louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002339: A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Official title: An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candidiasis, Esophageal
HIV Infections
Keywords: Esophagitis
Fluconazole
Acquired Immunodeficiency Syndrome
Candidiasis
Immunocompromised Host
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.

Detailed description: Patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks. Patients are evaluated weekly, and treatment continues for 2 weeks after resolution of symptoms. Endoscopic exams and possibly biopsies are performed at baseline and at the end of treatment. Patients undergo follow-up at 2 weeks post-treatment.

Eligibility criteria: Inclusion Criteria

Patients must have:

* AIDS or other immunocompromising condition.
* Candidal esophagitis.
* Life expectancy of at least 2 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Evidence of non-candidal systemic fungal infection.
* Abnormalities that may preclude esophagoscopy or endoscopy.
* Unable to tolerate fluconazole.
* Unable to give informed consent.
* Enrollment in other experimental trials of approved or non-approved drugs or systemic compounds (unless approved by the Pfizer Clinical Monitor).
* Other condition that would make patient unsuitable for enrollment.

Concurrent Medication:

Excluded:

* Concomitant oral or topical antifungal agent.
* Other experimental medications.

Patients with the following prior condition are excluded:

History of allergy to imidazoles or azoles.

Prior Medication:

Excluded:

* Any oral or topical antifungal therapy within the past 3 days. Active use of illicit or illegal drugs.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles County - USC Med Ctr
state: California
city: Houston
country: United States
facility: Houston Veterans Administration Med Ctr
state: Texas
Study officials:
References:
citation: Agresti MG, de Bernardis F, Mondello F, Bellocco R, Carosi GP, Caputo RM, Milazzo F, Chiodo F, Giannini V, Minoli L, et al. Clinical and mycological evaluation of fluconazole in the secondary prophylaxis of esophageal candidiasis in AIDS patients. An open, multicenter study. Eur J Epidemiol. 1994 Feb;10(1):17-22. doi: 10.1007/BF01717446.
Clinical trial NCT02554539: Transciptomic Modification Induced by miRNAs in Endometrial Fluid
Official title: Human Embryonic Transciptomic Modification Induced by miRNAs Secreted by Human Endometrium to Endometrial Fluid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MicroRNA in Endometrial Fluid
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to understand the mechanism of communication between the uterine environment and the preimplantation human embryo. The investigators are interested in understanding how the in-utero environment during the window of implantation is different in normal weight and overweight/obese women and how this may impact the programming of the developing embryo.


Eligibility criteria: Inclusion Criteria:

* Meet the WHO criteria for normal weight (BMI \< 25) and overweight/obese (BMI \> 25)
* Age 21-45

Exclusion Criteria:

* Age \< 21 or \> 45
* Women with history of hysterectomy

Primary outcomes:
measure: Gene expression profile in human embryos
timeFrame: Samples will be collected within 1 month of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT05892939: Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts
Official title: Effects of Intranasal Oxytocin on Fear Processing in Naturalistic Contexts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Oxytoxin
Fear
Social
fMRI
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 69
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled double-blind between-subject design
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the study is to investigate the modulatory effects of intranasal oxytocin (24IU) on fear in naturalistic social and non-social contexts and the underlying neural mechanisms.

Detailed description: In a double-blind placebo-controlled between-subject experimental design, 60 adult male subjects will be randomly allocated to receive either intranasal oxytocin (24IU, n= 30) or placebo (n = 30) nasal spray. 45 minutes after treatment the participants will undergo a naturalistic fear induction paradigm during fMRI. During the paradigm video clips of 25s lengths will be presented showing fear-inducing situations in social and non-social contexts as well as corresponding control video clips. Following each clip subjects are required to rate their level of subjective fear on a rating scale ranging from 1 (no fear) to 9 (highest fear). Participants will undergo screening for psychopathological and emotional states before treatment. Together with a randomized assignment to the treatment groups, this will allow controlling for confounding between-group differences.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders
* Right-handedness
* Normal or corrected-normal version

Exclusion Criteria:

* History of head injury
* Medical or psychiatric illness
* Hypertension
* General cardio-vascular alteration or diseases
* Allergy against medications
* Visual or motor impairments
* Claustrophobia
* Drug addiction
* Nicotine dependence
* FMRI contradictions

Primary outcomes:
measure: BOLD-level activity as assessed by functional magnetic resonance imaging (fMRI)
timeFrame: 45 minutes to 70 minutes after treatment
Secondary outcomes:
measure: Experienced fear during the paradigm as assessed by self-reported ratings
timeFrame: 45 minutes to 70 minutes after treatment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Benjamin Becker, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05565339: PMEI Post-Market Clinical Follow-Up
Official title: PMEI Post-Market Clinical Follow-Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-existing Condition
Keywords: passive middle ear implant
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2022-10-04
Enrollment: 497
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included MED-EL PMEI implanted patients with a pre-existing condition which made the implantation of a MED-EL PMEI necessary.

Brief summary: Confirm safety and performance of passive middle ear implants (PMEIs) in subjects with pre-existing condition which made the implantation of a MED-EL PMEI necessary

Detailed description: Collect retrospective audiological and safety results of PMEI implanted subjects. A post-operative minimum and maximum follow-up period was not defined. The mean of the post-operative follow-up period of all patients was calculated.

Eligibility criteria: • Inclusion Criteria: Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI

• Exclusion Criteria: None

Primary outcomes:
measure: ABG
timeFrame: A post-operative minimum and maximum follow-up period was not defined.
Secondary outcomes:
measure: adverse events
timeFrame: A post-operative minimum and maximum follow-up period was not defined.
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Linz Kepler Universitätsklinikum GmbH, Klinik für Hals-, Nasen- und Ohrenheilkunde
state: Oberösterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH, Abteilung für Hals-, Nasen- und Ohrenkrankheiten, Logopädie
state: Oberösterreich
city: Sankt Pölten
country: Austria
facility: Universitätsklinikum St. Pölten, Klinische Abteilung für Hals-Nasen-Ohren
city: Wien
country: Austria
facility: Wiener Gesundheitsverbund, Klinik Landstraße, Hals-Nasen-Ohren-Allgemeine Ambulanz
city: Wien
country: Austria
facility: Universitätskliniken der MedUni Wien/AKH Wien, Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Hals-Nasen-Ohren-Klinik, Kopf- und Halschirurgie der Universität Erlangen-Nürnberg
city: Freiburg im Breisgau
country: Germany
facility: Universitätsklinikum Freiburg, Universitätsklinik für Hals, - Nasen und Ohrenheilkunde Sektionsleitung Experimentell-klinische Otologie
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen, Klinik für Hals-Nasen-Ohrenheilkunde
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für HNO-Krankheiten
city: Lünen
country: Germany
facility: Zentrum für Mittelohrchirurgie, Belegabteilung für Abteilung Hals-Nasen-Ohrenheilkunde
city: Nadarzyn
country: Poland
facility: Center of Hearing and Speech Medincus, Clinical Trials Department
state: Kajetany
Study officials:
References:
Clinical trial NCT01088139: Nutritional Intervention for Geriatric Hip Fracture Patients
Official title: A Randomized Controlled Study of Nutritional Intervention for Geriatric Hip Fracture Patients and Its Effect on Rehabilitation Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Keywords: Nutritional support
Rehabilitation outcomes
Lead sponsor: Kowloon Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2010-03-17
Enrollment: 126
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized controlled, observer blinded trial to study the beneficial effect of nutritional supplementation in elderly Hong Kong patients after hip fracture surgery during rehabilitation and at 4 weeks follow up. The control group will receive Calcium and Vitamin D supplementation whereas the intervention group will receive a moderately high dose protein nutritional supplementation in addition to Vitamin D and Calcium. Both groups undergo the same rehabilitation program and dietary counseling before discharge. They are followed up 4 weeks after discharge or completion of supplementation. The outcome parameters are nutritional parameters and rehabilitation outcomes.


Eligibility criteria: Inclusion Criteria:

* Age 60 years or older
* Recent low impact osteoporotic fracture of the proximal femur surgically repaired within 4 weeks before recruitment

Exclusion Criteria:

* Patients who require tube feeding
* Patients in unstable medical condition
* Body mass index (BMI) ≧ 25
* Malignancy
* Conditions with contraindication for high protein diet
* Mentally incapacitated and inability to communicate or understand the consent.

Primary outcomes:
measure: Nutritional parameters
timeFrame: Change from Baseline in nutritional parameters at discharge from hospital and at 4 weeks after discharge
Secondary outcomes:
measure: Rehabilitation Outcomes
timeFrame: Change from Baseline in rehabilitation outcomes at discharge from hospital and at 4 weeks after discharge
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Department of Rehabilitation, Kowloon Hospital
Study officials:
affiliation: Kowloon Hospital, Hong Kong
name: Ma Wai Wai MYINT, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00673439: Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
Official title: A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heparin-Induced Thrombocytopenia
Keywords: heparin-induced thrombocytopenia
thrombocytopenia
HIT
thrombosis
blood clot
blood thinner
anticoagulant
heparin
warfarin
fondaparinux
Arixtra
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2008-05-07
Enrollment: 3
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 study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).

Detailed description: Currently, standard treatment of HIT involves the transition from a direct thrombin inhibitor (a type of anticoagulant or "blood thinner") to warfarin, a different type of anticoagulant. Direct thrombin inhibitors (DTIs) require IV administration and frequent blood draws for dose adjustments, which can lead to prolonged hospitalization. DTIs also affect blood test measurements, making it difficult to determine proper dosages of warfarin.

Fondaparinux is a drug that is approved by the FDA for the treatment of blood clots in deep veins and in the lungs. Fondaparinux is not FDA approved for the treatment of HIT. However, an increasing number of doctors are using fondaparinux instead of DTIs to treat HIT. Although fondaparinux appears to be more convenient and predictable than DTI medications, more research is needed to support its use as a treatment for HIT.

Eligibility criteria: Inclusion Criteria:

* high risk for HIT based on "Four Ts score" of 6 or more

Exclusion Criteria:

* pulmonary emboli at the time of enrollment
* arterial thrombosis at the time of enrollment
* limb threatening phlegmasia cerulea dolens at the time of enrollment
* Calculated Creatinin Clearance less than 50 ml/hr
* platelet count less than 50
* Weight less than 50 kg
* pregnancy
* allergy to fondaparinux
* bacterial endocarditis
* history of neuraxial anesthesia and post-operative indwelling epidural catheter
* active major bleeding (hemodynamically significant or requiring transfusions)
* inability to give informed consent

Primary outcomes:
measure: Number of Participants Showing Clinically Significant Bleeding
timeFrame: 4 weeks after INR reaches 2 or more
Secondary outcomes:
measure: the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux
timeFrame: 4 weeks after INR reaches 2 or more
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center
name: Goetz H Kloecker, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06384339: ID-ClimAct. Influence of Social Motives of Clients and Staff on the Social Climate of Secure Settings
Official title: ID-ClimAct. Influence of Social Motives of Clients and Staff on the Social Climate of Secure Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Environment
Correctional Institutions
Rehabilitation of Criminals
Social Dominance
Interpersonal Relations
Lead sponsor: University Psychiatric Clinics Basel
Sponsor class: NETWORK
Collaborators: name: University of Basel
First posted: 2024-04-25
Enrollment: 453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will involve approximately 200 participants, consisting of both clients and staff members from various secure settings such as prisons and forensic psychiatries in Switzerland.

Brief summary: The social climate in secure settings is an essential element to successful rehabilitation. Previous studies indicate that staff characteristics are a relevant factor contributing to a beneficial social climate. Yet, secure settings form a specific and challenging work environment. Staff members are faced with clients who present a variety of difficult emotional and behavioural problems. Social motives for caring and cooperation can be blocked in a threatening environment, favouring dysfunctional interpersonal dynamics between individuals. This observational study explores the reciprocal influences of social motives between clients and staff on the social climate within secure settings.


Eligibility criteria: Inclusion Criteria:

* Clients who are currently incarcerated within the specified secure settings.
* Staff members currently employed in the specified secure settings.
* Individuals (both clients and staff) who are capable of providing informed consent.
* Clients who are deemed competent and not under any disciplinary restrictions that would preclude participation.
* Staff members who are directly involved with client care and management.

Exclusion Criteria:

* Clients who are not considered competent to provide informed consent.
* Staff members who do not have direct interactions with clients (e.g., administrative staff not involved in direct care).
* Clients and staff from open prisons

Primary outcomes:
measure: Social Climate Perception
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Psychiatric Clinics Basel, Clinic for Forensics
state: Basel-Stadt
Study officials:
affiliation: University Psychiatric Clinics Basel
name: Marc Graf, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05465239: Intelligent and Adaptive Control Applied to Powered Walkers
Official title: Intelligent and Adaptive Control Applied to Powered Walkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Barron Associates, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Virginia
name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-07-19
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research is towards an advanced control and computer learning strategy that will intelligently drive a powered walker for people with walking disabilities. The aim of the control strategy is to provide powered assistance that optimally reduces the metabolic cost of walking. The goal of the proposed intelligent walker is to reduce the workload of walking, keeping this population walking longer, providing critical exercise, continued muscle development and improved quality of life.


Eligibility criteria: Inclusion Criteria:

Typically developed subjects:

• No walking disabilities

Subjects with CP:

* Diagnosed with spastic CP
* GMFCS level II-III
* Ages 5-25 inclusive
* No surgeries in last 6 months
* Able to ambulate 40ft unaided (excluding walker)
* Understand and follow commands

Exclusion Criteria:

Typically developed subjects:

• Observed intramuscular pathology

Subjects with CP:

* Mental retardation
* Severe uncontrolled seizures
* Leg or foot surgery in last 12 months
* Surgery or significant injury in last 6 months affecting
* walking ability
* Inability to ambulate unassisted (other than walker) 40ft
* without stopping to rest
* Inability to understand or follow commands

Primary outcomes:
measure: Metabolic Cost (Oxygen Consumption)
timeFrame: Five minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Motion Analysis and Motor Performance Lab
state: Virginia
Study officials:
affiliation: Barron Associates, Inc.
name: Jason Burkholder, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05699239: A Phase 2 Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Official title: A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-finding Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperphosphatemia Patients on Hemodialysis
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis


Eligibility criteria: Inclusion Criteria:

1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -4)
2. Patients aged ≥18 to \<80 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of ≥ 3.5 mg/dL and ≤ 6.0 mg/dL at Visit 1 (Week -4)

Exclusion Criteria:

1. Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -4) to Visit 5 (Week 0)
2. Patients with serum phosphorus concentration ≥ 10.0 mg/dL from Visit 2 (Week -3) to Visit 5 (Week 0)
3. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Primary outcomes:
measure: Change from baseline in serum concentration of phosphorus
timeFrame: Week 4
Secondary outcomes:
measure: Achievement ratio of patients with the target serum concentration of phosphorus
timeFrame: Up to Week 4
measure: Concentration of corrected serum calcium
timeFrame: Up to Week 4
measure: Serum calcium times phosphorus product
timeFrame: Up to Week 4
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References: