louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002269: A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
Official title: A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
ampligen
AIDS-Related Complex
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate ampligen at two dosage levels given twice weekly in combination with zidovudine (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count between 100 and 300 cells/mm3.


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* Absolute number of T4 cells 100-300 cells/mm3.
* Given informed consent.
* Zidovudine (AZT) therapy for 6 months prior to study entry.
* At least one of the listed HIV-related clinical symptoms or opportunistic infections:
* weight loss \> 10 percent, unexplained diarrhea, unexplained intermittent fever, oral candidiasis \> 1 month, decreased Karnofsky, oral hairy leukoplakia, chronic fatigue.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Evidence of AIDS.
* Intercurrent acute medical disorder.

Concurrent Medication:

Excluded:

* Chemotherapy for Kaposi's sarcoma (KS).
* Aspirin.
* Non-steroidal anti-inflammatory drugs.

Patients with the following are excluded:

* Inability to return for treatment and evaluation for 12 months.
* Intercurrent acute medical disorder.
* Evidence of AIDS.
* Receiving chemotherapy for Kaposi's sarcoma (KS).
* Unwilling or unable to give informed consent.

Required:

* Zidovudine (AZT).

Required at least 6 months prior to study entry:

* Zidovudine (AZT).

Active drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Veterans Administration Med Ctr
state: Florida
city: Portland
country: United States
facility: Oregon Health Sciences Univ
state: Oregon
city: Philadelphia
country: United States
facility: MCP Hahnemann Univ Hosp
state: Pennsylvania
city: Dallas
country: United States
facility: Nelson Tebedo Community Clinic
state: Texas
city: Houston
country: United States
facility: Dr Patricia Salvato
state: Texas
Study officials:
References:
Clinical trial NCT05943769: The Impact of Root End Filling Material Type and the Application of Bone Graft on Healing of Periapical Tissues After Endodontic Microsurgery (A Clinical Randomized Controlled Trial)
Official title: The Impact of Root End Filling Material Type and the Application of Bone Graft on Healing of Periapical Tissues After Endodontic Microsurgery (A Clinical Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Diseases
Periapical Cyst
Keywords: Apicoectomy
Bone graft
Endodontic surgery
MTA
TotalFill
Apical lesions
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this triple blinded randomized clinical trial is to evaluate the effect of combining different bioactive root end filling materials with composite bone graft (xenogeneic mixed with autogenous bone fragments) on the healing process of periapical tissues after endodontic micro-surgery procedure on patients with small to moderate sized lesions. The main questions it aims to answer are:

Will the use of Totalfill in Endodontic surgeries show comparable results to the gold standard MTA? Will the addition of composite bone graft (Xenogenic and Autogenous) affect the healing of small to moderate sized lesions? Is there any interaction between composite bone graft and different bioactive root-end filling materials? Participants were allocated to 4 different groups according to the root-end filling material used with or without bone graft.

Reseachers compared between MTA only group, Totalfill only group, MTA with bone group, and Totalfill with bone group to evaluate healing of the periapical lesion using CBCT after 12 months follow up period.


Eligibility criteria: Inclusion Criteria:

All patients must be medically free from any systemic disease that can affect bone healing.

Age range of the patient should be between 20 - 45 years old. All patients must have good oral hygiene. The size of the radiolucent area is of small-moderate size (up to 3 cm in highest diameter at any axis in CBCT), related to a single rooted maxillary tooth.

Periradicular disease in a root-filled tooth where orthograde root canal treatment options has failed,

Exclusion Criteria:

Patient with systemic disease that may affect bone healing. Patients above 45 years or patients below 20 years. Patients with very poor oral hygiene. Teeth presenting with apico-marginal defects or teeth with periodontal disease (periodontal pockets and/or mobility).

Surgery after previous endodontic surgery (re-surgery cases), root resections and amputations, cases presenting with root fractures.

Patients with history of allergies to any of the medications to be used during or after the surgery.

Primary outcomes:
measure: Healing
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams univetsity
Study officials:
References:
Clinical trial NCT01135069: Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
Official title: Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne
Lead sponsor: Spear Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 480
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.

Detailed description: Not required

Eligibility criteria: Inclusion Criteria:

* Normal, healthy male and female children and adult
* Written and verbal informed consent must be obtained. Patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent.
* Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study.
* Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
* Considered reliable and capable of understanding their responsibility and role in the study.

Exclusion Criteria:

* Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
* Abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).
* Use topical acne therapy during the two week period prior to study initiation.
* Use of systemic retinoid treatment within six months prior to study initiation.
* Pregnant or breast-feeding.
* Serious psychological illness.
* Participation in any clinical research study during the 30 day period preceding study initiation.

Primary outcomes:
measure: Improvement in Acne
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Land O Lakes
country: United States
facility: Moore Clinical Research
state: Florida
Study officials:
affiliation: Moore Clinical Research
name: Krunal Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00895869: Pain in Neonates During Screening for Retinopathy of Prematurity Using Two Methods
Official title: Pain in Neonates During Screening for Retinopathy of Prematurity Using Binocular Indirect Ophthalmoscopy and Wide-field Digital Retinal Imaging: a Randomized Comparison
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Pain
Keywords: Screening
Retinopathy
Prematurity
Pain
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2009-05-08
Enrollment: 76
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants

Brief summary: Retinopathy of prematurity screening is painful. Wide field digital retinal imaging (WFDRI) and binocular indirect ophthalmoscopy (BIO) are being used for screening examinations. The aim of Edinburgh, UK based study is to compare the pain experienced by infants using both examination techniques.

Detailed description: Infants undergoing routine eye screening at Edinburgh Royal Infirmary Neonatal Intensive Care Unit are to be recruited. Infants will be excluded if they require mechanical ventilation or analgesic medication or if they have moderate/severe neurological impairment. The first screening examination for each baby was included. Infants' eyes will be examined by both WFDRI and BIO with eyelid speculum by 2 experienced pediatric ophthalmologists in random order. Observations will be video-recorded during examinations to generate a pain score (premature infant pain profile) for both WFDRI and BIO. The pain scores, heart rates, oxygen saturations and time taken for WFDRI and BIO will be compared using paired t tests.

Eligibility criteria: Inclusion Criteria:

* Infants born at less than 32 weeks gestation and/or birth weight of less than 1500g.

Exclusion Criteria:

* Infants requiring mechanical ventilation
* Infants requiring analgesic medication
* Infants with moderate/sever neurological impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
affiliation: NHS Lothian
name: Dr B Fleck, MBChB FRCOpth BSc(Hons) MD
role: STUDY_CHAIR
affiliation: NHS Lothian
name: Dr C Dhaliwal, BSc(Hons) MBChB MRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00447369: Efficacy of Pregabalin in Migraine Prevention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Migraine Disorders
Keywords: pregabalin
Valproic acid
migraine
prophylaxis
prevention
treatment
Lead sponsor: Hospital Militar del General Luis Felipe Brieba Aran
Sponsor class: OTHER
First posted: 2007-03-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of pregabalin in comparison with sodium valproate in migraine prevention with a randomized blinded crossover study.

Detailed description: The anticonvulsants are effective in the treatment of migraine prevention. The sodium valproate has demonstrated to be effective as monotherapy for migraine prevention in placebo-controlled trials. Besides, other new drugs like gabapentin have been used in the prevention of migraine with a good level of evidence. The pregabalin is an anticonvulsant that has not been proved to use in migraine prevention and it has a similar action mechanisms of the gabapentin. The purpose of this study is the comparison of the effect of pregabalin and sodium valproate in migraine prevention in a randomized blinded crossover study.

Eligibility criteria: Inclusion Criteria:

* Migraine with or without aura according to International Headache Society (IHS) criteria for at least 6 months before study entry.
* Frequency of 3 or more headache attacks per month and less than 15 headache attacks per month.
* Available for follow-up at least 9 months.

Exclusion criteria:

* Patients with headache others than migraine.
* Patients failed to respond to more than 2 adequate previous regimen of migraine-preventive medications.
* Prophylactic drugs for migraine 12 weeks before randomization.
* Onset of migraine occurred after 50 years.
* Hypersensitivity to pregabalin or sodium valproate.

Primary outcomes:
measure: days with migraine
Secondary outcomes:
measure: hours with migraine
measure: headache severity index
measure: level of disability
measure: reports of adverse events
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Militar del General Luis Felipe Brieba Aran
state: Reg. Metropolitana
Study officials:
name: Norberto Bilbeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mathew NT, Rapoport A, Saper J, Magnus L, Klapper J, Ramadan N, Stacey B, Tepper S. Efficacy of gabapentin in migraine prophylaxis. Headache. 2001 Feb;41(2):119-28. doi: 10.1046/j.1526-4610.2001.111006119.x.
Clinical trial NCT00101569: Aripiprazole Oral Acceptability Trial
Official title: Aripiprazole Oral Acceptability Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka America Pharmaceutical
First posted: 2005-01-13
Enrollment: 59
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 purpose of this trial is to study liquid aripiprazole in patients with stable schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Stable patients currently receiving aripiprazole or other antipsychotic medications.

Primary outcomes:
measure: acceptability
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Local Institution
state: California
city: National City
country: United States
facility: Local Institution
state: California
city: North Miami Beach
country: United States
facility: Local Institution
state: Florida
city: Overland Park
country: United States
facility: Local Institution
state: Kansas
city: Staten Island
country: United States
facility: Local Institution
state: New York
city: Oklahoma City
country: United States
facility: Local Institution
state: Oklahoma
city: Falls Church
country: United States
facility: Local Institution
state: Virginia
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00443469: Spinal Magnetic Stimulation in Neuropathic Pain
Official title: A Randomized Placebo-controlled Trial on the Use of Repetitive Spinal Magnetic Stimulation as a Therapeutic Option in Patients With Intractable Neuropathic Pain of the Lower Limbs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuropathic Pain
Keywords: magnetic stimulation
neuropathic pain
spinal
lower limb
clinical trial
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2007-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It involves delivering a train of magnetic pulses, 5 at each time, to the brain. In the present study, we are using the same method to treat severe pain due to nerve conditions. You will be given up to 1000 pulses in total over the spine in the lower back (Spinal Magnetic Stimulation or SMS). Each train will be given in 10-second intervals. You will have SMS on a single day. You will be given SMS pulses at 1 or 10 per second. No stimulation will be given over the head.

You will be assessed before and after the study for up to 1 week. Your usual medical treatment will be continued

Detailed description: You must be aware of that this is a placebo-controlled trial. This means that you may either receive real SMS or sham SMS. The latter involves a harmless process of ineffective stimulation, designed for comparison with real SMS. Whether you receive either form of treatment will be assigned randomly, and there will be a 50% chance of being assigned to either.

Eligibility criteria: Inclusion Criteria:

* All with neuropathic lower limb pain

Exclusion Criteria:

* Contraindications to magnetic stimulation

Primary outcomes:
measure: Subjective pain score measurements
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: National Neuroscience Institute, Singapore General Hospital
name: YL Lo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02340169: Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
Official title: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With Topicort® (Desoximetasone) Topical Spray, 0.25% in Pediatric Patients With Plaque Psoriasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2015-01-16
Enrollment: 129
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.

Detailed description: An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.

Eligibility criteria: Inclusion Criteria:

* Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative
* Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)
* Physicians Global Assessment score of 3 or 4 at baseline

Exclusion Criteria:

* Has other dermatological conditions that may interfere with clinical assessments
* Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results
* History of an adverse reaction to Cortrosyn™ or similar test reagents
* Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation

Primary outcomes:
measure: The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test
timeFrame: 28 days
Secondary outcomes:
measure: Adverse Event
timeFrame: 28 days
measure: Cpre-ss
timeFrame: 28 Days
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA Inc.
state: New York
Study officials:
affiliation: http://www.novumprs.com/contact
name: Novum Pharmaceutical Research Services
role: STUDY_CHAIR
References:
Clinical trial NCT04983069: Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity
Official title: Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colic
Nephropathy
Keywords: Gynecology-Obstetrics
Ultrasound
Medical genetics
Pediatrics
Nephropathy
Colic hyperechogenicity
Antenatal
Lysinuria-cystinuria
lysinuric protein intolerance
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 400
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Foetuses with prenatal colic hyperechogenicity

Brief summary: Fetal colic hyper-echogenicity is a presenting symptoms for cystinuria lysinuria.

A few cases of fetuses with dibasic protein intolerance (more complex prognosis) presented with colic hyper-echogenicity antenatal.

The aim of this retrospective study is to assess the outcome of fetuses with colic hyperechogenicity in order to increase prenatal counseling

Detailed description: Observational multicenter retrospective study from january 2011 to january 2021.

No supplementary visit, directly related to the research, will be necessary. This study does not change the usual management of the patient.

Patients will be included after their usual medical check-up.

Eligibility criteria: Inclusion criteria:

* Fetuses with prenatal colic hyperechogenicity
* Between January 2011 and January 2021
* Born without term limitation.

Exclusion criteria:

* Intestinal hyperechogenicity
* polymalformative syndrome
* Patients Age\<15 years

Primary outcomes:
measure: Postnatal outcome of fetuses
timeFrame: day 1 (End of follow up)
Secondary outcomes:
measure: Rate of lysinuria/cystinuria
timeFrame: day 1 (End of follow up)
measure: Rate of dibasic protein intolerance
timeFrame: day 1 (End of follow up)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florent FUCHS, PhD
role: PRINCIPAL_INVESTIGATOR
References: