louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004293: Phase II Study of Glucocerebrosidase in Patients With Gaucher Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gaucher's Disease
Keywords: Gaucher's disease
inborn errors of metabolism
rare disease
sphingolipidoses
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Pittsburgh
First posted: 1999-10-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Evaluate the efficacy and toxicity of glucocerebrosidase enzyme therapy in patients with Gaucher disease.

Detailed description: PROTOCOL OUTLINE:

Patients are treated with intravenous glucocerebrosidase every 2 weeks. The dose is based on clinical severity of disease and response to therapy.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Gaucher disease with glucocerebrosidase deficiency confirmed by enzymatic or molecular assay At least 3 organ systems affected, based on the following criteria: Anemia Thrombocytopenia Organomegaly Bone deterioration on radiograph Pulmonary compromise Symptoms compromise daily activities or risk longevity No neurologic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John Barranger
role: STUDY_CHAIR
References:
Clinical trial NCT05101993: VClip Post-Market Study
Official title: Long-term Follow-up on LAA Exclusion Using AtriClip
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Left Atrial Appendage Absent
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-01
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retrospective-prospective, multi-center, non-randomized, unblinded, post-market study to evaluate the long-term performance and safety of AtriClip® FLEX-V LAA and PRO•V LAA Exclusion devices for exclusion of the left atrial appendage of the heart during concomitant cardiac procedures.


Eligibility criteria: Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age.
2. Subject who received the AtriClip FLEX-V or PRO•V implant during a non-emergent cardiac surgical procedure
3. Subject is willing and able to provide written informed consent
4. Subject is willing and able to return for scheduled follow-up visit and imaging (CTA or TEE)

Exclusion Criteria:

1. Inability, unwillingness, or contraindication to undergo TEE or CTA imaging
2. Subjects who are pregnant or breast feeding
3. Subjects with active COVID-19 infection

Primary outcomes:
measure: Primary Performance Endpoint
timeFrame: 12-months or greater post-procedure
measure: Primary Safety Endpoint
timeFrame: 30-days post-procedure
Secondary outcomes:
measure: Performance
timeFrame: 12-months or greater post-procedure
measure: Long-term thromboembolic events
timeFrame: 12-months or greater post-procedure
measure: Device and Procedure long-term Safety
timeFrame: 12-months or greater post-procedure
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Franciscan Health
state: Indiana
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: NYU
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cincinnati
country: United States
facility: Mercy Health Cincinnati
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital
state: Ohio
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Lynchburg
country: United States
facility: Centra Lynchburg General Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Research Institute LLC
state: Wisconsin
Study officials:
affiliation: NYU Langone Health
name: Elias Zias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06468293: Role of Caregiver in the Clinical Pathway of Patients With Breast and Prostate Cancer
Official title: The Role of Caregiver in the Clinical Pathway of Patients Newly Diagnosed With Breast and Prostate Cancer: a Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options.

Detailed description: The following randomized longitudinal study will evaluate the long term impact of caregivers' involvement in cancer care pathway, including a psychological support intervention on the dyads to be delivered after the detection of a suspected cancer and before the visit with the oncologist for discussing therapeutic options. Moreover, a battery of self-report questionnaires will be administered, and sociodemographic and clinical data will be collected. The time window in which to deliver the support intervention is after the detection of a suspected cancer and before the visit with the oncologist, at the time when the patient undergoes diagnostic exams (to understand the type of tumor he/she is affected by), and the most suitable therapeutic protocol have to be discussed with the oncologist.

Eligibility criteria: Inclusion Criteria:

Patient:

* Patient aged ≥18 years at the time of recruitment.
* Patients who have just received a cancer diagnosis and have yet to discuss with their oncologist the treatment to undergo after diagnosis of breast or prostate cancer.
* Early-stage cancer (I or II).

Caregiver:

* Age ≥ 18 at the time of recruitment.
* Taking care of the patient.

Exclusion Criteria:

Patients:

* Presence of early mental disorders (before age 40) or severe neurological disorder.
* Patients with advanced stage cancer for which the path is already defined (palliative care patients).

Caregivers:

● Presence of early mental disorders (before age 40) or severe neurological disorder.

Primary outcomes:
measure: Evaluation of the compliance with therapy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Gabriella Pravettoni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03162393: The Surgical Treatment of Total Brachial Plexus Avulsion Injury-A Retrospective Study of 73 Patients
Official title: The Optimal Surgical Strategy for the Treatment of Total Brachial Plexus Avulsion Injury Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brachial Plexus Injury
Keywords: brachial plexus; avulsion injury
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 73
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between 1999 and 2006, a total of approximately 200 patients with posttraumatic total BPAI underwent surgical exploration and reconstruction of the brachial plexus and 109 agreed to participate in our study. Seventy-three patients were enrolled and 36 were excluded.

Brief summary: Brachial plexus avulsion injury (BPAI) caused by traction injury, especially total root avulsion, represents a severe handicap for the patient. Despite recent progress in diagnosis and microsurgical repair, the prognosis in such cases remains unfavorable. We need to find an relatively optimal surgical treatment.

Detailed description: Brachial plexus avulsion injury (BPAI) caused by traction injury, especially total root avulsion, represents a severe handicap for the patient. Despite recent progress in diagnosis and microsurgical repair, the prognosis in such cases remains unfavorable. Nerve transfer is the most successful method for repairing cases of brachial plexus root avulsion. Phrenic nerve transfer, accessory nerve transfer, intercostal nerve transfer and contralateral C7 transfer are all well-established technique in the treatment of certain severe brachial plexus lesions in adults. As reported in previous articles, shoulder function, elbow flexion, elbow extension, and wrist and finger function have been restored successfully by spinal accessory, phrenic, intercostal, and contralateral C7 nerve transfers . However, the results of just one function reconstruction were evaluated in those articles. Few studies were found that focused on the whole function reconstructions of the affected limb. In different medical organizations even in our department, many different surgical strategies were used in treating total BPAI patients and the results differed significantly. Here, we investigated the results of different commonly used nerve transfer in order to determine a relatively optimal surgical strategy for treatment of total BPAI patients.

Eligibility criteria: Inclusion Criteria:

* global root avulsion brachial plexus injury, a minimum postoperative interval of 3 years, all operations performed by the same medical team, nerve transfer was the only reconstruction method.

Exclusion Criteria:

* diabetes, Volkmann contracture, fracture on the affected limb, rib fracture, brain trauma.

Primary outcomes:
measure: physical examination
timeFrame: at least 3 years post-operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00329693: Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide
Official title: A Randomised, Double-blind, Parallel Groups, Dose-finding, Placebo-controlled, Multi-centre, Proof of Concept Study Assessing the Effect of 3-wk Treatment With 1 of 3 Oral Doses of Quinagolide & Placebo in Preventing Ovarian Hyperstimulation Syndrome in Women Undergoing Controlled Ovarian Hyperstimulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Hyperstimulation Syndrome
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-05-25
Enrollment: 182
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.

Detailed description: No data to be entered.

Eligibility criteria: Inclusion Criteria

1. Signed Informed Consent Form, prior to screening evaluations
2. In good physical and mental health
3. Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation
4. Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility

Exclusion Criteria

1. Any clinically significant systemic disease
2. Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
3. History of recurrent miscarriage
4. Undiagnosed vaginal bleeding

Primary outcomes:
measure: OHSS
timeFrame: 41 days after hCG injection
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IVI Barcelona, Ronda General Mitre, 14
city: Leioa-Bizkaia
country: Spain
facility: IVI Bilbao, Paseo Landabarri, 1
city: Madrid
country: Spain
facility: IVI Madrid, Santiago de Compostela, 88
city: Murcia
country: Spain
facility: IVI Murcia, Navegante Macías del Poyo, 5, Edificio Delfín-Barrio La Flota
city: Sevilla
country: Spain
facility: IVI Sevilla, Avda. República Argentina, 58
city: Valencia
country: Spain
facility: IVI Valencia, Plaza de la Policía Local, 3
city: Vigo (Pontevedra)
country: Spain
facility: IVI Vigo, Plaza Francisco Fernández del Riego, 7 (Plaza Elíptica)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.
citation: Busso C, Fernandez-Sanchez M, Garcia-Velasco JA, Landeras J, Ballesteros A, Munoz E, Gonzalez S, Simon C, Arce JC, Pellicer A. The non-ergot derived dopamine agonist quinagolide in prevention of early ovarian hyperstimulation syndrome in IVF patients: a randomized, double-blind, placebo-controlled trial. Hum Reprod. 2010 Apr;25(4):995-1004. doi: 10.1093/humrep/deq005. Epub 2010 Feb 6.
Clinical trial NCT03114293: Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
Official title: Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis, Chronic Progressive
Keywords: Physical activity
Mobility
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Short, randomised waiting-group controlled explorative studies of a behavioural intervention.
Primary purpose: TREATMENT

Brief summary: Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to use feedback mechanism in an app-based intervention program to increase physical activity in Multiple Sclerosis (MS) patients. Internet based cognitive-behavioral interventions have been explored as effective in the last years. In addition, smartphone-based mobility assessment and intervention might be a promising approach in other MS types and for real-life mobility assessment in observational and interventional trials. The aim is to investigate the impact of a smartphone based information and feedback program on physical activity in a 3 months, randomised waiting-group controlled trial of 40 progressive MS patients.


Eligibility criteria: Inclusion Criteria:

* progressive MS

Exclusion Criteria:

* other major health disorder
* EDSS above 6

Primary outcomes:
measure: Rate of responders
timeFrame: 3 Months
Secondary outcomes:
measure: Physical activity: total activity
timeFrame: 3 Months
measure: Physical activity: distance per day
timeFrame: 3 Months
measure: Physical activity: number of steps per day
timeFrame: 3 Months
measure: Questionnaires on quality of life (QoL, HAQUAMS)
timeFrame: 3 Months
measure: Questionnaires on activities of daily living (ADL)
timeFrame: 3 Months
measure: Questionnaires on physical activity
timeFrame: 3 Months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02654093: A Drug-drug Interaction Study of DP-R213
Official title: A Randomized, Open-label, Single-dose, 3-period, 6-sequence Crossover Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of Raloxifene, Cholecalciferol in Healthy Korean Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2016-01-13
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn about the effect of raloxifene on how the body absorbs and processes cholecalciferol and how cholecalciferol affects raloxifene when they are taken together.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteer, age above 19
* The result of Ideal Body Weight(IBW) is not less than -20%, no more than +20%
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment in completion of this clinical study
* Treatment history of other drugs within last 10 days

Primary outcomes:
measure: Area under the plasma concentration versus time curve(AUCt) of raloxifene
timeFrame: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours
measure: Peak plasma concentration(Cmax) of raloxifene
timeFrame: 0, 2, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96 hours
measure: AUCt,corr of cholecalciferol
timeFrame: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours
measure: Cmax,corr of cholecalciferol
timeFrame: -20, -16, -12, 0, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 84 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jung-gu
country: Korea, Republic of
facility: Kyungbook National University Hospital
state: Daegu
Study officials:
References:
citation: Lee HW, Kang WY, Jung W, Gwon MR, Cho K, Lee B, Seong SJ, Yoon YR. Pharmacokinetic Drug Interaction Between Raloxifene and Cholecalciferol in Healthy Volunteers. Clin Pharmacol Drug Dev. 2022 May;11(5):623-631. doi: 10.1002/cpdd.1062. Epub 2022 Jan 4.
Clinical trial NCT05107193: Afatinib (GILOTRIF®) in Patients Suffering From Tumors Harboring Neuregulin 1 (NRG1) Gene Alterations (Specifically NRG1 Gene Fusion-positive Advanced Solid Tumors)
Official title: Assessment of Prospective Real-world Outcomes Based on Single-patient Protocol Data Collection of Afatinib (GILOTRIF®) Use in Patients With Solid Tumors Harboring NRG1 Gene Fusions
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Solid Tumors
Keywords: NRG1 fusion
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-11-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Gene fusions are defined as two separate genes joined together (gene 1, gene 2), generating a novel fusion gene. NRG1 fusions are rare and complex with regard to the fusion/fusion partner. The specific NRG1 gene fusion will be identified by a specialized molecular testing lab.

Detailed description: Afatinib is provided on a single-patient protocol basis to patients suffering from tumors harboring NRG1 fusions, a disease for which no satisfactory authorised alternative therapy exists.

In the context of this mechanism it is planned to collect and analyze limited clinical data in order to investigate the safety and efficacy of afatinib in patients with advanced and/or metastatic solid tumours harboring NRG1 gene fusions.

Eligibility criteria: Inclusion Criteria to participate in this program:

* Confirmed diagnosis of an advanced, unresectable and/or metastatic tumor harboring NRG1 gene fusions characterized as follows:

  * Gene 1: NRG1 (prerequisite: conservation of the epidermal growth factor (EGF) domain - this will be identified by the lab performing the molecular testing)
  * Gene 2: All fusion partners are allowed (prerequisite: the region must be a coding region - this will be identified by the lab performing the molecular testing)
* Patient must have measurable or evaluable lesions (according to RECIST 1.1).
* At least 18 years of age at the time of consent.

Exclusion Criteria:

* Treatment with a systemic anti-cancer therapy or investigational drug within 14 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication.
* Tumors carrying additional gene mutations other than NRG1 fusion where FDA-approved targeted therapy is available
* Prior treatment with a therapy targeting erythroblastic leukemia viral oncogene homologue receptors (ErbB)
* Any patient considered ineligible by the treating physician.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01793311: The Effect of Dosage of Caffeine on Intraocular Pressure
Official title: The Effect of Dosage of Caffeine on Intraocular Pressure in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraocular Pressure
Caffeine Dosage
Keywords: intraocular pressure
caffeine
dosage
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of the study is to determine the effect of different doses of caffeine on intraocular pressure. We hypothesized that higher dosage of caffeine would increase intraocular pressure more than lower doses.

Eligible subjects will be randomized into three groups:

1. group 1: intake of decaffeinated coffee
2. group 2: intake of coffee with lower caffeine dose
3. group 3: intake of coffee with higher caffeine dose

Intraocular pressure will be measured at 0, 30, 60 and 90 minutes after coffee intake.

Detailed description: decaffeinated coffee contains 0.5-2 mg of caffeine regular dose coffee contains 91.8 mg of caffeine high dose coffee contains 144 mg of caffeine

all three groups' intraocular pressure will be measured with the Goldmann applanation tonometer at 4 timepoints:

1. 0 minutes (baseline)
2. 30 minutes after intake
3. 60 minutes after intake
4. 90 minutes after intake

Eligibility criteria: Inclusion Criteria:

* healthy subjects
* normal central corneal thickness
* normal baseline intraocular pressure

Exclusion Criteria:

* any ocular disease
* baseline intraocular pressure over 21 mmHg
* central corneal thickness less than 520 microns or more than 540 microns

Primary outcomes:
measure: change from baseline in intraocular pressure (mmHg)after caffeine intake
timeFrame: 0, 30 minutes, 60 minutes, 90 minutes post-caffeine intake
Secondary outcomes:
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Chiang Mai University Hospital
state: Chiang Mai
Study officials:
affiliation: Chiang Mai University
name: Damrong Wiwatwongwana, M.D.
role: PRINCIPAL_INVESTIGATOR
References: