louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01000350: Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
Official title: Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postural Tachycardia Syndrome
Keywords: orthostatic intolerance
exercise capacity
tachycardia
POTS
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).


Eligibility criteria: Inclusion Criteria:

* Meet diagnostic criteria of Postural Tachycardia Syndrome (POTS) 28
* Age between 18-65 years
* Male and female are eligible (although the majority of POTS patients are female).
* Able and willing to provide informed consent

Exclusion Criteria:

* Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications)
* Pregnancy
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
* Patients who are bedridden or chair-ridden

Primary outcomes:
measure: Difference in VO2max between saline day and placebo day
timeFrame: Within 2 week
Secondary outcomes:
measure: Exercise capacity/Maximal Load (Watts) during peak VO2
timeFrame: Less than 2 weeks
measure: Cardiac output between exercise tests (inert gas rebreathing technique)
timeFrame: 2-10 Days between exercise tests
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Satish R Raj, MD MSCI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raj SR, Biaggioni I, Yamhure PC, Black BK, Paranjape SY, Byrne DW, Robertson D. Renin-aldosterone paradox and perturbed blood volume regulation underlying postural tachycardia syndrome. Circulation. 2005 Apr 5;111(13):1574-82. doi: 10.1161/01.CIR.0000160356.97313.5D. Epub 2005 Mar 21.
Clinical trial NCT01142050: Stem Cell Therapy for Type 2 Diabetes Mellitus
Official title: A Open Labeled and Self Controlled, Safety/Efficacy Assessed Pilot Study on Transplantation Therapy Using Bone Marrow Mesenchymal Stem Cells for Insulin Resistance of Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: stem cells;
diabetes mellitus;
treatment.
Lead sponsor: Cellonis Biotechnology Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2010-06-11
Enrollment: 24
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 the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.

Detailed description: * To evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments.
* To assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

1. Free will taking part in the study and ability to provide written informed consent;
2. Type 2 diabetes mellitus (as guideline WHO, 1999);
3. Age 18-75 years old，Male/Female;
4. 19≤Body mass index (BMI)≤30㎏/㎡;
5. Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％;
6. Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance;
7. Not pregnant or nursing;
8. Negative pregnancy test;
9. Fertile patients will use effective contraception.

Exclusion Criteria:

1. Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction);
2. Active infection requiring treatment;
3. Unexplained febrile illness;
4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.

Primary outcomes:
measure: ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;
timeFrame: one year
Secondary outcomes:
measure: Serious adverse event frequency and severity
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Armed Police General Hospital, P.R. China
Study officials:
References:
Clinical trial NCT00417950: Additional Glucose Lowering and Anti-Inflammatory Effects by Acarbose and Alcohol in Subjects With Impaired Glucose Tolerance or Mild Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Impaired Glucose Tolerance
Keywords: diabetes
acarbose
alcohol
inflammation
oxidative stress
Mild diabetes mellitus
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
First posted: 2007-01-04
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To understand if acarbose, an alpha-glucosidase inhibitor usually for treating diabetes, will further lower post meal glucose and inflammatory state when taking together with moderate amount of alcohol during meal tolerance test in subjects with impaired glucose tolerance or mild diabetes.


Eligibility criteria: Inclusion Criteria:

* Subjects with mild diabetes without prior medications or impaired glucose tolerance

Exclusion Criteria:

* Pregnancy
* Recent major cardiac, renal and hepatic disease
* Intolerance to alcohol
* Allergy to acarbose treatment

Primary outcomes:
measure: Postprandial hyperglycemia
Secondary outcomes:
measure: Postprandial inflammatory responses
measure: Postprandial oxidative stress
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Wayne H Sheu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01582750: Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy
Official title: Endoscopic Ultrasound Predict the Sensitivity of Stage II / III Rectal Cancer Preoperative Concurrent Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Keywords: endoscopic ultrasound
pre-operative concurrent chemoradiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2012-04-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Local advanced rectal cancer

Brief summary: The purpose of this study is to determine the role of endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values in predicting the tumor regression after concurrent chemoradiotherapy for rectal cancer.

Detailed description: We use endoscopic ultrasound to measure the primary tumor maximum diameter changes to predict the tumor regression after concurrent chemoradiotherapy for rectal cancer

Eligibility criteria: Inclusion Criteria:

* pathologically confirmed rectal cancer, preoperative stage II / III (T3-4N0 or T1-4N + M0).
* tumor distance from anus less than 12 cm.
* KPS score not less than 70
* can be tolerated chemotherapy and radiotherapy.
* pelvic who had no history of radiation therapy.
* Non-allergic history of fluorouracil or platinum-based chemotherapy drugs.
* a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent.

Exclusion Criteria:

* other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous).
* pregnant or lactating patients.
* fertility but did not use contraceptive measures.
* existing active infection.
* merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension.
* concurrent treatment with other anticancer drugs.
* can not complete treatment or follow-up.

Primary outcomes:
measure: Endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Li Ning
state: Beijing
Study officials:
affiliation: Chinese Acedemy of Medical Sciences
name: Jing Jin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li N, Dou L, Zhang Y, Jin J, Wang G, Xiao Q, Li Y, Wang X, Ren H, Fang H, Wang W, Wang S, Liu Y, Song Y. Use of sequential endorectal US to predict the tumor response of preoperative chemoradiotherapy in rectal cancer. Gastrointest Endosc. 2017 Mar;85(3):669-674. doi: 10.1016/j.gie.2016.06.042. Epub 2016 Jun 25.
Clinical trial NCT04384250: Genetic and Immunologic Basis of COVID-19 Infection
Official title: Genetic Factors Influencing the Response to Infection with SARS-COV-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetic Basis of COVID-19 Infection
Keywords: SARS-COV-2, Genetics
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 positive patients

Brief summary: We will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy


Eligibility criteria: Inclusion Criteria:

* severe COVID-19 infection

Exclusion Criteria:

* Comorbidity ((DM, hypertension, Chronic liver or Kidney diseases, HIV, morbid obesity, Malignancy, Immunosuppressive therapy)

Primary outcomes:
measure: Mutations leading to increase susceptibility to SARS-COV-2 infection
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlyia
Study officials:
References:
Clinical trial NCT05610150: Pharyngeal Airway Dimensions With Twinblock Versus Myobrace Appliances in Developing Skeletal Class II Patients
Official title: Cephalometric Changes in Pharyngeal Airway Dimensions After Functional Treatment With Twinblock Versus Myobrace Appliances in Developing Skeletal Class II Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class II, Division 1
Keywords: Airway
Myobrace
Twinblock
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 26
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the pharyngeal airway changes after treatment with Myobrace and after treatment with Twinblock in developing skeletal Class II patients.

The main question it aims to answer is: Is the efficacy of the twin-block Vs Myobrace appliances in the improvement of pharyngeal airway dimensions in adolescents having skeletal Class II malocclusion with retrognathic mandible utilizing sagittal pharyngeal airway area measurements.


Eligibility criteria: Inclusion Criteria:

* Healthy children
* 9-12 Years
* Skeletal Class II with mandibular defeciency and normal maxillary growth depending on clinical diagnosis and confirmed with lateral cephalometric x-reay readings ( ANB angle \>4 and SNA angle \<78)

Exclusion Criteria:

* Previous Orthodontic treatment
* Previous extractions
* mandibular shifts
* Severe Crowding
* Anterior open bite
* Any perioral habits

Primary outcomes:
measure: SNA
timeFrame: Six months
measure: SNB
timeFrame: Six months
measure: ANB
timeFrame: Six months
measure: Witts appraisal
timeFrame: Six months
measure: FMA
timeFrame: Six months
measure: Pharyngeal air way area measurement
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Ahmed Median
Study officials:
affiliation: Alexandria University
name: Ahmed Median, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01022450: Study of the Causes of the Breakdown of Muscle Fibers in Hospitalized Patients
Official title: Rhabdomyolysis - A Retrospective Study in Hospitalized Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rhabdomyolysis
Myopathy
Acute Renal Failure
Neuroleptic Malignant Syndrome
Keywords: rhabdomyolysis
myopathy
acute renal failure
neuroleptic malignant syndrome
Pharmaceutical Preparations
Hydroxymethylglutaryl-CoA Reductase Inhibitors
fibrates
creatine kinase
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who admitted to The National Taiwan University Hospital during 2003/1/1\~2008/12/31 with rhabdomyolysis or related muscle diseases dignosis and clinical presentation.

Brief summary: 1. Analyze the various causes of breakdown of muscle fibers in hospitalized patients.
2. Analyze the characteristics of these patients in Taiwan (including the drugs history, risk factors and the incidence of complications).

Detailed description: 1. Find the causes of breakdown of muscle fibers in hospitalized patients through medical record review.

   * especially drug-related
2. Find the risk factors of muscle fibers breakdown.

Eligibility criteria: Inclusion Criteria:

* Patients who admitted to The National Taiwan University Hospital during 2003/1/1\~2008/12/31 with the following discharge diagnosis: myoglobinuria, rhabdomyolysis, myopathy, toxic myopathy, malignant hyperthermia, neuroleptic malignant syndrome, polymyositis, myalgia and had acute neuromuscular illness presentations and serum creatinine kinase (CK) more than 5 times the upper limit of normal (male \> 900 IU/L; female \> 835 IU/L).

Exclusion Criteria:

* Patients with recent myocardial infarction or stroke, unless clinical history, examination, or electromyography showed a concomitant myopathy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Graduate Institute of Clinical Pharmacy, National Taiwan University
name: Fe-Lin L Wu, MSCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02408250: Tolerance of Early Exercise in Intensive Care Unit
Official title: Tolerance of Early Exercise in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: algorithm
critical illness
early exercise
feasibility
intensive care unit
physical therapy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critical care unit patients

Brief summary: Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.

Detailed description: Practice guidelines recommend early physical therapy in intensive care unit. Feasibility, safety and efficacy are confirmed by growing evidence based data. However, the scientific literature emphasizes the heterogeneity of targeted populations, lack of precisions concerning eligibility criteria, program modalities, timing initiation, progressions and stopping criteria. However, all these results remain to be precised and confirmed. So, the investigators hypothesize that an early exercise program in intensive care unit formalized from a decisional algorithm is well tolerated in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Men and women
* Over 18 years old
* Hospitalized in intensive care unit
* Patients whose clinical condition allows initiating an early exercise program from critical care physician inclusion

Exclusion Criteria:

* Less than 18 years old or disabled adult
* Head or spinal severe trauma
* Severe trauma of the lower limbs or pelvis
* Musculoskeletal and neurological conditions which do not permit to realise the exercise program
* Patient for whom the reason for hospitalization does not justify early physical therapy

Primary outcomes:
measure: Score difference on a discomfort visual analogic scale between before and after program completion
timeFrame: at day 1
Secondary outcomes:
measure: Functional capacity (PFIT: Physical Function ICU Test score)
timeFrame: at day 1
measure: length of stay on intensive care unit
timeFrame: at day 1
measure: mortality in ICU
timeFrame: at day 1
measure: Unit of discharge (specialty of the unit)
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
References:
Clinical trial NCT04493450: NEMO - an App for Side Effect Management in Oncology
Official title: NEMO - an App for Side Effect Management in Oncology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer Patients
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Phase I:

- 30 participants in total non-randomly divided into three age groups (\< 55 years, 55-75 years, \> 75 years) of 10 people each.

Phase II:

- 36 participants randomly assigned a group of 18 persons (smartphone users, non-smartphone users)

Brief summary: This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.

Detailed description: This research study is structured as a Phase I and II clinical trial. In phase I, the feasibility of using a smartphone application to document adverse events that have occurred during oncological therapies by the patient will be investigated. In phase II we will investigate whether the use of the smartphone app allows an improvement of patient care by reducing occurred adverse events.

Eligibility criteria: Inclusion Criteria:

* infusional combination therapy with at least two chemotherapy substances with or without further targeted therapies
* combination of at least two immune-checkpoint inhibitors
* able to read and understand German

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded:

* severe neurological disorders
* severe psychiatric disorders

Primary outcomes:
measure: Phase I: Patient acceptance of a new medium of communication
timeFrame: 6 months
measure: Phase II: Change of occurred adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Phase II: Doses of chemotherapy
timeFrame: 6 months
measure: Phase II: Incidence of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: University Hospital Ulm
name: Seufferlein
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kestler AMR, Kuhlwein SD, Kraus JM, Schwab JD, Szekely R, Thiam P, Huhne R, Jahn N, Furstberger A, Ikonomi N, Balig J, Schuler R, Kuhn P, Steger F, Seufferlein T, Kestler HA. Digitalization of adverse event management in oncology to improve treatment outcome-A prospective study protocol. PLoS One. 2021 Jun 4;16(6):e0252493. doi: 10.1371/journal.pone.0252493. eCollection 2021.
Clinical trial NCT06669650: Personalized Post-Operative Pain Management
Official title: Personalized Post-Operative Opiate Prescriptions Based on Pharmacogenetics of CytochromeP450, COMT, and OPRM1
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Persistent Post Operative Opioid Use
Post-surgical Pain
Keywords: CYP2D6 SNPs
OPRM1 SNPs
COMT SNPs
Pharmacogenomics
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Standard of Care (oxycodone) versus intervention group (hydromorphone)
Primary purpose: PREVENTION

Brief summary: The main questions this study aims to answer are:

Does perioperative PGx personalized opiate therapy reduce persistent post-operative opioid use dependency, improve pain management and reduce opiate related adverse events in opioid naïve patients after surgery?

Participants will:

Take hydromorphone if the PGx results determine they have a SNP indicating high or low metabolic activity in the CYP2D6 enzyme.

Complete a 7-day pain diary post-discharge. Complete a follow-up phone call once per month for 90 days.


Eligibility criteria: Inclusion Criteria:

1.18-85 years of age 2.Able to read and understand study procedures. 3.Willing to participate and sign an ICF. 4.Opioid naïve 90 days prior to surgery.

Exclusion Criteria:

1. \<18 years of age and \>85 years of age
2. Unable to understand study procedures.
3. Unwilling to give consent.
4. Patients with cognitive impairment that can affect their ability to give consent.
5. Previous Surgery \<14 days from time of enrollment.
6. Allergies to study intervention or oxycodone.

Primary outcomes:
measure: Persistent Post-Operative Opioid Use
timeFrame: 90 days
Secondary outcomes:
measure: Post-Surgical Pain
timeFrame: 7 days
Other outcomes:
measure: Opioid Related Adverse Events
timeFrame: 90 days
Locations:
city: Knoxville
country: United States
facility: The University of Tennessee Graduate School of Medicine
state: Tennessee
Study officials:
References: