louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04289376: Quiet Eye Duration in Baseball
Official title: Quiet Eye Duration in Baseball
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gaze Tracking
Keywords: Sports
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There is no intervention or treatment in this study
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to measure the gaze movements of individuals as they watch videos of a baseball pitcher throwing pitches. The goal will be to determine whether there is an anticipatory movement to the location where the ball is released, and whether this anticipatory movement occurs in experienced baseball players more commonly than in inexperienced players.

Detailed description: 20 subjects between 18 and 40 years of age (males and females) will participate. 10 subjects will be required to have experience in baseball or softball at the high school level or above within the last 10 years. A further 10 subjects will be recruited who did not have baseball experience at or above the high school level. Upon entering the laboratory, the experiment will be explained to the subjects. Subjects will be consented. Then, the subject's visual acuity and stereoacuity (depth perception) will be measured.

If subjects continue on to the experiment, they will also be asked to complete a short survey on previous baseball experience.

Subjects will stand in a batting stance facing a projector screen. They will then participate in trials in which they mimic batting a ball thrown by a pitcher. Six different pitch videos will be shown. The subjects will act as if they are batting the ball (no bat swing will occur) for each video. The movement of the subject's eye will be tracked using an eye tracker.

Eligibility criteria: Inclusion Criteria:

* 20/20 visual acuity in each eye Stereoacuity of 40 arc seconds are better

Exclusion Criteria:

* 20/25 or worse visual acuity in either eye Stereoacuity less than 40 arc seconds

Primary outcomes:
measure: Quiet eye duration
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Nick F Fogt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01974076: Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT)
Official title: A Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behavioural Therapy (CBT) for Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Belmont Private Hospital
First posted: 2013-11-01
Enrollment: 135
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 will investigate whether transcranial direct current stimulation (tDCS) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression.


Eligibility criteria: Inclusion Criteria:

1. Participants will be ≥ 18 years old.
2. Have a DSM-IV diagnosis of Major Depressive Episode of minimum 4 weeks duration.
3. MADRS score ≥ 20 at study entry.

Exclusion Criteria:

1. Participant is unable to give informed consent.
2. DSM-IV diagnosis of psychotic disorder (lifetime).
3. Bipolar disorder diagnosis and not on a mood stabiliser.
4. Eating disorder (current or within past year).
5. Obsessive compulsive disorder (lifetime).
6. Post-traumatic stress disorder (current or within past year).
7. Mental retardation.
8. Drug or alcohol abuse or dependence (preceding 3 months).
9. Inadequate response to ECT (current episode of depression).
10. Rapid clinical response required, e.g., high suicide risk, inanition or psychosis.
11. Clinically defined neurological disorder or insult.
12. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
13. Pregnancy.
14. Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
15. Change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial.
16. Participant becomes hypomanic or manic, as defined by DSM-IV.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale for Depression (MADRS)
timeFrame: 3 weeks
Secondary outcomes:
measure: Depression and Anxiety Stress Scale
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Carina, Brisbane
country: Australia
facility: Belmont Private Hospital
state: Queensland
Study officials:
References:
Clinical trial NCT04961476: Use of 1-MNA to Improve Exercise Tolerance and Fatigue in Patients After COVID-19
Official title: Use of 1-MNA to Improve Exercise Tolerance and Fatigue in Patients After COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Fatigue Syndrome, Chronic
Keywords: Covid19
Chronic Fatigue Syndrome
1-MNA
1-Methylnicotinamide
post-COVID syndrome
Lead sponsor: Saint Family Hospital Medical Center
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients after COVID-19, expressing subjective feelings of limited tolerance to exercise and above 50% greater fatigue compared to their pre-COVID-19 levels. These symptoms must have continued for at least four weeks since the last symptoms of infection.

Brief summary: Coronavirus disease 2019 (COVID-19) is a serious respiratory disease that results from infection with a newly discovered coronavirus (SARS-COV-2). Unfortunately, COVID-19 is not only a short-term infection but that patients (pts) recovering from SARS-COV2 infection complain of persisting symptoms including: fatigue, diffuse myalgia and weakness, which may lead to chronic fatigue syndrome. There is currently no evidence that nutritional supplements and/or physical exercise can assist in the recovery of pts with chronic fatigue syndrome. 1-Methylnicotinamide (1-MNA) is an endogenic substance that is produced in the liver when nicotinic acid is metabolized. 1-MNA demonstrates anti-inflammatory and anti-thrombotic properties. Therefore, we investigated whether 1-MNA supplements could improve exercise tolerance and decrease fatigue among patients recovering from SARS-COV-2.

Detailed description: The study population was composed of pts after COVID-19, expressing subjective feelings of limited tolerance to exercise. The selected pts were randomized into two groups: GrM0 - without supplementation; GrM1 - with 1-MNA supplementation. At the beginning of the study (Phase 0), in both groups, a 6-minute walk test (6MWT) was carried out and fatigue assessment with Fatigue Severity Scale (FSS) was performed. After 1 month (Phase 1), a fol-low up FSS and 6MWT once more were performed in both groups.

Eligibility criteria: Inclusion Criteria:

* Patients after COVID-19
* Patients expressing subjective feelings of limited tolerance to exercise and above 50% greater fatigue compared to their pre-COVID-19 levels (symptoms must have continued for at least four weeks since the last symptoms of infection)

Exclusion Criteria:

* Patients with cardiological complications
* Patients with pulmonological complications
* Patients with Chronic Obstructive Pulmonary Disease and/or asthma

Primary outcomes:
measure: 6MWT
timeFrame: 1 Month
measure: FSS
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Medical Center, Saint Family Hospital
Study officials:
References:
Clinical trial NCT06995976: Dosimetry and Preliminary Clinical Application Study of a Novel Probe Targeting CD73
Official title: Dosimetry and Preliminary Clinical Application Study of a Novel Probe Targeting CD73
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Malignant Tumour
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-dPNE in human volunteers. Furthermover, we conducted a comparative analysis of 68Ga-dPNE and 18F-FDG imaging to assess both the radiation dosimetry and diagnostic efficacy of 68Ga-dPNE.

Detailed description: The boom in radiopharmaceuticals continues to persist, including their driving effects in the field of immunotherapy. CD73 (ecto-5'-nucleotidase), a key purine metabolic enzyme, catalyzes the conversion of extracellular nucleotides to adenosine, promoting tumor immune evasion and unfavorable clinical outcomes. Notably, CD73 is highly expressed in 74.3% of breast cancer cases, with its prevalence exceeding 45% in liver, gastric, colorectal, and ovarian cancers. As a new CD73-targeted PET radiotracer, 68Ga-dPNE, is promising as an excellent imaging agent applicable to various cancers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-dPNE, and performed a head-to-head comparison with 18F-FDG PET/CT scans in patients with various cancers.

Eligibility criteria: Inclusion Criteria:

Signed informed consent and be able to follow up.

Exclusion Criteria:

Pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.

Primary outcomes:
measure: SUV of tumors
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Diagnostic value
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Weibing Miao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04016376: Study of Nerve Block Pain Management in Patients Undergoing a Double Mastectomy With Immediate Reconstruction
Official title: Cluster-Randomized, Prospective Assessment of Postoperative Pain Management in Patients Undergoing Bilateral Mastectomy With Immediate Reconstruction With Tissue Expander (BMWRw/TE) Using Preoperative Paravertebral (PVB), Serratus+PECS-1, or PVB+PECS-1 Nerve Blocks
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Breast Cancer
Breast Cancer Female
Keywords: Mastectomy
Double Mastectomy
Mastectomy with reconstruction
Double mastectomy with reconstruction
Double mastectomy with immediate reconstruction
Mastectomy with immediate reconstruction
Memorial Sloan Kettering Cancer Center
19-238
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-07-11
Enrollment: 1507
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to 1 of 3 groups (approximately n=500 patients per group) of standard of care preoperative nerve blocks consisting of either: i) PVB, ii) serratus+PECS-1, or iii) PVB+PECS-1. Each group will receive ropivacaine or bupivacaine +/- clonidine (0.5 - 1 mcg/kg not to exceed a total of 100 mcg) +/- dexamethasone (up to 4 mg) in one of three routine nerve block approaches prior to surgical procedure as is current standard of care.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the injection site or sites used for administering pain medication (nerve blocks) before a double mastectomy with immediate reconstruction with tissue expanders reduce the need for pain medication after surgery.


Eligibility criteria: Inclusion Criteria:

* Female patients \>/= 18 years old
* Undergoing Bilateral Mastectomy with immediate reconstruction (BMw/IR)
* Scheduled for surgery at Josie Robertson Surgical Center (JRSC)
* Must be appropriate for an agree to receive a nerve block
* Must be appropriate for randomization
* Able to read and speak English
* Willing and able to provide written informed consent

Exclusion Criteria:

* None applicable, as exclusion occurs prior to consent

Primary outcomes:
measure: Compare preoperative nerve blocks between a combination of nerve blocks and PVB alone to decrease postoperative opioid consumption
timeFrame: 30 days from study treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Hanae Tokita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06386276: Surgical TReatment of Women With Deep ENDometriosis
Official title: Surgical TReatment of Women With Deep ENDometriosis Infiltrating the Sigmoid Colon and/or the Rectum. A Monocentric Archive
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Deep Endometriosis
Surgery
Lead sponsor: Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A.
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing segmental sigmoid colon/rectal resection for deep endometriotic nodules infiltrating the tunica muscularis of the sigmoid colon/rectum preoperatively identified with imaging and surgically treated with segmental resection

Brief summary: TrEnd trial is aimed to collect data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis. The main purpose of this project is to gather a large series of cases treated using standardized surgical procedures, allowing a precise evaluation of complications and long-term outcomes.


Eligibility criteria: Inclusion Criteria:

* age \>/= 18 years;
* presence of deep endometriotic nodule(s) infiltrating the tunica muscularis of the sigmoid colon/rectum.

Exclusion Criteria:

* age \<18 years:
* presence of coexisting inflammatory bowel disease;
* patients who have received previous pelvic radiotherapy.

Primary outcomes:
measure: To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection
timeFrame: 10 years
measure: To assess the rate of complications
timeFrame: 10 years
measure: To assess the rate of conversion to open surgery
timeFrame: 10 years
measure: To assess the rate of endometriosis-free bowel resection margins
timeFrame: 10 years
measure: To assess the rate of recurrence
timeFrame: 10 years
Secondary outcomes:
measure: To assess the intraoperative blood loss
timeFrame: 10 years
measure: To assess the operating time
timeFrame: 10 years
measure: To assess the gastrointestinal function recovery
timeFrame: 10 years
measure: To assess the duration of hospital stay
timeFrame: 10 years
measure: To assess the reproductive outcomes
timeFrame: 10 years
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: Casa Di Cura Malzoni Villa Platani Spa
state: Campania
Study officials:
affiliation: malzonimario@gmail.com
name: Mario Malzoni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: francescafalcone@malzoni.org
name: Francesca Falcone, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05244876: Effect of Back School-based Intervention on Non-specific Neck Pain in Adults.
Official title: Effect of Back School-based Intervention on Non-specific Neck Pain in Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Exercise Therapy
Health Education
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 60
Sex: ALL
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: The study consists of a theoretical and practical intervention based on the Back School. This intervention will be carried out over 8 weeks with a frequency of two sessions per week, for a total of 16 sessions of 45 minutes duration. Of all the sessions, 14 had a practical focus (strength and stretching exercises) and the other two had a theoretical focus (self-management techniques and pain neuroscience education). In addition, they had an initial session and a session at the end of the of the intervention in which measurements of the different variables were taken (The Visual Analogue Scale; Neck Disability Index; Tampa Scale Of kinesiophobia).These variables will be measured on two occasions, at the beginning of the study and at the end of the intervention, an average of 2 months.

The clinical practice guidelines highlight the importance of neck pain prevention through exercise an education. There are previous studies of the effects of theoretical and practical programmes based on back school on the lumbar region but not on the cervical region. Therefore, the aim of this study is to investigate the effects of a BS-based intervention on neck pain and functionality as well as kinesiophobia and quality of life in adults. The hypothesis previously hypothesised that this BS-based intervention would have positive effects on pain, functionality, kinesiophobia and quality of life.


Eligibility criteria: Inclusion Criteria:

* 18-65 years of age.
* With non-specific neck pain for at least three months, with pain intensity (30-70 on a VAS).

Exclusion Criteria:

* Any previous neck or shoulder surgery, fibromyalgia, cervical radiculopathy/myelopathy, history of the whiplash injury, cognitive disorder.
* Missing more than two Back School sessions.
* Not being able to attend the measurement sessions.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Through study completion, an average of 2 months.
measure: Neck Disability Index
timeFrame: Through study completion, an average of 2 months.
measure: Short-Form Health Survey-36
timeFrame: Through study completion, an average of 2 months.
measure: Tampa Scale Of Kinesiophobia.
timeFrame: Through study completion, an average of 2 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Pontevedra
country: Spain
facility: Pablo Hernández Lucas
Study officials:
References:
Clinical trial NCT06761976: Expanded Access to Provide BAY2927088 for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation
Official title: Single Patient Expanded Access Use of BAY2927088 for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Advanced Non-small Cell Lung Cancer
Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-01-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this Expanded Access Program (EAP) is to allow patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human epidermal growth factor receptor 2 (HER2) gene, which have no other therapeutic option, to receive BAY2927088.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03977376: Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
Official title: Effectiveness of a Prequirurgic Instrument to Decrease Anxiety in Urogical Quirurgic Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Nurse-Patient Relations
Behavior
Keywords: anxiety
Urogical
Guide of Hosting
Comunication instrument
Patients
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overall aim of this program of research is to decrease anxiety in urogical scheduled patients for surgical intervention developing an nursing comunication instrument: a Guide of Hosting for urogical scheduled patients for surgical intervention.

Detailed description: The overall aim of this program of research is to decrease anxiety in urogical scheduled patients for surgical intervention developing an nursing communication instrument: a Guide of Hosting for urological scheduled patients for surgical intervention.

The purpose of the proposed project is to establish the feasibility and acceptability of this guide to decrease the anxiety in this patients, using a randomized clinical trial like a research design, which would test the effectiveness of this communication instrument in comparation to a control condition (patients without guide of housting).

To achieve the investigators specific aims, the investigator conducted a randomized clinical trial (n=50), with two groups: intervention group (with Guide of Hosting) and control group (which shows a control condition).

Valuation instruments were two validated scales: ESAS y HADS. Anxiety was the primary outcome variable assessed in the RCT; depression and pain were a secondary outcomes variables.

Eligibility criteria: Inclusion Criteria:

* Age limits: 18 years old.
* with hospital admission scheduled at 5ªA hospitalization service of the University Hospital of Guadalajara for surgical intervention with urological diagnosis

Exclusion Criteria:

* patients with cognitive deficit.
* patients with recurrent insomnia problems
* without Spanish language proficiency
* patients that have participated in a clinical trial in the last three months.

Primary outcomes:
measure: Anxiety: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 4-5 months
measure: Anxiety: Edmonton Symptom Assessment System (ESAS)
timeFrame: 4-5 months
Secondary outcomes:
measure: Pain: Edmonton Symptom Assessment System (ESAS)
timeFrame: 4-5 months
Other outcomes:
Locations:
city: Guadalajara
country: Spain
facility: EPECA
Study officials:
affiliation: Máster Universitario en Investigación en Ciencias Sociosanitarias - UAH
name: Carmen Gracia Ruiz Garcia
role: PRINCIPAL_INVESTIGATOR
References: