louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06743776: Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS
Official title: Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: ALS
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: WideTrial, Inc.
name: MediciNova
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2024-12-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this Expanded Access Program is to provide MN-166 (ibudilast) to ALS patients who are not eligible for an enrolling ALS clinical trial. This Expanded Access Program will assess if MN-166 can help people with ALS in slowing down the progression of the disease.


Eligibility criteria: Inclusion Criteria

* ALS by "Gold Coast" diagnostic criteria
* Age \> 18 years
* Either I) Ineligibility for other interventional ALS clinical research participation due to at least one of the following standard exclusion criteria:

  * Time since onset of weakness due to ALS \> 36 months
  * Vital Capacity less than 50% of predicted capacity for age, height, and sex measured (by Slow Vital Capacity (SVC) or Forced Vital Capacity (FVC))
  * Cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.
  * Geographic isolation from nearest actively enrolling research trial location, defined as either \>75 miles or \>120-minute travel time
  * OR II) Completed assigned regimen as participant in COMBAT-ALS clinical trial.

Exclusion Criteria

* Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to treating physician's judgment (e.g., psychiatric, cardiovascular instability, systemic infection, untreated thyroid dysfunction, or clinically significant laboratory abnormality or ECG changes).
* Clinically significant lab abnormalities including, but not limited to: hemoglobin \< 10 g/dL, white blood cells \< 3.0 x 103/mm3, neutrophils, absolute ≤ 1000/mm3, eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter), low platelet counts (\< 150 x 109 per liter), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN), eGFR \< 30 mL/min/1.73m2, thyroid-stimulating hormone (TSH) levels \>10 mIU/L or \<0.01 mIU/L.
* Active drug or alcohol abuse
* Concomitant use of another investigational medical product for treatment of ALS

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Bjorn E Oskarsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04191876: Financial Incentives to Improve Medication Adherence
Official title: Financial Incentives to Improve Medication Adherence: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Bipolar Disorder
Depression
Keywords: financial incentives
medication adherence
severe mental illness
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Medication adherence is a challenge in all of medicine and is associated with multiple negative outcomes. Strategies to better measure and enhance adherence to medication are urgent and necessary to minimize unwanted health outcomes, hospitalizations, poorer quality of life and excessive costs for individuals, insurers and caregivers. Recently, behavioral economics-based approaches have emerged as a promising tool to address this unmet need, but its effectiveness in oral antipsychotic treatment remains to be assessed. For this project, investigators will use an app that offers financial incentives to increase compliance for patients with chronic diseases. Investigators intend to enroll 25 patients in a pilot project to assess feasibility of offering financial incentives to improve medication adherence in severe mental illness.


Eligibility criteria: Inclusion Criteria:

1. Psychiatric patients with suspected or confirmed poor oral medication adherence.
2. Age 18-80 years old
3. English speaking, since the app being used is only available in English
4. Owning a Smartphone, since the app requires a Smartphone to work
5. Willing and able to participate.

Exclusion Criteria:

1. Acute anger to self or others as per investigator assessment
2. Unwilling or unable to participate

Primary outcomes:
measure: Change in medication adherence rate
timeFrame: Between baseline and study completion (10 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Glen Oaks
country: United States
facility: The Zucker Hillside Hospital
state: New York
Study officials:
References:
citation: Guinart D, Sobolev M, Patil B, Walsh M, Kane JM. A Digital Intervention Using Daily Financial Incentives to Increase Medication Adherence in Severe Mental Illness: Single-Arm Longitudinal Pilot Study. JMIR Ment Health. 2022 Oct 12;9(10):e37184. doi: 10.2196/37184.
Clinical trial NCT00480376: Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate
Official title: Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infection
Keywords: transrectal biopsy
prostate
prophylaxis antibiotic
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2007-05-30
Enrollment: 160
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prostate biopsy is usually conducted transrectal, ultrasonography guided. Since the area is not sterile, infection can be induced during the procedure.

Prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of infections. Quinolones are considered preferred treatment but there is already an increase in resistance rates. TMP-SMX can not be used empirically due to a high percent of resistant uropathogens. One of the options is aminoglycosides, especially gentamicin. Advantages: very low resistance rate in the community, high concentration is urinary tract, slow clearance, no resistance developed under treatment, chip and with very few side effects.

Detailed description: Prostate biopsy is usually conducted as an ambulatory transrectal needle aspiration, ultrasonography guided. The area is not sterile, with high concentration of gram-negative and anaerobic pathogens, infection can be induced during the procedure to the urinary tract, and even cause bacteremia.

Prior studies concluded that prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of infections and hence it is accepted to give prophylaxis antibiotics which will cover especially gram-negative bacteria. Other studies show decrease in infections percent in patients that received prophylaxis opposed to those who did not, from 5-30% to less than 1%. Yet, there was no significant difference between those who received one dose and those who were treated for 3-5 days. Quinolones are considered preferred treatment since they can be given orally, but there is already an increase in resistance rates. TMP-SMX can not be used empirically due to a high percent of resistant uropathogens. One of the options is aminoglycosides, especially gentamicin. Advantages: very low resistance rate in the community, high concentration is urinary tract, slow clearance, no resistance developed under treatment, chip and with very few side effects.

Eligibility criteria: Inclusion Criteria:

* Patients going under transrectal biopsy of prostate with sterile urine culture.

Exclusion Criteria:

* Urine culture not sterile

Primary outcomes:
measure: no infection
timeFrame: 48 hours
Secondary outcomes:
measure: no infection
timeFrame: 7 days
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Urology outpatient clinic, HaEmek MC
Study officials:
affiliation: Ha'Emek Medical Center, Afula, Israel
name: Genady Zelychenko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06924476: Optimization of a Decision Formula for Optimal Timing of Immunosuppressive Therapy Initiation in Primary Membranous Nephropathy: A Multicenter Retrospective Cohort Study
Official title: Optimization of a Decision Formula for Optimal Timing of Immunosuppressive Therapy Initiation in Primary Membranous Nephropathy: A Multicenter Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Primary Membranous Nephropathy
Keywords: Primary Membranous Nephropathy
Evaluation formula
Initiate immunosuppressive therapy
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
First posted: 2025-04-11
Enrollment: 282
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were registered in the Renal Disease Syndrome Multi-center Cohort Network (https://nsn.bjmu.edu.cn/index) and whose medical records were complete, and who met the PMN diagnostic criteria as stipulated in the KDIGO 2021 Clinical Practice Guidelines for the Management of Glomerular Diseases.

Brief summary: The goal of this observational study is to optimize the evaluation formula for the timing of initiating immunosuppressive therapy in primary membranous nephropathy in patients with primary membranous nephropathy. The main question it aims to answer is:When should immunosuppressive therapy be initiated?This study is a retrospective one. Participants will not receive any treatment.


Eligibility criteria: Inclusion Criteria:

* It meets one of the diagnostic criteria for PMN as stipulated in the KDIGO 2021 Clinical Practice Guidelines for the Management of Glomerular Diseases: patients with a clear diagnosis of PMN based on renal biopsy pathology or presenting with nephrotic syndrome and positive anti-PLA2R antibody detection (\>14RU/mL), and excluding secondary factors such as tumors, infections, drugs, and systemic autoimmune diseases.

Exclusion Criteria:

* (1) Patients who have received treatment with immunosuppressive medications other than oral prednisolone.

  (2) The time interval between the renal biopsy and the baseline measurement is longer than 3 years.

  (3) Initiate the use of immunosuppressive agents within 1 week after the diagnosis of PMN.

  (4) Participate in the immunosuppressive treatment trial during the follow-up period and be in the intervention group.

Primary outcomes:
measure: Reasonably add immunosuppressive therapy
timeFrame: From enrollment to the reasonable addition of immunosuppressive agent treatme，no less than one weeknt
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Yipeng Liu
role: STUDY_CHAIR
References:
Clinical trial NCT06040476: Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke (AIS)
Official title: A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Lead sponsor: StemCyte International, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: StemCyte Taiwan Co., Ltd.
First posted: 2023-09-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke

Detailed description: This is a phase II study to evaluate the safety and efficacy in hUCB treatment on the patients with acute ischemic stroke (AIS).

Eligibility criteria: Inclusion Criteria:

* Male or female subject ≥18 and ≤80 years of age.
* Subject with a confirmed diagnosis of AIS and hemiplegia

Exclusion Criteria:

* Subject with known immune disease, immunodeficiency, or receives immunosuppressive therapy/immunomodulators within 4 weeks or 5 half-lives prior to screening, whichever is longer.

Primary outcomes:
measure: safety-TEAE
timeFrame: From screening to 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03103776: Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.
Official title: Involvement of Polyomaviruses in the Pathogenesis of Autoimmune Thyroiditis and Goitrigenesis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polyoma Virus Infection
Thyroiditis, Autoimmune
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Autoimmune thyroiditis and goitres are frequent pathologies.

Detailed description: Autoimmune thyroiditis and goitres are frequent pathologies. On a predisposing genetic ground, environmental factors are potentially at their origin. Viral infections are the main factors involved in autoimmunity (herpes virus, viral hepatitis C, Erythrovirus B19 ..). However some viruses have an oncogenic potential and could be involved in goitrigenesis. It is also possible that some viruses are specifically implicated in the pathogenesis of Graves' disease or Hashimoto thyroiditis which combines goitre and autoimmunity.

The intrathyroidism of the viral genome of a polyomavirus, the BK virus, has recently been reported in patients with goitre or cancer. The BK virus is a small ubiquitous virus of 40 nm diameter with double-stranded DNA contained in a non-enveloped icosahedral capsid. It is mainly known for triggering renal and bladder pathologies including urothelial tumors in the immunocompromised patient, tubulo-interstitial nephropathy in the renal transplant patient, as well as hemorrhagic cystitis in the patient grafted to the bone marrow.

Eligibility criteria: Inclusion Criteria:

* Major Patient Age ≥ 18 years
* Patients referred to the ENT service of the CHU of Amiens for thyroidectomy in the context of a goitre, a Graves' disease or a thyroiditis of Hashimoto.
* Patients must have signed informed consent.
* Affiliation to a social security scheme

Exclusion Criteria:

* Minor Patients,
* Patient under tutorship or curatorship.

Primary outcomes:
measure: Investigate the presence of BK Polyomavirus and compare the prevalence in patients operated with goitre or Grave or Hashimoto's disease
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT03271476: EMDR Psychotherapy to Treat Anxious-depressive Symptoms in Breast Cancer Patient
Official title: EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Beast Cancer : a Faisability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Eye Movement Desensitization and Processing
Psychoterapy
Keywords: Breast Cancer
EMDR
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
Collaborators: name: University of Lorraine
First posted: 2017-09-05
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the women will receive the same intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will consist in an adjustment/adaptation of the "standard EMDR protocol" for cancer disease, and most particulary for women who present a breast cancer and during adjuvant therapy. It will also test the faisability of the research, with a view to adjust the calendar and the ressources to put at disposal for a randomized control trial that follow. This study will also allow to test the need and acceptibility of this new psychotherapy for the patient, and to identify facilitators and obstacles : participation/rejection ratio, inclusion rythm, adhesion of the medical staff about the project


Eligibility criteria: Inclusion Criteria:

* Being a woman aged of 18 years or more
* Having a primary invasive breast cancer
* Having undergo a mastectomy for a primary invasive breast cancer
* Being able to complete the questionnaires
* Being informed of the study and having signed the informed consent
* Being affiliated to a welfare system

Exclusion Criteria:

* having contraindications to recieve EMDR psychotherapy (neurologic disorders, dissociatif states, oculomotor issues)
* Having started adjuvant treatments following surgery
* Having metastatic breast cancer
* Presenting physical polypathologies
* Having psychiatric antecedents (included anxiety and depressif disorders - assessed with M.I.N.I. (Sheehan and al., 1997)).
* Having drug or alcohol addiction
* Being placed under the safeguard of justice, guardianship or trusteeship
* Being pregnant or breast-feeding

Primary outcomes:
measure: patients involvement
timeFrame: week 12
Secondary outcomes:
measure: adequacy of the intervention with the field
timeFrame: Week 12
measure: EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires
timeFrame: Week 12
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville
Study officials:
affiliation: CHR Metz-Thionville
name: Rafaele Longo, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05153876: An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
Official title: NLP Headache Open: an Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache Disorders
Tension-Type Headache
Migraine Disorders
Cluster Headache
TACS
Secondary Headache Disorder
Keywords: Migraine
Natural Language Processing
Headache
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with headache disorders

Brief summary: Headache disorders are among the most prevalent medical conditions worldwide. The diagnosis of headache disorders is based on medical history taking. Digital solutions such as natural language processing (NLP) may be of aid to understand the linguistic aspects of headache attack and headache related disability descriptions by patients. Participants will provide a written description of their headache disorder. The results will hopefully lead to a better understanding of the potential use of NLP in headache disorders.


Eligibility criteria: Inclusion Criteria:

* 18 year or older
* Have a headache disorder with at least one headache attack over the last three months
* voluntary participation
* accepted the patient information sheet and gave informed consent

Primary outcomes:
measure: Lexical diversity and differences between migraine and cluster headache
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Accuracy of machine learning experiments for the correct classification of headache disorders
timeFrame: through study completion, an average of 1 year
measure: F1 scores of machine learning experiments for the correct classification of headache disorders
timeFrame: through study completion, an average of 1 year
measure: Word counts
timeFrame: through study completion, an average of 1 year
measure: Sentences counts
timeFrame: through study completion, an average of 1 year
measure: Paragraph counts
timeFrame: through study completion, an average of 1 year
measure: Term-frequency inverse document frequency scores (TF-IDF)
timeFrame: through study completion, an average of 1 year
measure: Migraine Disabillity Assessment [MIDAS] score calculation with text input
timeFrame: through study completion, an average of 1 year
measure: Migraine Specific Questionaire versie 2.1 [MSQv2.1] score calculation with text input
timeFrame: through study completion, an average of 1 year
measure: RAND SF-36 Dutch version score calculation with text input
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital, Ghent: Department of Neurology
Study officials:
References: