louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01237223: Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
Official title: An 8-week Double-blind, Multicenter, Randomized, 6-arm, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Aliskiren
Amlodipine
Essential hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-09
Enrollment: 1342
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure \[msDBP\] ≥ 95 mmHg and \< 110 mmHg and mean sitting systolic blood pressure \[msSBP\] ≥ 140 mmHg ). This study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in Japan.


Eligibility criteria: Inclusion Criteria:

* Patients with essential hypertension (msDBP ≥ 95 mmHg and \< 110 mmHg and msSBP ≥140 mmHg )
* Outpatients

Exclusion Criteria:

* Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
* History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers
* History or evidence of a secondary hypertension

Other protocol-defined inclusion/exclusion criteria applied

Primary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)
timeFrame: Baseline, Week 8
measure: Percentage of Participants Achieving Blood Pressure Control at Endpoint
timeFrame: 8 weeks
measure: Percentage of Participants Achieving a Successful Response Rate
timeFrame: 8 weeks
measure: Number of Participants With Adverse Events, Serious Adverse Events and Death
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Investigative Site
city: Ehime
country: Japan
facility: Investigative Site
city: Fukuoka
country: Japan
facility: Investigative Site
city: Hokkaido
country: Japan
facility: Investigative Site
city: Hyogo
country: Japan
facility: Investigative Site
city: Kanagawa
country: Japan
facility: Investigative Site
city: Kyoto
country: Japan
facility: Investigative Site
city: Okayama
country: Japan
facility: Investigative Site
city: Osaka
country: Japan
facility: Investigative Site
city: Saitama
country: Japan
facility: Investigative Site
city: Tokyo
country: Japan
facility: Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06153823: Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure
Official title: Effectiveness of Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the impact of using virtual reality glasses using sign language as a distraction method to reduce the dental anxiety in moderate to severe hearing-impaired children compared to the conventional behavior management technique during pulpotomy treatment.

The study will be a randomized controlled parallel two arms clinical trial, a total of 40 healthy children aged 5-7 years with moderate to severe hearing disability, will be selected from Pediatric Dentistry and dental public health Department, Faculty of Dentistry, Alexandria University, Egypt. Children selected should have at least one primary molar indicated for pulpotomy. The eligible participants will be randomly assigned to one of two groups: the study group, which will use virtual reality glasses with sign language as a distraction method to manage children's behavior, and the control group, which will use the conventional behavior management strategies including show-tell-do, and positive reinforcement. Local anesthesia will be given and pulpotomy procedure will be done on the selected tooth followed by stainless steel crown restoration. Pre and post-operative assessment of child's dental anxiety will be done using three methods: physiologically using pulse oximeter for measuring the heart rate, objectively using Venham clinical anxiety rating scale, and subjectively using the modified facial image scale.


Eligibility criteria: Inclusion Criteria:

* Children with Frankl behavior rating score 2 or 3.
* Children requiring pulpotomy in one of their primary molars.
* Parents who accepted to give their consent and participate in the study.

Exclusion Criteria:

* Children with any medical condition other than hearing disability (ASA II, III \& IV).
* Syndromic children with hearing impairment.
* Children with previous bad dental experience.

Primary outcomes:
measure: Change in child anxiety level
timeFrame: up to 2 months
Secondary outcomes:
measure: Change in heart rate
timeFrame: up to 2 months
measure: Change in child anxiety level by subjective method
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
References:
Clinical trial NCT02793323: Superficial Cervical Nerve Block vs NSAIDs for the Relief of Shoulder Pain After Laparoscopic Surgeries
Official title: Superficial Cervical Nerve Block Versus NSAIDs for the Relief of Shoulder Tip Pain After Laparoscopic Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relieve Shoulder Pain After Laparoscopic Surgeries
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 60
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: Shoulder pain is frequently mentioned in recent literature following laparoscopic operations. Several pain relief strategies have been proposed to decrease shoulder tip pain post laparoscopic surgeries. This study will be conducted to compare the Superficial cervical nerve block vs. NSAIDs in terms of shoulder tip pain relief after laparoscopic surgeries.

Detailed description: The study will be conducted in the operating room and post anesthesia care unit (PACU) at Makassed General Hospital. This is a prospective double blind randomized clinical trial that will be conducted between June 2016 and June 2017 at Makassed General Hospital. Following the Institutional Review Board (IRB) approval, written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 groups. Group I will receive superficial cervical nerve block and intravenous saline. Group II will receive saline superficial cervical block and intravenous NSAID (Profenid).

All patients will receive general anesthesia. General anesthesia is induced with 1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen. Any hemodynamic change of 25% results in a gradual increase or decrease of the sevoflurane concentration.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic:

cholecystectomy, sleeve gastrectomy, mini bypass surgery, gastric plication

Exclusion Criteria:

* Patients with kidney disease (ACUTE OR CHRONIC)
* Patients with allergy to any medication used throughout the research
* Patients with gastroesophageal reflux disease (GERD), peptic ulcer or duodenal ulcer disease
* Patients with shoulder neck pain or complications pre-operatively

Primary outcomes:
measure: Pain scores assessed through the Visual Analogue Scale (VAS)
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Number of patients receiving analgesics
timeFrame: 48 hours postoperatively
measure: Length of hospital stay
timeFrame: An average of 24 hours
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Zoher Naja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04628923: Quadratus Lumborum Block by Paraspinous Sagittal Shift Approach for Hip Surgery
Official title: Tthe Anaesthetic Efficacy of Quadratus Lumborum Block by Paraspinous Sagittal Shift Approach for Hip Surgery:a Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Self Efficacy
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 5
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The quadratus lumborum block (QLB) was first described by Blanco. it is a compartment block procedure during which a local anesthetic is injected into the muscle plane of the quadratus lumborum (QL) muscle under ultrasound guidance Currently, QLB is divided into four types based on the injection point of the local anesthetic: lateral, anterior, posterior, and intramuscular QLB. QLB is widely used for various types of abdominal surgeries (

Detailed description: the investigators will evaluate the anesthetic efficacy of quadratus lumborum block by paraspinous sagittal shift approach for hip surgery by injecting 30 ml of 0. 5% bupivacaine.

Eligibility criteria: Inclusion Criteria:

-ASA I and II

Exclusion Criteria:

* Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy)
* Allergic reaction to drugs.
* opium addiction, any drug or substance abuse and chronic treatment with opium, non-steroidal anti-inflammatory drugs

Primary outcomes:
measure: sensory and motor block level
timeFrame: immediately after the intervention/procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03202823: Arachidonic Acid Metabolism in Carotid Stenosis Plaque in Diabetic Patients
Official title: Arachidonic Acid Metabolism in Carotid Stenosis Plaque in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Stenosis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 204
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: Diabetic and non-diabetic patients with carotid stenosis who undergo surgery

Brief summary: Diabetes is associated with an increased risk of cardiovascular complications, as a reflection of the chronic inflammatory status. Monocytes-macrophages in diabetic subjects present impaired arachidonic acid metabolism. Moreover, atheromatous plaques in diabetic subjects seem to be significantly enriched in 2-AA-LPC (2-arachidonoyl-lysophosphatidylcholine) and are more inflammatory and more likely to rupture than are plaques in non-diabetic subjects. We therefore hypothesize that this vulnerability of atheromatous plaques in diabetic subjects could be explained by impaired 2-AA-LPC metabolism within the plaque.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided explicit consent
* Patients older than 18 years
* Patients about to undergo surgery for carotid stenosis
* Haemoglobin ≥ 7g/dl at the time the sample is taken
* Respect the maximum volume of blood taken (treatment + research) in 30 days

SPECIFIC TO DIABETICS

- Patients with type 1 or 2 diabetes diagnosed more than 6 months earlier

Exclusion Criteria:

* Patients under guardianship
* Patients without health insurance cover
* Pregnant or breast-feeding women

Primary outcomes:
measure: Change in arachidonic acid metabolism of atheromatous plaques from diabetic versus non-diabetic subjects
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01861223: Afatinib Plus Nimotuzumb for NSCLC
Official title: A Phase Ib Study of Afatinib Plus Nimotuzumab in Non-small Cell Lung Cancer Patients Who Progressed With Reversible EGFR TKI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: NSCLC
Keywords: acquired resistance
gefitinib
erlotinib
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of stage IIIB or IV NSCLC
* Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months
* Disease progression on treatemtn with gefitinib or erlotinib within 30 days
* Biopsy on disease progression
* Age ≥20 years
* ECOG performance status of 0, 1, or 2
* Measurable disease by the criteria of RECIST 1.1
* Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 45 mL/min

Exclusion Criteria:

* Known interstitial lung disease
* Prior treatment with EGFR targeting antibodies or BIBW 2992
* Prior three or more lines of chemotherapy for advanced NSCLC
* Significant bowel disease impairing drug absorption
* Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
* Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic patients without history of CNS metastases is not required.

Primary outcomes:
measure: Maximal tolerated dose
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05167123: Pulp Capping in Primary Molars Using TheraCal (LC)
Official title: Radiographic and Clinical Evaluation of Indirect and Direct Pulp Capping in Primary Molars Using TheraCal (LC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep Caries
Indirect Pulp Capping
Direct Pulp Capping
Reversible Pulpitis
Decayed Teeth
Vital Pulp Therapy
Keywords: IPC , DPC
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Simple parallel randomization was performed by using computerized random numbers
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial that aims to evaluate clinical and radiographic success rates of indirect pulp capping and direct pulp capping in primary molars with reversible pulpitis using a light-cured tri-calcium silicate base material (TheraCal (LC)).

Detailed description: Participating primary molars will be randomly allocated to one of the following groups: Indirect pulp capping group or Direct pulp capping group. A light-cured tri-calcium silicate base material (TheraCal (LC) ) will be used in the two groups as a dressing material. Patients will be recruited from the outpatient clinic of the pediatric dentistry department, Faculty of Dentistry Ain Shams University. The participant will be recalled for follow-up assessments at 3, 6,9, and 12 months.

Eligibility criteria: Inclusion Criteria:

1. Age: 4-7 years.
2. Free medical history.
3. Complete physical and mental health.
4. Patient cooperation
5. restorable mandibular primary molars

Exclusion Criteria:

1. Clinical symptoms or irreversible pulpitis as (spontaneous pain, throbbing pain)
2. Soft tissue swelling, draining fistula or sinus tracts.
3. Tenderness to percussion.
4. Pathological Tooth mobility.
5. Widening of periodontal membrane space

Primary outcomes:
measure: recording signs and symptoms through clinical examination
timeFrame: one year follow-up
Secondary outcomes:
measure: recording pathological Changes in Radiographic examination
timeFrame: one year follow-up
measure: Evaluation of TheraCal (LC) as a pulp capping material
timeFrame: one year follow-up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Faculy of Dentistry
city: Cairo
country: Egypt
facility: Department of pediatric dentistry - Ain Shams University
city: Cairo
country: Egypt
facility: Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Yomna Hussein Moselhy, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06699823: Validation of the Greek Postoperative Quality of Recovery Score 15
Official title: Cultural Adaptation and Validation of the Greek Version of the Postoperative Quality of Recovery Score 15 (QoR-15Gr)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Recovery
Quality of Recovery From Anaesthesia
PROMs
Validation Study
Cultural Adaptation
Keywords: quality of recovery
patient reported outcomes
QoR-15
validation
cultural adaptation
Lead sponsor: IASO Thessalias
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 150
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: The study will take place in IASO Thessalias General Hospital (the largest private general hospital in the region of Thessaly in Greece).

Brief summary: The goal of this observational study is to translate a patient questionnaire about recovery after an operation into Greek and assess how accurate, reliable, acceptable, and feasible this Greek version is.

Detailed description: This study aims to culturally adapt and validate a Greek version of the Quality of Recovery - 15 (QoR-15), referred to as the QoR-15Gr, for Greek-speaking surgical patients. The investigators hypothesize that the QoR-15Gr will demonstrate psychometric properties comparable to the original English version.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years old
* Scheduled elective general surgery under general anesthesia

Exclusion Criteria:

* Emergency surgery
* Poor Greek comprehension
* Inability to give consent
* A psychiatric or neurological condition that precludes cooperation
* Known history of alcohol or drug dependence
* Life-threatening postoperative complications
* Postoperative admission to ITU

Primary outcomes:
measure: Translation and cultural adaptation of the Greek version of the postoperative quality of recovery score 15 (QoR-15Gr)
timeFrame: From enrollment until 20 first patient have been enrolled
measure: Psychometric properties of postoperative quality of recovery 15 (QoR-15Gr) will be assessed by evaluating validity (convergent, construct, and discriminant), reliability (internal consistency and repeatability), and responsiveness.
timeFrame: From enrollment until 150 patients have been enrolled
measure: Acceptability and feasibility of the postoperative quality of recovery 15 (QoR-15Gr) will be assessed by measuring patient recruitment rate as well as successful recruitment rate.
timeFrame: From enrollment until 150 patients have been enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: IASO Thessalias General Hospital
state: Thessaly
Study officials:
affiliation: IASO THESSALIAS GENERAL HOSPITAL
name: DESPOINA LIOTIRI, ANAESTHESIOLOGIST
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: DIMITRIOS ZACHAROULIS, PROFESSOR OF SURGERY
role: STUDY_CHAIR
References:
Clinical trial NCT03819023: Validation of RespiLife for Detection of Respiratory Suppression
Official title: Validation of RespiLife for Detection of Respiratory Suppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiration Disorders
Lead sponsor: Bioresp Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluation of the device on people with normal and suppressed respiration
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.

Detailed description: The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.

Eligibility criteria: Inclusion Criteria:

* Able to understand and sign the informed consent
* English speaking.
* Able to comply with visits and follow ups included in this protocol
* Ages 18-80 years

Exclusion Criteria:

* Mentally or cognitively incompetent persons who cannot understand the procedures or consent to the procedures.
* An unstable medical condition, acute of chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
* If a subject is not able to stop his CPAP or BiPAP therapy at least one week prior to the sleep study night. This will be determined ty the principal investigator based on her judgment.
* Skin rash on the forehead.
* A history of skin allergy to medical tape, even hypoallergenic tape.
* A history of skin cancer on the forehead.

Primary outcomes:
measure: oxygen saturation percentage using photoplethysmography
timeFrame: 6 hours
measure: Respiratory rate, breaths per minute using photoplethysmography
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Burlingame
country: United States
facility: Peninsula Sleep Center
state: California
Study officials:
References: