louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03432455: Incidence and Prevalence of Juvenile Dermatomyositis
Official title: Incidence and Prevalence of Juvenile Dermatomyositis in Alsace Between 2000 to 2015
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Juvenile Dermatomyositis
Keywords: Incidence
prevalence
epidemiology
juvenile dermatomyositis
inflammatory myopathy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 22
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975

Brief summary: This is a descriptive, retrospective, multi-center, cross-sectional and observational epidemiological study of incidence and prevalence of juvenile dermatomyositis in Alsace from 2000 to 2015. Alsace is a French region with a low migratory flow


Eligibility criteria: Inclusion Criteria:

* Age under 16 years
* Have a dermatomyositis according to the diagnostic criteria of Bohan and Peter of 1975

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Identify incident and prevalent cases of juvenile dermatomyositis according to Bohan and Peter's criteria at january 1st, 2016 via capture/recapture strategy
timeFrame: The period from from January 1st, 2000 to December 31st, 2015 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Dermatologie
Study officials:
References:
Clinical trial NCT01994655: Chinese Health Ivvestigation Of Nurse Aging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hot Flashes
Keywords: climacteric symptoms
menopause
nurses
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Climacteric symptoms can be treated by doing exercise,not hormone replacement therapy.

Detailed description: Hormone replacement therapy(HRT) is the main therapy to climacteric symptoms. But HRT also has a lot of disadvantages, such as cardiovascular disease, breast cancer .In our previous investigation,we found that doing exercise is helpful for climacteric symptoms.So we want to make a detailed investigation to research it.

Eligibility criteria: Inclusion Criteria:

- Women aged 40-55 who has climacteric symptoms

Exclusion Criteria:

- Women who have serious climacteric symptoms and other diseases which could interrupt the research.

Primary outcomes:
measure: KMI
timeFrame: up to 2 years
Secondary outcomes:
measure: blood lipid
timeFrame: up to 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04061850: Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma
Official title: Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma: Multicenter Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mantle Cell Lymphoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aged ≥ 19 years, relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation

Brief summary: To review the efficacy and the safety of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL).

Detailed description: # Background and Rationale Mantle cell lymphoma (MCL) is a rare subtype of lymphoma, accounting for about 3-6% of all non-Hodgkin's lymphoma. It is clinically prevalent in the elderly and men, commonly with gastrointestinal tract involvement. Since about 80% of patients present with advanced stage disease at diagnosis, the prognosis is very poor. Mantle cell lymphoma is less frequent in Korean than in Western countries, accounting for about 2% of all non-Hodgkin's lymphoma cases, with very poor treatment outcome as Western countries.

In Korea, the clinical information about patients with MCL is very scarce so far and does not reflect recent treatment patterns. Firstly, the incidence in Korea is relatively lower than that in Western countries, with only about 100 patients a year. Secondly, due to substandard national health insurance regulations in Korea, it was not until recently that ibrutinib for relapsed/refractory MCL was approved for coverage by the National Health Insurance. In this context, the study was designed to investigate the efficacy and safety of ibrutinib in patients with relapsed or refractory MCL in Korea.

Eligibility criteria: Inclusion Criteria:

* Patients with MCL diagnosed by a pathologist (based on the WHO 2017 classification)

  1. mantle cell lymphoma
  2. leukemic nonnodal mantle cell lymphoma
  3. in situ mantle cell neoplasia
* Aged ≥ 19 years
* Relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation

Exclusion Criteria:

* Patients whose clinical and pathological data are not available
* Patients who were not treated with ibrutinib

Primary outcomes:
measure: Progression free survival period
timeFrame: Up to 3 years, From the date of diagnosis with MCL to the date of relapse/disease progression, or last follow-up date
Secondary outcomes:
measure: Overall response rate
timeFrame: Up to 3 years, From the date of diagnosis with MCL to the date of death, or last follow-up date
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Study officials:
affiliation: Samsung Medical Center
name: Won Seog Kim, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05705050: Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy
Official title: Effect of Intraoperative Aminophylline Infusion on Pain Intensity After Ureterocopic Lithotripsy Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aminophylline
Pain
Ureterocopic Lithotripsy
Keywords: Aminophylline
Postoperative Pain
Ureterocopic Lithotripsy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to evaluate the effect of intraoperative systemic aminophylline infusion on pain intensity in patients undergoing ureteroscopic lithotripsy surgeries with ureteric stent placement at the end of the procedure.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 to 50 years
* American society of anesthesiology (ASA) physical status I - II
* Body mass index (BMI) less than 30.0 kg/m2
* Scheduled for ureteroscopic lithotripsy surgery with D-J ureteric stent placement at the end of procedure
* Under general anesthesia.

Exclusion Criteria:

1. Patients with central nervous system diseases, cardiovascular diseases, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
2. Pregnancy or lactation.
3. Patients with a history of allergy to aminophylline.
4. Coffee consumption (more than 2 cups/day)
5. Patients with opioid addiction or patients treated with B agonists, tranquilizers, or antidepressants.
6. Short procedures less than 30 minutes or procedures not requiring D-J stent placement.

Primary outcomes:
measure: Intensity of pain
timeFrame: In post anesthesia care unit (PACU)
Secondary outcomes:
measure: Intensity of pain
timeFrame: 24 hour after surgery
measure: Total amount of opioid dose
timeFrame: 24 hour after surgery
measure: The incidence of postoperative adverse reactions
timeFrame: 24 hour after surgery
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbiaa
Study officials:
References:
Clinical trial NCT06301750: Oral Enteral Nutrition Feeding in Alzheimer's Patients
Official title: A Randomly Controlled Study to Explore Oral vs Nasal Enteral Nutrition Feeding in Alzheimer's Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Ahmadu Bello University Teaching Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

Detailed description: The Alzheimer's disease in the elderly exhibits the high prevalence.This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

Eligibility criteria: Inclusion Criteria:

* age between 18 years and 85 years, meeting the diagnosis of Alzheimer's Disease.
* presence of no contraindication for enteral nutrition.
* with dysphagia verified by Imaging materials.
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications
* Minimum Mental State Examination ranging from 10-26

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders.
* complicated with other intracranial lesions, such as stroke.
* abnormal structure of swallowing-related organ and tissue.

Primary outcomes:
measure: Level of Hemoglobin
timeFrame: day 1 and day 15
measure: Level of Serum albumin
timeFrame: day 1 and day 15
measure: Level of Total serum protein
timeFrame: day 1 and day 15
measure: Level of Serum prealbumin
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Body Mass Index
timeFrame: day 1 and day 15
measure: Pulmonary Infections
timeFrame: day 1 and day 15
measure: Mini Nutritional Assessment
timeFrame: day 1 and day 15
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis, Master
role: STUDY_CHAIR
References:
Clinical trial NCT02013050: A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
Official title: A Phase 2,Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 For the Attenuation of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Mucositis
Lead sponsor: Soligenix
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 111
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: To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
* Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
* Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study

Exclusion Criteria:

* Current mucositis.
* Prior radiation to the head and neck.
* Chemotherapy treatment within the previous 12 months.
* Tumors of the lips, sinuses, salivary glands or nasopharynx.
* Unknown primary tumor.
* Stage 4c metastases.
* Evidence of significant hepatic, hematologic, or immunologic disease.
* Women who are pregnant or breast-feeding.

Primary outcomes:
measure: Duration of Severe Oral Mucositis (SOM)
timeFrame: 4 weeks after end of therapy
Secondary outcomes:
measure: Residual Severe Oral Mucositis (SOM)
timeFrame: 4 weeks after end of therapy
measure: Duration of Severe Oral Mucositis (SOM)
timeFrame: 4 weeks after end of therapy
measure: Incidence of Clinically Reported, Non-fungal Infections
timeFrame: 4 weeks after end of therapy
measure: Percent of Patients With RECIST 1.1 Classification of "Complete Response"
timeFrame: 4 weeks after end of therapy
measure: Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin
timeFrame: 4 weeks after end of therapy
measure: Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin
timeFrame: 4 weeks after end of therapy
measure: Survival
timeFrame: 12 months after end of therapy
measure: Percent of Patients With RECIST 1.1 Classification of "Complete Response"
timeFrame: 12 months after end of therapy
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Markey Cancer Center-University of Kentucky
state: Kentucky
Study officials:
References:
Clinical trial NCT06213350: Athlete Needs Assessment & Focus Groups
Official title: Athlete Needs Assessment & Focus Groups
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Athlete Support
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Current and previous collegiate athletes over the age of 18 and within two years before leaving sport or within five years after leaving sport.

Brief summary: The overall objective of this study is to investigate various physical and mental health needs of collegiate athletes and how they differ in and out of sport. Researchers aim to identify facets of support that athletes may need when transitioning out of sport. To achieve this objective, the study is broken down into two specific parts: 1) an online, anonymous survey assessing 200 athletes to evaluate support needed both during and post sport, quantitatively; and 2) focus groups with 50 athletes who are about to retire or have retired from sport recently to evaluate support needed both during and post sport, qualitatively.


Eligibility criteria: Inclusion Criteria:

* Current and previous collegiate athletes over the age of 18 and within two years before leaving sport or within five years after leaving sport.

Exclusion Criteria:

* Athletes under the age of 18 and not within two years before or five years after leaving sport will be excluded.

Primary outcomes:
measure: Qualitative Feedback
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT03942250: Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
Official title: Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidermolysis Bullosa
Chronic Skin Ulcer
Keywords: Epidermolysis Bullosa
Amniotic membrane
Lead sponsor: Egyptian Atomic Energy Authority
Sponsor class: OTHER_GOV
Collaborators: name: Waleed Nemr,Egyptian Atomic Energy Authority
First posted: 2019-05-08
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.

Detailed description: Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), under commercial name REGE pro.

Eligibility criteria: Inclusion Criteria:

1- Patients diagnosed as EB wounds must be chronic

Exclusion Criteria:

1. Patients Must stop other line of treatment
2. Exclude patients have:

   1. Autoimmune diseases
   2. Diabetes

Primary outcomes:
measure: Lesion area
timeFrame: 6 weeks
measure: Clinical progression sings
timeFrame: 6 weeks
Secondary outcomes:
measure: Patient complain (upon the weekly questionnaire)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Amniotic tissue lab
Study officials:
affiliation: NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY
name: Nashwa K Radwan, PhD
role: STUDY_DIRECTOR
References:
citation: Nemr W, Bashandy AS, Araby E, Khamiss O. Biological Activity Alterations of Human Amniotic Membrane Pre and Post Irradiation Tissue Banking. Pak J Biol Sci. 2016;19(7):289-298. doi: 10.3923/pjbs.2016.289.298.
citation: Lo V, Lara-Corrales I, Stuparich A, Pope E. Amniotic membrane grafting in patients with epidermolysis bullosa with chronic wounds. J Am Acad Dermatol. 2010 Jun;62(6):1038-44. doi: 10.1016/j.jaad.2009.02.048.
Clinical trial NCT01298050: Refractory IHCA and OHCA Treated With ECMO
Official title: Refractory In and Out of Hospital Cardiac Arrest Treated With Extracorporeal Membrane Oxygenation. Observational, Single Centre, Prospective Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrest
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: Ospedale San Gerardo. S.S.U.E.M. 118 Brianza
name: Ospedale San Gerardo. Terapia Intensiva Cardiochirurgica
First posted: 2011-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 18-75 years old, community sample

Brief summary: Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted the potential early application of this method in improving the prognosis of prolonged cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The rationale for use of ECMO in these patients is to optimize early perfusion of vital organs, curing the cause of CA and waiting for the recovery of the injured myocardium. The investigators have created a flow-chart to decide which patients are eligible. The aims of this study are to evaluate if, with this flow-chart, the investigators are able to detect which patients have more probability of survival.


Eligibility criteria: Inclusion Criteria:

* Adults 18-75 years old
* In and out of hospital Witnessed Cardiac Arrest
* No-flow time \< 5 min. or VF,VT,TP as rhythm of presentation
* Low-flow time \< 45 min.
* End Tidal CO2 \> 10 after 20 min.of CPR

Exclusion Criteria:

* Comorbidities such:
* Terminal Malignancy
* Aortic Dissection
* Severe Cardiac Failure without transplant indication
* Severe Aortic Valve Failure
* Known Severe Peripheral arteriopathy

Primary outcomes:
measure: 28 days survival
timeFrame: 28 days
Secondary outcomes:
measure: Neurologic recovery
timeFrame: 28 days
measure: Cardiac recovery
timeFrame: 28 days
measure: Six months survival with minimal neurologic impairment
timeFrame: 180 days
Other outcomes:
Locations:
city: Monza
country: Italy
facility: San Gerardo Hospital
state: MB
Study officials:
affiliation: Ospedale San Gerardo
name: Leonelllo Avalli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00169650: Laparoscopic Pyeloplasty Registry and Database
Official title: Laparoscopic Pyeloplasty: A Registry and Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureteral Obstruction
Keywords: UPJ Obstruction
Renal Obstruction
Delayed Renal Flow
Lead sponsor: Indiana Kidney Stone Institute
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 64
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: Subjects undergoing laparoscopic pyeloplasty for ureteropelvic junction obstruction

Brief summary: The gold standard for the treatment of ureteropelvic junction obstruction (UPJO) is the open pyeloplasty. As a minimally invasive alternative, many centers are currently offering laparoscopic pyeloplasty (LP) as primary therapy for UPJOs. Recent data has shown that laparoscopic pyeloplasty has comparable success rates to open pyeloplasties and produces durable results. The researchers are compiling a registry and database to review outcomes of laparoscopic pyeloplasty patients.


Eligibility criteria: Inclusion Criteria:

* Male or female patients of Methodist Urology in Indianapolis, IN over the age of 18 with ureteropelvic junction obstruction

Exclusion Criteria:

* Patients unable to give informed consent
* Patients with active bleeding diatheses
* Women who are pregnant or in whom pregnancy status cannot be confirmed
* Patients with medical conditions precluding laparoscopy
* Patients with active urinary tract infection

Primary outcomes:
measure: To record and review the surgical outcomes of our population of UPJO patients who have been treated with LP. Once all retrospective data has been reviewed, we will continue to collect outcome data on a prospective basis
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
Study officials:
affiliation: IU Health Physicians Urology
name: James E Lingeman, MD
role: PRINCIPAL_INVESTIGATOR
References: