louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00498511: Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia
Official title: Prospective Evaluation of the Gastrointestinal Tract in Young Men With Iron Deficiency Anemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia, Iron-Deficiency
Keywords: Anemia, Iron-Deficiency
Endoscopy, Gastrointestinal
Male, aged 18 to 40
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-07-10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Both upper gastrointestinal endoscopy and colonoscopy are recommended in men and post-menopausal women with iron deficiency anemia. Due to lack of data on the yield of these endoscopies in young men, they are currently investigated as older men. The aim of this study is to evaluate prospectively the prevalence of various gastrointestinal lesions in young men with iron deficiency anemia. Our hypothesis is that the diagnostic yield of colonoscopy in young anemic men without gastrointestinal symptoms is very low, especially if a potential lesion is detected during upper gastrointestinal endoscopy. Therefore, this study will try to identify predicting factors regarding the yield of both endoscopies. Another purpose is to evaluate the outcome of patients with negative endoscopic results, during a follow-up of two years.


Eligibility criteria: Inclusion Criteria:

* Men \< 40 years old of age with iron deficiency.
* hemoglobin level less than 13 gr/dl documented during the 2 years prior to entering the study with one of the following: 1) iron level less than 45 μg /dl and transferrin saturation less than 10%; 2) ferritin level less than 20 μg/L (both documented during the 4 months prior to entering the study).

Exclusion Criteria:

* Previously diagnosed disease that explain iron deficiency anemia
* Colonoscopy performed during the last 4 years
* Upper gastrointestinal endoscopy performed during the last 2 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Institute of Gastroenterology and Liver Diseases, Assaf harofeh Medical Center
Study officials:
affiliation: Institute of Gastroenterology and Liver Diseases, Assaf-Harofeh Medical Center, 70300 Zerifin, Israel
name: Alain Nimrod Kimchi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04705311: The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair
Official title: The Effect of Pain Neuroscience Education on Patients With Arthroscopic Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Kinesiophobia
Pain, Postoperative
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2021-01-12
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During the rehabilitation process after rotator cuff repair surgery, patients suffer from increased pain and discomfort due to dysfunction. Pain neuroscience education, a more modern educational method, has been reported to be effective in controlling pain by reducing the fear of movement based on an understanding of neurophysiology.


Eligibility criteria: Inclusion Criteria:

* Adults over 18 years old
* In case of 4 weeks after receiving arthroscopic rotator cuff repair
* If you wish to participate in research

Exclusion Criteria:

* 65 years old or older
* Those who are limited in conducting education remotely
* If the tear area is large and augmentation is performed
* If there is a previous surgical history at the surgical site
* Osteoarthritis in the shoulder joint
* If you cannot understand the guidelines for evaluation or intervention
* Mental health and cognitive problems

Primary outcomes:
measure: Pain intensity
timeFrame: Change in pain intensity from baseline to weeks 2, 4, and 6
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: The Better Hospital
Study officials:
References:
Clinical trial NCT01279993: Orthoptic Changes Following Photorefractive Keratectomy
Official title: Orthoptic Changes Following Photorefractive Keratectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Orthoptic Changes
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: To detect orthoptic changes in patients undergoing photorefractive keratectomy (PRK). Method: This interventional case series was performed on 297 eyes of 150 patients who were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations were performed before and 3 months after PRK. Results: Before PRK, two (1.3%) patients had esotropia that remained unchanged postoperatively. However, 3 (2%) patients had distance exotropia preoperatively which improved after PRK. Of 12 cases (8%) with preoperative exotropia at near, 3 (2%) cases became orthophoric. Six patients (4%) developed postoperative near exotropia. A significant reduction in means of convergence and divergence amplitudes (P\<0.001) and a meaningful increase in mean of near point of convergence (NPC) (P\<0.006) were noticed after PRK. A reduction of ≥10 PD in convergence amplitude and ≥5 PD in divergence amplitude were detected in 10 and 5 patients, respectively. Four patients had an preoperative NPC\>10 cm which was not changed by the surgery. Out of 9 (6%) patients with baseline stereopsis \>60 seconds of arc, 2 (1.33%) cases showed an improvement in stereopsis following PRK. None of the patients complained of postoperative diplopia. Conclusion: Eye deviation in patients undergoing PRK may improve or remain unchanged after operation and postoperative deviations can develop following this surgery. Diminishing of fusional amplitude and increasing of NPC as well as improving of stereopsis may also happen after PRK. Therefore, a preoperative orthoptic examination in patients with any concerning histories and/or motility issues on routine exam is recommended before performing PRK.


Eligibility criteria: Inclusion Criteria:

\>18 yrs / refractive errors / with consent

Exclusion Criteria:

\< 18 / corneal opacity - keratoconus

Dry eye / diabetes / collages vacuolar disease

Primary outcomes:
measure: orthoptic changes
timeFrame: before and after KRS
Secondary outcomes:
measure: VA , Streopsis , deviation , fusion , NPC
timeFrame: before and after KRS
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad medical center
Study officials:
affiliation: Imam Hossein Medical Center
name: zhaleh rajavi, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06109493: Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease
Official title: Effects of an ACT-based Psychological Treatment in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Depression
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
Collaborators: name: Fundación Renal Iñigo Alvarez De Toledo
name: Centro de Enseñanza Superior Cardenal Cisneros
First posted: 2023-10-31
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization assigned participants to 2 arms:

* ACT group
* Waiting list
Primary purpose: TREATMENT

Brief summary: Investigation of the efficacy of Acceptance and Commitment Therapy (ACT) for the psychological treatment of patients with chronic kidney disease.

Detailed description: After being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry.

The clinical trial will include a control group (waiting list).

Patients who meet eligibility requirements will be assigned to control group or intervention group.

Psychological intervention will consist in an 8-session individual face-to-face delivered ACT-based treatment.

The participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic kidney disease on haemodialysis
* Older than 18 years-old
* At least 3 months on haemodialysis
* HADS Global Scale Score ≥14

Exclusion Criteria:

* Diagnosis of severe or chronic mental disorder, mental retardation and cognitive impairment, or disabling illness.
* Antidepressant drugs consume
* Insufficient understanding of Spanish.
* Patients who are in the Advanced Chronic Kidney Disease Unit
* Receiving other psychological treatment

Primary outcomes:
measure: Change in emotional distress assessed through Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline Emotional Distress at 5 months
Secondary outcomes:
measure: Change in Simplified Medication Adherence Questionnaire (SMAQ)
timeFrame: Change from Baseline Adherence at 5 months
measure: Change in COOP/WONCA questionnaire
timeFrame: Change from Baseline health related Quality of Life at 5 months
measure: Change in Acceptance and Action Questionnaire in the context of Haemodialysis (CAAH-II)
timeFrame: Change from Baseline psychological inflexibility at 5 months
measure: Change in coping skills assessed through coping strategies inventory -short form (CSI-SF)
timeFrame: Change from Baseline coping strategies at 5 months
measure: Change in mood assessed through Daylio App
timeFrame: Change from Baseline mood at 5 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundación Renal Iñigo Alvarez de Toledo
Study officials:
affiliation: Universidad Europea de Madrid
name: Francisco Montesinos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06712693: Venting Effects on Speech Performance
Official title: Venting Effects on Speech Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2024-12-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will be fit with the investigational devices under three conditions: Power dome, Vented dome, and Open dome. Participant will complete the same tests under each condition. All participants will complete the same conditions.
Primary purpose: TREATMENT

Brief summary: This study aims to gather behavioral data on the effect of earmold venting on speech performance in noise with a new noise reduction feature.


Eligibility criteria: Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:

* 18-85 years of age
* Experienced hearing aid users
* N3-N4 hearing loss
* Fluent in English; ability to read and write in English
* Able to complete complex tasks
* Willing and able to provide informed consent
* Available for the data collection period

The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:

* Self-reported active ear-related pathology (otorrhea, dizziness, sudden hearing loss or worsening of hearing, otalgia)
* Visible deformity of the ear
* Chronic, severe tinnitus
* Unilateral hearing loss
* Cognitive impairment

Primary outcomes:
measure: AZ Bio Sentences
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Phonak Audiology Research Center
state: Illinois
Study officials:
References:
Clinical trial NCT02867293: Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.
Official title: Impact Of Timing Of Drainage Of Massive Ascites On Operative And Post-Operative Course In Living-Donor Liver Transplant Recipients. A Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Massive Ascites
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Massive ascites is usually controlled over several weeks pre-operatively in liver transplant recipients with the risk of encephalopathy and peritonitis. We hypothesized that intra-operative drainage of ascites will be safe and avoids the inherent risks of pre-operative drainage.


Eligibility criteria: Inclusion Criteria:

* liver transplant candidates with tense acsites

Exclusion Criteria:

* severe coagulpathy (INR more than 2 or platlet count less than 50) MELD more than 20

Primary outcomes:
measure: graft survival
timeFrame: one year
Secondary outcomes:
measure: patient survival
timeFrame: one year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahleya
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dkahleya
Study officials:
References:
Clinical trial NCT02577393: Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Neoplasms
Esophagitis
Prevention & Control
Epigallocatechin Gallate
Keywords: Lung Neoplasms
esophagitis
Prevention & Control
Epigallocatechin Gallate
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 83
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: The investigators conducted this phase II study of EGCG therapy protection of the esophagus from damage induced by radiotherapy. In order to observe the effectiveness of EGCG, esophageal toxicity was recorded weekly using a grading scale based on symptomatology, following the Radiation Therapy Oncology Group (RTOG) scoring system. Patient-reported pain related to esophagitis was measured using the numerical rating scale (NRS) every week from EGCG application to 2 weeks after the end of radiotherapy. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.


Eligibility criteria: Inclusion Criteria:

* pathologically documented LC
* considered medically inoperable stage IIIA or stage IIIB or limited stage small cell lung cancer
* age ≥18 years
* Karnofsky ≥70
* adequate hematologic, hepatic and renal function
* FEV1 \> 800 cc
* mean esophagus dose \>20 Gy

Exclusion criteria were as follows:

* a known allergy or hypersensitivity to EGCG
* pregnancy or lactation
* prior radiation to the thorax

Primary outcomes:
measure: Superiority of EGCG in reducing Grade II esophagitis as assessed by RTOG scores in patients with lung cancer receiving radiation
timeFrame: Each patient will be enrolled for a 8-9 week trial
Secondary outcomes:
measure: Superiority of EGCG in decreasing the serum Inflammatory factors in patients with lung cancer receiving radiation
timeFrame: Each patient will be enrolled for a 8-9 week trial
measure: Improved quality of life with usage of EGCG for treatment of radiation-esophagitis in patient with lung cancer.
timeFrame: Each patient will be enrolled for a 8-9 week trial
Other outcomes:
Locations:
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Ligang Xing, MD,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06451393: Predicting Gastric Cancer Response to Chemo With Multimodal AI Model
Official title: A Radio-Pathomic Multimodal Machine Learning Model for Predicting Pathological Complete Response to Neoadjuvant Chemotherapy in Advanced Gastric Cancer: A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Chemotherapy Effect
Keywords: Advanced gastric cancer
Neoadjuvant chemotherapy
Multimodal
Pathological complete response
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received neoadjuvant chemotherapy and radical gastrectomy;

Brief summary: This study aims to develop a multimodal model combining radiomic and pathomic features to predict pathological complete response (pCR) in advanced gastric cancer patients undergoing neoadjuvant chemotherapy (NAC). The researchers intended to collected pre-intervention CT images and pathological slides from patients, extract radiomic and pathomic features, and build a prediction model using machine learning algorithms. The model will be validated using a separate cohort of patients. This research intend to build a radiomic-pathomic model that can outperform models based on either radiomic or pathomic features alone, aiming to improve the prediction of pCR in gastric cancer.


Eligibility criteria: Inclusion Criteria:

* patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received NAC and radical gastrectomy;
* patients who underwent abdominal multidetector computed tomography (CT) inspection, gastroscope, and tumor tissue biopsy before any intervention started;
* Lesions that are assessable according to The Response Evaluation Criteria in Solid Tumors Version 1.1

Exclusion Criteria:

* Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection;
* patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling;
* patients with insufficient data.

Primary outcomes:
measure: Pathological Complete Response
timeFrame: Assessed within 30 days after radical resection surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Junsheng Peng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06299293: Facial Emotion Recognition in Anorexia Nervosa
Official title: Facial Emotion Recognition in Anorexia Nervosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Keywords: Facial emotion recognition
Fear
Anger
Redundant target effect
Alexithymia
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with anorexia nervosa will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy). Controls will be recruited out of the hospital.

Brief summary: Altered emotional processing is reported in Anorexia Nervosa. However, this capability is generally measured through explicit measures, like self-report questionnaires and facial emotion recognition tasks. Instead, no previous research has investigated implicit emotional processing in this clinical condition. In the implicit facial emotion recognition task grounded on the implicit "redundant target effect", individuals generally respond faster when two identical targets are presented simultaneously rather than when presented alone; moreover, the competitive presence of a distractor (that is another emotion or a neutral expression) affects the correct recognition of the target. The ability to recognize and detect facial expressions is explored about two main emotions, fear and anger, because of their role in the intra- and interindividual psychological processing.


Eligibility criteria: Inclusion Criteria:

* right-handed
* diagnosis of Anorexia Nervosa according to the APA criteria

Exclusion criteria:

- concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.

Primary outcomes:
measure: Behavioural measure relative to recognition ability
timeFrame: baseline
Secondary outcomes:
measure: Behavioural measure relative to the detection ability
timeFrame: baseline
Other outcomes:
Locations:
city: Piancavallo
country: Italy
facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
state: VCO
Study officials:
References:
Clinical trial NCT06088693: The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.
Official title: The Role of Electroacupuncture With Standard Therapy on Sperm Analysis and SOD Levels in Oligozoospermia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oligozoospermia
Oligoasthenozoospermia
Oligoasthenoteratozoospermia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 48
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare in Oligozoospermia Patient. The main questions it aims to answer are: 1. Electroacupuncture therapy and standard therapy can affect oligozoospermia. 2. Electroacupuncture therapy and standard therapy can affect semen and spermatozoa plasma SOD levels.

Researchers will compare patient with standard therapy with patient with standard therapy with electroacupuncture.

Detailed description: 1. Male subjects aged more than 25 years and less than 45 years.
2. Oligozoospermia according to the 2010 WHO criteria is mild (10-15 million spermatozoa/mL), moderate (5-10 million spermatozoa/mL) and severe (\<5 million spermatozoa/mL).
3. Willing to take part in research and sign informed consent.

Eligibility criteria: Inclusion Criteria:

* Male 25 to 45 years old.
* Oligozoospermia according to the 2010 WHO criteria is mild (10-15 million spermatozoa/mL), moderate (5-10 million spermatozoa/mL) and severe (\<5 million spermatozoa/mL).
* Willing to participate in research and sign informed consent.

Exclusion Criteria:

* Emergency case patient / bleeding disorders
* Have a tumor, scar tissue or infected wound in the area where the acupuncture needle will be inserted.
* Alcoholic
* Using a pacemaker (heart pacemaker).
* Azoospermia
* Varicocele

Primary outcomes:
measure: Sperm analysis
timeFrame: Before Treatment in day 1, After 30 days of treatment.
measure: SOD Spermatozoa
timeFrame: Before Treatment in day 1, After 30 days of treatment.
measure: SOD Plasma Semen
timeFrame: Before Treatment in day 1, After 30 days of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Lisa Yunita
state: Jakarta Timur
Study officials:
affiliation: Indonesia University
name: Lisa Yunita
role: PRINCIPAL_INVESTIGATOR
References: