louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01425606: Pseudohyponatremia of Multiple Myeloma is True Hyponatremia
Official title: a Study to Evaluate the Electrolyte Changes in Particular Sodium,in Multiple Myeloma and the Effect of the m- Proteins on the Strong Ion Difference
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyponatremia of Multiple Myeloma
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 50
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: patients with gammaglobulinemia and\\or multiple myeloma.

Brief summary: Hypothesis: the hyponatremia of multiple myeloma (m.m.)is true and not pseudohyponatremia by using the stewart approach to acid - base interpretation, would like to show that the positive charged m- proteins produced in m.m.result in true hyponatremia.


Eligibility criteria: Inclusion Criteria:

* patients with multiple myeloma

Primary outcomes:
measure: hyponatremia present or not
timeFrame: one year
measure: hyponatremia
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Hospital
Study officials:
References:
Clinical trial NCT02714699: Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy
Official title: Randomized Clinical Trial of Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium in Reducing Pain During Office Hysteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Endoscopy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 129
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy


Eligibility criteria: Inclusion Criteria:

1. Patients that must perform a diagnostic hysteroscopy.
2. Acceptance to participate in the study.
3. Signed informed consent.
4. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) before admission.
5. Absence of sedative use before admission

Exclusion Criteria:

1. Hypersensitivity to drugs
2. refusal of the patient
3. Patients are pregnant.

Primary outcomes:
measure: Mean pain score during hysteroscopy
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT03801499: Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma
Official title: Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma: a Single-arm, Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: Intrahepatic Cholangiocarcinoma
Lenvatinib
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 efficacy and safety of lenvatinib for patients with unresectable intrahepatic cholangiocarcinoma

Detailed description: Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma.No study has evaluated the efficacy and safety of lenvatinib in unresectable intrahepatic cholangiocarcinoma. Thus, the investigators carried out this prospective study to find out it.

Eligibility criteria: Inclusion Criteria:

* The diagnosis of unresectable ICC
* Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
* With no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease

Primary outcomes:
measure: overall survival (OS)
timeFrame: 12 months
Secondary outcomes:
measure: progression free survival (PFS)
timeFrame: 12 months
measure: Objective Response Rate (ORR)
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ming Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03467399: Clinical Evaluation of a Cochlear Implant System
Official title: Clinical Evaluation of a Cochlear Implant System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2018-03-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the usability of a Cochlear implant system.

Detailed description: Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.

Eligibility criteria: Inclusion Criteria:

1. Eighteen years of age or older
2. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear
3. At least 3 months experience with the CP810,CP920 or CP910 sound processor
4. Fluent speaker in the language used to assess speech perception performance
5. Willingness to participate in and to comply with all requirements of the protocol
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
2. Additional disabilities that would prevent participation in evaluations
3. Nucleus 22 Implant

Primary outcomes:
measure: Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor.
timeFrame: One year
Secondary outcomes:
measure: Speech perception performance of the CP1000 Sound Processor in quiet and in noise.
timeFrame: One year
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Cochlear Ltd
state: New South Wales
Study officials:
affiliation: Cochlear Ltd
name: Mary Beth Brinson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06112899: The Effects of Swedish Massage and Manual Lymph Drainage on Muscle Fatigue
Official title: The Effects of Swedish Massage and Manual Lymph Drainage After Muscle Fatigue in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Soreness
Keywords: Manual lympatic Drainage
Swedish Massage
Muscle Soreness
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 12 healthy men aged 18-30 will be included in the study. Participants will be selected from students who regularly train and do active sports at the Faculty of Sports Sciences. All participants will do nordic hamstring exercise. Participants will rest for 20 minutes after the Nordic hamstring exercise protocol in the first week. In the second week, manual lymph drainage covering the lower extremities will be applied for 20 minutes after exercise. In the third week, a Swedish massage covering the lower extremities will be applied after exercise. The exercise protocol is planned as 5 sets of 8 repetitions and 2 minutes of rest between each set. The evaluations of the participants will be repeated 3 times: just before the test, after the test and after the application.


Eligibility criteria: Inclusion Criteria:

* Being male between the ages of 18-30
* Doing sports and training regularly
* Not exercising until 1 week before the study

Exclusion Criteria:

* Having a previous lower extremity injury
* Having a neurological problem that prevents exercise
* Does not have a diagnosed cardiovascular problem

Primary outcomes:
measure: Lactic Acid Level
timeFrame: through study completion, an average of 1 year
measure: Gait and Balance
timeFrame: through study completion, an average of 1 year
measure: Jumping Performance
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
state: Kutahya
Study officials:
References:
citation: Mendiguchia J, Arcos AL, Garrues MA, Myer GD, Yanci J, Idoate F. The use of MRI to evaluate posterior thigh muscle activity and damage during nordic hamstring exercise. J Strength Cond Res. 2013 Dec;27(12):3426-35. doi: 10.1519/JSC.0b013e31828fd3e7.
citation: Poppendieck W, Wegmann M, Ferrauti A, Kellmann M, Pfeiffer M, Meyer T. Massage and Performance Recovery: A Meta-Analytical Review. Sports Med. 2016 Feb;46(2):183-204. doi: 10.1007/s40279-015-0420-x.
citation: Cairns SP. Lactic acid and exercise performance : culprit or friend? Sports Med. 2006;36(4):279-91. doi: 10.2165/00007256-200636040-00001.
Clinical trial NCT05660499: Impact of the Development of Pediatric Palliative Care
Official title: Assessment of the Presence of Symptoms of End-of-life Discomfort and Their Management in Children With a Primary Brain Tumor in the Grand Est Region. Impact of the Development of Pediatric Palliative Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Brain Tumor
Keywords: Primary Brain Tumor
Pediatric Palliative Care
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patient less than 17 years of age suffering from a primary brain tumor

Brief summary: Despite medical advances, cancer remains the leading cause of death by disease in children.

Brain tumors are the second most common cause of cancer in children after leukemia, representing 25% of pediatric cancers.

The overall survival rate is about 50% with extremes ranging from less than 5% to more than 90% depending on the histological type of brain tumor.

The end of life of children with a brain tumor is marked by the possibility of discomfort symptoms, painful or not, and by a progressive neurological deterioration, which makes the management of these children complex for both families and health professionals.

Over the last decade, the concept of palliative care has been increasingly integrated into pediatric onco-hematology services with the primary objective of better symptom control in a global approach to the child and his or her family in order to aim at a better quality of life.

Detailed description: The main objective of the study is to compare the occurrence and management of end-of-life symptoms in children who died of a primary brain tumor over 2 periods, in 2009 - 2010 and in 2019 - 2020, followed in the Pediatric Oncology departments of Strasbourg, Besançon, Dijon, Nancy and Reims.

Eligibility criteria: Inclusion criteria:

* Patient less than 17 years of age
* Suffering from a primary brain tumor
* Died during the period 2009-2010 or during the period 2019-2020
* Follow-up in one of the Pediatric Oncology departments participating in the study (Strasbourg, Besançon, Dijon, Nancy and Reims)
* Absence of refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes.

Exclusion criteria:

* Refusal expressed in the medical file by the parents or the holder(s) of parental authority concerning the reuse of the child's personal data for research purposes
* Patient with a brain tumor secondary to another cancer

Primary outcomes:
measure: Presence of symptoms of physical or psychological discomfort in the last 4 months of life
timeFrame: up to the last 4 months of life
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de soins Palliatifs - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02769299: Cardiotoxicity of Radiation Therapy (CTRT)
Official title: Cardiotoxicity of Radiation Therapy (CTRT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lung Cancer
Mediastinal Lymphomas
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: breast cancer, lung cancer, and mediastinal lymphomas

Brief summary: The overall objective of this proposal is to determine the utility of sensitive imaging and biomarker measures in detecting subclinical cardiotoxicity across a spectrum of radiation doses to the heart. We will focus specifically on patients receiving photon or proton chest radiotherapy. Our broad working hypothesis is that RT induces early, subclinical CV injury, as evidenced by cardiomyocyte inflammation and necrosis, and worsening CV function.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older.
* Patients with left sided breast cancer newly initiating fractionated whole breast/chest wall with regional nodal photon or proton radiation therapy.
* Patients with right sided breast cancer with newly initiating fractionated photon or proton radiation therapy with mediastinal nodal proton or photon radiation therapy that will include cardiac dose.
* Lung cancer patients treated with definitive intent (greater than or equal to 50 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy. Patients receiving concurrent chemotherapy will be allowed.
* Patients with mediastinal lymphoma, whose lowest extent of mediastinal disease is at or below the level of the carina, treated with consolidative radiation with definitive intent (greater than or equal to 20 Gy) using fractionated thoracic radiotherapy with proton or photon radiation therapy.
* Ability to read and comprehend English.

Exclusion Criteria:

* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Patients receiving stereotactic body radiotherapy
* Patients unable to undergo MR imaging will be excluded from the optional MR, but will not be excluded from the main study.
* Life expectancy less than 12 months
* Vulnerable patients as noted in 5 below (children, pregnant women, fetuses, neonates, or prisoners)
* Patients with estimated glomerular filtration rate of less than 60 ml/min/1.73sq.m will be excluded from the optional MR, but will not be excluded from the main study.
* Non-diagnostic echocardiography windows

Primary outcomes:
measure: Number of CV injury
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Bonnie Ky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05354999: Effects of Combinations of Performance-enhancing Supplements on Exercise Performance
Official title: Effects of Different Combinations of Performance-enhancing Supplements on High Intensity Exercise Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Exercise
Performance
Supplementation
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate the effect of combinations of creatine monohydrate, sodium bicarbonate and caffeine on exercise performance and fatigability.


Eligibility criteria: Inclusion Criteria:

* Healthy
* VO2max of \>50 ml/min/kg for men and \>45 ml/min/kg for women
* Performs endurance training \>3 times per week

Exclusion Criteria:

* Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
* Smoking
* Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study

Primary outcomes:
measure: Work performed (kJ/Watt)
timeFrame: Measured at each trial throughout the study, on average 4 weeks
Secondary outcomes:
measure: Work performed (kJ/Watt)
timeFrame: Measured at each trial throughout the study, on average 4 weeks
measure: Muscle strength (Nm)
timeFrame: Measured at each trial throughout the study, on average 4 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
Study officials:
References:
Clinical trial NCT01625299: Pilot Study of Diet and Behavior in Children With Autism
Official title: PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: intestinal permeability
diet
gluten
dairy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: We hypothesize that in children with autism dietary antigens can change the intestine, making it "leaky" and then affecting the brain changing their behavior.

Detailed description: Subjects in 2 different diets (gluten/dairy and placebo) will be monitored for changes in intestinal permeability (urine lactulose mannitol ratio) and behavior (psychometric testing).

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 3 and 12 years,
* DSM-IV (APA, 2000) diagnosis of Autistic Disorder (DSM-IV 299.90),
* willingness to follow and maintain a gluten-free-dairy-free-diet for 4 weeks.

Exclusion Criteria:

* food allergies,
* celiac disease,
* inflammatory bowel disease,
* infectious gastrointestinal,
* seizure disorder,
* neurological problems with behavioral changes,
* unwillingness to undertake the dietary challenge with milk and gluten or to maintain a gluten-free-dairy-free-diet during the study were excluded

Primary outcomes:
measure: Intestinal Permeability
timeFrame: baseline, 2 weeks and 4 weeks
Secondary outcomes:
measure: Psychometric testing
timeFrame: baseline, 2 weeks and 4 weeks
measure: Gastrointestinal symptoms
timeFrame: baseline, week 2, week 4
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center At Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Fernando Navarro, M.D>
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00416299: Prognostic Value of New Cardiac Biomarkers in Elderly Patients Undergoing Cardiac Surgery
Official title: Observational Cohort Study on the Prognostic Value of New Cardiac Biomarkers in Elderly Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Keywords: Cardiac biomarker
cardiac surgery
elderly
postoperative complications
Patients aged 75 years or older undergoing cardiac surgery
Lead sponsor: Klinikum Ludwigshafen
Sponsor class: OTHER
First posted: 2006-12-27
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: To evaluate the use of new cardiac biomarker for the prediction of in-hospital cardiovascular complications in elderly patients undergoing elective cardiac surgery.

Detailed description: Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP, cardiac troponin T (cTnT), pregnancy-associated plasma protein A (PAPP-A), ischemia-modified albumin (IMA), myeloperoxidase (MPO), metalloproteinase (MMP) soluble CD 40 ligand (sCD40L), and inflammatory cytokine levels will be measured in 100 elderly patients undergoing elective cardiac surgery with cardiopulmonary bypass before induction of anesthesia and 12 h, 24 h, and 48 h after surgery. Optimum discriminators for prediction of postoperative cardiovascular complications wil be determined by the use of receiver operating characteristics (ROC) curves analyses.

Eligibility criteria: Inclusion Criteria:

* patients aged 75 years or older undergoing elective cardiac surgery with CPB

Exclusion Criteria:

* positive cardiac troponin T test within the week before surgery
* patients undergoing emergent procedures
* patients with preoperative mechanical cardiac support
* patients undergoing hemodialysis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine Klinikum Ludwigshafen
Study officials:
affiliation: Klinikum Ludwigshafen
name: Stefan W. Suttner, MD
role: PRINCIPAL_INVESTIGATOR
References: