louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02794025: The Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis
Official title: The Effect of Esmolol on Tissue Perfusion and Clinical Prognosis of Patients With Severe Sepsis: a Prospective Cohort Study .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Sepsis
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effect of esmolol on hemodynamic parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis

Detailed description: enrollment:151 patients

Inclusion criteria: (1) age \> 18 years; (2) severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock, who (3) mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg; and (4) satisfactory sedation and analgesic treatment, with HR \> 100 bpm.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years;
* severe sepsis (acute organ dysfunction secondary to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment Guidelines for Severe Sepsis and Septic Shock,
* mechanical ventilation via endotracheal intubation with a tidal volume of 6 mL/kg;
* satisfactory sedation and analgesic treatment, with HR \> 100 bpm.

Exclusion Criteria:

* pre-existing cardiac dysfunction, valvular heart disease, high-degree atrioventricular block;
* acute or chronic pulmonary heart disease;
* a history of serious asthma;
* chronic renal insufficiency;
* cancer, autoimmune diseases, or contraindications for placement of deep venous catheter;
* insulin-dependent diabetes.

Primary outcomes:
measure: The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fujian Provincial Hospital
name: Rongguo Yu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005425: Statistical Analysis of Vlagtwedde-Vlaardingen Data Set
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases, Obstructive
Chronic Obstructive Pulmonary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the effects in early adulthood of asthma, increased bronchial responsiveness, markers of allergy and smoking on pulmonary function level and the effects of these same risk factors on subsequent decline in pulmonary function, because these early adult factors presumably profoundly influence the risk for chronic obstructive pulmonary disease.

Detailed description: DESIGN NARRATIVE:

The questions studied included whether the above named risk factors reduced the maximally attained level of pulmonary function in early adulthood, foreshortened the postulated stability of level of pulmonary function between age 18 and 35 and/or unfavorably affected subsequent decline in level of pulmonary function. FEV1/h2, VC/h2 and FEV1/IVC were studied, using graphic smooth techniques and regression analyses techniques on both cross-sectional and longitudinal datasets. In addition, the investigators tested the hypothesis stating that early adult symptoms of asthma, increased bronchial responsiveness, markers of allergy influenced who became a smoker, influenced the amount smoked and/or influenced who stopped smoking relatively early in adult life, using logistic regression analyses and survival analyses.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Shimada M, Matsumata T, Itasaka H, Shirabe K, Taketomi A, Sugimachi K. The prediction of portal pressure: a multivariate analysis of clinical data and intraoperative portal pressure. Surg Today. 1994;24(4):309-12. doi: 10.1007/BF02348558.
citation: Xu X, Weiss ST, Dockery DW, Schouten JP, Rijcken B. Comparing FEV1 in adults in two community-based studies. Chest. 1995 Sep;108(3):656-62. doi: 10.1378/chest.108.3.656.
citation: Rijcken B, Schouten JP, Xu X, Rosner B, Weiss ST. Airway hyperresponsiveness to histamine associated with accelerated decline in FEV1. Am J Respir Crit Care Med. 1995 May;151(5):1377-82. doi: 10.1164/ajrccm.151.5.7735588.
citation: Xu X, Laird N, Dockery DW, Schouten JP, Rijcken B, Weiss ST. Age, period, and cohort effects on pulmonary function in a 24-year longitudinal study. Am J Epidemiol. 1995 Mar 15;141(6):554-66. doi: 10.1093/oxfordjournals.aje.a117471.
Clinical trial NCT00664625: A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects
Official title: Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-791325 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-04-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 in subjects with chronic hepatitis C infection


Eligibility criteria: Inclusion Criteria:

* Chronically infected with HCV genotype 1
* Treatment naive or treatment non-responders or treatment intolerant
* HCV RNA viral load of ≥10\*5\* IU/mL
* BMI 18 to 35 kg/m²

Exclusion Criteria:

* Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
* Co-infection with HIV or HBV

Primary outcomes:
measure: Safety Outcome Measures
timeFrame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose
Secondary outcomes:
measure: Pharmacokinetic Measures
timeFrame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose
measure: Pharmacodynamic Measures
timeFrame: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Res Inst
state: California
city: Cypress
country: United States
facility: West Coast Clinical Trials, Llc
state: California
city: St. Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Buenos Aires
country: Argentina
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Sims KD, Lemm J, Eley T, Liu M, Berglind A, Sherman D, Lawitz E, Vutikullird AB, Tebas P, Gao M, Pasquinelli C, Grasela DM. Randomized, placebo-controlled, single-ascending-dose study of BMS-791325, a hepatitis C virus (HCV) NS5B polymerase inhibitor, in HCV genotype 1 infection. Antimicrob Agents Chemother. 2014 Jun;58(6):3496-503. doi: 10.1128/AAC.02579-13. Epub 2014 Apr 14.
Clinical trial NCT03268525: The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy
Official title: The Effect of Local Anesthesia on Postoperative Pain in Vaginal Hysterectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain, Postoperative
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-08-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Drug group versus placebo group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators aim is to study the effect of pre-operative local anesthetic on post vaginal hysterectomy pain.

Detailed description: This is a double-blinded, randomized, controlled trial. Women who undergone elective vaginal hysterectomy and gave their informed consent were included. Exclusion criteria included additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.

Solutions of either Bupivacaine-Hydrochloride 0.5%, or Sodium-Chloride 0.9% as a placebo, were prepared prior to surgery, according to randomization. The chosen solution was injected before incision, as a modified paracervical block, and in each resection line (sacro-uterine and cardinal ligaments). The amount of fluid administered was 10 ml. When colporrhaphy was also performed, an additional 5 ml of solution were injected in the midline of the vaginal wall prior to each incision line.

By utilizing the 10 cm Visual-analogue-scale (VAS) we examined the differences in post-operative pain at rest at 3, 8, and 24 hours, and during ambulation at 8 and 24 hours using multivariate linear regression models. We also assessed the differences in analgesics given at the different time points between the groups using multivariate negative binomial regression models.

Eligibility criteria: Inclusion Criteria:

* Elective vaginal hysterectomy on benign indication

Exclusion Criteria:

additional abdominal, chronic pelvic pain, malignancy, and allergy to Bupivacaine.

Primary outcomes:
measure: Pain at movement
timeFrame: 24 hours
Secondary outcomes:
measure: pain at rest
timeFrame: 24 hours
Other outcomes:
Locations:
city: H̱olon
country: Israel
facility: Wolfson medical center
Study officials:
affiliation: Wolfson Medical Center
name: Shimon Ginat, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00420225: Mesh Repair of Anterior Vaginal Wall Prolapse
Official title: Low-Weight Polypropylene Mesh for Anterior Vaginal Wall Prolapse: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anterior Vaginal Wall Prolapse
Keywords: Cystocele
surgery
mesh
genital prolapse
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 202
Sex: FEMALE
Minimum age (years): 50
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 determine whether reenforcement with polypropylen mesh compared with traditional anterior colporrhaphy for anterior vaginal wall prolapse results in fewer recurrences.

Detailed description: Anterior vaginal wall prolapse is the most common type of pelvic organ prolapse in postmenopausal women. This anatomic defect has traditionally been repaired with anterior colporrhaphy plication, a series of interrupted stitches being the main surgical component. The procedure is associated with a high recurrence rate, up to 32 % even after using paravaginal repair along with anterior colporrhaphy.It has been sought to resolve the problem of recurrence using artificial mesh as in the repair of abdominal hernias.

Comparison: Anterior vaginal wall repair with or without reinforcement with polypropylene mesh were compared in a prospective randomized study

Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond when under strain and referred for reconstructive pelvic surgery

Exclusion Criteria:

* an apical defect indicating concomitant vaginal fixation, or stress urinary incontinence necessitating surgery, or her main symptomatic prolapse component was in the posterior vaginal wall.

Primary outcomes:
measure: Recurrence of anterior vaginal wall prolapse
Secondary outcomes:
measure: Postvoidal residual urine
measure: Symptom resolution
measure: Complications
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital, Department of Obstetrics and Gynaecology
Study officials:
affiliation: Tampere University Hospital, Department of Obstetrics and Gynecology
name: Kari Nieminen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nieminen K, Hiltunen R, Heiskanen E, Takala T, Niemi K, Merikari M, Heinonen PK. Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1611-6. doi: 10.1007/s00192-008-0707-7. Epub 2008 Aug 21.
Clinical trial NCT06846125: Mindfulness Training Along Strength Training Among Sprinters With Patellofemoral Pain
Official title: Effect of Mindfulness Training Along With Strength Training on Psychological Rehabilitation and Knee Function Among Sprinters With Patellofemoral Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain
Keywords: PFPs
Agility strength training
Strength training mindfulness training
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to find out of the comparative Sprinting-induced patellofemoral pain syndrome (PFPS) causes physical and psychologicalal distress in athletes. While strength training has been used for physical rehabilitation, mindfulness training is a recent addition to rehabilitation science with the potential to improve both physical AND psychological protocols.

Detailed description: Research on the effects of mindfulness and strength training on knee function in sprinters with patellofemoral pain is lacking, despite a wealth of studies on the psychological rehabilitation of athletes. The study's findings indicated that stress reduction and pain management enhance knee function. To improve the physical and psychological elements of sprinters with patellofemoral discomfort, this research assists them integrate mindfulness training with strength training. Strength training to improve knee stability and muscle balance, as well as mindfulness to lessen the psychological effects of pain and stress, can help sprinters with both the mental and physical aspects of patellofemoral pain. Research was being done on this combined approach in this specific population.

Eligibility criteria: Inclusion Criteria:

* Age group between 18 to 25 years.
* Female runners.
* PFP conformation check (Single leg squat, and Eccentric step) (24)

Exclusion Criteria:

* Post-surgical condition from the past 6 months
* Chronic medical condition (cancer, COPD)
* Players addicted to any drugs or alcohol

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Baseline, Week 4, and Week 8 (Post-Intervention Assessment)
measure: Knee Range of Motion
timeFrame: Baseline, Week 4, and Week 8 (Post-Intervention Assessment)
measure: Knee Outcome Survey - Sports Activities Scale
timeFrame: Baseline, Week 4, and Week 8 (Post-Intervention Assessment)
Secondary outcomes:
measure: Single-Leg Wall Sit Test
timeFrame: Baseline, Week 4, and Week 8 (Post-Intervention Assessment)
measure: Self-Rating Anxiety Scale
timeFrame: Baseline, Week 4, and Week 8 (Post-Intervention Assessment)
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Lahore sports complex
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ameena Iqbal, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05093725: CD49 in Optimization The Cologenicity of Mesenchymal Stem Cell Culture Passage
Official title: CD49 in Optimization The Cologenicity of Mesenchymal Stem Cell Culture Passage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Umbilical Cord of Normal Labor
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: taking umbilical cord of normally labored babies

Brief summary: Human mesenchymal stem cells (MSCs) due to their regenerative and immunomodulatory properties are widely used for the treatment of bone and cartilage damage, cardiovascular, gastrointestinal, autoimmune, neurodegenerative diseases and cancer .It is shown that the use of MSCs in therapy is safe and can be effective .In 2006, the International Society for Cellular Therapy (ISCT) proposed the minimal criteria to define human MSCs. First, MSCs must be plastic-adherent when maintained in the standard culture conditions. Second MSCs must express CD105, CD73 and CD90, and lack expression of CD45, CD34, CD14 or CD11b, CD79a or CD19 and HLA-DR surface molecules.


Eligibility criteria: Inclusion Criteria:

normal babies delivered by normal labor

Exclusion Criteria:

diseased or congenital anomalies

Primary outcomes:
measure: evaluation the best passage of MSC culture by CD49 surface marker
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Lv FJ, Tuan RS, Cheung KM, Leung VY. Concise review: the surface markers and identity of human mesenchymal stem cells. Stem Cells. 2014 Jun;32(6):1408-19. doi: 10.1002/stem.1681.
citation: Madrigal M, Rao KS, Riordan NH. A review of therapeutic effects of mesenchymal stem cell secretions and induction of secretory modification by different culture methods. J Transl Med. 2014 Oct 11;12:260. doi: 10.1186/s12967-014-0260-8.
Clinical trial NCT05360225: Testing of DNA Extracted From Tumor Tissue Biopsy Samples Using Therascreen KRAS RGQ PCR Kit
Official title: Non-interventional Biomarker Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit, From Patients With Non-Small Cell Lung Cancer, Screened in Clinical Study (Protocol No. 20190294).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2022-05-04
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with NSCLC with KRAS G12C mutation positive tumours.

Brief summary: A Non-interventional Biomarker Study for the testing of DNA extracted from tumour tissue biopsy samples, using the therascreen® KRAS RGQ PCR Kit, from patients with Non-Small Cell Lung Cancer, screened in Clinical Study (Protocol No. 20190294).

Detailed description: This is a non-interventional, biomarker screening clinical performance study protocol, for the testing of DNA extracted from tumour tissue biopsy samples (resected and core needle biopsy \[CNB\]/fine needle aspiration \[FNA\] tumour tissue) obtained from patients with Non-Small Cell Lung Cancer (NSCLC), using the KRAS Kit. A formal hypothesis will not be tested in this study.

Up to 7000 patient tissue samples (from approximately 5000 patients at 500 clinical trial sites), obtained in the Clinical Study (Protocol No. 20190294), will be tested using the KRAS kit. The testing will be performed at the investigational device clinical testing sites, Q2 Solutions Laboratories in the four geographical locations: USA, Singapore, UK and China

Eligibility criteria: Inclusion Criteria:

* All patients who provided consent (by signing and dating the ICF for Protocol No.

20190294), may be included in the Clinical Performance Study.

Exclusion Criteria:

* Patients whose tumour tissue biopsy samples that are not Clinical Study Assay evaluable
* Patients with samples identified for the study which have insufficient testing material
* Specimens which have undergone decalcification.

Primary outcomes:
measure: patients with NSCLC with KRAS G12C mutation positive tumours.
timeFrame: 5 business days
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: QIAGEN Gaithersburg, Inc
Study officials:
References:
Clinical trial NCT04136925: Evaluation of the Preparation of Runners and the Impact of an Ultra-trail Event in a Hot and Humid Environment
Official title: Evaluation of the Preparation of Runners and the Impact of an Ultra-trail Event in a Hot and Humid Environment (Ultra Trail Adaptation Environment)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Sport
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Runners participating in one of the 3 individual races of the "Grand Raid" 2019 in Reunion Island

Brief summary: Human beings are characterized by their extraordinary ability to thermoregulate. During a physical exercise, only 25% of the energy provided by the substrates is converted into muscular mechanical work. The remaining 75% is released as heat.

In fact, thermoregulation has always been an integral part of exercise's physiology.

Due to current climate change, study and understand the mechanisms of thermoregulation and the practices of runners to cope with these constraints becomes increasingly necessary in order to optimize the sports performance and protect the health of athletes of all levels.

Heat stroke is responsible for more deaths than any other environmental disaster and is the second leading cause of sport mortality after heart problems.

The exercise-related hyperthermia and malignant hyperthermia, dehydration and hyponatremia problems have been relatively well studied in several sports. For ultra endurance disciplines, the data remains very fragmentary.


Eligibility criteria: Inclusion Criteria:

* All major runners participating in one of the 3 individual races of the "Grand Raid" 2019 in Reunion Island

Exclusion Criteria:

* Refusal to participate
* Runners who do not understand French

Primary outcomes:
measure: Repercussion of the race on health evaluate by proportion of heat symptoms on our sample
timeFrame: during the 3 days of the race
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Pierre
country: France
facility: Centre Hospitalier Universitaire de la Réunion
Study officials:
affiliation: Centre Hospitalier Universitaire de La REUNION
name: Nicolas BOUSCAREN
role: PRINCIPAL_INVESTIGATOR
References: