louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03561610: Novel Form of Nutritional Supplementation in Cancer Patients
Official title: Impact of a Novel Form of Oral Nutritional Supplement Application in Cancer Patients With a High Risk for Malnutrition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Malnutrition
Cachexia
Keywords: cancer cachexia
malnutrition
nutritional supplement
sip feed
nutritional risk
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates if a novel form of oral nutritional Supplement application in the form of gumdrops may serve as an alternative to common sip Feeds in cancer patients with high risk for malnutrition. Within this context the Impact of these two different supplements on General condition, Quality of life, muscle function, Body composition, Appetite and Nutrition Status are investigated. Patients are randomly allocated either to a study group with oral Supplementation in the form of sip feed or to a study Group receiving gumdrops for 4 weeks. After a washout period of 5-7 days study Groups are switched for another 4 week Intervention period.


Eligibility criteria: Inclusion Criteria:

* adult patients with solid and hematological malignancies
* BMI \< 20 kg/m² and/or NRS-2002 Score ≥ 3

Exclusion Criteria:

* pregnant or nursing women
* persons with psychiatric disorders with doubts about legal and cognitive capacity
* participation in nutritional Intervention Trials within the last 4 weeks

Primary outcomes:
measure: Compliance
timeFrame: 4 weeks
measure: Tolerance of the form of oral supplementation
timeFrame: 4 weeks
Secondary outcomes:
measure: Body weight
timeFrame: 4 weeks
measure: Body composition
timeFrame: 4 weeks
measure: Physical function - Isometric muscle strength
timeFrame: 4 weeks
measure: Physical function - Lower limb strength
timeFrame: 4 weeks
measure: Physical function - Endurance
timeFrame: 4 weeks
measure: Patient-reported performance status
timeFrame: 4 weeks
measure: subjective Physical activity
timeFrame: 4 weeks
measure: objective Physical activity
timeFrame: 4 weeks
measure: Patient-reported Quality of Life (QoL)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Study officials:
References:
Clinical trial NCT01397110: Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects
Official title: Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life in Patients With Severe Associated Pulmonary Arterial Hypertension (APAH) as Part of a Congenital Heart Defect With / Without Eisenmenger's Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Eisenmenger Syndrome
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated pulmonary arterial hypertension (APAH) as part of a congenital heart defect with / without Eisenmenger's Syndrome


Eligibility criteria: Inclusion Criteria:

* signed consent form
* men and women\> 18 years \<80 years
* APAH with congenital heart defects with / without Eisenmenger syndrome (WHO functional class II-IV), invasively diagnosed by right heart and left heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, with targeted PAH medication for at least two months stable before study inclusion (exception: compensated WHO class II without vasodilating drug therapy)

Exclusion Criteria:

* Pregnancy or lactation
* Change in medication during the last 2 months
* severe walking disturbance
* uncertain diagnoses
* No previous invasively confirmation of PH
* acute diseases, infections, fever
* Serious lung disease with FEV1 \<50% or TLC \<70% of target
* Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, recurrent syncope within 4 weeks before study entry

Primary outcomes:
measure: Changes in the maximum 6-minute walk distance (6MGT)
timeFrame: up to 15 weeks
measure: Changes in quality of life
timeFrame: up to 15 weeks
Secondary outcomes:
measure: Changes in hemodynamics
timeFrame: up to 15 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: : Center for pulmonary Hypertension, Thoraxclinic Heidelberg
Study officials:
affiliation: Center for pulmonary hypertension, Thoraxclinic Heidelberg
name: Ekkehard Gruenig, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00725010: Temozolomide in Concomitant Radiochemotherapy Followed by Sequential Temozolomide Chemotherapy - Observational Program (Study P04816)
Official title: Temodal (TMZ) in Concomitant Radiochemotherapy Followed by Sequential TMZ Chemotherapy in Newly Diagnosed Glioblastoma Multiforme Patients - an Observational Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with newly diagnosed Glioblastoma multiforme

Brief summary: The purpose of this program is to evaluate the safety, tolerability, and efficacy of the new concomitant and sequential temozolomide regimen in newly diagnosed Glioblastoma patients in a routine care setting.

Detailed description: Participant sampling method: consecutive patient sampling.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed Glioblastoma multiforme

Exclusion Criteria:

* History of hypersensitivity to temozolomide or its components, or to dacarbazine.
* Women who are pregnant or breast-feeding.
* Patients with severe myelosuppression.

Primary outcomes:
measure: Safety: Number of Adverse Events in the Indicated Categories
timeFrame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
measure: Number of Participants Who Discontinued Due to Toxicity
timeFrame: Weekly during the concomitant treatment phase, and then monthly during the monotherapy phase
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06429410: Effects of Milk Powder Intervention on Body Composition and Physical Performance in Middle-aged and Older Adults
Official title: Effects of Daily Supplementation With Milk Powder on Body Composition and Physical Performance in Middle-aged and Older Adults: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to conduct a 24-week intervention involving formula milk powder for middle-aged and elderly individuals, assessing its impact on body composition and physical performance in comparison to interventions using regular milk powder and individuals without intervention.


Eligibility criteria: Inclusion Criteria:

* Aged 50 years old and older;
* BMI \<22kg/m2;
* Calf circumference \<33cm in women or \<34cm in men, or SARC-F ≥ 4, or SARC-Claf ≥ 11;
* Living in Guangzhou and having no plan to move in the next 6 months;
* Willing to participate in the study.

Exclusion Criteria:

* Lactose intolerance;
* Complicated with severe diseases;
* Unable to conduct study procedures;
* Participating in any other intervention studies.

Primary outcomes:
measure: lean body mass
timeFrame: up to 24 weeks
Secondary outcomes:
measure: cardiorespiratory fitness
timeFrame: up to 24 weeks
measure: muscle strength
timeFrame: up to 24 weeks
measure: physical performance
timeFrame: up to 24 weeks
measure: the levels of blood metabolic markers for bone and muscle
timeFrame: up to 24 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02117310: ICG Use in Angiography for Nasoseptal Flap Harvest
Official title: Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Sphenopalatine Artery Location and Patency in Harvesting and Positioning a Pedicled Nasoseptal Mucosal Flap in Endoscopic Endonasal Cranial Base Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skull Base Neoplasms
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2014-04-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a feasibility study in which indocyanine green (ICG) will be administered during routine expanded endonasal approach (EEA) for cranial base pathologies in which a nasoseptal flap harvest will be necessary. The research entails administering ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.

Detailed description: This study is being done to determine if it is feasible to use angiography during endo-nasal surgery. During the angiography indocyanine green (ICG) will be injected into the patients IV tubing to help see the arteries. ICG is routinely used in vascular surgeries on the brain but not for endo-nasal surgery. The purpose of this study is to see how well intraoperative angiography using ICG can be done during endonasal surgery.

Eligibility criteria: Inclusion Criteria:

* Age 18 and above
* Patients undergoing an EEA for cranial base pathology that may require nasoseptal flap harvest

Exclusion Criteria:

* History of sulfa, iodide, or penicillin allergy
* Pregnant or breast feeding
* Preoperative lack of indication for nasoseptal flap harvest
* Previous anaphylactic reaction to ICG

Primary outcomes:
measure: Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Daniel Prevedello, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04486612: Ultrasonographic Measurement of Internal Jugular Vein as a Predictor of Hypotension Following Spinal Anesthesia
Official title: Department of Anesthesiology and Reanimation, Faculty of Medicine, Osmangazi University, Eskişehir, Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Hypotension Postprocedural
Keywords: spinal anesthesia
internal jugular vein
hypotension
ultrasonography
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-65

Brief summary: Hypotension after spinal anesthesia is associated with significant perioperative morbidity and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal jugular vein (IJV) has been recently shown as effective in predicting the intravascular volume status. The aim was to investigate the reliability of preanesthetic ultrasound measurements of IJV in predicting hypotension after spinal anesthesia.

Detailed description: Hypotension after spinal anesthesia is associated with significant perioperative morbidity and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal jugular vein (IJV) has been recently shown as effective in predicting the intravascular volume status. The aim was to investigate the reliability of preanesthetic ultrasound measurements of IJV in predicting hypotension after spinal anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-65 Patients who read and accept the consent form of the study Patients undergoing elective surgery under spinal anesthesia

Exclusion Criteria:

* under 18 years old, ASA scores 3-4, presence of any significant hepatic, renal, cardiavasculary, or respiratory disease, having left ventricular ejection fraction less than 40%, and allergy to study medications.

Primary outcomes:
measure: The association between sonographic measurements and postspinal hypotension
timeFrame: first 30 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi Univercity
Study officials:
affiliation: Eskişehir Osmangazi Univercity
name: yeliz kılıç, Ass. Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04760912: General Anesthesia With and Without Muscle Relaxation and Muscle Strength Recovery
Official title: Comparison of General Anesthesia With Use of Muscle Relaxation and General Anesthesia Without Muscle Relaxation on Recovery of Muscle Strength of the Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rocuronium
Muscle Weakness
General Anaesthesia
Keywords: Rocuronium
Muscle strength
Residual blockade
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Neuromuscular blocking agents are often used during general anesthesia. Also, general anesthesia may be performed without use of neuromuscular blocking agents.

Avoiding neuromuscular relaxation enables better muscle strength recovery.

Detailed description: Rocuronium is well used neuromuscular blocking agent during general anesthesia. Although very often used, neuromuscular blocking agents may sometimes have consequence in form of residual neuromuscular block.

Tha aim of the study is to compare influence of rocuronium during general anesthesia on muscle strength recovery measured by hand grip dynamometer. Measuremwnt of hand grip strength is perforrmed before and after general anesthesia. This research should contribute to better choice of anesthesia technique and better quality of patient recovery, as studies so far have not been detaily carried out.

Hypothesis of the research is that anesthesia without use of neuromuscular blocking agents may enable better recovery of muscle strength in immediate postoperative period.

Eligibility criteria: Inclusion Criteria:

* patients ASA status I-III for surgery under general anesthesia
* signed informed consent for participating in research

Exclusion Criteria:

* neuromuscular disease
* poorly controled chronic or acute cardiovascular, respiratory or autoimmune disease
* known allergic reaction to any medication used in this research
* pregnancy
* refusal to participate in this research

Primary outcomes:
measure: Muscle strenght recovery after general anesthesia
timeFrame: Perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: UHCZagreb
Study officials:
References:
citation: Bowman WC. The neuromuscular junction: recent developments. Eur J Anaesthesiol. 1985 Mar;2(1):59-93. No abstract available.
citation: Gatke MR, Viby-Mogensen J, Rosenstock C, Jensen FS, Skovgaard LT. Postoperative muscle paralysis after rocuronium: less residual block when acceleromyography is used. Acta Anaesthesiol Scand. 2002 Feb;46(2):207-13. doi: 10.1034/j.1399-6576.2002.460216.x.
citation: Fuchs-Buder T, Schmartz D. [Residual neuromuscular blockade]. Anaesthesist. 2017 Jun;66(6):465-476. doi: 10.1007/s00101-017-0325-1. German.
Clinical trial NCT01578512: SPARK a Healthy and Fit Lifestyle
Official title: SPARK a Healthy and Fit Lifestyle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-04-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the best format for delivering a brief behavioral weight loss intervention to young adults 18-25 years of age.


Eligibility criteria: Inclusion Criteria:

* 18-25 years old
* body mass index 25-45
* willing to be randomly assigned to any of the 3 arms
* available during the time frame of the study
* willing to complete assessment visits at 0, 2, 4 and 6 months

Exclusion Criteria:

* Age or BMI outside of eligible range
* Medical condition that would interfere with weight loss or make unsupervised physical activity unsafe
* Pregnant or nursing within 6 months
* recent weight loss \>10% of body weight
* History of eating disorder
* Substance abuse or dependence

Primary outcomes:
measure: Weight
timeFrame: 2 months (post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center, the Miriam Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT03059212: rTMS in Facilitation of Working Memory in PD
Official title: rTMS in Facilitation of Working Memory in PD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: working memory
parkinson's disease
cognition
rTMS
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Real rTMS, sham rTMS
Primary purpose: TREATMENT

Brief summary: Ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing.

Detailed description: Excitatory (\>3Hz) rTMS could facilitate the brain cortex and neuroplasticity that benefits motor control and working memory when the coil is applied over primary motor cortex or dorsolateral prefrontal cortex.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson's Disease
* With symptoms of cognitive impairments, such as memory, attention, or language decline.

Exclusion Criteria:

* History of seizure attack
* Alzheimer's disease
* With cardiac pacemaker implantation

Primary outcomes:
measure: Change of Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Change of Montreal Cognitive Assessment ; MoCA
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Po-Yi Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Preston G, Anderson E, Silva C, Goldberg T, Wassermann EM. Effects of 10 Hz rTMS on the neural efficiency of working memory. J Cogn Neurosci. 2010 Mar;22(3):447-56. doi: 10.1162/jocn.2009.21209.
Clinical trial NCT04820712: Surgical Therapy and Survival in HCC/ C.F. Zhang et al.
Official title: Surgical Therapy and Survival in Young Patients With Stage I-II Hepatocellular Carcinoma: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Surgery
Lead sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-45, regardless of race。

Brief summary: This study utilizes a new method to explore compare the overall survival (OS) and cancer-specific survival (CSS) in patients aged 18-45 years with stage I-II HCC who underwent different types of surgery. The SEER database, which is one of the most comprehensive and authoritative databases concerning cancer, was used to estimate the survival benefit of patients who underwent local tumor destruction (LTD), wedge or segmental resection (WSR), lobectomy resection (LR), liver transplantation (LT), or non-surgery. This study discovered surgery offered a survival benefit compared with non-surgery for young patients with stage I-II HCC. Furtherly, LT is associated with superior survival than WSR, LR and LTD in those patients. Our results facilitate the selection of surgical strategies.

Detailed description: The SEER data contain no identifiers and are publicly available for studies of cancer-based epidemiology and survival analysis. Therefore, the current study was deemed to be exempt from Institutional Review Board approval and the need for informed consent was waived. The submitted magazine requires registration on the website, so this operation is needed.

Eligibility criteria: Inclusion Criteria:

1. Patients were diagnosed with colorectal cancer only;
2. Patients with simultaneous metastasis of liver and lung cancer cells;
3. Patients without metastasis resection;
4. whether they underwent palliative primary tumor resection was known;
5. Their cause of death was known;
6. Their survival time were known and greater than 0 month;
7. Patients were diagnosed with microscopic confirmation.

Exclusion Criteria:

* No

Primary outcomes:
measure: Overall survival
timeFrame: 2004.1.1-2013.12.31
Secondary outcomes:
measure: Cancer-specific survival
timeFrame: 2004.1.1-2013.12.31
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: linzhu Zhai
state: Guangdong
Study officials:
References: