louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02137096: Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
Official title: High Dose Conditioning With Ifosfamide, Carboplatin, and Etoposide With Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Recurrent Nasopharynx Carcinoma
Keywords: Recurrent nasopharynx carcinoma
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-05-13
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to evaluate the response rates for patients undergoing high dose conditioning chemotherapy using Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation for the treatment of recurrent Nasopharyngeal Cancer (NPC) in children, adolescents, and young adults.

Detailed description: The use of high dose chemotherapy followed by autologous peripheral blood stem cell (PBSC) transplantation in recurrent nasopharyngeal carcinoma has shown promise when compared with standard chemotherapy. This study has been designed to evaluate response rates and toxicities associated with undergoing high dose conditioning with Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation support in the treatment of recurrent nasopharyngeal carcinoma in children, adolescents, and young adults.

Eligibility criteria: Inclusion Criteria:

* Imaging and tissue diagnosis of recurrent or progressive nasopharyngeal carcinoma
* Documentation of previous treatment including conventional chemotherapy and/or radiation therapy as clinically appropriate
* Ages 2 to 30 years of age
* Negative serum pregnancy test if applicable
* Calculated creatinine clearance of greater than 60 mL/minute, serum creatinine of less than 12o micromoles/L, total bilirubin less than 2 mg/dL and aspartate aminotransferase (AST) must be less than twice the upper limit of normal

Exclusion Criteria:

* Unsuitable candidate for autologous transplantation due to comorbidities or intractable psychosocial issues
* Pregnancy
* Breast-feeding women

Primary outcomes:
measure: Evaluate the Tumor Response
timeFrame: 12 months after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Shands Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: John Fort, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06492096: Bibloc Mandibular Advancement Oral Device and Its Effect on TMJ Health
Official title: Relation Between Bibloc Mandibular Advancement Oral Appliance Used In Treatment of Obstructive Sleep Apnea and Tempromandibular Joint Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if Mandibular Advancement Device( MAD) works to treat Obstructive sleep apnea in adults. It will also learn about the effect of the device on the Tempromandibular Joint Health . The main questions it aims to answer are:

Does MAD lower the number of apnoea and hypopnea participants suffer from during sleep? Would it cause any effect on TMJ health? Researchers will compare between a group of TMD patients with OSA to a non_TMD group of patients also with sleep apnea and both groups will receive a Bibloc MADplacebo (a look-alike substance that contains no drug) to see if it affect the TMJ health.

Participants will:

Wear MAD during sleep (at least 6 hours) every day for 6 months Visit the clinic once after the first week for checkups and adjustment of MAD If needed and then after 3 months and 6 months.

Polysomnography, MRI, and tmd screening was done before the appliance insertion and after 6 months of its insertion.


Eligibility criteria: Inclusion Criteria:

- Patients having obstructive sleep apnea syndrome (OSAS) as determined by polysomnography with mild to moderate apnea/hypopnea index ranging from 5 to 30 events per hour of sleep. ( As 5-15 events per hour is considered mild condition, 16-30 is considered moderate).(1)

2- Adequate nasal air flow capacity as determined by qualified otolaryngologist.

Exclusion Criteria:

* patients having Central sleep apnea events as determined by the polysomnography.

  2- patients having cardiovascular disease. 3- History of alcohol, narcotic or psychoactive medications. 4- Serious nasal passage obstructions or allergies. 5- Previous history of treatment with any type of obstructive sleep apnea oral appliances.

  6- Obese patients with BMI more than 30. 7- Missing more than five teeth (excluding third molar). 8- Allergy to acrylic resin.

Primary outcomes:
measure: Apnea/Hypopnea index
timeFrame: 6 months
Secondary outcomes:
measure: Condylar disc position
timeFrame: 6 months
measure: Joint space of TMJ
timeFrame: 6 months
Other outcomes:
Locations:
city: Al Manşūrah
country: Egypt
facility: Faculty of dentistry, Mansoura university
state: Ad Dakahlia
Study officials:
References:
Clinical trial NCT01749696: Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse
Official title: Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Pelvic organ prolapse
Connective tissue
Elastin
Collagen
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2012-12-17
Enrollment: 78
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 39 patients with pelvic organ prolapse and as controls 39 patients without prolapse.

Brief summary: The aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (POP).

Detailed description: The tissue samples were taken from the anterior wall of vagina in the midline close to cervix or apex. The tissue samples were collected from the vaginal wall of the patients with pelvic organ prolapse (n=39) during vaginal prolapse surgery. Control samples (n=39) were taken from patients after vaginal or laparoscopic removal of the uterus.

The formalin-fixed and paraffin embedded tissue samples were stained with Verhoeff van Gieson and Movat's pentachrome. Samples were examined by pathologist and gynecologist blinded as to the other investigator and to the pelvic organ prolapse status. In case of discrepancy investigators evaluated the samples together to gain consensus.

Eligibility criteria: Inclusion Criteria:

* surgery for pelvic organ prolapse
* hysterectomy due to other benign reasons than pelvic organ prolapse

Exclusion Criteria:

* surgery due to malignancy

Primary outcomes:
measure: The elastin content in tissue samples in patients with or without pelvic organ prolapse.
timeFrame: september 2012
Secondary outcomes:
measure: The collagen content in tissue samples in women with or without pelvic organ prolapse.
timeFrame: September 2012
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Obstetrics and Gynecology, Turku University Central Hospital
Study officials:
References:
Clinical trial NCT04555096: A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
Official title: A Pilot, Randomized, Placebo-Controlled Trial of GC4419 (Avasopasem Manganese) in Patients With Critical Illness Due to SARS-CoV-2 Infection (COVID-19)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
SARS-CoV-2 Infection
Keywords: COVID19
SARS-CoV-2 Infection
Lead sponsor: Galera Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Trial of GC4419 in Patients with Critical Illness due to COVID-19


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects at least 18 years of age.
2. Ability to understand and the willingness to sign a written informed consent.
3. Laboratory-confirmed SARS-CoV-2 infection as determined by a positive PCR test documented prior to randomization
4. Requirement for intensive inpatient hospital care
5. Acute hypoxemic respiratory failure typifying ARDS
6. Adequate liver function
7. Use of effective contraception

Exclusion Criteria:

1. Expected survival for less than 48 hours after randomization
2. Child-Pugh stage C hepatic impairment and/or portal hypertension secondary to cirrhosis
3. Stage IV chronic kidney disease or end-stage kidney disease on maintenance hemodialysis
4. Requirement for extra-corporeal membrane oxygenation (ECMO)
5. Acute Myocardial Infarction (AMI)
6. Active bleeding requiring transfusion
7. Concurrent participation in another clinical trial of experimental treatment for SARSCoV-2
8. Female patients who are pregnant or breastfeeding
9. Requirement for concurrent treatment with nitrates

Primary outcomes:
measure: 28 Day All-cause Mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Research
state: Missouri
Study officials:
affiliation: Study Chair
name: Jon Holmlund, MD
role: STUDY_CHAIR
References:
citation: Karlsson JOG, Jynge P, Ignarro LJ. May Mangafodipir or Other SOD Mimetics Contribute to Better Care in COVID-19 Patients? Antioxidants (Basel). 2020 Oct 10;9(10):971. doi: 10.3390/antiox9100971.
Clinical trial NCT03474796: Clinical Observation During Anaesthetic Induction: Which Difference Between Novice and Expert ?
Official title: Clinical Observation During Anaesthetic Induction: Which Difference Between Novice and Expert ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nurse's Role
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aims to show a difference of observation and data integration between novice and expert during anaesthetic induction, in a population of nurse anesthetists.


Eligibility criteria: Inclusion Criteria:

* Groupe "novice" : nurse anesthetist students, in 1st or 2nd years at Besançon nursing school OR nurse anesthetists with less than 1 year experience at Besançon University Hospital
* Group "expert" : full-time employed nurse anesthetists, with at least 5 years experience at Besançon University Hospital
* Correct vision with or without correction

Primary outcomes:
measure: Number of eye-fixations on each Region Of Interest (ROI)
timeFrame: Day 1
measure: Duration of eye-fixation on each ROI
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de Besancon
Study officials:
affiliation: CHU DE BESANCON
name: Magali Nicolier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06293196: Effects of Acupoint Massage Around Eyes on Ocular Biological Indexes
Official title: Effects of Acupoint Massage Around Eyes on Ocular Biological Indexes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Investigating the Effects of Periocular Acupressure on Ocular Biological Indicators
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to investigate whether the acupoint eye exercise could impact the biological parameters of the eye.


Eligibility criteria: Inclusion Criteria:

* healthy people of all ages

Exclusion Criteria:

* presence of systemic diseases
* history of other eye diseases, surgeries, and/or medications, as well as eye trauma
* incomplete healing of the surgical site after eye surgery
* consumption of coffee, tea, or vasodilators within 6 hours before the commencement of the test
* exclusion of children, pregnant, and lactating women

Primary outcomes:
measure: Changes in blood flow to the eye
timeFrame: Measurements were taken once after 20 minutes of near eye use, once immediately after the operation, and once at 10, 20, and 30 minutes after the operation, respectively.
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT06177496: Influence of Sarcopenia in Hepatocellular Carcinoma Patients
Official title: Influence of Sarcopenia on Mortality and Disease Progression in Hepatocellular Carcinoma Treated With Ablation, Embolization and Sorafenib
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Sarcopenia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 600
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: Treatment-naive hepatocellular carcinoma patients who underwent local ablation, TACE or sorafenib as a primary treatment.

Brief summary: Liver cancer poses a major threat to the global cancer burden, and the number of deaths is estimated to be more than one million annually by 2030. Locoregional therapies such as transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and radiation are associated with improved survival and quality of life for patients with unresectable HCC \[Couri and Pillai, 2019\]. However, curative therapies or locoregional therapies are not applicable to approximately 50% of HCC cases who are diagnosed at an advanced stage and have progression with transarterial therapies \[Park et al., 2015\]. For these patients, sorafenib, lenvatinib, and atezolizumab combined with bevacizumab have been approved as the first-line systemic therapy \[Fan et al., 2022\].

Sarcopenia is a progressive and generalized skeletal muscle disease characterized by accelerated loss of muscle mass and function \[Cruz-Jentoft and Sayer, 2019\]. It has been associated with higher mortality among the general population and patients with cancer. This study aims to assess the possible role of sarcopenia in predicting the outcome of HCC patients following a variety of treatments including local ablation, TACE and sorafenib.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of hepatocellular carcinoma.
2. Treatment-naive patients who underwent local ablation, TACE or sorafenib as a primary treatment .

Exclusion Criteria:

1. Use of other another HCC treatment modality e.g., resection.
2. Use of combined treatments e.g., simultaneous use of embolic therapy with ablation.
3. Patients with recurrent HCC.
4. Patients with secondaries from extra-hepatic primary tumors.
5. Incomplete data at the diagnosis, treatment or follow up time-points.
6. Loss of patients follow up.

Primary outcomes:
measure: overall survival
timeFrame: for at least 1 year from the treatment
Secondary outcomes:
measure: Recurrence-free survival
timeFrame: for at least 1 year from the treatment
measure: Progression-free survival
timeFrame: for at least 1 year from the treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00723996: Preventive Health Behavior in Women
Official title: Preventive Health Behavior in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 254
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are scheduled for a screening mammogram at a University Medical Center who are between 50 and 75 years old will recruited.

Brief summary: The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography.

Detailed description: The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography and to develop an innovative approach for reducing barriers colorectal cancer screening in women, using screening mammography, an existing non-colon cancer related screening test that has widespread public acceptance, as a "teachable moment." Although screening for colorectal cancer (CRC) has been shown to decrease the incidence of CRC and CRC associated mortality, adherence to screening guidelines from the American Cancer Society and the American Gastroenterological Association remains poor.1-5 Barriers to adherence are not fully defined, but may include poor understanding of the relative benefits and risks of CRC screening, absence of physician recommendation, lack of insurance coverage for screening procedures, and poor patient acceptance of screening procedures. A potential challenge in increasing patient knowledge may be the milieu in which the educational intervention is administered. This study will be the first prospective study to evaluate the effectiveness of an educational intervention designed to increase CRC screening administered at a cancer screening visit unrelated to CRC.

Eligibility criteria: Inclusion Criteria:

1. Women between the ages of 50 and 75 years old.
2. Scheduled for a screening mammogram.

Exclusion Criteria:

1. CRC screening current (FOBT within preceding 12 months, FS within 5 years, or colonoscopy within 10 years).
2. Family history of CRC in a first-degree relative.
3. Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease

Primary outcomes:
measure: The primary outcome will be determined through review of medical records or a telephone follow-up 6 months after enrollment
timeFrame: At 6 month intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ruth Carlos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03060941: Promoting Activity in Cancer Survivors
Official title: Promoting Activity in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Breast Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2017-02-23
Enrollment: 355
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 500 participants in the physical activity intervention will be randomly assigned to one of sixteen intervention groups (see Table below). Randomization will be stratified by clinical site. The randomization scheme will be conducted by the study statistician. The randomization scheme will consist of balanced blocks within each stratum, with block size will be varied and randomly permuted. Allocation will occur following completion of baseline assessments.
Primary purpose: PREVENTION

Brief summary: A randomized multi-component physical activity intervention for breast cancer survivors.

Detailed description: The research project is a study to assess the effects of a multi-component intervention in increasing physical activity among breast cancer survivors. Individuals meeting inclusion/exclusion criteria will be randomized to one of sixteen intervention groups for the 6 months. Intervention components will include print-based education, self-monitoring, Active Living counseling, supervised exercise sessions, and facility access. Blood samples will be collected at baseline. Assessments (anxiety, stress, sleep) and sample collection will also occur at 3 time points during the intervention (Weeks 13 and 25). Changes in physical activity will be assessed for each intervention group.

Eligibility criteria: Inclusion Criteria:

* breast cancer survivors between 3 months and 5 years post-treatment
* report \<150 minutes of moderate-to-vigorous physical activity (MVPA) on the GPAQ
* physically able to engage in physical activity

Exclusion Criteria:

* medical condition contraindicating physical activity participation
* cognitively unable to give informed consent

Primary outcomes:
measure: Moderate-to-vigorous physical activity measured by Actigraph accelerometer
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UTSW
name: Madhukar H Trivedi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rethorst CD, Hamann HA, Carmody TJ, Sharp KJ, Argenbright KE, Haley BB, Skinner CS, Trivedi MH. The Promoting Activity in Cancer Survivors (PACES) trial: a multiphase optimization of strategy approach to increasing physical activity in breast cancer survivors. BMC Cancer. 2018 Jul 18;18(1):744. doi: 10.1186/s12885-018-4662-5.
Clinical trial NCT05835141: Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium
Official title: Rates and Risk Factors of Contact Between the OTX-TIC Intracameral Ocular Implant and Corneal Endothelium
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Corneal Endothelium
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims to enroll 100 patients undergoing routine evaluation with Dr. Benjamin Xu at the USC Roski Eye Institute.

Brief summary: To determine what proportion of patients have inferior angle recess dimensions that could accommodate the OTX-TIC, and what are risk factors for implant contact with the corneal endothelium.


Eligibility criteria: Inclusion Criteria:

* Age over 40 years
* No history of ocular surgery other than cataract surgery

Exclusion Criteria:

- Media opacities that preclude OCT imaging of the anterior segment

Primary outcomes:
measure: Primary Outcome 1
timeFrame: 4-6 Months
measure: Primary Outcome 2
timeFrame: 4-6 Months
measure: Primary Outcome 3
timeFrame: 4-6 Months
measure: Primary Outcome 4
timeFrame: 4-6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Roski Eye Institute
state: California
Study officials:
References: