louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05141825: Proton and Carbon Ion Radiotherapy for Cervical Cancer
Official title: Proton and Carbon Ion Radiotherapy for Cervical Cancer : A Retrospective Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: proton and carbon ion radiotherapy
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the toxicity and tolerance of proton and carbon ion radiotherapy (PCRT) for cervical cancer.

Detailed description: To retrospectively analyze cervical cancer patients received radical proton and carbon radiotherapy in our center. The acute and late toxicities, overall survival (OS), local control rate (LC), progression-free survival (PFS) and distant metastasis-free survival (DMFS) were analyzed.

Eligibility criteria: Inclusion Criteria:

1. . histologically diagnosis of squamous cell carcinoma of the cervix;
2. . International Federation of Gynecology and Obstetrics (FIGO) stage (2014) IB2 - IIIB, without rectum invasion; or FIGO stage IA - IB1, who refused surgery or were contraindication for surgery due to comorbidity diseases;
3. . received proton and carbon ion radiotherapy (PCRT) with or without chemotherapy for curative intention;
4. . Follow-up data available.

Exclusion Criteria:

1. a previous history of other malignancy;
2. squamous cell carcinoma of the cervix patients who had received surgery;
3. rectum was invaded.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: overall survival rate
timeFrame: 3 years
measure: local control rate
timeFrame: 3 years
measure: progression-free survival
timeFrame: 3 years
measure: distant metastasis-free survival
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center
name: Qing Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01780025: Objective Measures in Implantable Hearing Devices
Official title: Clinical Trial on Objective Measures in Implantable Hearing Devices for Subjects With Mixed Hearing Loss.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mixed Hearing Loss
Keywords: Hearing
Thresholds
Coupling to the inner ear
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2013-01-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mixed hearing loss

Brief summary: The purpose of this study is to measure objectively the coupling from direct acoustic cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked potentials.

Detailed description: A new technique, called Direct Acoustic Cochlear Stimulation, has very recently been introduced to restore hearing in patients with severe hearing loss due to the immobility of a small ossicle in the middle ear, the stapes. A piston-like prosthesis, which is placed up into the inner ear, is connected to an implantable mechanical stimulator, named DACS. Unfortunately, as with other active middle ear implants, until now the correct function of this technique cannot be checked during the surgery, leading to a possibly variable outcome of hearing. In this project, the objective auditory evoked potentials, like Auditory Steady-State Response (ASSR), will be used to measure the efficacy of this method of inner ear stimulation. This highly innovative, non-invasive research will provide valuable insight in a new promising way of inner ear stimulation and may give a unique possibility to measure the correct connection from an implantable hearing device to the inner ear.

Eligibility criteria: Inclusion Criteria:

* adults
* mixed hearing loss

Exclusion Criteria:

* children

Primary outcomes:
measure: auditory evoked potentials
timeFrame: 1 - 3 - 6 months
Secondary outcomes:
measure: speech audiometry
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT06423625: Hemorrhagic MI Prediction Score Model
Official title: Developing a Prediction Score Model for Predicting the Likelihood of Hemorrhagic MI Before Percutaneous Coronary Reperfusion Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
Prediction Score
Machine Learning
Hemorrhagic MI
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of individuals aged 18 - 80 yrs who have been diagnosed with acute ST-elevation myocardial infarction (STEMI) and are scheduled for emergency percutaneous coronary intervention (PCI).

Brief summary: Developing a prediction score model for predicting the likelihood of Hemorrhagic MI


Eligibility criteria: Inclusion Criteria:

* Age \> 18 yrs
* Index MI
* Primary PCI

Exclusion Criteria:

* History of prior myocardial infarction,
* Thrombolysis before PCI
* Contraindication to Cardiac MRI

Primary outcomes:
measure: Hemorrhagic MI
timeFrame: Emergency admission to Percutaneous Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Krannert Cardiovascular Research Center, Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine, Krannert Cardiovascular Research Center
name: Keyur P Vora, MD FACC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02752425: Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation
Official title: Visual Feedback of Tongue by Ultrasound Echography for Speech Trouble Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Speech Disorders
Keywords: Speech disorders
Speech therapy
Visual feedback
Buccopharyngeal surgery
Central nervous system damage
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 18
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Speech is a privileged means of communication for humans: its trouble can thus prove being extremely handicapping. Standard speech therapy is limited in some cases by the lack of sensory feedback available to the patient (hearing, surgery, neural damage, etc.).

The present study aims at quantify the contribution of the tongue articulatory visual feedback offered by ultrasound echography to speech trouble rehabilitation.

Two complementary populations will be studied : 30 adults with buccopharyngeal surgery, and 10 childrens with important speech troubles due to central nervous system damage.

The principle is to conduct standard speech therapy sessions, alternating series of sessions with the use of visual feedback and sessions without visual feedback.

The progress will be regularly measured by means of standard batteries of speech articulation tests.


Eligibility criteria: Inclusion Criteria:

* Articulatory troubles needing speech therapy
* French mother tongue
* Adult patients \[18 ≥ age \< 80 years\] who underwent buccopharyngeal surgery after cancer diagnostic OR children \[8 ≥ age \< 18 years\] suffering from central nervous system damage

Exclusion Criteria:

* Incapacity to easily understand the speech therapist instructions
* People protected by the law
* People deprived from freedom by judiciary decision
* Potential allergy to the water-based conducting gel used to ensure good skin - probe contact
* Overweight if large fatty mass under chin
* Major edema under chin limiting echogenicity
* Non corrected vision or hearing problems
* For the adults: central or peripheral neural damage
* History of Ear, Nose, and Throat surgery or radiotherapy
* For the adults: isolated articulatory trouble, former articulatory trouble not treated, disfluency
* Massive orofacial dyspraxia
* Posture trouble
* Motor problem in upper limbs

Primary outcomes:
measure: BECD test score
timeFrame: 4 months
measure: MBLF test score
timeFrame: 4 months
Secondary outcomes:
measure: Perception test scores
timeFrame: 4 months
Other outcomes:
Locations:
city: Eybens
country: France
facility: Institut d'Education Motrice
city: Saint Martin d'Hères
country: France
facility: Centre Médical Rocheplane
Study officials:
affiliation: GIPSA-lab, CNRS, Univ. Grenoble Alpes
name: Pierre BADIN, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06020625: Mutational Oncology in Clinical Practice
Official title: Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Genome Instability
Genetic Predisposition to Disease
Gene Rearrangement
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 20000
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 study of biological profiling is of fundamental importance in the diagnosis and treatment of many diseases, particularly oncological ones, and for this reason, the integration of molecular characterization into clinical practice becomes essential. NGS allows a high number of samples to be sequenced simultaneously, generating a great deal of genomic information in a short time and at reasonable cost. This information is of fundamental importance for the study of oncogenic drivers and gene alterations that may have a prognostic and/or predictive role in response to new molecularly targeted drugs.

Policlinico A. Gemelli has begun a process of internal reorganization of the research infrastructure following its recognition in 2018 as an Institute of Hospitalization and Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of "Personalized Medicine" and "Innovative Biotechnology." In particular, with regard to genomics, will be equipped with a state-of-the-art technological asset that includes a fully automated process for sample preparation and the highest gene sequencing power available today. This condition makes it possible to perform extensive genomic profiling for large numbers of patients at low cost and in reasonable time.


Eligibility criteria: - Patients with neoplasm of the lung, breast, ovary, pancreas, prostate, colorectum, melanoma, GIST, thyroid neoplasm, endometrium, and cholangiocarcinoma:

1. BREAST Locally advanced or metastatic, hormone-responsive, HER2-negative breast neoplasm, progressing after endocrine therapy.
2. LUNG Metastatic disease.
3. OVARY Any stage of nonmucinous, non-borderline epithelial carcinoma of the ovary, fallopian tube, or primary peritoneal carcinoma.
4. PANCREAS Metastatic disease.
5. PROSTATE Metastatic castration-resistant disease.
6. COLORECTUM Metastatic disease.
7. MELANOMA Stage IV or stage III undergoing surgery.
8. GIST Profiling of c-KIT in case of metastatic disease or for patients undergoing surgery and of PDGFRα for all patients with inoperable or metastatic disease.
9. THYROID
10. ENDOMETRIUM
11. CHOLANGIOCARCINOMA

Primary outcomes:
measure: Comprehensive Genome Profiling
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT02647125: A Study of Comparing Huachansu Plus Thoracic RT Versus RT Alone For ESCC
Official title: A Phase II Study of Comparing Huachansu Combination With Thoracic Radiotherapy Versus Radiotherapy Alone For Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 126
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 primary objective of the trial is to study whether the local control of Huachansu plus thoracic radiotherapy is better compared to thoracic radiotherapy alone for patients with esophageal squamous cell carcinoma. It's a phase II study, 134 patients are expected to be recruited into the trial.


Eligibility criteria: Inclusion Criteria:

1. Joined the study voluntarily and signed informed consent form.
2. Age \>75 or age 18-75 who are intolerant of or reject intravenous chemotherapy.
3. Both genders.
4. Esophageal squamous cell carcinoma confirmed by pathology.
5. Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a,TxN1M0-1a,TxNxM1a, AJCC 6th).
6. No radiotherapy, chemotherapy or other treatments prior to enrollment.
7. PS ECOG 0-2，wight loss\<30% during the latest 6 months.
8. Life expectancy of more than 3 months.
9. Hemoglobin（Hb）≥9 g/dL,WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L platelet count (Pt) ≥100x 109/L.Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN.Renal function: creatinine \< 1.5 x ULN.
10. No immuno-deficiency
11. No heart diseases that need cardiac glycoside
12. Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

1. Complete esophageal obstruction.
2. Deep esophageal ulcer.
3. Esophageal perforation.
4. Haematemesis.
5. After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy.
6. Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years.
7. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
8. Drug addiction,Alcoholism or AIDS.

Primary outcomes:
measure: Local control rate
timeFrame: the date of randomization until progression inside the irradiation field, up to 3 years.
Secondary outcomes:
measure: overall survival
timeFrame: the date of randomization until the death or the last follow up of the patients, up to 3 years.
measure: progress-free survival
timeFrame: the date of randomization until progression or death from any cause, up to 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan Universtiy Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT06543225: Awareness Of Gynecologists About Role Of Physical Therapy In Management Of Polycystic Ovarian Syndrome
Official title: Awareness Of Gynecologists About Role Of Physical Therapy In Management Of Polycystic Ovarian Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 399
Sex: ALL
Minimum age (years): 29
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian gynecologists were included in the study to determine their awareness about the role of physiotherapists in the treatment of PCOS.

Brief summary: This study aimed to measure the extent of knowledge of gynecologists about the role of physical therapy in the management of PCOS.

Detailed description: Physical therapists are good communicators and also have the knowledge and skills to make a substantial impact in this field of management of polycystic ovarian syndrome.

It is important for the gynecologists to have awareness about the role of physical therapy in polycystic ovarian syndrome to encourage patient to seek physical therapy help instead of suffering in silence and improve their quality of life

Eligibility criteria: Inclusion Criteria:

* Gynecologists with more than 2 years' experience.
* Had managed cases of PCOS.

Exclusion Criteria:

* Gynecologists with less than 2 years' experience.
* Gynecologists who didn't deal with PCOS.

Primary outcomes:
measure: Awareness and knowledge of gynecologists about role of physiotherapists in the treatment of PCOS
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Rolan Khaled Kamal El Dein
state: El Gharbia
Study officials:
affiliation: Cairo University
name: Soheir EL-Kosery, professor
role: STUDY_CHAIR
References:
Clinical trial NCT04757025: Intraoperative Electrical Impedance Tomography in Obese Patients Undergoing Robotic Assisted Radical Prostatectomy.
Official title: Optimization of Intraoperative Ventilation Guided by Electrical Impedance Tomography in Combination With Oxygen Saturation by Pulse Oximetry (SpO2) Versus SpO2 Alone in Obese Patients Undergoing Robotic Assisted Radical Prostatectomy: Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obese
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of our study will be verify a possible improvement in arterial oxygenation in the obese patient undergoing robotic-assisted radical prostatectomy if the ventilation will be guided by electrical impedance tomography rather than peripheral saturation alone.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for laparoscopic radical prostatectomy
* BMI ≥ 30 kg/m2

Exclusion Criteria:

* surgery duration \< 2 hours
* history of lung diseases

Primary outcomes:
measure: The arterial oxygen pressure / fraction of inspired oxygen (pO2 /FiO2) ratio
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Regina Elena Cancer Institute
state: RM
Study officials:
References:
Clinical trial NCT01473225: Can Calorie Labels Increase Caloric Intake
Official title: Can Calorie Labels Increase Caloric Intake? A Test of Possible Perverse Effects of Calorie Labels
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Food Consumption
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a test of possible mechanisms by which calorie labels might lead people to increase calorie intake. The investigators hypothesize that calorie labels might increase calorie intake because 1) people infer that higher calorie foods are tastier, 2) calorie labels invoke thoughts of dieting, leading people to overconsume as a reaction, 3) people try to maximize calories consumed per dollar spent, and 4) calorie labels change one's goal motivation toward food, causing people to eat more.


Eligibility criteria: Inclusion Criteria:

* Must be able to taste items used in study

Exclusion Criteria:

* Food allergies to items used in study

Primary outcomes:
measure: Calories consumed
timeFrame: At time of intervention (30 minutes)
Secondary outcomes:
measure: Attitudes toward food
timeFrame: At time of intervention (30 minutes)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
affiliation: Carnegie Mellon University
name: Eric M VanEpps, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05118425: Dietary Perceptions and Practices in Chinese Psoriasis Patients
Official title: A Real-world Study of the Dietary Perceptions and Practices in Chinese Psoriasis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Diet
psoriasis
perception
practice
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 3453
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The survey is a nation-wide study conducted in 25 hospitals or institutions in China, aiming to observe the dietary perceptions and practices in Chinese adult psoriasis patients. The patient population covered 31 provinces and 241 cities over China.

Brief summary: The influences of diet on psoriasis have been long discussed. As reported in previous publications, a majority of U.S. psoriasis population show high interest in the role of diet on their skin conditions. Given the distinct traditional perceptions and lifestyles in China, the dietary beliefs and behaviors in Chinese psoriasis patients would be very likely to show different patterns. Nevertheless, the information of this large population is still unknown. In this regard, the investigators conduct a questionnaire-based survey, aiming to assess the dietary perceptions and behaviors of Chinese psoriasis patients.

Detailed description: A total of 25 medical institutions all over China participated in the survey. Psoriasis patients surveyed were from both outpatient and inpatient dermatology departments. Researchers from each institution were trained for assisting patients to fill the questionnaire. Each participant filled the online-based questionnaire anonymously in a private setting. The questionnaire consisted of 54 main questions and extended questions, concerning the profile of disease conditions, perceptions and behaviors of diet in their daily life.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old.
* Confirmed diagnosis of psoriasis.
* Duration of psoriasis ≥ 3 years.
* Must be able to read and understand the questionnaire.
* Receive a full explanation of the purpose and content of the trial before the study begins, and voluntarily sign a written consent form.

Exclusion Criteria:

* Unable to read or understand the questionnaire.
* Other conditions deemed by the investigator to be inappropriate for this study.

Primary outcomes:
measure: Practices of food choice in Chinese psoriasis patients.
timeFrame: Information collection: over a span of 2 months
Secondary outcomes:
measure: Perceptions of the correlation between diet choice and disease severity in Chinese psoriasis patients.
timeFrame: Information collection: over a span of 2 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Dermatology Derpartment of Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Dermatology Derpartment of Xijing Hospital
name: Gang Wang
role: PRINCIPAL_INVESTIGATOR
References: