louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05326724: The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia
Official title: The Role of Acupuncture-induced Exosome in Treating Post-stroke Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exosome
Post-stroke Dementia
Acupuncture
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Stroke is the main cause of disability and the second main cause of dementia. Approximately 21.5% of patients develop dementia within 4 years after stroke. The main clinical manifestation of dementia is memory and cognitive impairment. At present, acetylcholinesterase inhibitors and NMDA glutamate receptor antagonists, were used for dementia treatment, but those drugs have limited efficacy. Exosome is an extracellular vesicle from the endosomal, size range from \~40 to 160 nm (average \~100 nm). It contains many cells including DNA, RNA, fat, and metabolites, as well as cytoplasm and cell surface proteins that play a role in regulating intercellular communication. Some studies believe that exosomes in the circulation are an ideal marker to reflect the pathological progress and recovery of stroke, and play a key role in the reorganization of tissues and the progress of neurodegeneration after stroke. Our previous studies have known that acupuncture can increase the long-term potentiation of hippocampal CA1 in rats with ischemic stroke, and improve learning-memory and neurological function. Therefore, the purpose of this study is to explore the role of acupuncture-induced exosome in the treatment of post-stroke dementia.


Eligibility criteria: Inclusion Criteria:

1. History of stroke.
2. MMSE score between 16 and 26.

Exclusion Criteria:

1. Those with serious diseases, such as heart failure, chronic failure or cancer patients, etc.
2. Intolerance to acupuncture treatment.
3. Allergy to acupuncture needles.
4. Refusal to sign the informed consent form.

Primary outcomes:
measure: concentration of Exosome
timeFrame: 12 weeks
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale scale
timeFrame: 12 weeks
measure: Behavioural and Psychological Symptoms of Dementia scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: North District
Study officials:
References:
Clinical trial NCT01051024: Diamel in the Treatment of Polycystic Ovary Syndrome
Official title: Efficacy of Diamel in the Treatment of Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycystic Ovary Syndrome
Keywords: Dietary supplement
Diamel
Polycystic Ovary Syndrome
Female Infertility
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Polycystic Ovary Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Two of the following criteria:

  * Oligo or Anovulation
  * Polycystic Ovary diagnosed by ultrasound technique
  * Clinical signs of Hyperandrogenism
* Signed informed consent

Exclusion Criteria:

* Personal history of other causes of hyperandrogenism: Hyperprolactinemia, suprarenal tumors, ovary tumors, suprarenal hyperplasia, hypercortisolism.
* Patients under other experimental treatment
* Treatment with ovulation inducers and/or insulin sensitizers within 60 days before treatment
* Treatment with vitamins within 7 days before treatment
* Treatment with dietary supplements within 60 days before treatment
* Non-compensated intercurrent diseases: diabetes mellitus, thyroid disease, hypertension

Primary outcomes:
measure: Normalization of blood concentrations of androgens at week 24
timeFrame: 24 weeks
measure: Normalization of blood concentrations prolactin at week 24
timeFrame: 24 weeks
measure: Normalization of blood concentrations of estrogens at week 24
timeFrame: 24 weeks
measure: Normalization of blood concentrations of FSH at week 24
timeFrame: 24 weeks
measure: Normalization of blood concentrations of LH at week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Regularization of the menstrual cycle at week 24.
timeFrame: 24 weeks
measure: Reappearance of ovulatory cycles at week 24
timeFrame: 24 weeks
measure: Normalization of blood concentrations of insulin at week 24
timeFrame: 24 weeks
measure: Normalization of blood concentrations of cholesterol at week 24
timeFrame: 24 weeks
measure: Normalization of blood concentrations of triglycerides at week 24
timeFrame: 24 weeks
measure: Normalization of blood concentrations of glucose at week 24
timeFrame: 24 weeks
measure: Improvement of clinical signs associated with polycystic ovary syndrome: acne, hirsutism, abdominal obesity, and blood pressure at week 24.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: "Ramón González Coro" Gynecologic and Obstetric Hospital
state: Havana
Study officials:
affiliation: "Ramón González Coro" Gynecologic and Obstetric Hospital
name: Mercedes Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06321224: Effects of Breathing Exercises on Women With Primary Dysmenorhea
Official title: Effects of Breathing Exercises on Women With Primary Dysmenorhea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysmenorrhea
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effects of breathing exercises in women with primary dysmenorrhea.

Detailed description: Primary dysmenorrhea (PD) is the most common gynecological disorder and constitutes a serious health and economic problem. PD is defined as painful menstrual cramps in the lower abdomen during or a few days before the menstrual period with no detectable organic disease. Breathing exercises are an effective method for pain relief. However, breathing exercises need to be examined in PD management.

Eligibility criteria: Inclusion Criteria:

* Having PD symptoms according to the Primary Dysmenorrhea Consensus criteria,
* Having menstrual pain intensity of 4 or higher according to the Visual Analog Scale in the last 6 months,
* Having a regular menstrual cycle (28±7 days)
* Volunteering to participate in the study.

Exclusion Criteria:

* Being pregnant or suspected of pregnancy,
* Using oral contraceptives or antidepressants in the last 6 months,
* Using intrauterine devices,
* Having a history of other gynecological diseases
* Having pulmonary, neurological and/or systemic disease,
* Having undergone abdominal or cardiothoracic surgery within the last year.

Primary outcomes:
measure: Menstrual pain intensity
timeFrame: After 2 menstrual periods
Secondary outcomes:
measure: Menstrual symptoms
timeFrame: After 2 menstrual periods
measure: Life quality
timeFrame: After 2 menstrual periods
measure: Stress level
timeFrame: After 2 menstrual periods
measure: Sleep quality
timeFrame: After 2 menstrual periods
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931124: High Intensity and Moderate Training and Maximal Oxygen Uptake and Activity Levels
Official title: Effect of High Intensity and Moderate Training on Maximal Oxygen Uptake and Activity Levels in an Elderly Norwegian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ageing
Keywords: maximal oxygen uptake, activity levels, elderly
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 1576
Sex: ALL
Minimum age (years): 70
Maximum age (years): 77
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to investigate the effect of different types of training (high intensity and moderate training) on maximal oxygen uptake and activity levels in an elderly Norwegian population after one year training intervention. Baseline data include the activity levels assessed through self reported means as well as objectively measured activity data using activity monitors.


Eligibility criteria: Inclusion Criteria:

* ability to walk at least 1km,
* born in 1938,1939,1940,1941 or 1942
* Sufficiently good health to be able to take part in the study, as determined by the researchers

Exclusion Criteria:

* Illness or disability that precludes exercise or hinders completion of the study
* Uncontrolled hypertension
* Symptomatic valve disease, hyper tropic cardio-myopathy or unstable angina
* Active cancer
* Test results indicating that study participation is unsafe
* Inclusion in other studies conflicting with participation in this one

Primary outcomes:
measure: maximal oxygen uptake
timeFrame: 1 year
measure: activity level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: dorthe stensvold, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03931824: Efficacy Of Platelet Rich Plasma In The Treatment Of Hemiplegıc Shoulder Pain
Official title: Efficacy Of Platelet Rich Plasma In The Treatment Of Hemiplegıc Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Shoulder Impingement
Hemiplegia, Infantile
Shoulder Subluxation
Spasticity, Muscle
Keywords: Shoulder Pain
Hemiplegia
Shoulder Subluxation
Spasticity
Stroke
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study assessing whether platelet rich plasma injections(PRP) are effective in the management hemiplegic shoulder pain, 55 patients with hemiplegic shoulder pain was recruited to this randomized controlled study. Patients were randomized into two groups, first getting PRP injections, and other group taking sham injections.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were being an adult stroke patient with more than two weeks of shoulder pain and restriction, and not having a history of stroke before the recent incident.

Exclusion Criteria:

* Patients with aphasia, severe cognitive or psychiatric disorders, history of trauma, recent injection (\<3 months) or surgery on the affected joint, complex regional pain syndrome, infections, pregnancy, thrombocytopenia(\<150000 per microliter) or coagulation disorders or severe spasticity of the affected limb(Modified Ashworth Scale \>3) were excluded from the study

Primary outcomes:
measure: Visual Analogous Scale
timeFrame: 3 months
Secondary outcomes:
measure: Shoulder ranges of motion
timeFrame: 3 months
measure: Functional Independence Measure(FIM)
timeFrame: 3 months
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege university school of medicine
Study officials:
References:
citation: Uzdu A, Kirazli Y, Karapolat H, Unlu B, Tanigor G, Calis FA. Efficacy of platelet-rich plasma in the treatment of hemiplegic shoulder pain. Neurol Sci. 2021 May;42(5):1977-1986. doi: 10.1007/s10072-020-04710-0. Epub 2020 Sep 29.
Clinical trial NCT06674824: Role of Spectrophotometer in Early Prediction of Weaning Induced Cardiac Dysfunction
Official title: Role of Spectrophotometer in Early Prediction of Weaning Induced Cardiac Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Weaning Failure
Keywords: Massimo
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: intubated mechanically ventilated patients candidate for extubation

Brief summary: Weaning induced cardiac dysfunction is a common cause of weaning failure in critically ill patients. plethysmography variability index (PVI) is a non-invasive, real-time, and automated parameter for evalu¬ating fluid responsiveness.

By proving the validity of (PVI) in predicting successful spontaneous breathing trial Massimo can be used an easy noninvasive method that help in deciding the right time for weaning.


Eligibility criteria: Inclusion Criteria:

1. Intubation and mechanical ventilation
2. Fulfilling criteria for extubation
3. Fraction inspired oxygen less than 50%

Exclusion Criteria:

* a. Hemodynamic instability b. b. tracheostomy

Primary outcomes:
measure: accuracy of change PVI in detecting volume responsiveness
timeFrame: 1 hour
Secondary outcomes:
measure: Sensitivity of trend of changes in hemoglobin by Massimo to detect WIPO and
timeFrame: 1 hour
measure: time in minutes between rise of hemoglobin and clinical diagnosis of WIPO
timeFrame: 1 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT00424424: A Study to Evaluate the Efficacy of MK0719 in the Prevention of Postoperative Dental Pain (0719-002)
Official title: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: Postoperative Dental Pain
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 81
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is being conducted to evaluate the safety and tolerability of the drug and to evaluate its efficacy compared to placebo and to ibuprofen in the prevention of postoperative dental pain in male patients.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria :

* Patients in generally good health who are scheduled to have 2 or more third molars removed, at least 1 of which is partially or completely embedded in bone and is a mandibular impaction

Exclusion Criteria :

* Patient has a history of any illness or condition that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient

Primary outcomes:
measure: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary outcomes:
measure: Proprietary Information - Exploratory (Non-Confirmatory) Trial
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00215124: A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction
Official title: Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Myocardial Infarction
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to obtain initial information regarding the safety and efficacy of the use of Filgrastim in the setting of acute myocardial infarction.

The secondary objectives are to obtain information regarding the mobilization of relevant stem cell progenitor cells by Filgrastim in this setting and to obtain further clinical information that may be helpful in the assessment of safety and efficacy of this drug as utilized.

It is a one center, randomized, placebo controlled, dose escalation, blinded study. It will be 2:1 randomization with 9 patients total.

Filgrastim 10 mcg/kg/day will be administered SQ for 5 days vs. placebo.

Primary endpoint is death /or myocardial rupture or change in left ventricular ejection fraction from baseline to 30 days.

9 pts. have already completed the first phase of the trial using Filgrastim 5 mcg/kg/day.


Eligibility criteria: Inclusion Criteria:

Acute Myocardial Infarction within 6 hours of symptoms

Exclusion Criteria:

-

Primary outcomes:
measure: Death or myocardial rupture at 30 days; change in left ventricular ejection fraction from baseline to 30 days
timeFrame: 30 days
Secondary outcomes:
measure: i) Survival through 12 months ii) Re-hospitalization for CHF through 12 months iii) Improvement in LVEF at days 7 and 12 months iv) Infarct wall thickness at 30 days v) Re-infarction within 30 days v
timeFrame: specified above
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Stephen Ellis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellis SG, Penn MS, Bolwell B, Garcia M, Chacko M, Wang T, Brezina KJ, McConnell G, Topol EJ. Granulocyte colony stimulating factor in patients with large acute myocardial infarction: results of a pilot dose-escalation randomized trial. Am Heart J. 2006 Dec;152(6):1051.e9-14. doi: 10.1016/j.ahj.2006.09.003.
Clinical trial NCT06256224: Toripalimab Combined With Definitive CCRT for LACC Patients
Official title: Toripalimab Combined With Definitive Chemoradiotherapy for Locally Advanced Cervical Squamous Cell Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Chemoradiotherapy
Immunotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cervical cancer constitutes a significant health burden for women globally. While most patients with early-stage disease can be cured with radical surgery or chemoradiotherapy, patients with high-risk locally advanced disease or with recurrent/metastatic disease have a poor prognosis with standard treatments. Immunotherapies are a rational treatment for this HPV-driven cancer that commonly expresses programmed cell death ligand-1. Toripalimab, a humanized immunoglobulin G4 monoclonal antibody against PD-1, showed promising anti-tumor efficacy in multiple solid tumors. This randomised study is evaluating toripalimab combined with CCRT versus CCRT alone for treatment-naïve LACC.


Eligibility criteria: Inclusion Criteria:

* more than 18 years old females
* had newly diagnosed and previously untreated locally advanced squamous cell carcinoma of the uterine cervix
* FIGO 2018 stage IB3 to IVA with no evidence of distant metastasis
* ECOG PS 0-1 without major organ failure
* signed informed consent voluntarily

Exclusion Criteria:

* previously suffered from immunodeficiency disorders
* had any condition that researchers believed to be associated with increased risk of treatment
* Previously received or currently receiving other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1

Primary outcomes:
measure: 2-year progression-free survival
timeFrame: 2 year
Secondary outcomes:
measure: 2-year local control
timeFrame: 2 year
measure: 2-year local regional control
timeFrame: 2 year
measure: 2-year overall survival
timeFrame: 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Haoping Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01079624: GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose
Official title: Effects of GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose Homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Physiology
Gastroenterology
Endocrinology
Keywords: Incretin hormones
Glucose-insulinotropic peptide
Glucagon-like peptide-1
Gastric emptying
Appetite
Glucose disposal
Gut hormones
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: University of Copenhagen
First posted: 2010-03-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Academic phase 1 study which investigates the effects of the two incretin hormones glucose-insulinotropic peptide (GIP) and glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite, insulin release and glucose disposal in the body. The hypothesis is that incretin hormones not only stimulate insulin release but also inhibits gastric emptying. This effect can be utilized for further drug development.

Detailed description: Effects of GIP and GLP-1 on gastric emptying, appetite control and insulin release in relation to glucose levels in the bloodstream. Infusions of GIP and GLP-1 are given under simultaneous gastric emptying study and appetite questionnaires and blood sampling for analysis of insulin, glucose, and other gut hormones such as glucagon, ghrelin, and PYY, as well as those administered, GIP and GLP-1.

Eligibility criteria: Inclusion Criteria:

* Men and women
* 18-50 years old;
* otherwise healthy and HIV and HCB, HCV negative

Exclusion Criteria:

* Age \>50,
* all types of diseases and drug users.

Primary outcomes:
measure: Gastric emptying rate
timeFrame: 2005-2006
Secondary outcomes:
measure: Plasma glucose, insulin release, appetite
timeFrame: 2005-2006
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet, Uppsala University
name: Per M Hellstrom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: