louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06475898: Longitudinal Endpoint Assessment of Disease Burden in HD
Official title: Longitudinal Endpoint Assessment of Disease Burden in HD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Huntington Disease
Lead sponsor: Huntington Study Group
Sponsor class: NETWORK
Collaborators: name: University of Rochester Center for Health + Technology
name: Modality.AI, Inc
name: Neurotargeting LLC
First posted: 2024-06-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Must self-report they have been diagnosed with HD by a doctor or have undergone genetic testing, been found to carry the expanded allele responsible for HD and have no clinical diagnosis (prodromal HD) (HD-ISS Stage 2 or 3).

Brief summary: LEAD-HD is intended to collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD participating in a 24-month longitudinal natural history study using remote technologies.

Detailed description: The LEAD-HD study will be offered via HSG's online observational research platform called myHDstory®. This direct to patient study will collect and analyze self-reported health information from individuals with Huntington Disease (HD) or prodromal HD in a 24-month longitudinal natural history study that participants complete at any time and with their own electronic device.

Eligibility criteria: Inclusion Criteria:

* Be 18 years of age or older;
* Be willing and able to provide informed consent electronically;
* Self-report, when answering as a participant, that you have been diagnosed with HD by a doctor, or have undergone genetic testing and been found to carry the gene mutation responsible for HD but have not been clinically diagnosed with HD (prodromal HD);
* Have the ability to answer online questions or direct someone else to enter answers for them;
* Have the ability to ambulate independently and take care of some of your personal needs;
* Have the ability to read and understand English;
* Be willing to create a unique identifier based on personal demographic information;
* Reside in the United States or its territories. Surveys can only be completed in the US. If you move outside of the US, you will no longer be able to participate;
* Own or have access to an electronic device and secure internet connectivity

Exclusion Criteria:

-

Primary outcomes:
measure: PRO natural history
timeFrame: December 2026
measure: Demographic characteristics
timeFrame: December 2026
measure: Assess the ability to consent and enroll
timeFrame: December 2026
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Huntington Study Group
state: New York
Study officials:
affiliation: University of Rochester Center for Health + Technology
name: Jamison Seabury
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06666998: Real-World Pharmacokinetic/Pharmacodynamic Study of Eravacycline in Critically III Patients
Official title: Real-World Pharmacokinetic/Pharmacodynamic Study of Eravacycline in Critically III Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Eravacycline
Pharmacokinetics
Bacteria Infection
Bacterial Resistance to Antimicrobial
Empirical Antimicrobial Therapy
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 critically infected patients

Brief summary: The aim of this study is to evaluate the efficacy of Eravacycline in the treatment of patients with bacterial infection and to assess the pharmacokinetics of Eravacycline and to establish a population pharmacokinetic model of Eravacycline.


Eligibility criteria: Inclusion Criteria:

* Adult male or female aged 18-75 years
* Not respond to initial empirical treatment, treatment time to reach Eravacycline steady-state concentration
* Empirical antimicrobial treatment is ineffective
* Eravacycline application for ≥ 3 days
* Understand and sign informed consent

Exclusion Criteria:

* Urinary tract infection
* Allergic to Eravacycline, Tigecycline antibiotics or any excipients or have previously experienced serious adverse reactions
* Any unstable or potentially endangering the safety of the subject and their compliance with the study as judged by the investigator; comorbidities or social circumstances that can make the subject unable to follow the study plan or even endanger the safety of the patient
* Patients expected to survive for no longer than 48h.

Primary outcomes:
measure: Clinical remission rate
timeFrame: At the end of treatment；2 weeks（estimated）
measure: Microbiological efficacy
timeFrame: From enrollment to the end of treatment at 28 days
Secondary outcomes:
measure: Develop Population Pharmacokinetic Model
timeFrame: From enrollment to the end of treatment at 28 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02340598: Pilot Study of Effects of Cold Vests on Cardiovascular Risk Markers
Official title: Prospective Randomized Pilot Study of the Effects of Cold Vests on Cardiovascular Risk Markers and Basal Metabolic Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Basal Metabolic Rate
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 50
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: PREVENTION

Brief summary: Randomized trial of supplying a cold vest as compared with controls (no cold vest) on cardiovascular risk factors such as blood lipids, insulin, blood pressure and body weight and also on basal metabolic rate. Recruitment of 100 participants and 70 are randomized to being given a vest which they can use to increase basal metabolic rate during 1-2 hours (as long as the pre-cooled vest stays cool) by activating brown adipose tissue and/or shivering. The remaining 30 subjects will constitute a control group. Lab tests and anthropometrics are checked at baseline, after 2 months and after 1 year.


Eligibility criteria: Inclusion Criteria:

* healthy subjects that have no known metabolic relevant diseases

Exclusion Criteria:

* thyroid disease,
* mental disorders,
* language problems

Primary outcomes:
measure: basal metabolic rate
timeFrame: up to 1 year
measure: Composite measure of cardiovascular risk factors
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: University Hospital of Linkoping
Study officials:
affiliation: Linkoeping University
name: Fredrik H Nystrom, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03393598: Recipient Site Pre-conditioning in Fat Grafting
Official title: Randomized Multi-centered Study on Enhancement of Autologous Fat Graft Survival by Recipient Site Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft Loss
Condition
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
name: Ospedale Regionale di Lugano
First posted: 2018-01-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the preparation of the recipient site prior to autologous fat grafting (AFG) using different methods.

Detailed description: Autologous fat grafting is emerging as a powerful tool for soft tissue reconstruction and augmentation and is widely used in plastic surgery. However, there is great variability in terms of long-term graft retention (survival). Moreover, the recipient site preparation is the phase of the procedure which received less attention in clinical and pre-clinical investigations. To provide information regarding an effective preparation of the recipient site may potentially lead to improvements in fat graft survival.

Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* Patients presenting with contracted scars or body contouring deformities, especially as a result of previous radiation therapy or infection, in and around the breast.
* Body mass index superior than 18.5

Exclusion Criteria:

* Need for antiplatelets drugs in the 5 days before surgery and 3 days after,
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study due to language problems, psychological disorders, dementia of the participant,
* Previous enrolment into the current study,
* Enrolment of the investigator, his or her family members, employees and other dependent persons,
* Patients with haemorrhagic diatheses.

Primary outcomes:
measure: Fat-graft survival volume
timeFrame: 24 (+/-2) weeks after surgery
Secondary outcomes:
measure: POSAS (Patient and Observer Scar Assesment Scale)
timeFrame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
measure: Occurence of Site infection
timeFrame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
measure: Surgical complication rate
timeFrame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
measure: Pain assessed by VAS (Visual Analogue Scale)
timeFrame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Switzerland, Dept. of plastic, reconstructive, aestetic and hand surgery
city: Zuerich
country: Switzerland
facility: Klinik Hirslanden, Plastic Surgery Group AG
Study officials:
affiliation: Plastic, Reconstructive, Aesthetic, and Hand Surgery,
name: Dirk J Schaefer, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02834598: Towards an Objectivation of the Therapeutic Effect of a Rocking Movement
Official title: Objectivating the Therapeutic Effect of a Rocking Movement by High Density Electroencephalography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rocking Movement
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study evaluates the benefits of a rocking movement on well-being and attention, through high-density electroencephalography recordings. The effect of the rocking movement is compared to a seated position and a lying position.


Eligibility criteria: Inclusion Criteria:

* Right handed
* Informed consent

Exclusion Criteria:

* Pregnancy
* subjects with analgesic treatment
* subjects dependent on psychotropic substances

Primary outcomes:
measure: Difference of amplitude between standard and deviant sounds
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Service douleur - soins palliatifs
name: Régis Aubry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03383198: Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine for Breast Surgery
Official title: Pectoralis (II) Block With Liposomal Bupivacaine vs Bupivacaine Plus Dexamethasone for Mastectomy With Immediate Reconstruction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate reconstruction.

Detailed description: This research hopes to determine the duration of patient-reported analgesia provided by ultrasound guided PEC II field block injections. The design of the study randomly assigns the side of injection of the study drugs into each patient. All patients are having bilateral mastectomy with immediate reconstruction. Visual analog pain scores (VAS) will be recorded serially for both sides of the patient's chest in hopes of determining a difference in duration and efficacy of the two drugs. In addition to VAS scores, a subjective, binary question will be our primary outcome: does one side of your chest have more surgical pain than the other? We hope that his question, despite being entirely subjective, overcomes interpatient variability of numerical pain score reporting.

Eligibility criteria: Inclusion Criteria:

* Scheduled for bilateral mastectomy

Exclusion Criteria:

* allergy to local anesthetics, prior breast surgery, asymmetric surgical plan

Primary outcomes:
measure: Subjective Bilateral Pain Comparison
timeFrame: up to 48 hours
Secondary outcomes:
measure: Duration of Analgesia
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Patewood Memorial Hospital
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: William Hand, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
citation: Amundson AW, Johnson RL, Abdel MP, Mantilla CB, Panchamia JK, Taunton MJ, Kralovec ME, Hebl JR, Schroeder DR, Pagnano MW, Kopp SL. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150. doi: 10.1097/ALN.0000000000001586.
Clinical trial NCT02995798: The Characteristics of Regional Bone Quality in the Cervical Vertebrae Considering BMD
Official title: The Characteristics of Regional Bone Quality in the Cervical Vertebrae Considering BMD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cortical Bone Thickness
Lead sponsor: Gangneung Asan Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of Korea
First posted: 2016-12-16
Enrollment: 99
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months)

Brief summary: Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months) from April 2009 to December 2014. There were 52 females and 47 males. The mean age was 63.7 year (female: 63.4 years, male: 64.1; range 32-86 years). The patient was excluded who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass. Patients were divided into three groups according to femoral neck BMD (Group A, T-score ≥-1; Group B, -2.5\<T-score\<-1.0; Group C, T-score≤-2.5). Group A had normal BMD patients, Group B had lower normal patients including osteopenic patients and Group C presented osteoporotic patients. The mean HU numbers of cortical bone area in the vertebral canal (cHU, the medial wall of the lateral mass), the posterior wall of transverse foramen (fHU), the medial (mHU), lateral wall (lHU) and trabecular area of pedicle (pHU) were measured on the axial CT images in clinical images.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months)

Exclusion Criteria:

* Who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass.

Primary outcomes:
measure: Cortical bone Thickness
timeFrame: two weeks
measure: HU number
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gangneung
country: Korea, Republic of
facility: Moon-Kyu Kim
state: Kangwondo
Study officials:
References:
Clinical trial NCT01574898: Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations
Official title: Pilot Pharmacokinetic Study of Three New Nicotine Lozenge Formulations (V0474) Versus Two Reference Formulations (V0018 B mg and Niquitin® Fresh Mint, 4mg) After Single Oral Administration in Healthy Male Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Smokers
Keywords: Smoking cessation
Nicotine
Tobacco Use Disorder
Central Nervous System Agents
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (V0474) in comparison with two reference products. The clinical and biological safety of V0474 and the lozenge acceptability will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy male subject aged 18 to 45 years (inclusive)
* Current smoker of \< or = 10 cigarettes/day
* Fagerström score \< or = 5
* Absence of any clinically significant abnormal finding at physical, ECG, biological examinations in the Investigator's opinion

Exclusion Criteria:

* Presence of any significant medical finding or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer or oesophagitis) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
* Current or recurrent buccal lesions

Primary outcomes:
measure: Pharmacokinetic profile of nicotine following a single oral nicotine lozenge administration in healthy smokers
timeFrame: 12 time points up to 6h after oral administration
Secondary outcomes:
measure: Clinical safety (reported adverse events)
timeFrame: Screening up to Day 5
measure: Acceptability questionnaire
timeFrame: Up to complete lozenge dissolution, about 30 minutes (4 times)
Other outcomes:
Locations:
city: Gieres
country: France
facility: Eurofins Optimed
Study officials:
References:
Clinical trial NCT06562998: Pentoxifylline Role Against Chemotherapy-induced Neuropathy
Official title: Pentoxifylline Prophylactic Role Against Paclitaxel Chemotherapy-induced Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating side effect of neurotoxic cancer treatment. Estimated to occur in up to 80% of paclitaxel-treated patients with breast cancer, neuropathy symptoms can interfere with function, increasing the risk of falls and reducing quality of life. To date, there are no approved medications for the prevention and/or treatment of CIPN. The objective of the present study is to investigate the beneficial effects of pentoxifylline (PTX) against CIPN in breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients\> 18 years old.
* Female patients Breast cancer patients who received paclitaxel-based regimen for 12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance ≤ 2-Adequate bone marrow function.
* Adequate liver and kidney function.

Exclusion Criteria:

* Children less than 18 years old.
* Evidence of physical diseases or major surgery.
* Patientswith a history of chronic diseases including; renal, hepatic, gastrointestinal, respiratory, hematological, and metabolic or other diseases.
* Patients with preexisting clinical neuropathy.
* Patients with diabetes mellitus.
* Metastatic breast cancer.
* Patients receiving medications that ameliorate neuropathy like; antidepressants, anticonvulsants, opioids, adjuvant or topical analgesics.
* Patients treated with medications that increase the risk of neuropathy.
* Hypersensitivity to pentoxifylline or xanthine derivatives.
* Patients retinal bleeding or active peptic ulcer.
* Patients at high risk for bleeding or taking medications that increase risk of bleeding.

Primary outcomes:
measure: The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group Neurotoxicity(FACT-GOG-NTX) subscale
timeFrame: 12 weeks
Secondary outcomes:
measure: Common Terminology Criteria for Adverse Events Version 5 (CTCAE v5)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: University Hospital
state: Beni-Suef
Study officials:
References: