louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02532387: Outpatient Treatment of PE and DVT in the Emergency Department
Official title: Outpatient Treatment of Pulmonary Embolism and Deep Vein Thrombosis: Impact of a New Protocol on Emergency Department Efficiency and Patient Safety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Deep Vein Thrombosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a multi-center prospective, observational study of MGH or BWH patients with PE or DVTwith historical and contemporary controls.

Brief summary: Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment.

Detailed description: In the current protocol, we will study the outcomes most likely to influence emergency physician behavior, such as improved Emergency Department (ED) throughput, and decreased ED and Emergency Department Observation Unit (EDOU) length of stay. Metrics such as decreased admissions are also very important to hospital administrators so our results will have impact outside the ED as well. At the end of this study we will demonstrate that a carefully planned and data-driven approach to the outpatient treatment of Pulmonary Embolism (PE) is safe, improves operational metrics, and reduces cost.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older at time of enrollment.
* Subject is diagnosed with acute VTE (DVT or PE) in the MGH or BWH ED or transferred to the MGH or BWH ED (e.g from a clinic or outside hospital) with a diagnosis of acute VTE.
* Subject is treated as an outpatient (i.e. discharged) directly from the ED or admitted to the ED Observation Unit/ED Short Stay Unit on the outpatient treatment protocol.

Exclusion Criteria:

* Subjects admitted from the ED to an inpatient service will not be enrolled as study subjects, but will be used as contemporary controls.
* Subjects who are unable to understand or provide informed consent.
* Subjects unable or unlikely to follow up (e.g. prisoners).

Primary outcomes:
measure: Efficiency & cost of clinical protocol
timeFrame: Up to 30 days
measure: Safety of clinical protocol
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christopher Kabrhel, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01124487: The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers
Official title: The Acute Effects of Oleic Acid Enriched-diets on Lipids, Insulin Sensitivity and Serum Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Profile
Keywords: fat
inflammation
lipids
total cholesterol
Triglycerides
insulin sensitivity
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: University of Malaya
First posted: 2010-05-17
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Objectives: To investigate the acute effects of olive oil, palm olein and lard on lipid profile, insulin sensitivity and inflammatory markers.

Hypothesis: Different dietary fats will alter lipid profile, insulin sensitivity and inflammatory markers postprandially.

Detailed description: A randomized, single blind, crossover design was undertaken to test meals enriched with palm olein vs olive oil vs lard. Volunteers were asked to participate in three postprandial challenges, separated by at least 3-days. Subjects were provided a low fat meal(\<10g fat) the day before the intervention. Fasting blood was collected the next day and the subjects were instructed to consume test meals (50g high fat meal). Further venous blood was collected at 30 min, 1h, 2h, 3h and 4h postprandially.

Primary outcome variable: Triacylglycerol (TAG) Secondary outcome variables: Insulin sensitivity (glucose, insulin), non esterified fatty acids (NEFA), inflammatory markers

Eligibility criteria: Inclusion Criteria:

* Age: 18-45 years
* BMI : 18.5-30 kg/m\^2
* Healthy, men

Exclusion Criteria:

* medical history of cardiovascular disease, cancer, diabetes or chronic diseases
* BMI \< 18.5 OR \> 30 kg/m\^2
* waist hip ratio \> 0.9
* total cholesterol \> 5.2 mmol/L
* triacylglycerol (TAG) \> 2.2 mmol/L
* current use of antihypertensive or lipid lowering medication

Primary outcomes:
measure: Triacylglycerol (TAG)
timeFrame: 4 h
Secondary outcomes:
measure: Insulin sensitivity (glucose, insulin), non-esterified fatty acids (NEFA), inflammatory markers
timeFrame: 4 h
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysian Palm Oil Board
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board and University of Malaya
name: Teng Kim Tiu, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01088087: Effect of Colostrum on Gut Permeability and Endotoxin Level in Chronic Alcoholic Disease
Official title: Effect of Colostrum Administration on Improving Gut Permeability and Serum Endotoxin Level in Chronic Alcohol Drinkers With Hepatic Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Leaky Gut Syndrome
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
Collaborators: name: Cell Biotech Co., Ltd.
First posted: 2010-03-17
Enrollment: 34
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic alcohol ingestion is related with leaky gut syndrome. Colostrum is well-studied that it has a effect of decreasing the degree of leaky gut syndrome.

So the investigators are planning to find out whether Colostrum has a effect of decreasing the degree of leaky gut syndrome.

Detailed description: We randomly sort the participant as placebo group and colostrum group. Each group consists of 17 people. and the duration of our study for one participant is 3 weeks. (Participant takes colostrum for 3 weeks.)

When a person gets leaky gut syndrome, his or her endotoxin and lactulose/mannitol ratio (L/M ratio, in urine) can elevate.

So We will compare the value of those two parameters and LFT. etc. after the administration of colostrum or placebo.

Eligibility criteria: Inclusion Criteria:

* Men aged over 20 who's alcohol consumption per day is 20.0gram average

  * He must agree to participate this trial voluntarily.
* Liver function test within 3 months :

AST more than 30 or ALT more than 33 or Gamma-GT more than 46

* Men who have result of Ultra-sono result of abdomen without Liver cirrhosis

Exclusion Criteria:

* Hepatitis B or C , liver cirrhosis patient
* Men who have undergo bowel operation
* Men who are taking NSAIDs
* Periodontitis or GERD or other G-I tract infection within 2 weeks before enrollment
* Men who have been given anticancer drug within one year
* Men who have been given antibiotics within 2 weeks
* Creatinine level \>= 1.4mg/dl
* Men who are taking G-I motility drugs or anti-ulcer drug
* Milk allergy

Primary outcomes:
measure: endotoxin
timeFrame: 1st visit and 3 weeks after 1st visit
Secondary outcomes:
measure: lactulose/mannitol ratio
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital : Family medicine department
Study officials:
affiliation: Gangnam Severance Hospital
name: Jae Yong Shim, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT06278987: Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture
Official title: Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hip Fractures
Keywords: Hip fractures
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized prospective controlled trial. This will be single blinded trial. Randomization will be 1:1
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery when compared to those who have a fascia iliaca catheter.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing hip fracture repair aged 18-85.

Exclusion Criteria:

* Patients who have an exclusion to regional anesthesia.
* Patients who are pregnant assessed via self-report or pregnancy test if they have taken one.
* Non-English speakers
* Patients who already had their fracture repaired"

Primary outcomes:
measure: Maximum pain score on Post-operative day 30
timeFrame: 30 days post surgery
measure: Opioid use
timeFrame: day 0, 1, 2, 3, 4, 5, 6, 7 post surgery
measure: functional pain scores
timeFrame: day 0, 1, 2, 3, 4, 5, 6, 7 post surgery post surgery
measure: number of patients using opioids
timeFrame: 30 days post surgery
measure: Length of Hospital Stay
timeFrame: 30 days post surgery
measure: Time to first ambulation
timeFrame: 30 days post surgery
measure: Number of patients returned home by Post Operative Day 30
timeFrame: 30 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jason Habeck
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03441087: The Role of TVSG and HS in Determining Endometrial Pathologies
Official title: Ultrasound and Hysteroscopy's Place on the Diagnosis of Abnormal Uterin Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Uterine Bleeding
Keywords: transvaginal ultrasonography
hysteroscopy
abnormal uterine bleeding
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 216
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Although hysteroscopy (HS) and transvaginal ultrasonography (TVSG) are methods in the diagnosis of AUB, there is some suspicion about their efficacy. The aim of this study was to determine the efficacy and safety of HS and TVSG on diagnosing abnormal uterine bleeding(AUB) .216 women admitted to the investigators clinic (Sisli Ethal Training and Research Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 21-51 years of age. These patients were divided into two groups; menopause (71women) and pre-menopause (145 women). HS and endometrial sampling were performed both groups after TVSG.The success of these methods was assessed by kappa analysis


Eligibility criteria: Inclusion Criteria:

* patients who have no history of hysteroscopy and curettage,
* patients who have no history of ovulatory dysfunction
* women who have active vaginal bleeding.

Exclusion Criteria:

* presence of genital infections/PID
* presence of pregnancy
* presence of vaginal or cervical pathology causing vaginal bleeding
* women who are receiving hormonal treatment (COC/HRT)
* patients formerly diagnosed with endometrial pathology
* patients having coagulopathy
* women who are using intrauterine device.

Primary outcomes:
measure: accuracy of diagnostic performance transvaginal ultrasonography and hysteroscopy
timeFrame: up to 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sisli Etfal Research and Training hospital, Obstetrics and gynecology department Istanbul, Marmara Turkey
name: Nefise Nazlı YENIGUL, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05515887: Influence of Shenqu Xiaoshi Oral Liquid on Intestinal Microbiome of Children With Functional Dyspepsia
Official title: Evaluation on the Influence of Shenqu Xiaoshi Oral Liquid for the Intestinal Microbiome of Children With Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyspepsia
Child
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: It has been confirmed that treatment with Shenqu Xiaoshi Oral liquid (SXOL) effectively improves dyspeptic symptoms and is well tolerated. It is not inferior to domperidone syrup and leads to sustained improvement in Chinese children with functional dyspepsia (FD). This study aims to evaluate the possible regulatory effect of SXOL on intestinal microbiome in children with FD, further exploring its related mechanism.


Eligibility criteria: Inclusion Criteria:

1. Outpatients aged 3-14 years old;
2. Meeting ≥1 condition(s): (1)Postprandial fullness;(2)early satiation;(3)Epigastric pain or burning not associated with defecation;
3. Having symptoms at least 2 months and at least 4 days per month before diagnosis;
4. During the 2-wk lead-in period, no relevant drugs for the treatment of dyspepsia and anorexia were used, good eating habits have been established, and the FD symptoms still existed (symptom score≥3).
5. Informed consent was obtained from the parents/guardians of the participant. If the child was more than 8 years old, additional informed consent would be required from the participant.

Exclusion Criteria:

1. Anorexia and dyspepsia caused by certain drugs and confirmed organic diseases such as erosive gastritis, peptic ulcer, etc;
2. Severe malnutrition;
3. Serious primary diseases of the cardiovascular, nervous, respiratory, hepatobiliary and endocrine systems;
4. Mental disorders, intellectual disabilities, and/or communication impairments;
5. Lactose intolerant or allergic to the ingredients of Shenqu Xiaoshi Oral Liquid or Traditional Chinese medicine;
6. Probiotics or antibiotics within 4-wk;
7. Participated in a clinical trial within the past 12-wk;
8. Individuals deemed unsuitable for this clinical trial.

Primary outcomes:
measure: Intestinal microbiome characteristics
timeFrame: Treatment for 2-week
measure: Intestinal microbiome metabolites
timeFrame: Treatment for 2-week
measure: Levels of hormones
timeFrame: Treatment for 2-week
measure: Levels of inflammatory cytokines
timeFrame: Treatment for 2-week
measure: Clinical symptoms evaluation
timeFrame: Treatment for 1-week and 2-week
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Chundi Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01132287: An Evaluation of a Marketed Lubricated Eye Drop in Soft Contact Lens Wearers Who Experience Ocular Dryness
Official title: An Evaluation of a Marketed Lubricated Eye Drop in Soft Contact Lens Wearers Who Experience Ocular Dryness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wear
Keywords: Contact lens wear
lubricant eye drops
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.

Detailed description: The objective of this study is to evaluate subjective comfort associated with the use of a marketed lubricant eye drop, by subjects reporting ocular dryness and wearing soft contact lenses on a daily disposable replacement schedule.

Eligibility criteria: Inclusion Criteria:

* Normal eyes

Exclusion Criteria:

* Topical ocular medication use Unstable or active ocular issues

Primary outcomes:
measure: Subjective Comfort
timeFrame: 14 days
Secondary outcomes:
measure: Slit Lamp
timeFrame: 14 Days
measure: Visual Acuity
timeFrame: 14 Days
Other outcomes:
Locations:
Study officials:
References:
citation: McDonald M, Schachet JL, Lievens CW, Kern JR. Systane(R) ultra lubricant eye drops for treatment of contact lens-related dryness. Eye Contact Lens. 2014 Mar;40(2):106-10. doi: 10.1097/ICL.0000000000000018.
Clinical trial NCT01999387: Follow up of Patients After Oral Immunotherapy for Cow's Milk, Eggs and Peanuts
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergy
Keywords: food
consumption
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-03
Enrollment: 500
Sex: ALL
Minimum age (years): 4
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 4 years old with IgE mediated allergy to cow;s milk, eggs or peanuts who completed an OIT program \>6 months ago

Brief summary: Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction.

Recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and peanuts.

We conduct an oral immunotherapy program with \~500 patients so far. In this study we intent to follow patients who completed the program and assess their allergy status and quality of life.

Detailed description: Food allergy is a potentially life threatening condition. The current practice consists of elimination diet and injectable epinephrine in case of a reaction.

Recently, oral immunotherapy (OIT) has emerged as an treatment for food allergy in milk eggs and peanuts. Since 4/2010,a clinical OIT program for milk eggs and peanuts is performed at the Institute fir Allergy Asthma and Immunology at Assaf Harofeh Medical Center with \~500 patients so far. Patients with IgE-mediated food allergy that are \>4 years old are eligible.

In this study we intent to follow patients who completed the program. Patients will fill a questionnaire regarding current consumption of the allergenic food, adverse reactions experienced and treatments required including the use of EpiPen. Patients underwent skim prick tests (SPT) for the allergenic food prior to initiation and treatment and will undergo SPT again upon entering the study. Blood tests for IgE, IGG4, basophil activation and cytokines will be obtained.

Patients who are not consuming the allergenic food regularly will undergo an oral food challenge in clinic.

Eligibility criteria: Inclusion Criteria:

* age\>4 years old IgE mediated allergy to milk eggs or peanuts Completion of OIT \>6 months ago

Exclusion Criteria:

* Non approval to participate

Primary outcomes:
measure: Allergenic food consumption questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Asaf Harofeh Medical Center
Study officials:
affiliation: Asaf Harofeh Medical enter
name: Yitzhak Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05189587: Home-based Transcranial Electrical Stimulation (TES) in Patients With Chronic Tinnitus
Official title: A Preliminary Clinical Trial for Efficacy of Non-invasive Home-based Transcranial Electrical Stimulation (TES) Therapy in Patients With Intractable Chronic Tinnitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Depression
Depressive Disorder
Hearing Disorders
Otorhinolaryngologic Diseases
Keywords: Transcranial electrical stimulation
Tinnitus
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators applied home-based transcranial electrical stimulation (TES) for neuromodulative treatment in patients with intractable chronic tinnitus.

Detailed description: For treatment of motor and psychiatric disorders, transcranial electrical stimulation including transcranial direct current stimulation (tDCS), transcranial magnetic stimulation (TMS), or transcranial random noise stimulation (tRNS) are in use worldwidely. The investigators applied these neuromodulation techniques into patients with intractable chronic tinnitus for symptom relief. Experimental groups with 60 subjective tinnitus subjects will be consisted of three different treatment groups which are: TES group, TES with sham stimulation group, and control group. Subjects will be given 1.0 milliampere (mA) TES on bifrontal areas for neuromodulation.

Eligibility criteria: Inclusion Criteria:

* Research volunteers with intractable chronic tinnitus who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the Department of Otorhinolaryngology Head-and-Neck Surgery, Seoul National University Bundang Hospital

Exclusion Criteria:

* psychoactive drug user
* implanted material
* pacemaker user

Primary outcomes:
measure: Tinnitus handicap inventory (THI)
timeFrame: the same 1 week after treatment
Secondary outcomes:
measure: resting-state quantitative electroencephalography (rs-qEEG)
timeFrame: the same 1 week after treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Bae EB, Lee JH, Song JJ. Single-Session of Combined tDCS-TMS May Increase Therapeutic Effects in Subjects With Tinnitus. Front Neurol. 2020 Mar 27;11:160. doi: 10.3389/fneur.2020.00160. eCollection 2020.