louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00850655: Genetic Association Mapping of Malaria Resistance in Anopheles Gambiae
Official title: Genetic Association Mapping of Malaria Resistance in Anopheles Gambiae
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2009-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: This is a study of the genetics of malaria transmission by the mosquito vector in Africa, Anopheles gambiae. The study focuses on the mosquito vector, not the human subjects infected with malaria. DNA extracted from infected mosquitoes will be analyzed genetically by microsatellite and single-nucleotide polymorphisms (SNPs) to identify mosquito genes that control mosquito resistance to malaria parasites.

Detailed description: A standard diagnostic blood smear from a drop of blood will be carried out on 20 study subjects once per month. One malaria-positive subject from among the 20 will be asked to donate 5cc of blood, also no more frequently than once per month. The blood will be placed in a water-jacketed heated membrane feeding device that will be positioned on top of a cage of mosquitoes. The mosquitoes are attracted to the warmth and drink the blood through the artificial skin-like membrane. The goal of the research is to study the infected mosquitoes. No studies will be carried out on the human subjects. The point of human subjects involvement is to obtain the naturally malaria-infected blood for feeding of mosquitoes. After blood feeding, the mosquitoes are held in an environmental chamber for one week, at which time they are dissected to count numbers of malaria parasites developing on the mosquito stomach wall. This number constitutes the quantitative phenotype, and we extract genomic DNA from the carcass for genetic marker typing, which constitutes the genotype. Genetic linkage analysis identifies markers near genes that control parasite number, thus resistance or susceptibility to parasite infection.

Eligibility criteria: Inclusion Criteria:

* 5-10 years old, and general good health

Exclusion Criteria:

* Outside age group
* Specific diagnosable health problems
* General poor health

Primary outcomes:
measure: mosquito infection
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Kenneth D Vernick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06276855: Sleep Hygiene Education in Individuals With Fibromyalgia; Sleep Quality, Pain and Depression
Official title: Associate Professor Registered Nurse Doctor of Philosophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Sleep Hygiene
Sleep Quality
Pain
Depression
Fibromyalgia
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group Control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.

Patients and methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory.

Detailed description: Objective: This semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia.

Background: Sleep problems, pain, and depression are common health issues in individuals with fibromyalgia. However, studies on sleep hygiene education to address these problems are limited in the literature.

Methods: A sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. Data was collected using the Pittsburgh Sleep Quality Index, the Visual Analog Scale, and the Beck Depression Inventory.

Eligibility criteria: Inclusion Criteria:

The inclusion criteria for the study were as follows:

* Being 18 years of age or older,
* Having a diagnosis of Fibromyalgia (FM) for at least 3 months,
* Being reachable,
* Agreeing to participate in the study,
* Not receiving treatment for depression,
* Not having received similar education on sleep hygiene,
* Having a VAS pain score \>3,
* Having a PSQI score \>5.

Exclusion Criteria:

Additionally, the exclusion criteria for the study were as follows:

* Having a diagnosis of FM for less than 3 months,
* Using sleep medication,
* Having chronic illnesses that could interfere with sleep such as Chronic Obstructive Pulmonary Disease (COPD) or asthma,
* Working on night shifts.

Primary outcomes:
measure: Demographic Information Form (DIF).
timeFrame: 1 month
measure: Pittsburgh Sleep Quality Index (PSQI).
timeFrame: 1 month
measure: Visual Analog Scale (VAS).
timeFrame: 1 month
measure: Beck Depression Inventory (BDI).
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
state: Center
Study officials:
References:
Clinical trial NCT06635655: Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
Official title: Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Limb Amputation Above Knee (Injury)
Keywords: microprocessor controlled
lower limb prosthesis
mental workload
Lead sponsor: Proteor Group
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population usually living or receiving care around investigation centers

Brief summary: New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life. Following users feedback, it is desirable to better understand why and how mental workload is impacted by new technologies or features. This clinical investigation will try to measure a difference between different prosthetic systems, in lab and in daily life.

Detailed description: Multicentric, national, observational, prospective study, using AB type SCED.

Eligibility criteria: Inclusion Criteria:

* above-knee lower limb amputation
* using an above-knee prosthesis with prosthetic knee and foot
* eligible to use Synsys
* able to design therapeutic objectives for the GAS
* having a smartphone

Exclusion Criteria:

* protected person
* pregnant or breast-feeding lady
* knee-to-ground height lower than 43cm
* weighting more than 125kg
* using their prosthesis for less than 2 weeks
* not covered by health insurance
* aged less than 18 or more than 84 years old
* bilateral amputee or hip disarticulated

Primary outcomes:
measure: Goal Attainment Scale (GAS)
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: L-test and Dual-task L-test
timeFrame: Initial visit, at 4 weeks, and at 8 weeks
measure: Two-minute walk test (2MWT) and 2MWT in divided attention
timeFrame: Initial visit, at 4 weeks, and at 8 weeks
measure: Activity Balance Confidence Scale (ABC-scale)
timeFrame: at 4 weeks, and at 8 weeks
measure: Prosthesis Evaluation Questionnaire (PEQ-A)
timeFrame: at 4 weeks, and at 8 weeks
measure: Stumbles and falls
timeFrame: at 4 weeks, and at 8 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: France
facility: Multiple sites
Study officials:
affiliation: Proteor Group
name: Laurine Calistri, MS
role: STUDY_DIRECTOR
affiliation: UGECM Nord-Est, IRR, Centre Louis Pierquin
name: Isabelle Loiret, DR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03381755: Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI
Official title: Comparative Effectiveness and Safety Analysis of Low-dose and Standard-dose Ticagrelor in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 200
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: PREVENTION

Brief summary: Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor.

Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But the effectiveness and safety of low-dose ticagrelor remain yet not very clearly in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

* After half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram.
* planned to undergo PCI recently
* planned to DAPT for 1 year after PCI

Exclusion Criteria:

* taken adenosine diphosphate (ADP) receptor antagonists within 2 weeks
* Platelet count \<100g/L;
* A history of bleeding tendency;
* Aspirin, ticagrelor or clopidogrel allergies;
* Severe liver injury.

Primary outcomes:
measure: thromboela-stogram
timeFrame: up to 6 months
measure: thromboela-stogram
timeFrame: up to 1 year
Secondary outcomes:
measure: MACE
timeFrame: up to 1 year
measure: Side effects including bleeding and dyspnea
timeFrame: up to 1 year
measure: The rate of treatment interruption due to ticagrelor intolerance.
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Thromboela-Stogram
state: Beijing
Study officials:
affiliation: Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University
name: Yue Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06018155: Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation
Official title: Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Degenerative Condition, Neurologic
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted

Brief summary: The aim of this study is to evaluate the correlation between the fat infiltration of the lumbar multifidus muscle and several parameters including the severity of the lumbar foraminal stenosis. The investigators will analyse lumbar MRI of patients previously included in a database of patients suffering from low back pain. Foraminal stenosis, muscle fat infiltration and other imaging lumbar parameters will be studied by 2D and 3D manuel segmentation, semi-automatic segmentation. Correlations between factors influencing the muscle fat infiltration will be studied by univariate and multivariate statistical analysis.


Eligibility criteria: Patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted, for who the following parameters are available: lumbar 3D MRI with T2 weighted sequences, informed consent.

Primary outcomes:
measure: Percentage of muscle fat infiltration
timeFrame: 1 year
measure: Percentage of muscle fat infiltration
timeFrame: 1 year
Secondary outcomes:
measure: Lumbar foraminal stenosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Nice
country: France
facility: University Hospital of Nice
Study officials:
References:
Clinical trial NCT00822055: Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1 and Month 3 for ophthalmic evaluations.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years
* Female subjects of childbearing potential must have negative pregnancy test and practice contraception
* Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
* Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate
* Subjects able to complete questionnaires and provide informed consent

Exclusion Criteria:

* Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control
* Subjects wherein the study drugs are contraindicated
* Subjects who have had intraocular surgery with 6 months (3 months for laser)
* Subjects with known side effects/allergy or sensitivity to any component of study treatments
* Subjects with any uncontrolled systemic disease

Primary outcomes:
measure: Change from baseline in mean IOP
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient tolerability/comfort measured by Likert scale
timeFrame: Month 1
Other outcomes:
Locations:
city: Barrie
country: Canada
state: Ontario
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Nixon DR, Yan DB, Chartrand JP, Piemontesi RL, Simonyi S, Hollander DA. Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy. Curr Med Res Opin. 2009 Jul;25(7):1645-53. doi: 10.1185/03007990902994041.
Clinical trial NCT02801955: Serum and Peritoneal CEA and CA 19-9 for Gastric Adenocarcinoma
Official title: Predictive Value of Serum and Peritoneal CEA and CA 19-9 for TNM Stage and Peritoneal Dissemination of Gastric Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Adenocarcinoma
Keywords: gastric adenocarcinoma
tumor markers
peritoneal cytology
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: gastric adenocarcinoma treated with curative gastrectomy

Brief summary: For preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma, usage of serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 may be helpful. Additionally, the prognosis of the patients with gastric adenocarcinoma treated with gastrectrectomy may be associated with serum and peritoneal levels of tumor markers.

Detailed description: Clinical usage of tumor markers on preoperative staging and prediction of peritoneal dissemination of gastric adenocarcinoma is a controversial issue. It has been thought that there is a positive correlation between serum and peritoneal levels of carcinoembryonic antigen (CEA) and CA 19-9 and pathologic features of gastric tumors and peritoneal dissemination.

In this study, it was aimed to evaluate the effect of serum and peritoneal CEA and CA 19-9 to predict TNM stages and peritoneal washing cytology in patients with gastric adenocarcinoma after curative gastrectomy, and to determine predictive value of these measurements to the development of recurrence and death.

Eligibility criteria: Inclusion Criteria:

* Endoscopically proven gastric adenocarcinoma
* Standard gastrectomy and a D2 lymph node dissection;
* Desire to attend the study protocol

Exclusion Criteria:

* Metastatic or overt peritoneal disseminated cancer
* Undesired reaction to attend the study protocol

Primary outcomes:
measure: TNM stage
timeFrame: through pathologic report completion, an average of 1 month
Secondary outcomes:
measure: peritoneal washing cytology
timeFrame: through pathologic report completion, an average of 1 month
measure: recurrence/death
timeFrame: through follow-up period, an average of 24 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Mustafa Hasbahceci
Study officials:
affiliation: bezmialem vakif university faculty of medicine
name: mustafa hasbahceci, assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04879355: Spinal Needles in Ultrasound-guided Fine Needle Aspirations From Thyroid Nodules
Official title: The Use of Spinal Needles for Ultrasound-guided Fine Needle Aspiration From Thyroid Nodules - a Protocol for a Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Rigshospitalet, Denmark
First posted: 2021-05-10
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients are randomised at a 1:1-ratio to one of two parallel groups, and all patients are included in the analysis on an intention-to-treat basis.
Primary purpose: DIAGNOSTIC

Brief summary: This is a multicentre, two-arm, randomised and controlled trial. Adults with thyroid nodules suspected of malignancy are to be included consecutively. A total of 350 patients are randomly assigned 1:1 to have FNA with a spinal (25G) or a conventional (25G) needle. The primary outcome is the rate of diagnostic cytological samples according to the Bethesda system. Secondary outcomes are diagnostic accuracy, patient's experienced pain and complication rates.


Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age.
2. Patients referred for evaluation of a cold nodule on thyroid scintigraphy and with EU-TIRADS score of 3 or higher.

   * Score 3 and \> 20 mm in size.
   * Score 4 and \>15 mm in size.
   * Score 5 and \>10 mm in size.
3. Clinical suspicion of thyroid cancer:

   * PET-positive thyroid tumor.
   * Thyroid tumor and palsy of the recurrent laryngeal nerve.
   * Rapidly growing thyroid tumor.
   * Hard and/or immobile thyroid tumor.
   * Tumor in the thyroid with suspicious lymph nodes.

Exclusion Criteria:

* Previous participation in the study.
* Language or other barriers not allowing adequate information.

Primary outcomes:
measure: Diagnostic rate
timeFrame: 1 year
Secondary outcomes:
measure: Complication rate
timeFrame: Till 1 month after last inclusion. Corresponding to about 1 year
measure: Pain assessment
timeFrame: About 2 years
measure: Diagnostic accuracy
timeFrame: About 2 years
Other outcomes:
Locations:
city: Koege
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital, Køge, Denmark.
name: Tobias Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen TV, Bennedbaek FN, Pedersen J, Rosenorn MR, Kiss K, Lelkaitis G, Andersen L, Hegedus L, Lomholt AF, Hahn CH, Hvilsom GB, Homoe P, Todsen T. Spinal versus conventional fine needle for ultrasound-guided thyroid nodule biopsy: a protocol for a randomised clinical trial. Dan Med J. 2022 Jul 21;69(8):A03220165.
Clinical trial NCT02553655: Remote Ischemic Limb Preconditioning In Healthy Volunteers
Official title: Does Remote Ischemic Limb Preconditioning Improve Cerebral Vasomotor Reactivity in Healthy Volunteers?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Disease
Stroke
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators would like to determine if remote ischemic leg preconditioning in healthy volunteers improves cerebral vasomotor reactivity as measured by breath holding and transcranial doppler vasomotor reactivity.

Detailed description: This study is to determine if remote ischemic leg preconditioning improves short and long term cerebral vasomotor reactivity in healthy volunteers as measured by breath holding and transcranial doppler vasomotor reactivity. Previous studies on brachial vasomotor reactivity have shown a beneficial effect of remote ischemic preconditioning. It remains uncertain if a similar beneficial effect can be reproduced with cerebral vasomotor testing. Many biological mechanisms and effector pathways triggered by preconditioning have demonstrated endothelial protection and beneficial vascular effects.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Presence of chronic medical conditions such as diabetes, hypertension, cardiac disease etc.
* Any prescribed medication
* Pregnancy \[by history and last menstrual period\]
* Any leg injury that would, in the opinion of the investigator, affect preconditioning

Primary outcomes:
measure: Change in Vasomotor Reactivity to Carbon Dioxide (CO2)
timeFrame: Baseline to 24 hours, Baseline to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sebastian Koch, MD
role: PRINCIPAL_INVESTIGATOR
References: