louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04578730: aCute HemORrhoidal Disease evALuation International Study
Official title: A Prospective, Observational (Non-interventional), International Study to Assess Conservative Treatments Effectiveness in Acute Phase of Hemorrhoidal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhoids
Keywords: observationnal
QoL
Lead sponsor: Servier
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 3592
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 suffering from hemorrhoidal disease in the acute phase

Brief summary: The primary objective of this study is to assess in real-life setting the effectiveness of conservative treatments on signs, symptoms and quality of life in patients consulting for hemorrhoids in acute phase of the disease


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years old;
* Patient consulting for symptomatic acute phase of hemorrhoidal disease
* Confirmed diagnosis of hemorrhoidal disease

Exclusion Criteria:

* Patient consulting for emergency not related to hemorrhoidal disease;
* Patient currently taking any treatment for hemorrhoidal disease;
* Any anorectal procedure or surgery planned during the study ;
* Anorectal procedure or surgery performed or incomplete convalescence following anorectal procedure/surgery;
* Known present perianal sepsis, inflammatory bowel disease, colorectal malignancy, pre-existing sphincter injury, diseases of the anal canal;
* Pregnant or breastfeeding woman.

Primary outcomes:
measure: Global improvement
timeFrame: Week 4
measure: Signs and symptoms severity: pain, discomfort, bleeding, prolapse, swelling, itching, and soiling
timeFrame: Week 4
measure: Quality of Life
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Servier Affaires Medicales
Study officials:
References:
Clinical trial NCT03308630: Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents
Official title: Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents: Stomach Aches, Musculoskeletal Pains, and Headaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Related Disorder
Musculoskeletal Pain
Headache
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
name: Hong Kong Academy of Yoga Therapy
First posted: 2017-10-12
Enrollment: 218
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Psychiatrists have expressed concern at the emergence of education as a serious source of stress for school-going children - causing high incidence of deaths by suicide. Many adolescents in India are referred to hospital psychiatric units for school-related distress - exhibiting symptoms of depression, high anxiety, frequent school refusal, phobia, physical complaints, irritability, weeping spells, and decreased interest in school work. Previous studies have found significant anxiety, distress, depression, worn outs and severe impact of psychological factors on the performances of dental, engineering and medical student. But students preparing for competitive exams have not been studied yet.

Current study reports the scientific evidence of immediate effect of yoga based techniques combined with music and Vedic chants on adolescents preparing for competitive exams.


Eligibility criteria: Inclusion Criteria:

* All adolescents enrolled at the participating centers and that agree to sign informed consent.

Exclusion Criteria:

* not agreement to sign the informed consent

Primary outcomes:
measure: Self reported Stress
timeFrame: 2 Weeks
Secondary outcomes:
measure: Change in Musculo-skeleton Pain measured on VAS
timeFrame: 2 weeks
measure: Change in Headache severity on VAS
timeFrame: 2 weeks
measure: Change in Stomach pain on VAS
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bikaner
country: India
facility: NMP Medical Research Institute
state: Rajasthan
Study officials:
affiliation: Hong Kong Academy of yoga therapy, Hong Kong
name: Naveen Meghwal
role: PRINCIPAL_INVESTIGATOR
affiliation: Warwick Research Services
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: NMP Medical Research Institute, India
name: Puneet Sharma
role: STUDY_CHAIR
References:
Clinical trial NCT00004330: Studies in Porphyria IV: Gonadotropin-Releasing Hormone (GnRH) Analogues for Prevention of Cyclic Attacks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Porphyria
Keywords: inborn errors of metabolism
porphyria
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-10-19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: OBJECTIVES:

Assess whether chronic administration of gonadotropin-releasing hormone analogues is safe and effective for the prevention of cyclic attacks of acute porphyria in women.

Detailed description: PROTOCOL OUTLINE: All patients receive a gonadotropin-releasing hormone (GnRH) analogue. Treatment begins on days 1 to 3 of a menstrual cycle.

Low-dose estrogen begins at approximately 3 months. All patients must have a daily calcium intake of at least 1 gram; supplements are allowed.

Patients are followed for at least 1 year.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Acute porphyria, i.e.: Acute intermittent porphyria Hereditary coproporphyria Variegate porphyria Definite cyclic attacks with severe abdominal pain and other porphyria symptoms during luteal phase of menstrual cycle only Attacks resolve completely within 5 days of onset of menses, i.e., no symptoms between attacks At least 4 to 6 attacks during the 6 months prior to entry More than half of these attacks must meet the following criteria: Readily distinguishable from menstrual cramps and premenstrual syndrome Required hospitalization for narcotic analgesics, phenothiazines, hematin, intravenous fluids, or other treatment Luteal attacks not requiring hospitalization must be similar in symptoms and differ only in severity No life-threatening porphyria attacks No cyclic abdominal pain unless caused by porphyria --Prior/Concurrent Therapy-- At least 6 months since ovulation suppression --Patient Characteristics-- Reproductive: Menstrual cycle 25-35 days for at least 6 months prior to entry Pelvic exam normal within 60 days prior to entry Pap smear normal, i.e., no dysplasia No amenorrhea No other menstrual abnormality No other gynecologic abnormality Negative pregnancy test Medically approved contraception required for 2 months prior to entry and throughout study OR at least 1 menstrual cycle following tubal ligation Other: No allergy to gonadotropin-releasing hormone analogues No clinically significant abnormal laboratory test results No medical contraindication to protocol treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Karl E Anderson
role: STUDY_CHAIR
References:
Clinical trial NCT01028430: B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging
Official title: B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Lymphocytic Leukemia Community Sample

Brief summary: B-CLL is the most prevalent leukemia in the Western hemisphere, accounting for \~25% of all leukemia's (1). This disease occurs virtually exclusively in the aging population, with the median age of diagnosis ranging between the mid 60s and the early 70s. Indeed, its occurrence before the age of 50 is quite unusual. This increase in occurrence with age is not unique to B-CLL; rather, it is characteristic several B cell lymphoproliferative disorders (e.g., non-Hodgkin's lymphoma, multiple myeloma). Gender and race also influence the development of B-CLL. Thus, the ratio of men: women is \~2:1 and the prevalence is increased in Caucasians. The rate of occurrence of B-CLL among Asians is significantly lower than for Caucasians and this does not increase with immigration to the West. DNA sequence analyses performed in our laboratory and in those of others indicate that B-CLL cells from unrelated patients share Ig V gene characteristics. These include the use of selected genes, the association of these genes with certain D and JH gene segments that code for unique CDR3 motifs, and the occasional occurrence of highly similar VHDJH + VLJL pairs. In \~50% cases, these rearranged genes are mutated, whereas in the others mutations are infrequent; this difference is related to the VH gene family used by the B-CLL cell.


Eligibility criteria: Inclusion Criteria:

* 18 years of age Patients must be willing to be contacted in the future

Exclusion Criteria:

* Patients who are known to be anemic, with a hemoglobin \<8 PAtients who are known to be infected with HIV

Primary outcomes:
measure: expression of cell surface antigens HLA-DR and CD38+ markers in B-CLL cells compared to normal B-lymphocytes
timeFrame: samples will be taken at the beginning, week 2, 4,6,8,12,and 24 (for blood), and bone marrow samples at weeks 2 and 6.
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: Northwell Health
name: Nicholas Chiorazzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00590330: Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs
Official title: Microbial Community Composition and Dynamics in Lungs of Cystic Fibrosis Sibling Pairs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2008-01-10
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pulmonary clinic

Brief summary: The purpose of this study is to identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF), and to connect them with clinical information. Traditional culture methods of throat swab and sputum samples can only identify the most prevalent bacteria in samples, those of which there are over about 5 million bacteria per teaspoon. A recently developed method has been found to be more sensitive and can detect up to several hundred bacterial species in throat swab or sputum sample of individual CF patients.

Detailed description: This study does not include testing of any investigational drugs and this is a noninvasive study requiring only a sputum/swab sample paired with information contained in the routine clinic letters and laboratory results your CF physicians obtain at your regular clinic visits.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 1-16 upon enrollment
* Diagnosis of Cystic Fibrosis

Exclusion Criteria:

* None

Primary outcomes:
measure: To identify all the bacterial species present in the respiratory tracts of patients with Cystic Fibrosis (CF).
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Thomas Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912730: A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma
Official title: A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: melanoma
imaging
sentinel node
biopsy
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with melanoma scheduled to undergo sentinel node biopsy as part of recommended clinical care, age 18 years or older.

Brief summary: This is a single-institution pilot study seeking preliminary evidence of the usefulness of mobile gamma cameras in patients undergoing sentinel node biopsy for melanoma.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older, AND
* plan to go to the operating room for sentinel node biopsy using technicium-99 labeled colloid.

Exclusion Criteria:

* under 18 years of age,
* unable to give informed consent, OR
* not planned to go to operating room for sentinel node biopsy using technicium-99 labeled colloid.

Primary outcomes:
measure: Sensitivity of the Mobile gamma camera (MGC)for detection of sentinel nodes, compared to fixed gamma camera (primary)
Secondary outcomes:
measure: sensitivity of the MGC for detection of sentinel nodes, compared to handheld gamma probe (secondary)
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Craig L Slingluff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02098330: The Efficacy of Steroid Therapy in Vestibular Neuritis
Official title: The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vestibular Neuritis
Keywords: Vestibular neuritis
Vertigo
Head impulse test
Steroid
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the treatment effectiveness of steroid therapy for vestibular neuritis by using video head impulse test.

Detailed description: This study was a prospective, randomized controlled study. The enrolled vestibular neuritis patients were randomized to conservative treatment or steroid treatment when they are diagnosed with caloric test. After initial vestibular work-up including caloric, video head impulse tests, and a questinnaire (DHI), the patient was examined with the same tests again at 6 months later. The efficacy of steroid for the patients with vestibular neuritis would be determined by the comparison of the data of each group.

Eligibility criteria: Inclusion Criteria:

* Ages over 18 years
* Acute vertigo that occurred within 7 days
* The spontaneous nystagmus should be detected
* Caloric weakness over 20%

Exclusion Criteria:

* Suspicious or verified a central nervous system lesion
* If the patient has denied.
* Other otologic disease (acute/chronic otitis media, otosclerosis, etc)
* The patient with history of otologic surgery
* The patient with history of brain surgery

Primary outcomes:
measure: The improvement in vestibular function test (caloric & videop HIT) after treatment
timeFrame: The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.
Secondary outcomes:
measure: The improvement in dizziness handicap inventory after treatment
timeFrame: The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Hong Ju Park, Professor
role: STUDY_DIRECTOR
References:
citation: Yoo MH, Yang CJ, Kim SA, Park MJ, Ahn JH, Chung JW, Park HJ. Efficacy of steroid therapy based on symptomatic and functional improvement in patients with vestibular neuritis: a prospective randomized controlled trial. Eur Arch Otorhinolaryngol. 2017 Jun;274(6):2443-2451. doi: 10.1007/s00405-017-4556-1. Epub 2017 Apr 8.
Clinical trial NCT01319630: The Effect of Three Different Fluids(Albumin 5%, Normal Saline, Hydroxyethyl Starch 130 kD) on Microcirculation in Severe Sepsis/Septic Shock Patients
Official title: The Effect of Three Different Fluids(Albumin 5%, Normal Saline, HES 130 kD) on Microcirculation in Severe Sepsis/Septic Shock Patients Using Sidestream Dark Field (SDF) Microscopy and Near-Infrared Spectroscopy (NIRS) Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Septic Shock
Microcirculation
Keywords: sepsis
microcirculation
saline
crystalloid
colloid
albumin
hydroxyethyl starch
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2011-03-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients admitted to the Intensive Care Unit with diagnosis of sepsis.

Brief summary: Major microvascular blood flow alterations have been documented in patients with severe sepsis. It was also demonstrated that the microcirculation improved in survivors of septic shock but failed to do so in patients dying from acute circulatory failure or with multiple organ failure after shock resolution. Early, effective fluid resuscitation is a key component in the management of patients with severe sepsis and septic shock with the goal of improving tissue perfusion. The best fluid in this early resuscitation phase has been and still is under debate. The aim of this study is to evaluate the effect of Three different Fluids(Albumin 5%, Normal Saline, HES 130 kD) on microcirculation in severe sepsis/septic shock patients using Sidestream Dark Field (SDF) Microscopy and Near-Infrared Spectroscopy (NIRS) analysis.


Eligibility criteria: Inclusion Criteria:

* Adult patients will be enrolled within 24 hrs of onset of severe sepsis/septic shock with an indication for fluid bolus administration.

Exclusion Criteria:

* Liver cirrhosis
* shock from other causes
* Oral injuries (precluding SDF imaging)
* Severe peripheral vascular disease, dialysis fistula, or mastectomies precluding safe forearm occlusion
* Age \< 18 years

Primary outcomes:
measure: Microcirculatory perfusion and flow variables
timeFrame: 1 hour after fluid bolus
measure: Muscle tissue oxygenation and oxygen consumption
timeFrame: 1 hour after fluid bolus
measure: change in microcirculatory and oxygenation variables
timeFrame: 1 hour after fluid bolus compared to baseline microcirculatory and oxygenation variables
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
Study officials:
affiliation: Mercy Hospital St. Louis
name: Farid G Sadaka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03342430: Early Dieting in Girls: a Longitudinal Cohort Study
Official title: Early Dieting in Girls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Behavior
Dietary Habits
Weight, Body
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 197
Sex: FEMALE
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Families in central Pennsylvania with a 5-6 year old daughter.

Brief summary: This longitudinal observational cohort followed the growth and development of non-Hispanic white girls from age 5 to 15 years, with a focus on the development of the controls of food intake.

Detailed description: This longitudinal observational cohort followed the growth and development of non-Hispanic white girls from age 5 to 15 years, with a focus on the development of the controls of food intake. Data was collected biennially from girls and their mothers and fathers. Measures included anthropometrics, questionnaires and laboratory measures of eating behavior, dietary recalls, psychosocial characteristics, and parenting measures.

Eligibility criteria: Inclusion Criteria:

* Living with both biological parents

Exclusion Criteria:

* Severe food allergies
* Chronic medical conditions affecting food intake

Primary outcomes:
measure: Dieting practices
timeFrame: Pattern of development from age 5 to 15 years
measure: Dietary restraint
timeFrame: Pattern of development from age 5 to 15 years
measure: Disinhibition
timeFrame: Pattern of development from age 5 to 15 years
measure: Disordered eating
timeFrame: Pattern of development from age 5 to 15 years
Secondary outcomes:
measure: Body mass index
timeFrame: Age 5, 7, 9, 11, 13, and 15 years
measure: Total body bone mineral content
timeFrame: Age 9, 11, 13, and 15 years
measure: Dietary intake
timeFrame: Age 5, 7, 9, 11, 13, and 15 years
Other outcomes:
Locations:
Study officials:
affiliation: Penn State University (at time study was conducted)
name: Leann L Birch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hohman EE, Balantekin KN, Birch LL, Savage JS. Dieting is associated with reduced bone mineral accrual in a longitudinal cohort of girls. BMC Public Health. 2018 Nov 22;18(1):1285. doi: 10.1186/s12889-018-6206-y.