louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01764971: Cerebral Dysfunction in Chronic ITPwith High Risk of Serious Bleeding Excluding Intracranial Hemorrhage.
Official title: Cerebral Dysfunction in Chronic ITP With High Risk of Serious Bleeding Excluding Intracranial Hemorrhage.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Thrombocytopenia
Keywords: Chronic ITP, Cerebral dysfunction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from those treated in Hematology Clinic, Ain Shams University.

Brief summary: Intracranial hemorrhage despite being rare, several chronic ITP patients experience moderate to severe behavioral problems including learning difficulties, memory affection .These changes could be due to the presence of minute capillary dysfunction

Detailed description: * First identify the presence of cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP and correlate these changes with radiological evidence of minimal CNS bleeding.
* Second investigate the correlation between these behavioral and/or minimal neurological deficits and duration, site and severity of bleeding (a total of 200 patient of persistently low platelet count \< 20x 10 9 for at least more than one month duration).
* The aim is to assess the behavioral changes in chronic ITP patients, and to assess the possible relation of such changes to duration and recurrence of very low platelet count as well as pattern of bleeding excluding frank intracranial hemorrhage.

Eligibility criteria: Inclusion Criteria:

1. Chronic ITP patients with persistent platelet count \< 20 x 109/L for a period more than one month.
2. Chronic ITP with more than one attack of wet purpura and OR internal bleeding.

Exclusion Criteria:

1. Patients' with platelet count persistently more than 40 x 109/L.
2. Past history of intracranial hemorrhage.
3. Past history of known neurological or psychological deficit diagnosed before onset of ITP diagnosis

Primary outcomes:
measure: cognitive, behavioral and/or minimal neurological deficit in patients with chronic ITP
timeFrame: 6 month
Secondary outcomes:
measure: duration, site and severity of bleeding effect of duration, site and severity of bleeding
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: hematology clinic, pediatric hospital, Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Mohsen S Elalfy, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01161771: Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-07-14
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cataract extraction and limbal relaxing incision

Brief summary: This is a multicenter evaluation of the effects of the cataract extraction and limbal relaxing incisions (LRI) on corneal sensation and dry eye signs and symptoms.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled to undergo clear corneal cataract extraction with planned limbal relaxing incision for correction of a corneal astigmatism

Exclusion Criteria:

* Uncontrolled systemic disease
* Have undergone refractive surgery or any surgery involving a limbal or corneal incision
* Use of topical cyclosporine (Restasis) within three months of baseline/randomization visit
* Temporary or permanent occlusion of the lacrimal puncta

Primary outcomes:
measure: The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
timeFrame: Month 3
Secondary outcomes:
measure: Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Corneal Staining at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Conjunctival Staining at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Tear Break-Up Time at Month 3
timeFrame: Baseline, Month 3
measure: Change From Baseline in Schirmer's Test at Month 3
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Long Island
country: United States
state: New York
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02606071: Italian Registry On Multipoint Left Ventricular Pacing
Official title: Italian Registry On Multipoint Left Ventricular
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Ventricular Fibrillation
Ventricular Tachycardia
Keywords: cardiac resynchronization therapy
multipoint left ventricular pacing
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HF patients treated in clinical practice with a CRT-D device with the ability to deliver MPP

Brief summary: The IRON-MPP is a prospective multicenter, observational registry designed to collect clinical and device data from a large cohort of HF patients treated in clinical practice with a CRT-D device with the ability to deliver Multi Point Pacing.

The purpose of the Registry is to collect data on how MPP-devices are being used by physicians in order to better understand how to improve the clinical care of patients and effectiveness of MPP therapy.


Eligibility criteria: Inclusion Criteria:

- Patients implanted with a St. Jude Medical CRT-D system with MPP capability

Exclusion Criteria:

- Patients currently participating in any other clinical investigation

Primary outcomes:
measure: Left ventricular ejection fraction
timeFrame: 6 Months
Secondary outcomes:
measure: Heart Failure Hospitalizations
timeFrame: 12 months
measure: Appropriate device interventions
timeFrame: 12 months
measure: Echocardiographic changes
timeFrame: 12 months
measure: QRS Duration
timeFrame: Baseline and six months
Other outcomes:
Locations:
city: Rovigo
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo della Sofferenza
city: Torino
country: Italy
facility: Ospedale Maria Vittoria
Study officials:
affiliation: Policlinico Tor Vergata
name: Giovanni Forleo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forleo GB, Santini L, Giammaria M, Potenza D, Curnis A, Calabrese V, Ricciardi D, D'agostino C, Notarstefano P, Ribatti V, Morani G, Mantica M, Di Biase L, Bertaglia E, Calo L, Zanon F. Multipoint pacing via a quadripolar left-ventricular lead: preliminary results from the Italian registry on multipoint left-ventricular pacing in cardiac resynchronization therapy (IRON-MPP). Europace. 2017 Jul 1;19(7):1170-1177. doi: 10.1093/europace/euw094.
Clinical trial NCT03250871: Hypnosis in Interventional Electrophysiology
Official title: Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flutter, Atrial
Over 18 Years Old
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hypnosis has already shown to decrease pain and anxiety in different surgical specialities. Nevertheless, its input has never been studied in cardiology. This research is a prospective, monocentric, controlled and randomized study.

Patients over 18 years old and hospitalized for atrial flutter ablation may be included and randomized into one of the arms: placebo or hypnosis.

Global pain will be assessed by a visual analogue pain scale. Anxiety, morphine consumption, and patient sedation will also be assessed.

The aim of this study is to improve the care given to patient undergoing atrial flutter ablation.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Surgery ablation of atrial flutter
* Agreement to participate of the study

Exclusion Criteria:

* Person who does not speak French or deaf
* Chronic pain with the visual analogue scale \> 5
* Psychiatric pathology
* Contraindication to paracetamol, lidocaine, morphine
* Pregnant women, or breast-feeding women or without effective contraception

Primary outcomes:
measure: Global pain self-assessment during the procedure
timeFrame: Collected 45 min after the procedure
Secondary outcomes:
measure: Anxiety during the procedure
timeFrame: Collected after the procedure
measure: Morphine consumption
timeFrame: Collected after the procedure
measure: Patient sedation evaluation
timeFrame: Collected after the procedure
measure: Pain assessed prospectively during the procedure;
timeFrame: Evaluated every 5 minutes during the procedure;
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU DE Poitiers
Study officials:
References:
Clinical trial NCT04957771: Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation
Official title: Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker DDD
Cardiopulmonary Endurance
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to observe the changes of cardiopulmonary endurance in patients with pacemaker implantation after long-term exercise, to explore the significance of exercise on patients with pacemaker implantation, and to analyze the difference of the effect of exercise on cardiopulmonary endurance in patients with normal LVEF of different pacing ratios


Eligibility criteria: Inclusion Criteria:

* 18-75 years old patients with pacemaker implantation for the first time,
* 3-6 months after operation
* stable condition,
* independent walking ability.

Exclusion Criteria:

* Cognitive impairment;
* ICD, CRT / Crtd implanted,
* patients with neurogenic syncope;
* Atrial tachycardia, atrial fibrillation,
* NYHA class II or above,
* difficult to control hypertension;
* Musculoskeletal disease limiting activity
* nervous system disease,
* severe respiratory disease,
* Patients with acute inflammation,
* cancer and other diseases uncontrolled.

Primary outcomes:
measure: Parameters related to exercise cardiopulmonary assessment
timeFrame: followed up for one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Haidian
Study officials:
affiliation: Peking University Third Hospital
name: lijie sun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00496171: Phase I Study of HAL Formulations Applied to the Cervix in Healthy Volunteers
Official title: A Phase I Hexaminolevulinate (HAL) Dose-Finding Study Applying Different Formulations to the Cervix in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
Lead sponsor: Photocure
Sponsor class: INDUSTRY
First posted: 2007-07-04
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of the study is to determine the most effective formulation of HAL for release of hexaminolevulinate to the cervical epithelium at different doses.


Eligibility criteria: Inclusion Criteria:

* Healthy, pre-menopausal female volunteers

Exclusion Criteria:

* Acute or chronic disease which could influence the study results

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Riks-Radium University Hospital
Study officials:
affiliation: Riks-Radium University Hospital
name: Claes G Tropé, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00960271: Evaluation of Preoperative Endobronchial Ultrasound (EBUS) in Non Small Cell Lung Cancer (NSCLC)
Official title: Medico-economic Evaluation of a Preoperative Algorithm Including EBUS for NSCLC Initial Staging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Non-small cell lung cancer
mediastinal lymph node
resectable
EBUS
stage IIIA
significant mediastinal lymph node at thoracic CT Scan
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2009-08-17
Enrollment: 363
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 study will include non small cell lung cancer patients, stage III A (before PET Scan), with resectable tumors.

Brief summary: This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. In phase 1, one investigator in each center will prospectively be evaluated for its ability to perform EBUS, with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2 will include the medico-economic assessment of the technique in the preoperative setting. A maximum of 420 patients for each phase is forecasted.


Eligibility criteria: Inclusion Criteria:

* adult patients over 18
* non small cell lung cancer histologically or cytologically proved
* Clinical Stage IIIA
* anatomically and functionally resectable

Exclusion Criteria:

* uncorrected bleeding disorders
* absence of lymphadenopathy superior to 1cm in small axis at CT scan
* contraindication to bronchoscopy
* extrathoracic or intrathoracic metastasis
* respiratory function tests not compatible with curative resection of lung cancer

Primary outcomes:
measure: number of mediastinoscopy avoided
timeFrame: 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
References:
citation: Chouaid C, Salaun M, Gounant V, Febvre M, Vergnon JM, Jouniaux V, Fournier C, Lachkar S, Hermant C, Raspaud C, Quantin X, Quiot JJ, Molard A, Dayen C, Marquette CH, Lena H, Zalcman G, Thiberville L. Clinical efficacy and cost-effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration for preoperative staging of non-small-cell lung cancer: Results of a French prospective multicenter trial (EVIEPEB). PLoS One. 2019 Jan 7;14(1):e0208992. doi: 10.1371/journal.pone.0208992. eCollection 2019.
Clinical trial NCT00643071: Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients
Official title: Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Tacrolimus
FK506
Treatment outcome
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.

Detailed description: Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 study can participate in this study. Patients will receive tacrolimus for a maximum of 12 weeks in an open-label study manner. Improvement of Disease Activity Index (DAI) score and other efficacy scores will be evaluated during the drug administration period.

Eligibility criteria: Inclusion Criteria:

* Severe refractory UC patients who meets the following criteria

  * Disease activity: more than 6 times of stool a day, bloody stool, moderate to severe endoscopic finding
  * Steroid resistant or dependent

OR

* Moderate to severe refractory UC patients who participated and received placebo in F506-CL-1107 study

Exclusion Criteria:

* Mild or fulminant type
* Renal failure patients, hepatic failure patients
* Patients taking 6-mercaptopurine, cyclosporin or other immunosuppressants within 12 weeks prior to entry
* Patients who received LCAP or GCAP within 2 weeks prior to entry
* Patients who changed the dose of steroid or started steroid within 2 weeks prior to entry
* Patients who changed the dose of steroid or started steroid within 1 week prior to entry in case they received more than 40 mg/ day or 1mg/kg/day of steroid just before the study

Primary outcomes:
measure: Improvement of Disease Activity Index score (DAI score)
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of DAI score ( Total & each item)
timeFrame: 2 weeks
measure: Changes of clinical severity and symptom
timeFrame: 12 weeks
measure: Endoscopic finding
timeFrame: 12 weeks
measure: Patients impression
timeFrame: 12 weeks
measure: Amount of steroid
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyusyu
country: Japan
city: Shin'etsu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02836171: Effect of Itraconazole on the Pharmacokinetics of Apatinib
Official title: Effect of Itraconazole on the Pharmacokinetics of Apatinib in Chinese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: he primary purpose of this study is to investigate potential pharmacokinetic interaction in healthy volunteers when apatinib is administered in combination with itraconazole. Secondary objective is evaluating the safety and tolerability of apatinib alone and when co-administered with itraconazole.


Eligibility criteria: Inclusion Criteria:

* female of non-childbearing potential or male;
* age 18-45 years;
* body mass index 19-24 kg/m2 with total body weight;

Exclusion Criteria:

* clinically signiWcant medical or surgical conditions with the potential to interfere with the absorption, distribution, metabolism or excretion of the study drugs;
* history of alcohol abuse; smoker;
* electrocardiogram(ECG) abnormality;
* blood pressure \>140/90 mmHg;
* treatment with an investigational drug or any known CYP450 enzyme inducing/-inhibiting agents or herbal supplements within 14 days prior to first dose of study medication;
* Subjects were to abstain from using prescription and non-prescription drugs (other than acetaminophen as deemed necessary), vitamins and dietary supplements within 14 days prior to the first dose of study medication and throughout the study.

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of Apatinib
timeFrame: 0~72h after apatinib administration
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: From first administration to the seventh day after last administration
measure: Peak Plasma Concentration (Cmax) of Apatinib
timeFrame: 0~72h after apatinib administration
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Xuhui Central Hospital
name: Chen Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06500871: Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis.
Official title: Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Teeth With Acute Irreverseble Pulpitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effect the intraligamentary injection of Diclofenac Potassium versus Articaine 4% on the anaesthetic efficacy \& intensity of intraoperative \& postoperative pain during single visit root canal treatment in patients with symptomatic irreversible pulpitis in mandibular molar teeth


Eligibility criteria: Inclusion Criteria:

* Systemically healthy patient (ASA I or II).
* Mandibular Posterior teeth with:

Preoperative sharp pain, Absence or slight widening in the periodontal ligament (PDL), Vital response of pulp tissue to cold pulp test.

* patients who agree to provide written consent and the patients able to understand the pain scale and attend for recall appointments

Exclusion Criteria:

1. Patients allergic to anesthetic solutions \& other NSAIDs.
2. Pregnant or nursing females.
3. Patients having significant systemic disorder (ASA III or IV).
4. Gastrointestinal disorders.
5. If the initial diagnosis revealed pain in more than one tooth.
6. Hemostatic disorders or anti-coagulant therapy during the last month.
7. Consumption of opioid or non-opioid analgesics or NSAIDs during the last 12 hours before treatment.
8. Teeth that have:

   i. Periodontal involvement (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility).

   ii. No possible restorability. iii.Signs of pulpal necrosis; associated sinus tract or swelling.

   -

Primary outcomes:
measure: Efficacy of local anesthesia
timeFrame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
Secondary outcomes:
measure: Intensity of intraoperative pain
timeFrame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
measure: Post-operative pain
timeFrame: 6, 12, 24 and 48 hours post-operatively
measure: Number of needed analgesic tablets in case of intolerable pain
timeFrame: Up to 2 days post operatively
Other outcomes:
Locations:
Study officials:
References: