louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01159015: Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers
Official title: A Multi-center, Double-masked, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy, Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 534
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.


Eligibility criteria: Inclusion Criteria:

* Subjects less than 18 years of age, have either a history or family history of ocular allergy.
* ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentally unable to use the ETDRS chart, visual acuity will be made using the LEA symbols. For these subjects, 20-foot Snellen equivalent units of 20/63 or better in both eyes will be required.

Exclusion Criteria:

* Contraindications or sensitivities to the use of any of the investigational product(s) or their components.
* Subjects less than 18 years of age that have had symptoms and/or signs of allergic conjunctivitis/rhinitis and/or treatment with topical or systemic anti-allergy therapy, or have had a history of ragweed hypersensitivity during the 21-day period prior to visit 1.
* Surgical intervention within three months prior to Visit 1 or during the refractive surgery within the past 6 months.
* A known history of retinal detachment, diabetic retinopathy, or active retinal disease;
* An active ocular infection (bacterial, viral or fungal
* Use of any topical ophthalmic agents other than investigational products during study participation or within 5 days of beginning study treatment.
* Current or anticipated use of contact lenses during study participation or within 5 days of beginning study treatment.
* Current, prior (within 14 days of beginning study treatment) or anticipated use of systemic corticosteroids, and/or any other systemic medications which the Investigator feels may confound study data or interfere with the subject's study participation. Prior (within 21 days of beginning study treatment), current or anticipated use of any topical (including nasal) or systemic anti-allergy medications.
* Intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.

Primary outcomes:
measure: Percentage of Participants With at Least One Adverse Event.
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Tuyen Ong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03283215: Causes and Underlying Factors of Faltering Growth Among Infants
Official title: Causes and Underlying Factors of Faltering Growth Among Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infants Aged One Month to 2 Years , Infants With Any Type of Feeding (Breast or Artificial or Weaned Attend Assiut University Children Hospital )
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infants aged 1month upto 2 years infants with any type of feeding (breast , artificial or weaned)

Brief summary: to research in the different causes of failure to thrive in children including organic and non organic causes

Detailed description: Altered growth velocity in infants has been traditionally described by the term (failure to thrive ) . More recently the preferred terms are faltering growth ,slow weight gain or undernourishment as failure to thrive has been associated with negative connotations of parents failing in their job as careproviders.

The expression 'to falter' means to hesitate. Faltering growth is an observation,without value judgement, of slower than expected rate of growth along an infant's previously defined growth curve.

Faltering growth is a common pediatric problem with many untoward effects . More studies showed that children who failed to thrive in infancy are lighter and shorter at school age with adverse intellectual outcomes (corbett and drewett,2004)(Natale etal., 2014). Weight faltering in the first months of life is particularly associated with these adverse effects.

Infants with faltering growth also have a higher prevalence of feeding problems (Young etal., 2013).Growth failure is more common during infancy than during any other stage of life because programmed growth rates and nutritional needs are high (

Eligibility criteria: Inclusion Criteria:

:Infants attending assiut university children hospital who are stunting(decrease height for age ), wasting(decrease weight for lenght ), and underweight (decreases weight for age ) . When all of theses less than -1 Z scores (normal Z-score from -1 to +1 ) . Also mid arm circumference below than 115 mm

Exclusion criteria:

Children complaining of any of the follolowing:

* Malignancy

Primary outcomes:
measure: to recognize nutritional causes of faltering growth
timeFrame: from october 2017 to september 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03073915: Evaluation of the Risk of VTE Among Patients Hospitalized in Non-surgical Departments
Official title: The Risk for VTE Among Patients in the Medical Wards - Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thromboembolism
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the medical wards at the Hadassah University Hospital

Brief summary: Patients hospitalized in internal wards are at risk for VTE. The current guidelines recommend the use of thromboprophylaxis for 7-10 days among patients who are at increased risk for VTE. Yet several retrospective studies have shown that the compliance with this guideline is low. Physicians are often reluctant to administer LMWH to their fragile patients mainly because they are not convince that the risk associated with such therapy is greater than the risk for VTE.

In the current study, data concerning the use of thromboprophylaxis among patients admitted to the medical wards will be collected. The occurrence of bleeding or thrombotic event will be evaluated prospectively.

Detailed description: Data concerning the use of LMWH among patients admitted to the medical wards at the Hadassah University Hospital will be collected prospectively from the electronic medical records. The occurrence of bleeding episodes or thrombotic events will be followed for the next 90 days following discharge from the hospital.

The percent of patients actually treated by LMWH among patients entitled for such therapy according to the most updated international guidelines will be evaluated. The risk of minor and major bleeding will be compared among those given thromboprophylaxis and those who were not treated. Similar comparison will be made for thrombotic events.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to the medical wards at the Hadassah University Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Thrombosis
timeFrame: 90 days
measure: Bleeding
timeFrame: 90 days
measure: Compliance
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04177615: Randomized Assessment of Rapid Endovascular Treatment in Basilar Artery Occlusion Stroke in 115 Hospital
Official title: Randomized Assessment of Rapid Endovascular Treatment in Basilar Artery Occlusion Stroke in 115 Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute
Basilar Artery Occlusion
Keywords: Ischemic stroke
Basilar Artery Occlusion
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open lable studies conducted in 115 hospital to compare between thromboectomy and Recombinant Tisue Plasminogen Activator only to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients

Detailed description: Acute basilar artery thrombosis is associated with a poor prognosis. Prevalence of basilar artery occlusion are not known. Although basilar artery occlusion has been reported in 2 per 1000 autopsy cases, basilar artery thrombosis may, in stroke registries, explain as many as 27% of ischemic strokes occurring in the posterior circulation.Various treatments were tried in groups of patients with vertebrobasilar territory infarction but evidence based was not cleared previous studies. Therefore, we conduct this study to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients

Eligibility criteria: Inclusion Criteria:

* Patients admit to 115 hospital in 24h of Basilar Artery Occlusion Stroke
* NIHSS \> 4 points

Exclusion Criteria:

* Patients refuse to participate in studies
* Patients with contraindication of either rTPA or thromboectomy

Primary outcomes:
measure: NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission
timeFrame: 24 hours from admission
measure: Survival rate in patients with Basilar Artery Occlusion Stroke
timeFrame: 3 months from admission
Secondary outcomes:
measure: mRS in patients with Basilar Artery Occlusion Stroke
timeFrame: 3 months from admission
Other outcomes:
Locations:
Study officials:
affiliation: UMP university
name: TUAN D Tran, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02425332: Validation of a Novel Robot-aided Assessment of Gait Ability
Official title: Validation of Lokomat-aided Assessment of Gait Ability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
adaptive control
assessment
assist-as-needed
walking ability
Lokomat
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. The outcome measures of this algorithm will be the support needed in the different gait phases (guidance force of hip and knee joints) and the support required to the body weight support system (unloading). The hypothesis is that the guidance force and the support of the device will converge to a profile individual for each subject that is representative of one's impairment in the different gait phases. The reliability of the method will be tested collecting data from two sessions of Lokomat training. The validity of the method will be tested comparing the outcome of the assessment task with established clinical walking assessment measures.


Eligibility criteria: Inclusion Criteria:

* individuals \>1 year post Spinal Cord Injury or able bodied persons

Exclusion Criteria:

* presence of contraindications to Lokomat training, inability or unwillingness to provide written informed consent or follow study procedures

Primary outcomes:
measure: Intraclass Correlation Coefficient between Lokomat score.
timeFrame: up to one week
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsklinik Balgrist
Study officials:
References:
Clinical trial NCT06837532: Ultrasound Guided Versus Surgical Rectus Sheath Block Versus Local Anesthesia Infiltration for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy
Official title: Ultrasound Guided Versus Surgical Rectus Sheath Block Versus Local Anesthesia Infiltration for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasound
Surgical
Rectus Sheath Block
Local Anesthesia Infiltration
Postoperative Analgesia
Total Abdominal Hysterectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 90
Sex: FEMALE
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: The aim of this work is to compare the efficacy and safety of the effectiveness and safety of ultrasound-guided surgical rectus sheath block and local anesthetic infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.

Detailed description: Total abdominal hysterectomy (TAH) is a commonly performed major surgical procedure that results in substantial postoperative pain and discomfort.

Local anesthetic infiltration (LAI) at the end of surgery is one of the most common technique employed in laparotomies for postoperative analgesia.

Rectus sheath block (RSB) has been used as a part of multimodal analgesia, especially when neuraxial techniques are unsuitable.The RSB was used to achieve peri-operative relaxation of the anterior abdominal wall.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years old.
* American Society of Anesthesiologists (ASA) physical status I - II.
* Patients scheduled for elective total abdominal hysterectomy under general anesthesia.

Exclusion Criteria:

* Hepatic, renal or cardiac disease.
* Any known allergy to local anesthetic.
* Physical or mental conditions which may vaguely measure postoperative pain following surgery.
* History of chronic use of analgesic as nonsteroidal anti-inflammatory drugs (NSAIDs) or central nervous system (CNS) depressants as antiepileptic, and bleeding disorders.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Heart rate
timeFrame: Till the end of surgery (Up to 4 hours)
measure: Mean arterial pressure
timeFrame: Till the end of surgery (Up to 4 hours)
measure: Time to the first request for the rescue analgesia
timeFrame: 24 hours postoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Degree of patient satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT06680232: Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients with Chronic Hepatitis B
Official title: A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants with Chronic Hepatitis B (ELIMINATE-B)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: HEPATITIS B CHRONIC
Keywords: HEPATITIS B CHRONIC
Gene Therapy
Gene Editing
PBGENE-HBV
Lead sponsor: Precision BioSciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Part 1 is to identify a safe and well tolerated dose regimen of PBGENE-HBV Part 2 is an expansion cohort to aid in selecting a dosing regimen.
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.

Detailed description: Refer to key Inclusion and Exclusion criteria.

Eligibility criteria: Key Inclusion Criteria:

* Male or women of non-child bearing potential
* BMI 18.0 to 35.0
* Good overall health deemed by the study Investigator
* CHB infection documented at least 12 months prior to screening
* HBeAg-negative CHB
* Must be virologically suppressed on current NA treatment

Key Exclusion Criteria:

* No history of cirrhosis of the liver
* No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.
* No signs of hepatocellular carcinoma
* Not received an organ transplant
* No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)
* No investigational agent received within 6 months of screening

Primary outcomes:
measure: Safety to Assess Treatment-emergent Adverse Events (TEAEs)
timeFrame: 4 weeks after final dose
Secondary outcomes:
measure: Additional Safety
timeFrame: 48 weeks
measure: Pharmacokinetics of AUC
timeFrame: 4 weeks
measure: Pharmacokinetics of Cmax
timeFrame: 4 weeks
measure: Pharmacokinetics of Cmin
timeFrame: 4 weeks
measure: Pharmacokinetics of half life (t1/2)
timeFrame: 4 weeks
measure: Antiviral Activity of HBsAg and Anti-HBs
timeFrame: 48 weeks
measure: Antiviral Activity of HBV DNA
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Pok Fu Lam
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
city: Chisinau
country: Moldova, Republic of
facility: ICS ARENSIA Exploratory Medicine SRL
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research
Study officials:
affiliation: Precision BioSciences, Inc.
name: Murray A. Abramson, MD MPH, Sr. VP of Clinical Development
role: STUDY_DIRECTOR
References:
Clinical trial NCT00700232: ABCB4 Gene Mutations in Intrahepatic Cholestasis of Pregnancy and Controls
Official title: Mutations and Polymorphisms of Gene ABCB4 Among Women Suffering From Intrahepatic Cholestasis of Pregnancy. A Study With a Control Group.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrahepatic Cholestasis of Pregnancy
Keywords: genetics
gene expression
MDR3
estrogens
cholestasis
pregnancy
controls
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: multiparous normal pregnant women (control group)from a single University center

Brief summary: Mutations of the ATP binding cassette subfamily B member 4 (ABCB4) gene, a gene involved in a subtype of progressive familial intrahepatic cholestasis, have been reported in women suffering from intrahepatic cholestasis of pregnancy. The true incidence and the role of these ABCB4 gene mutations in patients suffering from intrahepatic cholestasis of pregnancy have not been clearly established.

The aim of the present study is to describe the nature and frequency of these mutations in a series of patients with intrahepatic cholestasis of pregnancy and to compare with a control group of pregnant women without intrahepatic cholestasis of pregnancy.

Detailed description: Intrahepatic cholestasis of pregnancy was defined by pruritus and elevated serum alanine aminotransferase activity or bile acid concentration, with recovery after delivery. Patients with intercurrent liver disease were excluded.

The entire ABCB4 gene coding sequence and the promoter region were analyzed, during the routine medical management, by single strand conformation polymorphism and/or sequencing in 50 unrelated Caucasian patients with intrahepatic cholestasis of pregnancy.

The genomic variants detected in these patients with intrahepatic cholestasis of pregnancy will be sought in 100 control women from Caucasian origin recruited in the same hospital.

Eligibility criteria: For the control group :

Inclusion Criteria:

* pregnant woman (age \> 18 years) during the third trimester
* caucasian and born in France
* multiparous (with at least 2 full term pregnancies)
* with informed written consent

Exclusion Criteria:

* generalized pruritus and/or liver disease during pregnancy
* liver disease secondary to oral contraception
* Chronic liver disease
* disease during current pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: Service de Gynécologie Obstétrique CHRU Tours
Study officials:
affiliation: Service d'hépato-gastro-entérologie CHRU Tours
name: BACQ Yannick, MD
role: STUDY_DIRECTOR
References: