louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01535599: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Official title: Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Externa
Keywords: Acute Otitis Externa
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-02-20
Enrollment: 768
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).

Detailed description: Patients were evaluated for safety and efficacy during the visits conducted at Day 3 (on-therapy), Day 8 (end-of-therapy), and Day 11 (TOC). Patients or parents/legal guardians completed a telephone diary twice daily to record assessments of ear pain, ear pain medication use, and the impact of ear pain on sleep and other daily activities.

Eligibility criteria: Inclusion Criteria:

* At least 6 months of age.
* Clinical diagnosis of acute otitis externa (AOE) based on clinical observation and of presumed bacterial origin in at least one ear.
* Combined numerical score of ≥4 in at least one affected ear at the Day 1 exam for tenderness, erythema, and edema.
* Agree to refrain from water immersion of the ears during the conduct of the entire study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Duration of signs or symptoms of AOE greater than 28 days in the affected ear(s) as reported by patient or parent/guardian.
* Presence of a tympanostomy tube or perforated tympanic membrane in the affected ear(s).
* Clinically diagnosed otic disease other than AOE (eg, malignant otitis externa) in the affected ear(s).
* Known or suspected ear infection of yeast, fungal or mycobacterial origin in the affected ear(s).
* Prior otologic surgery within 6 months of study entry in the affected ear(s).
* Known or suspected allergy or hypersensitivity to quinolones or other ingredients present in the medications to be used in the study.
* Patients who use ear plugs, head phones or ear buds and are unwilling to discontinue their use during the study period.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit
timeFrame: Day 11
Secondary outcomes:
measure: Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit
timeFrame: Day 11
measure: Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary
timeFrame: Time to event, up to Day 11
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sally Scheib, Sr. Clinical Project Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT06766799: Comparison Between Handheld Rebound Tonometer and Applanation Tonometer in IOP Measurement in Paediatric Glaucomas
Official title: Comparison Between Handheld Rebound Tonometer and Applanation Tonometer in IOP Measurement in Paediatric Glaucomas
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glaucoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 100 Cases of Glaucomatous Patients and 60 Cases of Healthy Individuals

Brief summary: To compare the accuracy between handheld rebound tonometer \& applanation tonometer in IOP measurement in pediatric glaucoma cases


Eligibility criteria: Inclusion Criteria:

* Patients attending to our pediatric glaucoma clinic diagnosed with glaucoma aged \>18 years old are subjected to IOP Measurements.

Exclusion Criteria:

* \*\*Patients aged more than 18 years old

  * patients with scarred cornea

Primary outcomes:
measure: Comparison between the IOP Measurments by Rebound Tonometer & Applanation tonometer
timeFrame: over nine months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05084599: Effect of 90% Effective Dose of Metaraminol in Supine and Left Tilt Positions on Cesarean Section
Official title: Effect of 90% Effective Dose of Metaraminol in Supine and Left Tilt Positions on Cesarean Section：A Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section Complications
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: For hypotension after spinal anesthesia, metaraminol has different 90% effective doses in the supine position and the left-tilt position. We plan to conduct a non-inferiority trial to compare the effects of the two on the fetus and the mother.


Eligibility criteria: Inclusion Criteria:

1. Singleton pregnancy at term scheduled to be delivered via elective cesarean delivery;
2. height 150-180 cm;
3. American Society of Anesthesiologists (ASA) physical status II-III;
4. body mass index (BMI) \<35 kg/m2.

Exclusion Criteria:

1. transverse presentation, fetal macrosomia;
2. uterine abnormalities (eg, large fibroids, bicornuate uterus);
3. polyhydramnios;
4. ruptured membranes, oligohydramnios;
5. intrauterine growth restriction;
6. gestational or nongestational hypertension, diabetes, or eclampsia;
7. hypertensive disorders or any condition associated with autonomic neuropathy (such as diabetes mellitus for \>10 years) or renal failure;
8. contraindications for combined spinal-epidural anesthesia;
9. participants who declined to sign informed consent forms.

Primary outcomes:
measure: Umbilical artery blood pH
timeFrame: 30 seconds after delivery
Secondary outcomes:
measure: hypotension
timeFrame: Intraoperative
measure: bradycardia
timeFrame: Intraoperative
measure: The incidence of nausea in pregnant women
timeFrame: Intraoperative
measure: Umbilical artery blood base excess
timeFrame: 30sec after delivery
measure: The incidence of vomiting in pregnant women
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Feng Yi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05748899: Effect of Applying Ujjayi Pranayama on Cortisol in Lupus Patients
Official title: Effect of Applying Ujjayi Pranayama on Cortisol in Lupus Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: stress vulnerability is very common in lupus patients, specifically women, hence the rates of depression , insomnia, easy fatigue perception, anxiety are high in those women. pranayama is a yogic intervention that may treat the above problems

Detailed description: lupus patients, specifically 40 women, will divided to group number 1 and group number 2. the women in every group will be 20 women. Group number 1 will receive home-based ujjayi pranayama for six weeks (fifteen minutes in the morning and 15 min in the evening, this training will be online supervised). The group number 2 will not receive Ujjayi pranayama, so it serves as control lupus group

Eligibility criteria: Inclusion Criteria:

* 40 lupus women

Exclusion Criteria:

* lupus co-morbidities
* illiteracy

Primary outcomes:
measure: serum cortisol
timeFrame: it will be measured after 6 weeks
Secondary outcomes:
measure: systolic blood pressure
timeFrame: it will be measured after 6 weeks
measure: diastolic blood pressure
timeFrame: it will be measured after 6 weeks
measure: pulse rate
timeFrame: it will be measured after 6 weeks
measure: respiratory rate
timeFrame: it will be measured after 6 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: it will be measured after 6 weeks
measure: Fatigue severity scale
timeFrame: it will be measured after 6 weeks
measure: Beck Depression Inventory
timeFrame: it will be measured after 6 weeks
measure: State Trait Anxiety Inventory
timeFrame: it will be measured after 6 weeks
measure: Stress Vulnerability Scale
timeFrame: it will be measured after 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Badr University
Study officials:
affiliation: Badr University
name: ahmed elfahl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06991699: A Novel Digitally Driven Approach for Gummy Smile Solution Using Milled Sub-nasal Stent
Official title: A Novel Digitally Driven Approach for Gummy Smile Solution Using Milled Sub-nasal Stent: A Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gummy Smile
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 8
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: The objective of this study is to assess the effectiveness of a Polyether ether ketone (PEEK) stent for management of gummy smile.


Eligibility criteria: Inclusion Criteria:

* Systemically healthy individuals
* Chiefs complain gummy smile
* Gummy smile due to short hypermobile upper lip
* Gingival Display not more than 5 mm

Exclusion Criteria:

* Pregnancy
* Lactation
* History of smoking more than 10 cigarettes per day
* Systemic conditions or intake of medications that could affect soft and hard tissue healing
* Use of orthodontic appliances
* Gingival display above 5mm

Primary outcomes:
measure: Gingival display
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
References:
Clinical trial NCT01556399: Endoscopic Characteristics of Duodenal and Ampullary Lesions
Official title: A Correlation of the Endoscopic Characteristics of Duodenal and Ampullary Laterally Spreading Tumours With Their Somatic or Germline Mutations.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenal Diseases
Keywords: Duodenal adenoma
Ampullary adenoma
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 Duodenal and/or ampullary adenomas or cancers.

Brief summary: The purpose is to investigate whether polyps that look different at endoscopy, have formed via different mutations and have different risks of turning into cancer.

Detailed description: Laterally spreading tumours (LSTs), are polyps that have a lateral extension along the duodenal wall with minimal vertical growth. It has become evident over the last few years that rather than being a single entity requiring an accumulation of mutations, Duodenal and ampullary cancer is in fact a heterogenous disease forming via multiple distinct genetic pathways. It is therefore hypothesised that different polyp types have different genetic abnormalities, and potentially form via distinct genetic pathways, although this theory has not been widely examined.

This knowledge would be important in furthering our understanding of the development of cancer. There is accumulating evidence that genetic abnormalities may be a better predictor of cancer behaviour than histological grade. Additionally, guidelines for endoscopy surveillance are currently a one size fits all approach that do not reflect the genetic heterogeneity of the disease and the knowledge that only 5% of polyps progress to cancer. Genetic studies may assess future cancer risk to a person in polyps once removed and plan surveillance endoscopy frequency.

Eligibility criteria: Inclusion Criteria:

* Intention to perform Endoscopic Mucosal Resection
* Adenoma equal to or greater than 20mm
* over 18 years of age
* Able to give informed consent to involvement in trial

Exclusion Criteria:

* Pregnancy
* Lactation: currently breastfeeding
* Taken clopidogrel within 7 days
* Taken warfarin within 5 days
* Had full therapeutic dose unfractionated heparin within 6 hours
* Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
* Known clotting disorder

Primary outcomes:
measure: Significant differences in molecular abnormalities.
timeFrame: Specimens will be stored and used for up to 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
affiliation: Western Sydney Local Health District
name: Michael Bourke, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03450499: Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
Official title: Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Elective Cesarean Section and Ketamine Analgesia
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.


Eligibility criteria: Inclusion Criteria:

* • All women at term(\>or =37 weeks of gestation)

  * Healthy
  * American Society of Anesthesiologists(ASA) class1 and 2
  * Women undergoing non-elective caesarean section whose anesthetic plan is for spinal anesthesia with bupivacaine and fentanyl

Exclusion Criteria:

* • Women with American society of anesthesiologist physical status\>2

  * Body mass index \>or =40 kg per square meter
  * Height \<150 cm
  * Any contraindication to the spinal anesthesia
  * History of substance abuse
  * History of hallucinations
  * Chronic opioid therapy
  * Chronic pain or on any pain medication currently
  * Patient with maternal complications,like cardiovascular disease pre-eclampsia,diabetes,multiple gestation,known fetal abnormality
  * Cases with severely compromised fetus where immediate administration of general anesthesia is required.

Primary outcomes:
measure: Total opioid requirement postoperatively
timeFrame: 24 hrs
Secondary outcomes:
measure: Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )
timeFrame: 24 hrs
measure: Time to first perception of pain
timeFrame: 24 hrs
measure: Incidence of side effects
timeFrame: 24 hrs
Other outcomes:
Locations:
city: Dharān Bāzār
country: Nepal
facility: BP Koirala Institute of Health Sciences (BPKIHS)
state: Koshi
Study officials:
References:
citation: Adhikari P, Subedi A, Sah BP, Pokharel K. Analgesic effects of intravenous ketamine after spinal anaesthesia for non-elective caesarean delivery: a randomised controlled trial. BMJ Open. 2021 Jun 30;11(6):e044168. doi: 10.1136/bmjopen-2020-044168.
Clinical trial NCT04075942: Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate
Official title: Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophic Anterior Maxillary Ridges
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 8
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Using customized Xenograft bone shell with mixture of autogenous and xenograft particulate in modified cortical shell technique. by 3D printed model from The CT scans segmentation by special software

Detailed description: Using customized Xenograft bone shell by 3D printed model from The CT scans segmentation by special software ( Mimics ) . All surgeries were performed by the same surgeon .

All surgical procedures were performed under strict aseptic conditions, all patients received infiltration local anesthesia (Articaine 4% 1:100 000 epinephrine).

a midcrestal incision was made in the anterior region using No. 15 blade. A full thickness mucoperiosteal flap was raised to expose the underlying alveolar ridge. The residual remaining bone in the area was minimal, with a maximum measured ridge thickness of 3 or 4 mm. 'To reconstruct the lost alveolar bone, an xenograft bone shell approximately 1 to 2 mm thick was shaped, after 3D print the bone shell were fixed to the buccal defect, using screws . 'The space between the plate and the existing palatal bone wall was then filled using a combination of autograft bone chips and xenograft bone particles

. Periosteal releasing incision is done to obtain stress free primary closure. The flap will then be closed using interrupted 4/0 resorbable sutures. After 4 month will insert implant . After 3 month will insert final restoration which will be mostly PMF .

Eligibility criteria: Inclusion Criteria:

* patients with atrophic Anterior Maxillary Ridges

Exclusion Criteria:

* Heavy smokers
* Uncontrolled diabetic patients.
* Pregnant patients. Psychiatric patient
* pathology related to bone.

Primary outcomes:
measure: Bucco-lingual bone width gain.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00455442: A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain
Official title: A Two-Week, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Weight-Gain Prevention
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2007-04-03
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a two-week study testing the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight and BMI.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers between 18 and 40 years of age
* BMI between ≥ 18 and ≤ 25
* Able to provide written informed consent
* Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits

Exclusion Criteria:

* History of Cushing's syndrome or Addison's disease
* Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
* Positive urine drug screen for any non-prescribed drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines)
* Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
* Have a history of an allergic reaction to either mifepristone or olanzapine
* Any clinically significant abnormality on screening laboratory tests
* QTc Bazzett's ≥ 450 msec
* Any major medical condition, which in the opinion of the Investigator would place the patient at undue risk.
* Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight
* History of recent (within 6 months of screening) significant weight fluctuation

Primary outcomes:
measure: To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.
Secondary outcomes:
measure: To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers.
Other outcomes:
Locations:
city: Bangalore
country: India
facility: St. John's Medical College
Study officials:
affiliation: Corcept Therapeutics
name: Thad Block, MD
role: STUDY_DIRECTOR
References:
citation: Beebe KL, Block T, Debattista C, Blasey C, Belanoff JK. The efficacy of mifepristone in the reduction and prevention of olanzapine-induced weight gain in rats. Behav Brain Res. 2006 Aug 10;171(2):225-9. doi: 10.1016/j.bbr.2006.03.039. Epub 2006 Jun 19.
Clinical trial NCT02764242: The Causative Insects in Severe Insect Sting Allergy
Official title: Evaluating the Causative Insects in the Cases With Severe Insect Sting Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insect Sting Allergy
Keywords: insect sting allergy
recombinant venom allergen
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study the causative insect by skin prick test and sIgE to wasp, bee and fire ants are important but false positive by crossreactivity can occur. sIgE to recombinant venom allergen is proposed to help in finding the causative insect.

Detailed description: Insect sting allergy from insects in Hymenoptera is not uncommon. The reaction maybe very severe and life threatening. To find the cause of insect sting allergy is important in prevention and specific treatment such as immunotherapy. The skin prick test and sIgE of these insects may have cross reactions so it is difficult to be interpreted.

The usage of sIgE recombinant venom allergen can benefit in separate cross reaction and dual allergy reaction.

Eligibility criteria: Inclusion Criteria:

* Cases with severe insect sting allergy reactions

Exclusion Criteria:

* Without other severe systemic diseases
* Not pregnant or lactation

Primary outcomes:
measure: Mean wheal diameters of skin prick test of local and imported insect allergens
timeFrame: 12 months
Secondary outcomes:
measure: specific IgE level to stinging insect allergen and recombinant venom allergens
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: