louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00035438: St. John's Wort Vs. Placebo in Obsessive-Compulsive Disorder.
Official title: St. John's Wort Vs. Placebo in Obsessive-Compulsive Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: obsessive compulsive disorder
ocd
Anxiety
St. John's Wort
Wisconsin
Psychiatric
Mental health
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of St. John's Wort as compared to placebo (an inactive substance) in the treatment of outpatients with obsessive compulsive disorder.

Detailed description: The objective of the proposed study is to assess the efficacy of the herbal St. John's Wort (SJW) in the treatment of symptoms of obsessive-compulsive disorder (OCD). The approach is to conduct a 12-week, randomized, double blind, placebo controlled, parallel group pilot trial with 30 subjects in each of two arms. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) will be the primary measure for evaluating OCD. An intention-to-treat analysis will be done to compare the two arms.

Eligibility criteria: Inclusion criteria

* Female patients: at least 2 years post-menopausal, surgically sterile, or practicing a medically acceptable method of contraception.
* Meets DSM-IV criteria for obsessive compulsive disorder

Exclusion criteria

* Primary diagnosis of major depression, dysthymia, panic disorder, social phobia, schizophrenia, schizo-affective disorder, bipolar disorder, or PTSD
* Substance abuse or dependence in the past 6 months
* Vascular dementia or primary degenerative dementia of the Alzheimer's type
* Treatment with MAOIs, TCAs, SSRIs, venlafaxine, nefazodone, remeron, citalopram, or bupropion within 14 days of first visit.
* Fluoxetine within 5 weeks of first visit.
* Failure to respond to at least two adequate antidepressant trials for obsessive compulsive disorder
* Investigational drugs within 30 days of baseline
* Known allergy or hypersensitivity to St. John's Wort
* Currently in behavior therapy for obsessive compulsive disorder

ALL INQUIRIES WILL UNDERGO A PHONE SCREENING TO DETERMINE WHETHER THEY MEET ELIGIBLITY REQUIREMENTS.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Madison
country: United States
facility: Dean Foundation
state: Wisconsin
Study officials:
affiliation: Dean Foundation for Health, Research and Analysis
name: Kenneth Kobak, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dean Foundation for Health, Research and Analysis
name: Leslie Taylo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03372538: Multidisciplinary Team in Management of Placenta Accreta
Official title: is There Any Superior Benefit of Multidisciplinary Team in Management of Placenta Accreta
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta
Keywords: placenta accreta
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1000 patients pregnant 38 weeks with placenta accreta

Brief summary: comparative study between the incidence of urological injury in case of placenta accreta in cases where urological surgical staff are participating in the operation from the start and in cases where the operation is carried by the gynecological staff only

Detailed description: cohort of 1000 patients of placenta accreta are followed regarding the incidence of urological injury in the cases with assistance from the urological staff members

Eligibility criteria: Inclusion Criteria:

* pregnant 38 weeks
* placenta accreta

Exclusion Criteria:

* medical disorders complicating pregnancy

Primary outcomes:
measure: urological injury
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainiy Hospital
Study officials:
References:
Clinical trial NCT01711138: An Intervention Study to Assess the Role of the Built Environment on Physical Activity and Active Transportation to School in Children and Youth
Official title: Active Streets, Active People - Junior: An Integrated Community Partnership to Enhance Physical Activity and Active Transport to School in Children and Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Keywords: Physical Activity
Physical Fitness
Transportation
Environment Design
Child
Adolescent
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: City of Vancouver
name: Vancouver School Board
name: JW Sporta
name: City of Surrey
name: Surrey School Board
First posted: 2012-10-22
Enrollment: 573
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who attend school grades 4-10 at baseline (Fall 2012) will be invited to participate (intervention group). Participants (n-matched) who attend school grades 4-10 at baseline (Fall 2012) in a neighbouring catchment boundary will be invited to participate (comparison group).

Brief summary: The purpose of this study is to evaluate if changes to the built environment influence physical activity and active transport to school in children and youth.


Eligibility criteria: Inclusion Criteria:

* Student is in grade 4 - 10 at start of study (fall 2012), or grade 4 at any of the subsequent study years (2013-2015).
* Student's parent(s) or guardian(s) provide(s) consent.

Exclusion Criteria:

* Student is not in grade 4 - 10 at start of study (fall 2012).
* Student's parent(s) or guardian(s) do(es) not provide consent.
* Student cannot read or write in English.

Primary outcomes:
measure: Objectively measured physical activity overall (minutes of moderate-to-vigorous physical activity per day)
timeFrame: up to 3 years
Secondary outcomes:
measure: Objectively measured physical activity during commuting to and from school (minutes of moderate-to-vigorous physical activity during commuting)
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Heather A McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01287338: A Study to Evaluate the Safety and Efficacy of the QLT Proprietary Olopatadine-PPDS in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.
Official title: A Randomized, Double-Masked, Placebo-Controlled, Proof of Concept Study to Evaluate the Short-term Safety and Efficacy of the QLT Proprietary Olopatadine Punctal Plug Delivery System in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Seasonal Allergic Conjunctivitis to Ragweed
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-01
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.


Eligibility criteria: Inclusion Criteria:

* History of allergic conjunctivitis to ragweed for at least one year
* Positive skin prick test to ragweed pollen within 12 months prior to visit 1
* BCVA of at leat 20/400

Exclusion Criteria:

* Structural lid abnormalities (ectropion, entropion)
* Active lid disease ( ie moderate or severe blepharitis, meibomianitis) that requires medical treatment
* Presence of follicular conjunctivitis, anterior uveitis or preauricular lymphadenopathy
* History of ophthalmic abnormality, including a history of dry eye
* Perennial allergic rhinoconjunctivitis having significant allergy to animal dander that cannot be avoided during the study period
* History of chronic bacterial or viral ocular infection, such as herpes keratitis, and/or presence of active bacterial or viral ocular infection
* presence of mucous discharge, excess lacrimation or burning as a symptoms of ocular disease
* Currently on any chronic ocular topical medications
* Use of topical or systemic ocular medications during the study period
* History of complications, adverse events, trauma or disease in the nasolacrimal area
* History of symptomatic epiphoria

Primary outcomes:
measure: Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed
timeFrame: 4 Days
measure: Change from baseline in subject-rated ocular itching scores in treated vs placebo control arms in subjects with seasonal allergic conjunctivitis to ragweed
timeFrame: 4 days
Secondary outcomes:
measure: Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms
timeFrame: 4
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Cetero Research
state: Ontario
Study officials:
affiliation: QLT Inc.
name: Dipak Panigrahi, MD
role: STUDY_DIRECTOR
affiliation: Cetero Research, San Antonio
name: Deepen Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03133338: Effect of Early Pelvic Binder Use in Emergency Management of Suspected Pelvic Trauma: a Retrospective Cohort Study
Official title: Division of Traumatic and General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Fracture
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 204
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We enrolled trauma patients with initial stabilization using a pelvic binder for suspecting pelvic injury. Inclusion criteria were traumatic injury requiring a trauma team and at least one of the following: loss of consciousness or Glasgow coma score (GCS) \< 13; systolic blood pressure \< 90 mmHg; falling from ≥6 m; injury to multiple vital organs; and suspected pelvic injury. Various parameters, including gender, age, mechanism of injury, GCS, mortality, hospital stay, initial vital sign, revised trauma score, injury severity score, and outcome, were assessed and compared with historical controls.

Brief summary: The investigators aimed to evaluate the effect of early pelvic binder use in emergency management of suspected pelvic trauma, compared with the conventional stepwise approach.

Detailed description: There is currently no universal consensus on all aspects of management of pelvic injuries.

Among patients with multiple injuries because of blunt trauma, 5%-16% sustain injuries to the pelvic ring, resulting in a mortality rate of 11%-54% primarily due to hemorrhagic shock. In theory, the reduction and stabilization of the pelvic ring can decrease bleeding from the fracture site, as reduction of pelvic volume has been shown to reduce the extent of hemorrhage from such injuries.The application of a pelvic binder has become part of the emergency care of all trauma patients with suspected pelvic fractures, in both the pre-hospital environment and emergency department (ED). The present study aimed to assess the effectiveness of the early use of pelvic binders to treat patients with a suspected high risk of pelvic bleeding from blunt force pelvic fractures.

Eligibility criteria: Inclusion Criteria:

* Traumatic injury requiring a trauma team and at least one of the following: loss of consciousness or Glasgow coma score (GCS) \< 13; systolic blood pressure \< 90 mmHg; falling from ≥6 m; injury to multiple vital organs; and suspected pelvic injury. -

Exclusion Criteria:

* Not meet the criteria and loss follow up (transfer to other hospital or data not available) -

Primary outcomes:
measure: Blood transfusion
timeFrame: admission
Secondary outcomes:
measure: admission mortality
timeFrame: mortality in the same admission
Other outcomes:
Locations:
Study officials:
affiliation: Institutional Review Board II of the Tri-Service General Hospital, National Defense Medical Center.
name: Mu-Hsien Yu, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00581438: Study Evaluating Approach to Treatment of Haemophilia A and B in Spain
Official title: Actual Approach to Treatment of Haemophilia A and B in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Hemophilia B
Keywords: Approach Haemophilia A and B
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People known to have Haemophilia A or B

Brief summary: Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain.

Detailed description: Analyze the clinical and therapeutic approach to treatment of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis.

Assess haemophilia A or B patient profile, study different kinds of hanitual clinical treatment of haemophilia A and B patients, and estimate the kind of treatment and dosage units used per year in patients under habitual clinical practice conditions.

Eligibility criteria: Inclusion Criteria:

* Haemophilia A or B patients of any age
* Written informed consent

Primary outcomes:
measure: Analyze the clinical and therapeutic approach to treament of haemophilia A and B in habitual clinical practice conditions in Spain during the first 3 years since diagnosis.
timeFrame: 3 months
Secondary outcomes:
measure: Assess haemophilia A or B patient profile, study different kinds of habitual clinical treatment of haemophilia A and B patients, and estimate the dosage units used per year in patients under habitual clinical practice conditions.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01193738: Osteopathy and Obstructive Sleep Apnea Syndrome
Official title: a Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Placebo Compression in Obstructive Sleep Apnea Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: osteopathy
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective is to evaluate an osteopathic compression of pterygopalatine node on sleep obstructive apnea syndrome (OSA).

Detailed description: Osteopathic compression will be compared to a placebo manoeuvre. Efficacy will be assessed by measuring pharyngeal collapsibility

Eligibility criteria: Inclusion Criteria:

* Male or Female aged 18 years or more
* obstructive sleep apnea syndrome with apnea/hypopnea index \> or = 15/hour
* Body mass Index \<40kg/m2

Exclusion Criteria:

* pregnant or lactating women
* participating to another trial
* acute infectious disease of upper respiratory airway tract at inclusion
* facial neuralgia at inclusion
* patients not able to stop treatment for OSA within one week before each visit
* allergy to latex
* dental extraction within 15 days before inclusion
* pharyngeal surgery in the past
* incapable adult

Primary outcomes:
measure: pharyngeal critical pressure
timeFrame: 30 minutes after osteopathic compression
Secondary outcomes:
measure: pharyngeal critical pressure
timeFrame: 48 hours
measure: symptoms
timeFrame: 48 hours
measure: adverse events
timeFrame: 48 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Pathologies Du Sommeil Pitie Salpetriere
Study officials:
affiliation: Federation des pathologies du sommeil
name: valerie attali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacq O, Arnulf I, Similowski T, Attali V. Upper airway stabilization by osteopathic manipulation of the sphenopalatine ganglion versus sham manipulation in OSAS patients: a proof-of-concept, randomized, crossover, double-blind, controlled study. BMC Complement Altern Med. 2017 Dec 20;17(1):546. doi: 10.1186/s12906-017-2053-0.
Clinical trial NCT05776238: Lateral Position MRI in Preterm Infants, an Observational Study
Official title: Lateral Position for Premature Babies Undergone Sedation During Magnetic Resonance Imaging: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prematurity
Magnetic Field Exposure
Sedation Complication
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 22
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prematures babies during in hospital stay

Brief summary: The goal of this observational study is to evaluate safety of sedation in lateral position in premature babies undergone MRI. The main question it aims to answer are:

* number of apneas during sedation
* Maintenance of eupnea during deep sedation

Detailed description: Premature babies will be sedated in lateral position during Magnetic Resonance Imaging. During procedure we provide a close control about eupnea maintenance (SaO2 and EtCO2) in order to verify the safety of laying.

Eligibility criteria: Inclusion Criteria:

* \< 40 weeks Post Conceptional Age (PCA)

Exclusion Criteria:

* \> 50 weeks PCA
* previous treatment with hypothermia for neonatal asphyxia
* patients who received invasive positive pressure ventilation within the previous 48 h
* preexisting cardiac arrhythmias
* presence or suspicion of oncological pathology
* neuromuscular or metabolic diseases
* previous brain or abdominal surgery
* presence of epicranial venous accesses
* upper respiratory tract infections
* refusal of informed consent by parents or inability to express it

Primary outcomes:
measure: Peripheral oxygen desaturation
timeFrame: Through study completion, an average of 7 month
measure: Apnea
timeFrame: Through study completion, an average of 7 month
Secondary outcomes:
measure: Subjective evaluation of imaging quality
timeFrame: Through study completion, an average of 7 month
measure: Objective evaluation of imaging quality
timeFrame: Through study completion, an average of 7 month
measure: Post-operative temperature control
timeFrame: Through study completion, an average of 7 month
measure: Time for full enteral feeding
timeFrame: Through study completion, an average of 7 month
measure: Objective evaluation of imaging quality
timeFrame: Through study completion, an average of 7 month
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Univeristario Agostino Gemelli
state: Rome
Study officials:
affiliation: Fondazione Policlinico Gemelli IRCCS
name: fabio sbaraglia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05290038: ARON-2 Study-Multicentric International Retrospective Study
Official title: ARON-2 Study-Multicentric International Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Carcinoma
Keywords: immunotherapy
real world experience
efficacy of pembrolizumab
artificial intelligence technology
Artificial Neural Network
Lead sponsor: Hospital of Macerata
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy, or patient treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.

Brief summary: The ARON-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. The amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.


Eligibility criteria: Inclusion Criteria:

* Patients aged \>18y
* Histologically confirmed diagnosis of UC of upper and/or lower urinary tract
* Histologically or radiologically confirmed metastatic disease
* Patients treated with at least one of the following:
* Treatment with pembrolizumab in patients progressed after previous platinum-based chemotherapy or as first-line therapy in patients platinum-unfit, and at least 1 cycle of pembrolizumab within the period from 1 January 2018 to 30 November 2021
* Treatment with enfortumab vedotin in patients progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor and at least 1 cycle of enfortumab vedotin within the period from June 1st 2022 to July 31st 2023

Exclusion Criteria:

* Patients without histologically confirmed diagnosis of UC
* Patients without histologically or radiologically confirmed metastatic disease

Primary outcomes:
measure: Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
timeFrame: November 15th, 2023
measure: Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
timeFrame: November 15th, 2023
measure: Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
timeFrame: November 15th, 2023
Secondary outcomes:
measure: prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotin
timeFrame: November 15th, 2023
Other outcomes:
Locations:
city: Macerata
country: Italy
facility: Ospedale di Macerata, UOC Oncologia
Study officials:
References: