louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03804333: Short Course Radiation Therapy in Palliative Treatment of Pelvic Cancer
Official title: SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Pelvic Cancer: an Interventional, Randomized, Multicentric Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Cancer
Radiotherapy
Palliative Care
Keywords: short course radiotherapy
symptomatic pelvic lesions
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 54
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: Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic pelvic malignant lesions

Detailed description: standard treatment for pelvic lesions (300 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility criteria: Inclusion Criteria:

* symptomatic pelvic malignant lesions (primary solid tumors or metastases from solid tumor)
* age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region

Primary outcomes:
measure: efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
timeFrame: 3 months
Secondary outcomes:
measure: acute toxicity in the two treatment groups
timeFrame: 3 months
measure: late toxicity in the two treatment groups
timeFrame: 12 months
measure: Quality of Life (QoL) assessment in the two groups: EORTC questionnaire C15-PAL
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
state: BO
Study officials:
affiliation: Radiation Oncology Center, Dept of Experimental, Diagnostic and Speciality Medicine-DIMES, University of Bologna, S.Orsola-Malpighi Hospital
name: Alessio G Morganti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02852733: Better Understand End-of-life Emergencies' Management Among Elderly in Nursing Homes: a Pilot Study in Brittany, France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Died
in End-of-life Situation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Résidents of 150 nursing homes randomly selected in Brittany

Brief summary: The purposes of this study are :

* To know and to understand frequency and variability (quantitative and qualitative) of end-of-life emergencies in nursing homes.
* To know and to understand practices applied in these situations depending on the institution and the different reasons of hospital use.
* To know and to understand the practical and organizational elements, in nursing homes, that can determine a (re) hospitalization or an end-of-life


Eligibility criteria: Inclusion Criteria:

* dead residents during the quarter preceding the date of the Survey Or
* Residents in end-of-life situation the day of the survey, as determined by the physician coordinator of nursing homes (we will use the definition of "terminal condition" contained in the guide of the CNSA (coding PATHOS - April 2011)).

Exclusion Criteria:

* patients opposing the study,
* patients aged below 18 year old

Primary outcomes:
measure: number of end-of-life emergencies' episodes
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de RENNES
Study officials:
affiliation: Rennes University Hospital
name: Francoise FR RIOU, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02782533: DBS of the Third Ventricle for Cluster Headache and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cluster Headache
Obesity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study of Deep Brain Stimulation of the Third ventricle in Cluster Headache and Obesity treatment.


Eligibility criteria: Inclusion Criteria :

* Male or female aged between 18 and 65 years
* Ambulatory or hospitalized monitoring
* Fluent in French and able to understand the study procedures, including completing the auto-questionnaires
* Registered in the French social security scheme
* Signed informed consent of the patient will be collected before inclusion in the study
* Cluster Headache or Obesity patients

Exclusion Criteria:

* Contraindication to Magnetoencephalography (MEG) and/or Electroencephalography (EEG)
* Contraindication to Magnetic resonance imaging (MRI)
* All categories of protected persons

Primary outcomes:
measure: Quality of Life Questionnaire
timeFrame: weekly up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CLINATEC
Study officials:
References:
Clinical trial NCT03411733: Prevalence of H.Pylori in Patients With Acne Vulgaris Acne Vulgaris
Official title: Prevalence of Helicobacter Pylori in Patients With Acne Vulgaris
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori Infection
Acne Vulgaris
Keywords: acne vlugaris
prevalence
Helicobacter Pylori
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acne vulgaris and presented to Dermatology outpatient clinic, Sohag University hospital.

Healthy volunteers.

Brief summary: The objective of the study is to investigate prevalence of H.Pylori infection among acne vulgaris patients.

Detailed description: The study included patients with acne vulgaris and healthy control participants. The study recruited both sexes, all grades of acne, adolescents and young adults.

All patients were subjected to complete history, general and skin examination Acne vlugaris Patients were classified into mild, moderate and severe according to the classification of American Academy of dermatology for acne vulgaris.

Detection of H. pylori infection:

Blood and stool samples were taken from each participant and was directly transferred to laboratory for detection of H. Pylori antigen and antibody.

An enzyme-linked immune sorbent assay (ELISA) was used for quantitative assessment of IgG antibodies against H.Pylori in human serum.

A monoclonal antibodies based enzyme-linked immunosorbent assay was used to detect H.Pylori specific antigen in stool samples.

Eligibility criteria: Inclusion Criteria:

* Acne vulgaris patients
* Healthy volunteers (control)

Exclusion Criteria:

* Patients with a history of drug intake that affects H. Pylori such as proton-pump inhibitors, clarithromycin, tetracyclines, amoxicillin or metronidazole within previous two weeks were excluded.

Primary outcomes:
measure: H.pylori infection
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Dermatology outpatient clinic, Sohag University Hospital
Study officials:
affiliation: Sohag Faculty of Medicine
name: Ramadan Saleh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01817387: Enhancing Motivation in Recent Onset Schizophrenia
Official title: Developing an Intervention Strategy to Enhance Motivation in Recent Onset Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This project will result in the development of a personalized intervention strategy to improve motivation for treatment engagement and functional outcomes in individuals with a recent onset of schizophrenia. Motivational impairment is arguably the single most important factor that determines a patient's ability to engage in and adhere to effective treatment. In our study, sixty participants will be enrolled in a randomized controlled trial comparing the feasibility and tolerability of two types of motivational interventions (Daily Goals or PRIME), and a neuroplasticity-based cognitive training program. Participants are randomized to either receive Daily Goals or PRIME for 8 weeks, after which, both conditions will also receive an 8-week course of cognitive training delivered via iPads. Participants will undergo pre/post-testing and a 6-month follow-up to determine feasibility and efficacy of the interventions. By enhancing motivation, schizophrenia patients would be able to engage more fully with treatment and develop full and productive lives. This study may also pave the way forward for other health conditions in which motivational impairments impede health outcomes.

All assessments will be conducted at the University of California, San Francisco; however, we offer some assessments to be done remotely.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder.
* Onset of diagnosis within 5 years.
* 14-30 years old.
* Clinically stable (outpatient status for 1 month and stable dose of medication for 1 month).
* Good general health

Exclusion Criteria:

* Substance dependence within the past 12 months,
* Current substance abuse,
* No history of neurological disorder

Primary outcomes:
measure: Psychosocial functioning
timeFrame: past 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Danielle A Schlosser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01439087: Optical Frequency Domain Imaging for Assessing Colonic Polyps
Official title: Pilot Study to Evaluate Optical Frequency Domain Imaging as a Tool for Assessing Colonic Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyps
Keywords: Colonic Polyps
OCT
Imaging
Colon
Polyp
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this research is to conduct a pilot clinical study to image colonic polyps with the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to identify the extent of invasion (if present), differentiate between hyperplastic polyps and adenomas, and identify serrated polyps.

Detailed description: The colon OFDI catheter will be used in conjunction with a sigmoidoscope. If a sigmoid polyp is identified, the colonoscope will be removed and a sigmoidoscope inserted. The colon OFDI catheter will be advanced through the sigmoidoscope accessory port and positioned adjacent to the colon wall. Imaging will be performed with the OFDI system across the polyp's surface and the base/stalk if pedunculated. The investigators anticipate that on average the investigators will utilize 4 helical scans per polyp. Each of the scans will take less than 30 seconds.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a screening colonoscopy
* Patients must be over the age of 18
* Patient must be able to give informed consent

Exclusion Criteria:

* Patients with hemostasis disorders
* Patients taking any anti-coagulants such as Coumadin or Plavix,

Primary outcomes:
measure: Feasibility and Sensitivity of OFDI Imaging in the Colon
timeFrame: During the OFDI imaging session which should take an average of 5 mintues
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00731887: Large Burn Outcome Study
Official title: Assessment of the Treatment of the Severely Burned With Anabolic Agents on Improved Wound Healing, Recovery and Rehabilitation: Large Burn Outcome Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Burns
Keywords: Burn injury
Burn recovery
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
name: Shriners Hospitals for Children
First posted: 2008-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those that have received a burn injury at least 3 years ago and that recieved acute burn treatment at Shriners Hospital for Children - Galveston between 1986-2005.

Brief summary: To examine long term physical and psychosocial outcomes of pediatric burn survivors. We want to learn about thoughts, feelings, coping style, social support, and overall adjustment following burn injury.

Detailed description: To evaluate the long term quality of life of adolescents and adults who suffered severe pediatric burns. This study will include an array of physical and psychosocial assessments, thus providing a unique and complete set of information on the long term outcomes in this population.

Eligibility criteria: Inclusion Criteria:

* At least 60% third degree total body surface area
* Acute burn treatment at Shriners Burns Hospital for Children - Galveston between 1986-2005
* Three years post injury
* Current age of at least 16 years

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01813487: Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E
Official title: Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy in Patients Who Have Been Treated With HB110E Hepatitis B DNA Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis B
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the immunogenicity and efficacy of HBsAg Vaccine in combination with Entecavir in patients who have been treated with HB110E HBV DNA vaccine.


Eligibility criteria: Inclusion Criteria:

* subjects who have been treated with HB110E 2mg or 4mg within 6 months prior to screening.
* positive HBsAg at screening
* serum HBV DNA level below 300copies/mL at screening
* ALT level within 2 x ULN at screening
* voluntarily provide the informed consent

Exclusion Criteria:

* participation in other study within 30 days of screening
* subjects with severe allergic reaction or severe adverse event to HBsAg vaccine, or not suitable for HBsAg vaccine.
* any other conditions that are considered inappropriate for the study by the investigator

Primary outcomes:
measure: Immunogenicity: HBV specific T-cell response by ELISPOT
timeFrame: Change from Baseline in HBV specificic T-cell response at 16 weeks
Secondary outcomes:
measure: HBsAg titer
timeFrame: Change from baseline in HBsAg titer at 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Seung Yoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03023787: Study of Hepalatide(L47) at Phase Ib in Healthy Volunteers
Official title: A Randomized, Double-Blinded, Safety and Pharmacokinetic Study of Escalating Single Doses of Hepalatide in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B， Chronic
Lead sponsor: Shanghai HEP Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-01-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.

Detailed description: This is a randomized, double-blinded, dose escalating, phase Ib trial, which will be conducted in No. 302 Hospital of China. There are three cohorts at dose of 4.2mg, 6.3mg and 8.4mg. All healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, all healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be observed for 3 days.

Eligibility criteria: Inclusion Criteria:

* Ages between 18 and 45 years
* BMI Index between 19 and 25 (BMI=weight/height2)
* Normal previous history and physical exam
* No drug and alcohol abuse
* No illness in 4 weeks and no drug therapy in 2 weeks
* No blood donation or subject not sampled in 3 months
* Consistent and correct use of recommended methods of birth control for men and women
* Good compliance with study protocol
* Understand and agree to sign a consent form

Exclusion Criteria:

* Infection with HAV, HBV, HCV, HEV, HIV, EBV or CMV
* Abnormal and clinical significance test of physical examination, vital signs, blood routines, urine routines, liver and kidney functions, coagulation indicator, electrolyte, glucose, blood lipid, thyroid functions, chest X-Ray, ECG, B ultrasound of gallbladder, spleen and kidney, AFP ,and CEA
* Positive for anti-Pre-S1 antibody
* Women being pregnant or nursing, or with abnormal sex hormones, B ultrasound of ovaries/uterus proliferative diseases or breast mass
* Unable to quit smoking in trial
* Subject with little chance of enrollment (i.e. the weak)
* Subject not suitable to join the trial under other circumstances judged by investigator.

Primary outcomes:
measure: Healthy participants with treatment-related adverse events as assessed by "guiding principle of grading standards for the adverse reactions in clinical trials of vaccine for prevention" or CTCAE v4.0
timeFrame: 6 months
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 6 months
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 6 months
measure: half-time
timeFrame: 6 months
measure: apparent volume of distribution
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hospital
Study officials:
affiliation: 302 Military Hospital
name: zhenman wei
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03816787: Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain
Official title: Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oxygen Metabolism
Muscle Spasticity
Keywords: Cupping Therapy
Near Infrared Spectroscopy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2019-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the hemodynamic changes during dry cupping therapy (DCT) on low back pain. 50 patients with low back pain as experimental group and 50 healthy people as control group are treated by DCT. They will receive four consecutive WCT application in one month. Optical sensors were used to monitor the hemodynamic changes including oxyhemoglobin (\[HbO2\]), deoxy-hemoglobin (\[Hb\]) and the derived change in blood volume (\[tHb\]) in/surround the cupping sites during treatment. The investigators hope to interpret the curative effect of DCT from the perspective of modern hemodynamics.


Eligibility criteria: Inclusion Criteria:

* Patients who have had non-specific low back pains at least 12 weeks now.
* Healthy people who are interested in dry cupping therapy

Exclusion Criteria:

* Patients who have had non-specific low back pains at least 12 weeks now.
* Healthy people who are interested in dry cupping therapy

Exclusion Criteria:

* Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
* Patients who are inappropriate to the wet cupping treatment.

  * AIDS, Active Hepatitis, Tuberculosis, Syphilis
  * Patients who regularly take anticoagulants, antiplatelet drugs
  * Anemia, thrombocytopenia
  * Hemorrhagic disease like hemophilia
  * Diabetes
  * Severe cardiovascular disease
  * Kidney diseases (renal failure, chronic renal disease)
* Patients who have experiences of wet cupping treatment during last 3 months.
* Patients who have had treatment for low back pain during last 2 weeks.
* Patients who are in pregnancy or have plan to conception.
* Patients who have vertebra surgery or have plan of surgery.
* Patients who are inappropriate to join this trial judged by the radiologists or specialists.

Primary outcomes:
measure: Δ[HbO2]
timeFrame: all groups: up to 4 weeks
measure: Δ[Hb]
timeFrame: all groups: up to 4 weeks
Secondary outcomes:
measure: Δ[tHb]
timeFrame: all groups: up to 4 weeks
measure: NRS
timeFrame: experimental group: up to 4 weeks
Other outcomes:
Locations:
Study officials:
References: