louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02763163: Examination of the Link Between Sun Exposure Routine and Bacteria Population of the Skin
Official title: Examination of the Link Between Sun Exposure Routine and Bacteria Population of the Skin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: Institute for Skin Research, Israel
Sponsor class: INDUSTRY
Collaborators: name: Fischer Pharmaceuticals Ltd.
First posted: 2016-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: 100 healthy volunteers

Brief summary: These days many studies are conducted testing the symbiosis between the bacteria population to the human body's functioning. The research of the connection between the skin condition and the bacteria population is in its early stages. There is a characterization of different bacteria for different body areas depending on their composition, humidity etc. In addition, there are preliminary findings of biological receptors that react to the contact with bacteria on the surface of the skin and turn on the immune system, awakening it to cope with the new invader. Based on the above information, the investigators hypothesis is that there is a connection between the degrees of sun exposure of individuals to the growing of beneficial bacteria populations on the surface of the skin. The study will compare between the bacteria population on the skin of Israeli subjects, divided to two groups, one with an excessive exposure to the sun on a daily basis, (such as agricultural workers, lifeguards, construction, etc.), and the other of the office worker who spend most of the day in a closed shaded room.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between the age of 20-60.

Exclusion Criteria:

* Pregnant or lactating women.
* Volunteers with a known allergy to one of the tested materials or to their ingredients.
* Treatment with medication such as anti-inflammatories, antihistamines,corticosteroids, systemically or topically applied, unless stopped for 2 weeks prior to the trial in the case of systemic treatment and 3 days in the case of topical treatment.

Primary outcomes:
measure: Scanning the bacteria population of the surface of the skin by using swab on the cheek area. The samples of bacteria will be characterized by genetic sequencing.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00586963: Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed Esophagitis
Official title: How Does Proton Pump Inhibitor Therapy Impact Quality of Life in Patients Newly Diagnosed With Erosive Reflux Esophagitis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erosive Esophagitis
Reflux Esophagitis
GERD
Keywords: Erosive Esophagitis
Reflux Esophagitis
GERD
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 65
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: Patients age 18 and older, diagnosed with reflux esophagitis, being seen at Mayo Clinic Rocheser.

Brief summary: This study is being done to for two reasons:

* To learn about the effects (good and bad) esomeprazole (an FDA approved drug for reflux esophagitis) has on your esophagus when taken correctly.
* To learn about the quality of life changes (good and bad) you may experience with this medication.

Detailed description: The plan is to have 50 people take part in this study at Mayo Clinic Rochester. This research study is looking at people who have a new condition called erosive reflux esophagitis. Esophagitis is defined as mucosal damage produced by the abnormal reflux of gastric contents into the esophagus. Acid reflux, over time, can wear away or erode the lining of your esophagus. This condition is called erosive esophagitis. The treating physician may start you on prescription strength acid reducing group of medications called Proton Pump Inhibitors (PPI). PPI medications can provide 24-hour relief from your painful heartburn symptoms and it can help you heal the erosions in the esophagus that acid reflux may cause.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Have either mild-to-moderate erosive reflux esophagitis
* Meet criteria for GERD symptoms.

Exclusion Criteria:

* Patients already on esomeprazole therapy, have previously failed to respond to esomeprazole, or are intolerant to PPI therapy.
* Patients expected to travel outside of the United States during the initial 8 weeks of PPI therapy.
* Pregnant women will be excluded as PPI's are not thought safe for the fetus (Pregnancy Category C). - Children younger than 18 years of age will be excluded.
* Other vulnerable populations, such as those with diminished mental acuity, will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yvonne Romero, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01896063: Sedative and Hypnotic Effects Induced by EA
Official title: EA Induces Sedative and Hypnotic Effects by Detecting BIS Value and MRI.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bypass Complications
Keywords: Electroacupuncture, Sedation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 45
Sex: ALL
Minimum age (years): 24
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Insomnia is a common clinical disease.The serious patients could not sleep all night, often accompanied by headache, dizziness, forgetfulness and so on. All of these increase the mental burden of insomnia patients and seriously affected the normal work and quality of life of patients. Modern medical treatment to treat insomnia is using sedative and hypnotic drugs, mainly benzodiazepine, zopiclone. But long-term use of these drugs can induce the adverse reactions, including resistance, dependence and addiction. Many articles indicate that electroacupuncture can effectively improve insomnia, play the role of sedative and hypnotic effect and avoid many adverse reactions and side effects. Then there are no more objective indicators to affirm that which part of brain takes place the appropriate changes when electroacupuncture induces the sedative effect. So we designed this experiment.


Eligibility criteria: Inclusion Criteria:

* Must be able to go with EA
* Can not have any disease

Exclusion Criteria:

* Overworked recently

Primary outcomes:
measure: BIS value
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Qiang Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04068363: Donor Gender Effect on Graft Function in Adult Egyptian Patients Undergoing Living Donor Liver Transplant
Official title: Donor Gender Effect on Graft Function in Adult Egyptian Patients Undergoing Living Donor Liver Transplant: A Single Centre Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Donor to Recipient Gender Mismatch in LDLT
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intraoperatively, Both standard anesthetic and piggyback liver transplant for hepatic transplantation will be performed by the same anesthesia and surgical team . Intraoperative hemodynamics (MAP and HR), graft weight to recipient weight ratio (GWRWR), blood products transfused and intraoperative adverse events will be recorded. At the end of surgery patients will be transferred to the ICU where they will be monitored and will receive the standard protocol for postoperative management after liver transplantation.

- Recipients will be divided into two groups ( matched and mismatched) and will be subdivided based on the following variables: recipient age, MELD score, intraoperative packed red blood cells (PRBC) and fresh frozen plasma (FFP) transfusions, duration of cold ischemia. These subgroups will be compared with respect to 2-year graft survival separately in recipients of sex matched and mismatched transplantation.

Brief summary: Liver transplantation (LT) represents the gold-standard therapy for the treatment in case of dreadful liver pathologies . It is thus a main concern to optimize the results in terms of post-LT survivals. The effect of gender match on post-transplant outcome is still debatable. Hormonal , and size difference between female and male may be proposed to affect the post transplant outcome . The aim of this study is to evaluate the effect of donor-recipient gender mismatch on survival rates


Eligibility criteria: Inclusion Criteria:

* Adult Egyptian Patients \>18 years.

Exclusion Criteria:

* Patient refusal.
* Patients who underwent re-transplantation before discharge from the ICU after the first liver transplant.
* Intraoperative cardiac arrest or immediately postoperative cardiac arrest within the first 6 hours postoperative.
* Massive blood loss.
* Pre-existing renal failure requiring hemodialysis or continuous hemofiltration.
* Pregnancy.

Primary outcomes:
measure: 2 years survival post liver transplant.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa El Gendy
state: Ain Shams University Specialized Hospital
Study officials:
References:
Clinical trial NCT04392063: Melatonin for Cerebral Palsy Children's Sleep and Health
Official title: Effect of Melatonin Supplementation on Sleep and Health of Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Melatonin
Growth
Children, Only
Keywords: Children's sleep habits questionnaire (CSHQ) Arabic version
Anthropometry
GERD
Constipation
Polysomnography
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, cohort study
Primary purpose: TREATMENT

Brief summary: The present study was prospective uncontrolled, single-armed and un-blinded study. Held in the Pediatric neurology clinic, Children's hospital l, Faculty of Medicine, Ain Shams University from June 2016 to June 2018 of 24 months timeframe. All cerebral palsy (CP) patients following up in Pediatric neurology clinic aged between 2 and 12 years. Melatonin given for 3 months. Anthropmetric measures, gastroeintestinal symptoms, Children's sleep habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at enrollment and after the 3-months.

Detailed description: A prospective, cohort study conducted in Pediatric Neurology Clinic, Children's Hospital, Faculty of Medicine, Ain Shams University. Forty children with sCP with sleep and seizure problems, aged 2-12 years were enrolled. The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months. Children's sleep habits questionnaire (CSHQ) Arabic version, polysomnography, Chalfont epilepsy severity score, and EEG were done at enrollment and after the 3-months. The ethical approval number is (FMASU MD 202/2016).

Eligibility criteria: Inclusion Criteria:

* All cerebral palsy children with sleep problem and seizure disorder,
* aged 2 - 12 years

Exclusion Criteria:

* any auditory and peripheral visual impairments

Primary outcomes:
measure: Decrease in total Children's sleep habits questionnaire score
timeFrame: after 3-months
measure: Improvement in growth
timeFrame: 3-months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's Hospital, Faculty of Medicine, Ain Shams University
Study officials:
References:
citation: Elkhayat HA, Hassanein SM, Tomoum HY, Abd-Elhamid IA, Asaad T, Elwakkad AS. Melatonin and sleep-related problems in children with intractable epilepsy. Pediatr Neurol. 2010 Apr;42(4):249-54. doi: 10.1016/j.pediatrneurol.2009.11.002.
Clinical trial NCT01434563: The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort -
Official title: The CNS HAND Study: The Prevalence of Neurocognitive Disorder in a Primary Care-based HIV Cohort Compared to a HIV-negative Control Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-Associated Cognitive Motor Complex
Keywords: HIV
neurocognitive disorder
primary care
HIV negative
HAND
CNS
Lead sponsor: Holdsworth House Medical Practice
Sponsor class: OTHER
First posted: 2011-09-15
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending Holdsworth House Medical Practice, Sydney, Australia

Brief summary: To determine the prevalence of HIV associated Neurological Disorder (HAND) in a population of HIV positive patients within a primary care setting compared with the HIV negative population. The investigators aim is to assess the use of optimal screening methods to assess HAND. For this the investigators will be comparing the performance of a group of persons who are HIV positive and a group of persons who are HIV negative to test their memory and concentration abilities over-time.


Eligibility criteria: HIV positive Inclusion Criteria:

* Documented HIV infection
* Able to participate in study procedures

HIV positive Exclusion Criteria:

* Inability to comprehend or read English (as established by the English proficiency questionnaire)
* Drug or alcohol intoxicated (as determined by the investigator)
* Lack of information in medical records to determine the HAND predictive algorithm (current CD4 count, past CNS HIV-related disease, and duration of HIV therapy)
* Life expectancy \<6 months
* Inability to attend the clinic for required study follow up visits

HIV-negative Inclusion Criteria:

* Negative HIV-1 test within 12 months of study entry

HIV-negative Exclusion Criteria:

* Life time traumatic brain injury leading to loss of consciousness of at least 30 minutes.
* Inability to comprehend or read English (as established by the English proficiency questionnaire).
* Inability to attend the clinic for required study follow up visits.
* History of chronic neurological illness.
* Unstable psychiatric conditions such as bipolar disorder or depression.
* Individuals with psychiatric disorder on the psychotic axis.
* Active or past (within the last 6 months) severe alcohol or substance abuse sufficient, in the investigator's judgement, to prevent completion of tests or Inability to attend for the planned required study follow up visits.

Primary outcomes:
measure: The primary outcome measure is percentage of patients with abnormal (-1.5 SD in 2 domains) CogState battery in HIV positive patients vs HIV negative patients.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04914663: All-extremity Exercise During Breast Cancer Chemotherapy
Official title: All-extremity Exercise as a Novel Strategy for Optimizing Cardiovascular Function During Chemotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-06-04
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.


Eligibility criteria: Inclusion Criteria:

* Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III
* Female
* 18 to 85 years of age
* Scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane)
* Absence of contraindications to exercise
* Study clinician approval
* Able to give consent
* Informed consent obtained from the subject and documentation of subject agreement to comply with study-related process

Exclusion Criteria:

* Do not meet inclusion criteria
* Receiving targeted therapies (CDK4/6 or PARP inhibitors)
* Receiving radiation therapy concurrent with chemotherapy
* Lymphedema stage ≥ 2 prior to study enrollment
* Any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
* Current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)

Primary outcomes:
measure: Change in brachial artery FMD
timeFrame: 12 weeks
measure: Change in global longitudinal strain
timeFrame: 12 weeks
measure: Feasibility, tolerability and safety of exercise training during breast cancer chemotherapy
timeFrame: Monitored throughout the 12 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Integrative Cardiovasculal Physiology Laboratory, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Demetra Christou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01535963: Patient Satisfaction in Cutaneous Surgery
Official title: A Pilot Study of Patient Satisfaction After Cutaneous Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Skin Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cutaneous surgery

Brief summary: The primary objective of this study is to measure the overall level of satisfaction in patients after cutaneous surgery in 4 different categories, including the surgeon, facility, procedure and recovery and outcome.

Detailed description: Secondary objectives are to identify factors associated with patient satisfaction level and determine the correlation between patient satisfaction and surgeon clinical perception.

Eligibility criteria: Inclusion Criteria:

* 18-80 years old
* Is in a self-reported stable health condition
* English speaking
* Is willing and has the ability to understand the study, provide informed consent and communicate with the investigator
* Recommended to have and scheduled for cutaneous surgery
* Agrees to follow-up at scheduled times

Exclusion Criteria:

* Unable to speak or read English
* Did not complete an 8th grade education
* A history of mental illness
* Any other disability or condition that would prevent completion of questionnaire

Primary outcomes:
measure: Patient rating
timeFrame: at time of visit
Secondary outcomes:
measure: Patient ranking
timeFrame: at time of visit
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00646763: A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation
Official title: A Phase II Single Institution Randomized Study Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients Undergoing Autologous Hematopoietic Progenitor Cell Transplant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cytokines
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 35
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 purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.

Detailed description: The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood.

Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with myeloma. All patients must meet criteria for transplantation.

Exclusion Criteria:

* Patients with active, invasive/systemic fungal infection.
* Patients who are pregnant or lactating females.
* Patients with active CNS malignant disease or life expectancy limited by diseases other than the disease for which the patient is being transplanted.
* Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.

Primary outcomes:
measure: The Total Number of CD34+ Cells Collected.
timeFrame: 4 days
measure: Number of Participants for Whom Target Number of CD34+ Cells Were Collected.
timeFrame: 7 days
Secondary outcomes:
measure: Total Number of Days of Apheresis
timeFrame: 7 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: Edmund Waller, MD
role: PRINCIPAL_INVESTIGATOR
References: