louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04599673: Prospective Analysis of Intraoperative AMNIOGEN® Injection in Patients With Rotator Cuff Tear
Official title: Prospective Analysis of Intraoperative AMNIOGEN® Injection in Patients With Rotator Cuff Tear
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rotator Cuff Tears
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose of this article is to examine the clinical application of AMNIOGEN® in patients with rotator cuff tear.

Methods:

The study was conducted on 100 adult participants with age over affected by unilateral shoulder rotator cuff tear and receiving RCT repair. The investigators divided the participants in two groups, and the group A was treated with perioperative injection of AMNIOGEN® A, group B with perioperative normal saline.

Follow-up:

Every 1,3,and 12months, the investigators recheck physical exmianation at OPD and recheck MRI at postoperative 3 months.


Eligibility criteria: Inclusion Criteria:

* receiving unilateral shoulder RCT repair in our hospital postoperative follow-up over 3 month

Exclusion Criteria:

* postoperative follow-up less than 3 month possible pregnency with coagulation disease NSAIDs intake during study period

Primary outcomes:
measure: 100 of participants with preoperative and postoperative physical examination are accessed by Empty can test
timeFrame: postoperative 1 month
measure: 100 of participants with preoperative and postoperative physical examination are accessed by Empty can test
timeFrame: postoperative 3 month
measure: 100 of participants with preoperative and postoperative physical examination are accessed by Empty can test
timeFrame: postoperative 12 month
measure: 100 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed
timeFrame: postoperative 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Yi Ping Wei
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Yi Ping Wei, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04717973: Nutritional Deficiency After Bariatric Surgeries
Official title: Comparison of Post-Operative Nutritional Deficiency Between Laparoscopic Sleeve Gastrectomy Versus Laparoscopic Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional Deficiency
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The General surgery department will be reviewed for a period of six months duration. All patients who admitted to the department and subjected to laparoscopic GP and SG during the study period will be included in the study after securing an informedconsent; both written and verbal consent approved by the Sohag Ethics Committee will be taken from all patients included in the study postoperative.

Brief summary: comparing micro-nutrient deficiencies in postoperative morbid obese patients who will be undergoing gastric bypass and sleeve gastrectomy with regards to vit B 12, vitamin D,iron studies and calcium .

Detailed description: The General surgery department will be reviewed for a period of six months duration. All patients who admitted to the department and subjected to laparoscopic GP and SG during the study period will be included in the study after securing an informed consent; both written and verbal consent approved by the Sohag Ethics Committee will be taken from all patients included in the study.

Patients will be followed for one year by laboratory testing of CBC, serum ferritin, and vitamin B 12, vitamin D and ionized serum calcium after the 1st month, 3rd month, 6th month, and then after one year postoperative.

The pre-operative and post-operative measures will be compared in patients who will be subjected to Laparoscopic Sleeve Gastrectomy versus Laparoscopic Gastric Bypass.

Eligibility criteria: Inclusion Criteria:

1. Age from 18 to 65.
2. BMI more than 40 and more than 30 with co morbidities
3. Both sexes with history of failed weight loss attempts in the past for two years and good motivation for surgery.

Exclusion Criteria:

1. Age less than 18, more than 65.
2. Revisional bariatric surgery.
3. Previous gastric surgery
4. Patients with endocrinal disturbance except hypothyroidism and DM
5. Psychological disturbed patients
6. Females during pregnancy

Primary outcomes:
measure: the degree of nutritional deficiency after gasteric bypass and sleeve gasterectomy 3 months postoperative
timeFrame: From Jan 2021 to april 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Farida sami abdou
Study officials:
References:
Clinical trial NCT01873573: Randomized Controlled Trial of Endoscopic Dilation: Triamcinolone Injection
Official title: Randomized Controlled Trial of Endoscopic Dilation With or Without Triamcinolone Injection in Patients With Non-malignant Radiation or Anastomotic Esophageal Strictures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Keywords: radiation-induced stricture
anastomotic stricture
esophagogastroduodenoscopy (EGD)
dilation
steroid injection
triamcinolone
difficulty swallowing
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to find out if adding triamcinolone (steroid) injection at the participant's initial esophagogastroduodenoscopy (EGD) procedure will improve the opening of their esophagus and decrease the need for repeat dilations.

Detailed description: This is a randomized two-arms cross-over trial. In this study there are two groups, the control group and the triamcinolone treatment group. The cross-over design will apply only in the control group when patients are not responding to EGD dilations alone (defined as no sustained improvement in baseline dysphagia) and they will be allowed to cross-over to the triamcinolone group and undergo 3 successive EGDs with triamcinolone injection.

Typically, triamcinolone (steroid) injection is given as a standard of care after several esophageal dilations are performed and failed to improve the condition. Therefore, researchers want to find out if adding triamcinolone (steroid) injection at the participant's initial EGD procedure will improve the opening of their esophagus and decrease the need for repeat dilations.

Eligibility criteria: Inclusion Criteria:

* Patients who present for EGD with dilation for dysphagia symptoms thought secondary to either radiation-induced stricture or anastomotic stricture based on history

Exclusion Criteria:

* Inability to consent for the procedure
* Known coagulopathy \[International Normalized Ratio (INR) \>1.5, Platelets \<75 K\]
* Endoscopic finding of a stricture that is not caused by either radiation or anastomotic narrowing
* Nasopharyngeal strictures

Primary outcomes:
measure: Number of Visits to Receive Esophageal Dilation During the 12 Month Follow-up Period
timeFrame: 12 months
Secondary outcomes:
measure: Final Dysphagia Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Jason Klapman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02387073: The Efficacy of Electrical Version of Patient Reported Outcome
Official title: The Efficacy of Electrical Version of Patient Reported Outcome: Patient Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Disease
Keywords: outcome assessment
self-reported
patient
clinical outcome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SK Telecom Consortium
First posted: 2015-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients who have experienced paper questionnaire

Brief summary: Recently the importance of electrical PRO system is increased for the accuracy, convenience, and efficiency for both patients and physicians. For the evaluation of quality of life, various self-reported questionnaires is filled-out by the patient, mostly in front of outpatient clinic, and doctor usually take times to calculate the score. If there is electrical PRO which is available with mobile device, the efficacy of clinic would be improved. The investigators developed such a system and applied the system for patients with spinal disease. The investigators assessed the effectiveness of application of electrical-PRO in outpatients' clinic for patients who had filled-up same questionnaire in paper version.

Detailed description: Age, sex, education levels, use of smartphone, the number of applications.

Eligibility criteria: Inclusion Criteria:

* We assessed the effectiveness of application of electrical-PRO in outpatients' clinic for patients who had filled-up same questionnaire in paper version

Exclusion Criteria:

* Computer illiterate
* Uncooperative patient

Primary outcomes:
measure: The necessity of electrical PRO system (quantitative analysis)
timeFrame: up to 6 months after introduction of e-PRO system
Secondary outcomes:
measure: Consultation efficacy with doctor Satisfaction for the enough exchange of information
timeFrame: up to 6 months after introduction of e-PRO system
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Chun Kee Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06376773: Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping.
Official title: Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping: Chemotherapy, Immunotherapy, or Targeted Therapy? -A Retrospective Real-World Data Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Gastric Cancer
Neoadjuvant Therapy
Multi-omics Analysis
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study collected data from 234 patients diagnosed with gastric adenocarcinoma at Fujian Medical University Union Hospital (FMUUH) who underwent gastrectomy after receiving neoadjuvant therapy (NAT) between January 2019 and January 2022.

Brief summary: Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. This study aimed to identify the most effective drug therapeutics for patients with the mesenchymal subtype of gastric cancer.Based on RNA-seq transcriptome, 234 patients were divided into four molecular subtypes: mesenchymal, immunogenic, metabolic, and classic.Our analysis has revealed that, for neoadjuvant therapy in advanced gastric cancer (AGC), the mesenchymal subtype stands out as the ideal patient population benefiting from Apatinib, without a concurrent increase in postoperative complications.

Detailed description: The advent of immunotherapy and targeted therapies has recently provided new options for AGC treatment. However, not all patients benefit from immunotherapy or targeted therapy, resulting in unsatisfactory overall treatment outcomes during the perioperative period. An ineffective treatment imposes significant financial burden, causes drug-related side effects that deteriorate their quality of life, and potentially delays subsequent treatment.

Evaluate the objective response rate (ORR) of the combination of camrelizumb, apatinib, and neoadjuvant chemotherapy for the treatment of advanced gastric patient Median survival time (OS);

Disease free survival time (DFS);

Eligibility criteria: Inclusion Criteria:

* diagnosed with gastric adenocarcinoma and received neoadjuvant therapy

Exclusion Criteria:

* Patients with distant metastases, gastric stump cancer, or missing neoadjuvant chemotherapy data were excluded from the study.

Primary outcomes:
measure: overall survival
timeFrame: 2years
Secondary outcomes:
measure: objective response rate
timeFrame: 6months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT00784173: Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome
Official title: Middle and Inner Ear Malformation in Children With Velocardiofacial Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ear Malformations in the Velocardiofacial Syndrome
Keywords: Syndrome
Velocardiofacial
Middle ear
Inner ear
Malformation
Lead sponsor: Pontificia Universidade Catolica de Sao Paulo
Sponsor class: OTHER
First posted: 2008-11-02
Enrollment: 2
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with velocardiofacial syndrome

Brief summary: Middle and inner ear malformations on two boys with velocardiofacial syndrome are discussed.Special attention should be given to the presence of hearing loss due to middle and inner ear malformations, in addition to frequent conductive hearing loss regarding mastoid and middle ear inflammatory processes.

Detailed description: Two boys with clinical signs of velocardiofacial syndrome, at ages of 4.7 and 6,7 years old are the subjects of this study.Audiological evaluation, including pure tone audiometry, tympanometry, acoustical reflex, and Computerized Tomography of temporal bones, and analyses of DNA sample with markers of 22q11 region were performed.

Eligibility criteria: Inclusion Criteria:

* Subjects with velocardiofacial syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pontificia Universidade Católica de São Paulo
name: Alfredo Tabith-Junior, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06918873: Quality of Life During Different Regimens of Combined Hormonal Contraceptives in Women of Reproductive Age
Official title: Quality of Life During Different Regimens of Combined Hormonal Contraceptives in Women of Reproductive Age
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hormonal Contraception
Keywords: combined hormonal contraception
female sexual dysfunction
mood disorders
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referred for prescription of a hormonal contraceptive.

Brief summary: The aim of the present study is to investigate the psychosexual effects of combined hormonal contraception regimens, comparing them in terms of estrogen type and dosage, hormonal combination regimen and different routes of administration, in women seeking a hormonal contraception method to prevent unwanted pregnancies. In particular, the study focuses on the incidence of mood disorders and sexual dysfunctions associated with distress in the entire study population using combined hormonal contraception. It will also examine the incidence of these conditions under the influence of specific combined hormonal contraceptives, as well as whether different types of progestins and the route of administration (oral, vaginal or transdermal) may affect the occurrence of mood disorders and sexual dysfunctions.


Eligibility criteria: Inclusion Criteria:

* women of childbearing age (aged 18-40) who seek advice for use of combined hormonal contraception (CHC).
* stable relationship

Primary outcomes:
measure: Impact of different estrogen-progestin contraception regimens on sexual function and sexually related distress.
timeFrame: 6 months
Secondary outcomes:
measure: Impact of combined hormonal contraception on mood disorders
timeFrame: 6 months
measure: Impact of basal clinical variables mood disorders and sexual dysfunction in women using combined hormonal contraception
timeFrame: 6 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita
Study officials:
References:
Clinical trial NCT06792773: 2024 NewAnescat Register
Official title: 2024 NewAnescat Register
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anesthesia
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 13634
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is all patients involving anaesthetic activity during the study days (14 days in a year).

Brief summary: 20 years ago, for the first time in Spain, a record was made of all the activity carried out by a medical speciality, called ANESCAT 2003. After 20 years, the increase in healthcare activity has exceeded the expectations and predictions that were made at the time. Therefore, it is necessary to make a new assessment of the work situation in which our speciality finds itself in order to be able to evaluate whether the increase in resources allocated has been proportional and therefore to be able to have objective data with a view to making new demands and planning future needs.


Eligibility criteria: The activity of all the areas in which the anaesthesiologist has some kind of work involvement over 24 hours during 14 days in a year is included through several questionnaires with different formats. Therefore all patients will be included without restriction criteria.

Primary outcomes:
measure: Anaesthesia surgical activity
timeFrame: Assessed during the 14-day cut-off period of the study over one year
measure: Anaesthesia activity in the Intensive Care Units
timeFrame: Assessed during the 14-day cut-off period of the study over one year
measure: Anaesthesia activity in the Chronic Pain Units
timeFrame: Assessed during the 14-day cut-off period of the study over one year
measure: Anaesthesia activity in the delivery rooms
timeFrame: Assessed during the 14-day cut-off period of the study over one year
Secondary outcomes:
measure: Percentage of active staff in anaesthesiology services
timeFrame: Assessed during the 14-day cut-off period of the study over one year
measure: The role of anaesthesiology services in Catalonia with regard to polytrauma patients
timeFrame: Assessed during the 14-day cut-off period of the study over one year
measure: The role of anaesthesiology services in Catalonia with regard to cardiorespiratory arrest
timeFrame: Assessed during the 14-day cut-off period of the study over one year
Other outcomes:
Locations:
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Carles Espinós, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06665373: Fitness and Nutrition in Glioma
Official title: A Pilot Study to Investigate the Effects of Combining a Modified Atkins Diet With a Physical Fitness Regimen in Patients Diagnosed With Malignant Glioma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Glioma
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study assessing the effects of combining a modified Atkins diet with a physical fitness regimen in patients with malignant glioma. A sample size of 15 participants will be enrolled in a 15-week program consisting of two weekly supervised exercise sessions combined with an individualized home exercise program and a modified Atkins diet.


Eligibility criteria: Inclusion Criteria:

* Tissue confirmed diagnosis of high-grade glioma (World Health Organization grade III or IV)
* Karnofsky Performance Status (KPS) ≥ 70%
* Willing to follow the study intervention and follow-up
* Able to give full informed consent

Exclusion Criteria:

* Currently undergoing initial concurrent radiation/chemotherapy
* Severe medical co-morbidities
* Any medical condition which prohibits moderate to vigorous physical activity (60-85% HRmax)
* Any medical condition which prohibits a restrictive diet
* Neurological deficit preventing participation in moderate to vigorous physical activity
* Severe psychiatric illness

Primary outcomes:
measure: Change in Short Form (SF)-36 Version 2 Score
timeFrame: Baseline, Week 12
measure: Number of Participants who Complete Full 12-Week Program
timeFrame: Week 12
Secondary outcomes:
measure: Change in Blood Ketone Levels
timeFrame: Baseline, Week 12
measure: Change in Resting Heart Rate
timeFrame: Baseline, Week 12
measure: Change in 400-meter Walk Time
timeFrame: Baseline, Week 12
measure: Change in 1 Repetition Maximum (1RM) - Chest Press
timeFrame: Baseline, Week 12
measure: Change in 1 Repetition Maximum (1RM) - Leg Press
timeFrame: Baseline, Week 12
measure: Change in Satisfaction With Life Scale (SWLS) Score
timeFrame: Baseline, Week 12
measure: Change in Hospital Anxiety And Depression Scale (HADS) - Anxiety Subscale Score
timeFrame: Baseline, Week 12
measure: Change in Hospital Anxiety And Depression Scale (HADS) Score
timeFrame: Baseline, Week 12
measure: Change in Fatigue Severity Scale (FSS) Score
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lee Tessler, MD
role: PRINCIPAL_INVESTIGATOR
References: