louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05957744: Nutritional Risk Factors and Colorectal Surgery
Official title: Nutritional Risk Factors in Patients With Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Nutrition Related Cancer
Lead sponsor: University Clinic Dr Dragisa Misovic-Dedinje
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 120
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: PROBABILITY_SAMPLE
Study population: Patients with operable carcinoma of the colon or rectum

Brief summary: This observational study aims to learn about the relationship between the nutritional status of patients with colorectal cancer and clinical outcome after colorectal surgery.

The main question\[s\] it aims to answer are:

* which anthropometric, laboratory and specific parameters best define that patient is at nutritional risk
* will patients that are at nutritional risk stay longer in the hospital after surgery than those who are not at nutritional risk Patients will be preoperatively examined anthropometrically, radiologically and laboratoryally. Postoperatively, the course of their treatment will be monitored, as well as the monitoring of postoperative complications. A group of patients with and without malnutrition will be compared.


Eligibility criteria: Inclusion Criteria:

* Colorectal cancer
* First operation of this type

Exclusion Criteria:

* Urgent surgery
* Peritoneal carcinomatosis

Primary outcomes:
measure: Length of stay
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"
Study officials:
References:
Clinical trial NCT02878044: Shared Decision Making in Patients With Thyroid Nodules
Official title: Shared Decision Making in Patients With Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Nodule
Thyroid Cancer
Keywords: Shared Decision Making, Decision Aid
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this project is to evaluate a treatment decision aid for patients with low risk thyroid cancer.


Eligibility criteria: Inclusion Criteria:

-Clinical diagnosis of low risk thyroid cancer

Exclusion Criteria:

-Does not have the cognitive capacity to provide consent

Primary outcomes:
measure: Distribution of treatment choices between patients receiving usual care versus decision aid
timeFrame: Up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Juan P Brito Campana, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05874544: Rescue Therapy for Helicobacter Pylori Infection
Official title: Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
rescue therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.


Eligibility criteria: Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Confirmed H. pylori infection and with previous treatment experience

Exclusion Criteria:

* subjects naive to H. pylori treatment,
* under 18 or over 80 years old
* history of gastrectomy
* pregnant or lactating women
* Previous history of tuberculosis
* Allergy to any of the study drugs
* severe systemic diseases or malignancy
* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Within 7 days after completion of therapy
measure: Compliance rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Songjiang District Central Hospital
state: Shanghai
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University school of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT06961344: An Open-label Extension Safety Study of MELAS Patients Who Completed TIS6463-203 (PRIZM)
Official title: An Open-label Extension Study Evaluating the Safety of Zagociguat in Participants With MELAS Who Completed TIS6463-203
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)
Keywords: MELAS
Lead sponsor: Tisento Therapeutics
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An open-label, single-group assignment extension study.

Eligible patients will be entered into a single treatment sequence. The treatment period will last for the shortest of the following: 104 weeks; regulatory approval and commercial availability of zagociguat in the participant's respective country; or termination of the clinical development of zagociguat in MELAS
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the long-term safety and tolerability of zagociguat in patients with MELAS who completed the lead-in study TIS6463-203. TIS6463-204 is evaluating zagociguat in an open-label extension study at the daily dose of 15mg. The study medication is a once daily oral table and will be provided at the clinic and/or shipped to the participant's home. Study assessments will be conducted during clinic visits which will occur at three months and then at six months. Thereafter, clinic visits will occur every six months.

Detailed description: On Screening Visit Day -1 (which corresponds to Period 2 Week 12 Visit from lead-in study TIS6463-203), participants will sign the informed consent form, be confirmed eligible for this open-label extension study and undergo Screening Visit assessments. Eligible participants will begin dosing the next day on Day 1 (there is no Day 0) at home. Participants will have a 3-month visit and 6-month study visit at the clinic and thereafter will have a clinic visit every 6 months. Participants should have a Follow-up Visit 4 (+1) weeks after zagociguat discontinuation.

Eligibility criteria: Inclusion Criteria:

1. Signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form (ICF).
2. Completed TIS6463-203 treatment through the Period 2 Week 12 Visit.
3. Agrees to follow lifestyle restrictions.
4. Other criteria per the protocol.

Exclusion Criteria:

1. Any medical condition or clinical finding that, per investigator judgement, would preclude safe study participation and/or completion of all trial requirements.

Primary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 through the Follow-up for treatment period 4 weeks after last dose of study medication.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06859944: Prospective Randomized Non-Inferiority Study Comparing Natural Cycle Frozen Embryo Transfer (NC-FET) to a New Type of Endometrial Preparation for FET: Natural Proliferative Phase (NPP-FET)
Official title: Prospective Randomized Non-Inferiority Study Comparing Natural Cycle Frozen Embryo Transfer (NC-FET) to a New Type of Endometrial Preparation for FET: Natural Proliferative Phase (NPP-FET)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Comparison of Pregnancy Rate (HCG+ Level) Obtained After a Replacement Embryonic in Spontaneous Cycle and Following Protocol "NPP". Comparison
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 272
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with regular cycles, candidates for replacement of embryos frozen in spontaneous cycle

Brief summary: Frozen embryo replacement cycle :Two methods traditionally used: the spontaneous cycle and the artificial cycle.Now, Emergence of new protocols: NPP-FET or "Natural proliferative phase - frozen embryo transfer" Demonstrate non-inferiority between the NPP-FET and the spontaneous cycle, and superiority in terms of planning.

Detailed description: The protocol Natural proliferative phase/Natural Programmed by Progesterone, Patients with regular cycles, candidates for replacement of embryos frozen in a spontaneous cycle. The monitoring of the cycle is carried out by taking blood and follicular ultrasound between the 10th and 13th day of the cycle. Support luteal phase by intravaginal progesterone (utrogestan 200 mg) 1 tablet, 2 times per day, is initiated once the following criteria are met:

* Thickness of the endometrium \> 7 mm on ultrasound
* Ovarian follicle \> 14 mm
* Estradiol( E2) \> 120 pg/mL Embryo transfer is scheduled on the 6th day of progesterone exposure exogenous. A progesterone dosage on the day of transfer will be systematically realized

Eligibility criteria: Inclusion Criteria:

* Single transfer Blastocyste

Exclusion Criteria:

* PGT (Preimplantation genetic diagnosis)
* Testicular Sperm
* Donor oocytes

Primary outcomes:
measure: Comparison of the pregnancy rate (Human chorionic gonadotropin hormone) (HCG+ level) obtained after spontaneous embryo replacement and following the "NPP" protocol.
timeFrame: Thrugh study completion (9 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hopital Erasme
Study officials:
References:
Clinical trial NCT03201692: Improving Dynamic Balance and Gait Adaptability Using Treadmill Training
Official title: Improving Dynamic Balance and Gait Adaptability Using Treadmill Training With Visual Cues in Subjects With Neurological Disorders: Design of a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Stroke
Parkinson Disease
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Balance and gait problems in subjects with neurological disease lead to reduced mobility, loss of independence and frequent falls. Treadmill training is a widely used form of treatment and it has been used in subjects with neurological disease to ameliorate walking and balance deficits. The Virtual Reality Treadmill as a therapeutic tool has been recently introduced to practice gait adaptability elicited by aligning foot placement relative to the projected visual context.

Forty-eight subjects with neurological disease will receive treadmill training treatment randomly divided in Traditional Treadmill training and Virtual Reality Treadmill training.

The aim of this randomized controlled study is to assess whether Treadmill training with Virtual Reality is better than Traditional Treadmill training in improving dynamic balance and cognitive aspects in subjects with neurological diseases.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Multiple Sclerosis (no relapse within the previous three months;), Parkinsons Disease (Hoenhn and Yahr Scale ≤4), Stroke (Time from onset \>2 months)
* Able to walk 20 meters with or without assistive device
* Cognitive impairment (MMSE score ≥ 21)

Exclusion Criteria:

* Unable to understand the aim of the study and unable to sign the informed consent
* Steroidal drugs therapy for subjects with Multiple Sclerosis
* Subjects with Psychiatric disorders
* Subjects with Visual impairments
* Subjects with cardiovascular disease

Primary outcomes:
measure: Change in the Modified Dynamic Gait Index
timeFrame: Change from Baseline Modified Dynamic Gait Index scores at 3-5 weeks
measure: Change in the 6 minutes walking test
timeFrame: Change from Baseline 6 minutes walking test scores at 3-5 weeks
Secondary outcomes:
measure: Change in Activity Balance Confidence
timeFrame: Change from Baseline Activity Balance Confidence scores at 3-5 weeks
measure: Change in 10-meter walking test
timeFrame: Change from Baseline10-meter walking test scores at 3-5 weeks
measure: Change in Trial Making test
timeFrame: Change from Baseline Trial Making test scores at 3-5 weeks
measure: Change in Raven's Matrices
timeFrame: Change from Baseline Raven's Matrices scores at 3-5 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Don Gnocchi Foundation
Study officials:
References:
Clinical trial NCT00506792: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis
Official title: A Two-part, Randomized, Double-blind, Placebo-controlled, Ascending Single-dose, Adaptive Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAU145 Administered Via a Nasal Spray Pump to Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis, QAU145, nasal potential difference
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the safety, tolerability, pharmacokinetic, and pharmacodynamic response of patients with cystic fibrosis to administration of QAU145 via intranasal spray.


Eligibility criteria: Inclusion Criteria:

* Male and female (women must be post-menopausal or surgically sterile) subjects with cystic fibrosis ages 18 to 50.

Exclusion Criteria:

* Any presence of seasonal or non-seasonal allergies affecting the nose, nasal passages, throat or sinuses within 2 weeks prior to dosing.
* Any upper respiratory tract infection or signs or symptoms within 2 weeks prior to dosing.
* Any presence of nasal polyps or structural abnormalities, frequent history of nose bleeding, or any recent nasal surgery (within 12 weeks prior to dosing).

Primary outcomes:
measure: Pharmacodynamic response to single intranasal doses of QAU145 in cystic fibrosis patients using nasal potential difference measurements up to 6 hours post-dose.
timeFrame: Part I: Baseline, 2 hr post dose, after each dose, end of Part I. Part II: Pre dose and 2 hours post each dose
Secondary outcomes:
measure: Safety and tolerability of single ascending doses assessed by nasal examinations, adverse events, medications, and a nasal symptom questionnaire. Pharmacokinetics up to 6 hours post-dose
timeFrame: Part I: Throughout study (about 8 weeks) Part II: Throughout study (about 9 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Investigative site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rowe SM, Reeves G, Hathorne H, Solomon GM, Abbi S, Renard D, Lock R, Zhou P, Danahay H, Clancy JP, Waltz DA. Reduced sodium transport with nasal administration of the prostasin inhibitor camostat in subjects with cystic fibrosis. Chest. 2013 Jul;144(1):200-207. doi: 10.1378/chest.12-2431.
Clinical trial NCT02019992: Investigation of Plasma Mitochondrial DNA Level in Septic Patients
Official title: Plasma Levels of Mitochondrial DNA in Patients Presenting to ICU With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Inflammation
Keywords: sepsis
mitochondrial DNA
systemic inflammation
outcome
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sepsis and severe septic patients enrolled in 2014 will be collected.

Brief summary: To determine the plasma levels of mtDNA in ICU department patients with and without sepsis and evaluate their association with severity, systemic inflammation and outcomes. Plasma from control, septic and severe septic patients will be collected. The level of mtDNA and systemic cytokine will be measured.

Detailed description: Clinical protocol:

Patients were enrolled into one of three cohorts: (i) sepsis defined as suspected infection and systemic inflammatory response, (ii) septic shock defined as sepsis plus hypotension, and (iii) control defined as non-infected patients without systemic inflammatory response.

Methods:

Plasma levels of mtDNAs were measured using real-time quantitative polymerase chain reaction. Levels of mtDNAs were compared among each group, and linear regression was used to assess the association between mtDNAs, IL-6, TNF a and IL-1b in patients with sepsis. The correlation between plasma mtDNA and severity, systemic inflammation and outcomes will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of sepsis and severe sepsis was according to the following guild-line. "Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2012"

Exclusion Criteria:

* Patients lost following-up. Patients who refuse to sign the consent form.

Primary outcomes:
measure: change from baseline in plasma mtDNA in septic patients at 7 days
timeFrame: 7 days
Secondary outcomes:
measure: change from baseline in plasma IL-6, TNF a and IL-1b level in septic patients at 7 days
timeFrame: 7 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
Study officials:
affiliation: Central South University
name: lemeng zhang, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04073992: Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment
Official title: Chronic Insomnia and CSF Markers of Dementia - Effects of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 9
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. However, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. Longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years. The purpose of this study is to examine whether treatment of insomnia with cognitive behavioral therapy (CBT-I) is associated with a decrease in dementia biomarkers found in cerebrospinal fluid (CSF). Fifteen adults age 30-50 with chronic insomnia will undergo overnight polysomnography and CSF sampling in the morning. This will be followed by 8 weeks of treatment with CBT-I and then repeat CSF sampling.


Eligibility criteria: Inclusion Criteria:

* Age 30-50
* Men and women
* Meet DSM5 Diagnostic Criteria for insomnia disorder

Exclusion Criteria:

* Diagnosis or evidence of sleep disorders other than insomnia as determined by the screening questionnaires and clinical history
* Women who have been pregnant or lactating within the past six months
* Non-fluency in spoken or written English
* Current or past month shiftwork defined as working during the evening or night shift
* Current use of medications or OTC products that impact sleep
* Evidence of neurological abnormalities that could include the risks associated with lumbar puncture (e.g.papilledema, mass lesion, Chiari malformation).

Primary outcomes:
measure: CSF markers related to dementia
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Philip Gehrman, PhD
role: PRINCIPAL_INVESTIGATOR
References: