louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00291785: Phase I/II CT 2106 and 5-FU/FA in Colorectal Cancer
Official title: Phase I/II Study of CT-2106 in Combination With Infusional 5-fluorouracil/Folinic Acid (5-FU/FA)(de Gramont Schedule) as Second Line in Patients With Metastatic Colorectal Cancer Failing an Oxaliplatin Plus 5-FU/FA Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Keywords: colorectal cancer
camptothecin
Lead sponsor: CTI BioPharma
Sponsor class: INDUSTRY
First posted: 2006-02-15
Enrollment: 48
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: CT-2106, a camptothecin (CPT) conjugate, is a new generation of topoisomerase I inhibitors designed to deliver higher, more effective chemotherapy to tumor tissue with less toxicity to normal tissues. The objective of this study is to determine the dose limiting toxicities, safety profile and antitumor activity of CT-2016 in combination with 5-FU and folic acid for the treatment of colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically proven metastatic colorectal adenocarcinoma, failing one prior treatment containing oxaliplatin plus 5-FU/FA
* At least one measurable lesion according to RECIST criteria for both Phase I and II
* ECOG performance status 0 or 1
* Adequate hematologic, renal and hepatic function
* Wash out period of at least 4 weeks from surgery, 4 weeks from radiotherapy

Exclusion Criteria:

* Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix.
* Pregnant or lactating patients
* Prior treatment with camptothecins
* Presence or history of CNS metastasis or carcinomatous leptomeningitis
* Current active infection per investigator assessment
* Unresolved bowel obstruction or partial obstruction, uncontrolled Crohn's disease or ulcerative colitis
* Current history of chronic diarrhea greater than or equal to grade 1 (CTCAE version 3)

Primary outcomes:
measure: Phase I: determine the Maximum Tolerated Dose, dose limiting toxicities, safety profile and antitumor activity
timeFrame: Each cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario "A.Gemelli"
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
Study officials:
affiliation: Policlinico Universitario "A.Gemelli"
name: Barone C., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00029185: Study of Dehydrex in Patients With Corneal Erosion
Official title: Topical Dehydrex in Treating Recurrent Corneal Erosion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Diseases
Recurrence
Keywords: Corneal Erosion
Dextrans
Administration, Topical
Ophthalmic Solutions
Thimerosal
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2002-01-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a compassionate-use treatment study to provide Dehydrex to patients with corneal erosion syndrome who have previously used Dehydrex.

Detailed description: This study continues to provide Dehydrex to patients who have received it previously under other studies. Patients continue to be treated with their current dose of Dehydrex. Upward dose adjustments may be made as clinically indicated. Patients undergo eye exams every 3 to 4 months or more often. Downward dose titration will be attempted in patients who are stable, free of symptoms, and willing to attempt downward adjustments. In patients who are able to discontinue the medication, duration of healing will be determined. In those patients who experience a recurrence after discontinuing the medication, Dehydrex will be restarted at a dose higher than the minimum effective dose. After at least 8 weeks of treatment and resolution of symptoms, the dose may again be reduced. Further attempts to discontinue the medication will not be made.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Inclusion criteria:

* Clinical diagnosis of symptomatic recurrent corneal syndrome due to anterior membrane dystrophy or posttraumatic abrasion
* Not responsive to standard medical therapy with artificial tears, hypertonic saline, or bandage soft contact lenses
* At least 3 episodes of erosion within the past 4 months documented by slit lamp examination

Exclusion criteria:

* Allergy to any component of the medications to be used
* Active ocular surface infection due to bacteria, virus, or fungus
* Chronic atopic disease affecting the ocular surface or adnexa
* Dry eye, exposure, trichiasis, entropion, ectropion, or neurotrophic keratopathy
* Concurrent use of contact lenses
* Diagnosis of persistent epithelial defect in eye to be treated
* Concurrent use of topical medication to eye to be treated
* Any ocular eyelid surgery within the past 6 months
* Pre-existing corneal stromal edema
* Diabetes mellitus
* Postsurgical infection
* Dry eye condition of 16 or greater on Patient's Dry Eye Questionnaire
* Other investigational medications within the past 6 months
* Other corneal dystrophy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cohasset
country: United States
facility: Holles Laboratories, Inc.
state: Massachusetts
Study officials:
References:
Clinical trial NCT00589485: Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement
Official title: Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
Knee Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: New Lexington Clinic
First posted: 2008-01-09
Enrollment: 0
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: The study population will include patients who require total knee replacement.

Brief summary: The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Detailed description: The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Eligibility criteria: Inclusion Criteria:

* Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
* Patients requiring correction of varus, valgus, or posttraumatic deformity
* Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

Exclusion Criteria:

* Infection, sepsis, and osteomyelitis

Primary outcomes:
measure: Radiographic analysis and Knee Society Score
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: United States
facility: Biomet Orthopedics, LLC
state: Indiana
Study officials:
References:
Clinical trial NCT02534285: the Impact of Noise on Requirements of Anesthetics During General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Anesthesia, Inhalation
Hearing
Noise, Occupational
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 100
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: The investigators hypothesize that the noise level in the operating theatre influences the patients' requirements of anesthetics. Study subject are patients undergoing abdominal surgery in combined general and epidural anesthesia. Analgesia is maintained by epidural injections of sufentanil and ropivacaine whereas general anesthesia is maintained using the inhalational anesthetic desflurane. Desflurane requirements are adjusted using neuromonitoring (BIS-Index). Intraoperative noise levels are recorded. Patients are randomized to receive hearing protections or not.

Detailed description: All patients receive standardized anesthesia and monitoring according to the usual clinical care in the department. Placement of epidural catheters takes place before induction of general anesthesia. Thereafter, 10 ml ropivacaine 0.3% with 10 µg sufentanil are administered epidurally every 60 min to induce and maintain analgesia during surgery.

Following induction of general anesthesia and tracheal Intubation, intraoperative hypnosis is maintained using desflurane.

Eligibility criteria: Inclusion Criteria:

* full contractual capability
* written informed consent
* abdominal surgery in combined general/epidural anesthesia
* position during surgery: supine
* clinically normal hearing

Exclusion Criteria:

* history of psychiatric disease
* history of intraoperative awareness
* clinically impaired Hearing
* contraindication for placing an epidural catheter

Primary outcomes:
measure: Requirements of the Inhalational Anesthetic Desflurane, Measured in Expiratory Volume Percentage, to Maintain a BIS-Index Triggered Depth of Anesthesia
timeFrame: one hour
Secondary outcomes:
measure: Awareness Using a Structured Interview ("Modified Brice Questionnaire")
timeFrame: 1 day
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital, Dept. of Anesthesia
Study officials:
affiliation: Consultant Dept. of Anesthesia; University Hospital Dresden; Technische Universität Dresden
name: Matthias Hübler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02384785: Effectiveness of of Therapeutic Currents in Clinical Dimension and Penetration Depth Dimension in Lower Back
Official title: Effectiveness of Different Types of Therapeutic Currents in Clinical Dimension and Penetration Depth Dimension in Lower Back
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-03-10
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who undergo electrodes implantation in lumbar spine due to chronic pain. Thease patients arrives 7 days after implantation to the clinic for a procedure of removing the electrodes.

Brief summary: Electrical stimulation therapy for pain reduction was performed already 2000 years ago. In recent years many studies had proved the effectiveness of electrical stimulation in pain management, tissue healing and muscle strengthening. Today there are devices with many types of currents. Each current comes with different statements for its effectiveness and its penetration depth yet there is no consensus on the most effective current in the dimension of penetration depth.

Detailed description: The study shall be recruited patients who underwent implantation of electrodes in the spine (Spinal Cord Stimulation- SCS). The electrode will serve as a voltage reader deep in the tissue. The voltage is generated from electrodes applied on the skin and delivers therapeutic currents to the patients back. The study will be tested 4 different types of currents and number of electrode placement.

Eligibility criteria: Inclusion Criteria:

* Normal cognitive status.
* language comprehension (understanding and speaking)a way that allows voluntary cooperation in research and compliance with the testing.

Exclusion Criteria:

* Pregnant women.
* neurological pathologies (such as -head injury) or other systemic diseases that affect the sensation (such as diabetes).
* Each participant which at any stage in research expresses his wish to resign.

Primary outcomes:
measure: The amount of electric voltage
timeFrame: monitoring voltage takes a few minutes only. Reading Voltage immidiatly- one test only for each current
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Site Sub-Investigator
name: Moty Mr Ratmansky, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01096485: Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel
Official title: Open-label, Randomized, Crossover Study to Compare the Bioavailability of One Coated Tablet of Opxion® (Levonorgestrel 1.5 mg From Bayer de Mexico) vs. Two Tablets of Postday® (Levonorgestrel 0.75 mg From Investigacion Farmaceutica), in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Contraception
Contraception, Postcoital
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-03-31
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis.

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study.
* History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs.
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.

Primary outcomes:
measure: Least square estimator of average maximum plasmatic concentration (log transformed)
timeFrame: After 2 months
measure: Least square estimator of area under the pharmacokinetic curve (log transformed)
timeFrame: After 2 months
Secondary outcomes:
measure: Time at which maximum concentration is reached
timeFrame: After 2 months
measure: Area under the pharmacokinetic curve from time=0 to time of last blood sample
timeFrame: After 2 months
measure: Clearance constant of plasmatic concentration of study drug
timeFrame: After 2 months
measure: Half life of plasmatic concentration of study drug
timeFrame: After 2 months
measure: Adverse events collection
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Morelia
country: Mexico
state: Michoacán
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06120985: Rural Appalachia Pilot Water Treatment Trial
Official title: Expanding Safe Water Access to Improve Health Outcomes in Rural Appalachia: a Pilot Water Treatment Intervention Trial in Virginia & Tennessee
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Water-Related Diseases
Enteric Pathogens
Exposure to Chemical Pollution
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: East Tennessee State University
name: University of North Carolina, Chapel Hill
name: Ballad Health
First posted: 2023-11-07
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Consumption of unsafe drinking water is associated with a substantial burden of disease globally. In the USA, the burden of disease associated with consumption of contaminated drinking water from non-regulated private wells and springs in rural areas is relatively understudied and unclear. For some lower-income households in rural areas of the USA without access to reliably safe drinking water, point-of-use treatment with relatively low-cost pitcher filters could help to reduce exposures to contaminated water and associated adverse health outcomes. This pilot randomized controlled intervention trial will provide information and data on water quality and contamination exposures, associated health outcomes, and the adoption potential of point-of-use water filters in rural areas of Virginia and Tennessee.


Eligibility criteria: Inclusion Criteria:

* The household does not have utility-supplied water at the time of enrollment,
* The household is considered to be "low-income" (based on federally defined income limits),
* The household is in one of the selected study counties in TN or VA.

Exclusion Criteria:

* None (no exclusion criterion based on gender, race, ethnicity, language, or literacy).

Primary outcomes:
measure: E. coli detection in drinking water
timeFrame: 12 months
measure: Heavy metals or other contaminants exceeding EPA MCL
timeFrame: 12 months
Secondary outcomes:
measure: Gastrointestinal illness
timeFrame: 12 months
measure: Pathogen infection
timeFrame: 12 months
Other outcomes:
Locations:
city: Johnson City,
country: United States
facility: East Tennessee State University
state: Tennessee
city: Blacksburg
country: United States
facility: Virginia Tech
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Alasdair Cohen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06756685: Effects of Core Strengthening Versus Motor Control Training on Pain, Disability & Endurance in Low Back Pain
Official title: Effects of Core Strengthening Versus Motor Control Training on Pain, Disability & Endurance in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: back pain
disability
endurance
core strengthening
motor control
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 74
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare the effects of core strengthening versus motor control training on pain, disability \& endurance in patients with low back pain

Detailed description: The study aims to compare the effects of core strengthening versus motor control training on pain, disability \& endurance in patients with low back pain.

Comparing core strength and conditioning versus motor control for low back pain on physical and self-report outcomes lies in identifying the most effective treatment approach for this condition. This will help to determine which one yields better results in terms of improving physical function and reducing self-reported pain and disability associated with low back pain. This study can provide valuable insights for clinicians and patients in selecting the most appropriate treatment option.

Eligibility criteria: Inclusion Criteria:

* Non-specific Chronic low back pain (\>3 months)
* Pain between the T12 vertebra and gluteal fold with pain of 2-8 on the numerical rating scale of 0-10
* Both Genders
* Age of 25 and above

Exclusion Criteria:

* Participants fall in this category would be excluded of the study.

  * Lumbar radiculopathy
  * Structural scoliosis
  * Traumatic spinal injury
  * Cauda equina syndrome
  * History of seizures, epilepsy, stroke or head injury
  * Metal implants
  * Pregnancy or considering pregnancy in near future
  * Body mass \>/= 100kg

Primary outcomes:
measure: Goniometer
timeFrame: 8 weeks
measure: Lower body strength
timeFrame: 8 weeks
measure: Modified Oswestry disability index
timeFrame: 8 weeks
measure: Tampa scale of kinesiophobia
timeFrame: 8 weeks
measure: Visual analog scale
timeFrame: 8 weeks
measure: Japanese orthopedic association back pain evaluation questionnaire
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Mediplex Health Care Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sabiha Fayyaz, MS-NMPT*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01351285: Comparison of Effect-site Concentration of Remifentanil for Preventing Cough Against Endotracheal Tube During Anesthetic Emergence According to Anesthetics (Sevoflurane, Desflurane, and Propofol)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Patients Undergoing Thyroidectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 78
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: It has been reported that target-controlled infusion of remifentanil can reduce cough against endotracheal tube during emergence from general anesthesia. We hypothesized that effective concentration of remifentanil for preventing cough during anesthetic emergence varies depending on the type of main anesthetic agents which is administered with remifentanil during general anesthesia. The purpose of this study is to evaluate the effective concentrations of remifentanil to prevent coughing during emergence from general anesthesia according to main anesthetic agent (sevoflurane, desflurane, and propofol).


Eligibility criteria: Inclusion Criteria:

* aged 20-60
* ASA classification I\~II
* female patients
* patients who undergoing thyroidectomy

Exclusion Criteria:

* Patients with acute or chronic respiratory disease
* patient who has smoking history
* patient who has hypertension
* patient who has esophageal reflux
* patient who having an expectorant or cough remedy

Primary outcomes:
measure: occurrence of cough
timeFrame: From the completion of surgery to 5minute after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: