louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06332781: Intravesical Gentamicin to Prevent Recurrent UTI
Official title: Intravesical Gentamicin to Prevent Recurrent UTI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Recurrent Uti
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI)

Detailed description: The overall goal of this project is to assess the feasibility of a larger trial investigating the use of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day). Investigators plan to gain patient perspective regarding preferences for study design and assess associations between the treatments with changes in the postmenopausal urinary microbiome (urobiome).

Eligibility criteria: Inclusion criteria:

* Postmenopausal
* 2 UTIs in 6 months
* desire to start antibiotic prophylaxis to prevent UTIs

Exclusion criteria:

* Parkinsons disease
* myasthenia gravis
* renal failure
* liver failure
* bladder pain syndrome
* multiple negative urine cultures associated with UTI symptoms (\>/= 3)
* bladder Botox treatments in the past
* treatment planned for UI and prolapse
* unevaluated microscopic hematuria
* history of kidney stones
* no antibiotics within 4 weeks
* most recent weight \<40kg (88.18lbs)
* surgically altered urinary tract (urinary diversion, phalloplasty, etc)
* allergy or hypersensitivity to either of the study medications or medications in the same family including but not limited to: amikacin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin.

Primary outcomes:
measure: Assess feasibility of trial recruitment
timeFrame: 6 months
measure: Examine treatment compliance
timeFrame: 6 months
measure: Examine trial retention
timeFrame: 6 months
Secondary outcomes:
measure: culture-proven UTIs
timeFrame: 3 and 6 months
measure: Patient reported outcome measures
timeFrame: 3 months, 6 months
measure: Patient reported outcome measures
timeFrame: 3 months, 6 months
measure: Patient reported outcome measures
timeFrame: 3 months, 6 months
measure: Patient reported outcome measures
timeFrame: 3 months, 6 months
measure: Patient reported outcome measures
timeFrame: 3 months, 6 months
measure: Patient reported outcome measures
timeFrame: 3 months, 6 months
Other outcomes:
measure: urobiome analysis
timeFrame: 3 months, 6 months
measure: urobiome analysis
timeFrame: 3 months, 6 months
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT05914181: The Relationship Between Self-disclosure, Perceived Social Support and Reproductive Concerns
Official title: How Self-disclosure Influences Reproductive Concerns Among Young Male Cancer Patients? The Mediating Role of Perceived Social Support
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Survivors of Young Male Cancer Survivors
Keywords: reproductive concerns
young male cancer survivors
self-disclosure
perceived social support
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recruited from oncology units in two hospitals in Shanxi, China using a convenience sampling. The eligible participants were invited to complete the questionnaire after they agree to participate.

Brief summary: Participants were recruited from oncology units in two hospitals in Shanxi, China using a convenience sampling.Data were collected using a self-report questionnaire consisting of demographic and disease-related characteristics, and instruments measuring self-disclosure, social support and reproductive concerns.


Eligibility criteria: Inclusion criteria : ① male; ② Age 18-40 years old; ③ Diagnosed with cancer for 1 year or more; ④ Know the disease; ⑤ Clear mind, able to understand and cooperate with the investigation; ⑥ Sign informed consent to participate in the study voluntarily. Exclusion criteria: ① There were serious primary diseases of liver, kidney, hematopoietic, and serious organ failure; ② He has a history of mental illness, personality disorder, cognitive impairment, and organic brain disease.

Primary outcomes:
measure: Participants characteristics
timeFrame: once
measure: self-disclosure
timeFrame: once
measure: perceived social support
timeFrame: once
measure: reproductive concerns
timeFrame: once
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Jun Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT04460781: Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring
Official title: Post-Licensure Database Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2020-07-08
Enrollment: 96175
Sex: ALL
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women were not randomized. A modified-cluster randomization scheme was used. Facilities were assigned to blocks and were randomized within blocks, ensuring that roughly half the facilities within each block initially administer one vaccine of the 2 vaccines planned in the study, and the other half administer the alternate vaccine. Iteratively, over time, the vaccine administered within each facility will then alternate.

Brief summary: Primary Objective:

To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28 days preceding the estimated date of conception with regards to pregnancy, birth, and neonatal/infant outcomes

Secondary Objective:

Detailed description: Data will be recorded prospectively during the safety follow-up for pregnant women until delivery (or pregnancy outcome, whichever is later), and for infants of pregnant women for 1 year after birth.

Eligibility criteria: Inclusion criteria

Pregnant women:

* Laboratory or medical professional confirmation of pregnancy
* Exposure to either Flublok Quadrivalent influenza vaccine or standard-dose quadrivalent inactivated influenza vaccine (SD-IIV4) in the VAP00003 Study during pregnancy or within 28 days preceding conception

Offspring:

* Infants delivered by pregnant women who satisfy the criteria above Exclusion criteria
* Documented receipt of any other influenza vaccine at any other time during the pregnancy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Incidence Rates of Pregnancy Outcome Events
timeFrame: From start of pregnancy or up to 28 days prior to conception until delivery or pregnancy outcome
measure: Incidence Rates of Birth Events
timeFrame: At birth
measure: Incidence Rates of Neonatal/ Infant Outcomes
timeFrame: From birth to Day 365 post-birth
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT05247281: NGS vs Culture Outcomes for Treatment of PJI
Official title: Randomized Controlled Trial Investigating the Use of Next-generation Sequencing in Directing the Antimicrobial Treatment of Periprosthetic Joint Infection
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prosthetic Joint Infection
Lead sponsor: Center for Innovation and Research Organization
Sponsor class: NETWORK
First posted: 2022-02-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.


Eligibility criteria: Inclusion Criteria:

* Adults (age \> 18 years)
* Undergoing single stage revision or 1st stage resection arthroplasty/spacer placement for PJI (ICM-positive) of the hip or knee
* Written informed consent

Exclusion Criteria:

* Ongoing participation in another clinical trial
* Megaprosthesis

Primary outcomes:
measure: Number of participants who have been diagnosed with prosthetic joint infection as assessed by the 2018 International Consensus Definition of prosthetic joint infection
timeFrame: 90 days from time of surgery
Secondary outcomes:
measure: Number of subjects who have a re-operation as assessed by inpatient hospitalization medical records
timeFrame: one year from time to surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Staten Island
country: United States
facility: Northwell Health
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Ohio
state: Ohio
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Center for Innovation and Research Organization
name: Tiffany Morrison
role: STUDY_DIRECTOR
References:
Clinical trial NCT02205281: Partners in Health: A Couples-based Approach to Obesity Prevention
Official title: Partners in Health: A Couples-based Approach to Obesity Prevention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Overweight
Obese
Pregnancy
Weight Gain
Weight Loss
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
Collaborators: name: Dignity Health- French Hospital Medical Center
First posted: 2014-07-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to test the feasibility of an innovative, couples based approach to weight management during pregnancy. The primary hypothesis is that a couples-based behavioral weight management program will reduce the rate of gestational weight gain compared to standard care.


Eligibility criteria: Inclusion Criteria:

Pregnant Women

* \>18 years old
* 15-22 weeks gestation
* BMI \>= 25
* cohabitating with partner for at least 3 months or recently married
* willing to consent

Non-pregnant Partner

* BMI \>= 25
* cohabitating with partner for at least 3 months or recently married
* willing to consent

Exclusion Criteria:

* Untreated medical or psychological problem
* Inability to be physically active

Primary outcomes:
measure: Gestational weight gain
timeFrame: 16 weeks gestation, 35 weeks gestation
Secondary outcomes:
measure: Partner's weight loss
timeFrame: study entry, when pregnant partner reaches 35 weeks gestation
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: Cal Poly
state: California
Study officials:
affiliation: Cal Poly
name: Suzanne Phelan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00731081: Study About the Evolution of Severe Late Onset Pompe Disease Patient With Pulmonary Dysfunction and Receiving Myozyme®
Official title: Observational Study About the Evolution of Severe Late Onset Pompe Disease Patient With Pulmonary Dysfunction and Receiving Myozyme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pompe Disease (Late-Onset)
Glycogen Storage Disease Type II (GSD II)
Glycogenesis 2 Acid Maltase Deficiency
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-08-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe late onset of Pompe disease with respiratory deficiency and treated by Myozyme

Brief summary: To describe severe late onset patients with pompe disease receiving Myozyme®


Eligibility criteria: Inclusion Criteria:

* Male or Female ≥ 18 years of age;
* The patient and/or patient's legal representative has given their informed consent in writing before any study procedure is initiated;
* Pompe disease confirmed by documented deficit in endogenous acid alpha-glucosidase (GAA) activity;
* A severe form of the disease as defined as follows: a. Moderate to severe limb girdle muscle weakness requiring help for walking around (sticks, crutches, walking frame or wheelchair); and b. Symptoms of diaphragmatic dysfunction defined by at least 2 out of the 3 following criteria: orthopnea, vital capacity \< 50%, paradoxical respiration detected in measurement of transdiaphragmatic pressure; and c. Use of invasive ventilation (defined by need for tracheotomy) or noninvasive ventilation (defined by utilization of assisted ventilation using a nasal or facial mask)day and night prescribed ≥ 12 hours/day;
* Treated for ≥6 months with Myozyme;
* Followed-up in a reference center according to the CETP recommendations.

Exclusion Criteria:

* The patient presents with a major congenital anomaly;
* The patient presents with a clinically important organic disease (except for symptoms related to Pompe disease) such as cardiovascular, hepatic, pulmonary, neurological or renal disease or any other medical condition, serious disease or particular circumstances that in the investigator's opinion, should preclude the patient's participation.

Primary outcomes:
measure: To describe severe late onset patients with Pompe disease receiving Myozyme and follow-up according to the CETP recommendations
timeFrame: 12 to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitie-Salpetriere Hospital
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02635581: A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Total Hip Replacement
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2015-12-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the osteointegrative potential of the Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD) around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months after surgery.


Eligibility criteria: Inclusion Criteria:

* BMI\< 40 kg/m2
* Indication suitable to the implantation of Delta TT acetabular cup (First implant)
* Idiopathic osteoarthritis
* Avascular necrosis
* Post-traumatic arthritis
* Presence of sufficient periacetabular bone stock
* Ability to understand the investigation, cooperate with the investigational procedure and willing to return to the hospital for the required post-operative follow-ups
* Written informed consent

Exclusion Criteria:

* Patients found unsuitable for an implantation of Delta TT acetabular cup (Revision)
* Patients aged 76 or older
* Haemophilic disease
* Femur neck fracture
* Insulin Dependent Diabetes Mellitus (IDDM)
* Severe kidney failure (grade 4)
* Not responder Hypo- or Hyperthyroidism
* Paget's disease
* Tumours
* Active or suspicious infections
* Neurosensory deficits or neuromuscular diseases
* Severe and impairing vascular diseases
* Known incompatibility or allergy to products materials
* Woman with pregnancy or childbearing capacity or breast-feeding
* Subjects already enrolled in other clinical trials

Primary outcomes:
measure: The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan
timeFrame: From baseline to 5 year Follow-up
Secondary outcomes:
measure: Harris Hip Score (HHS)
timeFrame: From baseline to 5 year Follow-up
measure: SF-36 score
timeFrame: From baseline to 5 year Follow-up
Other outcomes:
Locations:
city: Cona
country: Italy
facility: Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna
state: Ferrara
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Dipartimento di Ortopedia, Traumatologia e Riabilitazione, Ospedale CTO, Clinica II
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Dipartimento di Ortopedia, Traumatologia e Riabilitazione, Ospedale CTO, Clinica I
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria di Udine, Santa Maria della Misericordia
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna
name: Leo Massari
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04720495: One-stage Versus Two-stage Inverted U-shaped Ridge Splitting
Official title: One-stage Versus Two-stage Inverted U-shaped Ridge Splitting With Simultaneous Implant Placement for Treatment of Anterior Maxillary Alveolar Ridge Undercut (a Comparative Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Ridge Augmentation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fourteen patients having anterior maxillary undercut defect were selected to match a list of inclusion and exclusion criteria.

The participants were randomly allocated using a computer system into two groups:

Group A undergo inverted U-shaped maxillary ridge splitting using piezotomes with simultaneous implant placement in the same surgery.

Group B undergo inverted U-shaped maxillary ridge splitting as a first stage and after four weeks, ridge expansion and implant placement will be performed with only envelop flap.

Assessment included measurements of bone gain at the undercut defect and bone density labial to implants in each group from the cone-beam computed tomography


Eligibility criteria: Inclusion criteria

* Adult patients (20-45) years of age with no sex predilection
* At least one tooth missing in the anterior maxilla
* The presence of a labial undercut \>2 mm in thickness which is not able to house an implant
* The presence of adequate bone width near the alveolar bone crest
* The absence of a vertical bone defect.

Exclusion criteria

* History of any systemic disease that would contraindicate surgery example uncontrolled diabetes.
* Pregnancy or lactation.
* Long-term amino-bisphosphonate therapy.
* Smoking more than 10 cigarettes per day.
* Alcohol or drug abuse.
* Uncontrolled periodontal disease.
* Active infection.
* Inadequate inter-incisal space.
* Bruxism or clenching.

Primary outcomes:
measure: Change in bone density buccal to the implant
timeFrame: baseline and 4 months
measure: Change in bone width gain at the undercut area
timeFrame: baseline and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Study officials:
References: