louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01392794: A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet
Official title: Bioequivalence Study of YM060 Orally-disintegrating Tablet and Conventional Tablet - Ingestion Without Water
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Plasma Concentration of YM060
Keywords: YM060
ramosetron
orally-disintegrating tablet
OD tablet
bioequivalence
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-07-13
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A study to compare time-course changes of plasma concentration of YM060 after intake of conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be administered without water.


Eligibility criteria: Inclusion Criteria:

* healthy assessed by the principal investigator or sub-investigators
* non-smoking or stop smoking at least 90 days before the study
* body weight: over 50.0kg and less than 80.0kg
* body mass index (BMI): over 17.6 and less than 26.4

Exclusion Criteria:

* participated in another clinical trial (including a post-marketing clinical study) within 120 days before the study
* donated 400mL of whole blood within 90 days, 200mL of whole blood within 30 days or blood components within 14 days before the study
* received any drugs within 7 days before the study or going to receive any drugs
* deviance from normal range in vital signs (blood pressure, pulse rate, and body temperature) or 12-lead ECG
* deviance from normal range in lab-tests
* history of drug allergy
* history or current diagnosis of stomach, small intestine or large intestine diseases
* history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
* history or current diagnosis of colitis ischemic
* history or current diagnosis of hepatic diseases
* history or current diagnosis of cardiovascular diseases
* history or current diagnosis of respiratory diseases
* history or current diagnosis of malignant tumor
* received ramosetron tablet

Primary outcomes:
measure: Area under the curve of YM060 plasma concentration -time curve
timeFrame: up to 24 hours after administration
measure: Maximal concentration of YM060 plasma concentration
timeFrame: up to 24 hours after administration
Secondary outcomes:
measure: Safety assessed by the incidence of adverse events, vital signs, lab-tests and 12-lead ECG
timeFrame: up to 24 hours after administration
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT04267094: Reduced Radiation Dose and IR-impact on Coronary Calcium Quantification
Official title: A Single-center, Multi-scanner, Observational Study to Investigate the Impact of Reduced Radiation Dose and Iterative Reconstruction Algorithms on Coronary Calcium Score in Comparison to the Standard Normal Radiation Dose -Filtered Back Projection Method
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atherosclerotic Plaque
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of reduced radiation dose iterative reconstruction reconstructions for calcium scoring compared to full dose filtered back projection reconstructions


Eligibility criteria: Inclusion Criteria:

* Patients undergoing routine calcium scoring CT at facilities at the University of Pennsylvania

Exclusion Criteria:

* Patients found to have no coronary calcium on full dose FBP reconstructions

Primary outcomes:
measure: Calcium score
timeFrame: immediate
Secondary outcomes:
measure: Risk stratification
timeFrame: immediate
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01075594: Study of Undertreatment of Patients With Dyslipidemia in Bulgaria
Official title: Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Keywords: Dyslipidemia
Target cholesterol
Undertreatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-25
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of this study is to establish the proportion of Bulgarian patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth Joint European Task Force guidelines.


Eligibility criteria: Inclusion Criteria:

* Lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks
* Signed Informed Consent

Exclusion Criteria:

* Informed Consent not provided

Primary outcomes:
measure: The number and percentage of patients achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines
timeFrame: 6 months - one visit only, no follow-up visits
Secondary outcomes:
measure: The number and percentage of subjects achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines for several subject subsets
timeFrame: 6 months - one visit only, no follow-up visits
measure: The number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III / 2004 updated 2004 NCEP ATP III guidelines, overall and for several subject subsets
timeFrame: 6 months - one visit only, no follow-up visits
measure: The number and percentage of subjects achieving the non HDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III/national guidelines [<130mg/dL (3,37mmol/L)], in the following sub-population: patients with fasting triglycerides >200 mg/dL
timeFrame: 6 months - one visit only, no follow-up visits
Other outcomes:
Locations:
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Burgas
country: Bulgaria
facility: Research Site
city: Haskovo
country: Bulgaria
facility: Research Site
city: Montana
country: Bulgaria
facility: Research Site
city: Pazardjik
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Russe
country: Bulgaria
facility: Research Site
city: Shumen
country: Bulgaria
facility: Research Site
city: Sliven
country: Bulgaria
facility: Research Site
city: Smolyan
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Veliko Turnovo
country: Bulgaria
facility: Research Site
Study officials:
References:
Clinical trial NCT03795194: Antibiotic Duration in Post-appendectomy Abscess
Official title: A Prospective, Randomized Trial of Antibiotic Duration in Post-appendectomy Abscess
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Complicated Appendicitis
Perforated Appendicitis
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 7
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized study of patients 2-17 years old who are diagnosed with perforated appendicitis and develop an abscess after laparoscopy that is subsequently drained. Patients will be randomized to either receive an 8-day or a 4-day course of antibiotics. The aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in clinical outcomes.

Detailed description: The central aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in primary and secondary clinical outcomes. Specifically, this research aims to determine whether the readmission rate and length of stay for pediatric patients diagnosed with perforated appendicitis who form a post-laparoscopic abscess that is treated with percutaneous drainage and are treated with a 8-day oral antibiotic regimen at discharge is significantly different from those treated with a fixed 4-day regimen at discharge.

This study includes patients ages 2-17 years old who present with perforated appendicitis-as diagnosed at laparoscopy and photographed as either a hole or as feces in the abdomen-and who develop an abscess after laparoscopy that is treated with percutaneous drainage.

All post-laparoscopic abscess patients will receive the standard of care for antibiotic therapy at Phoenix Children's Hospital-IV ceftriaxone/metronidazole-until afebrile and tolerating food. All patients will be treated with the PCH standard of care and receive in-patient treatment for abscess until afebrile.

At discharge, study patients will be randomly assigned to either an 8-day ampicillin/clavulanate regimen or a 4-day ampicillin/clavulanate regimen. Pediatric patients who are allergic to ampicillin will be excluded from the study. Patients will be followed thirty days post discharge to assess clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Age: 2 to 17 years of age
* Diagnosis of perforated appendicitis at laparoscopy
* Development of a post-appendectomy abscess that is treated with percutaneous drainage.

Exclusion Criteria:

* Patients who are allergic to ampicillin

Primary outcomes:
measure: Hospital Readmission Rate
timeFrame: 30 days
measure: Length of Hospital Stay
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
affiliation: Phoenix Children's
name: Craig Egan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005394: Diagnosis/Pathophysiology of Glucocorticoid Remediable Aldosteronism Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Hypertension
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To identify and study a large cohort of glucocorticoid remediable aldosteronism (GRA) patients.

Detailed description: DESIGN NARRATIVE:

The spectrum of the severity and the natural history of the disorder was characterized. Modifying environmental and genetic factors important in regulation of blood pressure were determined. Also, renal physiology was studied in GRA patients to determine how these patients escaped hypokalemia in spite of mineralocorticoid excess. There were four specific aims including: 1) to determine the natural history and prevalence of GRA in various hypertensive populations, 2) to characterize the magnitude of effect imparted on blood pressure by inheritance of GRA and the sources of variation in phenotype expression of the hypertension, 3) to investigate the renal and hormonal mechanisms regulating potassium conservation and loss in GRA, and 4) to characterize the disequilibrium of GRA with Irish and Scottish descent and specific alleles of the aldosterone synthase gene.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Richard Lifton
References:
citation: Litchfield WR, Coolidge C, Silva P, Lifton RP, Fallo F, Williams GH, Dluhy RG. Impaired potassium-stimulated aldosterone production: a possible explanation for normokalemic glucocorticoid-remediable aldosteronism. J Clin Endocrinol Metab. 1997 May;82(5):1507-10. doi: 10.1210/jcem.82.5.3964.
citation: Litchfield WR, Anderson BF, Weiss RJ, Lifton RP, Dluhy RG. Intracranial aneurysm and hemorrhagic stroke in glucocorticoid-remediable aldosteronism. Hypertension. 1998 Jan;31(1 Pt 2):445-50. doi: 10.1161/01.hyp.31.1.445.
citation: Litchfield WR, New MI, Coolidge C, Lifton RP, Dluhy RG. Evaluation of the dexamethasone suppression test for the diagnosis of glucocorticoid-remediable aldosteronism. J Clin Endocrinol Metab. 1997 Nov;82(11):3570-3. doi: 10.1210/jcem.82.11.4381.
Clinical trial NCT06965894: Lower Extremity Pressure Splints in HP
Official title: Effect of Pressure Splints on Lower Extremity Functions in Hemiplegic Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia
Lower Extremity Dysfunction
Stroke Rehabilitation
Keywords: Stroke
Rehabilitation
Gait
Johnstone Splint
Motor Recovery
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemiplegia (weakness or paralysis on one side of the body) often impacts the lower extremities, making it challenging for patients to walk or move their legs effectively. This study aims to explore the effects of pressure splints on the lower extremity movement and function in individuals who have experienced a stroke and suffer from hemiplegia. Pressure splints are specialized devices designed to support and enhance muscle function by applying gentle pressure to the affected limbs.

Participants in this study will be randomly assigned to one of two groups: the Splint Group (SG) or the Control Group (CG). The duration of the intervention will be six weeks. During this period, all the participants will receive neurodevelopmental therapy. In the SG exercises will be done with the help of the lower extremity pressure splints while participants in the CG will join the exercises without any splint.

This study is significant as it may lead to the development of new methods to enhance recovery for stroke patients and offer better rehabilitation options.


Eligibility criteria: Inclusion Criteria:

* Having hemiplegia because of stroke
* Time since stroke: 1 month to 1 year
* Ability to Participate (a score of \>24 on the Mini-Mental State Examination).
* Being voluntary
* Age between 50-80

Exclusion Criteria:

Severe Cognitive Impairment Other Neurological Disorders Severe Comorbidities or Spasticity on Lower Extremity Contraindications to Exercise Recurrent Stroke

Primary outcomes:
measure: Lower Extremity Motor Function
timeFrame: Through study completion, an average of 8 months
measure: Balance
timeFrame: Through study completion, an average of 8 months
measure: Lower Extremity Strength
timeFrame: Through study completion, an average of 8 months
measure: Mobility
timeFrame: Through study completion, an average of 8 months
Secondary outcomes:
measure: Stroke Recovery
timeFrame: Through study completion, an average of 8 months
measure: Ambulation
timeFrame: Through study completion, an average of 8 months
measure: Independence
timeFrame: Through study completion, an average of 8 months
measure: Muscle Tone
timeFrame: Through study completion, an average of 8 months
Other outcomes:
Locations:
city: Jounieh
country: Lebanon
facility: Monseigneur Cortbawi Hospital
state: Keserwan
Study officials:
affiliation: Mgr Cortbawi Hospital
name: Mansour Dib, Doctor
role: STUDY_CHAIR
References:
Clinical trial NCT02696694: Predictive Value of Mid-luteal Serum Progesterone Levels in Egg Donation Cycles
Official title: Impact of Serum Progesterone Levels on the Day of Embryo Transfer on the Success Rate in Egg Donation Cycles Under Hormonal Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 242
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile patients undergoing their first or second egg donation cycle

Brief summary: This study aims to investigate the impact of serum progesterone concentrations on the day of embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary outcomes, the investigators will investigate if endometrial volume measured by three-dimensional (3D) ultrasound on the day of embryo transfer is related with progesterone levels and with chances of pregnancy.


Eligibility criteria: Inclusion Criteria:

* Age\<50 yo
* BMI \< 30Kg/m2
* Hormonal replacement cycle
* Endometrial thickness \>6.5 mm during proliferative phase
* Transfer of one or two blastocyst grade A-B according to ASEBIR

Exclusion Criteria:

* Uterine pathology
* Cryptozoospermia
* Severe implantation failure (\>6 GQ embryos transferred without success)

Primary outcomes:
measure: mid-luteal serum progesterone level
timeFrame: one year
Secondary outcomes:
measure: endometrial volume
timeFrame: one year
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References:
citation: Labarta E, Mariani G, Holtmann N, Celada P, Remohi J, Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective study. Hum Reprod. 2017 Dec 1;32(12):2437-2442. doi: 10.1093/humrep/dex316.
Clinical trial NCT00372294: To Compare Intravitreal Clindamycin & Dexamethasone With Classic Treatment of Toxoplasmic Retinochoroiditis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chorioretinitis
Keywords: Toxoplasmosis
Chorioretinitis
Intravitreal Clindamycin
Dexamethasone in chorioretinitis
Toxoplasmic
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-06
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Toxoplasmosis, an intra cellular parasite, is a very important cause of chorioretinitis. The goal of treatment is arresting multiplication of the parasite in its inflammatory active phase. In this study the investigators try to compare the efficacy of the classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon) with intravitreal Clindamycin \& Dexamethasone.


Eligibility criteria: Inclusion Criteria:

* Patients with Toxoplasmic chorioretinitis
* Location of the lesion within zone I of the retina or a lesion greater than 2DD with 3+-4+ vitreous inflammation in zone II or III
* No allergic history to the used drugs
* No any other diseases

Exclusion Criteria:

* Any allergic reaction to the used medications
* One eyed patients
* Partially treated patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Masoud Soheilian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03691194: The Effects of 8 oz Fresh vs. Commercial Orange Juice on Blood Pressure In Normotensive Males Aged 18-59
Official title: The Effects of 8 oz Fresh vs. Commercial Orange Juice on Blood Pressure In Normotensive Males Aged 18-59
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this graduate student research study is to determine the effects of drinking eight ounces of fresh vs. commercial orange juice on blood pressure in males with normal blood pressure.

Detailed description: Visit 1

-

Beginning of the first four weeks:

Upon arrival, subjects will be given a consent form to sign. The student investigators will go over the layoutof the research study such as the procedures, and compliance with them. Then, subjects will be asked if they agree with drinking orange juice daily for two months. If they agree, they will be asked to relax for five minutes, and the student investigators will take their blood pressure reading three times using a blood pressure monitor. The subjects will complete the Perceived Stress Scale (PSS) survey before leaving. The subject will drink orange juice for 28 days.

•

Visits 2, 3, and 4:

Subjects will meet with the student investigators at a convenient location. Subjects will be asked to rest for five minutes. Student investigators will then take their blood pressure reading three times using a blood pressure monitor. The subjects will complete the PSS survey before leaving.

•

Between visit 2 and 3:

There is a washout period of approximately eight weeks. • During the first and second set of the 4

-week intervention phase, subjects will visit student investigators to retrieve orange juice samples every 3 or 4 days.

Eligibility criteria: Inclusion Criteria: Healthy 18-59 years old males, willing to keep the same lifestyle, not taking any medications or antioxidant supplements to control blood pressure, and do not drink any types of orange juice within 30 days.

Exclusion Criteria: Diabetic, smoke cigarettes, marijuana or electronic cigarettes, drink alcohol more than one a week, allergic to oranges, and diagnosed as hypotensive or hypertensive.

Primary outcomes:
measure: blood pressure
timeFrame: change from baseline to 4 weeks
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: change from baseline to 4 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Universtiy
state: California
Study officials:
affiliation: Loma Linda University
name: Cory Gheen, MS RD
role: PRINCIPAL_INVESTIGATOR
References: