louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03119311: A Novel Diagnostic Method for Exotropia Using Video-oculography
Official title: A Novel Diagnostic Method for Exotropia Using Video-oculography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strabismus
Exotropia
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 34
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Thirty-four subjects with constant exotropia were included. Two independent ophthalmologists measured the angle of ocular deviation using alternate prism cover test (APCT). The video files and data with the changes in ocular deviation during the alternate cover test were obtained using video-oculography (VOG). To verify the accuracy of VOG, Investigator compared the value obtained using VOG and the angle of a rotating model eye, and subsequently made a new linear equation using these data. The calculated values obtained using VOG were compared with those obtained using APCT to determine the diagnostic accuracy of VOG.


Eligibility criteria: Inclusion Criteria:

* have horizontal strabismus, cooperative, visual acuity \>= 1.0/1.0

Exclusion Criteria:

* have vertical strabimus\> 5prism diopter, not cooperative, no agree

Primary outcomes:
measure: The angle of ocular deviation (degree,°) measured by VOG and PCT
timeFrame: 2 weeks after approval
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik hospital
Study officials:
References:
citation: Park N, Park B, Oh M, Moon S, Kim M. A quantitative analysis method for comitant exotropia using video-oculography with alternate cover. BMC Ophthalmol. 2018 Mar 22;18(1):80. doi: 10.1186/s12886-018-0747-9.
Clinical trial NCT01530711: Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response
Official title: Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cirrhosis
Hepatorenal Syndrome Type I
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response.


Eligibility criteria: Inclusion Criteria:

* Patients with hepatorenal syndrome type 1.
* Signed informed consent.
* No exclusion criteria.
* At least 18 years old
* Negative pregnancy test in serum or urine in women of childbearing age, and agree to use adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last.

Exclusion Criteria:

* Hepatocellular carcinoma: exclusion of patients with hepatocellular carcinoma who present more than 3 nodules, single nodule larger than 5 cm, tumor portal thrombosis or extrahepatic tumor spread.
* Active bacterial infection with symptoms of systemic inflammatory response (fever, tachycardia, tachypnea, hypotension, septic or blood count).
* Cardiac or respiratory failure clinically significant.
* Clinically significant peripheral artery disease.
* A history of ischemic heart disease.
* Hypersensitivity to terlipressin and / or albumin or any of the excipients.
* Pregnancy.
* Septic shock.
* Chronic renal failure.
* Women in lactation

Primary outcomes:
measure: Changes in arterial pressure and creatinine
timeFrame: 4 months
Secondary outcomes:
measure: Changes in plasmatic renin activity and aldosterone and noradrenaline concentration.
timeFrame: 4 months
measure: Treatment-related adverse events
timeFrame: 4 months
measure: Hepatorenal Syndrome reversion due to hemodynamic changes.
timeFrame: 4 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital Moisés Broggi
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: gsoriano@santpau.cat
name: German Soriano Pastor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: jcordoba@vhebron.net
name: Juan Cordoba, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ICirera@parcdesalutmar.cat
name: Isabel Cirera Lorenzo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: martinllahi@gmail.com
name: Marta Martín Llahí, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: jsanchezd@tauli.cat
name: Jordi Sánchez Delgado, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04119011: Probiotics in Women With Primary Dysmenorrhoea
Official title: A Novel Approach to Manipulate Intestinal Homeostasis in Primary Dysmenorrhoea Women: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Primary Dysmenorrhea
Keywords: probiotics
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: B-Crobes Marketing(M) Sdn Bhd
First posted: 2019-10-08
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized placebo-controlled trial
Primary purpose: TREATMENT

Brief summary: This study compares the effect of probiotics versus placebo in women with primary dysmenorrhoea

Detailed description: This is a randomized controlled trial comparing probiotics against placebo in women with primary dysmenorrhoea

Eligibility criteria: Inclusion Criteria:

* regular menstrual cycles between 21 to 45 days
* primary dysmenorrhoea only
* willing to consume sachets twice daily for 3 months

Exclusion Criteria:

* current Intrauterine Copper Device (IUCD) user
* recent hormonal (estrogen or progesterone) therapy in last 3 months
* on treatment for allergy such as antihistamine
* diarrhoea with dairy product
* often take drugs which may affect the test results (such as medicines treating constipation or digestive medicine such as laxatives or enema)
* any malignant tumor regardless of type or site

Primary outcomes:
measure: pain score before treatment (visual analog scale VAS)
timeFrame: baseline
measure: pain score after treatment (visual analog scale VAS)
timeFrame: after 3 months of treatment
measure: severity score before treatment (verbal rating score)
timeFrame: baseline
measure: severity score after treatment (verbal rating score)
timeFrame: after 3 months of treatment
measure: Quality of life before treatment (Physical and mental health score assessed by SF12v2 questionnaire)
timeFrame: baseline
measure: Quality of life after treatment (physical and mental health score assessed by SF12v2 questionnaire)
timeFrame: at 3 months after completed treatment with probiotic or placebo
measure: Frequency of Non-steroidal Anti-Inflammatory Drugs (NSAIDs) use between placebo and probiotic group
timeFrame: 3 months during treatment with probiotic or placebo
Secondary outcomes:
measure: Concentration of inflammatory markers pre-treatment
timeFrame: baseline
measure: Concentration of inflammatory markers post-treatment
timeFrame: At 3 months after commencement of treatment
measure: intestinal microbiota before and after treatment with probiotics
timeFrame: on date of randomization and at 3 month after completed treatment with probiotic or placebo
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: National University of Malaysia
state: Kuala Lumpur
Study officials:
affiliation: National University of Malaysia
name: Nur Azurah Abd Ghani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01346111: Multicenter Study of Generation Comorbidity Score
Official title: Multicenter Study for the Generation of a Score of Comorbidities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 2640
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults, who were admitted to hospital for a non programme admission, medical or surgical admission

Brief summary: The purpose of the study is to generate and valid a co-morbidity score with updated definitions and suitable for use in Argentina in both public and private settings. These tools would allow us to compare different populations in Argentina adjusting for comorbidities. Also, this would potentially help attending physicians and health administrators.

Detailed description: The investigators will generate a co-morbidity score, perform the score validation and generate an online calculator for the score (open access).

Finally, a score validation for extreme values of score will be performed to ensure representativeness of these patients.

Eligibility criteria: Inclusion Criteria:

* Adult 17 older
* admitted to hospital within 72 hours of admission
* non programed admission

Exclusion Criteria:

* negative to participate
* 72 hs mortality expected
* obstetrics admissions

Primary outcomes:
measure: generate a co-morbidity score
timeFrame: 12 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Junin
country: Argentina
facility: Hospital Interzonal General de Agudos Piñeyro
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Complejo Médico de la Policía Federal Argentina Churruca-Visca
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos Vélez Sarfield
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Mendoza
country: Argentina
facility: Hospital Lagomaggiore
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Diego H Giunta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02747511: IV Haloperidol for the Treatment of Headache in the ED
Official title: Intravenous Haloperidol for the Treatment of Headache in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Headache
Migraine Disorders
Lead sponsor: Western Michigan University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 118
Sex: ALL
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain scores in patients who present to the emergency department (ED) with a complaint of headache. A total of 150 patients age 13-55 presenting to the emergency department with headache will be enrolled from October 2015 - October 2016. Patients will be randomized and pain scores and side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will be performed by telephone at 24 hours.


Eligibility criteria: Inclusion Criteria:

* Emergency Department patients that complain of headache or migraine
* Males and females age 13-55
* English is primary language

Exclusion Criteria:

* Abnormal blood pressure (\>200/100)
* Sudden rapid onsent (normal to worst pain in minutes)
* Fever
* Trauma
* Any history of masses, strokes, head injury or other causes of abnormal anatomy
* QT greater than 450 ms on EKG
* Allergy to Haldon
* Any altered mental status (GCS \<15)
* Pregnancy
* Any abnormalities on neurologic exam
* Any clinician concern that would require CT scan of brain
* Any prisoner or ward of state

Primary outcomes:
measure: >50% reduction in pain per Visual Analog Scale (VAS)
timeFrame: 90 minute interval
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: McCoy JJ, Aldy K, Arnall E, Petersen J. Treatment of Headache in the Emergency Department: Haloperidol in the Acute Setting (THE-HA Study): A Randomized Clinical Trial. J Emerg Med. 2020 Jul;59(1):12-20. doi: 10.1016/j.jemermed.2020.04.018. Epub 2020 May 10.
Clinical trial NCT02625311: Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty
Official title: A Prospective Comparative Randomized International Multicenter Study Comparing MIS Computer Navigated Total Knee Arthroplasty vs Conventional Computer Navigated Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 69
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis.

Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.

Detailed description: Study executed with 3 centers and 69 patients.

Eligibility criteria: Inclusion Criteria:

* patient requiring Total Knee Arthroplasty (TKA)
* patients with Osteo arthritis
* intact collateral ligaments and patella tendon
* patients willing and able to comply with the post-operative schedule

Exclusion Criteria:

* patients who require a revision TKA
* patients with TKA contralateral knee within 6 months with bad outcomes
* patients who need a TKA on contralateral side within 2 years
* intraoperative resurfacing of patella
* intraoperative eversion of patella
* patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy
* BMI \> 30
* patients with fixed flexion contracture\> 15 degrees
* patients with deformity greater than 20 degrees of varus or 15 degrees of valgus
* Patient with Mediolateral stability \> 10 degrees patient with active or suspected malignancy
* patient with Rheumatoid arthritis
* patient with systemic disease that would effect subject's wellfare or overall outcome of the study
* patient with other severe concurrent joint involvement which can effect their outcome
* patients with an immobile hip
* patient with a history of Pulmonary embolism or Deep venous thrombosis

Primary outcomes:
measure: range of motion
timeFrame: pre-op vs post-op until 5 years post-op
measure: blood loss
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: patient questionnaire
timeFrame: pre-op vs post-op until 5 year post operative
measure: chair rise and stair climb test
timeFrame: pre-op vs post-op until 5 years post operative
Other outcomes:
Locations:
Study officials:
References:
citation: Feczko P, Engelmann L, Arts JJ, Campbell D. Computer-assisted total knee arthroplasty using mini midvastus or medial parapatellar approach technique: A prospective, randomized, international multicentre trial. BMC Musculoskelet Disord. 2016 Jan 13;17:19. doi: 10.1186/s12891-016-0872-7.
Clinical trial NCT01317511: Protein Supply in Elderly
Official title: Overnight Protein Supply as a Dietary Strategy to Improve Muscle Mass in Elderly.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Synthesis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 16
Sex: MALE
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Stimulating overnight muscle protein synthesis, might augment muscle hypertrophy, increase mitochondrial mass, and/or improve muscle tissue repair. The goal of this proposal will be to provide further insight into the responsiveness of the muscle protein synthetic machinery to food intake in relation to age.


Eligibility criteria: Inclusion Criteria:

* Males
* Age between 65 and 80 years
* BMI \< 30 kg/m2

Exclusion Criteria:

* Type 2 diabetic patients
* Use of medication
* All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. artrosis, arthritis, spasticity/rigidity, all neurological disorders and paralysis).
* Use of anticoagulants, blood diseases, allergy for lidocain.
* Contra indications for the use of a nasogastric tube: high risk of aspiration, gastric stasis, gastro-oesophageal reflux, upper gastrointestinal stricture, nasal injuries and base of skull fractures.
* Patients suffering from PKU (Phenylketonuria).

Primary outcomes:
measure: Protein synthesis
timeFrame: overnight (12 h)
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht UMC
name: Luc van Loon, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gorissen SHM, Trommelen J, Kouw IWK, Holwerda AM, Pennings B, Groen BBL, Wall BT, Churchward-Venne TA, Horstman AMH, Koopman R, Burd NA, Fuchs CJ, Dirks ML, Res PT, Senden JMG, Steijns JMJM, de Groot LCPGM, Verdijk LB, van Loon LJC. Protein Type, Protein Dose, and Age Modulate Dietary Protein Digestion and Phenylalanine Absorption Kinetics and Plasma Phenylalanine Availability in Humans. J Nutr. 2020 Aug 1;150(8):2041-2050. doi: 10.1093/jn/nxaa024.
Clinical trial NCT05031611: Intuitive Eating for Disordered Eating
Official title: A Web-based Intuitive Eating Intervention for Young Women With Disordered Eating: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder Symptom
Eating Behavior
Body Image
Psychological Distress
Lead sponsor: Yeshiva University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: Research on intuitive eating is growing, but there are few interventions demonstrating the effect of learning to eat intuitively for people with disordered eating. Young women in particular are at high-risk for developing disordered eating. This study aimed to test the outcomes of a novel intuitive eating intervention for young women with disordered eating.

Methods: This study is the first randomized controlled trial introducing intuitive eating to a sample of participants with disordered eating. Participants with current eating disorders were excluded from this study. Women (n=123) ages 18-30 with high levels of disordered eating participated in this study and were randomized to either a treatment (10-week web-based intervention) or control group (10-week waitlist).


Eligibility criteria: Inclusion Criteria:

* Female
* Between 18 and 30 years of age
* Located in the United States or Canada
* No eating disorder
* No previous participation in an intuitive eating intervention
* Score greater than or equal to 25 on the TFEQ-r18 at baseline

Exclusion Criteria:

* Gender not female
* Younger than 18 years of age
* Older than 30 years of age
* Located outside the United States or Canada
* Score less than 25 on the TFEQ-r18 at baseline
* Previously participated in an intuitive eating intervention
* Current eating disorder

Primary outcomes:
measure: Intuitive Eating
timeFrame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
measure: Disordered Eating
timeFrame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Secondary outcomes:
measure: Body Appreciation
timeFrame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
measure: Dichotomous Thinking Around Food
timeFrame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
measure: Psychological Flexibility
timeFrame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
measure: Food Intake
timeFrame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
measure: Body Mass Index (BMI)
timeFrame: Baseline (Time 1) through study completion, 10 weeks (Time 2)
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Study was conducted exclusively online
state: New York
Study officials:
References:
Clinical trial NCT01295411: Morphological, Structural and Functional Neural Substrates of Quality of Life in Schizophrenia
Official title: Morphological, Structural and Functional Neural Substrates of Quality of Life in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of the investigators analysis is to identify the neural correlates of quality of life scores in schizophrenia. For this, the investigators will constitute group of patients according to their quality of life scores and the investigators will analyze their differences in patterns of brain structures and activations.


Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria (American Psychiatric Association(APA), 1994),
* age over 18 years,
* informed consent to participate in the studies
* French as native language

Exclusion Criteria:

* diagnosis other than schizophrenia on Axis I of DSM-IV,
* decompensated organic disease and mental retardation

Primary outcomes:
measure: to study the relationships between quality of life and the morphologic, structural and functional substrates in schizophrenia
timeFrame: 36 months
Secondary outcomes:
measure: to determine whether quality of life is correlated with brain modifications using functional Magnetic Resonance Imaging
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
References:
citation: Faget-Agius C, Boyer L, Wirsich J, Ranjeva JP, Richieri R, Soulier E, Confort-Gouny S, Auquier P, Guye M, Lancon C. Neural substrate of quality of life in patients with schizophrenia: a magnetisation transfer imaging study. Sci Rep. 2015 Dec 3;5:17650. doi: 10.1038/srep17650.
Clinical trial NCT00000211: Treatment Efficacy for Drug Abuse and AIDS Prevention - 2
Official title: Treatment Efficacy for Drug Abuse and AIDS Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Heroin Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Mclean Hospital
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 26
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of buprenorphine for treatment of concurrent intravenous heroin and cocaine dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital, Dept. of Psychiatry
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Jack Mendelson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: