louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01167439: Dysphagia in Oculopharyngeal Muscular Dystrophy (OPMD)- Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up
Official title: Dysphagia in Oculopharyngeal Muscular Dystrophy. Evaluation, Endoscopic Examination of Swallowing, Treatment and Long Term Follow up.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dysphagia
Keywords: OPMD, dysphagia
Dysphagia severity
Nutritional state
Speech quality
Upper esophageal sphincter myotomy
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in order to identify the best candidates and the proper timing to perform dysphagia alleviating procedures in both heterozygote and homozygote patients from the large pool of cases with this disease in Israel.

Detailed description: Clinical evaluation of patients suspected of having OPMD. Genetic confirmatory tests (diagnostic DNA test) at the genetic unit in Afula Hospital. Clinical follow-up with endoscopic fiber optic evaluation of swallowing. Pre-operative assessment. Crycopharyngeal myotomy intervention in selected patients. Nutrition follow-up.

Eligibility criteria: Inclusion Criteria:

* heterozygote and homozygote OPMD patients

Exclusion Criteria:

-

Primary outcomes:
measure: Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty.
timeFrame: at least 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: POB 169, Hadera
country: Israel
facility: Israel National Center for OPMD and Dysphagia, HYMC
Study officials:
References:
Clinical trial NCT06887439: Association of EASIX in Sepsis
Official title: Association of Endothelial Activation and Stress Index With Mortality and Poor Prognosis in Sepsis: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Septic Shock
Septic Syndrome
Keywords: sepsis
septic shock
endothelium
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥18 years old) diagnosed with sepsis were included.

Brief summary: This prospective study aims to determine the relationship between the EASIX score and mortality and prognosis in sepsis.

Detailed description: Sepsis is a life-threatening condition characterized by a dysregulated host response to infection, leading to organ dysfunction. Despite advancements in medicine, sepsis remains a significant cause of death worldwide. An international study showed that 48.9 million sepsis cases were diagnosed in 195 countries between 1990 and 2017, resulting in 11 million deaths. Recent studies have demonstrated that early diagnosis and treatment reduce sepsis mortality. Therefore, research has focused on identifying biomarkers that aid in early diagnosis and prognosis.

The Endothelial Activation and Stress Index (EASIX) was first defined by Luft et al. as a biomarker reflecting endothelial damage. Calculated using readily available laboratory parameters-serum lactate dehydrogenase (LDH) level (U/L) x creatinine level (mg/dL) / platelet count (10⁹/L)-it has been commonly used to predict mortality and prognosis in hematological malignancies. Recently, its application in predicting sepsis mortality and prognosis has gained attention, although only limited retrospective studies have been published.

Eligibility criteria: Inclusion Criteria:

* • Patients diagnosed with sepsis during intensive care admission or admitted to intensive care with a diagnosis of sepsis

  * All patients over the age of 18

Exclusion Criteria:

* • Patients under the age of 18

  * Patients with a history of multiple intensive care admissions
  * Patients who died within 24 hours of diagnosis
  * Patients diagnosed with CRF or currently treated for ARF
  * Patients with deficient serum creatinine, LDH and platelet values at the time of diagnosis Patients for whom consent could not be obtained from themselves or their relatives

Primary outcomes:
measure: mortality
timeFrame: 28 days
Secondary outcomes:
measure: Septic shock
timeFrame: 28 days
measure: Acute kidney injury
timeFrame: 28 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli etfal research and training hospital
Study officials:
affiliation: şişli etfal eğitim araştırma hastanesi
name: AYSE SURHAN CINAR
role: STUDY_CHAIR
References:
Clinical trial NCT03491839: A Modeling of Changes in Tidal Volume With Concentration of Inhalational Anesthetics
Official title: A Modeling of Changes in Tidal Volume With Concentration of Inhalational Anesthetics Under General Anesthesia Using Laryngeal Mask Airway
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 50
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children under general anesthesia

Brief summary: modelling of tidal volume with inhalational anesthetic concentration

Detailed description: The investigators would like to develop the modelling of tidal volume with inhalational anesthetic concentration during spontaneous breathing during general anesthesia in children

Eligibility criteria: Inclusion Criteria:

- general anesthesia

Exclusion Criteria:

-

Primary outcomes:
measure: concentration
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02089139: Treatment of Discogenic Back Pain
Official title: Intradiscal Injection of Gelified Ethanol for the Treatment of Discogenic Back Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Discogenic Back Pain
Keywords: Back pain
Discogel
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Gelscom SAS
First posted: 2014-03-17
Enrollment: 40
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: Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is mainly based on MR imaging, showing MODIC I or II changes in patients with concordant symptomatology. The treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects.

In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in patients with disabling discogenic pain is assessed.


Eligibility criteria: Inclusion Criteria:

* MR imaging : MODIC 1or MODIC 2 changes limited to one single lumbar disc;
* X rays: normal disc height, no instability;
* Back pain for at least 3 months, without argument for another etiology;
* Mean pain on 5 days VAS ≥ 5

Exclusion Criteria:

* age \<18 years or \> 50 ; concomitant radicular pain ;
* psychiatric pathology that may modify the perception or the evolution of pain;
* MR imaging: multi-level discopathy, MODIC 3 changes;
* X ray: loss of disc height \> 50%, segmental instability;
* previous history of lumbar surgery with or without instrumentation.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Six months after the procedure.
Secondary outcomes:
measure: Visual Analog Scale (VAS),
timeFrame: one month, three months, six months and 1 year after the procedure
measure: Oswestry Disability Index (ODI)
timeFrame: one month, three months, six months and 1 year after the procedure
measure: Euroqol score
timeFrame: month, three months, six months and 1 year after the procedure
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU Limoges
Study officials:
affiliation: University Hospital, Limoges
name: CAIRE François, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000239: Buprenorphine Pharmacology Related to Addiction Treatment - 21
Official title: Buprenorphine Pharmacology Related to Addiction Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Vermont
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if chronic buprenorphine administration will generate supersensitivity to opiates.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Opioid agonist effects
measure: Opiate withdrawal
measure: Physiological changes in: pupil diameter, blood pressure, heart rate, respiration
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bickel, Amass (1995 Experimental & Clinical Psychopharmacology. 3: 477-489 Amass et al 91996) Journal of Substance Abuse Treatment. 13: 43-49 Madden et al., (1997) Experimental & Clinical Psychopharmacology. 5: 1-7. Bickel, Amass (1995) Experimental & Clinical Psychopharmacology. 3: 477-489. Amass et al., (1996) Journal of Substance Abuse Treatment. 13:43-49. Madden et al., (1997) ) Experimental & Clinical Psychopharmacology. 5:1-7.
Clinical trial NCT05023239: Ultrasound-Guided Suprazygomatic Maxillary Nerve Block as A Part of Multimodal Analgesic Regimens
Official title: The Effect of Ultrasound-Guided Suprazygomatic Maxillary Nerve Block for Minimize the Post-operative Pain in Tonsillectomy Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Suprazygomatic Maxillary Nerve Block
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Inadequate peri-operative analgesia may contribute to an increased risk of bleeding, suture dehiscence and unacceptable surgical outcomes. Moreover, these patients are at high risk of postoperative airway obstruction and respiratory failure.

Opioids may contribute to these complications. Appropriate use of regional anaesthesia may mitigate or eliminate many of these concerns. The maxillary nerve is responsible for the sensory innervation of the midface, including the hard and soft palates, upper jaw, upper dental arch and upper lip.Recently, the successful use of maxillary nerve block by the suprazygomatic approach has been reported in children undergoing cleft palate surgery. However, the use of this block has not been described in large series of patients, and the effectiveness of the suprazygomatic approach has not been evaluated in patients undergoing tonsillectomy .


Eligibility criteria: * Inclusion criteria

  1. Pediatric patients aged 4-12 years
  2. Genders eligible for study: both sexes
  3. ASA physical status I and II
  4. Undergoing tonsillectomy surgery

     Exclusion criteria
* Parents' refusal
* Contraindications to regional anesthesia
* Known allergy to local anesthetics
* Bleeding disorders
* Children with diabetes mellitus, obstructive sleep apnea syndrome, cardiac, renal, liver or blood diseases, swallowing disorders or peritonsillar abscess,
* Children receiving regular analgesia within the last week before surgery,
* Children undergoing simultaneous procedure in the field of surgery like adenoidectomy or tongue tie will be all excluded from the study.

Primary outcomes:
measure: postoperative Meperidine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: incidence of complication
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01554839: The Family of Heroes: an Evaluation of an Online Educational Tool
Official title: The Family of Heroes Program for Veterans and Their Families: An Evaluation of an Online Educational Tool for Helping Veterans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
PTSD
Lead sponsor: Department of Veterans Affairs, New Jersey
Sponsor class: FED
First posted: 2012-03-15
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of a unique web based educational tool called "Family of Heroes," which is designed to educate families about Post Traumatic Stress Disorder (PTSD) and provide them with practical tools for interacting with affected veteran family members. The study includes veterans and a family member of their choosing. Participants are randomly assigned to a group which takes the online training or a group that does not take the training. Both groups complete a baseline questionnaire and a follow up questionaire 60 days later. The study will examine the number of Veteran Affairs (VA) mental health visits.


Eligibility criteria: Inclusion Criteria:

* Male or female Operation Iraqi Freedom/ Operation Enduring Freedom (OIF/OEF) veteran
* Positive for PTSD, based on PTSD Checklist (PCL) score greater than or equal to 50
* Availability of a family member who is both willing to participate in the study AND has contact with the veteran 3 or more times per week
* Ability to access a computer with internet access to take educational training and surveys

Exclusion Criteria:

* Not and OIF/OEF veteran
* Negative for PTSD, based on PCL score less than 50
* Unavailability of a family member who is both willing to participate in the study or has contact with the veteran 3 or more times per week
* Inability to access a computer with internet access to take the educational training and surveys

Primary outcomes:
measure: Mental Health Treatment Engagement
timeFrame: 6 months post enrollment
Secondary outcomes:
measure: Change in Perceived Criticism Score
timeFrame: Baseline and 2 months
measure: Change in Family Empowerment Scale Score
timeFrame: Baseline and 2 months
Other outcomes:
Locations:
city: Lyons
country: United States
facility: VANJHCS (Veterans Administration New Jersey Health Care Services)
state: New Jersey
Study officials:
affiliation: Department of Veteran Affairs, New Jersey
name: Alejandro Interian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Interian A, Kline A, Perlick D, Dixon L, Feder A, Weiner MD, Goldstein MF, Hennessy K, St Hill L, Losonczy M. Randomized controlled trial of a brief Internet-based intervention for families of Veterans with posttraumatic stress disorder. J Rehabil Res Dev. 2016;53(5):629-640. doi: 10.1682/JRRD.2014.10.0257.
Clinical trial NCT00925639: Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
Official title: Effects of the Concentrated Extract of Soy on Coagulation Factors After Menopause
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Menopause
Keywords: phytoestrogen
coagulation
menopause
ddimer
antithrombin
hypercoagulation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-06-22
Enrollment: 84
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypoestrogenism, common in menopause, is responsible for systemic and metabolic changes affecting women's wellness, favoring hot flashes, urogenital atrophy and bone mass loss. Hormone reposition therapy (HRT) with estrogen or estrogen associated to progesterone is administered to minimize these effects. Meanwhile, the beneficial effects of HRT are known, there is still concern about its adverse effects such as thromboembolic and cardiovascular effects, increased risk of breast and endometrial cancer. Thus, there is an increasing interest in the development of phytohormonal HRT. The aim of the investigators' study is to evaluate the effects of concentrated extract of soy on hypercoagulation markers in menopausal women.


Eligibility criteria: Inclusion Criteria:

* \> 1 year of amenorrhea
* 45 to 65 years old
* without hormone reposition treatment or herbal medications in the 6 months preceding the research

Exclusion Criteria:

* history of thromboembolism
* history of cardiovascular disease
* presence of estrogen dependent neoplasia
* presence of abnormal genital bleeding
* uncontrolled metabolic diseases
* smoking or drinking habits
* use of anticoagulants or acetyl salicylic acid

Primary outcomes:
measure: Concentration of serum DDimer
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Ambulatório de Ginecologia Endócrina
Study officials:
affiliation: Universidade Federal de São Paulo
name: Mauro A Aidar, M.D., PhD.
role: STUDY_CHAIR
References:
Clinical trial NCT00362739: Blood Collection From Individuals With Lung Disease for Genetic Studies
Official title: Collection of Blood for Gene Expression/Genomic Studies in Individuals With Chronic Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
COPD
Interstitial Lung Disease
Cystic Fibrosis
Lung Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2006-08-10
Enrollment: 3087
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals visiting the Starr-5 Pulmonary, Critical Care Unit, and 5 West floor for standard clinical care will be recruited. Controls will be obtained from volunteers without a history of lung disease.

Brief summary: This is a research study where researchers are collecting blood to evaluate the genetic characteristics of individuals with chronic lung diseases, including asthma, chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, and lung cancer.

Detailed description: The investigators hope to be able to identify an association between a genetic make-up in the blood samples and the risks of developing a particular lung disease, or severity of a lung disease. The findings of this study might be important to develop future preventative methods and potential treatments for the management of lung disease. The investigators aim to collect blood samples from 300 people with lung disease and 300 controls over 5 years.

Eligibility criteria: Inclusion Criteria:

* Must provide informed consent
* Males and females, age 18 years and older
* Lung disease proven by at least one of the following:

  * symptoms consistent with pulmonary disease
  * chest X-rays consistent with lung disease
  * pulmonary function tests consistent with lung disease
  * lung biopsy consistent with lung disease
  * family history of lung disease
  * disease of organs with know associated with lung disease
  * individuals suspected of history of lung disease based on history and/or physical examination
  * normal controls (individuals without history of lung disease) to be sampled to provide a comparison to the lung disease cohort.

Exclusion Criteria:

* Drug and/or alcohol abuse within the past six months
* Females who are pregnant or nursing

Primary outcomes:
measure: Establish a set of normal ranges for various parameters in healthy individual specimens and compare to specimens from individuals with lung disease to determine parameters resulting in disease susceptibility and severity.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital -- Weill Cornell Medical College of Cornell University
state: New York
Study officials:
affiliation: The New York Presbyterian Hospital -- Weill Medical College of Cornell University
name: Ronald G Crystal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912639: A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer
Official title: A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Recurrent Breast Cancer
Keywords: recurrent breast cancer
Genexol-PM
Lead sponsor: Korean Breast Cancer Study Group
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 90
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 purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).

Detailed description: Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.

Eligibility criteria: Inclusion Criteria:

1. Women aged \>=18 years
2. WHO (ECOG) performance status 0-2
3. Estimated life expectancy of \>=3 months
4. Have given written informed consent and are available for prolonged follow-up

Exclusion Criteria:

1. Patients with previous chemotherapy for recurrent breast cancer
2. Breast cancer recurrence within 12 months after taxane treatment
3. Her-2/neu expression
4. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
5. Brain metastasis
6. uncontrolled infection, medically uncontrollable heart disease
7. other serious medical illness or prior malignancies
8. Pregnant or lactating women were excluded.

Primary outcomes:
measure: Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
timeFrame: 1 year
Secondary outcomes:
measure: Toxicity
timeFrame: 1 year
measure: Progression Free Survival
timeFrame: 1 year
measure: Tumor control rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of surgery, The Catholoic university of Korea, St. Mary's hospital.
Study officials:
affiliation: The Catholoic university of Korea, St. Mary's hospital.
name: Byung-Joo Song, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References: