 weeks to patients with malignancies of the brain, head and neck, and cervix who receive 2-8 weeks of radiotherapy
timeFrame: 2-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Adam Dicker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02708589: The Effects of Probiotic Supplementation on the Results of Gastric Bypass Surgery
Official title: The Effects of Probiotic Supplementation on Anthropocentric, Nutrients Status, Inflammation, GI Hormones, Quality of Life, and Microflora in Patients Undergoing Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gastric Bypass Surgery
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, patients undergoing the bariatric surgery will be assigned to take either probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery. Their anthropometric and biochemical measurements will be assessed every 3-6 months, and will be compared in two groups.


Eligibility criteria: Inclusion Criteria:

* BMI\> 40 or \>35 plus other morbidities
* Undergoing the gastric bypass surgery
* Willing to participate in the study

Exclusion Criteria:

* History of any chronic GI or kidney disorders, malignancies, or immune deficiencies
* Taking any immunomodulatory or immunosuppressor medications
* Taking Antibiotics from 4 weeks before and during the intervention
* Being on special diet such as vegetarian diet
* Doing as a professional Athlete
* Pregnancy and Lactation

Primary outcomes:
measure: weigh of the participants will be measured in Kg.
timeFrame: 3 months after surgery
Secondary outcomes:
measure: serum level of vitamin B12 (mg/dl)
timeFrame: 3 months after surgery
measure: serum level of vitamin B12 (mg/dl)
timeFrame: 12 months after surgery
measure: serum level of vitamin D(ng/ml)
timeFrame: 3 months after surgery
measure: serum level of vitamin D (ng/ml)
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NNFTRI clinic
Study officials:
References:
citation: Mokhtari Z, Karbaschian Z, Pazouki A, Kabir A, Hedayati M, Mirmiran P, Hekmatdoost A. The Effects of Probiotic Supplements on Blood Markers of Endotoxin and Lipid Peroxidation in Patients Undergoing Gastric Bypass Surgery; a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial with 13 Months Follow-Up. Obes Surg. 2019 Apr;29(4):1248-1258. doi: 10.1007/s11695-018-03667-6.
citation: Karbaschian Z, Mokhtari Z, Pazouki A, Kabir A, Hedayati M, Moghadam SS, Mirmiran P, Hekmatdoost A. Probiotic Supplementation in Morbid Obese Patients Undergoing One Anastomosis Gastric Bypass-Mini Gastric Bypass (OAGB-MGB) Surgery: a Randomized, Double-Blind, Placebo-Controlled, Clinical Trial. Obes Surg. 2018 Sep;28(9):2874-2885. doi: 10.1007/s11695-018-3280-2.
Clinical trial NCT01485289: Stabilimax Investigational Device Exemption (IDE) Clinical Investigation Patient Followup Study
Official title: Stabilimax Study Participants Collection of Additional Follow-up Data Clinical Investigation Plan R-001
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Stenosis
Lead sponsor: Rachiotek LLC
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The intent of this study is to complete the collection of clinical data on subjects enrolled in the Stabilimax Dynamic Spine Stabilization IDE clinical trial (#G060214) sponsored by the now defunct Applied Spine Technologies Inc . The Applied Spine assets, including the clinical trial data, were acquired by Rachiotek, LLC in 2010. When Applied Spine ceased their funding of the trial, a number of enrolled patients had not yet completed the two year follow-up visit defined as the study endpoint in the clinical investigation plan. No additional patient treatment is required to complete the study. Rachiotek has interest in pursuing IDE approval for a new study and the information collected in this study is essential for supporting the new Investigational Device Exemption application.


Eligibility criteria: Inclusion Criteria:

* Any patient that after having met all of the inclusion/exclusion criteria identified for the Stabilimax Investigational Device Exemption study had enrolled in the Stabilimax Investigational Device Exemption study and were implanted with the Stabilimax NZ or the control device.

Exclusion Criteria:

* Any patient that has had the device removed and the adverse event follow-up report stated that the event was resolved. This applies only if the patient was formally withdrawn from the study at that time.

Primary outcomes:
measure: Visual Analog Scale (VAS) for Leg Pain
timeFrame: Minimum 24 months post procedure
measure: Zurich Claudication Questionnaire (ZCQ)
timeFrame: Minimum 24 months post procedure
measure: Major Device Related (MDR) Complications
timeFrame: Minimum 24 months post procedure
measure: Revision, Reoperation, or Removal
timeFrame: Minimum 24 months post procedure
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Minimum 24 months post procedure
measure: Presence (control) or Absence (Stabilimax)of fusion
timeFrame: Minimum 24 months post procedure
measure: Adverse Events (AE)
timeFrame: Minimum 24 months post procedure
measure: Physician Satisfaction Scale
timeFrame: Immediately post procedure
Other outcomes:
Locations:
city: Durham
country: United States
facility: Triangle Orthopedics
state: North Carolina
Study officials:
References:
Clinical trial NCT05049889: Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema
Official title: Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Edema
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The model includes 2 groups:

* 1 group of divers with a history of immersion pulmonary edema
* 1 group of matched divers without a history of immersion pulmonary edema
Primary purpose: SCREENING

Brief summary: Immersion Pulmonary Edema (IPE) is a relatively new form of hemodynamic pulmonary edema. The number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. The pathophysiological mechanisms of IPE are not completely known. Its occurrence is linked to a combination of factors related to the environmental constraints of diving, as well as to the diver's equipment. The main external factors are increased hydrostatic pressure, cold, intense effort and emotional stress. The impact of internal factors is not known. At this time, no severe forms of IPE have been identified in the military. However, it is important to identify this pathology at an early stage, even if the signs appear minor, because the continuation of underwater activity can significantly worsen the clinical picture. The risk of recurrence (greater than 15%) could result in a severe or even lethal accident.


Eligibility criteria: Inclusion Criteria:

* Military or civilian diver with at least 100 dives
* Between the ages of 18 and 60
* Good physical condition (able to run/swim for 30 minutes at a constant pace).

Exclusion Criteria:

* Divers with a current temporary medical incapacity to dive
* Persons with contraindications to physical exercise and/or scuba diving
* Pregnant or breastfeeding women

Primary outcomes:
measure: Hemodynamic modifications of the cardiac cavities after exercise
timeFrame: Until the end of the study (49 months)
measure: Ventilatory regimes
timeFrame: Until the end of the study (49 months)
measure: Pulmonary compliance
timeFrame: Until the end of the study (49 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Toulon
country: France
facility: Equipe Résidente de Recherche Subaquatique Opérationnelle
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte-Anne
Study officials:
References:
Clinical trial NCT06577389: Enhanced Recovery After Surgery for Spine Fusion Surgeries in the Elderly
Official title: Enhanced Recovery After Surgery for Spine Fusion Surgeries in the Elderly
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Spinal Stenosis
Keywords: spine fusion surgery
Lead sponsor: Sixth Affiliated Hospital of Xinjiang Medical University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 1500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elderly patients who received spinal fusion surgeries

Brief summary: elderly patients in our hospital who received spinal fusion surgery after the year 2025 will receive ERAS treatment.


Eligibility criteria: Inclusion Criteria:

* elderly patients who received spinal fusion surgeries

Exclusion Criteria:

* patients who received non-fusion surgeries

Primary outcomes:
measure: ambulation time
timeFrame: 7 days
Secondary outcomes:
measure: mean hospital length of stay
timeFrame: one month
measure: cost of hosptial stay
timeFrame: 1 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00559689: Study of Inhaled Glucocorticosteroid Administration in Asthma Patients
Official title: Phase 4 Study of Once-Daily Inhaled Glucocorticosteroid Administration in Asthma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma patients
well-controlled
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
First posted: 2007-11-16
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: University Hospital

Brief summary: Once-daily inhaled glucocorticosteroids treatment can sufficiently control airway inflammation in asthma patients.


Eligibility criteria: Inclusion Criteria:

* Receive ICS for one year or more, with no change in dose within the previous 8 weeks

Exclusion Criteria:

* Two or more courses of oral corticosteroid in the previous 12 months
* Admission to hospital due to asthma in the previous 6 months
* Admission to the intensive care unit due to asthma at any time in the past
* Current cigarette smoker.

Primary outcomes:
measure: once-daily administration of inhaled glucocorticosteroids can control airway inflammation
timeFrame: two-year
Secondary outcomes:
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
Study officials:
name: Kingo Chida, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06737289: SURGICAL GUIDES EFFECTIVENESS
Official title: PRECISION OF SURGICAL GUIDES FOR PLACEMENT OF EXTRA-LARGE DENTAL IMPLANTS. A PILOT STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrophic Maxilla
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split Mouth Design
Primary purpose: TREATMENT

Brief summary: The use of zygomatic implants is a technique that is becoming more and more widespread in daily clinical practice, however, few professionals feel safe and confident in performing this type of procedure. We therefore believe that a line of research focused on simplifying this technique will have an extraordinary impact on the safety of both patients and surgeons. Currently, new surgical guides have emerged that guarantee greater precision in the placement of zygomatic implants. However, no comparative clinical studies have yet been performed to evaluate the degree of accuracy of guided implant placement compared to the conventional freehand technique.

Detailed description: The primary objective of the study is to study the accuracy of the use of guided surgical splints compared to traditional freehand zygomatic implant placement.

The secondary objectives are:

* To compare the magnitude of variations depending on implant length by superimposing postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
* To compare the magnitude of the variations depending on the location of the implant by superimposing postoperative and postoperative CT scans using 3DSlicer® (http://www.slicer.org) and exocad® software.
* To assess the clinical relevance of cogomatic implant placement using guided surgical splinting on pain parameters and surgical time.

Eligibility criteria: Inclusion Criteria:

• Age between 18-80 years of age, patients who sign the informed consent form and patients who consent to undergo preoperative and postoperative orthopantomography and CT scans.

Exclusion Criteria:

* Smoking (more than 10 cigarettes per day).
* Alcoholism (more than 25g/day in women and more than 40g/day in men according to WHO criteria),
* Oncological treatment (history of treatment in the last 6 months or current treatment with chemotherapy or radiotherapy).
* History of head and neck radiotherapy.
* Allergic to anesthetics or antibiotics.

Primary outcomes:
measure: Accuracy of Surgical Guides in implant placement
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Jesus
city: Madrid
country: Spain
facility: UCM
Study officials:
affiliation: UCM
name: JEsus Torres, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03627689: Molekule for Allergic Rhinitis/Asthma
Official title: Molekule for Allergic Rhinitis/Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Allergic Rhinitis
Allergic Conjunctivitis
Keywords: asthma
environmental intervention
allergies
air purifier
Lead sponsor: Molekule
Sponsor class: INDUSTRY
First posted: 2018-08-13
Enrollment: 49
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: PREVENTION

Brief summary: Exposure to airborne allergens and pollutants is linked to symptom severity of allergies, asthma and other respiratory problems. In this study an air purifier using photo-electrochemical oxidation technology (PECO) will be used in the home environment of study participants. The investigator will assess the reduction of symptoms from allergic rhinitis/conjunctivitis and asthma.

Detailed description: The purpose of this study is to assess the efficacy of the portable PECO air purifier in reducing symptoms from allergic rhinitis and asthma. Using a randomized, double blinded placebo, controlled trial we will be then able to assess if there are any changes after the use of the PECO air purifier after completing an initial baseline survey \& comparing to the exit survey. This is a double-blind study, which means that neither the participant nor the investigator knows which device is being used until after the trial is over.

Eligibility criteria: Inclusion Criteria:

1. Chronic allergic rhinitis and/or conjunctivitis by history
2. History of adult asthma requiring medications now or in the past
3. Age ≥18
4. CARAT score less than 24

Exclusion Criteria:

1. Participant is \<18 years-old
2. Use of systemic corticosteroids within 14 days of study initiation
3. Treatment with biologic agents or allergen immunotherapy
4. Treatment with other immunomodulators (cyclosporine, azathioprine, hydroxychloroquine, etc)
5. Sensitive to fan sound or blue/purple light at night time

Primary outcomes:
measure: Control of Allergic Rhinitis and Asthma Test (CARAT) score
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Molekule
state: California
Study officials:
affiliation: Molekule
name: Nikhil G Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00689689: A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements
Official title: A Randomized Clinical Study Comparing a Fully-Coated Cementless Stem Versus a Cemented Stem for Total Hip Replacements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 48
Sex: ALL
Minimum age (years): 72
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to answer the question as to whether or not a fully coated cementless stem is equal to or better than a cemented stem in patients over 72 years with good bone quality.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing surgery for total hip replacements, including diagnosis of osteoarthritis, rheumatoid arthritis, traumatic and post-traumatic arthritis, avascular necrosis and congenital dislocation of the hip. Congenital dislocation of the hip will be included where small but anatomical acetabuli are present, ie., the acetabuli located near the tear-drop
* Revisions of failed osteotomies may be included
* Bone quality felt to be acceptable to the surgeon for cementless arthroplasty preoperatively in patients \> 72 years of age

Exclusion Criteria:

* Patients with active infection
* Revision cemented total hip replacement
* Charcot joints
* Patients with primary or secondary bone tumors in the vicinity of the joint to be replaced
* C.D.H. with abnormally placed acetabuli or femoral canals
* Fibromyalgia patients

Primary outcomes:
measure: Revision
Secondary outcomes:
measure: Womac
measure: SF-12
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Capital Health, Canada
name: Ross K Leighton, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00159289: Endotoxin and Inflammatory Markers in Healthy Non-Smokers and Current Smokers Including Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Effect of Endotoxin on Inflammatory Markers in Exhaled Breath, Sputum, Saliva and Nasal Lavage in Healthy Non-Smokers and Current Smokers Including Patients With COPD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Mild to moderate Chronic Obstructive Pulmonary Disease (COPD)
Volunteers (healthy non-smokers)
Volunteers (current or ex-smokers)
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary aim of this study is to investigate the effects of inhaled lipopolysaccharide endotoxin (LPS) on bronchial and alveolar exhaled nitric oxide (NO) and NO metabolites and other inflammatory markers and mediators in exhaled breath condensate, induced sputum, nasal lavage and mouthwash fluid in healthy non-smokers and current smokers, including patients with chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Healthy non-smokers: normal spirometry (forced expiratory volume in 1 second \[FEV1\] more than or equal to 90% predicted) and normal exhaled NO (between 8 and 24 ppb; flow 50 ml/s)
* 0: At risk (current or ex-smokers): normal spirometry, with or without chronic symptoms (cough, sputum production)
* I-II: Mild-moderate COPD

  * FEV1 reversibility of \< 15% after inhaled beta2-agonists
  * FEV1/forced vital capacity (FVC) \< 70% predicted
  * FEV1 between greater than or equal to 50% and less than 80%
  * With or without chronic symptoms (cough, sputum production)
* Able to comprehend and grant a written informed consent

Exclusion Criteria:

* Concomitant use or pre-treatment within the last 4 weeks with oral steroids
* Respiratory infection within 4 weeks prior to entry into the trial
* Females who are pregnant or lactating
* History of current or past drug or alcohol abuse

Primary outcomes:
measure: sputum induced
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital
Study officials:
affiliation: Imperial College London
name: Sergei A Kharitonov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: