louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00159068: Analysis of Genetic Factors Which May Influence the Course of HIV Infection
Official title: Genetic Influences on the Course and Response to Treatment of HIV: Contribution of Polymorphisms in Drug Metabolism and Disposition Genes and Haptoglobin Polymorphisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HIV attending the HIV clinic at Hadassah colden globes.

Brief summary: Patients with HIV an have a variable course of their infection. We are trying to identify factors which worsen or ameliorate the course of the disease. Such factors may be related to metabolism (breakdown) of drugs or to iron handling by the body.

Detailed description: Patients with HIV can have a variable course and the disease may be influenced by polymorphisms in drug metabolism and disposition genes such as MDR1 and CYP3A4. In addition, reports have linked changes in the course of the disease with iron status, with high iron being detrimental. We will study polymorphisms in these genes and correlate with clinical course in HIV patients and also with phenotype of drug resistance and disease parameters (such as CD4 counts and opportunistic infections).

Eligibility criteria: Inclusion Criteria:

* diagnosis of HIV

Exclusion Criteria:

* under 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Deborah Rund, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang J, Kaslow RA. The impact of host genetics on HIV infection and disease progression in the era of highly active antiretroviral therapy. AIDS. 2003;17 Suppl 4:S51-60. doi: 10.1097/00002030-200317004-00006. No abstract available.
Clinical trial NCT02023268: Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome
Official title: Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndrome
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2013-12-30
Enrollment: 105
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: Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from ≥ 18 years old.
* Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.

Exclusion Criteria:

* Best far corrected visual acuity \< 1/10
* Severe blepharitis
* Severe Dry Eye

Primary outcomes:
measure: Global Ocular Staining (With Oxford Scale - Ranges : 0-15)
timeFrame: Baseline and Day 35
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
Study officials:
References:
Clinical trial NCT05728268: Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Official title: Neoadjuvant Dose-dense Chemotherapy for HR+/HER2- Breast Cancer Patients With High Proliferation Index
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Shantou Central Hospital
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. But some research data indicate that HR+/HER2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. How to identify HR+/HER2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. Ki67 is a marker reflecting the proliferation of tumor cells. Breast cancer patients with high Ki67 are more likely to benefit from dose-dense chemotherapy. The purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for HR+/HER2- breast cancer patients with high proliferation index. At the same time, we will explore biomarkers, such as MammaPrint and BluePrint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Females with age of 18 to 70 years old.
* Newly diagnosed breast cancer patients.
* Planned neoadjuvant chemotherapy.
* Hormone receptor status: Estrogen receptor (ER)-positive or Progesterone Receptor (PR)- positive.
* HER2/neu-negative.
* Ki67≥30%.
* Clinical stage IIB-IIIC.
* Informed consent form understood and signed.
* Patient agrees to all follow-up visits.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
* Women of childbearing potential must have a negative serum pregnancy test.

Exclusion Criteria:

* Metastatic disease
* Pregnancy.
* Nursing mothers.
* Active or uncontrolled infection.
* Presence of another malignancies.
* Granulocyte count \< 1.5\*10\^9/L.
* Platelet count \< 100\*10\^9/L.
* Hemoglobin \< 90g/L.
* Serum Creatinine more than 1.5 upper limit.
* AST and ALT more than 2.5 upper limit.
* LVEF\< 50%.

Primary outcomes:
measure: RCB
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shantou
country: China
facility: Shantou Central Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT00723268: Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
Official title: Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oral Aphthae
Keywords: Oral ulcers
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: University of Tehran
First posted: 2008-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.

Detailed description: Treatment of recurrent aphthous stomatitis (RAS) remains, to date, empirical and non-specific. The main goals of therapy are to minimize pain and functional disabilities as well as decrease inflammatory reactions and frequency of recurrences.

Eligibility criteria: Inclusion Criteria:

* Confirmation of clinical diagnosis of aphthae
* Having the experience of oral aphthae at least once in a month
* Two weeks wash out periods after the last treatment

Exclusion Criteria:

* History of any systemic disease
* Using drugs which affect immune system
* Pregnancy and breast feeding
* Aphthous related syndromes

Primary outcomes:
measure: frequency of ulcers
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad Dental school
state: Khorasan Razavi
Study officials:
References:
Clinical trial NCT05690568: Changes in Functional Movement Scores Associated With Multimodal Chiropractic Care: a Pilot Feasibility Study
Official title: Changes in Functional Movement Scores Associated With Multimodal Chiropractic Care: a Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chiropractic
Lead sponsor: Cleveland University Kansas City
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: single group pilot study to determine feasibility and potential effect size
Primary purpose: OTHER

Brief summary: Emergency medical services (EMS) personnel are at high risk of injuries, often related to overexertion while lifting or carrying patients or equipment. They require a high level of functional fitness to operate safely and avoid injuries. The purpose of this pilot study was to explore feasibility and assess effects of multimodal chiropractic care on Functional Movement Screen (FMS) scores among EMS students.

Detailed description: EMS students at a local community college voluntarily completed baseline FMS testing. Those who obtained 14 or less, a sign of movement dysfunction, were recruited to participate in a study to evaluate effects of multimodal chiropractic care on FMS scores. Participants received multimodal chiropractic care with an emphasis on spinal manipulation and corrective exercise for up to 6 weeks.

Eligibility criteria: Inclusion Criteria:

* current healthy paramedic students;

Exclusion Criteria:

-

Primary outcomes:
measure: Functional movement screen score (FMS)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Cleveland University Kansas City Chiropractic Health Center
state: Kansas
Study officials:
affiliation: Cleveland University Kansas City
name: Mark Pfefer, RN, MS, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02441868: Feasibility Testing of a Hospice Family Caregiver Intervention to Improve Patient Dyspnea Care
Official title: Feasibility Testing of a Hospice Family Caregiver Intervention to Improve Patient Dyspnea Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 7
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: This study is a pilot test of an intervention to train family caregivers of home hospice patients about recognizing and treating shortness of breath.

Detailed description: Shortness of breath is a prevalent symptom causing distress among patients at the end of life. In home hospice care family caregivers are expected to assist their family member with symptom management. This is often accomplished with little or no training.

The investigators have developed a bundle of training materials targeted for family caregivers of home hospice patients at risk for shortness of breath. The investigators will pilot test the intervention in this clinical trial. A future randomized clinical trial is planned and the evidence from this pilot will enhance the planning of that future trial.

Eligibility criteria: Inclusion Criteria:

* Patient in home hospice care with an estimated survival of 3-4 weeks, at risk for dyspnea secondary to lung cancer, COPD, or heart failure.
* Family caregiver in patient's home must speak and read English.

Exclusion Criteria:

* Patients with bulbar ALS or quadriplegia.

Primary outcomes:
measure: Change in patient respiratory comfort
timeFrame: Baseline and up to four weeks until patient death
Secondary outcomes:
measure: Family caregiver burden index
timeFrame: Baseline and participants will be followed for an average of 4 weeks until date of death
Other outcomes:
measure: Family caregiver stress as measured by Salivary cortisol
timeFrame: Baseline and participants will be followed for an average of four weeks to end at time of death.
measure: Family anxiety questionnaire
timeFrame: Baseline and participants will be followed for an average of four weeks to end at time of death
measure: Family depression questionnaire
timeFrame: Baseline and participants will be followed for an average of four weeks to end at time of death
Locations:
city: Livonia
country: United States
facility: Angela Hospice
state: Michigan
Study officials:
affiliation: Wayne State University
name: Margaret L. Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01381068: Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)
Official title: Quantitative End Tidal CO2 Monitoring in the Delivery Room: Can we Prevent Hypo/Hypercapnia Upon Admission to the NICU?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delivery Room Resuscitation
Keywords: ventilation
end tidal carbon dioxide
hypercapnia
hypocapnia
positive pressure ventilation
neonates
delivery room resuscitation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 50
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation. The hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the NICU.


Eligibility criteria: Inclusion Criteria:

* Need for ventilation in the delivery room

Exclusion Criteria:

* Tracheal suctioning for meconium
* Congenital Diaphragmatic Hernia
* Suspected hypoplasia of the lungs
* Oligohydramnios \<28 weeks gestation or AFI\<5
* Known or suspected airway anomaly
* Mother not speaking English or Spanish
* Refusal of consent

Primary outcomes:
measure: PCO2 Level Outside of Desired Range (40-60 mmHg)
timeFrame: Admission to NICU, approximately 1 hour of life
Secondary outcomes:
measure: End Tidal CO2 Levels
timeFrame: At the conclusion of resuscitation, approximately 15 minutes of life.
measure: Duration of Ventilation
timeFrame: Duration of the hospital course, approximately 2-3 months
measure: Oxygen Use at 36 Weeks
timeFrame: Hospital course, approximately 2-3 months
measure: Incidence of Pneumothorax/Airleak
timeFrame: Hospital course, approximately 2-3 months
measure: Number of Patients Ventilated on NICU Admission
timeFrame: On NICU admission, approximately 15 minutes of life
measure: Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow
timeFrame: Within 12 hours of life
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
Study officials:
affiliation: UCSD
name: Tina A Leone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06434168: Impact of Yoga on Cognitive Function
Official title: A Pilot and Feasibility Study of a Yoga Intervention in Heart Failure Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Mild Cognitive Impairment
Keywords: Yoga intervention
cognitive function
Lead sponsor: Auburn University
Sponsor class: OTHER
Collaborators: name: VCOM, Auburn campus
First posted: 2024-05-30
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mild cognitive impairment is highly prevalent in patients with heart failure and results in poor well-being and quality of life. While yoga has proven effective in promoting cognitive health in older adults through its gentle movements, controlled breathing, and meditation, its effects on patients with heart failure remain unknown. Therefore, this feasibility and pilot study plans to deliver a 12-week yoga intervention and test its effects on cognitive function in patients with heart failure and mild cognitive impairment.

Detailed description: A prospective, 2-arm comparative feasibility design will be used. The investigators will enroll 24 patients with a confirmed heart failure diagnosis with mild cognitive impairment. Patients will be randomized equally into yoga intervention or control group. Patients in the yoga intervention group will receive a 60-minute yoga session twice per week for 12-week. Survey, cognitive function data, MRI scans, and blood samples will be collected at baseline and at 3 months (after completion of yoga intervention).

Eligibility criteria: Inclusion Criteria:

* Aged 55 years and older
* Confirmed heart failure diagnosis with mild cognitive impairment
* New York Heart Association functional class II-IV

Exclusion Criteria:

* Co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses
* Have implanted defibrillator, left ventricular assist device placement or cardiac transplant
* Have any other implanted metals that interfere with the MRI magnetic field for patient safety
* Substance abuse
* Pregnant
* Unable to perform yoga due to physical limitations or severity of illness

Primary outcomes:
measure: Brain structure
timeFrame: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
measure: Brain functional connectivity
timeFrame: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
measure: Cognitive function
timeFrame: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
measure: Serum brain-derived neurotrophic factor
timeFrame: Change from 0-12 weeks, from baseline pre-intervention to 12 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
References:
Clinical trial NCT06260072: Magnesium and Riboflavin Treatment for Post-Concussion Headache
Official title: Magnesium and Riboflavin Treatment for Post-Concussion Headache
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Concussion, Intermediate
Keywords: Concussion; Headache
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person.


Eligibility criteria: Inclusion Criteria:

* Seen at University of Virginia Student Health and Wellness Center or Emergency Department for Initial Visit for Concussion;
* Less than 3 days have elapsed since their injury;
* Able to swallow capsules

Exclusion Criteria:

* Concussion complicated by cranial bleed, skull fracture, additional severe injury;
* Kidney disfunction or failure;
* Significant gastro-intestinal dysfunction;
* Varsity Athlete;
* Two or more previous concussions;
* Women who are pregnant or breast feeding;
* Taking tetracycline, fluoroquinolone, iron digoxin, chlorpromazine or penicillamine

Primary outcomes:
measure: Headache Intensity and Duration
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Student Health and Wellness Center
state: Virginia
Study officials:
affiliation: UVA Student Health and Wellness
name: Stephanie Hartman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002072: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Official title: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Cytopenias
Keywords: Recombinant Proteins
Erythropoietin
Acquired Immunodeficiency Syndrome
Anemia
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of erythropoietin (r-HUEPO) administered to AIDS patients with anemia secondary to their disease and/or concomitant zidovudine (AZT) therapy.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of any primary hematologic disease.
* Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS.
* AIDS-related dementia.
* Uncontrolled hypertension (diastolic Blood Pressure \> 100 mmHg).
* Presence of concomitant iron deficiency.
* Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
* Acute opportunistic infection.
* History of seizures.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

Prior Medication:

Excluded within 30 days of study entry:

* Experimental drug or experimental device.
* Cytotoxic chemotherapy.
* Excluded within 2 months of study entry:
* Androgen therapy.

Clinical diagnosis of AIDS and related anemia.

* Clinical diagnosis of AIDS.
* Clinically stable for 1 month preceding study entry.

Substance abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Raritan
country: United States
facility: Ortho Pharmaceutical Corp
state: New Jersey
Study officials:
References:
Clinical trial NCT04693572: Anesthetic Considerations for Repeat Cesarean Section - a Prospective Study
Official title: Anesthetic Considerations for Repeat Cesarean Section - a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia
Pregnancy, High Risk
Pregnancy Related
Keywords: Caesarian Section
Repeated Caesarian Section
Anesthesia
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 1500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients undergoing repeated caesarean section.

Brief summary: The purpose of this study is to examine the anesthetic considerations and outcomes during repeated caesarean section and to compare such considerations in low-order vs high-order repeated caesarean sections.

Detailed description: Data concerning anesthetic considerations and outcomes will be gathered from the electronic medical records of all parturients undergoing repeated caesarean sections in our medical center. the collected data will be stored anonymously.

Different aspects of anesthetic considerations and outcomes will be compared and subjected to analysis.

Eligibility criteria: Inclusion Criteria:

* Parturients undergoing repeated caesarean section.

Exclusion Criteria:

-

Primary outcomes:
measure: Percentage of sections performed under general anesthesia
timeFrame: 1 day
measure: Percentage of in-surgery conversion from regional to general anesthesia
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: