louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04502277: Bioavailability of Flucanazole
Official title: Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of 40mgm/ml 35 ml Suspension and Pfizer (Diflucan®) 40 mg/ml 35 ml Fluconazole Suspension of Participants Under Fed Condition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Candidiasis
Lead sponsor: Sutphin Drugs
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Flucanazole 40mgm/ml 35 ml Suspension and Pfizer (Diflucan®) 40 mg/ml 35 ml Fluconazole Suspension Under Fed Condition

Detailed description: The study is to be conducted as an open-label, randomized, single-dose, 2-way crossover, relative bio availability study performed on 200 healthy adult volunteers. A total 200 subjects will be assessed for AUC for 72 hours after administration of flucanazole suspension

Eligibility criteria: Inclusion Criteria Male and females between the ages of 18 and 35 years

* Healthy Individual
* Able to swallow

Exclusion Criteria:

* History or presence of significant:

  * cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

In addition, history or presence of:

alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.

Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 30 days prior to first dose.

Subjects who have been anormal diet during the 30 days prior to the first dosing.

Primary outcomes:
measure: Bio availability
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jamaica
country: United States
facility: Sutphin Drugs
state: New York
city: Navsari
country: India
facility: Lifein Multi-Specialty Hospital
state: Gujarat
Study officials:
References:
Clinical trial NCT01703377: Effect of Constraining Joint Motions on Postural Control
Official title: Effect of Constraining Joint Motions on Postural Control
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Adults
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults from 18-65 years old

Brief summary: A major advantage of understanding a neural control scheme is able to simultaneously perform multiple tasks based on the Uncontrolled Manifold (UCM) hypothesis by taking advantage of motor redundancy. The present study aims to investigate this hypothesis further by examining the effect of artificially eliminating knee and lumbar-thoracic joint motions on postural control when the arms performing targeting task simultaneously in standing. Subjects (Younger group: 20\~35 years old; Elder group: 60\~85 years old) will execute a targeting task with and without an additional ball-balancing task in standing with free joint motions and with restricted joint motions. The investigators expect to recruit 50 subjects for each group. Analyses of joint configuration variance on the stability of the center of mass (COM) position and the hand path will be performed using the UCM method of variance analysis. This method partitions joint configuration variance into one component consistent with the use of motor abundance and a component that leads to COM position or hand path variability. Furthermore, the differences between the younger group and the elder group will be evaluated.


Eligibility criteria: Inclusion Criteria:

Participants are healthy with no self-reported neurological deficits, musculoskeletal conditions or motion sickness that affected their ability to maintain stable upright posture.

Exclusion Criteria:

Participants are healthy with self-reported neurological deficits, musculoskeletal conditions or motion sickness that affected their ability to maintain stable upright posture.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Wei-Li Hsu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00112177: Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
Official title: A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: Functional dyspepsia
Abdominal Symptom relief
Fullness
Bloating
Indigestion
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2005-06-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. They feel full after eating a few bites; they feel bloated and their stomachs hurt. The goal of this study is to see if itopride helps to relieve the symptoms of functional dyspepsia.

Detailed description: The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a sugar pill called placebo. They have equal chances of receiving either treatment. After having completed this study, patients may be eligible to continue treatment for a longer period. At that point, all patients receive itopride.

Patients need to come to the clinic for evaluations 4 times during the trial. Various evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the heart condition, and questionnaires need to be completed by the patient to see if the drug helps them in relieving their symptoms.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from functional dyspepsia according to Rome II criteria

  * 18-65 years old
  * Absence of, or infrequent heartburn (one episode per week or less)
  * Helicobacter pylori (H. pylori) negative
  * Normal upper endoscopy

Primary outcomes:
measure: Symptom relief
Secondary outcomes:
measure: Impact of symptom relief on quality of life
measure: Safety
Other outcomes:
Locations:
city: Mont-Saint-Hilaire
country: Canada
facility: Monique Giguère, Ph.D. - Programs Director
state: Quebec
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Tack, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06623877: Using Renal Elastography Measurements for Evaluation of Glomerulonephritis Patients
Official title: Using Renal Elastography Measurements for Evaluation of Glomerulonephritis Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Evaluation of Biopcy Proven Glomerulonephritis Patients by Renal Shear Wave Elastography
Keywords: elastography
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: All participants will clinically evaluated by history taking, full physical examination including body weight and assessment of fluid status, and blood and urine samples for lab analysis (serum creatinine, urea, sodium, potassium, corrected calcium, phosphorous, estimated glomerular filtration rate(GFR) by Cokcroft equation ((140 - age ) x body weight by Kg/creatinine by µmol )complete urine analysis including microscopic examination of urine , 24 hours urinary protein , haemoglobin level .

All participants will undergo renal shear wave elastography measurements. Values will be obtained from the upper, middle, and lower zones of each kidney. A total of six shear wave elastography measurements will be collected to get mean elastography values (MEVs) of each participant.

Detailed description: We will collect results of MEV plus blood and urine samples of each participant then data will undergo statistical analysis to compare between MEV of healthy persons and biopcy proven glomerulonephritis patients

Eligibility criteria: a-inclusion criteria :

* adult patients aged 18 years old or more
* patients diagnosed as glomerulonephritis ( biopcy proven ) and not started specific tratement in Assiut University Hospitals

  b. Exclusion criteria:
* patient with urinary tract obstruction
* patient who has GN and started corticosteroid and/or immunosuppressive drugs
* patient who has congenital anomalies in renal system

Primary outcomes:
measure: comparisons between the shear wave elastography measurements in GN patients and healthy persons .
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine,Assiut universty,Egypy
Study officials:
References:
Clinical trial NCT00580177: PHS, Lichtenstein Mesh, and PerFixPlug for Primary Inguinal Hernia Repair - 3 Years Results
Official title: Prolene Hernia System, Lichtenstein Mesh, and Plug-and-Patch for Primary Inguinal Hernia Repair - Three Year Outcome of a Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hernia, Inguinal
Keywords: Inguinal hernia
Randomized controlled trial
Surgery
Complications
Surgical mesh
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 472
Sex: MALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Three different techniques for the surgical repair of groin hernias are compared. Focus has been set on operation times, time to full return of functional abilities like walking in stairs etc, and if any technique has more complications than the others. Three years results are presented in the study.

Detailed description: Dissection requirements differ between various methods for inguinal hernia repair, which may effect operation times, pain response and possibly recovery time. The objectives of this study were to establish if any differences concerning these aspects could be detected after three principally different techniques for primary inguinal hernia repair.

472 men between 30 and 75 years with primary inguinal hernias were included in a prospective controlled study and randomised to Lichtenstein mesh (L), PerFix Plug® (P) or the Prolene® Hernia System (PHS) procedure. All patients were seen and data were collected after 2 weeks, 3 months, 1 year, and 3 years.

Eligibility criteria: Inclusion Criteria:

* Age 30-75 years
* Men
* Primary inguinal hernia
* ASA I-III

Exclusion Criteria:

* \> 75 years
* Females
* ASA IV
* Previous ipsi-lateral hernia surgery
* Drug or alchol abuse
* Severe illness

Primary outcomes:
measure: Time until full functional recovery
timeFrame: 2 weeks, 3 months, 1 year, 3 years
measure: Operation time
timeFrame: Registered after completion of surgery
measure: Pain after operation measured on a VAS-scale and amount of consumed analgesics
timeFrame: Day 1-14, 3 months, 1 year, 3 years after surgery
Secondary outcomes:
measure: Complication rate
timeFrame: 2 weeks, 3 months, 1 year, 3 years
measure: Aptness for beeing performed under local anaesthesia
timeFrame: During surgery
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Frolunda Specialist Hoospital/University of Gothenburg, Lundby Hospital, Molndals Hospital/Sahlgrens University Hospital
state: Vastra Gotalandsregionen
Study officials:
affiliation: Frolunda Specialist Hospital, University of Gothenburg
name: Jan A Dalenbäck, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Frolunda Specialist Hospital, University of Gothenburg
name: Jan A Dalenbäck, Ass. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01660945: Vascular and Metabolic Effects of Vytorin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: statins, insulin resistance
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 204
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigator hypothesize that vytorin may improve vascular and insulin resistance in hypercholesterolemic patients


Eligibility criteria: Inclusion Criteria:

* hypercholesterolemia

Exclusion Criteria:

* overt liver disease, chronic renal failure, hypothyroidism, myopathy, uncontrolled diabetes (HbA1c \> 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

Primary outcomes:
measure: flow-mediated dilation
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: insulin resistance
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
Study officials:
References:
Clinical trial NCT03818945: the Efficacy of Giomer Versus Sodium Fluoride in the Treatment of Hypersensitivity
Official title: Clinical Efficacy of Giomer Versus Sodium Fluoride Varnish for Management of Hypersensitivity: Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Tooth Hypersensitivity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to solve the problem of hypersensitivity, I will use two different materials ( Giomer versus Sodium Fluoride) and compare between their effects in reliving the symptoms

Detailed description: The dentin hypersensitivity is characterized by short, sharp pain which can be detected by several methods. The problem is very annoying for the patients and making them seek for effective rapid treatment.

It can affect several teeth in one area of the mouth or only one specific tooth. Careful diagnosis of such condition necessitates precise differentiation of its signs and symptoms from the other causes of tooth sensitivity which may be resulted from dental caries, micro leakage, cracked tooth or fractured restoration. There are two well-known ways to reduce the discomfort of the hypersensitivity either by blocking the exposed dentinal tubules by occluding materials or use some depolarizing agents that reducing the excitability of the intra dental nerves.Most of the desensitizing agents reduces the dentin hypersensitivity by its own way and each one has different long lasting effect. But there are some drawbacks that appeared with their use. Fluoride based agents were appeared in 90's but it was clarified that their high concentration irritated the odontoblasts. Furthermore, the oxalates and potassium nitrate were introduced to treat the hypersensitivity effectively but their effects did not persist for a long period of time.

Sodium fluoride varnish is one from the most commonly used desensitizing agent and its efficacy was approved in many studies. The Giomer varnish containing surface pre-reactive glass particles (S-PRG) is a light-cured protective varnish and it was introduced to promote prolonged protection for the hypersensitive dentin.

Eligibility criteria: Inclusion Criteria:

* Patients aged from 18 to 40 years.
* No gender restriction.
* Patients should have pain score in the visual analog scale two or more.
* Patients must have at least one sensitive tooth in one of four quadrants.

Exclusion Criteria:

* Patients with active carious lesions.
* Needing restorative treatment.
* Receiving periodontal treatment.
* Taking desensitizing treatment in the last 6 months.
* Taking anti-inflammatory drugs.
* Pregnant patients.
* Smokers.

Primary outcomes:
measure: relieving of hypersensitivity
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT04247945: Co-transplantation of MSC in the Setting of Allo-HSCT
Official title: Co-transplantation of Mesenchymal Stromal Cells in Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 120
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs infusion during allogeneic HSCT, with regard to the engraftment, graft versus host disease (GVHD), post-transplant relapse and survival.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Aged \<65 years
* Willing to transplant
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females.
* Any co-morbidity precluding the administration of MSCs.

Primary outcomes:
measure: Survival Rate
timeFrame: up to 2 years after HSCT
Secondary outcomes:
measure: Cumulative Incidence of Graft-versus Host Disease
timeFrame: up to 2 years after HSCT
measure: Incidence of Systemic Infections
timeFrame: up to 2 years after HSCT
measure: Mean Time to Engraftment
timeFrame: Baseline to engraftment, assessed minimally 28 days post transplant
measure: Transplant-Related Mortality
timeFrame: up to 1 months after HSCT
measure: Rates of Relapse
timeFrame: up to 2 years after HSCT
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Union Hospital,Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT04467645: The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women
Official title: The Effect of Reflexology on Sleep Quality and Fatigue in Postmenopausal Women: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Nursing Caries
Keywords: Nurse
postmenopausal women
sleep
reflexology
fatigue
Lead sponsor: Dicle University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 72
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study was conducted as a pretest-posttest trial model with a control group in order to determine the effect of reflexology applications on sleep quality and fatigue in postmenopausal women
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: This study was conducted to determine the effect of reflexology on sleep quality and fatigue in postmenopausal women.

Detailed description: This study was conducted in Batıkent Family Health Center of the Ministry of Health between May-December 2018. The sample of the study consisted of 72 postmenopausal women. The data were collected by using the Introductory Information Form, Pittsburgh Sleep Quality Index and Fatigue Severity Scale. A total of 12 reflexology sessions were applied to the postmenopausal women by the researcher twice a week. No intervention was applied to the postmenopausal women in the control group.

Eligibility criteria: Inclusion Criteria:

* able to communicate,
* aged 50 to 65,

Exclusion Criteria:

* taking hormone replacement therapy,
* chronic diseases (such as diabetes, hypertension, and so on),
* psychiatric disease,
* diagnosed with a sleep disorder attributed to other cause
* menstruation for more than one year
* history of alcohol or drug addiction

Primary outcomes:
measure: Reflexology Application, Pre-tests applied Pittsburgh Sleep Quality Index (PSQI), and Fatigue Severity Scale (FSS).
timeFrame: first week
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Leyla ZENGİN AYDIN
state: Sur
Study officials:
affiliation: Dicle University, Diyarbakır, Turkey. 21100/Diyarbakır
name: Leyla ZENGİN AYDIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01842347: Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)
Official title: Treatment of C. Difficile Infection With Fecal Microbiota Transplantation (FMT)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Clostridium Difficile Infection
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to treat children with severe, moderate, resistant or relapsing C. difficile infection and to determine the changes in the intestinal microbiome (all of the bacteria living in the intestines) in children receiving FMT for C. difficile infection. Data will be collected throughout the FMT procedure to determine effectiveness and to help standardize this procedure. Stool samples will be collected to look at the different bacteria that are in the intestines before and after FMT.


Eligibility criteria: Recipient Inclusion Criteria

1. Older than 18 months of age
2. FMT procedure has been decided by the treating gastroenterologist and was based on:

   1. Recurrent or relapsing CDI and:

      * Failure of standard medical therapy with metronidazole, vancomycin and fidaxomicin (over age 18 years. Fidaxomicin is not approved for \<18years and insurance authorization may not be possible).
      * At least 2 episodes of CDI requiring hospitalization
   2. Moderate CDI not responding to vancomycin for at least a week.
   3. Severe CDI with no response to vancomycin after 4 hours.
3. English speaking

Recipient Exclusion Criteria

1. Lack of informed consent/assent.
2. Not eligible for FMT procedure

Primary outcomes:
measure: Treatment of C. Difficile Infection with Fecal Microbiota Transplantation (FMT)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Steven Werlin, MD
role: PRINCIPAL_INVESTIGATOR
References: