louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06275074: Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance
Official title: Effects of Dry Needling and Therapeutic Exercise on Sleep in Individuals With Chronic Neck Pain and Sleep Disturbance - A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neck Pain
Sleep Disturbance
Keywords: Needling
Sleep Disturbance
Chronic pain
Neck Pain
Actigraphy
Physical Therapy
Feasibility
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 28
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: OTHER

Brief summary: Feasibility study investigating the effects of dry needling on individuals with chronic neck pain and sleep disturbance.

Detailed description: The purpose of this pilot study is to determine the feasibility of a large randomized clinical trial (RCT) which aims to investigate the effects of dry needling (DN) in addition to therapeutic exercise (TE) on sleep duration and quality in patients with chronic neck pain (CNP) and sleep disturbance (SD). Specifically, the objective is to explore feasibility of a study protocol and examine the preliminary data of a small sample size for the effectiveness of DN and TE for individuals with CNP and SD to determine effect size of the intervention.

Eligibility criteria: Inclusion Criteria:

* Neck pain lasting greater than 3 months 28,29
* Age: 18-75 years
* Presence of sleep disturbance - to be defined as a score ≥ 8 on the Insomnia Severity Index
* Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

* Previous surgery to the neck or thoracic spine
* Central nervous system disorders
* Systemic joint disease (e.g. rheumatoid arthritis)
* Infection
* Cancer
* Raynaud's disease
* Pregnancy
* Immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
* Insufficient English-language skills to complete all questionnaires.
* Contraindications to dry needling:

  * Presence of needle phobia
  * History of abnormal reaction to needling or injection
  * History of bleeding disorder (e.g., current anticoagulant therapy or known thrombocytopenia)

Primary outcomes:
measure: Participant retention rate
timeFrame: 1 year
measure: Participant intervention adherence
timeFrame: 1 year
measure: Number of adverse responses to treatment
timeFrame: 1 year
Secondary outcomes:
measure: Sleep Duration
timeFrame: 5 weeks
measure: Sleep Quality
timeFrame: 13 weeks
Other outcomes:
measure: Disability Level
timeFrame: 13 weeks
measure: Pain Level
timeFrame: 13 weeks
Locations:
city: Rochester
country: United States
facility: Mayo Clinic - Motion Analysis Lab
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ray Lunasin, P.T., D.P.T.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01809574: The Role of Rheumatological Evaluation in the Management of Patients With Interstitial Lung Disease
Official title: The Role of Rheumatological Evaluation in the Management of Patients With Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Connective Tissue Disease
Keywords: Interstitial lung disease
Idiopathic pulmonary fibrosis
Connective tissue disease
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-03-12
Enrollment: 60
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: 60 patients that will refer to the pulmonary outpatient or inpatients department for evaluation due to ILD will be included

Brief summary: We hypothesized that the multi-disciplinary assessment of interstitial lung disease patients would lead to a more accurate diagnosis and consequently alterations in treatment regimens that may lead to improved outcomes.


Eligibility criteria: Inclusion Criteria:

* Age above 18 years old
* ILD according to ATS/ERS guidelines
* Signed inform consent

Exclusion Criteria:

* Previous lung surgery
* Other significant systemic disease

Primary outcomes:
measure: The number of patients with collagen related pulmonary fibrosis that are diagnosed by Rheumatologists compared to Pulmonologists.
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Head of Pulmonary departmant, Meir Medical Center.
name: David Shitrit, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00538174: Phase I Multiple-Ascending Dose (Japan)
Official title: A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days


Eligibility criteria: Inclusion Criteria:

* Japanese male and female subjects
* Ages 20 to 70 years old
* Established diagnosis of T2DM
* BMI \< 32 kg/m2
* Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone
* HbA1C 6.0 - 10.0%

Exclusion Criteria:

* Symptomatic T2DM defined as polyuria and/or polydipsia within 2 months of enrollment
* History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
* History of incontinence or bladder dysfunction including nocturia

Primary outcomes:
measure: AEs, vital signs & physical exam
timeFrame: scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21
measure: ECGs
timeFrame: scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21
measure: Clinical labs
timeFrame: scr, Days -1, 2, 7, 12, 14, 15, 21
measure: Urine safety markers
timeFrame: Days -1, 1, 14
Secondary outcomes:
measure: 24 hr PK blood & urine samples
timeFrame: Days 1 & 14
measure: Serum glucose, serum insulin, serum c-peptide
timeFrame: Days -1, 1, 14
measure: Serum fructosamine
timeFrame: Days -1, 14, 4 h
measure: OGTT
timeFrame: Days -2, 13 (after 10 h fast)
measure: 24h urine
timeFrame: Days -1, 1 & 14 for glucose, creatinine & calcium
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Local Institution
state: Osaka
Study officials:
affiliation: Bristol-Myers K.K.
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Kasichayanula S, Chang M, Hasegawa M, Liu X, Yamahira N, LaCreta FP, Imai Y, Boulton DW. Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium-glucose co-transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Apr;13(4):357-65. doi: 10.1111/j.1463-1326.2011.01359.x.
Clinical trial NCT01095874: Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study
Official title: Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study Comparing Outcome of Patients Aged From 50 to 70 Years With or Without Donor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplasia
Keywords: myelodysplasia
allogeneic hematopoietic stem cell transplantation
Survival
Transplantation
Lead sponsor: Saint-Louis Hospital, Paris, France
Sponsor class: OTHER
Collaborators: name: Hospital Avicenne
name: University Hospital, Grenoble
name: University Hospital, Clermont-Ferrand
First posted: 2010-03-30
Enrollment: 164
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 50 to 70 years with high risk myelodysplasia and eligible for transplantation

Brief summary: The purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. Patients are registered when they acquire risk factors.


Eligibility criteria: Inclusion Criteria:

* 50 to 70 years
* For myelodysplasia other than CMML: patients can be included if they have at least one of these criteria:

  1. IPSSintermediate 1 and poor cytogenetics (complex, 3 or 7 abnormality);
  2. thrombopenia \< 20x10ex9/L:
  3. IPSS intermediate 2 or high
* For CMML: patients can be included if they have at least one of these criteria:

  1. 2 of these criteria: hyperleucocytosis \> 10x10exp9/L, splenomegaly\>18cm, hemoglobin \< 10gr/dl, platelet \< 100x10ex9/L
  2. IPSS intermediate 2 or high

Exclusion Criteria:

* Patient not eligible for transplantation (including patients without donor)because of severe co-morbidity including:
* Renal failure with creatinine clearance \< 30ml/min
* Cirrhosis or hepatic failure
* Respiratory disease with vital capacity \< 30%
* Uncontrolled cardiac failure
* Uncontrolled neurological disease
* Poor performance status with karnofsky \< or = 60%

Primary outcomes:
measure: overall survival in patient with or without donor
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris Cedex 10
country: France
facility: Hôpital Saint-Louis
Study officials:
References:
Clinical trial NCT00735774: Suitability of 11C-ORM-13070 as a PET Tracer
Official title: Suitability of 11C-ORM-13070 as a Positron Emission Tomography Tracer; an Open Study in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer study
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron emission tomography tracer.


Eligibility criteria: Inclusion Criteria:

* Good general health ascertained by detailed medical history and physical examination
* Males between 18 and 45 years
* Body mass index (BMI) between 18-30 kg/m2
* Weight 55-95 kg (inclusive)

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator
* Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study.
* Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol)
* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
* Inability to refrain from using nicotine-containing products during the stay in the study centre
* Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre e.g. propensity in getting headache when refraining from caffeine-containing beverages
* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
* Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance
* Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study
* Anatomical abnormality in MRI which may in the opinion of the investigator interfere with the interpretation of PET results
* Participation in a drug study within 3 months prior to the entry into this study
* Participation in a prior PET study

Primary outcomes:
measure: Suitability of 11C-ORM-13070 as a PET tracer
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku PET centre
Study officials:
affiliation: Turku PET Centre
name: Juha Rinne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05786274: Predicting Cerebrovascular Adverse Events Post Cardiac Surgery
Official title: Predicting Cerebrovascular Adverse Events Post Cardiac Surgery With Cardiopulmonary Bypass by Means of Cerebral AutoreguLation Indices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Disease
Keywords: cerebral autoregulation
cardiopulmonary bypass
stroke
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2023-03-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of this study are: i) to assess cerebral autoregulation and autonomic control within the different phases of cardiac surgery with cardiopulmonary bypass; ii) to compare cerebral autoregulation measures derived via cerebral blood flow velocity estimated by transcranial Doppler device with simpler measurements derived from near infrared spectroscopy; iii) to develop a predictive model of postoperative cerebrovascular outcome (overt or silent stroke) based on the extracted indices.


Eligibility criteria: Inclusion Criteria:

* age older than 18 years
* spontaneous sinus rhythm
* no pregnancy
* signed informed consent

Exclusion Criteria:

* age lower than 18 years
* absence of sinus rhythm
* autonomic disorders
* concomitant carotid intervention
* reintervention
* contraindication to MRI
* pregnancy
* impossibility of informed consent

Primary outcomes:
measure: Autoregulation index (ARI)
timeFrame: 36 months
measure: Cerebral Oxymetry index (CoX)
timeFrame: 36 months
measure: number of patients developing cerebrovascular adverse events
timeFrame: 36 months
Secondary outcomes:
measure: Baroreflex sensitivity
timeFrame: 36 months
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
Study officials:
References:
Clinical trial NCT03392974: Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients at a Dose of 4E13 vg/kg
Official title: A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII at a Dose of 4E13vg/kg in Hemophilia A Patients With Residual FVIII Levels ≤1IU/dL Receiving Prophylactic FVIII Infusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemophilia A
Keywords: Hemophilia A
Gene Therapy
Clotting Disorders
Blood Disorder
Blood Coagulation Disorders
Inherited Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases
Inborn
Factor VIII
Coagulants
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-01-08
Enrollment: 1
Sex: MALE
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 Phase III clinical study will assess the efficacy of BMN 270 defined as FVIII activity, during weeks 49-52 following intravenous infusion of BMN 270 and assess the impact of BMN 270 on usage of exogenous FVIII replacement therapy and the number of bleeding episodes from week 5 to week 52.


Eligibility criteria: Inclusion Criteria:

1. Males ≥ 18 years of age with hemophilia A and residual FVIII levels ≤ 1 IU/dL as evidenced by medical history.
2. Must have been on prophylactic FVIII replacement therapy for at least 12 months prior to study entry.
3. Treated/exposed to FVIII concentrates or cryoprecipitate for a minimum of 150 exposure days.
4. No previous documented history of a detectable FVIII inhibitor of less than 0.6 Bethesda Units (BU).

Exclusion Criteria:

1. Detectable pre-existing antibodies to the AAV5 capsid.
2. Any evidence of active infection or any immunosuppressive disorder, including HIV infection.
3. Significant liver dysfunction, prior liver biopsy showing significant fibrosis, liver cirrhosis of any etiology or history of hepatic malignancy.
4. Evidence of any bleeding disorder not related to hemophilia A.
5. Active Hepatitis C.
6. Prior treatment with any vector/gene transfer agent.

Primary outcomes:
measure: Change of the Median Factor VIII (FVIII) Activity
timeFrame: Week 52
Secondary outcomes:
measure: Change in the Annualized Utilization (IU/kg) of Exogenous FVIII Replacement Therapy
timeFrame: Weeks 5 through Week 52
measure: Change in the Annualized Number of Bleeding Episodes Requiring Exogenous FVIII Replacement Treatment
timeFrame: Weeks 5 though Week 52
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Hemophilia Center of Western Pennsylvania
state: Pennsylvania
Study officials:
affiliation: BioMarin Pharmaceutical
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06330974: Allergy, Asthma, and Atopic Eczema in Finland
Official title: Allergy, Asthma, and Atopic Eczema in Finland - A Nationwide Study on Prevalence, Comorbidities, Treatment and Economic Burden
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma
Asthma in Children
Allergy
Rhinitis, Allergic
Atopic Dermatitis
Allergen Immunotherapy
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Professor Lauri Lehtimäki
name: Professor Mika Mäkelä
name: Professor Sanna Toppila-Salmi
name: Professor Ilkka Junttila
First posted: 2024-03-26
Enrollment: 2000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: https://www.finnatopy.fi/methods

Brief summary: The summary is available at --\> https://www.finnatopy.fi/summary

Detailed description: Aims and objectives ---\> https://www.finnatopy.fi/aims-and-objectives Methods ---\> https://www.finnatopy.fi/methods

Eligibility criteria: Inclusion/Exclusion Criteria ---\> https://www.finnatopy.fi/methods

Primary outcomes:
measure: Epidemiology of atopic diseases and allergic sensitization profiles in Finland
timeFrame: 7 years
measure: Burden of atopic diseases (allergies, asthma, and atopic eczema) as well as comorbidities in Finland
timeFrame: 7 years
measure: Evaluate and improve the current use of diagnostic tests for atopic diseases
timeFrame: 7 years
measure: Use and effectiveness of allergen immunotherapy in real world setting
timeFrame: 7 years
measure: Direct and indirect costs related to atopic diseases and comorbidities
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University
Study officials:
affiliation: Tampere University
name: Péter Csonka
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02610374: Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients
Official title: Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Gut microbiota composition
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective is to assess the effect of short-term diet modification on the microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative controls in the United States.

Detailed description: This is a randomized clinical trial. Fifty (50) Antiretroviral therapy (ART)-treated Human immunodeficiency virus (HIV) positive participants, 24 HIV negative controls matched for age and sex, and 24 HIV negative controls from a population at high risk for contracting HIV will be recruited into 3 cohorts. All participants will undergo a 4 week diet modification and will be randomly assigned to receive either an Agrarian diet or a Western-type diet. For the first 2 weeks, food will be provided to the participant, followed by an additional 2 weeks where participants will be provided a diet menu with recipes to prepare themselves. There will be 4 study visits and participation will last for up to 2 months.

Eligibility criteria: Inclusion Criteria:

* HIV-infected cohort (Cohort A)

  * Documentation of HIV-1 infection defined as a positive antibody test or plasma HIV-1 RNA (ribosomal ribonucleic acid).
  * Treated with ART (minimum of three antiretroviral drugs in regimen) for at least 12 months with no changes in antiretroviral drugs over the past 6 months
  * Plasma HIV-1 RNA ≤ 50 copies/mL in the preceding 6 months.
* HIV-negative cohorts (Cohort B and C)

  * Documentation of a negative HIV-1 antibody test
* All Cohorts

  * Age 18 to 65 years
  * Body mass index between 21-29 kg/m2 (non-obese)
  * Stable weight for at least 3 months (≤15% change in body weight)
  * Negative pregnancy test (if female)

Exclusion Criteria:

* Use of systemic (oral or parenteral) antibiotics within two months prior to study entry
* Active chronic infection such as hepatitis B or C or an active malignancy that requires systemic chemotherapy.

Primary outcomes:
measure: Change in plasma IL-6 concentration (All Participants)
timeFrame: 4 weeks
measure: Change in plasma IL-6 concentration (HIV-Infected Participants)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Catherine Lozupone, PhD
role: PRINCIPAL_INVESTIGATOR
References: