louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06490081: Trilaciclib Prevents Myelosuppression With Chemoradiotherapy
Official title: To Evaluate the Protective Effect of Trilaciclib on Myelosuppression in Patients With Limited-stage Small Cell Lung Cancer Associated With Concurrent Chemoradiotherapy and Discuss the Effect of Gut Microbiota Changes on Myelosuppression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Myelosuppression
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the protective effect of Trilaciclib on myelosuppression in patients with limited-stage small cell lung cancer associated with concurrent chemoradiotherapy and discuss the effect of gut microbiota changes on myelosuppression

Detailed description: The occurrence of myelosuppression following chemotherapy, including severe neutropenia and hematological toxicity (Grade 3/4), as well as its association with dynamic changes in the gut microbiota, was investigated in conjunction with prophylactic administration of the CDK4/6 inhibitor Trilaciclib prior to the initiation of chemotherapy during radiotherapy for limited stage small cell lung cancer.

Eligibility criteria: Inclusion Criteria:

1. The histopathology is limited-stage small cell lung cancer.
2. ECOG score 0-2.
3. Good organ function (no blood transfusions, no hematopoietic stimulating factors, no transfusions of albumin or blood products within 14 days prior to the examination).
4. It is suitable for patients treated with Trilaciclib combined with etoposide plus cisplatin or carboplatin.
5. Understand and can sign informed consent

Exclusion Criteria:

1. Brain metastases with clinical symptoms require local radiotherapy or hormone therapy.
2. Active infections require systemic treatment.
3. Subjects with active, known or suspected autoimmune disease or history of autoimmune disease.
4. Combined with other tumors.
5. The current or previous presence of a clinically significant and medically unstable condition, which in the investigator's professional judgment may compromise subject safety, interfere with study evaluation or endpoint assessment, or otherwise impact the reliability of study results.

Primary outcomes:
measure: Occurrence of severe neutropenia
timeFrame: 14 days
measure: Duration of severe neutropenia
timeFrame: 5 days
measure: Occurrence of hematological toxicity
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Lei Deng, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04185181: Virtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema
Official title: Virtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmastectomy Lymphedema
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the therapeutic efficacy of VR and PNF on lymphedema and function in unilateral post-mastectomy lymphedema (UPML) patients. The patients were subdivided into two equal groups, 15 in each. Fifteen patients performed virtual reality-based exercises plus complete decongestive therapy, while the other fifteen patients performed proprioceptive neuromuscular facilitation plus complete decongestive therapy. The volume difference between normal and affected limbs was calculated before and after eight sessions of treatment for both groups by using the circumferential method. And the upper limb function was assessed before and after eight sessions of treatment for both groups by using the Arabic version of the Quick DASH scale.


Eligibility criteria: Inclusion Criteria:

* Patients will suffer from unilateral post-mastectomy lymphedema.
* Stage I and stage II lymphedema as defined by the classification of the International Society of Lymphology (The International Society of Lymphology, 2003).
* Patients had no physical therapy before the current treatment or the last time to receive sessions was at least three months ago.

Exclusion Criteria:

* Excluded patients were having musculoskeletal or neurological disorders that would impair performance during training and tests.
* Visual disorders that could affect imitation of video game-based exercise.
* Uncontrolled cardiovascular or pulmonary diseases.
* Psychiatric illness, severe behavior, and cognitive disorders.

Primary outcomes:
measure: lymphedema volume
timeFrame: 4 weeks
measure: upper limb function
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy, Cairo university
Study officials:
affiliation: assistant lecturer at faculty of physical therapy, Cairo university
name: doaa AA abd-el-wahed, A.lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atef D, Elkeblawy MM, El-Sebaie A, Abouelnaga WAI. A quasi-randomized clinical trial: virtual reality versus proprioceptive neuromuscular facilitation for postmastectomy lymphedema. J Egypt Natl Canc Inst. 2020 Jun 15;32(1):29. doi: 10.1186/s43046-020-00041-5.
Clinical trial NCT03649581: Investigation of Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders
Official title: Investigation of Clinical, Cognitive and Neurophysiological Markers, Possibly Specific of Two Subforms of Psychotic Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current diagnostic criteria for schizophrenia and other psychotic disorders are relatively broad and lack precision. Therefore, distinct diseases may be grouped together under the same diagnostic category, although these diseases may differ according to their clinical expression, prognosis and perhaps their physiopathological causes.

We think that identifying subforms of psychotic disorders that are more homogeneous will better enable to understand their respective physiopathological causes and find personalized treatments.

This study will compare two subforms of psychotic disorders that have been clinically distinguished in the 1970s. These phenotypes have however not been validated yet using scientific investigations.

Using clinical assessments, cognitive evaluations and neurophysiological measures (fMRI) investigating the domains of affect and psychomotoricity , we expect that these two subforms will differ on their clinical, cognitive and neurophysiological characteristics, namely: hebephrenia will be associated with deficits on the affect markers , and respect psychomotoricity (catatonia scales, tests assessing movement planification) whereas the opposite pattern will be observed for periodic catatonia.


Eligibility criteria: Inclusion Criteria:

* for both patients and controls
* male or female willing to participate and who have signed up the legal document
* under the protection of health insurance for patients only
* schizophrenia or schizo-affective disorder according to the DSM-5 criteria
* periodic catatonia or hebephrenia accordin to WKL classification
* clinically stable for at least 2 months
* in or out patients for controls only
* no psychiatric history

Exclusion Criteria:

* for both patients and controls
* current severe or unstable somatic illness
* neurological history (epilepsia, brain injury, brain surgery...)
* current substance use disorder (DSM-5)
* current major depressive disorder (DSM-5)
* mental retardation (IQ \< 70)
* pregnancy, breast feeding
* current legal control
* contra-indication for fMRI for controls only psychotropic intake during the last 3 weeks

Primary outcomes:
measure: Index of affect
timeFrame: 6 months after inclusion
measure: Index of psychomotoricity
timeFrame: 6 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie I, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT02063581: A Study Evaluating the Effect of Formulation on the Bioavailability of Ipatasertib in Healthy Volunteers
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of Formulation on the Bioavailability of Ipatasertib (GDC-0068) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase I, open-label, randomized, 2-period crossover study was designed to determine the relative bioavailability of ipatasertib administered as capsule and tablet formulations to healthy adult volunteers. Participants will be randomized to one of two treatment sequences to receive a single oral administration of ipatasertib in tablet or capsule formulation followed, after a washout period, by a single oral administration of ipatasertib in the second formulation. Pharmacokinetics will be assessed, and standard physical and clinical evaluations will be performed throughout the study. Time on study is expected to be 2 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers aged 18 to 55 years, inclusive
* Body mass index (BMI) from 18.5-29.9 kg/m2, inclusive

Exclusion Criteria:

* Clinically significant findings from medical history or screening evaluations

Primary outcomes:
measure: Area under the concentration time curve (AUC) of ipatasertib
timeFrame: Days 1-13
measure: Maximum concentration (Cmax) reached of ipatasertib
timeFrame: Days 1-13
measure: Time to maximum concentration (Tmax) of ipatasertib
timeFrame: Days 1-13
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: From check-in (Day -1) to Day 13
Other outcomes:
Locations:
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03943381: Duplex US in Pelvic Congestion Syndrome in Females (PCS)
Official title: Duplex US in Pelvic Congestion Syndrome in Females
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Pain Syndrome
Keywords: PCS
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 25
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: females with chronic lower abdominal pain, signs and symptoms of pelvic congestion syndrome

Brief summary: To investigate the feasibility of Duplex US in Diagnosis of Pelvic Congestion Syndrome

Detailed description: * In the past, a diagnosis of chronic pelvic pain left many women frustrated with few treatment options and a lack of available resources. Their physicians were likewise perplexed, despite the endless acquisition of negative laboratory and imaging data as well as inconclusive consultations obtained. In the last 10 years, improved scientiﬁc understanding and increased physician awareness have lessened the confusion surrounding this condition and its distinct association with pelvic congestion syndrome (PCS). Furthermore, reﬁnements of medical and minimally invasive surgical solutions give affected patients more therapeutic choices today.
* Since anatomical venous variations in the pelvis are common, it is important to know the anatomy of these vessels for treatment planning. Imaging is critical in the evaluation of pelvic varices, both to differentiate them from other condition and also because pelvic varices may be secondary to serious underlying pathology, such as inferior vena caval obstruction, portal hypertension, increased pelvic blood flow, and vascular malformations.

Sonographic findings of pelvic congestion syndrome were dilated left ovarian vein with reversed caudal flow, presence of varicocele, dilated arcuate veins crossing the uterine myometrium, polycystic changes of the ovary, and variable duplex waveform during the Valsalva's maneuver. Combined transabdominal and transvaginal sonography are potentially useful as a noninvasive screening \& grading tool for determining which patients with chronic pelvic pain may benefit from selective ovarian venography and transcatheter embolization

Eligibility criteria: Inclusion Criteria:

* All patients with signs and symptoms of PCS

Exclusion Criteria:

* No

Primary outcomes:
measure: Duplex US in Pelvic Congestion Syndrome in females
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University, Egypt
name: Hossam M Galal
role: STUDY_CHAIR
References:
Clinical trial NCT04664881: Home Telemonitoring In Patients After Myocardial Infarction
Official title: Home Telemonitoring In Patients After Myocardial Infarction, HELP ME Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Heart Attack
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is being done to determine if taking an electrocardiogram (ECG) by a portable device (SmartHeart) followed by a phone call will improve patient outcomes by early recognition of abnormalities and decrease emergency room visits and hospital readmissions compared to standard therapy alone.


Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction, both STEMI and non-STEMI.
* Able to use the home ECG telemonitoring.
* Must have smartphone device with home wi-fi/mobile internet which allows for 24/7 ability to transmit ECG.
* Caring family member who will be able to help/perform the ECG in case the patient won't be able to do it.

Exclusion Criteria:

* No ability to use the device at home/unable to comply with the device instructions
* No smartphone device or home wi-fi/mobile internet which prevent 24/7 ability to transmit ECG
* Cannot download the smartheart app
* No support in home environment
* Out of hospital cardiac arrest: secondary to a non-shockable rhythm, unrelated to an acute coronary syndrome, or with any level of neurologic damage.
* Resident of nursing home or acute care facility
* Uninterpretable ECG at discharge - left bundle branch block (LBBB), pacemaker or implantable cardioverter defibrillator (ICD) with pacing dependence.
* Patients who are planned for staged PCI after the index hospitalization

Primary outcomes:
measure: Emergency Room Visits
timeFrame: 90 days after hospital discharge
measure: Re-hospitalizations
timeFrame: 90 days after hospital discharge
measure: Mortality Rate
timeFrame: 90 days after hospital discharge
measure: Major Adverse Cardiovascular Events
timeFrame: 90 days after hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joerg Herrmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01174381: The Use of a Community-based Organization to Change Lifestyle Characteristics Related to Non Communicable Diseases
Official title: The Use of a Community-based Organization to Change Lifestyle Characteristics Related to Non Communicable Diseases: A Community Based Intervention Study Among 25-60 Year Olds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Stroke
Ischemic Heart Disease
Keywords: Non communicable disease
Lifestyle Modification
Community Based organization
community based study
Lead sponsor: University of Kelaniya
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 440
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study attempts to implement a lifestyle intervention programme aimed at changing the dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old adults in the MOH area, Ragama and measure the effectiveness of the programme.

Detailed description: Sri Lanka as a developing nation needs to identify feasible and cost effective measures to face the epidemic of NonCommunicable Diseases(NCDs) in the future. Experiences gained over many years in the developed countries can be of great value in planning and implementing NCD prevention and control activities in the developing countries Results from many studies have emphasized the fact that merely providing risk reduction measures for clinically high-risk people in health service settings would have only a limited impact in the whole country. On the other hand, if the population as a whole were to be targeted, even a modest risk factor and healthy lifestyle change would potentially have a huge public impact.This study attempts to implement a lifestyle intervention programme aimed at changing the dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old adults in the MOH area, Ragama and measure the effectiveness of the programme. Outcome measures are process indicators, as measured by change in the dietary patterns, alcohol and tobacco consumption and physical activity. Short term outcome indicators would be blood pressure and anthropometric measurements. The long term outcome indicators such as morbidity and mortality due to NCD will not be measured as this will be a short term study.

Eligibility criteria: Inclusion Criteria:

* adults between 25-60 years

Exclusion Criteria:

* adults with psychiatric disorders

Primary outcomes:
measure: Proportion of participants who change their lifestyle characteristics related to NCDs
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of participants with decrease in Body Mass Index following lifestyle modification programme
timeFrame: 6 months
Other outcomes:
Locations:
city: Ragama
country: Sri Lanka
facility: University of Kelaniya
state: Western
Study officials:
affiliation: University of Kelaniya
name: Thushani M Dabrera, MBBS, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04429581: Differences in Fat Mass Estimation Formulas in Physically Active Adult Population and Relation With Skinfold Sums.
Official title: Differences in Fat Mass Estimation Formulas in Physically Active Adult Population and Relation With Skinfold Sums.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Weight Changes
Body Weight
Keywords: Fat mass
Body composition assessement
Health
Antropometry
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 2458
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present study was conducted with a sample of 2,458 active subjects (mean age: 27,98±7,43 year-old), 1775 men (mean age: 27,99±7,46 years) and 681 women (mean age: 27,94±7,37 years) from Región de Murcia (Spain)

Brief summary: The objective of the present study was to analyze the differences between the formulas used to estimate fat mass and to establish the existing relationship with the skinfold sum in anthropometry. A total of 2,458 active subjects participated in the study (mean age: 27.98±7.43 years-old). Basic measurements and skinfolds variables were measured following the guidelines of the International Society for the Advancement in Kinanthropometry (ISAK), and Kerr, Durnin-Womersley, Faulkner and Carter equations were used to assess fat mass. Significative differences were found between all the formulas for the percentage of fat mass and the fat mass in kilograms. The correlations among the skinfolds sums and the different equations were high and significative in all the cases. There were differences between all the formulas used to estimate the fat mass. The six or eight skinfold sums could be a valid and better alternative than the fat mass equations or the BMI to assess the subcutaneous fat mass in physically active adults.


Eligibility criteria: Inclusion Criteria:

* To be between 18 and 50 years old and to practice any sport in a regular basis

Exclusion Criteria:

* To have overweight or obesity

Primary outcomes:
measure: Fat mass weight
timeFrame: 6 years
measure: Fat mass percentage
timeFrame: 6 years
measure: Six and eight skinfold sums
timeFrame: 6 years
Secondary outcomes:
measure: Body Mass Index
timeFrame: 6 years
measure: Weight
timeFrame: 6 years
measure: Height
timeFrame: 6 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06495281: Observational Study of Triple Combination Therapy of Zemidapa Tab. and Metformin in Type 2 Diabetes Mellitus Patients
Official title: A Observational Study to Evaluate Effectiveness, Safety of Triple Combination Therapy of Zemidapa and Metformin in Patients With Type 2 DM Who Received Double or Triple Combination Therapy Including DPP4-inhibitor Other Than Gemigliptin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, secondary and tetiary hospital

Brief summary: The aim of this study is to evaluate the effectiveness and safety of the triple combination therapy of Zemidapa Tab. and Metformin in patients with type 2 diabete mellitus


Eligibility criteria: Inclusion Criteria:

* type 2 DM Patients who are receiving one of the following three therapies during which the patients are prescribed with Zemidapa Tab. for the first time at the discretion of the attending physician:

  1. Double combination therapy (Metformin and a DPP-4 inhibitor other than Gemigliptin)
  2. Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and a SGLT-2 inhibitor)
  3. Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and Sulfonylurea \[SU\])
* patients with HbA1c results and who signed the written consent form

Exclusion Criteria:

- Patients contraindicated for the approved use of Zemidapa Tab. or have participated in another clinical study within 12 weeks

Primary outcomes:
measure: change from baseline of HbA1c at 12 weeks
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: the rate of subjects who reached the target value of less than 7% HbA1c
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeollanam-do
Study officials:
References: