louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00597649: A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Official title: An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Peripheral Neuropathy Pain in Diabetics
Lead sponsor: XTL Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-01-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18 years or older
* Diagnosis of type 1 or type 2 non-insulin dependent diabetes mellitus
* Chronic bilateral pain due to diabetic neuropathy, pain for at least six months.
* Primary pain is located in the feet.
* Subject participated in and completed the XTL 07-001 clinical trial.

Contact site for additional information.

Exclusion Criteria:

* Symptoms of other painful conditions
* Presence of amputations other than toes
* Clinically significant psychiatric or other neuropsychological disorder
* Use of certain medications
* Clinically important other diseases
* Pregnancy
* History of alcohol or narcotic abuse within two years.

Contact site for additional information.

Primary outcomes:
measure: Pain and safety
timeFrame: one year
Secondary outcomes:
measure: Clinical Global Impression of Improvement; McGill Pain Questionnaire; Amount of Rescue Medication Used for Pain; Quality of Life Survey (SF-36); Patient Global Impression of Change
timeFrame: One year
Other outcomes:
Locations:
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
Study officials:
affiliation: XTL Biopharmaceuticals
name: Mark Roffman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00652249: Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
Official title: A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hydrocephalus
Keywords: Hydrocephalus
shunt dysfunction
shunt flow
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-04-03
Enrollment: 0
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric hydrocephalus patients under the care of the Children's Hospital of Wisconsin, who have had an external ventriculostomy and are instrumented with an Extra-Ventricular Drainage system.

Brief summary: The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve.

The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag.

By monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Hydrocephalus
* Newborn through age 20
* External Ventriculostomy with an Extra-Ventricular Drainage system installed

Exclusion Criteria:

* Not diagnosed with Hydrocephalus
* Older than age 20
* No External Ventriculostomy with an Extra-Ventricular Drainage system installed

Primary outcomes:
measure: Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage System as a function of the shunt valve pressure release setting and drainage bag position.
timeFrame: 24 to 48 hours
Secondary outcomes:
measure: Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
timeFrame: 24 to 48 hours
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Transonic Systems Inc.
name: Cornelis J Drost, BS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Bruce A Kaufman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06355349: To Evaluate the Safety and PK Characteristics in Healthy Volunteers
Official title: A Randomized, Open-label, Single Dose, 2x4 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0101 and C2101 and Administration of JW0102 in Healthy Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-04-09
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions

Detailed description: Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria

Primary outcomes:
measure: AUCt
timeFrame: Day1 0h ~ Day4 72h
measure: Cmax
timeFrame: Day1 0h ~ Day4 72h
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center, Jeonbuk National University Hospital
Study officials:
affiliation: Jeonbuk National University Hospital
name: SeolJu Moon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05050149: Study Evaluating the Safety and Efficacy of PTX-022 (QTORIN Sirolimus) in the Treatment of Microcystic Lymphatic Malformations
Official title: A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Microcystic Lymphatic Malformation
Lead sponsor: Palvella Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label, baseline-controlled study
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and efficacy of PTX-022 (sirolimus) Topical Gel 3.9% w/w in the treatment of Microcystic Lymphatic Malformations. The participant will receive 3 months of PTX-022 treatment by the end of the study.


Eligibility criteria: Inclusion Criteria:

* Participants must be 6 years or older
* Diagnosed with Microcystic Lymphatic Malformations
* Able and willing to comply with all protocol-required activities
* Willing and able to provide written informed consent

Exclusion Criteria:

* Any significant concurrent condition that could adversely affect participation.
* Any history of allergy or hypersensitivity to sirolimus, or sirolimus-like medications or to PTX-022
* Patient's deemed by the investigator as unwilling or unable to remain compliant with all tests and procedures, including adherence to study drug administration and other protocol-required activities.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: New York
country: United States
facility: Vascular Birthmark Institute
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Pennsylvania (CHOP)
state: Pennsylvania
Study officials:
References:
citation: Teng JMC, Hammill A, Martini J, Treat J. Sirolimus in the Treatment of Microcystic Lymphatic Malformations: A Systematic Review. Lymphat Res Biol. 2023 Apr;21(2):101-110. doi: 10.1089/lrb.2021.0103. Epub 2022 Jul 18.
Clinical trial NCT03813849: Remnants of Conception After Suction Evacuation of Missed Abortion
Official title: Sonographic Detection of Remnants After Surgical Evacuation of Missed Abortion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Miscarriage
Keywords: remnants of conception
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: multiparous women, aged 18 to 45 years with missed abortion up to 12 weeks gestational age, with normal uterus and without suspicion of sepsis.

Brief summary: All women admitted for surgical evacuation of missed abortion after failure of medical treatment from June 2016 underwent transvaginal sonography immediately after completion of the procedure as judged by the operator to ensure absence of remnants.

Detailed description: Women indicated for surgical evacuation of missed abortion up to 12 weeks were included. Standard surgical evacuation of uterus by suction followed by sharp curettage under general anaesthesia were done for all cases. When the operator judged the procedure as complete, transvaginal sonography was done by dedicated sonographer using portable ultrasound machine in theatre. If remnants were detected the procedure was repeated till the cavity seen empty.

Eligibility criteria: Inclusion Criteria:

multiparous. have missed abortion up to 12 weeks gestational age by dating. failed medical evacuation. consented for the procedure.

Exclusion Criteria:

suspicion of sepsis. Suspected molar pregnancy. previous evacuation trial. abnormal uterus like fibroids.

-

Primary outcomes:
measure: presence remnants of conception
timeFrame: immediately after the end of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Shatby maternity university hospital
Study officials:
References:
Clinical trial NCT03861949: Effectiveness of Preoxygenation With Positive Airway Pressure: a Comparison of the Supine and 25° Head up Position
Official title: Effectiveness of Preoxygenation With Positive Airway Pressure in Non-obese Healthy Patient: a Comparison of the Supine and 25° Head up Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Keywords: apnea
CPAP
Preoxygenation
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Several techniques such as positive airway pressure and head-up tilt during preoxygenation have shown to prolong non-hypoxic apnea period compared to conventional technique. However, uniform recommendations have not yet been made. Therefore, in the present study the investigators attempted to find out the effect of combination of 5 cmH2O CPAP and 25° head up position during preoxygenation.

Detailed description: In this study 60 non-obese healthy adult patients were divided into three groups; Group C receiving preoxygenation in conventional technique, Group S receiving preoxygenation with 5 cmH2O CPAP and Group H receiving preoxygenation in 25° head-up position with 5 cmH2O CPAP. After 3 min of preoxygenation, anesthesia was induced and trachea intubated. After confirming the tracheal intubation by direct visualization, all patients were left apneic in supine position with the tracheal tube exposed to atmosphere till the SpO2 dropped to 92%. The primary outcome compared between the groups was the non-hypoxic apnoeic period (time to fall SpO2 to 92%).

Eligibility criteria: Inclusion Criteria:

* adult patients of ASA physical status I and II undergoing surgery under general anaesthesia

Exclusion Criteria:

* anticipated difficult mask ventilation/ intubation
* individuals with significant cardiorespiratory or cerebrovascular disease
* pregnant ladies
* patient with history of epilepsy
* body mass index \>25 kg/m2
* hemoglobin \<8 gm/dL
* patients who were non-ambulant for \>24 h, having SpO2 \< 97% while breathing in room air
* phobia to facemask.

Primary outcomes:
measure: non-hypoxic apnoeic period (time to fall SpO2 to 92%)
timeFrame: 2 hours
Secondary outcomes:
measure: Comparison of pH at different time points
timeFrame: 2 hours
measure: Comparison of PaO2 at different time points
timeFrame: 2 hours
measure: Comparison of PaCO2 at different time points
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
affiliation: B.P. Koirala Institute of Health Sciences
name: Balkrishna Bhattarai, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: B.P. Koirala Institute of Health Sciences
name: Sindhu Khatiwada, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: B.P. Koirala Institute of Health Sciences
name: Asish Subedi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06742749: Level of Iliopsoas Tenotomy in DDH Surgery
Official title: Proximal Versus Distal Tenotomy of the Iliopsoas Tendon in the Surgical Treatment of Developmental Dysplasia of the Hip: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Dysplasia of the Hip (DDH)
Keywords: Hip
Developmental Dysplasia of the hip
surgical treatment
Iliopsoas Tenotomy
Randomized Clinical Trial
Lead sponsor: University of Duhok
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 54
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a randomized clinical trial. It was done to check the equivalence between two parallel groups of patients with DDH who underwent open reduction operation for their hips. In the first group, the psoas tendon was sectioned at the pelvic brim (proximal level), while in the second group, the section of the tendon was done just above the lesser trochanter (distal level). The allocation ratio was 1:1.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the postoperative clinical outcome of iliopsoas tenotomy in open reduction operation for developmental dysplasia of the hip. The main aim is to compare the postoperative clinical outcome of division of iliopsoas tendon at two levels, proximally at the pelvic brim and distally just above the lesser trochanter.

Detailed description: All the patients with DDH included in the current study underwent open reduction of their dislocated hip through the anterior approach. None of the included patients underwent hip surgery through the medial approach.

For the proximal level of psoas tenotomy at the pelvic brim, the hip was slightly flexed to relax the iliopsoas muscle; the iliacus muscle fibers were retracted anteriorly until the deeply seated posteromedially psoas tendon was isolated and transected. For the distal level of iliopsoas tenotomy just above the lesser trochanter, the thigh was put in the position of FABER (flexion, abduction, and external rotation). A curved right-angle hemostatic clamp was used to retract and bring the iliopsoas tendon into the field. Then, the tendinous fibers were transected.

Eligibility criteria: Inclusion Criteria:

* Children with DDH.
* Required open reduction of their hip problem.

Exclusion Criteria:

* Patients who underwent hip surgery without the need for sectioning the iliopsoas tendon.
* Children with mental retardation who were not cooperative in the assessment of the hip flexion strength.

Primary outcomes:
measure: hip flexion strength
timeFrame: at 6th, 12th, and 24th months post-operatively
Secondary outcomes:
measure: complications
timeFrame: 12 months
Other outcomes:
Locations:
city: Duhok
country: Iraq
facility: College of Medicine/University of Duhok
Study officials:
References:
Clinical trial NCT01924949: Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection
Official title: An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: 7977
5885
GS-7977
GS-5885
SOF
LDV
Sofosbuvir
Ledipasvir
FDC
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-08-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial genotype 1 hepatitis C virus (HCV) infection.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) greater than or equal to 18 kg/m\^2.
* HCV RNA greater than or equal to 1000 IU/mL at screening.
* Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
* Screening laboratory values within predefined thresholds.
* Use of two effective contraception methods if female of childbearing potential or sexually active male.
* Healthy according to medical history and physical examination with the exception of HCV diagnosis.

Exclusion Criteria:

* Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
* Prior exposure to an HCV NS5a inhibitor.
* Pregnant or nursing female.
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
* History of solid organ transplantation.
* Current or prior history of clinical hepatic decompensation.
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
* Known hypersensitivity to LDV, SOF, or formulation excipients.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants With HCV RNA < LLOQ on Treatment
timeFrame: Up to 12 weeks
measure: HCV RNA Change From Baseline
timeFrame: Baseline; Weeks 1, 4, and 8
measure: Percentage of Participants Experiencing Virologic Failure
timeFrame: Baseline to posttreatment Week 24
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
Study officials:
affiliation: Gilead Sciences
name: Luisa Stamm, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04254549: Rifaximin in Patients With Diabetic Gastroparesis
Official title: Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Crohn Disease
Diabetic Gastroparesis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin.


Eligibility criteria: Inclusion Criteria

* Men and women adult patients, aged 18-75, with diabetic gastroparesis
* Diagnosis of diabetic gastroparesis will have been made previously using a combination of symptoms (e.g., nausea, vomiting, bloating, early satiety, abdominal pain), the absence of mechanical obstruction, and delayed gastric emptying using a 4-hour, solid phase scintigraphic study (GES; \> 20% remaining at 4 hours)

Exclusion Criteria

* Prior surgery to the stomach or esophagus
* Known mechanical obstruction of the GI tract
* Current or recent (\< 4 weeks) use of opioids
* Current/active use of cannabis
* Current or recent (\< 4 weeks) use of antibiotics
* Current or recent use of antifungal agents (\< 4 weeks)
* Prior treatment with rifaximin (\< 1 year)
* Uncontrolled diabetes with a HgbA1c \> 12
* Severe uncontrolled or untreated anxiety or depression.

Primary outcomes:
measure: Improvement in bloating
timeFrame: Week 2, week 4, week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Brian E Lacy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04554849: Demographic Characteristics and Psychosocial Health of Transgender People
Official title: Demographic Characteristics and Psychosocial Health of Transgender People
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gender Dysphoria
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who met diagnostic criteria for gender dysphoria (International Classification of Diseases 11th Revision. https://icdwhoint. 2018) and were seen regularly in the outpatient clinic at our department of endocrinology

Brief summary: To study demographic characteristics of subjects referred to endocrine care for gender dysphoria and their psychosocial health


Eligibility criteria: Inclusion criteria - Person having received complete information on the organization of the research and willing to participate to research

Exclusion criteria:

- lack of data in the patients' records

Primary outcomes:
measure: Retrospective analysis of medical records
timeFrame: 2004-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References: