louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05828875: A Multicenter, Cross-sectional Study on the Quality of Life in Long-term Survival Esophageal Cancer Patients After Radical Radiochemotherapy/Radiotherapy
Official title: A Multicenter, Cross-sectional Study on the Quality of Life in Long-term Survival Esophageal Cancer Patients After Radical Radiochemotherapy/Radiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Assessing the Current Quality of Life Status of Esophageal Cancer Patients Who Have Undergone Radical Chemoradiotherapy/Radiotherapy and Long-term Survival
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The age at the time of radiotherapy is between 18-75 years old, and the age at the time of investigation is\<80 years old;

* Histologically confirmed esophageal squamous cell carcinoma without undergoing surgical resection;
* Received radical chemoradiotherapy/radiotherapy from July 2017 to July 2020, currently alive and without disease progression;
* Radiotherapy dose ≥ 45Gy.

Brief summary: This study is a multicenter cross-sectional survey of esophageal cancer patients who underwent radical chemoradiotherapy/radiotherapy from July 2017 to July 2020 in various medical centers, and who survived without disease progression at the time of the survey. The purpose of this study is to evaluate the current quality of life, as well as the incidence of long-term toxic side effects, nutritional status, and psychological status of esophageal cancer patients cured by radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Voluntarily accept this survey and research;
* The age at the time of radiotherapy is between 18-75 years old, and the age at the time of investigation is\<80 years old;
* Histologically confirmed esophageal squamous cell carcinoma without undergoing surgical resection;
* Received radical chemoradiotherapy/radiotherapy from July 2017 to July 2020, currently alive and without disease progression;
* Radiotherapy dose ≥ 45Gy.

Exclusion Criteria:

* Patients who do not cooperate with this survey;
* Patients who have died at the time of investigation;
* Patients who experience tumor progression within the time frame from the end of radiotherapy to receiving this survey;
* Patients diagnosed with other malignant tumors within the time frame from the end of radiotherapy to receiving this survey;
* Patients with incorrect contact information and missing visits

Primary outcomes:
measure: Quality of Life Assessment survey
timeFrame: Two years after the end of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT00267475: Data Bank for Eosinophilic Disorders
Official title: Clinical and Immunological Evaluation of Eosinophil Associated Gastrointestinal Disorders (EGID)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Gastritis
Enteritis
Eosinophilic Colitis
Eosinophilic Gastroenteritis
Keywords: eosinophilic esophagitis
eosinophilic gastritis
eosinophilic enteritis
eosinophilic colitis
eosinophilic gastroenteritis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2005-12-21
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with an eosinophilic disorder and patients without an eosinophilic disorder to serve as normal controls

Brief summary: The purpose of this study is to conduct a translational study in patients with primary eosinophil associated gastrointestinal disorders \[EGID\] (e.g. eosinophilic esophagitis eosinophilic gastritis, eosinophilic enteritis \[EE\], eosinophilic colitis, and eosinophilic gastroenteritis \[EGE\]) with the aim of developing a data bank containing pertinent patient demographic information, tissue samples, and DNA, which will facilitate research on the pathophysiology of inflammatory disorders and the development of a verified successful clinical treatment program.


Eligibility criteria: Patients with an eosinophil associated gastrointestinal disorder (EGID), family members of patients with EGID, or normal controls.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Marc E. Rothenberg, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05315375: Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages
Official title: Post-trauma Lumbar Vertebral Body Reconstruction Using Expandable Cages: Comprehensive Long-term Follow-up Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disc Degeneration
Lead sponsor: Centre de l'arthrose, Paris
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients suffered from a traumatic lumbar fracture requiring a posterior fusion first

Brief summary: INTRODUCTION

The expandable cage technology is not new, but several questions remain under-studied. Among them, there are the sagittal balance, the subsidence and the adjacent disc degeneration. Moreover, assessment of the correction and kyphosis regardless of the physiological angles can possibly lead to calculation bias.

The objective of this study was to assess the extent to which the functional outcomes were correlated to the quality of the reduction, within a homogeneous series of lumbar vertebral body reconstruction with expandable cages for trauma.

MATERIAL AND METHODS Twenty-seven patients with a mean follow-up of 3.9 years were retrospectively analyzed. The Oswestry Disability Index (ODI) was the main outcome and its association with other variables was sought. The local kyphosis and the regional traumatic angle using Stagnara's physiological angles were measured. The lumbar lordosis (LL) was compared to the Pelvic Incidence (PI). The subsidence of the cage and the adjacent disc degeneration (using the UCLA grading score) were quantified. Bone quality was assessed through the Hounsfield Unit of the vertebral body.


Eligibility criteria: Inclusion Criteria:

* All patients suffered from a traumatic lumbar fracture requiring a posterior fusion first

Exclusion Criteria:

-

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: APHP
name: cedric maillot
role: STUDY_DIRECTOR
References:
Clinical trial NCT04189575: A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medication in Adults With ADHD in the Primary Care Setting
Official title: A Text Messaging (SMS) Intervention to Improve Adherence to Stimulant Medication in Adults With ADHD in the Primary Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: Attention Deficit/Hyperactivity Disorder
ADHD
SMS Intervention
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Shire Human Genetic Therapies, Inc.
First posted: 2019-12-06
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will assess the efficacy of the text messaging (SMS-based) disease management intervention to improve adherence to stimulants in adults with Attention Deficit/Hyperactivity Disorder (ADHD) within the Partners primary and psychiatry care settings.

Participants in the study will receive customized text messages twice a day, every day, for a duration of 9 months. The text messages will include reminders to adhere to the individualized medication regimen, reminders to call their clinician for a prescription refill followed by reminders to pick up medication from the pharmacy, and educational reminders about ADHD and its treatment


Eligibility criteria: Inclusion Criteria:

* Male and female adults ages 18-55 years
* Receipt of a prescription for stimulant medication by their primary care physician or psychiatrist
* Proficient in English
* Has a cellular phone with text messaging capabilities and is interested in and willing to receive free of charge planned text messages

Exclusion Criteria:

* Investigator and his/her immediate family
* Unwilling/unable to comply with study procedures

Primary outcomes:
measure: Adherence to Stimulants
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01953575: Mucosal Impedance and Eosinophilic Esophagitis
Official title: Mucosal Impedance in Eosinophilic Esophagitis and the Effect of Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eosinophilic Esophagitis
Keywords: Mucosal Impedance
Eosinophilic Esophagitis
EoE
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal impedance?

And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities in mucosal impedance?


Eligibility criteria: Inclusion criteria:

* Adults ages 18-90 undergoing clinically indicated upper endoscopy
* Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field on esophageal biopsy despite at least 6 weeks of twice daily proton pump inhibitor therapy
* Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or Gastroesophageal reflux disease (GERD) with normal appearing esophageal mucosa.

Exclusion criteria:

* Medical conditions such as severe heart or lung disease that preclude safe performance of endoscopy
* Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy

Primary outcomes:
measure: Esophageal Mucosal Impedance (MI)
timeFrame: baseline to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David Katzka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04930575: Muscle Energy Technique Versus Mulligan Technique for Treating Neck Pain in Breast Feeding Women
Official title: Muscle Energy Technique Versus Mulligan Technique for Treating Neck Pain in Breast Feeding Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Breast Feeding
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 32
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will determine the effect of muscle energy technique versus mulligan technique on neck pain in breastfeeding women.

Detailed description: Conservative treatments used to manage neck pain are numerous and include usual medical care ( face to face interview, education, reassurance, medication, ergonomic and stay active advice), various forms of exercise, massage, and acupuncture among others, but a lack of evidence regarding their relative efficacy was found.

More research is needed to determine specific exercise programs that can decrease neck pain in breastfeeding women. So, this study will be conducted to determine clinical evidence of the effectiveness of muscle energy technique versus mulligan technique on neck pain, which constituted a great problem facing the mother during the breastfeeding period.

Eligibility criteria: Inclusion Criteria:

* Patients will be examined by a physician before the study and will be chosen according to the following criteria:
* All patients will be in the breastfeeding period at least 6 weeks after delivery.
* All patients will be clinically diagnosed with neck pain (with no neurological or rheumatological problem).
* Their ages will range from 25-35years.
* Their BMI will be less than 30 kg/m².
* Their parity will not be more than 3 times.

Exclusion Criteria:

* The patients will be excluded if they have any of the followings:

  1. Any contraindication to spinal mobilization (e.g., inflammation, infection, advanced degeneration, congenital malformation, trauma, cerebrovascular abnormalities).
  2. Positive neurological examination (presence of positive motor reflex, or sensory abnormalities indicating spinal root compression).
  3. Cervical spine surgery or stenosis, metabolic or systemic disorder, or cancer.
  4. Associated pathology of the upper cervical region or upper limb that may cause overlapping with the clinical finding as referred pain from the costotransverse joint, rotator cuff tendonitis, and cervical rib syndrome.

Primary outcomes:
measure: Assessing the change in Cervical pain level
timeFrame: Baseline and 4 weeks post-intervention
measure: Assessing the change in Functional disability
timeFrame: Baseline and 4 weeks post-intervention
measure: Assessing the change in Cervical Range Of Motion
timeFrame: Baseline and 4 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Faculty of Physical Therapy Cairo University
Study officials:
References:
Clinical trial NCT06188975: Expanded Access to ABBV-CLS-484
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Advanced Solid Tumor Cancer
Lead sponsor: Calico Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2024-01-03
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-CLS-484 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05978375: A Prospective Cohort Study of for Surgical Treatment of Irreducible Atlantoaxial Dislocation
Official title: A Prospective Cohort Study of for Surgical Treatment of Irreducible Atlantoaxial Dislocation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atlantoaxial Dislocation
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-70, exclude traumatic, RA and previous surgery.

Brief summary: The management of irreducible atlantoaxial dislocation associated is challenging. Direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In 2020, we modified this technique and proposed a posterior intra-articular distraction technique. The intra-articular distraction technique could theoretically achieve satisfactory reduction and fusion. However, its superiority has not been proven. Therefore, we design a prospective study to compare the reduction rate and fusion rate of different strategies.


Eligibility criteria: Inclusion Criteria:

CT indicated atlantoaxial dislocation Agree with the operation plan Agree to be followed up

Exclusion Criteria:

The pathology is traumatic or RA Underwent operations in occipital-cervical region before With mortal diseases Without ability to sign papers

Primary outcomes:
measure: Fusion Rates
timeFrame: 12 months
Secondary outcomes:
measure: Japanese Orthopaedic Association Scores
timeFrame: 12 months
measure: Visual Analogue Scale
timeFrame: 12 months
measure: Neck Disability Index
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Chen Z, Duan W, Chou D, Guan J, Liu Z, Jian Q, Zhang B, Bo X, Jian F. A Safe and Effective Posterior Intra-Articular Distraction Technique to Treat Congenital Atlantoaxial Dislocation Associated With Basilar Invagination: Case Series and Technical Nuances. Oper Neurosurg (Hagerstown). 2021 Mar 15;20(4):334-342. doi: 10.1093/ons/opaa391.
Clinical trial NCT02187575: Bioequivalence Study of UHAC62XX Tablets Compared With Capsules in Healthy Volunteers
Official title: Bioequivalence Study of UHAC62XX 10 mg Tablets Compared With 10 mg Capsules Following Multiple Peroral Administration in Healthy Volunteers (An Open-label, Randomised, Two-way Crossover Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 26
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to investigate the bioequivalence between 10 mg tablets (test drug) and 10 mg capsules (reference drug) of meloxicam (UHAC 62 XX) after 7-day administration.


Eligibility criteria: Inclusion Criteria:

* Age \>= 20 and \<= 35 years
* Weight: Body Mass Index \>= 18.5 and \< 25
* Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
* Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent

Exclusion Criteria:

* History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
* History of hypersensitivity to UHAC 62 XX and/or salicylate (aspirin etc.) and/or Non-steroidal anti-inflammatory drugs (NSAIDs)
* History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
* History of bleeding tendency
* History of alcohol or drug abuse
* Participation to another trial with an investigational drug within 4 months prior to the trial
* Whole blood donation more than 400 ml within 3 months prior to the trial
* Whole blood donation more than 100 ml within 1 month prior to the trial
* Donation of constituent of blood of more than 400 ml within 1 month prior to the trial
* Any medication which might influence the results of the trial within 10 days prior to the trial
* Excessive physical activities within 7 days prior to the trial
* Alcohol drinking within 3 days prior to the trial
* History of orthostatic hypotension, fainting spells or blackouts
* Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study

Primary outcomes:
measure: Cmax (maximum observed concentration of the analyte in plasma)
timeFrame: up to day 8
measure: AUC 0-τ (Area under the concentration time curve in plasma from zero time to 24 hours after 7-day administration)
timeFrame: up to day 8
Secondary outcomes:
measure: Tmax (Time to reach Cmax)
timeFrame: up to day 8
measure: T1/2 (Terminal half-life in plasma)
timeFrame: up to day 8
measure: MRT 0-τ (Mean residence time in the body after 7-day administration)
timeFrame: up to day 8
measure: Cτ (Concentration of the analyte in plasma 24 hours after 7-day administration)
timeFrame: up to day 8
measure: Number of patients with adverse events
timeFrame: up to 20 days after final administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01047475: A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer (FDA IND 103675)
Official title: A Phase II Trial of MB-6 Plus FOLFOX4 for Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: MB-6
FOLFOX4
Metastatic Colorectal Cancer
Lead sponsor: Microbio Co Ltd
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 72
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: This is a randomized, double-blind, parallel group, placebo-controlled study evaluate the preliminary efficacy and safety of MB-6 (320 mg/capsule, 6 capsules tid) versus placebo in addition to standard chemotherapy in the treatment of patients with metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Patient with histologically confirmed colorectal cancer and/or clinical evidence of metastasis;
2. At least one measurable lesion either by computer tomography (CT) scan or magnetic resonance imaging (MRI);
3. Aged 20 years old or above;
4. Eastern Cooperative Oncology Group (ECOG) performance status \< 2;
5. Adequate bone marrow reserve (hemoglobin \> 9 g/dl, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L);
6. Adequate renal and hepatic functions: total bilirubin \< 1.25 x upper normal limit, creatinine \< 1.25 x upper normal limit, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5 x upper normal limit;
7. Patients willing to participate in the trial and giving written informed consent.

Exclusion Criteria:

1. Pregnant or lactating patients;
2. Patients (male or female) with reproductive potential not using adequate contraceptive measures;
3. Patients with evidence of central nervous system metastasis;
4. Subject with active infection which requires systemic treatment of antibiotic, antifungal, or antiviral agents
5. Current history of chronic diarrhea;
6. Other serious illness or medical conditions (e.g.: history of angina, myocardial infarction);
7. History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
8. Concurrent treatment with any other anticancer therapy;
9. Patients with congestive heart failure (New York Heart Association Functional Classification III or IV), epilepsy, or other significant medical conditions as judged by the investigator;
10. Patients treated with another investigational drug within 4 weeks of entry into this study.

Primary outcomes:
measure: The Primary Efficacy Endpoint of This Study is the Best Overall Response (Complete Response + Partial Response)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Microbio Co., Ltd.
Study officials:
affiliation: China Medical University Hospital
name: William Chen, B.S.
role: PRINCIPAL_INVESTIGATOR
References: