louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00912002: A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)
Official title: A Study to Investigate the Absorption, Metabolism, Excretion and Mass Balance After Administration of a Single Dose of [14C]MK-0941
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single dose, open label study to characterize the routes of elimination and determine the mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples will be collected to determine relative quantities of 14C-labeled MK-0941.


Eligibility criteria: Inclusion Criteria:

* Subject has been diagnosed with type 2 diabetes, and is being treated with diet and exercise or with an oral anti-hyperglycemic agent
* Subject is willing to follow the American Heart Association diet and exercise program throughout the study
* Subject is a nonsmoker and/or has not used nicotine products for at least 6 months

Exclusion Criteria:

* Subject has a history of stroke, seizures, or major neurological disorder
* Subject has a history of neoplastic disease
* Subject has recently had abnormal bowel habits, such as diarrhea, loose stools or constipation
* Subject has a history of type 1 diabetes mellitus
* Subject has received insulin within the past 12 weeks
* Subject has a recent history of eye infection
* Subject has been diagnosed with glaucoma or is blind
* Subject consumes more than 3 alcoholic beverages per day
* Subject consumes more than 6 servings of coffee, tea, cola per day
* Subject has had major surgery, donated or lost blood in the past 4 weeks
* Subject has multiple or severe allergies to any food or drugs

Primary outcomes:
measure: Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).
timeFrame: Up to 168 hours after study drug administration
Secondary outcomes:
measure: Number of Participants Who Experienced An Adverse Event
timeFrame: Up to 14 days after study drug administration
measure: Number of Participants Who Discontinued the Study Due to An Adverse Event
timeFrame: Up to 14 days after study drug administration
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05022602: Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System
Official title: Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Stage
Lead sponsor: Seno Medical Instruments Inc.
Sponsor class: INDUSTRY
Collaborators: name: American College of Radiology
First posted: 2021-08-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe).

Detailed description: 1. Obtain ultrasound only probe images and duplex probe OA/US (both gray scale and OA) probe images. This includes doppler and elastography imaging with the gray scale only ultrasound probe and ultrasound mode of the duplex OA/US probe.
2. Provide breast and lymph node pathology results (except BI-RADS 1, 2 and 3 (as applicable))

Eligibility criteria: Inclusion Criteria:

1. Has a signed and dated informed consent, prior to initiation of any study-related activities.
2. Is at least 18 years of age.
3. Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging.
4. Is willing and able to comply with protocol-required scans

Exclusion Criteria:

1. Is pregnant or lactating.
2. Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) which could interfere with the intended field of view.
3. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as some sulfur containing drugs, ampicillin, tetracycline.
4. Is currently undergoing phototherapy.
5. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
6. Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
7. Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.
8. Currently has mastitis.
9. Prisoners

Primary outcomes:
measure: Number of Participants With Imagio Image Sets Collected
timeFrame: Baseline
measure: Number of Subjects With Completed Pathology Results
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health
state: Texas
Study officials:
affiliation: UTHSC
name: Pam Otto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06836102: Usage of Orange Peel Extract in Management of Epistaxis
Official title: The Potential of Nano-based Gel of Orange Peel Extract in Management of Epistaxis : a Randomized Double Blind Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epistaxis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of orange peel extract in treatment of epistaxis in children

Detailed description: Formulation of orange peel extract into gel substance and usage of it in local treatment of epistaxis

Eligibility criteria: Inclusion Criteria:

* children with anterior epistaxis from little's area

Exclusion Criteria:

* patient with nasal polyp.
* patients with hematological abnormalities.
* patients with general diseases affecting coagulation system.

Primary outcomes:
measure: The potential of nano-based gel of Orange peel extract in management of epistaxis
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Andrade MA, Barbosa CH, Shah MA, Ahmad N, Vilarinho F, Khwaldia K, Silva AS, Ramos F. Citrus By-Products: Valuable Source of Bioactive Compounds for Food Applications. Antioxidants (Basel). 2022 Dec 25;12(1):38. doi: 10.3390/antiox12010038.
Clinical trial NCT00115102: Sensory Examination and Pharmacological Modulation of Oral Hyperexcitability in Patients With Atypical Odontalgia and Matched Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Odontalgia
Keywords: Atypical odontalgia
capsaicin
pain
neuropathic pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Pain Research Center
First posted: 2005-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This project examines experimental pain and chronic pain in the mouth, specifically the condition called atypical odontalgia (AO:atypical toothpain). In 16 patients with AO and 16 healthy persons, capsaicin (chili-pepper) is applied to the gingiva to cause pain. This pain is evaluated by the participants. In three sessions, 3 different medications are tested for effect on the pain. The medications are fentanyl, S-ketamine and placebo-treatment (saline). The aim is to know more about pain mechanisms in AO in order to develop an effective treatment.


Eligibility criteria: Inclusion Criteria:

* Atypical odontalgia

Exclusion Criteria:

* BMI \> 30
* Heart conditions
* Lung disease
* Diseases of the liver or kidneys
* Hypertension, untreated

Primary outcomes:
measure: Pain
measure: Sensitivity to heat and cold
measure: Sensitivity to mechanical stimuli
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center
Study officials:
affiliation: Aarhus University Hospital
name: Troels Staehelin Jensen, MD, PhD, Dr.Sci
role: STUDY_CHAIR
References:
Clinical trial NCT04500002: Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion
Official title: Adjuvant Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IUCD Complication
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized parallel assign controlled trial
Primary purpose: PREVENTION

Brief summary: The primary endpoint was the success rate of adjuvant isonicotinic acid hydrazide (INH) and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.

Detailed description: According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 10 weeks based on the last menstrual period

Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week

Adjuvant isonicotinic acid hydrazide (INH) administration with misoprostol raises the rate of complete abortion

Eligibility criteria: Inclusion Criteria:

* Gestational age less than 70 days gestation (\<10 wks)
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 30 kg/m2.
* Missed abortion

Exclusion Criteria:

* Molar pregnancy.
* Fibroid uterus.
* Uterine anomalies.
* Coagulopathy.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.
* Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).

Primary outcomes:
measure: number of patients with complete abortion
timeFrame: 12 hours
measure: time from induction to abortion
timeFrame: 12 hours
Secondary outcomes:
measure: number of the women will undergo dilatation and curettage after failed medical induction of abortion
timeFrame: 12 hours
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
References:
Clinical trial NCT01298102: Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients
Official title: Safety and Efficacy of Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Transplant and Dialyzed Patients: a Prospective Cohort Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Decreased Immunologic Activity [PE]
Influenza
Rejection
Keywords: kidney
transplantation
haemodialysis
vaccination
influenza H1N1 2009
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about vaccination. There is no data concerning the immunogenicity nor the security of the adjuvanted-A/H1N1 vaccine in renal disease patients. The aim of this study is to observe the effects of this vaccine on transplanted and hemodialyzed patients.

Detailed description: The serologic responses to the Pandemrix vaccine will assess the efficacy, with the determination of the seroconversion rate among the patients.

The anti-HLA and anti-MICA antibodies will be determined to assess the safety among the renal transplanted patients.

Eligibility criteria: Inclusion Criteria:

1. Adult patients
2. Haemodialyzed patients
3. Renal transplant recipients who have stable renal function for the last 3 months

Exclusion Criteria:

1. No pneumonia or severe infection during 1 month before vaccination
2. No Ivig (intravenous immunoglobulins) treatment during the last 3 months

Primary outcomes:
measure: to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls
timeFrame: one month post-vaccination
Secondary outcomes:
measure: to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination
timeFrame: follow-up 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hospital Erasme
state: Brabant
Study officials:
affiliation: Hospital Erasme
name: Daniel Abramowicz, PhD
role: STUDY_DIRECTOR
References:
citation: Candon S, Thervet E, Lebon P, Suberbielle C, Zuber J, Lima C, Charron D, Legendre C, Chatenoud L. Humoral and cellular immune responses after influenza vaccination in kidney transplant recipients. Am J Transplant. 2009 Oct;9(10):2346-54. doi: 10.1111/j.1600-6143.2009.02787.x. Epub 2009 Jul 28.
Clinical trial NCT00987402: Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
Official title: Surgical Site Infections: a Cluster-randomized, Cross-over Study of the Efficacy of Plain Soap and Water Versus Alcohol-based Rubs for Surgical Hand Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Postoperative Wound Infection
Keywords: Surgery
hand scrubbing
post-operative infection
surgical site infection
surgical hand preparation
plain soap and water
alcohol-based hand rub
Cost of surgical hand preparation agent
Side effects of use of hand preparation agent
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: AIC Kijabe Hospital
First posted: 2009-10-01
Enrollment: 3317
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Surgical site infections (SSI) constitute a significant health-economic and clinical challenge. The investigators conducted a cluster-randomized, cross-over study to compare the efficacy of plain soap and water (PSW), used ubiquitously across sub-Saharan Africa for surgical hand preparation, to alcohol-based hand rub (ABHR), with SSI rates as the main outcome measure.

A total of 3317 patients undergoing clean and clean-contaminated surgery were included in the study and followed up for 30 days.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing clean or clean-contaminated surgery at AIC Kijabe Hospital

Exclusion Criteria:

* All patients undergoing contaminated, dirty surgeries and those undergoing repeat procedures within 2 weeks after the initial surgical intervention.
* Patients who did not consent to participate in the study

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 30 days post-operatively
Secondary outcomes:
measure: Cost of Hand Preparation Agent
timeFrame: 30 days
Other outcomes:
Locations:
city: Kijabe
country: Kenya
facility: Africa Inland Church Kijabe Hospital
state: Central
Study officials:
affiliation: AIC Kijabe Hospital
name: Peter M Nthumba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wood JH, Nthumba PM, Stepita-Poenaru E, Poenaru D. Pediatric surgical site infection in the developing world: a Kenyan experience. Pediatr Surg Int. 2012 May;28(5):523-7. doi: 10.1007/s00383-012-3058-x.
citation: Nthumba PM, Stepita-Poenaru E, Poenaru D, Bird P, Allegranzi B, Pittet D, Harbarth S. Cluster-randomized, crossover trial of the efficacy of plain soap and water versus alcohol-based rub for surgical hand preparation in a rural hospital in Kenya. Br J Surg. 2010 Nov;97(11):1621-8. doi: 10.1002/bjs.7213.
Clinical trial NCT04622202: Pre-emptive Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section
Official title: The Effects Of Pre-emptive Single Oral Dose Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Anxiety State
Sedation
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-11-09
Enrollment: 74
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is exaggerated neuroendocrine stress response to laryngoscopy and endotracheal intubation during the Induction to anesthesia-delivery (I-D) period under light anesthesia. Mechanical stimulation of laryngeal proprioceptors elicits increased secretion of cortisol and catecholamine with subsequent elevation of blood pressure from 40 to 50 % and heart rate up to 20 % during direct laryngoscopy and endotracheal intubation

Detailed description: The sample size was calculated using OPEN EPI program assuming that the mean visual analogue scale anxiety score was 49.3±14.1 among oral pregabalin group and was 58.6± 14.4 among Placebo group (8) so at power of study 80% confidence interval 95%, the sample size was calculated to be 74 cases (37in each group

Eligibility criteria: Inclusion Criteria:

* Age: 21-38 years old.
* Pregnant Female with a singleton fetus of at least 36 weeks of gestation.
* American Society of Anesthesiologist Physical status: 1\& II.
* Body Mass Index (BMI) (25-30kg/m²).
* Type of operations: elective caesarean section under general anesthesia.
* Written informed consent from the parturient.

Exclusion Criteria:

* Altered mental state.
* Women with known history of allergy to pregabalin.
* Women with uncontrolled diabetes mellitus, bleeding, coagulation disorders, Hepatic, renal, Cardiovascular, respiratory disease and neuropsychiatric disorders.
* Patients receiving anticonvulsants, antidepressants.
* Pregnancy induced hypertension, intrauterine growth restriction or fetal compromise

Primary outcomes:
measure: preoperative maternal anxiety changes
timeFrame: change from baseline at 60 minutes after giving drug preoperative.
Secondary outcomes:
measure: Number of participant with changes in level of consciousness
timeFrame: at 60 minutes preoperative
measure: Heart rate
timeFrame: at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
measure: mean arterial blood pressure
timeFrame: at baseline, 0 (at intubation) 1, 3, 5, 10 and 15 minutes after intubation.
measure: Serum glucose
timeFrame: preoperative and at 10 minutes after intubation.
measure: cortisol level
timeFrame: preoperative and at 10 minutes after intubation.
measure: Baby Apgar score
timeFrame: at 1 and 5 minutes after delivery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Sara Mohamed Abdel Nabi
Study officials:
affiliation: Zagazig University
name: Sara Abdel Naby, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01025102: The Addition of Sufentanil Interscalene Block in Shoulder Surgery
Official title: Phase III Study of the Addition of Sufentanil to Interscalene Block in Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Shoulder Surgery
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare the effects and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.

Detailed description: The purpose of this study is to compare the duration of postoperative analgesia and supplemental opioid consumption and side effects of interscale block performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery

Eligibility criteria: Inclusion Criteria:

* ASA I-III
* Age 18-80
* Shoulder surgery performed under interscalene block and general anesthesia

Exclusion Criteria:

* Contraindication of interscalene block
* Severe chronic obstructive lung disease
* Non-cooperative patient
* Intolerance to opioids
* Pregnancy
* Rheumatoid arthritis and diabetes with peripheral polyneuropathy
* Chronic pain or daily opioid intake

Primary outcomes:
measure: Time to experience of moderate to severe postoperative pain
timeFrame: On day of surgery and 1., 2. and 3. postop. day
Secondary outcomes:
measure: Side effects
timeFrame: On day of surgery and 1., 2. and. 3. postop. day
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Anesthetic Clinic, Frederiksberg University Hospital
Study officials:
affiliation: Anesthetic Clinic, Frederiksberg University Hospital
name: Bent G Jørgensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05016102: Exercise Enhances Brain Function in Attention-deficit/Hyperactivity Disorder (ADHD)
Official title: Different Exercise Types on Inhibitory Control in Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
ADHD
Executive Dysfunction
Keywords: intensity
exercise
executive function
ADHD
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of the study was to investigate the different effects of exercise types on inhibitory control in children with attention-deficit/ hyperactivity disorder.

Detailed description: Study inclusion criteria were as follows: (1) age between 8 and 12 years; (2) diagnosed with ADHD by a pediatric psychiatrist; and (3) no history of brain injury or neurological conditions, such as exhibited epileptic seizures, serious head injuries, and periods of unconsciousness.

Eligibility criteria: Inclusion Criteria:

1. aged between 7 and 12 years
2. diagnosed by a pediatric psychiatrist
3. no history of brain injury
4. no neurological conditions

Exclusion Criteria:

1. less than 50% accuracy
2. failed to complete the task
3. cannot follow the instruction

Primary outcomes:
measure: Behavioral performance
timeFrame: around 10-30 minutes after exercise intervention
Secondary outcomes:
measure: P3 component
timeFrame: around 10-30 minutes after exercise intervention
Other outcomes:
measure: EEG
timeFrame: around 10-30 minutes after exercise intervention
Locations:
Study officials:
affiliation: Department of Physical Education, National Taiwan Normal University
name: Tsung-Min Hung
role: STUDY_CHAIR
References: