louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01036139: Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
Official title: A Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: EDS in Parkinson's Disease
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2009-12-21
Enrollment: 268
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.

Detailed description: As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.

Eligibility criteria: Inclusion Criteria:

* Patients with a documented history of Parkinson's disease according to UPDRS,fluctuating and non-fluctuating patients, Hoehn and Yahr score \<5;
* stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
* presenting an Excessive Daytime Sleepiness as indicated by an ESS\>or=12

Exclusion Criteria:

* Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
* Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
* Patients with a severe depression indicated by (BDI\>= 16)or at suicidal risk (BDI item G\>0) or depression treated for less than 8 weeks
* Patients with a cognitive impairment

Primary outcomes:
measure: ESS change (Epworth Sleepiness Scale)
timeFrame: at week 12 / 52 versus baseline
Secondary outcomes:
measure: Safety
timeFrame: 12-week and 52-week
Other outcomes:
Locations:
city: Paris
country: France
facility: Pr Arnulf
Study officials:
affiliation: Bioprojet
name: Kati Gutierrez, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00893139: A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-05-05
Enrollment: 765
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.


Eligibility criteria: Inclusion Criteria:

* Composite corneal staining score of greater than 5 in one or both eyes.
* Schirmer II score of greater than 4 mm.
* OSDI score of greater than 23.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean change from baseline in sodium fluorescein corneal staining score
timeFrame: Baseline, up to Day 35
Secondary outcomes:
measure: Mean change from baseline in phenol red thread length
timeFrame: Baseline, up to Day 35
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Ravaughn Williams, OD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00942539: Midazolam Sedation for Neonatal Lumbar Puncture
Official title: Midazolam Sedation for Neonatal Lumbar Puncture in the Emergency Department: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Anxiety
Keywords: Neonates
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2009-07-21
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lumbar puncture is one of the most common painful procedures performed on neonates in the Emergency Department (ED). The investigators will study in a randomized controlled trial, the efficacy of intravenous administration of a single dose of Midazolam in reducing pain and anxiety in neonates undergoing lumbar puncture in the ED, as well as the rate of adverse sedation reactions. The investigators hypothesize that compared with placebo, single dose Midazolam would significantly decrease pain and anxiety and will have low rate of adverse reactions.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score I, II
* Post natal age ≤ 30 days
* Fasting of at least 2 hours before the procedure

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) score III or greater
* Gestational age of 37 weeks or younger
* Congenital disease or defect
* Any medication provided by the caregiver prior ED admission
* Fasting of less than 2 hours

Primary outcomes:
measure: The Simplified Neonatal Facial Coding System will be used for assessment of pain. Scoring will be composed from four specific facial actions (brow bulge, nasolabial furrow, eye squeeze, and open mouth) and the presence or absence of crying
timeFrame: 20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion
Secondary outcomes:
measure: Physician's level of satisfaction from the procedural conditions
timeFrame: Five minutes post successful LP
measure: LP Success rate
timeFrame: Five minutes post successful LP
measure: Adverse sedation reactions
timeFrame: During procedure and during recovery phase
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Itai Shavit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05826639: A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions
Official title: Risks, Safety, and Outcomes of Temperature-sensitive Endobiliary Radiofrequency Ablation in Patients With Malignant Biliary Obstructions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Stricture
Keywords: Bile duct obstruction
Biliary stent
Temperature-Sensitive Radiofrequency Ablation (RFA)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 176
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 that have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents.

Brief summary: The purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival. This is a research study meant to collect information to help other patients with malignant biliary strictures in the future.


Eligibility criteria: Inclusion Criteria:

* Malignant biliary stricture
* participants have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents
* Patients with life expectancy greater than 3 months
* Able to provide consent

Exclusion Criteria:

* Patients who are pregnant
* Patients with cirrhosis
* Patients with significant liver metastasis \&gt;30% on radiologic imaging suggestive of poor liver function that will not improve despite endoscopic drainage.
* Patients who have undergone prior biliary decompression stents or percutaneous drainage that cannot be removed at time of ERCP and thus preclude effective RFA
* Patients with altered anatomy unable to undergo conventional ERCP (i.e., history of Roux-en-Y gastric bypass)

Primary outcomes:
measure: Stent patency
timeFrame: 6 months
measure: Re-intervention free survival
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 6 months
measure: Time until first adverse event
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vinay Chandrasekhara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00120939: Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer
Official title: Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Neoplasms
Ovarian Neoplasms
Prostatic Neoplasms
Lung Neoplasms
Gastrointestinal Neoplasms
Keywords: Lung Cancer
Breast Cancer
Prostate Cancer
Ovarian Cancer
Head and Neck Cancer
Gastrointestinal Cancer
Metastatic Cancer
Advanced Cancer
Genitourinary Cancer
Glioblastoma Multiforme
Recurrent Cancer
Colon Cancer
Gastric Cancer
Stomach Cancer
Pancreatic Cancer
Esophageal Cancer
Throat Cancer
Bladder Cancer
Kidney Cancer
Renal Cancer
Cervical Cancer
Endometrial Cancer
Colorectal Cancer
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
First posted: 2005-07-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the safety, side effects, and dosage for Motexafin Gadolinium given with the chemotherapy drug docetaxel to patients with advanced cancers. Secondly, tumor response to the combined treatment, drug levels in the body, and drug interactions will be evaluated.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Metastatic, or unresectable solid tumors from breast, head, and neck, gastrointestinal, genitourinary, lung, or ovarian cancer or recurrent glioblastoma multiforme
* ECOG performance status score either 0, 1, or 2
* Willing and able to provide written informed consent

Exclusion Criteria:

* Greater than two prior cytotoxic regimens
* Laboratory values showing adequate function of bone marrow, liver, and kidneys
* Uncontrolled hypertension
* Known sensitivity to or intolerable adverse effects from taxanes (eg. paclitaxel, docetaxel) or polysorbate 80

Primary outcomes:
measure: Determine the Dose Limiting Toxicity at 8 weeks (2 cycles), and the Maximum Tolerated Dose at 24 weeks.
Secondary outcomes:
measure: Tumor response rate 8, 16 and 24 weeks, and common PK parameters at 24 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Gurkamal Chatta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02260739: Sequential Analysis in Patients With an Hemopathy
Official title: Sequential Analysis in Patients With an Hemopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemopathy
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Recent advances in hematology clearly illustrate that the simple "clonal" nature of various hematological malignancies may not really reflect the reality of malignant cells natural expansion. This has been nicely illustrated in recent works in AML for example where subclones coexists in the same patient at the same time, but could also differentially expand over time because of effects of therapeutics intervention, but also by oncogenic spontaneous events (1).

These observations have been done recently because of next generation sequencing that allows to discriminate in the same tumor samples, different subclones and to analyse the clonal architecture. Sequential analyses could help us to identify the first oncogenic event and to correlate disease progression to the emergence of subclones.

For all these reasons it is of a major interest to precisely understand the architecture of the clone in MPNs, especially to understand which is the initiating event and how from this initial event the clone develops.

In MPNs in which JAK2V617F is the initiating event, its targeting is expected to be extremely effective. If JAK2V617F is a secondary event its targeting might allow to alleviate the MPN, but may favor the development of other malignant hemopathies.


Eligibility criteria: Inclusion Criteria:

* Patients with a malignant hematological disease.
* Signed written informed consent
* Age and Sex : men and women aged 18 years or older
* Patients affiliated to a social security system

Exclusion Criteria:

- Patients protected by law, in accordance with Articles L1121-L1121-5 to 8 of the Code of Public Health.

Primary outcomes:
measure: Identification of new genetic alterations
timeFrame: At baseline and then every 6 months up to 24 months
Secondary outcomes:
measure: Sequential analysis of the malignant clones
timeFrame: At baseline and 12 months after inclusion
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val de Marne
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Vincent RIBRAG, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02148939: Antiplatelet Effects in Stroke-Patients
Official title: Dipyrone Nullifies Aspirin Antiplatelet Effects in Stroke-Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: ischemic stroke
Antiplatelet Effects
aspirin
metamizole
dipyrone
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 61
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 ischemic stroke

Brief summary: Many patients suffer from acute and chronic pain. The incidence of chronic pain correlates with increased age. Most of patients rely on analgesic medication to control the pain. Dipyrone is an extensively used drug in Western and Eastern Europe as well as Central and South America, largely due to its favorable analgesic and antipyretic effects in conjunction with a low incidence of gastrointestinal complications when compared to other non-steroidal anti-inflammatory drugs (NSAIDs).

Aspirin is the backbone of antiplatelet therapy in patients after ischemic stroke. However, it is known that there are substantial inter-individual response variabilities to antiplatelet medication. Furthermore, patients with impaired response to aspirin have a significant higher risk of recurrent cerebrovascular events. The investigators have recently shown that co-medication with aspirin and dipyrone in patients with coronary artery disease lead to insufficient antiplatelet effects of aspirin.

The incidence of chronic pain is very high in patients with ischemic stroke. Therefore, in this study the investigators aim to examine, if co-medication of aspirin and dipyrone interaction also occurs in patients after ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients with ischemic stroke and ASS-medication (80-320 mg/day) with/without analgesic comedication

Exclusion Criteria:

* Reanimation
* cardiogenic shock

Primary outcomes:
measure: Laboratory response to aspirin therapy in metamizole co-medicated Stroke patients
timeFrame: Baseline
Secondary outcomes:
measure: Major adverse cardiac and cerebrovascular events (MACCE Events) during hospital stay
timeFrame: participants are followed until discharge up to 4 weeks
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Klinik für Kardiologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf
name: Amin Polzin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Kardiologie, Pneumologie und Angiologie, Universtiätsklinikum Düsseldorf
name: Tobias Zeus, MD
role: STUDY_CHAIR
References:
citation: Dannenberg L, Erschoff V, Bonner F, Gliem M, Jander S, Levkau B, Kelm M, Hohlfeld T, Zeus T, Polzin A. Dipyrone comedication in aspirin treated stroke patients impairs outcome. Vascul Pharmacol. 2016 Dec;87:66-69. doi: 10.1016/j.vph.2016.06.003. Epub 2016 Jun 11.
Clinical trial NCT05419739: Prognostic Value of Pediatric GCS-Pupil Score in Pediatric Patients With Traumatic Brain Injury
Official title: Prognostic Value of Pediatric GCS-Pupil Score in Pediatric Patients With Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries, Traumatic
Keywords: Brain traumatic
GCS-Pupil score
Pediatric
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 128
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients younger than 18 years with traumatic brain injury

Brief summary: There are studies reporting that the survival rate in pediatric patients with abnormal pupillary response is 23% and that pupillary response is effective on mortality and patient outcomes. Studies in the literature examining the effect of pupillary response on mortality and outcome in pediatric patients with traumatic brain injury reported that bilaterally dilated pupils were associated with a higher mortality rate.

Considering the literature results, we believe that obtaining the GCS-Pupil score by combining GCS and pupillary reaction in pediatric patients with traumatic brain injury will be effective in predicting patient outcomes.

Detailed description: Obtaining a GCS-Pupil score using the total GCS score: 0 points are given for pupillary reaction if both pupils react to light, 1 point if one pupil does not react to light, and 2 points if both pupils do not react to light. Total GCS-P score is calculated by the formula of Eye Response + Verbal Response + Motor Response - Pupil Reaction and scores between 1-15.

In the study, the worst GCS and current pupillary light reaction score in the first 24 hours will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Be under the age of 18,
* Not having mental and motor developmental retardation,
* Having had a traumatic brain injury,
* Alive at admission and followed up for at least 24 hours

Exclusion Criteria:

* Eye trauma or severe facial trauma that will affect the assessment,
* Those under deep sedation,
* Those who have been administered drugs (Atropine and mydriatic) that will affect the pupillary response.

Primary outcomes:
measure: Death rate
timeFrame: one year
Secondary outcomes:
measure: Adverse functional outcomes
timeFrame: one year
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Provincial Health Directorate University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
affiliation: Uludag University
name: AKİF BULUT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01462539: Adenotonsillectomy and Obstructive Sleep Apnea Study
Official title: Factors That Increase Length of Stay After Outpatient Surgery of 3-6 Year Olds With OSAS Symptoms Versus Without OSAS Symptoms After Adenotonsillectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenotonsillectomy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2011-10-31
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing adenotonsillectomy only with no concurrent surgery

Brief summary: Adenotonsillectomies are one of the most common childhood surgeries and are first-line treatment to correct childhood obstructive sleep apnea syndrome (OSAS). This is a study comparing patients with and without OSA looking at the length of stay following adenotonsillectomy and the factors affecting length of stay.


Eligibility criteria: Inclusion Criteria:

1. history of snoring/gasping/ or pause in breathing reported by caregivers.
2. age 3-6 years old
3. undergoing adenotonsillectomy only no concurrent surgery
4. scheduled as outpatient and plan for discharge home

Exclusion Criteria:

1. Preoperatively requiring additional respiratory support
2. scheduled for concurrent surgery that could increase total general anesthetic time
3. recurrent adenotonsillitis as sole indication for surgery

Primary outcomes:
measure: Length of stay (LOS)
timeFrame: 1 Day (Day of Surgery)
Secondary outcomes:
measure: Cause of increased Length of stay (LOS)
timeFrame: 1 Day (Day of Surgery)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Childrens Hospital
name: Vidya Raman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04130139: Benefits of an Oocyte Pickup Simulation Training Program
Official title: Benefits of an Oocyte Pickup Simulation Training Program Using a High-fidelity Simulator for Obstetrics and Gynecology Residents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Simulation Training
IVf
Education
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-10-17
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obstetrics and gynecology residents from France participating in a national training conference organized by the national college of french gynecologists and obstetricians.

Brief summary: The primary objective of this study was to evaluate oocyte pick up simulation training program for teaching residents. The secondary objectives were to evaluate resident satisfaction and the overall current state of oocyte pick up training in France.

Detailed description: simulation workshop using PickupSim simulator. inclusion: obstetrics and gynecology residents from France simulator: 7 scenarios available

1 simulation training/resident main outcome: successful completion of the scenario (oocyte retrieval rate \>=70%) secondary outcome: time for completion, complications, satisfaction survey

Eligibility criteria: Inclusion Criteria:

* obstetrics and gynecology residents
* french residents

Exclusion Criteria:

* no

Primary outcomes:
measure: successful scenario
timeFrame: 1 day
Secondary outcomes:
measure: completion time
timeFrame: 1 day
measure: complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire Angers
Study officials:
affiliation: Centre hospitalier d'Angers
name: Pierre Emmanuel Bouet, MD
role: PRINCIPAL_INVESTIGATOR
References: